chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Chills, Discomfort, Dizziness, Fatigue, Haematochezia
Clinical narrative: blood in my stool; I coughed up a minor amount of blood; slept all day/difficult to stay awake; very fatigued/still experiencing the fatigue; chills/still experiencing the fever/chills; dizziness; on and off cold; slight discomfort; mild fever/overnight fever/still experiencing the fever; sleeping about 2-4 hours a day; I'be been waking up every hour since the booster shot; This spontaneous case was reported by a non-health professional and describes the occurrence of HAEMATOCHEZIA (blood in my stool), HAEMOPTYSIS (I coughed up a minor amount of blood), DISCOMFORT (slight discomfort), DIZZINESS (dizziness) and NASOPHARYNGITIS (on and off cold) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and Tobacco user (currently rotate a vape and a regular tobacco product.).    On 27-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced INSOMNIA (sleeping about 2-4 hours a day) and SLEEP DISORDER (I'be been waking up every hour since the booster shot). On 27-Nov-2021, the patient experienced DISCOMFORT (slight discomfort) and PYREXIA (mild fever/overnight fever/still experiencing the fever). On 28-Nov-2021, the patient experienced DIZZINESS (dizziness), NASOPHARYNGITIS (on and off cold) and CHILLS (chills/still experiencing the fever/chills). On 30-Nov-2021, the patient experienced FATIGUE (very fatigued/still experiencing the fatigue). On 01-Dec-2021, the patient experienced HAEMATOCHEZIA (blood in my stool), HAEMOPTYSIS (I coughed up a minor amount of blood) and SOMNOLENCE (slept all day/difficult to stay awake). On 01-Dec-2021, SOMNOLENCE (slept all day/difficult to stay awake) had resolved. At the time of the report, HAEMATOCHEZIA (blood in my stool), HAEMOPTYSIS (I coughed up a minor amount of blood), DISCOMFORT (slight discomfort), DIZZINESS (dizziness), INSOMNIA (sleeping about 2-4 hours a day) and SLEEP DISORDER (I'be been waking up every hour since the booster shot) outcome was unknown and NASOPHARYNGITIS (on and off cold), FATIGUE (very fatigued/still experiencing the fatigue), CHILLS (chills/still experiencing the fever/chills) and PYREXIA (mild fever/overnight fever/still experiencing the fever) had not resolved.            No concomitant drug details were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Haemoptysis, Insomnia, Nasopharyngitis, Pyrexia, Sleep disorder
Clinical narrative: blood in my stool; I coughed up a minor amount of blood; slept all day/difficult to stay awake; very fatigued/still experiencing the fatigue; chills/still experiencing the fever/chills; dizziness; on and off cold; slight discomfort; mild fever/overnight fever/still experiencing the fever; sleeping about 2-4 hours a day; I'be been waking up every hour since the booster shot; This spontaneous case was reported by a non-health professional and describes the occurrence of HAEMATOCHEZIA (blood in my stool), HAEMOPTYSIS (I coughed up a minor amount of blood), DISCOMFORT (slight discomfort), DIZZINESS (dizziness) and NASOPHARYNGITIS (on and off cold) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and Tobacco user (currently rotate a vape and a regular tobacco product.).    On 27-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced INSOMNIA (sleeping about 2-4 hours a day) and SLEEP DISORDER (I'be been waking up every hour since the booster shot). On 27-Nov-2021, the patient experienced DISCOMFORT (slight discomfort) and PYREXIA (mild fever/overnight fever/still experiencing the fever). On 28-Nov-2021, the patient experienced DIZZINESS (dizziness), NASOPHARYNGITIS (on and off cold) and CHILLS (chills/still experiencing the fever/chills). On 30-Nov-2021, the patient experienced FATIGUE (very fatigued/still experiencing the fatigue). On 01-Dec-2021, the patient experienced HAEMATOCHEZIA (blood in my stool), HAEMOPTYSIS (I coughed up a minor amount of blood) and SOMNOLENCE (slept all day/difficult to stay awake). On 01-Dec-2021, SOMNOLENCE (slept all day/difficult to stay awake) had resolved. At the time of the report, HAEMATOCHEZIA (blood in my stool), HAEMOPTYSIS (I coughed up a minor amount of blood), DISCOMFORT (slight discomfort), DIZZINESS (dizziness), INSOMNIA (sleeping about 2-4 hours a day) and SLEEP DISORDER (I'be been waking up every hour since the booster shot) outcome was unknown and NASOPHARYNGITIS (on and off cold), FATIGUE (very fatigued/still experiencing the fatigue), CHILLS (chills/still experiencing the fever/chills) and PYREXIA (mild fever/overnight fever/still experiencing the fever) had not resolved.            No concomitant drug details were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: blood in my stool; I coughed up a minor amount of blood; slept all day/difficult to stay awake; very fatigued/still experiencing the fatigue; chills/still experiencing the fever/chills; dizziness; on and off cold; slight discomfort; mild fever/overnight fever/still experiencing the fever; sleeping about 2-4 hours a day; I'be been waking up every hour since the booster shot; This spontaneous case was reported by a non-health professional and describes the occurrence of HAEMATOCHEZIA (blood in my stool), HAEMOPTYSIS (I coughed up a minor amount of blood), DISCOMFORT (slight discomfort), DIZZINESS (dizziness) and NASOPHARYNGITIS (on and off cold) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and Tobacco user (currently rotate a vape and a regular tobacco product.).    On 27-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced INSOMNIA (sleeping about 2-4 hours a day) and SLEEP DISORDER (I'be been waking up every hour since the booster shot). On 27-Nov-2021, the patient experienced DISCOMFORT (slight discomfort) and PYREXIA (mild fever/overnight fever/still experiencing the fever). On 28-Nov-2021, the patient experienced DIZZINESS (dizziness), NASOPHARYNGITIS (on and off cold) and CHILLS (chills/still experiencing the fever/chills). On 30-Nov-2021, the patient experienced FATIGUE (very fatigued/still experiencing the fatigue). On 01-Dec-2021, the patient experienced HAEMATOCHEZIA (blood in my stool), HAEMOPTYSIS (I coughed up a minor amount of blood) and SOMNOLENCE (slept all day/difficult to stay awake). On 01-Dec-2021, SOMNOLENCE (slept all day/difficult to stay awake) had resolved. At the time of the report, HAEMATOCHEZIA (blood in my stool), HAEMOPTYSIS (I coughed up a minor amount of blood), DISCOMFORT (slight discomfort), DIZZINESS (dizziness), INSOMNIA (sleeping about 2-4 hours a day) and SLEEP DISORDER (I'be been waking up every hour since the booster shot) outcome was unknown and NASOPHARYNGITIS (on and off cold), FATIGUE (very fatigued/still experiencing the fatigue), CHILLS (chills/still experiencing the fever/chills) and PYREXIA (mild fever/overnight fever/still experiencing the fever) had not resolved.            No concomitant drug details were reported. No treatment details were reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Muscle contractions involuntary, Weight decreased
Clinical narrative: Muscle fasciculations; Feels tired; Lost 15 pounds; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Lost 15 pounds), MUSCLE CONTRACTIONS INVOLUNTARY (Muscle fasciculations) and FATIGUE (Feels tired) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 024H20A) for COVID-19 vaccination. Concomitant products included OMEPRAZOLE and LOSARTAN for an unknown indication.On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced MUSCLE CONTRACTIONS INVOLUNTARY (Muscle fasciculations). In April 2021, the patient experienced WEIGHT DECREASED (Lost 15 pounds) and FATIGUE (Feels tired). At the time of the report, WEIGHT DECREASED (Lost 15 pounds) and FATIGUE (Feels tired) outcome was unknown and MUSCLE CONTRACTIONS INVOLUNTARY (Muscle fasciculations) had not resolved. Patient was taking acupuncture treatment. Reporter mentioned that patient saw that the biceps in both arms were twitching and it progressed to his forearms and wrists then to his torso and thighs and ankles. This was very prevalent especially the one in his extremities. He lost 15 pounds and he feels tried. He consulted his primary care physician and was told that these were muscle fasciculations. patient underwent 5 sessions with an acupuncturist but this did not resolve the condition.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Loss of consciousness, Sinusitis, Somnolence
Clinical narrative: very sleepy that evening and passed out on her bed; eyes were spinning around in my head; very sleepy that evening and passed out on her bed; sinus is acting up; headache; During the call she was coughing; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (very sleepy that evening and passed out on her bed), VERTIGO (eyes were spinning around in my head), SOMNOLENCE (very sleepy that evening and passed out on her bed), COUGH (During the call she was coughing) and SINUSITIS (sinus is acting up) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced COUGH (During the call she was coughing). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (very sleepy that evening and passed out on her bed), VERTIGO (eyes were spinning around in my head), SOMNOLENCE (very sleepy that evening and passed out on her bed), SINUSITIS (sinus is acting up) and HEADACHE (headache). At the time of the report, LOSS OF CONSCIOUSNESS (very sleepy that evening and passed out on her bed), VERTIGO (eyes were spinning around in my head), SOMNOLENCE (very sleepy that evening and passed out on her bed), COUGH (During the call she was coughing), SINUSITIS (sinus is acting up) and HEADACHE (headache) outcome was unknown.            No concomitant medications were reported   It was reported that After the 2nd dose she had a headache, her eyes were spinning around in her head, and she was very sleepy that evening and passed out on her bed. During the call she was coughing and stated that her sinuses are acting up.  No treatment information was provided   This case was linked to MOD-2021-405166 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: very sleepy that evening and passed out on her bed; eyes were spinning around in my head; very sleepy that evening and passed out on her bed; sinus is acting up; headache; During the call she was coughing; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (very sleepy that evening and passed out on her bed), VERTIGO (eyes were spinning around in my head), SOMNOLENCE (very sleepy that evening and passed out on her bed), COUGH (During the call she was coughing) and SINUSITIS (sinus is acting up) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced COUGH (During the call she was coughing). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (very sleepy that evening and passed out on her bed), VERTIGO (eyes were spinning around in my head), SOMNOLENCE (very sleepy that evening and passed out on her bed), SINUSITIS (sinus is acting up) and HEADACHE (headache). At the time of the report, LOSS OF CONSCIOUSNESS (very sleepy that evening and passed out on her bed), VERTIGO (eyes were spinning around in my head), SOMNOLENCE (very sleepy that evening and passed out on her bed), COUGH (During the call she was coughing), SINUSITIS (sinus is acting up) and HEADACHE (headache) outcome was unknown.            No concomitant medications were reported   It was reported that After the 2nd dose she had a headache, her eyes were spinning around in her head, and she was very sleepy that evening and passed out on her bed. During the call she was coughing and stated that her sinuses are acting up.  No treatment information was provided   This case was linked to MOD-2021-405166 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Tinnitus
Clinical narrative: tinnitus which was pretty loud and severe, still occasions when she experiences it and it can be maddening sometimes.; itching; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus which was pretty loud and severe, still occasions when she experiences it and it can be maddening sometimes.) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21C and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced TINNITUS (tinnitus which was pretty loud and severe, still occasions when she experiences it and it can be maddening sometimes.) (seriousness criterion medically significant), PRURITUS (itching) and PAIN (Soreness). At the time of the report, TINNITUS (tinnitus which was pretty loud and severe, still occasions when she experiences it and it can be maddening sometimes.) had not resolved and PRURITUS (itching) and PAIN (Soreness) had resolved.            No concomitant medications were provided. Treatment for the events were not provided. It was reported that, the most disturbing is the tinnitus which was pretty loud and severe. She states that it has gone for a bit but there are still occasions when she experiences it and it can be maddening sometimes.  Company comment: This is a spontaneous case concerning a 56 year-old, female patient with no reported medical history, who experienced the serious (due to medically important condition, as reported by the patient) unexpected, according RA, event of tinnitus. The event occurred after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event was reported exclusively after the second dose and no information on additional dosing is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-403774 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 56 year-old, female patient with no reported medical history, who experienced the serious (due to medically important condition, as reported by the patient) unexpected, according RA, event of tinnitus. The event occurred after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event was reported exclusively after the second dose and no information on additional dosing is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis, Thrombosis, Vaccination site pain
Clinical narrative: clots in her legs; clots/clots in her lung; arm sore; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (clots in her legs) and PULMONARY THROMBOSIS (clots/clots in her lung) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (arm sore). On 13-Mar-2021, the patient experienced THROMBOSIS (clots in her legs) (seriousness criteria hospitalization and medically significant) and PULMONARY THROMBOSIS (clots/clots in her lung) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 13-Mar-2021 due to PULMONARY THROMBOSIS and THROMBOSIS. The patient was treated with APIXABAN (ELIQUIS) for Adverse event, at a dose of 5 mg twice a day. On 27-Feb-2021, VACCINATION SITE PAIN (arm sore) had resolved. At the time of the report, THROMBOSIS (clots in her legs) and PULMONARY THROMBOSIS (clots/clots in her lung) outcome was unknown.            No concomitant medication was reported by the reporter. On 13Mar2021 she was in hospital with clots in her lung and legs.  Company comment: This is a spontaneous case concerning a 79 year-old, female patient with no reported medical history, who experienced the serious (due to hospitalization) unexpected, according RA, AESI of Thrombosis (LLT: thrombosis leg) and Pulmonary thrombosis. The events occurred approximately 16 days after the second dose of mRNA-1273 vaccine. The patient was hospitalized and has been prescribed Apixaban. The rechallenge was not applicable, as the events were reported exclusively after the second dose and no information on additional dosing is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 79 year-old, female patient with no reported medical history, who experienced the serious (due to hospitalization) unexpected, according RA, AESI of Thrombosis (LLT: thrombosis leg) and Pulmonary thrombosis. The events occurred approximately 16 days after the second dose of mRNA-1273 vaccine. The patient was hospitalized and has been prescribed Apixaban. The rechallenge was not applicable, as the events were reported exclusively after the second dose and no information on additional dosing is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity, Vein rupture
Clinical narrative: Patient experienced a pierced vein or capillary; Had a large bruise/bruise is still visible on 2DEC2021; Lot of soreness; This spontaneous case was reported by a consumer and describes the occurrence of VEIN RUPTURE (Patient experienced a pierced vein or capillary), CONTUSION (Had a large bruise/bruise is still visible on 2DEC2021) and PAIN IN EXTREMITY (Lot of soreness) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902, 041L20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Cancer.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021, the patient experienced VEIN RUPTURE (Patient experienced a pierced vein or capillary), CONTUSION (Had a large bruise/bruise is still visible on 2DEC2021) and PAIN IN EXTREMITY (Lot of soreness). At the time of the report, VEIN RUPTURE (Patient experienced a pierced vein or capillary) and PAIN IN EXTREMITY (Lot of soreness) outcome was unknown and CONTUSION (Had a large bruise/bruise is still visible on 2DEC2021) had not resolved.            No Concomitant medications were reported. No Treatment details were reported. Patient received the vaccine in his left arm shoulder deltoid muscle. The patient feels that the events was caused by administration technique. The patient stated that the he received the received the correct dosage of a 3rd dose for immunocompromised patients.   This case was linked to MOD-2021-404030, MOD-2021-403976 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Dec-2021: Follow up received. Event related information was updated that the patient received correct dosage.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Headache, Hypotension, Pain, Pyrexia
Clinical narrative: Aches; Fever; Headache; Pain at injection site; The morning after my second dose I fainted.; I had low blood pressure, aches, fever, headache, pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (The morning after my second dose I fainted.), HYPOTENSION (I had low blood pressure, aches, fever, headache, pain at injection site), PAIN (Aches), PYREXIA (Fever) and HEADACHE (Headache) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced SYNCOPE (The morning after my second dose I fainted.) and HYPOTENSION (I had low blood pressure, aches, fever, headache, pain at injection site). On an unknown date, the patient experienced PAIN (Aches), PYREXIA (Fever), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at injection site). At the time of the report, SYNCOPE (The morning after my second dose I fainted.), HYPOTENSION (I had low blood pressure, aches, fever, headache, pain at injection site), PAIN (Aches), PYREXIA (Fever), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) Abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On unknown date, Laboratory test EKG was done and result was unknown.  Relevant concomitant medications included Birth control unspecified.  No treatment information was provided. Company comment: This is a spontaneous case concerning a 25 year-old, female patient with no medical history reported, who experienced the non-serious unexpected (expected for US), event of Syncope. The event occurred approximately 1day after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable since the event happened after the second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 25 year-old, female patient with no medical history reported, who experienced the non-serious unexpected (expected for US), event of Syncope. The event occurred approximately 1day after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable since the event happened after the second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Vaccination site pain
Clinical narrative: Aches; Fever; Headache; Pain at injection site; The morning after my second dose I fainted.; I had low blood pressure, aches, fever, headache, pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (The morning after my second dose I fainted.), HYPOTENSION (I had low blood pressure, aches, fever, headache, pain at injection site), PAIN (Aches), PYREXIA (Fever) and HEADACHE (Headache) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced SYNCOPE (The morning after my second dose I fainted.) and HYPOTENSION (I had low blood pressure, aches, fever, headache, pain at injection site). On an unknown date, the patient experienced PAIN (Aches), PYREXIA (Fever), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at injection site). At the time of the report, SYNCOPE (The morning after my second dose I fainted.), HYPOTENSION (I had low blood pressure, aches, fever, headache, pain at injection site), PAIN (Aches), PYREXIA (Fever), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) Abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On unknown date, Laboratory test EKG was done and result was unknown.  Relevant concomitant medications included Birth control unspecified.  No treatment information was provided. Company comment: This is a spontaneous case concerning a 25 year-old, female patient with no medical history reported, who experienced the non-serious unexpected (expected for US), event of Syncope. The event occurred approximately 1day after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable since the event happened after the second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 25 year-old, female patient with no medical history reported, who experienced the non-serious unexpected (expected for US), event of Syncope. The event occurred approximately 1day after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable since the event happened after the second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: Deaf in one ear after 2nd Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Deaf in one ear after 2nd Moderna shot) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS UNILATERAL (Deaf in one ear after 2nd Moderna shot) (seriousness criterion medically significant). At the time of the report, DEAFNESS UNILATERAL (Deaf in one ear after 2nd Moderna shot) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  Company comment:  This spontaneous case concerns a patient of unknown age and gender, with unknown medical history, who experienced the serious (medically significant) unexpected event of DEAFNESS UNILATERAL. The event occurred on an unknown date after receiving the second dose of mRNA-1273. The rechallenge is not applicable since the outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was upgraded to medically significant according to IME list and considering the nature of the event was kept as such, even if there is very limited information for medical assessment. A query was sent for further information.   This case was linked to MOD-2021-404251 (Patient Link).; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender, with unknown medical history, who experienced the serious (medically significant) unexpected event of DEAFNESS UNILATERAL. The event occurred on an unknown date after receiving the second dose of mRNA-1273. The rechallenge is not applicable since the outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was upgraded to medically significant according to IME list and considering the nature of the event was kept as such, even if there is very limited information for medical assessment. A query was sent for further information.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose, Blood glucose increased, Headache, Hypokinesia
Clinical narrative: headache; Blood sugar was 274 and normally it is 110 to 115; had no energy/was stuck at home because he was totally down; did not move at all; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (had no energy/was stuck at home because he was totally down), HYPOKINESIA (did not move at all), BLOOD GLUCOSE INCREASED (Blood sugar was 274 and normally it is 110 to 115) and HEADACHE (headache) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939909, 025A21A and 028A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN for Diabetes.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced ASTHENIA (had no energy/was stuck at home because he was totally down) and HYPOKINESIA (did not move at all). On 03-Dec-2021, the patient experienced BLOOD GLUCOSE INCREASED (Blood sugar was 274 and normally it is 110 to 115). On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, ASTHENIA (had no energy/was stuck at home because he was totally down), HYPOKINESIA (did not move at all), BLOOD GLUCOSE INCREASED (Blood sugar was 274 and normally it is 110 to 115) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Dec-2021, Blood glucose: 274 (High) Patient reported his blood sugar was 274 and normally it was 110 to 115.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was on metformin for diabetes, but after the events he doubled his medication.  He thinks that his side effects may be because he did not move yesterday and part may be due to the booster dose. Patient is planning to go for a walk and If it does not get better in a couple of days he will contact his doctor.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 breakthrough infection. Also developed fever, coughing, achiness at injection site.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 breakthrough infection. Also developed fever, coughing, achiness at injection site.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 breakthrough infection. Also developed fever, coughing, achiness at injection site.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency; AMOXICILLIN for Adverse event, at an unspecified dose and frequency and REMDESIVIR for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19 breakthrough infection. Also developed fever, coughing, achiness at injection site.) outcome was unknown.            Monoclonal antibodies reported as treatment medication.  Company comment: This Spontaneous case concerns a 73-year-old, female patient with no reported medical history, who experienced the unexpected, non-serious and AESI of COVID-19. The event occurred on an unknown date after booster dose of mRNA-1273 vaccine. The patient was treated with amoxicillin, Tylenol and Remdesivir. The outcome of the event is unknown. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-405192 (Patient Link).; Sender's Comments: This Spontaneous case concerns a 73-year-old, female patient with no reported medical history, who experienced the unexpected, non-serious and AESI of COVID-19. The event occurred on an unknown date after booster dose of mRNA-1273 vaccine. The patient was treated with amoxicillin, Tylenol and Remdesivir. The outcome of the event is unknown. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered >12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   13 patients received on the 7th Dec 2021 doses from 2 vials that were first punctured on the 30th Nov 2021 and put on the refrigerator since then  No Concomitant and Treatment medication were reported.   This case was linked to MOD-2021-406677, MOD-2021-406693, MOD-2021-406698, MOD-2021-406702, MOD-2021-406705, MOD-2021-406711, MOD-2021-406712, MOD-2021-406714, MOD-2021-406716, MOD-2021-406721, MOD-2021-406726, MOD-2021-406728 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Terrible Rash; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (Terrible Rash) 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 an unknown date, the patient experienced RASH (Terrible Rash). At the time of the report, RASH (Terrible Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-393255, MOD-2021-392096 (Patient Link).
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A, 031M20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included NAPROXEN and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine). On 08-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Headache, Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Is cold all the time), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient reports that she got to Pfizer vaccines 9 months ago, and 3Dec2021, doctor gave her the Moderna booster), FATIGUE (Fatigue/Is tired), CHILLS (Chills) and NAUSEA (Little nausea  but not vomiting or anything) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: COVID 19 Vaccine Pfizer (Got to Pfizer vaccines 9 months ago and had a sore arm) in March 2021. Past adverse reactions to the above products included Pain in arm with COVID 19 Vaccine Pfizer.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced FEELING COLD (Is cold all the time), FATIGUE (Fatigue/Is tired), CHILLS (Chills), NAUSEA (Little nausea  but not vomiting or anything) and HEADACHE (Headache). On 03-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient reports that she got to Pfizer vaccines 9 months ago, and 3Dec2021, doctor gave her the Moderna booster). On 03-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient reports that she got to Pfizer vaccines 9 months ago, and 3Dec2021, doctor gave her the Moderna booster) had resolved. At the time of the report, FEELING COLD (Is cold all the time), FATIGUE (Fatigue/Is tired), CHILLS (Chills) and NAUSEA (Little nausea  but not vomiting or anything) had not resolved and HEADACHE (Headache) had resolved.            No concomitant medications were mentioned. No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Is cold all the time), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient reports that she got to Pfizer vaccines 9 months ago, and 3Dec2021, doctor gave her the Moderna booster), FATIGUE (Fatigue/Is tired), CHILLS (Chills) and NAUSEA (Little nausea  but not vomiting or anything) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: COVID 19 Vaccine Pfizer (Got to Pfizer vaccines 9 months ago and had a sore arm) in March 2021. Past adverse reactions to the above products included Pain in arm with COVID 19 Vaccine Pfizer.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced FEELING COLD (Is cold all the time), FATIGUE (Fatigue/Is tired), CHILLS (Chills), NAUSEA (Little nausea  but not vomiting or anything) and HEADACHE (Headache). On 03-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient reports that she got to Pfizer vaccines 9 months ago, and 3Dec2021, doctor gave her the Moderna booster). On 03-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient reports that she got to Pfizer vaccines 9 months ago, and 3Dec2021, doctor gave her the Moderna booster) had resolved. At the time of the report, FEELING COLD (Is cold all the time), FATIGUE (Fatigue/Is tired), CHILLS (Chills) and NAUSEA (Little nausea  but not vomiting or anything) had not resolved and HEADACHE (Headache) had resolved.            No concomitant medications were mentioned. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Vaccination complication
Clinical narrative: I feel weak; side effects of booster shot; This spontaneous case was reported by a nurse and describes the occurrence of ASTHENIA (I feel weak) and VACCINATION COMPLICATION (side effects of booster shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Dec-2021, the patient experienced ASTHENIA (I feel weak) and VACCINATION COMPLICATION (side effects of booster shot). At the time of the report, ASTHENIA (I feel weak) and VACCINATION COMPLICATION (side effects of booster shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral, Overdose, Pruritus, SARS-CoV-2 test, Urticaria
Clinical narrative: The hives are itchy; That was my 4th Moderna shot; 4 hrs later, I broke out in hives; My right right leg, below my knee, had a big cluster; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (4 hrs later, I broke out in hives), OEDEMA PERIPHERAL (My right right leg, below my knee, had a big cluster), PRURITUS (The hives are itchy) and OVERDOSE (That was my 4th Moderna shot) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0311921A, 046A21A and 047C21A) for COVID-19 vaccination.     The patient's past medical history included Melanoma (Melanoma in left arm.).   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, the patient experienced URTICARIA (4 hrs later, I broke out in hives) and OEDEMA PERIPHERAL (My right right leg, below my knee, had a big cluster). On 10-Dec-2021, the patient experienced PRURITUS (The hives are itchy) and OVERDOSE (That was my 4th Moderna shot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) on 10-Dec-2021 for Hives, at a dose of 1 every 6 hrs.. On 10-Dec-2021, OVERDOSE (That was my 4th Moderna shot) had resolved. At the time of the report, URTICARIA (4 hrs later, I broke out in hives), OEDEMA PERIPHERAL (My right right leg, below my knee, had a big cluster) and PRURITUS (The hives are itchy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, SARS-CoV-2 test: positive (Positive) Tested positive for Covid.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No any concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Bladder discomfort
Clinical narrative: Something in her bladder; This spontaneous case was reported by a consumer and describes the occurrence of BLADDER DISCOMFORT (Something in her bladder) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLADDER DISCOMFORT (Something in her bladder). The patient was treated with NITROFURANTOIN (MACRODANTIN) for Bladder discomfort, at an unspecified dose and frequency. At the time of the report, BLADDER DISCOMFORT (Something in her bladder) outcome was unknown.            No Concomitant product use was reported.  The patient reported that they had 2 doses of the Moderna vaccine and was ready for their booster shot but the patient was presently taking Macrodantin with nitrofurantoin, substituted for the Macrodantin.  Upon call back, the patient's husband answered and was hard of hearing. It was reported that the patient had an examination a couple of days ago, and their husband was not sure exactly what it was. It was a test. Something in patient's bladder and the antibiotic was a precaution from their doctor. The patient had only taken it for a couple of days, and they had to insert something to check their bladder and they prescribed this antibiotic so there wouldn't be any problems with that. The patient was having the booster shot next week.   Most recent FOLLOW-UP information incorporated above includes: On 10-Dec-2021: Follow-up received contains no new information.