chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Illness, Nausea
Clinical narrative: stomach aches; I was sick for a day; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach aches), ILLNESS (I was sick for a day) and NAUSEA (Nauseous) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach aches), ILLNESS (I was sick for a day) and NAUSEA (Nauseous). At the time of the report, ABDOMINAL PAIN UPPER (stomach aches), ILLNESS (I was sick for a day) and NAUSEA (Nauseous) had resolved.            No concomitant medications were reported No treatment medications were reported
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: SHINGRIX (Dose 1), SHINGRIX (Dose 2) and SHINGRIX (Dose 2). Past adverse reactions to the above products included Pain in arm with SHINGRIX and SHINGRIX; and Sickness with SHINGRIX. Concomitant products included ATORVASTATIN for Cholesterol, ESTRADIOL for Hormone therapy, LEVOTHYROXINE for Thyroid disorder.    On 07-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 PAIN IN EXTREMITY (very sore arm). At the time of the report, PAIN IN EXTREMITY (very sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided.   This case was linked to MOD-2021-370088, MOD-2021-404925 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: very sore arm; aches all over; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore arm), PAIN (aches all over) and FATIGUE (tiredness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Shingles vaccine (Dose 1), Shingles vaccine (Dose 2) and Shingles vaccine (Dose 2). Past adverse reactions to the above products included Pain in arm with Shingles vaccine and Shingles vaccine; and Sickness with Shingles vaccine. Concomitant products included ATORVASTATIN for Cholesterol, ESTRADIOL for Hormone therapy, LEVOTHYROXINE for Thyroid disorder.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-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 PAIN IN EXTREMITY (very sore arm), PAIN (aches all over) and FATIGUE (tiredness). At the time of the report, PAIN IN EXTREMITY (very sore arm), PAIN (aches all over) and FATIGUE (tiredness) outcome was unknown.            No treatment medication were reported.   This case was linked to MOD-2021-404920, MOD-2021-370088 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Received 1st dose being a 0.25 mL Moderna booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 1st dose being a 0.25 mL Moderna booster) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (Received 1st dose being a 0.25 mL Moderna booster). On 03-Dec-2021, ACCIDENTAL UNDERDOSE (Received 1st dose being a 0.25 mL Moderna booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.  Reporter stated that patient had not reported any symptoms.   Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Malaise
Clinical narrative: under the weather for a day or two; dizziness; headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (under the weather for a day or two), DIZZINESS (dizziness) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A 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) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (under the weather for a day or two), DIZZINESS (dizziness) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MALAISE (under the weather for a day or two), DIZZINESS (dizziness) and HEADACHE (headache) had resolved.            No Concomitant product use was reported.  The reporter was calling on behalf of their wife who was the patient and reported that the patient felt under the weather for a day or two and experienced headache and dizziness, after dose 2. Reportedly, by the morning it was gone.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Diarrhoea, Incorrect dose administered, Vomiting
Clinical narrative: Diarrhea; Vomiting; Given an incorrect dose; Overdosed; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), VOMITING (Vomiting), INCORRECT DOSE ADMINISTERED (Given an incorrect dose) and ACCIDENTAL OVERDOSE (Overdosed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), VOMITING (Vomiting), INCORRECT DOSE ADMINISTERED (Given an incorrect dose) and ACCIDENTAL OVERDOSE (Overdosed). At the time of the report, DIARRHOEA (Diarrhea) and VOMITING (Vomiting) outcome was unknown and INCORRECT DOSE ADMINISTERED (Given an incorrect dose) and ACCIDENTAL OVERDOSE (Overdosed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information were reported.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Mental adverse reactions/Physical adverse reactions; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Mental adverse reactions/Physical adverse reactions) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE REACTION (Mental adverse reactions/Physical adverse reactions). At the time of the report, VACCINATION SITE REACTION (Mental adverse reactions/Physical adverse reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain
Clinical narrative: Pain; Aches; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), MYALGIA (Aches) and FATIGUE (tired) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 023M20A) 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 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PAIN (Pain), MYALGIA (Aches) and FATIGUE (tired). At the time of the report, PAIN (Pain), MYALGIA (Aches) and FATIGUE (tired) outcome was unknown.            Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.  Patient is taking other medication.   This case was linked to MOD-2021-404948, MOD-2021-404958 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vomiting
Clinical narrative: dizziness for over two days; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness for over two days) and VOMITING (vomiting) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Aug-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 DIZZINESS (dizziness for over two days) and VOMITING (vomiting). At the time of the report, DIZZINESS (dizziness for over two days) had resolved and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  Patient stated that he cannot got the second dose on time due to the work. Also stated that when he received the first doce he felt dizziness for over two days and vomiting. that is other reason about he doesn't got the second dose.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin irritation
Clinical narrative: experiencing itchiness on head, and skin becomes itchy and irritated when touched; experiencing itchiness on head, and skin becomes itchy and irritated when touched; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (experiencing itchiness on head, and skin becomes itchy and irritated when touched) and PRURITUS (experiencing itchiness on head, and skin becomes itchy and irritated when touched) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H321B, 041C21A and 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN IRRITATION (experiencing itchiness on head, and skin becomes itchy and irritated when touched) and PRURITUS (experiencing itchiness on head, and skin becomes itchy and irritated when touched). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Adverse event, at an unspecified dose and frequency. At the time of the report, SKIN IRRITATION (experiencing itchiness on head, and skin becomes itchy and irritated when touched) and PRURITUS (experiencing itchiness on head, and skin becomes itchy and irritated when touched) had not resolved.            No concomitant medications was reported.    This case was linked to MOD-2021-404946 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Frequent bowel movements, Limb discomfort, Pain, Palpitations
Clinical narrative: increased bowel movements after the vaccine when she goes like 3 times a day; heart palpitations; could not lift her arm; pain; cough; hot on his right arm; itchy on his right arm; hard on his right arm; red on his right arm/red mark 2 in wide 1 in wide; very swollen area,/approximately 2 inch high and 3 in wide/raised; This spontaneous case was reported by a consumer and describes the occurrence of FREQUENT BOWEL MOVEMENTS (increased bowel movements after the vaccine when she goes like 3 times a day), PALPITATIONS (heart palpitations), LIMB DISCOMFORT (could not lift her arm), PAIN (pain) and COUGH (cough) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Flu in 2020. Concurrent medical conditions included Autoimmune deficiency syndrome (with MTHFH methyltetrohydrofolate reductase deficient and cant convert Vitamin B.), Gluten intolerance and Homocysteinemia. Concomitant products included THYROID, PREDNISOLONE ACETATE and FISH OIL (OMEGA 3 COMPLETE) for an unknown indication.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In November 2021, the patient experienced VACCINATION SITE WARMTH (hot on his right arm), VACCINATION SITE PRURITUS (itchy on his right arm), VACCINATION SITE INDURATION (hard on his right arm), VACCINATION SITE ERYTHEMA (red on his right arm/red mark 2 in wide 1 in wide) and VACCINATION SITE SWELLING (very swollen area,/approximately 2 inch high and 3 in wide/raised). On an unknown date, the patient experienced FREQUENT BOWEL MOVEMENTS (increased bowel movements after the vaccine when she goes like 3 times a day), PALPITATIONS (heart palpitations), LIMB DISCOMFORT (could not lift her arm), PAIN (pain) and COUGH (cough). At the time of the report, FREQUENT BOWEL MOVEMENTS (increased bowel movements after the vaccine when she goes like 3 times a day), LIMB DISCOMFORT (could not lift her arm), PAIN (pain), COUGH (cough), VACCINATION SITE WARMTH (hot on his right arm), VACCINATION SITE PRURITUS (itchy on his right arm), VACCINATION SITE INDURATION (hard on his right arm), VACCINATION SITE ERYTHEMA (red on his right arm/red mark 2 in wide 1 in wide) and VACCINATION SITE SWELLING (very swollen area,/approximately 2 inch high and 3 in wide/raised) outcome was unknown and PALPITATIONS (heart palpitations) had not resolved.      Co-suspect product included  Pfizer with unknown batch number on unknown date. Patient reported that C reactive proteins levels were natural high for her. It was also reported that patient was on OTC medications. No treatment reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: increased bowel movements after the vaccine when she goes like 3 times a day; heart palpitations; could not lift her arm; pain; cough; hot on his right arm; itchy on his right arm; hard on his right arm; red on his right arm/red mark 2 in wide 1 in wide; very swollen area,/approximately 2 inch high and 3 in wide/raised; This spontaneous case was reported by a consumer and describes the occurrence of FREQUENT BOWEL MOVEMENTS (increased bowel movements after the vaccine when she goes like 3 times a day), PALPITATIONS (heart palpitations), LIMB DISCOMFORT (could not lift her arm), PAIN (pain) and COUGH (cough) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Flu in 2020. Concurrent medical conditions included Autoimmune deficiency syndrome (with MTHFH methyltetrohydrofolate reductase deficient and cant convert Vitamin B.), Gluten intolerance and Homocysteinemia. Concomitant products included THYROID, PREDNISOLONE ACETATE and FISH OIL (OMEGA 3 COMPLETE) for an unknown indication.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In November 2021, the patient experienced VACCINATION SITE WARMTH (hot on his right arm), VACCINATION SITE PRURITUS (itchy on his right arm), VACCINATION SITE INDURATION (hard on his right arm), VACCINATION SITE ERYTHEMA (red on his right arm/red mark 2 in wide 1 in wide) and VACCINATION SITE SWELLING (very swollen area,/approximately 2 inch high and 3 in wide/raised). On an unknown date, the patient experienced FREQUENT BOWEL MOVEMENTS (increased bowel movements after the vaccine when she goes like 3 times a day), PALPITATIONS (heart palpitations), LIMB DISCOMFORT (could not lift her arm), PAIN (pain) and COUGH (cough). At the time of the report, FREQUENT BOWEL MOVEMENTS (increased bowel movements after the vaccine when she goes like 3 times a day), LIMB DISCOMFORT (could not lift her arm), PAIN (pain), COUGH (cough), VACCINATION SITE WARMTH (hot on his right arm), VACCINATION SITE PRURITUS (itchy on his right arm), VACCINATION SITE INDURATION (hard on his right arm), VACCINATION SITE ERYTHEMA (red on his right arm/red mark 2 in wide 1 in wide) and VACCINATION SITE SWELLING (very swollen area,/approximately 2 inch high and 3 in wide/raised) outcome was unknown and PALPITATIONS (heart palpitations) had not resolved.      Co-suspect product included  Pfizer with unknown batch number on unknown date. Patient reported that C reactive proteins levels were natural high for her. It was also reported that patient was on OTC medications. No treatment reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Rash, Rash erythematous, Rash morbilliform, Vaccination site erythema
Clinical narrative: rash looks like a sunburn; measles like rash that developed under her bra line and down both sides of the abdomen; rash extended a little further down around the back/mainly on the left side/rash got worse in the evening/rash is worse this time; red patch on her left arm/more towards her armpit; muscle pain; This spontaneous case was reported by a non-health professional and describes the occurrence of RASH ERYTHEMATOUS (rash looks like a sunburn), RASH MORBILLIFORM (measles like rash that developed under her bra line and down both sides of the abdomen), RASH (rash extended a little further down around the back/mainly on the left side/rash got worse in the evening/rash is worse this time), VACCINATION SITE ERYTHEMA (red patch on her left arm/more towards her armpit) and MYALGIA (muscle pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 037C21A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (muscle pain). On 05-Dec-2021, the patient experienced RASH ERYTHEMATOUS (rash looks like a sunburn), RASH MORBILLIFORM (measles like rash that developed under her bra line and down both sides of the abdomen), RASH (rash extended a little further down around the back/mainly on the left side/rash got worse in the evening/rash is worse this time) and VACCINATION SITE ERYTHEMA (red patch on her left arm/more towards her armpit). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Muscle pain, at a dose of two aspirin at bedtime. At the time of the report, RASH ERYTHEMATOUS (rash looks like a sunburn), RASH MORBILLIFORM (measles like rash that developed under her bra line and down both sides of the abdomen), RASH (rash extended a little further down around the back/mainly on the left side/rash got worse in the evening/rash is worse this time), VACCINATION SITE ERYTHEMA (red patch on her left arm/more towards her armpit) and MYALGIA (muscle pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2021-403704, MOD-2021-403687 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenitis
Clinical narrative: Lymph node inflammation in the collarbone area; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENITIS (Lymph node inflammation in the collarbone area) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SPIRONOLACTONE for an unknown indication.    On 04-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Dec-2021, the patient experienced LYMPHADENITIS (Lymph node inflammation in the collarbone area). At the time of the report, LYMPHADENITIS (Lymph node inflammation in the collarbone area) outcome was unknown.            No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Vaccination complication
Clinical narrative: Reaction after booster dose; Fever; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction after booster dose), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction after booster dose), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, VACCINATION COMPLICATION (Reaction after booster dose), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.            The reporter wanted to report on behalf of their friend who was the patient and who experienced reaction after vaccination with booster dose of Moderna COVID-19 vaccine. It was also reported that the patient was more than 60 year old.  No Concomitant product use was reported. No treatment information was provided.   Reporter did not allow further contact
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Tooth infection
Clinical narrative: Has an infection in her tooth, in the bone of her teeth; This spontaneous case was reported by a nurse and describes the occurrence of TOOTH INFECTION (Has an infection in her tooth, in the bone of her teeth) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TOOTH INFECTION (Has an infection in her tooth, in the bone of her teeth). The patient was treated with AMOXICILLIN for Tooth infection, at a dose of 500 mg. At the time of the report, TOOTH INFECTION (Has an infection in her tooth, in the bone of her teeth) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter stated that they had a patient who wanted to get a Moderna booster. The patient received both doses of the Moderna Covid-19 vaccine and had an infection in their tooth, in the bone of their teeth, and had completed a round of antibiotics Amoxicillin 500mg for 5 days for that, a month and a half ago. It was also reported that the patient hasn't had another X-ray, so they don't know whether it was still active or not. Reportedly, the patient was not having their teeth out until January, when they would have them removed.   No Concomitant product use was reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Discomfort, Dysstasia, Myalgia
Clinical narrative: Can't feel bones from hips to lower tibia.; Stand for 10 minutes and has to sit down; can't feel bones from hips to lower tibia, pain in the knee joint; running a temp, like having covid; Body aches; No appetite; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (No appetite), OROPHARYNGEAL PAIN (Sore throat), DISCOMFORT (Can't feel bones from hips to lower tibia.), DYSSTASIA (Stand for 10 minutes and has to sit down) and ARTHRALGIA (can't feel bones from hips to lower tibia, pain in the knee joint) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005c21a, 039k202a and 012l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was not provided.  Concomitant products included METFORMIN HYDROCHLORIDE (MEDFORMIN) and METOPROLOL for an unknown indication.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Nov-2021, the patient experienced DECREASED APPETITE (No appetite), OROPHARYNGEAL PAIN (Sore throat) and MYALGIA (Body aches). On 17-Nov-2021, the patient experienced DISCOMFORT (Can't feel bones from hips to lower tibia.), DYSSTASIA (Stand for 10 minutes and has to sit down), ARTHRALGIA (can't feel bones from hips to lower tibia, pain in the knee joint) and PYREXIA (running a temp, like having covid). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 17-Nov-2021, DECREASED APPETITE (No appetite), OROPHARYNGEAL PAIN (Sore throat) and MYALGIA (Body aches) had resolved. At the time of the report, DISCOMFORT (Can't feel bones from hips to lower tibia.), DYSSTASIA (Stand for 10 minutes and has to sit down), ARTHRALGIA (can't feel bones from hips to lower tibia, pain in the knee joint) and PYREXIA (running a temp, like having covid) outcome was unknown.            Patient had never had any problems after the first and second dose.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Can't feel bones from hips to lower tibia.; Stand for 10 minutes and has to sit down; can't feel bones from hips to lower tibia, pain in the knee joint; running a temp, like having covid; Body aches; No appetite; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (No appetite), OROPHARYNGEAL PAIN (Sore throat), DISCOMFORT (Can't feel bones from hips to lower tibia.), DYSSTASIA (Stand for 10 minutes and has to sit down) and ARTHRALGIA (can't feel bones from hips to lower tibia, pain in the knee joint) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005c21a, 039k202a and 012l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was not provided.  Concomitant products included METFORMIN HYDROCHLORIDE (MEDFORMIN) and METOPROLOL for an unknown indication.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Nov-2021, the patient experienced DECREASED APPETITE (No appetite), OROPHARYNGEAL PAIN (Sore throat) and MYALGIA (Body aches). On 17-Nov-2021, the patient experienced DISCOMFORT (Can't feel bones from hips to lower tibia.), DYSSTASIA (Stand for 10 minutes and has to sit down), ARTHRALGIA (can't feel bones from hips to lower tibia, pain in the knee joint) and PYREXIA (running a temp, like having covid). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 17-Nov-2021, DECREASED APPETITE (No appetite), OROPHARYNGEAL PAIN (Sore throat) and MYALGIA (Body aches) had resolved. At the time of the report, DISCOMFORT (Can't feel bones from hips to lower tibia.), DYSSTASIA (Stand for 10 minutes and has to sit down), ARTHRALGIA (can't feel bones from hips to lower tibia, pain in the knee joint) and PYREXIA (running a temp, like having covid) outcome was unknown.            Patient had never had any problems after the first and second dose.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Somnolence
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept a lot), MYALGIA (achy all over the body/still experiencing achiness in her lower extremities, achiness in legs/achiness in knees/achiness in back) and FATIGUE (very tired, still tired) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 1 Pfizer, lot/batch - EM9810) on 06-Feb-2021, Pfizer vaccine (Dose 2 Pfizer and lot/batch - EN6203) on 27-Feb-2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine. Concomitant products included METFORMIN, LEVOTHYROXINE and ATORVASTATIN for an unknown indication.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced SOMNOLENCE (slept a lot), MYALGIA (achy all over the body/still experiencing achiness in her lower extremities, achiness in legs/achiness in knees/achiness in back) and FATIGUE (very tired, still tired). At the time of the report, SOMNOLENCE (slept a lot) outcome was unknown and MYALGIA (achy all over the body/still experiencing achiness in her lower extremities, achiness in legs/achiness in knees/achiness in back) and FATIGUE (very tired, still tired) had not resolved.            Treatment information was not provided.  Patient received first and second dose Pfizer's vaccine and decided to take Moderna as booster.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Pyrexia, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: issues with breathing; injection site is swollen red and hot; fever; injection site is swollen red and hot; injection site is swollen red and hot; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (issues with breathing), VACCINATION SITE WARMTH (injection site is swollen red and hot), PYREXIA (fever), VACCINATION SITE SWELLING (injection site is swollen red and hot) and VACCINATION SITE ERYTHEMA (injection site is swollen red and hot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced DYSPNOEA (issues with breathing), VACCINATION SITE WARMTH (injection site is swollen red and hot), PYREXIA (fever), VACCINATION SITE SWELLING (injection site is swollen red and hot) and VACCINATION SITE ERYTHEMA (injection site is swollen red and hot). At the time of the report, DYSPNOEA (issues with breathing), VACCINATION SITE WARMTH (injection site is swollen red and hot), PYREXIA (fever), VACCINATION SITE SWELLING (injection site is swollen red and hot) and VACCINATION SITE ERYTHEMA (injection site is swollen red and hot) outcome was unknown.       No concomitant medication were reported.   No Treatment drug were not reported.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: soreness in the arm, the right arm; body ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in the arm, the right arm) and MYALGIA (body ache) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 03-Dec-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 in the arm, the right arm) and MYALGIA (body ache). At the time of the report, VACCINATION SITE PAIN (soreness in the arm, the right arm) and MYALGIA (body ache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient takes a blood thinner medication as regular medication. Patient did not take anything to treat his symptoms only, a hot tea.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Hypersensitivity, Rash
Clinical narrative: blister on her arm; rash on her neck; severe allergic reaction to a booster dose; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (blister on her arm), RASH (rash on her neck) and HYPERSENSITIVITY (severe allergic reaction to a booster dose) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLISTER (blister on her arm), RASH (rash on her neck) and HYPERSENSITIVITY (severe allergic reaction to a booster dose). At the time of the report, BLISTER (blister on her arm), RASH (rash on her neck) and HYPERSENSITIVITY (severe allergic reaction to a booster dose) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was unknown.  The patient seemed distressed and hung up.   Reporter did not allow further contact
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: Fever of 100.1; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 100.1) and HEADACHE (Headache) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 002B21A and 002M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever of 100.1) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever of 100.1) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.1 (High) 100.1.         No pre existing condition and allergy was reported. No concomitant drug details were reported. No treatment details were reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Pyrexia
Clinical narrative: I got sick; chills; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I got sick), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (I got sick), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (I got sick), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.            Patient is on Compound hormone therapy in a capsule form and Medication to control bladder leakage.   This case was linked to MOD-2021-404997 (Patient Link).   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Mass
Clinical narrative: Experiencing bruising, when she bumps herself; Lumps on leg and hand; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Experiencing bruising, when she bumps herself) and MASS (Lumps on leg and hand) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016M20A) for COVID-19 vaccination.     The patient's past medical history included Anxiety (history of anxiety attack years ago), Heart murmur and COVID-19 in October 2020.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced CONTUSION (Experiencing bruising, when she bumps herself) and MASS (Lumps on leg and hand). At the time of the report, CONTUSION (Experiencing bruising, when she bumps herself) and MASS (Lumps on leg and hand) outcome was unknown.            No concomitant medications provided.  No treatment medications provided.   This case was linked to MOD-2021-405008 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Pyrexia
Clinical narrative: I got sick; chills; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I got sick), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A, 013L20A and 058H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-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 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced ILLNESS (I got sick), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. In February 2021, ILLNESS (I got sick), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) had resolved.            Concomitant given as Compound hormone therapy in a capsule form , Medication to control bladder leakage.   This case was linked to MOD-2021-404993 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo bad; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo bad) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (vertigo bad). At the time of the report, VERTIGO (vertigo bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment reported.   This case was linked to MOD-2021-405009 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Ear pruritus, Headache, Lip dry, Oral discomfort
Clinical narrative: Scratching; Burning; Trembling from head to feet; lips is burning; lips is so dry; Ears is itching; Ears is black.; Sometimes his whole head is painful/the left and right side of his head is painful; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Scratching), BURNING SENSATION (Burning), TREMOR (Trembling from head to feet), ORAL DISCOMFORT (lips is burning) and LIP DRY (lips is so dry) in a 76-year-old male 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Scratching), BURNING SENSATION (Burning), TREMOR (Trembling from head to feet), ORAL DISCOMFORT (lips is burning), LIP DRY (lips is so dry), EAR PRURITUS (Ears is itching), SKIN DISCOLOURATION (Ears is black.) and HEADACHE (Sometimes his whole head is painful/the left and right side of his head is painful). At the time of the report, PRURITUS (Scratching), BURNING SENSATION (Burning), TREMOR (Trembling from head to feet), ORAL DISCOMFORT (lips is burning), LIP DRY (lips is so dry), EAR PRURITUS (Ears is itching), SKIN DISCOLOURATION (Ears is black.) and HEADACHE (Sometimes his whole head is painful/the left and right side of his head is painful) outcome was unknown.            No concomitant medication was reported.  No treatment medication use was reported.  Patient stated that something happens to patient after finishing the vaccination series a few months ago. Patient noticed about the symptoms at about 3 weeks before reporting.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Skin discolouration, Tremor
Clinical narrative: Scratching; Burning; Trembling from head to feet; lips is burning; lips is so dry; Ears is itching; Ears is black.; Sometimes his whole head is painful/the left and right side of his head is painful; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Scratching), BURNING SENSATION (Burning), TREMOR (Trembling from head to feet), ORAL DISCOMFORT (lips is burning) and LIP DRY (lips is so dry) in a 76-year-old male 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Scratching), BURNING SENSATION (Burning), TREMOR (Trembling from head to feet), ORAL DISCOMFORT (lips is burning), LIP DRY (lips is so dry), EAR PRURITUS (Ears is itching), SKIN DISCOLOURATION (Ears is black.) and HEADACHE (Sometimes his whole head is painful/the left and right side of his head is painful). At the time of the report, PRURITUS (Scratching), BURNING SENSATION (Burning), TREMOR (Trembling from head to feet), ORAL DISCOMFORT (lips is burning), LIP DRY (lips is so dry), EAR PRURITUS (Ears is itching), SKIN DISCOLOURATION (Ears is black.) and HEADACHE (Sometimes his whole head is painful/the left and right side of his head is painful) outcome was unknown.            No concomitant medication was reported.  No treatment medication use was reported.  Patient stated that something happens to patient after finishing the vaccination series a few months ago. Patient noticed about the symptoms at about 3 weeks before reporting.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administered to a patient of 5 yeas old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a patient of 5 yeas old) in a 5-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Dec-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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a patient of 5 yeas old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a patient of 5 yeas old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: mighty bad headaches, really really bad; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (mighty bad headaches, really really bad) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (mighty bad headaches, really really bad). At the time of the report, HEADACHE (mighty bad headaches, really really bad) outcome was unknown.            No concomitant medications were reported No treatment medications were reported   This case was linked to MOD-2021-404999 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore injection site Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site Arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore injection site Arm). At the time of the report, VACCINATION SITE PAIN (Sore injection site Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.