chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: Face numbness of unknown origin lately; an extremely heavy period that not only came two weeks early but still has yet to end; knot was red; burning feeling; knot was itchy; arm hurt; had a knot; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Face numbness of unknown origin lately) and MENSTRUATION IRREGULAR (an extremely heavy period that not only came two weeks early but still has yet to end) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Face numbness of unknown origin lately) and MENSTRUATION IRREGULAR (an extremely heavy period that not only came two weeks early but still has yet to end). At the time of the report, HYPOAESTHESIA (Face numbness of unknown origin lately) outcome was unknown and MENSTRUATION IRREGULAR (an extremely heavy period that not only came two weeks early but still has yet to end) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received on 07-JUN-2021 included additional AE information.; 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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: received 1st Moderna vaccine and is pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (received 1st Moderna vaccine and is pregnant) in a 31-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, full-term birth) on 07-Aug-2017. Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]) and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 06-Aug-2020 and the estimated date of delivery was 13-May-2021. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (received 1st Moderna vaccine and is pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy.  On 08-Jan-2021, EXPOSURE DURING PREGNANCY (received 1st Moderna vaccine and is pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2020, Pregnancy test: positive (Positive) Positive.     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 medication not reported.    Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: follow-up received on 10-JUN-2021 and contains no new infromation; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 31-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Injection site it is itchy; Arm was sore; A red dot around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Arm was sore), INJECTION SITE ERYTHEMA (A red dot around the injection site) and INJECTION SITE PRURITUS (Injection site it is itchy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced INJECTION SITE PAIN (Arm was sore) and INJECTION SITE ERYTHEMA (A red dot around the injection site). On 17-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Injection site it is itchy). At the time of the report, INJECTION SITE PAIN (Arm was sore), INJECTION SITE ERYTHEMA (A red dot around the injection site) and INJECTION SITE PRURITUS (Injection site it is itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (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.; 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: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Vaccination site pain
Clinical narrative: Lethargic; Tired all day; Tenderness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), FATIGUE (Tired all day) and VACCINATION SITE PAIN (Tenderness at the injection site) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LETHARGY (Lethargic), FATIGUE (Tired all day) and VACCINATION SITE PAIN (Tenderness at the injection site). At the time of the report, LETHARGY (Lethargic), FATIGUE (Tired all day) and VACCINATION SITE PAIN (Tenderness at the injection site) 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 medications were not reported. Treatment details not provided.    This case was linked to MOD21-074744 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Follow up was received on 13 Apr 2021 included no new information.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive after Moderna COVID vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive after Moderna COVID vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 SARS-COV-2 TEST POSITIVE (tested positive after Moderna COVID vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive after Moderna COVID vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     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 reported. No treatment information provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Pain in extremity, Pruritus
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (a little tenderness in the arm), pruritus (itching), induration (the arm is hard) and erythema (the arm is red) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 025L20A) for COVID-19 immunization. No medical history reported. On Jan 8, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 16, 2021, patient experienced pain in extremity (a little tenderness in the arm) and pruritus (itching). On Jan 18, 2021, patient experienced induration (the arm is hard) and erythema (the arm is red). At the time of the report, pain in extremity (a little tenderness in the arm), pruritus (itching), induration (the arm is hard) and erythema (the arm is red) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications or treatment information provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Hard circle near injection site; Redness/2 inches diameter red near injection site; Swollen near injection site; Vaccination site tenderness; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hard circle near injection site), VACCINATION SITE ERYTHEMA (Redness/2 inches diameter red near injection site), VACCINATION SITE SWELLING (Swollen near injection site), VACCINATION SITE PAIN (Vaccination site tenderness) and FATIGUE (Tiredness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Exercise induced asthma (mild) since 2010. Concomitant products included THERAGRAN M from 01-Jan-1978 to an unknown date for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site tenderness) and FATIGUE (Tiredness). On 18-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Hard circle near injection site), VACCINATION SITE ERYTHEMA (Redness/2 inches diameter red near injection site) and VACCINATION SITE SWELLING (Swollen near injection site). On 12-Jan-2021, VACCINATION SITE PAIN (Vaccination site tenderness) and FATIGUE (Tiredness) had resolved. On 25-Jan-2021, VACCINATION SITE INDURATION (Hard circle near injection site), VACCINATION SITE ERYTHEMA (Redness/2 inches diameter red near injection site) and VACCINATION SITE SWELLING (Swollen near injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment information was not provided.   This case was linked to MOD-2021-199359 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: No significant information was received.Reporter contact information is updated On 02-Jun-2021: Events and concomitant medication added, action taken, event information, patient information and reporter causality updated.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: Nauseous; Fatigue; A regulatory authority report was received from a health care professional concerning a 60-year old, female patient who received Moderna's COVID-19 Vaccine (m-RNA-1273) and experienced very nauseous and fatigue.    Concomitant medication was not reported.  On 13-Jan-2021, prior to the onset of the events, the patient received their first of two doses of mRNA-1273(Batch no: 41L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 15-Jan-2021 patient experienced very nauseous and fatigue and got better but still feels it.  The final diagnosis made on was Nausea and Fatigue.  Patient medical history and Lab data was not reported.  Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events was  Unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Her arm got very itchy at the injection site; Have big red oval shape at the injection site; injection site felt warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Her arm got very itchy at the injection site), VACCINATION SITE ERYTHEMA (Have big red oval shape at the injection site) and VACCINATION SITE WARMTH (injection site felt warm to the touch) in a 72-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. Concomitant products included SIMVASTATIN and VITAMINS NOS for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Her arm got very itchy at the injection site), VACCINATION SITE ERYTHEMA (Have big red oval shape at the injection site) and VACCINATION SITE WARMTH (injection site felt warm to the touch). On 19-Jan-2021, VACCINATION SITE ERYTHEMA (Have big red oval shape at the injection site) outcome was unknown. At the time of the report, VACCINATION SITE PRURITUS (Her arm got very itchy at the injection site) had not resolved and VACCINATION SITE WARMTH (injection site felt warm to the touch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were nor ptovided by reporter.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test, Prenatal screening test, Ultrasound scan
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 30-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 004m20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use. Family history included Hypercholesterolemia (cholesterol increases in pregnancy). Concurrent medical conditions included Sulfonamide allergy and Herpes simplex. Concomitant products included VALACYCLOVIR [VALACICLOVIR] from 2020 to an unknown date for Herpes simplex, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 2020 to an unknown date for an unknown indication.   On 29-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021 at 9:00 AM, 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 02-Dec-2020 and the estimated date of delivery was 08-Sep-2021. On 29-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighth week of the pregnancy. The patient gave birth to 1 neonate.  For neonate 1, the delivery occurred on an unknown date. For neonate 2, the vaginal delivery occurred on 15-Oct-2018, which was reported as Full-term. The outcome was reported as Delivered NOS. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2021, Pregnancy test: positive (Positive) Positive pregnancy test. On 25-Feb-2021, Ultrasound scan: normal (normal) normal growth. On 25-Mar-2021, Prenatal screening test: normal (normal) Normal. On 07-May-2021, Ultrasound scan: normal (normal) normal growth.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Estimated date of conception was on 20-DEC-2020 Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Significant follow up received on 06-AUG-2021. pregnancy report form  received provided patient demographics, second dose details, concomitant medications, lab tests, pregnancy details and medical history.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vertigo
Clinical narrative: Chronic headaches; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) and HEADACHE (Chronic headaches) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VERTIGO (Vertigo). On an unknown date, the patient experienced HEADACHE (Chronic headaches). The patient was treated with MECLIZINE HCL for Vertigo, at a dose of 1 dosage form. At the time of the report, VERTIGO (Vertigo) and HEADACHE (Chronic headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Event added.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: positive test for covid after receiving 1st dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (positive test for covid after receiving 1st dose of vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (positive test for covid after receiving 1st dose of vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (positive test for covid after receiving 1st dose of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Fatigue, Limb discomfort, Loss of personal independence in daily activities
Clinical narrative: lost of appetite; runny nose; feel very tired, has struggle doing anything; fever between 100.7- 100.8 °F; has struggle doing anything; sore right arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Jan-2021 and was forwarded to Moderna on 19-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (has struggle doing anything) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O12AO20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported historical condition). Concomitant products included Cholesterol medication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (has struggle doing anything). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (has struggle doing anything) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Body temperature: 100.7-100.8f (High) Since 15Jan2021, patient has been experiencing fever between 100.7- 100.8 °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.   Treatment taken included acetaminophen.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Initiative
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: lost of appetite; runny nose; feel very tired, has struggle doing anything; fever between 100.7- 100.8 °F; has struggle doing anything; sore right arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Jan-2021 and was forwarded to Moderna on 19-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (has struggle doing anything) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O12AO20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported historical condition). Concomitant products included Cholesterol medication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (has struggle doing anything). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (has struggle doing anything) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Body temperature: 100.7-100.8f (High) Since 15Jan2021, patient has been experiencing fever between 100.7- 100.8 °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.   Treatment taken included acetaminophen.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Initiative
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: woke up with swelling at the vaccine site and itching; woke up with swelling at the vaccine site and itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (woke up with swelling at the vaccine site and itching) and VACCINATION SITE SWELLING (woke up with swelling at the vaccine site and itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (woke up with swelling at the vaccine site and itching) and VACCINATION SITE SWELLING (woke up with swelling at the vaccine site and itching). At the time of the report, VACCINATION SITE PRURITUS (woke up with swelling at the vaccine site and itching) and VACCINATION SITE SWELLING (woke up with swelling at the vaccine site and itching) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: No significant information was received.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypokinesia, Pain, Pain in extremity
Clinical narrative: Injection site arm hurt; Could not lift injection site arm up straight above head; Injection site arm pain got progressively worse; Fatigue; A spontaneous report was received from a female patient concerning herself, a 82-year-old, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site arm hurt (Pain in extremity), not lift injection site arm up straight above head (Hypokinesia), injection site arm pain got progressively worse (pain) and fatigue (fatigue).    The patient's medical history was not provided. Concomitant product included latanoprost.  On an unknown date, the patient received the first of two planned doses of mRNA-1273 (Batch number: 013L20) via intravenous route in her left arm shoulder deltoid for prophylaxis of COVID-19 infection.  On an unspecified date, after vaccination the patient experienced some reactions including injection site arm hurt, not lift injection site arm up straight above head, injection site arm pain got progressively worse and fatigue. Treatment for the event was not provided.  Action taken with mRNA-1273 in response to the events were unknown.  The outcome of the events injection site arm hurt, not lift injection site arm up straight above head, injection site arm pain got progressively worse and fatigue were considered unknown.; Reporter's Comments: This case concerns an 82-year-old female who experienced NS unexpected events of pain in extremity, worsened pain, and hypokinesia, and NS expected fatigue. The events occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. 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.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Ultrasound foetal
Clinical narrative: Pregnancy Registry (Pregnant and received vaccine); This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy Registry (Pregnant and received vaccine)) in a 33-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use on 31-Oct-2020, Pregnancy (Live - full term birth) on 13-Nov-2018 and Complication of delivery (Past-due and low-amniotic fluid led to labor induction, high blood pressure) on 13-Nov-2018. Concurrent medical conditions included Seasonal allergy, Allergic asthma and Gluten sensitivity. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Seasonal allergy, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Vitamin supplementation.    On 28-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 09-Oct-2020 and the estimated date of delivery was 13-Jul-2021. On 28-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy Registry (Pregnant and received vaccine)). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixteenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 28-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy Registry (Pregnant and received vaccine)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Oct-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Ultrasound foetal: normal (normal) 172 heart rate at 7 weeks..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.  The estimated date of conception was reported as 31-Oct-2020. The patient had no maternal history of subfertility and had established prenatal care. There was no complications or acute illness reported during tis pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: firmness under the injection site; Rash; redness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDURATION (firmness under the injection site), INJECTION SITE RASH (Rash) and INJECTION SITE ERYTHEMA (redness) 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) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced INJECTION SITE INDURATION (firmness under the injection site), INJECTION SITE RASH (Rash) and INJECTION SITE ERYTHEMA (redness). At the time of the report, INJECTION SITE INDURATION (firmness under the injection site), INJECTION SITE RASH (Rash) and INJECTION SITE ERYTHEMA (redness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Contact information(email) was updated. NNI
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; A spontaneous report was received from a  Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient wanted to know if false positive test is possible after being tested COVID-19.    The patient's medical history was not provided. The patient's concomitant therapy is not given.    On 19/01/2021, the patient tested positive for COVID-19 after, the patient received their first of two planned doses of mRNA-1273.  On 19/01/2021, The patient was tested positive for covid-19 .  Laboratory detail are not provided.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events are not reported.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dysphonia, Fatigue, Gingival pain
Clinical narrative: nose was runny; voice was a little scratchy; Tired and nostalgic; bad headache; tenderness of her arms; Felt sick; Nauseous; throwing up; Fever; Shaking; teeth were clattering; Joints and elbow were hurting; Gums were hurting; Cheeks hurting; A spontaneous report was received from a consumer who was also a 60 year old female got the Moderna COVID-19 vaccine around 10:00 am on Jan13 in her left deltoid muscle at her house (foster care location).   Right after administration she did not feel anything besides tenderness of her arms but nothing bad. By 19:00 she felt so sick she did not want to eat; the smell of food was making her nauseous but forced herself to. By 21:00 she was throwing up her food, had a fever of 104 degrees F and was shaking. She drank tea to help but she couldn't hold the cup right because she was shaking, her teeth were clattering, and her joints and elbow were hurting even though her rheumatoid arthritis is under control. She also mentioned her cheeks and gums were hurting also. This lasted a total of two hours.   She took Tylenol also which helped. The next day she was feeling out of it, tired and nostalgic. She had a bad headache but the third day she was feeling better. Jan 15 she was feeling a little tired, but she was better overall. Now (Jan 19) she noticed her nose is runny and her voice is a little scratchy.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Nausea, Pain, Pain in extremity
Clinical narrative: nose was runny; voice was a little scratchy; Tired and nostalgic; bad headache; tenderness of her arms; Felt sick; Nauseous; throwing up; Fever; Shaking; teeth were clattering; Joints and elbow were hurting; Gums were hurting; Cheeks hurting; A spontaneous report was received from a consumer who was also a 60 year old female got the Moderna COVID-19 vaccine around 10:00 am on Jan13 in her left deltoid muscle at her house (foster care location).   Right after administration she did not feel anything besides tenderness of her arms but nothing bad. By 19:00 she felt so sick she did not want to eat; the smell of food was making her nauseous but forced herself to. By 21:00 she was throwing up her food, had a fever of 104 degrees F and was shaking. She drank tea to help but she couldn't hold the cup right because she was shaking, her teeth were clattering, and her joints and elbow were hurting even though her rheumatoid arthritis is under control. She also mentioned her cheeks and gums were hurting also. This lasted a total of two hours.   She took Tylenol also which helped. The next day she was feeling out of it, tired and nostalgic. She had a bad headache but the third day she was feeling better. Jan 15 she was feeling a little tired, but she was better overall. Now (Jan 19) she noticed her nose is runny and her voice is a little scratchy.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, Tremor, Vomiting
Clinical narrative: nose was runny; voice was a little scratchy; Tired and nostalgic; bad headache; tenderness of her arms; Felt sick; Nauseous; throwing up; Fever; Shaking; teeth were clattering; Joints and elbow were hurting; Gums were hurting; Cheeks hurting; A spontaneous report was received from a consumer who was also a 60 year old female got the Moderna COVID-19 vaccine around 10:00 am on Jan13 in her left deltoid muscle at her house (foster care location).   Right after administration she did not feel anything besides tenderness of her arms but nothing bad. By 19:00 she felt so sick she did not want to eat; the smell of food was making her nauseous but forced herself to. By 21:00 she was throwing up her food, had a fever of 104 degrees F and was shaking. She drank tea to help but she couldn't hold the cup right because she was shaking, her teeth were clattering, and her joints and elbow were hurting even though her rheumatoid arthritis is under control. She also mentioned her cheeks and gums were hurting also. This lasted a total of two hours.   She took Tylenol also which helped. The next day she was feeling out of it, tired and nostalgic. She had a bad headache but the third day she was feeling better. Jan 15 she was feeling a little tired, but she was better overall. Now (Jan 19) she noticed her nose is runny and her voice is a little scratchy.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Urticaria
Clinical narrative: A large welt; Itchy; Red; This spontaneous case was reported by a non-health professional and describes the occurrence of URTICARIA (A large welt), INJECTION SITE PRURITUS (Itchy) and INJECTION SITE ERYTHEMA (Red) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included CITALOPRAM HYDROBROMIDE 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 19-Jan-2021, the patient experienced URTICARIA (A large welt), INJECTION SITE PRURITUS (Itchy) and INJECTION SITE ERYTHEMA (Red). At the time of the report, URTICARIA (A large welt), INJECTION SITE PRURITUS (Itchy) and INJECTION SITE ERYTHEMA (Red) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2021: No specific follow-up information recorded.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-012697 (Linked Report).; Sender's Comments:  MOD-2021-012697:same reporter, different patient
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Maternal exposure during pregnancy, Myalgia, Pyrexia
Clinical narrative: Chills; Elevated fever for herself at 99.4-99.8F; 11 weeks pregnant; Felt achy; Sore arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (11 weeks pregnant), VACCINATION SITE PAIN (Sore arm), PYREXIA (Elevated fever for herself at 99.4-99.8F), CHILLS (Chills) and MYALGIA (Felt achy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.  On 25-Jan-2021 at 9:50 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 16-Aug-2021. On 25-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (11 weeks pregnant), VACCINATION SITE PAIN (Sore arm) and PYREXIA (Elevated fever for herself at 99.4-99.8F). On an unknown date, the patient experienced CHILLS (Chills) and MYALGIA (Felt achy). On 25-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (11 weeks pregnant) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore arm), PYREXIA (Elevated fever for herself at 99.4-99.8F), CHILLS (Chills) and MYALGIA (Felt achy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Body temperature: 99.4 °F (abnormal) elevated fever for herself at 99.4-99.8F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was 11 weeks of pregnant at time of vaccination. Concomitant product was not provided. Treatment medication was not reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Chills; Elevated fever for herself at 99.4-99.8F; 11 weeks pregnant; Felt achy; Sore arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (11 weeks pregnant), VACCINATION SITE PAIN (Sore arm), PYREXIA (Elevated fever for herself at 99.4-99.8F), CHILLS (Chills) and MYALGIA (Felt achy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.  On 25-Jan-2021 at 9:50 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 16-Aug-2021. On 25-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (11 weeks pregnant), VACCINATION SITE PAIN (Sore arm) and PYREXIA (Elevated fever for herself at 99.4-99.8F). On an unknown date, the patient experienced CHILLS (Chills) and MYALGIA (Felt achy). On 25-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (11 weeks pregnant) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore arm), PYREXIA (Elevated fever for herself at 99.4-99.8F), CHILLS (Chills) and MYALGIA (Felt achy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Body temperature: 99.4 °F (abnormal) elevated fever for herself at 99.4-99.8F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was 11 weeks of pregnant at time of vaccination. Concomitant product was not provided. Treatment medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: rash on her arm; hot; itchy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (rash on her arm), INJECTION SITE WARMTH (hot) and INJECTION SITE PRURITUS (itchy) 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 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE RASH (rash on her arm), INJECTION SITE WARMTH (hot) and INJECTION SITE PRURITUS (itchy). At the time of the report, INJECTION SITE RASH (rash on her arm), INJECTION SITE WARMTH (hot) and INJECTION SITE PRURITUS (itchy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid-19; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (covid-19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced COVID-19 (covid-19). At the time of the report, COVID-19 (covid-19) 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.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Throat irritation
Clinical narrative: sore throat; like a spot deep down inside the throat by the Adam's apple; burning sensation; sore throat; like a spot deep down inside the throat by the Adam's apple; burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat; like a spot deep down inside the throat by the Adam's apple; burning sensation) and THROAT IRRITATION (sore throat; like a spot deep down inside the throat by the Adam's apple; burning sensation) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concomitant products included METOPROLOL and TAMSULOSIN for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat; like a spot deep down inside the throat by the Adam's apple; burning sensation) and THROAT IRRITATION (sore throat; like a spot deep down inside the throat by the Adam's apple; burning sensation). At the time of the report, OROPHARYNGEAL PAIN (sore throat; like a spot deep down inside the throat by the Adam's apple; burning sensation) and THROAT IRRITATION (sore throat; like a spot deep down inside the throat by the Adam's apple; burning sensation) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow-up information received contains non-significant information. On 29-Jul-2021: Follow-up information: Updated outcome of the events.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: Site was warm a few days after receiving the vaccine; warm to touch on arm at site of injection; Some redness has developed in the arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Site was warm a few days after receiving the vaccine; warm to touch on arm at site of injection) and VACCINATION SITE ERYTHEMA (Some redness has developed in the arm at the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Latex allergy. Concomitant products included GLIPIZIDE, LEVOTHYROXINE SODIUM (SYNTHROID), FENOFIBRATE and LOSARTAN for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE WARMTH (Site was warm a few days after receiving the vaccine; warm to touch on arm at site of injection) and VACCINATION SITE ERYTHEMA (Some redness has developed in the arm at the injection site). On 27-Jan-2021, VACCINATION SITE WARMTH (Site was warm a few days after receiving the vaccine; warm to touch on arm at site of injection) and VACCINATION SITE ERYTHEMA (Some redness has developed in the arm at the injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment information included antihistamine and ice pack.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Follow-up received on 13-Apr-2021 included no new information. On 14-Jun-2021: New information included concomitant products.; 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.