chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia
Clinical narrative: Hand feels like its going numb; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Hand feels like its going numb) and CHILLS (Chills) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history per source document.).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced HYPOAESTHESIA (Hand feels like its going numb) and CHILLS (Chills). At the time of the report, HYPOAESTHESIA (Hand feels like its going numb) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No conmeds were provided.  Treatment information was not provided.   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.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: was hurting on every single part of her body; she threw up all night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (was hurting on every single part of her body) and VOMITING (she threw up all night) 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 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VOMITING (she threw up all night). On 10-Jan-2021, the patient experienced PAIN (was hurting on every single part of her body). At the time of the report, PAIN (was hurting on every single part of her body) and VOMITING (she threw up all night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was 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 events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Eye swelling, Joint swelling, Mass, Ocular hyperaemia
Clinical narrative: A lump like a bubble under her left/right knee cap; Swelling in her knees; tingling in her left heel; Left eye swollen; Left eye red; Left eye irritating her contact eye glass; This spontaneous case was reported by a physician assistant and describes the occurrence of JOINT SWELLING (Swelling in her knees), PARAESTHESIA (tingling in her left heel), MASS (A lump like a bubble under her left/right knee cap), EYE SWELLING (Left eye swollen) and OCULAR HYPERAEMIA (Left eye red) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included METOPROLOL SUCCINATE and LEVOTHYROXINE for Hypertension.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced PARAESTHESIA (tingling in her left heel), EYE SWELLING (Left eye swollen), OCULAR HYPERAEMIA (Left eye red) and EYE IRRITATION (Left eye irritating her contact eye glass). On 13-Jan-2021, the patient experienced JOINT SWELLING (Swelling in her knees) and MASS (A lump like a bubble under her left/right knee cap). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (Swelling in her knees), PARAESTHESIA (tingling in her left heel), MASS (A lump like a bubble under her left/right knee cap), EYE SWELLING (Left eye swollen), OCULAR HYPERAEMIA (Left eye red) and EYE IRRITATION (Left eye irritating her contact eye glass) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medications Metoprolol succinate, levothyroxine.; 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: Paraesthesia
Clinical narrative: A lump like a bubble under her left/right knee cap; Swelling in her knees; tingling in her left heel; Left eye swollen; Left eye red; Left eye irritating her contact eye glass; This spontaneous case was reported by a physician assistant and describes the occurrence of JOINT SWELLING (Swelling in her knees), PARAESTHESIA (tingling in her left heel), MASS (A lump like a bubble under her left/right knee cap), EYE SWELLING (Left eye swollen) and OCULAR HYPERAEMIA (Left eye red) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included METOPROLOL SUCCINATE and LEVOTHYROXINE for Hypertension.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced PARAESTHESIA (tingling in her left heel), EYE SWELLING (Left eye swollen), OCULAR HYPERAEMIA (Left eye red) and EYE IRRITATION (Left eye irritating her contact eye glass). On 13-Jan-2021, the patient experienced JOINT SWELLING (Swelling in her knees) and MASS (A lump like a bubble under her left/right knee cap). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (Swelling in her knees), PARAESTHESIA (tingling in her left heel), MASS (A lump like a bubble under her left/right knee cap), EYE SWELLING (Left eye swollen), OCULAR HYPERAEMIA (Left eye red) and EYE IRRITATION (Left eye irritating her contact eye glass) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medications Metoprolol succinate, levothyroxine.; 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: her neck is hurting; neck stiffness; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (her neck is hurting) and MUSCULOSKELETAL STIFFNESS (neck stiffness) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-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 NECK PAIN (her neck is hurting) and MUSCULOSKELETAL STIFFNESS (neck stiffness). At the time of the report, NECK PAIN (her neck is hurting) and MUSCULOSKELETAL STIFFNESS (neck stiffness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that she doesn't think the events are from the vaccine, but possibly due to working from home. patient has not taken any treatment medications.  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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, SARS-CoV-2 test
Clinical narrative: Headache; Fatigue; Severe pain all over my body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Severe pain all over my body), HEADACHE (Headache) and FATIGUE (Fatigue) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 PAIN (Severe pain all over my body). On 15-Jan-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, PAIN (Severe pain all over my body), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not 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: Nausea
Clinical narrative: Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) 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 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced NAUSEA (Nausea). At the time of the report, NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       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 start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore injection  site; This spontaneous case was reported by a consumer and describes the occurrence of   in a 75-year-old male patient 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) at an unspecified dose.        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 relevant concomitant medications were reported. 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 start date of the event, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-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 PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Body temperature increased: 102 (High) 102. On 13-Jan-2021, Body temperature increased: 103 (High) 103. On 15-Jan-2021, Body temperature increased: 103.1 (High) 103.1.     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 event, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pruritus, Skin warm, Swelling
Clinical narrative: itch systemic; Swelling raised; Lump; Warm skin; Fatigue; Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm), PRURITUS (itch systemic), SWELLING (Swelling raised), VACCINATION SITE MASS (Lump) and SKIN WARM (Warm skin) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011T20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer and Mastectomy (Right breast). Concurrent medical conditions included Diabetes.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm), SWELLING (Swelling raised), VACCINATION SITE MASS (Lump), SKIN WARM (Warm skin) and FATIGUE (Fatigue). On 10-Jan-2021, the patient experienced PRURITUS (itch systemic). On 08-Jan-2021, FATIGUE (Fatigue) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (Sore left arm), PRURITUS (itch systemic), SWELLING (Swelling raised), VACCINATION SITE MASS (Lump) and SKIN WARM (Warm skin) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information provided included paracetamol.  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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: itch systemic; Swelling raised; Lump; Warm skin; Fatigue; Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm), PRURITUS (itch systemic), SWELLING (Swelling raised), VACCINATION SITE MASS (Lump) and SKIN WARM (Warm skin) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011T20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer and Mastectomy (Right breast). Concurrent medical conditions included Diabetes.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm), SWELLING (Swelling raised), VACCINATION SITE MASS (Lump), SKIN WARM (Warm skin) and FATIGUE (Fatigue). On 10-Jan-2021, the patient experienced PRURITUS (itch systemic). On 08-Jan-2021, FATIGUE (Fatigue) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (Sore left arm), PRURITUS (itch systemic), SWELLING (Swelling raised), VACCINATION SITE MASS (Lump) and SKIN WARM (Warm skin) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information provided included paracetamol.  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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itchiness all over her body; This spontaneous case was reported by an other health professional and describes the occurrence of PRURITUS (Itchiness all over her body) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013C20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 13-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 PRURITUS (Itchiness all over her body). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchiness all over her body) 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.; 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: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance test, Maternal exposure during pregnancy, Pregnancy test, Prenatal screening test, Ultrasound scan
Clinical narrative: vaccination exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccination exposure during pregnancy) in a 28-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02SJ20-2A and 042L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (2 drinks/week. Stopped drinking every time I've been pregnant.) on 12-Oct-2014 and Miscarriage (baby stopped growing at 7w1d, identified via ultrasound at 11w3d. Pathology report revealed baby girl had a fatal & severe chromosomal abnormality called Triploidy (3 full sets of chromosomes)) on 17-Jan-2019. Concurrent medical conditions included Hashimoto's thyroiditis (increased TSH levels due to pregnancy). Concomitant products included MAGNESIUM for Headache, IRON for Iron low, 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] for Pregnancy, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Seasonal allergy, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 18-Sep-2020 and the estimated date of delivery was 25-Jun-2021. On 14-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccination exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixteenth week of the pregnancy.  On 14-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (vaccination exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Oct-2020, Pregnancy test: positive (Positive) Positive. On 15-Dec-2020, Prenatal screening test: normal (normal) Results were negative for any chromosomal abnormalities.. On 04-Feb-2021, Ultrasound scan: normal (normal) growth normal.. On 12-Mar-2021, Glucose tolerance test: inconclusive (Inconclusive) passed.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The pregnancy history of the patient included 2 prior pregnancy history with 1 live, full term birth on 15-FEB-2020  and one spontaneous abortion on 17 jan 2019. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2021: Internal review on 19-Jul-2021 resulted in updates to the pregnancy details On 13-Apr-2021: Follow up received on 13-Apr-2021 lab data added.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Delayed allergic reaction; Itchy at injection site; Hard at injection site; Injection site is red; Vaccination site swelling; Pain at the injection site; Raised at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Delayed allergic reaction), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE INDURATION (Hard at injection site), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE SWELLING (Raised at injection site) in a 29-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.     Previously administered products included for Granulomatosis with polyangiitis: rituximab (She takes Rituximab for an autoimmune disease: Granulomatosis with polyangiitis and an ANCA-Associated vasculitis. She receives Rituximab  to reduce her B-cells.) until November 2019. Concurrent medical conditions included Granulomatosis with polyangiitis.    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 (Pain at the injection site) and VACCINATION SITE SWELLING (Raised at injection site). On 14-Jan-2021, the patient experienced HYPERSENSITIVITY (Delayed allergic reaction), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE INDURATION (Hard at injection site), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Vaccination site swelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 08-Jan-2021, VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE SWELLING (Raised at injection site) had resolved. At the time of the report, HYPERSENSITIVITY (Delayed allergic reaction), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE INDURATION (Hard at injection site), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Vaccination site swelling) 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.   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2021: Additional information added to case on 01FEB2021, contains significant information, about new events; 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Delayed allergic reaction; Itchy at injection site; Hard at injection site; Injection site is red; Vaccination site swelling; Pain at the injection site; Raised at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Delayed allergic reaction), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE INDURATION (Hard at injection site), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE SWELLING (Raised at injection site) in a 29-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.     Previously administered products included for Granulomatosis with polyangiitis: rituximab (She takes Rituximab for an autoimmune disease: Granulomatosis with polyangiitis and an ANCA-Associated vasculitis. She receives Rituximab  to reduce her B-cells.) until November 2019. Concurrent medical conditions included Granulomatosis with polyangiitis.    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 (Pain at the injection site) and VACCINATION SITE SWELLING (Raised at injection site). On 14-Jan-2021, the patient experienced HYPERSENSITIVITY (Delayed allergic reaction), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE INDURATION (Hard at injection site), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Vaccination site swelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 08-Jan-2021, VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE SWELLING (Raised at injection site) had resolved. At the time of the report, HYPERSENSITIVITY (Delayed allergic reaction), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE INDURATION (Hard at injection site), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Vaccination site swelling) 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.   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2021: Additional information added to case on 01FEB2021, contains significant information, about new events; 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; Body aches; Chills; Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Broken wrist (Fell on ice and broke her wrist.) on 24-Dec-2020.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 11-Jan-2021, the patient experienced PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Chills) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, Pyrexia: 37.77-38.77 degree Celsius (Inconclusive) Fever of 100-101 degrees F. In January 2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the events included Acetaminophen and ibuprofen.  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
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Eye pruritus
Clinical narrative: looked more like a rash, eczema rash around her eye; eye itchy; This spontaneous case was reported by a consumer and describes the occurrence of EYE PRURITUS (eye itchy) and ECZEMA (looked more like a rash, eczema rash around her eye) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-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 EYE PRURITUS (eye itchy). On 15-Jan-2021, the patient experienced ECZEMA (looked more like a rash, eczema rash around her eye). At the time of the report, EYE PRURITUS (eye itchy) and ECZEMA (looked more like a rash, eczema rash around her eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was 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 events, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Got worse with a white blush and some late kind of allergic reaction to vaccine; soreness on trapezius and back of the shoulder on that side; Redness on injection site; Swelling on injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE REACTION (Got worse with a white blush and some late kind of allergic reaction to vaccine), VACCINATION SITE ERYTHEMA (Redness on injection site), VACCINATION SITE SWELLING (Swelling on injection site) and MYALGIA (soreness on trapezius and back of the shoulder on that side) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness on injection site) and VACCINATION SITE SWELLING (Swelling on injection site). On 13-Jan-2021, the patient experienced MYALGIA (soreness on trapezius and back of the shoulder on that side). On an unknown date, the patient experienced VACCINATION SITE REACTION (Got worse with a white blush and some late kind of allergic reaction to vaccine). At the time of the report, VACCINATION SITE REACTION (Got worse with a white blush and some late kind of allergic reaction to vaccine), VACCINATION SITE ERYTHEMA (Redness on injection site), VACCINATION SITE SWELLING (Swelling on injection site) and MYALGIA (soreness on trapezius and back of the shoulder on that side) 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.; 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: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills/had chills all day/cold; Fever of 102; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills/had chills all day/cold) and PYREXIA (Fever of 102) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Pneumonia. Concurrent medical conditions included Cancer. Concomitant products included LOSARTAN and AMLODIPINE for an unknown indication, HYDROCHLOROTHIAZIDE.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced CHILLS (Chills/had chills all day/cold) and PYREXIA (Fever of 102). At the time of the report, CHILLS (Chills/had chills all day/cold) and PYREXIA (Fever of 102) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Small rash on the chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Small rash on the chest) in a 42-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 recorded medical history).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced RASH (Small rash on the chest). At the time of the report, RASH (Small rash on the chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was 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: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     The patient's past medical history included Polycystic ovarian syndrome since an unknown date. Concomitant products included MAGNESIUM and SPIRONOLACTONE for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information 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 event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash around injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE RASH (rash around injection site) 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.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE RASH (rash around injection site). At the time of the report, VACCINATION SITE RASH (rash around injection site) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  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 start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Nausea, SARS-CoV-2 test, Taste disorder
Clinical narrative: No appetite; does not taste food very well; either really hot or really cold; headache; Nauseous; arm was very sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was very sore), NAUSEA (Nauseous), HEADACHE (headache), DECREASED APPETITE (No appetite) and TASTE DISORDER (does not taste food very well) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm was very sore). On 09-Jan-2021, the patient experienced NAUSEA (Nauseous). On 12-Jan-2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced DECREASED APPETITE (No appetite), TASTE DISORDER (does not taste food very well) and TEMPERATURE REGULATION DISORDER (either really hot or really cold). On 12-Jan-2021, NAUSEA (Nauseous) had resolved. At the time of the report, VACCINATION SITE PAIN (arm was very sore), HEADACHE (headache), DECREASED APPETITE (No appetite), TASTE DISORDER (does not taste food very well) and TEMPERATURE REGULATION DISORDER (either really hot or really cold) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, SARS-CoV-2 test: negative Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was 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 events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Temperature regulation disorder, Vaccination site pain
Clinical narrative: No appetite; does not taste food very well; either really hot or really cold; headache; Nauseous; arm was very sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was very sore), NAUSEA (Nauseous), HEADACHE (headache), DECREASED APPETITE (No appetite) and TASTE DISORDER (does not taste food very well) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm was very sore). On 09-Jan-2021, the patient experienced NAUSEA (Nauseous). On 12-Jan-2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced DECREASED APPETITE (No appetite), TASTE DISORDER (does not taste food very well) and TEMPERATURE REGULATION DISORDER (either really hot or really cold). On 12-Jan-2021, NAUSEA (Nauseous) had resolved. At the time of the report, VACCINATION SITE PAIN (arm was very sore), HEADACHE (headache), DECREASED APPETITE (No appetite), TASTE DISORDER (does not taste food very well) and TEMPERATURE REGULATION DISORDER (either really hot or really cold) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, SARS-CoV-2 test: negative Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was 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 events, a causal relationship cannot be excluded.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: Vomiting; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), VOMITING (Vomiting) and NAUSEA (Nausea) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced CHILLS (Chills). On 13-Jan-2021, the patient experienced VOMITING (Vomiting) and NAUSEA (Nausea). On 11-Jan-2021, CHILLS (Chills) had resolved. On 14-Jan-2021, VOMITING (Vomiting) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) 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.; 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: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Pyrexia, Vaccination site induration, Vaccination site swelling
Clinical narrative: Became hot; indurated (left) shoulder; Really swollen (left) shoulder; Fever; Chills/Rigors; This spontaneous case was reported by a physician and describes the occurrence of FEELING HOT (Became hot), VACCINATION SITE INDURATION (indurated (left) shoulder), VACCINATION SITE SWELLING (Really swollen (left) shoulder), PYREXIA (Fever) and CHILLS (Chills/Rigors) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Jan-2021 at 9:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced FEELING HOT (Became hot), VACCINATION SITE INDURATION (indurated (left) shoulder), VACCINATION SITE SWELLING (Really swollen (left) shoulder), PYREXIA (Fever) and CHILLS (Chills/Rigors). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-Jan-2021, FEELING HOT (Became hot), VACCINATION SITE INDURATION (indurated (left) shoulder), VACCINATION SITE SWELLING (Really swollen (left) shoulder), PYREXIA (Fever) and CHILLS (Chills/Rigors) 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.   Other treatment medications include Motrin. All listed adverse events developed within 12 hours of vaccinations and had resolved within 12 hours of taking Motrin and Tylenol. No concomitant medications were 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.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Muscle spasms, Nightmare, Pain in extremity
Clinical narrative: Severe cramping in her left leg; Pain in arm occassionally; Sharp pain above the heart occassionally; Bad nightmares; This spontaneous case was reported by a consumer and describes the occurrence of NIGHTMARE (Bad nightmares), MUSCLE SPASMS (Severe cramping in her left leg), PAIN IN EXTREMITY (Pain in arm occassionally) and CHEST PAIN (Sharp pain above the heart occassionally) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced NIGHTMARE (Bad nightmares). On an unknown date, the patient experienced MUSCLE SPASMS (Severe cramping in her left leg), PAIN IN EXTREMITY (Pain in arm occassionally) and CHEST PAIN (Sharp pain above the heart occassionally). At the time of the report, NIGHTMARE (Bad nightmares), MUSCLE SPASMS (Severe cramping in her left leg), PAIN IN EXTREMITY (Pain in arm occassionally) and CHEST PAIN (Sharp pain above the heart occassionally) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: 12 weeks and 2 days pregnant when administed the vaccine; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (12 weeks and 2 days pregnant when administed the vaccine) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 09-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 an unknown date and the estimated date of delivery was 22-Jul-2021. On 09-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (12 weeks and 2 days pregnant when administed the vaccine). On 09-Jan-2021, EXPOSURE DURING PREGNANCY (12 weeks and 2 days pregnant when administed the vaccine) had resolved. 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.   Concomitant medications were not provided. Treatment details were not provided; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 42-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Pain in extremity, Vaccination site erythema, Vaccination site rash
Clinical narrative: Her arm is paining; Bad rash; Redness; Itchy at the site of injection on her left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm is paining), VACCINATION SITE RASH (Bad rash), VACCINATION SITE ERYTHEMA (Redness) and INJECTION SITE PRURITUS (Itchy at the site of injection on her left arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Diabetes since an unknown date.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Her arm is paining), VACCINATION SITE RASH (Bad rash), VACCINATION SITE ERYTHEMA (Redness) and INJECTION SITE PRURITUS (Itchy at the site of injection on her left arm). At the time of the report, PAIN IN EXTREMITY (Her arm is paining), VACCINATION SITE RASH (Bad rash), VACCINATION SITE ERYTHEMA (Redness) and INJECTION SITE PRURITUS (Itchy at the site of injection on her left arm) 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.; 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.