chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: swelling; redness about size of pancake; Soreness; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (swelling), VACCINATION SITE ERYTHEMA (redness about size of pancake) and VACCINATION SITE PAIN (Soreness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 29-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 VACCINATION SITE SWELLING (swelling), VACCINATION SITE ERYTHEMA (redness about size of pancake) and VACCINATION SITE PAIN (Soreness). At the time of the report, VACCINATION SITE SWELLING (swelling), VACCINATION SITE ERYTHEMA (redness about size of pancake) and VACCINATION SITE PAIN (Soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. Concomitant medication was not provided.    Reporter did not allow further contact
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Diarrhoea, Dyspnoea
Clinical narrative: Wheezing; Difficulty breathing; Weakness; Sore arm; Vomiting; Nausea; Chills; Body aches; Joint aches; Possible Fever; Diarrhea; A spontaneous report was received from a consumer, concerning a 73- year-old female patient, who received Moderna's COVID-19 vaccine and experienced sore arm, vomiting, diarrhea, nausea, chills, body aches, joint aches, felt like she was running a fever, wheezing and difficulty breathing.  Patient medical history was unknown. Concomitant product use was not provided by the reporter.    On 24 Jan 2021, the patient received their first dose of mRNA-1273 (025L2OA) intramuscularly for COVID-19 infection prophylaxis    On 24 Jan 2021, after the first dose of  Moderna's COVID-19 vaccine, the patient experienced sore arm. On 25 Jan 2021, next morning after receiving the vaccine the patient experienced vomiting, diarrhea, chills, body aches, weakness. On 27 Jan 2021, on the third day after receiving the vaccine the patient experienced Wheezing  No treatment medication was reported.  The second dose of mRNA-1273 was discontinued by the patient in response to the events.   The outcome of the events, sore arm, vomiting, diarrhea, nausea, chills, body aches, joint aches, felt like she was running a fever, wheezing and difficulty breathing were considered recovered on an unknown date.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: Wheezing; Difficulty breathing; Weakness; Sore arm; Vomiting; Nausea; Chills; Body aches; Joint aches; Possible Fever; Diarrhea; A spontaneous report was received from a consumer, concerning a 73- year-old female patient, who received Moderna's COVID-19 vaccine and experienced sore arm, vomiting, diarrhea, nausea, chills, body aches, joint aches, felt like she was running a fever, wheezing and difficulty breathing.  Patient medical history was unknown. Concomitant product use was not provided by the reporter.    On 24 Jan 2021, the patient received their first dose of mRNA-1273 (025L2OA) intramuscularly for COVID-19 infection prophylaxis    On 24 Jan 2021, after the first dose of  Moderna's COVID-19 vaccine, the patient experienced sore arm. On 25 Jan 2021, next morning after receiving the vaccine the patient experienced vomiting, diarrhea, chills, body aches, weakness. On 27 Jan 2021, on the third day after receiving the vaccine the patient experienced Wheezing  No treatment medication was reported.  The second dose of mRNA-1273 was discontinued by the patient in response to the events.   The outcome of the events, sore arm, vomiting, diarrhea, nausea, chills, body aches, joint aches, felt like she was running a fever, wheezing and difficulty breathing were considered recovered on an unknown date.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Wheezing; Difficulty breathing; Weakness; Sore arm; Vomiting; Nausea; Chills; Body aches; Joint aches; Possible Fever; Diarrhea; A spontaneous report was received from a consumer, concerning a 73- year-old female patient, who received Moderna's COVID-19 vaccine and experienced sore arm, vomiting, diarrhea, nausea, chills, body aches, joint aches, felt like she was running a fever, wheezing and difficulty breathing.  Patient medical history was unknown. Concomitant product use was not provided by the reporter.    On 24 Jan 2021, the patient received their first dose of mRNA-1273 (025L2OA) intramuscularly for COVID-19 infection prophylaxis    On 24 Jan 2021, after the first dose of  Moderna's COVID-19 vaccine, the patient experienced sore arm. On 25 Jan 2021, next morning after receiving the vaccine the patient experienced vomiting, diarrhea, chills, body aches, weakness. On 27 Jan 2021, on the third day after receiving the vaccine the patient experienced Wheezing  No treatment medication was reported.  The second dose of mRNA-1273 was discontinued by the patient in response to the events.   The outcome of the events, sore arm, vomiting, diarrhea, nausea, chills, body aches, joint aches, felt like she was running a fever, wheezing and difficulty breathing were considered recovered on an unknown date.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Arthropod sting
Clinical narrative: Vaccine protected him from inflammation after getting stung 8 times by fire ants; A spontaneous report was received from a consumer concerning a 45-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events patient believes vaccine protected him from inflammation after getting stung 8 times by fire ants.  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 their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 3 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.  On 3 Feb 2021, the patient experienced the event(s) patient believes vaccine protected him from inflammation after getting stung 8 times by fire ants.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), patient believes vaccine protected him from inflammation after getting stung 8 times by fire ants was resolved.
Sex: F
Vaccine: COVID19
Symptoms: Angular cheilitis, Gingival pain, Oropharyngeal pain
Clinical narrative: Soreness in mouth, gums, same side of throat; Soreness in mouth, gums, same side of throat; Soreness in mouth, gums, same side of throat; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL PAIN (Soreness in mouth, gums, same side of throat), ANGULAR CHEILITIS (Soreness in mouth, gums, same side of throat) and OROPHARYNGEAL PAIN (Soreness in mouth, gums, same side of throat) 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 26-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 GINGIVAL PAIN (Soreness in mouth, gums, same side of throat), ANGULAR CHEILITIS (Soreness in mouth, gums, same side of throat) and OROPHARYNGEAL PAIN (Soreness in mouth, gums, same side of throat). At the time of the report, GINGIVAL PAIN (Soreness in mouth, gums, same side of throat), ANGULAR CHEILITIS (Soreness in mouth, gums, same side of throat) and OROPHARYNGEAL PAIN (Soreness in mouth, gums, same side of throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.    Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: No specific follow-up information recorded.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature increased, Influenza like illness, Myalgia
Clinical narrative: feeling bad; flulike symptoms such as nausea; 99.5F temperature; he had pain in the lower back; muscular cramps; muscle and joint aches; A spontaneous report  was received from a consumer concerning a 57-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events feeling bad, he had pain in the lower back, tight very bad muscular cramps in his back, arm, and legs, flulike symptoms such as nausea, 99.5f temperature, muscle and joint aches.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) feeling bad. he had pain in the lower back, tight very bad muscular cramps in his back, arm, and legs, flulike symptoms such as nausea, 99.5f temperature, muscle and joint aches.  Treatment details included He took 5-6 tablets of extra strength Tylenol.  Action taken with mRNA-1273 in response to the events were not applicable.   The outcome of event(s), feeling bad, he had pain in the lower back,tight very bad muscular cramps in his back,arm,and legs,flulike symptoms such as nausea,99,5f temperature,muscle and joint aches was unknown.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: feeling bad; flulike symptoms such as nausea; 99.5F temperature; he had pain in the lower back; muscular cramps; muscle and joint aches; A spontaneous report  was received from a consumer concerning a 57-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events feeling bad, he had pain in the lower back, tight very bad muscular cramps in his back, arm, and legs, flulike symptoms such as nausea, 99.5f temperature, muscle and joint aches.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) feeling bad. he had pain in the lower back, tight very bad muscular cramps in his back, arm, and legs, flulike symptoms such as nausea, 99.5f temperature, muscle and joint aches.  Treatment details included He took 5-6 tablets of extra strength Tylenol.  Action taken with mRNA-1273 in response to the events were not applicable.   The outcome of event(s), feeling bad, he had pain in the lower back,tight very bad muscular cramps in his back,arm,and legs,flulike symptoms such as nausea,99,5f temperature,muscle and joint aches was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity
Clinical narrative: Feverish arm; Arm started being sore; A spontaneous report was received from a consumer concerning a 75-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm started being sore/ pain in extremity, feverish/ feeling hot.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) Intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events arm started being sore, feverish.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, arm started being sore, feverish was not resolved.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Fatigue
Clinical narrative: sharp chest pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and CHEST PAIN (sharp chest pain) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 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 FATIGUE (fatigue). On 11-Feb-2021, the patient experienced CHEST PAIN (sharp chest pain). At the time of the report, FATIGUE (fatigue) and CHEST PAIN (sharp chest pain) 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.   Treatment details were not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Fatigue, Gait disturbance, Nausea
Clinical narrative: she felt really really dizzy; Couldn't walk; Equilibrium was off; very tired; nausea; A spontaneous report was received from a consumer concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events really dizzy, couldn't walk, equilibrium was off, very tired, nausea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031M20A) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Really dizzy, Couldn't walk, Equilibrium was off, Very tired, Nausea.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), really dizzy, couldn't walk, equilibrium was off, very tired, nausea was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema of eyelid, Scab, Swelling of eyelid
Clinical narrative: red lower eyelids; swollen lower eyelids; crusting on the lower eyelids; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA OF EYELID (red lower eyelids), SWELLING OF EYELID (swollen lower eyelids) and SCAB (crusting on the lower eyelids) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 ERYTHEMA OF EYELID (red lower eyelids), SWELLING OF EYELID (swollen lower eyelids) and SCAB (crusting on the lower eyelids). At the time of the report, ERYTHEMA OF EYELID (red lower eyelids), SWELLING OF EYELID (swollen lower eyelids) and SCAB (crusting on the lower eyelids) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment include Triple antibiotic eye ointment   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Patient stated that She wasn't sure if the AE were because of the vaccine. She usually has allergies anyway. It lasted for only two days.She didn't want to follow-up and asked to close the case.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Limb discomfort, Vaccination site movement impairment
Clinical narrative: As if it was paralyzed; He couldn't lift it for 3 days; Very painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (As if it was paralyzed), LIMB DISCOMFORT (He couldn't lift it for 3 days) and AXILLARY PAIN (Very painful) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-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 MOVEMENT IMPAIRMENT (As if it was paralyzed), LIMB DISCOMFORT (He couldn't lift it for 3 days) and AXILLARY PAIN (Very painful). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency. On 09-Feb-2021, VACCINATION SITE MOVEMENT IMPAIRMENT (As if it was paralyzed), LIMB DISCOMFORT (He couldn't lift it for 3 days) and AXILLARY PAIN (Very painful) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported patient used ice to relieve the symptoms.  Concomitant product use was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up received on 04 Jun 2021contains event outcome and patient declined further follow-up; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Body tinea
Clinical narrative: left and right hand feels like ring worms and also has the ring worms in the back; A spontaneous report was received from a healthcare professional concerning a 78-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events feels like ringworms in the left hand, feels like ringworms in the right hand, feels like ring worms in the back.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 02ELWA) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 30 Jan 2021, the patient experienced the event(s) feels like ringworms in the left hand, feels like ringworms in the right hand, feels like ring worms in the back.  Treatment details included Psoriasis cream.  Action taken with mRNA-1273 in response to the events was not reported.  On 6 Feb 2021 the outcome of event(s), feels like ringworms in the left hand was resolved. The outcome of event(s), feels like ringworms in the right hand, feels like ring worms in the back was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pharyngeal swelling, Throat tightness
Clinical narrative: felt like her previous allergic reaction; swelling of her throat; tightness/ felt like someone was squeezing her throat; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (swelling of her throat), THROAT TIGHTNESS (tightness/ felt like someone was squeezing her throat) and HYPERSENSITIVITY (felt like her previous allergic reaction) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PHARYNGEAL SWELLING (swelling of her throat) and THROAT TIGHTNESS (tightness/ felt like someone was squeezing her throat). On an unknown date, the patient experienced HYPERSENSITIVITY (felt like her previous allergic reaction). At the time of the report, PHARYNGEAL SWELLING (swelling of her throat), THROAT TIGHTNESS (tightness/ felt like someone was squeezing her throat) and HYPERSENSITIVITY (felt like her previous allergic reaction) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (shingles) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Shingles. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF), AMLODIPINE BESILATE (NORVASC), BENAZEPRIL, FINASTERIDE and SIMVASTATIN (ZOCOR) 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 an unknown date, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown. Not Provided      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.   Treatment details included valacyclovir tablets 500mg three times a day for 7 days, acyclovir ointment 5% three times a day.   Reporter did not allow further contact
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Paraesthesia
Clinical narrative: Lost his sense of smell; Tingling in the arm of injection which was is left arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in the arm of injection which was is left arm) and ANOSMIA (Lost his sense of smell) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) 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 05-Feb-2021, the patient experienced PARAESTHESIA (Tingling in the arm of injection which was is left arm). On 10-Feb-2021, the patient experienced ANOSMIA (Lost his sense of smell). At the time of the report, PARAESTHESIA (Tingling in the arm of injection which was is left arm) and ANOSMIA (Lost his sense of smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported No treatment medication were reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Faeces discoloured, Fatigue, Pyrexia
Clinical narrative: Big bout of diarrhea; Stool was black; fatigue; tiny bit of chills; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Big bout of diarrhea), FAECES DISCOLOURED (Stool was black), PYREXIA (low grade fever), FATIGUE (fatigue) and CHILLS (tiny bit of chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010m20a) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PYREXIA (low grade fever). On 03-Feb-2021, the patient experienced DIARRHOEA (Big bout of diarrhea), FAECES DISCOLOURED (Stool was black), FATIGUE (fatigue) and CHILLS (tiny bit of chills). At the time of the report, DIARRHOEA (Big bout of diarrhea), FAECES DISCOLOURED (Stool was black), PYREXIA (low grade fever), FATIGUE (fatigue) and CHILLS (tiny bit of chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included diabetes medicines. Treatment information was not reported.; 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: Dizziness, Nausea
Clinical narrative: Dizzy; Sick in the stomach; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) and NAUSEA (Sick in the stomach) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 06-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 DIZZINESS (Dizzy) and NAUSEA (Sick in the stomach). At the time of the report, DIZZINESS (Dizzy) and NAUSEA (Sick in the stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported No treatment medication were reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Limb discomfort, Neurological symptom
Clinical narrative: drenched in sweat; can't see/ vission was blurry; moving his arms up in the air; skin was white; bad body aches; neurological reaction; fatigue; temperature was 99.8°F; Headache/head was pounding; A spontaneous report was received from a consumer concerning a 78-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events temperature was 99.8°f/pyrexia, headache, fatigue, drenched in sweat/hyperhyridosis, head was pounding/headache, i can't see, vision was blurred so badly/blurred vision, moving his arms up in the air/limb discomfort, skin was white/skin discoluration, really bad body aches/pain, neurological reaction/neurological symptoms.  The patient's medical include Parkinson's  disease. No relevant concomitant medications were reported.  On 09 Feb 2021, approximately 2 days prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 025L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) temperature was 99.8°f, headache, fatigue, drenched in sweat, head was pounding, i can't see, vision was blurred so badly, moving his arms up in the air, skin was white, really bad body aches, neurological reaction.  Treatment details included acetaminophen.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of event(s), temperature was 99, 8°f, headache, fatigue, drenched in sweat, head was pounding, i can't see, vision was blurred so badly, moving his arms up in the air, skin was white, really bad body aches, neurological reaction was unknown.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Skin discolouration, Vision blurred
Clinical narrative: drenched in sweat; can't see/ vission was blurry; moving his arms up in the air; skin was white; bad body aches; neurological reaction; fatigue; temperature was 99.8°F; Headache/head was pounding; A spontaneous report was received from a consumer concerning a 78-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events temperature was 99.8°f/pyrexia, headache, fatigue, drenched in sweat/hyperhyridosis, head was pounding/headache, i can't see, vision was blurred so badly/blurred vision, moving his arms up in the air/limb discomfort, skin was white/skin discoluration, really bad body aches/pain, neurological reaction/neurological symptoms.  The patient's medical include Parkinson's  disease. No relevant concomitant medications were reported.  On 09 Feb 2021, approximately 2 days prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 025L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) temperature was 99.8°f, headache, fatigue, drenched in sweat, head was pounding, i can't see, vision was blurred so badly, moving his arms up in the air, skin was white, really bad body aches, neurological reaction.  Treatment details included acetaminophen.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of event(s), temperature was 99, 8°f, headache, fatigue, drenched in sweat, head was pounding, i can't see, vision was blurred so badly, moving his arms up in the air, skin was white, really bad body aches, neurological reaction was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: Itchy Sensation - Near Injection Site; Swelling - Near Injection Site; Headache; Chills; Nausea/Vomiting; Body Aches; Arm Pain - Near Injection Site; Hardness - Near Injection Site; Hot to Touch Sensation - Near Injection Site; A spontaneous report was received from a consumer concerning a 61-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm pain - near injection site, hardness - near injection site, hot to touch sensation - near injection site, itchy sensation - near injection site, swelling - near injection site, headache, chills, nausea vomiting, body aches.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 7 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: N A (Not Written on Card)) intramuscularly in the right upper arm for prophylaxis of COVID-19 infection. On 4 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: N A (Not Written on Card)) intramuscularly in the left upper arm for prophylaxis of COVID-19 infection.  On 5 Feb 2021, the patient experienced the event(s) arm pain - near injection site, hardness - near injection site. On 5 Feb 1900, the patient experienced the event(s) hot to touch sensation - near injection site, itchy sensation - near injection site, swelling - near injection site, headache, chills, nausea vomiting, body aches.  Treatment details included Benadryl - Advised by HCP to try to alleviate symptoms, Zyrtec - Advised by HCP to try to alleviate symptoms.  Action taken with mRNA-1273 in response to the events was not reported.  On 10 Feb 2021 the outcome of event(s), arm pain - near injection site, hardness - near injection site, hot to touch sensation - near injection site, itchy sensation - near injection site, swelling - near injection site, headache, chills, nausea vomiting, body aches was resolved.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Itchy Sensation - Near Injection Site; Swelling - Near Injection Site; Headache; Chills; Nausea/Vomiting; Body Aches; Arm Pain - Near Injection Site; Hardness - Near Injection Site; Hot to Touch Sensation - Near Injection Site; A spontaneous report was received from a consumer concerning a 61-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm pain - near injection site, hardness - near injection site, hot to touch sensation - near injection site, itchy sensation - near injection site, swelling - near injection site, headache, chills, nausea vomiting, body aches.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 7 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: N A (Not Written on Card)) intramuscularly in the right upper arm for prophylaxis of COVID-19 infection. On 4 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: N A (Not Written on Card)) intramuscularly in the left upper arm for prophylaxis of COVID-19 infection.  On 5 Feb 2021, the patient experienced the event(s) arm pain - near injection site, hardness - near injection site. On 5 Feb 1900, the patient experienced the event(s) hot to touch sensation - near injection site, itchy sensation - near injection site, swelling - near injection site, headache, chills, nausea vomiting, body aches.  Treatment details included Benadryl - Advised by HCP to try to alleviate symptoms, Zyrtec - Advised by HCP to try to alleviate symptoms.  Action taken with mRNA-1273 in response to the events was not reported.  On 10 Feb 2021 the outcome of event(s), arm pain - near injection site, hardness - near injection site, hot to touch sensation - near injection site, itchy sensation - near injection site, swelling - near injection site, headache, chills, nausea vomiting, body aches was resolved.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Nausea
Clinical narrative: nausea  after the first dose; upset stomach after the first dose; After the second feeling worse nausea; After the second now upset stomach and feel bowels are loose; A spontaneous report was received from a consumer concerning a 70-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nausea and an upset stomach after the first dose, after the second, now, they are feeling worse nausea, upset stomach and feel their bowels are.  The patient's medical history was not provided. Concomitant medications reported were blood pressure medication, others, they did not remember at the time for drug use for unknown indication.  On 12 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 026L20A) via unknown route in the right arm for prophylaxis of COVID-19 infection. On 9 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 028L20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) nausea and an upset stomach after the first dose, After the second, now, they are feeling worse nausea, upset stomach and feel their bowels are.  Treatment details included Mylanta.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), nausea and an upset stomach after the first dose, after the second, now, they are feeling worse nausea, upset stomach and feel their bowels are was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Nausea, Pain
Clinical narrative: Flue like symtoms; body ache; headache; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flue like symtoms), PAIN (body ache), HEADACHE (headache), CHILLS (Chills) and NAUSEA (Nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flue like symtoms), PAIN (body ache), HEADACHE (headache), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, INFLUENZA LIKE ILLNESS (Flue like symtoms), PAIN (body ache), HEADACHE (headache), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient said that she got same symptoms after 3 weeks. No concomitant medications provided. No treatment information provided.   This case was linked to MOD-2021-015298 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia, Somnolence
Clinical narrative: very sleepy; nausea; severe headache; chills; fever; soreness at the injection site; swelling at the injection site; A spontaneous report  was received from a consumer concerning a female patient of 69 year old, who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced events nausea,severe headache, chills, fever, felt very sleepy ,injection site sore (vaccination site pain ) and swelling at injection site  The patients medical history was not provided.No relevant Concomitant medications were reported.  On 26 feb 2021,prior to the onset of events, the Patient received their first of two planned dose of mRNA-1273(Lot number: 013A21A) vaccine intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 27 feb 2021,one day after vaccination, patient experienced nausea, a severe headache, chills, fever and felt very sleepy.patient also started having soreness and swelling at the injection site, which lasted for the next 3 days. Treatment for the event included Tylenol.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the events, nausea, severe headache, chills, fever, felt very sleepy were considered resolved on 01 Mar 2021.  The outcome of the events, injection site sore and swelling at injection site were considered resolved on 02 Mar 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: very sleepy; nausea; severe headache; chills; fever; soreness at the injection site; swelling at the injection site; A spontaneous report  was received from a consumer concerning a female patient of 69 year old, who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced events nausea,severe headache, chills, fever, felt very sleepy ,injection site sore (vaccination site pain ) and swelling at injection site  The patients medical history was not provided.No relevant Concomitant medications were reported.  On 26 feb 2021,prior to the onset of events, the Patient received their first of two planned dose of mRNA-1273(Lot number: 013A21A) vaccine intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 27 feb 2021,one day after vaccination, patient experienced nausea, a severe headache, chills, fever and felt very sleepy.patient also started having soreness and swelling at the injection site, which lasted for the next 3 days. Treatment for the event included Tylenol.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the events, nausea, severe headache, chills, fever, felt very sleepy were considered resolved on 01 Mar 2021.  The outcome of the events, injection site sore and swelling at injection site were considered resolved on 02 Mar 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Influenza like illness, Injection site pain
Clinical narrative: feel like crap; flu like symptoms; welts that resemble hives; hardness at injection site; tired; headache; muscle aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (hardness at injection site), FATIGUE (tired), HEADACHE (headache), MYALGIA (muscle aches) and FATIGUE (fatigue) in a 50-year-old female 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.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (hardness at injection site), FATIGUE (tired), HEADACHE (headache), MYALGIA (muscle aches), FATIGUE (fatigue), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (feel like crap) and URTICARIA (welts that resemble hives). At the time of the report, INJECTION SITE PAIN (hardness at injection site), FATIGUE (tired), HEADACHE (headache), MYALGIA (muscle aches), FATIGUE (fatigue), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (feel like crap) and URTICARIA (welts that resemble hives) 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.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Urticaria
Clinical narrative: feel like crap; flu like symptoms; welts that resemble hives; hardness at injection site; tired; headache; muscle aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (hardness at injection site), FATIGUE (tired), HEADACHE (headache), MYALGIA (muscle aches) and FATIGUE (fatigue) in a 50-year-old female 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.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (hardness at injection site), FATIGUE (tired), HEADACHE (headache), MYALGIA (muscle aches), FATIGUE (fatigue), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (feel like crap) and URTICARIA (welts that resemble hives). At the time of the report, INJECTION SITE PAIN (hardness at injection site), FATIGUE (tired), HEADACHE (headache), MYALGIA (muscle aches), FATIGUE (fatigue), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (feel like crap) and URTICARIA (welts that resemble hives) 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.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash 3 x 3 area; itching; A spontaneous report was received from a consumer concerning a 87-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash 3 x 3 area, itching.  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 their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   rash 3 x 3 area, itching.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), rash 3 x 3 area was unknown.The outcome of event(s), itching was unknown..
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Dizziness, Fatigue, Headache
Clinical narrative: Very Sick; Fever 101.9 F; Headache; Very Tired; Weak; Hot Body but very cold Feet and Hands; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), PERIPHERAL COLDNESS (Hot Body but very cold Feet and Hands), DIZZINESS (Dizzy), ILLNESS (Very Sick) and FATIGUE (Very Tired) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 ASTHENIA (Weak), PERIPHERAL COLDNESS (Hot Body but very cold Feet and Hands), DIZZINESS (Dizzy) and FATIGUE (Very Tired). On 04-Feb-2021, the patient experienced HEADACHE (Headache). On 05-Feb-2021, the patient experienced ILLNESS (Very Sick) and PYREXIA (Fever 101.9 F). On 07-Feb-2021, PYREXIA (Fever 101.9 F) had resolved. On 08-Feb-2021, ASTHENIA (Weak), PERIPHERAL COLDNESS (Hot Body but very cold Feet and Hands), DIZZINESS (Dizzy), FATIGUE (Very Tired) and HEADACHE (Headache) had resolved and ILLNESS (Very Sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Body temperature increased: high (High) 101.9 degree Fahrenheit..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Peripheral coldness, Pyrexia
Clinical narrative: Very Sick; Fever 101.9 F; Headache; Very Tired; Weak; Hot Body but very cold Feet and Hands; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), PERIPHERAL COLDNESS (Hot Body but very cold Feet and Hands), DIZZINESS (Dizzy), ILLNESS (Very Sick) and FATIGUE (Very Tired) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 ASTHENIA (Weak), PERIPHERAL COLDNESS (Hot Body but very cold Feet and Hands), DIZZINESS (Dizzy) and FATIGUE (Very Tired). On 04-Feb-2021, the patient experienced HEADACHE (Headache). On 05-Feb-2021, the patient experienced ILLNESS (Very Sick) and PYREXIA (Fever 101.9 F). On 07-Feb-2021, PYREXIA (Fever 101.9 F) had resolved. On 08-Feb-2021, ASTHENIA (Weak), PERIPHERAL COLDNESS (Hot Body but very cold Feet and Hands), DIZZINESS (Dizzy), FATIGUE (Very Tired) and HEADACHE (Headache) had resolved and ILLNESS (Very Sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Body temperature increased: high (High) 101.9 degree Fahrenheit..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.