chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Decreased appetite, Dyspnoea, Headache, Heart rate increased
Clinical narrative: Rapid heart beat; Chest pain; arm pain .pain 8/10; No appetite; Shortness of breath; Headache; Soreness in the arm  I received the vaccine; Numbness in my face; Did not sleep well last night; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), HEART RATE INCREASED (Rapid heart beat), CHEST PAIN (Chest pain), PAIN IN EXTREMITY (arm pain .pain 8/10) and HYPOAESTHESIA (Numbness in my face) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history provided).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 12-Jan-2021, the patient experienced HYPOAESTHESIA (Numbness in my face), INSOMNIA (Did not sleep well last night), HEADACHE (Headache) and INJECTION SITE PAIN (Soreness in the arm  I received the vaccine). On 13-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), PAIN IN EXTREMITY (arm pain .pain 8/10) and DECREASED APPETITE (No appetite). On an unknown date, the patient experienced HEART RATE INCREASED (Rapid heart beat). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and ALPRAZOLAM (XANAX) at an unspecified dose and frequency. On 12-Jan-2021, HYPOAESTHESIA (Numbness in my face) had resolved. At the time of the report, DYSPNOEA (Shortness of breath), HEART RATE INCREASED (Rapid heart beat), CHEST PAIN (Chest pain), PAIN IN EXTREMITY (arm pain .pain 8/10), INSOMNIA (Did not sleep well last night), DECREASED APPETITE (No appetite), HEADACHE (Headache) and INJECTION SITE PAIN (Soreness in the arm  I received the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant history provided patient has taken treatment with prescription; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pain, Insomnia, Pain in extremity
Clinical narrative: Rapid heart beat; Chest pain; arm pain .pain 8/10; No appetite; Shortness of breath; Headache; Soreness in the arm  I received the vaccine; Numbness in my face; Did not sleep well last night; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), HEART RATE INCREASED (Rapid heart beat), CHEST PAIN (Chest pain), PAIN IN EXTREMITY (arm pain .pain 8/10) and HYPOAESTHESIA (Numbness in my face) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history provided).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 12-Jan-2021, the patient experienced HYPOAESTHESIA (Numbness in my face), INSOMNIA (Did not sleep well last night), HEADACHE (Headache) and INJECTION SITE PAIN (Soreness in the arm  I received the vaccine). On 13-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), PAIN IN EXTREMITY (arm pain .pain 8/10) and DECREASED APPETITE (No appetite). On an unknown date, the patient experienced HEART RATE INCREASED (Rapid heart beat). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and ALPRAZOLAM (XANAX) at an unspecified dose and frequency. On 12-Jan-2021, HYPOAESTHESIA (Numbness in my face) had resolved. At the time of the report, DYSPNOEA (Shortness of breath), HEART RATE INCREASED (Rapid heart beat), CHEST PAIN (Chest pain), PAIN IN EXTREMITY (arm pain .pain 8/10), INSOMNIA (Did not sleep well last night), DECREASED APPETITE (No appetite), HEADACHE (Headache) and INJECTION SITE PAIN (Soreness in the arm  I received the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant history provided patient has taken treatment with prescription; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: Exposed to COVID; This spontaneous case was reported by a non-health professional and describes the occurrence of EXPOSURE TO SARS-COV-2 (Exposed to COVID) 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 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced EXPOSURE TO SARS-COV-2 (Exposed to COVID). On 13-Jan-2021, EXPOSURE TO SARS-COV-2 (Exposed to COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact; Sender's Comments: This case is under consideration for deletion.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Hot flush, Oropharyngeal pain
Clinical narrative: Light headedness; Sore throat; Hot Flashes; Fatigue; Headache; Soreness in the left arm; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Light headedness), OROPHARYNGEAL PAIN (Sore throat), HOT FLUSH (Hot Flashes), FATIGUE (Fatigue) and HEADACHE (Headache) in a 26-year-old female 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 No adverse event (No reported medical history). Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 10-Jan-2021 at 2:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Light headedness), OROPHARYNGEAL PAIN (Sore throat), HOT FLUSH (Hot Flashes), FATIGUE (Fatigue), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness in the left arm). At the time of the report, DIZZINESS (Light headedness), OROPHARYNGEAL PAIN (Sore throat), HOT FLUSH (Hot Flashes), FATIGUE (Fatigue), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness in the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.    Reporter did not allow further contact; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Light headedness; Sore throat; Hot Flashes; Fatigue; Headache; Soreness in the left arm; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Light headedness), OROPHARYNGEAL PAIN (Sore throat), HOT FLUSH (Hot Flashes), FATIGUE (Fatigue) and HEADACHE (Headache) in a 26-year-old female 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 No adverse event (No reported medical history). Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 10-Jan-2021 at 2:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Light headedness), OROPHARYNGEAL PAIN (Sore throat), HOT FLUSH (Hot Flashes), FATIGUE (Fatigue), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness in the left arm). At the time of the report, DIZZINESS (Light headedness), OROPHARYNGEAL PAIN (Sore throat), HOT FLUSH (Hot Flashes), FATIGUE (Fatigue), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness in the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.    Reporter did not allow further contact; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Influenza like illness, Pain, Pruritus
Clinical narrative: Redness in the stomach,red spot in left abdominal zone,redness growing; pain in the red spots; the red spots are itching and expanding; flu like symptoms; A spontaneous report was received from a consumer concerning a female patient of 86 year old, who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced event(s) Redness in the stomach,pain,itchiness,redness is growing, Red spots in the left abdominal zone, Itching in the red spots, Pain in the red spots, Red spots expanding and Flu like symptoms.  The patients medical history ,as provided by the reporter included hypertension.Concomitant medications reported included METROPROLOL 50 mg two times a day for hypertension,SATUTEN and AMLODIPINE,used for unknown indication.  On 12 jan 2021,at 2 pm, prior to the onset of events, the Patient received their first of two planned dose of mRNA-1273(Lot number: 026L20A ) vaccine through unknown route in the left arm for prophylaxis of COVID-19 infection.  On 12 jan 2021,patient experienced redness in her stomach, pain and itchiness. The redness was growing. Patient remained in the facility for 20 minutes to look after any allergic reaction. The patient left the facility ok. When arrived home,approximately 40 minutes after receiving the vaccine, patient noticed red spots in the left abdominal zone, starting under her breast and expanding to the ribs. This red spots are itching and expanding since then. The patient is also experienced pain in the spots and "flu-like"symptoms. Treatment for the event included Amphetamine C and an antihistaminic to treat the symptoms but on her own behalf.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  the outcome of the event(s) Redness in the stomach,pain,itchiness,redness is growing, Red spots in the left abdominal zone, Itching in the red spots, Pain in the red spots, Red spots expanding and Flu like symptoms was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot to the touch near the injection site; Itchy; swelling; Red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to the touch near the injection site), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (Red) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot to the touch near the injection site), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, VACCINATION SITE WARMTH (Hot to the touch near the injection site), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.   No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Body chills; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Body chills), HEADACHE (Headache) and PYREXIA (Fever) 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 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jan-2021, the patient experienced CHILLS (Body chills), HEADACHE (Headache) and PYREXIA (Fever). In January 2021, CHILLS (Body chills), HEADACHE (Headache) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  No concomitant medication was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Warmness at the injection site; Soreness at the injection site; Itchiness at the injection site; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE PAIN (Soreness at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE PAIN (Soreness at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE PAIN (Soreness at the injection site), VACCINATION SITE PRURITUS (Itchiness 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.       Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: Enlarged, tender submandibular lymph nodes (both sides); Mild, normal pain at the injection site area that lasted 2 days and resolved; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Enlarged, tender submandibular lymph nodes (both sides)) and VACCINATION SITE PAIN (Mild, normal pain at the injection site area that lasted 2 days and resolved) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis since 2018. Concomitant products included CERTOLIZUMAB PEGOL (CIMZIA) for Rheumatoid arthritis.    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 VACCINATION SITE PAIN (Mild, normal pain at the injection site area that lasted 2 days and resolved). On 13-Jan-2021, the patient experienced LYMPHADENOPATHY (Enlarged, tender submandibular lymph nodes (both sides)). The patient was treated with TRAMADOL at an unspecified dose and frequency. On 31-Dec-2020, VACCINATION SITE PAIN (Mild, normal pain at the injection site area that lasted 2 days and resolved) had resolved. At the time of the report, LYMPHADENOPATHY (Enlarged, tender submandibular lymph nodes (both sides)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Burning sensation, Contusion, Dizziness, Electrocardiogram
Clinical narrative: blood pressure 81 systolic; Dizziness/Lightheadedness; Injection site bruise; Very hungry; Felt abonormally cold; Pain with injection; Burning during injection; Not feeling 100% normal; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness/Lightheadedness), CONTUSION (Injection site bruise), BURNING SENSATION (Burning during injection), HUNGER (Very hungry) and FEELING COLD (Felt abonormally cold) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2020, the patient experienced FEELING ABNORMAL (Not feeling 100% normal). On 12-Jan-2021, the patient experienced BURNING SENSATION (Burning during injection) and VACCINATION SITE PAIN (Pain with injection). On 13-Jan-2021, the patient experienced DIZZINESS (Dizziness/Lightheadedness), CONTUSION (Injection site bruise), HUNGER (Very hungry), FEELING COLD (Felt abonormally cold) and HYPOTENSION (blood pressure 81 systolic). On 12-Jan-2021, BURNING SENSATION (Burning during injection) and VACCINATION SITE PAIN (Pain with injection) had resolved. On 13-Jan-2021, HYPOTENSION (blood pressure 81 systolic) outcome was unknown. At the time of the report, DIZZINESS (Dizziness/Lightheadedness), CONTUSION (Injection site bruise), HUNGER (Very hungry), FEELING COLD (Felt abonormally cold) and FEELING ABNORMAL (Not feeling 100% normal) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Blood pressure measurement: 1)81 systolic 2) Increased to 100 which is less than normal for her at 120/70, but better.. On 13-Jan-2021, Electrocardiogram: (normal) 1)Normal with exception of some "slight thing that went down and was basically insignificant. 2)Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included IV fluids, food and water. No concomitant medications were provided by reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold, Hunger, Hypotension, Vaccination site pain
Clinical narrative: blood pressure 81 systolic; Dizziness/Lightheadedness; Injection site bruise; Very hungry; Felt abonormally cold; Pain with injection; Burning during injection; Not feeling 100% normal; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness/Lightheadedness), CONTUSION (Injection site bruise), BURNING SENSATION (Burning during injection), HUNGER (Very hungry) and FEELING COLD (Felt abonormally cold) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2020, the patient experienced FEELING ABNORMAL (Not feeling 100% normal). On 12-Jan-2021, the patient experienced BURNING SENSATION (Burning during injection) and VACCINATION SITE PAIN (Pain with injection). On 13-Jan-2021, the patient experienced DIZZINESS (Dizziness/Lightheadedness), CONTUSION (Injection site bruise), HUNGER (Very hungry), FEELING COLD (Felt abonormally cold) and HYPOTENSION (blood pressure 81 systolic). On 12-Jan-2021, BURNING SENSATION (Burning during injection) and VACCINATION SITE PAIN (Pain with injection) had resolved. On 13-Jan-2021, HYPOTENSION (blood pressure 81 systolic) outcome was unknown. At the time of the report, DIZZINESS (Dizziness/Lightheadedness), CONTUSION (Injection site bruise), HUNGER (Very hungry), FEELING COLD (Felt abonormally cold) and FEELING ABNORMAL (Not feeling 100% normal) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Blood pressure measurement: 1)81 systolic 2) Increased to 100 which is less than normal for her at 120/70, but better.. On 13-Jan-2021, Electrocardiogram: (normal) 1)Normal with exception of some "slight thing that went down and was basically insignificant. 2)Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included IV fluids, food and water. No concomitant medications were provided by reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Dizzy) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced DIZZINESS (Dizzy). At the time of the report, DIZZINESS (Dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache/ Feels like headache is double today from yesterday; Fatigue/ Feels like Fatigue is double today from yesterday; This spontaneous case was reported by a health care professional and describes the occurrence of HEADACHE (Headache/ Feels like headache is double today from yesterday) and FATIGUE (Fatigue/ Feels like Fatigue is double today from yesterday) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.  On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 12-Jan-2021, the patient experienced HEADACHE (Headache/ Feels like headache is double today from yesterday) and FATIGUE (Fatigue/ Feels like Fatigue is double today from yesterday).   At the time of the report, HEADACHE (Headache/ Feels like headache is double today from yesterday) and FATIGUE (Fatigue/ Feels like Fatigue is double today from yesterday) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 34-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Graves' disease (Required medication modifications during pregnancy, otherwise fine) since 2006. Concomitant products included LEVOTHYROXINE for Thyroid disorder.   On 07-Jan-2021 at 6:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021 at 5:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 08-Oct-2020 and the estimated date of delivery was 02-Aug-2021. On 07-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirteenth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jul-2020, Ultrasound scan: normal (normal) Dating ultrasound, normal. On 03-Sep-2020, Ultrasound scan: normal (normal) Anatomy ultrasound, normal. On 17-Nov-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Blood test: normal (normal) Prenatal genetic screen at 11 weeks, blood test,normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had 1 previous live pregnancy.  Treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Reporter address added, Pregnancy information added, Medical history added, Lab data added, Product dose details updated, concomitant medication added and Vaccine facility information added.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 34-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Headache, Heart rate, Heart rate increased
Clinical narrative: pain in arm and big swollen; Irregular heartbeat, heart rate went up, rate was under 140; Blood pressure was high; Heart rate increased; mild headache; couldn't breathe; regular pain in arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PERIPHERAL SWELLING (pain in arm and big swollen), HEART RATE IRREGULAR (Irregular heartbeat, heart rate went up, rate was under 140), HYPERTENSION (Blood pressure was high) and HEART RATE INCREASED (Heart rate increased) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX (Shingles) on 16-Dec-2020. Concomitant products included FISH OIL, VITAMIN D [VITAMIN D NOS], VITAMIN C [ASCORBIC ACID], TOCOPHEROL (VITAMIN E [TOCOPHEROL]), COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE], SELENIUM and VITAMIN B COMPLEX for Supplementation therapy.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jan-2021, the patient experienced HYPERTENSION (Blood pressure was high) and HEART RATE INCREASED (Heart rate increased). On 12-Jan-2021, the patient experienced HEART RATE IRREGULAR (Irregular heartbeat, heart rate went up, rate was under 140). On 18-Jan-2021, the patient experienced PERIPHERAL SWELLING (pain in arm and big swollen). On 09-Jan-2021, HYPERTENSION (Blood pressure was high) had resolved. At the time of the report, PERIPHERAL SWELLING (pain in arm and big swollen) outcome was unknown and HEART RATE IRREGULAR (Irregular heartbeat, heart rate went up, rate was under 140) and HEART RATE INCREASED (Heart rate increased) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jan-2021, Blood pressure measurement: >150 (High) blood pressure was high over 150. On 09-Jan-2021, Heart rate: <140 (High) Heart rate went up and was below 140.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported that on the third day after the shot, her heart beat was 42 per minute to 85 per minute. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Patient demographics, medical history, product information, concomitant medications and event details 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.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Hypertension, Pain in extremity, Peripheral swelling
Clinical narrative: pain in arm and big swollen; Irregular heartbeat, heart rate went up, rate was under 140; Blood pressure was high; Heart rate increased; mild headache; couldn't breathe; regular pain in arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PERIPHERAL SWELLING (pain in arm and big swollen), HEART RATE IRREGULAR (Irregular heartbeat, heart rate went up, rate was under 140), HYPERTENSION (Blood pressure was high) and HEART RATE INCREASED (Heart rate increased) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX (Shingles) on 16-Dec-2020. Concomitant products included FISH OIL, VITAMIN D [VITAMIN D NOS], VITAMIN C [ASCORBIC ACID], TOCOPHEROL (VITAMIN E [TOCOPHEROL]), COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE], SELENIUM and VITAMIN B COMPLEX for Supplementation therapy.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jan-2021, the patient experienced HYPERTENSION (Blood pressure was high) and HEART RATE INCREASED (Heart rate increased). On 12-Jan-2021, the patient experienced HEART RATE IRREGULAR (Irregular heartbeat, heart rate went up, rate was under 140). On 18-Jan-2021, the patient experienced PERIPHERAL SWELLING (pain in arm and big swollen). On 09-Jan-2021, HYPERTENSION (Blood pressure was high) had resolved. At the time of the report, PERIPHERAL SWELLING (pain in arm and big swollen) outcome was unknown and HEART RATE IRREGULAR (Irregular heartbeat, heart rate went up, rate was under 140) and HEART RATE INCREASED (Heart rate increased) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jan-2021, Blood pressure measurement: >150 (High) blood pressure was high over 150. On 09-Jan-2021, Heart rate: <140 (High) Heart rate went up and was below 140.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported that on the third day after the shot, her heart beat was 42 per minute to 85 per minute. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Patient demographics, medical history, product information, concomitant medications and event details 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.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) in a 77-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 Vertigo. Concomitant products included LISINOPRIL and VERAPAMIL for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Soreness of arm; A spontaneous report was received from a 67-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness of arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: 026L20A) intramuscularly for prophylaxis of COVID-19.  On an unknown date, the patient experienced soreness of arm and inquired how long it would last. No treatment information provided.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the event, soreness of arm was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Vaccination site erythema, Vaccination site mass
Clinical narrative: itching of the right arm; headache; hot to touch injection site right arm; hard injection site right arm; swelling of the injection site was a little bigger than a silver dollar; A little nausea; Tired & fatigue; red injection site right arm; sore injection site right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to touch injection site right arm), VACCINATION SITE MASS (hard injection site right arm), VACCINATION SITE PRURITUS (itching of the right arm), FATIGUE (Tired & fatigue) and VACCINATION SITE ERYTHEMA (red injection site right arm) in a 68-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.     No Medical History information was reported.    On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced FATIGUE (Tired & fatigue), VACCINATION SITE ERYTHEMA (red injection site right arm), VACCINATION SITE PAIN (sore injection site right arm) and NAUSEA (A little nausea). On 05-Jan-2021, the patient experienced VACCINATION SITE WARMTH (hot to touch injection site right arm), VACCINATION SITE MASS (hard injection site right arm) and VACCINATION SITE SWELLING (swelling of the injection site was a little bigger than a silver dollar). On 06-Jan-2021, the patient experienced HEADACHE (headache). On 11-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching of the right arm). At the time of the report, VACCINATION SITE WARMTH (hot to touch injection site right arm), VACCINATION SITE MASS (hard injection site right arm), VACCINATION SITE PRURITUS (itching of the right arm), FATIGUE (Tired & fatigue), VACCINATION SITE ERYTHEMA (red injection site right arm), VACCINATION SITE PAIN (sore injection site right arm), VACCINATION SITE SWELLING (swelling of the injection site was a little bigger than a silver dollar), NAUSEA (A little nausea) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    Treatment information was not provided.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: itching of the right arm; headache; hot to touch injection site right arm; hard injection site right arm; swelling of the injection site was a little bigger than a silver dollar; A little nausea; Tired & fatigue; red injection site right arm; sore injection site right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to touch injection site right arm), VACCINATION SITE MASS (hard injection site right arm), VACCINATION SITE PRURITUS (itching of the right arm), FATIGUE (Tired & fatigue) and VACCINATION SITE ERYTHEMA (red injection site right arm) in a 68-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.     No Medical History information was reported.    On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced FATIGUE (Tired & fatigue), VACCINATION SITE ERYTHEMA (red injection site right arm), VACCINATION SITE PAIN (sore injection site right arm) and NAUSEA (A little nausea). On 05-Jan-2021, the patient experienced VACCINATION SITE WARMTH (hot to touch injection site right arm), VACCINATION SITE MASS (hard injection site right arm) and VACCINATION SITE SWELLING (swelling of the injection site was a little bigger than a silver dollar). On 06-Jan-2021, the patient experienced HEADACHE (headache). On 11-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching of the right arm). At the time of the report, VACCINATION SITE WARMTH (hot to touch injection site right arm), VACCINATION SITE MASS (hard injection site right arm), VACCINATION SITE PRURITUS (itching of the right arm), FATIGUE (Tired & fatigue), VACCINATION SITE ERYTHEMA (red injection site right arm), VACCINATION SITE PAIN (sore injection site right arm), VACCINATION SITE SWELLING (swelling of the injection site was a little bigger than a silver dollar), NAUSEA (A little nausea) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    Treatment information was not provided.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant of 24 weeks (second trimester); This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant of 24 weeks (second trimester)) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Fish allergy (Patient had allergy towards shell fish). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ENOXAPARIN SODIUM (LOVENOX HP) for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 07-May-2021. On 16-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant of 24 weeks (second trimester)). On 16-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant of 24 weeks (second trimester)) 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.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Follow up received as no new information.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 24-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination complication
Clinical narrative: symptoms of COVID; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (symptoms of COVID) 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 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION COMPLICATION (symptoms of COVID). On 02-Jan-2021, VACCINATION COMPLICATION (symptoms of COVID) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Negative.     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 medications details were not reported by the reporter. Treatment details was not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Hyperhidrosis, Pain, Pain in extremity
Clinical narrative: has weird reaction; left leg is sore like arm and can't move; The left side of her body is sore; really sweaty; hand is super hot and can't move it; This spontaneous case was reported by a health care professional and describes the occurrence of FEELING ABNORMAL (has weird reaction), PAIN IN EXTREMITY (left leg is sore like arm and can't move), PAIN (The left side of her body is sore), HYPERHIDROSIS (really sweaty) and FEELING HOT (hand is super hot and can't move it) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.  Concomitant products included AMOXICILLIN for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced FEELING ABNORMAL (has weird reaction), PAIN IN EXTREMITY (left leg is sore like arm and can't move), PAIN (The left side of her body is sore), HYPERHIDROSIS (really sweaty) and FEELING HOT (hand is super hot and can't move it). At the time of the report, FEELING ABNORMAL (has weird reaction), PAIN IN EXTREMITY (left leg is sore like arm and can't move), PAIN (The left side of her body is sore), HYPERHIDROSIS (really sweaty) and FEELING HOT (hand is super hot and can't move it) 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.   Treatment included ibuprofen 800mg and Tylenol 1000mg.; 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: Headache, Pain in extremity
Clinical narrative: Headache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache) and PAIN IN EXTREMITY (Sore arm). At the time of the report, HEADACHE (Headache) and PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.    Treatment medications were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.