chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Rash
Clinical narrative: Rash on Bilateral arms; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of RASH (Rash on Bilateral arms) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Mitral valve prolapse. Concurrent medical conditions included Hypertension and Iodine allergy.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced RASH (Rash on Bilateral arms). The patient was treated with LOSARTAN at an unspecified dose and frequency and SPIRONOLACTONE (SPIROLACTON) at an unspecified dose and frequency. At the time of the report, RASH (Rash on Bilateral arms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Electrocardiogram: normal (normal) Normal.     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 relevant concomitant medications reported.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2021: Follow up received on 9-Feb-2021 Regulatory Authority On 22-Apr-2021: Follow-up received on 22-Feb-2021
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: VAccination site itchiness; Rash; Vaccination site swelling; VAccination site redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (VAccination site itchiness), RASH (Rash), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE ERYTHEMA (VAccination site redness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (VAccination site itchiness), RASH (Rash), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE ERYTHEMA (VAccination site redness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) ongoing since an unknown date at an unspecified dose and frequency and HYDROCORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (VAccination site itchiness), RASH (Rash), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE ERYTHEMA (VAccination site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported by the reporter. Treatment included ice pack.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: No specific follow-up information recorded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Feeling jittery, Headache, Hypoaesthesia, Nausea
Clinical narrative: Ongoing nausea; Headache; Sore arm; Loss of appetite; Felt sluggish; Numb feeling all the way down arm to hand; Tingly feeling all te way down arm to hand; Nausea; A spontaneous report was received from Consumer concerning a patient 64 year old, female and who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced Headache, Sore arm, Loss of appetite, Nausea, Felt sluggish, Numb feeling all the way down arm to hand and Tingly feeling all the way down arm to hand  The patient's medical history was COPD.  Concomitant products were not provided.  On 24 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number unknown) viz intramuscular route for prophylaxis of COVID-19 infection. Patient stated she had mild side effects of headache, sore arm, loss of appetite and nausea. Patient stated she felt sluggish. Patient stated she had numb and tingly feeling all the way down her arm to her hand. Patient stated she has COPD.  Treatment provided was unknown.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event  Headache, Sore arm, Loss of appetite, Nausea, Felt sluggish, Numb feeling all the way down arm to hand, Tingly feeling all the way down arm to hand is unknown.  Follow up :  A spontaneous report was received from Consumer concerning a patient 64 years old, female and who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced mild intermittent nausea, sore arm, mild headache, ongoing nausea and nausea returned.  The patient's medical history was reported as borderline obesity, high cholesterol, mild COPD, Hepatitis C (15 years ago), foot surgery (3 years ago). The consumer stated she quit drinking alcohol 15 years ago.  Concomitant products was Lipitor unknown indication.  On 24 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number 022M20A), dose quantity 0.5 ml millilitre(s) viz intramuscular route for prophylaxis of COVID-19 infection. Patient stated five hours after the vaccination she experienced mild intermittent nausea. On 25Feb2021, she reported a sore arm, mild headache, and ongoing nausea. On 26Feb2021, she reported the events resolved. No treatment medications reported. She did not report these events to her HCP. On or around 01Mar2021, she reported the nausea returned and is ongoing.  Treatment was not provided .  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event mild intermittent nausea, sore arm, mild headache, ongoing nausea was Recovered / Resolved and nausea returned was Not Recovered / Not Resolved.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sluggishness
Clinical narrative: Ongoing nausea; Headache; Sore arm; Loss of appetite; Felt sluggish; Numb feeling all the way down arm to hand; Tingly feeling all te way down arm to hand; Nausea; A spontaneous report was received from Consumer concerning a patient 64 year old, female and who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced Headache, Sore arm, Loss of appetite, Nausea, Felt sluggish, Numb feeling all the way down arm to hand and Tingly feeling all the way down arm to hand  The patient's medical history was COPD.  Concomitant products were not provided.  On 24 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number unknown) viz intramuscular route for prophylaxis of COVID-19 infection. Patient stated she had mild side effects of headache, sore arm, loss of appetite and nausea. Patient stated she felt sluggish. Patient stated she had numb and tingly feeling all the way down her arm to her hand. Patient stated she has COPD.  Treatment provided was unknown.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event  Headache, Sore arm, Loss of appetite, Nausea, Felt sluggish, Numb feeling all the way down arm to hand, Tingly feeling all the way down arm to hand is unknown.  Follow up :  A spontaneous report was received from Consumer concerning a patient 64 years old, female and who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced mild intermittent nausea, sore arm, mild headache, ongoing nausea and nausea returned.  The patient's medical history was reported as borderline obesity, high cholesterol, mild COPD, Hepatitis C (15 years ago), foot surgery (3 years ago). The consumer stated she quit drinking alcohol 15 years ago.  Concomitant products was Lipitor unknown indication.  On 24 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number 022M20A), dose quantity 0.5 ml millilitre(s) viz intramuscular route for prophylaxis of COVID-19 infection. Patient stated five hours after the vaccination she experienced mild intermittent nausea. On 25Feb2021, she reported a sore arm, mild headache, and ongoing nausea. On 26Feb2021, she reported the events resolved. No treatment medications reported. She did not report these events to her HCP. On or around 01Mar2021, she reported the nausea returned and is ongoing.  Treatment was not provided .  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event mild intermittent nausea, sore arm, mild headache, ongoing nausea was Recovered / Resolved and nausea returned was Not Recovered / Not Resolved.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Myalgia
Clinical narrative: Pain in Hips; Injection Site Pain; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in Hips), INJECTION SITE PAIN (Injection Site Pain) and MYALGIA (Body Aches) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced ARTHRALGIA (Pain in Hips), INJECTION SITE PAIN (Injection Site Pain) and MYALGIA (Body Aches). At the time of the report, ARTHRALGIA (Pain in Hips), INJECTION SITE PAIN (Injection Site Pain) and MYALGIA (Body Aches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Heart rate increased, Nausea
Clinical narrative: Fast pulse; No energy; achiness; Severe headache; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast pulse), ASTHENIA (No energy), PAIN (achiness), HEADACHE (Severe headache) and CHILLS (Chills) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030LZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced HEART RATE INCREASED (Fast pulse), ASTHENIA (No energy), PAIN (achiness), HEADACHE (Severe headache), CHILLS (Chills) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (Fast pulse), ASTHENIA (No energy), PAIN (achiness), CHILLS (Chills) and NAUSEA (Nausea) had resolved and HEADACHE (Severe headache) 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.   Concomitant medication details was not reported by the reporter.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Fast pulse; No energy; achiness; Severe headache; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast pulse), ASTHENIA (No energy), PAIN (achiness), HEADACHE (Severe headache) and CHILLS (Chills) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030LZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced HEART RATE INCREASED (Fast pulse), ASTHENIA (No energy), PAIN (achiness), HEADACHE (Severe headache), CHILLS (Chills) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (Fast pulse), ASTHENIA (No energy), PAIN (achiness), CHILLS (Chills) and NAUSEA (Nausea) had resolved and HEADACHE (Severe headache) 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.   Concomitant medication details was not reported by the reporter.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia
Clinical narrative: fatigued; slept all day; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigued) and HYPERSOMNIA (slept all day) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced HYPERSOMNIA (slept all day). On 20-Feb-2021, the patient experienced FATIGUE (fatigued). At the time of the report, FATIGUE (fatigued) and HYPERSOMNIA (slept all day) outcome was unknown.            Treatment details not provided.   This case was linked to MOD21-038182, MOD-2021-025031 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Redness in hands; Itchiness at hands; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness in hands) and PRURITUS (Itchiness at hands) 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 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced ERYTHEMA (Redness in hands) and PRURITUS (Itchiness at hands). At the time of the report, ERYTHEMA (Redness in hands) and PRURITUS (Itchiness at hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow up received on 21-Apr-2021 contains no new information as reporter declined further follow up.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; A spontaneous report was received from a consumer concerning a 72-years-old male patient who received Moderna's COVID-19 1556210(mRNA-1273) and experienced events sore arm/pain in extremity.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unavailable) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient experienced the event(s) sore arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event sore arm was unknown at the time of reporting.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site inflammation, Vaccination site pain
Clinical narrative: inflammation in the injection site; pinkish discoloration around the circle; arm tenderness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (inflammation in the injection site), VACCINATION SITE DISCOLOURATION (pinkish discoloration around the circle) and VACCINATION SITE PAIN (arm tenderness) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included ACETYLSALICYLIC ACID (ECOTRIN) for Anticoagulant therapy, LISINOPRIL for Hypertension, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Skin disorder, FOLIC ACID for Vitamin B complex supplementation.    On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm tenderness). On 06-Feb-2021, the patient experienced VACCINATION SITE INFLAMMATION (inflammation in the injection site) and VACCINATION SITE DISCOLOURATION (pinkish discoloration around the circle). At the time of the report, VACCINATION SITE INFLAMMATION (inflammation in the injection site), VACCINATION SITE DISCOLOURATION (pinkish discoloration around the circle) and VACCINATION SITE PAIN (arm tenderness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: aches; nausea; Low grade Fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (aches), NAUSEA (nausea), PYREXIA (Low grade Fever) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (aches), NAUSEA (nausea), PYREXIA (Low grade Fever) and FATIGUE (fatigue). At the time of the report, MYALGIA (aches), NAUSEA (nausea), PYREXIA (Low grade Fever) and FATIGUE (fatigue) outcome was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Small rash at the site; the site of injection is incredibly itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (the site of injection is incredibly itchy) and VACCINATION SITE RASH (Small rash at the site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (the site of injection is incredibly itchy). On 07-Feb-2021, the patient experienced VACCINATION SITE RASH (Small rash at the site). At the time of the report, VACCINATION SITE PRURITUS (the site of injection is incredibly itchy) and VACCINATION SITE RASH (Small rash at the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Injection site itchiness in the arm at injection site; blush colored redness at injection site after scratching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itchiness in the arm at injection site) and VACCINATION SITE ERYTHEMA (blush colored redness at injection site after scratching) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 06-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itchiness in the arm at injection site) and VACCINATION SITE ERYTHEMA (blush colored redness at injection site after scratching). At the time of the report, VACCINATION SITE PRURITUS (Injection site itchiness in the arm at injection site) and VACCINATION SITE ERYTHEMA (blush colored redness at injection site after scratching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling hot, Pyrexia
Clinical narrative: Temperature was 101.8; Felt a little warm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temperature was 101.8) and FEELING HOT (Felt a little warm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included COPD since an unknown date. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN), METHADONE, DILTIAZEM, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and VITAMINS NOS for an unknown indication.    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 PYREXIA (Temperature was 101.8) and FEELING HOT (Felt a little warm). At the time of the report, PYREXIA (Temperature was 101.8) and FEELING HOT (Felt a little warm) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.8 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 07-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temperature was 101.8) and FEELING HOT (Felt a little warm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included COPD since an unknown date. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN), METHADONE, DILTIAZEM, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and VITAMINS NOS for an unknown indication.    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 PYREXIA (Temperature was 101.8) and FEELING HOT (Felt a little warm). At the time of the report, PYREXIA (Temperature was 101.8) and FEELING HOT (Felt a little warm) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.8 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information for the event was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, COVID-19
Clinical narrative: Back pain; Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain) and COVID-19 (Covid-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced BACK PAIN (Back pain) and COVID-19 (Covid-19). At the time of the report, BACK PAIN (Back pain) had not resolved and COVID-19 (Covid-19) outcome was unknown.            No concomitant medication was provided.  No treatment details were provided.    Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: had soreness where the vaccine was given; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (had soreness where the vaccine was given) 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 10-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 INJECTION SITE PAIN (had soreness where the vaccine was given). On 10-Feb-2021, INJECTION SITE PAIN (had soreness where the vaccine was given) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysphagia, Dyspnoea, Fatigue, Hypokinesia
Clinical narrative: a shortness of breath; difficulty swallowing food; Lots of tiredness; feeling weak; warm; nausea; fatigue; body Aches; couldn't move her arm although now she can; 4th day post vaccination, she had red spots; itchiness at the vaccination site; The red spots that are hard to touch and similar to chicken pox; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Lots of tiredness), ASTHENIA (feeling weak), VACCINATION SITE WARMTH (warm), NAUSEA (nausea) and FATIGUE (fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced FATIGUE (Lots of tiredness), ASTHENIA (feeling weak), VACCINATION SITE WARMTH (warm), NAUSEA (nausea), FATIGUE (fatigue), MYALGIA (body Aches), HYPOKINESIA (couldn't move her arm although now she can), VACCINATION SITE ERYTHEMA (4th day post vaccination, she had red spots), VACCINATION SITE PRURITUS (itchiness at the vaccination site), VACCINATION SITE ERYTHEMA (The red spots that are hard to touch and similar to chicken pox) and DYSPHAGIA (difficulty swallowing food). On an unknown date, the patient experienced DYSPNOEA (a shortness of breath). At the time of the report, FATIGUE (Lots of tiredness), ASTHENIA (feeling weak), VACCINATION SITE WARMTH (warm), NAUSEA (nausea), FATIGUE (fatigue), MYALGIA (body Aches), HYPOKINESIA (couldn't move her arm although now she can), VACCINATION SITE ERYTHEMA (4th day post vaccination, she had red spots), VACCINATION SITE PRURITUS (itchiness at the vaccination site), VACCINATION SITE ERYTHEMA (The red spots that are hard to touch and similar to chicken pox), DYSPNOEA (a shortness of breath) and DYSPHAGIA (difficulty swallowing food) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included  includes warm patches and pain pills.   Reporter did not allow further contact
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: a shortness of breath; difficulty swallowing food; Lots of tiredness; feeling weak; warm; nausea; fatigue; body Aches; couldn't move her arm although now she can; 4th day post vaccination, she had red spots; itchiness at the vaccination site; The red spots that are hard to touch and similar to chicken pox; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Lots of tiredness), ASTHENIA (feeling weak), VACCINATION SITE WARMTH (warm), NAUSEA (nausea) and FATIGUE (fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced FATIGUE (Lots of tiredness), ASTHENIA (feeling weak), VACCINATION SITE WARMTH (warm), NAUSEA (nausea), FATIGUE (fatigue), MYALGIA (body Aches), HYPOKINESIA (couldn't move her arm although now she can), VACCINATION SITE ERYTHEMA (4th day post vaccination, she had red spots), VACCINATION SITE PRURITUS (itchiness at the vaccination site), VACCINATION SITE ERYTHEMA (The red spots that are hard to touch and similar to chicken pox) and DYSPHAGIA (difficulty swallowing food). On an unknown date, the patient experienced DYSPNOEA (a shortness of breath). At the time of the report, FATIGUE (Lots of tiredness), ASTHENIA (feeling weak), VACCINATION SITE WARMTH (warm), NAUSEA (nausea), FATIGUE (fatigue), MYALGIA (body Aches), HYPOKINESIA (couldn't move her arm although now she can), VACCINATION SITE ERYTHEMA (4th day post vaccination, she had red spots), VACCINATION SITE PRURITUS (itchiness at the vaccination site), VACCINATION SITE ERYTHEMA (The red spots that are hard to touch and similar to chicken pox), DYSPNOEA (a shortness of breath) and DYSPHAGIA (difficulty swallowing food) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included  includes warm patches and pain pills.   Reporter did not allow further contact
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Hyperhidrosis, Joint swelling, Pyrexia
Clinical narrative: Tendonitis is flaring up/ ankles have had a tendonitis flare up; Excruciating pain in the right wrist; Pain was so excruciating that the patient couldn't even walk; Knees are flaring up and are swollen; Low grade fever; Sweating; This spontaneous case was reported by a consumer and describes the occurrence of TENDONITIS (Tendonitis is flaring up/ ankles have had a tendonitis flare up), ARTHRALGIA (Excruciating pain in the right wrist), GAIT DISTURBANCE (Pain was so excruciating that the patient couldn't even walk), JOINT SWELLING (Knees are flaring up and are swollen) and PYREXIA (Low grade fever) in a 69-year-old male 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 Tendonitis.    On 28-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 TENDONITIS (Tendonitis is flaring up/ ankles have had a tendonitis flare up), ARTHRALGIA (Excruciating pain in the right wrist), GAIT DISTURBANCE (Pain was so excruciating that the patient couldn't even walk), JOINT SWELLING (Knees are flaring up and are swollen), PYREXIA (Low grade fever) and HYPERHIDROSIS (Sweating). At the time of the report, TENDONITIS (Tendonitis is flaring up/ ankles have had a tendonitis flare up), ARTHRALGIA (Excruciating pain in the right wrist), GAIT DISTURBANCE (Pain was so excruciating that the patient couldn't even walk), JOINT SWELLING (Knees are flaring up and are swollen), PYREXIA (Low grade fever) and HYPERHIDROSIS (Sweating) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment medications were not provided by reporter.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Tendonitis
Clinical narrative: Tendonitis is flaring up/ ankles have had a tendonitis flare up; Excruciating pain in the right wrist; Pain was so excruciating that the patient couldn't even walk; Knees are flaring up and are swollen; Low grade fever; Sweating; This spontaneous case was reported by a consumer and describes the occurrence of TENDONITIS (Tendonitis is flaring up/ ankles have had a tendonitis flare up), ARTHRALGIA (Excruciating pain in the right wrist), GAIT DISTURBANCE (Pain was so excruciating that the patient couldn't even walk), JOINT SWELLING (Knees are flaring up and are swollen) and PYREXIA (Low grade fever) in a 69-year-old male 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 Tendonitis.    On 28-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 TENDONITIS (Tendonitis is flaring up/ ankles have had a tendonitis flare up), ARTHRALGIA (Excruciating pain in the right wrist), GAIT DISTURBANCE (Pain was so excruciating that the patient couldn't even walk), JOINT SWELLING (Knees are flaring up and are swollen), PYREXIA (Low grade fever) and HYPERHIDROSIS (Sweating). At the time of the report, TENDONITIS (Tendonitis is flaring up/ ankles have had a tendonitis flare up), ARTHRALGIA (Excruciating pain in the right wrist), GAIT DISTURBANCE (Pain was so excruciating that the patient couldn't even walk), JOINT SWELLING (Knees are flaring up and are swollen), PYREXIA (Low grade fever) and HYPERHIDROSIS (Sweating) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment medications were not provided by reporter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: itchy at the injection site; red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 Vaccination.     Concurrent medical conditions included Hypertension, Cholesterol, Diabetes and Breast cancer. Concomitant products included NICOTINAMIDE (VITAMIN B COMPLEX [NICOTINAMIDE]) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchy at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site). On 25-Feb-2021, VACCINATION SITE PRURITUS (itchy at the injection site) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (red at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medications included unspecified blood pressure medication, cholesterol medication, diabetes medication and unspecified medication for breast cancer. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Experienced a weird reaction; A spontaneous report  was received from a consumer concerning an unknown-years-old Female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events experienced a weird reaction/vaccination site reaction.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via intramuscular route for prophylaxis of COVID-19 infection.  On unknown date, the patient experienced the event(s) experienced a weird reaction.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event experienced a weird reaction was unknown.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Parosmia, SARS-CoV-2 test, Taste disorder
Clinical narrative: Distortion of smell and taste; Distortion of smell and taste; Problems with remembering things , like "fogs" in the memory; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Distortion of smell and taste), PAROSMIA (Distortion of smell and taste) and FEELING ABNORMAL (Problems with remembering things , like "fogs" in the memory) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 09-Oct-2020.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced TASTE DISORDER (Distortion of smell and taste), PAROSMIA (Distortion of smell and taste) and FEELING ABNORMAL (Problems with remembering things , like "fogs" in the memory). At the time of the report, TASTE DISORDER (Distortion of smell and taste), PAROSMIA (Distortion of smell and taste) and FEELING ABNORMAL (Problems with remembering things , like "fogs" in the memory) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Oct-2020, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Fever) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Body temperature: 101.8 (High) 101.8 degree F.     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 relevant concomitant medications were reported. No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Neck pain
Clinical narrative: Patient is experiencing pain across all shoulder, back of neck is sore and stiffness on left arm; Patient is experiencing pain across all shoulder, back of neck is sore and stiffness on left arm; Patient is experiencing pain across all shoulder, back of neck is sore and stiffness on left arm; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Patient is experiencing pain across all shoulder, back of neck is sore and stiffness on left arm), MUSCULOSKELETAL STIFFNESS (Patient is experiencing pain across all shoulder, back of neck is sore and stiffness on left arm) and ARTHRALGIA (Patient is experiencing pain across all shoulder, back of neck is sore and stiffness on left arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 22-Feb-2021, the patient experienced NECK PAIN (Patient is experiencing pain across all shoulder, back of neck is sore and stiffness on left arm), MUSCULOSKELETAL STIFFNESS (Patient is experiencing pain across all shoulder, back of neck is sore and stiffness on left arm) and ARTHRALGIA (Patient is experiencing pain across all shoulder, back of neck is sore and stiffness on left arm). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 4 dosage form and ASPIRIN [ACETYLSALICYLIC ACID] for Pain, at a dose of 4 dosage form. At the time of the report, NECK PAIN (Patient is experiencing pain across all shoulder, back of neck is sore and stiffness on left arm) and ARTHRALGIA (Patient is experiencing pain across all shoulder, back of neck is sore and stiffness on left arm) had not resolved and MUSCULOSKELETAL STIFFNESS (Patient is experiencing pain across all shoulder, back of neck is sore and stiffness on left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment for the event also included pain relieving cream.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; mild fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (mild fatigue) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002H20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Feb-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 PAIN IN EXTREMITY (Sore arm) and FATIGUE (mild fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (mild fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: severe reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (severe reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE REACTION (severe reaction). At the time of the report, VACCINATION SITE REACTION (severe reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medicines were not provided  Action taken with mRNA-1273 in response to the event was unknown
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A sore arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History Information was Reported.  Concomitant products included MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) for Birth control.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (A sore arm). At the time of the report, PAIN IN EXTREMITY (A sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information for the event was provided.   This case was linked to MOD-2021-025587 (Patient Link). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 09-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A sore arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History Information was Reported.  Concomitant products included MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) for Birth control.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (A sore arm). At the time of the report, PAIN IN EXTREMITY (A sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information for the event was provided.   This case was linked to MOD-2021-025587 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Asthenia, Cough, Decreased appetite
Clinical narrative: lost sense of taste; lost sense of taste smell; cough; no appetite; weak; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost sense of taste), ANOSMIA (lost sense of taste smell), COUGH (cough), DECREASED APPETITE (no appetite) and ASTHENIA (weak) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-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 AGEUSIA (lost sense of taste), ANOSMIA (lost sense of taste smell), COUGH (cough), DECREASED APPETITE (no appetite) and ASTHENIA (weak). At the time of the report, AGEUSIA (lost sense of taste), ANOSMIA (lost sense of taste smell), COUGH (cough), DECREASED APPETITE (no appetite) and ASTHENIA (weak) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: a ringing in the ears, tinnitus,It's like a hissing and it's been consisting; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (a ringing in the ears, tinnitus,It's like a hissing and it's been consisting) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced TINNITUS (a ringing in the ears, tinnitus,It's like a hissing and it's been consisting). At the time of the report, TINNITUS (a ringing in the ears, tinnitus,It's like a hissing and it's been consisting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.    This case was linked to MOD-2021-075096 (Patient Link).