chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Influenza, Nausea
Clinical narrative: really bad stomach pain; extreme flu symptoms; really bad headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (really bad stomach pain), INFLUENZA (extreme flu symptoms), HEADACHE (really bad headache) and NAUSEA (Nausea) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025D21A and 49EZ1A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, the patient experienced ABDOMINAL PAIN UPPER (really bad stomach pain), INFLUENZA (extreme flu symptoms), HEADACHE (really bad headache) and NAUSEA (Nausea). At the time of the report, ABDOMINAL PAIN UPPER (really bad stomach pain), INFLUENZA (extreme flu symptoms), HEADACHE (really bad headache) and NAUSEA (Nausea) outcome was unknown.            No concomitant medication listed.   No treatment information provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; They both missed their second dose due to quarantine; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (tested positive for COVID-19) and PRODUCT DOSE OMISSION ISSUE (They both missed their second dose due to quarantine) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for COVID-19) and PRODUCT DOSE OMISSION ISSUE (They both missed their second dose due to quarantine). At the time of the report, COVID-19 (tested positive for COVID-19) and PRODUCT DOSE OMISSION ISSUE (They both missed their second dose due to quarantine) 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 action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication listed.   No treatment information provided.  The patient missed their second dose due to quarantine and are now going to get vaccinated past the 42 day window. This case concerns Product dose omission in a 44 year-old female patient with no reported medical history, who experienced the unexpected non-serious AESI of COVID-19. The event occurred an unknown number of days after the first dose of mRNA-1273 vaccine. It was reported that the second dose had not been administered due to quarantine and that it was outside of the 42 day window at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns Product dose omission in a 44 year-old female patient with no reported medical history, who experienced the unexpected non-serious AESI of COVID-19. The event occurred an unknown number of days after the first dose of mRNA-1273 vaccine. It was reported that the second dose had not been administered due to quarantine and that it was outside of the 42 day window at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administered vaccine after 33 days in the refrigerator; Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) and PRODUCT STORAGE ERROR (Administered vaccine after 33 days in the refrigerator) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) and PRODUCT STORAGE ERROR (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) and PRODUCT STORAGE ERROR (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administered vaccine after 33 days in the refrigerator; Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) and PRODUCT STORAGE ERROR (Administered vaccine after 33 days in the refrigerator) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) and PRODUCT STORAGE ERROR (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) and PRODUCT STORAGE ERROR (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was reported.    This case was linked to MOD-2021-356818, MOD-2021-357274.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash, Urticaria
Clinical narrative: Urticaria; Allergic reaction; Rash in my body, stomach, over the chest, over the back; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Urticaria), RASH (Rash in my body, stomach, over the chest, over the back) and HYPERSENSITIVITY (Allergic reaction) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 012M20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included FEXOFENADINE for Allergy.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, the patient experienced RASH (Rash in my body, stomach, over the chest, over the back). On an unknown date, the patient experienced URTICARIA (Urticaria) and HYPERSENSITIVITY (Allergic reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (Urticaria) and HYPERSENSITIVITY (Allergic reaction) outcome was unknown and RASH (Rash in my body, stomach, over the chest, over the back) had not resolved.            Treatment Benadryl (didn't help), a cream from the dermatologist.  Patient who is not immunocompromised got the third shot. Patient didn't remember in which arm she got the shots
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, 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 VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.      No concomitant medications were reported.  No treatment information was provided.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: difficulty stretching left arm; left arm became sore; site of injection is tender; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injected limb mobility decreased, pain in arm and injection site tenderness. On an unknown date, the outcome of the injected limb mobility decreased, pain in arm and injection site tenderness were not recovered/not resolved.   It was unknown if the reporter considered the injected limb mobility decreased, pain in arm and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The patient received first dose of Shingrix approximately 4 to 6 weeks ago of reporting date  in left arm (patient did not remember the exact date). The patient's left arm became sore immediately after dose and had remained sore. The soreness had not worsened or lessened, but had remained consistently the same. The patient had difficulty stretching left arm out and need to use right arm to pick up objects such as laptop due to soreness in left arm. The patient mentioned site of injection was still tender to the touch. Arm soreness and decreased mobility were ongoing, all symptoms were ongoing. The patient consented to follow up.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Nausea
Clinical narrative: Stomach pain; Dizzy; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), DIZZINESS (Dizzy) and NAUSEA (Nauseous) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 05UE211A) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism. Concurrent medical conditions included Penicillin allergy, Allergy to antibiotic and Drug allergy. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 12-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), DIZZINESS (Dizzy) and NAUSEA (Nauseous). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain), DIZZINESS (Dizzy) and NAUSEA (Nauseous) had resolved.            No Treatment medication information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Antibody test
Clinical narrative: loss of taste and smell; loss of taste and smell; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste and smell) and ANOSMIA (loss of taste and smell) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Crohn's disease.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AGEUSIA (loss of taste and smell) and ANOSMIA (loss of taste and smell). At the time of the report, AGEUSIA (loss of taste and smell) and ANOSMIA (loss of taste and smell) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Antibody test: 1200 (High) Done bloodwork after second dose, in July. Level of antibodies was 1200 .. In August 2021, Antibody test: 2500 (High) After 3rd dose, patient did another blood work and level of antibodies was 2500..         Concomitant medication includes Opioids. No treatment medication was provided. Patient said to be immunocompromised and has Chron's disease.  After third dose patient experienced loss of taste and smell.  This case concerns a patient of unknown age and gender, with no relevant medical history, who experienced the non-serious unexpected AESI's of AGEUSIA and ANOSMIA. The events occurred on an unknown date after receiving the third dose of Spikevax. The rechallenge is not applicable since the events have not resolved and no further dose is expected. The benefit-risk relation of Spikevax is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Significant followup appended, Email address and outcome of events updated.; Sender's Comments: This case concerns a patient of unknown age and gender, with no relevant medical history, who experienced the non-serious unexpected AESI's of AGEUSIA and ANOSMIA. The events occurred on an unknown date after receiving the third dose of Spikevax. The rechallenge is not applicable since the events have not resolved and no further dose is expected. The benefit-risk relation of Spikevax is not affected by this report.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Oxygen saturation
Clinical narrative: so breathless he cannot take off his coat.; feels very fatigue.; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (so breathless he cannot take off his coat.) and FATIGUE (feels very fatigue.) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A, 002A21A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included RUXOLITINIB for Cancer, PHENYTOIN (DILANTIN [PHENYTOIN]), PHENOBARBITAL SODIUM (PHENOBARBITAL [PHENOBARBITAL SODIUM]), LEVOTHYROXINE SODIUM (SYNTHROID), SPIRONOLACTONE and TORSEMIDE for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Oct-2021, the patient experienced DYSPNOEA (so breathless he cannot take off his coat.) and FATIGUE (feels very fatigue.). At the time of the report, DYSPNOEA (so breathless he cannot take off his coat.) and FATIGUE (feels very fatigue.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Oct-2021, Oxygen saturation: 93-96 (abnormal) abnormal.         weight was reported as 200. No treatment medications were reported.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19.missed their second dose due to quarantine and are nowgoing to get vaccinated past the 42 day window; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Tested positive for COVID-19) and PRODUCT DOSE OMISSION ISSUE (Tested positive for COVID-19.missed their second dose due to quarantine and are nowgoing to get vaccinated past the 42 day window) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID-19) and PRODUCT DOSE OMISSION ISSUE (Tested positive for COVID-19.missed their second dose due to quarantine and are nowgoing to get vaccinated past the 42 day window). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Tested positive for COVID-19.missed their second dose due to quarantine and are nowgoing to get vaccinated past the 42 day window) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant products were  reported. No Treatment information was provided.  The reporter stated that the patient got the first Moderna COVID-19 vaccination and then tested positive for COVID-19. The patient missed their second dose due to quarantine and were now going to get vaccinated past the 42 day window. The reporter did not want to provide the patients concomitant medication list and was unsure of when the patient tested positive for COVID-19. This case concerns a 47 year old male with no reported medical history, who experienced the non-serious, unexpected event of Covid 19 and Product dose omission issue  , which occurred on  an unknown time  after vaccination with the 1st dose of mRNA - 1273 (Moderna). The re-challenge for this case is not applicable. The benefit - risk relationship of mRNA-1273 (Moderna ) is not affected by this report.; Sender's Comments: This case concerns a 47 year old male with no reported medical history, who experienced the non-serious, unexpected event of Covid 19 and Product dose omission issue  , which occurred on  an unknown time  after vaccination with the 1st dose of mRNA - 1273 (Moderna). The re-challenge for this case is not applicable. The benefit - risk relationship of mRNA-1273 (Moderna ) is not affected by this report.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired second dose) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired second dose). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-357255 (Patient Link).
Age: 82.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in an 82-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No symptoms reported. No concomitant medication were provided. No treatment information were provided.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: In August she was diagnosed with a blood clot on her leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (In August she was diagnosed with a blood clot on her leg) 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 04-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced THROMBOSIS (In August she was diagnosed with a blood clot on her leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (In August she was diagnosed with a blood clot on her leg) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  Company Comment: This case concerns an unknown age female patient with no relevant medical history, who experienced serious unexpected event of thrombosis. The event occurred approximately 25 days after the second dose of mRNA-1273 vaccine. Rechallenge was not applicable since the event occurred after the second dose and no additional dosing is expected. The benefit-risk relationship of vaccine is not affected by this report.; Sender's Comments: This case concerns an unknown age female patient with no relevant medical history, who experienced serious unexpected event of thrombosis. The event occurred approximately 25 days after the second dose of mRNA-1273 vaccine. Rechallenge was not applicable since the event occurred after the second dose and no additional dosing is expected. The benefit-risk relationship of vaccine is not affected by this report.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: no longer wanted cigarettes, quit smoking; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (no longer wanted cigarettes, quit smoking) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059E21A and 061E21A) for COVID-19 vaccination.     The patient's past medical history included Smoker (smoking for 40 years).   On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (no longer wanted cigarettes, quit smoking). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (no longer wanted cigarettes, quit smoking) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment informations were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Disturbance in attention, Erythema
Clinical narrative: Feeling better, but weak; Arm has a slightly reddened area and is warm to the touch; Foggy brain; warm to touch; Unable to concentrate; Chills; Temperature started going up fast, Highest temperature 100.6 degrees Fahrenheit; Received 2nd dose 36 days after first dose; Right arm was sore\aches and pains; Poor Sleep; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Right arm was sore\aches and pains), ASTHENIA (Feeling better, but weak), ERYTHEMA (Arm has a slightly reddened area and is warm to the touch), FEELING ABNORMAL (Foggy brain) and FEELING HOT (warm to touch) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906 and 939906) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Oct-2021, the patient experienced PAIN IN EXTREMITY (Right arm was sore\aches and pains), POOR QUALITY SLEEP (Poor Sleep) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 36 days after first dose). On 18-Oct-2021, the patient experienced ASTHENIA (Feeling better, but weak), ERYTHEMA (Arm has a slightly reddened area and is warm to the touch), FEELING ABNORMAL (Foggy brain), FEELING HOT (warm to touch), DISTURBANCE IN ATTENTION (Unable to concentrate), CHILLS (Chills) and PYREXIA (Temperature started going up fast, Highest temperature 100.6 degrees Fahrenheit). On 17-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 36 days after first dose) had resolved. On 18-Oct-2021, POOR QUALITY SLEEP (Poor Sleep) and PYREXIA (Temperature started going up fast, Highest temperature 100.6 degrees Fahrenheit) had resolved. At the time of the report, PAIN IN EXTREMITY (Right arm was sore\aches and pains), ASTHENIA (Feeling better, but weak), ERYTHEMA (Arm has a slightly reddened area and is warm to the touch), FEELING ABNORMAL (Foggy brain), FEELING HOT (warm to touch), DISTURBANCE IN ATTENTION (Unable to concentrate) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Oct-2021, Body temperature: 100.6 (High) 100.6 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment informations were reported.   This case was linked to -MODERNATX, INC.-MOD-2021-357651 (E2B Linked Report). This case was linked to MOD21-144365 (Patient Link).; Sender's Comments:  -MODERNATX, INC.-MOD-2021-357651:daughter case
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Inappropriate schedule of product administration, Pain in extremity, Poor quality sleep
Clinical narrative: Feeling better, but weak; Arm has a slightly reddened area and is warm to the touch; Foggy brain; warm to touch; Unable to concentrate; Chills; Temperature started going up fast, Highest temperature 100.6 degrees Fahrenheit; Received 2nd dose 36 days after first dose; Right arm was sore\aches and pains; Poor Sleep; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Right arm was sore\aches and pains), ASTHENIA (Feeling better, but weak), ERYTHEMA (Arm has a slightly reddened area and is warm to the touch), FEELING ABNORMAL (Foggy brain) and FEELING HOT (warm to touch) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906 and 939906) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Oct-2021, the patient experienced PAIN IN EXTREMITY (Right arm was sore\aches and pains), POOR QUALITY SLEEP (Poor Sleep) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 36 days after first dose). On 18-Oct-2021, the patient experienced ASTHENIA (Feeling better, but weak), ERYTHEMA (Arm has a slightly reddened area and is warm to the touch), FEELING ABNORMAL (Foggy brain), FEELING HOT (warm to touch), DISTURBANCE IN ATTENTION (Unable to concentrate), CHILLS (Chills) and PYREXIA (Temperature started going up fast, Highest temperature 100.6 degrees Fahrenheit). On 17-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 36 days after first dose) had resolved. On 18-Oct-2021, POOR QUALITY SLEEP (Poor Sleep) and PYREXIA (Temperature started going up fast, Highest temperature 100.6 degrees Fahrenheit) had resolved. At the time of the report, PAIN IN EXTREMITY (Right arm was sore\aches and pains), ASTHENIA (Feeling better, but weak), ERYTHEMA (Arm has a slightly reddened area and is warm to the touch), FEELING ABNORMAL (Foggy brain), FEELING HOT (warm to touch), DISTURBANCE IN ATTENTION (Unable to concentrate) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Oct-2021, Body temperature: 100.6 (High) 100.6 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment informations were reported.   This case was linked to -MODERNATX, INC.-MOD-2021-357651 (E2B Linked Report). This case was linked to MOD21-144365 (Patient Link).; Sender's Comments:  -MODERNATX, INC.-MOD-2021-357651:daughter case
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Feeling better, but weak; Arm has a slightly reddened area and is warm to the touch; Foggy brain; warm to touch; Unable to concentrate; Chills; Temperature started going up fast, Highest temperature 100.6 degrees Fahrenheit; Received 2nd dose 36 days after first dose; Right arm was sore\aches and pains; Poor Sleep; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Right arm was sore\aches and pains), ASTHENIA (Feeling better, but weak), ERYTHEMA (Arm has a slightly reddened area and is warm to the touch), FEELING ABNORMAL (Foggy brain) and FEELING HOT (warm to touch) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906 and 939906) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Oct-2021, the patient experienced PAIN IN EXTREMITY (Right arm was sore\aches and pains), POOR QUALITY SLEEP (Poor Sleep) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 36 days after first dose). On 18-Oct-2021, the patient experienced ASTHENIA (Feeling better, but weak), ERYTHEMA (Arm has a slightly reddened area and is warm to the touch), FEELING ABNORMAL (Foggy brain), FEELING HOT (warm to touch), DISTURBANCE IN ATTENTION (Unable to concentrate), CHILLS (Chills) and PYREXIA (Temperature started going up fast, Highest temperature 100.6 degrees Fahrenheit). On 17-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 36 days after first dose) had resolved. On 18-Oct-2021, POOR QUALITY SLEEP (Poor Sleep) and PYREXIA (Temperature started going up fast, Highest temperature 100.6 degrees Fahrenheit) had resolved. At the time of the report, PAIN IN EXTREMITY (Right arm was sore\aches and pains), ASTHENIA (Feeling better, but weak), ERYTHEMA (Arm has a slightly reddened area and is warm to the touch), FEELING ABNORMAL (Foggy brain), FEELING HOT (warm to touch), DISTURBANCE IN ATTENTION (Unable to concentrate) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Oct-2021, Body temperature: 100.6 (High) 100.6 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment informations were reported.   This case was linked to -MODERNATX, INC.-MOD-2021-357651 (E2B Linked Report). This case was linked to MOD21-144365 (Patient Link).; Sender's Comments:  -MODERNATX, INC.-MOD-2021-357651:daughter case
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Patient was administered an injection from a vial that had expired a week ago; 1st dose was administered on 30Jul21 and 2nd dose on 18Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered an injection from a vial that had expired a week ago) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered on 30Jul21 and 2nd dose on 18Oct2021) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 040C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered an injection from a vial that had expired a week ago) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered on 30Jul21 and 2nd dose on 18Oct2021). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered an injection from a vial that had expired a week ago) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered on 30Jul21 and 2nd dose on 18Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment informations were reported. Concomitant product use was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Magnetic resonance imaging, Rotator cuff syndrome, X-ray
Clinical narrative: little bit of discomfort; Torn rotator Cuff muscle; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (little bit of discomfort) and ROTATOR CUFF SYNDROME (Torn rotator Cuff muscle) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Shoulder discomfort.   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 DISCOMFORT (little bit of discomfort) and ROTATOR CUFF SYNDROME (Torn rotator Cuff muscle). The patient was treated with Physical therapy (Exercises) for Rotator cuff syndrome. At the time of the report, DISCOMFORT (little bit of discomfort) and ROTATOR CUFF SYNDROME (Torn rotator Cuff muscle) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: abnormal (abnormal) diagnosed with a Torn rotator Cuff muscle. On an unknown date, X-ray: abnormal (abnormal) diagnosed with a Torn rotator Cuff muscle.         Concomitant medications was not provided by the reporter.  Treatment information was not provided.  Patient said that after the shots , she developed a LOT of shoulder pain ( 8 to 9 out of 10 ) in a 10 scale range .   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Follow up received. Updated the Medical history, Lab data, Vaccine information (Dose 1 and 2), Action taken (from unknown to not applicable) and Events (Hypokinesia and Arthralgia).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Fatigue, Pain
Clinical narrative: Ache/Pain; Fatigue/tired; Nurse accidentally administered 2 vials after 10 days after expiry to 18 patients; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Ache/Pain), FATIGUE (Fatigue/tired) and EXPIRED PRODUCT ADMINISTERED (Nurse accidentally administered 2 vials after 10 days after expiry to 18 patients) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) 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. In October 2021, the patient experienced PAIN (Ache/Pain), FATIGUE (Fatigue/tired) and EXPIRED PRODUCT ADMINISTERED (Nurse accidentally administered 2 vials after 10 days after expiry to 18 patients). In October 2021, EXPIRED PRODUCT ADMINISTERED (Nurse accidentally administered 2 vials after 10 days after expiry to 18 patients) had resolved. At the time of the report, PAIN (Ache/Pain) and FATIGUE (Fatigue/tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 information was provided.  Patient either received first dose, second dose or the booster shot.He stated the department of Pennsylvania thought Moderna will extended the lot 045B21A for 9months. When the reporter checked the online tools, it showed the vaccine expired 10 days. The vials were removed from the freezer. The first vial was removed on 15 Oct 2021 and the second vial on 18 Oct 2021. The vials were defrosted for one hour at room temperature and administer in a period of four hours. The vials were initially stored in the freezer and used within six hours. The dates of administration were 15 Oct 2021 to eight or nine patients and 18 Oct 2021 to eight  or nine patient. The vials have never undergone any temperature excursions.   This case was linked to MOD-2021-357469, MOD-2021-357755 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 16-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-357792 (Patient Link).
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired first dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first dose.) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first dose.). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired first dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not reported.  Treatment information was not reported.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient have reported symptoms. Concomitant product information was not provided. Treatment information was not provided.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine after 33 days in the refrigerator; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Oct-2021 and was forwarded to Moderna on 19-Oct-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Patient is calling to update her own adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patient is calling to update her own adverse reaction) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient is calling to update her own adverse reaction). At the time of the report, VACCINATION COMPLICATION (Patient is calling to update her own adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and medication information provided.  No treatment information provided
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site reaction
Clinical narrative: COVID arm/hurting/it is a reaction/COVID shoulder; little pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm/hurting/it is a reaction/COVID shoulder) and VACCINATION SITE PAIN (little pain) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical history was reported.  Concomitant products included METFORMIN, HCTZ, ICOSAPENT ETHYL and FLUTICASONE for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm/hurting/it is a reaction/COVID shoulder) and VACCINATION SITE PAIN (little pain). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (COVID arm/hurting/it is a reaction/COVID shoulder) and VACCINATION SITE PAIN (little pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant product included spectrum and is used as Multivitamin Men's Health  It was reported that there was a little pain prior to the second shot that was a level 1 out of 10 usually when patient was doing things like mowing the grass or putting up lights. He would take ibuprofen to help.   This case was linked to MOD-2021-357899.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Patient did not received treatment.