chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pain in extremity, Rash, Rash pruritic, Swelling
Clinical narrative: feeling lethargic; arm began to hurt; Scabs ich like crazy; Bumps; sporadic rash under bra strap and across shoulders; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (feeling lethargic), PAIN IN EXTREMITY (arm began to hurt), RASH PRURITIC (Scabs ich like crazy), SWELLING (Bumps) and RASH (sporadic rash under bra strap and across shoulders) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 004M20A) for COVID-19 vaccination.     The patient's past medical history included Neuropathy (in arms and legs due to spinal fusion.) and Weight loss (138lbs to 118lbs .). Concomitant products included CALCIUM, MAGNESIUM, ZINC and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced LETHARGY (feeling lethargic), PAIN IN EXTREMITY (arm began to hurt), RASH PRURITIC (Scabs ich like crazy), SWELLING (Bumps) and RASH (sporadic rash under bra strap and across shoulders). At the time of the report, LETHARGY (feeling lethargic), PAIN IN EXTREMITY (arm began to hurt), RASH PRURITIC (Scabs ich like crazy) and SWELLING (Bumps) outcome was unknown and RASH (sporadic rash under bra strap and across shoulders) had resolved.            Treatment medication included  Hydrocortisone twice daily Action taken with mRNA-1273 in response to the events were Not Applicable   This case was linked to MOD-2021-025222 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Fatigue, Pyrexia
Clinical narrative: Hard to breath; Fever; Body ache; Tiredness; This spontaneous case was reported by a non-health professional and describes the occurrence of DYSPNOEA (Hard to breath), PYREXIA (Fever), FATIGUE (Tiredness) and ARTHRALGIA (Body ache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 006C21A) for COVID-19 immunisation.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced FATIGUE (Tiredness). On 01-May-2021, the patient experienced DYSPNOEA (Hard to breath), PYREXIA (Fever) and ARTHRALGIA (Body ache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Hard to breath), PYREXIA (Fever), FATIGUE (Tiredness) and ARTHRALGIA (Body ache) outcome was unknown.            No concomitant medication details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 48-year-old female patient who received mRNA-1273 (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Intramuscular) dosing remained unchanged.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Condition aggravated, Feeling abnormal, Oedema peripheral, Pain in extremity
Clinical narrative: "pain is in different areas" (back of the knee in calf area); this morning is worse than yesterday; "swollen, raised, puffy area on his left leg"; "raised veins"; rope- like; "warm to the touch"; Something isn't right here; worried about a possible blood clot; possible varicose veins; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OEDEMA PERIPHERAL ("swollen, raised, puffy area on his left leg"), VARICOPHLEBITIS ("raised veins"; rope- like), SKIN WARM ("warm to the touch"), PAIN IN EXTREMITY ("pain is in different areas" (back of the knee in calf area)) and FEELING ABNORMAL (Something isn't right here) in a 52-year-old male patient who received mRNA-1273 (batch nos. 038B21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's medical history was not reported.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 16-Apr-2021 at 4:00 AM, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced VARICOPHLEBITIS ("raised veins"; rope- like), SKIN WARM ("warm to the touch"), FEELING ABNORMAL (Something isn't right here), ANXIETY (worried about a possible blood clot) and VARICOSE VEIN (possible varicose veins). On 29-Apr-2021 at 10:00 AM, the patient experienced OEDEMA PERIPHERAL ("swollen, raised, puffy area on his left leg"). On 30-Apr-2021, the patient experienced PAIN IN EXTREMITY ("pain is in different areas" (back of the knee in calf area)) and CONDITION AGGRAVATED (this morning is worse than yesterday). At the time of the report, OEDEMA PERIPHERAL ("swollen, raised, puffy area on his left leg"), VARICOPHLEBITIS ("raised veins"; rope- like), SKIN WARM ("warm to the touch"), PAIN IN EXTREMITY ("pain is in different areas" (back of the knee in calf area)), FEELING ABNORMAL (Something isn't right here), ANXIETY (worried about a possible blood clot), CONDITION AGGRAVATED (this morning is worse than yesterday) and VARICOSE VEIN (possible varicose veins) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       No treatment medications were reported Action taken with mRNA-1273 in response to the events were Not Applicable
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Skin warm, Varicophlebitis, Varicose vein
Clinical narrative: "pain is in different areas" (back of the knee in calf area); this morning is worse than yesterday; "swollen, raised, puffy area on his left leg"; "raised veins"; rope- like; "warm to the touch"; Something isn't right here; worried about a possible blood clot; possible varicose veins; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OEDEMA PERIPHERAL ("swollen, raised, puffy area on his left leg"), VARICOPHLEBITIS ("raised veins"; rope- like), SKIN WARM ("warm to the touch"), PAIN IN EXTREMITY ("pain is in different areas" (back of the knee in calf area)) and FEELING ABNORMAL (Something isn't right here) in a 52-year-old male patient who received mRNA-1273 (batch nos. 038B21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's medical history was not reported.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 16-Apr-2021 at 4:00 AM, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced VARICOPHLEBITIS ("raised veins"; rope- like), SKIN WARM ("warm to the touch"), FEELING ABNORMAL (Something isn't right here), ANXIETY (worried about a possible blood clot) and VARICOSE VEIN (possible varicose veins). On 29-Apr-2021 at 10:00 AM, the patient experienced OEDEMA PERIPHERAL ("swollen, raised, puffy area on his left leg"). On 30-Apr-2021, the patient experienced PAIN IN EXTREMITY ("pain is in different areas" (back of the knee in calf area)) and CONDITION AGGRAVATED (this morning is worse than yesterday). At the time of the report, OEDEMA PERIPHERAL ("swollen, raised, puffy area on his left leg"), VARICOPHLEBITIS ("raised veins"; rope- like), SKIN WARM ("warm to the touch"), PAIN IN EXTREMITY ("pain is in different areas" (back of the knee in calf area)), FEELING ABNORMAL (Something isn't right here), ANXIETY (worried about a possible blood clot), CONDITION AGGRAVATED (this morning is worse than yesterday) and VARICOSE VEIN (possible varicose veins) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       No treatment medications were reported Action taken with mRNA-1273 in response to the events were Not Applicable
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0020B20A and 007C21A0) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-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 PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were not provided No treatment medication information were not provided
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received past the 12 hours expiration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received past the 12 hours expiration) in a 65-year-old male patient who received mRNA-1273 (batch no. 025C21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ALLOPURINOL, PAROXETINE, SIMVASTATIN and GATIFLOXACIN, LOTEPREDNOL ETABONATE (LOTREL G) for an unknown indication.    On 30-Apr-2021, the patient received dose of mRNA-1273 (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received past the 12 hours expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received past the 12 hours expiration) had resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site warmth
Clinical narrative: after the vaccine, she experience a swollen arm and says it was kind of hot; Swollen arm; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (after the vaccine, she experience a swollen arm and says it was kind of hot), the first episode of PERIPHERAL SWELLING (Swollen arm) and the second episode of PERIPHERAL SWELLING (Swollen arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concurrent medical conditions included Seizure. Concomitant products included LISINOPRIL, SERTRALINE and LEVETIRACETAM (KEPPRA) for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE WARMTH (after the vaccine, she experience a swollen arm and says it was kind of hot), the first episode of PERIPHERAL SWELLING (Swollen arm) and the second episode of PERIPHERAL SWELLING (Swollen arm). At the time of the report, VACCINATION SITE WARMTH (after the vaccine, she experience a swollen arm and says it was kind of hot) had resolved and last episode of PERIPHERAL SWELLING (Swollen arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Neck injury, Pain
Clinical narrative: pain; hurt her neck; This spontaneous case was reported by a consumer and describes the occurrence of NECK INJURY (hurt her neck) and PAIN (pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced NECK INJURY (hurt her neck). On an unknown date, the patient experienced PAIN (pain). At the time of the report, NECK INJURY (hurt her neck) and PAIN (pain) outcome was unknown. Not Provided          No concomitant medications reported. No treatment information provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Headache, Heart rate decreased, Hypotension
Clinical narrative: she usually would take 50 mg of losartan, her HCP reduced it to 20mg and because it didn't regulate, she took her off the losartan completely.; headache; heart rate has been dropping; blood pressure has been going crazy, really high, really low; very stressed out; blood pressure was low 94/62; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOTENSION (blood pressure was low 94/62), PRE-EXISTING CONDITION IMPROVED (she usually would take 50 mg of losartan, her HCP reduced it to 20mg and because it didn't regulate, she took her off the losartan completely.), HEART RATE DECREASED (heart rate has been dropping), BLOOD PRESSURE ABNORMAL (blood pressure has been going crazy, really high, really low) and STRESS (very stressed out) in a 73-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included BISACODYL (DULCOLAX [BISACODYL]) for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced HYPOTENSION (blood pressure was low 94/62). On 05-May-2021, the patient experienced HEART RATE DECREASED (heart rate has been dropping), BLOOD PRESSURE ABNORMAL (blood pressure has been going crazy, really high, really low) and STRESS (very stressed out). On an unknown date, the patient experienced PRE-EXISTING CONDITION IMPROVED (she usually would take 50 mg of losartan, her HCP reduced it to 20mg and because it didn't regulate, she took her off the losartan completely.) and HEADACHE (headache). At the time of the report, HYPOTENSION (blood pressure was low 94/62) had resolved, PRE-EXISTING CONDITION IMPROVED (she usually would take 50 mg of losartan, her HCP reduced it to 20mg and because it didn't regulate, she took her off the losartan completely.), HEART RATE DECREASED (heart rate has been dropping), BLOOD PRESSURE ABNORMAL (blood pressure has been going crazy, really high, really low) and STRESS (very stressed out) outcome was unknown and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 94/62 (Low) low.     The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown.       Treatment medications taken were Steroids   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up document was attached on 05-May-2021 in which treatment and concomitant drugs are added.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pre-existing condition improved, Stress
Clinical narrative: she usually would take 50 mg of losartan, her HCP reduced it to 20mg and because it didn't regulate, she took her off the losartan completely.; headache; heart rate has been dropping; blood pressure has been going crazy, really high, really low; very stressed out; blood pressure was low 94/62; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOTENSION (blood pressure was low 94/62), PRE-EXISTING CONDITION IMPROVED (she usually would take 50 mg of losartan, her HCP reduced it to 20mg and because it didn't regulate, she took her off the losartan completely.), HEART RATE DECREASED (heart rate has been dropping), BLOOD PRESSURE ABNORMAL (blood pressure has been going crazy, really high, really low) and STRESS (very stressed out) in a 73-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included BISACODYL (DULCOLAX [BISACODYL]) for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced HYPOTENSION (blood pressure was low 94/62). On 05-May-2021, the patient experienced HEART RATE DECREASED (heart rate has been dropping), BLOOD PRESSURE ABNORMAL (blood pressure has been going crazy, really high, really low) and STRESS (very stressed out). On an unknown date, the patient experienced PRE-EXISTING CONDITION IMPROVED (she usually would take 50 mg of losartan, her HCP reduced it to 20mg and because it didn't regulate, she took her off the losartan completely.) and HEADACHE (headache). At the time of the report, HYPOTENSION (blood pressure was low 94/62) had resolved, PRE-EXISTING CONDITION IMPROVED (she usually would take 50 mg of losartan, her HCP reduced it to 20mg and because it didn't regulate, she took her off the losartan completely.), HEART RATE DECREASED (heart rate has been dropping), BLOOD PRESSURE ABNORMAL (blood pressure has been going crazy, really high, really low) and STRESS (very stressed out) outcome was unknown and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 94/62 (Low) low.     The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown.       Treatment medications taken were Steroids   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up document was attached on 05-May-2021 in which treatment and concomitant drugs are added.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Palpitations, Panic attack
Clinical narrative: Having a reaction; his heart was beating fast; experiencing a panic attack; This spontaneous case was reported by a health care professional and describes the occurrence of ADVERSE EVENT (Having a reaction), PALPITATIONS (his heart was beating fast) and PANIC ATTACK (experiencing a panic attack) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to chemicals (allergic to saline).    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced ADVERSE EVENT (Having a reaction), PALPITATIONS (his heart was beating fast) and PANIC ATTACK (experiencing a panic attack). On 01-May-2021, ADVERSE EVENT (Having a reaction), PALPITATIONS (his heart was beating fast) and PANIC ATTACK (experiencing a panic attack) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: TCR added; Significant FU- Added AE and patient gender
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: spasms in her lip; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (spasms in her lip) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced MUSCLE SPASMS (spasms in her lip). At the time of the report, MUSCLE SPASMS (spasms in her lip) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported No treatment medications were reported
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Myalgia, Pain
Clinical narrative: A little sore; pain; Heaviness on the site of injection; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (pain), LIMB DISCOMFORT (Heaviness on the site of injection) and MYALGIA (A little sore) 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 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN (pain) and LIMB DISCOMFORT (Heaviness on the site of injection). On an unknown date, the patient experienced MYALGIA (A little sore). At the time of the report, PAIN (pain), LIMB DISCOMFORT (Heaviness on the site of injection) and MYALGIA (A little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information provided.   This case was linked to MOD-2021-098361 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up document was attached which contains new added events : pain and Limb discomfort and details of first and second dose.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: 3x1 inch oval red, itchy, blotchy, achy spot where the shot was; 3x1 inch oval red, itchy, blotchy, achy spot where the shot was; 3x1 inch oval red, itchy, blotchy, achy spot where the shot was; 3x1 inch oval red, itchy, blotchy, achy spot where the shot was; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-May-2021 and was forwarded to Moderna on 02-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (3x1 inch oval red, itchy, blotchy, achy spot where the shot was), VACCINATION SITE PRURITUS (3x1 inch oval red, itchy, blotchy, achy spot where the shot was), VACCINATION SITE ERYTHEMA (3x1 inch oval red, itchy, blotchy, achy spot where the shot was) and VACCINATION SITE PAIN (3x1 inch oval red, itchy, blotchy, achy spot where the shot was) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced RASH MACULAR (3x1 inch oval red, itchy, blotchy, achy spot where the shot was), VACCINATION SITE PRURITUS (3x1 inch oval red, itchy, blotchy, achy spot where the shot was), VACCINATION SITE ERYTHEMA (3x1 inch oval red, itchy, blotchy, achy spot where the shot was) and VACCINATION SITE PAIN (3x1 inch oval red, itchy, blotchy, achy spot where the shot was). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH MACULAR (3x1 inch oval red, itchy, blotchy, achy spot where the shot was), VACCINATION SITE PRURITUS (3x1 inch oval red, itchy, blotchy, achy spot where the shot was), VACCINATION SITE ERYTHEMA (3x1 inch oval red, itchy, blotchy, achy spot where the shot was) and VACCINATION SITE PAIN (3x1 inch oval red, itchy, blotchy, achy spot where the shot was) 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. Pharmacist had  recommended patient to take Benadryl but patient only took Tylenol.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: Sore arm; Very very tired; Swelling arm; Redness; Ten days before second shot she was waking up with just a dull headache in the middle of the; 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 PAIN IN EXTREMITY (Sore arm), FATIGUE (Very very tired), PERIPHERAL SWELLING (Swelling arm), ERYTHEMA (Redness) and HEADACHE (Ten days before second shot she was waking up with just a dull headache in the middle of the) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (Very very tired), PERIPHERAL SWELLING (Swelling arm), ERYTHEMA (Redness) and HEADACHE (Ten days before second shot she was waking up with just a dull headache in the middle of the). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Sore arm), FATIGUE (Very very tired), PERIPHERAL SWELLING (Swelling arm), ERYTHEMA (Redness) and HEADACHE (Ten days before second shot she was waking up with just a dull headache in the middle of the) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching all over body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over body) in a female patient of an unknown age who received mRNA-1273 (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced PRURITUS (Itching all over body). At the time of the report, PRURITUS (Itching all over body) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       Concomitant medications and treatment medications were not provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Chest pain, Headache, Hyperhidrosis
Clinical narrative: left arm shaking; sweating; every bone in the body aches; really bad headaches; left arm hurts/pain in both arms; right shoulder hurts; pain in front of the chest to the back side on the right side; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (left arm shaking), HYPERHIDROSIS (sweating), CHEST PAIN (pain in front of the chest to the back side on the right side), BONE PAIN (every bone in the body aches) and PAIN IN EXTREMITY (left arm hurts/pain in both arms) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN (ADVIL 12 HOUR), INSULIN, FUROSEMIDE, ATORVASTATIN, SALBUTAMOL (ALBUTEROL HFA), METFORMIN, GABAPENTIN, LANSOPRAZOLE, TOPIRAMATE, GLIPIZIDE and MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE] for an unknown indication.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced CHEST PAIN (pain in front of the chest to the back side on the right side), PAIN IN EXTREMITY (left arm hurts/pain in both arms) and ARTHRALGIA (right shoulder hurts). On 02-May-2021, the patient experienced TREMOR (left arm shaking), HYPERHIDROSIS (sweating), BONE PAIN (every bone in the body aches) and HEADACHE (really bad headaches). At the time of the report, TREMOR (left arm shaking), HYPERHIDROSIS (sweating), CHEST PAIN (pain in front of the chest to the back side on the right side), BONE PAIN (every bone in the body aches), PAIN IN EXTREMITY (left arm hurts/pain in both arms), ARTHRALGIA (right shoulder hurts) and HEADACHE (really bad headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment info provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tremor
Clinical narrative: left arm shaking; sweating; every bone in the body aches; really bad headaches; left arm hurts/pain in both arms; right shoulder hurts; pain in front of the chest to the back side on the right side; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (left arm shaking), HYPERHIDROSIS (sweating), CHEST PAIN (pain in front of the chest to the back side on the right side), BONE PAIN (every bone in the body aches) and PAIN IN EXTREMITY (left arm hurts/pain in both arms) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN (ADVIL 12 HOUR), INSULIN, FUROSEMIDE, ATORVASTATIN, SALBUTAMOL (ALBUTEROL HFA), METFORMIN, GABAPENTIN, LANSOPRAZOLE, TOPIRAMATE, GLIPIZIDE and MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE] for an unknown indication.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced CHEST PAIN (pain in front of the chest to the back side on the right side), PAIN IN EXTREMITY (left arm hurts/pain in both arms) and ARTHRALGIA (right shoulder hurts). On 02-May-2021, the patient experienced TREMOR (left arm shaking), HYPERHIDROSIS (sweating), BONE PAIN (every bone in the body aches) and HEADACHE (really bad headaches). At the time of the report, TREMOR (left arm shaking), HYPERHIDROSIS (sweating), CHEST PAIN (pain in front of the chest to the back side on the right side), BONE PAIN (every bone in the body aches), PAIN IN EXTREMITY (left arm hurts/pain in both arms), ARTHRALGIA (right shoulder hurts) and HEADACHE (really bad headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment info provided.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea, Pyrexia
Clinical narrative: felt bad; High Fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt bad), PYREXIA (High Fever) and NAUSEA (nausea) 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 11-Feb-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt bad), PYREXIA (High Fever) and NAUSEA (nausea). At the time of the report, FEELING ABNORMAL (felt bad), PYREXIA (High Fever) and NAUSEA (nausea) had resolved.            No treatment information provided. No concomitant medications were reported.   This case was linked to MOD-2021-040604 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Heart rate increased, Myalgia, Pyrexia
Clinical narrative: rapid heartbeat; fever of 100; body ache; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heartbeat), PYREXIA (fever of 100), MYALGIA (body ache) and CHILLS (chills) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included Hyperthyroidism and Thyroidectomy. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced HEART RATE INCREASED (rapid heartbeat), PYREXIA (fever of 100), MYALGIA (body ache) and CHILLS (chills). At the time of the report, HEART RATE INCREASED (rapid heartbeat), PYREXIA (fever of 100), MYALGIA (body ache) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 fever of 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. she will seek immediate medical attention and contact her family HCP.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  However, the previous history of Hyperthyroidism, is a confounder.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  However, the previous history of Hyperthyroidism, is a confounder.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Fever 100.9; Headache; Had sore arm; Chills; This spontaneous case was reported by an other and describes the occurrence of CHILLS (Chills), PYREXIA (Fever 100.9), HEADACHE (Headache) and VACCINATION SITE PAIN (Had sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included Pacemaker insertion (cardiac) on 26-Mar-2020. Concurrent medical conditions included Drug allergy (Allergy to Levaquin.), Drug allergy (Allergy to Cipro.) and Drug allergy (Allergy to Avelox.). Concomitant products included VITAMIN C [ASCORBIC ACID] from 2000 to an unknown date for Sinus infection, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) from 2018 to an unknown date for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021 at 1:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced CHILLS (Chills) and VACCINATION SITE PAIN (Had sore arm). On 27-Feb-2021, the patient experienced PYREXIA (Fever 100.9) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 27-Feb-2021, CHILLS (Chills) had resolved. On 28-Feb-2021, PYREXIA (Fever 100.9) and HEADACHE (Headache) had resolved. On 03-Mar-2021, VACCINATION SITE PAIN (Had sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Body temperature: 100.9 (abnormal) 100.9- oral.         Treatment medication provided by the patient included lots of fluids.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-024820.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Vaccination site reaction
Clinical narrative: arm painful; arm red; COVID arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (arm painful), ERYTHEMA (arm red) and VACCINATION SITE REACTION (COVID arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm painful), ERYTHEMA (arm red) and VACCINATION SITE REACTION (COVID arm). At the time of the report, PAIN IN EXTREMITY (arm painful), ERYTHEMA (arm red) and VACCINATION SITE REACTION (COVID arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Non-significant follow up
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood pressure measurement, C-reactive protein, Fatigue, Hypersomnia
Clinical narrative: Tired with the first one and spent more time sleeping; tired with the first one and spent more time sleeping; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Tired with the first one and spent more time sleeping) and FATIGUE (tired with the first one and spent more time sleeping) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) 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 HYPERSOMNIA (Tired with the first one and spent more time sleeping) and FATIGUE (tired with the first one and spent more time sleeping). At the time of the report, HYPERSOMNIA (Tired with the first one and spent more time sleeping) and FATIGUE (tired with the first one and spent more time sleeping) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Blood cholesterol: 165 (Inconclusive) His cholesterol is 165. Annual physical exam result.. On 30-Apr-2021, Blood pressure measurement: high (High) High blood pressure Annual physical exam result.. On 30-Apr-2021, C-reactive protein: 0.6 (Inconclusive) 0.6 Annual physical exam result..     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.     This case was linked to MOD-2021-101049 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Dizziness, Fatigue
Clinical narrative: when I stand up and begin walking, I have hold on to whatever is available and consciously control my body from stumbling; could not get out of bed on her own and felt like some one was pushing her back; weakness; light headedness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIZZINESS (light headedness), BALANCE DISORDER (when I stand up and begin walking, I have hold on to whatever is available and consciously control my body from stumbling) and FATIGUE (could not get out of bed on her own and felt like some one was pushing her back) 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 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced ASTHENIA (weakness), DIZZINESS (light headedness) and FATIGUE (could not get out of bed on her own and felt like some one was pushing her back). On 08-Apr-2021, the patient experienced BALANCE DISORDER (when I stand up and begin walking, I have hold on to whatever is available and consciously control my body from stumbling). At the time of the report, ASTHENIA (weakness), DIZZINESS (light headedness), BALANCE DISORDER (when I stand up and begin walking, I have hold on to whatever is available and consciously control my body from stumbling) and FATIGUE (could not get out of bed on her own and felt like some one was pushing her back) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no Concomitant products were provided. no treatment medications were provided.  Patient could not get out of bed on her own and felt like some one was pushing her back. She has been to emergency room by emergency services. It lasted for three days. She also has weakness and light headedness. This is still happening from 7th or 8th day after the vaccine but not as severe as it was. Caller would like to know if she can get the second shot and also would like to know how long the symptoms last for.    Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Patient mentioned still have symptoms but not as strong and uncontrollable. Patient have to hold on to whatever available to control from stumbling.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush
Clinical narrative: Hot flashes; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced HOT FLUSH (Hot flashes). At the time of the report, HOT FLUSH (Hot flashes) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information provided. No concomitant medications reported. Patient reported to get hot flushes about 15 min after vaccine and started to fade away and came back again.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Influenza like illness, Pyrexia
Clinical narrative: Flu like symptoms; Feeling badly; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), FEELING ABNORMAL (Feeling badly), CHILLS (Chills) and PYREXIA (Fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), FEELING ABNORMAL (Feeling badly), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), FEELING ABNORMAL (Feeling badly) and CHILLS (Chills) had not resolved and PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is on several concomitant medications and stated it will be available if necessary.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Vaccination site erythema
Clinical narrative: Injection site erythema; slight arthralgia; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (slight arthralgia), FATIGUE (Tiredness) and VACCINATION SITE ERYTHEMA (Injection site erythema) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced ARTHRALGIA (slight arthralgia) and FATIGUE (Tiredness). On 28-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site erythema). On 07-Apr-2021, ARTHRALGIA (slight arthralgia) and FATIGUE (Tiredness) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Injection site erythema) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant and treatment information was provided.