chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Dose given to 1 patient after 12 hours opened; temperature excursion where the vaccine went to room temperature for more than 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given to 1 patient after 12 hours opened) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion where the vaccine went to room temperature for more than 24 hours) 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 28-Jan-2022 at 2:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given to 1 patient after 12 hours opened) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion where the vaccine went to room temperature for more than 24 hours). On 28-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Dose given to 1 patient after 12 hours opened) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion where the vaccine went to room temperature for more than 24 hours) 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 information was provided.  It was reported that the vial was stored post punctured at room temperature. The time vial was exposed to room temperature for 27 hours.   Most recent FOLLOW-UP information incorporated above includes: On 31-Jan-2022: Added additional reporter details.
Sex: M
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Cough, Dyspnoea
Clinical narrative: SEVERE COPD; Breathing more than usual.; Coughing more than usual.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (SEVERE COPD), DYSPNOEA (Breathing more than usual.) and COUGH (Coughing more than usual.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 CHRONIC OBSTRUCTIVE PULMONARY DISEASE (SEVERE COPD), DYSPNOEA (Breathing more than usual.) and COUGH (Coughing more than usual.). At the time of the report, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (SEVERE COPD), DYSPNOEA (Breathing more than usual.) and COUGH (Coughing more than usual.) outcome was unknown. Not Provided          No concomitant medication information was provided. No treatment information was provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Fatigue, Hypokinesia, Nausea
Clinical narrative: Low fever; Extreme fatigue; Nausea; Couldn´t raise her arms/could only move her arms from the elbows down; Lost of appetite for a week or maybe more; Hives at the injection site; Severe pain in both soulders; Severe pain in neck; This spontaneous case was reported by an occupational therapist and describes the occurrence of NECK PAIN (Severe pain in neck), HYPOKINESIA (Couldn´t raise her arms/could only move her arms from the elbows down), DECREASED APPETITE (Lost of appetite for a week or maybe more), ARTHRALGIA (Severe pain in both soulders) and PYREXIA (Low fever) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROXYZINE for Antihistamine therapy, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced NECK PAIN (Severe pain in neck) and ARTHRALGIA (Severe pain in both soulders). On 07-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Hives at the injection site). On an unknown date, the patient experienced HYPOKINESIA (Couldn´t raise her arms/could only move her arms from the elbows down), DECREASED APPETITE (Lost of appetite for a week or maybe more), PYREXIA (Low fever), FATIGUE (Extreme fatigue) and NAUSEA (Nausea). On 02-Jan-2021, NECK PAIN (Severe pain in neck) and ARTHRALGIA (Severe pain in both soulders) had resolved. At the time of the report, HYPOKINESIA (Couldn´t raise her arms/could only move her arms from the elbows down), PYREXIA (Low fever), FATIGUE (Extreme fatigue), NAUSEA (Nausea) and VACCINATION SITE URTICARIA (Hives at the injection site) outcome was unknown and DECREASED APPETITE (Lost of appetite for a week or maybe more) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No medical history was provided by the reporter. Concomitant medication included medication for birth control. It was reported that the patent experienced loss of appetite for a week or maybe more. Treatment information was not provided.   This case was linked to MOD-2022-466753, MOD-2022-466777 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pyrexia, Vaccination site urticaria
Clinical narrative: Low fever; Extreme fatigue; Nausea; Couldn´t raise her arms/could only move her arms from the elbows down; Lost of appetite for a week or maybe more; Hives at the injection site; Severe pain in both soulders; Severe pain in neck; This spontaneous case was reported by an occupational therapist and describes the occurrence of NECK PAIN (Severe pain in neck), HYPOKINESIA (Couldn´t raise her arms/could only move her arms from the elbows down), DECREASED APPETITE (Lost of appetite for a week or maybe more), ARTHRALGIA (Severe pain in both soulders) and PYREXIA (Low fever) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROXYZINE for Antihistamine therapy, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced NECK PAIN (Severe pain in neck) and ARTHRALGIA (Severe pain in both soulders). On 07-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Hives at the injection site). On an unknown date, the patient experienced HYPOKINESIA (Couldn´t raise her arms/could only move her arms from the elbows down), DECREASED APPETITE (Lost of appetite for a week or maybe more), PYREXIA (Low fever), FATIGUE (Extreme fatigue) and NAUSEA (Nausea). On 02-Jan-2021, NECK PAIN (Severe pain in neck) and ARTHRALGIA (Severe pain in both soulders) had resolved. At the time of the report, HYPOKINESIA (Couldn´t raise her arms/could only move her arms from the elbows down), PYREXIA (Low fever), FATIGUE (Extreme fatigue), NAUSEA (Nausea) and VACCINATION SITE URTICARIA (Hives at the injection site) outcome was unknown and DECREASED APPETITE (Lost of appetite for a week or maybe more) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No medical history was provided by the reporter. Concomitant medication included medication for birth control. It was reported that the patent experienced loss of appetite for a week or maybe more. Treatment information was not provided.   This case was linked to MOD-2022-466753, MOD-2022-466777 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Nausea, Pyrexia, Urticaria
Clinical narrative: 103-104°F fever; nausea; severe pain at the injection site; had hives on the neck, which came and go for about a week.; flu like symptoms; This spontaneous case was reported by an occupational therapist and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), URTICARIA (had hives on the neck, which came and go for about a week.), PYREXIA (103-104°F fever), NAUSEA (nausea) and VACCINATION SITE PAIN (severe pain at the injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043I20A and 025L20A) for COVID-19 vaccination.     Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR HFA) and HYDROXYZINE for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced URTICARIA (had hives on the neck, which came and go for about a week.). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (103-104°F fever), NAUSEA (nausea) and VACCINATION SITE PAIN (severe pain at the injection site). In February 2021, URTICARIA (had hives on the neck, which came and go for about a week.) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved and PYREXIA (103-104°F fever), NAUSEA (nausea) and VACCINATION SITE PAIN (severe pain at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) 103-104°F fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was on birth control. Treatment medication was not reported. No medical history was provided by the reporter.  After the second dose, patient experienced flu like symptoms for 3 days. 8 days later she had hives on the neck, which came and go for about a week.   This case was linked to MOD-2022-466775, MOD-2022-466753 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: 103-104°F fever; nausea; severe pain at the injection site; had hives on the neck, which came and go for about a week.; flu like symptoms; This spontaneous case was reported by an occupational therapist and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), URTICARIA (had hives on the neck, which came and go for about a week.), PYREXIA (103-104°F fever), NAUSEA (nausea) and VACCINATION SITE PAIN (severe pain at the injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043I20A and 025L20A) for COVID-19 vaccination.     Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR HFA) and HYDROXYZINE for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced URTICARIA (had hives on the neck, which came and go for about a week.). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (103-104°F fever), NAUSEA (nausea) and VACCINATION SITE PAIN (severe pain at the injection site). In February 2021, URTICARIA (had hives on the neck, which came and go for about a week.) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved and PYREXIA (103-104°F fever), NAUSEA (nausea) and VACCINATION SITE PAIN (severe pain at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) 103-104°F fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was on birth control. Treatment medication was not reported. No medical history was provided by the reporter.  After the second dose, patient experienced flu like symptoms for 3 days. 8 days later she had hives on the neck, which came and go for about a week.   This case was linked to MOD-2022-466775, MOD-2022-466753 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Patient received booster dose of 0.25ml; now states he is immunocompromised and wants an additional dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received booster dose of 0.25ml; now states he is immunocompromised and wants an additional dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 05-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (Patient received booster dose of 0.25ml; now states he is immunocompromised and wants an additional dose). On 05-Nov-2021, ACCIDENTAL UNDERDOSE (Patient received booster dose of 0.25ml; now states he is immunocompromised and wants an additional dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  It was reported that, the patient wanted additional dose.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Nausea, Pyrexia
Clinical narrative: stomach issues; diarrhea; having nausea; vomiting; fever; fatigue; pain in the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL DISCOMFORT (stomach issues), DIARRHOEA (diarrhea), NAUSEA (having nausea), VOMITING (vomiting) and PYREXIA (fever) 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.     No Medical History information was reported.    On 26-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach issues), DIARRHOEA (diarrhea), NAUSEA (having nausea), VOMITING (vomiting), PYREXIA (fever), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain in the injection site). At the time of the report, ABDOMINAL DISCOMFORT (stomach issues), DIARRHOEA (diarrhea), NAUSEA (having nausea) and VOMITING (vomiting) outcome was unknown and PYREXIA (fever), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain in the injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided No treatment details were provided. Patient had the booster shot on last Wednesday.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: stomach issues; diarrhea; having nausea; vomiting; fever; fatigue; pain in the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL DISCOMFORT (stomach issues), DIARRHOEA (diarrhea), NAUSEA (having nausea), VOMITING (vomiting) and PYREXIA (fever) 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.     No Medical History information was reported.    On 26-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach issues), DIARRHOEA (diarrhea), NAUSEA (having nausea), VOMITING (vomiting), PYREXIA (fever), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain in the injection site). At the time of the report, ABDOMINAL DISCOMFORT (stomach issues), DIARRHOEA (diarrhea), NAUSEA (having nausea) and VOMITING (vomiting) outcome was unknown and PYREXIA (fever), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain in the injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided No treatment details were provided. Patient had the booster shot on last Wednesday.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: gave booster dose from a vial that had been first punctured a little over 26 hours earlier & had been left at room temperature that entire time; gave booster dose from a vial that had been first punctured a little over 26 hours earlier & had been left at room temperature that entire time; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave booster dose from a vial that had been first punctured a little over 26 hours earlier & had been left at room temperature that entire time) and PRODUCT STORAGE ERROR (gave booster dose from a vial that had been first punctured a little over 26 hours earlier & had been left at room temperature that entire time) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2022 at 11:36 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave booster dose from a vial that had been first punctured a little over 26 hours earlier & had been left at room temperature that entire time) and PRODUCT STORAGE ERROR (gave booster dose from a vial that had been first punctured a little over 26 hours earlier & had been left at room temperature that entire time). On 22-Jan-2022, EXPIRED PRODUCT ADMINISTERED (gave booster dose from a vial that had been first punctured a little over 26 hours earlier & had been left at room temperature that entire time) and PRODUCT STORAGE ERROR (gave booster dose from a vial that had been first punctured a little over 26 hours earlier & had been left at room temperature that entire time) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 13-Jan-2022 and was first punctured on  21-Jan-2022 at 9:21am and did not underwent temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 26 hours and give or take 20 minutes. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   This case was linked to MOD-2022-459034, MOD-2022-466912 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: gave 0.30 ml of booster rather than .25 ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (gave 0.30 ml of booster rather than .25 ml) 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) .3 milligram. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (gave 0.30 ml of booster rather than .25 ml). At the time of the report, ACCIDENTAL OVERDOSE (gave 0.30 ml of booster rather than .25 ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided. The reporter reported that 0.30 ml of booster was given rather than .25 ml.   Reporter did not allow further contact
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Gastrointestinal infection, Pyrexia, Vaccination complication
Clinical narrative: atypical and severe diarrhea; I want to declare side effect; GI infection; fever; This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA (atypical and severe diarrhea), VACCINATION COMPLICATION (I want to declare side effect), GASTROINTESTINAL INFECTION (GI infection) and PYREXIA (fever) in a 46-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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (atypical and severe diarrhea), VACCINATION COMPLICATION (I want to declare side effect), GASTROINTESTINAL INFECTION (GI infection) and PYREXIA (fever). At the time of the report, DIARRHOEA (atypical and severe diarrhea) had not resolved and VACCINATION COMPLICATION (I want to declare side effect), GASTROINTESTINAL INFECTION (GI infection) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  Patient had atypical and severe diarrhea for several days (still ongoing).   After 3rd dose little fever no relevant other symptoms(notably not respiratory symptoms) no contact or other reasons to believe that it was a gastrointestinal infection of other origin, symptoms unusual for GI infection.  Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 31-Jan-2022: Follow-up information includes patient and event details.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: Very sore all over; Throwing up; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Very sore all over) and VOMITING (Throwing up) 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 PAIN (Very sore all over) and VOMITING (Throwing up). At the time of the report, PAIN (Very sore all over) and VOMITING (Throwing up) 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 medication information was provided.  No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Mechanical urticaria, Urticaria
Clinical narrative: dermographia with welts & hives; dermographia with welts & hives; This spontaneous case was reported by an other health care professional and describes the occurrence of MECHANICAL URTICARIA (dermographia with welts & hives) and URTICARIA (dermographia with welts & hives) 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 MECHANICAL URTICARIA (dermographia with welts & hives) and URTICARIA (dermographia with welts & hives). At the time of the report, MECHANICAL URTICARIA (dermographia with welts & hives) and URTICARIA (dermographia with welts & hives) 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 reported.  Treatment medications were not provided by the reporter.    This case was linked to MOD22-005471 (Patient Link).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: he was sore; tired; headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (he was sore), FATIGUE (tired) and HEADACHE (headaches) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 05BF21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (he was sore), FATIGUE (tired) and HEADACHE (headaches). At the time of the report, MYALGIA (he was sore) and FATIGUE (tired) had resolved and HEADACHE (headaches) outcome was unknown.            No treatment drug were reported.   No concomitant medication were reported.   This case was linked to MOD-2022-467168 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Asthenia, Fatigue, Feeling abnormal, Impaired work ability
Clinical narrative: Intestinal parasites (saw them in her stool); Parasites in her skin; Weakness/She continues to feel weak; She has felt anemic; Just off/It started to feel gradually horrible until it was really bad; Couldn't work, had to quit job; Fatigue; Nauseous; This spontaneous case was reported by an other health care professional and describes the occurrence of PARASITIC GASTROENTERITIS (Intestinal parasites (saw them in her stool)), SKIN INFECTION (Parasites in her skin), ASTHENIA (Weakness/She continues to feel weak), ANAEMIA (She has felt anemic) and FEELING ABNORMAL (Just off/It started to feel gradually horrible until it was really bad) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced PARASITIC GASTROENTERITIS (Intestinal parasites (saw them in her stool)), SKIN INFECTION (Parasites in her skin), ASTHENIA (Weakness/She continues to feel weak), ANAEMIA (She has felt anemic), FEELING ABNORMAL (Just off/It started to feel gradually horrible until it was really bad), IMPAIRED WORK ABILITY (Couldn't work, had to quit job), FATIGUE (Fatigue) and NAUSEA (Nauseous). At the time of the report, PARASITIC GASTROENTERITIS (Intestinal parasites (saw them in her stool)), SKIN INFECTION (Parasites in her skin), ASTHENIA (Weakness/She continues to feel weak), ANAEMIA (She has felt anemic), FEELING ABNORMAL (Just off/It started to feel gradually horrible until it was really bad), IMPAIRED WORK ABILITY (Couldn't work, had to quit job), FATIGUE (Fatigue) and NAUSEA (Nauseous) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received two Moderna shots. Patient stated that symptoms started 1 or 2 weeks after the second shot.  It was reported that patient is in treatment for the parasites which started in November, treatment medication reported included unspecified antibiotics.  Patient was not taking any regular medications.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Parasitic gastroenteritis, Skin infection
Clinical narrative: Intestinal parasites (saw them in her stool); Parasites in her skin; Weakness/She continues to feel weak; She has felt anemic; Just off/It started to feel gradually horrible until it was really bad; Couldn't work, had to quit job; Fatigue; Nauseous; This spontaneous case was reported by an other health care professional and describes the occurrence of PARASITIC GASTROENTERITIS (Intestinal parasites (saw them in her stool)), SKIN INFECTION (Parasites in her skin), ASTHENIA (Weakness/She continues to feel weak), ANAEMIA (She has felt anemic) and FEELING ABNORMAL (Just off/It started to feel gradually horrible until it was really bad) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced PARASITIC GASTROENTERITIS (Intestinal parasites (saw them in her stool)), SKIN INFECTION (Parasites in her skin), ASTHENIA (Weakness/She continues to feel weak), ANAEMIA (She has felt anemic), FEELING ABNORMAL (Just off/It started to feel gradually horrible until it was really bad), IMPAIRED WORK ABILITY (Couldn't work, had to quit job), FATIGUE (Fatigue) and NAUSEA (Nauseous). At the time of the report, PARASITIC GASTROENTERITIS (Intestinal parasites (saw them in her stool)), SKIN INFECTION (Parasites in her skin), ASTHENIA (Weakness/She continues to feel weak), ANAEMIA (She has felt anemic), FEELING ABNORMAL (Just off/It started to feel gradually horrible until it was really bad), IMPAIRED WORK ABILITY (Couldn't work, had to quit job), FATIGUE (Fatigue) and NAUSEA (Nauseous) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received two Moderna shots. Patient stated that symptoms started 1 or 2 weeks after the second shot.  It was reported that patient is in treatment for the parasites which started in November, treatment medication reported included unspecified antibiotics.  Patient was not taking any regular medications.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: rash on both her arms and it itched; a little bit of a rash on both her arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash on both her arms and it itched) and RASH (a little bit of a rash on both her arms) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included ESOMEPRAZOLE MAGNESIUM TRIHYDRATE (NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]), BALSALAZIDE, CARBAMAZEPINE, CLONAZEPAM, APIXABAN (ELIQUIS), LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), METHOTREXATE and CALCIUM for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced RASH PRURITIC (rash on both her arms and it itched) and RASH (a little bit of a rash on both her arms). In 2021, RASH PRURITIC (rash on both her arms and it itched) and RASH (a little bit of a rash on both her arms) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was reported. It was reported that a couple of weeks later the events went away pretty much.   This case was linked to MOD-2022-467166, MOD-2022-467167 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash pruritic
Clinical narrative: rash on both her arms and it itched; a little bit of a rash on both her arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash on both her arms and it itched) and RASH (a little bit of a rash on both her arms) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included ESOMEPRAZOLE MAGNESIUM TRIHYDRATE (NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]), BALSALAZIDE, CARBAMAZEPINE, CLONAZEPAM, APIXABAN (ELIQUIS), LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), METHOTREXATE and CALCIUM for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced RASH PRURITIC (rash on both her arms and it itched) and RASH (a little bit of a rash on both her arms). In 2021, RASH PRURITIC (rash on both her arms and it itched) and RASH (a little bit of a rash on both her arms) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was reported. It was reported that a couple of weeks later the events went away pretty much.   This case was linked to MOD-2022-467166, MOD-2022-467167 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: it itched everywhere for a long time, She had a rash; it itched everywhere for a long time; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (it itched everywhere for a long time, She had a rash) and PRURITUS (it itched everywhere for a long time) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 007M20A) for COVID-19 vaccination.     Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), BALSALAZIDE, CARBAMAZEPINE, CLONAZEPAM, APIXABAN (ELIQUIS), LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), METHOTREXATE and CALCIUM for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-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 RASH PRURITIC (it itched everywhere for a long time, She had a rash) and PRURITUS (it itched everywhere for a long time). The patient was treated with PREDNISONE for Rash pruritic, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (it itched everywhere for a long time, She had a rash) and PRURITUS (it itched everywhere for a long time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history was reported.   This case was linked to MOD-2022-467153, MOD-2022-467167 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash pruritic
Clinical narrative: it itched everywhere for a long time, She had a rash; it itched everywhere for a long time; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (it itched everywhere for a long time, She had a rash) and PRURITUS (it itched everywhere for a long time) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 007M20A) for COVID-19 vaccination.     Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), BALSALAZIDE, CARBAMAZEPINE, CLONAZEPAM, APIXABAN (ELIQUIS), LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), METHOTREXATE and CALCIUM for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-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 RASH PRURITIC (it itched everywhere for a long time, She had a rash) and PRURITUS (it itched everywhere for a long time). The patient was treated with PREDNISONE for Rash pruritic, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (it itched everywhere for a long time, She had a rash) and PRURITUS (it itched everywhere for a long time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history was reported.   This case was linked to MOD-2022-467153, MOD-2022-467167 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash pruritic
Clinical narrative: Sometimes it itches and sometimes it doesn´t; Rashes in different places of her body; It itches everywhere; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (It itches everywhere), RASH PRURITIC (Sometimes it itches and sometimes it doesn´t) and RASH (Rashes in different places of her body) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 048A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), BALSALAZIDE, CARBAMAZEPINE, CLONAZEPAM, APIXABAN (ELIQUIS), LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), METHOTREXATE and CALCIUM for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (It itches everywhere). On an unknown date, the patient experienced RASH PRURITIC (Sometimes it itches and sometimes it doesn´t) and RASH (Rashes in different places of her body). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, PRURITUS (It itches everywhere), RASH PRURITIC (Sometimes it itches and sometimes it doesn´t) and RASH (Rashes in different places of her body) had not resolved.            Patient stated that since she received the booster dose, her life had been hell and also stated that she never had something like this. Patient also stated that she had consulted several doctors and was given prednisone but it did not helped.   This case was linked to MOD-2022-467166, MOD-2022-467153 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Confusional state, Fatigue
Clinical narrative: hand shaking; can't sleep; lays bed most of the day and is confused; Panic attack; has no energy; she is tired; has chills; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (hand shaking), INSOMNIA (can't sleep), CONFUSIONAL STATE (lays bed most of the day and is confused), PANIC ATTACK (Panic attack) and ASTHENIA (has no energy) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 05BF21A, 010A21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, 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 NERVOUSNESS (hand shaking), INSOMNIA (can't sleep), CONFUSIONAL STATE (lays bed most of the day and is confused), PANIC ATTACK (Panic attack), ASTHENIA (has no energy), FATIGUE (she is tired), CHILLS (has chills) and ARTHRALGIA (joint pain). At the time of the report, NERVOUSNESS (hand shaking), INSOMNIA (can't sleep), CONFUSIONAL STATE (lays bed most of the day and is confused), PANIC ATTACK (Panic attack), ASTHENIA (has no energy), FATIGUE (she is tired), CHILLS (has chills) and ARTHRALGIA (joint pain) outcome was unknown.            No concomitant medications were provided. Patient reported that her doctor gave her a medicine for panic attacks, but her doctor did not know what was wrong. Patient went to ER 3-4 times   This case was linked to MOD-2022-467151 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2022: Significant Followup received on 01-FEB-2022 includes Dose 1 and Dose 2 information like drug start date and LOT no. is updated. Secondary Reporter is also added (consumer). Address of primary reporter is updated. Pregnancy status of patient is updated as No.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nervousness, Panic attack
Clinical narrative: hand shaking; can't sleep; lays bed most of the day and is confused; Panic attack; has no energy; she is tired; has chills; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (hand shaking), INSOMNIA (can't sleep), CONFUSIONAL STATE (lays bed most of the day and is confused), PANIC ATTACK (Panic attack) and ASTHENIA (has no energy) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 05BF21A, 010A21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, 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 NERVOUSNESS (hand shaking), INSOMNIA (can't sleep), CONFUSIONAL STATE (lays bed most of the day and is confused), PANIC ATTACK (Panic attack), ASTHENIA (has no energy), FATIGUE (she is tired), CHILLS (has chills) and ARTHRALGIA (joint pain). At the time of the report, NERVOUSNESS (hand shaking), INSOMNIA (can't sleep), CONFUSIONAL STATE (lays bed most of the day and is confused), PANIC ATTACK (Panic attack), ASTHENIA (has no energy), FATIGUE (she is tired), CHILLS (has chills) and ARTHRALGIA (joint pain) outcome was unknown.            No concomitant medications were provided. Patient reported that her doctor gave her a medicine for panic attacks, but her doctor did not know what was wrong. Patient went to ER 3-4 times   This case was linked to MOD-2022-467151 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2022: Significant Followup received on 01-FEB-2022 includes Dose 1 and Dose 2 information like drug start date and LOT no. is updated. Secondary Reporter is also added (consumer). Address of primary reporter is updated. Pregnancy status of patient is updated as No.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: >35 days after first shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (>35 days after first 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 19-Dec-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 PRODUCT DOSE OMISSION ISSUE (>35 days after first shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (>35 days after first shot) had resolved.            No Concomitant medication were reported. No treatment medication were reported.  It was reported that the patient was scheduled to have second Moderna vaccine on 19 January and was unable to make it.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Illness, Vomiting projectile
Clinical narrative: Got deathly sick; projectile vomiting; major diarrhea; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Got deathly sick), VOMITING PROJECTILE (projectile vomiting) and DIARRHOEA (major diarrhea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Cardiovascular disorder NOS (I'm open heart patient and have cardiovascular disease).   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 ILLNESS (Got deathly sick), VOMITING PROJECTILE (projectile vomiting) and DIARRHOEA (major diarrhea). At the time of the report, ILLNESS (Got deathly sick), VOMITING PROJECTILE (projectile vomiting) and DIARRHOEA (major diarrhea) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Illness, Influenza like illness
Clinical narrative: got really sick after both shots/ get too sick, and never get sick; Like get the flu; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got really sick after both shots/ get too sick, and never get sick) and INFLUENZA LIKE ILLNESS (Like get the flu) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced ILLNESS (got really sick after both shots/ get too sick, and never get sick) and INFLUENZA LIKE ILLNESS (Like get the flu). At the time of the report, ILLNESS (got really sick after both shots/ get too sick, and never get sick) and INFLUENZA LIKE ILLNESS (Like get the flu) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient not having any pre existing health condition.  Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2022-465262 (Patient Link).