chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain
Clinical narrative: Fatigued; Muscle pains in my legs/muscle pain all over body; Achy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of   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 (No medical history reported).    On 28-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Limb discomfort, Pain in extremity
Clinical narrative: Difficult to lift arm; Severe pain in injection site; Swelling at the injection site; Mild soreness in arm; A spontaneous report was received from a dentist, concerning herself, a 42-year-old, female patient, who received Moderna's COVID-19 vaccine and experienced mild soreness in the arm, difficult to lift arm, severe pain and swelling at the injection site.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 30-Dec-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On an unspecified date, after receiving the vaccine patient experienced soreness in the arm for two days and felt fine after that. Additionally, on 06-Jan-2021, the patient developed swelling and pain at the injection site and felt difficult to lift her arm. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of event, mild soreness in the arm was considered resolved on 01-Jan-2021. The outcome for the events, difficult to lift arm, severe pain and swelling at the injection site was unknown.; Reporter's Comments: A spontaneous report concerns a 42-year-old, female patient who experienced mild soreness in the arm, difficult to lift arm, severe pain and swelling at the injection site. The events occurred on an unknown day after the administration of the first dose of the mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown). No treatment was reported, and outcome is resolved. Based on the information provided, which includes a temporal association between the reported events and the administration of mRNA-1273 vaccine, a causal association cannot be excluded. The events injection site pain and injection site swelling are consistent with the known safety profile of mRNA-1273 vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: Lower eyelids were swollen; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of SWELLING OF EYELID (Lower eyelids were swollen) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for an unknown indication.     Concurrent medical conditions included Glaucoma. Concomitant products included BRIMONIDINE TARTRATE (ALPHAGAN) for Glaucoma.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced SWELLING OF EYELID (Lower eyelids were swollen). At the time of the report, SWELLING OF EYELID (Lower eyelids were swollen) 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.   Based on the information provided, a strong temporal association between the reported events and administration of mRNA-1273 vaccine, and excluding any other etiology, a causal association cannot be excluded; Reporter's Comments: Based on the information provided, a strong temporal association between the reported events and administration of mRNA-1273 vaccine, and excluding any other etiology, a causal association cannot be excluded
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Tongue spasm
Clinical narrative: numbness to the tip of tonge; cramps to the tip of tongue; This spontaneous case was reported by a nurse and describes the occurrence of HYPOAESTHESIA ORAL (numbness to the tip of tonge) and TONGUE SPASM (cramps to the tip of tongue) in a 52-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 07-Jan-2021 at 10:42 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced TONGUE SPASM (cramps to the tip of tongue). On 07-Jan-2021 at 11:32 AM, the patient experienced HYPOAESTHESIA ORAL (numbness to the tip of tonge). At the time of the report, HYPOAESTHESIA ORAL (numbness to the tip of tonge) and TONGUE SPASM (cramps to the tip of tongue) 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.   No concomitant medications were reported.  Treatment details were 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 events, a causal relationship cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, SARS-CoV-2 test positive, Vaccination site pain
Clinical narrative: metallic or saltytaste; tenderness at the injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of   in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 virus test positive in October 2020, Dyslipidemia and Hypothyroidism. Concurrent medical conditions included Loss of taste and Loss of smell. Concomitant products included PRAVASTATIN for Hyperlipidemia, LEVOTHYROXINE for Hypothyroidism, MULTIVITAMIN [ASCORBIC ACID;CALCIUM PANTOTHENATE;CHROMIUM;COLECALCIFEROL;COPPER;CYANOCOBALAMIN;FOLIC ACID;IODINE;IRON;MAGNESIUM;MANGANESE;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;SELENIUM;THIAMINE HYDROCHLORIDE;TOCOPHEROL;ZINC], VITAMIN D [VITAMIN D NOS] and PROBIOTICS NOS for an unknown indication.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, SARS-CoV-2 test positive: positive (Positive) Tested positive for COVID-19, specific date not provided..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   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.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Additional information added; 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
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Round red rash, swelling, and warmth at the injection site; Round red rash, swelling, and warmth at the injection site; Round red rash, swelling, and warmth at the injection site; Round red rash, swelling, and warmth at the injection site; A spontaneous report was received from a consumer concerning 4 patients who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a round red rash, swelling, and warmth at the injection site.  The patient's medical history was not included. Products known to have been used by the patient were not provided.  On an unknown date, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.    Approximately, 8-10 days after the vaccine was given, the patient developed a round red rash, swelling and warmth at the injection site. Treatment information was not provided.   Action taken with mRNA-1273 was not reported.  The outcome of the events, a round red rash, swelling, and warmth at the injection site were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 36-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Fertility testing. Family history included Diabetes (father) since an unknown date. Concurrent medical conditions included Pregnancy and Alcohol use (2 drinks/week). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, PROBIOTICS NOS and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 07-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 03-Aug-2020 and the estimated date of delivery was 11-May-2021. On 07-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy.  On 07-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 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.   Patient's mother has history of fertility treatment. Patient has history of Pre-term labor scare in 01 OCT 2018.  Treatment information for the event was not provided. Estimated date of conception on 15 Aug 2020  patient take Alcohol 2drinks/week; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 36-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pain in extremity
Clinical narrative: Injection site was red, swollen, and itching; Injection site was red, swollen, and itching; Injection site was red, swollen, and itching; Sore arm; A spontaneous report was received from a consumer concerning herself, a 46-year-old female patient, who received Moderna's COVID-19 vaccine and experienced injection site being red, swollen, itching and sore arm.  The patient's medical history was not provided.  Concomitant medications were not reported.  On 06-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273(Lot number: 025L20A) intramuscularly in the right arm as prophylaxis of COVID-19 infection.  On an unspecified date in Jan-2021, after receiving the first dose of vaccine, the patient had experienced sore arm for a few days.  On 14 Jan 2021, when patient woke-up, she had experienced injection site being red, swollen, and itching. Reporter provided consent to follow up. No treatment information was provided for the event.  Action taken for the events injection site being red, swollen, itching and sore arm were not reported.  The event, injection site being red, swollen and itching were considered to be not resolved. The event, sore arm, was considered to be resolved on an unspecified date in Jan-2021.; Reporter's Comments: This case concerns a 46 year-old, female patient, who experienced events of injection site being red, swollen, itching and sore arm.  The event of sore arm occurred for a few days after the first and only dose of mRNA-1273 vaccine administration. The events of injection site being red, swollen, itching  occurred 9 days after the first and only dose of mRNA-1273 vaccine administration. 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 and the events are assessed as possibly related.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: My arm was swollen. My arm swelled up.; It feels sore even now. It is not the whole arm. It is the fatty part of the arm.; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (My arm was swollen. My arm swelled up.) and PAIN IN EXTREMITY (It feels sore even now. It is not the whole arm. It is the fatty part of the arm.) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (medication history not provided).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced PERIPHERAL SWELLING (My arm was swollen. My arm swelled up.) and PAIN IN EXTREMITY (It feels sore even now. It is not the whole arm. It is the fatty part of the arm.). At the time of the report, PERIPHERAL SWELLING (My arm was swollen. My arm swelled up.) and PAIN IN EXTREMITY (It feels sore even now. It is not the whole arm. It is the fatty part of the arm.) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Arm was hot, red, and swollen around the place of shot; Arm was hot, red, and swollen around the place of shot; Arm was hot, red, and swollen around the place of shot; Headache; Tired; A spontaneous report was received from a consumer, concerning herself, a 39-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history included headche. No relevant concomitant medications were reported.   On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in the right upper arm for prophylaxis of COVID-19 infection.   On 31 Dec 2020, immediately post vaccination, the patient had a headache and tiredness for two days. On 07 Jan 2021, 7 days after vaccination patient noticed her vaccination site hot, red, and swollen. Patient's concern was possible infection at the administration site. Treatment for the events included hot packs, cold packs, ibuprofen, and diphenhydramine.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, headache and tiredness was resolved on 02 Jan 2021. The outcome of events vaccination site hot, red, and swollen were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Neck pain; A spontaneous report was received from a 24-year-old female male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced neck pain.   The patient's medical history was not provided. Concomitant medications were not reported.  On 03 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 026C20A) intramuscularly in arm for prophylaxis of COVID-19 infection.  On 04 Jan 2021, 24 hours post dose, the patient experienced neck pain. She described the pain as off and on for past four days.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event neck pain was unknown.; Reporter's Comments: This case concerns a 24-year-old female who experienced NS unexpected event of neck pain. Event onset occurred 2 days after the first dose of mRNA-1273. Treatment not reported. Event outcome 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Irritable bowel syndrome
Clinical narrative: irritable bowel syndrome; This spontaneous case was reported by a consumer and describes the occurrence of   in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Irritable bowel syndrome. Concomitant products included LOSARTAN for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included over the counter gas medicine (unspecified).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased
Clinical narrative: Blood sugar dropped to 33; A spontaneous report was received from a consumer concerning a 51-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced her blood sugar dropped to 33/blood sugar decreased.   The patient's medical history, as provided by the reporter, included Type 1 diabetes, acid reflux, blood pressure and cholesterol. Concomitant medications reported included insulin (via pump), lansoprazole, carvedilol, lisinopril, bupropion, simvastatin, multivitamin, vitamin C and vitamin D.  On 06 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot# unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 06 Jan 2021, prior to receiving the vaccine, her blood sugar was 92. She ate a little bit of carbohydrates beforehand as she didn't know how long it would take to receive her vaccine. She received the vaccine about 45 minutes after she ate and did not have any problems. On her way home, the patient didn't remember driving and didn't have recollection for ten miles. She stated that she parked at times and then drove at times. Finally, when the paramedics got to her, her blood sugar was at 33. She reported that she usually had seizures with such a low blood sugar, but did not that time. The patient also reported that the incident resolved within three hours. The patient spoke to her doctor and they advised her to get the second dose, but to start off with a higher blood sugar level.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, blood sugar dropped to 33, was resolved on 06 Jan 2021.; Reporter's Comments: The event was consistent with increased risk of complications associated with history of diabetes. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Redness at the injection site; Redness at the injection site; A spontaneous report was received from a consumer, concerning herself, an 81-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness at the injection site (onset 30-Dec-2020 and 07-Jan-2021).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 30-Dec-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 30-Dec-2020, after receiving the vaccine, the patient experienced redness at the injection site which had lasted for two days. On 07-Jan-2020 (yesterday), the event redness at the injection site had returned which was ongoing at the time of this report and patient has not tried any treatments for the same.   Action taken with mRNA-1273 in response to the events were not reported.   The event, redness at the injection site (30-Dec-2020) was considered resolved on 31-Dec-2020. The event, redness at the injection site (onset 07-Jan-2021) was considered not resolved at the time of this report.; Reporter's Comments: A spontaneous report concerns an 81-year-old female patient, who experienced redness at the injection site. The event occurred on the same day after the administration of the first dose of the mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown) and reoccurred 8 days later. No treatment was provided, and outcome was ongoing. Based on the information provided, which indicates a temporal association and redness occurring at the site of administration of mRNA-1273 vaccine, a causal association cannot be excluded. Redness at the injection site is consistent with the known safety profile of mRNA-1273 vaccine.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chills, Fatigue, Headache
Clinical narrative: Chest Tightness; Headache; Joint pain; Fever; Experienced chills; Fatigue; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CHEST DISCOMFORT (Chest Tightness), CHILLS (Experienced chills), FATIGUE (Fatigue), HEADACHE (Headache) and ARTHRALGIA (Joint pain) in a 47-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.     The patient's past medical history included COVID-19 (Past symptoms felt similar to her past diagnosis of Covid-19).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced CHILLS (Experienced chills) and FATIGUE (Fatigue). On 06-Jan-2021, the patient experienced CHEST DISCOMFORT (Chest Tightness), HEADACHE (Headache), ARTHRALGIA (Joint pain) and PYREXIA (Fever). On 07-Jan-2021, CHILLS (Experienced chills), HEADACHE (Headache), ARTHRALGIA (Joint pain) and PYREXIA (Fever) had resolved. At the time of the report, CHEST DISCOMFORT (Chest Tightness) and FATIGUE (Fatigue) 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.   Company Comment Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chest Tightness; Headache; Joint pain; Fever; Experienced chills; Fatigue; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CHEST DISCOMFORT (Chest Tightness), CHILLS (Experienced chills), FATIGUE (Fatigue), HEADACHE (Headache) and ARTHRALGIA (Joint pain) in a 47-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.     The patient's past medical history included COVID-19 (Past symptoms felt similar to her past diagnosis of Covid-19).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced CHILLS (Experienced chills) and FATIGUE (Fatigue). On 06-Jan-2021, the patient experienced CHEST DISCOMFORT (Chest Tightness), HEADACHE (Headache), ARTHRALGIA (Joint pain) and PYREXIA (Fever). On 07-Jan-2021, CHILLS (Experienced chills), HEADACHE (Headache), ARTHRALGIA (Joint pain) and PYREXIA (Fever) had resolved. At the time of the report, CHEST DISCOMFORT (Chest Tightness) and FATIGUE (Fatigue) 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.   Company Comment Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal sounds abnormal, Headache, Injection site pain, Pollakiuria
Clinical narrative: frequent urination/increase urination; soreness at injection site; gurgling on stomach; headache; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (frequent urination/increase urination), INJECTION SITE PAIN (soreness at injection site), GASTROINTESTINAL SOUNDS ABNORMAL (gurgling on stomach) and HEADACHE (headache) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 13-Jan-2021, the patient experienced POLLAKIURIA (frequent urination/increase urination), INJECTION SITE PAIN (soreness at injection site), GASTROINTESTINAL SOUNDS ABNORMAL (gurgling on stomach) and HEADACHE (headache).   At the time of the report, POLLAKIURIA (frequent urination/increase urination), INJECTION SITE PAIN (soreness at injection site), GASTROINTESTINAL SOUNDS ABNORMAL (gurgling on stomach) and HEADACHE (headache) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: NNI On 12-Apr-2021: Patient doesn't need further follow-up; 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; A spontaneous report was received from a consumer who was also a 36-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) while patient was pregnant/exposure during pregnancy.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  The patient received a positive pregnancy test on an unspecified date. Last menstrual date and conception date was not provided. The patient's estimated due date is on 18 Jun 2021.  On 13 Jan 2021 at 03:00 pm the patient was exposed to the mRNA-1273.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided. The event, vaccine exposure during pregnancy, was recovered on 13 Jan 2021.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 36-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 40-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy on 19-Nov-2015 and Miscarriage on 15-Jun-2020. Concurrent medical conditions included Vegetable allergy (Allergic to tomatoes), Pollen allergy (tree pollen), Allergy to molds, Drug allergy (Allergic to Advil/Aleve), Seasonal allergy (Gotten better over the pandemic), Migraine and Acid reflux (esophageal). Concomitant products included CALCIUM CARBONATE (ANTACID [CALCIUM CARBONATE]) from January 2020 to an unknown date for Acid reflux (esophageal), MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 2014 to an unknown date for Pregnancy, PROBIOTICS NOS from 2014 to an unknown date for an unknown indication.    On 11-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 15-Sep-2020 and the estimated date of delivery was 19-Jun-2021. On 11-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixteenth week of the pregnancy.  On 11-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she had grandparents who have had heart attacks, stroke, and Alzheimer's.   On 20-Nov-2020, lab test also included genetic test; however, the result was normal. Patient's estimated date of conception was on 26-Sep-2020. Number of fetus was found to be one. Previous pregnancies reported on 19-Nov-2015 with live full-term birth without complication and miscarriage on 15-Jun-2020.  Treatment information was not provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 40-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pain in extremity
Clinical narrative: Vaccine exposure during Pregnancy; arm soreness; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during Pregnancy) and PAIN IN EXTREMITY (arm soreness) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concomitant products included 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) (unknown route) 1 dosage form. The patient's last menstrual period was on 30-Sep-2020 and the estimated date of delivery was 07-Jul-2021. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during Pregnancy) and PAIN IN EXTREMITY (arm soreness). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy.  On 08-Jan-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during Pregnancy) had resolved. On 09-Jan-2021, PAIN IN EXTREMITY (arm soreness) 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.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 27-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Glucose tolerance test, Pregnancy test, Ultrasound scan
Clinical narrative: vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 29-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Obesity in 2012 and Alcohol use from 2011 to May 2020. Concurrent medical conditions included Sulfonamide allergy. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Nutritional supplement, VITAMIN D2 for Prophylaxis against vitamin deficiency.    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 15-Jun-2020 and the estimated date of delivery was 21-Mar-2021. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-ninth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jul-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Glucose tolerance test: normal (normal) normal. On an unknown date, Ultrasound scan: normal (normal) normal at 8, 12, and 20 weeks..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 29-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Illness, Nausea, Pyrexia
Clinical narrative: Sick; She was soak; Nausea; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), HYPERHIDROSIS (She was soak), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The medical history was not provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (ATORVASTIN), ACETYLSALICYLIC ACID (BABY ASPIRIN), AMLODIPINE BESYLATE and OMEPRAZOLE for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Fever). On an unknown date, the patient experienced ILLNESS (Sick) and HYPERHIDROSIS (She was soak). At the time of the report, ILLNESS (Sick), HYPERHIDROSIS (She was soak), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of the events included, ibuprofen. 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.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Follow up information was received on 30 Mar 2021; included,  patient reported that she do not have a primary doctor he retired.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: lost sense of smell; This spontaneous case was reported by an other health care professional and describes the occurrence of ANOSMIA (lost sense of smell) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L00A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2020.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced ANOSMIA (lost sense of smell). At the time of the report, ANOSMIA (lost sense of smell) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This spontaneous case was reported by an other health care professional and describes the occurrence of ANOSMIA (lost sense of smell) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L00A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2020.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced ANOSMIA (lost sense of smell). At the time of the report, ANOSMIA (lost sense of smell) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Momentary soreness in his arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Momentary soreness in his arm) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Concussion (had  a couple of concussions (dates unknown).) and Surgery (had a couple of surgeries (dates unknown),). Concurrent medical conditions included Prostate cancer (prostate cancer (5 or 6 years ago)) and Drug allergy (patient has medication allergy to Tegretol (carbamazepine) and sulfa drugs).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 02-Jan-2021, the patient experienced PAIN IN EXTREMITY (Momentary soreness in his arm). At the time of the report, PAIN IN EXTREMITY (Momentary soreness in his arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included anti-hormonal medication once a day (unknown name) for prostate cancer.  The patient had no lasting muscle soreness.   No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: Swelling at the site that was about 2.5 inches in diameter; A spontaneous report was received from a consumer, concerning herself, a female patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed swelling at the site that was about 2.5 inches in diameter.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 31-Dec-2020, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly for prophylaxis of COVID-19.  On an unknown date, the patient stated that, still she has swelling at the site that was about 2.5 inches in diameter and does not have any pain. No treatment information provided.   Action taken with mRNA-1273 in response to the event were not reported.   The outcome for the event, swelling at the site that was about 2.5 inches in diameter was considered not resolved at the time of this report.; Reporter's Comments: A spontaneous report concerns a female patient of unspecified age, who developed swelling at the site that was about 2.5 inches in diameter. The event occurred on an unknown day day after the administration of the first dose of the mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown). Based on the information provided, which indicates the location of the swelling at the site of administration of mRNA-1273 vaccine, a causal association cannot be excluded. Swelling at the injection site is consistent with the known safety profile of mRNA-1273 vaccine.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes on neck and jaw; A spontaneous report was received from a consumer concerning a 75-years-old, male patient who received Moderna's COVID-19 Vaccine, and who experienced swollen lymph nodes on the neck and under the jaw.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 05 Jan 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 012L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 06 Jan 2021, the patient experienced swollen lymph nodes on the neck and under the jaw after vaccination. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event swollen lymph nodes on the neck and under the jaw was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: hot lump at injection site; sore arm; Upper arm itching; Hard lump at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot lump at injection site), VACCINATION SITE PAIN (sore arm), VACCINATION SITE PRURITUS (Upper arm itching) and VACCINATION SITE INDURATION (Hard lump at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Upper arm itching) and VACCINATION SITE INDURATION (Hard lump at injection site). On an unknown date, the patient experienced VACCINATION SITE WARMTH (hot lump at injection site) and VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE WARMTH (hot lump at injection site), VACCINATION SITE PRURITUS (Upper arm itching) and VACCINATION SITE INDURATION (Hard lump at injection site) outcome was unknown and VACCINATION SITE PAIN (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.   Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Pyrexia, Tremor
Clinical narrative: Shoulder pain; Fever; hurt so bad, she's never had so much pain in her back, it felt like a truck ran her over; body had a shaky attack; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (hurt so bad, she's never had so much pain in her back, it felt like a truck ran her over), TREMOR (body had a shaky attack), PYREXIA (Fever) and ARTHRALGIA (Shoulder pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart murmur. Concomitant products included GABAPENTIN and TRAMADOL for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced TREMOR (body had a shaky attack). On 06-Jan-2021, the patient experienced BACK PAIN (hurt so bad, she's never had so much pain in her back, it felt like a truck ran her over). On 07-Jan-2021, the patient experienced PYREXIA (Fever). On 08-Jan-2021, the patient experienced ARTHRALGIA (Shoulder pain). On 05-Jan-2021, TREMOR (body had a shaky attack) had resolved. On 08-Jan-2021, BACK PAIN (hurt so bad, she's never had so much pain in her back, it felt like a truck ran her over) and PYREXIA (Fever) had resolved. At the time of the report, ARTHRALGIA (Shoulder pain) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.