chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: shortness of breath when up and down stairs; light headedness; low grade temperature; more fatigue; rash at injection site; tenderness at injection site; itching at injection site; soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in her arm), DYSPNOEA (shortness of breath when up and down stairs), DIZZINESS (light headedness), PYREXIA (low grade temperature) and FATIGUE (more fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D), LOVASTATIN and ATORVASTATIN CALCIUM (AVASTATIN) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in her arm). On 18-Feb-2021, the patient experienced DYSPNOEA (shortness of breath when up and down stairs), DIZZINESS (light headedness), PYREXIA (low grade temperature), FATIGUE (more fatigue), VACCINATION SITE RASH (rash at injection site), VACCINATION SITE PAIN (tenderness at injection site) and VACCINATION SITE PRURITUS (itching at injection site). At the time of the report, PAIN IN EXTREMITY (soreness in her arm), DYSPNOEA (shortness of breath when up and down stairs), DIZZINESS (light headedness), PYREXIA (low grade temperature), FATIGUE (more fatigue), VACCINATION SITE RASH (rash at injection site), VACCINATION SITE PAIN (tenderness at injection site) and VACCINATION SITE PRURITUS (itching at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Pruritus
Clinical narrative: chills; sick in the stomach; itching; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), ABDOMINAL PAIN UPPER (sick in the stomach) and PRURITUS (itching) 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 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), ABDOMINAL PAIN UPPER (sick in the stomach) and PRURITUS (itching). At the time of the report, CHILLS (chills), ABDOMINAL PAIN UPPER (sick in the stomach) and PRURITUS (itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Diagnosed with positive COVID-19 a few days after receiving the first dose of Moderna COVID19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with positive COVID-19 a few days after receiving the first dose of Moderna COVID19 vaccine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced COVID-19 (Diagnosed with positive COVID-19 a few days after receiving the first dose of Moderna COVID19 vaccine). At the time of the report, COVID-19 (Diagnosed with positive COVID-19 a few days after receiving the first dose of Moderna COVID19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, SARS-CoV-2 test: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity
Clinical narrative: Sore arm; Insomnia; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and INSOMNIA (Insomnia) 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 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and INSOMNIA (Insomnia). At the time of the report, PAIN IN EXTREMITY (Sore arm) and INSOMNIA (Insomnia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-022904 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site pain
Clinical narrative: fever; Chills; arm sore at the shot site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (Chills) and VACCINATION SITE PAIN (arm sore at the shot site) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), CHILLS (Chills) and VACCINATION SITE PAIN (arm sore at the shot site). At the time of the report, PYREXIA (fever), CHILLS (Chills) and VACCINATION SITE PAIN (arm sore at the shot site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Pyrexia
Clinical narrative: COVID-19 test on 14JAN2021 and found out it was positive; Fever; Developed chills; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 test on 14JAN2021 and found out it was positive), PYREXIA (Fever) and CHILLS (Developed chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 PYREXIA (Fever) and CHILLS (Developed chills). On 14-Jan-2021, the patient experienced COVID-19 (COVID-19 test on 14JAN2021 and found out it was positive). At the time of the report, COVID-19 (COVID-19 test on 14JAN2021 and found out it was positive), PYREXIA (Fever) and CHILLS (Developed chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events pyrexia and chills, a causal relationship cannot be excluded. Very limited information regarding the COVID-19 event was provided. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.   This case was linked to MOD-2021-022419, MOD-2021-016883 (Patient Link).; 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 pyrexia and chills, a causal relationship cannot be excluded. Very limited information regarding the COVID-19 event was provided. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chillblains, Myalgia, Swelling
Clinical narrative: swelling, painful, multiple areas of his body, chilbrains; swelling, painful, multiple areas of his body, chilbrains; swelling, painful, multiple areas of his body, chilbrains; This spontaneous case was reported by a nurse and describes the occurrence of SWELLING (swelling, painful, multiple areas of his body, chilbrains), CHILLBLAINS (swelling, painful, multiple areas of his body, chilbrains) and MYALGIA (swelling, painful, multiple areas of his body, chilbrains) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced SWELLING (swelling, painful, multiple areas of his body, chilbrains), CHILLBLAINS (swelling, painful, multiple areas of his body, chilbrains) and MYALGIA (swelling, painful, multiple areas of his body, chilbrains). At the time of the report, SWELLING (swelling, painful, multiple areas of his body, chilbrains), CHILLBLAINS (swelling, painful, multiple areas of his body, chilbrains) and MYALGIA (swelling, painful, multiple areas of his body, chilbrains) 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.   No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Events outcome was updated.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: Left arm itchy; left arm hurting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Left arm itchy) and VACCINATION SITE PAIN (left arm hurting) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Cholesterol and Depression.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Left arm itchy) and VACCINATION SITE PAIN (left arm hurting). At the time of the report, VACCINATION SITE PRURITUS (Left arm itchy) and VACCINATION SITE PAIN (left arm hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Swollen arm Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen arm Injection Site) in an 80-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 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swollen arm Injection Site). On 30-Jan-2021, VACCINATION SITE SWELLING (Swollen arm Injection Site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided by the reporter. Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Non-Significant follow up appeneded
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash all over left side of body; A spontaneous report was received from a consumer concerning an 80 years old, female patient who experienced rash all over left side of her body/rash.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 22 Jan 2021, prior to the onset of the symptoms, the patient received their first/second (not specified) of two planned doses of mRNA-1273 (Batch number: 029L20A) in the left arm for prophylaxis of COVID-19 infection.   On 22 Jan 2021, the patient experienced rash all over left side of body.  Treatment for the event included antihistamine.   Action taken with mRNA-1273 in response to the event was not provided.  The event rash all over left side of body was considered resolved on 22 Jan 2021.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Fatigue, Musculoskeletal stiffness, Vomiting
Clinical narrative: has stomach pain; VOMITING; he got dizziness (got worse now); stiff neck (getting better); he got very tired; A spontaneous report was received from a consumer concerning a 83-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events he got very tired/fatigue, he got dizziness, stiff neck/musculoskeletal stiffness, vomiting, has stomach pain.  The patient's medical history was not provided. Concomitant medications reported were Metformin, dulaglutide, quinapril, HCTZ for drug use for unknown indication.  On 12 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 00SM20A) intramuscularly for prophylaxis of COVID-19 infection.  On 14 Feb 2021, the patient experienced the event(s) he got very tired. On 20 Feb 2021, the patient experienced the event(s) he got dizziness (got worse now), stiff neck (getting better). On 23 Feb 2021, the patient experienced the event(s) vomiting, has stomach pain.  Treatment details included acetaminophen for stiff neck.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), he got very tired, he got dizziness, stiff neck ,vomiting, has stomach pain was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 63-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 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Viral infection
Clinical narrative: she was around a baby and got another virus; This spontaneous case was reported by a consumer and describes the occurrence of VIRAL INFECTION (she was around a baby and got another virus) 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 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 VIRAL INFECTION (she was around a baby and got another virus). At the time of the report, VIRAL INFECTION (she was around a baby and got another virus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Headache, Mood altered, Pain
Clinical narrative: next day it was bad; limping but can "walk it off"; sore arm; leg started bothering him; from his knee to ankle when he bends it; headache; Had same pain about 10 days before; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (leg started bothering him), MOOD ALTERED (next day it was bad), GAIT DISTURBANCE (limping but can "walk it off") and PAIN (Had same pain about 10 days before) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension. Concomitant products included ALPRAZOLAM for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PAIN (Had same pain about 10 days before). On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (leg started bothering him), ARTHRALGIA (from his knee to ankle when he bends it) and HEADACHE (headache). On 20-Feb-2021, the patient experienced MOOD ALTERED (next day it was bad) and GAIT DISTURBANCE (limping but can "walk it off"). At the time of the report, PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (leg started bothering him), MOOD ALTERED (next day it was bad), GAIT DISTURBANCE (limping but can "walk it off"), PAIN (Had same pain about 10 days before), ARTHRALGIA (from his knee to ankle when he bends it) and HEADACHE (headache) outcome was unknown.             Treatment information was not provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: next day it was bad; limping but can "walk it off"; sore arm; leg started bothering him; from his knee to ankle when he bends it; headache; Had same pain about 10 days before; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (leg started bothering him), MOOD ALTERED (next day it was bad), GAIT DISTURBANCE (limping but can "walk it off") and PAIN (Had same pain about 10 days before) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension. Concomitant products included ALPRAZOLAM for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PAIN (Had same pain about 10 days before). On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (leg started bothering him), ARTHRALGIA (from his knee to ankle when he bends it) and HEADACHE (headache). On 20-Feb-2021, the patient experienced MOOD ALTERED (next day it was bad) and GAIT DISTURBANCE (limping but can "walk it off"). At the time of the report, PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (leg started bothering him), MOOD ALTERED (next day it was bad), GAIT DISTURBANCE (limping but can "walk it off"), PAIN (Had same pain about 10 days before), ARTHRALGIA (from his knee to ankle when he bends it) and HEADACHE (headache) outcome was unknown.             Treatment information was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: Arm warm/hot to touch; Redness the size of a grapefruit; 3 welts on arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm warm/hot to touch), VACCINATION SITE URTICARIA (3 welts on arm of injection) and VACCINATION SITE ERYTHEMA (Redness the size of a grapefruit) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE URTICARIA (3 welts on arm of injection). On 16-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Arm warm/hot to touch) and VACCINATION SITE ERYTHEMA (Redness the size of a grapefruit). At the time of the report, VACCINATION SITE WARMTH (Arm warm/hot to touch), VACCINATION SITE URTICARIA (3 welts on arm of injection) and VACCINATION SITE ERYTHEMA (Redness the size of a grapefruit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       . No relevant concomitant medications were reported  No treatment information was provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Hypoaesthesia, Malaise, Nausea, Pain in extremity
Clinical narrative: arm pain; body pain; tinging sensation at her finders, toe, leg; tinging sensation at her finders, toe, leg; stomach cramp; nausea ; still feels nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), MALAISE (body pain), HYPOAESTHESIA (tinging sensation at her finders, toe, leg), PARAESTHESIA (tinging sensation at her finders, toe, leg) and ABDOMINAL PAIN UPPER (stomach cramp) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 and Lupus enteritis.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain), MALAISE (body pain), HYPOAESTHESIA (tinging sensation at her finders, toe, leg), PARAESTHESIA (tinging sensation at her finders, toe, leg), ABDOMINAL PAIN UPPER (stomach cramp) and NAUSEA (nausea ; still feels nausea). The patient was treated with IBUPROFEN at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm pain), MALAISE (body pain), HYPOAESTHESIA (tinging sensation at her finders, toe, leg), PARAESTHESIA (tinging sensation at her finders, toe, leg), ABDOMINAL PAIN UPPER (stomach cramp) and NAUSEA (nausea ; still feels nausea) 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 which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Nausea is consistent with the known safety profile of mRNA-1273.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: arm pain; body pain; tinging sensation at her finders, toe, leg; tinging sensation at her finders, toe, leg; stomach cramp; nausea ; still feels nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), MALAISE (body pain), HYPOAESTHESIA (tinging sensation at her finders, toe, leg), PARAESTHESIA (tinging sensation at her finders, toe, leg) and ABDOMINAL PAIN UPPER (stomach cramp) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 and Lupus enteritis.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain), MALAISE (body pain), HYPOAESTHESIA (tinging sensation at her finders, toe, leg), PARAESTHESIA (tinging sensation at her finders, toe, leg), ABDOMINAL PAIN UPPER (stomach cramp) and NAUSEA (nausea ; still feels nausea). The patient was treated with IBUPROFEN at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm pain), MALAISE (body pain), HYPOAESTHESIA (tinging sensation at her finders, toe, leg), PARAESTHESIA (tinging sensation at her finders, toe, leg), ABDOMINAL PAIN UPPER (stomach cramp) and NAUSEA (nausea ; still feels nausea) 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 which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Nausea is consistent with the known safety profile of mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Niece received second vaccine and was sick for two days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Niece received second vaccine and was sick for two days) 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 Heart failure.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced ILLNESS (Niece received second vaccine and was sick for two days). At the time of the report, ILLNESS (Niece received second vaccine and was sick for two days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Although a temporal association exist, there is not enough information to adequately assess the causal association between the reported event and mRNA-1273 vaccine administration as the symptoms of the illness is lacking in the case additional information is being requested
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site reaction
Clinical narrative: COVID ARM; itching at the injection site; Rash at the injection site; redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID ARM), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE RASH (Rash at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0132A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE REACTION (COVID ARM), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE RASH (Rash at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). At the time of the report, VACCINATION SITE REACTION (COVID ARM), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE RASH (Rash at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant details were provided   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Additional event added. On 03-Jul-2021: Follow-up received on 03-JUL-2021 updated reporter details, added patients date of birth, age at vaccination, batch number of vaccine and events onset date.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Muscle spasms, Nausea
Clinical narrative: fever; Nausea; Loss of appetite; Dry heaves; Still feeling weak; Chills; Arms spasms; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Arms spasms), DECREASED APPETITE (Loss of appetite), RETCHING (Dry heaves), ASTHENIA (Still feeling weak) and CHILLS (Chills) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced MUSCLE SPASMS (Arms spasms), ASTHENIA (Still feeling weak) and CHILLS (Chills). On 26-Jan-2021, the patient experienced DECREASED APPETITE (Loss of appetite), RETCHING (Dry heaves) and NAUSEA (Nausea). On an unknown date, the patient experienced PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at a dose of 1 dosage form. At the time of the report, MUSCLE SPASMS (Arms spasms), DECREASED APPETITE (Loss of appetite), RETCHING (Dry heaves), CHILLS (Chills) and NAUSEA (Nausea) was resolving and ASTHENIA (Still feeling weak) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2021: Follow up received and contains no new information.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Nausea  and chills are consistent with the known safety profile of mRNA-1273.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Retching
Clinical narrative: fever; Nausea; Loss of appetite; Dry heaves; Still feeling weak; Chills; Arms spasms; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Arms spasms), DECREASED APPETITE (Loss of appetite), RETCHING (Dry heaves), ASTHENIA (Still feeling weak) and CHILLS (Chills) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced MUSCLE SPASMS (Arms spasms), ASTHENIA (Still feeling weak) and CHILLS (Chills). On 26-Jan-2021, the patient experienced DECREASED APPETITE (Loss of appetite), RETCHING (Dry heaves) and NAUSEA (Nausea). On an unknown date, the patient experienced PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at a dose of 1 dosage form. At the time of the report, MUSCLE SPASMS (Arms spasms), DECREASED APPETITE (Loss of appetite), RETCHING (Dry heaves), CHILLS (Chills) and NAUSEA (Nausea) was resolving and ASTHENIA (Still feeling weak) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2021: Follow up received and contains no new information.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Nausea  and chills are consistent with the known safety profile of mRNA-1273.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Peripheral swelling, Photophobia
Clinical narrative: it was sore for a couple of days; sensitivity to light; headache; arm is swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is swollen), PAIN IN EXTREMITY (it was sore for a couple of days), PHOTOPHOBIA (sensitivity to light) and HEADACHE (headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PERIPHERAL SWELLING (arm is swollen). On 13-Feb-2021, the patient experienced PHOTOPHOBIA (sensitivity to light) and HEADACHE (headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (it was sore for a couple of days). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 14-Feb-2021, PHOTOPHOBIA (sensitivity to light) and HEADACHE (headache) had resolved. At the time of the report, PERIPHERAL SWELLING (arm is swollen) and PAIN IN EXTREMITY (it was sore for a couple of days) 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 which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache is consistent with the known safety profile of mRNA-1273.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Injection site erythema, Lymphadenopathy
Clinical narrative: Got redness dropped down from the bicep to the insight part of her arm, where the elbow bent; Lump on the bicep; Fever; Extreme chills; Headache; Swollen lymph node; Circles of redness on the injection site; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Got redness dropped down from the bicep to the insight part of her arm, where the elbow bent), MASS EXCISION (Lump on the bicep), PYREXIA (Fever), CHILLS (Extreme chills) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced ERYTHEMA (Got redness dropped down from the bicep to the insight part of her arm, where the elbow bent), MASS EXCISION (Lump on the bicep), PYREXIA (Fever), CHILLS (Extreme chills), HEADACHE (Headache), LYMPHADENOPATHY (Swollen lymph node) and INJECTION SITE ERYTHEMA (Circles of redness on the injection site). On 20-Feb-2021, PYREXIA (Fever), CHILLS (Extreme chills) and HEADACHE (Headache) had resolved. On 23-Feb-2021, ERYTHEMA (Got redness dropped down from the bicep to the insight part of her arm, where the elbow bent), MASS EXCISION (Lump on the bicep), LYMPHADENOPATHY (Swollen lymph node) and INJECTION SITE ERYTHEMA (Circles of redness on the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Chills, headache, axillary lymphadenopathy, injection site erythema and fever are consistent with the known safety profile of mRNA-1273.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Mass excision, Pyrexia
Clinical narrative: Got redness dropped down from the bicep to the insight part of her arm, where the elbow bent; Lump on the bicep; Fever; Extreme chills; Headache; Swollen lymph node; Circles of redness on the injection site; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Got redness dropped down from the bicep to the insight part of her arm, where the elbow bent), MASS EXCISION (Lump on the bicep), PYREXIA (Fever), CHILLS (Extreme chills) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced ERYTHEMA (Got redness dropped down from the bicep to the insight part of her arm, where the elbow bent), MASS EXCISION (Lump on the bicep), PYREXIA (Fever), CHILLS (Extreme chills), HEADACHE (Headache), LYMPHADENOPATHY (Swollen lymph node) and INJECTION SITE ERYTHEMA (Circles of redness on the injection site). On 20-Feb-2021, PYREXIA (Fever), CHILLS (Extreme chills) and HEADACHE (Headache) had resolved. On 23-Feb-2021, ERYTHEMA (Got redness dropped down from the bicep to the insight part of her arm, where the elbow bent), MASS EXCISION (Lump on the bicep), LYMPHADENOPATHY (Swollen lymph node) and INJECTION SITE ERYTHEMA (Circles of redness on the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Chills, headache, axillary lymphadenopathy, injection site erythema and fever are consistent with the known safety profile of mRNA-1273.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival discolouration, Hyperaesthesia teeth, Pyrexia
Clinical narrative: Sensitivity in her teeth; Discoloration near her gums; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERAESTHESIA TEETH (Sensitivity in her teeth), GINGIVAL DISCOLOURATION (Discoloration near her gums) and PYREXIA (Fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 02-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 03-Feb-2021, the patient experienced HYPERAESTHESIA TEETH (Sensitivity in her teeth), GINGIVAL DISCOLOURATION (Discoloration near her gums) and PYREXIA (Fever). At the time of the report, HYPERAESTHESIA TEETH (Sensitivity in her teeth), GINGIVAL DISCOLOURATION (Discoloration near her gums) and PYREXIA (Fever) outcome 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 which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Fever is consistent with the known safety profile of mRNA-1273.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vaccination site pain, Vaccination site swelling
Clinical narrative: dizziness; Injection site is painful; Injection site is swollen; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), VACCINATION SITE PAIN (Injection site is painful) and VACCINATION SITE SWELLING (Injection site is swollen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L02A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, ALBUTEROL [SALBUTAMOL], HYDRALAZINE, ALPRAZOLAM, CELECOXIB (CELEBREX), INSULIN GLARGINE (LANTUS) and INSULIN ASPART (NOVOLOG) for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced DIZZINESS (dizziness), VACCINATION SITE PAIN (Injection site is painful) and VACCINATION SITE SWELLING (Injection site is swollen). At the time of the report, DIZZINESS (dizziness), VACCINATION SITE PAIN (Injection site is painful) and VACCINATION SITE SWELLING (Injection site is swollen) 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 which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.  Vaccination site pain and vaccination site swelling are consistent with the known safety profile of mRNA-1273.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Coordination abnormal, Vaccination site pain
Clinical narrative: stumbled all over the place; pain at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of COORDINATION ABNORMAL (stumbled all over the place) and VACCINATION SITE PAIN (pain at the site of injection) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain at the site of injection).   On 05-Feb-2021, the patient experienced COORDINATION ABNORMAL (stumbled all over the place). The patient was treated with DIPHENHYDRAMINE CITRATE, IBUPROFEN (ADVIL PM [DIPHENHYDRAMINE CITRATE;IBUPROFEN]) for Adverse event, at an unspecified dose and frequency.   At the time of the report, COORDINATION ABNORMAL (stumbled all over the place) and VACCINATION SITE PAIN (pain at the site of injection) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Event outcome updated.; 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: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Fatigue, Pruritus, Swelling face
Clinical narrative: itch; fatigue; swelling face; Ear lobe swelling both; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelling face), EAR SWELLING (Ear lobe swelling both), PRURITUS (itch) and FATIGUE (fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20I) for COVID-19 vaccination.     The patient's past medical history included Cancer. Concurrent medical conditions included Allergy aggravated since 18-Feb-2021.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced SWELLING FACE (swelling face), EAR SWELLING (Ear lobe swelling both) and FATIGUE (fatigue). On 22-Feb-2021, the patient experienced PRURITUS (itch). At the time of the report, SWELLING FACE (swelling face), EAR SWELLING (Ear lobe swelling both), PRURITUS (itch) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medications were  provided by Reporter. No Treatment Medications were  provided by Reporter.   This case was linked to MOD-2021-096583 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: event outcome
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: High blood pressure; A spontaneous report was received from a consumer concerning a female  patient  of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events high blood pressure/hypertension.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011M204) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event, High blood pressure.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, high blood pressure was unknown.; Sender's Comments: There is not enough information to assess the reported event as critical details such as vaccine administration date, onset date of the event, patient's medical history and concomitant medications are lacking.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Mass, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Knot; Red/Pink; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Knot), VACCINATION SITE ERYTHEMA (Red/Pink) and VACCINATION SITE SWELLING (Swollen) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced MASS (Knot), VACCINATION SITE ERYTHEMA (Red/Pink) and VACCINATION SITE SWELLING (Swollen). On 22-Feb-2021, VACCINATION SITE ERYTHEMA (Red/Pink) and VACCINATION SITE SWELLING (Swollen) had resolved. At the time of the report, MASS (Knot) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: TCR