chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
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 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K21A, 039D21A, 017B21A and 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Drug was not specified). Concomitant products included DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (VICKS DAYQUIL/NYQUIL) from 19-May-2022 to 20-May-2022, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), CALCIUM, ERGOCALCIFEROL (CALCIUM +D [CALCIUM;ERGOCALCIFEROL]), MULTIVITAMIN [VITAMINS NOS], PARACETAMOL (TYLENOL) and IBUPROFEN for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022, 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 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 18-May-2022 to 23-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient experienced recurrence of symptoms 7 days after finishing full course of Paxlovid. The patient was taking other medications within 2 weeks of COVID-19 treatment.  Company Comment: This is a spontaneous case concerning a 67-year-old female 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 fourth dose of mRNA-1273 Vaccine. As reported, the patient was treated with Paxlovid for COVID-19 for 6 days and had COVID reinfection 7 days after treatment with Paxlovid. No other clinical or treatment details were given. The reported outcome of the event was unknwon. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 67-year-old female 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 fourth dose of mRNA-1273 Vaccine. As reported, the patient was treated with Paxlovid for COVID-19 for 6 days and had COVID reinfection 7 days after treatment with Paxlovid. No other clinical or treatment details were given. The reported outcome of the event was unknwon. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid rebound/Treatment of COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid rebound/Treatment of COVID-19) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002m21a) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: morphine. Past adverse reactions to the above products included Allergy with morphine. Concurrent medical conditions included Hypertension, Type 2 diabetes mellitus and Adhesive tape allergy.    On 12-Apr-2022 at 11:00 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid rebound/Treatment of COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 18-May-2022 to 24-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid rebound/Treatment of COVID-19) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Company Comment: This is a spontaneous case concerning a 75-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 after receiving the fourth dose of mRNA-1273 Vaccine. As reported, the patient was treated with Paxlovid for COVID-19 for 6 days and had COVID rebound. No other clinical or treatment details were given. The reported outcome of the event has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 75-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 after receiving the fourth dose of mRNA-1273 Vaccine. As reported, the patient was treated with Paxlovid for COVID-19 for 6 days and had COVID rebound. No other clinical or treatment details were given. The reported outcome of the event has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Headache, Inappropriate schedule of product administration, Malaise
Clinical narrative: First dose on 06 Feb 2021 and second dose on 18 Mar 2021; Bones ache; Felt very sick for almost a week; Felt weak; Headache; Bodyache; This spontaneous case was reported by a patient and describes the occurrence of BONE PAIN (Bones ache), MALAISE (Felt very sick for almost a week), ASTHENIA (Felt weak), HEADACHE (Headache) and MYALGIA (Bodyache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high (High blood pressure), COPD, Cholesterol, Osteoporosis, Thyroid disorder NOS, Heart disease, unspecified, Acid reflux (esophageal) and Lung disorder NOS. Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for COPD, EZETIMIBE for Cholesterol, ROSUVASTATIN for Heart disease, unspecified, LISINOPRIL for Hypertension, ALBUTEROL [SALBUTAMOL] for Lung disorder NOS, DENOSUMAB (PROLIA) for Osteoporosis, LEVOTHYROXINE for Thyroid disorder NOS, ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 06 Feb 2021 and second dose on 18 Mar 2021). On an unknown date, the patient experienced BONE PAIN (Bones ache), MALAISE (Felt very sick for almost a week), ASTHENIA (Felt weak), HEADACHE (Headache) and MYALGIA (Bodyache). At the time of the report, BONE PAIN (Bones ache), MALAISE (Felt very sick for almost a week), ASTHENIA (Felt weak), HEADACHE (Headache) and MYALGIA (Bodyache) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 06 Feb 2021 and second dose on 18 Mar 2021) outcome was unknown.            No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  The AE did not cause patient to seek medical care.  Treatment information was not provided.   This case was linked to MOD-2022-582490, MOD-2022-582635 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: First dose on 06 Feb 2021 and second dose on 18 Mar 2021; Bones ache; Felt very sick for almost a week; Felt weak; Headache; Bodyache; This spontaneous case was reported by a patient and describes the occurrence of BONE PAIN (Bones ache), MALAISE (Felt very sick for almost a week), ASTHENIA (Felt weak), HEADACHE (Headache) and MYALGIA (Bodyache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high (High blood pressure), COPD, Cholesterol, Osteoporosis, Thyroid disorder NOS, Heart disease, unspecified, Acid reflux (esophageal) and Lung disorder NOS. Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for COPD, EZETIMIBE for Cholesterol, ROSUVASTATIN for Heart disease, unspecified, LISINOPRIL for Hypertension, ALBUTEROL [SALBUTAMOL] for Lung disorder NOS, DENOSUMAB (PROLIA) for Osteoporosis, LEVOTHYROXINE for Thyroid disorder NOS, ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 06 Feb 2021 and second dose on 18 Mar 2021). On an unknown date, the patient experienced BONE PAIN (Bones ache), MALAISE (Felt very sick for almost a week), ASTHENIA (Felt weak), HEADACHE (Headache) and MYALGIA (Bodyache). At the time of the report, BONE PAIN (Bones ache), MALAISE (Felt very sick for almost a week), ASTHENIA (Felt weak), HEADACHE (Headache) and MYALGIA (Bodyache) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 06 Feb 2021 and second dose on 18 Mar 2021) outcome was unknown.            No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  The AE did not cause patient to seek medical care.  Treatment information was not provided.   This case was linked to MOD-2022-582490, MOD-2022-582635 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vaccine administered; Expired vaccine was kept it in the fridge (CDC expiration date was 03-Apr-2022 and vaccine was removed from the fridge on 03-May-2022); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Expired vaccine was kept it in the fridge (CDC expiration date was 03-Apr-2022 and vaccine was removed from the fridge on 03-May-2022)) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Expired vaccine was kept it in the fridge (CDC expiration date was 03-Apr-2022 and vaccine was removed from the fridge on 03-May-2022)). On 03-May-2022, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Expired vaccine was kept it in the fridge (CDC expiration date was 03-Apr-2022 and vaccine was removed from the fridge on 03-May-2022)) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  The vaccine provider removed the vaccine from the fridge, thawed it if needed and administered it on the same day of removal. The expired vaccine was kept it in the fridge and only removed to administer the patients.  No treatment information was provided by the reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vials were stored in the refrigerator and thawed on same day of administration; Vial was expired on 04-APR-2022 and administered on 13-MAY-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial was expired on 04-APR-2022 and administered on 13-MAY-2022) and PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial was expired on 04-APR-2022 and administered on 13-MAY-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial was expired on 04-APR-2022 and administered on 13-MAY-2022) and PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported  HCP stated that there was no information about side effects after administration of expired dose. The vial did not undergone any temperature excursion.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated; Vaccine administered after date of expiry to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to patient) and PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to patient) and PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. It was reported that the 2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated.Nurse confirmed that vaccine was administered to 7 patients on 2 different days. The total number of vials were 2. The vial was not initially stored in the refrigerator. The vial did not undergo any temperature excursions. No adverse event reported. No treatment medication details was reported.   This case was linked to MOD-2022-582650, MOD-2022-582640 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated; Vaccine administered after date of expiry to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to patient) and PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to patient) and PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. It was reported that the 2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated.Nurse confirmed that vaccine was administered to 7 patients on 2 different days. The total number of vials were 2. The vial was not initially stored in the refrigerator. The vial did not undergo any temperature excursions. No adverse event reported. No treatment medication details was reported.   This case was linked to MOD-2022-582650, MOD-2022-582640 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: experienced a rebound infection after completing the Paxlovid medication and became sick again 3 days after completion; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (experienced a rebound infection after completing the Paxlovid medication and became sick again 3 days after completion) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Unspecified drug), Hypothyroidism, Type 2 diabetes mellitus and Obesity. Concomitant products included TRAZODONE, IBUPROFEN (ADVIL [IBUPROFEN]), METFORMIN, BUPROPION, MULTIVITAMINS [VITAMINS NOS], LEVOTHYROXINE SODIUM (LEVOTHYROXIN) and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) for an unknown indication.    On 06-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2022, the patient experienced COVID-19 (experienced a rebound infection after completing the Paxlovid medication and became sick again 3 days after completion). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 18-May-2022 to 23-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (experienced a rebound infection after completing the Paxlovid medication and became sick again 3 days after completion) was resolving.            It was reported patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. It was reported patient had previously received a COVID-19 Vaccine. COMPANY COMMENT: This is an spontaneous case concerning an 51-year-old female patient with  medical history of Drug allergy, Hypothyroidism, Type 2 diabetes mellitus, Obesity, Concomitant products included TRAZODONE, IBUPROFEN, METFORMIN, BUPROPION, MULTIVITAMINS, LEVOTHYROXINE, DEXTROMETHORPHAN, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE, PAXLOVID for COVID-19 treatment from 18-May-2022 to 23-May-2022 who experienced the unexpected event of COVID-19 (AESI) 205 days after  3rd dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning an 51-year-old female patient with  medical history of Drug allergy, Hypothyroidism, Type 2 diabetes mellitus, Obesity, Concomitant products included TRAZODONE, IBUPROFEN, METFORMIN, BUPROPION, MULTIVITAMINS, LEVOTHYROXINE, DEXTROMETHORPHAN, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE, PAXLOVID for COVID-19 treatment from 18-May-2022 to 23-May-2022 who experienced the unexpected event of COVID-19 (AESI) 205 days after  3rd dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive for COVID-19) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-May-2022, the patient experienced COVID-19 (Positive for COVID-19). At the time of the report, COVID-19 (Positive for COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         In November 2021, the patient received Booster dose of Moderna COVID-19 Vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The causality between ADALIMUMAB (HUMIRA) and events COVID-19 (Positive for COVID-19) was reported as not related.  No treatment medication was provided.  Company Comment: This is a spontaneous case concerning a 54-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of COVID-19 (Positive for COVID-19), approximately 6 months after receiving the third dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided in the case. The event had resolved on unknown date. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 54-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of COVID-19 (Positive for COVID-19), approximately 6 months after receiving the third dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided in the case. The event had resolved on unknown date. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 36-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.    Concomitant products included SUMATRIPTAN, BUPROPION HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE (CONTRAVE), IRON, VITAMIN C [ASCORBIC ACID], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 04-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. In May 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.            No medical history information was reported. On 02 Jun 2022, the patient had rebound infection after taking Paxlovid. Patient did not receive any treatment for rebound infection. COMPANY COMMENT: This is an spontaneous case concerning an 36-year-old female patient with  medical history of Concomitant products included SUMATRIPTAN, BUPROPION HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE, IRON, VITAMIN C, VITAMIN B12, VITAMIN D for an unknown indication and PAXLOVID for COVID-19 treatment who experienced the unexpected event of COVID-19 (AESI) unknown days after  3rd dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event´s seriousness assessed as reporting.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning an 36-year-old female patient with  medical history of Concomitant products included SUMATRIPTAN, BUPROPION HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE, IRON, VITAMIN C, VITAMIN B12, VITAMIN D for an unknown indication and PAXLOVID for COVID-19 treatment who experienced the unexpected event of COVID-19 (AESI) unknown days after  3rd dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event´s seriousness assessed as reporting.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, SARS-CoV-2 test
Clinical narrative: administered the Moderna COVID-19 vaccine and found out that the vaccine had been expired for 2 weeks; Expired vaccine was stored in refrigerator on 17-May-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered the Moderna COVID-19 vaccine and found out that the vaccine had been expired for 2 weeks) and PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on 17-May-2022) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A and 076C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Janssen COVID-19 Vaccine (Lot-1805031) on 12-Mar-2021. Past adverse reactions to the above products included No adverse event with Janssen COVID-19 Vaccine. Concurrent medical conditions included Iodine allergy and Drug allergy.   On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered the Moderna COVID-19 vaccine and found out that the vaccine had been expired for 2 weeks) and PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on 17-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered the Moderna COVID-19 vaccine and found out that the vaccine had been expired for 2 weeks) and PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on 17-May-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   It was reported that since the expiration date was not written on the vial, they did not notice it had already expired. The patient did not report any side effects. The patient had no symptoms. The vial was stored in refrigerator on 17-May-2022. The vial did not undergo any temperature excursions.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2022: Follow-up information included patient initials, patient demographics, patient's history and suspect vaccine dosage information.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) 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 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.            No concomitant medication was provided. It was reported that the patient previously received a COVID-19 Vaccine. It was reported that the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that the patient received unspecified drug for treatment of COVID-19 from 23-May-2022 to 28-May-2022. On 01-Jun-2022 at 12:00 PM, the patient experienced nasal congestion. Device Date : 01-Jun-2022.  Company Comment: This spontaneous case concerns a patient with unknown age and  unknown  gender with no medical history reported , who experienced Non-serious , unexpected, AESI of Covid 19 which occurred on an unknown date after vaccination with the 3rd dose of mRNA-1273 vaccine ( date of vaccination was not reported) . The information regarding the dose 1 and dose 2 of the Covid 19 vaccine of this patient was not reported. It  was reported that the patient received unspecified drug for treatment of COVID-19 from 23-May-2022 to 28-May-2022. And on 01-06-2022 experienced nasal congestion . The other details of the events like if any medical consult done, results of laboratories/diagnostic procedures were not reported. Outcome of the event Covid 19 was reported as unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient with unknown age and  unknown  gender with no medical history reported , who experienced Non-serious , unexpected, AESI of Covid 19 which occurred on an unknown date after vaccination with the 3rd dose of mRNA-1273 vaccine ( date of vaccination was not reported) . The information regarding the dose 1 and dose 2 of the Covid 19 vaccine of this patient was not reported. It  was reported that the patient received unspecified drug for treatment of COVID-19 from 23-May-2022 to 28-May-2022. And on 01-06-2022 experienced nasal congestion . The other details of the events like if any medical consult done, results of laboratories/diagnostic procedures were not reported. Outcome of the event Covid 19 was reported as unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Initial COVID-19 Infection after vacciantion/ Rebound COVID-19 Infection; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Initial COVID-19 Infection after vacciantion/ Rebound COVID-19 Infection) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066H21A, 052E21A, 030M20A and 013L209) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Coronary artery disease and Drug allergy (Unspecified Drug).   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (Initial COVID-19 Infection after vacciantion/ Rebound COVID-19 Infection). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) 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 (Initial COVID-19 Infection after vacciantion/ Rebound COVID-19 Infection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  It was reported as, the patient was treated with Paxlovid for COVID-19 and experienced rebound COVID-19 Infection even after treatment. The device date was reported as 01-Jun-2022.  Company comment- This spontaneous case concerns a 68-year-old male patient with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 which occurred at an unknown time with regards to the mRNA-1273 vaccination. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 68-year-old male patient with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 which occurred at an unknown time with regards to the mRNA-1273 vaccination. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid rebound 2 days after completion of 5 day course of paxlovid. Rebound period lasted 9 days (positive test and symptoms); This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid rebound 2 days after completion of 5 day course of paxlovid. Rebound period lasted 9 days (positive test and symptoms)) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease and Drug allergy (Allergy to unspecified drug). Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (TRI LO MARZIA) and USTEKINUMAB (STELARA) for an unknown indication.    On 04-Feb-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid rebound 2 days after completion of 5 day course of paxlovid. Rebound period lasted 9 days (positive test and symptoms)). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at a dose of 5 days course. At the time of the report, COVID-19 (Covid rebound 2 days after completion of 5 day course of paxlovid. Rebound period lasted 9 days (positive test and symptoms)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         It was reported that patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received COVID-19 vaccine.  Company Comment: This is a Spontaneus case concerning 39-year-old female patient with no previous relevant medical history reported, who experienced the non-serious unexpected AESI of COVID-19 as a rebound 2 days after completion of 5 day course of treatment with paxlovid and on an unknown latency after a dose of mRNA-1273 received as the fourth dose for COVID-19 vaccination. By the time of the report the event had resolved. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.; Sender's Comments: This is a Spontaneus case concerning 39-year-old female patient with no previous relevant medical history reported, who experienced the non-serious unexpected AESI of COVID-19 as a rebound 2 days after completion of 5 day course of treatment with paxlovid and on an unknown latency after a dose of mRNA-1273 received as the fourth dose for COVID-19 vaccination. By the time of the report the event had resolved. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis worsen; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis worsen) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis worsen) (seriousness criterion medically significant). The patient was treated with NIRMATRELVIR in 2021 for Arthritis rheumatoid aggravated, at an unspecified dose and frequency and RITONAVIR in 2021 for Arthritis rheumatoid aggravated, at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis worsen) was resolving.            No concomitant product was provided. The patient was treated with Nirmatrelvir and Ritonavir. The reporter's causality for the event rheumatoid arthritis worsen with co-suspect Humira was not provided. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Company Comment:  This is a spontaneous case concerning  a  62-year-old, female patient with no reported medical history, who experienced the unexpected serious (medically significant) AESI  event of Rheumatoid arthritis. The event occurred in 2021 of unknown month and date. On an unknown date patient started on Adalimumab at unknown dose. It is reported that patient received first dose of mRNA-1273 COVID 19 Vaccine administered on January 28, 2021 and second dose of mRNA-1273 COVID 19 Vaccine was administered on February 25, 2021. Patient was treated with nirmatrelvir and ritonavir of unknown dosage and frequency. The event was reported as resolving. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: Company Comment:  This is a spontaneous case concerning  a  62-year-old, female patient with no reported medical history, who experienced the unexpected serious (medically significant) AESI  event of Rheumatoid arthritis. The event occurred in 2021 of unknown month and date. On an unknown date patient started on Adalimumab at unknown dose. It is reported that patient received first dose of mRNA-1273 COVID 19 Vaccine administered on January 28, 2021 and second dose of mRNA-1273 COVID 19 Vaccine was administered on February 25, 2021. Patient was treated with nirmatrelvir and ritonavir of unknown dosage and frequency. The event was reported as resolving. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 1 was taken on 28-Jan-2021 and Dose 2 was taken on 21-Feb-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was taken on 28-Jan-2021 and Dose 2 was taken on 21-Feb-2021) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010M20A) for COVID-19 vaccination.     The patient previously had received a COVID-19 Vaccine.  The patient's past medical history included Kidney stones. Concurrent medical conditions included Blood pressure high and Drug allergy (unknown drug). Concomitant products included LOSARTAN for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was taken on 28-Jan-2021 and Dose 2 was taken on 21-Feb-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was taken on 28-Jan-2021 and Dose 2 was taken on 21-Feb-2021) outcome was unknown.            No concomitant medication information provided.  Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  No treatment information provided.   This case was linked to MOD-2022-582729 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Dose 1 was taken on 28-Jan-2021 and Dose 2 was taken on 21-Feb-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was taken on 28-Jan-2021 and Dose 2 was taken on 21-Feb-2021) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010M20A) for COVID-19 vaccination.     The patient previously had received a COVID-19 Vaccine.  The patient's past medical history included Kidney stones. Concurrent medical conditions included Blood pressure high and Drug allergy (unknown drug). Concomitant products included LOSARTAN for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was taken on 28-Jan-2021 and Dose 2 was taken on 21-Feb-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was taken on 28-Jan-2021 and Dose 2 was taken on 21-Feb-2021) outcome was unknown.            No concomitant medication information provided.  Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  No treatment information provided.   This case was linked to MOD-2022-582729 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in the refrigerator for 7 days post puncture; Received expired 2nd booster 7 days post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster 7 days post puncture) and PRODUCT STORAGE ERROR (Vial was stored in the refrigerator for 7 days post puncture) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2022 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2022 at 9:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster 7 days post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in the refrigerator for 7 days post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster 7 days post puncture) and PRODUCT STORAGE ERROR (Vial was stored in the refrigerator for 7 days post puncture) 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 medications were reported.  On 19-May-2022, the vial was initially stored in the refrigerator and was first punctured on same date about 9:30AM. The vial was stored in refrigerator post puncture. The vial did not undergo any temperature excursions. It was in the refrigerator for 7 days post puncture and was exposed to room temperature for more than 24 hours.  On 26-May-2022, the patient received expired second Booster.   This case was linked to MOD-2022-583054 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was in the refrigerator for 7 days post puncture; Received expired 2nd booster 7 days post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster 7 days post puncture) and PRODUCT STORAGE ERROR (Vial was in the refrigerator for 7 days post puncture) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2022 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2022 at 9:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster 7 days post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was in the refrigerator for 7 days post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster 7 days post puncture) and PRODUCT STORAGE ERROR (Vial was in the refrigerator for 7 days post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.    It was reported that the expiration date was unknown. The number of doses per vials was 2 doses per 1 vial. On 19-May-2022 the vial was initially stored in refrigerator. The vial was first punctured on 19-May-2022 about 9:30AM. Vial was stored in refrigerator post puncture. It was in the refrigerator for 7 days post puncture. The vail did not undergo any temperature excursions. Vial was exposed to room temperature for more than 24 hours.  No treatment information was reported.   This case was linked to MOD-2022-583040 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: Taking Keflex 3000 mg and Azithromycin for an infection he had; This spontaneous case was reported by a patient and describes the occurrence of INFECTION (Taking Keflex 3000 mg and Azithromycin for an infection he had) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Nov-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFECTION (Taking Keflex 3000 mg and Azithromycin for an infection he had). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) for Infection, at a dose of 3000 milligram and AZITHROMYCIN for Infection, at an unspecified dose and frequency. At the time of the report, INFECTION (Taking Keflex 3000 mg and Azithromycin for an infection he had) outcome was unknown.            No concomitant medications were reported.   Reporter did not allow further contact