chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Retching, Vaccination site pain
Clinical narrative: dry heaves; arm hurting; muscle pain; joint pain; fever; chills; nausea; Headache; A spontaneous report was received from a Other Health Professional concerning a 45-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed muscle pain, joint pain, fever, chills, arm hurting, nausea, dry heaves, and headache.   The patient's medical history, included positive COVID-19 test in Nov 2020. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (lot: unknown) intramuscularly for prophylaxis of COVID-19 infection.   28 Dec 2020 the patient experienced fever of 99.4 to 99.6 joint pain, muscle pain, and her skin hurt. The patient also experienced dry heaves, nausea, and headache.   At the time of the report on 07 Jan 2021 the events had resolved.  Treatment of the events included Tylenol every four hours.  Action taken with mRNA-1273 in response to the events was not provided .   The outcome of the events muscle pain, joint pain, fever, chills, arm hurting, nausea, dry heaves, and headache were recovered.  Reporter causality for the events was not provided.  Additional information received on 07 Jan 2021 included units for fever and date of outcome for the events.; 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: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: A spontaneous report was received from a Physician concerning a male patient who received COVID-19 vaccine (mRNA-1273) and experienced erythema (redness)/vaccination site erythema, pain/vaccination site pain and swelling/vaccination site swelling in left arm.mThe patient's medical history was not provided. No relevant concomitant medications were reported. On 23 Dec 2020, 12 days prior to onset of events, the patient received their dose of mRNA-1273 (Batch Number: Unknown) in the left arm for prophylaxis of COVID-19 infection. On 4 Jan 2021, the patient experienced erythema (redness), pain and swelling in left arm where vaccine was given. Treatment details included warm compress. Action taken with mRNA-1273 in response to the events erythema (redness), pain and swelling in left arm was not reported. The outcome of the events, erythema (redness), pain and swelling in left arm 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.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Injection site hypoaesthesia
Clinical narrative: A weird slight metallic taste; Slight numbness in the injection site; A spontaneous report was received from a 31 year old female patient (other health care professional) concerning herself who participated in the mRNA-1273 Emergency Use Program and experienced slight numbness in the injection site arm and a weird slight metallic taste.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021 at two-thirty pm, the patient received their first of two planned doses of mRNA-1273 (post-meridiem) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 04 Jan 2021, 15 minutes after receiving the first dose of mRNA-1273,the patient noticed slight numbness in the injection site arm and a weird slight metallic taste. The patient gave consent to follow up from safety.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events were not reported.   The reporter did not provide an assessment for the events, slight numbness in the injection site arm and a weird slight metallic taste.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site is itchy; Big orange puppy raised area at the injection site; Injection site swelling; Injection site pain; A spontaneous report was received from a consumer concerning herself, a 53-year-old, female patient who experienced pain at the injection site [Injection site pain], "a big orange puppy raised area at the injection site [Injection site erythema/Injection site swelling] and injection site was itchy [Injection side pruritis].   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 24-Dec-2020, the same day as the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (02FJ202A) intramuscularly in the left upper arm for prophylaxis of COVID-19 infection.   The patient experienced injection site pain on the same day she received the vaccine. This pain went away. On 01-Jan-2021, she noticed a "big orange puppy raised area at the injection site". She also reported that it was itchy. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, injection site pain was resolved on 24 DEC 2020. The outcome of the remaining events, were unknown.; Reporter's Comments: This case concerns a 53-year-old female who experienced NS events of expected injection site pain, injection site pruritus, injection site erythema, injection site swelling. Injection site pain occurred the same day as the first dose of mRNA-1273, followed by other events on Day 9. Treatment not reported. 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Dyspnoea, Headache, Lethargy
Clinical narrative: Lethargic; Stomach feeling nauseous; Headaches; Shortness of breath; Dizzy on and off; A spontaneous report was received from a consumer who was a 45-years-old, female patient who received Moderna's COVID-19 vaccine and experienced shortness of breath, headaches, stomach feeling nauseous, dizziness on and off, and lethargy.  The patient's medical history, as provided by the reporter, included post-nasal drip.  No relevant concomitant medications were reported.  On 26 Dec 2020, the patient experienced post-nasal drip.  On 30 Dec 2020 at approximately 1600PM, 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 mRNA-1273 vaccination, the patient experienced shortness of breath (SOB). She reported SOB to be not urgent. The patient also developed headaches, nauseous feeling in the stomach, and dizziness on and off.   On 01 Jan 2021, she experienced lethargy and continued headaches. The patient's blood pressure was reported as normal.  Treatment for the events included taking deep breaths, drinking almost a liter of water a day, ibuprofen for headaches and saline drops for post-nasal drip.  Action taken with the second dose of mRNA-1273 in response to the event was not reported. However, the patient expressed hesitancy in obtaining the second dose.  The outcome for the events, shortness of breath, headaches, stomach feeling nauseous, dizziness on and off, and lethargy, were unknown.; Reporter's Comments: This case concerns a 45-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the non-serious listed events of nausea and headache, and the non-serious unlisted events of shortness of breath, dizziness, and lethargy.  Based on the current available information and temporal association between the use of the product and the onset of events starting  on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.  However, the presence of post-nasal drip prior to vaccination and persistence of symptoms may be due to an undiagnosed viral illness.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Lethargic; Stomach feeling nauseous; Headaches; Shortness of breath; Dizzy on and off; A spontaneous report was received from a consumer who was a 45-years-old, female patient who received Moderna's COVID-19 vaccine and experienced shortness of breath, headaches, stomach feeling nauseous, dizziness on and off, and lethargy.  The patient's medical history, as provided by the reporter, included post-nasal drip.  No relevant concomitant medications were reported.  On 26 Dec 2020, the patient experienced post-nasal drip.  On 30 Dec 2020 at approximately 1600PM, 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 mRNA-1273 vaccination, the patient experienced shortness of breath (SOB). She reported SOB to be not urgent. The patient also developed headaches, nauseous feeling in the stomach, and dizziness on and off.   On 01 Jan 2021, she experienced lethargy and continued headaches. The patient's blood pressure was reported as normal.  Treatment for the events included taking deep breaths, drinking almost a liter of water a day, ibuprofen for headaches and saline drops for post-nasal drip.  Action taken with the second dose of mRNA-1273 in response to the event was not reported. However, the patient expressed hesitancy in obtaining the second dose.  The outcome for the events, shortness of breath, headaches, stomach feeling nauseous, dizziness on and off, and lethargy, were unknown.; Reporter's Comments: This case concerns a 45-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the non-serious listed events of nausea and headache, and the non-serious unlisted events of shortness of breath, dizziness, and lethargy.  Based on the current available information and temporal association between the use of the product and the onset of events starting  on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.  However, the presence of post-nasal drip prior to vaccination and persistence of symptoms may be due to an undiagnosed viral illness.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Fatigue, Headache, Hypoaesthesia
Clinical narrative: Loss of taste; Loss of smell; Injection arm pain; Injection site swelling; Injection site redness; Headache; General exhaustion; Fever low grade, 101 max; Hand,finger, arm numbness; Nasal congestion; This spontaneous case was reported by a non-health professional and describes the occurrence of HYPOAESTHESIA (Hand,finger, arm numbness), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell) and VACCINATION SITE PAIN (Injection arm pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) 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 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Dec-2020, the patient experienced HYPOAESTHESIA (Hand,finger, arm numbness), NASAL CONGESTION (Nasal congestion), VACCINATION SITE PAIN (Injection arm pain), VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (Injection site redness), HEADACHE (Headache), FATIGUE (General exhaustion) and PYREXIA (Fever low grade, 101 max). On 26-Dec-2020, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell). On 25-Dec-2020, FATIGUE (General exhaustion) and PYREXIA (Fever low grade, 101 max) had resolved. On 26-Dec-2020, HYPOAESTHESIA (Hand,finger, arm numbness), VACCINATION SITE PAIN (Injection arm pain), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Injection site redness) had resolved. On 30-Dec-2020, NASAL CONGESTION (Nasal congestion) and HEADACHE (Headache) had resolved. At the time of the report, AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2020, SARS-CoV-2 test: negative (Negative) Negative. On 29-Dec-2020, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Action taken with mRNA-1273 in response to the events was not reported.   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 the events, a causal relationship cannot be excluded. However, the events loss of taste and smell is unlikely related to mRNA-1273. Further information has been requested.; 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. However, the events loss of taste and smell is unlikely related to mRNA-1273. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Pyrexia, SARS-CoV-2 test, Vaccination site erythema, Vaccination site pain
Clinical narrative: Loss of taste; Loss of smell; Injection arm pain; Injection site swelling; Injection site redness; Headache; General exhaustion; Fever low grade, 101 max; Hand,finger, arm numbness; Nasal congestion; This spontaneous case was reported by a non-health professional and describes the occurrence of HYPOAESTHESIA (Hand,finger, arm numbness), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell) and VACCINATION SITE PAIN (Injection arm pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) 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 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Dec-2020, the patient experienced HYPOAESTHESIA (Hand,finger, arm numbness), NASAL CONGESTION (Nasal congestion), VACCINATION SITE PAIN (Injection arm pain), VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (Injection site redness), HEADACHE (Headache), FATIGUE (General exhaustion) and PYREXIA (Fever low grade, 101 max). On 26-Dec-2020, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell). On 25-Dec-2020, FATIGUE (General exhaustion) and PYREXIA (Fever low grade, 101 max) had resolved. On 26-Dec-2020, HYPOAESTHESIA (Hand,finger, arm numbness), VACCINATION SITE PAIN (Injection arm pain), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Injection site redness) had resolved. On 30-Dec-2020, NASAL CONGESTION (Nasal congestion) and HEADACHE (Headache) had resolved. At the time of the report, AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2020, SARS-CoV-2 test: negative (Negative) Negative. On 29-Dec-2020, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Action taken with mRNA-1273 in response to the events was not reported.   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 the events, a causal relationship cannot be excluded. However, the events loss of taste and smell is unlikely related to mRNA-1273. Further information has been requested.; 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. However, the events loss of taste and smell is unlikely related to mRNA-1273. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Loss of taste; Loss of smell; Injection arm pain; Injection site swelling; Injection site redness; Headache; General exhaustion; Fever low grade, 101 max; Hand,finger, arm numbness; Nasal congestion; This spontaneous case was reported by a non-health professional and describes the occurrence of HYPOAESTHESIA (Hand,finger, arm numbness), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell) and VACCINATION SITE PAIN (Injection arm pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) 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 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Dec-2020, the patient experienced HYPOAESTHESIA (Hand,finger, arm numbness), NASAL CONGESTION (Nasal congestion), VACCINATION SITE PAIN (Injection arm pain), VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (Injection site redness), HEADACHE (Headache), FATIGUE (General exhaustion) and PYREXIA (Fever low grade, 101 max). On 26-Dec-2020, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell). On 25-Dec-2020, FATIGUE (General exhaustion) and PYREXIA (Fever low grade, 101 max) had resolved. On 26-Dec-2020, HYPOAESTHESIA (Hand,finger, arm numbness), VACCINATION SITE PAIN (Injection arm pain), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Injection site redness) had resolved. On 30-Dec-2020, NASAL CONGESTION (Nasal congestion) and HEADACHE (Headache) had resolved. At the time of the report, AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2020, SARS-CoV-2 test: negative (Negative) Negative. On 29-Dec-2020, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Action taken with mRNA-1273 in response to the events was not reported.   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 the events, a causal relationship cannot be excluded. However, the events loss of taste and smell is unlikely related to mRNA-1273. Further information has been requested.; 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. However, the events loss of taste and smell is unlikely related to mRNA-1273. Further information has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Tenderness
Clinical narrative: Arm pit tenderness in same arm  of vaccination; Swollen lymph nodes in same arm of vaccination; A spontaneous report was received from a Nurse concerning a 59 years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Arm pit tenderness in same arm of vaccination (Tenderness) and Swollen lymph nodes in same arm of vaccination (Lymphadenopathy).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 28 Dec 2020, approximately five days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 02J20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 2 Jan 2021, the patient experienced Arm pit tenderness in same arm of vaccination and Swollen lymph nodes in same arm of vaccination. No laboratory details were provided.  Treatment information for the events provided by the reporter included Aleve.  Action taken with mRNA-1273 in response to the events was unknown.   On an Unknown date, the outcome of the events, herpes zoster infection and overloaded immune system, were considered resolving.; Reporter's Comments: This case concerns a 59-year-old female who had nonserious expected events of lymphadenopathy, tenderness.  Event onset occurred 6 days after the first dose of mRNA-1273. Treated with Aleve. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the lymphadenopathy and tenderness, a causal relationship cannot be excluded.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Muscle tightness, Vaccination complication
Clinical narrative: Right side of the neck became tight; Lymph nodes on the right side of the neck became swollen; Possibly a reaction; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (Right side of the neck became tight), LYMPHADENOPATHY (Lymph nodes on the right side of the neck became swollen) and VACCINATION COMPLICATION (Possibly a reaction) in a 30-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 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced MUSCLE TIGHTNESS (Right side of the neck became tight), LYMPHADENOPATHY (Lymph nodes on the right side of the neck became swollen) and VACCINATION COMPLICATION (Possibly a reaction). On 03-Jan-2021, MUSCLE TIGHTNESS (Right side of the neck became tight) and LYMPHADENOPATHY (Lymph nodes on the right side of the neck became swollen) had resolved. At the time of the report, VACCINATION COMPLICATION (Possibly a reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  After few minutes of vaccine administration the patient experienced the right side of the neck became tight and the lymph node on the right side of neck became swollen. Treatment information included diphenhydramine and ibuprofen.  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.  The initial report of "possibly a reaction" likely refers to the later report of tight neck and lymphadenopathy, but this is not specified so agree with retaining the general event of vaccination complication   Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2021: Patient age, Batch number, events including outcome, and treatment.; 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.  The initial report of "possibly a reaction" likely refers to the later report of tight neck and lymphadenopathy, but this is not specified so agree with retaining the general event of vaccination complication
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Tachycardia; A report was received from a physician concerning a female patient who was participating in the mRNA-1273 Emergency Use Program and developed/experienced tachycardia.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 03 Jan 2021, approximately 2 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 05 Jan 2020, the patient experienced tachycardia. 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: 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: Glucose tolerance test, Maternal exposure during pregnancy, Pain in extremity, Pregnancy test, Trisomy 21
Clinical narrative: Maternal exposure during pregnancy; Arm was sore; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and PAIN IN EXTREMITY (Arm was sore) in a 27-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concomitant products included DOXYLAMINE SUCCINATE (UNISOM 2) and PYRIDOXINE HYDROCHLORIDE (B6) for Nausea, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 30-Dec-2020 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in May 2020 and the estimated date of delivery was 11-Mar-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and PAIN IN EXTREMITY (Arm was sore). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. On 31-Dec-2020, PAIN IN EXTREMITY (Arm was sore) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jul-2021, Pregnancy test: positive (Positive) Positive. On an unknown date, Glucose tolerance test: normal (normal) Normal. On an unknown date, Trisomy 21: low risk (Borderline) Low Risk.     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 medication details was reported.  The patent's estimated date of conception was 20-Jun-2020.  The patient's previous pregnancy included a full term birth on 25-Jan-20219.; Sender's Comments: This is a case of product exposure during pregnancy with one reported AE for this 27-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the arm pain, a causal relationship cannot be excluded. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: injection site redness; injection site swelling; A report was received from a consumer concerning a female patient of an unknown age, who received Moderna's mRNA-1273 and developed redness and swelling around the injection site.   The patient's medical history and relevant concomitant medications were not reported.   On 28 Dec 2020, approximately one week prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 intramuscularly in the for prophylaxis of COVID-19 infection.   The patient experienced redness and swelling around the injection site on an unknown date about a week after receiving vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events redness and swelling 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 events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure increased, Headache, Heart rate increased, Pain
Clinical narrative: tremor on her index finger; pain on below her elbow; generalized body aches; Right Arm Pain; increase in her blood pressure 194/128; heart rate of 138; bad migraine on the right side of her head; A report was received from a consumer on 03 JAN 2021 concerning a female patient who experienced an increased blood pressure and heart rate, headache, right arm pain, body aches, and finger tremors after receiving the Moderna COVID-19 vaccine.  The patient's medical history was not provided. No relevant concomitant medications were provided.   The patient received her first of two planned doses of mRNA-1273 vaccine (batch# 037K20A) on 28 DEC 2020 intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On the same day, about 15 minutes later, the patient reported to have developed a blood pressure of 194/128 mmHg, and a heart rate of 138 beats/minute, along with a right-sided headache. The increased blood pressure and increased heart rate were reported to have resolved 15 minutes later (repeat blood pressure and heart rate values were not provided). On 29 DEC 2020, the patient experienced pain in the right arm along with generalized body aches. She expressed that she developed tremors in her index finger on 02 JAN 2021. There is no information regarding the intensity of her pains, or how long each of the event had lasted before resolving.  No interventions or treatment information was provided for the events.  The outcome of all events was reported as recovered/resolved on the same day that they occurred. There is no report regarding a reoccurrence. Any action taken regarding the vaccine as a result of the events is not applicable.  Reporter causality for the events was not provided.  The patient provided consent to follow-up with Safety.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tremor
Clinical narrative: tremor on her index finger; pain on below her elbow; generalized body aches; Right Arm Pain; increase in her blood pressure 194/128; heart rate of 138; bad migraine on the right side of her head; A report was received from a consumer on 03 JAN 2021 concerning a female patient who experienced an increased blood pressure and heart rate, headache, right arm pain, body aches, and finger tremors after receiving the Moderna COVID-19 vaccine.  The patient's medical history was not provided. No relevant concomitant medications were provided.   The patient received her first of two planned doses of mRNA-1273 vaccine (batch# 037K20A) on 28 DEC 2020 intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On the same day, about 15 minutes later, the patient reported to have developed a blood pressure of 194/128 mmHg, and a heart rate of 138 beats/minute, along with a right-sided headache. The increased blood pressure and increased heart rate were reported to have resolved 15 minutes later (repeat blood pressure and heart rate values were not provided). On 29 DEC 2020, the patient experienced pain in the right arm along with generalized body aches. She expressed that she developed tremors in her index finger on 02 JAN 2021. There is no information regarding the intensity of her pains, or how long each of the event had lasted before resolving.  No interventions or treatment information was provided for the events.  The outcome of all events was reported as recovered/resolved on the same day that they occurred. There is no report regarding a reoccurrence. Any action taken regarding the vaccine as a result of the events is not applicable.  Reporter causality for the events was not provided.  The patient provided consent to follow-up with Safety.; 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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain, Vaccination site swelling, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: Injection site warm to touch but not itchy; 2-3 inches of raised hives; Solid raised rash around the injection site; Sore spot; Mild ache; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Injection site warm to touch but not itchy), MYALGIA (Mild ache), VACCINATION SITE URTICARIA (2-3 inches of raised hives), VACCINATION SITE SWELLING (Solid raised rash around the injection site) and VACCINATION SITE PAIN (Sore spot) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 29-Dec-2020, the patient experienced MYALGIA (Mild ache) and VACCINATION SITE PAIN (Sore spot). On 05-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm to touch but not itchy), VACCINATION SITE URTICARIA (2-3 inches of raised hives) and VACCINATION SITE SWELLING (Solid raised rash around the injection site). On 29-Dec-2020, MYALGIA (Mild ache) and VACCINATION SITE PAIN (Sore spot) had resolved. At the time of the report, VACCINATION SITE WARMTH (Injection site warm to touch but not itchy) outcome was unknown and VACCINATION SITE URTICARIA (2-3 inches of raised hives) and VACCINATION SITE SWELLING (Solid raised rash around the 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 considered VACCINATION SITE WARMTH (Injection site warm to touch but not itchy), VACCINATION SITE URTICARIA (2-3 inches of raised hives), VACCINATION SITE SWELLING (Solid raised rash around the injection site) and VACCINATION SITE PAIN (Sore spot) to be related. No further causality assessment was provided for MYALGIA (Mild ache).    The patient did not take any concomitant medication at the time of vaccination.  The patient did not receive any treatment.  No reaction following the second dose. Reportedly, the patient had no known drug allergy (NKDA).   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Action taken, event outcome, causality, and event description; Reporter's Comments: This case concerns a 68-year-old female who experienced NS events of unexpected urticaria, pain, Injection site warmth and expected injection site pain, injection site rash.  Event onset occurred 2 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain, Rash
Clinical narrative: burns like she got burned by a curling iron; very painful; large rash on the side of my neck like I got burned by a curling iron; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (very painful) in a 24-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 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 PAIN (very painful). At the time of the report, PAIN (very painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Arm  extremely swollen; A spontaneous report was received from a female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm extremely swollen.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, about a week prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   She had no reactions but now, her arm was extremely swollen a week later.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The event arm extremely swollen was unknown.  The reporter did not provide an assessment for the event arm extremely swollen.; Reporter's Comments: This case concerns a female patient of unknown age. The patient's medical history was not provided. The patient experienced an event of extremely swollen arm. The event occurred a week after the first dose of mRNA-1273. 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: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Malaise, Pyrexia
Clinical narrative: Malaise; pain at the injection site; slight fever (100F); in bed all day; Headache; Just felt tired; A spontaneous report was received from a consumer concerning a male patient who received COVID-19 (mRNA-1273) experienced fatigue, was in bed all day, slight fever, headache, malaise, and injection site pain.    The patient's medical history included Covid-19 in March 2020. Concomitant product use was not provided/unknown by the reporter  On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 31 Dec 2020 that day, after he got home, he just felt tired and went to sleep. On 01 Jan 2021 he reported that he was in bed all day, had a slight fever (100 F) and headache. The next day on 02 Jan 2021, he still had some malaise in the morning, but felt better as the day progressed. He also stated that he had pain in his arm at the injection site.   Treatment for the event included paracetamol.   Action taken with mRNA-1273 in response to the events was not provided/unknown.   The outcome of the events, fatigue, was in bed all day, slight fever, headache and injection site pain were unknown and recovering for malaise.; Reporter's Comments: This case concerns a male of unknown age, with PMH of COVID-19, who had NS events of unexpected malaise and somnolence and expected pyrexia, headache, fatigue and injection site pain.  Event onset 2 days after the first dose of mRNA-1273. Treated with paracetamol. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Malaise; pain at the injection site; slight fever (100F); in bed all day; Headache; Just felt tired; A spontaneous report was received from a consumer concerning a male patient who received COVID-19 (mRNA-1273) experienced fatigue, was in bed all day, slight fever, headache, malaise, and injection site pain.    The patient's medical history included Covid-19 in March 2020. Concomitant product use was not provided/unknown by the reporter  On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 31 Dec 2020 that day, after he got home, he just felt tired and went to sleep. On 01 Jan 2021 he reported that he was in bed all day, had a slight fever (100 F) and headache. The next day on 02 Jan 2021, he still had some malaise in the morning, but felt better as the day progressed. He also stated that he had pain in his arm at the injection site.   Treatment for the event included paracetamol.   Action taken with mRNA-1273 in response to the events was not provided/unknown.   The outcome of the events, fatigue, was in bed all day, slight fever, headache and injection site pain were unknown and recovering for malaise.; Reporter's Comments: This case concerns a male of unknown age, with PMH of COVID-19, who had NS events of unexpected malaise and somnolence and expected pyrexia, headache, fatigue and injection site pain.  Event onset 2 days after the first dose of mRNA-1273. Treated with paracetamol. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: heart rate increase; A spontaneous report was received from a consumer who was also a female patient, unknown age, who was participating in the mRNA-1273 Emergency Use Program and experienced heart rate increase.  The patient's medical history was not provided.  No concomitant medications were reported.  On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 05 Jan 2021, after receiving the vaccine, the patient experienced an elevated heart rate of 96 to 99 beats per minute.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, heart rate increase, was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hypertension, Palpitations, Paraesthesia oral
Clinical narrative: flush; lips tingling; heart was racing; high blood pressure; Felt dizzy; A spontaneous report was received from a physician concerning a 47-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizziness/dizziness, flushing/flushing, lips tingling/ paraesthesia oral, heart racing/palpitation and high blood pressure/hypertension.  The patient's medical history, as provided by the reporter, included sleep apnea. No relevant concomitant medications were reported.   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (011L20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient immediately began to experience dizziness. He also reported being flush, lips tingling, a racing heart and increased blood pressure. Treatment for event included loratadine.    Action taken with mRNA-1273 in response to the events was not reported.   The events, dizziness, flushing, lips tingling, heart racing and high blood pressure, was considered recovered/resolved on 04 Jan 2021.; 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. However, further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Running fever; Sore arm; Headache; Been tired; Feeling aches, his muscles are hurting all over body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN (Feeling aches, his muscles are hurting all over body), HEADACHE (Headache), FATIGUE (Been tired) and PYREXIA (Running fever) in a 59-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 (Medical History not Provided).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2020, the patient experienced PAIN (Feeling aches, his muscles are hurting all over body). On 31-Dec-2020, the patient experienced PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Been tired). On 06-Jan-2021, the patient experienced PYREXIA (Running fever). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 31-Dec-2020, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) had resolved. At the time of the report, PAIN (Feeling aches, his muscles are hurting all over body) and PYREXIA (Running fever) had not resolved and FATIGUE (Been tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.; Sender's Comments: This case concerns a 59-year-old male who experienced nonserious events of unexpected pain, pain in extremity and expected fever, headache, fatigue.  Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment with ibuprofen and pseudoephedrine. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: itching and swelling, redness at the site of vaccine(left arm); swelling,  at the site of vaccine(left arm); itching and swelling, redness at the site of vaccine(left arm); pain on injection site; fatigue; A spontaneous report was received from a non-health professional who was a female consumer, of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced fatigue, itching, swelling, pain and redness at the site of vaccination.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Dec 2020, prior to the onset of the events, the patient received their first of two scheduled doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On 25 Dec 2020, the day after receiving her vaccination, the patient began to feel fatigued. On 01 Jan-2021, she developed itching, swelling, pain and redness at the site of vaccination. Treatment for the event included topical hydrocortisone applied to the injection site.   Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events, fatigue, itching, swelling, pain and redness at the site of vaccination, were considered unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced NS events of expected vaccination site urticaria, vaccination site pain, vaccination site erythema, vaccination site swelling, fatigue. Fatigue onset on Day 2 after the first dose of mRNA-1273, followed by other events on Day 9. Treated with topical hydrocortisone. 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.