chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Headache
Clinical narrative: back pain; headache; A spontaneous report was received from a consumer concerning a 91 year old male patients who received   Moderna's  Covid 19 vaccine(mRNA1273) experienced headache and back pain. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Amlodipine, Finasteride, Aspirin, Semi Bi Statin, OraVital.  The patient received their first of two planned doses of mRNA-1273Batch number:014L20A ) on 21-JAN-2021.  On 18-FEB-2021  the patient received their second of two planned doses of mRNA-1273 (Batch number-unknown) intramuscularly for prophylaxis of Covid 19.Since administration of the second dose of vaccine patient had experienced back pain that has been constant as well as a headache that has not subsided. No other side effects were reported for the first vaccination.  The treatment for the event include Tylenol and heating pad.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of the events, headache and backpain were considered as not recovered/not resolved.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: swelling around the injection site; Hot around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (swelling around the injection site) and INJECTION SITE WARMTH (Hot around the injection site) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) 1 dosage form. On 18-Feb-2021, the patient experienced INJECTION SITE SWELLING (swelling around the injection site) and INJECTION SITE WARMTH (Hot around the injection site). At the time of the report, INJECTION SITE SWELLING (swelling around the injection site) and INJECTION SITE WARMTH (Hot around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) was unknown.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Mild hives on arm, neck and face; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Mild hives on arm, neck and face) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Mild hives on arm, neck and face). At the time of the report, URTICARIA (Mild hives on arm, neck and face) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dyspnoea, Erythema, Fatigue, Headache
Clinical narrative: Redness on Arm; Difficulty Breathing; Vision Problems; Balance Problems; Headache; Tiredness; Low Oxygen Levels; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness on Arm), DYSPNOEA (Difficulty Breathing), VISUAL IMPAIRMENT (Vision Problems), BALANCE DISORDER (Balance Problems) and HEADACHE (Headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD, Lung cancer (Small cell lung cancer) and Bell's palsy. Concomitant products included ACETAMINOPHEN, ALPRAZOLAM, ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN CALCIUM (AVASTIN [ATORVASTATIN CALCIUM]), ERYTHROMYCIN, Corbideral, CLOPIDOGREL BISULFATE (PLAVIX), Gabastatin, HYDROCODONE, ALBUTEROL [SALBUTAMOL], LIOTHYRONINE SODIUM (CYTOMEL), MIRTAZAPINE (REMERON), MONTELUKAST SODIUM (SINGULAIR), OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), XYLOMETAZOLINE HYDROCHLORIDE (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]) and TRAMADOL for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced ERYTHEMA (Redness on Arm), DYSPNOEA (Difficulty Breathing), VISUAL IMPAIRMENT (Vision Problems), BALANCE DISORDER (Balance Problems), HEADACHE (Headache), FATIGUE (Tiredness) and OXYGEN SATURATION DECREASED (Low Oxygen Levels). The patient was treated with OXYGEN for Oxygen saturation low, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness on Arm), DYSPNOEA (Difficulty Breathing), VISUAL IMPAIRMENT (Vision Problems), BALANCE DISORDER (Balance Problems), HEADACHE (Headache), FATIGUE (Tiredness) and OXYGEN SATURATION DECREASED (Low Oxygen Levels) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Visual impairment
Clinical narrative: Redness on Arm; Difficulty Breathing; Vision Problems; Balance Problems; Headache; Tiredness; Low Oxygen Levels; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness on Arm), DYSPNOEA (Difficulty Breathing), VISUAL IMPAIRMENT (Vision Problems), BALANCE DISORDER (Balance Problems) and HEADACHE (Headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD, Lung cancer (Small cell lung cancer) and Bell's palsy. Concomitant products included ACETAMINOPHEN, ALPRAZOLAM, ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN CALCIUM (AVASTIN [ATORVASTATIN CALCIUM]), ERYTHROMYCIN, Corbideral, CLOPIDOGREL BISULFATE (PLAVIX), Gabastatin, HYDROCODONE, ALBUTEROL [SALBUTAMOL], LIOTHYRONINE SODIUM (CYTOMEL), MIRTAZAPINE (REMERON), MONTELUKAST SODIUM (SINGULAIR), OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), XYLOMETAZOLINE HYDROCHLORIDE (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]) and TRAMADOL for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced ERYTHEMA (Redness on Arm), DYSPNOEA (Difficulty Breathing), VISUAL IMPAIRMENT (Vision Problems), BALANCE DISORDER (Balance Problems), HEADACHE (Headache), FATIGUE (Tiredness) and OXYGEN SATURATION DECREASED (Low Oxygen Levels). The patient was treated with OXYGEN for Oxygen saturation low, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness on Arm), DYSPNOEA (Difficulty Breathing), VISUAL IMPAIRMENT (Vision Problems), BALANCE DISORDER (Balance Problems), HEADACHE (Headache), FATIGUE (Tiredness) and OXYGEN SATURATION DECREASED (Low Oxygen Levels) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PREDNISONE, ETANERCEPT (ENBREL), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), METHOTREXATE and VITAMINS NOS for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypersensitivity, Nausea, Vaccination site discolouration, Vaccination site erythema
Clinical narrative: Injection site warm; Injection site hard; Itchiness at injection site; Hard lump at injection site; pink ring at injection site; left arm red at injection site; left arm puffy at injection site; pain at injection site; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Hard lump at injection site), VACCINATION SITE DISCOLOURATION (pink ring at injection site), VACCINATION SITE WARMTH (Injection site warm), HYPERSENSITIVITY (Itchiness at injection site) and NAUSEA (Nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced NAUSEA (Nausea) and CHILLS (Chills). On 23-Jan-2021, the patient experienced VACCINATION SITE MASS (Hard lump at injection site), VACCINATION SITE DISCOLOURATION (pink ring at injection site), VACCINATION SITE ERYTHEMA (left arm red at injection site), VACCINATION SITE SWELLING (left arm puffy at injection site) and VACCINATION SITE PAIN (pain at injection site). On 25-Jan-2021, the patient experienced HYPERSENSITIVITY (Itchiness at injection site). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site warm) and VACCINATION SITE PAIN (Injection site hard). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of UNK dosage form. On 18-Jan-2021, NAUSEA (Nausea) and CHILLS (Chills) had resolved. On 25-Jan-2021, VACCINATION SITE MASS (Hard lump at injection site), VACCINATION SITE ERYTHEMA (left arm red at injection site), VACCINATION SITE SWELLING (left arm puffy at injection site) and VACCINATION SITE PAIN (pain at injection site) had resolved. At the time of the report, VACCINATION SITE DISCOLOURATION (pink ring at injection site), VACCINATION SITE WARMTH (Injection site warm) and VACCINATION SITE PAIN (Injection site hard) outcome was unknown and HYPERSENSITIVITY (Itchiness at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Pharmacist advised patient to treat the symptoms with ice and Diphenhydramine. No concomitant medications were reported.  The rash resolved in approximately two weeks. Patient's second dose was scheduled on 11-Feb-2021.   Most recent FOLLOW-UP information incorporated above includes: On 11-Feb-2021: Follow up received on 11 Feb 2021. Significant follow up, additional events added as injection site warm and hard.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site warm; Injection site hard; Itchiness at injection site; Hard lump at injection site; pink ring at injection site; left arm red at injection site; left arm puffy at injection site; pain at injection site; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Hard lump at injection site), VACCINATION SITE DISCOLOURATION (pink ring at injection site), VACCINATION SITE WARMTH (Injection site warm), HYPERSENSITIVITY (Itchiness at injection site) and NAUSEA (Nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced NAUSEA (Nausea) and CHILLS (Chills). On 23-Jan-2021, the patient experienced VACCINATION SITE MASS (Hard lump at injection site), VACCINATION SITE DISCOLOURATION (pink ring at injection site), VACCINATION SITE ERYTHEMA (left arm red at injection site), VACCINATION SITE SWELLING (left arm puffy at injection site) and VACCINATION SITE PAIN (pain at injection site). On 25-Jan-2021, the patient experienced HYPERSENSITIVITY (Itchiness at injection site). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site warm) and VACCINATION SITE PAIN (Injection site hard). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of UNK dosage form. On 18-Jan-2021, NAUSEA (Nausea) and CHILLS (Chills) had resolved. On 25-Jan-2021, VACCINATION SITE MASS (Hard lump at injection site), VACCINATION SITE ERYTHEMA (left arm red at injection site), VACCINATION SITE SWELLING (left arm puffy at injection site) and VACCINATION SITE PAIN (pain at injection site) had resolved. At the time of the report, VACCINATION SITE DISCOLOURATION (pink ring at injection site), VACCINATION SITE WARMTH (Injection site warm) and VACCINATION SITE PAIN (Injection site hard) outcome was unknown and HYPERSENSITIVITY (Itchiness at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Pharmacist advised patient to treat the symptoms with ice and Diphenhydramine. No concomitant medications were reported.  The rash resolved in approximately two weeks. Patient's second dose was scheduled on 11-Feb-2021.   Most recent FOLLOW-UP information incorporated above includes: On 11-Feb-2021: Follow up received on 11 Feb 2021. Significant follow up, additional events added as injection site warm and hard.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: left side of my face looked swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (left side of my face looked swollen) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     no medical history was reported.  Concomitant products included AMLODIPINE, POTASSIUM and OLMESARTAN for an unknown indication.    On 16-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 SWELLING FACE (left side of my face looked swollen). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form and IBUPROFEN at a dose of UNK dosage form. At the time of the report, SWELLING FACE (left side of my face looked swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: No new information was provided
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Injection site haemorrhage, Myalgia
Clinical narrative: nausea; bleeding at injection sight; sore arm; chills; fatigue; joint pain; muscle pain; A spontaneous report was received from a consumer concerning a 70 year old, female patient who experienced bleeding at injection sight / Injection site hemorrhage, chills, fatigue, sore arm /pain in extremity, joint pain /arthralgia, muscle pain /myalgia, nausea.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On 18 Feb 2021, approximately 1 day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 18 Feb 2021, the patient experienced the event(s), bleeding at injection sight, chills, fatigue, sore arm, joint pain, muscle pain and nausea.   Treatment for the event included acetaminophen.    Action taken with mRNA-1273 in response to the event(s) was unknown.  The outcome of the event(s) bleeding at injection sight, chills, fatigue, sore arm, joint pain, muscle pain and nausea were unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: nausea; bleeding at injection sight; sore arm; chills; fatigue; joint pain; muscle pain; A spontaneous report was received from a consumer concerning a 70 year old, female patient who experienced bleeding at injection sight / Injection site hemorrhage, chills, fatigue, sore arm /pain in extremity, joint pain /arthralgia, muscle pain /myalgia, nausea.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On 18 Feb 2021, approximately 1 day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 18 Feb 2021, the patient experienced the event(s), bleeding at injection sight, chills, fatigue, sore arm, joint pain, muscle pain and nausea.   Treatment for the event included acetaminophen.    Action taken with mRNA-1273 in response to the event(s) was unknown.  The outcome of the event(s) bleeding at injection sight, chills, fatigue, sore arm, joint pain, muscle pain and nausea were unknown.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 016M20A) for COVID-19 vaccination.     The patient's past medical history included COPD, Vitamin D deficiency and DVT in 2018. Concurrent medical conditions included Hypertension, Clotting disorder and Hypertension. Concomitant products included MOMETASONE FUROATE (ASMANEX), IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (COMBIVENT) and SALBUTAMOL (ALBUTEROL) for COPD, APIXABAN (ELIQUIS) for DVT, LOSARTAN for Hypertension, VITAMIN D3 for Vitamin D deficiency.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-017443 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: No new information (NNI) was added On 27-Apr-2021: patient demographic details was updated, medical history information was updated, concomitant medications was updated, events was updated; Sender's Comments:  MOD-2021-017443:same patient, two doses
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Pain in extremity
Clinical narrative: sore arm; Little achy in my back; tired; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), BACK PAIN (Little achy in my back), FATIGUE (tired) and FATIGUE (fatigue) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety, Depression and Sleep disorder. Concomitant products included Metamucil and PROBIOTICS NOS for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), BACK PAIN (Little achy in my back), FATIGUE (tired) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (sore arm), BACK PAIN (Little achy in my back), FATIGUE (tired) and FATIGUE (fatigue) outcome was unknown.            Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pain, Pruritus
Clinical narrative: Itchy spot; Red Spot; Painful spot; A spontaneous report was received from a consumer concerning a 75 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Itchy spot /pruritus, red spot /erythema, painful spot /vaccination site pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Feb 2021, approximately 2 days prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Not given) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) Itchy spot, red spot, painful spot.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), Itchy spot, red spot, painful spot was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: "Sick for a few days"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION ("Sick for a few days") in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 VACCINATION COMPLICATION ("Sick for a few days"). At the time of the report, VACCINATION COMPLICATION ("Sick for a few days") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site rash
Clinical narrative: ITCHY; NOT GOING AWAY; GETTING BIGGER , 3 BY 3 INCHES IN DIAMETER; GETTING WORSE; some kind of rash, circular in nature at the site of injection; A spontaneous report was received from a consumer concerning a 78-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events some kind of rash, circular in nature at the site of injection, itchy, not going away, getting bigger , 3 by 3 inches in diameter, getting worse.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A) via unknown route for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced the event(s) some kind of rash, circular in nature at the site of injection, itchy. On an unknown date, the patient experienced the event(s) , not going away, getting bigger , 3 by 3 inches in diameter, getting worse.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), some kind of rash, circular in nature at the site of injection, itchy, not going away, getting bigger , 3 by 3 inches in diameter, getting worse was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of UNK dosage form, qd. At the time of the report, PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment reported.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Positive COVID Test Post Vaccination; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive COVID Test Post Vaccination) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive COVID Test Post Vaccination). On 19-Feb-2021, SARS-COV-2 TEST POSITIVE (Positive COVID Test Post Vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: redness at the injection site that spread to elbow; Pain; Itching; Swelling; Warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at the injection site that spread to elbow), VACCINATION SITE PAIN (Pain), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE WARMTH (Warm) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site that spread to elbow), VACCINATION SITE PAIN (Pain), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE WARMTH (Warm). On 05-Feb-2021, VACCINATION SITE PAIN (Pain) and VACCINATION SITE PRURITUS (Itching) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (redness at the injection site that spread to elbow), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE WARMTH (Warm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Treatment details was reported as hydrocortisone 2.5% cream and ice for several days.   This case was linked to MOD-2021-017279 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: No specific follow-up information recorded.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Myalgia
Clinical narrative: SHORTNESS OF BREATH; MUSCLE PAIN IN THE BACK AND THIGH; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (SHORTNESS OF BREATH) and MYALGIA (MUSCLE PAIN IN THE BACK AND THIGH) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMOXICILLIN for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (SHORTNESS OF BREATH) and MYALGIA (MUSCLE PAIN IN THE BACK AND THIGH). At the time of the report, DYSPNOEA (SHORTNESS OF BREATH) and MYALGIA (MUSCLE PAIN IN THE BACK AND THIGH) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Coronavirus test, Headache, SARS-CoV-2 test positive
Clinical narrative: Tested positive to COVID-19; Headache; This spontaneous case was reported by a nurse and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive to COVID-19) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 SARS-COV-2 TEST POSITIVE (Tested positive to COVID-19) and HEADACHE (Headache). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive to COVID-19) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Coronavirus test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Pain in extremity
Clinical narrative: lower back hurts; calves were hurting; soreness in hips; chills; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back hurts), PAIN IN EXTREMITY (calves were hurting), ARTHRALGIA (soreness in hips) and CHILLS (chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 022M20A) 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) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced CHILLS (chills). On 19-Feb-2021, the patient experienced BACK PAIN (lower back hurts), PAIN IN EXTREMITY (calves were hurting) and ARTHRALGIA (soreness in hips). At the time of the report, BACK PAIN (lower back hurts), PAIN IN EXTREMITY (calves were hurting), ARTHRALGIA (soreness in hips) and CHILLS (chills) outcome was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Pain in extremity
Clinical narrative: irritation on the left eye; the arm hurt a little while; started now in the right eye; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (irritation on the left eye), PAIN IN EXTREMITY (the arm hurt a little while) and EYE IRRITATION (started now in the right eye) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (the arm hurt a little while) and EYE IRRITATION (started now in the right eye). On an unknown date, the patient experienced EYE IRRITATION (irritation on the left eye). At the time of the report, EYE IRRITATION (irritation on the left eye), PAIN IN EXTREMITY (the arm hurt a little while) and EYE IRRITATION (started now in the right eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Washed the eye with water, warm soaked.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Violent diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Violent diarrhea) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided bye the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced DIARRHOEA (Violent diarrhea). On 17-Feb-2021, DIARRHOEA (Violent diarrhea) had resolved.            Concomitant medications reported included medicine for her blood pressure and cholesterol. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Contact information updated
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Visual impairment
Clinical narrative: Vision tingles; Receive vaccine in the gluteus; A spontaneous report was received from a physician for a female patient of an unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vision tingles and received vaccine in the gluteus.  The patient's medical history included breast cancer and had 18 lymph nodes removed. No concomitant product use was reported.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. It was stated that the patient had received vaccine in the gluteus and had experienced vision tingles, noticed by the patient while driving. The vaccine was administered in gluteus on the request by the patient.    Treatment information was unknown.  Action taken with mRNA-1273 for the event, vision tingles, was unknown and for the event, vaccine in the gluteus, was not applicable.  The outcome of the event, vision tingles, was unknown and for the event, vaccine in the gluteus, was resolved.; Reporter's Comments: This report of product administered at inappropriate site refers to a case of for mRNA-1273 with  associated AE of "vision tingles", a causal relationship cannot be excluded.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 symptoms) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic. Concomitant products included IBUPROFEN for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced COVID-19 (COVID-19 symptoms). At the time of the report, COVID-19 (COVID-19 symptoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event included Inhaler and cough medication. Concomitant medications reported also included diabetic medication, cholesterol medication, blood pressure medication.  The patient recovered from COVID-19 after a period of 3 weeks to a months and had symptoms for 7 to 10 days.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: The second dose of vaccine was added. The event outcome updated to recovered.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Chills; Fever; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body ache) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage #1. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body ache). At the time of the report, CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body ache) outcome was unknown.            This case was linked to MOD-2021-017264 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: a ball with inflammation on the right arm; redness on the right arm; itches on the right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (a ball with inflammation on the right arm), VACCINATION SITE ERYTHEMA (redness on the right arm) and VACCINATION SITE PRURITUS (itches on the right arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (a ball with inflammation on the right arm), VACCINATION SITE ERYTHEMA (redness on the right arm) and VACCINATION SITE PRURITUS (itches on the right arm). At the time of the report, VACCINATION SITE SWELLING (a ball with inflammation on the right arm), VACCINATION SITE ERYTHEMA (redness on the right arm) and VACCINATION SITE PRURITUS (itches on the right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, COVID-19, Diarrhoea, Nausea
Clinical narrative: tested positive for covid; diarrhea; stomach upset; nausea; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid), DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (stomach upset) and NAUSEA (nausea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, CLONIDINE, DILTIAZEM, GABAPENTIN, LOSARTAN, QUETIAPINE, TRAMADOL, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HCTZ), INSULIN ASPART (NOVOLOG) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced COVID-19 (tested positive for covid), DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (stomach upset) and NAUSEA (nausea). The patient was treated with ONDANSETRON ongoing since an unknown date at an unspecified dose and frequency; DIAZEPAM at an unspecified dose and frequency; HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE [HYDRALAZINE HYDROCHLORIDE]) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; PANTOPRAZOLE ongoing since an unknown date at an unspecified dose and frequency; BAMLANIVIMAB at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ACRIVASTINE (BENADRYL [ACRIVASTINE]) at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for covid), DIARRHOEA (diarrhea), ABDOMINAL DISCOMFORT (stomach upset) and NAUSEA (nausea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) tested positive for COVID-19.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       On 11Feb2021, the patient visited ER and received infusion of Bamlanivimab
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: sore arm; Headache; Fatigued/ Tired; Fever of 100.4°-100.7°; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), HEADACHE (Headache), FATIGUE (Fatigued/ Tired) and PYREXIA (Fever of 100.4°-100.7°) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021L20A and 010M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), HEADACHE (Headache), FATIGUE (Fatigued/ Tired) and PYREXIA (Fever of 100.4°-100.7°). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 12-Feb-2021, PAIN IN EXTREMITY (sore arm), HEADACHE (Headache), FATIGUE (Fatigued/ Tired) and PYREXIA (Fever of 100.4°-100.7°) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient concomitant medication included thyroid medication.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site rash
Clinical narrative: Rash underneath the injection site; Rash go down to the elbow; Very Itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash underneath the injection site), RASH (Rash go down to the elbow) and PRURITUS (Very Itchy) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Hypersensitivity to medications. Develop rash for any medication.).    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash underneath the injection site), RASH (Rash go down to the elbow) and PRURITUS (Very Itchy). The patient was treated with HYDROCORTISONE on 15-Feb-2021 at an unspecified dose and frequency. On 19-Feb-2021, PRURITUS (Very Itchy) had resolved. At the time of the report, VACCINATION SITE RASH (Rash underneath the injection site) and RASH (Rash go down to the elbow) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up received on 26-apr-2021. The outcome of the event updated to resolved.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Cough, Diarrhoea, Fatigue, Headache
Clinical narrative: A tiny bit of soreness for 24 hrs; Coughing; scratchy throat; diarrhea; no stability standing up; slight runny nose; Fatigue; Headache; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (A tiny bit of soreness for 24 hrs), COUGH (Coughing), THROAT IRRITATION (scratchy throat), DIARRHOEA (diarrhea) and BALANCE DISORDER (no stability standing up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 23-Jan-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 (A tiny bit of soreness for 24 hrs), COUGH (Coughing), THROAT IRRITATION (scratchy throat), DIARRHOEA (diarrhea), BALANCE DISORDER (no stability standing up), RHINORRHOEA (slight runny nose), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, PAIN (A tiny bit of soreness for 24 hrs), COUGH (Coughing), THROAT IRRITATION (scratchy throat), DIARRHOEA (diarrhea), BALANCE DISORDER (no stability standing up), RHINORRHOEA (slight runny nose), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Rhinorrhoea, Throat irritation
Clinical narrative: A tiny bit of soreness for 24 hrs; Coughing; scratchy throat; diarrhea; no stability standing up; slight runny nose; Fatigue; Headache; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (A tiny bit of soreness for 24 hrs), COUGH (Coughing), THROAT IRRITATION (scratchy throat), DIARRHOEA (diarrhea) and BALANCE DISORDER (no stability standing up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 23-Jan-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 (A tiny bit of soreness for 24 hrs), COUGH (Coughing), THROAT IRRITATION (scratchy throat), DIARRHOEA (diarrhea), BALANCE DISORDER (no stability standing up), RHINORRHOEA (slight runny nose), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, PAIN (A tiny bit of soreness for 24 hrs), COUGH (Coughing), THROAT IRRITATION (scratchy throat), DIARRHOEA (diarrhea), BALANCE DISORDER (no stability standing up), RHINORRHOEA (slight runny nose), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: heart started beating a lot faster than usual; A spontaneous report was received from a consumer concerning a 77-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273)  and experienced heart beating a lot faster than usual (tachycardia).  The patient's medical history was not provided. Concomitant medications reported included medicine for blood pressure and cholesterol (medication names not specified).   On 17-Feb-2021, the patient received their first of two planned doses of mRNA-1273 (Lot # 006M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 18-Feb-2021, the patient experienced heart beating a lot faster than usual. Treatment was not taken for the symptoms.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, heart beating a lot faster than usual,  was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event/s has been provided at this time. Further information has been requested.