chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Discomfort, Fatigue, Headache, Pyrexia
Clinical narrative: not been functional; body was removed from her soul"; Sleepiness; Tiredness; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (not been functional), DISCOMFORT (body was removed from her soul"), SOMNOLENCE (Sleepiness), FATIGUE (Tiredness) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced ASTHENIA (not been functional), DISCOMFORT (body was removed from her soul"), SOMNOLENCE (Sleepiness), FATIGUE (Tiredness), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, ASTHENIA (not been functional), DISCOMFORT (body was removed from her soul"), SOMNOLENCE (Sleepiness), FATIGUE (Tiredness), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.      No concomitant details were provided Treatment details include Advil, Tylenol   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: not been functional; body was removed from her soul"; Sleepiness; Tiredness; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (not been functional), DISCOMFORT (body was removed from her soul"), SOMNOLENCE (Sleepiness), FATIGUE (Tiredness) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced ASTHENIA (not been functional), DISCOMFORT (body was removed from her soul"), SOMNOLENCE (Sleepiness), FATIGUE (Tiredness), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, ASTHENIA (not been functional), DISCOMFORT (body was removed from her soul"), SOMNOLENCE (Sleepiness), FATIGUE (Tiredness), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.      No concomitant details were provided Treatment details include Advil, Tylenol   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Myalgia, Nausea
Clinical narrative: a vein in his pimple popped out yesterday; smashing and splitting headache; loss of appetite; slept most of the day on and off; heart racing; severe shaking/chills; SEVERE BODY ACHES; highest fever of 101F; really bad nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (severe shaking/chills), MYALGIA (SEVERE BODY ACHES), PYREXIA (highest fever of 101F), NAUSEA (really bad nausea) and HEADACHE (smashing and splitting headache) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 12-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) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced CHILLS (severe shaking/chills), MYALGIA (SEVERE BODY ACHES), PYREXIA (highest fever of 101F), NAUSEA (really bad nausea), DECREASED APPETITE (loss of appetite), SOMNOLENCE (slept most of the day on and off) and PALPITATIONS (heart racing). On 13-Feb-2021, the patient experienced HEADACHE (smashing and splitting headache). On 16-Feb-2021, the patient experienced VASCULAR COMPRESSION (a vein in his pimple popped out yesterday). On 13-Feb-2021, CHILLS (severe shaking/chills), MYALGIA (SEVERE BODY ACHES), PYREXIA (highest fever of 101F), NAUSEA (really bad nausea), HEADACHE (smashing and splitting headache), DECREASED APPETITE (loss of appetite), SOMNOLENCE (slept most of the day on and off) and PALPITATIONS (heart racing) had resolved. At the time of the report, VASCULAR COMPRESSION (a vein in his pimple popped out yesterday) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia, Somnolence, Vascular compression
Clinical narrative: a vein in his pimple popped out yesterday; smashing and splitting headache; loss of appetite; slept most of the day on and off; heart racing; severe shaking/chills; SEVERE BODY ACHES; highest fever of 101F; really bad nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (severe shaking/chills), MYALGIA (SEVERE BODY ACHES), PYREXIA (highest fever of 101F), NAUSEA (really bad nausea) and HEADACHE (smashing and splitting headache) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 12-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) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced CHILLS (severe shaking/chills), MYALGIA (SEVERE BODY ACHES), PYREXIA (highest fever of 101F), NAUSEA (really bad nausea), DECREASED APPETITE (loss of appetite), SOMNOLENCE (slept most of the day on and off) and PALPITATIONS (heart racing). On 13-Feb-2021, the patient experienced HEADACHE (smashing and splitting headache). On 16-Feb-2021, the patient experienced VASCULAR COMPRESSION (a vein in his pimple popped out yesterday). On 13-Feb-2021, CHILLS (severe shaking/chills), MYALGIA (SEVERE BODY ACHES), PYREXIA (highest fever of 101F), NAUSEA (really bad nausea), HEADACHE (smashing and splitting headache), DECREASED APPETITE (loss of appetite), SOMNOLENCE (slept most of the day on and off) and PALPITATIONS (heart racing) had resolved. At the time of the report, VASCULAR COMPRESSION (a vein in his pimple popped out yesterday) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pleurisy, Vaccination site erythema, Vaccination site inflammation, Vaccination site pruritus
Clinical narrative: Pleurisy; Redness - Near Injection Site; Itchy Sensation - Near Injection Site; Swelling - Near Injection Site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PLEURISY (Pleurisy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Pleurisy.    On 27-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 PLEURISY (Pleurisy). At the time of the report, PLEURISY (Pleurisy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Concomitant medication included steroid injections for pleurisy.
Sex: F
Vaccine: COVID19
Symptoms: Irritability, Tinnitus
Clinical narrative: It's starting to get annoying now; terrible ring in my ear for 3 days; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events terrible ring in my ear for 3 days, it's starting to get annoying now, a sore arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011L20A) via unknown route for prophylaxis of COVID-19 infection. On 5 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 031L20A) via unknown route for prophylaxis of COVID-19 infection.  On 7 Feb 2021, the patient experienced the event(s) terrible ring in my ear for 3 days,On an unknown date, the patient experienced the event(s) It's starting to get annoying now, a sore arm.  Treatment details included Patient reports using ear drops for tinnitus called Simalasan starting today 09Feb2021.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, terrible ring in my ear for 3 days, it's starting to get annoying now, a sore arm was unknown.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Headache, Nasal congestion
Clinical narrative: cough; nasal congestion; headache; really tired; a little fever; COVID-19; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), COUGH (cough), COVID-19 (COVID-19), NASAL CONGESTION (nasal congestion) and HEADACHE (headache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) 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 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 29-Jan-2021, the patient experienced COUGH (cough), COVID-19 (COVID-19), NASAL CONGESTION (nasal congestion), HEADACHE (headache), FATIGUE (really tired) and PYREXIA (a little fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), COUGH (cough), COVID-19 (COVID-19), NASAL CONGESTION (nasal congestion), HEADACHE (headache), FATIGUE (really tired) and PYREXIA (a little fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included medications for the patient's cholesterol, blood pressure, gout, prostate.   This case was linked to US-MODERNATX, INC.-MOD-2021-024415, US-MODERNATX, INC.-MOD-2021-024415 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-024415: US-MODERNATX, INC.-MOD-2021-024415:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: cough; nasal congestion; headache; really tired; a little fever; COVID-19; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), COUGH (cough), COVID-19 (COVID-19), NASAL CONGESTION (nasal congestion) and HEADACHE (headache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) 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 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 29-Jan-2021, the patient experienced COUGH (cough), COVID-19 (COVID-19), NASAL CONGESTION (nasal congestion), HEADACHE (headache), FATIGUE (really tired) and PYREXIA (a little fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), COUGH (cough), COVID-19 (COVID-19), NASAL CONGESTION (nasal congestion), HEADACHE (headache), FATIGUE (really tired) and PYREXIA (a little fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included medications for the patient's cholesterol, blood pressure, gout, prostate.   This case was linked to US-MODERNATX, INC.-MOD-2021-024415, US-MODERNATX, INC.-MOD-2021-024415 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-024415: US-MODERNATX, INC.-MOD-2021-024415:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Experiencing tiredness after receiving the vaccine; A spontaneous report was received from a consumer concerning a 74-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tiredness.  On 4/Feb/2021,  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:Unknown) for prophylaxis of COVID-19 infection.   On 10/Feb/2021 , after receiving mRNA-1273,  patient experienced tiredness. Also patient states she had Chron disease. Action taken with mRNA-1273 in response to the events was not reported.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Muscle spasticity, Nasopharyngitis, Palpitations
Clinical narrative: arms, legs and chest were spastic; chills; heart was racing; soaking wet; cold; A spontaneous report was received from a consumer concerning a 75-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced spasticity in arms, legs and chest , chills, heart racing, soaking wet,  and cold.  The patient's medical history was not provided. Concomitant medications reported were Tylenol, albuterol (Rescue inhaler), albuterol tablets, Proventil, baby aspirin, Lipitor, Symbicort, budesonide formoterol, Trulicity, iron, finasteride, Flonase, gabapentin, Lispro U-200, Humalog quick pen, lamotrigine, Toprol XL, Flomax, Effexor XR ( for unknown indication).  On 14 Feb 2021, prior to the onset of the events the patient received their unknown dose of two planned doses of mRNA-1273 (lot/batch: 006M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 14 Feb 2021, the patient experienced the events-  spasticity in arms, legs and chest , chills, heart racing, soaking wet,  and cold.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events- spasticity in arms, legs and chest , chills, heart racing, soaking wet,  and cold-  was considered resolved on 15 Feb 2021.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Pink rash on the arm; Head ache/tired of having a head ache every day/ slight head ache; arm has been itching; arm is swollen from the injection; A spontaneous report was received from a consumer concerning a 74-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  arm has been itching it's been happening/vaccination site pruritus, found a pink rash on the arm/vaccination site rash, head ache, tired of having a head ache every day, slight head ache, the arm was swollen from the injection/vaccination site swelling.  The patient's medical history was not provided. Concomitant medications included aspirin, blood pressure medicine, pill for the bladder,and vitamins.  On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (batch number: 013M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 4 Feb 2021, the patient experienced arm has been itching it's been happening,the arm was swollen from the injection. On 10 Feb 2021, the patient  found a pink rash on the arm, mentioned that he had head ache, tired of having a head ache every day, and at the time of call, he said that he had slight head ache.  Treatment medication included paracetamol for headache.  Action taken with mRNA-1273 in response to the events were  not reported.   The outcome of events, arm has been itching it's been happening, found a pink rash on the arm, head ache, tired of having a head ache every day, slight head ache, the arm was swollen from the injection, were  unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (redness on the injection site) and INJECTION SITE SWELLING (swelling on the injection site). At the time of the report, INJECTION SITE ERYTHEMA (redness on the injection site) and INJECTION SITE SWELLING (swelling on the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Based on MSA comment, Injection site erythema coded to Vaccination site erythema. Injection site swelling coded to Vaccination site swelling
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: pain in extremity; 3 by 2 in. red rash around injection site with random edges; Raised a little around injection site; Shoulder sore; Injection site feels warm to the touch; A spontaneous report was received from a consumer concerning a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Injection site warmth, 3 by 2 inch red rash around injection site with random edges/vaccination site erythema, raised a little around injection site/injection site swelling, shoulder sore/arthralgia, arm sore/pain in extremity  The patient's medical history was not provided. Concomitant medications reported were metoprolol, lisinopril,  alprazolam for drug use for unknown indication.  On 29 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 027L20A) Intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 8 Feb 2021, the patient experienced the events Injection site warmth, 3 by 2 inch red rash around injection site with random edges/vaccination site erythema, raised a little around injection site/injection site swelling, shoulder sore/arthralgia, arm sore/pain in extremity.Treatment details included Benadryl oral and cream.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, Injection site warmth, 3 by 2 inch red rash around injection site with random edges/vaccination site erythema, raised a little around injection site/injection site swelling, shoulder sore/arthralgia, arm sore/pain in extremity were considered not resolved.  Based on MSA comment, Injection site swelling is coded to Vaccination site swelling
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Feb-2021 and was forwarded to Moderna on 17-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included pain medication for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.    Headache was treated with Barbuteral.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache; Injection site pain; Red rash under arm; Injection site swelling; Fatigue; Muscle pain; Joint pain; Chills; Nausea; Fever; A spontaneous report was received from a consumer concerning a 66-year old female patient who developed headache, injection site pain, red rash under arm, injection site swelling, fatigue, muscle pain, joint pain, chills, nausea and fever. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.     The patient received their first of the two planned doses of mRNA-1273 (Batch number: 010M20A) on 16 Feb 2021 for prophylaxis of COVID-19 infection.  Reporter got the vaccine on 16 Feb 2021 and that afternoon headaches started. She mentions she has all the listed side effects and the injection site swelling, pain, redness and inside the arm is the rash. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event(s) headache, injection site pain, red rash under arm, injection site swelling, fatigue, muscle pain, joint pain, chills, nausea and fever, was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: Headache; Injection site pain; Red rash under arm; Injection site swelling; Fatigue; Muscle pain; Joint pain; Chills; Nausea; Fever; A spontaneous report was received from a consumer concerning a 66-year old female patient who developed headache, injection site pain, red rash under arm, injection site swelling, fatigue, muscle pain, joint pain, chills, nausea and fever. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.     The patient received their first of the two planned doses of mRNA-1273 (Batch number: 010M20A) on 16 Feb 2021 for prophylaxis of COVID-19 infection.  Reporter got the vaccine on 16 Feb 2021 and that afternoon headaches started. She mentions she has all the listed side effects and the injection site swelling, pain, redness and inside the arm is the rash. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event(s) headache, injection site pain, red rash under arm, injection site swelling, fatigue, muscle pain, joint pain, chills, nausea and fever, was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Myalgia
Clinical narrative: Soreness; Weakness; A spontaneous report (United States) was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness, weakness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) soreness, weakness.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), soreness, weakness was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Gingivitis, Tooth infection
Clinical narrative: gum infection; Tooth infection; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tooth/gum infection.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 09 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection. After this he had tooth/gum infection.  Treatment included amoxicillin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), tooth/gum infection was unknown..
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site swelling
Clinical narrative: Rash, pink and red at injection site; Rash, pink and red at injection site; Swelling(3.5 inches in circumference) at injection site; A spontaneous report was received from a consumer concerning a 94-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash, pink and red at injection site, swelling(3.5 inches in circumference) at injection site.  The patient's medical history was not provided. Concomitant medications reported were Heart Medications, HBP Medications, Vitamin D, Lutein Vitamin, Diuretic for drug use for unknown indication.  On 25 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 25 Jan 2021, the patient experienced the events, rash, pink and red at injection site, swelling(3.5 inches in circumference) at injection site.  Treatment details mentioned as agent forgot to ask.  Action taken with mRNA-1273 in response to the events were  not reported.   The outcome of events, rash, pink and red at injection site,swelling(3,5 inches in circumference) at injection site was unknown.  Based on comment, events LLt coded to Vaccination site erythema, Vaccination site Rash and Vaccination site swelling
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pyrexia
Clinical narrative: Sweating mainly from the waist up.; chills; fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERHIDROSIS (Sweating mainly from the waist up.), CHILLS (chills) and PYREXIA (fever) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced HYPERHIDROSIS (Sweating mainly from the waist up.), CHILLS (chills) and PYREXIA (fever). At the time of the report, HYPERHIDROSIS (Sweating mainly from the waist up.), CHILLS (chills) and PYREXIA (fever) 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 history not provided. Treatment included Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: initial additional On 04-May-2021: initial additional On 10-May-2021: initial additional
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Felt Tired; Felt Achy; A spontaneous report was received from a Consumer concerning a 80-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tiredness and felt achy The patient's medical history was not provided. No relevant concomitant medications were reported. On 15 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: Not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.The patient has received her first dose of mRNA-1273 on 18 Jan 2021. On 15 Feb 2021, the patient felt tired and achy.No laboratory details was provided.Treatment details was not provided  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, fatigue and pain was considered as resolved on 17 Feb 2021.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Headache, Pain in extremity
Clinical narrative: soreness in the arm - left; potentially exposed to the virus; headache; A spontaneous report was received from a consumer, concerning a 59-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness in the arm - left, headache, potentially exposed to the virus.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (Batch number: 012M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the event(s) soreness in the arm - left, headache, potentially exposed to the virus. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event(s), soreness in the arm - left, headache, potentially exposed to the virus was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain
Clinical narrative: neck problem; Ache; A spontaneous report was received from a consumer concerning a male  patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events neck problem, ache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 2 Feb 2021, the patient experienced the event(s) neck problem, ache.  Treatment for the event,included Tylenol, Physical Therapy.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), neck problem, ache was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Chills; Nausea; Fever; Soreness in arm of injection; A spontaneous report was received from a Consumer concerning a 58-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness in arm of injection, chills, nausea, fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 024M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 15 Feb 2021, the patient experienced the events soreness in arm of injection . On 16 Feb 2021, the patient experienced the events chills. nausea, fever.  Treatment details included Tylenol  Action taken with mRNA-1273 in response to the events was not reported.   On 16 Feb 2021 the outcome of events chills was resolved.On 16 Feb 2021 the outcome of events nausea was resolved. On an unknown date the outcome of events, soreness in arm of injection, On an unknown date the outcome of events, fever was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Hot at injection site; itchy at injection site; Redness at injection site; A spontaneous report was received from a Consumer concerning a 89-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itchy at injection site, redness at injection site, hot at injection site.  The patient's medical history was not provided. Concomitant medications reported were xanax for drug use for unknown indication.  On 6 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 14 Feb 2021, the patient experienced the events itchy at injection site. redness at injection site, hot at injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  On an unknown date the outcome of events, itchy at injection site,redness at injection site, hot at injection site were not reported.  Based on comment Injection site Pain, Injection site erythema and Pruritus coded (Vaccination site warmth, Vaccination site erythema and Vaccination site Pruritus)
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Arm started getting hot to the touch; Arm started getting a bit swollen; Arm started getting red; Arm started getting rashy; Arm started getting itchy; Arm was sore for two days afterwards; A spontaneous report was received from a consumer concerning a 65-year old female patient who developed a sore arm for 2 days and arm started getting itchy, red, rashy, hot to the touch, and a bit swollen.   The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.     The patient received their first of the two planned doses of mRNA-1273 (Batch number: 013M20A) intramuscularly in the left arm on 06 Feb 2021 for prophylaxis of COVID-19 infection.   Reporter got the vaccine on 06 Feb 2021 and for the next 2 days her arm was sore. On 15 Feb 2021 she reports arm started getting itchy, red, rashy, hot to the touch and a bit swollen. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event(s) developed a sore arm for 2 days and arm started getting itchy, red, rashy, hot to the touch, and a bit swollen, was unknown.  Based on comment, all event coded Vaccination Site Pain, Vaccination site warmth, Vaccination site Pruritus, Vaccination site swelling, Vaccination site rash, Vaccination site erythema.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: A spontaneous report  was received from a Consumer concerning a  patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events broke out in hives and rashes all over.  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  dose of mRNA-1273 (lot/batch: unknown) through unknown route for prophylaxis of COVID-19 infection.    No treatment information was provided.  On an unspecified date, after dose of vaccine, the patient experienced  broke out in hives and rashes all over.   No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event,  broke out in hives and rashes all over was considered to be unknown  at the time of this report.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; A spontaneous report was received from a healthcare professional concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fatigue.  The patient's medical history was not provided. No relevant concomitant medications were reported.  No relevant lab data was provided by the reporter.  On 16 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 010M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient experienced the event(s) fatigue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, fatigue was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash
Clinical narrative: Rash; itchiness; Radiating pain up and down leg;  A spontaneous report was received from a Consumer concerning a 82-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash, itchiness, radiating pain up and down leg.  The patient's medical history was not provided. Concomitant medications reported were Blood Pressure Medication for drug use for unknown indication.  On 2 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: OO7M2OA) intramuscularly for prophylaxis of COVID-19 infection.   Rash, Itchiness, Radiating pain up and down leg.  Treatment details included Put cream on rash, Ibuprofen  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, rash, On an unknown date the outcome of events, itchiness, On an unknown date the outcome of events, radiating pain up and down leg was not reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: leg ache; body ache; headache; fever; rash at the site of injection; inner part of arm was swollen like half a football; A spontaneous report was received from a Consumer concerning a 83 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events leg ache, body ache, headache, fever, rash at the site of injection, her inner part of arm was swollen like half a football.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 016M20A.)for prophylaxis of COVID-19 infection.  On an unspecified date,patient experienced leg ache, body ache, headache, fever, rash at the site of injection, Her inner part of arm was swollen like half a football.No laboratory details was provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, leg ache, body ache, headache, fever, rash at the site of injection and peripheral swelling was considered as unknown at the time of the report.  Based MSA comment, coded Rash as Vaccination site pain
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: leg ache; body ache; headache; fever; rash at the site of injection; inner part of arm was swollen like half a football; A spontaneous report was received from a Consumer concerning a 83 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events leg ache, body ache, headache, fever, rash at the site of injection, her inner part of arm was swollen like half a football.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 016M20A.)for prophylaxis of COVID-19 infection.  On an unspecified date,patient experienced leg ache, body ache, headache, fever, rash at the site of injection, Her inner part of arm was swollen like half a football.No laboratory details was provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, leg ache, body ache, headache, fever, rash at the site of injection and peripheral swelling was considered as unknown at the time of the report.  Based MSA comment, coded Rash as Vaccination site pain
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Red arm; Itchy arm; Looks like a bullseye at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red arm), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE SWELLING (Looks like a bullseye at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 VACCINATION SITE ERYTHEMA (Red arm), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE SWELLING (Looks like a bullseye at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red arm), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE SWELLING (Looks like a bullseye at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: red blotchy rash; itching; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red blotchy rash) and PRURITUS (itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-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 RASH ERYTHEMATOUS (red blotchy rash) and PRURITUS (itching). At the time of the report, RASH ERYTHEMATOUS (red blotchy rash) and PRURITUS (itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Gastrointestinal sounds abnormal
Clinical narrative: gurgling noises from her stomach; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and GASTROINTESTINAL SOUNDS ABNORMAL (gurgling noises from her stomach) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, LISINOPRIL, EZETIMIBE, OMEPRAZOLE, PROBIOTICS NOS and VITAMINS NOS for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced GASTROINTESTINAL SOUNDS ABNORMAL (gurgling noises from her stomach). At the time of the report, DIARRHOEA (Diarrhea) and GASTROINTESTINAL SOUNDS ABNORMAL (gurgling noises from her stomach) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       o No treatment medications provided by the reporter
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Illness
Clinical narrative: Aches and pains; Felt very weak; Tiredness; Chills; Aches in her joints, specifically behind her knees; Felt sick; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Felt sick), PAIN (Aches and pains), ASTHENIA (Felt very weak), FATIGUE (Tiredness) and CHILLS (Chills) 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.     The patient's past medical history included Joint pain (Patient experienced joint pain after taking levofloxacin.). Previously administered products included for an unreported indication: LEVAQUIN. Concurrent medical conditions included Hypertension and High cholesterol.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced ILLNESS (Felt sick). On 06-Feb-2021, the patient experienced PAIN (Aches and pains), ASTHENIA (Felt very weak), FATIGUE (Tiredness), CHILLS (Chills) and ARTHRALGIA (Aches in her joints, specifically behind her knees). The patient was treated with PARACETAMOL (TYLENOL) for Pain joint, at an unspecified dose and frequency. At the time of the report, ILLNESS (Felt sick), PAIN (Aches and pains), ASTHENIA (Felt very weak), FATIGUE (Tiredness), CHILLS (Chills) and ARTHRALGIA (Aches in her joints, specifically behind her knees) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Aches and pains; Felt very weak; Tiredness; Chills; Aches in her joints, specifically behind her knees; Felt sick; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Felt sick), PAIN (Aches and pains), ASTHENIA (Felt very weak), FATIGUE (Tiredness) and CHILLS (Chills) 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.     The patient's past medical history included Joint pain (Patient experienced joint pain after taking levofloxacin.). Previously administered products included for an unreported indication: LEVAQUIN. Concurrent medical conditions included Hypertension and High cholesterol.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced ILLNESS (Felt sick). On 06-Feb-2021, the patient experienced PAIN (Aches and pains), ASTHENIA (Felt very weak), FATIGUE (Tiredness), CHILLS (Chills) and ARTHRALGIA (Aches in her joints, specifically behind her knees). The patient was treated with PARACETAMOL (TYLENOL) for Pain joint, at an unspecified dose and frequency. At the time of the report, ILLNESS (Felt sick), PAIN (Aches and pains), ASTHENIA (Felt very weak), FATIGUE (Tiredness), CHILLS (Chills) and ARTHRALGIA (Aches in her joints, specifically behind her knees) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: weak, weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak, weakness) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K204 or 038L204) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced ASTHENIA (weak, weakness). At the time of the report, ASTHENIA (weak, weakness) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.