chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present
Clinical narrative: Blood in the urine; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD URINE PRESENT (Blood in the urine) 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 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD URINE PRESENT (Blood in the urine). At the time of the report, BLOOD URINE PRESENT (Blood in the urine) outcome was unknown. Not Provided          No relevant concomitant medications were reported. No treatment information was reported.    Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Additional information received included no new information.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Urinary tract infection
Clinical narrative: Developed UTI; Blood in the urine; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Developed UTI) and BLOOD URINE PRESENT (Blood in the urine) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced BLOOD URINE PRESENT (Blood in the urine). On an unknown date, the patient experienced URINARY TRACT INFECTION (Developed UTI). The patient was treated with MELOXICAM (MOBIC) at an unspecified dose and frequency. At the time of the report, URINARY TRACT INFECTION (Developed UTI) and BLOOD URINE PRESENT (Blood in the urine) outcome was unknown.            No relevant concomitant medications were provided. Concomitant medications reported included antibiotics which patient had not started at the time of reporting.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Additional information received included no new information.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pyrexia
Clinical narrative: Diarrhea; Throbbing headache; Chills; Fever; Vomiting twice; Nausea; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Diarrhea), HEADACHE (Throbbing headache), CHILLS (Chills), PYREXIA (Fever) and VOMITING (Vomiting twice) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), HEADACHE (Throbbing headache), CHILLS (Chills), PYREXIA (Fever), VOMITING (Vomiting twice) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 15-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, DIARRHOEA (Diarrhea), HEADACHE (Throbbing headache), CHILLS (Chills), VOMITING (Vomiting twice) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  Reportedly, the patient began experiencing the symptoms that evening the same day she received the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Diarrhea; Throbbing headache; Chills; Fever; Vomiting twice; Nausea; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Diarrhea), HEADACHE (Throbbing headache), CHILLS (Chills), PYREXIA (Fever) and VOMITING (Vomiting twice) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), HEADACHE (Throbbing headache), CHILLS (Chills), PYREXIA (Fever), VOMITING (Vomiting twice) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 15-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, DIARRHOEA (Diarrhea), HEADACHE (Throbbing headache), CHILLS (Chills), VOMITING (Vomiting twice) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  Reportedly, the patient began experiencing the symptoms that evening the same day she received the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vomiting (threw-up), nausea (feeling nauseous) and chills in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Mar 15, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 15, 2021, patient experienced vomiting (threw-up). On Mar 16, 2021, patient experienced nausea (feeling nauseous) and chills. On Mar 15, 2021, vomiting (threw-up) resolved. At the time of the report, nausea (feeling nauseous) and chills outcome: unknown. No concomitant medications or treatment information provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 25-Jun-2021. On 11-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient was treated with MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) ongoing since an unknown date at an unspecified dose and frequency. On 11-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.            No concomitant medications were provided.  Treatment medication also included an over the counter allergy pill. Action taken with mRNA-1273 Moderna COVID-19 Vaccine was not applicable
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Received appointment 25 days later; This spontaneous case was reported by a consumer and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Received appointment 25 days later) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-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 CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Received appointment 25 days later). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Received appointment 25 days later) outcome was unknown. Not applicable      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Lymphadenopathy, Myalgia, Oral herpes
Clinical narrative: sick; cold sore; body aches; chills; a little fever; very swollen lymph nodes on the side of her jaw and throat; This spontaneous case was reported by a  and describes the occurrence of ILLNESS (sick), PAIN (body aches), CHILLS (chills), PYREXIA (a little fever) and ORAL HERPES (cold sore) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ILLNESS (sick), PAIN (body aches), CHILLS (chills), PYREXIA (a little fever), ORAL HERPES (cold sore) and LYMPHADENOPATHY (very swollen lymph nodes on the side of her jaw and throat). Not Provided          Reporter did not allow further contact
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: sick; cold sore; body aches; chills; a little fever; very swollen lymph nodes on the side of her jaw and throat; This spontaneous case was reported by a  and describes the occurrence of ILLNESS (sick), PAIN (body aches), CHILLS (chills), PYREXIA (a little fever) and ORAL HERPES (cold sore) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ILLNESS (sick), PAIN (body aches), CHILLS (chills), PYREXIA (a little fever), ORAL HERPES (cold sore) and LYMPHADENOPATHY (very swollen lymph nodes on the side of her jaw and throat). Not Provided          Reporter did not allow further contact
Age: 41.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Bone pain, Fatigue, Influenza like illness, Lip swelling, Malaise
Clinical narrative: was felling better but not that better to go to work, she can not drive her car; started having some buzzing in her ears; since one hour ago her lips started to swollen up again, and has an itchy rush all over her body; patient is afraid that her throat can close,; felt tired; body aches; nauseas; bone pain; muscles aches; flu like symptoms; After the vaccination her lips were swollen, and half of her face had some movements , that lasted for around 30-40 minutes.; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (After the vaccination her lips were swollen, and half of her face had some movements , that lasted for around 30-40 minutes.), INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (was felling better but not that better to go to work, she can not drive her car), TINNITUS (started having some buzzing in her ears) and RASH PRURITIC (since one hour ago her lips started to swollen up again, and has an itchy rush all over her body) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product METHIMAZOLE for an unknown indication.    The patient's past medical history included No adverse event. Concomitant products included Quintiles Inc                                                                                                     Case and REPAGLINIDE (PAGE) for an unknown indication.   On 13-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 started METHIMAZOLE (unknown route) at an unspecified dose. On 13-Mar-2021, the patient experienced LIP SWELLING (After the vaccination her lips were swollen, and half of her face had some movements , that lasted for around 30-40 minutes.). On 14-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), FATIGUE (felt tired), PAIN (body aches), NAUSEA (nauseas), BONE PAIN (bone pain) and MYALGIA (muscles aches). On 16-Mar-2021, the patient experienced MALAISE (was felling better but not that better to go to work, she can not drive her car), TINNITUS (started having some buzzing in her ears), RASH PRURITIC (since one hour ago her lips started to swollen up again, and has an itchy rush all over her body) and OROPHARYNGEAL DISCOMFORT (patient is afraid that her throat can close,). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), OROPHARYNGEAL DISCOMFORT (patient is afraid that her throat can close,), FATIGUE (felt tired), PAIN (body aches), NAUSEA (nauseas), BONE PAIN (bone pain) and MYALGIA (muscles aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Myalgia, Nausea, Oropharyngeal discomfort, Pain, Rash pruritic
Clinical narrative: was felling better but not that better to go to work, she can not drive her car; started having some buzzing in her ears; since one hour ago her lips started to swollen up again, and has an itchy rush all over her body; patient is afraid that her throat can close,; felt tired; body aches; nauseas; bone pain; muscles aches; flu like symptoms; After the vaccination her lips were swollen, and half of her face had some movements , that lasted for around 30-40 minutes.; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (After the vaccination her lips were swollen, and half of her face had some movements , that lasted for around 30-40 minutes.), INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (was felling better but not that better to go to work, she can not drive her car), TINNITUS (started having some buzzing in her ears) and RASH PRURITIC (since one hour ago her lips started to swollen up again, and has an itchy rush all over her body) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product METHIMAZOLE for an unknown indication.    The patient's past medical history included No adverse event. Concomitant products included Quintiles Inc                                                                                                     Case and REPAGLINIDE (PAGE) for an unknown indication.   On 13-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 started METHIMAZOLE (unknown route) at an unspecified dose. On 13-Mar-2021, the patient experienced LIP SWELLING (After the vaccination her lips were swollen, and half of her face had some movements , that lasted for around 30-40 minutes.). On 14-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), FATIGUE (felt tired), PAIN (body aches), NAUSEA (nauseas), BONE PAIN (bone pain) and MYALGIA (muscles aches). On 16-Mar-2021, the patient experienced MALAISE (was felling better but not that better to go to work, she can not drive her car), TINNITUS (started having some buzzing in her ears), RASH PRURITIC (since one hour ago her lips started to swollen up again, and has an itchy rush all over her body) and OROPHARYNGEAL DISCOMFORT (patient is afraid that her throat can close,). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), OROPHARYNGEAL DISCOMFORT (patient is afraid that her throat can close,), FATIGUE (felt tired), PAIN (body aches), NAUSEA (nauseas), BONE PAIN (bone pain) and MYALGIA (muscles aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Tinnitus
Clinical narrative: was felling better but not that better to go to work, she can not drive her car; started having some buzzing in her ears; since one hour ago her lips started to swollen up again, and has an itchy rush all over her body; patient is afraid that her throat can close,; felt tired; body aches; nauseas; bone pain; muscles aches; flu like symptoms; After the vaccination her lips were swollen, and half of her face had some movements , that lasted for around 30-40 minutes.; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (After the vaccination her lips were swollen, and half of her face had some movements , that lasted for around 30-40 minutes.), INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (was felling better but not that better to go to work, she can not drive her car), TINNITUS (started having some buzzing in her ears) and RASH PRURITIC (since one hour ago her lips started to swollen up again, and has an itchy rush all over her body) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product METHIMAZOLE for an unknown indication.    The patient's past medical history included No adverse event. Concomitant products included Quintiles Inc                                                                                                     Case and REPAGLINIDE (PAGE) for an unknown indication.   On 13-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 started METHIMAZOLE (unknown route) at an unspecified dose. On 13-Mar-2021, the patient experienced LIP SWELLING (After the vaccination her lips were swollen, and half of her face had some movements , that lasted for around 30-40 minutes.). On 14-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), FATIGUE (felt tired), PAIN (body aches), NAUSEA (nauseas), BONE PAIN (bone pain) and MYALGIA (muscles aches). On 16-Mar-2021, the patient experienced MALAISE (was felling better but not that better to go to work, she can not drive her car), TINNITUS (started having some buzzing in her ears), RASH PRURITIC (since one hour ago her lips started to swollen up again, and has an itchy rush all over her body) and OROPHARYNGEAL DISCOMFORT (patient is afraid that her throat can close,). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), OROPHARYNGEAL DISCOMFORT (patient is afraid that her throat can close,), FATIGUE (felt tired), PAIN (body aches), NAUSEA (nauseas), BONE PAIN (bone pain) and MYALGIA (muscles aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: fatigue; fewhours of heat, had a fever; a little bit of sore arm had to touch it to feel it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (a little bit of sore arm had to touch it to feel it), FATIGUE (fatigue) and PYREXIA (fewhours of heat, had a fever) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE PAIN (a little bit of sore arm had to touch it to feel it). On an unknown date, the patient experienced FATIGUE (fatigue) and PYREXIA (fewhours of heat, had a fever). At the time of the report, VACCINATION SITE PAIN (a little bit of sore arm had to touch it to feel it), FATIGUE (fatigue) and PYREXIA (fewhours of heat, had a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product included supplements. The treatment information was unknown.   This case was linked to MOD-2021-046398, MOD-2021-046398 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: New events added. On 10-May-2021: clarification regarding events
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash on arm; itchy arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of RASH (rash on arm) and PRURITUS (itchy arm) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced RASH (rash on arm) and PRURITUS (itchy arm). On 04-Mar-2021, RASH (rash on arm) and PRURITUS (itchy arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain, Rash macular
Clinical narrative: Spot the size of a dollar; Soreness; bright redness; Warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Spot the size of a dollar), PAIN (Soreness), ERYTHEMA (bright redness) and FEELING HOT (Warm to touch) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) 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 an unknown date, the patient experienced RASH MACULAR (Spot the size of a dollar), PAIN (Soreness), ERYTHEMA (bright redness) and FEELING HOT (Warm to touch). At the time of the report, RASH MACULAR (Spot the size of a dollar), PAIN (Soreness), ERYTHEMA (bright redness) and FEELING HOT (Warm to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: The additional source document contains NNI.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site indentation, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Bump like a big mosquito bite 4 to 5 inches; Redness around arm; Itchy at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDENTATION (Bump like a big mosquito bite 4 to 5 inches), VACCINATION SITE ERYTHEMA (Redness around arm) and VACCINATION SITE PRURITUS (Itchy at injection site) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 9137275) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included CALCIUM and VITAMIN D NOS for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy at injection site). On 18-Feb-2021, the patient experienced INJECTION SITE INDENTATION (Bump like a big mosquito bite 4 to 5 inches) and VACCINATION SITE ERYTHEMA (Redness around arm). At the time of the report, INJECTION SITE INDENTATION (Bump like a big mosquito bite 4 to 5 inches), VACCINATION SITE ERYTHEMA (Redness around arm) and VACCINATION SITE PRURITUS (Itchy at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were Blood pressure meds and Immune system meds.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 15-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 15-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired 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.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 014M20A)  with no associated AEs
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 15-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 15-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) 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 relevant concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD21-054673, MOD21-054574, MOD21-054744, MOD21-054746, MOD21-054749, MOD21-054751 (E2B Linked Report).; Sender's Comments:  MOD21-054673: MOD21-054574: MOD21-054744: MOD21-054746: MOD21-054749: MOD21-054751:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence, Swelling, Vaccination site erythema, Vaccination site pain
Clinical narrative: redness, hot and felt sore at injection site and below; redness, hot and felt sore at injection site and below; redness, hot and felt sore at injection site and below; Slept all day; Extremely tired; swelling; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept all day), VACCINATION SITE WARMTH (redness, hot and felt sore at injection site and below), SWELLING (swelling), FATIGUE (Extremely tired) and VACCINATION SITE ERYTHEMA (redness, hot and felt sore at injection site and below) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concomitant products included LISINOPRIL for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced SOMNOLENCE (Slept all day) and FATIGUE (Extremely tired). On 15-Mar-2021, the patient experienced VACCINATION SITE WARMTH (redness, hot and felt sore at injection site and below), VACCINATION SITE ERYTHEMA (redness, hot and felt sore at injection site and below) and VACCINATION SITE PAIN (redness, hot and felt sore at injection site and below). On an unknown date, the patient experienced SWELLING (swelling). At the time of the report, SOMNOLENCE (Slept all day), VACCINATION SITE WARMTH (redness, hot and felt sore at injection site and below), FATIGUE (Extremely tired) and VACCINATION SITE PAIN (redness, hot and felt sore at injection site and below) outcome was unknown and SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redness, hot and felt sore at injection site and below) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment included cold compresses.   This case was linked to MOD-2021-219933 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Updated reporter contact details, Outcome of events vaccination site erythema changed from unknown to recovered/resolved. Added medical history and 1 new event of swelling.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: redness, hot and felt sore at injection site and below; redness, hot and felt sore at injection site and below; redness, hot and felt sore at injection site and below; Slept all day; Extremely tired; swelling; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept all day), VACCINATION SITE WARMTH (redness, hot and felt sore at injection site and below), SWELLING (swelling), FATIGUE (Extremely tired) and VACCINATION SITE ERYTHEMA (redness, hot and felt sore at injection site and below) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concomitant products included LISINOPRIL for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced SOMNOLENCE (Slept all day) and FATIGUE (Extremely tired). On 15-Mar-2021, the patient experienced VACCINATION SITE WARMTH (redness, hot and felt sore at injection site and below), VACCINATION SITE ERYTHEMA (redness, hot and felt sore at injection site and below) and VACCINATION SITE PAIN (redness, hot and felt sore at injection site and below). On an unknown date, the patient experienced SWELLING (swelling). At the time of the report, SOMNOLENCE (Slept all day), VACCINATION SITE WARMTH (redness, hot and felt sore at injection site and below), FATIGUE (Extremely tired) and VACCINATION SITE PAIN (redness, hot and felt sore at injection site and below) outcome was unknown and SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redness, hot and felt sore at injection site and below) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment included cold compresses.   This case was linked to MOD-2021-219933 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Updated reporter contact details, Outcome of events vaccination site erythema changed from unknown to recovered/resolved. Added medical history and 1 new event of swelling.
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Not sure if actually got thevaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Not sure if actually got thevaccine) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Not sure if actually got thevaccine). On 15-Mar-2021, PRODUCT ADMINISTRATION ERROR (Not sure if actually got thevaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: This report refers to a case of Product Administration Error for mRNA-1273 (Lot #: 047A21A)  with no associated AEs.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: couldn't breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (couldn't breath) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M2DA) for COVID-19 vaccination.     Concurrent medical conditions included COPD (Had for 10 years).   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced DYSPNOEA (couldn't breath). At the time of the report, DYSPNOEA (couldn't breath) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, SARS-CoV-2 test positive: positive (Positive) Positive.         The patient reported she was in the hospital for 5 hours and had no symptoms.  Concomitant product use was not provided by the reporter.  No treatment information was reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Apraxia, Chills, Chromaturia
Clinical narrative: Blotchy rash on face and neck; Could not sleep; Excessive bloating; Gas; Abdominal pain; Diarrhea; Hard to open eyes; Dark urine; Throat congestion; Blister rash on two fingers of left hand about an inch in diameter; Body aches; Very painful arm; Felt like I was hit by a bus; Chills; Headache like a migraine, headache; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH MACULAR (Blotchy rash on face and neck), INSOMNIA (Could not sleep), ABDOMINAL DISTENSION (Excessive bloating), FLATULENCE (Gas) and ABDOMINAL PAIN (Abdominal pain) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Splenectomy. Concurrent medical conditions included Immunocompromised.    On 12-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 RASH MACULAR (Blotchy rash on face and neck), INSOMNIA (Could not sleep), ABDOMINAL DISTENSION (Excessive bloating), FLATULENCE (Gas), ABDOMINAL PAIN (Abdominal pain), DIARRHOEA (Diarrhea), APRAXIA (Hard to open eyes), CHROMATURIA (Dark urine), THROAT TIGHTNESS (Throat congestion), RASH VESICULAR (Blister rash on two fingers of left hand about an inch in diameter), PAIN (Body aches), PAIN IN EXTREMITY (Very painful arm), MALAISE (Felt like I was hit by a bus), CHILLS (Chills), HEADACHE (Headache like a migraine, headache) and NAUSEA (Nausea). The patient was treated with HYDROCORTISONE for Rash, at a dose of 1 dosage form; SUMATRIPTAN SUCCINATE (IMITREX [SUMATRIPTAN SUCCINATE]) for Headache, at a dose of 1 dosage form and IBUPROFEN for Pain, at a dose of 1 dosage form. At the time of the report, RASH MACULAR (Blotchy rash on face and neck), INSOMNIA (Could not sleep), ABDOMINAL DISTENSION (Excessive bloating), FLATULENCE (Gas), ABDOMINAL PAIN (Abdominal pain), DIARRHOEA (Diarrhea), APRAXIA (Hard to open eyes), CHROMATURIA (Dark urine), THROAT TIGHTNESS (Throat congestion), RASH VESICULAR (Blister rash on two fingers of left hand about an inch in diameter), PAIN (Body aches), PAIN IN EXTREMITY (Very painful arm), MALAISE (Felt like I was hit by a bus), CHILLS (Chills), HEADACHE (Headache like a migraine, headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  Additional treatment for events included IV fluids that patient received at an outpatient clinic. She also stated that she will not be getting the second dose of the vaccine.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Flatulence, Headache, Insomnia, Malaise
Clinical narrative: Blotchy rash on face and neck; Could not sleep; Excessive bloating; Gas; Abdominal pain; Diarrhea; Hard to open eyes; Dark urine; Throat congestion; Blister rash on two fingers of left hand about an inch in diameter; Body aches; Very painful arm; Felt like I was hit by a bus; Chills; Headache like a migraine, headache; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH MACULAR (Blotchy rash on face and neck), INSOMNIA (Could not sleep), ABDOMINAL DISTENSION (Excessive bloating), FLATULENCE (Gas) and ABDOMINAL PAIN (Abdominal pain) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Splenectomy. Concurrent medical conditions included Immunocompromised.    On 12-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 RASH MACULAR (Blotchy rash on face and neck), INSOMNIA (Could not sleep), ABDOMINAL DISTENSION (Excessive bloating), FLATULENCE (Gas), ABDOMINAL PAIN (Abdominal pain), DIARRHOEA (Diarrhea), APRAXIA (Hard to open eyes), CHROMATURIA (Dark urine), THROAT TIGHTNESS (Throat congestion), RASH VESICULAR (Blister rash on two fingers of left hand about an inch in diameter), PAIN (Body aches), PAIN IN EXTREMITY (Very painful arm), MALAISE (Felt like I was hit by a bus), CHILLS (Chills), HEADACHE (Headache like a migraine, headache) and NAUSEA (Nausea). The patient was treated with HYDROCORTISONE for Rash, at a dose of 1 dosage form; SUMATRIPTAN SUCCINATE (IMITREX [SUMATRIPTAN SUCCINATE]) for Headache, at a dose of 1 dosage form and IBUPROFEN for Pain, at a dose of 1 dosage form. At the time of the report, RASH MACULAR (Blotchy rash on face and neck), INSOMNIA (Could not sleep), ABDOMINAL DISTENSION (Excessive bloating), FLATULENCE (Gas), ABDOMINAL PAIN (Abdominal pain), DIARRHOEA (Diarrhea), APRAXIA (Hard to open eyes), CHROMATURIA (Dark urine), THROAT TIGHTNESS (Throat congestion), RASH VESICULAR (Blister rash on two fingers of left hand about an inch in diameter), PAIN (Body aches), PAIN IN EXTREMITY (Very painful arm), MALAISE (Felt like I was hit by a bus), CHILLS (Chills), HEADACHE (Headache like a migraine, headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  Additional treatment for events included IV fluids that patient received at an outpatient clinic. She also stated that she will not be getting the second dose of the vaccine.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Rash macular, Rash vesicular
Clinical narrative: Blotchy rash on face and neck; Could not sleep; Excessive bloating; Gas; Abdominal pain; Diarrhea; Hard to open eyes; Dark urine; Throat congestion; Blister rash on two fingers of left hand about an inch in diameter; Body aches; Very painful arm; Felt like I was hit by a bus; Chills; Headache like a migraine, headache; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH MACULAR (Blotchy rash on face and neck), INSOMNIA (Could not sleep), ABDOMINAL DISTENSION (Excessive bloating), FLATULENCE (Gas) and ABDOMINAL PAIN (Abdominal pain) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Splenectomy. Concurrent medical conditions included Immunocompromised.    On 12-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 RASH MACULAR (Blotchy rash on face and neck), INSOMNIA (Could not sleep), ABDOMINAL DISTENSION (Excessive bloating), FLATULENCE (Gas), ABDOMINAL PAIN (Abdominal pain), DIARRHOEA (Diarrhea), APRAXIA (Hard to open eyes), CHROMATURIA (Dark urine), THROAT TIGHTNESS (Throat congestion), RASH VESICULAR (Blister rash on two fingers of left hand about an inch in diameter), PAIN (Body aches), PAIN IN EXTREMITY (Very painful arm), MALAISE (Felt like I was hit by a bus), CHILLS (Chills), HEADACHE (Headache like a migraine, headache) and NAUSEA (Nausea). The patient was treated with HYDROCORTISONE for Rash, at a dose of 1 dosage form; SUMATRIPTAN SUCCINATE (IMITREX [SUMATRIPTAN SUCCINATE]) for Headache, at a dose of 1 dosage form and IBUPROFEN for Pain, at a dose of 1 dosage form. At the time of the report, RASH MACULAR (Blotchy rash on face and neck), INSOMNIA (Could not sleep), ABDOMINAL DISTENSION (Excessive bloating), FLATULENCE (Gas), ABDOMINAL PAIN (Abdominal pain), DIARRHOEA (Diarrhea), APRAXIA (Hard to open eyes), CHROMATURIA (Dark urine), THROAT TIGHTNESS (Throat congestion), RASH VESICULAR (Blister rash on two fingers of left hand about an inch in diameter), PAIN (Body aches), PAIN IN EXTREMITY (Very painful arm), MALAISE (Felt like I was hit by a bus), CHILLS (Chills), HEADACHE (Headache like a migraine, headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  Additional treatment for events included IV fluids that patient received at an outpatient clinic. She also stated that she will not be getting the second dose of the vaccine.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Blotchy rash on face and neck; Could not sleep; Excessive bloating; Gas; Abdominal pain; Diarrhea; Hard to open eyes; Dark urine; Throat congestion; Blister rash on two fingers of left hand about an inch in diameter; Body aches; Very painful arm; Felt like I was hit by a bus; Chills; Headache like a migraine, headache; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH MACULAR (Blotchy rash on face and neck), INSOMNIA (Could not sleep), ABDOMINAL DISTENSION (Excessive bloating), FLATULENCE (Gas) and ABDOMINAL PAIN (Abdominal pain) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Splenectomy. Concurrent medical conditions included Immunocompromised.    On 12-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 RASH MACULAR (Blotchy rash on face and neck), INSOMNIA (Could not sleep), ABDOMINAL DISTENSION (Excessive bloating), FLATULENCE (Gas), ABDOMINAL PAIN (Abdominal pain), DIARRHOEA (Diarrhea), APRAXIA (Hard to open eyes), CHROMATURIA (Dark urine), THROAT TIGHTNESS (Throat congestion), RASH VESICULAR (Blister rash on two fingers of left hand about an inch in diameter), PAIN (Body aches), PAIN IN EXTREMITY (Very painful arm), MALAISE (Felt like I was hit by a bus), CHILLS (Chills), HEADACHE (Headache like a migraine, headache) and NAUSEA (Nausea). The patient was treated with HYDROCORTISONE for Rash, at a dose of 1 dosage form; SUMATRIPTAN SUCCINATE (IMITREX [SUMATRIPTAN SUCCINATE]) for Headache, at a dose of 1 dosage form and IBUPROFEN for Pain, at a dose of 1 dosage form. At the time of the report, RASH MACULAR (Blotchy rash on face and neck), INSOMNIA (Could not sleep), ABDOMINAL DISTENSION (Excessive bloating), FLATULENCE (Gas), ABDOMINAL PAIN (Abdominal pain), DIARRHOEA (Diarrhea), APRAXIA (Hard to open eyes), CHROMATURIA (Dark urine), THROAT TIGHTNESS (Throat congestion), RASH VESICULAR (Blister rash on two fingers of left hand about an inch in diameter), PAIN (Body aches), PAIN IN EXTREMITY (Very painful arm), MALAISE (Felt like I was hit by a bus), CHILLS (Chills), HEADACHE (Headache like a migraine, headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  Additional treatment for events included IV fluids that patient received at an outpatient clinic. She also stated that she will not be getting the second dose of the vaccine.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: injection site became hard; injection site became swollen; injection site became sore; redness came back and injection site became red; redness at injection site; headache; arm hurt; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (arm hurt), VACCINATION SITE INDURATION (injection site became hard), VACCINATION SITE SWELLING (injection site became swollen), VACCINATION SITE PAIN (injection site became sore) and VACCINATION SITE ERYTHEMA (redness came back and injection site became red) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurt), VACCINATION SITE ERYTHEMA (redness at injection site) and HEADACHE (headache). On 11-Mar-2021, the patient experienced VACCINATION SITE INDURATION (injection site became hard), VACCINATION SITE SWELLING (injection site became swollen), VACCINATION SITE PAIN (injection site became sore) and VACCINATION SITE ERYTHEMA (redness came back and injection site became red). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm hurt), VACCINATION SITE INDURATION (injection site became hard), VACCINATION SITE SWELLING (injection site became swollen), VACCINATION SITE PAIN (injection site became sore), VACCINATION SITE ERYTHEMA (redness came back and injection site became red), VACCINATION SITE ERYTHEMA (redness at injection site) and HEADACHE (headache) 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.   This case was linked to MOD21-054701, MOD-2021-046326, MOD-2021-046269 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Updated outcome  of events Resolved