chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Very fatigued; Severely sick; Slept the day and night; regurgitation; Chills; Fever (101F); Muscle pain; Nausea; Vomiting; Arm was extremely sore; Could not move arm; Lethargic; Didn't want to eat; So dizzy to the point that I couldn't walk because of the dizziness; Diarrhea; Shortness of breath; A spontaneous report was received from a consumer concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events muscle pain / myalgia, arm was extremely sore / pain in extremity, could not move arm / limb discomfort, lethargic, didn`t want to eat / decreased appetite, so dizzy to the point that i couldn't walk because of the dizziness / dizziness, nausea, vomiting, diarrhea, shortness of breath / dyspnea, chills, fever (101f) / pyrexia, kept on regurgitating, came very close to going to the er, very fatigued, severely sick / illness and slept the day and night / hypersomnia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 025L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 5 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 043L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 8 Jan 2021, the patient had muscle pain, arm was extremely sore and could not move arm. On 5 Feb 2021, after receiving the second dose, the patient had same muscle pain with extremely sore arm that she could not move the arm. She also felt lethargic, didn`t wanted to eat, was so dizzy to the point that she could not walk because of dizziness, had nausea, vomiting, diarrhea, shortness of breath, chills, fever (101f), kept on regurgitating and came very close to going to the emergency room. On 6 Feb 2021, the patient was very fatigued and severely sick that she slept the day and night.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, muscle pain, arm was extremely sore, could not move arm, lethargic, didn`t want to eat, so dizzy to the point that i couldn't walk because of the dizziness, nausea, vomiting, diarrhea, shortness of breath, chills, fever (101f), kept on regurgitating, came very close to going to the er, very fatigued, severely sick and slept the day and night was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Paraesthesia, Paraesthesia oral
Clinical narrative: chest tightness; unusual sensation on tongue; mild tingling; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest tightness), PARAESTHESIA ORAL (unusual sensation on tongue) and PARAESTHESIA (mild tingling) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included Glaucoma. Concurrent medical conditions included Kidney disorder, Drug allergy (Allergic to statins, Indocin, doxycycline and sulfa Repatha (possible PEG2000-DMG connection),) and Penicillin allergy. Concomitant products included HYDROCHLOROTHIAZIDE, METOPROLOL, LOSARTAN, LATANOPROST and TIMOLOL for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced CHEST DISCOMFORT (chest tightness), PARAESTHESIA ORAL (unusual sensation on tongue) and PARAESTHESIA (mild tingling). At the time of the report, CHEST DISCOMFORT (chest tightness), PARAESTHESIA ORAL (unusual sensation on tongue) and PARAESTHESIA (mild tingling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Fallow up received and reporter information were added.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Fatigue, Hypersomnia, Nasopharyngitis
Clinical narrative: feel weak; tired; had slept 3 times due to weakness; slight cough; feel like he is getting a cold; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feel weak), FATIGUE (tired), HYPERSOMNIA (had slept 3 times due to weakness), COUGH (slight cough) and NASOPHARYNGITIS (feel like he is getting a cold) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced ASTHENIA (feel weak), FATIGUE (tired), HYPERSOMNIA (had slept 3 times due to weakness), COUGH (slight cough) and NASOPHARYNGITIS (feel like he is getting a cold). At the time of the report, ASTHENIA (feel weak), FATIGUE (tired), HYPERSOMNIA (had slept 3 times due to weakness), COUGH (slight cough) and NASOPHARYNGITIS (feel like he is getting a cold) outcome was unknown.      No relevant concomitant medications were reported.  Treatment information not provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache
Clinical narrative: weak; pounding headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak) and HEADACHE (pounding headache) 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 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced ASTHENIA (weak) and HEADACHE (pounding headache). At the time of the report, ASTHENIA (weak) and HEADACHE (pounding headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.; Sender's Comments:  MODERNATX, INC.-MOD-2021-032600:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site rash, Vaccination site warmth
Clinical narrative: hot to touch; redness around the injection site; hard lump; small lump in the injection site; rash on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (small lump in the injection site), VACCINATION SITE RASH (rash on the injection site), VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE ERYTHEMA (redness around the injection site) and VACCINATION SITE MASS (hard lump) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041LD0H) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE MASS (small lump in the injection site) and VACCINATION SITE RASH (rash on the injection site). On 20-Feb-2021, the patient experienced VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE ERYTHEMA (redness around the injection site) and VACCINATION SITE MASS (hard lump). At the time of the report, VACCINATION SITE MASS (small lump in the injection site), VACCINATION SITE RASH (rash on the injection site), VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE ERYTHEMA (redness around the injection site) and VACCINATION SITE MASS (hard lump) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  Treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Myalgia, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Hot red ring around injection site; Hot red ring around injection site; rashes disappear from one place and show up on another body part; swollen left arm; red/hot ears; Aches and pain, low grade fever; Aches and pain, low grade fever; Severe case of hives; Hives were extremely itchy; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MYALGIA (Aches and pain, low grade fever), PYREXIA (Aches and pain, low grade fever), URTICARIA (Severe case of hives) and PRURITUS (Hives were extremely itchy) in a 67-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.     No Medical History information was reported.   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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 18-Feb-2021, the patient experienced MYALGIA (Aches and pain, low grade fever), PYREXIA (Aches and pain, low grade fever), URTICARIA (Severe case of hives) and PRURITUS (Hives were extremely itchy). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot red ring around injection site), VACCINATION SITE ERYTHEMA (Hot red ring around injection site), RASH (rashes disappear from one place and show up on another body part), PERIPHERAL SWELLING (swollen left arm) and FEELING HOT (red/hot ears). At the time of the report, PAIN IN EXTREMITY (Sore arm), MYALGIA (Aches and pain, low grade fever), PYREXIA (Aches and pain, low grade fever), URTICARIA (Severe case of hives), PRURITUS (Hives were extremely itchy), VACCINATION SITE WARMTH (Hot red ring around injection site), VACCINATION SITE ERYTHEMA (Hot red ring around injection site), RASH (rashes disappear from one place and show up on another body part), PERIPHERAL SWELLING (swollen left arm) and FEELING HOT (red/hot ears) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment details included : Antihistmine, Oral Antihistamines, Topical Antihistamines,steroid cream-Triamcinolone Acetonide Cream 0.1%, Other Remedies, Baking soda baths,Asper Cream Lidocaine, Tichnors Mouth Wash.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Urticaria, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Hot red ring around injection site; Hot red ring around injection site; rashes disappear from one place and show up on another body part; swollen left arm; red/hot ears; Aches and pain, low grade fever; Aches and pain, low grade fever; Severe case of hives; Hives were extremely itchy; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MYALGIA (Aches and pain, low grade fever), PYREXIA (Aches and pain, low grade fever), URTICARIA (Severe case of hives) and PRURITUS (Hives were extremely itchy) in a 67-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.     No Medical History information was reported.   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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 18-Feb-2021, the patient experienced MYALGIA (Aches and pain, low grade fever), PYREXIA (Aches and pain, low grade fever), URTICARIA (Severe case of hives) and PRURITUS (Hives were extremely itchy). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot red ring around injection site), VACCINATION SITE ERYTHEMA (Hot red ring around injection site), RASH (rashes disappear from one place and show up on another body part), PERIPHERAL SWELLING (swollen left arm) and FEELING HOT (red/hot ears). At the time of the report, PAIN IN EXTREMITY (Sore arm), MYALGIA (Aches and pain, low grade fever), PYREXIA (Aches and pain, low grade fever), URTICARIA (Severe case of hives), PRURITUS (Hives were extremely itchy), VACCINATION SITE WARMTH (Hot red ring around injection site), VACCINATION SITE ERYTHEMA (Hot red ring around injection site), RASH (rashes disappear from one place and show up on another body part), PERIPHERAL SWELLING (swollen left arm) and FEELING HOT (red/hot ears) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment details included : Antihistmine, Oral Antihistamines, Topical Antihistamines,steroid cream-Triamcinolone Acetonide Cream 0.1%, Other Remedies, Baking soda baths,Asper Cream Lidocaine, Tichnors Mouth Wash.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraine increased; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine increased) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine (Prone to migraines).  On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (migraine increased). At the time of the report, MIGRAINE (migraine increased) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: her neighbors also got sick from the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (her neighbors also got sick from the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (her neighbors also got sick from the vaccine). At the time of the report, ILLNESS (her neighbors also got sick from the vaccine) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications taken by the patient were not provided.  Treatment activities for event was not provided.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Insomnia, Nausea, Neck pain
Clinical narrative: Major soreness in right arm at injection site, then all around my arm, neck and upper back; Major soreness in right arm at injection site, then all around my arm, neck and upper back; insomnia; some nausea; Major soreness in right arm at injection site, then all around my arm, neck and upper back; chills; Simlar symptoms as with 1st dose but a little worse,pain in the left arm is not getting better and is only getting worse,The pain is worse with movement; pain in his left arm; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Major soreness in right arm at injection site, then all around my arm, neck and upper back), BACK PAIN (Major soreness in right arm at injection site, then all around my arm, neck and upper back), INSOMNIA (insomnia), NAUSEA (some nausea) and PAIN IN EXTREMITY (Major soreness in right arm at injection site, then all around my arm, neck and upper back) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026l20a) for an unknown indication. The occurrence of additional non-serious events is detailed below.     Concomitant products included INFLIXIMAB (REMICADE) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in his left arm). On an unknown date, the patient experienced NECK PAIN (Major soreness in right arm at injection site, then all around my arm, neck and upper back), BACK PAIN (Major soreness in right arm at injection site, then all around my arm, neck and upper back), INSOMNIA (insomnia), NAUSEA (some nausea), PAIN IN EXTREMITY (Major soreness in right arm at injection site, then all around my arm, neck and upper back), CHILLS (chills) and PAIN (Simlar symptoms as with 1st dose but a little worse,pain in the left arm is not getting better and is only getting worse,The pain is worse with movement). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and Advil at an unspecified dose and frequency. At the time of the report, NECK PAIN (Major soreness in right arm at injection site, then all around my arm, neck and upper back), BACK PAIN (Major soreness in right arm at injection site, then all around my arm, neck and upper back), INSOMNIA (insomnia), NAUSEA (some nausea), PAIN IN EXTREMITY (Major soreness in right arm at injection site, then all around my arm, neck and upper back), CHILLS (chills) and PAIN IN EXTREMITY (pain in his left arm) outcome was unknown and PAIN (Simlar symptoms as with 1st dose but a little worse,pain in the left arm is not getting better and is only getting worse,The pain is worse with movement) had resolved.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Major soreness in right arm at injection site, then all around my arm, neck and upper back; Major soreness in right arm at injection site, then all around my arm, neck and upper back; insomnia; some nausea; Major soreness in right arm at injection site, then all around my arm, neck and upper back; chills; Simlar symptoms as with 1st dose but a little worse,pain in the left arm is not getting better and is only getting worse,The pain is worse with movement; pain in his left arm; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Major soreness in right arm at injection site, then all around my arm, neck and upper back), BACK PAIN (Major soreness in right arm at injection site, then all around my arm, neck and upper back), INSOMNIA (insomnia), NAUSEA (some nausea) and PAIN IN EXTREMITY (Major soreness in right arm at injection site, then all around my arm, neck and upper back) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026l20a) for an unknown indication. The occurrence of additional non-serious events is detailed below.     Concomitant products included INFLIXIMAB (REMICADE) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in his left arm). On an unknown date, the patient experienced NECK PAIN (Major soreness in right arm at injection site, then all around my arm, neck and upper back), BACK PAIN (Major soreness in right arm at injection site, then all around my arm, neck and upper back), INSOMNIA (insomnia), NAUSEA (some nausea), PAIN IN EXTREMITY (Major soreness in right arm at injection site, then all around my arm, neck and upper back), CHILLS (chills) and PAIN (Simlar symptoms as with 1st dose but a little worse,pain in the left arm is not getting better and is only getting worse,The pain is worse with movement). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and Advil at an unspecified dose and frequency. At the time of the report, NECK PAIN (Major soreness in right arm at injection site, then all around my arm, neck and upper back), BACK PAIN (Major soreness in right arm at injection site, then all around my arm, neck and upper back), INSOMNIA (insomnia), NAUSEA (some nausea), PAIN IN EXTREMITY (Major soreness in right arm at injection site, then all around my arm, neck and upper back), CHILLS (chills) and PAIN IN EXTREMITY (pain in his left arm) outcome was unknown and PAIN (Simlar symptoms as with 1st dose but a little worse,pain in the left arm is not getting better and is only getting worse,The pain is worse with movement) had resolved.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Vaccination site pain
Clinical narrative: severe chest pain like a crashing pain that comes and goes; pain at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of CHEST PAIN (severe chest pain like a crashing pain that comes and goes) and VACCINATION SITE PAIN (pain at the injection site) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site). On 21-Feb-2021, the patient experienced CHEST PAIN (severe chest pain like a crashing pain that comes and goes). On 21-Feb-2021, VACCINATION SITE PAIN (pain at the injection site) had resolved. At the time of the report, CHEST PAIN (severe chest pain like a crashing pain that comes and goes) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CHEST PAIN (severe chest pain like a crashing pain that comes and goes) to be related. No further causality assessment was provided for VACCINATION SITE PAIN (pain at the injection site).    Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Followup information was received on 17-Apr-2021.Patient demographic details was reported. Causality was reported for chest pain.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Pain at injection; 3 inches of redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection) and VACCINATION SITE ERYTHEMA (3 inches of redness at injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer.    On 12-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 experienced VACCINATION SITE PAIN (Pain at injection) and VACCINATION SITE ERYTHEMA (3 inches of redness at injection site). At the time of the report, VACCINATION SITE PAIN (Pain at injection) and VACCINATION SITE ERYTHEMA (3 inches of redness at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; 100.7 F fever.; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (100.7 F fever.) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032Z20A) for COVID-19 vaccination.     No Medical History information was reported.  On 21-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced CHILLS (chills) and PYREXIA (100.7 F fever.). At the time of the report, CHILLS (chills) and PYREXIA (100.7 F fever.) outcome was unknown.      No relevant concomitant medications were reported.  No treatment.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain
Clinical narrative: sore arm "sore muscle feeling"; a little bit of hardness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm "sore muscle feeling") and VACCINATION SITE INDURATION (a little bit of hardness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included METFORMIN, AMLODIPINE, LISINOPRIL, ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMINS NOS for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm "sore muscle feeling") and VACCINATION SITE INDURATION (a little bit of hardness). At the time of the report, VACCINATION SITE PAIN (sore arm "sore muscle feeling") and VACCINATION SITE INDURATION (a little bit of hardness) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Treatment details included ice pack, icy hot, and ibuprofen.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Energy increased, Feeling abnormal, Injection site pain, Oral discomfort
Clinical narrative: Strange dreams (vivid and more frequent); Mouth seems to be more irritated; Tongue feels bigger/swollen; Sense of smell is stronger; Toothache; Rush of energy; Arm was sore; Felt foggy; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (Felt foggy), ENERGY INCREASED (Rush of energy), ABNORMAL DREAMS (Strange dreams (vivid and more frequent)), ORAL DISCOMFORT (Mouth seems to be more irritated) and SWOLLEN TONGUE (Tongue feels bigger/swollen) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to chemicals.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced FEELING ABNORMAL (Felt foggy). On 16-Jan-2021, the patient experienced INJECTION SITE PAIN (Arm was sore). On 17-Jan-2021, the patient experienced ENERGY INCREASED (Rush of energy). On 25-Jan-2021, the patient experienced TOOTHACHE (Toothache). On an unknown date, the patient experienced ABNORMAL DREAMS (Strange dreams (vivid and more frequent)), ORAL DISCOMFORT (Mouth seems to be more irritated), SWOLLEN TONGUE (Tongue feels bigger/swollen) and PAROSMIA (Sense of smell is stronger). At the time of the report, FEELING ABNORMAL (Felt foggy), ENERGY INCREASED (Rush of energy), ABNORMAL DREAMS (Strange dreams (vivid and more frequent)), ORAL DISCOMFORT (Mouth seems to be more irritated), SWOLLEN TONGUE (Tongue feels bigger/swollen), PAROSMIA (Sense of smell is stronger), TOOTHACHE (Toothache) and INJECTION SITE PAIN (Arm was sore) 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 relevant concomitant medications were reported. Treatment details included Ice; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Swollen tongue, Toothache
Clinical narrative: Strange dreams (vivid and more frequent); Mouth seems to be more irritated; Tongue feels bigger/swollen; Sense of smell is stronger; Toothache; Rush of energy; Arm was sore; Felt foggy; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (Felt foggy), ENERGY INCREASED (Rush of energy), ABNORMAL DREAMS (Strange dreams (vivid and more frequent)), ORAL DISCOMFORT (Mouth seems to be more irritated) and SWOLLEN TONGUE (Tongue feels bigger/swollen) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to chemicals.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced FEELING ABNORMAL (Felt foggy). On 16-Jan-2021, the patient experienced INJECTION SITE PAIN (Arm was sore). On 17-Jan-2021, the patient experienced ENERGY INCREASED (Rush of energy). On 25-Jan-2021, the patient experienced TOOTHACHE (Toothache). On an unknown date, the patient experienced ABNORMAL DREAMS (Strange dreams (vivid and more frequent)), ORAL DISCOMFORT (Mouth seems to be more irritated), SWOLLEN TONGUE (Tongue feels bigger/swollen) and PAROSMIA (Sense of smell is stronger). At the time of the report, FEELING ABNORMAL (Felt foggy), ENERGY INCREASED (Rush of energy), ABNORMAL DREAMS (Strange dreams (vivid and more frequent)), ORAL DISCOMFORT (Mouth seems to be more irritated), SWOLLEN TONGUE (Tongue feels bigger/swollen), PAROSMIA (Sense of smell is stronger), TOOTHACHE (Toothache) and INJECTION SITE PAIN (Arm was sore) 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 relevant concomitant medications were reported. Treatment details included Ice; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Pyrexia, Renal disorder
Clinical narrative: temp is keep going up today, went from 100.5 then I manage to lower it to 99.2; Chills; Fever; I think it is messing up my kidneys; This spontaneous case was reported by a consumer and describes the occurrence of RENAL DISORDER (I think it is messing up my kidneys), BODY TEMPERATURE INCREASED (temp is keep going up today, went from 100.5 then I manage to lower it to 99.2), CHILLS (Chills) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L209) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced RENAL DISORDER (I think it is messing up my kidneys), CHILLS (Chills) and PYREXIA (Fever). On 22-Feb-2021, the patient experienced BODY TEMPERATURE INCREASED (temp is keep going up today, went from 100.5 then I manage to lower it to 99.2). At the time of the report, RENAL DISORDER (I think it is messing up my kidneys), BODY TEMPERATURE INCREASED (temp is keep going up today, went from 100.5 then I manage to lower it to 99.2), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.     No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Myalgia, Oropharyngeal pain, Vocal cord inflammation
Clinical narrative: Difficulty swallowing; Sore throat, voice; Sore throat, voice; Body achy; A spontaneous report was received from a consumer concerning her mother, who is a unknown aged female patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events difficult swallowing, sore throat, voice, body achy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Jan 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events sore throat, voice body achy, difficulty swallowing. She went to see her hcp who referred her to see ear nose throat doctor which is not due until 03 03 Mar 2021, so she want to know what to do for the sore throat.  Treatment information was not provided.  Patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event was not applicable.   The outcome of event difficult swallowing, sore throat, voice, body achy was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site warmth, Rash
Clinical narrative: Warm to touch at injection site; Redness at injection site; rash; Pain at injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm to touch at injection site), RASH (rash), INJECTION SITE PAIN (Pain at injection site), HEADACHE (Headache) and INJECTION SITE ERYTHEMA (Redness at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced RASH (rash), INJECTION SITE PAIN (Pain at injection site) and HEADACHE (Headache). On 16-Feb-2021, the patient experienced INJECTION SITE WARMTH (Warm to touch at injection site) and INJECTION SITE ERYTHEMA (Redness at injection site). The patient was treated with TYLENOL for Pain and Headache, at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (Warm to touch at injection site), INJECTION SITE PAIN (Pain at injection site), HEADACHE (Headache) and INJECTION SITE ERYTHEMA (Redness at injection site) outcome was unknown and RASH (rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Received follow up on 14 JUL 2021: TCR  form  provided which contains new Event (Rash) and event outcome.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Paraesthesia, Pruritus, Rash, Tenderness
Clinical narrative: Tender; Sore/Arm was sore from elbow to shoulder; Very itchy; Rash; From elbow to wrist was tingly; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tender), INJECTION SITE PAIN (Sore/Arm was sore from elbow to shoulder), PRURITUS (Very itchy), RASH (Rash) and PARAESTHESIA (From elbow to wrist was tingly) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, PRAVASTATIN and ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced TENDERNESS (Tender), INJECTION SITE PAIN (Sore/Arm was sore from elbow to shoulder), PRURITUS (Very itchy), RASH (Rash) and PARAESTHESIA (From elbow to wrist was tingly). At the time of the report, TENDERNESS (Tender), INJECTION SITE PAIN (Sore/Arm was sore from elbow to shoulder), PRURITUS (Very itchy), RASH (Rash) and PARAESTHESIA (From elbow to wrist was tingly) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   Treatment includes Benadryl gel.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Malaise, Urticaria
Clinical narrative: hives; red blotches on the arm; did not feel good; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (did not feel good), URTICARIA (hives) and ERYTHEMA (red blotches on the arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced MALAISE (did not feel good). On 21-Feb-2021, the patient experienced URTICARIA (hives) and ERYTHEMA (red blotches on the arm). At the time of the report, MALAISE (did not feel good), URTICARIA (hives) and ERYTHEMA (red blotches on the arm) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, Injection site erythema, Pain
Clinical narrative: fatigue; Covid antigen; ache; fever; Redness 6 inch down injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (ache), PYREXIA (fever), INJECTION SITE ERYTHEMA (Redness 6 inch down injection site), HEADACHE (Headache) and FATIGUE (fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN (ache), PYREXIA (fever), INJECTION SITE ERYTHEMA (Redness 6 inch down injection site), HEADACHE (Headache) and COVID-19 (Covid antigen). On 22-Feb-2021, the patient experienced FATIGUE (fatigue). On 17-Feb-2021, PAIN (ache) and PYREXIA (fever) had resolved. On 19-Feb-2021, INJECTION SITE ERYTHEMA (Redness 6 inch down injection site) had resolved. At the time of the report, HEADACHE (Headache), FATIGUE (fatigue) and COVID-19 (Covid antigen) 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 relevant concomitant medications were reported.  No treatment.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fatigue; Covid antigen; ache; fever; Redness 6 inch down injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (ache), PYREXIA (fever), INJECTION SITE ERYTHEMA (Redness 6 inch down injection site), HEADACHE (Headache) and FATIGUE (fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN (ache), PYREXIA (fever), INJECTION SITE ERYTHEMA (Redness 6 inch down injection site), HEADACHE (Headache) and COVID-19 (Covid antigen). On 22-Feb-2021, the patient experienced FATIGUE (fatigue). On 17-Feb-2021, PAIN (ache) and PYREXIA (fever) had resolved. On 19-Feb-2021, INJECTION SITE ERYTHEMA (Redness 6 inch down injection site) had resolved. At the time of the report, HEADACHE (Headache), FATIGUE (fatigue) and COVID-19 (Covid antigen) 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 relevant concomitant medications were reported.  No treatment.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pruritus, Rash
Clinical narrative: Itch; I can't sleep that night; can't wear a lot of stuff; Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), PRURITUS (Itch), INSOMNIA (I can't sleep that night) and PRURITUS (can't wear a lot of stuff) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L28) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced RASH (Rash), PRURITUS (Itch), INSOMNIA (I can't sleep that night) and PRURITUS (can't wear a lot of stuff). At the time of the report, RASH (Rash), PRURITUS (Itch), INSOMNIA (I can't sleep that night) and PRURITUS (can't wear a lot of stuff) 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.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: hardness near the injection site; Redness near the injection site; soreness near injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness near the injection site), VACCINATION SITE INDURATION (hardness near the injection site) and VACCINATION SITE PAIN (soreness near injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness near the injection site), VACCINATION SITE INDURATION (hardness near the injection site) and VACCINATION SITE PAIN (soreness near injection site). The patient was treated with PARACETAMOL (TYLENOL) on 18-Feb-2021 at a dose of UNK dosage form. At the time of the report, VACCINATION SITE ERYTHEMA (Redness near the injection site), VACCINATION SITE INDURATION (hardness near the injection site) and VACCINATION SITE PAIN (soreness near injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.
Age: 78.0
Sex: M
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 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-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.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported. The patient was due for second vaccine on 22-Feb-2021.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymph nodes have swelled up in both arms (under both armpits); This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph nodes have swelled up in both arms (under both armpits)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (lymph nodes have swelled up in both arms (under both armpits)). At the time of the report, LYMPHADENOPATHY (lymph nodes have swelled up in both arms (under both armpits)) outcome was unknown. Not Provided          Concomitant medication was not reported. Treatment medication was not used.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain in extremity
Clinical narrative: Muscle ached; Sore arm; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle ached), PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004m20a) 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 17-Feb-2021, the patient experienced MYALGIA (Muscle ached), PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills). At the time of the report, MYALGIA (Muscle ached), PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: COVID arm; Big lump on arm; Arm very itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), VACCINATION SITE MASS (Big lump on arm) and VACCINATION SITE PRURITUS (Arm very itchy) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm), VACCINATION SITE MASS (Big lump on arm) and VACCINATION SITE PRURITUS (Arm very itchy). At the time of the report, VACCINATION SITE REACTION (COVID arm), VACCINATION SITE MASS (Big lump on arm) and VACCINATION SITE PRURITUS (Arm very itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.