chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Blood pressure measurement, Body temperature, Chills
Clinical narrative: Very very lethargic; Joint pain; Chills; Headache; Muscle pain/ Felt sore; Stuffy nose; Runny nose; Sneezing; Short of breath; Could barely walk; Ears ringing; Blood pressure 149/82; No appetite; Nausea; Low grade fever 99.9; Threw up; Light sensitivity at night; Tired; Felt weak; Dizzy; A spontaneous report was received from a consumer, concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple events of headache, fatigue, chills, muscle pain, joint pain, felt dizzy, felt weak, tired, no appetite, nauseous, threw up, low grade fever 99.9 temp, short of breath, could barely walk, ears ringing, blood pressure was 148/82, felt sore, sneezing, runny nose, stuffy nose and light sensitivity.  The patient's medical history included autoimmune disease, psoriatic arthritis and psoriasis. No concomitant medications were reported.  On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection. 30 minutes after receiving the vaccine, the patient experienced felt dizzy, weak and tired.   On 30 Dec 2020, the patient experienced, felt weak, tired, no appetite, nauseous, threw up and low-grade fever 99.9 degree fahrenheit and light sensitivity at night. No treatment was administered at this point.  On 31 Dec 2020, the patient experienced, short of breath, could barely walk, ears ringing, and blood pressure was 148/82 mmHg. The treatment information included nyquil.  On 01 Jan 2021, the patient reported she felt sore. The treatment information included celebrex.   On 02 Jan 2021 and 03 Jan 2021, the patient experienced sneezing and runny nose.  On 06 Jan 2021, the patient stated she only had stuffy nose and weakness.   On an unknown date, the patient experienced, headache, fatigue, chills, muscle pain and joint pain.  Action taken with mRNA-1273 in response to the events was not provided.  The events, felt dizzy, tired, no appetite, nauseous, threw up, low grade fever 99.9 temp, short of breath, could barely walk, ears ringing, blood pressure was 148/82, felt sore, sneezing and runny nose was considered resolved on an unknown date.   The outcome for the events, headache, fatigue, chills, muscle pain and joint pain was unknown.  The outcome for the events, felt weak, stuffy nose and light sensitivity at night was not resolved.; Reporter's Comments: This case concerns a female with psoriasis and NS unexpected hypertension, dizziness, dyspnea, nasal congestion, rhinorrhea, sneezing, asthenia, lethargy, photophobia, tinnitus, decreased appetite, gait disturbance and expected fever, chills, fatigue, headache, myalgia, nausea, vomiting, arthralgia. Event onset Day 1 after 1st dose. 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: Decreased appetite, Dizziness, Dyspnoea, Fatigue, Gait disturbance
Clinical narrative: Very very lethargic; Joint pain; Chills; Headache; Muscle pain/ Felt sore; Stuffy nose; Runny nose; Sneezing; Short of breath; Could barely walk; Ears ringing; Blood pressure 149/82; No appetite; Nausea; Low grade fever 99.9; Threw up; Light sensitivity at night; Tired; Felt weak; Dizzy; A spontaneous report was received from a consumer, concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple events of headache, fatigue, chills, muscle pain, joint pain, felt dizzy, felt weak, tired, no appetite, nauseous, threw up, low grade fever 99.9 temp, short of breath, could barely walk, ears ringing, blood pressure was 148/82, felt sore, sneezing, runny nose, stuffy nose and light sensitivity.  The patient's medical history included autoimmune disease, psoriatic arthritis and psoriasis. No concomitant medications were reported.  On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection. 30 minutes after receiving the vaccine, the patient experienced felt dizzy, weak and tired.   On 30 Dec 2020, the patient experienced, felt weak, tired, no appetite, nauseous, threw up and low-grade fever 99.9 degree fahrenheit and light sensitivity at night. No treatment was administered at this point.  On 31 Dec 2020, the patient experienced, short of breath, could barely walk, ears ringing, and blood pressure was 148/82 mmHg. The treatment information included nyquil.  On 01 Jan 2021, the patient reported she felt sore. The treatment information included celebrex.   On 02 Jan 2021 and 03 Jan 2021, the patient experienced sneezing and runny nose.  On 06 Jan 2021, the patient stated she only had stuffy nose and weakness.   On an unknown date, the patient experienced, headache, fatigue, chills, muscle pain and joint pain.  Action taken with mRNA-1273 in response to the events was not provided.  The events, felt dizzy, tired, no appetite, nauseous, threw up, low grade fever 99.9 temp, short of breath, could barely walk, ears ringing, blood pressure was 148/82, felt sore, sneezing and runny nose was considered resolved on an unknown date.   The outcome for the events, headache, fatigue, chills, muscle pain and joint pain was unknown.  The outcome for the events, felt weak, stuffy nose and light sensitivity at night was not resolved.; Reporter's Comments: This case concerns a female with psoriasis and NS unexpected hypertension, dizziness, dyspnea, nasal congestion, rhinorrhea, sneezing, asthenia, lethargy, photophobia, tinnitus, decreased appetite, gait disturbance and expected fever, chills, fatigue, headache, myalgia, nausea, vomiting, arthralgia. Event onset Day 1 after 1st dose. 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: Headache, Hypertension, Lethargy, Myalgia, Nasal congestion
Clinical narrative: Very very lethargic; Joint pain; Chills; Headache; Muscle pain/ Felt sore; Stuffy nose; Runny nose; Sneezing; Short of breath; Could barely walk; Ears ringing; Blood pressure 149/82; No appetite; Nausea; Low grade fever 99.9; Threw up; Light sensitivity at night; Tired; Felt weak; Dizzy; A spontaneous report was received from a consumer, concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple events of headache, fatigue, chills, muscle pain, joint pain, felt dizzy, felt weak, tired, no appetite, nauseous, threw up, low grade fever 99.9 temp, short of breath, could barely walk, ears ringing, blood pressure was 148/82, felt sore, sneezing, runny nose, stuffy nose and light sensitivity.  The patient's medical history included autoimmune disease, psoriatic arthritis and psoriasis. No concomitant medications were reported.  On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection. 30 minutes after receiving the vaccine, the patient experienced felt dizzy, weak and tired.   On 30 Dec 2020, the patient experienced, felt weak, tired, no appetite, nauseous, threw up and low-grade fever 99.9 degree fahrenheit and light sensitivity at night. No treatment was administered at this point.  On 31 Dec 2020, the patient experienced, short of breath, could barely walk, ears ringing, and blood pressure was 148/82 mmHg. The treatment information included nyquil.  On 01 Jan 2021, the patient reported she felt sore. The treatment information included celebrex.   On 02 Jan 2021 and 03 Jan 2021, the patient experienced sneezing and runny nose.  On 06 Jan 2021, the patient stated she only had stuffy nose and weakness.   On an unknown date, the patient experienced, headache, fatigue, chills, muscle pain and joint pain.  Action taken with mRNA-1273 in response to the events was not provided.  The events, felt dizzy, tired, no appetite, nauseous, threw up, low grade fever 99.9 temp, short of breath, could barely walk, ears ringing, blood pressure was 148/82, felt sore, sneezing and runny nose was considered resolved on an unknown date.   The outcome for the events, headache, fatigue, chills, muscle pain and joint pain was unknown.  The outcome for the events, felt weak, stuffy nose and light sensitivity at night was not resolved.; Reporter's Comments: This case concerns a female with psoriasis and NS unexpected hypertension, dizziness, dyspnea, nasal congestion, rhinorrhea, sneezing, asthenia, lethargy, photophobia, tinnitus, decreased appetite, gait disturbance and expected fever, chills, fatigue, headache, myalgia, nausea, vomiting, arthralgia. Event onset Day 1 after 1st dose. 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: Nausea, Photophobia, Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: Very very lethargic; Joint pain; Chills; Headache; Muscle pain/ Felt sore; Stuffy nose; Runny nose; Sneezing; Short of breath; Could barely walk; Ears ringing; Blood pressure 149/82; No appetite; Nausea; Low grade fever 99.9; Threw up; Light sensitivity at night; Tired; Felt weak; Dizzy; A spontaneous report was received from a consumer, concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple events of headache, fatigue, chills, muscle pain, joint pain, felt dizzy, felt weak, tired, no appetite, nauseous, threw up, low grade fever 99.9 temp, short of breath, could barely walk, ears ringing, blood pressure was 148/82, felt sore, sneezing, runny nose, stuffy nose and light sensitivity.  The patient's medical history included autoimmune disease, psoriatic arthritis and psoriasis. No concomitant medications were reported.  On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection. 30 minutes after receiving the vaccine, the patient experienced felt dizzy, weak and tired.   On 30 Dec 2020, the patient experienced, felt weak, tired, no appetite, nauseous, threw up and low-grade fever 99.9 degree fahrenheit and light sensitivity at night. No treatment was administered at this point.  On 31 Dec 2020, the patient experienced, short of breath, could barely walk, ears ringing, and blood pressure was 148/82 mmHg. The treatment information included nyquil.  On 01 Jan 2021, the patient reported she felt sore. The treatment information included celebrex.   On 02 Jan 2021 and 03 Jan 2021, the patient experienced sneezing and runny nose.  On 06 Jan 2021, the patient stated she only had stuffy nose and weakness.   On an unknown date, the patient experienced, headache, fatigue, chills, muscle pain and joint pain.  Action taken with mRNA-1273 in response to the events was not provided.  The events, felt dizzy, tired, no appetite, nauseous, threw up, low grade fever 99.9 temp, short of breath, could barely walk, ears ringing, blood pressure was 148/82, felt sore, sneezing and runny nose was considered resolved on an unknown date.   The outcome for the events, headache, fatigue, chills, muscle pain and joint pain was unknown.  The outcome for the events, felt weak, stuffy nose and light sensitivity at night was not resolved.; Reporter's Comments: This case concerns a female with psoriasis and NS unexpected hypertension, dizziness, dyspnea, nasal congestion, rhinorrhea, sneezing, asthenia, lethargy, photophobia, tinnitus, decreased appetite, gait disturbance and expected fever, chills, fatigue, headache, myalgia, nausea, vomiting, arthralgia. Event onset Day 1 after 1st dose. 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: Tinnitus, Vomiting
Clinical narrative: Very very lethargic; Joint pain; Chills; Headache; Muscle pain/ Felt sore; Stuffy nose; Runny nose; Sneezing; Short of breath; Could barely walk; Ears ringing; Blood pressure 149/82; No appetite; Nausea; Low grade fever 99.9; Threw up; Light sensitivity at night; Tired; Felt weak; Dizzy; A spontaneous report was received from a consumer, concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple events of headache, fatigue, chills, muscle pain, joint pain, felt dizzy, felt weak, tired, no appetite, nauseous, threw up, low grade fever 99.9 temp, short of breath, could barely walk, ears ringing, blood pressure was 148/82, felt sore, sneezing, runny nose, stuffy nose and light sensitivity.  The patient's medical history included autoimmune disease, psoriatic arthritis and psoriasis. No concomitant medications were reported.  On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection. 30 minutes after receiving the vaccine, the patient experienced felt dizzy, weak and tired.   On 30 Dec 2020, the patient experienced, felt weak, tired, no appetite, nauseous, threw up and low-grade fever 99.9 degree fahrenheit and light sensitivity at night. No treatment was administered at this point.  On 31 Dec 2020, the patient experienced, short of breath, could barely walk, ears ringing, and blood pressure was 148/82 mmHg. The treatment information included nyquil.  On 01 Jan 2021, the patient reported she felt sore. The treatment information included celebrex.   On 02 Jan 2021 and 03 Jan 2021, the patient experienced sneezing and runny nose.  On 06 Jan 2021, the patient stated she only had stuffy nose and weakness.   On an unknown date, the patient experienced, headache, fatigue, chills, muscle pain and joint pain.  Action taken with mRNA-1273 in response to the events was not provided.  The events, felt dizzy, tired, no appetite, nauseous, threw up, low grade fever 99.9 temp, short of breath, could barely walk, ears ringing, blood pressure was 148/82, felt sore, sneezing and runny nose was considered resolved on an unknown date.   The outcome for the events, headache, fatigue, chills, muscle pain and joint pain was unknown.  The outcome for the events, felt weak, stuffy nose and light sensitivity at night was not resolved.; Reporter's Comments: This case concerns a female with psoriasis and NS unexpected hypertension, dizziness, dyspnea, nasal congestion, rhinorrhea, sneezing, asthenia, lethargy, photophobia, tinnitus, decreased appetite, gait disturbance and expected fever, chills, fatigue, headache, myalgia, nausea, vomiting, arthralgia. Event onset Day 1 after 1st dose. 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: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue
Clinical narrative: Felt so debiliated; Fatigue; Chills; A spontaneous report was received from a consumer who received Moderna's COVID-19 vaccine and experienced felt so debilitated, fatigue and chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an Unknown date prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.   After receiving the vaccine, the patient experienced fatigue, chills, and felt debilitated. The treatment for the events are unknown.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events, felt so debilitated, fatigue and chills were considered as 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: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; A spontaneous report was received from a physician concerning a male patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273 ) and experienced hives.  The patient's medical history was not provided.  No relevant concomitant medications were provided.   On 30 Dec 2020, approximately half an hour prior to onset of the event, the patient received their dose of mRNA-1273 (lot/batch number: unknown) for prophylaxis of COVID-19 infection.  On 30 Dec 2020, the patient experienced hives half an hour later after the injection. Treatment for the event included Benadryl and physician was not sure if patient took steroid as well.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event hives was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Decreased appetite, Dizziness, Dyspnoea, Fatigue
Clinical narrative: sleepy; no apetite; sore and pain at the injection site; swelling at injection site; fatigue; nausea; shortness of breath; very shaky; tremor; dizzy; difficulty breathing; chest pressure; This spontaneous case was reported by a physician and describes the occurrence of DECREASED APPETITE (no apetite), DYSPNOEA (shortness of breath), VACCINATION SITE PAIN (sore and pain at the injection site), FATIGUE (fatigue) and VACCINATION SITE SWELLING (swelling at injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Migraine. Concomitant products included CETIRIZINE.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced DYSPNOEA (shortness of breath). On 31-Dec-2020, the patient experienced FATIGUE (fatigue). On 01-Jan-2021, the patient experienced DECREASED APPETITE (no apetite), VACCINATION SITE PAIN (sore and pain at the injection site) and VACCINATION SITE SWELLING (swelling at injection site). On 01-Jan-2021, DECREASED APPETITE (no apetite), VACCINATION SITE PAIN (sore and pain at the injection site) and VACCINATION SITE SWELLING (swelling at injection site) outcome was unknown. On 05-Jan-2021, FATIGUE (fatigue) outcome was unknown. At the time of the report, DYSPNOEA (shortness of breath) 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 events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow-up received on 16 Apr 2021 included no new information; 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: Nausea, Nervousness, Somnolence, Tremor, Vaccination site pain
Clinical narrative: sleepy; no apetite; sore and pain at the injection site; swelling at injection site; fatigue; nausea; shortness of breath; very shaky; tremor; dizzy; difficulty breathing; chest pressure; This spontaneous case was reported by a physician and describes the occurrence of DECREASED APPETITE (no apetite), DYSPNOEA (shortness of breath), VACCINATION SITE PAIN (sore and pain at the injection site), FATIGUE (fatigue) and VACCINATION SITE SWELLING (swelling at injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Migraine. Concomitant products included CETIRIZINE.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced DYSPNOEA (shortness of breath). On 31-Dec-2020, the patient experienced FATIGUE (fatigue). On 01-Jan-2021, the patient experienced DECREASED APPETITE (no apetite), VACCINATION SITE PAIN (sore and pain at the injection site) and VACCINATION SITE SWELLING (swelling at injection site). On 01-Jan-2021, DECREASED APPETITE (no apetite), VACCINATION SITE PAIN (sore and pain at the injection site) and VACCINATION SITE SWELLING (swelling at injection site) outcome was unknown. On 05-Jan-2021, FATIGUE (fatigue) outcome was unknown. At the time of the report, DYSPNOEA (shortness of breath) 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 events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow-up received on 16 Apr 2021 included no new information; 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: Vaccination site swelling
Clinical narrative: sleepy; no apetite; sore and pain at the injection site; swelling at injection site; fatigue; nausea; shortness of breath; very shaky; tremor; dizzy; difficulty breathing; chest pressure; This spontaneous case was reported by a physician and describes the occurrence of DECREASED APPETITE (no apetite), DYSPNOEA (shortness of breath), VACCINATION SITE PAIN (sore and pain at the injection site), FATIGUE (fatigue) and VACCINATION SITE SWELLING (swelling at injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Migraine. Concomitant products included CETIRIZINE.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced DYSPNOEA (shortness of breath). On 31-Dec-2020, the patient experienced FATIGUE (fatigue). On 01-Jan-2021, the patient experienced DECREASED APPETITE (no apetite), VACCINATION SITE PAIN (sore and pain at the injection site) and VACCINATION SITE SWELLING (swelling at injection site). On 01-Jan-2021, DECREASED APPETITE (no apetite), VACCINATION SITE PAIN (sore and pain at the injection site) and VACCINATION SITE SWELLING (swelling at injection site) outcome was unknown. On 05-Jan-2021, FATIGUE (fatigue) outcome was unknown. At the time of the report, DYSPNOEA (shortness of breath) 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 events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow-up received on 16 Apr 2021 included no new information; 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: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Incoherent, Pain, Pain in extremity
Clinical narrative: Sensation that "everything hurts"; Feeling not coherent; "COVID brain" with lightheadedness; "Covid brain" with lightheadedness; Arm pain; A spontaneous report was received from a health professional concerning a 48-year-old, male patient who received Moderna's COVID-19 vaccine and experienced arm pain, "COVID brain" with lightheadedness, felt not coherent and a sensation that "everything hurt".  The patient's medical history included COVID-19 infection one month prior. He has continued nausea, mild headaches, no taste and smell sensations.  Concomitant products known to have been used by the patient, within two weeks prior to the event, included adalimumab.   On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) via unknown route in the left shoulder for prophylaxis of COVID-19 infection.    On 29 Dec 2020, after the vaccination, the patient experienced pain in his arm. On 30 Dec 2020, the patient developed "covid brain" accompanied by lightheadedness, felt not coherent and had a sensation that everything hurt.   Treatment for the event included acetaminophen.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The events, arm pain, "covid brain" with lightheadedness, felt not coherent and a sensation that "everything hurt", were considered recovered on 04 Jan 2021.; Reporter's Comments: Based on the established safety profile and a temporal association between the reported events of experienced arm pain, "covid brain" with lightheadedness, felt not coherent and a sensation that "everything hurt and administration of mRNA-1273 vaccine, a causal association cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling abnormal, Nausea
Clinical narrative: sore arm; body aches; felt bad all day; Nauseous; fever; chills; feels tired; A spontaneous report was received from a consumer concerning a 53-year old, female patient who received Moderna's COVID-19 vaccine and experienced fever, body ache, chills, nausea, sore arm, feeling bad, and feeling tired.   The patient's medical history, as provided by the reporter, included hypertension, high cholesterol, pre-diabetes, and total hysterectomy. Concomitant medications reported included progesterone, testosterone, telmisartan, and estradiol/estriol for drug use for unknown indication.    On 02 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (025L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 02 Jan 2021, the patient experienced nausea and a sore arm after vaccination. Five hours late, she reported having chills, a fever of 102 degrees Fahrenheit, and feeling bad all day. The symptoms lasted about 18 hours, however patient was still feeling tired at the time of report. No treatment was provided.    Action taken with mRNA-1273 in response to the event was not reported.   The events, fever, body ache, chills, nausea, sore arm and feeling bad, were considered recovered/resolved on 03 Jan 2021.  The outcome of the event, feeling tired, was unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: sore arm; body aches; felt bad all day; Nauseous; fever; chills; feels tired; A spontaneous report was received from a consumer concerning a 53-year old, female patient who received Moderna's COVID-19 vaccine and experienced fever, body ache, chills, nausea, sore arm, feeling bad, and feeling tired.   The patient's medical history, as provided by the reporter, included hypertension, high cholesterol, pre-diabetes, and total hysterectomy. Concomitant medications reported included progesterone, testosterone, telmisartan, and estradiol/estriol for drug use for unknown indication.    On 02 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (025L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 02 Jan 2021, the patient experienced nausea and a sore arm after vaccination. Five hours late, she reported having chills, a fever of 102 degrees Fahrenheit, and feeling bad all day. The symptoms lasted about 18 hours, however patient was still feeling tired at the time of report. No treatment was provided.    Action taken with mRNA-1273 in response to the event was not reported.   The events, fever, body ache, chills, nausea, sore arm and feeling bad, were considered recovered/resolved on 03 Jan 2021.  The outcome of the event, feeling tired, was unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
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 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported.; 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.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site paraesthesia, Lymphadenitis, Swelling, Tenderness
Clinical narrative: Some paresthesia in injection site arm; Robust lymphatic response; Tenderness; Swelling; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PARAESTHESIA (Some paresthesia in injection site arm), LYMPHADENITIS (Robust lymphatic response), TENDERNESS (Tenderness) and SWELLING (Swelling) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PARAESTHESIA (Some paresthesia in injection site arm), LYMPHADENITIS (Robust lymphatic response), TENDERNESS (Tenderness) and SWELLING (Swelling). At the time of the report, INJECTION SITE PARAESTHESIA (Some paresthesia in injection site arm), LYMPHADENITIS (Robust lymphatic response), TENDERNESS (Tenderness) and SWELLING (Swelling) 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. No relevant concomitant medications were reported.   Based on the established safety profile and a temporal association between the reported events of and administration of mRNA-1273 vaccine, a causal association cannot be excluded. swelling and tenderness in injection site arm  are consistent with the product safety profile.; Reporter's Comments: Based on the established safety profile and a temporal association between the reported events of and administration of mRNA-1273 vaccine, a causal association cannot be excluded. swelling and tenderness in injection site arm  are consistent with the product safety profile.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: Sore; Higher fever; headache; Nausea; A spontaneous report was received from a consumer concerning 59-year old, female patient who received Moderna's COVID-19 vaccine and experienced headache, fever, soreness, and nausea.  The patient's medical history was not provided. The concomitant medications included Baby aspirin, Zyrtec, Sertraline, Atorvastatin and Hydrochlorothiazide.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (037K20A) intramuscularly in upper left arm for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient experienced high fever, headache, nausea and soreness during the night. On 06 Jan 2021, the patient's fever improved, but was still present. No treatment information was reported.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of headache, fever, nausea, and soreness were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm is a little sore; A spontaneous report was received from a male consumer of unknown age who received Moderna's COVID-19 vaccine and experienced sore arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On Unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.   After receiving the vaccine, he experienced sore arm. Treatment for the event was unknown.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the event was Unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: redness of the area, now turning to pinkish; Soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness of the arm) and INJECTION SITE ERYTHEMA (redness of the area, now turning to pinkish) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025I20A) for Covid-19 vaccination.     Concurrent medical conditions included Low platelets.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced INJECTION SITE PAIN (Soreness of the arm). On 05-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (redness of the area, now turning to pinkish). At the time of the report, INJECTION SITE PAIN (Soreness of the arm) and INJECTION SITE ERYTHEMA (redness of the area, now turning to pinkish) 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.  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.; 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Lymphadenopathy
Clinical narrative: Large Lymph Node (about 2 inches) Left Arm Injection Site; 2 Inch Redness Injection Site Left Arm; 2 Inch Swelling on the Injection Site Left Arm; A spontaneous report was received from a consumer regarding a 45-year-old female patient who received Moderna's COVID-19 Vaccine, and who developed a large lymph node (about 2 inches) on the injection site, and the injection site was red and swollen (2inches).   The patient's medical history was not provided. Concomitant medications use was not provided by the reporter.   The patient received her first of two planned doses of mRNA-1273 (Lot number 025J20-2A) on 29 Dec 2020 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 04 Jan 2021, six days post first dose of the COVID  19 vaccine the patient developed a large lymph node (about 2 inches) on the injection site, and the injection site was red and swollen (2 inches). At the time of the report the patient's side effects are getting better. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event(s) was unknown.   The outcome of the events was reported as resolving.; 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. The reported events are consistent with the known safety profile of the vaccine.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID-19 (chills, diarrhoea); A spontaneous report was received from a 62-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced symptoms of COVID-19 which included chills, diarrhea, and tested positive for COVID-19.  The patient's medical history was not provided. Concomitant medication included multivitamins.  On 28 DEC 2020, the patient received their first of two planned doses of mRNA-1273 (Batch number: 037K20A) for prophylaxis of COVID-19 infection.  On 31 DEC 2020, the patient experienced symptoms of COVID-19 which included chills and diarrhea. On 04 JAN 2021, the patient did a quick test and she was tested positive for COVID-19. On 06 JAN 2021, the patient is planning on taking PCR test. No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the event, tested positive for COVID-19 was unknown.; Reporter's Comments: Based on the current available information, the mRNA-1723 does not contain a virus capable of causing infection and with the occurrence of Covid-19 test positive after vaccination, this event is assessed as unlikely related to mRNA-1273.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Cough, Hypogeusia, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: This spontaneous case reported by a physician (subsequently medically confirmed), describes the occurrence of SARS-CoV-2 positive test (positive for COVID-19), cough, hypogeusia (decreased taste and smell) and anosmia (decreased taste and smell) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 011J20A) for COVID-19 immunization. Concurrent medical conditions included asthma since Jun 5, 1960. On Dec 23, 2020, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 23, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. In December 2020, patient experienced cough, hypogeusia (decreased taste and smell) and anosmia (decreased taste and smell). On Dec 26, 2020, patient had a SARS-COV-2 positive test (positive for COVID-19). The patient treated with prednisone on Dec 27, 2020 for COVID-19, at a dose of 40 milligram once a day and Regeneron monoclonal antibodies, on Dec 27, 2020, for COVID-19, at an unspecified dose and frequency. On Dec 27, 2020, SARS-CoV-2 positive test (positive for COVID-19), cough, hypogeusia (decreased taste and smell) and anosmia (decreased taste and smell) resolved. Diagnostic results: On Dec 26, 2020; SARS-CoV-2 test: Positive. The reporter did not provide any causality assessments. Patient reported he experienced fever, rigors and severe fatigue after receiving Regeneron monoclonal antibodies but is feeling better now. Most recent follow-up information incorporated above includes: On Apr 17, 2021: Follow up information received on Apr 17, 2021. Added event stop date Dec 27, 2021 and updated outcome of the event as recovered/resolved. Patient details and medical history added. Action taken updated. Sender's comments: Based on the available  information the events mentioned unlikely related to mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Allergic respiratory symptom, Nasal congestion, Rhinorrhoea
Clinical narrative: Runny nose; Stuffy nose; Sniffles; allergy-like symptoms; A spontaneous report was received from a consumer concerning herself, age not provided, a female patient who received Moderna's COVID-19 vaccine and experienced runny nose, sniffles, stuffy nose and allergy-type symptoms.  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 04 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.    On 04 Jan 2021, after she received the mRNA-1273 vaccination, patient experienced a runny nose, sniffles, stuffy nose and allergy-type symptoms. Treatment information was not provided. Patient reports that these symptoms resolved on 05 Jan 2021.  On 06 Jan 2021, the patient reports that the same symptoms returned. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome of the events, runny nose, sniffles, stuffy nose was not recovered and allergy-type symptoms 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.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Pyrexia
Clinical narrative: Fever/raising temperature; Chills; A spontaneous report was received from a consumer, concerning herself, a female patient of unspecified age, who received Moderna's COVID-19 Vaccine and experienced fever/raising temperature/ pyrexia and chills.  The patient's medical history was not provided. Concomitant product use was not provided.  On 05 Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) via unknown route for prophylaxis of COVID-19 infection.    On 06 Jan 2021, after the first dose of vaccine, the patient experienced fever, chills and a raising temperature. Treatment for the events were not provided.   Action taken with mRNA-1273 in response to the events were unknown.   The events, fever/ raising temperature and chills were considered not resolved as it was ongoing at the time of the report.; 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: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Pain, Pyrexia
Clinical narrative: Feeling very week; body aches; pain all over her body; Fever; Headache; Vomits; Chills; A spontaneous report was received from a healthcare professional concerning a 51-year old, female patient who received Moderna's COVID-19 vaccine and experienced chills, fever, headache, body ache, pain all over, vomiting and feeling weak.    The patient's medical history included COVID-19. No relevant concomitant medications were reported.   On 02 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 02 Jan 2021, the patient experienced chills. On 03 Jan 2021, she began to experience chills, fever, headache, body aches, pain all over her body, and vomiting. On 04 Jan 2021, the patient reported feeling very weak, but better. No symptoms persisted at the time of report (06 Jan 2021). Treatment included paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.   The events, chills, fever, headache, body ache, pain all over, vomiting and feeling weak, were considered recovered on 06 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Feeling very week; body aches; pain all over her body; Fever; Headache; Vomits; Chills; A spontaneous report was received from a healthcare professional concerning a 51-year old, female patient who received Moderna's COVID-19 vaccine and experienced chills, fever, headache, body ache, pain all over, vomiting and feeling weak.    The patient's medical history included COVID-19. No relevant concomitant medications were reported.   On 02 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 02 Jan 2021, the patient experienced chills. On 03 Jan 2021, she began to experience chills, fever, headache, body aches, pain all over her body, and vomiting. On 04 Jan 2021, the patient reported feeling very weak, but better. No symptoms persisted at the time of report (06 Jan 2021). Treatment included paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.   The events, chills, fever, headache, body ache, pain all over, vomiting and feeling weak, were considered recovered on 06 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Little pain in the injection site; A spontaneous report was received from a consumer concerning a male patient of an unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced little pain at the injection site/vaccination site pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 05 Jan 2021, approximately two days prior to the onset of the events, the patient received their dose of mRNA-1273 (lot/batch Number: Unknown) in left arm for prophylaxis of COVID-19 infection.  On 06 Jan 2021, the patient experienced little pain at the injection site. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the event little pain at the injection site was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.