chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Fatigue, Headache, Lip swelling, Paraesthesia oral
Clinical narrative: tingling in her lip; dry mouth; top lip swollen; Fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling in her lip), DRY MOUTH (dry mouth), LIP SWELLING (top lip swollen), FATIGUE (Fatigue) and HEADACHE (headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Pituitary tumor NOS. Concurrent medical conditions included Diabetes since 2000, Hypertension since 1982, Chronic kidney disease and Allergy to antibiotic. Concomitant products included GLIMEPIRIDE (GLIPIRIDE) from 17-May-2017 to an unknown date for Diabetes, AMLODIPINE from 30-Jan-2008 to an unknown date and METOPROLOL from February 2017 to an unknown date for Hypertension, FENOFIBRATE, ATORVASTATIN CALCIUM (LIPITOR), SIMVASTATIN and LEVOTHYROXINE for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PARAESTHESIA ORAL (tingling in her lip), DRY MOUTH (dry mouth), LIP SWELLING (top lip swollen), FATIGUE (Fatigue) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 19-Feb-2021, PARAESTHESIA ORAL (tingling in her lip), DRY MOUTH (dry mouth), LIP SWELLING (top lip swollen) and FATIGUE (Fatigue) had resolved. On 20-Feb-2021, HEADACHE (headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient took second dose on 19-MAR-2021.   This case was linked to MOD-2021-228960 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Patient's demographics and other relevant history and concomitant medications were added. Added new events.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: redness of the arm she got the injection; swelling 2-6 inches long and its traveled to the back of the arm she got the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness of the arm she got the injection) and VACCINATION SITE SWELLING (swelling 2-6 inches long and its traveled to the back of the arm she got the injection) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Constipation, Heart disease, unspecified, Blood pressure abnormal, Anxiety, Dementia and Clot blood.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness of the arm she got the injection) and VACCINATION SITE SWELLING (swelling 2-6 inches long and its traveled to the back of the arm she got the injection). At the time of the report, VACCINATION SITE ERYTHEMA (redness of the arm she got the injection) and VACCINATION SITE SWELLING (swelling 2-6 inches long and its traveled to the back of the arm she got the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included medications for blood clots, constipation, heart condition, blood pressure, anxiety and dementia. Treatment details included ice on the arm.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Rash erythematous, Rash pruritic
Clinical narrative: really tired; headache; she broke out from top to bottom with a red, itchy rash; she broke out from top to bottom with a red, itchy rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH ERYTHEMATOUS (she broke out from top to bottom with a red, itchy rash), RASH PRURITIC (she broke out from top to bottom with a red, itchy rash), FATIGUE (really tired) and HEADACHE (headache) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced RASH ERYTHEMATOUS (she broke out from top to bottom with a red, itchy rash) and RASH PRURITIC (she broke out from top to bottom with a red, itchy rash). On an unknown date, the patient experienced FATIGUE (really tired) and HEADACHE (headache). At the time of the report, RASH ERYTHEMATOUS (she broke out from top to bottom with a red, itchy rash), FATIGUE (really tired) and HEADACHE (headache) outcome was unknown and RASH PRURITIC (she broke out from top to bottom with a red, itchy rash) had resolved.            Concomitant medications were not provided. Treatment medication included diphenhydramine and hydrocortisone cream on the spots.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Pruritus, Tenderness
Clinical narrative: Swollen ankle; Itches; Tenderness to touch; A spontaneous report was received from a consumer concerning a 81-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swollen ankle, itches, tenderness to touch.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 5 Feb 2021, the patient experienced the event(s) swollen ankle, itches, tenderness to touch.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), swollen ankle, itches, tenderness to touch was unknown.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID a week after the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID a week after the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID a week after the vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID a week after the vaccine) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.    Reporter did not allow further contact
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Influenza like illness, Lymph node pain, Lymphadenopathy, Nasal congestion
Clinical narrative: horrible aches; flu like symptoms; could not get out of bed; fever; lymph nodes swelled under her arms to the size of lemons; lymph nodes are sore; congestion; intermittent smelling of cigarette smoke; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (horrible aches), PAROSMIA (intermittent smelling of cigarette smoke), INFLUENZA LIKE ILLNESS (flu like symptoms), GAIT DISTURBANCE (could not get out of bed) and NASAL CONGESTION (congestion) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PAROSMIA (intermittent smelling of cigarette smoke), NASAL CONGESTION (congestion), LYMPHADENOPATHY (lymph nodes swelled under her arms to the size of lemons) and LYMPH NODE PAIN (lymph nodes are sore). On 18-Feb-2021, the patient experienced PAIN (horrible aches), INFLUENZA LIKE ILLNESS (flu like symptoms), GAIT DISTURBANCE (could not get out of bed) and PYREXIA (fever). The patient was treated with FLUTICASONE at an unspecified dose and frequency. In February 2021, PAIN (horrible aches), INFLUENZA LIKE ILLNESS (flu like symptoms), GAIT DISTURBANCE (could not get out of bed) and PYREXIA (fever) had resolved. At the time of the report, PAROSMIA (intermittent smelling of cigarette smoke), NASAL CONGESTION (congestion), LYMPHADENOPATHY (lymph nodes swelled under her arms to the size of lemons) and LYMPH NODE PAIN (lymph nodes are sore) outcome was unknown. 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.   no concomitant medications reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Parosmia, Pyrexia
Clinical narrative: horrible aches; flu like symptoms; could not get out of bed; fever; lymph nodes swelled under her arms to the size of lemons; lymph nodes are sore; congestion; intermittent smelling of cigarette smoke; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (horrible aches), PAROSMIA (intermittent smelling of cigarette smoke), INFLUENZA LIKE ILLNESS (flu like symptoms), GAIT DISTURBANCE (could not get out of bed) and NASAL CONGESTION (congestion) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PAROSMIA (intermittent smelling of cigarette smoke), NASAL CONGESTION (congestion), LYMPHADENOPATHY (lymph nodes swelled under her arms to the size of lemons) and LYMPH NODE PAIN (lymph nodes are sore). On 18-Feb-2021, the patient experienced PAIN (horrible aches), INFLUENZA LIKE ILLNESS (flu like symptoms), GAIT DISTURBANCE (could not get out of bed) and PYREXIA (fever). The patient was treated with FLUTICASONE at an unspecified dose and frequency. In February 2021, PAIN (horrible aches), INFLUENZA LIKE ILLNESS (flu like symptoms), GAIT DISTURBANCE (could not get out of bed) and PYREXIA (fever) had resolved. At the time of the report, PAROSMIA (intermittent smelling of cigarette smoke), NASAL CONGESTION (congestion), LYMPHADENOPATHY (lymph nodes swelled under her arms to the size of lemons) and LYMPH NODE PAIN (lymph nodes are sore) outcome was unknown. 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.   no concomitant medications reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: Inside is less red and the outside is more red; rash, large circle; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Inside is less red and the outside is more red) and RASH (rash, large circle) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ERYTHEMA (Inside is less red and the outside is more red) and RASH (rash, large circle). At the time of the report, ERYTHEMA (Inside is less red and the outside is more red) and RASH (rash, large circle) 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 con meds were provided.  Treatment details included None.; 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: Abdominal discomfort, Nausea, Vomiting
Clinical narrative: vomited once; Nausea; Stomach felt uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach felt uncomfortable), VOMITING (vomited once) and NAUSEA (Nausea) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Vertigo.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach felt uncomfortable). On 18-Feb-2021, the patient experienced VOMITING (vomited once) and NAUSEA (Nausea). On 23-Feb-2021, ABDOMINAL DISCOMFORT (Stomach felt uncomfortable), VOMITING (vomited once) and NAUSEA (Nausea) had resolved. Not Provided          She was not able to eat anything but crackers and water. The patient did not receive any concomitant medications. Treatment information was not reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Palpitations, Tremor
Clinical narrative: dizziness; slightly lightheaded; Heart Palpatations; Hands were shaking; I felt like I could almost fall; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), DIZZINESS (slightly lightheaded), PALPITATIONS (Heart Palpatations), TREMOR (Hands were shaking) and BALANCE DISORDER (I felt like I could almost fall) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced DIZZINESS (slightly lightheaded), PALPITATIONS (Heart Palpatations), TREMOR (Hands were shaking) and BALANCE DISORDER (I felt like I could almost fall). On 22-Feb-2021, the patient experienced DIZZINESS (dizziness). The patient was treated with ALPRAZOLAM (XANAX) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), DIZZINESS (slightly lightheaded), PALPITATIONS (Heart Palpatations), TREMOR (Hands were shaking) and BALANCE DISORDER (I felt like I could almost fall) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment medications included antihistamine.   Most recent FOLLOW-UP information incorporated above includes: On 26-Feb-2021: Added reporter's information.
Age: 98.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; A spontaneous report () was received from a consumer concerning a 98-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) sore arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore arm was unknown.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Vaccination site pain
Clinical narrative: Patient reported that 10 minutes after vaccination, she started having a hot flush that started just below the waistline and went down to her vagal, and it went away in 30 seconds; Soreness at the injection site; A spontaneous report () was received from a consumer concerning a 86 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events patient reported that 10 minutes after vaccination, she started having a hot flush that started just /hot flush, soreness at the injection site /injection site pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14 Feb 2021, approximately 1 day prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 006M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 14 Feb 2021, the patient experienced the event(s) patient reported that 10 minutes after vaccination, she started having a hot flush that started just, soreness at the injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), patient reported that 10 minutes after vaccination, she started having a hot flush that started just, soreness at the injection site was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: slightly more sore arm for a little bit longer as compared to flu shot; A spontaneous report was received from a Other health care professional (HCP) concerning a  female patient unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event slightly more sore arm for a little bit longer as compared to flu shot.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) Anatomical location unspecified for prophylaxis of COVID-19 infection.  On unknown date, The patient experienced the event slightly more sore arm for a little bit longer as compared to flu shot.   Laboratory details were not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event include slightly more sore arm for a little bit longer as compared to flu shot was considered unknown.  The reporter assessed the event include slightly more sore arm for a little bit longer as compared to flu shot related to the study drug was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: extreme fatigue; tired; A spontaneous report was received from a consumer concerning a 68-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events extreme fatigue, tired.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 024M20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events extreme fatigue, tired.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, extreme fatigue, tired was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Nausea, Pain, Peripheral swelling
Clinical narrative: injection arm is swollen and aches; seems like having Covid-19 again; bone, joint and body ache; red circle around the injection site; nausea; wants to throw up; injection arm aches; tired and sleepy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (injection arm is swollen and aches), COVID-19 (seems like having Covid-19 again), PAIN (bone, joint and body ache), FATIGUE (tired and sleepy) and VACCINATION SITE ERYTHEMA (red circle around the injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic.   On 22-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 22-Feb-2021, the patient experienced FATIGUE (tired and sleepy). On 23-Feb-2021, the patient experienced PERIPHERAL SWELLING (injection arm is swollen and aches), COVID-19 (seems like having Covid-19 again), PAIN (bone, joint and body ache), VACCINATION SITE ERYTHEMA (red circle around the injection site), NAUSEA (nausea), VOMITING (wants to throw up) and VACCINATION SITE PAIN (injection arm aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (injection arm is swollen and aches), COVID-19 (seems like having Covid-19 again), PAIN (bone, joint and body ache), FATIGUE (tired and sleepy), VACCINATION SITE ERYTHEMA (red circle around the injection site), NAUSEA (nausea), VOMITING (wants to throw up) and VACCINATION SITE PAIN (injection arm aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant  medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vomiting
Clinical narrative: injection arm is swollen and aches; seems like having Covid-19 again; bone, joint and body ache; red circle around the injection site; nausea; wants to throw up; injection arm aches; tired and sleepy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (injection arm is swollen and aches), COVID-19 (seems like having Covid-19 again), PAIN (bone, joint and body ache), FATIGUE (tired and sleepy) and VACCINATION SITE ERYTHEMA (red circle around the injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic.   On 22-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 22-Feb-2021, the patient experienced FATIGUE (tired and sleepy). On 23-Feb-2021, the patient experienced PERIPHERAL SWELLING (injection arm is swollen and aches), COVID-19 (seems like having Covid-19 again), PAIN (bone, joint and body ache), VACCINATION SITE ERYTHEMA (red circle around the injection site), NAUSEA (nausea), VOMITING (wants to throw up) and VACCINATION SITE PAIN (injection arm aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (injection arm is swollen and aches), COVID-19 (seems like having Covid-19 again), PAIN (bone, joint and body ache), FATIGUE (tired and sleepy), VACCINATION SITE ERYTHEMA (red circle around the injection site), NAUSEA (nausea), VOMITING (wants to throw up) and VACCINATION SITE PAIN (injection arm aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant  medications were reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever of 100.4; Chills, Shivering; A spontaneous report () was received from a consumer concerning a 68-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, fever of 100.4, shivering.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 025L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the events, chills. On 19 Feb 2021, the patient experienced the events fever of 100.4, shivering.  Treatment details included 2 Motrin.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, chills, fever of 100, 4, shivering was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Asthenia, Fall, Pain in extremity
Clinical narrative: fell off the bed and could not get back up; very weak/Moves around with help; weak knees; legs ache; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced weak knees,legs ache,Fell off the Bed and could not get back up and has been very weak.  The patient's medical history was not reported. Concomitant medication was not reported.  22-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 22-FEB-2021, The patient experienced weak knees,legs ache,Fell off the Bed and could not get back up and  has been very weak.She lives with someone whom helps her move around.  No Laboratory details provided.  treatment information- tylenol 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 fall,asthenia,arthropathy and leg pain is Unknown.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm hurt a little bit; A spontaneous report () was received from a consumer concerning a 86-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm hurt a little bit.  The patient's medical history was not provided. Concomitant medications reported were Thyroid meds, Blood pressure meds, Vitamins, Ibuprofen for drug use for unknown indication.  On 20 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient experienced the event arm hurt a little bit.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event, arm hurt a little bit was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Fatigue, Headache, Malaise
Clinical narrative: nausea; fever; fatigue; headache; sick; dizziness; Lightheadedness; tested positive for covid; A spontaneous report was received from a consumer concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nausea, fever, fatigue, headache, sick, dizziness, lightheadedness, tested positive for covid.  The patient's medical history was not provided. Concomitant medications reported were Aspirin , Losartan, Megestrol, Januvia, Metformin, Glipizide for drug use for unknown indication.  On 28 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A)  unknown route in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events, Nausea, Fever, Fatigue, headache, sick, dizziness, lightheadedness. On 8 Feb 2021, the patient experienced the events,tested positive for covid.  Treatment details included AZITHROMYCIN.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, nausea, fever, fatigue, headache, sick, dizziness, lightheadedness, tested positive for covid was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: nausea; fever; fatigue; headache; sick; dizziness; Lightheadedness; tested positive for covid; A spontaneous report was received from a consumer concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nausea, fever, fatigue, headache, sick, dizziness, lightheadedness, tested positive for covid.  The patient's medical history was not provided. Concomitant medications reported were Aspirin , Losartan, Megestrol, Januvia, Metformin, Glipizide for drug use for unknown indication.  On 28 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A)  unknown route in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events, Nausea, Fever, Fatigue, headache, sick, dizziness, lightheadedness. On 8 Feb 2021, the patient experienced the events,tested positive for covid.  Treatment details included AZITHROMYCIN.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, nausea, fever, fatigue, headache, sick, dizziness, lightheadedness, tested positive for covid was unknown.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site induration
Clinical narrative: itchy at injection site; Vaccination site induration; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itchy at injection site), VACCINATION SITE INDURATION (Vaccination site induration) and INJECTION SITE ERYTHEMA (redness at injection site) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PRAVASTATIN for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced INJECTION SITE PRURITUS (itchy at injection site), VACCINATION SITE INDURATION (Vaccination site induration) and INJECTION SITE ERYTHEMA (redness at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PRURITUS (itchy at injection site), VACCINATION SITE INDURATION (Vaccination site induration) and INJECTION SITE ERYTHEMA (redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Heart rate increased, Nausea, Pain in extremity
Clinical narrative: Dizziness; Fast heart rate; Sore arm; Hives in injection arm; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEART RATE INCREASED (Fast heart rate), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE URTICARIA (Hives in injection arm) and NAUSEA (Nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported.  Concomitant products included VALSARTAN (DIOVAN), LEVOTHYROXINE and PRAVASTATIN for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced DIZZINESS (Dizziness), HEART RATE INCREASED (Fast heart rate), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE URTICARIA (Hives in injection arm), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, DIZZINESS (Dizziness), HEART RATE INCREASED (Fast heart rate), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE URTICARIA (Hives in injection arm), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: Dizziness; Fast heart rate; Sore arm; Hives in injection arm; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEART RATE INCREASED (Fast heart rate), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE URTICARIA (Hives in injection arm) and NAUSEA (Nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported.  Concomitant products included VALSARTAN (DIOVAN), LEVOTHYROXINE and PRAVASTATIN for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced DIZZINESS (Dizziness), HEART RATE INCREASED (Fast heart rate), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE URTICARIA (Hives in injection arm), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, DIZZINESS (Dizziness), HEART RATE INCREASED (Fast heart rate), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE URTICARIA (Hives in injection arm), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: sore arm; fever(100.5F); A spontaneous report was received from a consumer concerning a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, fever(100.5f).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 023M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 23 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 023M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 23 Feb 2021, the patient experienced the event(s) sore arm, fever(100.5f).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore arm, fever(100, 5f) was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Nasal congestion, Pain, Pain in extremity
Clinical narrative: fever; body pain; severe headache; Sneezing; arm pain; congestion; right ear pain; A spontaneous report was received from a nurse concerning a 54-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm pain, severe headache, body pain, right ear pain, congestion, fever, sneezing.  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 first of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 10 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 030M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) arm pain. On 11 Feb 2021, the patient experienced the event(s) severe headache, body pain, right ear pain, congestion. On 17 Feb 2021, the patient experienced the event(s) fever, sneezing.  Treatment details included 2 Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), arm pain, severe headache, body pain, right ear pain, congestion, fever, sneezing was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sneezing
Clinical narrative: fever; body pain; severe headache; Sneezing; arm pain; congestion; right ear pain; A spontaneous report was received from a nurse concerning a 54-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm pain, severe headache, body pain, right ear pain, congestion, fever, sneezing.  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 first of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 10 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 030M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) arm pain. On 11 Feb 2021, the patient experienced the event(s) severe headache, body pain, right ear pain, congestion. On 17 Feb 2021, the patient experienced the event(s) fever, sneezing.  Treatment details included 2 Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), arm pain, severe headache, body pain, right ear pain, congestion, fever, sneezing was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Antineutrophil cytoplasmic antibody, Chills, Malaise, Tremor
Clinical narrative: Her myeloperoxidase level went from 234 - 756; very sick; shaking; chills; A spontaneous report was received from a healthcare professional concerning a 48-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events very sick, shaking, chills, her myeloperoxidase level went from 234 - 756.  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 first of two planned doses of mRNA-1273 (lot/batch: 011J20A) via unknown route in the right arm for prophylaxis of COVID-19 infection. On 26 Jan 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 028L20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced the event(s) very sick, shaking, chills. On 16 Feb 2021, the patient experienced the event(s) her myeloperoxidase level went from 234 - 756.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On 28 Jan 2021 the outcome of event(s), very sick, shaking, chills was resolved. On23 Feb 2021 the outcome of event(s), her myeloperoxidase level went from 234 - 756 was resolved.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Influenza like illness, Pain in extremity, Rhinorrhoea
Clinical narrative: Pain in left shoulder; Pain in my hand; Flu like symptoms; Cough; Feeling weak; Runny nose; A spontaneous report  was received from a Consumer concerning a  74Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Pain in left shoulder, Pain in my hand, Flu like symptoms, Cough, Feeling weak and Runny nose.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 21-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 Right Arm for prophylaxis of COVID-19 infection.  On date, The patient experienced the events Pain in left shoulder, Pain in my hand, Flu like symptoms, Cough, Feeling weak and Runny nose.  Laboratory details were not provided.  Treatment details include Cough medicine (Mucinex) and Vanclox  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events Pain in left shoulder, Pain in my hand, Flu like symptoms, Cough, Feeling weak and Runny nose was unknown.  The reporter assessed the event Pain in left shoulder, Pain in my hand, Flu like symptoms, Cough, Feeling weak and Runny nose related to the study drug was unknown.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash macular, Urticaria, Weight decreased
Clinical narrative: Hives; Blotchiness; Itchy; Rash; Lost weight; A spontaneous report was received from a consumer who was also a 31-years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced rash, hives/urticaria, blotchiness/rash macular, lost weight/weight decreased and itchy/pruritus.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Zyrtec, Allegra, Singular and pantoprazole unspecified.  On 31 Dec 2021, approximately 9 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 09 Jan 2021, 9 days after vaccination patient had hives and a rash appear so patient visited patient's doctor who gave prescribed few medications. After 7 days symptoms got worse. The hives and blotchiness spread to patient's face and the rash was from neck down to thighs. The rash looked like red dots like chicken pox or poison ivy, but nothing came out of them but was itchy. It was also concentrated on the right side of patient's body. patient went back to the doctor. Patient also mentioned that in the first fourteen days after the Moderna COVID-19 vaccine patient lost 10 pounds.   Treatment for the event included prednisone 10 milligram 4 times a day and cream for rash and hives and steroid for hives and blotchiness and rash.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events was not reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abnormal dreams, Arthralgia, Asthenia, Cold sweat
Clinical narrative: weakness; hot and cold sweats; very odd dreams; fogginess; Upset stomach; Cold sweats; joint achiness; Fatigue; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), COLD SWEAT (Cold sweats) and FATIGUE (Fatigue) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), COLD SWEAT (Cold sweats) and FATIGUE (Fatigue). At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach) outcome was unknown and COLD SWEAT (Cold sweats) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Updated the Contact information.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hot flush, Influenza like illness
Clinical narrative: weakness; hot and cold sweats; very odd dreams; fogginess; Upset stomach; Cold sweats; joint achiness; Fatigue; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), COLD SWEAT (Cold sweats) and FATIGUE (Fatigue) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), COLD SWEAT (Cold sweats) and FATIGUE (Fatigue). At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach) outcome was unknown and COLD SWEAT (Cold sweats) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Updated the Contact information.
Sex: F
Vaccine: COVID19
Symptoms: Type IV hypersensitivity reaction
Clinical narrative: had the COVID arm; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events had the covid arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) had the COVID arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), had the covid arm was unknown.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; A spontaneous report was received from a consumer concerning a 70 years old, male patient who experienced chills, aches/myalgia, headache and felt cold/feeling cold.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 27 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 038K20A) via unknown route in his right arm for prophylaxis of COVID-19 infection.   On 12 Feb 2021, the patient tested positive on COVID-19 test and was diagnosed with COVID-19.  Treatment for the event included none.   Action taken with mRNA-1273 in response to the events was not provided.  The events COVID-19 was resolving.