chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Palpitations, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Mild difficulty breathing), HEART RATE INCREASED (Had a fast hearbeat (strong palpitations)), HEART RATE IRREGULAR (Heart beats irregular), PALPITATIONS (Palpitation) and CHEST DISCOMFORT (Mild chest pressure) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Spinal cord disorder, Back pain, Muscle pain and Heart attack.    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 DYSPNOEA (Mild difficulty breathing), HEART RATE INCREASED (Had a fast hearbeat (strong palpitations)), HEART RATE IRREGULAR (Heart beats irregular), PALPITATIONS (Palpitation), CHEST DISCOMFORT (Mild chest pressure) and VACCINATION SITE PAIN (Arm is still a little sore from vaccination). On 10-Jan-2021, the patient experienced BACK PAIN (Backache) and MYALGIA (Muscle aches). On 09-Jan-2021, DYSPNOEA (Mild difficulty breathing), HEART RATE INCREASED (Had a fast hearbeat (strong palpitations)), HEART RATE IRREGULAR (Heart beats irregular), PALPITATIONS (Palpitation) and CHEST DISCOMFORT (Mild chest pressure) had resolved. At the time of the report, BACK PAIN (Backache) and MYALGIA (Muscle aches) outcome was unknown and VACCINATION SITE PAIN (Arm is still a little sore from vaccination) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current information and the 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: M
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Peripheral swelling
Clinical narrative: arm was pretty swollen; Redness; Arthritc pain went down metacarpal joint; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of   in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritic pains.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        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 information was reported.   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's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Rash, Somnolence
Clinical narrative: Eyes got swollen and swell shut day after; Bendadryl and Zyrtec has not helped just makes her sleepy; Rash that lasted for 15-30 min after vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EYE SWELLING (Eyes got swollen and swell shut day after), SOMNOLENCE (Bendadryl and Zyrtec has not helped just makes her sleepy) and RASH (Rash that lasted for 15-30 min after vaccine) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.  Concomitant products included MELATONIN and ALPRAZOLAM for an unknown indication.    On 05-Jan-2021 at 2:10 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced EYE SWELLING (Eyes got swollen and swell shut day after), SOMNOLENCE (Bendadryl and Zyrtec has not helped just makes her sleepy) and RASH (Rash that lasted for 15-30 min after vaccine). At the time of the report, EYE SWELLING (Eyes got swollen and swell shut day after) had not resolved, SOMNOLENCE (Bendadryl and Zyrtec has not helped just makes her sleepy) outcome was unknown and RASH (Rash that lasted for 15-30 min after vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   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: Body temperature, Cough, Fatigue, Headache, Hepatic pain
Clinical narrative: Severe body aches; Jaw aches; liver ache "like in the upper part of the abdomen"; Headache; Coughing; Fatigue; large, red induration at the injection site; large, red induration at the injection site; Fever; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (Severe body aches), PAIN IN JAW (Jaw aches), HEPATIC PAIN (liver ache "like in the upper part of the abdomen"), HEADACHE (Headache) and COUGH (Coughing) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 27-Apr-2020.    On 04-Jan-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Severe body aches), PAIN IN JAW (Jaw aches), HEPATIC PAIN (liver ache "like in the upper part of the abdomen"), HEADACHE (Headache), COUGH (Coughing), FATIGUE (Fatigue), VACCINATION SITE INDURATION (large, red induration at the injection site), VACCINATION SITE ERYTHEMA (large, red induration at the injection site) and PYREXIA (Fever). At the time of the report, PAIN (Severe body aches), PAIN IN JAW (Jaw aches), HEPATIC PAIN (liver ache "like in the upper part of the abdomen"), HEADACHE (Headache), COUGH (Coughing), FATIGUE (Fatigue), VACCINATION SITE INDURATION (large, red induration at the injection site), VACCINATION SITE ERYTHEMA (large, red induration at the injection site) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Body temperature: 101.7 °F.     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.; Reporter'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, Pain in jaw, Pyrexia, Vaccination site erythema, Vaccination site induration
Clinical narrative: Severe body aches; Jaw aches; liver ache "like in the upper part of the abdomen"; Headache; Coughing; Fatigue; large, red induration at the injection site; large, red induration at the injection site; Fever; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (Severe body aches), PAIN IN JAW (Jaw aches), HEPATIC PAIN (liver ache "like in the upper part of the abdomen"), HEADACHE (Headache) and COUGH (Coughing) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 27-Apr-2020.    On 04-Jan-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Severe body aches), PAIN IN JAW (Jaw aches), HEPATIC PAIN (liver ache "like in the upper part of the abdomen"), HEADACHE (Headache), COUGH (Coughing), FATIGUE (Fatigue), VACCINATION SITE INDURATION (large, red induration at the injection site), VACCINATION SITE ERYTHEMA (large, red induration at the injection site) and PYREXIA (Fever). At the time of the report, PAIN (Severe body aches), PAIN IN JAW (Jaw aches), HEPATIC PAIN (liver ache "like in the upper part of the abdomen"), HEADACHE (Headache), COUGH (Coughing), FATIGUE (Fatigue), VACCINATION SITE INDURATION (large, red induration at the injection site), VACCINATION SITE ERYTHEMA (large, red induration at the injection site) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Body temperature: 101.7 °F.     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.; Reporter'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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Hypoaesthesia, Skin discolouration, Tremor, Vein disorder
Clinical narrative: Swollen vein; Numbness; High blood pressure; Shaking; Area became numb; Area became bluish purple; A spontaneous report was received from a 72-year-old of female patient who developed swollen vein/ Vein disorder, numbness/ Hypoesthesia, high blood pressure/ Hypertension, shaking/ Tremor, Area became numb/ Hypoesthesia and area became bluish purple/ Skin discolouration   The patient's medical history included asthma, COPD, and osteoarthritis and the prior allergies of penicillin and antibiotics. Concomitant medication included thyroxine, benzonatate and Flovent.  On 07 Jan 2021 at 11:15 am, the patient received first dose of mRNA-1273 (Lot number: unknown) via unknown route left shoulder intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 07 Jan 2021, after receiving the first dose of mRNA-1273, the patients vein on left hand became so full, area between thumb and index finger became numb bluish purple within seconds. It was thick and full of blood, it become normal. Blood pressure was a little high because she was shaking. Veins became so bloated. Vein was visibly blue and swollen from hand to about the elbow.  Treatment for the event included Ice pack and Tylenol.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of events like swollen vein/ Vein disorder, numbness/ Hypoesthesia, high blood pressure/ Hypertension, shaking/ Tremor, Area became numb/ Hypoesthesia and area became bluish purple/ Skin discolouration were not reported.; Reporter's Comments: This case concerns a 72-year-old female who experienced NS unexpected events of vein blue and swollen (vein disorder), hypoaesthesia, skin discoloration, hypertension and tremor.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment included Tylenol. Event outcomes unknown. Based on 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: Arthralgia, Fatigue
Clinical narrative: Fatigue; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and ARTHRALGIA (Soreness) 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 (No medical history reported.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced FATIGUE (Fatigue) and ARTHRALGIA (Soreness). At the time of the report, FATIGUE (Fatigue) and ARTHRALGIA (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events of fatigue and arthralgia, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events of fatigue and arthralgia, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Maternal exposure during breast feeding, Vaccination site pain
Clinical narrative: Got vaccine and breast feeding her son; Mild fatigue; Soreness at the injection site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Got vaccine and breast feeding her son), FATIGUE (Mild fatigue) and VACCINATION SITE PAIN (Soreness at the injection site) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Gestational diabetes on 06-Sep-2020, Anemia on 06-Sep-2020 and Pre-eclampsia on 06-Sep-2020. Concurrent medical conditions included Breast feeding since 06-Sep-2020.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 06-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Got vaccine and breast feeding her son), FATIGUE (Mild fatigue) and VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Got vaccine and breast feeding her son) had resolved and FATIGUE (Mild fatigue) and VACCINATION SITE PAIN (Soreness at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Follow-up received on 31 Mar 2021 included no new information
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was very painful and she could hardly lift it/her arm pain and soreness was back; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm was very painful and she could hardly lift it/her arm pain and soreness was back) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included no adverse event (no medical history reported).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced PAIN IN EXTREMITY (Arm was very painful and she could hardly lift it/her arm pain and soreness was back). At the time of the report, PAIN IN EXTREMITY (Arm was very painful and she could hardly lift it/her arm pain and soreness was back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment for the event included Ibuprofen 800 milligrams.   Company comment: This case concerns a 71-year-old female who experienced a nonserious unexpected event of severe pain in extremity.  Event onset within a few hours on Day 1 after the first dose of mRNA-1273. Event resolved and then recurred on Day 8. Treatment with ibuprofen. Based on 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.; Reporter's Comments: This case concerns a 71-year-old female who experienced a nonserious unexpected event of severe pain in extremity.  Event onset within a few hours on Day 1 after the first dose of mRNA-1273. Event resolved and then recurred on Day 8. Treatment with ibuprofen. Based on 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 discharge
Clinical narrative: Product leaked out from his left arm at injection site; A spontaneous report  was received from a nurse concerning a 53-year-old, male patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced some of the product leaked out of his left arm at the injection site.   The patient's medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) on (date of vaccination not provided) in the left arm for prophylaxis of COVID-19 infection.   A nurse called to report that a patient who had received their first dose of the Moderna COVID-19 vaccine, experience some of the product leaking out of his left arm at the injection site. Nurse stated that the patient did not receive a full dose.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The events, some of the product leaked out of his left arm at the injection site, was considered resolved.  The reporter did not provide an assessment of the events, some of the product leaked out of his left arm at the injection site.; Reporter's Comments: This case concerns a 53 year old male patient who experienced a non-serious unexpected event of Vaccination site discharge.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Topical allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Topical allergic reaction) 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 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Topical allergic reaction). At the time of the report, HYPERSENSITIVITY (Topical allergic reaction) outcome was unknown.        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: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort
Clinical narrative: has a knot in his throat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL DISCOMFORT (has a knot in his throat) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Autism and GERD. Concurrent medical conditions included Drug allergy (Allergies to sulfa drugs.). Concomitant products included OMEPRAZOLE, ALPRAZOLAM (XANAX), GUANFACINE HYDROCHLORIDE (TENEX), CLONAZEPAM, DONEPEZIL HYDROCHLORIDE (ARICEPT), QUETIAPINE FUMARATE (SEROQUEL) and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 06-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 OROPHARYNGEAL DISCOMFORT (has a knot in his throat). At the time of the report, OROPHARYNGEAL DISCOMFORT (has a knot in his throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Case comment: 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.   Reporter did not allow further contact; Reporter'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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: itchy; Injection site warm; Swelling in the injection site (7 inches in length); Redness in the injection site; A spontaneous report  was received from a healthcare facility staff member concerning, a 29 years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness/vaccination site erythema and swelling/vaccination site swelling in the injection site (7 inches in length), grade III erythema/erythema, itchy/Pruritus. and injection site warm/vaccination site warmth.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 28 Dec 2020, approximately seven days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 4 Jan 2021, the patient experienced redness and swelling in the injection site (7 inches in length), erythema, warm and itchy. On 6 Jan 2021, the patient reported about their symptoms to the reporter (HCP). On 7 Jan 2021, the patient reported Minimum itching, not warm, less red and same size. Th The patient had No sign of Cellulitis and No pain. No laboratory details were provided.  Treatment information for the events provided by the reporter included Benadryl and Cold pack.  Action taken with mRNA-1273 in response to the events was unknown.   On 7 Jan 2021, the outcome of the events, redness and itchy, were considered resolving.  On 7 Jan 2021, the outcome of the event, swelling in the injection site (7 inches in length), was considered not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Palpitations
Clinical narrative: felt dizzy; heart was racing; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt dizzy) and PALPITATIONS (heart was racing) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced DIZZINESS (felt dizzy) and PALPITATIONS (heart was racing). On 05-Jan-2021, DIZZINESS (felt dizzy) and PALPITATIONS (heart was racing) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's medical history was not provided. No relevant concomitant medications were reported.   No treatment medications were given  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's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test positive, Ultrasound foetal
Clinical narrative: Pregnant/ maternal exposure; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant/ maternal exposure) in a 35-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy and Pregnancy. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for Anxiety depression, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 06-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 01-Sep-2020 and the estimated date of delivery was 16-Jun-2021. On 06-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant/ maternal exposure). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighteenth week of the pregnancy.  On 06-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant/ maternal exposure) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Oct-2020, Pregnancy test positive: positive (Positive) positive. On 14-Dec-2020, Ultrasound foetal: normal (normal) Normal.     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 treatment information was provided. It was reported that this was the third pregnancy and gestational age was 17 weeks of pregnancy. On 14 Dec 2020 Noninvasive prenatal testing was performed which showed low risk for genetic complication. Patient had two previous pregnancies which was live, full term birth and 36 weeks 4 days and was live and pre-term birth.   Case comment: This is a case of product exposure during pregnancy with no associated AEs for this 35-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 35-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of ARTHRALGIA (Shoulder sore) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hives and Angioedema. Concurrent medical conditions included Food allergy (Has had hives, angioedema in lips and tongue; and cheers swollen in the past) and Environmental allergy (Has had hives, angioedema in lips and tongue; and cheers swollen in the past).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced ARTHRALGIA (Shoulder sore). At the time of the report, ARTHRALGIA (Shoulder sore) 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.  Case comment: Based on the current available information and temporal association between the use of the product and the onset date of the event of arthralgia, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of arthralgia, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (adverse event). At the time of the report, ADVERSE EVENT (adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Gait disturbance, Joint stiffness, Pyrexia
Clinical narrative: Shaken so bad; Stiffness; Couldn't walk to the bathroom; Joint pain; Chills; Fever; A spontaneous report  was received from consumer concerning a 50Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Pyrexia, Tremor, Chills, Arthralgia, Joint stiffness and Gait disturbance.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 30-DEC-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:039k20A) intramuscularly in the Anatomical location unspecified for prophylaxis of COVID-19 infection.  On 30-DEC-2020, The patient experienced the events fever, shaken so bad with chills, could not walk to bathroom, joint pain and stiffness.   Laboratory details were not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   On 30-DEC-2020 the outcome of the events fever, shaken so bad with chills, could not walk to bathroom, joint pain and stiffness was unknown.  The reporter assessed the events fever, shaken so bad with chills, could not walk to bathroom, joint pain and stiffness related to study drug was unknown.; Reporter'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: Tremor
Clinical narrative: Shaken so bad; Stiffness; Couldn't walk to the bathroom; Joint pain; Chills; Fever; A spontaneous report  was received from consumer concerning a 50Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Pyrexia, Tremor, Chills, Arthralgia, Joint stiffness and Gait disturbance.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 30-DEC-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:039k20A) intramuscularly in the Anatomical location unspecified for prophylaxis of COVID-19 infection.  On 30-DEC-2020, The patient experienced the events fever, shaken so bad with chills, could not walk to bathroom, joint pain and stiffness.   Laboratory details were not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   On 30-DEC-2020 the outcome of the events fever, shaken so bad with chills, could not walk to bathroom, joint pain and stiffness was unknown.  The reporter assessed the events fever, shaken so bad with chills, could not walk to bathroom, joint pain and stiffness related to study drug was unknown.; Reporter'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: U
Vaccine: COVID19
Symptoms: Injection site extravasation
Clinical narrative: Had significant leakage from the sight of injection; A spontaneous report was received from a pharmacist concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and had significant leakage from the sight of injection.  No relevant medical history and concomitant medications were reported.  On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot number was unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient received the vaccine and had significant leakage at the sight of the injection. No treatment information was provided.  Action taken with mRNA-1273 in response to the event were not reported.   The outcome of the event had significant leakage from the sight of injection was considered to be resolved on an unspecified date.; Reporter's Comments: This concerns a patient of unknown age who received their first of two planned doses of mRNA-1273 (lot number was unknown) intramuscularly for prophylaxis of COVID-19 infection and had significant leakage at the sight of the injection. There were no reported adverse events associated with the event of injection site leaking.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: A spontaneous report was received from a physician, whose patient (age and gender are unknown) received Moderna's COVID-19 vaccine and experienced to feel ill. 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 their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection. After receiving the vaccine, the patient started to feel ill. Treatment for the event is unknown. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the event is 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: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram, Muscle spasms, Palpitations, SARS-CoV-2 test
Clinical narrative: Difficult to breathe; palpitations; spasms from midline to the back/complete muscle spasms in both legs/back spasms; A spontaneous report was received from a Health Care Professional Nurse on 06-jan-2021. The HCP was reporting on herself, a 53 year old patient who developed muscle spasms from the mid-line to the back and legs, difficulty breathing and palpitations.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included sertraline hydrochloride, montelukast sodium, fluoxetine hydrochloride, alprazolam, levothyroxine sodium and metformin.   On 30-dec-2020 at 9:30 am approximately 4 hours prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 (Batch number not provided ) for prophylaxis of COVID-19 infection in her left arm   The patient stated  approximately 4 hours after receiving the vaccine she started with muscle spasms from the mid line area to the back. She stated she started with palpitations, performed an EKG which resulted in a normal result. The palpitations remain unresolved. The next day the patient stated she took a muscle relaxer (type and dosage unknown) and this helped with the spasms. Subsequently the patient stated that two nights later she woke up with complete muscle spasms in both legs. She stated she increased her potassium (dose and schedule unknown). This morning , 05-jan-2021 the patient stated she started with the back spasm again saying that it was so hard that it made it difficult to breathe. She referred the sensation as when "someone hits you in the back and you cannot breathe". The patient stated she was tested yesterday (05JAN2021) for COVID and the result was negative. The patient also states that spasms have improved but are still present.    Action taken with the second dose of mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the event(s), muscle spasms from midline to back, difficulty breathing, palpitations and complete muscle spasms of both legs is unknown.; Reporter'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 pain
Clinical narrative: Arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm is sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concomitant products included ALENDRONATE SODIUM (FOSAMAX), LEVOTHYROXINE SODIUM (SYNTHROID), MULTIVITAMIN FOR WOMEN, FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA D), PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (SUDAFED PRESSURE + PAIN), MAGNESIUM, AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE (DYMISTA) and CHOLINE, SILICON (BIOSIL) for an unknown indication.    On 06-Jan-2021, 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 PAIN (Arm is sore). The patient was treated with NAPROXEN SODIUM (ALEVE) ongoing since an unknown date at a dose of 1 dosage form and MELATONIN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Arm is sore) 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: heat; rash; injection site swelling; redness on the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE WARMTH (heat), INJECTION SITE RASH (rash), INJECTION SITE SWELLING (injection site swelling) and INJECTION SITE ERYTHEMA (redness on the injection site) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included VITAMIN C [ASCORBIC ACID] and CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]) for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced INJECTION SITE WARMTH (heat), INJECTION SITE RASH (rash), INJECTION SITE SWELLING (injection site swelling) and INJECTION SITE ERYTHEMA (redness on the injection site). At the time of the report, INJECTION SITE WARMTH (heat), INJECTION SITE RASH (rash), INJECTION SITE SWELLING (injection site swelling) and INJECTION SITE ERYTHEMA (redness on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The events were treated with three doses of acetaminophen 325 mg. The patient also applied cold at the injection site.  Case comment: 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'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: Injection site erythema, Injection site pain, Pain, Pain in extremity
Clinical narrative: Hand pain; Throbbing in hand; Hand is like red; Burning sensation; A spontaneous report was received from a 54-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced throbbing, burning sensation, hand pain, and hand is like red.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) on her right hand for prophylaxis of COVID-19. She stated that her hand was like red and it was throbbing, had burning sensation and pain, red sharp pain. The patient took ibuprofen, which helped.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the events, throbbing, burning sensation, and hand pain, was resolving.; Reporter's Comments: This case concerns a 54-year-old, female patient, who experienced a non-serious unexpected event of pain in extremity and pain, and a non-serious expected events of injection site erythema, and injection site pain. The events occurred 1 day after first dose of mRNA-1273, lot # unknown. Treatment included Advil. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Feeling hot, Pain in extremity, Vaccination site movement impairment, Vaccination site rash
Clinical narrative: could barely lift my arm; warmth; A 2x3 inch red rash, hot to the touch; bruise that she got from the vaccine; severe pain the 1st day; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE RASH (A 2x3 inch red rash, hot to the touch), CONTUSION (bruise that she got from the vaccine), PAIN IN EXTREMITY (severe pain the 1st day), FEELING HOT (hot to the touch) and VACCINATION SITE MOVEMENT IMPAIRMENT (could barely lift my arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 030L20A) for COVID-19 vaccination.     No medical history was provide by the reporter.  Concurrent medical conditions included Drug allergy (Clindamycin). Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (VIENVA) from 01-Feb-2020 to an unknown date for Birth control.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Dec-2020, the patient experienced CONTUSION (bruise that she got from the vaccine) and PAIN IN EXTREMITY (severe pain the 1st day). On 05-Jan-2021, the patient experienced VACCINATION SITE RASH (A 2x3 inch red rash, hot to the touch) and FEELING HOT (hot to the touch). On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (could barely lift my arm). On 28-Dec-2020, PAIN IN EXTREMITY (severe pain the 1st day) had resolved. On 30-Dec-2020, CONTUSION (bruise that she got from the vaccine) had resolved. On 07-Jan-2021, VACCINATION SITE RASH (A 2x3 inch red rash, hot to the touch) had resolved. At the time of the report, FEELING HOT (hot to the touch) and VACCINATION SITE MOVEMENT IMPAIRMENT (could barely lift my arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Treatment details were not provided.    Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: Follow-up received on 01-May-2021: Dose added, action taken updated, and outcome. Product batch number. Added concomitant medication.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant and treatment information was provided.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this unknown age female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.