chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Exposure during pregnancy, Tachycardia
Clinical narrative: Tachycardia up to 160  with exertion; Shortness of breath; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (Tachycardia up to 160  with exertion), DYSPNOEA (Shortness of breath) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 25-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 027A21A) for COVID-19 vaccination.     The patient's past medical history included Tachycardia (History of tachycardia with previous pregnancy.). Concurrent medical conditions included Bee sting hypersensitivity.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 28-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 29-Dec-2020, the patient experienced TACHYCARDIA (Tachycardia up to 160  with exertion) and DYSPNOEA (Shortness of breath). On 28-Dec-2020, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, TACHYCARDIA (Tachycardia up to 160  with exertion) and DYSPNOEA (Shortness of breath) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.    Cardiac monitor, CXR, CBC, TSH, CMP in the Emergency Department and physician evaluation.   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: No specific follow-up information recorded.; Sender's Comments: This is a case of product exposure during pregnancy with associated AEs of tachycardia and dyspnea  for this 25-year-old female.   Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Tremor
Clinical narrative: chills; feeling fatigued; loopy (Spacey); didn't feel right; hands were shaky; A spontaneous report 1was received from a health care professional concerning a 47-year-old female patient who received Moderna's COVID-19 vaccine and experienced chills, feeling fatigued (fatigue), loopy (Spacey) (Feeling abnormal), didn't feel right andhands were shaky (tremor).  The patient's medical history was not provided. Concomitant product use was not provided.  On 23-Dec-2020, the patient received their first of two planned doses of mRNA-1273 (Lot number was unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 24-Dec-2020 the patient started to fell chills, she felt fatigued, loopy, didn't feel right, and her hands were shaky.  Lab results and treatments for the events were not provided.    Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcomes of the events were chills, feeling fatigued (fatigue), loopy (Spacey) (Feeling abnormal) and didn't feel right was considered unknown and for hands were shaky (tremor) was considered as resolved on 24-Dec-2020.; Reporter's Comments: This case concerns a 47-year-old, female patient, who experienced a non-serious unexpected event of feeling abnormal- (loopy spacey), feeling abnormal- (didn't feel right) and tremor, and non-serious expected event of chills, and fatigue. The events occurred 1 day after first dose of mRNA-1273, lot # unknown. Treatment details not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling hot, Headache, Pyrexia
Clinical narrative: Headache; body temperature at 99.9F; Whole body feels really hot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Whole body feels really hot) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetes. Concomitant products included METFORMIN for Diabetes, LOSARTAN for Hypertension.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 29-Dec-2020, the patient experienced FEELING HOT (Whole body feels really hot). The patient was treated with IBUPROFEN at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING HOT (Whole body feels really hot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, Body temperature: 99.9 °F 99.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to MOD-2021-051429 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2021: The event outcomes, patient's medical history and treatment information were updated.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; A report was received from a nurse concerning a 36 years old, female patient who was participating in the mRNA-1273 Emergency Use Program and who experienced fever.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Dec 2020 the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 22 Dec 2020, the nurse administered the mRNA-1273 vaccine to a patient. The patient spiked a fever about 8 hours after vaccination. Fever only lasted for a few hours and resolved at night.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.  The event, fever, was considered resolved on 22 Dec 2020.  The reporter did not provide an assessment for the event, fever.; Reporter's Comments: This case concerns a 36-year-old, female, patient, who experienced an expected non-serious event of Pyrexia. The event occurred approximately 8 hours after first dose of mRNA-1273. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: hardness at injection site; swelling at the injection site; A spontaneous report was received from a health care professional concerning a 57 year old female patient who received Moderna's COVID-19 vaccine and experienced swelling and hardness at the injection site.  The patient's medical history was not provided. No concomitant medications were reported.  On 26-Dec-2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly for prophylaxis of COVID-19 infection. Soon after, the patient experienced swelling and hardness at the injection site. The patient reported that the size of the hardness at the injection site is increasing on 27 Dec 2020. No treatment was administered.   The Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the events, swelling and hardness at the injection site, were considered unknown.; Reporter's Comments: This case concerns a 57-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 026L20A), and who experienced the non-serious listed events of swelling and hardness at the injection site.  Based on the current available information and temporal association between the use of the product and the onset of events on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pain in extremity
Clinical narrative: Pregnancy; Sore left arm; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) and PAIN IN EXTREMITY (Sore left arm) in a 34-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 23-Dec-2020, 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 31-Mar-2021. On 23-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) and PAIN IN EXTREMITY (Sore left arm). On 23-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. On 24-Dec-2020, PAIN IN EXTREMITY (Sore left arm) 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.; Reporter's Comments: This is a case of product exposure during pregnancy with associated AE (sore left arm) for a 34-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. Based on the current available information and temporal association between the use of the product and the start date of the event of sore left arm, a causal relationship cannot be excluded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: Minor upset stomach; A spontaneous report was received from physician (reporting on self) and concerns a 41-year-old female patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced a minor upset stomach.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown day in Dec 2020, the patient experienced a minor upset stomach. There was no treatment information provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event was unknown.; Reporter'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: Injection site lymphadenopathy, Injection site pain
Clinical narrative: Really swollen lymph node in her axillary; Soreness in arm; A spontaneous report was received from a 42-year-old female consumer, who received Moderna's COVID-19 vaccine and experienced soreness in her arm and really swollen lymph node in her axillary.  There were no medical history and concomitant medications reported.  On 23 DEC 2020 the patient received the first of the two planned doses of mRNA-1273 vaccine intramuscularly in her left arm for the prophylaxis of COVID-19 infection.  The patient experienced soreness in her arm on 24 DEC 2020 and really swollen lymph node in her axillary on 28 DEC 2020 and got more painful over the course of the day on 28 DEC 2020. As of 29 DEC 2020, it was not that swollen unless she touched it.   Treatment received for soreness in arm, really swollen lymph nodes was not provided.   Action taken with the second dose of mRNA-1273 vaccine in relation to reported events was not provided.  Outcome of the events, soreness in arm and really swollen lymph nodes was not provided.; Reporter's Comments: This case concerns a 42-year-old female patient, who experienced expected non-serious events of Injection site pain and Injection site lymphadenopathy. The event of Injection site pain occurred approximately one day after first dose of mRNA-1273, lot # unknown. The event of Injection site lymphadenopathy occurred approximately five days after first dose of mRNA-1273, lot # unknown. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Mydriasis
Clinical narrative: Very dilated right pupil; A report was received from a health care professional concerning a patient female who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event very dilated right pupil.  The patient's medical history was not provided. No concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. Soon after they experienced the event of very dilated right pupil. No treatment information was reported.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the event, very dilated right pupil was unknown.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the non-serious unlisted event of very dilated right pupil.  Based on the current available information and temporal association between the use of the product and the onset of event after vaccination, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Hyperhidrosis, Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: Swollen lymph nodes in throat; Sore arm; Tenderness on the injection site; Throat hurts; Sweating; Fever 99.9 °F; Injection site swelling on and off; A report was received from a consumer concerning a 23-year-old, female patient of unknown race participating in the mRNA-1273 Emergency Use Program and experienced swelling on the injection site, low grade fever 99.9 Fahrenheit, sweating, sore arm, tenderness on the injection site, swollen lymph nodes in the throat, and throat pain.   The patient's medical history was not provided.  No relevant concomitant medications were reported.    On 28 December 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 injection for prophylaxis of COVID-19 infection.     She developed swelling on the injection site on 28 December 2021. That was resolved that day.  The next day 29 December 2020 she developed a low-grade fever 99.9 Fahrenheit and sweating. The patient stated that all symptoms went away.  On 30 December 2020 the patient developed a sore arm, tenderness on the injection site, swollen lymph nodes in the throat, and throat pain. She states the soreness is not going away. There was no treatment taken for the events.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the swelling on the injection site, low grade fever 99.9 Fahrenheit, and sweating were all reported as resolved on 30 December 2020. The events of sore arm, tenderness on the injection site, swollen lymph nodes in the throat, and throat pain are considered unresolved.  The causality assessment of the reported events swelling on the injection site, low grade fever 99.9 Fahrenheit, sweating, sore arm, tenderness on the injection site, swollen lymph nodes in the throat, and throat pain has not been provided.; Reporter's Comments: This case concerns a 23-year-old, female patient. The patient's medical history was not provided. The patient experienced the expected events of pyrexia, injection site swelling, injection site pain, pain in arm, lymphadenopathy and unexpected event of hyperhidrosis and throat pain. The events occurred over the period of 1 day to 3 days after the first dose of mRNA-1273 administration. 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: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: Swollen lymph nodes in throat; Sore arm; Tenderness on the injection site; Throat hurts; Sweating; Fever 99.9 °F; Injection site swelling on and off; A report was received from a consumer concerning a 23-year-old, female patient of unknown race participating in the mRNA-1273 Emergency Use Program and experienced swelling on the injection site, low grade fever 99.9 Fahrenheit, sweating, sore arm, tenderness on the injection site, swollen lymph nodes in the throat, and throat pain.   The patient's medical history was not provided.  No relevant concomitant medications were reported.    On 28 December 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 injection for prophylaxis of COVID-19 infection.     She developed swelling on the injection site on 28 December 2021. That was resolved that day.  The next day 29 December 2020 she developed a low-grade fever 99.9 Fahrenheit and sweating. The patient stated that all symptoms went away.  On 30 December 2020 the patient developed a sore arm, tenderness on the injection site, swollen lymph nodes in the throat, and throat pain. She states the soreness is not going away. There was no treatment taken for the events.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the swelling on the injection site, low grade fever 99.9 Fahrenheit, and sweating were all reported as resolved on 30 December 2020. The events of sore arm, tenderness on the injection site, swollen lymph nodes in the throat, and throat pain are considered unresolved.  The causality assessment of the reported events swelling on the injection site, low grade fever 99.9 Fahrenheit, sweating, sore arm, tenderness on the injection site, swollen lymph nodes in the throat, and throat pain has not been provided.; Reporter's Comments: This case concerns a 23-year-old, female patient. The patient's medical history was not provided. The patient experienced the expected events of pyrexia, injection site swelling, injection site pain, pain in arm, lymphadenopathy and unexpected event of hyperhidrosis and throat pain. The events occurred over the period of 1 day to 3 days after the first dose of mRNA-1273 administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: Felt dizzy; Stomach wasn't feeling right; Face was tingling; Mild to moderate numbness around forehead; Mild to moderate numbness around mouth; A spontaneous report was received from a consumer concerning herself, a 34 year old, female patient, who developed dizziness, abdominal discomfort, tingling face and mild to moderate numbness around the forehead and mouth.   The patient's medical history was not provided. There were no relevant concomitant products reported.   On 30-Dec-2020, approximately 15 minutes prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the left deltoid arm for prophylaxis of COVID-19 infection.    On that same day, the patient was monitored for approximately 15 minutes after receiving mRNA-1273, she began to feel dizzy and her stomach was not "feeling right".  After 2 hours had passed, her face was tingling and she experienced mild to moderate numbness around the forehead and mouth. She reported she was continuing to monitor symptoms at the time of this report.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcomes of the events were not reported.; Reporter's Comments: This case concerns a 34-year-old, female patient. The patient's medical history was not provided. The patient experienced an unexpected event of dizziness, abdominal discomfort, paraesthesia, hypoaesthesia of forehead and oral hypoaesthesia. The event of dizziness and abdominal discomfort occurred after 15 minutes and the event of paraesthesia, hypoaesthesia of head and oral hypoaesthesia occurred after 2 hours of 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.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Rhinorrhoea
Clinical narrative: Sore arm; Runny nose; Chills; Headache; A report was received from a consumer concerning a 77-year old, female patient who was participating in the mRNA-1273 Emergency Use Program and developed chills, headache, runny nose, and sore arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 26 Dec 2020, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number 037K2014) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 27 Dec 2020, the patient woke up with a headache, chills, runny nose and a sore arm. Treatment for the event included Allegra, after which the patient reported her symptoms improving.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, chills, headache, runny nose, and sore arm, were not reported.; Reporter's Comments: This case concerns a 77-year old female patient, who experienced unexpected non-serious events of Rhinorrhoea and Pain in extremity, and expected non-serious events of Chills and Headache. The events occurred approximately one day after receiving their first of two planned doses of mRNA-1273 (Lot # 037K2014). Treatment for the event included Allegra. Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Feeling abnormal, Injection site pain
Clinical narrative: not feeling well; Fever; Fatigue; Muscle pain; Joint pain; Chills; Injection site pain; A spontaneous report was received from an HCP concerning a female patient who experienced not feeling well, fever, fatigue, muscle pain, joint pain, chills, and injection site pain.  The patient's medical history was not provided by the reporter. Concomitant product use was not provided by the reporter.   On 29 DEC 2020, the patient received their first of two planned doses of mRNA-1273 (LOT/BATCH# Not Provided) for prophylaxis of COVID-19 infection.   On 29 DEC 2020, after receiving the COVID-19 vaccine, the patient experienced fever, fatigue, muscle pain, join pain, chills, injection site pain, and was not feeling well. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not reported.   The event not feeling well was considered not resolved on 30 DEC 2020.   The outcomes for the events fever, fatigue, muscle pain, joint pain, chills, and injection site pain were not provided.   The reporter did not provide an assessment for the events not feeling well, fever, fatigue, muscle pain, joint pain, chills, and injection site pain.; Reporter's Comments: This case concerns a female patient of unknown age. The patient's medical history was not reported. The patient experienced expected events of pyrexia, fatigue, myalgia, arthralgia, chills and injection site pain and unexpected event of feeling abnormal. The events occurred the day the first dose of mRNA-1273 was administered. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: not feeling well; Fever; Fatigue; Muscle pain; Joint pain; Chills; Injection site pain; A spontaneous report was received from an HCP concerning a female patient who experienced not feeling well, fever, fatigue, muscle pain, joint pain, chills, and injection site pain.  The patient's medical history was not provided by the reporter. Concomitant product use was not provided by the reporter.   On 29 DEC 2020, the patient received their first of two planned doses of mRNA-1273 (LOT/BATCH# Not Provided) for prophylaxis of COVID-19 infection.   On 29 DEC 2020, after receiving the COVID-19 vaccine, the patient experienced fever, fatigue, muscle pain, join pain, chills, injection site pain, and was not feeling well. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not reported.   The event not feeling well was considered not resolved on 30 DEC 2020.   The outcomes for the events fever, fatigue, muscle pain, joint pain, chills, and injection site pain were not provided.   The reporter did not provide an assessment for the events not feeling well, fever, fatigue, muscle pain, joint pain, chills, and injection site pain.; Reporter's Comments: This case concerns a female patient of unknown age. The patient's medical history was not reported. The patient experienced expected events of pyrexia, fatigue, myalgia, arthralgia, chills and injection site pain and unexpected event of feeling abnormal. The events occurred the day the first dose of mRNA-1273 was administered. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash on face and neck; A spontaneous report was received from a consumer (occupation nurse), a 47-year-old, female patient who received Moderna's COVID-19 vaccine and experienced an itchy rash on her face and neck.   There were no medical history and concomitant medications reported.  On 29 Dec 2020, approximately two hours 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 29-Dec-2020, about 2 hours after the vaccine, the consumer reported feeling itchy on her face and neck. She went to the mirror and there was a rash on her forehead, side of cheek and side of neck. Treatment for the event included oral diphenhydramine on the same day.  Action taken with mRNA-1273 in response to the event was not reported.   The event, itchy rash was considered resolved on 29 Dec 2020.; Reporter's Comments: This case concerns a 47-year old female nurse who experienced a nonserious event of an itchy rash on her face and neck. The event occurred approximately 2 hours after she received the first of two planned doses of mRNA-1273 vaccine. The patient's past medical history and con meds were not provided. The rash event was considered resolved the same day. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of mRNA-1273 and the event, a causal relationship cannot be excluded. Additional information is required for further assessment.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: Body Aches; Chills; Fever; Headache; Fatigue; Flu like symptoms; A spontaneous report was received from a consumer concerning a patient of age 31 years old, male who received Moderna's COVID-19 vaccine (mRNA-1273)  and experienced multiple events of flu like symptoms, body aches, chills, fever, headache and fatigue.  The patient's medical history was not provided. Concomitant medications reported included gliclazide and esomeprazole sodium for unknown indication.   On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273.   On 30 Dec 2020, the patient developed flu like symptoms and experienced body aches, chills, fever, headache and fatigue. The treatment for the events included, Tylenol.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the events flu like symptoms, body aches, chills, fever, headache and fatigue were unknown.; Reporter's Comments: This case concerns a 31 year old male patient who received their first of two planned doses of mRNA-1273 (Lot 025L2014), and who experienced the non-serious listed events of chills, fever, headache, and fatigue, and the non-serious unlisted events of flu-like symptoms and body aches.  Based on the current available information and temporal association between the use of the product and the onset of events on the day after vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Body Aches; Chills; Fever; Headache; Fatigue; Flu like symptoms; A spontaneous report was received from a consumer concerning a patient of age 31 years old, male who received Moderna's COVID-19 vaccine (mRNA-1273)  and experienced multiple events of flu like symptoms, body aches, chills, fever, headache and fatigue.  The patient's medical history was not provided. Concomitant medications reported included gliclazide and esomeprazole sodium for unknown indication.   On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273.   On 30 Dec 2020, the patient developed flu like symptoms and experienced body aches, chills, fever, headache and fatigue. The treatment for the events included, Tylenol.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the events flu like symptoms, body aches, chills, fever, headache and fatigue were unknown.; Reporter's Comments: This case concerns a 31 year old male patient who received their first of two planned doses of mRNA-1273 (Lot 025L2014), and who experienced the non-serious listed events of chills, fever, headache, and fatigue, and the non-serious unlisted events of flu-like symptoms and body aches.  Based on the current available information and temporal association between the use of the product and the onset of events on the day after vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 32-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to animals (Cats).    On 30-Dec-2020 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 15-Jul-2020 and the estimated date of delivery was 22-Apr-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Aug-2020, Pregnancy test: postive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.  Estimated date of conception was reported as 01-Aug-2020.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 32-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Maternal exposure during pregnancy, Oropharyngeal pain
Clinical narrative: Pregnant; Sore throat, throat irritation; Cough; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant), OROPHARYNGEAL PAIN (Sore throat, throat irritation) and COUGH (Cough) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 30-Dec-2020, the patient experienced OROPHARYNGEAL PAIN (Sore throat, throat irritation) and COUGH (Cough). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved and OROPHARYNGEAL PAIN (Sore throat, throat irritation) and COUGH (Cough) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were reported. No treatment medication details was reported.; Reporter's Comments: This is a case of product exposure during pregnancy associated with sore throat and cough for this 57-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Muscle pain left arm injection site; A spontaneous report was received from a consumer concerning a 35-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and muscle pain in left arm at injection site.  The patient's medical history was not provided.  No relevant concomitant medications were reported.    On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot# 011J20A) by injection for prophylaxis of COVID-19 infection.     On 29 Dec 2020, patient developed minimal soreness and muscle pain in left arm at injection site. The pain and soreness increased on 30 December 2020. Patient also, developed discomfort when raising left arm over his head. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome of the event was unknown.; Reporter's Comments: This case concerns a 35 year-old, male patient, who experienced events of muscle pain in left arm at injection site.  The event occurred the same day 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Pain in extremity
Clinical narrative: Fever of 100.5 F; Headache; Chills; Tired; Flu-like symptoms; Arm was sore; A spontaneous report was received from a consumer, concerning herself, a 61-year-old female patient, who received Moderna's COVID-19 vaccine and experienced flu-like symptoms, arm was sore, fever of 100.5 f, headache, chills and tired.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29-Dec-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot# 026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 29-Dec-2020, the patient experienced soreness in her left arm and on 30-Dec-2020, she developed fever of 100.5 F, flu-like symptoms, headache, chills and fatigue. Reporter provided consent to follow up. No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.  The outcomes of the events, flu-like symptoms, arm was sore, fever of 100.5 f, headache, chills and tired were not-resolved and was ongoing at the time of this report.; Reporter's Comments: This case concerns a 61-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 026L20A), and who experienced the non-serious unlisted event of flu-like symptoms, and the non-serious listed events of arm sore, fever, headache, chills, and fatigue.  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.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 100.5 F; Headache; Chills; Tired; Flu-like symptoms; Arm was sore; A spontaneous report was received from a consumer, concerning herself, a 61-year-old female patient, who received Moderna's COVID-19 vaccine and experienced flu-like symptoms, arm was sore, fever of 100.5 f, headache, chills and tired.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29-Dec-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot# 026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 29-Dec-2020, the patient experienced soreness in her left arm and on 30-Dec-2020, she developed fever of 100.5 F, flu-like symptoms, headache, chills and fatigue. Reporter provided consent to follow up. No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.  The outcomes of the events, flu-like symptoms, arm was sore, fever of 100.5 f, headache, chills and tired were not-resolved and was ongoing at the time of this report.; Reporter's Comments: This case concerns a 61-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 026L20A), and who experienced the non-serious unlisted event of flu-like symptoms, and the non-serious listed events of arm sore, fever, headache, chills, and fatigue.  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.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Premature labour, Ultrasound scan
Clinical narrative: one episode of pre-term contractions; Got vaccinated during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Got vaccinated during pregnancy) and PREMATURE LABOUR (one episode of pre-term contractions) in a 34-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 immunisation.     The patient's past medical history included Alcohol use (1 drink/day) from 03-Aug-2006 to 02-Oct-2020, Cigarette smoker (1 pack cigarettes/week) from 03-Aug-2003 to 06-Sep-2018, Pregnancy (live, full-term  birth) on 09-Jun-2018 and Pregnancy (live, full-term  birth) on 09-Sep-2014. Concurrent medical conditions included Depression and Anxiety. Concomitant products included CELEXA for Anxiety, VITAMIN D and PRENATAL VITAMINS for Pregnancy.   On 29-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 1 dosage form. The patient's last menstrual period was on 21-Sep-2020 and the estimated date of delivery was 28-Jun-2021. On 29-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Got vaccinated during pregnancy). On 27-Mar-2021, the patient experienced PREMATURE LABOUR (one episode of pre-term contractions). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy. The delivery occurred on an unknown date.  At the time of the report, EXPOSURE DURING PREGNANCY (Got vaccinated during pregnancy) had resolved and PREMATURE LABOUR (one episode of pre-term contractions) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Ultrasound scan: normal (normal) normal findings.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for pre-term contractions included unspecified medication.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: The patient information including medical history and lab tests, pregnancy information and vaccine information were provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling abnormal, Head discomfort, Insomnia
Clinical narrative: weak; Uneasiness; Tired like the energy was sucked of me; Arm sore; Weight/pressure on my head; body aches all night; could not sleep; A spontaneous report was received from a 50 year old female patient who is also a nurse. The patient is a participating in the mRNA-1273 Emergency Use Program and who experienced uneasiness, tired like the energy was sucked of me, arm sore, weight/pressure on my head, body aches all night, could not sleep, and weak with the use of mRNA-1273.    There were no relevant medical history or concomitant medications provided.  On 28 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Dec 2020, the patient, experienced the non-serious events of uneasiness, tired like the energy was sucked of me, arm sore, weight/pressure on my head, body aches all night, could not sleep, and weak. The patient noted she took the vaccine the day prior at work, at approximately 10:00am, and experienced the reported events when she got home. The patient confirmed she felt a little better the morning after, but still weak. Treatment included 500mg paracetamol before bed.   There were no relevant laboratory tests provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the reported events of uneasiness, tired like the energy was sucked of me, arm sore, weight/pressure on my head, body aches all night, could not sleep, and weak were unknown at the time of this report.  Causality was not provided for the events of uneasiness, tired like the energy was sucked of me, arm sore, weight/pressure on my head, body aches all night, could not sleep, and weak.; Reporter's Comments: This case concerns a 50 year old, female patient, who experienced non-serious unexpected event of feeling abnormal, pain in extremity, head discomfort, insomnia, and asthenia, and non-serious expected event of myalgia and fatigue. The event of feeling abnormal, fatigue, pain in extremity, head discomfort, myalgia and insomnia occurred 1 day (same day) after mRNA-1273 (lot# Unknown). The event of asthenia occurred 2 days after mRNA-1273 (lot# Unknown). Treatment included paracetamol. Based on 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: Myalgia, Pain in extremity
Clinical narrative: weak; Uneasiness; Tired like the energy was sucked of me; Arm sore; Weight/pressure on my head; body aches all night; could not sleep; A spontaneous report was received from a 50 year old female patient who is also a nurse. The patient is a participating in the mRNA-1273 Emergency Use Program and who experienced uneasiness, tired like the energy was sucked of me, arm sore, weight/pressure on my head, body aches all night, could not sleep, and weak with the use of mRNA-1273.    There were no relevant medical history or concomitant medications provided.  On 28 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Dec 2020, the patient, experienced the non-serious events of uneasiness, tired like the energy was sucked of me, arm sore, weight/pressure on my head, body aches all night, could not sleep, and weak. The patient noted she took the vaccine the day prior at work, at approximately 10:00am, and experienced the reported events when she got home. The patient confirmed she felt a little better the morning after, but still weak. Treatment included 500mg paracetamol before bed.   There were no relevant laboratory tests provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the reported events of uneasiness, tired like the energy was sucked of me, arm sore, weight/pressure on my head, body aches all night, could not sleep, and weak were unknown at the time of this report.  Causality was not provided for the events of uneasiness, tired like the energy was sucked of me, arm sore, weight/pressure on my head, body aches all night, could not sleep, and weak.; Reporter's Comments: This case concerns a 50 year old, female patient, who experienced non-serious unexpected event of feeling abnormal, pain in extremity, head discomfort, insomnia, and asthenia, and non-serious expected event of myalgia and fatigue. The event of feeling abnormal, fatigue, pain in extremity, head discomfort, myalgia and insomnia occurred 1 day (same day) after mRNA-1273 (lot# Unknown). The event of asthenia occurred 2 days after mRNA-1273 (lot# Unknown). Treatment included paracetamol. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.