chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: really really itchy; anytime after you scratch or touch anywhere on the skin becomes red; anytime after you scratch or touch anywhere on the skin becomes welty; anytime after you scratch or touch anywhere on the skin becomes bumpy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (really really itchy), ERYTHEMA (anytime after you scratch or touch anywhere on the skin becomes red), URTICARIA (anytime after you scratch or touch anywhere on the skin becomes welty) and RASH (anytime after you scratch or touch anywhere on the skin becomes bumpy) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 017C21A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-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. In December 2021, the patient experienced PRURITUS (really really itchy), ERYTHEMA (anytime after you scratch or touch anywhere on the skin becomes red), URTICARIA (anytime after you scratch or touch anywhere on the skin becomes welty) and RASH (anytime after you scratch or touch anywhere on the skin becomes bumpy). The patient was treated with FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA D) for Allergy, at an unspecified dose and frequency. At the time of the report, PRURITUS (really really itchy), ERYTHEMA (anytime after you scratch or touch anywhere on the skin becomes red), URTICARIA (anytime after you scratch or touch anywhere on the skin becomes welty) and RASH (anytime after you scratch or touch anywhere on the skin becomes bumpy) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. The patient got the booster shot and got a reaction 10 days later. He got really really itchy, and anytime after he scratch or touch anywhere on the skin, it becomes red and bumpy and Welty. Patient was using allergy medication to help with it. As soon as he stopped taking the medication, it starts right back up. The reactions were still going on now.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Muscular weakness, Pain in extremity
Clinical narrative: Felt her legs were tired; Wanted to stay in bed and not do much; Tiny bit of pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Felt her legs were tired), ASTHENIA (Wanted to stay in bed and not do much) and PAIN IN EXTREMITY (Tiny bit of pain in her arm) 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 MUSCULAR WEAKNESS (Felt her legs were tired), ASTHENIA (Wanted to stay in bed and not do much) and PAIN IN EXTREMITY (Tiny bit of pain in her arm). At the time of the report, MUSCULAR WEAKNESS (Felt her legs were tired), ASTHENIA (Wanted to stay in bed and not do much) and PAIN IN EXTREMITY (Tiny bit of pain in her arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication details were reported. Treatment medication included natural remedies.   This case was linked to MOD-2022-440647 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Frustration tolerance decreased, Tinnitus
Clinical narrative: ringing in the ear; very frustrated; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS, FRUSTRATION TOLERANCE DECREASED, and DIZZINESS in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced TINNITUS, FRUSTRATION TOLERANCE DECREASED, and DIZZINESS. At the time of the report, TINNITUS had not resolved and FRUSTRATION TOLERANCE DECREASED and DIZZINESS outcome was unknown.            Concomitant medications were not reported.  Patient had ringing in her ears since last spring, and there was no cure for it. She was very frustrated because it happened every single day. She never had it before she had the first Modern dose. She stated she would not be taking a third one.  The patient stated that she had to pay for lipoflavonoid.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little sore arm) in a 74-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 COVID-19 in 2020, Hypoxia (Oxygen level had dropped to 80) on 05-Nov-2020, Heart attack, STEMI (15 Stems), Hospitalization (for 6 days.) on 05-Nov-2020, Oxygen supplementation (On oxygen for 3 weeks), Bypass surgery (Triple bypass) and Weight control. Concurrent medical conditions included Diabetes.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (little sore arm). At the time of the report, PAIN IN EXTREMITY (little sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient state they take around 20 different pills a day because of their heart condition. No treatment details were reported.   This case was linked to MOD-2022-440853, MOD-2022-440854 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Vaccination site mass
Clinical narrative: Not feeling well and in bed; Arm has extreme sore; A good size place where the shot was given; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well and in bed), PAIN IN EXTREMITY (Arm has extreme sore) and VACCINATION SITE MASS (A good size place where the shot was given) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (Not feeling well and in bed), PAIN IN EXTREMITY (Arm has extreme sore) and VACCINATION SITE MASS (A good size place where the shot was given). At the time of the report, MALAISE (Not feeling well and in bed), PAIN IN EXTREMITY (Arm has extreme sore) and VACCINATION SITE MASS (A good size place where the shot was given) outcome was unknown.            No concomitant medications were reported.  No treatment details were reported.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Fever; Headaches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headaches) and FATIGUE (Fatigue) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), HEADACHE (Headaches) and FATIGUE (Fatigue). At the time of the report, PYREXIA (Fever), HEADACHE (Headaches) and FATIGUE (Fatigue) outcome was unknown.            The  concomitant medications on use were not provided. No treatment information was provided.  The patient had no side effects after the first vaccine. Patient has not yet received his booster dose. No Physician contact in the case.   This case was linked to MOD-2022-440740, MOD-2022-440806 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose administered to a patient; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED. At the time of the report, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at injection site after 1st dose) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 027C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Aug-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection site after 1st dose). On 12-Aug-2021, VACCINATION SITE PAIN (Soreness at injection site after 1st dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Reporter stated that soreness was not even the whole arm on both incidents, but was just a golf ball sized area right around the injection site.   This case was linked to MOD-2022-440861 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Has a severe cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Has a severe cough) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (Has a severe cough). At the time of the report, COUGH (Has a severe cough) outcome was unknown.            No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD-2022-440015 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Headache, Polydipsia, Pyrexia
Clinical narrative: head is swollen on the top of her head; Thirsty; bruise on her right knee\bruise on her ankle is on her left leg; Tired; throbbing headache.; fever; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (head is swollen on the top of her head), POLYDIPSIA (Thirsty), CONTUSION (bruise on her right knee\bruise on her ankle is on her left leg), FATIGUE (Tired) and HEADACHE (throbbing headache.) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003J21-2A, 040B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022, the patient experienced POLYDIPSIA (Thirsty), CONTUSION (bruise on her right knee\bruise on her ankle is on her left leg), FATIGUE (Tired), HEADACHE (throbbing headache.) and PYREXIA (fever). On 04-Jan-2022, the patient experienced SWELLING (head is swollen on the top of her head). At the time of the report, SWELLING (head is swollen on the top of her head), POLYDIPSIA (Thirsty), CONTUSION (bruise on her right knee\bruise on her ankle is on her left leg), FATIGUE (Tired), HEADACHE (throbbing headache.) and PYREXIA (fever) outcome was unknown.            No Concomitant medication was reported.    No treatment medications were reported. The patient experienced fever, tired, thirsty, and the patient had a bruise on her right knee. The bruise on her ankle was on her left leg. The patient had a throbbing headache. The patients head was swollen on the top of her head. That started on 04-Jan-2022.   This case was linked to MOD-2022-440740, MOD-2022-440720 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: head is swollen on the top of her head; Thirsty; bruise on her right knee\bruise on her ankle is on her left leg; Tired; throbbing headache.; fever; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (head is swollen on the top of her head), POLYDIPSIA (Thirsty), CONTUSION (bruise on her right knee\bruise on her ankle is on her left leg), FATIGUE (Tired) and HEADACHE (throbbing headache.) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003J21-2A, 040B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022, the patient experienced POLYDIPSIA (Thirsty), CONTUSION (bruise on her right knee\bruise on her ankle is on her left leg), FATIGUE (Tired), HEADACHE (throbbing headache.) and PYREXIA (fever). On 04-Jan-2022, the patient experienced SWELLING (head is swollen on the top of her head). At the time of the report, SWELLING (head is swollen on the top of her head), POLYDIPSIA (Thirsty), CONTUSION (bruise on her right knee\bruise on her ankle is on her left leg), FATIGUE (Tired), HEADACHE (throbbing headache.) and PYREXIA (fever) outcome was unknown.            No Concomitant medication was reported.    No treatment medications were reported. The patient experienced fever, tired, thirsty, and the patient had a bruise on her right knee. The bruise on her ankle was on her left leg. The patient had a throbbing headache. The patients head was swollen on the top of her head. That started on 04-Jan-2022.   This case was linked to MOD-2022-440740, MOD-2022-440720 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Mobility decreased
Clinical narrative: could not turn over, could not get out of bed; lot of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (could not turn over, could not get out of bed) and FATIGUE (lot of fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (could not turn over, could not get out of bed) and FATIGUE (lot of fatigue). At the time of the report, MOBILITY DECREASED (could not turn over, could not get out of bed) and FATIGUE (lot of fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information provided Patient reported her sister had to make sure if she didn't fell out of bed.   This case was linked to MOD-2022-441213, MOD-2022-441214 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Gait disturbance, Oxygen saturation decreased
Clinical narrative: could not walk, had to be carried to the vehicle; oxygen level had dropped to 85; felt weak; extreme chills; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (could not walk, had to be carried to the vehicle), OXYGEN SATURATION DECREASED (oxygen level had dropped to 85), ASTHENIA (felt weak) and CHILLS (extreme chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack, Weight loss and Bypass surgery (15 Stems). Concurrent medical conditions included Diabetes.    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (could not walk, had to be carried to the vehicle), OXYGEN SATURATION DECREASED (oxygen level had dropped to 85), ASTHENIA (felt weak) and CHILLS (extreme chills). At the time of the report, GAIT DISTURBANCE (could not walk, had to be carried to the vehicle), OXYGEN SATURATION DECREASED (oxygen level had dropped to 85), ASTHENIA (felt weak) and CHILLS (extreme chills) outcome was unknown.            Patient state they take around 20 different pills a day because of their heart condition (had a heart attack, a triple bypass and 15 stems) and diabetes, but were generally in good shape, and even lost weight intentionally for the diabetes.   This case was linked to MOD-2022-440706, MOD-2022-440854 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure decreased, Blood pressure measurement, Chills, Oxygen saturation
Clinical narrative: not feeling quite well; feel weak, not quite as bad as after the second dose; blood pressure was 105/60 when usually it is 120-135/70-85; oxygen level  dropped to 85 again; extreme chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (not feeling quite well), ASTHENIA (feel weak, not quite as bad as after the second dose), BLOOD PRESSURE DECREASED (blood pressure was 105/60 when usually it is 120-135/70-85), OXYGEN SATURATION DECREASED (oxygen level  dropped to 85 again) and CHILLS (extreme chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 016M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (05Nov2020 had to be hospitalized for 6 days because their oxygen level had dropped to 80, and had to be on oxygen for 3 weeks.) in 2020, Heart attack, Weight loss (lost weight intentionally for the diabetes.) and Bypass surgery (triple bypass and 15 stems). Concurrent medical conditions included Diabetes.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, the patient experienced OXYGEN SATURATION DECREASED (oxygen level  dropped to 85 again) and CHILLS (extreme chills). On 05-Jan-2022, the patient experienced VACCINATION COMPLICATION (not feeling quite well), ASTHENIA (feel weak, not quite as bad as after the second dose) and BLOOD PRESSURE DECREASED (blood pressure was 105/60 when usually it is 120-135/70-85). At the time of the report, VACCINATION COMPLICATION (not feeling quite well), ASTHENIA (feel weak, not quite as bad as after the second dose) and BLOOD PRESSURE DECREASED (blood pressure was 105/60 when usually it is 120-135/70-85) had not resolved and OXYGEN SATURATION DECREASED (oxygen level  dropped to 85 again) and CHILLS (extreme chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2022, Oxygen saturation: 85 (Low) oxygen level dropped to 85 again.. On 05-Jan-2022, Blood pressure measurement: 105/60 (Low) 105/60.         Patient stated he takes around 20 different pills a day because of their heart condition. No treatment medications was provided.   This case was linked to MOD-2022-440853, MOD-2022-440706 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Vaccination complication
Clinical narrative: not feeling quite well; feel weak, not quite as bad as after the second dose; blood pressure was 105/60 when usually it is 120-135/70-85; oxygen level  dropped to 85 again; extreme chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (not feeling quite well), ASTHENIA (feel weak, not quite as bad as after the second dose), BLOOD PRESSURE DECREASED (blood pressure was 105/60 when usually it is 120-135/70-85), OXYGEN SATURATION DECREASED (oxygen level  dropped to 85 again) and CHILLS (extreme chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 016M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (05Nov2020 had to be hospitalized for 6 days because their oxygen level had dropped to 80, and had to be on oxygen for 3 weeks.) in 2020, Heart attack, Weight loss (lost weight intentionally for the diabetes.) and Bypass surgery (triple bypass and 15 stems). Concurrent medical conditions included Diabetes.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, the patient experienced OXYGEN SATURATION DECREASED (oxygen level  dropped to 85 again) and CHILLS (extreme chills). On 05-Jan-2022, the patient experienced VACCINATION COMPLICATION (not feeling quite well), ASTHENIA (feel weak, not quite as bad as after the second dose) and BLOOD PRESSURE DECREASED (blood pressure was 105/60 when usually it is 120-135/70-85). At the time of the report, VACCINATION COMPLICATION (not feeling quite well), ASTHENIA (feel weak, not quite as bad as after the second dose) and BLOOD PRESSURE DECREASED (blood pressure was 105/60 when usually it is 120-135/70-85) had not resolved and OXYGEN SATURATION DECREASED (oxygen level  dropped to 85 again) and CHILLS (extreme chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2022, Oxygen saturation: 85 (Low) oxygen level dropped to 85 again.. On 05-Jan-2022, Blood pressure measurement: 105/60 (Low) 105/60.         Patient stated he takes around 20 different pills a day because of their heart condition. No treatment medications was provided.   This case was linked to MOD-2022-440853, MOD-2022-440706 (Patient Link).
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site, not even the whole arm but just on a golf ball sized area right around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at injection site, not even the whole arm but just on a golf ball sized area right around the injection site) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 027C21A) for COVID-19 vaccination.     Family history included Anemia (patient's both daughters and their grandfather have anemia) since an unknown date.   On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Soreness at injection site, not even the whole arm but just on a golf ball sized area right around the injection site). On 08-Sep-2021, VACCINATION SITE PAIN (Soreness at injection site, not even the whole arm but just on a golf ball sized area right around the injection site) had resolved.            No concomitant medication was reported.  No treatment medication use was reported.  The patient had a question regarding some of the ingredients that the patient was concerned about Moderna vaccine and wished not to vaccinate the patient's children with Pfizer vaccine because the patient had heard about much more serious side effects being reported with the latter vaccine and asked whether the Moderna vaccine was approved for 12 years and younger ages or not.   This case was linked to MOD-2022-440747 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Polymerase chain reaction, Pyrexia
Clinical narrative: Fever after 2nd shot; Shivering  and chills after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever after 2nd shot) and CHILLS (Shivering  and chills after 2nd shot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had COVID disease & positive PCR 6 months ago, prior to vaccination.), Heart disorder (Patient has heart problems and has a couple of stents in her heart.) and Stent insertion NOS.   On 04-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2022, the patient experienced PYREXIA (Fever after 2nd shot) and CHILLS (Shivering  and chills after 2nd shot). At the time of the report, PYREXIA (Fever after 2nd shot) and CHILLS (Shivering  and chills after 2nd shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Polymerase chain reaction: positive (Positive) positive PCR 6 months ago, prior to vaccination..         No concomitant medication reported. No treatment information was provided It was reported that reporter mother did not complain of any heart symptoms so far, and she does not had medical history of Pericarditis and Myocarditis that he knows of.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Feeling abnormal, Headache, Pain, Pyrexia
Clinical narrative: Body aches/body aches after 2nd dose; Bone-aches grade 1, in a scale from 1 to 10, not very intense/Bone-aches after 2nd dose; Patient feels terrible/Patient feels scared/Patient felt terrible after 2nd dose; Headache/Headache after 2nd dose; Fever/Fever after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches/body aches after 2nd dose), BONE PAIN (Bone-aches grade 1, in a scale from 1 to 10, not very intense/Bone-aches after 2nd dose), FEELING ABNORMAL (Patient feels terrible/Patient feels scared/Patient felt terrible after 2nd dose), HEADACHE (Headache/Headache after 2nd dose) and PYREXIA (Fever/Fever after 2nd dose) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches/body aches after 2nd dose), BONE PAIN (Bone-aches grade 1, in a scale from 1 to 10, not very intense/Bone-aches after 2nd dose), FEELING ABNORMAL (Patient feels terrible/Patient feels scared/Patient felt terrible after 2nd dose), HEADACHE (Headache/Headache after 2nd dose) and PYREXIA (Fever/Fever after 2nd dose). At the time of the report, PAIN (Body aches/body aches after 2nd dose), BONE PAIN (Bone-aches grade 1, in a scale from 1 to 10, not very intense/Bone-aches after 2nd dose), FEELING ABNORMAL (Patient feels terrible/Patient feels scared/Patient felt terrible after 2nd dose), HEADACHE (Headache/Headache after 2nd dose) and PYREXIA (Fever/Fever after 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medication reported No treatment medication reported It was reported that patient had concern about spread her illness to her son.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Body aches/body aches after 2nd dose; Bone-aches grade 1, in a scale from 1 to 10, not very intense/Bone-aches after 2nd dose; Patient feels terrible/Patient feels scared/Patient felt terrible after 2nd dose; Headache/Headache after 2nd dose; Fever/Fever after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches/body aches after 2nd dose), BONE PAIN (Bone-aches grade 1, in a scale from 1 to 10, not very intense/Bone-aches after 2nd dose), FEELING ABNORMAL (Patient feels terrible/Patient feels scared/Patient felt terrible after 2nd dose), HEADACHE (Headache/Headache after 2nd dose) and PYREXIA (Fever/Fever after 2nd dose) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches/body aches after 2nd dose), BONE PAIN (Bone-aches grade 1, in a scale from 1 to 10, not very intense/Bone-aches after 2nd dose), FEELING ABNORMAL (Patient feels terrible/Patient feels scared/Patient felt terrible after 2nd dose), HEADACHE (Headache/Headache after 2nd dose) and PYREXIA (Fever/Fever after 2nd dose). At the time of the report, PAIN (Body aches/body aches after 2nd dose), BONE PAIN (Bone-aches grade 1, in a scale from 1 to 10, not very intense/Bone-aches after 2nd dose), FEELING ABNORMAL (Patient feels terrible/Patient feels scared/Patient felt terrible after 2nd dose), HEADACHE (Headache/Headache after 2nd dose) and PYREXIA (Fever/Fever after 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medication reported No treatment medication reported It was reported that patient had concern about spread her illness to her son.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: little body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (little body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (little body aches). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, PAIN (little body aches) was resolving.            No concomitant medication details was provided.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well) 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 MALAISE (not feeling well). At the time of the report, MALAISE (not feeling well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided by reporter. No concomitant medication was provided by reporter.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-440822, MOD-2022-441214 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Respiratory syncytial virus infection
Clinical narrative: RSV; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY SYNCYTIAL VIRUS INFECTION (RSV) 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, 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 RESPIRATORY SYNCYTIAL VIRUS INFECTION (RSV). At the time of the report, RESPIRATORY SYNCYTIAL VIRUS INFECTION (RSV) had not resolved.            The  concomitant medications on use were not provided. No treatment information was provided.  Patient got vaccinated twice and now have Respiratory Syncytial Virus (RSV) Infection.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dyspepsia, Gait disturbance, Loss of personal independence in daily activities, Malaise
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not being well), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not being able to live her normal life), BALANCE DISORDER (balance is not good), GAIT DISTURBANCE (can't run) and DYSPEPSIA (heartburn) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939676, 001a21a and 042120a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) and PREDNISONE for an unknown indication. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 25-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On 25-Aug-2021, the patient experienced MALAISE (not being well), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not being able to live her normal life), BALANCE DISORDER (balance is not good), GAIT DISTURBANCE (can't run), DYSPEPSIA (heartburn) and NAUSEA (nausea). The patient was treated with FRUCTOSE, GLUCOSE, PHOSPHORIC ACID (EMETROL [FRUCTOSE;GLUCOSE;PHOSPHORIC ACID]) for Nausea, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Heartburn, at an unspecified dose and frequency. At the time of the report, MALAISE (not being well), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not being able to live her normal life), BALANCE DISORDER (balance is not good), GAIT DISTURBANCE (can't run), DYSPEPSIA (heartburn) and NAUSEA (nausea) outcome was unknown. The prednisone was used for PRM.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not being well), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not being able to live her normal life), BALANCE DISORDER (balance is not good), GAIT DISTURBANCE (can't run) and DYSPEPSIA (heartburn) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939676, 001a21a and 042120a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) and PREDNISONE for an unknown indication. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 25-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On 25-Aug-2021, the patient experienced MALAISE (not being well), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not being able to live her normal life), BALANCE DISORDER (balance is not good), GAIT DISTURBANCE (can't run), DYSPEPSIA (heartburn) and NAUSEA (nausea). The patient was treated with FRUCTOSE, GLUCOSE, PHOSPHORIC ACID (EMETROL [FRUCTOSE;GLUCOSE;PHOSPHORIC ACID]) for Nausea, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Heartburn, at an unspecified dose and frequency. At the time of the report, MALAISE (not being well), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not being able to live her normal life), BALANCE DISORDER (balance is not good), GAIT DISTURBANCE (can't run), DYSPEPSIA (heartburn) and NAUSEA (nausea) outcome was unknown. The prednisone was used for PRM.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Received a 0.25ml dose of the Moderna Covid-19 Vaccine instead of a 0.5ml dose as their 3rd dose today; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received a 0.25ml dose of the Moderna Covid-19 Vaccine instead of a 0.5ml dose as their 3rd dose today) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 05-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Jan-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received a 0.25ml dose of the Moderna Covid-19 Vaccine instead of a 0.5ml dose as their 3rd dose today). On 05-Jan-2022, ACCIDENTAL UNDERDOSE (Received a 0.25ml dose of the Moderna Covid-19 Vaccine instead of a 0.5ml dose as their 3rd dose today) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.     No treatment medications were reported.    The patient did receive Moderna as 1st two doses as well.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria, Urticaria chronic
Clinical narrative: severe hives; itchy hives; chronic hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (severe hives), PRURITUS (itchy hives) and URTICARIA CHRONIC (chronic hives) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903 and 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced URTICARIA CHRONIC (chronic hives). On 17-Dec-2021, the patient experienced URTICARIA (severe hives) and PRURITUS (itchy hives). At the time of the report, URTICARIA (severe hives), PRURITUS (itchy hives) and URTICARIA CHRONIC (chronic hives) had not resolved.            No Concomitant Medications were provided. On 25 Dec 2021 Patient went to an urgent care where they gave her a shot on her butt and was given 2 oral allergy medications to take.   This case was linked to MOD-2022-441495 (Patient Link).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Headache, Magnetic resonance imaging head, Pyrexia
Clinical narrative: Constant head aches; Fever; Tiredness; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Constant head aches), PYREXIA (Fever) and FATIGUE (Tiredness) in a 45-year-old male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Constant head aches), PYREXIA (Fever) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Constant head aches) outcome was unknown and PYREXIA (Fever) and FATIGUE (Tiredness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) No reasons of headache were found. On an unknown date, Magnetic resonance imaging head: normal (normal) No reasons of headache were found.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HEADACHE (Constant head aches) to be related. No further causality assessments were provided for PYREXIA (Fever) and FATIGUE (Tiredness).    It was reported that the headaches were not so bad as to take medication, except in some situations when the patient got some Tylenol.  No concomitant medications were reported.   This case was linked to MOD-2022-441554 (Patient Link).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever; Headaches reappeared; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever) and HEADACHE (Headaches reappeared) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 PYREXIA (Fever) and HEADACHE (Headaches reappeared). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Headache, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever) and HEADACHE (Headaches reappeared) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided. Reporter stated that the headaches are not so bad as to take medication, except in some situations when he got some Tylenol.   This case was linked to MOD-2022-441545 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Sore; Sore throat; Fever; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (Sore), OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Fever) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Sore), OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Fever). At the time of the report, PAIN (Sore), OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Fever) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided.