chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dysphonia, Heart rate increased, Tremor, Vaccination site pain
Clinical narrative: Heart palpations; confusion; legs and abdomen shaking; injection site soreness; voice shaking; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Heart palpations), CONFUSIONAL STATE (confusion), TREMOR (legs and abdomen shaking), VACCINATION SITE PAIN (injection site soreness) and DYSPHONIA (voice shaking) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced HEART RATE INCREASED (Heart palpations), CONFUSIONAL STATE (confusion), TREMOR (legs and abdomen shaking), VACCINATION SITE PAIN (injection site soreness) and DYSPHONIA (voice shaking). At the time of the report, HEART RATE INCREASED (Heart palpations), CONFUSIONAL STATE (confusion), TREMOR (legs and abdomen shaking), VACCINATION SITE PAIN (injection site soreness) and DYSPHONIA (voice shaking) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment medication was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Rhinorrhoea
Clinical narrative: Runny nose; Cough; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical reported hsitory).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced RHINORRHOEA (Runny nose). At the time of the report, RHINORRHOEA (Runny nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Rash
Clinical narrative: Rash on face, arm and legs; Body aches; 102.7 Fever; Chills; Headaches; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (Rash on face, arm and legs), PAIN (Body aches), PYREXIA (102.7 Fever), CHILLS (Chills) and HEADACHE (Headaches) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Jan-2021, the patient experienced PAIN (Body aches), PYREXIA (102.7 Fever), CHILLS (Chills) and HEADACHE (Headaches). On 09-Jan-2021, the patient experienced RASH (Rash on face, arm and legs). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. On 13-Jan-2021, PAIN (Body aches), PYREXIA (102.7 Fever), CHILLS (Chills) and HEADACHE (Headaches) had resolved. On 12-Mar-2021, RASH (Rash on face, arm and legs) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 35-year-old female patient (gravida 5, para 4) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Depression since 2019, Allergic rhinitis since 1990 and Alcohol use since 03-Mar-2006. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) from 01-May-2020 to an unknown date, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Allergic rhinitis, CELECOXIB (CELEXA [CELECOXIB]) from 01-Sep-2019 to an unknown date for Depression, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] from 01-Jul-2020 to an unknown date for Vitamin A.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 06-Dec-2020 and the estimated date of delivery was 12-Sep-2021. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  On 08-Jan-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.; Sender's Comments: Based on current available information and the temporal relationship between product use and the start date of the event a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Nausea, Pain
Clinical narrative: Body pain; Exhausted; Joint pain; Nausea; Diarrhea; Vomited; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PAIN (Body pain), VACCINATION SITE PAIN (Vaccination site pain), VOMITING (Vomited) and FATIGUE (Exhausted) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 11-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), VOMITING (Vomited) and NAUSEA (Nausea). On 12-Jan-2021, the patient experienced PAIN (Body pain), FATIGUE (Exhausted) and ARTHRALGIA (Joint pain). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Vomiting, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Pain in extremity, at an unspecified dose and frequency. On 08-Jan-2021, VACCINATION SITE PAIN (Vaccination site pain) had resolved. On 12-Jan-2021, DIARRHOEA (Diarrhea), VOMITING (Vomited) and NAUSEA (Nausea) had resolved. At the time of the report, PAIN (Body pain), FATIGUE (Exhausted) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jan-2021: No specific information was updated.; Sender's Comments: Based on current available information and the temporal association between product and the start date of the events a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: Body pain; Exhausted; Joint pain; Nausea; Diarrhea; Vomited; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PAIN (Body pain), VACCINATION SITE PAIN (Vaccination site pain), VOMITING (Vomited) and FATIGUE (Exhausted) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 11-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), VOMITING (Vomited) and NAUSEA (Nausea). On 12-Jan-2021, the patient experienced PAIN (Body pain), FATIGUE (Exhausted) and ARTHRALGIA (Joint pain). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Vomiting, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Pain in extremity, at an unspecified dose and frequency. On 08-Jan-2021, VACCINATION SITE PAIN (Vaccination site pain) had resolved. On 12-Jan-2021, DIARRHOEA (Diarrhea), VOMITING (Vomited) and NAUSEA (Nausea) had resolved. At the time of the report, PAIN (Body pain), FATIGUE (Exhausted) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jan-2021: No specific information was updated.; Sender's Comments: Based on current available information and the temporal association between product and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Dizziness, Muscle spasms, Pyrexia
Clinical narrative: weird muscle spasms all over my body; Fever; Diarrhea; Loss of appetite; lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (weird muscle spasms all over my body), PYREXIA (Fever), DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite) and DIZZINESS (lightheaded) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced MUSCLE SPASMS (weird muscle spasms all over my body), PYREXIA (Fever), DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite) and DIZZINESS (lightheaded). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Jan-2021, PYREXIA (Fever) had not resolved. At the time of the report, MUSCLE SPASMS (weird muscle spasms all over my body), DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite) and DIZZINESS (lightheaded) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Soreness of the muscle area; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness of the muscle area) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not reported).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced MYALGIA (Soreness of the muscle area). At the time of the report, MYALGIA (Soreness of the muscle area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-006200 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-006200:Crosslink (MOD21-04960)
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: I am a little concern my neck is stiff; horrible horrible pain in the arm of injection, even up into my neck; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (I am a little concern my neck is stiff) and VACCINATION SITE PAIN (horrible horrible pain in the arm of injection, even up into my neck) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (I am a little concern my neck is stiff) and VACCINATION SITE PAIN (horrible horrible pain in the arm of injection, even up into my neck). At the time of the report, MUSCULOSKELETAL STIFFNESS (I am a little concern my neck is stiff) and VACCINATION SITE PAIN (horrible horrible pain in the arm of injection, even up into my neck) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported. Treatment information was not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow up received on 12-Apr-2021 did not contain any new information. On 07-Jun-2021: Outcome of events changed to recovered or resolved.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, SARS-CoV-2 test, Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: Itchy; It developed rash and beginning to extend the lower part of the injection site; injection site soreness; injection site redness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE RASH (It developed rash and beginning to extend the lower part of the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concomitant products included MONASCUS PURPUREUS, NICOTINAMIDE, PHYTOSTEROLS NOS (RED YEAST RICE WITH PLANT STEROLS) and ATORVASTATIN CALCIUM (LIPITOR) for Hyperlipidemia, CENTRUM SILVER +50 for Immunodeficiency.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site redness). On 19-Jan-2021, the patient experienced PRURITUS (Itchy) and VACCINATION SITE RASH (It developed rash and beginning to extend the lower part of the injection site). At the time of the report, PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE RASH (It developed rash and beginning to extend the lower part of the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Benadryl cream.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: This spontaneous case was reported by an other and describes the occurrence of PYREXIA (a low fever like like chills) and CHILLS (a low fever like like chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PYREXIA (a low fever like like chills) and CHILLS (a low fever like like chills). At the time of the report, PYREXIA (a low fever like like chills) and CHILLS (a low fever like like chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Treatment medication included Tylenol. Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Cough, Emotional disorder, Fatigue
Clinical narrative: Heart palpitation; Emotions; Anxiety; brain fog; Sweat; Shaking; Joint stiffness; Dry cough; Neck stiffness; Muscle pain; Chills; Nausea; under arm lymph pain on the side she got the shot; Fatigue/extreme fatigue; Sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PALPITATIONS (Heart palpitation), EMOTIONAL DISORDER (Emotions), ANXIETY (Anxiety) and FEELING ABNORMAL (brain fog) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037kz0A/037K70A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue/extreme fatigue). On 07-Jan-2021, the patient experienced PALPITATIONS (Heart palpitation), EMOTIONAL DISORDER (Emotions), ANXIETY (Anxiety), FEELING ABNORMAL (brain fog), HYPERHIDROSIS (Sweat), TREMOR (Shaking), JOINT STIFFNESS (Joint stiffness), COUGH (Dry cough), MUSCULOSKELETAL STIFFNESS (Neck stiffness), MYALGIA (Muscle pain), CHILLS (Chills), NAUSEA (Nausea) and LYMPH NODE PAIN (under arm lymph pain on the side she got the shot). On 06-Jan-2021, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue/extreme fatigue) had resolved. At the time of the report, PALPITATIONS (Heart palpitation), EMOTIONAL DISORDER (Emotions), ANXIETY (Anxiety), FEELING ABNORMAL (brain fog), HYPERHIDROSIS (Sweat), TREMOR (Shaking), JOINT STIFFNESS (Joint stiffness), COUGH (Dry cough), MUSCULOSKELETAL STIFFNESS (Neck stiffness), MYALGIA (Muscle pain), CHILLS (Chills), NAUSEA (Nausea) and LYMPH NODE PAIN (under arm lymph pain on the side she got the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hyperhidrosis, Joint stiffness, Lymph node pain, Musculoskeletal stiffness
Clinical narrative: Heart palpitation; Emotions; Anxiety; brain fog; Sweat; Shaking; Joint stiffness; Dry cough; Neck stiffness; Muscle pain; Chills; Nausea; under arm lymph pain on the side she got the shot; Fatigue/extreme fatigue; Sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PALPITATIONS (Heart palpitation), EMOTIONAL DISORDER (Emotions), ANXIETY (Anxiety) and FEELING ABNORMAL (brain fog) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037kz0A/037K70A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue/extreme fatigue). On 07-Jan-2021, the patient experienced PALPITATIONS (Heart palpitation), EMOTIONAL DISORDER (Emotions), ANXIETY (Anxiety), FEELING ABNORMAL (brain fog), HYPERHIDROSIS (Sweat), TREMOR (Shaking), JOINT STIFFNESS (Joint stiffness), COUGH (Dry cough), MUSCULOSKELETAL STIFFNESS (Neck stiffness), MYALGIA (Muscle pain), CHILLS (Chills), NAUSEA (Nausea) and LYMPH NODE PAIN (under arm lymph pain on the side she got the shot). On 06-Jan-2021, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue/extreme fatigue) had resolved. At the time of the report, PALPITATIONS (Heart palpitation), EMOTIONAL DISORDER (Emotions), ANXIETY (Anxiety), FEELING ABNORMAL (brain fog), HYPERHIDROSIS (Sweat), TREMOR (Shaking), JOINT STIFFNESS (Joint stiffness), COUGH (Dry cough), MUSCULOSKELETAL STIFFNESS (Neck stiffness), MYALGIA (Muscle pain), CHILLS (Chills), NAUSEA (Nausea) and LYMPH NODE PAIN (under arm lymph pain on the side she got the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity, Palpitations, Tremor
Clinical narrative: Heart palpitation; Emotions; Anxiety; brain fog; Sweat; Shaking; Joint stiffness; Dry cough; Neck stiffness; Muscle pain; Chills; Nausea; under arm lymph pain on the side she got the shot; Fatigue/extreme fatigue; Sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PALPITATIONS (Heart palpitation), EMOTIONAL DISORDER (Emotions), ANXIETY (Anxiety) and FEELING ABNORMAL (brain fog) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037kz0A/037K70A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue/extreme fatigue). On 07-Jan-2021, the patient experienced PALPITATIONS (Heart palpitation), EMOTIONAL DISORDER (Emotions), ANXIETY (Anxiety), FEELING ABNORMAL (brain fog), HYPERHIDROSIS (Sweat), TREMOR (Shaking), JOINT STIFFNESS (Joint stiffness), COUGH (Dry cough), MUSCULOSKELETAL STIFFNESS (Neck stiffness), MYALGIA (Muscle pain), CHILLS (Chills), NAUSEA (Nausea) and LYMPH NODE PAIN (under arm lymph pain on the side she got the shot). On 06-Jan-2021, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue/extreme fatigue) had resolved. At the time of the report, PALPITATIONS (Heart palpitation), EMOTIONAL DISORDER (Emotions), ANXIETY (Anxiety), FEELING ABNORMAL (brain fog), HYPERHIDROSIS (Sweat), TREMOR (Shaking), JOINT STIFFNESS (Joint stiffness), COUGH (Dry cough), MUSCULOSKELETAL STIFFNESS (Neck stiffness), MYALGIA (Muscle pain), CHILLS (Chills), NAUSEA (Nausea) and LYMPH NODE PAIN (under arm lymph pain on the side she got the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site hypersensitivity
Clinical narrative: delayed-type hypersensitivity reaction at the site of injection; A spontaneous report was received from consumer concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  Vaccination site hyper sensitivity/Delayed type hypersensitivity reaction at the site injection.  The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies were provided. The reported stated that the patient was physically and mentally healthy before vaccination.   On unknown date, prior to the onset of the events, the patient received their first planned dose of mRNA-1273 (Lot number: unknown)  via unknown route  at unknown location for prophylaxis of COVID-19 infection.   On 21 Jan 2021 caller had  provided with a delayed type hypersensitivity reaction at the site of the injection to the Moderna vaccine. On a unknown date patient experienced with the event Delayed type hypersensitivity reaction at the site injection to the Moderna vaccine. Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the event Delayed type hypersensitivity reaction at the site injection was considered unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment
Clinical narrative: Forgetfulness; A spontaneous report was received from a consumer concerning a 78-years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced forgetfulness/Memory impairment.    The patient's medical history was not provided.   Relevant concomitant medications were not reported.  On 14 JAN 2021, approximately 2 days prior to the onset of the events the patient received their planned dose of mRNA-1273 (lot/batch: 039K202A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 15 JAN 2021, the patient experienced forgetfulness.  Laboratory details were not provided.   Treatment information was provided as blood pressure medication, vitamin D & C.   Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the event's forgetfulness was considered as unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Muscular weakness
Clinical narrative: Light headed; Leg collapse; break out in a big sweat; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed), MUSCULAR WEAKNESS (Leg collapse) and HYPERHIDROSIS (break out in a big sweat) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.  On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 12-Jan-2021, the patient experienced DIZZINESS (Light headed), MUSCULAR WEAKNESS (Leg collapse) and HYPERHIDROSIS (break out in a big sweat).   At the time of the report, DIZZINESS (Light headed), MUSCULAR WEAKNESS (Leg collapse) and HYPERHIDROSIS (break out in a big sweat) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on his/her face; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of RASH (rash on his/her face) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no adverse event reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash on his/her face). At the time of the report, RASH (rash on his/her face) 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 reported by investigator o No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: Hard in the injection site area; Itchy in the injection site area; Had rash in the injection site area; Red in the injection site area/red area 14cm; Swollen; Pain; This spontaneous case was reported by an other health care professional and describes the occurrence of PERIPHERAL SWELLING (Swollen), PAIN (Pain), VACCINATION SITE INDURATION (Hard in the injection site area), VACCINATION SITE PRURITUS (Itchy in the injection site area) and VACCINATION SITE RASH (Had rash in the injection site area) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pain in hip since April 2016 and Low back pain since April 2016.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swollen) and PAIN (Pain). On 13-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Hard in the injection site area), VACCINATION SITE PRURITUS (Itchy in the injection site area), VACCINATION SITE RASH (Had rash in the injection site area) and VACCINATION SITE ERYTHEMA (Red in the injection site area/red area 14cm). On 20-Jan-2021, VACCINATION SITE INDURATION (Hard in the injection site area), VACCINATION SITE PRURITUS (Itchy in the injection site area), VACCINATION SITE RASH (Had rash in the injection site area) and VACCINATION SITE ERYTHEMA (Red in the injection site area/red area 14cm) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen) and PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported that rash at the injection site was red, itchy and about 20 cm across. Concomitant medications were not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: Contact information and event information updated. On 13-Apr-2021: patient demographics, medical history, product information and event details updated On 23-Jun-2021: Follow-up received contains updated patient relevant history is date is changed low back pain from ??-Mar-2019 to ??-Apr-2016
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Hard in the injection site area; Itchy in the injection site area; Had rash in the injection site area; Red in the injection site area/red area 14cm; Swollen; Pain; This spontaneous case was reported by an other health care professional and describes the occurrence of PERIPHERAL SWELLING (Swollen), PAIN (Pain), VACCINATION SITE INDURATION (Hard in the injection site area), VACCINATION SITE PRURITUS (Itchy in the injection site area) and VACCINATION SITE RASH (Had rash in the injection site area) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pain in hip since April 2016 and Low back pain since April 2016.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swollen) and PAIN (Pain). On 13-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Hard in the injection site area), VACCINATION SITE PRURITUS (Itchy in the injection site area), VACCINATION SITE RASH (Had rash in the injection site area) and VACCINATION SITE ERYTHEMA (Red in the injection site area/red area 14cm). On 20-Jan-2021, VACCINATION SITE INDURATION (Hard in the injection site area), VACCINATION SITE PRURITUS (Itchy in the injection site area), VACCINATION SITE RASH (Had rash in the injection site area) and VACCINATION SITE ERYTHEMA (Red in the injection site area/red area 14cm) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen) and PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported that rash at the injection site was red, itchy and about 20 cm across. Concomitant medications were not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: Contact information and event information updated. On 13-Apr-2021: patient demographics, medical history, product information and event details updated On 23-Jun-2021: Follow-up received contains updated patient relevant history is date is changed low back pain from ??-Mar-2019 to ??-Apr-2016
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant patient received the 1st dose of the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of the vaccine) in a 36-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy and Subfertility. Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included LEVOTHYROXINE SODIUM (TIROSINT) and INSULIN for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 25-Aug-2020 and the estimated date of delivery was 27-May-2021. On 16-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of the vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  On 16-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information for the event was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: Internal review on 19-JUL-2021 resulted in updates to pregnancy details.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 36-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product was not provided. Treatment medication was not reported.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: red rash right below the injection site about the size of a silver dollar; Red rash itches like crazy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (red rash right below the injection site about the size of a silver dollar) and INJECTION SITE PRURITUS (Red rash itches like crazy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced INJECTION SITE RASH (red rash right below the injection site about the size of a silver dollar) and INJECTION SITE PRURITUS (Red rash itches like crazy). At the time of the report, INJECTION SITE RASH (red rash right below the injection site about the size of a silver dollar) and INJECTION SITE PRURITUS (Red rash itches like crazy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no concomitant medication provided no treatment provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Peripheral swelling
Clinical narrative: Numbness in her 4th and 5th digit on the lateral part of her left arm; Swelling in left arm/left clavicle; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (Numbness in her 4th and 5th digit on the lateral part of her left arm) and PERIPHERAL SWELLING (Swelling in left arm/left clavicle) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced HYPOAESTHESIA (Numbness in her 4th and 5th digit on the lateral part of her left arm) and PERIPHERAL SWELLING (Swelling in left arm/left clavicle). The patient was treated with IBUPROFEN for Numbness, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Numbness in her 4th and 5th digit on the lateral part of her left arm) and PERIPHERAL SWELLING (Swelling in left arm/left clavicle) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) 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 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity, Peripheral swelling
Clinical narrative: flu like symptoms; swollen arm; sore arm; This spontaneous case was reported by a health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PERIPHERAL SWELLING (swollen arm) and PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2020, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PERIPHERAL SWELLING (swollen arm) and PAIN IN EXTREMITY (sore arm). On 30-Dec-2020, INFLUENZA LIKE ILLNESS (flu like symptoms), PERIPHERAL SWELLING (swollen arm) and PAIN IN EXTREMITY (sore arm) had resolved.        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 provided no treatment given; Sender's Comments: Very limited information regarding the events has been provided at this time. No consent was provided to follow-up.' Because the temporal association is not clearly stated.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Sore arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Migraine since an unknown date. Concomitant products included NORTRIPTYLINE, BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) and VITAMIN D NOS for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Lab tests were not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant or Treatment drugs were provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up received on 02-JUL-2021 contains No New Information. Patient declined further follow-up. Form attached.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.