chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache
Clinical narrative: Bad stomachache that has been going on and off for days until now. (pain scale level 6  1 being no pain and 10 with worst pain); Light headaches/small headache; chills at night around 8:30pm; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Bad stomachache that has been going on and off for days until now. (pain scale level 6  1 being no pain and 10 with worst pain)), HEADACHE (Light headaches/small headache) and CHILLS (chills at night around 8:30pm) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012120A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Bad stomachache that has been going on and off for days until now. (pain scale level 6  1 being no pain and 10 with worst pain)), HEADACHE (Light headaches/small headache) and CHILLS (chills at night around 8:30pm). At the time of the report, ABDOMINAL PAIN UPPER (Bad stomachache that has been going on and off for days until now. (pain scale level 6  1 being no pain and 10 with worst pain)), HEADACHE (Light headaches/small headache) and CHILLS (chills at night around 8:30pm) outcome was unknown.            No concomitant medication reported   No treatment medication reported   This case was linked to MOD-2021-019319 (Patient Link).
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site was red, hot; The injection site was red; Injection site was red, hot and swollen; A spontaneous report (United States) was received from a consumer concerning a 80-years-old patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site was red/ vaccination site erythema, hot/ vaccination site warmth and swollen/ vaccination site swelling.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Jan 2021, approximately nine days prior to the onset of the events the patient received their dose of mRNA-1273 (Batch Number: 029L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 30 Jan 2021, the patient experienced arm at the injection site was red, hot and swollen.  Treatment for the events included an ice pack and paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, injection site was red, hot and swollen was resolving (it is better).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in Right Cheek; A spontaneous report was received from a Healthcare Professional concerning a 51-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events numbness in right cheek.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 1 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 027L20A) intramuscularly for prophylaxis of COVID-19 infection.   on an unknown date, patient experienced Numbness in Right Cheek.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, numbness in right cheek was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Hypoaesthesia, SARS-CoV-2 test positive
Clinical narrative: Felt their legs were numb; Weakness; Extreme fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Felt their legs were numb), ASTHENIA (Weakness), FATIGUE (Extreme fatigue) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included COVID-19.    On 28-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 HYPOAESTHESIA (Felt their legs were numb), ASTHENIA (Weakness), FATIGUE (Extreme fatigue) and HEADACHE (Headache). At the time of the report, HYPOAESTHESIA (Felt their legs were numb), ASTHENIA (Weakness), FATIGUE (Extreme fatigue) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Dec-2020, SARS-CoV-2 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Myalgia, Pain in extremity
Clinical narrative: Arm pain from shoulder to elbow; Chills; Fever OF 102-103 F; Joint pain; Muscle pain; A spontaneous report was received from a Healthcare Professional concerning a 22-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, fever of 101-102 f, arm pain from the shoulder to elbow/pain in extremity, joint pain/arthralgia, muscle pain/myalgia  The patient's medical history was not provided. No relevant concomitant medications were reported.  No relevant lab data was reported by the reporter.  On 31 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 31 Jan 2021, the patient experienced the events chills. fever of 101-102 f, arm pain from the shoulder to elbow, joint pain, muscle pain.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 1 Feb 2021 the outcome of all events was recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Arm pain from shoulder to elbow; Chills; Fever OF 102-103 F; Joint pain; Muscle pain; A spontaneous report was received from a Healthcare Professional concerning a 22-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, fever of 101-102 f, arm pain from the shoulder to elbow/pain in extremity, joint pain/arthralgia, muscle pain/myalgia  The patient's medical history was not provided. No relevant concomitant medications were reported.  No relevant lab data was reported by the reporter.  On 31 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 31 Jan 2021, the patient experienced the events chills. fever of 101-102 f, arm pain from the shoulder to elbow, joint pain, muscle pain.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 1 Feb 2021 the outcome of all events was recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Lightheaded; Chills; Positive COVID test; No appetite; Low grade fever/fever of 100.6 F; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive COVID test), DECREASED APPETITE (No appetite), DIZZINESS (Lightheaded), PYREXIA (Low grade fever/fever of 100.6 F) and CHILLS (Chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for an unknown indication.     The patient's past medical history included Lung disorder NOS and Cough since an unknown date.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced DECREASED APPETITE (No appetite) and PYREXIA (Low grade fever/fever of 100.6 F). On 17-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive COVID test). On 20-Jan-2021, the patient experienced DIZZINESS (Lightheaded) and CHILLS (Chills). On 20-Jan-2021, CHILLS (Chills) had resolved. On 21-Jan-2021, PYREXIA (Low grade fever/fever of 100.6 F) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (Positive COVID test), DECREASED APPETITE (No appetite) and DIZZINESS (Lightheaded) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information reported included Bamlanivimab infusion received on 20-JAN-2021. Concomitant medication was not provided.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Insomnia, Muscular weakness, Nausea
Clinical narrative: Muscles very week and could not get out of bed; very dizzy; could not sleep; Nauseous; This spontaneous case was reported by a patient and describes the occurrence of MUSCULAR WEAKNESS (Muscles very week and could not get out of bed), DIZZINESS (very dizzy), INSOMNIA (could not sleep) and NAUSEA (Nauseous) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (In December). Concomitant products included ACETYLSALICYLIC ACID, CARVEDILOL, CILOSTAZOL, CLOPIDOGREL, INSULIN GLARGINE (LANTUS), LOSARTAN, METFORMIN, PRAVASTATIN and FLUOXETINE for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 18-Jan-2021, the patient experienced MUSCULAR WEAKNESS (Muscles very week and could not get out of bed), DIZZINESS (very dizzy), INSOMNIA (could not sleep) and NAUSEA (Nauseous). At the time of the report, MUSCULAR WEAKNESS (Muscles very week and could not get out of bed), DIZZINESS (very dizzy), INSOMNIA (could not sleep) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: dizziness; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and HEADACHE (headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.). Concomitant products included Allergy medicine for Allergy, Birth control pills for Birth control, MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]), GABAPENTIN (NEURONTIN), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and FISH OIL for an unknown indication.   On 27-Jan-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) (Intramuscular) dosage form. On 27-Jan-2021, the patient experienced DIZZINESS (dizziness) and HEADACHE (headache). At the time of the report, DIZZINESS (dizziness) and HEADACHE (headache) had not resolved.            Treatment information was not provided.  Reportedly, caller stated that she had headache and dizziness but is concerned because she had the vaccine 5 days ago and still feels this way. Wanted to know if this was normal. The patient denied allergies and PMH.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Redness at the injection site; Swelling at the injection site; Redness at the injection site; Swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of VACCINATION SITE ERYTHEMA (Redness at the injection site), the first episode of VACCINATION SITE SWELLING (Swelling at the injection site), the second episode of VACCINATION SITE ERYTHEMA (Redness at the injection site) and the second episode of VACCINATION SITE SWELLING (Swelling at the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (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 20-Jan-2021, the patient experienced the first episode of VACCINATION SITE ERYTHEMA (Redness at the injection site) and the first episode of VACCINATION SITE SWELLING (Swelling at the injection site). On 29-Jan-2021, the patient experienced the second episode of VACCINATION SITE ERYTHEMA (Redness at the injection site) and the second episode of VACCINATION SITE SWELLING (Swelling at the injection site). At the time of the report, last episode of VACCINATION SITE ERYTHEMA (Redness at the injection site) and the last episode of VACCINATION SITE SWELLING (Swelling at the injection site) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID; This spontaneous case was reported by a consumer and describes the occurrence of   in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN, LOSARTAN and ATORVASTATIN for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        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 included Tylenol, Vitamin C immune support, Zinc, Vitamin D3, Mucinex
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Nausea, Pruritus, Urticaria
Clinical narrative: Itchiness; Light Headed; Hives; Feels Weak; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous), PRURITUS (Itchiness), DIZZINESS (Light Headed), URTICARIA (Hives) and ASTHENIA (Feels Weak) in a 77-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 historical Condition reported.).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramammary) 1 dosage form. On 25-Jan-2021, the patient experienced NAUSEA (Nauseous). On 26-Jan-2021, the patient experienced PRURITUS (Itchiness), DIZZINESS (Light Headed), URTICARIA (Hives) and ASTHENIA (Feels Weak). At the time of the report, NAUSEA (Nauseous), PRURITUS (Itchiness), DIZZINESS (Light Headed), URTICARIA (Hives) and ASTHENIA (Feels Weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramammary) was unknown.       No concomitant medications reported. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyuria, Rash pruritic, Tenderness
Clinical narrative: Pyuria rosacea; Tender arm; Weird achy pain that was localized in her fingers; Itchy rash on her stomach and back; This spontaneous case was reported by an other health care professional and describes the occurrence of   in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for an unknown indication.     Concurrent medical conditions included Pyuria.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. Treatment included Benadryl , over the counter antihistamines
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site joint effusion, Vaccination site pruritus, Vaccination site rash
Clinical narrative: The shoulder where the vaccine was administered was full blown; Hard under the rash; Rash at the injection site; Redness area of about 2 or 3 inches; Itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE JOINT EFFUSION (The shoulder where the vaccine was administered was full blown), VACCINATION SITE INDURATION (Hard under the rash), VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE ERYTHEMA (Redness area of about 2 or 3 inches) and VACCINATION SITE PRURITUS (Itching) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METOPROLOL and HYDROCORTISONE for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE JOINT EFFUSION (The shoulder where the vaccine was administered was full blown), VACCINATION SITE INDURATION (Hard under the rash), VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE ERYTHEMA (Redness area of about 2 or 3 inches) and VACCINATION SITE PRURITUS (Itching). At the time of the report, VACCINATION SITE JOINT EFFUSION (The shoulder where the vaccine was administered was full blown), VACCINATION SITE INDURATION (Hard under the rash), VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE ERYTHEMA (Redness area of about 2 or 3 inches) and VACCINATION SITE PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Cream
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pyrexia, Rash, Vaccination site swelling
Clinical narrative: arm hot; Rash; feverish; Size of a tomato at injection site; red; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (arm hot), RASH (Rash), PYREXIA (feverish) and ERYTHEMA (red) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced FEELING HOT (arm hot), RASH (Rash), PYREXIA (feverish) and ERYTHEMA (red). At the time of the report, FEELING HOT (arm hot), RASH (Rash), PYREXIA (feverish) and ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (side effects) 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 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 ADVERSE REACTION (side effects). At the time of the report, ADVERSE REACTION (side effects) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: soreness and redness at site of injection; soreness and redness at site of injection; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness and redness at site of injection.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced  soreness and redness at site of injection.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of events, soreness and redness at site of injection was not reported.; Reporter'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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Injection site warmth, Pain in extremity, Paraesthesia
Clinical narrative: arm at the injection site very hot to the touch; feels tingling down her arm; arm at the injection site hurt; felt very dizzy; had difficulty swallowing; arm a little sore; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (felt very dizzy), DYSPHAGIA (had difficulty swallowing), PAIN IN EXTREMITY (arm a little sore), INJECTION SITE WARMTH (arm at the injection site very hot to the touch) and PARAESTHESIA (feels tingling down her arm) in a 67-year-old female 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.     No medical history was provided by reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced DIZZINESS (felt very dizzy), DYSPHAGIA (had difficulty swallowing) and PAIN IN EXTREMITY (arm a little sore). On 27-Jan-2021, the patient experienced INJECTION SITE WARMTH (arm at the injection site very hot to the touch), PARAESTHESIA (feels tingling down her arm) and VACCINATION SITE PAIN (arm at the injection site hurt). On 13-Jan-2021, DIZZINESS (felt very dizzy), DYSPHAGIA (had difficulty swallowing) and PAIN IN EXTREMITY (arm a little sore) had resolved. At the time of the report, INJECTION SITE WARMTH (arm at the injection site very hot to the touch) had resolved, PARAESTHESIA (feels tingling down her arm) outcome was unknown and VACCINATION SITE PAIN (arm at the injection site hurt) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm at the injection site very hot to the touch; feels tingling down her arm; arm at the injection site hurt; felt very dizzy; had difficulty swallowing; arm a little sore; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (felt very dizzy), DYSPHAGIA (had difficulty swallowing), PAIN IN EXTREMITY (arm a little sore), INJECTION SITE WARMTH (arm at the injection site very hot to the touch) and PARAESTHESIA (feels tingling down her arm) in a 67-year-old female 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.     No medical history was provided by reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced DIZZINESS (felt very dizzy), DYSPHAGIA (had difficulty swallowing) and PAIN IN EXTREMITY (arm a little sore). On 27-Jan-2021, the patient experienced INJECTION SITE WARMTH (arm at the injection site very hot to the touch), PARAESTHESIA (feels tingling down her arm) and VACCINATION SITE PAIN (arm at the injection site hurt). On 13-Jan-2021, DIZZINESS (felt very dizzy), DYSPHAGIA (had difficulty swallowing) and PAIN IN EXTREMITY (arm a little sore) had resolved. At the time of the report, INJECTION SITE WARMTH (arm at the injection site very hot to the touch) had resolved, PARAESTHESIA (feels tingling down her arm) outcome was unknown and VACCINATION SITE PAIN (arm at the injection site hurt) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Atrial flutter, Heart rate increased, Pain in extremity, Palpitations
Clinical narrative: flutters; palpitations; heartrate accelerated which was alarming and startling; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ATRIAL FLUTTER (flutters), PALPITATIONS (palpitations) and HEART RATE INCREASED (heartrate accelerated which was alarming and startling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot #010M20A) for COVID-19 vaccination.     Concomitant products included ATENOLOL for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 31-Jan-2021, the patient experienced ATRIAL FLUTTER (flutters), PALPITATIONS (palpitations) and HEART RATE INCREASED (heartrate accelerated which was alarming and startling). At the time of the report, PAIN IN EXTREMITY (sore arm), ATRIAL FLUTTER (flutters), PALPITATIONS (palpitations) and HEART RATE INCREASED (heartrate accelerated which was alarming and startling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by reporter.   Reporter did not allow further contact
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Headache, Musculoskeletal stiffness
Clinical narrative: Neck stiffness; right side ear; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Neck stiffness), EAR DISCOMFORT (right side ear) and HEADACHE (mild headache) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN for Cholesterol, PANTOPRAZOLE for GERD and Digestion impaired, LOSARTAN and METOPROLOL for Hypertension, CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12), MAGNESIUM ADVANCED and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Supplementation therapy, ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Neck stiffness), EAR DISCOMFORT (right side ear) and HEADACHE (mild headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 30-Jan-2021, EAR DISCOMFORT (right side ear) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (Neck stiffness) had not resolved and HEADACHE (mild headache) outcome was unknown. Not Provided          Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Patient received 2nd dose on 20-Feb-2021, states that she experienced no new reactions but neckstiffness remained.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Sleep disorder
Clinical narrative: got fever but never passed from 100°F; chills; head ache; both didn't get much sleep on Friday and Saturday night; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (got fever but never passed from 100°F), CHILLS (chills), HEADACHE (head ache) and SLEEP DISORDER (both didn't get much sleep on Friday and Saturday night) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced PYREXIA (got fever but never passed from 100°F), CHILLS (chills), HEADACHE (head ache) and SLEEP DISORDER (both didn't get much sleep on Friday and Saturday night). At the time of the report, PYREXIA (got fever but never passed from 100°F), CHILLS (chills), HEADACHE (head ache) and SLEEP DISORDER (both didn't get much sleep on Friday and Saturday night) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Pyrexia: (High) 100°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain, Paraesthesia
Clinical narrative: sore throat; swollen lymph nodes in neck ; swollen lymph node in injection arm that was injected; tingly cold sensation in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingly cold sensation in injection arm), OROPHARYNGEAL PAIN (sore throat) and LYMPHADENOPATHY (swollen lymph nodes in neck ; swollen lymph node in injection arm that was injected) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PARAESTHESIA (tingly cold sensation in injection arm). On 26-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and LYMPHADENOPATHY (swollen lymph nodes in neck ; swollen lymph node in injection arm that was injected). On 23-Jan-2021, PARAESTHESIA (tingly cold sensation in injection arm) had resolved. At the time of the report, OROPHARYNGEAL PAIN (sore throat) and LYMPHADENOPATHY (swollen lymph nodes in neck ; swollen lymph node in injection arm that was injected) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not provided by reporter.  No relevant concomitant medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills; Headache; Low graded fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Low graded fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Low graded fever). On 03-Jan-2021, CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Low graded fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment medication for event included acetaminophen.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: arm is very sore; low grade fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is very sore), PYREXIA (low grade fever) and CHILLS (chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011N20A) for COVID-19 vaccination.     Concomitant products included INSULIN GLARGINE (LANTUS), DULAGLUTIDE (TRULICITY), METFORMIN, LANSOPRAZOLE, ESCITALOPRAM OXALATE (LEXAPRO), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), BUPROPION and ATORVASTATIN for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm is very sore), PYREXIA (low grade fever) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (arm is very sore), PYREXIA (low grade fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Red; Sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE PAIN (Sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     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 VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE PAIN (Sore). At the time of the report, VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE PAIN (Sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Concomitant medications were not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Peripheral swelling, Pruritus
Clinical narrative: Swollen; Itching; Redness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), ERYTHEMA (Redness), HEADACHE (Headache) and PERIPHERAL SWELLING (Swollen) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced HEADACHE (Headache). On 27-Jan-2021, the patient experienced PRURITUS (Itching) and ERYTHEMA (Redness). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen). On 28-Jan-2021, HEADACHE (Headache) had resolved. At the time of the report, PRURITUS (Itching), ERYTHEMA (Redness) and PERIPHERAL SWELLING (Swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medications included medicines for cholesterol (10mg), Remicade injection and Prolia for the bones (injection every 6 months). No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2021: Concomitant medications were updated.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Disorientation, Dizziness, Nausea
Clinical narrative: feels light headed and dizziness; disorientated; does not have appetite.; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feels light headed and dizziness), DISORIENTATION (disorientated), DECREASED APPETITE (does not have appetite.) and NAUSEA (nausea) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced DIZZINESS (feels light headed and dizziness), DISORIENTATION (disorientated), DECREASED APPETITE (does not have appetite.) and NAUSEA (nausea). At the time of the report, DIZZINESS (feels light headed and dizziness), DISORIENTATION (disorientated), DECREASED APPETITE (does not have appetite.) and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included Dramamine.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Muscular weakness, Pain in extremity, Peripheral swelling
Clinical narrative: left hand was swollen; pain in left wrist joint; pain in his hand; can barely move it; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left hand was swollen), ARTHRALGIA (pain in left wrist joint), PAIN IN EXTREMITY (pain in his hand) and MUSCULAR WEAKNESS (can barely move it) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PERIPHERAL SWELLING (left hand was swollen), ARTHRALGIA (pain in left wrist joint), PAIN IN EXTREMITY (pain in his hand) and MUSCULAR WEAKNESS (can barely move it). At the time of the report, PERIPHERAL SWELLING (left hand was swollen), ARTHRALGIA (pain in left wrist joint), PAIN IN EXTREMITY (pain in his hand) and MUSCULAR WEAKNESS (can barely move it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Concomitant medications reported were blood pressure meds for drug use for unknown indication. Treatment details were not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness on her arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Hypertension.    On 04-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 PAIN IN EXTREMITY (Soreness on her arm). At the time of the report, PAIN IN EXTREMITY (Soreness on her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Concomitant product use was not provided by the reporter.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Nausea, Neoplasm
Clinical narrative: lump in the arm; chills; fever; nausea; headache; arm is sore; rash in the arm that is a big square, like a big band aid, about that size; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of NEOPLASM (lump in the arm), CHILLS (chills), PYREXIA (fever), NAUSEA (nausea) and HEADACHE (headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (She had had COVID-19 and was treated with plasma). Concomitant products included TAMOXIFEN, LEVOTHYROXINE and HYOSCYAMINE SULFATE (LEVSIN) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced CHILLS (chills), PYREXIA (fever), NAUSEA (nausea), HEADACHE (headache), INJECTION SITE PAIN (arm is sore) and RASH (rash in the arm that is a big square, like a big band aid, about that size). On an unknown date, the patient experienced NEOPLASM (lump in the arm). On 31-Jan-2021, CHILLS (chills), PYREXIA (fever), NAUSEA (nausea) and HEADACHE (headache) had resolved. At the time of the report, NEOPLASM (lump in the arm), INJECTION SITE PAIN (arm is sore) and RASH (rash in the arm that is a big square, like a big band aid, about that size) 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 treatment information was provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: lump in the arm; chills; fever; nausea; headache; arm is sore; rash in the arm that is a big square, like a big band aid, about that size; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of NEOPLASM (lump in the arm), CHILLS (chills), PYREXIA (fever), NAUSEA (nausea) and HEADACHE (headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (She had had COVID-19 and was treated with plasma). Concomitant products included TAMOXIFEN, LEVOTHYROXINE and HYOSCYAMINE SULFATE (LEVSIN) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced CHILLS (chills), PYREXIA (fever), NAUSEA (nausea), HEADACHE (headache), INJECTION SITE PAIN (arm is sore) and RASH (rash in the arm that is a big square, like a big band aid, about that size). On an unknown date, the patient experienced NEOPLASM (lump in the arm). On 31-Jan-2021, CHILLS (chills), PYREXIA (fever), NAUSEA (nausea) and HEADACHE (headache) had resolved. At the time of the report, NEOPLASM (lump in the arm), INJECTION SITE PAIN (arm is sore) and RASH (rash in the arm that is a big square, like a big band aid, about that size) 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 treatment information was provided.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Pruritus
Clinical narrative: kind of bad sometimes and kind of not; just kind of all over; havent had rash but whole body is red since 3 days after shot; itchy ( whole body since 3 days after shot); This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (havent had rash but whole body is red since 3 days after shot), PRURITUS (itchy ( whole body since 3 days after shot)) and FEELING ABNORMAL (kind of bad sometimes and kind of not; just kind of all over) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concomitant products included Vexer                                                          two and ATORVASTATIN for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced ERYTHEMA (havent had rash but whole body is red since 3 days after shot) and PRURITUS (itchy ( whole body since 3 days after shot)). On an unknown date, the patient experienced FEELING ABNORMAL (kind of bad sometimes and kind of not; just kind of all over). At the time of the report, ERYTHEMA (havent had rash but whole body is red since 3 days after shot), PRURITUS (itchy ( whole body since 3 days after shot)) and FEELING ABNORMAL (kind of bad sometimes and kind of not; just kind of all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Benadryl - 1 dose
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain in extremity, Urticaria
Clinical narrative: Welts; Shingles; sore arm; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm), URTICARIA (Welts) and HERPES ZOSTER (Shingles) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) 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) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 31-Jan-2021, the patient experienced URTICARIA (Welts) and HERPES ZOSTER (Shingles). On 26-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, URTICARIA (Welts) and HERPES ZOSTER (Shingles) 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.   Concomitant medication use was not provided. Treatment information included Valtrex and other vitamins.