chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: dose spilled out of needle; dose spilled out of needle; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (dose spilled out of needle) and DEVICE CONNECTION ISSUE (dose spilled out of needle) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced UNDERDOSE (dose spilled out of needle) and DEVICE CONNECTION ISSUE (dose spilled out of needle). On 29-Mar-2021, UNDERDOSE (dose spilled out of needle) and DEVICE CONNECTION ISSUE (dose spilled out of needle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: This report refers to a case of Underdose and device connection issue for mRNA-1273, lot #  028A21A  with no associated AEs.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo; room started spinning; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VERTIGO (vertigo) and VERTIGO (room started spinning) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Vertigo (had it 20 years ago). Concomitant products included DENOSUMAB (PROLIA), OMEPRAZOLE, DULOXETINE HYDROCHLORIDE (CYMBALTA), PRAVASTATIN and METOPROLOL for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced VERTIGO (vertigo) and VERTIGO (room started spinning). The patient was treated with MECLIZINE [MECLOZINE] for Vertigo, at an unspecified dose and frequency. At the time of the report, VERTIGO (vertigo) and VERTIGO (room started spinning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Chromaturia, Faeces discoloured, Urine abnormality
Clinical narrative: urine is now cloudy yellow; Black stoolS; opaque urine with black purple particulates and blotches of white particulates; This spontaneous case was reported by a consumer and describes the occurrence of FAECES DISCOLOURED (Black stoolS), URINE ABNORMALITY (opaque urine with black purple particulates and blotches of white particulates) and CHROMATURIA (urine is now cloudy yellow) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L02A) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 17-Feb-2021, the patient experienced FAECES DISCOLOURED (Black stoolS) and URINE ABNORMALITY (opaque urine with black purple particulates and blotches of white particulates). On 28-Feb-2021, the patient experienced CHROMATURIA (urine is now cloudy yellow). On 17-Feb-2021, FAECES DISCOLOURED (Black stoolS) had resolved. On 28-Feb-2021, URINE ABNORMALITY (opaque urine with black purple particulates and blotches of white particulates) had resolved. On 14-Mar-2021, CHROMATURIA (urine is now cloudy yellow) had resolved. Not Provided          No treatment medication was not reported  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-031222 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: no new information was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-031222:Crosslinked
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Hypoaesthesia, Nausea
Clinical narrative: Tired; Nausea has been coming and going; Extreme vertigo/ vertigo is worse with bending over, and lying on her back; Broke out in a sweat; Pain extending from her finger tips to her shoulder blades; Headaches which will start in the back of her head, move along the left side of her head and into the front; Pain in every extremity at once; A sequence of numbness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in every extremity at once), HYPOAESTHESIA (A sequence of numbness), VERTIGO (Extreme vertigo/ vertigo is worse with bending over, and lying on her back), HYPERHIDROSIS (Broke out in a sweat) and PAIN (Pain extending from her finger tips to her shoulder blades) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Osteoarthritis.   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 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in every extremity at once), HYPOAESTHESIA (A sequence of numbness), PAIN (Pain extending from her finger tips to her shoulder blades) and HEADACHE (Headaches which will start in the back of her head, move along the left side of her head and into the front). On 02-Mar-2021, the patient experienced VERTIGO (Extreme vertigo/ vertigo is worse with bending over, and lying on her back), HYPERHIDROSIS (Broke out in a sweat) and NAUSEA (Nausea has been coming and going). On 09-Mar-2021, the patient experienced FATIGUE (Tired). The patient was treated with MECLIZINE [MECLOZINE] for Vertigo, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. On 02-Mar-2021, HYPERHIDROSIS (Broke out in a sweat) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in every extremity at once), HYPOAESTHESIA (A sequence of numbness), VERTIGO (Extreme vertigo/ vertigo is worse with bending over, and lying on her back), PAIN (Pain extending from her finger tips to her shoulder blades), NAUSEA (Nausea has been coming and going) and FATIGUE (Tired) outcome was unknown and HEADACHE (Headaches which will start in the back of her head, move along the left side of her head and into the front) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.   This case was linked to MOD-2021-061028 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up received and contains No New Information
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vertigo
Clinical narrative: Tired; Nausea has been coming and going; Extreme vertigo/ vertigo is worse with bending over, and lying on her back; Broke out in a sweat; Pain extending from her finger tips to her shoulder blades; Headaches which will start in the back of her head, move along the left side of her head and into the front; Pain in every extremity at once; A sequence of numbness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in every extremity at once), HYPOAESTHESIA (A sequence of numbness), VERTIGO (Extreme vertigo/ vertigo is worse with bending over, and lying on her back), HYPERHIDROSIS (Broke out in a sweat) and PAIN (Pain extending from her finger tips to her shoulder blades) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Osteoarthritis.   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 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in every extremity at once), HYPOAESTHESIA (A sequence of numbness), PAIN (Pain extending from her finger tips to her shoulder blades) and HEADACHE (Headaches which will start in the back of her head, move along the left side of her head and into the front). On 02-Mar-2021, the patient experienced VERTIGO (Extreme vertigo/ vertigo is worse with bending over, and lying on her back), HYPERHIDROSIS (Broke out in a sweat) and NAUSEA (Nausea has been coming and going). On 09-Mar-2021, the patient experienced FATIGUE (Tired). The patient was treated with MECLIZINE [MECLOZINE] for Vertigo, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. On 02-Mar-2021, HYPERHIDROSIS (Broke out in a sweat) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in every extremity at once), HYPOAESTHESIA (A sequence of numbness), VERTIGO (Extreme vertigo/ vertigo is worse with bending over, and lying on her back), PAIN (Pain extending from her finger tips to her shoulder blades), NAUSEA (Nausea has been coming and going) and FATIGUE (Tired) outcome was unknown and HEADACHE (Headaches which will start in the back of her head, move along the left side of her head and into the front) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.   This case was linked to MOD-2021-061028 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up received and contains No New Information
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling hot, Influenza like illness, Malaise, Pain in extremity
Clinical narrative: feeling really sick; flu-like symptoms; diarrhea; felt warm a few times; vomiting; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling really sick), INFLUENZA LIKE ILLNESS (flu-like symptoms), DIARRHOEA (diarrhea), FEELING HOT (felt warm a few times) and PAIN IN EXTREMITY (sore arm) in a 69-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.     Concurrent medical conditions included Blood pressure high, Gout, Allergy and Enlarged prostate. Concomitant products included LORATADINE for Allergy, LOSARTAN and METOPROLOL for Blood pressure high, TAMSULOSIN for Enlarged prostate, ALOPURINOL for Gout, PANTOPRAZOLE, FENOFIBRATE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 13-Mar-2021, the patient experienced MALAISE (feeling really sick), INFLUENZA LIKE ILLNESS (flu-like symptoms), DIARRHOEA (diarrhea), FEELING HOT (felt warm a few times) and VOMITING (vomiting). At the time of the report, MALAISE (feeling really sick), INFLUENZA LIKE ILLNESS (flu-like symptoms), DIARRHOEA (diarrhea), FEELING HOT (felt warm a few times), PAIN IN EXTREMITY (sore arm) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: feeling really sick; flu-like symptoms; diarrhea; felt warm a few times; vomiting; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling really sick), INFLUENZA LIKE ILLNESS (flu-like symptoms), DIARRHOEA (diarrhea), FEELING HOT (felt warm a few times) and PAIN IN EXTREMITY (sore arm) in a 69-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.     Concurrent medical conditions included Blood pressure high, Gout, Allergy and Enlarged prostate. Concomitant products included LORATADINE for Allergy, LOSARTAN and METOPROLOL for Blood pressure high, TAMSULOSIN for Enlarged prostate, ALOPURINOL for Gout, PANTOPRAZOLE, FENOFIBRATE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 13-Mar-2021, the patient experienced MALAISE (feeling really sick), INFLUENZA LIKE ILLNESS (flu-like symptoms), DIARRHOEA (diarrhea), FEELING HOT (felt warm a few times) and VOMITING (vomiting). At the time of the report, MALAISE (feeling really sick), INFLUENZA LIKE ILLNESS (flu-like symptoms), DIARRHOEA (diarrhea), FEELING HOT (felt warm a few times), PAIN IN EXTREMITY (sore arm) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pruritus, Vaccination site rash, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Sore arm; Delayed baseball size red area under injection site; Warmth at the site of the injection on left arm; Itching at the site of the injection on left arm; Rash at the site of the injection on left arm; Swelling at the site of the injection on left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE REACTION (Delayed baseball size red area under injection site), VACCINATION SITE WARMTH (Warmth at the site of the injection on left arm), VACCINATION SITE PRURITUS (Itching at the site of the injection on left arm) and VACCINATION SITE RASH (Rash at the site of the injection on left arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-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 (Sore arm) and VACCINATION SITE REACTION (Delayed baseball size red area under injection site). an unknown date, the patient experienced VACCINATION SITE WARMTH (Warmth at the site of the injection on left arm), VACCINATION SITE PRURITUS (Itching at the site of the injection on left arm), VACCINATION SITE RASH (Rash at the site of the injection on left arm) and VACCINATION SITE SWELLING (Swelling at the site of the injection on left arm). At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE REACTION (Delayed baseball size red area under injection site), VACCINATION SITE WARMTH (Warmth at the site of the injection on left arm), VACCINATION SITE PRURITUS (Itching at the site of the injection on left arm), VACCINATION SITE RASH (Rash at the site of the injection on left arm) and VACCINATION SITE SWELLING (Swelling at the site of the injection on left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: New events; sore arm and baseball size red area below the injection site was added.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Sore arm; Delayed baseball size red area under injection site; Warmth at the site of the injection on left arm; Itching at the site of the injection on left arm; Rash at the site of the injection on left arm; Swelling at the site of the injection on left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE REACTION (Delayed baseball size red area under injection site), VACCINATION SITE WARMTH (Warmth at the site of the injection on left arm), VACCINATION SITE PRURITUS (Itching at the site of the injection on left arm) and VACCINATION SITE RASH (Rash at the site of the injection on left arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-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 (Sore arm) and VACCINATION SITE REACTION (Delayed baseball size red area under injection site). an unknown date, the patient experienced VACCINATION SITE WARMTH (Warmth at the site of the injection on left arm), VACCINATION SITE PRURITUS (Itching at the site of the injection on left arm), VACCINATION SITE RASH (Rash at the site of the injection on left arm) and VACCINATION SITE SWELLING (Swelling at the site of the injection on left arm). At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE REACTION (Delayed baseball size red area under injection site), VACCINATION SITE WARMTH (Warmth at the site of the injection on left arm), VACCINATION SITE PRURITUS (Itching at the site of the injection on left arm), VACCINATION SITE RASH (Rash at the site of the injection on left arm) and VACCINATION SITE SWELLING (Swelling at the site of the injection on left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: New events; sore arm and baseball size red area below the injection site was added.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced SINUSITIS (sinus infection). The patient was treated with AMOXICILLIN at an unspecified dose and frequency. At the time of the report, SINUSITIS (sinus infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: "not feeling well"; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE ("not feeling well") in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced MALAISE ("not feeling well"). On 13-Mar-2021, MALAISE ("not feeling well") had resolved.            No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-061036 (Patient Link).; Sender'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.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea
Clinical narrative: early and prolonged menstrual cycle; This spontaneous case was reported by a consumer and describes the occurrence of OLIGOMENORRHOEA (early and prolonged menstrual cycle) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced OLIGOMENORRHOEA (early and prolonged menstrual cycle). At the time of the report, OLIGOMENORRHOEA (early and prolonged menstrual cycle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was provided.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the injection site, hurt so bad, hurts less now, when they raise their arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site, hurt so bad, hurts less now, when they raise their arm) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) and IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at the injection site, hurt so bad, hurts less now, when they raise their arm). At the time of the report, VACCINATION SITE PAIN (pain at the injection site, hurt so bad, hurts less now, when they raise their arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. .
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Broke out in hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Broke out in hives) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No medical reported history provided by the reporter.  Concomitant products included LOSARTAN, METOPROLOL SUCCINATE and ATORVASTATIN for an unknown indication.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced URTICARIA (Broke out in hives). At the time of the report, URTICARIA (Broke out in hives) had resolved.            The patient was treated with Lotions as a corrective treatment for the event hives (around my waist).   This case was linked to MOD-2021-061009 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up was received on 13-May-2021, the outcome of event updated.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Blood pressure increased, Blood pressure measurement, Dizziness, Heart rate increased
Clinical narrative: Lingering daily dizzines; Lingering daily instability; Increased blood pressure of 155/80; Rapid heartbeat; Immediate reaction; Allergic reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Lingering daily dizzines), BALANCE DISORDER (Lingering daily instability), BLOOD PRESSURE INCREASED (Increased blood pressure of 155/80), HEART RATE INCREASED (Rapid heartbeat) and IMMEDIATE POST-INJECTION REACTION (Immediate reaction) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), MULTIVITAMINS [VITAMINS NOS], IRON, ZINC, SELENIUM, COLECALCIFEROL, MENAQUINONE-7, PHYTOMENADIONE, RETINOL PALMITATE, TOCOPHEROL, TOCOTRIENOLS NOS (VITAMIN D COMPLEX), MAGNESIUM CITRATE, CARNITINE, UBIDECARENONE (CO Q10), VITAMIN C [ASCORBIC ACID] and CALCIUM for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DIZZINESS (Lingering daily dizzines), BALANCE DISORDER (Lingering daily instability), BLOOD PRESSURE INCREASED (Increased blood pressure of 155/80), HEART RATE INCREASED (Rapid heartbeat), IMMEDIATE POST-INJECTION REACTION (Immediate reaction) and HYPERSENSITIVITY (Allergic reaction). On 05-Mar-2021, BLOOD PRESSURE INCREASED (Increased blood pressure of 155/80) and HEART RATE INCREASED (Rapid heartbeat) had resolved. At the time of the report, DIZZINESS (Lingering daily dizzines), BALANCE DISORDER (Lingering daily instability), IMMEDIATE POST-INJECTION REACTION (Immediate reaction) and HYPERSENSITIVITY (Allergic reaction) outcome was unknown. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Blood pressure measurement: 155/80 (High) 155/80 (patient normal blood pressure is 100/70)..     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.   The patient was monitored by nurse. Products known to have been used by the patient, within two weeks prior to the event, included ubinol. Treatment for the event included cranberry juice.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Immediate post-injection reaction
Clinical narrative: Lingering daily dizzines; Lingering daily instability; Increased blood pressure of 155/80; Rapid heartbeat; Immediate reaction; Allergic reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Lingering daily dizzines), BALANCE DISORDER (Lingering daily instability), BLOOD PRESSURE INCREASED (Increased blood pressure of 155/80), HEART RATE INCREASED (Rapid heartbeat) and IMMEDIATE POST-INJECTION REACTION (Immediate reaction) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), MULTIVITAMINS [VITAMINS NOS], IRON, ZINC, SELENIUM, COLECALCIFEROL, MENAQUINONE-7, PHYTOMENADIONE, RETINOL PALMITATE, TOCOPHEROL, TOCOTRIENOLS NOS (VITAMIN D COMPLEX), MAGNESIUM CITRATE, CARNITINE, UBIDECARENONE (CO Q10), VITAMIN C [ASCORBIC ACID] and CALCIUM for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DIZZINESS (Lingering daily dizzines), BALANCE DISORDER (Lingering daily instability), BLOOD PRESSURE INCREASED (Increased blood pressure of 155/80), HEART RATE INCREASED (Rapid heartbeat), IMMEDIATE POST-INJECTION REACTION (Immediate reaction) and HYPERSENSITIVITY (Allergic reaction). On 05-Mar-2021, BLOOD PRESSURE INCREASED (Increased blood pressure of 155/80) and HEART RATE INCREASED (Rapid heartbeat) had resolved. At the time of the report, DIZZINESS (Lingering daily dizzines), BALANCE DISORDER (Lingering daily instability), IMMEDIATE POST-INJECTION REACTION (Immediate reaction) and HYPERSENSITIVITY (Allergic reaction) outcome was unknown. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Blood pressure measurement: 155/80 (High) 155/80 (patient normal blood pressure is 100/70)..     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.   The patient was monitored by nurse. Products known to have been used by the patient, within two weeks prior to the event, included ubinol. Treatment for the event included cranberry juice.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Vaccination site pain
Clinical narrative: tiny knot in the are of the injection; extreme soreness at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (tiny knot in the area of the injection) and VACCINATION SITE PAIN (extreme soreness at the site of the injection) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (extreme soreness at the site of the injection). On an unknown date, the patient experienced INJECTION SITE MASS (tiny knot in the area of the injection). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 06-Mar-2021, VACCINATION SITE PAIN (extreme soreness at the site of the injection) had resolved. At the time of the report, INJECTION SITE MASS (tiny knot in the are of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment include Advil
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: itchy; severe rash hives; severe rash hives; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itchy), URTICARIA (severe rash hives) and RASH (severe rash hives) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchy), URTICARIA (severe rash hives) and RASH (severe rash hives). The patient was treated with PREDNISONE at an unspecified dose and frequency and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy), URTICARIA (severe rash hives) and RASH (severe rash hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.
Age: 76.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: burning at the injection site; red; there was a lump; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (burning at the injection site), INJECTION SITE ERYTHEMA (red) and INJECTION SITE MASS (there was a lump) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.    Co-suspect product included non-company product MECLIZINE [MECLOZINE] for Nausea.    Concurrent medical conditions included Osteoarthritis.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started MECLIZINE [MECLOZINE] (unknown route) at an unspecified dose. On 13-Mar-2021, the patient experienced INJECTION SITE PAIN (burning at the injection site), INJECTION SITE ERYTHEMA (red) and INJECTION SITE MASS (there was a lump). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 18-Mar-2021, INJECTION SITE PAIN (burning at the injection site) and INJECTION SITE MASS (there was a lump) had resolved and INJECTION SITE ERYTHEMA (red) outcome was unknown.            Action taken with vaccine was not applicable. No concomitant medication was reported.   This case was linked to MOD-2021-061017, MOD-2021-061017 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: soreness; achiness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness) and PAIN (achiness) 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.    In March 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) and PAIN (achiness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (soreness) and PAIN (achiness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 11A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-061049, MOD-2021-061049 (Patient Link).   Reporter did not allowfurther contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up received on 7-JUL-2021.event outcome updated and declined consent for follow up.; Sender'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.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: Asthma attack; A spontaneous report was received from a consumer (patient) which concerns a 64-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced an asthma attack.  The patient's medical history and concomitant medications were not reported.  On 02-Mar-2021, the patient received his first dose of two planned doses of mRNA-1273 (Lot number: 011A21A) intramuscularly for prophylaxis of COVID-19 infection.   On 25-Mar-2021, the patient had an asthma attack.  Treatment included prednisone and levabuterol nebulizer breo ellipta for 5 days.  Action taken with mRNA-1273 was unknown.  The outcome of the event asthma attack was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Vaccination site warmth
Clinical narrative: Hot arm; Arm swelling; Red arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot arm), PERIPHERAL SWELLING (Arm swelling) and ERYTHEMA (Red arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot arm), PERIPHERAL SWELLING (Arm swelling) and ERYTHEMA (Red arm). At the time of the report, VACCINATION SITE WARMTH (Hot arm), PERIPHERAL SWELLING (Arm swelling) and ERYTHEMA (Red arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for covid) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical condition reported).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced COVID-19 (Tested positive for covid). At the time of the report, COVID-19 (Tested positive for covid) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information provided include ibuprofen
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Paraesthesia
Clinical narrative: tingling sensation on the sides of patient face and on different parts of the body; feeling illness; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling illness) and PARAESTHESIA (tingling sensation on the sides of patient face and on different parts of the body) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   Concomitant medications were not reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced PARAESTHESIA (tingling sensation on the sides of patient face and on different parts of the body). On an unknown date, the patient experienced MALAISE (feeling illness).   At the time of the report, PARAESTHESIA (tingling sensation on the sides of patient face and on different parts of the body) outcome was unknown.      No treatment medications are included.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present
Clinical narrative: Passing of blood in urine; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD URINE PRESENT (Passing of blood in urine) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included Nephrectomy (kidney removal) on 26-Mar-2021. Concurrent medical conditions included Cancer.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD URINE PRESENT (Passing of blood in urine). At the time of the report, BLOOD URINE PRESENT (Passing of blood in urine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Dyspnoea, Ear pain, Fatigue
Clinical narrative: Pain in legs; Pain behind ears; Cough; Arm became red and inflamed; Arm became red and inflamed; Head ache; Fatigue; Trouble breathing; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Trouble breathing), CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Pain in legs), EAR PAIN (Pain behind ears) and COUGH (Cough) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy NOS. Concomitant products included MONTELUKAST and DUPILUMAB (DUPIXENT) for Allergy.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DYSPNOEA (Trouble breathing) and CHEST PAIN (Chest pain). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in legs), EAR PAIN (Pain behind ears), COUGH (Cough), VACCINATION SITE ERYTHEMA (Arm became red and inflamed), VACCINATION SITE SWELLING (Arm became red and inflamed), HEADACHE (Head ache) and FATIGUE (Fatigue). At the time of the report, DYSPNOEA (Trouble breathing) and CHEST PAIN (Chest pain) was resolving and PAIN IN EXTREMITY (Pain in legs), EAR PAIN (Pain behind ears), COUGH (Cough), VACCINATION SITE ERYTHEMA (Arm became red and inflamed), VACCINATION SITE SWELLING (Arm became red and inflamed), HEADACHE (Head ache) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, SARS-CoV-2 test: unknown Unknown/ Pending.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was tested for COVID-19 (result pending). Treatment medications included antihistaminic and ibuprofen.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, SARS-CoV-2 test, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Pain in legs; Pain behind ears; Cough; Arm became red and inflamed; Arm became red and inflamed; Head ache; Fatigue; Trouble breathing; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Trouble breathing), CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Pain in legs), EAR PAIN (Pain behind ears) and COUGH (Cough) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy NOS. Concomitant products included MONTELUKAST and DUPILUMAB (DUPIXENT) for Allergy.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DYSPNOEA (Trouble breathing) and CHEST PAIN (Chest pain). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in legs), EAR PAIN (Pain behind ears), COUGH (Cough), VACCINATION SITE ERYTHEMA (Arm became red and inflamed), VACCINATION SITE SWELLING (Arm became red and inflamed), HEADACHE (Head ache) and FATIGUE (Fatigue). At the time of the report, DYSPNOEA (Trouble breathing) and CHEST PAIN (Chest pain) was resolving and PAIN IN EXTREMITY (Pain in legs), EAR PAIN (Pain behind ears), COUGH (Cough), VACCINATION SITE ERYTHEMA (Arm became red and inflamed), VACCINATION SITE SWELLING (Arm became red and inflamed), HEADACHE (Head ache) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, SARS-CoV-2 test: unknown Unknown/ Pending.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was tested for COVID-19 (result pending). Treatment medications included antihistaminic and ibuprofen.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Knee arthroplasty, Pain in extremity
Clinical narrative: Sore arm; Knee replacement surgery; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and KNEE ARTHROPLASTY (Knee replacement surgery) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 36A21A) for COVID-19 vaccination.     Concurrent medical conditions included Knee deformity. Concomitant products included OXYCODONE and PARACETAMOL (TYLENOL) for Pain.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and KNEE ARTHROPLASTY (Knee replacement surgery). At the time of the report, PAIN IN EXTREMITY (Sore arm) and KNEE ARTHROPLASTY (Knee replacement surgery) 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.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: severe itchiness; redness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (severe itchiness) and ERYTHEMA (redness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PRURITUS (severe itchiness) and ERYTHEMA (redness). At the time of the report, PRURITUS (severe itchiness) and ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: fell sick; (got ill )with a fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (fell sick) and PYREXIA ((got ill )with a fever) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced MALAISE (fell sick) and PYREXIA ((got ill )with a fever). At the time of the report, MALAISE (fell sick) and PYREXIA ((got ill )with a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.