chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Dizziness, Eye movement disorder, Musculoskeletal stiffness
Clinical narrative: Little sore and stiff arm; Little sore and stiff arm; Eyeballs were shaking back and forth; body temperature dropped oral temp 89.2°F; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of EYE MOVEMENT DISORDER (Eyeballs were shaking back and forth), BODY TEMPERATURE DECREASED (body temperature dropped oral temp 89.2°F), DIZZINESS (Dizziness), MUSCULOSKELETAL STIFFNESS (Little sore and stiff arm) and PAIN IN EXTREMITY (Little sore and stiff arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Allergy. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma, VITAMINS NOS for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced EYE MOVEMENT DISORDER (Eyeballs were shaking back and forth), BODY TEMPERATURE DECREASED (body temperature dropped oral temp 89.2°F) and DIZZINESS (Dizziness). On 31-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Little sore and stiff arm) and PAIN IN EXTREMITY (Little sore and stiff arm). On 29-Jan-2021, EYE MOVEMENT DISORDER (Eyeballs were shaking back and forth), BODY TEMPERATURE DECREASED (body temperature dropped oral temp 89.2°F) and DIZZINESS (Dizziness) had resolved. On 31-Jan-2021, MUSCULOSKELETAL STIFFNESS (Little sore and stiff arm) and PAIN IN EXTREMITY (Little sore and stiff arm) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Body temperature: 89.2°f (Low) decreased.     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 included prescription nose spray for allergy. patient wears glasses.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Little sore and stiff arm; Little sore and stiff arm; Eyeballs were shaking back and forth; body temperature dropped oral temp 89.2°F; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of EYE MOVEMENT DISORDER (Eyeballs were shaking back and forth), BODY TEMPERATURE DECREASED (body temperature dropped oral temp 89.2°F), DIZZINESS (Dizziness), MUSCULOSKELETAL STIFFNESS (Little sore and stiff arm) and PAIN IN EXTREMITY (Little sore and stiff arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Allergy. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma, VITAMINS NOS for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced EYE MOVEMENT DISORDER (Eyeballs were shaking back and forth), BODY TEMPERATURE DECREASED (body temperature dropped oral temp 89.2°F) and DIZZINESS (Dizziness). On 31-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Little sore and stiff arm) and PAIN IN EXTREMITY (Little sore and stiff arm). On 29-Jan-2021, EYE MOVEMENT DISORDER (Eyeballs were shaking back and forth), BODY TEMPERATURE DECREASED (body temperature dropped oral temp 89.2°F) and DIZZINESS (Dizziness) had resolved. On 31-Jan-2021, MUSCULOSKELETAL STIFFNESS (Little sore and stiff arm) and PAIN IN EXTREMITY (Little sore and stiff arm) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Body temperature: 89.2°f (Low) decreased.     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 included prescription nose spray for allergy. patient wears glasses.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Myalgia, Vaccination complication
Clinical narrative: headache; fever; upper respiratory symptom like running nose; body ache; tremendously itching all over her body; A spontaneous report was received from a Healthcare Professional concerning a 35 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced myalgia, allergy to vaccine and vaccination adverse reactions.    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/batch: if reported or unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced headache, fever, upper respiratory symptom like running nose. Body aches and itching all over the body.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events (headache, fever, upper respiratory symptom like running nose, Body aches and itching all over the body), was unknown.  The reporter assessed the events, [headache, fever, upper respiratory symptom like running nose, Body aches and itching all over the body] as related to the suspect drug.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Pain in extremity; Vomiting; A spontaneous report was received from a Reporter like Consumer concerning a unknown  Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, vomiting are listed.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 17-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 Anatomical location for prophylaxis of COVID-19 infection.  On 25-JAN-2021, The patient experienced the event sore arm and vomiting.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events sore arm and vomiting were unknown.  The reporter assessed the events, sore arm and vomiting as related to study drug.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, COVID-19, Chills, Headache
Clinical narrative: Severe headache as similar to the one which the patient had when he was positive for covid; Chills; Fever; Weakness; A spontaneous report (US) was received from a 71-years-old male consumer, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe headache as similar as the one he had when he was positive for Covid, also had chills, fever up to 102F and felt weakness.  The patient's medical history was not provided. The patient was taking heart medications concomitantly.   On 20-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: D13L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 20-JAN-2021, the patient experienced severe headache as similar as the one he had in August2020 when he was positive for Covid, that lasted till 23Jan2021, also had chills, fever up to 102F and felt weakness till 23Jan2021.  The patient had fever upto 102 F  from 20-JAN-2021 till 23-JAN-2021.  The patient took Tylenol from 20-JAN-2021 to 23-JAN-2021, to subside the symptoms.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events was recovered/resolved.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Severe headache as similar to the one which the patient had when he was positive for covid; Chills; Fever; Weakness; A spontaneous report (US) was received from a 71-years-old male consumer, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe headache as similar as the one he had when he was positive for Covid, also had chills, fever up to 102F and felt weakness.  The patient's medical history was not provided. The patient was taking heart medications concomitantly.   On 20-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: D13L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 20-JAN-2021, the patient experienced severe headache as similar as the one he had in August2020 when he was positive for Covid, that lasted till 23Jan2021, also had chills, fever up to 102F and felt weakness till 23Jan2021.  The patient had fever upto 102 F  from 20-JAN-2021 till 23-JAN-2021.  The patient took Tylenol from 20-JAN-2021 to 23-JAN-2021, to subside the symptoms.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events was recovered/resolved.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Rash, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; rash; A spontaneous report was received from a consumer concerning herself, who is a unknown aged female patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash, tested positive for covid-19.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) through unknown route in the unknown location for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient experienced a rash that disappeared 2 weeks later, 8 days after vaccination on 21Jan2021, patient tested positive for COVID-19.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 27 Jan 2021 the outcome of event rash was resolved on 27 Jan 2021. The outcome of event tested positive for covid-19 was unknown.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood pressure measurement, Bone pain, Chills, Erythema
Clinical narrative: m ankles swollen; bones of right leg felt pain; Ankles red; muscle aches; stomach was tight and couldn't eat; chills; blood pressure went up 260/160; heart rate increased; trembling; right leg swelling; pain in arm; A spontaneous report  was received from a consumer concerning 69 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  some pain in arm/ pain in extremity, right leg swelling/peripheral swelling, chills,  trembling/ tremor, heart rate increased, blood pressure went up 260/160/ blood pressure high, stomach was tight and couldn't eat/ abdominal discomfort, muscle aches/ myalgia, bones of right leg felt pain/ bone pain, ankles also swollen/ swollen ankles and ankles red/ erythema.  The patient's medical history was reported by the reporter as he was a dialysis patient and had some heart problems. Concomitant medications taken by the patient were not provided.  On 22 Jan 2021, prior to the onset of the event, the patient received first of their two planned doses of mRNA-1273 (Lot number: 013L20A) through unknown route at right arm for prophylaxis of COVID-19 infection.  On 22 Jan 2021, patient experienced some pain in arm. Patient also experienced right leg swelling but that had not bother him. On 25 Jan 2021, morning he experienced chills, trembling, heart rate increased, blood pressure went up 260/160. Patient took 2 Tylenol and after 3 hours everything had went down like normal. Later his stomach was tight and couldn't eat and next day stomach was better. On 26 Jan 2021, he experienced muscle aches and bones of right leg felt pain, ankles were also swollen and red.   Treatment activities for event was done with paracetamol.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event, experienced some pain in arm/ pain in extremity, right leg swelling, muscle aches and bones of right leg felt pain, ankles were also swollen and red were unknown. The outcome of event, experienced chills, trembling, heart rate increased, blood pressure, stomach was tight went up 260/160 were resolved on 26 Jan 2021.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Hypertension, Joint swelling, Myalgia, Pain in extremity
Clinical narrative: m ankles swollen; bones of right leg felt pain; Ankles red; muscle aches; stomach was tight and couldn't eat; chills; blood pressure went up 260/160; heart rate increased; trembling; right leg swelling; pain in arm; A spontaneous report  was received from a consumer concerning 69 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  some pain in arm/ pain in extremity, right leg swelling/peripheral swelling, chills,  trembling/ tremor, heart rate increased, blood pressure went up 260/160/ blood pressure high, stomach was tight and couldn't eat/ abdominal discomfort, muscle aches/ myalgia, bones of right leg felt pain/ bone pain, ankles also swollen/ swollen ankles and ankles red/ erythema.  The patient's medical history was reported by the reporter as he was a dialysis patient and had some heart problems. Concomitant medications taken by the patient were not provided.  On 22 Jan 2021, prior to the onset of the event, the patient received first of their two planned doses of mRNA-1273 (Lot number: 013L20A) through unknown route at right arm for prophylaxis of COVID-19 infection.  On 22 Jan 2021, patient experienced some pain in arm. Patient also experienced right leg swelling but that had not bother him. On 25 Jan 2021, morning he experienced chills, trembling, heart rate increased, blood pressure went up 260/160. Patient took 2 Tylenol and after 3 hours everything had went down like normal. Later his stomach was tight and couldn't eat and next day stomach was better. On 26 Jan 2021, he experienced muscle aches and bones of right leg felt pain, ankles were also swollen and red.   Treatment activities for event was done with paracetamol.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event, experienced some pain in arm/ pain in extremity, right leg swelling, muscle aches and bones of right leg felt pain, ankles were also swollen and red were unknown. The outcome of event, experienced chills, trembling, heart rate increased, blood pressure, stomach was tight went up 260/160 were resolved on 26 Jan 2021.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Tremor
Clinical narrative: m ankles swollen; bones of right leg felt pain; Ankles red; muscle aches; stomach was tight and couldn't eat; chills; blood pressure went up 260/160; heart rate increased; trembling; right leg swelling; pain in arm; A spontaneous report  was received from a consumer concerning 69 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  some pain in arm/ pain in extremity, right leg swelling/peripheral swelling, chills,  trembling/ tremor, heart rate increased, blood pressure went up 260/160/ blood pressure high, stomach was tight and couldn't eat/ abdominal discomfort, muscle aches/ myalgia, bones of right leg felt pain/ bone pain, ankles also swollen/ swollen ankles and ankles red/ erythema.  The patient's medical history was reported by the reporter as he was a dialysis patient and had some heart problems. Concomitant medications taken by the patient were not provided.  On 22 Jan 2021, prior to the onset of the event, the patient received first of their two planned doses of mRNA-1273 (Lot number: 013L20A) through unknown route at right arm for prophylaxis of COVID-19 infection.  On 22 Jan 2021, patient experienced some pain in arm. Patient also experienced right leg swelling but that had not bother him. On 25 Jan 2021, morning he experienced chills, trembling, heart rate increased, blood pressure went up 260/160. Patient took 2 Tylenol and after 3 hours everything had went down like normal. Later his stomach was tight and couldn't eat and next day stomach was better. On 26 Jan 2021, he experienced muscle aches and bones of right leg felt pain, ankles were also swollen and red.   Treatment activities for event was done with paracetamol.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event, experienced some pain in arm/ pain in extremity, right leg swelling, muscle aches and bones of right leg felt pain, ankles were also swollen and red were unknown. The outcome of event, experienced chills, trembling, heart rate increased, blood pressure, stomach was tight went up 260/160 were resolved on 26 Jan 2021.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Oropharyngeal pain, Paranasal sinus discomfort
Clinical narrative: Sinus issues; Sore throat; Did not feel well for two days; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Did not feel well for two days), OROPHARYNGEAL PAIN (Sore throat) and PARANASAL SINUS DISCOMFORT (Sinus issues) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced MALAISE (Did not feel well for two days). On 01-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). On an unknown date, the patient experienced PARANASAL SINUS DISCOMFORT (Sinus issues). On 29-Jan-2021, MALAISE (Did not feel well for two days) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and PARANASAL SINUS DISCOMFORT (Sinus issues) outcome was unknown.            No  concomitant medical  provided by the reporter. No treatment medication provided by the reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was Not applicable; 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: hives; erupted in whelps at injection site; itchy at injection site; red at injection site; swollen at injection site; slightly hot at injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Feb-2021 and was forwarded to Moderna on 03-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (erupted in whelps at injection site), INJECTION SITE PRURITUS (itchy at injection site), INJECTION SITE ERYTHEMA (red at injection site), INJECTION SITE SWELLING (swollen at injection site) and INJECTION SITE WARMTH (slightly hot at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced INJECTION SITE RASH (erupted in whelps at injection site), INJECTION SITE PRURITUS (itchy at injection site), INJECTION SITE ERYTHEMA (red at injection site), INJECTION SITE SWELLING (swollen at injection site) and INJECTION SITE WARMTH (slightly hot at injection site). On an unknown date, the patient experienced URTICARIA (hives). On 03-Feb-2021, INJECTION SITE RASH (erupted in whelps at injection site), INJECTION SITE PRURITUS (itchy at injection site), INJECTION SITE ERYTHEMA (red at injection site), INJECTION SITE SWELLING (swollen at injection site) and INJECTION SITE WARMTH (slightly hot at injection site) had resolved. At the time of the report, URTICARIA (hives) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No concomitant medication was provided.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; erupted in whelps at injection site; itchy at injection site; red at injection site; swollen at injection site; slightly hot at injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Feb-2021 and was forwarded to Moderna on 03-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (erupted in whelps at injection site), INJECTION SITE PRURITUS (itchy at injection site), INJECTION SITE ERYTHEMA (red at injection site), INJECTION SITE SWELLING (swollen at injection site) and INJECTION SITE WARMTH (slightly hot at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced INJECTION SITE RASH (erupted in whelps at injection site), INJECTION SITE PRURITUS (itchy at injection site), INJECTION SITE ERYTHEMA (red at injection site), INJECTION SITE SWELLING (swollen at injection site) and INJECTION SITE WARMTH (slightly hot at injection site). On an unknown date, the patient experienced URTICARIA (hives). On 03-Feb-2021, INJECTION SITE RASH (erupted in whelps at injection site), INJECTION SITE PRURITUS (itchy at injection site), INJECTION SITE ERYTHEMA (red at injection site), INJECTION SITE SWELLING (swollen at injection site) and INJECTION SITE WARMTH (slightly hot at injection site) had resolved. At the time of the report, URTICARIA (hives) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No concomitant medication was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Pruritus
Clinical narrative: red; rash; ITCHY; hardness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (red), INJECTION SITE RASH (rash), PRURITUS (ITCHY) and INJECTION SITE INDURATION (hardness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041LZ019) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (red), INJECTION SITE RASH (rash), PRURITUS (ITCHY) and INJECTION SITE INDURATION (hardness). At the time of the report, INJECTION SITE ERYTHEMA (red), INJECTION SITE RASH (rash), PRURITUS (ITCHY) and INJECTION SITE INDURATION (hardness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling cold, Headache, Myalgia
Clinical narrative: joint pain; feels as if she had a cold, feels cold; headache; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain), FEELING COLD (feels as if she had a cold, feels cold), HEADACHE (headache) and MYALGIA (muscle aches) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01102QA) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical reported history).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced ARTHRALGIA (joint pain), FEELING COLD (feels as if she had a cold, feels cold), HEADACHE (headache) and MYALGIA (muscle aches). At the time of the report, ARTHRALGIA (joint pain), FEELING COLD (feels as if she had a cold, feels cold), HEADACHE (headache) and MYALGIA (muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient is on concomitant medication for Diabetes, cholesterol,blood pressure. no treatment medication; 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Laboratory test, Pain, Paraesthesia
Clinical narrative: sore on the chest; tingling feet; headache; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore on the chest), PARAESTHESIA (tingling feet), HEADACHE (headache) and FATIGUE (felt tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DILTIAZEM, ALPRAZOLAM, ESCITALOPRAM and OMEPRAZOLE for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (sore on the chest), PARAESTHESIA (tingling feet), HEADACHE (headache) and FATIGUE (felt tired). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Pain, at a dose of 1 g three times a day and MUPIROCIN for Pain, at a dose of 2 percent. At the time of the report, PAIN (sore on the chest), PARAESTHESIA (tingling feet), HEADACHE (headache) and FATIGUE (felt tired) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: negative (Negative) Test for shingles came back negative..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also includes, Blood thinner and eye drop; 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: strange buzzing, vibrating feeling in her chest; A spontaneous report was received from a consumer concerning herself, a 53 years old female patient who received Moderna's COVID-19 vaccine and experienced strange buzzing, vibrating feeling in her chest/chest discomfort.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 26-Jan-2021, prior to the onset of the symptoms, the patient received first of two planned doses of mRNA-1273 (batch number unknown) via unknown route for COVID-19 infection prophylaxis.  On 26-Jan-2021, the patient received her first dose of the vaccine. On 28-Jan-2021, patient experienced strange buzzing, vibrating feeling in her chest which is not painful. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event is not reported.  The outcome of the event strange buzzing, vibrating feeling in her chest was unknown.; 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.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Vaccination site erythema, Vaccination site pain
Clinical narrative: Shoulder is red at injection site; Blotchy redness and itchy; Just a mild pain in the arm; Severe pain at injection site; WARNING: THE STUDY CONFIGURATION IS MISSING THE STUDY PHASE. PLEASE UPDATE THE STUDY PHASE AND RE-GENERATE THE NARRATIVE AGAIN.    This     The subject received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown). The report describes a case of PAIN IN EXTREMITY (Just a mild pain in the arm), PRURITUS (Blotchy redness and itchy), VACCINATION SITE PAIN (Severe pain at injection site) and VACCINATION SITE ERYTHEMA (Shoulder is red at injection site).     Concomitant products included LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN D 12 HOUR) for Allergy, VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL), ESCITALOPRAM and BIFIDOBACTERIUM LACTIS (PROBIOTIC [BIFIDOBACTERIUM LACTIS]) for an unknown indication.  On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (Severe pain at injection site). On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (Just a mild pain in the arm). On 23-Jan-2021, the patient experienced PRURITUS (Blotchy redness and itchy). On 28-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Shoulder is red at injection site). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 16-Jan-2021, VACCINATION SITE PAIN (Severe pain at injection site) had resolved. On 24-Jan-2021, PRURITUS (Blotchy redness and itchy) had resolved. At the time of the report, PAIN IN EXTREMITY (Just a mild pain in the arm) and VACCINATION SITE ERYTHEMA (Shoulder is red at injection site) 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.; 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: Injection site swelling, Injection site warmth
Clinical narrative: lot of heat in it and it's very raised; lot of heat in it and it's very raised; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (lot of heat in it and it's very raised) and INJECTION SITE SWELLING (lot of heat in it and it's very raised) 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 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced INJECTION SITE WARMTH (lot of heat in it and it's very raised) and INJECTION SITE SWELLING (lot of heat in it and it's very raised). At the time of the report, INJECTION SITE WARMTH (lot of heat in it and it's very raised) and INJECTION SITE SWELLING (lot of heat in it and it's very raised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) 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 events, a causal relationship cannot be excluded.   Reporter did not allow further contact; 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itching; Arm got swollen; Sore injection site; Warm injection site; This spontaneous case was reported by a health care professional and describes the occurrence of INJECTION SITE WARMTH (Warm injection site), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (Arm got swollen) and VACCINATION SITE PAIN (Sore injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis, Allergy NOS and Seasonal allergy. Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (MUCINEX DM) and IPRATROPIUM BROMIDE for Allergy NOS, GLUCOSAMINE, METHYLSULFONYLMETHANE (GLUCOSAMINE/MSM) and FISH OIL for Arthritis, CALCIUM for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced INJECTION SITE WARMTH (Warm injection site), VACCINATION SITE SWELLING (Arm got swollen) and VACCINATION SITE PAIN (Sore injection site). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itching). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 18-Jan-2021, VACCINATION SITE PAIN (Sore injection site) had resolved. At the time of the report, INJECTION SITE WARMTH (Warm injection site), VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE SWELLING (Arm got swollen) 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.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Medical history added, event details updated, concomitant medication details updated
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site warmth
Clinical narrative: pain goes from my arm to across my shoulder; Injection site was warm to the touch; injection site hard; my arm, where they gave me the shot, was really sore; my arm, where they gave me the shot, red; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain goes from my arm to across my shoulder), VACCINATION SITE WARMTH (Injection site was warm to the touch), VACCINATION SITE INDURATION (injection site hard), VACCINATION SITE PAIN (my arm, where they gave me the shot, was really sore) and VACCINATION SITE ERYTHEMA (my arm, where they gave me the shot, red) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain goes from my arm to across my shoulder), VACCINATION SITE WARMTH (Injection site was warm to the touch), VACCINATION SITE INDURATION (injection site hard), VACCINATION SITE PAIN (my arm, where they gave me the shot, was really sore) and VACCINATION SITE ERYTHEMA (my arm, where they gave me the shot, red). At the time of the report, PAIN IN EXTREMITY (pain goes from my arm to across my shoulder) had not resolved and VACCINATION SITE WARMTH (Injection site was warm to the touch), VACCINATION SITE INDURATION (injection site hard), VACCINATION SITE PAIN (my arm, where they gave me the shot, was really sore) and VACCINATION SITE ERYTHEMA (my arm, where they gave me the shot, red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided Throbbing pain in the patient's right arm, is not continuous but comes and goes at least once each day. The patient is thinking of taking an X-ray or something as this should not still be bothering her. The patient's second shot caused no problems.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Event verbatim; throbbing pain in my right arm was added to pain at injection site that traveled across her shoulder, outcome for this event changed to not recovered/not resolved.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Body temperature abnormal, Chills, Dehydration
Clinical narrative: slept all day long; still weak; lightheadedness; dehydrated; body aches all over the place; 100.2 temperature; terrible chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept all day long), ASTHENIA (still weak), DIZZINESS (lightheadedness), DEHYDRATION (dehydrated) and PAIN (body aches all over the place) in a 68-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.     Concurrent medical conditions included Hypertension, Fibromyalgia and Arthritis. Concomitant products included PARACETAMOL, TRAMADOL HYDROCHLORIDE (ULTRAM [PARACETAMOL;TRAMADOL HYDROCHLORIDE]) and MELOXICAM (MOBIC) for an unknown indication.    On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced ASTHENIA (still weak), DIZZINESS (lightheadedness), DEHYDRATION (dehydrated), PAIN (body aches all over the place), BODY TEMPERATURE ABNORMAL (100.2 temperature), CHILLS (terrible chills) and NAUSEA (nausea). On 02-Feb-2021, the patient experienced SOMNOLENCE (slept all day long). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 02-Feb-2021, BODY TEMPERATURE ABNORMAL (100.2 temperature), CHILLS (terrible chills) and NAUSEA (nausea) had resolved. At the time of the report, SOMNOLENCE (slept all day long), ASTHENIA (still weak), DIZZINESS (lightheadedness), DEHYDRATION (dehydrated) and PAIN (body aches all over the place) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, Body temperature: 100.2f (normal) 100.2F.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pain, Somnolence
Clinical narrative: slept all day long; still weak; lightheadedness; dehydrated; body aches all over the place; 100.2 temperature; terrible chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept all day long), ASTHENIA (still weak), DIZZINESS (lightheadedness), DEHYDRATION (dehydrated) and PAIN (body aches all over the place) in a 68-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.     Concurrent medical conditions included Hypertension, Fibromyalgia and Arthritis. Concomitant products included PARACETAMOL, TRAMADOL HYDROCHLORIDE (ULTRAM [PARACETAMOL;TRAMADOL HYDROCHLORIDE]) and MELOXICAM (MOBIC) for an unknown indication.    On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced ASTHENIA (still weak), DIZZINESS (lightheadedness), DEHYDRATION (dehydrated), PAIN (body aches all over the place), BODY TEMPERATURE ABNORMAL (100.2 temperature), CHILLS (terrible chills) and NAUSEA (nausea). On 02-Feb-2021, the patient experienced SOMNOLENCE (slept all day long). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 02-Feb-2021, BODY TEMPERATURE ABNORMAL (100.2 temperature), CHILLS (terrible chills) and NAUSEA (nausea) had resolved. At the time of the report, SOMNOLENCE (slept all day long), ASTHENIA (still weak), DIZZINESS (lightheadedness), DEHYDRATION (dehydrated) and PAIN (body aches all over the place) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, Body temperature: 100.2f (normal) 100.2F.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Erythema, Fatigue, Headache
Clinical narrative: underneath of arm had swollen lymph node; hard bump under my skin; sore to touch; Temperature was 99F; something under the armpit is still bugging me; Dull headache; Feeling tired; big red circle that was raised; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (underneath of arm had swollen lymph node), VACCINATION SITE MASS (hard bump under my skin), PARAESTHESIA (sore to touch), BODY TEMPERATURE (Temperature was 99F) and AXILLARY PAIN (something under the armpit is still bugging me) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (underneath of arm had swollen lymph node), VACCINATION SITE MASS (hard bump under my skin), PARAESTHESIA (sore to touch), BODY TEMPERATURE (Temperature was 99F), AXILLARY PAIN (something under the armpit is still bugging me), HEADACHE (Dull headache), FATIGUE (Feeling tired) and ERYTHEMA (big red circle that was raised). At the time of the report, LYMPHADENOPATHY (underneath of arm had swollen lymph node), VACCINATION SITE MASS (hard bump under my skin), PARAESTHESIA (sore to touch), BODY TEMPERATURE (Temperature was 99F), AXILLARY PAIN (something under the armpit is still bugging me), HEADACHE (Dull headache), FATIGUE (Feeling tired) and ERYTHEMA (big red circle that was raised) outcome was unknown.        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 events, a causal relationship cannot be excluded.   Reporter did not allow further contact; 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Paraesthesia, Vaccination site mass
Clinical narrative: underneath of arm had swollen lymph node; hard bump under my skin; sore to touch; Temperature was 99F; something under the armpit is still bugging me; Dull headache; Feeling tired; big red circle that was raised; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (underneath of arm had swollen lymph node), VACCINATION SITE MASS (hard bump under my skin), PARAESTHESIA (sore to touch), BODY TEMPERATURE (Temperature was 99F) and AXILLARY PAIN (something under the armpit is still bugging me) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (underneath of arm had swollen lymph node), VACCINATION SITE MASS (hard bump under my skin), PARAESTHESIA (sore to touch), BODY TEMPERATURE (Temperature was 99F), AXILLARY PAIN (something under the armpit is still bugging me), HEADACHE (Dull headache), FATIGUE (Feeling tired) and ERYTHEMA (big red circle that was raised). At the time of the report, LYMPHADENOPATHY (underneath of arm had swollen lymph node), VACCINATION SITE MASS (hard bump under my skin), PARAESTHESIA (sore to touch), BODY TEMPERATURE (Temperature was 99F), AXILLARY PAIN (something under the armpit is still bugging me), HEADACHE (Dull headache), FATIGUE (Feeling tired) and ERYTHEMA (big red circle that was raised) outcome was unknown.        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 events, a causal relationship cannot be excluded.   Reporter did not allow further contact; 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Myalgia, Nausea, Tremor, Vomiting
Clinical narrative: mouth is very dry; vomiting profusely during the call; nauseous; muscle pain; body is shaking; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous), MYALGIA (muscle pain), TREMOR (body is shaking), DRY MOUTH (mouth is very dry) and VOMITING (vomiting profusely during the call) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057G20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, VITAMIN D3, TRIAMTERENE, AMLODIPINE BESILATE (SELODIPINE), BUPROPION and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced NAUSEA (nauseous), MYALGIA (muscle pain) and TREMOR (body is shaking). On an unknown date, the patient experienced DRY MOUTH (mouth is very dry) and VOMITING (vomiting profusely during the call). The patient was treated with BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, NAUSEA (nauseous), MYALGIA (muscle pain), TREMOR (body is shaking), DRY MOUTH (mouth is very dry) and VOMITING (vomiting profusely during the call) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications Metoprolol, Vitamin, triamterene, Felodipine, bupropion, Aspirin Patient had taken treatment medication OTC Pepto Bismol.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: NNI