chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Vaccination site pain
Clinical narrative: feeling bad; piercing pain is worst at night time and she can feel a knot inside and is wondering if they hit a nerve; and she can feel a knot inside and is wondering if they hit a nerve; pain spreading across chest into right arm/chest pain; muscle spasms; not able to lift right arm; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (pain spreading across chest into right arm/chest pain), MUSCLE SPASMS (muscle spasms), MOBILITY DECREASED (not able to lift right arm), FEELING ABNORMAL (feeling bad) and VACCINATION SITE PAIN (piercing pain is worst at night time and she can feel a knot inside and is wondering if they hit a nerve) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced CHEST PAIN (pain spreading across chest into right arm/chest pain), MUSCLE SPASMS (muscle spasms), MOBILITY DECREASED (not able to lift right arm), VACCINATION SITE PAIN (piercing pain is worst at night time and she can feel a knot inside and is wondering if they hit a nerve) and INJECTION SITE INDURATION (and she can feel a knot inside and is wondering if they hit a nerve). On an unknown date, the patient experienced FEELING ABNORMAL (feeling bad). The patient was treated with CORTISONE for Pain, at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, CHEST PAIN (pain spreading across chest into right arm/chest pain) and MUSCLE SPASMS (muscle spasms) was resolving and MOBILITY DECREASED (not able to lift right arm), FEELING ABNORMAL (feeling bad), VACCINATION SITE PAIN (piercing pain is worst at night time and she can feel a knot inside and is wondering if they hit a nerve) and INJECTION SITE INDURATION (and she can feel a knot inside and is wondering if they hit a nerve) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Electrocardiogram: unknown (Inconclusive) unknown..         Concomitant medications were not reported. Treatment was reported as:  pain pill, icy hot, hot baths, ice, heating pads   This case was linked to MOD-2021-132741 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Significant follow up  received on 26-may-2021 event outcome updated.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 61 after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (61 after first vaccine) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (61 after first vaccine). On 07-Apr-2021, PRODUCT DOSE OMISSION ISSUE (61 after first vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided.  No treatment information mentioned.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received first dose from a vial that's been punctured for more than 24hour; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received first dose from a vial that's been punctured for more than 24hour) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received first dose from a vial that's been punctured for more than 24hour). On 13-May-2021, EXPIRED PRODUCT ADMINISTERED (Received first dose from a vial that's been punctured for more than 24hour) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD21-090663, US-MODERNATX, INC.-MOD-2021-133697 (E2B Linked Report).; Sender's Comments:  MOD21-090663:Second patient case US-MODERNATX, INC.-MOD-2021-133697:Second patient case
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 exposure after 1st dose, Positive COVID-19,  test after 1st dose; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (COVID-19 exposure after 1st dose, Positive COVID-19,  test after 1st dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 exposure after 1st dose, Positive COVID-19,  test after 1st dose). At the time of the report, COVID-19 (COVID-19 exposure after 1st dose, Positive COVID-19,  test after 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: other (Positive) Result: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported. Reported that he received the COVID vaccine first dose. Afterwards, he was exposed to COVID-19 at a work event and later tested positive. Caller was no longer on the line after transfer.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: difference more than 35 days between 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (difference more than 35 days between 2 doses) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Patient's medical history is not provided by the reporter.     On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (difference more than 35 days between 2 doses). At the time of the report, PRODUCT DOSE OMISSION ISSUE (difference more than 35 days between 2 doses) outcome was unknown.        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 was reported . No treatment medication was reported .
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills one day last week and today 3 weeks after moderna Covid-19 injection was administered. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills one day last week and today 3 weeks after moderna Covid-19 injection was administered.) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concomitant products included LOSARTAN for Blood pressure high, METOPROLOL for Instability cardiovascular.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced CHILLS (Chills one day last week and today 3 weeks after moderna Covid-19 injection was administered.). The patient was treated with IBUPROFEN for Chills, at a dose of UNK dosage form; tea [SAMBUCUS NIGRA] for Chills, at a dose of 1 dosage form and CHLORPHENAMINE MALEATE, PARACETAMOL (CORICIDIN HBP COLD AND FLU) for Chills, at a dose of 1 dosage form. At the time of the report, CHILLS (Chills one day last week and today 3 weeks after moderna Covid-19 injection was administered.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included tea.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Reoccurrence of shingles; skin rash, skin rash on neck and forehead; Hot; swelling of arm at the injection site; Red; This spontaneous case was reported by a nurse and describes the occurrence of HERPES ZOSTER (Reoccurrence of shingles), RASH (skin rash, skin rash on neck and forehead), VACCINATION SITE WARMTH (Hot), VACCINATION SITE SWELLING (swelling of arm at the injection site) and VACCINATION SITE ERYTHEMA (Red) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Hot), VACCINATION SITE SWELLING (swelling of arm at the injection site) and VACCINATION SITE ERYTHEMA (Red). On 09-Apr-2021, the patient experienced HERPES ZOSTER (Reoccurrence of shingles) and RASH (skin rash, skin rash on neck and forehead). On 05-Apr-2021, VACCINATION SITE WARMTH (Hot), VACCINATION SITE SWELLING (swelling of arm at the injection site) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown. At the time of the report, HERPES ZOSTER (Reoccurrence of shingles) and RASH (skin rash, skin rash on neck and forehead) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter.  Treatment information included Ibuprofen, Lotrimin antifungal, Hydrocortisone, Destin and valacyclovir 1g every 8 hours for 7 days.  Action taken with mRNA-1273 in response to the event was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Translation received and does not contain any new information.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: first Pfizer dose and then received first dose of Moderna Covid-19 vaccine; over 44 days from the first Moderna dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (first Pfizer dose and then received first dose of Moderna Covid-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (over 44 days from the first Moderna dose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (first Pfizer dose and then received first dose of Moderna Covid-19 vaccine). 01-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (over 44 days from the first Moderna dose). On 01-Apr-2021, INTERCHANGE OF VACCINE PRODUCTS (first Pfizer dose and then received first dose of Moderna Covid-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (over 44 days from the first Moderna dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: The reporter confirmed that the patient was not administered the 2nd dose for Moderna vaccine thus avoiding giving the patient a 3rd m-RNA dose.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Headache, Influenza like illness, Mobility decreased, Myalgia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of influenza-like illness (flu-like symptoms), decreased mobility (could barely move and get out of bed), adverse drug reaction (severe side effects), myalgia (body aching) and vaccination site pain (sore arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. The patient's past medical history included COVID-19 (received monoclonal antibodies February 2021). May 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. May 2021, patient experienced influenza-like illness (flu-like symptoms), decreased mobility (could barely move and get out of bed), adverse drug reaction (severe side effects), myalgia (body aching), vaccination site pain (sore arm), pyrexia (temperature) and headache. At the time of the report, influenza-like illness (flu-like symptoms), decreased mobility (could barely move and get out of bed), adverse drug reaction (severe side effects), myalgia (body aching), vaccination site pain (sore arm), pyrexia (temperature) and headache resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of influenza-like illness (flu-like symptoms), decreased mobility (could barely move and get out of bed), adverse drug reaction (severe side effects), myalgia (body aching) and vaccination site pain (sore arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. The patient's past medical history included COVID-19 (received monoclonal antibodies February 2021). May 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. May 2021, patient experienced influenza-like illness (flu-like symptoms), decreased mobility (could barely move and get out of bed), adverse drug reaction (severe side effects), myalgia (body aching), vaccination site pain (sore arm), pyrexia (temperature) and headache. At the time of the report, influenza-like illness (flu-like symptoms), decreased mobility (could barely move and get out of bed), adverse drug reaction (severe side effects), myalgia (body aching), vaccination site pain (sore arm), pyrexia (temperature) and headache resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Myalgia, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE PAIN (Arm pain), FATIGUE (Fatigue) and MYALGIA (Muscle aches) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. No relevant medical history was provided. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (Arm pain), FATIGUE (Fatigue) and MYALGIA (Muscle aches). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE PAIN (Arm pain), FATIGUE (Fatigue) and MYALGIA (Muscle aches) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication reported. No treatment information provided by the reporter. This case was linked to MOD-2021-133027. Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up received updated patient initials and email address. On 12-Jul-2021: Non-Significant follow up appended.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Accidental underdose, Device connection issue, Pain in extremity
Clinical narrative: Given another full dose instead; needle went loose from the hub and most of the vaccine went down her arm; arm hurts in 2 places; needle went loose from the hub and most of the vaccine went down her arm; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Given another full dose instead), ACCIDENTAL UNDERDOSE (needle went loose from the hub and most of the vaccine went down her arm), PAIN IN EXTREMITY (arm hurts in 2 places) and DEVICE CONNECTION ISSUE (needle went loose from the hub and most of the vaccine went down her arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy (seasonal outdoor allergies) and Pollen allergy (allergic to pollen and probably other things too). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced ACCIDENTAL OVERDOSE (Given another full dose instead), ACCIDENTAL UNDERDOSE (needle went loose from the hub and most of the vaccine went down her arm), PAIN IN EXTREMITY (arm hurts in 2 places) and DEVICE CONNECTION ISSUE (needle went loose from the hub and most of the vaccine went down her arm). On 15-May-2021, ACCIDENTAL OVERDOSE (Given another full dose instead), ACCIDENTAL UNDERDOSE (needle went loose from the hub and most of the vaccine went down her arm) and DEVICE CONNECTION ISSUE (needle went loose from the hub and most of the vaccine went down her arm) had resolved. At the time of the report, PAIN IN EXTREMITY (arm hurts in 2 places) outcome was unknown.            No treatment medication was provided.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Presyncope, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itchy; Arm is red and swollen; Arm is red and swollen; felt like fainting; hard time breathing; heart rate increased; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (felt like fainting), DYSPNEA (hard time breathing), HEART RATE INCREASED (heart rate increased), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE SWELLING (Arm is red and swollen) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O17C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Blood pressure high and Drug allergy (allergy to unspecified medication).    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced PRESYNCOPE (felt like fainting), DYSPNEA (hard time breathing) and HEART RATE INCREASED (heart rate increased). On 12-May-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (Arm is red and swollen) and VACCINATION SITE ERYTHEMA (Arm is red and swollen). At the time of the report, PRESYNCOPE (felt like fainting), DYSPNEA (hard time breathing), HEART RATE INCREASED (heart rate increased), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (Arm is red and swollen) and VACCINATION SITE ERYTHEMA (Arm is red and swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient has medications for high blood pressure, diabetes and potassium pill but not specified.  Patient has allergies to some medications but caller is unsure about it.  Treatment included  Ibuprofen and Loratidine.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Itchy; Arm is red and swollen; Arm is red and swollen; felt like fainting; hard time breathing; heart rate increased; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (felt like fainting), DYSPNEA (hard time breathing), HEART RATE INCREASED (heart rate increased), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE SWELLING (Arm is red and swollen) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O17C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Blood pressure high and Drug allergy (allergy to unspecified medication).    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced PRESYNCOPE (felt like fainting), DYSPNEA (hard time breathing) and HEART RATE INCREASED (heart rate increased). On 12-May-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (Arm is red and swollen) and VACCINATION SITE ERYTHEMA (Arm is red and swollen). At the time of the report, PRESYNCOPE (felt like fainting), DYSPNEA (hard time breathing), HEART RATE INCREASED (heart rate increased), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (Arm is red and swollen) and VACCINATION SITE ERYTHEMA (Arm is red and swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient has medications for high blood pressure, diabetes and potassium pill but not specified.  Patient has allergies to some medications but caller is unsure about it.  Treatment included  Ibuprofen and Loratidine.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose left out at 2:36PM administered at 9:00AM the next day; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose left out at 2:36PM administered at 9:00AM the next day) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose left out at 2:36PM administered at 9:00AM the next day). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose left out at 2:36PM administered at 9:00AM the next day) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product information was provided.  Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Diplopia, Myalgia, Pruritus, Rash
Clinical narrative: 1st vaccine skin reaction at vaccine site; double vision; balance issues; Itching; had a rash that looked like a mosquito bite that was flat, hard and hot; couple of days of aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (1st vaccine skin reaction at vaccine site), DIPLOPIA (double vision), BALANCE DISORDER (balance issues), PRURITUS (Itching) and RASH (had a rash that looked like a mosquito bite that was flat, hard and hot) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-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 (1st vaccine skin reaction at vaccine site), DIPLOPIA (double vision), BALANCE DISORDER (balance issues), PRURITUS (Itching), RASH (had a rash that looked like a mosquito bite that was flat, hard and hot) and MYALGIA (couple of days of aches). At the time of the report, VACCINATION SITE REACTION (1st vaccine skin reaction at vaccine site), DIPLOPIA (double vision), PRURITUS (Itching), RASH (had a rash that looked like a mosquito bite that was flat, hard and hot) and MYALGIA (couple of days of aches) outcome was unknown and BALANCE DISORDER (balance issues) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-132988 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Vaccination site reaction, myalgia, diplopia and balance disorder were added. Action taken was updated.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: 1st vaccine skin reaction at vaccine site; double vision; balance issues; Itching; had a rash that looked like a mosquito bite that was flat, hard and hot; couple of days of aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (1st vaccine skin reaction at vaccine site), DIPLOPIA (double vision), BALANCE DISORDER (balance issues), PRURITUS (Itching) and RASH (had a rash that looked like a mosquito bite that was flat, hard and hot) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-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 (1st vaccine skin reaction at vaccine site), DIPLOPIA (double vision), BALANCE DISORDER (balance issues), PRURITUS (Itching), RASH (had a rash that looked like a mosquito bite that was flat, hard and hot) and MYALGIA (couple of days of aches). At the time of the report, VACCINATION SITE REACTION (1st vaccine skin reaction at vaccine site), DIPLOPIA (double vision), PRURITUS (Itching), RASH (had a rash that looked like a mosquito bite that was flat, hard and hot) and MYALGIA (couple of days of aches) outcome was unknown and BALANCE DISORDER (balance issues) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-132988 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Vaccination site reaction, myalgia, diplopia and balance disorder were added. Action taken was updated.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Decreased appetite, Diarrhoea, Fatigue, Illness
Clinical narrative: Diarrhea; Sick for 5 days; Achy; Black and Blue at injection site; Yellowish ring around injection site; Stomach didn't feel right and didn't throw up; Arm ache; no appetite,No appetite to eat,Little appetite; pain at injection site; More tired than usual; nausea; Hurting; Couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Black and Blue at injection site), VACCINATION SITE DISCOLOURATION (Yellowish ring around injection site), ABDOMINAL DISCOMFORT (Stomach didn't feel right and didn't throw up), PAIN IN EXTREMITY (Arm ache) and DECREASED APPETITE (no appetite,No appetite to eat,Little appetite) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PAIN (Hurting) and INSOMNIA (Couldn't sleep). On 08-Apr-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Black and Blue at injection site), VACCINATION SITE DISCOLOURATION (Yellowish ring around injection site), ABDOMINAL DISCOMFORT (Stomach didn't feel right and didn't throw up), PAIN IN EXTREMITY (Arm ache), DECREASED APPETITE (no appetite,No appetite to eat,Little appetite), ILLNESS (Sick for 5 days), PAIN (Achy), VACCINATION SITE PAIN (pain at injection site), FATIGUE (More tired than usual) and NAUSEA (nausea). On 10-Apr-2021, the patient experienced DIARRHEA (Diarrhea). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. On 08-Apr-2021, PAIN (Hurting) and INSOMNIA (Couldn't sleep) had resolved. On 12-Apr-2021, ABDOMINAL DISCOMFORT (Stomach didn't feel right and didn't throw up), PAIN (Achy) and FATIGUE (More tired than usual) had resolved. On 13-Apr-2021, DECREASED APPETITE (no appetite,No appetite to eat,Little appetite), ILLNESS (Sick for 5 days) and NAUSEA (nausea) had resolved. On 22-Apr-2021, VACCINATION SITE DISCOLOURATION (Black and Blue at injection site) and VACCINATION SITE DISCOLOURATION (Yellowish ring around injection site) had resolved. On 13-May-2021, DIARRHEA (Diarrhea) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm ache) and VACCINATION SITE PAIN (pain at injection site) had resolved.            This case was linked to MOD-2021-054381 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: First dose details and treatment medication updated. New events added.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nausea, Pain, Pain in extremity, Vaccination site discolouration
Clinical narrative: Diarrhea; Sick for 5 days; Achy; Black and Blue at injection site; Yellowish ring around injection site; Stomach didn't feel right and didn't throw up; Arm ache; no appetite,No appetite to eat,Little appetite; pain at injection site; More tired than usual; nausea; Hurting; Couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Black and Blue at injection site), VACCINATION SITE DISCOLOURATION (Yellowish ring around injection site), ABDOMINAL DISCOMFORT (Stomach didn't feel right and didn't throw up), PAIN IN EXTREMITY (Arm ache) and DECREASED APPETITE (no appetite,No appetite to eat,Little appetite) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PAIN (Hurting) and INSOMNIA (Couldn't sleep). On 08-Apr-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Black and Blue at injection site), VACCINATION SITE DISCOLOURATION (Yellowish ring around injection site), ABDOMINAL DISCOMFORT (Stomach didn't feel right and didn't throw up), PAIN IN EXTREMITY (Arm ache), DECREASED APPETITE (no appetite,No appetite to eat,Little appetite), ILLNESS (Sick for 5 days), PAIN (Achy), VACCINATION SITE PAIN (pain at injection site), FATIGUE (More tired than usual) and NAUSEA (nausea). On 10-Apr-2021, the patient experienced DIARRHEA (Diarrhea). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. On 08-Apr-2021, PAIN (Hurting) and INSOMNIA (Couldn't sleep) had resolved. On 12-Apr-2021, ABDOMINAL DISCOMFORT (Stomach didn't feel right and didn't throw up), PAIN (Achy) and FATIGUE (More tired than usual) had resolved. On 13-Apr-2021, DECREASED APPETITE (no appetite,No appetite to eat,Little appetite), ILLNESS (Sick for 5 days) and NAUSEA (nausea) had resolved. On 22-Apr-2021, VACCINATION SITE DISCOLOURATION (Black and Blue at injection site) and VACCINATION SITE DISCOLOURATION (Yellowish ring around injection site) had resolved. On 13-May-2021, DIARRHEA (Diarrhea) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm ache) and VACCINATION SITE PAIN (pain at injection site) had resolved.            This case was linked to MOD-2021-054381 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: First dose details and treatment medication updated. New events added.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Diarrhea; Sick for 5 days; Achy; Black and Blue at injection site; Yellowish ring around injection site; Stomach didn't feel right and didn't throw up; Arm ache; no appetite,No appetite to eat,Little appetite; pain at injection site; More tired than usual; nausea; Hurting; Couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Black and Blue at injection site), VACCINATION SITE DISCOLOURATION (Yellowish ring around injection site), ABDOMINAL DISCOMFORT (Stomach didn't feel right and didn't throw up), PAIN IN EXTREMITY (Arm ache) and DECREASED APPETITE (no appetite,No appetite to eat,Little appetite) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PAIN (Hurting) and INSOMNIA (Couldn't sleep). On 08-Apr-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Black and Blue at injection site), VACCINATION SITE DISCOLOURATION (Yellowish ring around injection site), ABDOMINAL DISCOMFORT (Stomach didn't feel right and didn't throw up), PAIN IN EXTREMITY (Arm ache), DECREASED APPETITE (no appetite,No appetite to eat,Little appetite), ILLNESS (Sick for 5 days), PAIN (Achy), VACCINATION SITE PAIN (pain at injection site), FATIGUE (More tired than usual) and NAUSEA (nausea). On 10-Apr-2021, the patient experienced DIARRHEA (Diarrhea). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. On 08-Apr-2021, PAIN (Hurting) and INSOMNIA (Couldn't sleep) had resolved. On 12-Apr-2021, ABDOMINAL DISCOMFORT (Stomach didn't feel right and didn't throw up), PAIN (Achy) and FATIGUE (More tired than usual) had resolved. On 13-Apr-2021, DECREASED APPETITE (no appetite,No appetite to eat,Little appetite), ILLNESS (Sick for 5 days) and NAUSEA (nausea) had resolved. On 22-Apr-2021, VACCINATION SITE DISCOLOURATION (Black and Blue at injection site) and VACCINATION SITE DISCOLOURATION (Yellowish ring around injection site) had resolved. On 13-May-2021, DIARRHEA (Diarrhea) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm ache) and VACCINATION SITE PAIN (pain at injection site) had resolved.            This case was linked to MOD-2021-054381 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: First dose details and treatment medication updated. New events added.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Flushing, Headache, Hypoaesthesia, Insomnia
Clinical narrative: looked flushed; Feels full; steady, moderate, dull headache; Fever of 102.4 degrees; dead arm, which means it felt like he got hit in the arm with a bat; Rough time sleeping last night; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (dead arm, which means it felt like he got hit in the arm with a bat), INSOMNIA (Rough time sleeping last night), FLUSHING (looked flushed), ABDOMINAL DISTENSION (Feels full) and HEADACHE (steady, moderate, dull headache) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2020.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced HYPOAESTHESIA (dead arm, which means it felt like he got hit in the arm with a bat) and INSOMNIA (Rough time sleeping last night). On 14-May-2021, the patient experienced FLUSHING (looked flushed), ABDOMINAL DISTENSION (Feels full), HEADACHE (steady, moderate, dull headache) and PYREXIA (Fever of 102.4 degrees). The patient was treated with PARACETAMOL at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (dead arm, which means it felt like he got hit in the arm with a bat), ABDOMINAL DISTENSION (Feels full) and HEADACHE (steady, moderate, dull headache) had not resolved and INSOMNIA (Rough time sleeping last night), FLUSHING (looked flushed) and PYREXIA (Fever of 102.4 degrees) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications on use were not provided.  No laboratory data was provided. Treatment included: 64 ounces of Gatorade, and soup.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: looked flushed; Feels full; steady, moderate, dull headache; Fever of 102.4 degrees; dead arm, which means it felt like he got hit in the arm with a bat; Rough time sleeping last night; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (dead arm, which means it felt like he got hit in the arm with a bat), INSOMNIA (Rough time sleeping last night), FLUSHING (looked flushed), ABDOMINAL DISTENSION (Feels full) and HEADACHE (steady, moderate, dull headache) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2020.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced HYPOAESTHESIA (dead arm, which means it felt like he got hit in the arm with a bat) and INSOMNIA (Rough time sleeping last night). On 14-May-2021, the patient experienced FLUSHING (looked flushed), ABDOMINAL DISTENSION (Feels full), HEADACHE (steady, moderate, dull headache) and PYREXIA (Fever of 102.4 degrees). The patient was treated with PARACETAMOL at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (dead arm, which means it felt like he got hit in the arm with a bat), ABDOMINAL DISTENSION (Feels full) and HEADACHE (steady, moderate, dull headache) had not resolved and INSOMNIA (Rough time sleeping last night), FLUSHING (looked flushed) and PYREXIA (Fever of 102.4 degrees) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications on use were not provided.  No laboratory data was provided. Treatment included: 64 ounces of Gatorade, and soup.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient did not get her 2nd dose on the due date; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient did not get her 2nd dose on the due date) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient did not get her 2nd dose on the due date). On 15-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient did not get her 2nd dose on the due date) had resolved.        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 and treatment medications were reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Diplopia, Fatigue, Lip swelling, Optic nerve disorder
Clinical narrative: Balance issue; Double vision; Problem with nerve in the eyes; inside his upper lip was swollen; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (Double vision), OPTIC NERVE DISORDER (Problem with nerve in the eyes), LIP SWELLING (inside his upper lip was swollen), BALANCE DISORDER (Balance issue) and FATIGUE (Tired) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.  On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced FATIGUE (Tired). On 10-May-2021, the patient experienced DIPLOPIA (Double vision), OPTIC NERVE DISORDER (Problem with nerve in the eyes) and LIP SWELLING (inside his upper lip was swollen). On an unknown date, the patient experienced BALANCE DISORDER (Balance issue). At the time of the report, DIPLOPIA (Double vision), OPTIC NERVE DISORDER (Problem with nerve in the eyes), LIP SWELLING (inside his upper lip was swollen) and FATIGUE (Tired) outcome was unknown and BALANCE DISORDER (Balance issue) was resolving.      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.   Concomitant product use was not provided by the reporter. No treatment information was provided.  Reporter stated that, he developed double vision- balance issues after 2 weeks of first vaccination. it was resolving slowing and depending on being rested or fatigued.   This case was linked to MOD-2021-255911 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: New event "balance disorder" was added. On 14-Jul-2021: Non-Significant follow-up appended, contains information about patient race.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: No reflux since receiving Moderna vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-May-2021 and was forwarded to Moderna on 14-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (No reflux since receiving Moderna vaccine) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 004M2dA) for COVID-19 vaccination.     The patient's past medical history included Acid reflux (esophageal) (30 years old Chronic Acid Reflux Condition.), Heart disease, unspecified and Peripheral arterial disease. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) and ALUMINIUM HYDROXIDE, MAGNESIUM CARBONATE, SODIUM ALGINATE (GAVISCON [ALUMINIUM HYDROXIDE;MAGNESIUM CARBONATE;SODIUM ALGINATE]) for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (No reflux since receiving Moderna vaccine). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (No reflux since receiving Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up information was received : updated reporter name. On 22-Jun-2021: Significant follow up:: Details updated were: patient race, Height and weight, Relevant History, Vaccine dose 2 info with time of administration. No new event was reported.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Tooth fracture
Clinical narrative: molar's cracked; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH FRACTURE (molar's cracked) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007CZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Tomatoes and Mangoes).    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced TOOTH FRACTURE (molar's cracked). At the time of the report, TOOTH FRACTURE (molar's cracked) outcome was unknown.        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 reported. Consumer reported that no treatment was taken for the events.; Sender's Comments: Based on the nature of the event and physiologic plausibility, the event is assessed as unlikely related to mRNA-1273.