chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Skin irritation
Clinical narrative: Blisters on his hand and feet; it was all red; blisters are on fire/hand feels like burn; hot all the time; itching is coming back and forth; irritation; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blisters on his hand and feet), ERYTHEMA (it was all red), BURNING SENSATION (blisters are on fire/hand feels like burn), FEELING HOT (hot all the time) and PRURITUS (itching is coming back and forth) in a male patient of an unknown age 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 was provided by the reporter.     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 BLISTER (Blisters on his hand and feet), ERYTHEMA (it was all red), BURNING SENSATION (blisters are on fire/hand feels like burn), FEELING HOT (hot all the time), PRURITUS (itching is coming back and forth) and SKIN IRRITATION (irritation). The patient was treated with BETAMETHASONE DIPROPIONATE (BETAMETHASONE DIPROPIONATE CREAM) ongoing since an unknown date for Adverse event, at a dose of 0.05%; SILVER SULFADIAZINE for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of cream and pills. At the time of the report, BLISTER (Blisters on his hand and feet), ERYTHEMA (it was all red), BURNING SENSATION (blisters are on fire/hand feels like burn), FEELING HOT (hot all the time), PRURITUS (itching is coming back and forth) and SKIN IRRITATION (irritation) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported.   This case was linked to MOD-2021-321355 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pruritus
Clinical narrative: blister; itching; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (blister) and PRURITUS (itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLISTER (blister) and PRURITUS (itching). At the time of the report, BLISTER (blister) and PRURITUS (itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment medications were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore right injection site arm) in a 70-year-old female patient 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 VACCINATION SITE PAIN (Sore right injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore right injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-321418, MOD-2021-321420 (Patient Link).
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: got a headache since  the morning after getting their first dose; got pain in the injection site, and that has gotten worst; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (got a headache since  the morning after getting their first dose) and VACCINATION SITE PAIN (got pain in the injection site, and that has gotten worst) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062521a) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, the patient experienced VACCINATION SITE PAIN (got pain in the injection site, and that has gotten worst). On 17-Sep-2021, the patient experienced HEADACHE (got a headache since  the morning after getting their first dose). At the time of the report, HEADACHE (got a headache since  the morning after getting their first dose) and VACCINATION SITE PAIN (got pain in the injection site, and that has gotten worst) 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 unknown.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Experienced those symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Experienced those symptoms) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (Experienced those symptoms). At the time of the report, VACCINATION COMPLICATION (Experienced those symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: hives on her right arm further down where she got the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (hives on her right arm further down where she got the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021 at 1:30 PM, the patient experienced VACCINATION SITE URTICARIA (hives on her right arm further down where she got the injection). At the time of the report, VACCINATION SITE URTICARIA (hives on her right arm further down where she got the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was provided.  No treatment medication details was provided.
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia
Clinical narrative: Arrhythmia; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Arrhythmia) 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.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (Arrhythmia) (seriousness criterion medically significant). At the time of the report, ARRHYTHMIA (Arrhythmia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took  vaccine in March and experienced an Arrhythmia. Patient reported to VAERS and all the information needed was in VAERS.  Concomitant medication of the patient was not reported. No treatment information was provided by the reporter.  This case concerns a male patient with no relevant medical history, who experienced the unexpected event of arrhythmia. The event occurred in March 2021 after vaccination with Spikevax, it is unknown if it is first or second dose. . The rechallenge was unknown, as there is no information that states vaccination date or dose number and there is only one dose reported. The benefit-risk relationship of Spikevax is not affected by this report. Event arrhythmia was automatically upgraded as a Serious event as per RA list and kept as serious as per medical judgement, despite it was reported as non-serious. No further information is expected as the patient did not authorize follow-up.; Sender's Comments: This case concerns a male patient with no relevant medical history, who experienced the unexpected event of arrhythmia. The event occurred in March 2021 after vaccination with Spikevax, it is unknown if it is first or second dose. . The rechallenge was unknown, as there is no information that states vaccination date or dose number and there is only one dose reported. The benefit-risk relationship of Spikevax is not affected by this report. Event arrhythmia was automatically upgraded as a Serious event as per RA list and kept as serious as per medical judgement, despite it was reported as non-serious.No further information is expected as the patient did not authorize follow-up.
Age: 0.33
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Heat; Reddness; Swelling; Pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Heat), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Pain) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included Synthroid 100ug for Hypothyroidism.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, the patient experienced VACCINATION SITE WARMTH (Heat), VACCINATION SITE ERYTHEMA (Reddness), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 20-Aug-2021, VACCINATION SITE WARMTH (Heat), VACCINATION SITE ERYTHEMA (Reddness), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Pain) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment- Icepack to alleviate local reaction   This case was linked to MOD-2021-322356 (Patient Link).
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Malaise, Off label use, Pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell), OFF LABEL USE (Off label use), PRURITUS (Extremities itchy sensation of), ERYTHEMA (Skin red) and VACCINATION SITE URTICARIA (Vaccination site urticaria) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Feeling unwell), OFF LABEL USE (Off label use), PRURITUS (Extremities itchy sensation of), ERYTHEMA (Skin red), VACCINATION SITE URTICARIA (Vaccination site urticaria) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form; PREDNISONE ongoing since an unknown date for Itchy, at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date for Allergy, at a dose of 1 dosage form. At the time of the report, MALAISE (Feeling unwell), OFF LABEL USE (Off label use), PRURITUS (Extremities itchy sensation of), ERYTHEMA (Skin red), VACCINATION SITE URTICARIA (Vaccination site urticaria) and FATIGUE (Tiredness) outcome was unknown. No concomitant was provided. Steroids were given, but did not know if the symptoms were from the booster or not. This case was linked to MOD-2021-322305 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow-up received contains treatment medication and event outcome updated.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell), OFF LABEL USE (Off label use), PRURITUS (Extremities itchy sensation of), ERYTHEMA (Skin red) and VACCINATION SITE URTICARIA (Vaccination site urticaria) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Feeling unwell), OFF LABEL USE (Off label use), PRURITUS (Extremities itchy sensation of), ERYTHEMA (Skin red), VACCINATION SITE URTICARIA (Vaccination site urticaria) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form; PREDNISONE ongoing since an unknown date for Itchy, at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date for Allergy, at a dose of 1 dosage form. At the time of the report, MALAISE (Feeling unwell), OFF LABEL USE (Off label use), PRURITUS (Extremities itchy sensation of), ERYTHEMA (Skin red), VACCINATION SITE URTICARIA (Vaccination site urticaria) and FATIGUE (Tiredness) outcome was unknown. No concomitant was provided. Steroids were given, but did not know if the symptoms were from the booster or not. This case was linked to MOD-2021-322305 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow-up received contains treatment medication and event outcome updated.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Neck pain, Sinusitis
Clinical narrative: Experiencing sinus issues; chronic neck pain; chronic back pain; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Experiencing sinus issues), NECK PAIN (chronic neck pain) and BACK PAIN (chronic back pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Sinus disorder (has history of sinus issues).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, the patient experienced SINUSITIS (Experiencing sinus issues), NECK PAIN (chronic neck pain) and BACK PAIN (chronic back pain). At the time of the report, SINUSITIS (Experiencing sinus issues), NECK PAIN (chronic neck pain) and BACK PAIN (chronic back pain) outcome was unknown.            No concomitant medication were reported. No treatment information was provided by the reporter.  Patient said she is experiencing sinus issues and chronic neck and back pain side effects months after getting the two moderna doses. Patient  already went to clinic and was advised to get tested for covid.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Feeling hot, Headache, Testicular pain, Testicular swelling
Clinical narrative: My private felts like they were just sore/soreness in my testicle/my privates felt like they were tender; My privates felt like they were swollen/testicle; Heat flame over my whole body; Lost almost 3 pounds over night; Really bad back pain; Soreness in my right arm; Excruciating headache; This spontaneous case was reported by a consumer and describes the occurrence of TESTICULAR PAIN (My privates felt like they were just sore/soreness in my testicle/my privates felt like they were tender), TESTICULAR SWELLING (My privates felt like they were swollen/testicle), FEELING HOT (Heat flame over my whole body), WEIGHT DECREASED (Lost almost 3 pounds over night) and BACK PAIN (Really bad back pain) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, the patient experienced TESTICULAR PAIN (My private felts like they were just sore/soreness in my testicle/my privates felt like they were tender), TESTICULAR SWELLING (My privates felt like they were swollen/testicle), FEELING HOT (Heat flame over my whole body), WEIGHT DECREASED (Lost almost 3 pounds over night), BACK PAIN (Really bad back pain), VACCINATION SITE PAIN (Soreness in my right arm) and HEADACHE (Excruciating headache). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, TESTICULAR PAIN (My private felts like they were just sore/soreness in my testicle/my privates felt like they were tender) had not resolved, TESTICULAR SWELLING (My privates felt like they were swollen/testicle), FEELING HOT (Heat flame over my whole body) and WEIGHT DECREASED (Lost almost 3 pounds over night) outcome was unknown and BACK PAIN (Really bad back pain), VACCINATION SITE PAIN (Soreness in my right arm) and HEADACHE (Excruciating headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. The patient took one ibuprofen at night. Second shot was scheduled  on 13-Oct-2021.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Weight decreased
Clinical narrative: My private felts like they were just sore/soreness in my testicle/my privates felt like they were tender; My privates felt like they were swollen/testicle; Heat flame over my whole body; Lost almost 3 pounds over night; Really bad back pain; Soreness in my right arm; Excruciating headache; This spontaneous case was reported by a consumer and describes the occurrence of TESTICULAR PAIN (My privates felt like they were just sore/soreness in my testicle/my privates felt like they were tender), TESTICULAR SWELLING (My privates felt like they were swollen/testicle), FEELING HOT (Heat flame over my whole body), WEIGHT DECREASED (Lost almost 3 pounds over night) and BACK PAIN (Really bad back pain) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, the patient experienced TESTICULAR PAIN (My private felts like they were just sore/soreness in my testicle/my privates felt like they were tender), TESTICULAR SWELLING (My privates felt like they were swollen/testicle), FEELING HOT (Heat flame over my whole body), WEIGHT DECREASED (Lost almost 3 pounds over night), BACK PAIN (Really bad back pain), VACCINATION SITE PAIN (Soreness in my right arm) and HEADACHE (Excruciating headache). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, TESTICULAR PAIN (My private felts like they were just sore/soreness in my testicle/my privates felt like they were tender) had not resolved, TESTICULAR SWELLING (My privates felt like they were swollen/testicle), FEELING HOT (Heat flame over my whole body) and WEIGHT DECREASED (Lost almost 3 pounds over night) outcome was unknown and BACK PAIN (Really bad back pain), VACCINATION SITE PAIN (Soreness in my right arm) and HEADACHE (Excruciating headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. The patient took one ibuprofen at night. Second shot was scheduled  on 13-Oct-2021.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Got an expired dose; This spontaneous case was reported by an other and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Got an expired dose) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Sep-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 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Got an expired dose). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Got an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications information was not provided by the reporter. The number of doses/vials were one vial/ three doses. Treatment information was not provided by the reporter. The vial did not undergo any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow up received contains updated contact details.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm was sore) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Vasculitis (Patient has been diagnosed with vasculitis.). Concomitant products included LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE, METOPROLOL and ATORVASTATIN for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced MYALGIA (Arm was sore). On 06-Jan-2021, MYALGIA (Arm was sore) had resolved.        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 medication after first and second dose. Patient took Steroid shot yesterday 16sep21 (he cannot take prednisone because it gives her palpitations)   This case was linked to MOD-2021-322350 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Limb discomfort
Clinical narrative: second dose: arm pain; popping veins in ankle; headache; extremely exhausted; chills; nausea; right leg joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (second dose: arm pain), LIMB DISCOMFORT (popping veins in ankle), HEADACHE (headache), FATIGUE (extremely exhausted) and CHILLS (chills) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Sulfur medication). Concomitant products included AMLODIPINE for Blood pressure high, METFORMIN for Diabetes, MULTIVITAMINS [VITAMINS NOS] for Nutritional supplement.    On 16-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced PAIN IN EXTREMITY (second dose: arm pain), LIMB DISCOMFORT (popping veins in ankle), FATIGUE (extremely exhausted), NAUSEA (nausea) and ARTHRALGIA (right leg joint pain). 17-Sep-2021, the patient experienced HEADACHE (headache) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 4 doses in the span of 4 hours. At the time of the report, PAIN IN EXTREMITY (second dose: arm pain), LIMB DISCOMFORT (popping veins in ankle), HEADACHE (headache), FATIGUE (extremely exhausted), CHILLS (chills), NAUSEA (nausea) and ARTHRALGIA (right leg joint pain) outcome was unknown.            Other concomitant medications include Cardiac medication once a day and Vitamin 15mg.   This case was linked to MOD-2021-322206 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: second dose: arm pain; popping veins in ankle; headache; extremely exhausted; chills; nausea; right leg joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (second dose: arm pain), LIMB DISCOMFORT (popping veins in ankle), HEADACHE (headache), FATIGUE (extremely exhausted) and CHILLS (chills) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Sulfur medication). Concomitant products included AMLODIPINE for Blood pressure high, METFORMIN for Diabetes, MULTIVITAMINS [VITAMINS NOS] for Nutritional supplement.    On 16-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced PAIN IN EXTREMITY (second dose: arm pain), LIMB DISCOMFORT (popping veins in ankle), FATIGUE (extremely exhausted), NAUSEA (nausea) and ARTHRALGIA (right leg joint pain). 17-Sep-2021, the patient experienced HEADACHE (headache) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 4 doses in the span of 4 hours. At the time of the report, PAIN IN EXTREMITY (second dose: arm pain), LIMB DISCOMFORT (popping veins in ankle), HEADACHE (headache), FATIGUE (extremely exhausted), CHILLS (chills), NAUSEA (nausea) and ARTHRALGIA (right leg joint pain) outcome was unknown.            Other concomitant medications include Cardiac medication once a day and Vitamin 15mg.   This case was linked to MOD-2021-322206 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Chills, Erythema, Joint swelling, Malaise
Clinical narrative: swollen ankles; vasculitis; was not getting any better; she even had more bumps (not a rash, knuckles and bumps under skin),some of these bumps were on blood vessels; ache; red lumps under the skin; chills; fever; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (ache), ERYTHEMA (red lumps under the skin), NODULE (she even had more bumps (not a rash, knuckles and bumps under skin),some of these bumps were on blood vessels), JOINT SWELLING (swollen ankles) and VASCULITIS (vasculitis) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included LOSARTAN POTASSIUM, METOPROLOL, ATORVASTATIN and HYDROCHLOROTHIAZIDE for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced MYALGIA (arm was sore). On 07-Sep-2021, the patient experienced PAIN (ache), ERYTHEMA (red lumps under the skin), CHILLS (chills) and PYREXIA (fever). On 14-Sep-2021, the patient experienced NODULE (she even had more bumps (not a rash, knuckles and bumps under skin),some of these bumps were on blood vessels) and MALAISE (was not getting any better). On an unknown date, the patient experienced JOINT SWELLING (swollen ankles) and VASCULITIS (vasculitis). On 02-Feb-2021, MYALGIA (arm was sore) outcome was unknown. At the time of the report, PAIN (ache), ERYTHEMA (red lumps under the skin), NODULE (she even had more bumps (not a rash, knuckles and bumps under skin),some of these bumps were on blood vessels), JOINT SWELLING (swollen ankles), VASCULITIS (vasculitis), MALAISE (was not getting any better), CHILLS (chills) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2021, C-reactive protein: 137 (High) C-reactive protein increased.. On 14-Sep-2021, Red blood cell sedimentation rate: 78 (High) Red blood cell sedimentation rate increased.. On an unknown date, SARS-CoV-2 test negative: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication reported.   This case was linked to MOD-2021-322335.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nodule, Pain, Pyrexia, Red blood cell sedimentation rate
Clinical narrative: swollen ankles; vasculitis; was not getting any better; she even had more bumps (not a rash, knuckles and bumps under skin),some of these bumps were on blood vessels; ache; red lumps under the skin; chills; fever; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (ache), ERYTHEMA (red lumps under the skin), NODULE (she even had more bumps (not a rash, knuckles and bumps under skin),some of these bumps were on blood vessels), JOINT SWELLING (swollen ankles) and VASCULITIS (vasculitis) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included LOSARTAN POTASSIUM, METOPROLOL, ATORVASTATIN and HYDROCHLOROTHIAZIDE for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced MYALGIA (arm was sore). On 07-Sep-2021, the patient experienced PAIN (ache), ERYTHEMA (red lumps under the skin), CHILLS (chills) and PYREXIA (fever). On 14-Sep-2021, the patient experienced NODULE (she even had more bumps (not a rash, knuckles and bumps under skin),some of these bumps were on blood vessels) and MALAISE (was not getting any better). On an unknown date, the patient experienced JOINT SWELLING (swollen ankles) and VASCULITIS (vasculitis). On 02-Feb-2021, MYALGIA (arm was sore) outcome was unknown. At the time of the report, PAIN (ache), ERYTHEMA (red lumps under the skin), NODULE (she even had more bumps (not a rash, knuckles and bumps under skin),some of these bumps were on blood vessels), JOINT SWELLING (swollen ankles), VASCULITIS (vasculitis), MALAISE (was not getting any better), CHILLS (chills) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2021, C-reactive protein: 137 (High) C-reactive protein increased.. On 14-Sep-2021, Red blood cell sedimentation rate: 78 (High) Red blood cell sedimentation rate increased.. On an unknown date, SARS-CoV-2 test negative: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication reported.   This case was linked to MOD-2021-322335.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Vasculitis
Clinical narrative: swollen ankles; vasculitis; was not getting any better; she even had more bumps (not a rash, knuckles and bumps under skin),some of these bumps were on blood vessels; ache; red lumps under the skin; chills; fever; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (ache), ERYTHEMA (red lumps under the skin), NODULE (she even had more bumps (not a rash, knuckles and bumps under skin),some of these bumps were on blood vessels), JOINT SWELLING (swollen ankles) and VASCULITIS (vasculitis) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included LOSARTAN POTASSIUM, METOPROLOL, ATORVASTATIN and HYDROCHLOROTHIAZIDE for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced MYALGIA (arm was sore). On 07-Sep-2021, the patient experienced PAIN (ache), ERYTHEMA (red lumps under the skin), CHILLS (chills) and PYREXIA (fever). On 14-Sep-2021, the patient experienced NODULE (she even had more bumps (not a rash, knuckles and bumps under skin),some of these bumps were on blood vessels) and MALAISE (was not getting any better). On an unknown date, the patient experienced JOINT SWELLING (swollen ankles) and VASCULITIS (vasculitis). On 02-Feb-2021, MYALGIA (arm was sore) outcome was unknown. At the time of the report, PAIN (ache), ERYTHEMA (red lumps under the skin), NODULE (she even had more bumps (not a rash, knuckles and bumps under skin),some of these bumps were on blood vessels), JOINT SWELLING (swollen ankles), VASCULITIS (vasculitis), MALAISE (was not getting any better), CHILLS (chills) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2021, C-reactive protein: 137 (High) C-reactive protein increased.. On 14-Sep-2021, Red blood cell sedimentation rate: 78 (High) Red blood cell sedimentation rate increased.. On an unknown date, SARS-CoV-2 test negative: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication reported.   This case was linked to MOD-2021-322335.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and CHILLS (chills) 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 PYREXIA (fever) and CHILLS (chills). At the time of the report, PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. No Treatment medication were reported. How high and how long should the fever and chills last.   Reporter did not allow further contact
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold, Myalgia, Pain, Pyrexia
Clinical narrative: don't feel good; Feeling cold; arm hurts; body hurts/pain  in body; Fever; vaccinated arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (don't feel good), FEELING COLD (Feeling cold), PAIN (arm hurts), MYALGIA (body hurts/pain  in body) and PYREXIA (Fever) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2021, the patient experienced FEELING ABNORMAL (don't feel good), FEELING COLD (Feeling cold), PAIN (arm hurts), MYALGIA (body hurts/pain  in body), PYREXIA (Fever) and VACCINATION SITE PAIN (vaccinated arm hurts). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (don't feel good), FEELING COLD (Feeling cold), PAIN (arm hurts), MYALGIA (body hurts/pain  in body), PYREXIA (Fever) and VACCINATION SITE PAIN (vaccinated arm hurts) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative.         No relevant concomitant medications were reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: don't feel good; Feeling cold; arm hurts; body hurts/pain  in body; Fever; vaccinated arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (don't feel good), FEELING COLD (Feeling cold), PAIN (arm hurts), MYALGIA (body hurts/pain  in body) and PYREXIA (Fever) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2021, the patient experienced FEELING ABNORMAL (don't feel good), FEELING COLD (Feeling cold), PAIN (arm hurts), MYALGIA (body hurts/pain  in body), PYREXIA (Fever) and VACCINATION SITE PAIN (vaccinated arm hurts). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (don't feel good), FEELING COLD (Feeling cold), PAIN (arm hurts), MYALGIA (body hurts/pain  in body), PYREXIA (Fever) and VACCINATION SITE PAIN (vaccinated arm hurts) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative.         No relevant concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Past the 30 day beyond use date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past the 30 day beyond use date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A201) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past the 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past the 30 day beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and no treatment medication were given .
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hyperhidrosis, Tinnitus
Clinical narrative: woke up wet; her heart felt like her heart was going to burst out of her chest,beating very rapidly where she could hear it in her ears; beating very rapidly where she could hear it in her ears; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (woke up wet), HEART RATE INCREASED (her heart felt like her heart was going to burst out of her chest,beating very rapidly where she could hear it in her ears) and TINNITUS (beating very rapidly where she could hear it in her ears) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, 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 experienced HYPERHIDROSIS (woke up wet), HEART RATE INCREASED (her heart felt like her heart was going to burst out of her chest,beating very rapidly where she could hear it in her ears) and TINNITUS (beating very rapidly where she could hear it in her ears). At the time of the report, HYPERHIDROSIS (woke up wet), HEART RATE INCREASED (her heart felt like her heart was going to burst out of her chest,beating very rapidly where she could hear it in her ears) and TINNITUS (beating very rapidly where she could hear it in her ears) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Skin swelling
Clinical narrative: bumps on their scalp; losing hair; This spontaneous case was reported by a consumer and describes the occurrence of SKIN SWELLING (bumps on their scalp) and ALOPECIA (losing hair) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-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 SKIN SWELLING (bumps on their scalp) and ALOPECIA (losing hair). At the time of the report, SKIN SWELLING (bumps on their scalp) and ALOPECIA (losing hair) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No medical history was provided by the reporter. No treatment information was provided by the reporter. No Concomitant medicines were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Follow-up received for ID- Mod-20221-322410, but the form  has all reporter case i.e. MOD-2021-322385 Details .Hence attached in both cases. Follow-up non sig for this case
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pain on the wrist; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain on the wrist) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Triangular fibrocartilage complex injury.  On 20-Aug-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 ARTHRALGIA (pain on the wrist). At the time of the report, ARTHRALGIA (pain on the wrist) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication information was provided.  Patient was scheduled to received his second dose today but he cancel the appointment. His surgeon did not asked him if he had been vaccinated. Patient received a steroid injection last Friday 10Sep2021 because of a pain he was having on his wrist and now he had concerned because he read in Moderna's website that he should have not received steroids less than 2 weeks after the first dose.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness, Malaise, Product dose omission issue
Clinical narrative: sick; not quite feeling himself; not receiving 2nd dose of the Moderna COVID19 vaccine; COVID19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID19), ILLNESS (sick), MALAISE (not quite feeling himself) and PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose of the Moderna COVID19 vaccine) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047a21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, SIMVASTATIN, TAMSULOSIN, LISINOPRIL and FINASTERIDE for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced COVID-19 (COVID19). On an unknown date, the patient experienced ILLNESS (sick), MALAISE (not quite feeling himself) and PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose of the Moderna COVID19 vaccine). The patient was treated with METHYLPREDNISOLONE for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; ZINC for Adverse event, at an unspecified dose and frequency; ASCORBIC ACID (VITAMINS C) for Adverse event, at an unspecified dose and frequency; VITAMINS NOS for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID19), ILLNESS (sick) and MALAISE (not quite feeling himself) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose of the Moderna COVID19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was scheduled to receive the 2nd dose on April 17th2021 but he got COVID19, he was sick & in quarantine and did not receive 2nd dose
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discolouration
Clinical narrative: his arm has "turned green"; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE DISCOLOURATION (his arm has "turned green") in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-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 DISCOLOURATION (his arm has "turned green"). At the time of the report, VACCINATION SITE DISCOLOURATION (his arm has "turned green") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products was provided. No treatment products was provided. The caller stated that the patient's arm  turned green at his injection site in his left arm and started to go down the length of his arm.