chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling hot, Influenza like illness, Nausea
Clinical narrative: Felt like flu; Nausea; Lowgrade Fever; Chills; Fatigue; My arm got sore; Warm but Afebrile; body ache; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (My arm got sore), FEELING HOT (Warm but Afebrile), PAIN (body ache), INFLUENZA LIKE ILLNESS (Felt like flu) and NAUSEA (Nausea) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 30-Jul-2020. Concomitant products included CELECOXIB (CELEXA [CELECOXIB]) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced PAIN IN EXTREMITY (My arm got sore), FEELING HOT (Warm but Afebrile) and PAIN (body ache). On 02-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like flu), NAUSEA (Nausea), PYREXIA (Lowgrade Fever), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (My arm got sore), FEELING HOT (Warm but Afebrile), PAIN (body ache), INFLUENZA LIKE ILLNESS (Felt like flu), NAUSEA (Nausea), PYREXIA (Lowgrade Fever), CHILLS (Chills) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient took acetaminophen and ibuprofen.      Company comment:  This case concerns a 47-year-old female with PMH of COVID-19, who had NS events of unexpected pain in extremity, influenza like illness, feeling hot, pain, and expected fever, chills, fatigue, nausea.  Event onset the same day as the first dose of mRNA-1273. Treatment with acetaminophen and ibuprofen. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Reporter's Comments: This case concerns a 47-year-old female with PMH of COVID-19, who had NS events of unexpected pain in extremity, influenza like illness, feeling hot, pain, and expected fever, chills, fatigue, nausea.  Event onset the same day as the first dose of mRNA-1273. Treatment with acetaminophen and ibuprofen. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Felt like flu; Nausea; Lowgrade Fever; Chills; Fatigue; My arm got sore; Warm but Afebrile; body ache; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (My arm got sore), FEELING HOT (Warm but Afebrile), PAIN (body ache), INFLUENZA LIKE ILLNESS (Felt like flu) and NAUSEA (Nausea) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 30-Jul-2020. Concomitant products included CELECOXIB (CELEXA [CELECOXIB]) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced PAIN IN EXTREMITY (My arm got sore), FEELING HOT (Warm but Afebrile) and PAIN (body ache). On 02-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like flu), NAUSEA (Nausea), PYREXIA (Lowgrade Fever), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (My arm got sore), FEELING HOT (Warm but Afebrile), PAIN (body ache), INFLUENZA LIKE ILLNESS (Felt like flu), NAUSEA (Nausea), PYREXIA (Lowgrade Fever), CHILLS (Chills) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient took acetaminophen and ibuprofen.      Company comment:  This case concerns a 47-year-old female with PMH of COVID-19, who had NS events of unexpected pain in extremity, influenza like illness, feeling hot, pain, and expected fever, chills, fatigue, nausea.  Event onset the same day as the first dose of mRNA-1273. Treatment with acetaminophen and ibuprofen. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Reporter's Comments: This case concerns a 47-year-old female with PMH of COVID-19, who had NS events of unexpected pain in extremity, influenza like illness, feeling hot, pain, and expected fever, chills, fatigue, nausea.  Event onset the same day as the first dose of mRNA-1273. Treatment with acetaminophen and ibuprofen. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Injection site pain, Lymphadenopathy, Musculoskeletal stiffness, Neck pain
Clinical narrative: Painful to move neck; Muscle stiffness; Pain on injection side; Diarrhea; Swollen lymph nodes on neck and shoulder area; Being sore; A spontaneous report was received from a man calling on behalf of his wife who is a 38 year old, female consumer who received Moderna's COVID-19 vaccine and experienced swollen lymph nodes on neck and shoulder area, painful on the injection side, diarrhea, muscle stiffness and being sore.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) for prophylaxis of COVID-19 infection.   On 30 Dec 2020, within minutes of receiving the vaccine, the patient experienced swollen lymph nodes on neck and shoulder area, painful on the injection side, diarrhea, muscle stiffness and being sore. Treatments for the events is unknown. On 07 Jan 2021, the swollen area is pretty big and painful to move the neck. Treatment is Unknown.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events, swollen lymph nodes on neck and shoulder area, painful on the injection side, muscle stiffness and being sore is Unknown. Diarrhea was light at the beginning first few days and then got bad for a couple of days and fully recovered on the 5th Jan 2020.  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.; 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Painful to move neck; Muscle stiffness; Pain on injection side; Diarrhea; Swollen lymph nodes on neck and shoulder area; Being sore; A spontaneous report was received from a man calling on behalf of his wife who is a 38 year old, female consumer who received Moderna's COVID-19 vaccine and experienced swollen lymph nodes on neck and shoulder area, painful on the injection side, diarrhea, muscle stiffness and being sore.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) for prophylaxis of COVID-19 infection.   On 30 Dec 2020, within minutes of receiving the vaccine, the patient experienced swollen lymph nodes on neck and shoulder area, painful on the injection side, diarrhea, muscle stiffness and being sore. Treatments for the events is unknown. On 07 Jan 2021, the swollen area is pretty big and painful to move the neck. Treatment is Unknown.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events, swollen lymph nodes on neck and shoulder area, painful on the injection side, muscle stiffness and being sore is Unknown. Diarrhea was light at the beginning first few days and then got bad for a couple of days and fully recovered on the 5th Jan 2020.  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.; 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Pyrexia
Clinical narrative: slept all day; very sore arm from shoulder to elbow; Headache; Fever of 99.6; Fatigue; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of SOMNOLENCE (slept all day), ARTHRALGIA (very sore arm from shoulder to elbow), HEADACHE (Headache), PYREXIA (Fever of 99.6) and FATIGUE (Fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 206L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021 at 4:00 AM, the patient experienced SOMNOLENCE (slept all day), ARTHRALGIA (very sore arm from shoulder to elbow), HEADACHE (Headache), PYREXIA (Fever of 99.6) and FATIGUE (Fatigue). On 06-Jan-2021, HEADACHE (Headache), PYREXIA (Fever of 99.6) and FATIGUE (Fatigue) had resolved. At the time of the report, SOMNOLENCE (slept all day) had resolved and ARTHRALGIA (very sore arm from shoulder to elbow) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, Body temperature: 99.6 f (abnormal) Her usual temperatute is 97F..     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.   This case concerns a 66-year-old female who experienced NS events of unexpected somnolence and expected fever, fatigue, headache, arthralgia.  Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment with acetaminophen. Events resolved or resolving. 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's Comments: This case concerns a 66-year-old female who experienced NS events of unexpected somnolence and expected fever, fatigue, headache, arthralgia.  Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment with acetaminophen. Events resolved or resolving. 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: Somnolence
Clinical narrative: slept all day; very sore arm from shoulder to elbow; Headache; Fever of 99.6; Fatigue; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of SOMNOLENCE (slept all day), ARTHRALGIA (very sore arm from shoulder to elbow), HEADACHE (Headache), PYREXIA (Fever of 99.6) and FATIGUE (Fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 206L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021 at 4:00 AM, the patient experienced SOMNOLENCE (slept all day), ARTHRALGIA (very sore arm from shoulder to elbow), HEADACHE (Headache), PYREXIA (Fever of 99.6) and FATIGUE (Fatigue). On 06-Jan-2021, HEADACHE (Headache), PYREXIA (Fever of 99.6) and FATIGUE (Fatigue) had resolved. At the time of the report, SOMNOLENCE (slept all day) had resolved and ARTHRALGIA (very sore arm from shoulder to elbow) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, Body temperature: 99.6 f (abnormal) Her usual temperatute is 97F..     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.   This case concerns a 66-year-old female who experienced NS events of unexpected somnolence and expected fever, fatigue, headache, arthralgia.  Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment with acetaminophen. Events resolved or resolving. 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's Comments: This case concerns a 66-year-old female who experienced NS events of unexpected somnolence and expected fever, fatigue, headache, arthralgia.  Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment with acetaminophen. Events resolved or resolving. 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: Arthralgia, Asthenia, Dizziness, Fatigue, Feeling cold
Clinical narrative: Feeling freezing cold; Dizzy; Body ache; Weakness; Feeling sicker than a dog; flu like symptoms; Headache; Muscle pain; Joint pain; Fatigue; A spontaneous report was received from a 63 year old female consumer who was participating in the mRNA-1273 Emergency Use Program and experienced feeling freezing cold, muscle pain, joint pain, dizzy, body aches, headache, feeling sicker than a dog, having every flu symptom except fever, weakness and fatigue.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 03 Jan 2021, approximately 15 hours before the events, the patient received their first of two planned doses of mRNA-1273 (Lot 011-20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 4 Jan 2021, the patient reported she experienced feeling freezing cold, muscle pain, joint pain, dizzy, body aches, headache, feeling sicker than a dog, having every flu symptom except fever, weakness and fatigue.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of feeling freezing cold, muscle pain, joint pain, dizzy, body aches, headache, feeling sicker than a dog, having every flu symptom except fever, were resolved on 5 Jan 2021. The outcome of weakness and fatigue, were considered 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 events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Malaise, Myalgia, Pain
Clinical narrative: Feeling freezing cold; Dizzy; Body ache; Weakness; Feeling sicker than a dog; flu like symptoms; Headache; Muscle pain; Joint pain; Fatigue; A spontaneous report was received from a 63 year old female consumer who was participating in the mRNA-1273 Emergency Use Program and experienced feeling freezing cold, muscle pain, joint pain, dizzy, body aches, headache, feeling sicker than a dog, having every flu symptom except fever, weakness and fatigue.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 03 Jan 2021, approximately 15 hours before the events, the patient received their first of two planned doses of mRNA-1273 (Lot 011-20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 4 Jan 2021, the patient reported she experienced feeling freezing cold, muscle pain, joint pain, dizzy, body aches, headache, feeling sicker than a dog, having every flu symptom except fever, weakness and fatigue.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of feeling freezing cold, muscle pain, joint pain, dizzy, body aches, headache, feeling sicker than a dog, having every flu symptom except fever, were resolved on 5 Jan 2021. The outcome of weakness and fatigue, were considered 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 events, a causal relationship cannot be excluded.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: fever; lower back pain; headache; arm pain at injection site; generalized aches; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain), HEADACHE (headache), INJECTION SITE PAIN (arm pain at injection site), PAIN (generalized aches) and PYREXIA (fever) in a 42-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 medical history provided).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced BACK PAIN (lower back pain), HEADACHE (headache), INJECTION SITE PAIN (arm pain at injection site) and PAIN (generalized aches). On 08-Jan-2021, the patient experienced PYREXIA (fever). At the time of the report, BACK PAIN (lower back pain), HEADACHE (headache), INJECTION SITE PAIN (arm pain at injection site), PAIN (generalized aches) and PYREXIA (fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Pyrexia: 99.9 degree F This morning and 100.4 degree F This morning.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: Arm is a little tender; Arm is red and the redness has increased; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is a little tender) and ERYTHEMA (Arm is red and the redness has increased) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm is a little tender) and ERYTHEMA (Arm is red and the redness has increased). At the time of the report, PAIN IN EXTREMITY (Arm is a little tender) and ERYTHEMA (Arm is red and the redness has increased) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported. The treatment included as ice.  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.; 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat; A spontaneous report was received from consumer concerning a 36 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore throat.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm  for prophylaxis of COVID-19 infection.  On 08 Jan 2021, 3 days after vaccination the patient experienced sore throat.  Laboratory details were not provided. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   On 09 Jan 2021 the outcome of the events sore throat was recovered.    The reporter assessed the event sore throat related to the study drug 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.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain, Pyrexia
Clinical narrative: Couldn't sleep; Fever; Body aches; A spontaneous report was received from consumer concerning a female patient with unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events insomnia, pyrexia and pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) in unspecified location  for prophylaxis of COVID-19 infection.  On unknown date, The patient experienced the events could not sleep, fever(not anymore) and pain (not terrible).  Laboratory details were not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   On date the outcome of the events could not sleep, fever and pain 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.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site rash, Nausea, SARS-CoV-2 test
Clinical narrative: Extremely dizzy; Rashes on left arm injection site; Nauseated; A spontaneous report was received from a consumer, concerning herself, a 55-years-old female patient, who received Moderna's COVID-19 Vaccine and experienced rashes on left arm injection site, extremely dizzy and nauseated.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 28-Dec-2020, approximately 9 days prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 05-Jan-2020 (tuesday), patient developed rashes on left arm of injection site. Additionally, felt extremely dizzy and nauseated, due to which she was unable to go to work on 06-Jan-2021 (Wednesday), hence, underwent Covid rapid test, which showed negative. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events were not provided.   The outcome of the events, rashes on the injection site, extremely dizzy and nauseated were not reported.; Reporter's Comments: A spontaneous report concerns a 55-years-old female patient, who received experienced rashes on left arm injection site, extremely dizzy and nauseated. The events occurred 9 days after the administration of the first dose of the mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown). No treatment was reported, and outcome is unknown. Based on the information provided, which includes the site of vaccine administration and a temporal association with the administration of mRNA-1273 vaccine, a causal association cannot be excluded. The event of injection site rash and nausea is consistent with the known safety profile of mRNA-1273 vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: Temperature went up to105.6 degrees; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temperature went up to105.6 degrees) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H20A) for COVID-19 vaccination.     The patient's past medical history included Heart disorder (Patient states he has heart troubles) since an unknown date, Diabetes since an unknown date and COVID-19 (Patient  had COVID in September). Concomitant products included METFORMIN for Diabetes.    On 07-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 PYREXIA (Temperature went up to105.6 degrees). At the time of the report, PYREXIA (Temperature went up to105.6 degrees) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2020, SARS-CoV-2 antibody test: positive he had covid in September. On 08-Jan-2021, Body temperature: 105.6 degrees degree (plane angle) and 100.6 degree (plane angle) rechecked again at 5:30pm where the temperature was 100.6 degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2021: Follow-up received on 17 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 event, a causal relationship cannot be excluded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: injection site got extremely; injection site got extremely itchy; injection site got extremely red; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (injection site got extremely), VACCINATION SITE PRURITUS (injection site got extremely itchy) and VACCINATION SITE ERYTHEMA (injection site got extremely red) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced VACCINATION SITE WARMTH (injection site got extremely), VACCINATION SITE PRURITUS (injection site got extremely itchy) and VACCINATION SITE ERYTHEMA (injection site got extremely red). At the time of the report, VACCINATION SITE WARMTH (injection site got extremely), VACCINATION SITE PRURITUS (injection site got extremely itchy) and VACCINATION SITE ERYTHEMA (injection site got extremely red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment information provided; 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: injection site became warm to touch; Injection site became reddish; Injection site  became swollen and getting bigger; Slight pain in her arm for 1-2 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Slight pain in her arm for 1-2 days), INJECTION SITE WARMTH (injection site became warm to touch), INJECTION SITE ERYTHEMA (Injection site became reddish) and INJECTION SITE SWELLING (Injection site  became swollen and getting bigger) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No historical event reported).    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 PAIN IN EXTREMITY (Slight pain in her arm for 1-2 days). On 07-Jan-2021, the patient experienced INJECTION SITE WARMTH (injection site became warm to touch), INJECTION SITE ERYTHEMA (Injection site became reddish) and INJECTION SITE SWELLING (Injection site  became swollen and getting bigger). At the time of the report, PAIN IN EXTREMITY (Slight pain in her arm for 1-2 days) had resolved, INJECTION SITE WARMTH (injection site became warm to touch) and INJECTION SITE ERYTHEMA (Injection site became reddish) outcome was unknown and INJECTION SITE SWELLING (Injection site  became swollen and getting bigger) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There were no concomitant medications provided. The patient was taking doxycycline as prescribed by her doctor.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash
Clinical narrative: Rash on chest; MILD HEADACHE; A report was received from a consumer concerning a female patient participating in the mRNA-1273 Emergency Use Program and experienced a headache and rash on chest.   The patient's medical history, as provided by the reporter, included having experienced rashes from viral infections or in some cases from vaccines, to include this year's flu vaccine. No relevant concomitant medications were reported.   On 08 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.   The reporter reached out on behalf of his wife who received the vaccine on 08 Jan 2021. The next day, she had a mild headache, and the day after, 10 Jan 2021 she developed a rash on her chest. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events 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.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: exposure via breast feeding; A spontaneous report was received from a nurse concerning a 31-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) who would like to enroll in a Breast Feeding Study.   The patient's medical history, was not provided by the reporter. No Concomitant medications were reported.  On 08 Jan 2021 the patient received their first of two planned doses of mRNA-1273 (Lot number:  011J20A) intramuscularly in the left arm deltoid for prophylaxis of COVID-19 infection.   The patient would like to enroll in a breastfeeding study after receiving the Moderna COVID-19 vaccine.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event was nor recovered.; Reporter's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Oxygen saturation, Pain
Clinical narrative: Achiness; A spontaneous report was received from a consumer, concerning himself, an 83 years old male patient who received Moderna's Covid-19 Vaccine (mRNA-1273) and experienced achiness.  The patient's medical history reported included rheumatoid arthritis. Concomitant medications reported included prednisone 3 mg, qd and immunosuppressants.   On 09 Jan 2021 at 11:00 AM, 8 hours prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (Batch number: 04162OA) intramuscularly in the left upper arm for prophylaxis of COVID-19 infection.   On 09 Jan 2021 at 07:00 PM, after vaccination in noon, the patient developed achiness at night, hence he took tramadol 50mg along with maintenance for his rheumatoid arthritis, and prednisone. On an unspecified date in Jan-2021, the patient's temperature was 97.3 and O2 saturation was 95%.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event achiness was considered unknown at the time of this report.; 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.  Patient's significant medical history of rheumatoid arthritis is considered a confounder.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Malaise, Osteoporosis, Vaccination site pain
Clinical narrative: lower back pain; malaise; chills; muscle pain at the site; osteoporosis flared up; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain), MALAISE (malaise), OSTEOPOROSIS (osteoporosis flared up), VACCINATION SITE PAIN (muscle pain at the site) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (muscle pain at the site). On 08-Jan-2021, the patient experienced MALAISE (malaise) and CHILLS (chills). On 09-Jan-2021, the patient experienced BACK PAIN (lower back pain). In January 2021, the patient experienced OSTEOPOROSIS (osteoporosis flared up). In January 2021, VACCINATION SITE PAIN (muscle pain at the site) had resolved. At the time of the report, BACK PAIN (lower back pain), MALAISE (malaise) and CHILLS (chills) had not resolved and OSTEOPOROSIS (osteoporosis flared up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  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 The lower back pain and osteoporosis events may be related to the patient's history of osteoporosis.; 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 The lower back pain and osteoporosis events may be related to the patient's history of osteoporosis.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Vaccination site pain
Clinical narrative: I'm not feeling too hot...general blah feeling; My arm hurts; Headache; I had chills, would get hot then cold; Was a little tired; A spontaneous report was received via Social Media from a consumer who was a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced not feeling too hot, pain in arm, headache, general blah feeling, chills and was a little tired.  The patient's medical history was not reported. No concomitant medications were reported.  On an unknown date, prior to the onset of the events, the patient received one of their two planned doses of mRNA-1273  intramuscularly for prophylaxis of COVID-19 infection.   Approximately 24 hours after getting vaccinated, the patient reported that they were not feeling too hot, their arm hurt, they had a headache and a general blah feeling. The patient also endorsed chills, stating they would get hot then cold and reported being a little tired.  Treatment for the events not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcomes of the events, not feeling too hot, pain in arm, headache, general blah feeling, chills and was a little tired, 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.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Swelling
Clinical narrative: The area was larger, hot; Swelling; Redness; Itchiness in arm; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING HOT (The area was larger, hot), SWELLING (Swelling), ERYTHEMA (Redness) and PRURITUS (Itchiness in arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Jan-2021, the patient experienced FEELING HOT (The area was larger, hot), SWELLING (Swelling), ERYTHEMA (Redness) and PRURITUS (Itchiness in arm). At the time of the report, FEELING HOT (The area was larger, hot), SWELLING (Swelling), ERYTHEMA (Redness) and PRURITUS (Itchiness in arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information includes Cortisone Cream and ice packs  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
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Itching at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at site of injection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 29-Dec-2020, 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 PRURITUS (Itching at site of injection). At the time of the report, VACCINATION SITE PRURITUS (Itching at site of injection) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   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. Further information has been requested
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Hypoaesthesia
Clinical narrative: very cold; facial numbnes mostly in the nose; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (facial numbnes mostly in the nose) and FEELING COLD (very cold) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no adverse event).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced HYPOAESTHESIA (facial numbnes mostly in the nose). On an unknown date, the patient experienced FEELING COLD (very cold). On 07-Jan-2021, HYPOAESTHESIA (facial numbnes mostly in the nose) had resolved. At the time of the report, FEELING COLD (very cold) 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.   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.; Sender'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: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Vaccination site pain
Clinical narrative: Intense tinnitus flare up; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Intense tinnitus flare up) and VACCINATION SITE PAIN (Sore arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Tinnitus (for 15 years) and Sinusitis. Concomitant products included CLONAZEPAM for Anxiety, STEROIDS from an unknown date to 11-Jan-2021 for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced TINNITUS (Intense tinnitus flare up) and VACCINATION SITE PAIN (Sore arm). At the time of the report, TINNITUS (Intense tinnitus flare up) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included clonazepam at an unknown dose in night via an unknown route for tinnitus.; Sender'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. Patient's underlying tinnitus is considered a risk factor for tinnitus flare up.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Limb discomfort, Paraesthesia, Vaccination site erythema
Clinical narrative: Headache; Itchness at the injection site; Redness at the injection site; Tingling sensation at the injection site; Heaviness at the injection site; Soreness at the injection site; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of PARAESTHESIA (Tingling sensation at the injection site), LIMB DISCOMFORT (Heaviness at the injection site), HEADACHE (Headache), VACCINATION SITE PRURITUS (Itchness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced FATIGUE (Fatigue). On 12-Jan-2021, the patient experienced PARAESTHESIA (Tingling sensation at the injection site), LIMB DISCOMFORT (Heaviness at the injection site), VACCINATION SITE PRURITUS (Itchness at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PAIN (Soreness at the injection site). On 11-Mar-2021, the patient experienced HEADACHE (Headache). At the time of the report, PARAESTHESIA (Tingling sensation at the injection site), LIMB DISCOMFORT (Heaviness at the injection site), HEADACHE (Headache), VACCINATION SITE PRURITUS (Itchness at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Soreness at the injection site) 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.; 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: Headache; Itchness at the injection site; Redness at the injection site; Tingling sensation at the injection site; Heaviness at the injection site; Soreness at the injection site; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of PARAESTHESIA (Tingling sensation at the injection site), LIMB DISCOMFORT (Heaviness at the injection site), HEADACHE (Headache), VACCINATION SITE PRURITUS (Itchness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced FATIGUE (Fatigue). On 12-Jan-2021, the patient experienced PARAESTHESIA (Tingling sensation at the injection site), LIMB DISCOMFORT (Heaviness at the injection site), VACCINATION SITE PRURITUS (Itchness at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PAIN (Soreness at the injection site). On 11-Mar-2021, the patient experienced HEADACHE (Headache). At the time of the report, PARAESTHESIA (Tingling sensation at the injection site), LIMB DISCOMFORT (Heaviness at the injection site), HEADACHE (Headache), VACCINATION SITE PRURITUS (Itchness at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Soreness at the injection site) 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.; 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.