chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Oral discomfort, Paraesthesia, Pruritus, Pyrexia
Clinical narrative: rash to face; tingling to face (intermittent); feels like high histamine; chills; fever; mouth burns; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash to face), PARAESTHESIA (tingling to face (intermittent)), PRURITUS (feels like high histamine), CHILLS (chills) and PYREXIA (fever) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 07-Apr-2021, the patient experienced RASH (rash to face), PARAESTHESIA (tingling to face (intermittent)), PRURITUS (feels like high histamine), CHILLS (chills), PYREXIA (fever) and ORAL DISCOMFORT (mouth burns). On 09-Apr-2021, CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, RASH (rash to face), PARAESTHESIA (tingling to face (intermittent)), PRURITUS (feels like high histamine) and ORAL DISCOMFORT (mouth burns) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medicine has been reported by reporter   Reporter did not allow further contact
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash to face; tingling to face (intermittent); feels like high histamine; chills; fever; mouth burns; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash to face), PARAESTHESIA (tingling to face (intermittent)), PRURITUS (feels like high histamine), CHILLS (chills) and PYREXIA (fever) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 07-Apr-2021, the patient experienced RASH (rash to face), PARAESTHESIA (tingling to face (intermittent)), PRURITUS (feels like high histamine), CHILLS (chills), PYREXIA (fever) and ORAL DISCOMFORT (mouth burns). On 09-Apr-2021, CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, RASH (rash to face), PARAESTHESIA (tingling to face (intermittent)), PRURITUS (feels like high histamine) and ORAL DISCOMFORT (mouth burns) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medicine has been reported by reporter   Reporter did not allow further contact
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose decreased, Depressed mood, Fall, Fatigue
Clinical narrative: her blood sugar had gone extremely low and is having low blood sugars at night; Has had muscle soreness bilaterally in both upper arms and has been fatigued; Low-grade fever; Has been fatigued; Felt crappy, describing that the dose really took her down; Had a fall; She was weak; Not feeling very well; This spontaneous case was reported by a nurse and describes the occurrence of DEPRESSED MOOD (Felt crappy, describing that the dose really took her down), FALL (Had a fall), ASTHENIA (She was weak), FEELING ABNORMAL (Not feeling very well) and BLOOD GLUCOSE DECREASED (her blood sugar had gone extremely low and is having low blood sugars at night) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood sugar increased (140's and 150's at night). Concomitant products included METOPROLOL, METFORMIN HYDROCHLORIDE (GLUCOPHAGE FORTE), SEMAGLUTIDE (RYBELSUS), CITALOPRAM, OMEPRAZOLE, LEVOTHYROXINE SODIUM (SYNTHROID), EMPAGLIFLOZIN (JARDIANCE) and VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced DEPRESSED MOOD (Felt crappy, describing that the dose really took her down), FALL (Had a fall), ASTHENIA (She was weak), FEELING ABNORMAL (Not feeling very well), MYALGIA (Has had muscle soreness bilaterally in both upper arms and has been fatigued), PYREXIA (Low-grade fever) and FATIGUE (Has been fatigued). On an unknown date, the patient experienced BLOOD GLUCOSE DECREASED (her blood sugar had gone extremely low and is having low blood sugars at night). In April 2021, DEPRESSED MOOD (Felt crappy, describing that the dose really took her down) had resolved. At the time of the report, FALL (Had a fall), ASTHENIA (She was weak), FEELING ABNORMAL (Not feeling very well), BLOOD GLUCOSE DECREASED (her blood sugar had gone extremely low and is having low blood sugars at night), MYALGIA (Has had muscle soreness bilaterally in both upper arms and has been fatigued), PYREXIA (Low-grade fever) and FATIGUE (Has been fatigued) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Blood glucose decreased: 46 Low.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: No specific follow-up information recorded.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: her blood sugar had gone extremely low and is having low blood sugars at night; Has had muscle soreness bilaterally in both upper arms and has been fatigued; Low-grade fever; Has been fatigued; Felt crappy, describing that the dose really took her down; Had a fall; She was weak; Not feeling very well; This spontaneous case was reported by a nurse and describes the occurrence of DEPRESSED MOOD (Felt crappy, describing that the dose really took her down), FALL (Had a fall), ASTHENIA (She was weak), FEELING ABNORMAL (Not feeling very well) and BLOOD GLUCOSE DECREASED (her blood sugar had gone extremely low and is having low blood sugars at night) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood sugar increased (140's and 150's at night). Concomitant products included METOPROLOL, METFORMIN HYDROCHLORIDE (GLUCOPHAGE FORTE), SEMAGLUTIDE (RYBELSUS), CITALOPRAM, OMEPRAZOLE, LEVOTHYROXINE SODIUM (SYNTHROID), EMPAGLIFLOZIN (JARDIANCE) and VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced DEPRESSED MOOD (Felt crappy, describing that the dose really took her down), FALL (Had a fall), ASTHENIA (She was weak), FEELING ABNORMAL (Not feeling very well), MYALGIA (Has had muscle soreness bilaterally in both upper arms and has been fatigued), PYREXIA (Low-grade fever) and FATIGUE (Has been fatigued). On an unknown date, the patient experienced BLOOD GLUCOSE DECREASED (her blood sugar had gone extremely low and is having low blood sugars at night). In April 2021, DEPRESSED MOOD (Felt crappy, describing that the dose really took her down) had resolved. At the time of the report, FALL (Had a fall), ASTHENIA (She was weak), FEELING ABNORMAL (Not feeling very well), BLOOD GLUCOSE DECREASED (her blood sugar had gone extremely low and is having low blood sugars at night), MYALGIA (Has had muscle soreness bilaterally in both upper arms and has been fatigued), PYREXIA (Low-grade fever) and FATIGUE (Has been fatigued) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Blood glucose decreased: 46 Low.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: No specific follow-up information recorded.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: pain in injection site; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and VACCINATION SITE PAIN (pain in injection site) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus. Concomitant products included INSULIN GLARGINE (TOUJEO), METFORMIN and DICLOFENAC for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (sore arm). On 16-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain in injection site). At the time of the report, PAIN IN EXTREMITY (sore arm) and VACCINATION SITE PAIN (pain in injection site) outcome was unknown. Not Provided          Other concomitant medicine included other Heart medication. Treatment medication was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-079297 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079297:Case for dose 1
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Fatigue, Headache, Nasopharyngitis
Clinical narrative: headache; such big headache, not as a regular headache, extreme headache; redness in her shoulder and her neck, down little bit on her back. that's really bad; Fatigue; Some parts are very very red in her neck; Burning sensation all over her neck and shoulders; cold; Night sweat; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BURNING SENSATION (Burning sensation all over her neck and shoulders), NASOPHARYNGITIS (cold), NIGHT SWEATS (Night sweat), PYREXIA (Fever) and FATIGUE (Fatigue) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy and Shellfish allergy. Concomitant products included VITAMIN D3, VITAMIN B12 [VITAMIN B12 NOS], VITAMIN B6 and ZINC for an unknown indication.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced NASOPHARYNGITIS (cold), NIGHT SWEATS (Night sweat) and PYREXIA (Fever). On 12-Apr-2021, the patient experienced BURNING SENSATION (Burning sensation all over her neck and shoulders), FATIGUE (Fatigue) and ERYTHEMA (Some parts are very very red in her neck). On an unknown date, the patient experienced HEADACHE (headache), HEADACHE (such big headache, not as a regular headache, extreme headache) and ERYTHEMA (redness in her shoulder and her neck, down little bit on her back. that's really bad). At the time of the report, BURNING SENSATION (Burning sensation all over her neck and shoulders), NASOPHARYNGITIS (cold), NIGHT SWEATS (Night sweat), PYREXIA (Fever), FATIGUE (Fatigue) and ERYTHEMA (Some parts are very very red in her neck) outcome was unknown.            This case was linked to US-MODERNATX, INC.-MOD-2021-079352 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079352:DOSE 2
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pyrexia
Clinical narrative: headache; such big headache, not as a regular headache, extreme headache; redness in her shoulder and her neck, down little bit on her back. that's really bad; Fatigue; Some parts are very very red in her neck; Burning sensation all over her neck and shoulders; cold; Night sweat; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BURNING SENSATION (Burning sensation all over her neck and shoulders), NASOPHARYNGITIS (cold), NIGHT SWEATS (Night sweat), PYREXIA (Fever) and FATIGUE (Fatigue) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy and Shellfish allergy. Concomitant products included VITAMIN D3, VITAMIN B12 [VITAMIN B12 NOS], VITAMIN B6 and ZINC for an unknown indication.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced NASOPHARYNGITIS (cold), NIGHT SWEATS (Night sweat) and PYREXIA (Fever). On 12-Apr-2021, the patient experienced BURNING SENSATION (Burning sensation all over her neck and shoulders), FATIGUE (Fatigue) and ERYTHEMA (Some parts are very very red in her neck). On an unknown date, the patient experienced HEADACHE (headache), HEADACHE (such big headache, not as a regular headache, extreme headache) and ERYTHEMA (redness in her shoulder and her neck, down little bit on her back. that's really bad). At the time of the report, BURNING SENSATION (Burning sensation all over her neck and shoulders), NASOPHARYNGITIS (cold), NIGHT SWEATS (Night sweat), PYREXIA (Fever), FATIGUE (Fatigue) and ERYTHEMA (Some parts are very very red in her neck) outcome was unknown.            This case was linked to US-MODERNATX, INC.-MOD-2021-079352 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079352:DOSE 2
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Neck mass, Pruritus
Clinical narrative: itchy; arm is red; 3 knots behind her neck; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itchy), ERYTHEMA (arm is red) and NECK MASS (3 knots behind her neck) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 01-Apr-2021, the patient experienced PRURITUS (itchy), ERYTHEMA (arm is red) and NECK MASS (3 knots behind her neck). At the time of the report, PRURITUS (itchy), ERYTHEMA (arm is red) and NECK MASS (3 knots behind her neck) outcome was unknown. Not Provided          No concomitant and treatment medicine has been reported by reporter   This case was linked to US-MODERNATX, INC.-MOD-2021-079282 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079282:Case for first dose
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Pain, Pain in extremity
Clinical narrative: felt a little achy; felt a little off, described as having a little stomach upset; left arm hurt up in the muscle; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (felt a little achy), ABDOMINAL DISCOMFORT (felt a little off, described as having a little stomach upset) and PAIN IN EXTREMITY (left arm hurt up in the muscle) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 038K20A) for COVID-19 vaccination.     The patient's past medical history included Pneumonia and Transplant (heart valve transplant). Concomitant products included CARVEDILOL, OMEPRAZOLE, ATORVASTATIN, ALLOPURINOL, PRIMIDONE and DULOXETINE for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced PAIN (felt a little achy), ABDOMINAL DISCOMFORT (felt a little off, described as having a little stomach upset) and PAIN IN EXTREMITY (left arm hurt up in the muscle). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Feb-2021, PAIN (felt a little achy), ABDOMINAL DISCOMFORT (felt a little off, described as having a little stomach upset) and PAIN IN EXTREMITY (left arm hurt up in the muscle) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-079337 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079337:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 2nd dose has not been given after 43 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose has not been given after 43 days) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 PRODUCT DOSE OMISSION ISSUE (2nd dose has not been given after 43 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose has not been given after 43 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medicines was not reported by reporter   treatment information was not provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not  provide any causality assessments   This case was linked to MOD-2021-077613 (E2B Linked Report).; Sender's Comments:  MOD-2021-077613:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: A little under the weather (After First Vaccine); This spontaneous case was reported by a health care professional and describes the occurrence of FEELING ABNORMAL (A little under the weather (After First Vaccine)) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced FEELING ABNORMAL (A little under the weather (After First Vaccine)). On 20-Mar-2021, FEELING ABNORMAL (A little under the weather (After First Vaccine)) had resolved. Not Provided      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 treatment medications were provided. No concomitant medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-079320 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received on 24-MAY-2021. Patient stated that AEs resolved and no further information to report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079320:For second dose
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, SARS-CoV-2 test, Sinusitis
Clinical narrative: tested positive for COVID-19; chest cough; sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19), COUGH (chest cough) and SINUSITIS (sinus infection) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced COVID-19 (tested positive for COVID-19), COUGH (chest cough) and SINUSITIS (sinus infection). The patient was treated with AZITHROMYCIN (Z-PAK) for Sinus infection, at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for COVID-19), COUGH (chest cough) and SINUSITIS (sinus infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.  Treatment using azithromycin(Z-Pak)  was reported.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: invalid dose - administered to a patient under 18 years of age; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (invalid dose - administered to a patient under 18 years of age) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (invalid dose - administered to a patient under 18 years of age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (invalid dose - administered to a patient under 18 years of age) outcome was unknown. Not Provided      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.   It was reported that The COVID-19 volunteers made a mistake on reading the date of birth for the consumer No concomitant medication reported.  No treatment medication reported
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza, Pain in extremity
Clinical narrative: "Flu"; Arm pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA ("Flu"), PAIN IN EXTREMITY (Arm pain) and FATIGUE (Fatigue) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported ).    On 20-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 INFLUENZA ("Flu"), PAIN IN EXTREMITY (Arm pain) and FATIGUE (Fatigue). At the time of the report, INFLUENZA ("Flu"), PAIN IN EXTREMITY (Arm pain) and FATIGUE (Fatigue) outcome was unknown. Not Provided      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.   It was reported that the patient is concerned about the administration of 2nd dose of vaccine No concomitant medication reported  Treatment using  acetaminophen was reported
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Pain in extremity, Pyrexia
Clinical narrative: sore arm; Dizzy/light headed, might pass out; temp of 99.9; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), DIZZINESS (Dizzy/light headed, might pass out) and PYREXIA (temp of 99.9) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), DIZZINESS (Dizzy/light headed, might pass out) and PYREXIA (temp of 99.9). At the time of the report, PAIN IN EXTREMITY (sore arm), DIZZINESS (Dizzy/light headed, might pass out) and PYREXIA (temp of 99.9) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the patient might have had COVID-19 on SEP 2020, but did not get confirmation  No concomitant medication reported  No treatment medication reported
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Dizziness, Fall, Fatigue
Clinical narrative: I had a fever for 5 days; I felt like I was going to fall down; felt dizzy; headache; had a fever between 99.9°F-100.7°F; felt very tired; my back hurt; my shoulder hurt; my knees hurt; My arm hurt where I got the shot; This spontaneous case was reported by a consumer and describes the occurrence of FALL (I felt like I was going to fall down), DIZZINESS (felt dizzy), VACCINATION SITE PAIN (My arm hurt where I got the shot), HEADACHE (headache) and PYREXIA (had a fever between 99.9°F-100.7°F) in a 41-year-old female patient who received mRNA-1273 (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE PAIN (My arm hurt where I got the shot). On 11-Apr-2021, the patient experienced FALL (I felt like I was going to fall down), DIZZINESS (felt dizzy), HEADACHE (headache), PYREXIA (had a fever between 99.9°F-100.7°F), FATIGUE (felt very tired), ARTHRALGIA (my back hurt), ARTHRALGIA (my shoulder hurt) and ARTHRALGIA (my knees hurt). On 16-Apr-2021, the patient experienced PYREXIA (I had a fever for 5 days). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, FALL (I felt like I was going to fall down), DIZZINESS (felt dizzy), VACCINATION SITE PAIN (My arm hurt where I got the shot), HEADACHE (headache), PYREXIA (had a fever between 99.9°F-100.7°F), FATIGUE (felt very tired), ARTHRALGIA (my back hurt), ARTHRALGIA (my shoulder hurt), ARTHRALGIA (my knees hurt) and PYREXIA (I had a fever for 5 days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, Pyrexia: 99.9°f-100.7° 99.9°F-100.7°. On 14-Apr-2021, COVID-19: negative Negative.     The action taken with mRNA-1273 (Unknown) was unknown.       Treatment for the event included acetaminophen (Tylenol) and increased water intake. Concomitant medication details were not provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vaccination site pain
Clinical narrative: I had a fever for 5 days; I felt like I was going to fall down; felt dizzy; headache; had a fever between 99.9°F-100.7°F; felt very tired; my back hurt; my shoulder hurt; my knees hurt; My arm hurt where I got the shot; This spontaneous case was reported by a consumer and describes the occurrence of FALL (I felt like I was going to fall down), DIZZINESS (felt dizzy), VACCINATION SITE PAIN (My arm hurt where I got the shot), HEADACHE (headache) and PYREXIA (had a fever between 99.9°F-100.7°F) in a 41-year-old female patient who received mRNA-1273 (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE PAIN (My arm hurt where I got the shot). On 11-Apr-2021, the patient experienced FALL (I felt like I was going to fall down), DIZZINESS (felt dizzy), HEADACHE (headache), PYREXIA (had a fever between 99.9°F-100.7°F), FATIGUE (felt very tired), ARTHRALGIA (my back hurt), ARTHRALGIA (my shoulder hurt) and ARTHRALGIA (my knees hurt). On 16-Apr-2021, the patient experienced PYREXIA (I had a fever for 5 days). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, FALL (I felt like I was going to fall down), DIZZINESS (felt dizzy), VACCINATION SITE PAIN (My arm hurt where I got the shot), HEADACHE (headache), PYREXIA (had a fever between 99.9°F-100.7°F), FATIGUE (felt very tired), ARTHRALGIA (my back hurt), ARTHRALGIA (my shoulder hurt), ARTHRALGIA (my knees hurt) and PYREXIA (I had a fever for 5 days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, Pyrexia: 99.9°f-100.7° 99.9°F-100.7°. On 14-Apr-2021, COVID-19: negative Negative.     The action taken with mRNA-1273 (Unknown) was unknown.       Treatment for the event included acetaminophen (Tylenol) and increased water intake. Concomitant medication details were not provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: soreness for about 5 days; light prick for about 5 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness for about 5 days) and PARAESTHESIA (light prick for about 5 days) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness for about 5 days) and PARAESTHESIA (light prick for about 5 days). At the time of the report, PAIN IN EXTREMITY (soreness for about 5 days) and PARAESTHESIA (light prick for about 5 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-079326 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079326:First dose case
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: Both doses of the vaccine raised my blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Both doses of the vaccine raised my blood pressure) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 043L20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, LISINOPRIL and FINASTERIDE for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-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 HYPERTENSION (Both doses of the vaccine raised my blood pressure). At the time of the report, HYPERTENSION (Both doses of the vaccine raised my blood pressure) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Blood pressure measurement: 158/93 mmHg and 153/96 mmHg. On 19-Mar-2021, Blood pressure measurement: 148/91 mmHg. On an unknown date, Blood pressure measurement: 160/97 mmHg.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment lisinopril  was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-079349 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079349:First Dose
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Influenza like illness, Mouth swelling, Nasal congestion
Clinical narrative: Flu like response; Chills (After Second Shot); Sick; Swollen Mouth; Aches and pain; Nose Feels Stuffy; This spontaneous case was reported by a health care professional and describes the occurrence of ILLNESS (Sick), MOUTH SWELLING (Swollen Mouth), PAIN (Aches and pain), NASAL CONGESTION (Nose Feels Stuffy) and INFLUENZA LIKE ILLNESS (Flu like response) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced ILLNESS (Sick), MOUTH SWELLING (Swollen Mouth), PAIN (Aches and pain), NASAL CONGESTION (Nose Feels Stuffy) and CHILLS (Chills (After Second Shot)). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like response). At the time of the report, ILLNESS (Sick), MOUTH SWELLING (Swollen Mouth), PAIN (Aches and pain), NASAL CONGESTION (Nose Feels Stuffy), INFLUENZA LIKE ILLNESS (Flu like response) and CHILLS (Chills (After Second Shot)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-079311 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: No further information On 24-May-2021: Initial Additional document received on 24-May-2021 contains no further information. On 21-Jul-2021: Significant FU received on 21-Jul-2021, new event added- flu like response and event outcome updated from unknown to recovered/resolved.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079311:For first dose
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Flu like response; Chills (After Second Shot); Sick; Swollen Mouth; Aches and pain; Nose Feels Stuffy; This spontaneous case was reported by a health care professional and describes the occurrence of ILLNESS (Sick), MOUTH SWELLING (Swollen Mouth), PAIN (Aches and pain), NASAL CONGESTION (Nose Feels Stuffy) and INFLUENZA LIKE ILLNESS (Flu like response) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced ILLNESS (Sick), MOUTH SWELLING (Swollen Mouth), PAIN (Aches and pain), NASAL CONGESTION (Nose Feels Stuffy) and CHILLS (Chills (After Second Shot)). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like response). At the time of the report, ILLNESS (Sick), MOUTH SWELLING (Swollen Mouth), PAIN (Aches and pain), NASAL CONGESTION (Nose Feels Stuffy), INFLUENZA LIKE ILLNESS (Flu like response) and CHILLS (Chills (After Second Shot)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-079311 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: No further information On 24-May-2021: Initial Additional document received on 24-May-2021 contains no further information. On 21-Jul-2021: Significant FU received on 21-Jul-2021, new event added- flu like response and event outcome updated from unknown to recovered/resolved.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079311:For first dose
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chills, Cough, Fatigue, Headache
Clinical narrative: Sore throat; Runny nose; Coughing; Chills; Fatigue; Bad headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), COUGH (Coughing), CHILLS (Chills) and FATIGUE (Fatigue) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 14-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), COUGH (Coughing), CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Bad headache). The patient was treated with PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) for Runny nose, at a dose of 1 dosage form. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), COUGH (Coughing), CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood test: (Negative) Didn't detect anything bacterial.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant detals was not provided  by the reporter. Treatment details included Sudafed. It was reported that the events could possibly be covid-19 related, and would get the result by next Tuesday. Patient has the second dose scheduled on 29Apr2021.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Sore throat; Runny nose; Coughing; Chills; Fatigue; Bad headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), COUGH (Coughing), CHILLS (Chills) and FATIGUE (Fatigue) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 14-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), COUGH (Coughing), CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Bad headache). The patient was treated with PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) for Runny nose, at a dose of 1 dosage form. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), COUGH (Coughing), CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood test: (Negative) Didn't detect anything bacterial.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant detals was not provided  by the reporter. Treatment details included Sudafed. It was reported that the events could possibly be covid-19 related, and would get the result by next Tuesday. Patient has the second dose scheduled on 29Apr2021.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Illness, Malaise, Myalgia
Clinical narrative: dizzy; headache; Lousy; fever; generalized body aches; Did not feel well; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), MYALGIA (generalized body aches), MALAISE (Did not feel well), DIZZINESS (dizzy) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Apr-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. On 07-Apr-2021, the patient experienced PYREXIA (fever), MYALGIA (generalized body aches) and MALAISE (Did not feel well). On 16-Apr-2021, the patient experienced DIZZINESS (dizzy), HEADACHE (headache) and ILLNESS (Lousy). At the time of the report, PYREXIA (fever), MYALGIA (generalized body aches) and MALAISE (Did not feel well) had resolved and DIZZINESS (dizzy), HEADACHE (headache) and ILLNESS (Lousy) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment was reported.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: dizzy; headache; Lousy; fever; generalized body aches; Did not feel well; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), MYALGIA (generalized body aches), MALAISE (Did not feel well), DIZZINESS (dizzy) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Apr-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. On 07-Apr-2021, the patient experienced PYREXIA (fever), MYALGIA (generalized body aches) and MALAISE (Did not feel well). On 16-Apr-2021, the patient experienced DIZZINESS (dizzy), HEADACHE (headache) and ILLNESS (Lousy). At the time of the report, PYREXIA (fever), MYALGIA (generalized body aches) and MALAISE (Did not feel well) had resolved and DIZZINESS (dizzy), HEADACHE (headache) and ILLNESS (Lousy) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment was reported.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Sensory loss
Clinical narrative: Cannot feel anything; Left side of nose and cheek get numb; This spontaneous case was reported by a consumer and describes the occurrence of SENSORY LOSS (Cannot feel anything) and HYPOAESTHESIA (Left side of nose and cheek get numb) 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 21-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 SENSORY LOSS (Cannot feel anything) and HYPOAESTHESIA (Left side of nose and cheek get numb). At the time of the report, SENSORY LOSS (Cannot feel anything) and HYPOAESTHESIA (Left side of nose and cheek get numb) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  It was reported that patient did her cosmetic filler on 08 APR 2021, after that suddenly her left side of nose and cheek get numb, she could not feel anything at that time. I t was reported that she had to go through stroke evaluation.  No treatment information was reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Needle issue
Clinical narrative: suboptimal dose given (think it was between 0.2-0.3 mL); the needle popped off during vaccine administration; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (suboptimal dose given (think it was between 0.2-0.3 mL)) and NEEDLE ISSUE (the needle popped off during vaccine administration) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 16-Apr-2021, the patient experienced INCORRECT DOSE ADMINISTERED (suboptimal dose given (think it was between 0.2-0.3 mL)) and NEEDLE ISSUE (the needle popped off during vaccine administration). On 16-Apr-2021, INCORRECT DOSE ADMINISTERED (suboptimal dose given (think it was between 0.2-0.3 mL)) and NEEDLE ISSUE (the needle popped off during vaccine administration) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported. Action taken with mRNA-123 was not applicable.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness where they gave the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness where they gave the shot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 025B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).   On 04-Mar-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 SITE PAIN (Soreness where they gave the shot). On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.  At the time of the report, VACCINATION SITE PAIN (Soreness where they gave the shot) had resolved.            This case was linked to US-MODERNATX, INC.-MOD-2021-079343 (E2B Linked Report). This case was linked to MOD-2021-079343 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079343: