chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Prenatal screening test, Ultrasound scan
Clinical narrative: pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20a) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live full term birth) on 26-Mar-2019, Pregnancy (Live full term birth) on 24-Oct-2016 and Alcohol use. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-Jan-2015 to an unknown date for Pregnancy.    On 04-Jan-2021 at 7:20 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 02-Oct-2020 and the estimated date of delivery was 09-Jul-2021. On 04-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirteenth week of the pregnancy.  On 04-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2020, Prenatal screening test: normal (normal) Normal. On 01-Jan-2020, Ultrasound scan: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  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.  The estimated date of conception was unknown. The patient had no maternal history of subfertility and had established prenatal care. There was no complications or acute illness reported during tis pregnancy. Number of fetuses was reported as 1.; Reporter'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.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Hyperhidrosis, Nausea
Clinical narrative: Sweating; Body aches; Joint pain; Nausea; Chills; Fever; Fatigue; A report was received from a consumer concerning a 48 year old male patient who was participating in the mRNA-1273 and developed nausea, body aches, sweating, chills and fever, joint pain, and fatigue.   The patient's medical history included COVID-19 and blood pressure. No relevant concomitant medications were reported.   On 04 Jan 2021, within one day of the onset of the events, the patient received their first of two planned doses of mRNA-1273 (011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   That night the patient experienced nausea, body aches, sweating, chills, fever, joint pain and fatigue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided .   The outcome nausea, body aches, sweating, chills and fever, joint pain, and fatigue.were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Sweating; Body aches; Joint pain; Nausea; Chills; Fever; Fatigue; A report was received from a consumer concerning a 48 year old male patient who was participating in the mRNA-1273 and developed nausea, body aches, sweating, chills and fever, joint pain, and fatigue.   The patient's medical history included COVID-19 and blood pressure. No relevant concomitant medications were reported.   On 04 Jan 2021, within one day of the onset of the events, the patient received their first of two planned doses of mRNA-1273 (011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   That night the patient experienced nausea, body aches, sweating, chills, fever, joint pain and fatigue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided .   The outcome nausea, body aches, sweating, chills and fever, joint pain, and fatigue.were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Cough, Fatigue
Clinical narrative: body pain; sinus issue; feeling week; cough; sore throat; chills; joint pain; tired; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), CHILLS (chills) and FATIGUE (tired) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced COUGH (cough), CHILLS (chills) and FATIGUE (tired). At the time of the report, COUGH (cough), CHILLS (chills) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment included Motrin to help with pain.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain, Pain, Sinus disorder
Clinical narrative: body pain; sinus issue; feeling week; cough; sore throat; chills; joint pain; tired; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), CHILLS (chills) and FATIGUE (tired) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced COUGH (cough), CHILLS (chills) and FATIGUE (tired). At the time of the report, COUGH (cough), CHILLS (chills) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment included Motrin to help with pain.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: runny nose; cough; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of   in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2021, SARS-CoV-2 test: positve.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-002963, MOD-2021-003321 (Patient Link).   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 these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chills, Cold sweat, Dizziness, Headache
Clinical narrative: felt dizzy; Plapitation; tachycardia; Blood pressure went up; clammy; headache; cold and clammy; A spontaneous  report was received from a physician concerning a 74 year old, female patient who received  first dose of Moderna's COVID-19 vaccine and experienced headache, dizzy feeling, chill, palpitation, blood pressure went up, clummy and tachycardia.    The patient's medical history was not provided. Concomitant product used was not provided by the reporter.   On 29 DEC 2020, the patient received their first of two planned doses of mRNA-1273 (lot no: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient experienced headache, dizzy feeling, started getting palpitation, her heart beats was 132 bpm. her blood pressure increased and oxygen levels were normal and the patient did not required oxygen. She started feeling cold and clammy and was in injection area of hospital for 2 hours with constant monitoring. She did not take any medication but drank lots of water.   The patient was concerned of whether she should receive the second dose given the symptoms experienced after the first dose.    Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the events headache, dizzy feeling, chill, palpitation, clammy, blood pressure went up and tachycardia 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 these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypertension, Oxygen saturation, Palpitations, Tachycardia
Clinical narrative: felt dizzy; Plapitation; tachycardia; Blood pressure went up; clammy; headache; cold and clammy; A spontaneous  report was received from a physician concerning a 74 year old, female patient who received  first dose of Moderna's COVID-19 vaccine and experienced headache, dizzy feeling, chill, palpitation, blood pressure went up, clummy and tachycardia.    The patient's medical history was not provided. Concomitant product used was not provided by the reporter.   On 29 DEC 2020, the patient received their first of two planned doses of mRNA-1273 (lot no: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient experienced headache, dizzy feeling, started getting palpitation, her heart beats was 132 bpm. her blood pressure increased and oxygen levels were normal and the patient did not required oxygen. She started feeling cold and clammy and was in injection area of hospital for 2 hours with constant monitoring. She did not take any medication but drank lots of water.   The patient was concerned of whether she should receive the second dose given the symptoms experienced after the first dose.    Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the events headache, dizzy feeling, chill, palpitation, clammy, blood pressure went up and tachycardia 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 these events, a causal relationship cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Ageusia, Anosmia, Chest pain, Chills
Clinical narrative: Rash on the face and neck, becoming more generalized; Abdominal pain; fever; vomiting; chills; extreme fatigue; nausea; body ache; headache; shortness of breath; loss of taste; loss of smell; chest pain; A spontaneous report was received from nurse, concerning a 48-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced extreme fatigue, shortness of breath, fever, chills, nausea, vomiting, loss of taste and smell, abdominal pain, chest pain, rash on face and neck (becoming more generalized), headache and body ache.   The patient's medical history included hypothyroidism, morbid obesity, chronic lower back pain and urinary incontinence. Concomitant medications included levothyroxine and oxybutynin.   On 23 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 23 Dec 2020, within 2 hours of administration, the patient experienced extreme fatigue, shortness of breath, fever, chills, nausea, vomiting, loss of taste and smell, abdominal pain and chest pain. A few days later, on unknown date, she developed rash on the face and neck and it became more generalized.   On 30 Dec 2020, the reporter saw the patient and stated that she was still having shortness of breath with exertion and feeling tired. Treatment included over the counter ibuprofen and paracetamol.   Action taken with mRNA-1273 in response to the event was not reported.   The outcomes of the  events, extreme fatigue, fever, chills, nausea, vomiting, loss of taste and smell, abdominal pain, chest pain, rash on face and neck, headache and body aches, were considered recovering/resolving.   The outcome of the event, shortness of breath, was considered not recovered/not resolved.; 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Rash on the face and neck, becoming more generalized; Abdominal pain; fever; vomiting; chills; extreme fatigue; nausea; body ache; headache; shortness of breath; loss of taste; loss of smell; chest pain; A spontaneous report was received from nurse, concerning a 48-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced extreme fatigue, shortness of breath, fever, chills, nausea, vomiting, loss of taste and smell, abdominal pain, chest pain, rash on face and neck (becoming more generalized), headache and body ache.   The patient's medical history included hypothyroidism, morbid obesity, chronic lower back pain and urinary incontinence. Concomitant medications included levothyroxine and oxybutynin.   On 23 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 23 Dec 2020, within 2 hours of administration, the patient experienced extreme fatigue, shortness of breath, fever, chills, nausea, vomiting, loss of taste and smell, abdominal pain and chest pain. A few days later, on unknown date, she developed rash on the face and neck and it became more generalized.   On 30 Dec 2020, the reporter saw the patient and stated that she was still having shortness of breath with exertion and feeling tired. Treatment included over the counter ibuprofen and paracetamol.   Action taken with mRNA-1273 in response to the event was not reported.   The outcomes of the  events, extreme fatigue, fever, chills, nausea, vomiting, loss of taste and smell, abdominal pain, chest pain, rash on face and neck, headache and body aches, were considered recovering/resolving.   The outcome of the event, shortness of breath, was considered not recovered/not resolved.; 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Rash on the face and neck, becoming more generalized; Abdominal pain; fever; vomiting; chills; extreme fatigue; nausea; body ache; headache; shortness of breath; loss of taste; loss of smell; chest pain; A spontaneous report was received from nurse, concerning a 48-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced extreme fatigue, shortness of breath, fever, chills, nausea, vomiting, loss of taste and smell, abdominal pain, chest pain, rash on face and neck (becoming more generalized), headache and body ache.   The patient's medical history included hypothyroidism, morbid obesity, chronic lower back pain and urinary incontinence. Concomitant medications included levothyroxine and oxybutynin.   On 23 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 23 Dec 2020, within 2 hours of administration, the patient experienced extreme fatigue, shortness of breath, fever, chills, nausea, vomiting, loss of taste and smell, abdominal pain and chest pain. A few days later, on unknown date, she developed rash on the face and neck and it became more generalized.   On 30 Dec 2020, the reporter saw the patient and stated that she was still having shortness of breath with exertion and feeling tired. Treatment included over the counter ibuprofen and paracetamol.   Action taken with mRNA-1273 in response to the event was not reported.   The outcomes of the  events, extreme fatigue, fever, chills, nausea, vomiting, loss of taste and smell, abdominal pain, chest pain, rash on face and neck, headache and body aches, were considered recovering/resolving.   The outcome of the event, shortness of breath, was considered not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Heart rate went up; A spontaneous report was received from a consumer concerning a 66-year-old female patient who received Moderna's COVID-19 vaccine and experienced a heart rate increase.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event were not provided.  On 06 Jan 2021 at 14:00, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) for prophylaxis of COVID-19 infection.   On 06 Jan 2021 at 14:10, approximately 10 minutes after she received the mRNA-1273 vaccination, while she was waiting in her vehicle, patient experienced an increase in her heart rate to 164 for less than a minute, which then trended down to 120. On her drive home, it increased again to 152. She drove directly to her doctor's office who then told her she had the option of going to the emergency room since they did not know how to treat reactions to the vaccine. She waited in the waiting room until her heart rate went down to 109, at which point she went home. At approximately 16:00 she reports that her heart rate was 95.   Patient reports that her normal heart rate is 66-68. Consent has been given to contact.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the event was recovering.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash All Over; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash All Over) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medically reported 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 RASH (Rash All Over). On 31-Dec-2020, RASH (Rash All Over) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the event one hour later after vaccination, 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 one hour later after vaccination, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: very negative reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (very negative reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (very negative reaction). At the time of the report, VACCINATION SITE REACTION (very negative reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Very limited information regarding this event has been provided at this time.  Further information has been requested.   Reporter did not allow further contact; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: it was warm to the touch; arm was sore and red for 3 days/it started getting very tender and sore; arm was sore and red for 3 days/red spot where I got the injection; This spontaneous case was reported by a medical assistant (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (it was warm to the touch), VACCINATION SITE PAIN (arm was sore and red for 3 days/it started getting very tender and sore) and VACCINATION SITE ERYTHEMA (arm was sore and red for 3 days/red spot where I got the injection) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE PAIN (arm was sore and red for 3 days/it started getting very tender and sore) and VACCINATION SITE ERYTHEMA (arm was sore and red for 3 days/red spot where I got the injection). On 07-Jan-2021, the patient experienced VACCINATION SITE WARMTH (it was warm to the touch). On 01-Jan-2021, VACCINATION SITE PAIN (arm was sore and red for 3 days/it started getting very tender and sore) and VACCINATION SITE ERYTHEMA (arm was sore and red for 3 days/red spot where I got the injection) had resolved. At the time of the report, VACCINATION SITE WARMTH (it was warm to the touch) 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.   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: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Lost taste; Lost sense of smell; Covid test positive; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of AGEUSIA (Lost taste), ANOSMIA (Lost sense of smell) and SARS-COV-2 TEST POSITIVE (Covid test positive) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Coronavirus test positive (COVID-19) on 06-Jan-2021 and Cough.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 06-Jan-2021, the patient experienced AGEUSIA (Lost taste), ANOSMIA (Lost sense of smell) and SARS-COV-2 TEST POSITIVE (Covid test positive). At the time of the report, AGEUSIA (Lost taste), ANOSMIA (Lost sense of smell) and SARS-COV-2 TEST POSITIVE (Covid test positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, SARS-CoV-2 test: (Positive) COVID-19.     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.   Sender's Comment. This case concerns a 51-year-old male who experienced NS unexpected events of ageusia, anosmia and SARS-CoV-2 test positive. Event onset occurred Days 3 after the first dose of mRNA-1273. Treatment included dextromethorphan, doxylamine, acetaminophen, azithromycin. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Reporter's Comments: This case concerns a 51-year-old male who experienced NS unexpected events of ageusia, anosmia and SARS-CoV-2 test positive. Event onset occurred Days 3 after the first dose of mRNA-1273. Treatment included dextromethorphan, doxylamine, acetaminophen, azithromycin. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: redness of arm that won´t go away; A spontaneous report was received from a nurse concerning a 27-years old, female patient who experienced the event injection site erythema.   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 Topamax.   On 26 Dec 2020, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039k20a) via unknown route for prophylaxis of COVID-19 infection.  On 26 Dec 2020, the patient experienced redness on her arm that she got the first dose of vaccine. She reported that the size of the reaction remains the same and that isn't going away.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not unknown.  The outcome of the event injection site erythema was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; 100 degrees fever; A spontaneous report was received from a consumer, concerning his girlfriend, a female patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm and 100 degrees fever.  The patient's medical history was not provided. No relevant concomitant medications were reported  On 07 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 07 Jan 2021, after receiving vaccine, the patient (healthcare worker) experienced sore arm and on 08 Jan 2021, she also woke up with 100 degrees fever which was broken now.  Treatment for the events were not reported.   Action taken with mRNA-1273 in response to the events were not reported.   The outcome of the events, sore arm and 100 degrees fever were considered unknown at the time of this report.; Reporter's Comments: This case concerns a female of unknown age who experienced NS unexpected events of pain in extremity and NS expected events of fever. Event onset occurred Day 2 after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Headache; temperature, temperature of 100 ºF now, and that was around 102-103 ºF; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (temperature, temperature of 100 ºF now, and that was around 102-103 ºF) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced HEADACHE (Headache) and PYREXIA (temperature, temperature of 100 ºF now, and that was around 102-103 ºF). At the time of the report, HEADACHE (Headache) and PYREXIA (temperature, temperature of 100 ºF now, and that was around 102-103 ºF) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 100 ºf (High) 102 - 103 ºF.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2021: NNI; 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: Vaccination site erythema, Vaccination site paraesthesia
Clinical narrative: Tingling at the injection site; Red,raised, warm spot on my arm ,at where i got the shot; A spontaneous report was received from a consumer , concerning  30 years old female patient , who received Moderna COVID-19 vaccine(mRNA-1273)  and experienced events vaccination site erythema and vaccination site paraesthesia .  The patient's medical history was not provided .Concomitant medications were also not reported .   On 30 Dec 2020 , prior to the onset of events , the patient received their first of two planned doses  of mRNA-1273(Lot/batch: unknown) through intramuscular route of administration  for  prophylaxis of COVID-19 infection.   On 06 Jan 2021 ,  patient experienced events red, raised, warm spot on arm at the injection site. It was oblong, 3-4 inches in diameter and had a slight tingle and on 07 Jan 2021 , it got bigger .  Action taken with mRNA-1273 in response to the event was not reported .  At the time of this report ,outcome of the events vaccination site erythema and vaccination site paraesthesia 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: Exposure via breast milk, Pruritus, Urticaria
Clinical narrative: Breastfeeding; raised hives all over; itchy on my knees, palms, arms, and elbows; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PRURITUS (itchy on my knees, palms, arms, and elbows), URTICARIA (raised hives all over) and EXPOSURE VIA BREAST MILK (Breastfeeding) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): The mother's past medical history included Maternal exposure during breast feeding.    MEDICAL HISTORY (Patient): The patient's past medical history included No adverse event (No medical history was reported.).    On 28-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 PRURITUS (itchy on my knees, palms, arms, and elbows). On 02-Jan-2021, the patient experienced URTICARIA (raised hives all over). On an unknown date, the patient experienced EXPOSURE VIA BREAST MILK (Breastfeeding). At the time of the report, PRURITUS (itchy on my knees, palms, arms, and elbows) and URTICARIA (raised hives all over) was resolving and EXPOSURE VIA BREAST MILK (Breastfeeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication included Benadryl and topical steroid cream.  Company Comment: This is a case of product exposure during breastfeeding. 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. Patient will continue to be contacted for further monitoring of AEs.; Reporter's Comments: This is a case of product exposure during breastfeeding. 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. Patient will continue to be contacted for further monitoring of AEs.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: redness of at injection site; tenderness at injection; swelling of 5x7; A Spontaneous report was received from a nurse concerning a male patient who was participating in the mRNA-1273 Emergency Use Program and developed redness, swelling, and tenderness at the injection site   The patient's medical history not provided. No relevant concomitant medications were reported.   On 28 Dec 2020 the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced redness, swelling of 5x7, and tenderness at the injection site. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events redness, swelling, and tenderness at the injection site were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Heart rate, Heart rate increased
Clinical narrative: Rapidly lightheaded; Heart was pounding; Felt like she was shaking; Pulse rate was 162; Blood pressure was 112/92 high for her; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Rapidly lightheaded), PALPITATIONS (Heart was pounding), TREMOR (Felt like she was shaking), HEART RATE INCREASED (Pulse rate was 162) and BLOOD PRESSURE INCREASED (Blood pressure was 112/92 high for her) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lung infection (Bacterial lung infection) since 2012.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced DIZZINESS (Rapidly lightheaded), PALPITATIONS (Heart was pounding), TREMOR (Felt like she was shaking), HEART RATE INCREASED (Pulse rate was 162) and BLOOD PRESSURE INCREASED (Blood pressure was 112/92 high for her). The patient was treated with ALPRAZOLAM ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DIZZINESS (Rapidly lightheaded), PALPITATIONS (Heart was pounding), TREMOR (Felt like she was shaking), HEART RATE INCREASED (Pulse rate was 162) and BLOOD PRESSURE INCREASED (Blood pressure was 112/92 high for her) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement (120-80 mmHg): 112/92 mmHg high. On an unknown date, Heart rate (60-100 /min): 162 /min high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not provided.  Treatment medication not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Tremor
Clinical narrative: Rapidly lightheaded; Heart was pounding; Felt like she was shaking; Pulse rate was 162; Blood pressure was 112/92 high for her; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Rapidly lightheaded), PALPITATIONS (Heart was pounding), TREMOR (Felt like she was shaking), HEART RATE INCREASED (Pulse rate was 162) and BLOOD PRESSURE INCREASED (Blood pressure was 112/92 high for her) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lung infection (Bacterial lung infection) since 2012.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced DIZZINESS (Rapidly lightheaded), PALPITATIONS (Heart was pounding), TREMOR (Felt like she was shaking), HEART RATE INCREASED (Pulse rate was 162) and BLOOD PRESSURE INCREASED (Blood pressure was 112/92 high for her). The patient was treated with ALPRAZOLAM ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DIZZINESS (Rapidly lightheaded), PALPITATIONS (Heart was pounding), TREMOR (Felt like she was shaking), HEART RATE INCREASED (Pulse rate was 162) and BLOOD PRESSURE INCREASED (Blood pressure was 112/92 high for her) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement (120-80 mmHg): 112/92 mmHg high. On an unknown date, Heart rate (60-100 /min): 162 /min high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not provided.  Treatment medication not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Headache, Limb discomfort, SARS-CoV-2 test
Clinical narrative: COVID-19; Arm discomfort; Headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of LIMB DISCOMFORT (Arm discomfort), HEADACHE (Headache) and COVID-19 (COVID-19) in a 47-year-old male 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 30-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 LIMB DISCOMFORT (Arm discomfort) and HEADACHE (Headache). On 08-Jan-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, LIMB DISCOMFORT (Arm discomfort), HEADACHE (Headache) and COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, SARS-CoV-2 test: 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.   Concomitant product use was not provided by the reporter. Patient had mild cough, nose congestion and was diagnosed with COVID-19. Treatment medication included Advil.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded except for the event of COVID-19 test positive.  The event of COVID-19 test positive is unlikely related to mRNA-1273 since the vaccine does not contain virus capable of causing infection.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded except for the event of COVID-19 test positive.  The event of COVID-19 test positive is unlikely related to mRNA-1273 since the vaccine does not contain virus capable of causing infection.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Oxygen saturation, Oxygen saturation decreased, Pain in extremity
Clinical narrative: Arm was just a little sore; heart rate got up to 115; breathing hard; Oxygen saturation 70; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm was just a little sore), TACHYCARDIA (heart rate got up to 115), DYSPNOEA (breathing hard) and OXYGEN SATURATION DECREASED (Oxygen saturation 70) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation, Diabetes, Asthma and Hypertension.    On 07-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was just a little sore), TACHYCARDIA (heart rate got up to 115), DYSPNOEA (breathing hard) and OXYGEN SATURATION DECREASED (Oxygen saturation 70). At the time of the report, PAIN IN EXTREMITY (Arm was just a little sore), TACHYCARDIA (heart rate got up to 115), DYSPNOEA (breathing hard) and OXYGEN SATURATION DECREASED (Oxygen saturation 70) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Oxygen saturation: 70 (Low) via Oximeter. In January 2021, Heart rate: 90 (Inconclusive) resting and 110-115 (Inconclusive) when walking.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment included an ablation.   Company Comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Arm was just a little sore; heart rate got up to 115; breathing hard; Oxygen saturation 70; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm was just a little sore), TACHYCARDIA (heart rate got up to 115), DYSPNOEA (breathing hard) and OXYGEN SATURATION DECREASED (Oxygen saturation 70) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation, Diabetes, Asthma and Hypertension.    On 07-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was just a little sore), TACHYCARDIA (heart rate got up to 115), DYSPNOEA (breathing hard) and OXYGEN SATURATION DECREASED (Oxygen saturation 70). At the time of the report, PAIN IN EXTREMITY (Arm was just a little sore), TACHYCARDIA (heart rate got up to 115), DYSPNOEA (breathing hard) and OXYGEN SATURATION DECREASED (Oxygen saturation 70) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Oxygen saturation: 70 (Low) via Oximeter. In January 2021, Heart rate: 90 (Inconclusive) resting and 110-115 (Inconclusive) when walking.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment included an ablation.   Company Comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.