chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Allergy NOS (Unknown drug).    On 03-Dec-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 23-May-2022 to 27-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) was resolving.            The race was reported as No concomitant medication was reported. Symptoms happened after 7 days on 30-May-2022 with outcome as recovering. Patient previously received a COVID-19 Vaccine. Device date was reported as  04-Jun-2022  Company Comment: This is a spontaneous case concerning a 52-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. As reported, the patient was treated with Paxlovid for COVID-19, but symptoms returned after 7 days. No other clinical or treatment details were given. The reported outcome of the event was resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 52-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. As reported, the patient was treated with Paxlovid for COVID-19, but symptoms returned after 7 days. No other clinical or treatment details were given. The reported outcome of the event was resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) 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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that vaccine was administered to total of 24 patients including 15 males and 9 females. HCP reported administrations were mostly for booster shots. No side effects reported. No treatment information were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Initial COVID-19 infection prior to COVID-19 treatment; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had unknown past drug allergy.  The patient's past medical history included Cardiomyopathy.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022 at 2:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment). 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 (Initial COVID-19 infection prior to COVID-19 treatment) was resolving. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Patient was taking unknown other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received unknown COVID-19 Vaccine.  Company comment: This is a spontaneous case concerning a 70-year-old female patient with no relevant medical history, who experienced the unexpected non-serious event of Covid-19 on unknown days after fourth dose of mRNA-1273 (Spikevax) vaccine. The patient had received four doses of mRNA-1273 (Spikevax), last being on 31-Mar-2022. The patient was treated with Nirmatrelvir, ritonavir (Paxlovid) from 13-May-2022 to 18-May-2022 for COVID-19. Outcome of the event was resolving at the time of this report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 70-year-old female patient with no relevant medical history, who experienced the unexpected non-serious event of Covid-19 on unknown days after fourth dose of mRNA-1273 (Spikevax) vaccine. The patient had received four doses of mRNA-1273 (Spikevax), last being on 31-Mar-2022. The patient was treated with Nirmatrelvir, ritonavir (Paxlovid) from 13-May-2022 to 18-May-2022 for COVID-19. Outcome of the event was resolving at the time of this report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Bactrim. Past adverse reactions to the above products included Drug allergy with Bactrim. Concurrent medical conditions included Asthma. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (DUORESP), SALBUTAMOL (VENTOLINE [SALBUTAMOL]) and PROBIOTICS NOS for an unknown indication.    On 12-Nov-2021, the patient received second 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 22-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) was resolving. Not Provided          It was reported that on 30-May-2022,  there was a rebound after day nine of Paxlovid drug treatment.  Device date: 04Jun2022  Company Comment: This spontaneous case reported by a patient concerns a 41-year-old female patient, with no relevant medical history, who experienced unexpected, non-serious AESI Covid19 on an unknown date after receiving a second dose of mRNA-1273.  She was treated with a 5-day course of Nirmatrelvir/Ritonavir (Paxlovid).  However, after 9 days there was note of rebound Covid19 infection.  The ongoing Covid19 pandemic could e a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case reported by a patient concerns a 41-year-old female patient, with no relevant medical history, who experienced unexpected, non-serious AESI Covid19 on an unknown date after receiving a second dose of mRNA-1273.  She was treated with a 5-day course of Nirmatrelvir/Ritonavir (Paxlovid).  However, after 9 days there was note of rebound Covid19 infection.  The ongoing Covid19 pandemic could e a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Expired vaccine was administered to total of 24 patients including 15 males and 9 females. It was reported administrations were mostly for booster shots. No side effects were reported for the patient.  No treatment information was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. It was reported that vial that was expired on 03-Apr-2022 was administered to total of 24 patients including 15 males and 9 females. Health care professional reported administrations were mostly for booster shots. No side effects was reported. No treatment drug was reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vial which was expired on 3-Apr-2022 was administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial which was expired on 3-Apr-2022 was administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial which was expired on 3-Apr-2022 was administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vial which was expired on 3-Apr-2022 was administered) outcome was unknown.        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. It was reported that a vial which had expired on 03-Apr-2022 was administered to total of 24 patients which included 15 males and 9 females, the administrations were mostly for booster shots and no side effects were reported. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that vaccine administered to total of 24 patients including 15 males and 9 females, mostly for booster shots. No side effects was reported No concomitant medication was reported. No treatment medication was reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Speech disorder, Vaccination site nodule
Clinical narrative: had a hard nodule on Injection site on the right arm after 2nd booster; had a difficult time completing a sentence speech was greatly affected/speech came back on Saturday, but she was not able to respond clearly to questions; Memory was greatly affected after 2nd booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE NODULE (had a hard nodule on Injection site on the right arm after 2nd booster), SPEECH DISORDER (had a difficult time completing a sentence speech was greatly affected/speech came back on Saturday, but she was not able to respond clearly to questions) and MEMORY IMPAIRMENT (Memory was greatly affected after 2nd booster) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065K21A, 058F21A, 002A21A and 029L201A) for COVID-19 vaccination.     It was reported that patient had excellent medical history, no health concerns. Didn't take any medications or homeopathic medications prior to 2nd booster vaccination.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2022, the patient experienced VACCINATION SITE NODULE (had a hard nodule on Injection site on the right arm after 2nd booster), SPEECH DISORDER (had a difficult time completing a sentence speech was greatly affected/speech came back on Saturday, but she was not able to respond clearly to questions) and MEMORY IMPAIRMENT (Memory was greatly affected after 2nd booster). On 05-Jun-2022, SPEECH DISORDER (had a difficult time completing a sentence speech was greatly affected/speech came back on Saturday, but she was not able to respond clearly to questions) and MEMORY IMPAIRMENT (Memory was greatly affected after 2nd booster) had resolved. At the time of the report, VACCINATION SITE NODULE (had a hard nodule on Injection site on the right arm after 2nd booster) was resolving.            No concomitant medication was reported.  Patient's speech and Memory was greatly affected. Patient speech came back on 04-Jun-2022 (Saturday) but patient was not able to respond clearly to questions. That continued until 05-Jun-2022 (Sunday) evening when memory and clarity came back.  It was also reported that on 07-Jun-2022, the nodule was softening on the right arm injection site.  Treatment details was not reported by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported that vaccine administered to total 24 patients including 15 males and 9 females. No concomitant medications was reported. HCP reported administrations were mostly for booster shots. No treatment medications was reported. No side effects was reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Malaise
Clinical narrative: COVID-19; feeling ill; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling ill) and COVID-19 (COVID-19) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 27-May-2022, the patient experienced MALAISE (feeling ill). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, MALAISE (feeling ill) and COVID-19 (COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs are not reported.  On an unknown date in 2022 patient experienced COVID-19 after taking COVID vaccine. It was unknown that patient was enrolled in COVID-19 vaccine trials.  Action taken for Co-suspect drug was reported as Dose not changed and causality as not reported. Dechallenge reported as Not applicable.  No treatment medication information provided.  Company Comment: This is a Spontaneous case concerning a 52-year-old female patient, with no relevant medical history, who experienced the unexpected and non-serious AESI of COVID-19, which occurred approximately 4 to 7 months after the first dose of mRNA-1273 vaccine. Patient also received adalimumab (Humira) at an unspecified dose for Rheumatoid arthritis, remaining as a co-suspect product. No information disclosed regarding clinical course, diagnostic tests performed or treatment received. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a 52-year-old female patient, with no relevant medical history, who experienced the unexpected and non-serious AESI of COVID-19, which occurred approximately 4 to 7 months after the first dose of mRNA-1273 vaccine. Patient also received adalimumab (Humira) at an unspecified dose for Rheumatoid arthritis, remaining as a co-suspect product. No information disclosed regarding clinical course, diagnostic tests performed or treatment received. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that vaccine administered to total 24 patients including 15 males and 9 females, mostly for booster shots. No side effects was reported. No concomitant medications was reported. No treatment medications was reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Rebound of Covid symptoms after a negative test; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (Rebound of Covid symptoms after a negative test) 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, the patient experienced COVID-19 (Rebound of Covid symptoms after a negative test). 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 (Rebound of Covid symptoms after a negative test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medications were reported.  It was reported that patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Device date reported as 06-Jun-2022.  Company Comment: This Spontaneous case concerns a patient of unknown age and gender, with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19, which occurred on an unknown date after the third dose of mRNA-1273 vaccine. Patient reported rebound of COVID-19 symptoms after a negative SARS-CoV-2 test. The patient received treatment for COVID-19 with Nirmatrelvir, Ritonavir (Paxlovid). Additional information was solicited for accurate and complete medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This Spontaneous case concerns a patient of unknown age and gender, with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19, which occurred on an unknown date after the third dose of mRNA-1273 vaccine. Patient reported rebound of COVID-19 symptoms after a negative SARS-CoV-2 test. The patient received treatment for COVID-19 with Nirmatrelvir, Ritonavir (Paxlovid). Additional information was solicited for accurate and complete medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products
Clinical narrative: COVID-19; Interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 58-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Psoriasis (MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS) and Rheumatoid arthritis (MODERATE TO SEVERE RHEUMATOID ARTHRITIS). Concomitant products included ADALIMUMAB (HUMIRA) from 27-Apr-2022 to 12-May-2022 for Plaque psoriasis and Rheumatoid arthritis.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, COVID-19 (COVID-19) was resolving and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       The reporter's causality for event COVID-19 with respect to Humira was not provided. The reporter's causality for event COVID-19 with respect to Pfizer was related.  The patient experienced COVID-19 and sinus congestion in 2022. Treatment information was not provided. It was unknown if the patient was enrolled in a COVID-19 vaccine trial. It was reported that the primary reporter did not have lot number information, because the package was discarded. Company comment: This is a spontaneous case concerning a 58-year-old female  patient with rheumatoid arthritis and plaque psoriasis, who experienced the non-serious unexpected event of COVID-19 (AESI),  on an unknown lapse of time after receiving an unspecified dose of mRNA-1273 vaccine. Patient also receive a dose of COVID-19 vaccination with Tozineram Pfizer Biontech. Sinus congestion was reported as an associated symptom.  Clinical course, diagnostic test and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning a 58-year-old female  patient with rheumatoid arthritis and plaque psoriasis, who experienced the non-serious unexpected event of COVID-19 (AESI),  on an unknown lapse of time after receiving an unspecified dose of mRNA-1273 vaccine. Patient also receive a dose of COVID-19 vaccination with Tozineram Pfizer Biontech. Sinus congestion was reported as an associated symptom.  Clinical course, diagnostic test and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Expired vaccine was administered to total 24 patients including 15 males and 9 females. It was reported that administrations were mostly for booster shots. No side effects were reported for the patient. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired doses of Moderna COVID-19 were administered beyond the beyond use date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses of Moderna COVID-19 were administered beyond the beyond use date.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses of Moderna COVID-19 were administered beyond the beyond use date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired doses of Moderna COVID-19 were administered beyond the beyond use date.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. For Lot number 033H21A, 2 doses were administered that was initially stored in the refrigerator on 30-Dec-2021. The vial did not undergo any temperature excursions. No treatment medications were provided.   This case was linked to MOD-2022-584673, MOD-2022-584680 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Initial event of COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Initial event of COVID-19) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Obesity. Concurrent medical conditions included Drug allergy (Name of the drug was not reported.). Concomitant products included OMEPRAZOLE and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    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 COVID-19 (Initial event of COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-May-2022 to 28-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Initial event of COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         The patient was taking other medications/products within 2 weeks of starting COVID-19. The patient previously did receive a COVID-19 Vaccine. Reporter reported Paxlovid Rebound 4 days after treatment ended.  Device date was reported as 04Jun2022. Company comment: This spontaneous case concerns a 42-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse events of special interest, COVID-19 which occurred on unspecified day after the third dose of mRNA-1273 vaccine The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-May-2022 to 28-May-2022 for COVID-19 treatment SARS-CoV-2 test was positive as on unspecified date. It was reported that Paxlovid rebound 4 days after treatment completed. 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 42-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse events of special interest, COVID-19 which occurred on unspecified day after the third dose of mRNA-1273 vaccine The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-May-2022 to 28-May-2022 for COVID-19 treatment SARS-CoV-2 test was positive as on unspecified date. It was reported that Paxlovid rebound 4 days after treatment completed. 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.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Illness, Influenza like illness
Clinical narrative: Sick; SWEATING WITH HEADACHES; FATIGUED; VACCINE CAUSED SORE ARM; SWEATING WITH HEADACHES; FLU-LIKE SYMPTOMS with HUMIRA (ADALIMUMAB); This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), HYPERHIDROSIS (SWEATING WITH HEADACHES), FATIGUE (FATIGUED), VACCINATION SITE PAIN (VACCINE CAUSED SORE ARM) and HEADACHE (SWEATING WITH HEADACHES) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ILLNESS (Sick), HYPERHIDROSIS (SWEATING WITH HEADACHES), FATIGUE (FATIGUED), VACCINATION SITE PAIN (VACCINE CAUSED SORE ARM), HEADACHE (SWEATING WITH HEADACHES) and INFLUENZA LIKE ILLNESS (FLU-LIKE SYMPTOMS with HUMIRA (ADALIMUMAB)). At the time of the report, ILLNESS (Sick), HYPERHIDROSIS (SWEATING WITH HEADACHES), FATIGUE (FATIGUED), VACCINATION SITE PAIN (VACCINE CAUSED SORE ARM) and HEADACHE (SWEATING WITH HEADACHES) had resolved and INFLUENZA LIKE ILLNESS (FLU-LIKE SYMPTOMS with HUMIRA (ADALIMUMAB)) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event's of SICK, FATIGUED, SWEATING WITH HEADACHES unknown onset, VACCINE CAUSED SORE ARM, SWEATING WITH HEADACHES unknown onset and FLU-LIKE SYMPTOMS was not provided for Humira.  No treatment drug details was reported.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sick; SWEATING WITH HEADACHES; FATIGUED; VACCINE CAUSED SORE ARM; SWEATING WITH HEADACHES; FLU-LIKE SYMPTOMS with HUMIRA (ADALIMUMAB); This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), HYPERHIDROSIS (SWEATING WITH HEADACHES), FATIGUE (FATIGUED), VACCINATION SITE PAIN (VACCINE CAUSED SORE ARM) and HEADACHE (SWEATING WITH HEADACHES) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ILLNESS (Sick), HYPERHIDROSIS (SWEATING WITH HEADACHES), FATIGUE (FATIGUED), VACCINATION SITE PAIN (VACCINE CAUSED SORE ARM), HEADACHE (SWEATING WITH HEADACHES) and INFLUENZA LIKE ILLNESS (FLU-LIKE SYMPTOMS with HUMIRA (ADALIMUMAB)). At the time of the report, ILLNESS (Sick), HYPERHIDROSIS (SWEATING WITH HEADACHES), FATIGUE (FATIGUED), VACCINATION SITE PAIN (VACCINE CAUSED SORE ARM) and HEADACHE (SWEATING WITH HEADACHES) had resolved and INFLUENZA LIKE ILLNESS (FLU-LIKE SYMPTOMS with HUMIRA (ADALIMUMAB)) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event's of SICK, FATIGUED, SWEATING WITH HEADACHES unknown onset, VACCINE CAUSED SORE ARM, SWEATING WITH HEADACHES unknown onset and FLU-LIKE SYMPTOMS was not provided for Humira.  No treatment drug details was reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Accidental administration of 2nd booster dose to 48 year old patient; Administered a 2nd booster dose of the Moderna COVID-19 vaccine to a 48 year old patient.; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (Accidental administration of 2nd booster dose to 48 year old patient) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered a 2nd booster dose of the Moderna COVID-19 vaccine to a 48 year old patient.) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054A22A, 939903, 027B21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jun-2022 at 2:01 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jun-2022 at 2:01 PM, the patient experienced EXTRA DOSE ADMINISTERED (Accidental administration of 2nd booster dose to 48 year old patient) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered a 2nd booster dose of the Moderna COVID-19 vaccine to a 48 year old patient.). At the time of the report, EXTRA DOSE ADMINISTERED (Accidental administration of 2nd booster dose to 48 year old patient) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered a 2nd booster dose of the Moderna COVID-19 vaccine to a 48 year old patient.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient has not reported any adverse reactions to the 2nd booster dose. No treatment medications was reported.  .
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Vaccine was administered to total of 24 patients including 15 males and 9 females. HCP reported administrations were mostly for booster shots. No side effects reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: I accidently got an additional Moderna Covid-19 dose today; Incorrect dosing schedules between 06Apr2022 and 07Jun2022; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Incorrect dosing schedules between 06Apr2022 and 07Jun2022) and EXTRA DOSE ADMINISTERED (I accidently got an additional Moderna Covid-19 dose today) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jun-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Incorrect dosing schedules between 06Apr2022 and 07Jun2022). On 07-Jun-2022, the patient experienced EXTRA DOSE ADMINISTERED (I accidently got an additional Moderna Covid-19 dose today). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Incorrect dosing schedules between 06Apr2022 and 07Jun2022) and EXTRA DOSE ADMINISTERED (I accidently got an additional Moderna Covid-19 dose today) outcome was unknown.            No concomitant medications were reported. The patient did not have any underlying conditions and was not immunocompromised. The patient received the 3rd dose even though  was not immunocompromised. The patient was given another vaccination on 07Jun2022 at doctor's office.  No treatment medications were reported.   Reporter did not allow further contact
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I was diagnosed with COVID-19 on 19-May-2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I was diagnosed with COVID-19 on 19-May-2022) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified and Drug allergy (unknown drug allergy). Concomitant products included METOPROLOL from 29-Nov-2021 to an unknown date for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2022, the patient experienced COVID-19 (I was diagnosed with COVID-19 on 19-May-2022). 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. On 25-May-2022, COVID-19 (I was diagnosed with COVID-19 on 19-May-2022) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) tested negative on an antigen test. On 30-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         Patient was diagnosed with COVID-19 on 19-May-2022 and started taking Paxlovid on 20-May-2022. Patient cleared all symptoms on 25-May-2022 and released from isolation on 28-May -2022 and tested negative on an antigen test. Two days later on 30-May-2022, COVID symptoms started again and tested positive on antigen test. The device date was reported as 06-Jun-2022. Pfizer have permission to contact about this report but does not have permission to contact the patient's healthcare provider.  Company comment: This spontaneous case concerns a 60-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 20-may-2022 to 25-may-2022.After 5 days patient symptoms subsided released from isolation after 3 days and 2 days later covid symptoms started again tested positive on antigen test. 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 60-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 20-may-2022 to 25-may-2022.After 5 days patient symptoms subsided released from isolation after 3 days and 2 days later covid symptoms started again tested positive on antigen test. 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.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. It was reported that vaccine expired on 3 Apr 2022 was administered to total of 24 patients including 15 males and 9 females. The administrations were mostly for booster shots. No side effects was reported. No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.  It was reported that total of 24 patients including 15 males and 9 females were administered expired vaccine which were mostly for booster shots. No other side effects were reported.  Treatment medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vial with lot(066F21A) which was expired on 3-Apr-2022 was administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial with lot(066F21A) which was expired on 3-Apr-2022 was administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) 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 EXPIRED PRODUCT ADMINISTERED (vial with lot(066F21A) which was expired on 3-Apr-2022 was administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vial with lot(066F21A) which was expired on 3-Apr-2022 was administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported. No side effects were reported after vaccination.