chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: severe tight pain/ in a lot of pain; Muscle kept twitching that is very painful/ Twitching affecting all of her muscles; Arm is really tired and she is unable to brush her hair; cramps in her stomach; Left eye keeps twitching; Whole left leg from her knee to her ankle was really hard and solid, and it felt like it was tightening; Muscle contractions pretty much everywhere; Hard chest contractions; Has a lot of discomfort; Arm was a little tender the first day; runny nose; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Has a lot of discomfort), TENDERNESS (Arm was a little tender the first day), PAIN (severe tight pain/ in a lot of pain), MUSCLE TWITCHING (Muscle kept twitching that is very painful/ Twitching affecting all of her muscles) and MOBILITY DECREASED (Arm is really tired and she is unable to brush her hair) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced DISCOMFORT (Has a lot of discomfort), TENDERNESS (Arm was a little tender the first day) and RHINORRHOEA (runny nose). On 08-Mar-2021, the patient experienced PAIN (severe tight pain/ in a lot of pain), MUSCLE TWITCHING (Muscle kept twitching that is very painful/ Twitching affecting all of her muscles), MOBILITY DECREASED (Arm is really tired and she is unable to brush her hair), ABDOMINAL PAIN UPPER (cramps in her stomach), BLEPHAROSPASM (Left eye keeps twitching), PAIN IN EXTREMITY (Whole left leg from her knee to her ankle was really hard and solid, and it felt like it was tightening), MUSCLE CONTRACTIONS INVOLUNTARY (Muscle contractions pretty much everywhere) and CHEST PAIN (Hard chest contractions). On 07-Mar-2021, TENDERNESS (Arm was a little tender the first day) had resolved. On 09-Mar-2021, PAIN (severe tight pain/ in a lot of pain), MUSCLE TWITCHING (Muscle kept twitching that is very painful/ Twitching affecting all of her muscles), MOBILITY DECREASED (Arm is really tired and she is unable to brush her hair), ABDOMINAL PAIN UPPER (cramps in her stomach), PAIN IN EXTREMITY (Whole left leg from her knee to her ankle was really hard and solid, and it felt like it was tightening), MUSCLE CONTRACTIONS INVOLUNTARY (Muscle contractions pretty much everywhere) and CHEST PAIN (Hard chest contractions) had resolved. At the time of the report, DISCOMFORT (Has a lot of discomfort), BLEPHAROSPASM (Left eye keeps twitching) and RHINORRHOEA (runny nose) 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 concomitant medications and treatment medications were reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: itchy; red circle the size of a golf ball; Pain in right arm from hand up to shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy), ERYTHEMA (red circle the size of a golf ball) and PAIN IN EXTREMITY (Pain in right arm from hand up to shoulder) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in right arm from hand up to shoulder). On 03-Mar-2021, the patient experienced PRURITUS (itchy) and ERYTHEMA (red circle the size of a golf ball). The patient was treated with BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOCAINE HYDROCHLORIDE (NEOSPORIN + BURN RELIEF) at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy) and ERYTHEMA (red circle the size of a golf ball) outcome was unknown and PAIN IN EXTREMITY (Pain in right arm from hand up to shoulder) had not resolved. Not Provided          The patient reported, still has pain in her right arm from her hand up to her shoulder. She reports an 8 out of a 1-10 pain scale when she moves it.  Concomitant product use was not provided by the reporter. Treatment medication included Neosporin to treat the itchiness.  Action taken with mRNA-123 is not applicable.   This case was linked to MOD-2021-039742 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Reporter address updated, new event added.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Experienced worsening of fever this morning; Experiencing chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Experienced worsening of fever this morning), CHILLS (Experiencing chills) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 immunisation.     The patient's past medical history included Stroke.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced PYREXIA (Experienced worsening of fever this morning), CHILLS (Experiencing chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, Pyrexia and Chills, at an unspecified dose and frequency. At the time of the report, PYREXIA (Experienced worsening of fever this morning), CHILLS (Experiencing chills) and HEADACHE (Headache) was resolving.            Concomitant medication list was not provided. The patient also mentions a limited functionality on right arm due to health history therefore only receives vaccination and so on to her left arm.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Dyspnoea exertional, Heart rate, Hyperhidrosis, Malaise
Clinical narrative: shortness of breath; malaise; woke up during the night with/ night sweats; she walked 10 feet and had shortness of breath; she had sweats this morning and she lied down; severe nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), MALAISE (malaise), NIGHT SWEATS (woke up during the night with/ night sweats), DYSPNOEA EXERTIONAL (she walked 10 feet and had shortness of breath) and HYPERHIDROSIS (she had sweats this morning and she lied down) in a 78-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 Mitral valve disease, Blood disorder (Patient has rare blood condition ) and Polycythemia vera (PV). Concomitant products included CEFALEXIN (CEPHALEXINE) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced DYSPNOEA (shortness of breath), MALAISE (malaise), NIGHT SWEATS (woke up during the night with/ night sweats), DYSPNOEA EXERTIONAL (she walked 10 feet and had shortness of breath), HYPERHIDROSIS (she had sweats this morning and she lied down) and NAUSEA (severe nausea). At the time of the report, DYSPNOEA (shortness of breath), MALAISE (malaise), NIGHT SWEATS (woke up during the night with/ night sweats), DYSPNOEA EXERTIONAL (she walked 10 feet and had shortness of breath), HYPERHIDROSIS (she had sweats this morning and she lied down) and NAUSEA (severe nausea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Heart rate: rapid heart beat High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Night sweats
Clinical narrative: shortness of breath; malaise; woke up during the night with/ night sweats; she walked 10 feet and had shortness of breath; she had sweats this morning and she lied down; severe nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), MALAISE (malaise), NIGHT SWEATS (woke up during the night with/ night sweats), DYSPNOEA EXERTIONAL (she walked 10 feet and had shortness of breath) and HYPERHIDROSIS (she had sweats this morning and she lied down) in a 78-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 Mitral valve disease, Blood disorder (Patient has rare blood condition ) and Polycythemia vera (PV). Concomitant products included CEFALEXIN (CEPHALEXINE) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced DYSPNOEA (shortness of breath), MALAISE (malaise), NIGHT SWEATS (woke up during the night with/ night sweats), DYSPNOEA EXERTIONAL (she walked 10 feet and had shortness of breath), HYPERHIDROSIS (she had sweats this morning and she lied down) and NAUSEA (severe nausea). At the time of the report, DYSPNOEA (shortness of breath), MALAISE (malaise), NIGHT SWEATS (woke up during the night with/ night sweats), DYSPNOEA EXERTIONAL (she walked 10 feet and had shortness of breath), HYPERHIDROSIS (she had sweats this morning and she lied down) and NAUSEA (severe nausea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Heart rate: rapid heart beat High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia, Unevaluable event
Clinical narrative: Delayed reaction; Upper right arm hurts, left arm hurts; mild Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Delayed reaction), PAIN IN EXTREMITY (Upper right arm hurts, left arm hurts), PYREXIA (Fever) and CHILLS (mild Chills) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). On 03-Mar-2021, the patient experienced CHILLS (mild Chills). On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Upper right arm hurts, left arm hurts). On an unknown date, the patient experienced UNEVALUABLE EVENT (Delayed reaction). The patient was treated with NAPROXEN SODIUM (ALEVE) for Chills and Fever, at an unspecified dose and frequency. On 03-Mar-2021, CHILLS (mild Chills) had resolved. On 09-Apr-2021, PAIN IN EXTREMITY (Upper right arm hurts, left arm hurts) had resolved. At the time of the report, UNEVALUABLE EVENT (Delayed reaction) outcome was unknown and PYREXIA (Fever) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.    This case was linked to MOD-2021-039737.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Event (Right arm hurts and delayed reaction) added
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cold-stimulus headache, Dizziness, Electrocardiogram, Feeling jittery
Clinical narrative: slight numbness on upper lip; light headed; head felt heavy; fast heart beat; jitteriness; sore arm; slight brain freeze; tightness in chest; facial numbness on left side; headache; nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA ORAL (slight numbness on upper lip), DIZZINESS (light headed), HEAD DISCOMFORT (head felt heavy), PALPITATIONS (fast heart beat) and FEELING JITTERY (jitteriness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 HYPOAESTHESIA ORAL (slight numbness on upper lip), DIZZINESS (light headed), HEAD DISCOMFORT (head felt heavy), PALPITATIONS (fast heart beat), FEELING JITTERY (jitteriness), PAIN IN EXTREMITY (sore arm), COLD-STIMULUS HEADACHE (slight brain freeze), CHEST DISCOMFORT (tightness in chest), HYPOAESTHESIA (facial numbness on left side), HEADACHE (headache) and NAUSEA (nausea). On 10-Mar-2021, HYPOAESTHESIA ORAL (slight numbness on upper lip), DIZZINESS (light headed), HEAD DISCOMFORT (head felt heavy), PALPITATIONS (fast heart beat), FEELING JITTERY (jitteriness), PAIN IN EXTREMITY (sore arm), COLD-STIMULUS HEADACHE (slight brain freeze), CHEST DISCOMFORT (tightness in chest), HEADACHE (headache) and NAUSEA (nausea) had resolved. At the time of the report, HYPOAESTHESIA (facial numbness on left side) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) Normal. On an unknown date, Magnetic resonance imaging: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow-up information received on 08-JUN-2021 contains non-significant information: Updated Reporter contact details and address.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Hypoaesthesia, Hypoaesthesia oral, Magnetic resonance imaging
Clinical narrative: slight numbness on upper lip; light headed; head felt heavy; fast heart beat; jitteriness; sore arm; slight brain freeze; tightness in chest; facial numbness on left side; headache; nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA ORAL (slight numbness on upper lip), DIZZINESS (light headed), HEAD DISCOMFORT (head felt heavy), PALPITATIONS (fast heart beat) and FEELING JITTERY (jitteriness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 HYPOAESTHESIA ORAL (slight numbness on upper lip), DIZZINESS (light headed), HEAD DISCOMFORT (head felt heavy), PALPITATIONS (fast heart beat), FEELING JITTERY (jitteriness), PAIN IN EXTREMITY (sore arm), COLD-STIMULUS HEADACHE (slight brain freeze), CHEST DISCOMFORT (tightness in chest), HYPOAESTHESIA (facial numbness on left side), HEADACHE (headache) and NAUSEA (nausea). On 10-Mar-2021, HYPOAESTHESIA ORAL (slight numbness on upper lip), DIZZINESS (light headed), HEAD DISCOMFORT (head felt heavy), PALPITATIONS (fast heart beat), FEELING JITTERY (jitteriness), PAIN IN EXTREMITY (sore arm), COLD-STIMULUS HEADACHE (slight brain freeze), CHEST DISCOMFORT (tightness in chest), HEADACHE (headache) and NAUSEA (nausea) had resolved. At the time of the report, HYPOAESTHESIA (facial numbness on left side) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) Normal. On an unknown date, Magnetic resonance imaging: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow-up information received on 08-JUN-2021 contains non-significant information: Updated Reporter contact details and address.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Palpitations
Clinical narrative: slight numbness on upper lip; light headed; head felt heavy; fast heart beat; jitteriness; sore arm; slight brain freeze; tightness in chest; facial numbness on left side; headache; nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA ORAL (slight numbness on upper lip), DIZZINESS (light headed), HEAD DISCOMFORT (head felt heavy), PALPITATIONS (fast heart beat) and FEELING JITTERY (jitteriness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 HYPOAESTHESIA ORAL (slight numbness on upper lip), DIZZINESS (light headed), HEAD DISCOMFORT (head felt heavy), PALPITATIONS (fast heart beat), FEELING JITTERY (jitteriness), PAIN IN EXTREMITY (sore arm), COLD-STIMULUS HEADACHE (slight brain freeze), CHEST DISCOMFORT (tightness in chest), HYPOAESTHESIA (facial numbness on left side), HEADACHE (headache) and NAUSEA (nausea). On 10-Mar-2021, HYPOAESTHESIA ORAL (slight numbness on upper lip), DIZZINESS (light headed), HEAD DISCOMFORT (head felt heavy), PALPITATIONS (fast heart beat), FEELING JITTERY (jitteriness), PAIN IN EXTREMITY (sore arm), COLD-STIMULUS HEADACHE (slight brain freeze), CHEST DISCOMFORT (tightness in chest), HEADACHE (headache) and NAUSEA (nausea) had resolved. At the time of the report, HYPOAESTHESIA (facial numbness on left side) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) Normal. On an unknown date, Magnetic resonance imaging: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow-up information received on 08-JUN-2021 contains non-significant information: Updated Reporter contact details and address.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen gland under my left arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen gland under my left arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 025J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen gland under my left arm). At the time of the report, LYMPHADENOPATHY (Swollen gland under my left arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: TCR / NNI
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Head banging, Vomiting
Clinical narrative: couldn't breathe; throwing up; head hurting, like pounding real bad; This spontaneous case was reported by a consumer and describes the occurrence of HEAD BANGING (head hurting, like pounding real bad), DYSPNOEA (couldn't breathe) and VOMITING (throwing up) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M120A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery (Triple bypass) since an unknown date. Concurrent medical conditions included Diabetes.    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 HEAD BANGING (head hurting, like pounding real bad) and VOMITING (throwing up). On an unknown date, the patient experienced DYSPNOEA (couldn't breathe). At the time of the report, HEAD BANGING (head hurting, like pounding real bad), DYSPNOEA (couldn't breathe) and VOMITING (throwing up) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Redness at the injection site; Pain on and off on the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain on and off on the arm of the injection) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Bronchiectasis and Seasonal allergy. Concomitant products included BUDESONIDE;FORMOTEROL and FLUTICASONE;VILANTEROL for COPD and Bronchiectasis, XYLOMETAZOLINE HYDROCHLORIDEunited states (NASAL SPRAY II) for Seasonal allergy.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain on and off on the arm of the injection). On 10-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE PAIN (Pain on and off on the arm of the injection) had not resolved and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Fever/fluctuating; Chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever/fluctuating) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No past medical history was reported.     On 07-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever/fluctuating) and CHILLS (Chills). At the time of the report, PYREXIA (Fever/fluctuating) and CHILLS (Chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Body temperature: 101 (Inconclusive) 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported. Concomitant product use was not provided by the reporter.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold
Clinical narrative: Feel cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Feel cold) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa Allergy). Concomitant products included VITAMIN C [ASCORBIC ACID], VITAMIN D NOS, CLONAZEPAM and SIMVASTATIN (ZOCOR) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced FEELING COLD (Feel cold). At the time of the report, FEELING COLD (Feel cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Malaise, Pain in extremity, Pyrexia, Vaccination site mass
Clinical narrative: Feeling sick; weak, no strength at all around bedtime; Felt like she was starting to run a temperature; Big red knot; arm started feeling sore; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick), ASTHENIA (weak, no strength at all around bedtime), PAIN IN EXTREMITY (arm started feeling sore), VACCINATION SITE MASS (Big red knot) and PYREXIA (Felt like she was starting to run a temperature) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer. Concomitant products included LETROZOLE, ASPIRIN [ACETYLSALICYLIC ACID] and LOSARTAN for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm started feeling sore). On 03-Mar-2021, the patient experienced VACCINATION SITE MASS (Big red knot). On 09-Mar-2021, the patient experienced MALAISE (Feeling sick), ASTHENIA (weak, no strength at all around bedtime) and PYREXIA (Felt like she was starting to run a temperature). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, MALAISE (Feeling sick), ASTHENIA (weak, no strength at all around bedtime), PAIN IN EXTREMITY (arm started feeling sore), VACCINATION SITE MASS (Big red knot) and PYREXIA (Felt like she was starting to run a temperature) 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.   Treatment information was included Ibuprofen.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Malaise, Pain
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of PAIN (Had a lot of pain/and aching), ASTHENIA (No energy) and MALAISE (She just did not feel well) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The patient's past medical history included COVID-19 virus test positive. Concurrent medical conditions included Diabetes. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN (Had a lot of pain/and aching), ASTHENIA (No energy) and MALAISE (She just did not feel well). On 06-Mar-2021, PAIN (Had a lot of pain/and aching), ASTHENIA (No energy) and MALAISE (She just did not feel well) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness; Tingling; This spontaneous case was reported by a physician and describes the occurrence of HYPOAESTHESIA (Numbness) and PARAESTHESIA (Tingling) 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 HYPOAESTHESIA (Numbness) and PARAESTHESIA (Tingling). At the time of the report, HYPOAESTHESIA (Numbness) and PARAESTHESIA (Tingling) 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 relevant concomitant medications were reported.  No treatment information was provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache, Pyrexia, Vaccination site reaction
Clinical narrative: Joint aches; Fever 101.5; Vaccination site reaction; Back pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Vaccination site reaction), BACK PAIN (Back pain), HEADACHE (headache), ARTHRALGIA (Joint aches) and PYREXIA (Fever 101.5) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE REACTION (Vaccination site reaction), BACK PAIN (Back pain) and HEADACHE (headache). On 10-Mar-2021, the patient experienced ARTHRALGIA (Joint aches) and PYREXIA (Fever 101.5). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Vaccination site reaction), BACK PAIN (Back pain), HEADACHE (headache), ARTHRALGIA (Joint aches) and PYREXIA (Fever 101.5) outcome was unknown.            Concomitant product use was not provided. Action taken with mRNA-123 is not applicable.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site erythema, Vaccination site induration, Vaccination site rash, Vaccination site reaction
Clinical narrative: COVID arm; Injection site hardness; Injection site redness; Injection site rash; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), VACCINATION SITE INDURATION (Injection site hardness), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE RASH (Injection site rash) and FATIGUE (Very tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    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 FATIGUE (Very tired). On 25-Feb-2021, the patient experienced VACCINATION SITE REACTION (COVID arm), VACCINATION SITE INDURATION (Injection site hardness), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE RASH (Injection site rash). On 18-Feb-2021, FATIGUE (Very tired) had resolved. At the time of the report, VACCINATION SITE REACTION (COVID arm), VACCINATION SITE INDURATION (Injection site hardness), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE RASH (Injection site rash) 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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PREGNANCY (Pregnant) in a 32-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included PROGESTERONE from 23-Jan-2021 to an unknown date for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 27-Dec-2020 and the estimated date of delivery was 03-Oct-2021. On 02-Mar-2021, the patient experienced PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  ninth week of the pregnancy.  On 02-Mar-2021, PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This report refers to a case of pregnancy for mRNA-1273,  with no associated AEs. Patient will continue to be contacted for further monitoring of AE's during the pregnancy.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Itching in my left arm at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching in my left arm at site of injection) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.  Concomitant products included LISINOPRIL, TAMSULOSIN, ROSUVASTATIN, METFORMIN, OMEPRAZOLE and OMEGA-3 FATTY ACIDS for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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) at an unspecified dose. On 07-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching in my left arm at site of injection). On 07-Mar-2021, VACCINATION SITE PRURITUS (Itching in my left arm at site of injection) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information provided was rubbing alcohol applied topically. Action taken with mRNA-123 is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: TCR received. Second dose event reported. On 04-May-2021: Updated TCR. Second dose event reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Hot flush, Insomnia, Nausea
Clinical narrative: dizziness; Hot flashes; Didn't sleep well last night; Pain in arm at vaccination site; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HOT FLUSH (Hot flashes), INSOMNIA (Didn't sleep well last night), VACCINATION SITE PAIN (Pain in arm at vaccination site) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vertigo. Concomitant products included ATENOLOL, LISINOPRIL, GLIPIZIDE, OMEPRAZOLE, CALCIUM and UBIDECARENONE (COQ-10) for an unknown indication.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Mar-2021, the patient experienced HOT FLUSH (Hot flashes), INSOMNIA (Didn't sleep well last night), VACCINATION SITE PAIN (Pain in arm at vaccination site), CHILLS (Chills) and NAUSEA (Nausea). On an unknown date, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness), HOT FLUSH (Hot flashes), INSOMNIA (Didn't sleep well last night), VACCINATION SITE PAIN (Pain in arm at vaccination site), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. Action taken with mRNA-123 is not applicable.   This case was linked to MOD21-049743 (E2B Linked Report).; Sender's Comments:  MOD21-049743:Crosslinked Case
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: dizziness; Hot flashes; Didn't sleep well last night; Pain in arm at vaccination site; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HOT FLUSH (Hot flashes), INSOMNIA (Didn't sleep well last night), VACCINATION SITE PAIN (Pain in arm at vaccination site) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vertigo. Concomitant products included ATENOLOL, LISINOPRIL, GLIPIZIDE, OMEPRAZOLE, CALCIUM and UBIDECARENONE (COQ-10) for an unknown indication.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Mar-2021, the patient experienced HOT FLUSH (Hot flashes), INSOMNIA (Didn't sleep well last night), VACCINATION SITE PAIN (Pain in arm at vaccination site), CHILLS (Chills) and NAUSEA (Nausea). On an unknown date, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness), HOT FLUSH (Hot flashes), INSOMNIA (Didn't sleep well last night), VACCINATION SITE PAIN (Pain in arm at vaccination site), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. Action taken with mRNA-123 is not applicable.   This case was linked to MOD21-049743 (E2B Linked Report).; Sender's Comments:  MOD21-049743:Crosslinked Case
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inappropriate schedule of product administration, Pruritus, Rash erythematous, Swelling
Clinical narrative: Itching; Redness; Swelling; Rash increasing in size on right arm, triangular shape pink; Only received one moderna vaccine/42 Plus days after 1st shot, no 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), ERYTHEMA (Redness), SWELLING (Swelling), RASH ERYTHEMATOUS (Rash increasing in size on right arm, triangular shape pink) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Only received one moderna vaccine/42 Plus days after 1st shot, no 2nd shot) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diverticular disease.    On 28-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 PRURITUS (Itching), ERYTHEMA (Redness), SWELLING (Swelling), RASH ERYTHEMATOUS (Rash increasing in size on right arm, triangular shape pink) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Only received one moderna vaccine/42 Plus days after 1st shot, no 2nd shot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching), ERYTHEMA (Redness), SWELLING (Swelling) and RASH ERYTHEMATOUS (Rash increasing in size on right arm, triangular shape pink) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Only received one moderna vaccine/42 Plus days after 1st shot, no 2nd shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.    Action taken with mRNA-1273 in response to the event, only received one Moderna vaccine, was not applicable.   This case was linked to MOD21-055323 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: New event inappropriate schedule of vaccine administered was added. On 03-May-2021: Follow-up information received on 03-May-2021 contains non-significant information.; Sender's Comments:  MOD21-055323:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling of body temperature change, Sensory disturbance, Tremor, Upper-airway cough syndrome
Clinical narrative: Dripping in throat; Feel a sensation coming up both legs and spine before the shaking would start; Uncontrollable shaking/uncontrollable shaking that came in waves and lasted for 15 mins for every 5 mins; Chills; Feeling of warm  and cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Feeling of warm  and cold), UPPER-AIRWAY COUGH SYNDROME (Dripping in throat), SENSORY DISTURBANCE (Feel a sensation coming up both legs and spine before the shaking would start), TREMOR (Uncontrollable shaking/uncontrollable shaking that came in waves and lasted for 15 mins for every 5 mins) and CHILLS (Chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Feeling of warm  and cold), SENSORY DISTURBANCE (Feel a sensation coming up both legs and spine before the shaking would start) and CHILLS (Chills). 09-Mar-2021, the patient experienced TREMOR (Uncontrollable shaking/uncontrollable shaking that came in waves and lasted for 15 mins for every 5 mins). On 10-Mar-2021, the patient experienced UPPER-AIRWAY COUGH SYNDROME (Dripping in throat). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Throat discomfort, at an unspecified dose and frequency. On 10-Mar-2021, FEELING OF BODY TEMPERATURE CHANGE (Feeling of warm  and cold) outcome was unknown, SENSORY DISTURBANCE (Feel a sensation coming up both legs and spine before the shaking would start), TREMOR (Uncontrollable shaking/uncontrollable shaking that came in waves and lasted for 15 mins for every 5 mins) and CHILLS (Chills) had resolved. At the time of the report, UPPER-AIRWAY COUGH SYNDROME (Dripping in throat) outcome was unknown. Not Provided          No concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.    The patient mentioned that she had chills before but this was very different. The patient took 1 dose of Benadryl on 10-Mar- 2021 for dripping in her throat.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Reporter contact details was updated, events outcome was updated from unknown to recovered.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Insomnia, Pain in extremity, Sinus congestion, Vaccination site pruritus
Clinical narrative: Arm started itching at the injection site; Felt tired; Sinus congested; Felt odd that night and the next one and couldn't sleep well; Arm was a little bit sore; This spontaneous case was reported by a consumer and describes the occurrence of SINUS CONGESTION (Sinus congested), INSOMNIA (Felt odd that night and the next one and couldn't sleep well), PAIN IN EXTREMITY (Arm was a little bit sore), VACCINATION SITE PRURITUS (Arm started itching at the injection site) and FATIGUE (Felt tired) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced SINUS CONGESTION (Sinus congested), INSOMNIA (Felt odd that night and the next one and couldn't sleep well), PAIN IN EXTREMITY (Arm was a little bit sore) and FATIGUE (Felt tired). On 09-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Arm started itching at the injection site). On 03-Mar-2021, SINUS CONGESTION (Sinus congested), INSOMNIA (Felt odd that night and the next one and couldn't sleep well), PAIN IN EXTREMITY (Arm was a little bit sore) and FATIGUE (Felt tired) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Arm started itching at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication provided included medication for allergy. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow-up received on 04-May-2021 and does not contain any new information.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: The arm is still hurting , there is still pain in the arm for 5 weeks; Red arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (The arm is still hurting , there is still pain in the arm for 5 weeks) and ERYTHEMA (Red arm) 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 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (The arm is still hurting , there is still pain in the arm for 5 weeks). On an unknown date, the patient experienced ERYTHEMA (Red arm). At the time of the report, PAIN IN EXTREMITY (The arm is still hurting , there is still pain in the arm for 5 weeks) outcome was unknown.            Concomitant drug was not provided. Treatment is not reported. Action taken with mRNA-1273 in response to the event was not applicable.   Reporter did not allow further contact