chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity, Rash macular, Rash pruritic
Clinical narrative: itchy rash on her thigh/itchy rash and top of both hands; little spots at the bands of the elbow; Body ache; Mild headache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), RASH PRURITIC (itchy rash on her thigh/itchy rash and top of both hands), RASH MACULAR (little spots at the bands of the elbow), PAIN (Body ache) and HEADACHE (Mild headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028420A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PAIN (Body ache) and HEADACHE (Mild headache). On 25-Jan-2021, the patient experienced RASH PRURITIC (itchy rash on her thigh/itchy rash and top of both hands) and RASH MACULAR (little spots at the bands of the elbow). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), RASH PRURITIC (itchy rash on her thigh/itchy rash and top of both hands), RASH MACULAR (little spots at the bands of the elbow), PAIN (Body ache) and HEADACHE (Mild headache) had not 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 concomitant medications reported by investigator; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Pain in extremity
Clinical narrative: arm pain; when needle came out of arm felt coldness or fluid running down my arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (when needle came out of arm felt coldness or fluid running down my arm) and PAIN IN EXTREMITY (arm pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced FEELING COLD (when needle came out of arm felt coldness or fluid running down my arm). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain). At the time of the report, FEELING COLD (when needle came out of arm felt coldness or fluid running down my arm) had not resolved and PAIN IN EXTREMITY (arm pain) outcome was unknown.            No concomitant medications reported by investigator  No treatment medications provided by the reporter.    This case was linked to MOD21-033798 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2021: Follow up received included No new Information.; Reporter's Comments: This case concerns a 72-year-old female who experienced nonserious unexpected events of ARM PAIN and FEELING COLD described as "coldness or fluid running down her arm". The ARM PAIN occurred with first dose mRNA-1273 and FEELING COLD occurred the same day as second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Epistaxis
Clinical narrative: Chest pain; nose bleed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Chest pain) and EPISTAXIS (nose bleed) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD. Concomitant products included CARTHAMUS TINCTORIUS OIL, HYALURONIC ACID, NICOTINAMIDE (CERAVE ECZEMA CREAMY OIL), ASPIRIN [ACETYLSALICYLIC ACID], FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), MONTELUKAST, LOSARTAN, METOPROLOL and talopram for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain) and EPISTAXIS (nose bleed). At the time of the report, CHEST PAIN (Chest pain) and EPISTAXIS (nose bleed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient went to emergency room. Treatment details included Prednisone.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Vaccination site erythema, Vaccination site reaction, Vaccination site swelling
Clinical narrative: hot; reaction that she had 17 days after getting the first vaccine; red area that is 3 inches wide and 6 inches long; swollen; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hot), VACCINATION SITE REACTION (reaction that she had 17 days after getting the first vaccine), VACCINATION SITE ERYTHEMA (red area that is 3 inches wide and 6 inches long) and VACCINATION SITE SWELLING (swollen) 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 No adverse event.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced FEELING HOT (hot), VACCINATION SITE REACTION (reaction that she had 17 days after getting the first vaccine), VACCINATION SITE ERYTHEMA (red area that is 3 inches wide and 6 inches long) and VACCINATION SITE SWELLING (swollen). At the time of the report, FEELING HOT (hot), VACCINATION SITE REACTION (reaction that she had 17 days after getting the first vaccine), VACCINATION SITE ERYTHEMA (red area that is 3 inches wide and 6 inches long) and VACCINATION SITE SWELLING (swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information and concomitant medications were reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Loss of Taste; This spontaneous case was reported by a health care professional and describes the occurrence of AGEUSIA (Loss of Taste) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced AGEUSIA (Loss of Taste). At the time of the report, AGEUSIA (Loss of Taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No relevant concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Heart rate, Heart rate irregular, Nausea
Clinical narrative: pacing heartbeat 20-30 min later after getting the vaccine while driving home; felt like tachycardia; very anxious; pain/ache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (pacing heartbeat 20-30 min later after getting the vaccine while driving home), TACHYCARDIA (felt like tachycardia), ANXIETY (very anxious), PAIN (pain/ache) and NAUSEA (nausea) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20) for COVID-19 vaccination.     The patient's past medical history included Anxiety and Multiple sclerosis. Concomitant products included OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]), IBUPROFEN, CLONAZEPAM (KLONOPIN), DONEPEZIL, ACETYLSALICYLIC ACID (ASPIRIN 81), ARMODAFINIL, Cyclobenzopril, CHLORTHALIDONE, OMEPRAZOLE, LOSARTAN, PRAVASTATIN, IV IgG infusion, VITAMIN C [ASCORBIC ACID] and COLECALCIFEROL (VITAMIN D3 1000) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced HEART RATE IRREGULAR (pacing heartbeat 20-30 min later after getting the vaccine while driving home), TACHYCARDIA (felt like tachycardia), ANXIETY (very anxious), PAIN (pain/ache) and NAUSEA (nausea). At the time of the report, HEART RATE IRREGULAR (pacing heartbeat 20-30 min later after getting the vaccine while driving home), TACHYCARDIA (felt like tachycardia), ANXIETY (very anxious), PAIN (pain/ache) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 125/65-70 125/65-70. On an unknown date, Heart rate: 100 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Percocet, Ibuprofen.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Tachycardia
Clinical narrative: pacing heartbeat 20-30 min later after getting the vaccine while driving home; felt like tachycardia; very anxious; pain/ache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (pacing heartbeat 20-30 min later after getting the vaccine while driving home), TACHYCARDIA (felt like tachycardia), ANXIETY (very anxious), PAIN (pain/ache) and NAUSEA (nausea) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20) for COVID-19 vaccination.     The patient's past medical history included Anxiety and Multiple sclerosis. Concomitant products included OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]), IBUPROFEN, CLONAZEPAM (KLONOPIN), DONEPEZIL, ACETYLSALICYLIC ACID (ASPIRIN 81), ARMODAFINIL, Cyclobenzopril, CHLORTHALIDONE, OMEPRAZOLE, LOSARTAN, PRAVASTATIN, IV IgG infusion, VITAMIN C [ASCORBIC ACID] and COLECALCIFEROL (VITAMIN D3 1000) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced HEART RATE IRREGULAR (pacing heartbeat 20-30 min later after getting the vaccine while driving home), TACHYCARDIA (felt like tachycardia), ANXIETY (very anxious), PAIN (pain/ache) and NAUSEA (nausea). At the time of the report, HEART RATE IRREGULAR (pacing heartbeat 20-30 min later after getting the vaccine while driving home), TACHYCARDIA (felt like tachycardia), ANXIETY (very anxious), PAIN (pain/ache) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 125/65-70 125/65-70. On an unknown date, Heart rate: 100 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Percocet, Ibuprofen.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Feeling abnormal, Headache, Illness
Clinical narrative: huge lymhpnode on neck right side; awful pain in joints; didnt sleep at all last night; Chills/wild chills; headache was so bad; incredible joint pain; dont feel good; got sick wednesday night; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (dont feel good), ILLNESS (got sick wednesday night), INSOMNIA (didnt sleep at all last night), LYMPHADENOPATHY (huge lymhpnode on neck right side) and CHILLS (Chills/wild chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced HEADACHE (headache was so bad). On 18-Feb-2021, the patient experienced INSOMNIA (didnt sleep at all last night) and CHILLS (Chills/wild chills). On 19-Feb-2021, the patient experienced ARTHRALGIA (awful pain in joints). On an unknown date, the patient experienced FEELING ABNORMAL (dont feel good), ILLNESS (got sick wednesday night), LYMPHADENOPATHY (huge lymhpnode on neck right side) and ARTHRALGIA (incredible joint pain). The patient was treated with ACETAMINOPHEN on 17-Feb-2021 for Headache, at a dose of 1 dosage form and PROPRANOLOL HYDROCHLORIDE (INDERAL) on 17-Feb-2021 at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (dont feel good), ILLNESS (got sick wednesday night), INSOMNIA (didnt sleep at all last night), LYMPHADENOPATHY (huge lymhpnode on neck right side), CHILLS (Chills/wild chills), HEADACHE (headache was so bad), ARTHRALGIA (incredible joint pain) and ARTHRALGIA (awful pain in joints) had resolved.            No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Treatment medications were added, outcome of the events updated.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Lymphadenopathy
Clinical narrative: huge lymhpnode on neck right side; awful pain in joints; didnt sleep at all last night; Chills/wild chills; headache was so bad; incredible joint pain; dont feel good; got sick wednesday night; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (dont feel good), ILLNESS (got sick wednesday night), INSOMNIA (didnt sleep at all last night), LYMPHADENOPATHY (huge lymhpnode on neck right side) and CHILLS (Chills/wild chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced HEADACHE (headache was so bad). On 18-Feb-2021, the patient experienced INSOMNIA (didnt sleep at all last night) and CHILLS (Chills/wild chills). On 19-Feb-2021, the patient experienced ARTHRALGIA (awful pain in joints). On an unknown date, the patient experienced FEELING ABNORMAL (dont feel good), ILLNESS (got sick wednesday night), LYMPHADENOPATHY (huge lymhpnode on neck right side) and ARTHRALGIA (incredible joint pain). The patient was treated with ACETAMINOPHEN on 17-Feb-2021 for Headache, at a dose of 1 dosage form and PROPRANOLOL HYDROCHLORIDE (INDERAL) on 17-Feb-2021 at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (dont feel good), ILLNESS (got sick wednesday night), INSOMNIA (didnt sleep at all last night), LYMPHADENOPATHY (huge lymhpnode on neck right side), CHILLS (Chills/wild chills), HEADACHE (headache was so bad), ARTHRALGIA (incredible joint pain) and ARTHRALGIA (awful pain in joints) had resolved.            No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Treatment medications were added, outcome of the events updated.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Some soreness in the arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 20-Feb-2021.    This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Some soreness in the arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Some soreness in the arm). At the time of the report, PAIN IN EXTREMITY (Some soreness in the arm) outcome was unknown.        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 medication provided. No treatment medication provided.   This case was linked to MOD-2021-018929, MOD-2021-018929 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jul-2021: Follow up received on 17 Jul 2021 contains no significant information.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Nausea, Pyrexia, Vaccination site swelling
Clinical narrative: Shortness of breath; Nausea; Fever; Headache; Swollen at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), NAUSEA (Nausea), PYREXIA (Fever), HEADACHE (Headache) and VACCINATION SITE SWELLING (Swollen at the site of injection) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath), NAUSEA (Nausea), PYREXIA (Fever), HEADACHE (Headache) and VACCINATION SITE SWELLING (Swollen at the site of injection). At the time of the report, DYSPNOEA (Shortness of breath), NAUSEA (Nausea), PYREXIA (Fever), HEADACHE (Headache) and VACCINATION SITE SWELLING (Swollen at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment for the event included Tylenol. No relevant Concomitant medications were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives over the body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives over the body) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives over the body). At the time of the report, URTICARIA (Hives over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14 JUL 2021: Updated Contact information.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Vaccination site pain, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache), VOMITING (vomiting), VACCINATION SITE PAIN (arm is sore/arm is tender) and PAIN IN EXTREMITY (Pain in arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced HEADACHE (severe headache), VOMITING (vomiting), VACCINATION SITE PAIN (arm is sore/arm is tender) and PAIN IN EXTREMITY (Pain in arm). At the time of the report, HEADACHE (severe headache), VOMITING (vomiting), VACCINATION SITE PAIN (arm is sore/arm is tender) and PAIN IN EXTREMITY (Pain in arm) outcome was unknown. No treatment information was provided.  No relevant concomitant medications were reported. Action taken with  mRNA-1273 (Moderna COVID-19 Vaccine)  is not applicable.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Oral contusion, Rash, Tongue pruritus, Urticaria
Clinical narrative: rash; swollen lips; tongue itching; tongue felt scolded; hives; This spontaneous case was reported by a health care professional and describes the occurrence of LIP SWELLING (swollen lips), TONGUE PRURITUS (tongue itching), ORAL CONTUSION (tongue felt scolded), URTICARIA (hives) and RASH (rash) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced LIP SWELLING (swollen lips), TONGUE PRURITUS (tongue itching), ORAL CONTUSION (tongue felt scolded) and URTICARIA (hives). On 17-Feb-2021, the patient experienced RASH (rash). At the time of the report, LIP SWELLING (swollen lips), TONGUE PRURITUS (tongue itching), ORAL CONTUSION (tongue felt scolded), URTICARIA (hives) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment taken was Medrol dose pack and Benadryl . Concomitant product use was not provided by the patient.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea, Fatigue, Heart rate abnormal, Pain
Clinical narrative: body wide pain from head to feet; Anxiety; felt like i could not breathe, couldnt get enough air; heart rate was 148; fever 101F; extremely tired and fatigue; Pain in arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (body wide pain from head to feet), ANXIETY (Anxiety), DYSPNOEA (felt like i could not breathe, couldnt get enough air), PAIN IN EXTREMITY (Pain in arm) and HEART RATE ABNORMAL (heart rate was 148) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 08-Feb-2021, the patient experienced PAIN (body wide pain from head to feet), ANXIETY (Anxiety), DYSPNOEA (felt like i could not breathe, couldnt get enough air), HEART RATE ABNORMAL (heart rate was 148), PYREXIA (fever 101F) and FATIGUE (extremely tired and fatigue). At the time of the report, PAIN (body wide pain from head to feet), ANXIETY (Anxiety), DYSPNOEA (felt like i could not breathe, couldnt get enough air), PAIN IN EXTREMITY (Pain in arm), HEART RATE ABNORMAL (heart rate was 148), PYREXIA (fever 101F) and FATIGUE (extremely tired and fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was not reported.  Action taken with mRNA-1273 is not applicable.   This case was linked to MOD-2021-018913 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jul-2021: Non significant follow up received and contains updated reporter contact information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: body wide pain from head to feet; Anxiety; felt like i could not breathe, couldnt get enough air; heart rate was 148; fever 101F; extremely tired and fatigue; Pain in arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (body wide pain from head to feet), ANXIETY (Anxiety), DYSPNOEA (felt like i could not breathe, couldnt get enough air), PAIN IN EXTREMITY (Pain in arm) and HEART RATE ABNORMAL (heart rate was 148) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 08-Feb-2021, the patient experienced PAIN (body wide pain from head to feet), ANXIETY (Anxiety), DYSPNOEA (felt like i could not breathe, couldnt get enough air), HEART RATE ABNORMAL (heart rate was 148), PYREXIA (fever 101F) and FATIGUE (extremely tired and fatigue). At the time of the report, PAIN (body wide pain from head to feet), ANXIETY (Anxiety), DYSPNOEA (felt like i could not breathe, couldnt get enough air), PAIN IN EXTREMITY (Pain in arm), HEART RATE ABNORMAL (heart rate was 148), PYREXIA (fever 101F) and FATIGUE (extremely tired and fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was not reported.  Action taken with mRNA-1273 is not applicable.   This case was linked to MOD-2021-018913 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jul-2021: Non significant follow up received and contains updated reporter contact information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Oral pain, Oropharyngeal pain, Pain in jaw
Clinical narrative: pain high in throat; pain in mouth roof/pain near nose inside mouth; pain under jawline; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL PAIN (pain high in throat), ORAL PAIN (pain in mouth roof/pain near nose inside mouth) and PAIN IN JAW (pain under jawline) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (pain high in throat), ORAL PAIN (pain in mouth roof/pain near nose inside mouth) and PAIN IN JAW (pain under jawline).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   No relevant concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Shortness of breath) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Respiratory abnormality, unspecified.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) 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 product use was provided by the reporter.  No treatment medication was provided.  Reporter denies reporting this case or this patient. They stated that they have not been in practice for two years.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25-May-2021 and contains no new information.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pyrexia
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of FEELING ABNORMAL (Feeling miserable), HEADACHE (Headache) and PYREXIA (High temperature) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 18-Feb-2021, the patient experienced FEELING ABNORMAL (Feeling miserable), HEADACHE (Headache) and PYREXIA (High temperature). At the time of the report, FEELING ABNORMAL (Feeling miserable), HEADACHE (Headache) and PYREXIA (High temperature) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment information include Aspirin, Acetaminophen 500 mg. Action taken with mRNA-1273 is not applicable.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Mild body ache; Tenderness at the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Mild body ache) and VACCINATION SITE PAIN (Tenderness at the injection arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced MYALGIA (Mild body ache) and VACCINATION SITE PAIN (Tenderness at the injection arm). At the time of the report, MYALGIA (Mild body ache) and VACCINATION SITE PAIN (Tenderness at the injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information included acetaminophen and ibuprofen.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Feeling cold
Clinical narrative: a major dizziness spell and leaned against a wall; very cold in bed and took a nap before feeling better; feeling abnormal; exhausted; feeling sort of crummy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling sort of crummy), FEELING COLD (very cold in bed and took a nap before feeling better), FEELING ABNORMAL (feeling abnormal), DIZZINESS (a major dizziness spell and leaned against a wall) and FATIGUE (exhausted) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PREGABALIN for an unknown indication.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced FEELING ABNORMAL (feeling sort of crummy) and FATIGUE (exhausted). On 19-Feb-2021, the patient experienced FEELING COLD (very cold in bed and took a nap before feeling better) and FEELING ABNORMAL (feeling abnormal). On 20-Feb-2021, the patient experienced DIZZINESS (a major dizziness spell and leaned against a wall). On 20-Feb-2021, FEELING ABNORMAL (feeling sort of crummy), FEELING COLD (very cold in bed and took a nap before feeling better), FEELING ABNORMAL (feeling abnormal), DIZZINESS (a major dizziness spell and leaned against a wall) and FATIGUE (exhausted) had resolved.            Treatment details included None.  Action taken with mRNA-1273 in response to the events was not applicable..
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No relevant concomitant medications were reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Heart rate increased, Influenza like illness, Pyrexia, Tinnitus
Clinical narrative: fever of 38.5C; terrible ringing in the ears; heart rate was between 110 and 120; flu-like symptoms; This spontaneous case was reported by a health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), TINNITUS (terrible ringing in the ears), HEART RATE INCREASED (heart rate was between 110 and 120) and PYREXIA (fever of 38.5C) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concomitant products included samotidine, SIMVASTATIN, PROGESTERONE, DIVIGEL cream, ANTITHYROID PREPARATIONS and VITAMINS NOS for an unknown indication.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-1900, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms). On 05-Feb-2021, the patient experienced TINNITUS (terrible ringing in the ears) and HEART RATE INCREASED (heart rate was between 110 and 120). On 06-Feb-2021, the patient experienced PYREXIA (fever of 38.5C). On 05-Feb-2021, HEART RATE INCREASED (heart rate was between 110 and 120) had resolved. On 07-Feb-2021, PYREXIA (fever of 38.5C) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms) and TINNITUS (terrible ringing in the ears) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Body temperature: 38.5 (Inconclusive) 38.5.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included over the counter flavonoids.   This case was linked to MOD21-08524 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia, Swelling
Clinical narrative: fever (100.7); headache; Pain in arm; swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), SWELLING (swollen), PYREXIA (fever (100.7)) and HEADACHE (headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included SIMVASTATIN, AMITRIPTYLINE, IRON, METOPROLOL, UBIDECARENONE (COQ), flexseed oil, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), CENTRUM SILVER +50, HCTZ and COLESEVELAM for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) and SWELLING (swollen). On 20-Feb-2021, the patient experienced PYREXIA (fever (100.7)) and HEADACHE (headache). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in arm), SWELLING (swollen), PYREXIA (fever (100.7)) and HEADACHE (headache) outcome was unknown.            Treatment details included Baby Aspirin.  Action taken with mRNA-1273 is not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination complication
Clinical narrative: vaccination adverse reaction; little headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (vaccination adverse reaction) and HEADACHE (little headache) 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 No adverse event.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (vaccination adverse reaction) and HEADACHE (little headache). At the time of the report, VACCINATION COMPLICATION (vaccination adverse reaction) and HEADACHE (little headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No treatment information was provided.   No relevant concomitant medications were reported.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Headache, Influenza like illness
Clinical narrative: Flu-like symptoms; Weakness; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), ASTHENIA (Weakness) and HEADACHE (Headaches) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant concomitant medications reported. No relevant medical history was reported.     On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), ASTHENIA (Weakness) and HEADACHE (Headaches). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), ASTHENIA (Weakness) and HEADACHE (Headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative (Negative) patient was tested negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Medications were not provided by the reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: swollen rash that is 4 inches like hives; This spontaneous case was reported by a consumer and describes the occurrence of RASH (swollen rash that is 4 inches like hives) 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 Autoimmune disorder.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced RASH (swollen rash that is 4 inches like hives). At the time of the report, RASH (swollen rash that is 4 inches like hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication and treatment information were provided.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Nasopharyngitis, Product availability issue, Pyrexia
Clinical narrative: Could not receive vaccine; Felt crappy; Head cold; Town ran out of vaccinations; Fever; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THERAPY INTERRUPTED (Could not receive vaccine), MALAISE (Felt crappy), NASOPHARYNGITIS (Head cold), PRODUCT AVAILABILITY ISSUE (Town ran out of vaccinations) and PYREXIA (Fever) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shingles (Patient went to their HCP for an annual check up and during this appoint the patient Physician administered their Shingles shot administered on 09 Feb 2021.).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced THERAPY INTERRUPTED (Could not receive vaccine), MALAISE (Felt crappy), NASOPHARYNGITIS (Head cold), PRODUCT AVAILABILITY ISSUE (Town ran out of vaccinations), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, THERAPY INTERRUPTED (Could not receive vaccine), MALAISE (Felt crappy), NASOPHARYNGITIS (Head cold), PRODUCT AVAILABILITY ISSUE (Town ran out of vaccinations), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment information and concomitant medications were provided.
Sex: M
Vaccine: COVID19
Symptoms: Therapy interrupted
Clinical narrative: Could not receive vaccine; Felt crappy; Head cold; Town ran out of vaccinations; Fever; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THERAPY INTERRUPTED (Could not receive vaccine), MALAISE (Felt crappy), NASOPHARYNGITIS (Head cold), PRODUCT AVAILABILITY ISSUE (Town ran out of vaccinations) and PYREXIA (Fever) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shingles (Patient went to their HCP for an annual check up and during this appoint the patient Physician administered their Shingles shot administered on 09 Feb 2021.).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced THERAPY INTERRUPTED (Could not receive vaccine), MALAISE (Felt crappy), NASOPHARYNGITIS (Head cold), PRODUCT AVAILABILITY ISSUE (Town ran out of vaccinations), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, THERAPY INTERRUPTED (Could not receive vaccine), MALAISE (Felt crappy), NASOPHARYNGITIS (Head cold), PRODUCT AVAILABILITY ISSUE (Town ran out of vaccinations), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment information and concomitant medications were provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site pain, Vaccination site rash, Vaccination site warmth
Clinical narrative: itching; hot; swelling rash; red; Arm hurt for two days; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), INJECTION SITE RASH (swelling rash), INJECTION SITE ERYTHEMA (red), INJECTION SITE WARMTH (hot) and PAIN IN EXTREMITY (Arm hurt) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt). On an unknown date, the patient experienced PRURITUS (itching), INJECTION SITE RASH (swelling rash), INJECTION SITE ERYTHEMA (red) and INJECTION SITE WARMTH (hot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) (oral) at an unspecified dose and frequency. On 10-Feb-2021, PAIN IN EXTREMITY (Arm hurt) had resolved. At the time of the report, PRURITUS (itching), INJECTION SITE RASH (swelling rash), INJECTION SITE ERYTHEMA (red) and INJECTION SITE WARMTH (hot) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: TCR: Outcome of the events are Resolved & 2nd dose received was mentioned