chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: wanted to report that is pregnant and received the vaccine; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (wanted to report that is pregnant and received the vaccine) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 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 an unknown date and the estimated date of delivery was 22-Apr-2021. On 08-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (wanted to report that is pregnant and received the vaccine). On 08-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (wanted to report that is pregnant and received the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   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
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site mass
Clinical narrative: Growing lump around the injection site; Itchiness around the injection site; Redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Growing lump around the injection site), INJECTION SITE PRURITUS (Itchiness around the injection site) and INJECTION SITE ERYTHEMA (Redness around the injection site) 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 06-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 VACCINATION SITE MASS (Growing lump around the injection site), INJECTION SITE PRURITUS (Itchiness around the injection site) and INJECTION SITE ERYTHEMA (Redness around the injection site). At the time of the report, VACCINATION SITE MASS (Growing lump around the injection site), INJECTION SITE PRURITUS (Itchiness around the injection site) and INJECTION SITE ERYTHEMA (Redness around the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: some pain in arm; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (some pain in arm) in a male patient of an unknown age 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) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (some pain in arm). At the time of the report, VACCINATION SITE PAIN (some pain in arm) outcome was unknown. Not Provided      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.   No relevant 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 dates of the event, a causal relationship cannot be excluded.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: 22 weeks pregnant; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (22 weeks pregnant) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in August 2020 and the estimated date of delivery was 15-May-2021. In August 2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (22 weeks pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (22 weeks pregnant) had resolved. 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.   No concomitant and treatment information was provided.; Sender's Comments: Based on the current available information and the temporal association between the product sue and the start date of the event a causal relationship cannot be excluded.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Discomfort, Pyrexia
Clinical narrative: mild discomfort; chills; feverish condition 100.5; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (mild discomfort), CHILLS (chills) and PYREXIA (feverish condition 100.5) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) 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 an unknown date, the patient experienced DISCOMFORT (mild discomfort), CHILLS (chills) and PYREXIA (feverish condition 100.5). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at an unspecified dose and frequency and PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DISCOMFORT (mild discomfort) and CHILLS (chills) outcome was unknown and PYREXIA (feverish condition 100.5) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Body temperature: 100.5 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided 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 these events, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Diabetes.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). On 12-Jan-2021, DIARRHOEA (Diarrhea) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported included unspecified  diabetic pills, blood thinners and high blood pressure pills. 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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance test, Maternal exposure during pregnancy, Pregnancy test, Prenatal screening test, Ultrasound scan
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 31-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (1 drink/week) on 15-May-2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 14-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 16-May-2020 and the estimated date of delivery was 20-Feb-2021. On 14-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fourth week of the pregnancy.  On 14-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2020, Pregnancy test: positive (Positive) positive. On an unknown date, Glucose tolerance test: normal (normal) normal. On an unknown date, Prenatal screening test: normal (normal) Normal   Quad screen  (also known as the quadruple marker test, the second trimester screen or simply the quad test  is a prenatal test that measures levels of four substances in pregnant women's blood). On an unknown date, Ultrasound scan: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  Estimated date of conception reported as 01-Jun-2020. Previous pregnancy was ended on 22-Jan-2019 with full-term live birth without any complications.; 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: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site rash
Clinical narrative: Rash around the injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE RASH (Rash around the injection site) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included SERTRALINE and BUSPIRONE HYDROCHLORIDE (BUSPAR) for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2020, the patient experienced PAIN IN EXTREMITY (Sore arm). On 07-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash around the injection site). On 31-Dec-2020, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, VACCINATION SITE RASH (Rash around 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.   Based on the established safety profile and a strong temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded. Rash at the injection site is consistent with the known safety profile of the vaccine.; Reporter's Comments: Based on the established safety profile and a strong temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded. Rash at the injection site is consistent with the known safety profile of the vaccine.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Dizziness
Clinical narrative: Dizziness; Weakness; Disoriented; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness) and CONFUSIONAL STATE (Disoriented) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No medical history reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness) and CONFUSIONAL STATE (Disoriented). At the time of the report, DIZZINESS (Dizziness), ASTHENIA (Weakness) and CONFUSIONAL STATE (Disoriented) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medication was not reported.  Treatment information was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Light chills for the first hour, gone now; This spontaneous case was reported by a non-health professional and describes the occurrence of CHILLS (Light chills for the first hour, gone now) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Light chills for the first hour, gone now). At the time of the report, CHILLS (Light chills for the first hour, gone now) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site is itchy; injection site swollen; injection site red; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site is itchy), PYREXIA (Fever), VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE ERYTHEMA (injection site red) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced PYREXIA (Fever). On 07-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (injection site is itchy), VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE ERYTHEMA (injection site red). On 30-Dec-2020, PYREXIA (Fever) had resolved. On 07-Jan-2021, VACCINATION SITE PRURITUS (injection site is itchy), VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE ERYTHEMA (injection site red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included advil to treat her fever the night of the injection.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance test, Maternal exposure during pregnancy, Prenatal screening test, Scan
Clinical narrative: vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 35-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage (In NOV-2019, at 8 or 9 weeks), Alcohol use (1-2 glasses of wine a week.) and Delivery (Pregnancy outcome: Live, full-term birth) on 21-Nov-2017. Concurrent medical conditions included Hypothyroidism since 2017. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and LEVOTHYROXINE for an unknown indication.    On 07-Jan-2021 at 9:00 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 02-Feb-2021. On 07-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 07-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Glucose tolerance test: normal (normal) normal. On an unknown date, Prenatal screening test: normal (normal) Normal. On an unknown date, Scan: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 35-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: Received vaccine while breastfeeding; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Received vaccine while breastfeeding) 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 effect (No reported medical history).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Received vaccine while breastfeeding). On 06-Jan-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Received vaccine while breastfeeding) 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.   Treatment information was not provided  This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.   Reporter did not allow further contact; Reporter's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Area was also warm; Area was also itchy; Red circle at the injection site; Injection site swollen; Injection site soreness; Injection site sensitivity; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Injection site sensitivity), VACCINATION SITE WARMTH (Area was also warm), VACCINATION SITE PRURITUS (Area was also itchy), VACCINATION SITE ERYTHEMA (Red circle at the injection site) and VACCINATION SITE SWELLING (Injection site swollen) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Obesity.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced VACCINATION SITE REACTION (Injection site sensitivity) and VACCINATION SITE PAIN (Injection site soreness). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Area was also warm), VACCINATION SITE PRURITUS (Area was also itchy), VACCINATION SITE ERYTHEMA (Red circle at the injection site) and VACCINATION SITE SWELLING (Injection site swollen). At the time of the report, VACCINATION SITE REACTION (Injection site sensitivity), VACCINATION SITE WARMTH (Area was also warm), VACCINATION SITE PRURITUS (Area was also itchy), VACCINATION SITE ERYTHEMA (Red circle at the injection site), VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE PAIN (Injection site soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment medication included Doxycycline.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Area was also warm; Area was also itchy; Red circle at the injection site; Injection site swollen; Injection site soreness; Injection site sensitivity; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Injection site sensitivity), VACCINATION SITE WARMTH (Area was also warm), VACCINATION SITE PRURITUS (Area was also itchy), VACCINATION SITE ERYTHEMA (Red circle at the injection site) and VACCINATION SITE SWELLING (Injection site swollen) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Obesity.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced VACCINATION SITE REACTION (Injection site sensitivity) and VACCINATION SITE PAIN (Injection site soreness). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Area was also warm), VACCINATION SITE PRURITUS (Area was also itchy), VACCINATION SITE ERYTHEMA (Red circle at the injection site) and VACCINATION SITE SWELLING (Injection site swollen). At the time of the report, VACCINATION SITE REACTION (Injection site sensitivity), VACCINATION SITE WARMTH (Area was also warm), VACCINATION SITE PRURITUS (Area was also itchy), VACCINATION SITE ERYTHEMA (Red circle at the injection site), VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE PAIN (Injection site soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment medication included Doxycycline.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Real painful golf-ball sized clavicle lymph node; Golf-ball sized clavicle lymph node/lymph node was swollen; 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) and who experienced golf-ball sized clavicle lymph node/ lymphadenopathy and real painful golf-ball sized clavicle lymph node/ lymph node pain.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 03 Jan 2021, approximately 5 days prior to the onset of the symptoms, the patient received their unknown dose of two planned doses of mRNA-1273 (Batch number: 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 07 Jan 2021, patient had a golf-ball sized clavicle lymph node. The patient had a hospital visit and 2 doctors confirmed patient's lymph node is swollen on clavicle nd it is painful.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events was 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 events, a causal relationship cannot be excluded. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm is hurting; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced arm was hurting.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received a dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date the patient's partner reported their arm was hurting after getting the vaccine. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event was unknown.; Reporter's Comments: This case concerns a female patient, who experienced an event of arm was hurting. The event occurred 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: Abdominal pain upper, Dyspepsia, Flatulence, Muscle spasms
Clinical narrative: Stomach pain; Cramp; Indigestion; Flatulence; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), MUSCLE SPASMS (Cramp), DYSPEPSIA (Indigestion) and FLATULENCE (Flatulence) 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 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 ABDOMINAL PAIN UPPER (Stomach pain), MUSCLE SPASMS (Cramp), DYSPEPSIA (Indigestion) and FLATULENCE (Flatulence). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain) had resolved and MUSCLE SPASMS (Cramp), DYSPEPSIA (Indigestion) and FLATULENCE (Flatulence) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Lymphadenopathy, Pyrexia
Clinical narrative: 106 F fever; Swollen right armpit with size just under an egg; A spontaneous report was received from a consumer concerning a 52-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 106F and swollen right armpit with size just under an egg.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 07 Jan 2021, approximately two days prior to onset of the event, the patient received their dose of mRNA-1273 (lot/batch number: unknown) on intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 08 Jan 2021, the patient had 106 F fever and swollen right armpit with size just under an egg. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events 106 F fever and swollen right armpit with size just under an egg was not reported.; Reporter's Comments: Based on the established safety profile and a temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded. Fever and axillary lymphadenopathy is consistent with the known safety profile of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Bottom back of the spine hurting; A spontaneous report was received from a consumer concerning a female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced bottom back of the spine hurting.  The patient's medical history was not provided. Concomitant product use was not provided.  On an unknown date, the patient received an unknown dose of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection.   On an unknonwn date, the patient began to experience pain at the bottom back of her spine after receiving the vaccine. Treatment information was not provided  Action taken with mRNA-1273 in response to the events was not provided.   The event, bottom back of the spine hurting, was considered 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 event, a causal relationship cannot be excluded.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: Headache; Low grade fever 99.8 or there about; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (Headache) and PYREXIA (Low grade fever 99.8 or there about) in a 67-year-old male patient 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 06-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 HEADACHE (Headache) and PYREXIA (Low grade fever 99.8 or there about). On 08-Jan-2021, HEADACHE (Headache) and PYREXIA (Low grade fever 99.8 or there about) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Body temperature: 99.8 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included acetaminophen for the events.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness Near Injection Site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness Near Injection Site). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain, at an unspecified dose and frequency. On 13-Jan-2021, VACCINATION SITE PAIN (Soreness Near Injection Site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.; 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Myalgia, Nasal congestion
Clinical narrative: Sneezing; Head cold; Little cough; scratchy throat; scratchy sore throat; stuffed nose; Sore arm/pain in her arm; runny nose; chills; Feeling achy; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever), MYALGIA (Feeling achy), PAIN IN EXTREMITY (Sore arm/pain in her arm), CHILLS (chills) and NASAL CONGESTION (stuffed nose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Hypercholesteremia. Concomitant products included SIMVASTATIN for Hypercholesteraemia, METOPROLOL and OLMESARTAN for Hypertension.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PYREXIA (Low grade fever), MYALGIA (Feeling achy), CHILLS (chills) and RHINORRHOEA (runny nose). On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm/pain in her arm). On 10-Jan-2021, the patient experienced NASAL CONGESTION (stuffed nose), SNEEZING (Sneezing), NASOPHARYNGITIS (Head cold), COUGH (Little cough), THROAT IRRITATION (scratchy throat) and OROPHARYNGEAL PAIN (scratchy sore throat). The patient was treated with PARACETAMOL (TYLENOL) on 07-Jan-2021 for Adverse event, at a dose of UNK dosage form (2 doses at night); PARACETAMOL (TYLENOL) on 08-Jan-2021 for Adverse event, at a dose of UNK dosage form (2 doses) and PARACETAMOL (TYLENOL) on 09-Jan-2021 for Adverse event, at a dose of UNK dosage form (2 doses). At the time of the report, PYREXIA (Low grade fever), MYALGIA (Feeling achy), PAIN IN EXTREMITY (Sore arm/pain in her arm), CHILLS (chills), NASAL CONGESTION (stuffed nose), RHINORRHOEA (runny nose), SNEEZING (Sneezing), NASOPHARYNGITIS (Head cold), COUGH (Little cough), THROAT IRRITATION (scratchy throat) and OROPHARYNGEAL PAIN (scratchy sore throat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Body temperature: 99.5 °F (High) low grade fever (99.5F).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had plan to test to undergo COVID test soon.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jan-2021: No specific follow-up information recorded.; 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Oropharyngeal pain, Pain in extremity, Pyrexia, Rhinorrhoea
Clinical narrative: Sneezing; Head cold; Little cough; scratchy throat; scratchy sore throat; stuffed nose; Sore arm/pain in her arm; runny nose; chills; Feeling achy; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever), MYALGIA (Feeling achy), PAIN IN EXTREMITY (Sore arm/pain in her arm), CHILLS (chills) and NASAL CONGESTION (stuffed nose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Hypercholesteremia. Concomitant products included SIMVASTATIN for Hypercholesteraemia, METOPROLOL and OLMESARTAN for Hypertension.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PYREXIA (Low grade fever), MYALGIA (Feeling achy), CHILLS (chills) and RHINORRHOEA (runny nose). On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm/pain in her arm). On 10-Jan-2021, the patient experienced NASAL CONGESTION (stuffed nose), SNEEZING (Sneezing), NASOPHARYNGITIS (Head cold), COUGH (Little cough), THROAT IRRITATION (scratchy throat) and OROPHARYNGEAL PAIN (scratchy sore throat). The patient was treated with PARACETAMOL (TYLENOL) on 07-Jan-2021 for Adverse event, at a dose of UNK dosage form (2 doses at night); PARACETAMOL (TYLENOL) on 08-Jan-2021 for Adverse event, at a dose of UNK dosage form (2 doses) and PARACETAMOL (TYLENOL) on 09-Jan-2021 for Adverse event, at a dose of UNK dosage form (2 doses). At the time of the report, PYREXIA (Low grade fever), MYALGIA (Feeling achy), PAIN IN EXTREMITY (Sore arm/pain in her arm), CHILLS (chills), NASAL CONGESTION (stuffed nose), RHINORRHOEA (runny nose), SNEEZING (Sneezing), NASOPHARYNGITIS (Head cold), COUGH (Little cough), THROAT IRRITATION (scratchy throat) and OROPHARYNGEAL PAIN (scratchy sore throat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Body temperature: 99.5 °F (High) low grade fever (99.5F).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had plan to test to undergo COVID test soon.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jan-2021: No specific follow-up information recorded.; 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing, Throat irritation
Clinical narrative: Sneezing; Head cold; Little cough; scratchy throat; scratchy sore throat; stuffed nose; Sore arm/pain in her arm; runny nose; chills; Feeling achy; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever), MYALGIA (Feeling achy), PAIN IN EXTREMITY (Sore arm/pain in her arm), CHILLS (chills) and NASAL CONGESTION (stuffed nose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Hypercholesteremia. Concomitant products included SIMVASTATIN for Hypercholesteraemia, METOPROLOL and OLMESARTAN for Hypertension.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PYREXIA (Low grade fever), MYALGIA (Feeling achy), CHILLS (chills) and RHINORRHOEA (runny nose). On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm/pain in her arm). On 10-Jan-2021, the patient experienced NASAL CONGESTION (stuffed nose), SNEEZING (Sneezing), NASOPHARYNGITIS (Head cold), COUGH (Little cough), THROAT IRRITATION (scratchy throat) and OROPHARYNGEAL PAIN (scratchy sore throat). The patient was treated with PARACETAMOL (TYLENOL) on 07-Jan-2021 for Adverse event, at a dose of UNK dosage form (2 doses at night); PARACETAMOL (TYLENOL) on 08-Jan-2021 for Adverse event, at a dose of UNK dosage form (2 doses) and PARACETAMOL (TYLENOL) on 09-Jan-2021 for Adverse event, at a dose of UNK dosage form (2 doses). At the time of the report, PYREXIA (Low grade fever), MYALGIA (Feeling achy), PAIN IN EXTREMITY (Sore arm/pain in her arm), CHILLS (chills), NASAL CONGESTION (stuffed nose), RHINORRHOEA (runny nose), SNEEZING (Sneezing), NASOPHARYNGITIS (Head cold), COUGH (Little cough), THROAT IRRITATION (scratchy throat) and OROPHARYNGEAL PAIN (scratchy sore throat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Body temperature: 99.5 °F (High) low grade fever (99.5F).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had plan to test to undergo COVID test soon.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jan-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Moderate redness at injection site; Slight swelling at injection site; Moderate itching at injection site; A spontaneous report was received from a consumer of unspecified age and gender, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced moderate itching, moderate redness, slight swelling at injection site.  The patient's medical history was not reported. Concomitant product use was not provided by the reporter.  On an unspecified date, approximately 7 day prior to the onset of events, the patient received their first two planned doses of mRNA-1273 (lot number unknown) for the prophylaxis of COVID-19 infection.  On an unspecified date, seven days after the first dose of vaccine, the patient developed moderate redness, slight swelling and moderate itching at injection site. Treatment included diphenhydramine 50mg which helped. The patient's symptoms lasted about 48 hours.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of events, moderate itching, moderate redness, slight swelling at injection site were considered resolved on an unspecified date.; Reporter's Comments: This case concerns a patient, who experienced events of moderate itching, moderate redness, slight swelling at injection site. The events occurred 7 days after the first and last 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.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: Loss of appetite; Fatigue; Headache; Low fever; Muscle ache; Soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in her arm), DECREASED APPETITE (Loss of appetite), FATIGUE (Fatigue), HEADACHE (Headache) and PYREXIA (Low fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness in her arm). On 10-Jan-2021, the patient experienced DECREASED APPETITE (Loss of appetite), FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Low fever) and MYALGIA (Muscle ache). At the time of the report, PAIN IN EXTREMITY (Soreness in her arm), DECREASED APPETITE (Loss of appetite), FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Low fever) and MYALGIA (Muscle ache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided  Company assessment:Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Loss of appetite; Fatigue; Headache; Low fever; Muscle ache; Soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in her arm), DECREASED APPETITE (Loss of appetite), FATIGUE (Fatigue), HEADACHE (Headache) and PYREXIA (Low fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness in her arm). On 10-Jan-2021, the patient experienced DECREASED APPETITE (Loss of appetite), FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Low fever) and MYALGIA (Muscle ache). At the time of the report, PAIN IN EXTREMITY (Soreness in her arm), DECREASED APPETITE (Loss of appetite), FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Low fever) and MYALGIA (Muscle ache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided  Company assessment:Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.