chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: redness about 5 inches by 5 inches; This spontaneous case was reported by a nurse and describes the occurrence of   in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Balance disorder, Body temperature, Dizziness
Clinical narrative: shoulder blades were hurting and that pain goes all the way to his lower back of; felt nauseated; fever of 102. degrees; did not have any balance and fell on the bed; lower back pain that shot up to his upper back; Felt dizzy; lower back pain that shot up to his upper back; Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), DIZZINESS (Felt dizzy), the first episode of BACK PAIN (lower back pain that shot up to his upper back), BALANCE DISORDER (did not have any balance and fell on the bed) and the second episode of BACK PAIN (lower back pain that shot up to his upper back) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced PAIN IN EXTREMITY (Arm hurt). On 01-Jan-2021, the patient experienced DIZZINESS (Felt dizzy), the first episode of BACK PAIN (lower back pain that shot up to his upper back) and the second episode of BACK PAIN (lower back pain that shot up to his upper back). On 02-Jan-2021, the patient experienced BALANCE DISORDER (did not have any balance and fell on the bed), NAUSEA (felt nauseated) and PYREXIA (fever of 102. degrees). On 07-Jan-2021, the patient experienced ARTHRALGIA (shoulder blades were hurting and that pain goes all the way to his lower back of). On 02-Jan-2021, PYREXIA (fever of 102. degrees) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm hurt), DIZZINESS (Felt dizzy), BALANCE DISORDER (did not have any balance and fell on the bed), the last episode of BACK PAIN (lower back pain that shot up to his upper back) and NAUSEA (felt nauseated) outcome was unknown and ARTHRALGIA (shoulder blades were hurting and that pain goes all the way to his lower back of) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jan-2021, Body temperature: 102 °F (High) 102 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: shoulder blades were hurting and that pain goes all the way to his lower back of; felt nauseated; fever of 102. degrees; did not have any balance and fell on the bed; lower back pain that shot up to his upper back; Felt dizzy; lower back pain that shot up to his upper back; Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), DIZZINESS (Felt dizzy), the first episode of BACK PAIN (lower back pain that shot up to his upper back), BALANCE DISORDER (did not have any balance and fell on the bed) and the second episode of BACK PAIN (lower back pain that shot up to his upper back) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced PAIN IN EXTREMITY (Arm hurt). On 01-Jan-2021, the patient experienced DIZZINESS (Felt dizzy), the first episode of BACK PAIN (lower back pain that shot up to his upper back) and the second episode of BACK PAIN (lower back pain that shot up to his upper back). On 02-Jan-2021, the patient experienced BALANCE DISORDER (did not have any balance and fell on the bed), NAUSEA (felt nauseated) and PYREXIA (fever of 102. degrees). On 07-Jan-2021, the patient experienced ARTHRALGIA (shoulder blades were hurting and that pain goes all the way to his lower back of). On 02-Jan-2021, PYREXIA (fever of 102. degrees) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm hurt), DIZZINESS (Felt dizzy), BALANCE DISORDER (did not have any balance and fell on the bed), the last episode of BACK PAIN (lower back pain that shot up to his upper back) and NAUSEA (felt nauseated) outcome was unknown and ARTHRALGIA (shoulder blades were hurting and that pain goes all the way to his lower back of) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jan-2021, Body temperature: 102 °F (High) 102 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Diarrhea; Nausea; Vomiting; fever of 100.4 F; Arm sore; A spontaneous report was received from a 60-year-old, female nurse who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm sore, diarrhea, nausea, vomiting and fever of 100.4 F.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 02 Jan 2021 at noon, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  However, on 02 Jan 2021, after receiving the vaccine, later the patient had an arm sore for 24 hours.    On 04 Jan 2021, she had nausea, vomiting, fever (100.4F) and diarrhea.   Treatment for the events was acetaminophen.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the event, arm sore was resolved. The outcome for the events nausea, vomiting, fever of 100.4 F and diarrhea was unknown.; Reporter's Comments: This case concerns a 60-year-old, female, who experienced non-serious event of diarrhea, pain in extremity, nausea, vomiting and pyrexia. 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: Vomiting
Clinical narrative: Diarrhea; Nausea; Vomiting; fever of 100.4 F; Arm sore; A spontaneous report was received from a 60-year-old, female nurse who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm sore, diarrhea, nausea, vomiting and fever of 100.4 F.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 02 Jan 2021 at noon, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  However, on 02 Jan 2021, after receiving the vaccine, later the patient had an arm sore for 24 hours.    On 04 Jan 2021, she had nausea, vomiting, fever (100.4F) and diarrhea.   Treatment for the events was acetaminophen.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the event, arm sore was resolved. The outcome for the events nausea, vomiting, fever of 100.4 F and diarrhea was unknown.; Reporter's Comments: This case concerns a 60-year-old, female, who experienced non-serious event of diarrhea, pain in extremity, nausea, vomiting and pyrexia. 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: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: It felt warm to touch; indurated; Small local redness reaction; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE WARMTH (It felt warm to touch), INJECTION SITE ERYTHEMA (Small local redness reaction) and INJECTION SITE INDURATION (indurated) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included MULTIVITAMIN [VITAMINS NOS] and PROBIOTICS 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. On 24-Dec-2020, the patient experienced INJECTION SITE ERYTHEMA (Small local redness reaction). On 30-Dec-2020, the patient experienced INJECTION SITE WARMTH (It felt warm to touch) and INJECTION SITE INDURATION (indurated). At the time of the report, INJECTION SITE WARMTH (It felt warm to touch), INJECTION SITE ERYTHEMA (Small local redness reaction) and INJECTION SITE INDURATION (indurated) 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.   The patient's medical history was not provided.  Treatment included unspecified antibiotics.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Oropharyngeal pain
Clinical narrative: lack of smell; sore throat; On 04-Jan-2021 at 4:23PM a phone call voicemail report was received from a physician concerning himself. He experienced Covid 19 symptoms four days after receiving Moderna's Covid 19 vaccine.  The reporter/patient did not provide any medical history prior to receiving the vaccine.  No relevant concomitant medications were reported.  On 24-Dec-2020 prior to the onset of events, the reporter/patient stated he received the first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of Covid 19 infection.  On 27-Dec-2020, he stated that he started experiencing Covid symptoms like "lack of smell" and "sore throat".  The reporter/patient stated that he was diagnosed on 29-Dec-2020. He did not state what he was diagnosed with.  The patient/reporter stated that he received an immunoglobulin infusion for Covid treatment on 31-Dec-2020.  The outcome of the events, lack of smell and sore throat was considered as unknown at the time of this report.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling, Vaccination site mass
Clinical narrative: itchy; Swollen; allergic bump; A spontaneous report was received from a consumer who was a 30-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed an itchy, swollen and allergic bump.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (Lot number: 039K202A) intramuscularly in her left arm for prophylaxis of COVID-19 infection.   On the morning of 05 Jan 2021, the patient started to have an itchy, swollen and allergic bump. She did not apply any treatment medication as the itchy, swollen, allergic bump did not bother her, however she was concerned about the delayed reaction.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events itchy, swollen and allergic bump was not reported.; Reporter's Comments: This case concerns a 30-year old female patient with unknown medical history and concomitant medications. The patient experienced a non serious event of an itchy, swollen and allergic bump 6 days after the administration of first of 2 planned doses of the mRNA-1273 (Lot #: 039K202A).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
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, SARS-CoV-2 test, Sinus congestion
Clinical narrative: I just tested positive for COVID-19; I have a headache; Sinus congestion; A spontaneous report  was received from a health care professional who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, sinus congestion and tested positive for COVID-19.   The patient's medical history was not reported. No relevant concomitant medications were reported.  On 29 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (Lot number: not reported) for prophylaxis of COVID-19 infection.   On 05 Jan 2021, the patient had tested positive for COVID-19. She complained of a headache and sinus congestion, but she did not have any respiratory problem.  No treatment for the events was reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the events headache, sinus congestion and tested positive for COVID-19 were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of headache and sinus congestion, a causal relationship cannot be excluded.   The event of tested positive for COVID-19 is assessed as unlikely related to mRNA-1273 based on the fact that very limited information regarding the exposure and risk factors to the event has been provided at this time.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Fatigue, Feeling abnormal, Malaise
Clinical narrative: not feeling well; brain is foggy; Feeling tired; felt out of it; Fever; diarrhea; nausea; feels weak; A spontaneous report was received from a healthcare facility staff who was a 30-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced feeling tired and out of it, fever, diarrhea, nausea, felt weak, not feeling well and her brain was foggy.    The patient's medical history was not provided. Concomitant medication reported included vitamins.   On 31 Dec 2020, prior to the onset of the events the patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On 01 Jan 2021, patient reported feeling tired and out of it.  She also reported of having fever, diarrhea, nausea and feeling weak. She stated that she did not actually take her temperature, however, she said that she felt hot.    On 05 Jan 2021, she reported that she was not feeling well and that her brain felt foggy. Patient admitted taking paracetamol which helped her a little bit.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, feeling tired and out of it, fever, diarrhea, nausea, felt weak, not feeling well and her brain was foggy, was not reported.; Reporter's Comments: This case concerns a 30-year-old, female who experienced a non-serious event of Fatigue, feeling abnormal, pyrexia, diarrhoea, nausea, asthenia, malaise, and feeling abnormal after receiving first dose of mRNA-1273 (Lot# unknown). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Follow-up information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: not feeling well; brain is foggy; Feeling tired; felt out of it; Fever; diarrhea; nausea; feels weak; A spontaneous report was received from a healthcare facility staff who was a 30-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced feeling tired and out of it, fever, diarrhea, nausea, felt weak, not feeling well and her brain was foggy.    The patient's medical history was not provided. Concomitant medication reported included vitamins.   On 31 Dec 2020, prior to the onset of the events the patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On 01 Jan 2021, patient reported feeling tired and out of it.  She also reported of having fever, diarrhea, nausea and feeling weak. She stated that she did not actually take her temperature, however, she said that she felt hot.    On 05 Jan 2021, she reported that she was not feeling well and that her brain felt foggy. Patient admitted taking paracetamol which helped her a little bit.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, feeling tired and out of it, fever, diarrhea, nausea, felt weak, not feeling well and her brain was foggy, was not reported.; Reporter's Comments: This case concerns a 30-year-old, female who experienced a non-serious event of Fatigue, feeling abnormal, pyrexia, diarrhoea, nausea, asthenia, malaise, and feeling abnormal after receiving first dose of mRNA-1273 (Lot# unknown). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Follow-up information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Physical examination
Clinical narrative: red spot that keeps getting bigger and darker which is near the injection site, behind it and lower; Each day it gets bigger and redder; A spontaneous report was received from a nurse who was a 63-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed red spot that kept getting bigger and darker near the injection site, behind it and lower and each day it was getting bigger and redder.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Dec 2020, approximately 3 days prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: 011J20A) in the left arm for prophylaxis of COVID-19 infection.     On 29 Dec 2020, the patient developed a red spot located near the injection, behind it and lower than the injection site (it was not exactly located on the injection site). She stated that each day the spot was getting bigger and redder. She measured the size of redness with a measuring tape and noted that it was around 8 cm in diameter. The patient had not taken any medications or any treatment for the event.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome for the events, red spot that keeps getting bigger and darker near the injection site, behind it and lower and each day it gets bigger and redder was not reported.; Reporter's Comments: This case concerns a 63-year-old, female patient. The patient's medical history was not provided. The patient experienced a NS, expected event of injection site erythema and injection site swelling. The event occurred 4 days after the first dose of mRNA-1273 (Lot number: 011J20A) 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: Chills, Fatigue, Headache, Lymphadenopathy, Vaccination site movement impairment
Clinical narrative: Swollen lymph node; couldn't move/hurts to extend left arm; Arm sore; Chills; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node), VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move/hurts to extend left arm), VACCINATION SITE PAIN (Arm sore), CHILLS (Chills) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse effect (Medical History not provided).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced LYMPHADENOPATHY (Swollen lymph node), VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move/hurts to extend left arm), VACCINATION SITE PAIN (Arm sore), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, LYMPHADENOPATHY (Swollen lymph node), VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move/hurts to extend left arm), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown and VACCINATION SITE PAIN (Arm sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment for the event included ibuprofen.  Company Comment: Based on current available information and temporal association between the use of the product and the start date of the events, a causal relationship can not be excluded; Sender's Comments: Based on current available information and temporal association between the use of the product and the start date of the events, a causal relationship can not be excluded
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Swollen lymph node; couldn't move/hurts to extend left arm; Arm sore; Chills; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node), VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move/hurts to extend left arm), VACCINATION SITE PAIN (Arm sore), CHILLS (Chills) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse effect (Medical History not provided).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced LYMPHADENOPATHY (Swollen lymph node), VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move/hurts to extend left arm), VACCINATION SITE PAIN (Arm sore), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, LYMPHADENOPATHY (Swollen lymph node), VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move/hurts to extend left arm), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown and VACCINATION SITE PAIN (Arm sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment for the event included ibuprofen.  Company Comment: Based on current available information and temporal association between the use of the product and the start date of the events, a causal relationship can not be excluded; Sender's Comments: Based on current available information and temporal association between the use of the product and the start date of the events, a causal relationship can not be excluded
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy
Clinical narrative: swollen lymph node; Headache; A spontaneous report was received from a nurse who was an 28-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swollen lymph node and headache.  The patient's medical history was not provided. Concomitant medications reported included dexamfetamine sulfate and unknown birth control.  On 31 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039k20-2a) intramuscularly for prophylaxis of COVID-19 infection. On the same day, the patient experienced swollen lymph node near the collarbone in the same arm that the patient received the vaccine and headache. Treatment for the events included acetaminophen.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, swollen lymph node and headache was unknown.; Reporter's Comments: Based on a temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Headache, and lymphadenopathy are consistent with the known safety profile of the vaccine.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: 15 weeks pregnant; This spontaneous prospective pregnancy case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (15 weeks pregnant) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use. Concurrent medical conditions included Seasonal allergy.    On 04-Jan-2021 at 10:07 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 17-Sep-2020 and the estimated date of delivery was 24-Jun-2021. On 04-Jan-2021 at 10:07 AM, the patient experienced EXPOSURE DURING PREGNANCY (15 weeks pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifteenth week of the pregnancy.  On 04-Jan-2021, EXPOSURE DURING PREGNANCY (15 weeks pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Oct-2020, Pregnancy test: positive positive; estimated date of conception 04Oct2020.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 08-Jan-2021: No specific follow-up information recorded.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Malaise, Nausea
Clinical narrative: Patient felt sick all day long; High fever; Chills; Fatigue; Nauseous; Throwing up; A spontaneous report was received from a non-health professional concerning a 77-year-old, female patient who received Moderna's COVID-19 vaccine and threw up, had nausea, fatigue, chills, a high fever and felt sick all day long.  The patient's medical history, as provided by the reporter, included COVID-19 and pneumonia. Concomitant medications reported included heart tablets, blood pressure medication and estrogen.  On 02 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On 03 Jan 2021, the day after receiving the vaccine, the patient threw up, had nausea, fatigue, chills, a high fever and felt sick all day long. She stated she felt like she had COVID-19 again.  On 04 Jan 2021, the patient reported feeling better but not good.  Treatment for the events included ibuprofen.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the events, threw up, had nausea, fatigue, chills, a high fever and felt sick all day long, was not reported.  Reporter causality for the events was not provided.; 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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient felt sick all day long; High fever; Chills; Fatigue; Nauseous; Throwing up; A spontaneous report was received from a non-health professional concerning a 77-year-old, female patient who received Moderna's COVID-19 vaccine and threw up, had nausea, fatigue, chills, a high fever and felt sick all day long.  The patient's medical history, as provided by the reporter, included COVID-19 and pneumonia. Concomitant medications reported included heart tablets, blood pressure medication and estrogen.  On 02 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On 03 Jan 2021, the day after receiving the vaccine, the patient threw up, had nausea, fatigue, chills, a high fever and felt sick all day long. She stated she felt like she had COVID-19 again.  On 04 Jan 2021, the patient reported feeling better but not good.  Treatment for the events included ibuprofen.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the events, threw up, had nausea, fatigue, chills, a high fever and felt sick all day long, was not reported.  Reporter causality for the events was not provided.; 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Flushing, Headache, Heart rate increased
Clinical narrative: flushed like a naicin rush that lasted for 10-12 minutes and then faded; Felt racy; Face turned red; Headache; Felt tired; A spontaneous report was received from a consumer concerning a 44 year old, female patient who experienced headache, flushing, and fatigue.   The patient's medical history included auto-immune disease and severe rheumatoid arthritis. Products known to have been used by the patient, within two weeks prior to the event, included "Linvox" and etanercept.   The patient received their first of two planned doses of mRNA-1273 (Lot number unknown) on an unspecified date. Per the reporter, the patient received Moderna's Covid-19 vaccination "last Monday or Tuesday" (call received 04 Jan 2021) for prophylaxis of COVID-19 infection.   The patient's mother called to report that her daughter is immunocompromised and received the vaccine. She reported that her daughter was diagnosed with auto-immune disease and severe rheumatoid arthritis years ago. Her daughter had been on Enbrel for the last 6 years but was recently changed to "Linvox." She also provided that her daughter works in a nursing home. After receiving the vaccine, she reported that her daughter had a headache that lasted several minutes, her face turned red, she "felt racy" and flushed like a "niacin rush" that lasted 10-12 minutes and then faded. She also reported that her daughter felt tired this weekend. Treatment information was unknown.   Action taken with mRNA-1273 in response to the events was not provided/unknown.   The outcome of the events, headache, flushing, erythema were considered resolved the same day. The outcome of the event fatigue, 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 events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Rhinorrhoea
Clinical narrative: Runny nose; Headache; Chills; 1.5 Fever Temperature for 3 days; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine and experienced Headache, chills, runny nose and 1.5 fever temperature for 3 days.  The patient's medical history high blood pressure. Concomitant medication was High blood pressure medication (Name Unknown).   On 24 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly for prophylaxis of COVID-19 infection.   After receiving the vaccine, the patient experienced headache, chills, runny nose and 1.5 fever for 3 days. Treatment was Unknown.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Choking sensation, Confusional state, Dizziness
Clinical narrative: Alot of left arm pain; Body aches; Fever; Chills; Entire muscle in the left arm hurts; Facial flushing; Blurred vision; Dizziness; Confusion; Choking in the throat; No emotions; A spontaneous report was received from a pharmacist who was an 48-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple events of facial flush, blurred vision, dizziness, confusion, chocking in the throat, had no emotions, body aches, fever 99.8 degree fahrenheit, chills and a lot of left arm pain and entire muscle in left arm hurts.  The patient's medical history included migraine and hysterectomy. The concomitant medications reported included galcanezumab gnlm, sumatriptan and sertraline hydrochloride.  On 02 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A, Exp. date: 25 Jun 2021) intramuscularly for prophylaxis of COVID-19 infection.   Immediately after receiving the vaccine, the patient experienced facial flush, blurred vision, dizziness, confusion, chocking in the throat. It was noted that these effects lasted for 20 minutes after the vaccine. No treatment was administered, and the patient did not have any rash. On the same night, the patient experienced had no emotions and the confusion and dizziness got worse. The patient reported that she drank plenty of fluids to combat the symptoms.  On the morning of 03 Jan 2021, the patient experienced body aches, fever 99.8 degree fahrenheit, chills and a lot of left arm pain and entire muscle in left arm hurts. The treatment information included paracetamol for the fever and antihistamine for allergic reaction to the vaccine.   Action taken with mRNA-1273 in response to the events was withdrawn.  The events, facial flush, blurred vision and chocking in the throat, was considered resolved on 02 Jan 2021.  The events, dizziness, confusion and had no emotions was considered resolved on 03 Jan 2021.  The outcome for the events, body aches, fever 99.8 degree fahrenheit, chills and a lot of left arm pain and entire muscle in left arm hurts was not recovered/ not resolved.; Reporter's Comments: This case concerns a 48-year-old female who had unexpected pain, pain in extremity, choking sensation, dizziness, confusion, emotional withdraw, facial flushing, blurred vision and expected fever, chills, myalgia. Event onset the same day as the first dose of mRNA-1273. Treated with paracetamol and antihistamine. Events resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Emotional poverty, Flushing, Myalgia, Pain, Pain in extremity
Clinical narrative: Alot of left arm pain; Body aches; Fever; Chills; Entire muscle in the left arm hurts; Facial flushing; Blurred vision; Dizziness; Confusion; Choking in the throat; No emotions; A spontaneous report was received from a pharmacist who was an 48-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple events of facial flush, blurred vision, dizziness, confusion, chocking in the throat, had no emotions, body aches, fever 99.8 degree fahrenheit, chills and a lot of left arm pain and entire muscle in left arm hurts.  The patient's medical history included migraine and hysterectomy. The concomitant medications reported included galcanezumab gnlm, sumatriptan and sertraline hydrochloride.  On 02 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A, Exp. date: 25 Jun 2021) intramuscularly for prophylaxis of COVID-19 infection.   Immediately after receiving the vaccine, the patient experienced facial flush, blurred vision, dizziness, confusion, chocking in the throat. It was noted that these effects lasted for 20 minutes after the vaccine. No treatment was administered, and the patient did not have any rash. On the same night, the patient experienced had no emotions and the confusion and dizziness got worse. The patient reported that she drank plenty of fluids to combat the symptoms.  On the morning of 03 Jan 2021, the patient experienced body aches, fever 99.8 degree fahrenheit, chills and a lot of left arm pain and entire muscle in left arm hurts. The treatment information included paracetamol for the fever and antihistamine for allergic reaction to the vaccine.   Action taken with mRNA-1273 in response to the events was withdrawn.  The events, facial flush, blurred vision and chocking in the throat, was considered resolved on 02 Jan 2021.  The events, dizziness, confusion and had no emotions was considered resolved on 03 Jan 2021.  The outcome for the events, body aches, fever 99.8 degree fahrenheit, chills and a lot of left arm pain and entire muscle in left arm hurts was not recovered/ not resolved.; Reporter's Comments: This case concerns a 48-year-old female who had unexpected pain, pain in extremity, choking sensation, dizziness, confusion, emotional withdraw, facial flushing, blurred vision and expected fever, chills, myalgia. Event onset the same day as the first dose of mRNA-1273. Treated with paracetamol and antihistamine. Events resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vision blurred
Clinical narrative: Alot of left arm pain; Body aches; Fever; Chills; Entire muscle in the left arm hurts; Facial flushing; Blurred vision; Dizziness; Confusion; Choking in the throat; No emotions; A spontaneous report was received from a pharmacist who was an 48-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple events of facial flush, blurred vision, dizziness, confusion, chocking in the throat, had no emotions, body aches, fever 99.8 degree fahrenheit, chills and a lot of left arm pain and entire muscle in left arm hurts.  The patient's medical history included migraine and hysterectomy. The concomitant medications reported included galcanezumab gnlm, sumatriptan and sertraline hydrochloride.  On 02 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A, Exp. date: 25 Jun 2021) intramuscularly for prophylaxis of COVID-19 infection.   Immediately after receiving the vaccine, the patient experienced facial flush, blurred vision, dizziness, confusion, chocking in the throat. It was noted that these effects lasted for 20 minutes after the vaccine. No treatment was administered, and the patient did not have any rash. On the same night, the patient experienced had no emotions and the confusion and dizziness got worse. The patient reported that she drank plenty of fluids to combat the symptoms.  On the morning of 03 Jan 2021, the patient experienced body aches, fever 99.8 degree fahrenheit, chills and a lot of left arm pain and entire muscle in left arm hurts. The treatment information included paracetamol for the fever and antihistamine for allergic reaction to the vaccine.   Action taken with mRNA-1273 in response to the events was withdrawn.  The events, facial flush, blurred vision and chocking in the throat, was considered resolved on 02 Jan 2021.  The events, dizziness, confusion and had no emotions was considered resolved on 03 Jan 2021.  The outcome for the events, body aches, fever 99.8 degree fahrenheit, chills and a lot of left arm pain and entire muscle in left arm hurts was not recovered/ not resolved.; Reporter's Comments: This case concerns a 48-year-old female who had unexpected pain, pain in extremity, choking sensation, dizziness, confusion, emotional withdraw, facial flushing, blurred vision and expected fever, chills, myalgia. Event onset the same day as the first dose of mRNA-1273. Treated with paracetamol and antihistamine. Events resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: Little bit of itchiness; Redness; Substantial hives at the site of vaccination; A spontaneous report was received from a physician concerning a 42-year-old, female patient who was participating in the mRNA-1273 Emergency Use Program and who developed substantial hives at the site of the vaccination, a little bit of itchiness and redness.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included etanercept, hydroxychloroquine sulfate, omeprazole, aspirin and a multivitamin.   The patient received their first of two planned doses of mRNA-1273 (LOT: 011J20A) on 28-Dec-2020 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 04 Jan 2021, she had developed substantial hives at the injection site.  She also reported a little bit of itchiness & redness.    Treatment information was not provided.   Action taken with mRNA-1273 in response to the events, substantial hives at the site of the vaccination, a little bit of itchiness and redness, was not provided.   The outcome of the events, substantial hives at the site of the vaccination, a little bit of itchiness and redness, was not reported.   The reporter did not provide a causality assessment for the events, substantial hives at the site of the vaccination, a little bit of itchiness and redness.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: shortness of breath; tightness across her chest; soreness around her check and back of neck; sinus issues; sneezing; no appetite; tiredness; left arm began to hurt; chills; headache; felt an elevated body temperature, temperature of 99.8 degrees Fahrenheit; A spontaneous report was received from a pharmacist who was also 67-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a headache, her left arm began to hurt, felt an elevated body temperature, measured temperature of 99.8 degrees Fahrenheit, chills, tiredness, no appetite, shortness of breath, tightness across the chest, soreness around her chest and back of neck, sinus issues and sneezing.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 05 Jan 2021, 8 hours post injection, the patient developed headache, her left arm began to hurt, felt an elevated body temperature, measured temperature of 99.8 degrees Fahrenheit, chills and tiredness. On 06 Jan 2021, the patient stated that she slept all day. On 07 Jan 2021, she experienced shortness of breath, tightness across her chest, soreness around her chest and back of neck, sinus issues, sneezing, productive blowing of her nose. On 08 Jan 2021, the patient stated that when she woke up, she felt completely back to her normal self. Treatment included pseudoephedrine hydrochloride and ibuprofen.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, headache, her left arm began to hurt, felt an elevated body temperature, measured temperature of 99.8 degrees Fahrenheit, chills, tiredness, no appetite, shortness of breath, tightness across the chest, soreness around her chest and back of neck, sinus issues and sneezing, were considered resolved on 08 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 event, a causal relationship cannot be excluded.