chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Headache, Pruritus, Vaccination site pruritus
Clinical narrative: itching at front and back of neck and scalp; itching inside his left arm where he got the injection; Headache; elevated body temperature; itching at his chest; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching at his chest), PRURITUS (itching at front and back of neck and scalp), BODY TEMPERATURE INCREASED (elevated body temperature), VACCINATION SITE PRURITUS (itching inside his left arm where he got the injection) and HEADACHE (Headache) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included HYDROCHLOROTHIAZIDE and SIMVASTATIN for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PRURITUS (itching at his chest), BODY TEMPERATURE INCREASED (elevated body temperature) and HEADACHE (Headache). On 21-Feb-2021, the patient experienced PRURITUS (itching at front and back of neck and scalp) and VACCINATION SITE PRURITUS (itching inside his left arm where he got the injection). At the time of the report, PRURITUS (itching at his chest), PRURITUS (itching at front and back of neck and scalp), BODY TEMPERATURE INCREASED (elevated body temperature), VACCINATION SITE PRURITUS (itching inside his left arm where he got the injection) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Body temperature: elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pain in extremity, Pyrexia, Tremor
Clinical narrative: Shakes; arm pain; lost 10 lbs; nauseous; 102.2 F. fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shakes), PAIN IN EXTREMITY (arm pain), WEIGHT DECREASED (lost 10 lbs), NAUSEA (nauseous) and PYREXIA (102.2 F. fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced PYREXIA (102.2 F. fever). On an unknown date, the patient experienced TREMOR (Shakes), PAIN IN EXTREMITY (arm pain), WEIGHT DECREASED (lost 10 lbs) and NAUSEA (nauseous). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 18-Jan-2021, PYREXIA (102.2 F. fever) had resolved. At the time of the report, TREMOR (Shakes), PAIN IN EXTREMITY (arm pain), WEIGHT DECREASED (lost 10 lbs) and NAUSEA (nauseous) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, Body temperature: 102.2f (Inconclusive) 102.2F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient already received the second dose of the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Event outcome and product information updated
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Shakes; arm pain; lost 10 lbs; nauseous; 102.2 F. fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shakes), PAIN IN EXTREMITY (arm pain), WEIGHT DECREASED (lost 10 lbs), NAUSEA (nauseous) and PYREXIA (102.2 F. fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced PYREXIA (102.2 F. fever). On an unknown date, the patient experienced TREMOR (Shakes), PAIN IN EXTREMITY (arm pain), WEIGHT DECREASED (lost 10 lbs) and NAUSEA (nauseous). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 18-Jan-2021, PYREXIA (102.2 F. fever) had resolved. At the time of the report, TREMOR (Shakes), PAIN IN EXTREMITY (arm pain), WEIGHT DECREASED (lost 10 lbs) and NAUSEA (nauseous) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, Body temperature: 102.2f (Inconclusive) 102.2F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient already received the second dose of the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Event outcome and product information updated
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024L26A) for COVID-19 vaccination.     Concurrent medical conditions included Bell's palsy (Medical history reported as bell palsy.) and Diabetes (Medical history reported as diabetic).    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) 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.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Wheezing; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (Wheezing) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WHEEZING (Wheezing). At the time of the report, WHEEZING (Wheezing) outcome was unknown.            No concomitant products were reported. No treatments were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up information received on 14-JUL-2021 contains non significant information. The reporter contact details were updated.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Sluggishness, Vaccination site pain
Clinical narrative: feeling sluggish; warm; headache; Soreness at injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), SLUGGISHNESS (feeling sluggish), FEELING HOT (warm) and VACCINATION SITE PAIN (Soreness at injection site) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 029L20A) 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) dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On 17-Feb-2021, the patient experienced HEADACHE (headache), SLUGGISHNESS (feeling sluggish), FEELING HOT (warm) and VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, HEADACHE (headache), SLUGGISHNESS (feeling sluggish), FEELING HOT (warm) and VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Hypotension, Malaise, Pyrexia
Clinical narrative: Fever; Chills; Not feeling the greatest.; felt weak; Blood pressure dropped to 80/44; A spontaneous report was received from a consumer concerning a 78-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, chills, not feeling the greatest, and felt weak and blood pressure dropped to 80/44.  The patient medical history was not reported. No relevant concomitant medications were reported.  On 15 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (041L20A) in the right arm for prophylaxis of COVID-19 infection.  On 16 Jan 2021, the patient experienced fever, chills, not feeling the greatest, felt weak and blood pressure dropped to 80/44.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events fever, chills, not feeling the greatest, felt weak and blood pressure dropped to 80/44 was considered recovering.; Reporter's Comments: This case concerns a 78-year-old female who experienced nonserious unexpected events of asthenia, malaise, and hypotension and nonserious expected events of fever and chills.  The events occurred 2 days after the first dose of mRNA-1273. Treatment not reported.  Event outcome recovering. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Dyspnoea, Fatigue
Clinical narrative: dizziness; fatigue; headache; Arm pain; Shortness of breath; Fatigue; Headache; Muscle pain; Joint pain; Chills; Nausea; This spontaneous report was reported by a consumer and describes the occurrence of   in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included Blood Thinner, Flavrx Distorted Aortic Valve and CPAP Machine,  Sleep  Apnea for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The consumer reports the onset of symptoms as occurring after the first dose on 20JAN2021.These symptoms include Fatigue, Headache, Muscle Pain, Joint Pain, Chills, and Nausea. The consumer reports that these symptoms seemed to have gone away by 22-jan-2021.  On 16-Feb-2021,  the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   The consumer also reports symptoms occurring after her second dose on 17FEB2021. These symptoms include Dizziness, Fatigue, Headache, Arm Pain, and Shortness of Breath.     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.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pain
Clinical narrative: dizziness; fatigue; headache; Arm pain; Shortness of breath; Fatigue; Headache; Muscle pain; Joint pain; Chills; Nausea; This spontaneous report was reported by a consumer and describes the occurrence of   in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included Blood Thinner, Flavrx Distorted Aortic Valve and CPAP Machine,  Sleep  Apnea for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The consumer reports the onset of symptoms as occurring after the first dose on 20JAN2021.These symptoms include Fatigue, Headache, Muscle Pain, Joint Pain, Chills, and Nausea. The consumer reports that these symptoms seemed to have gone away by 22-jan-2021.  On 16-Feb-2021,  the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   The consumer also reports symptoms occurring after her second dose on 17FEB2021. These symptoms include Dizziness, Fatigue, Headache, Arm Pain, and Shortness of Breath.     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.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness of arm). At the time of the report, PAIN IN EXTREMITY (Soreness of arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph node swollen underneath arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph node swollen underneath arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced LYMPHADENOPATHY (Lymph node swollen underneath arm). At the time of the report, LYMPHADENOPATHY (Lymph node swollen underneath arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was available. No treatment Medication was available.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: red ring around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red ring around the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red ring around the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (red ring around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were  provided by Reporter. No Treatment Medications were  provided by Reporter.
Sex: U
Vaccine: COVID19
Symptoms: Aphthous ulcer, Arthralgia, Headache, Myalgia, Nausea
Clinical narrative: headache; joint and muscle pain; joint and muscle pain; Nausea; A canker sore on the side of the tongue; A spontaneous report was received from a consumer (patient type) concerning a patient (unknown gender) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event, Patient received first dose of Moderna Covid-19 vaccine on 22Jan2021 at 11:00 AM. On that night patient experienced headache, joint and muscle pain and nausea. Also, a canker sore on the side of the tongue was mentioned following the vaccination.    The patient's medical history were unknown.   Relevant concomitant medication include Clonazepam since an unknown date for unknown indication .   on 22Jan2021 at 11:00 AM prior to the onset of the events, the patient received their mRNA-1273 (lot/batch: 013L20A) unknown route for prophylaxis of COVID-19 infection.    On 22Jan2021  On that night patient experienced the event headache, joint and muscle pain and nausea. Also, a canker sore on the side of the tongue following the vaccination on Left arm. Facility of vaccination: Lot number: 013L20A. Expiration date is Not provided.Patient was angry and jealous because husband did not experienced any of these symptoms   Laboratory details was not provided.     Patient reports to take Advil and Tylenol for treatmen .  Action taken with mRNA-1273 in response to the events was not reported.      The outcome of all reported events were recovered/resolved on 25JAN2021 The reporter assessment for the event(s) headache, joint and muscle pain and nausea and canker sore were not provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint Pain) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057G20A) for COVID-19 vaccination. No Medical History information was reported. On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced ARTHRALGIA (Joint Pain). At the time of the report, ARTHRALGIA (Joint Pain) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant product was reported. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Contains non-significant information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymph node pain, Pain in extremity, Pyrexia
Clinical narrative: Tender lymph node on the side of the injection; Chills; Very mild fever; Headache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), LYMPH NODE PAIN (Tender lymph node on the side of the injection), CHILLS (Chills), PYREXIA (Very mild fever) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) for Blood pressure high.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 13-Feb-2021, the patient experienced LYMPH NODE PAIN (Tender lymph node on the side of the injection), CHILLS (Chills), PYREXIA (Very mild fever) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown and LYMPH NODE PAIN (Tender lymph node on the side of the injection), CHILLS (Chills), PYREXIA (Very mild fever) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included prelioxac to treat high blood pressure.  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neuralgia, Pain in extremity
Clinical narrative: a ain in their left arm,from the elbowto their fingers, like numbling sensation,like one hits bone on the elbow,like pnched nerve pain,And now they are feeling the same on their opposite arm; a pain in their left arm, from the elbow to their fingers, like a numbing sensation, like when one hits the bone on the elbow, like a pinched nerve pain. And now they are feeling the same on their opposite arm; a pain in their left arm, from the elbow to their fingers, like a numbing sensation, like when one hits the bone on the elbow, like a pinched nerve pain. And now they are feeling the same on their opposite arm; A spontaneous report was received from a healthcare professional concerning a 61-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events a pain in their left arm, from the elbow to their fingers, like a numbing sensation, like when one.  The patient's medical history was not provided. Concomitant medications reported were blood pressure medication, vitamins for drug use for unknown indication.  On 11 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 006M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 14 Feb 2021, the patient experienced the event(s) a pain in their left arm, from the elbow to their fingers, like a numbing sensation, like when one.  Treatment details included Steroid injection.  Action taken with mRNA-1273 in response to the events was not reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; A spontaneous report was received from a consumer concerning a 72-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache.  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: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the event(s) headache and wanted to know if he can take Tylenol or motrin for symptom relief  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache the next day; This spontaneous case was reported by a nurse and describes the occurrence of headache (headache the next day) in a male patient of an unknown age who received mRNA-1273 (Moderna covid-19 vaccine) for covid-19 vaccination.     The patient's past medical history included no adverse event (no historical condition reported).   No concomitant medication were reported.  on an unknown date, the patient received first dose of mrna-1273 (Moderna covid-19 vaccine) of (batch no. 013m20a) by (unknown route) 1 dosage form for prophylaxis of COVID-19 infection.   No treatment medication was reported.  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.  on an unknown date, the patient experienced headache (headache the next day). at the time of the report, headache (headache the next day) outcome was unknown.        reporter did not allow further contact; Sender's Comments:  MOD_2021_018653: MOD-2021-018418:
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: A spontaneous report was received from a healthcare professional concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache the next day.  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: 013M20A) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) headache the next day.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), headache the next day was unknown.; Sender's Comments: MOD_2021_018652:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Hyperhidrosis, Myalgia
Clinical narrative: ringing in his ears; felt like he was having a stroke; dizzy; sweating like crazy; nauseated; vomiting; tired; sore; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in his ears), FEELING ABNORMAL (felt like he was having a stroke), DIZZINESS (dizzy), HYPERHIDROSIS (sweating like crazy) and NAUSEA (nauseated) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced TINNITUS (ringing in his ears), FEELING ABNORMAL (felt like he was having a stroke), DIZZINESS (dizzy), HYPERHIDROSIS (sweating like crazy), NAUSEA (nauseated), VOMITING (vomiting), FATIGUE (tired) and MYALGIA (sore). At the time of the report, TINNITUS (ringing in his ears), FEELING ABNORMAL (felt like he was having a stroke), DIZZINESS (dizzy), HYPERHIDROSIS (sweating like crazy), NAUSEA (nauseated), VOMITING (vomiting), FATIGUE (tired) and MYALGIA (sore) outcome was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Tinnitus, Vomiting
Clinical narrative: ringing in his ears; felt like he was having a stroke; dizzy; sweating like crazy; nauseated; vomiting; tired; sore; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in his ears), FEELING ABNORMAL (felt like he was having a stroke), DIZZINESS (dizzy), HYPERHIDROSIS (sweating like crazy) and NAUSEA (nauseated) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced TINNITUS (ringing in his ears), FEELING ABNORMAL (felt like he was having a stroke), DIZZINESS (dizzy), HYPERHIDROSIS (sweating like crazy), NAUSEA (nauseated), VOMITING (vomiting), FATIGUE (tired) and MYALGIA (sore). At the time of the report, TINNITUS (ringing in his ears), FEELING ABNORMAL (felt like he was having a stroke), DIZZINESS (dizzy), HYPERHIDROSIS (sweating like crazy), NAUSEA (nauseated), VOMITING (vomiting), FATIGUE (tired) and MYALGIA (sore) outcome was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: rash; Redness; Swelling; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash), VACCINATION SITE PAIN (Soreness), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash), VACCINATION SITE PAIN (Soreness), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling). At the time of the report, VACCINATION SITE RASH (rash), VACCINATION SITE PAIN (Soreness), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling) was resolving.            Action taken with mRNA-1273 in response to the events was not Applicable.  No medical history was reported No concomitant medications were provided. No treatment drugs were reported.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (very sick). At the time of the report, ILLNESS (very sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment details were provided.    Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Email
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site swelling
Clinical narrative: Rash on back(Erythematous); Swelling on Injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on back(Erythematous)) and VACCINATION SITE SWELLING (Swelling on Injection site) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling on Injection site). On an unknown date, the patient experienced RASH (Rash on back(Erythematous)). At the time of the report, RASH (Rash on back(Erythematous)) and VACCINATION SITE SWELLING (Swelling on Injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Headache, Pain in extremity
Clinical narrative: Dizziness; Fatigue; Headache; Arm pain; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), FATIGUE (Fatigue), HEADACHE (Headache), PAIN IN EXTREMITY (Arm pain) and DYSPNOEA (Shortness of breath) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concomitant products included Blood Thinner, Flavrx                                                         Distorted Aortic Valve and CPAP Machine                                                   Sleep Apnea for an unknown indication.   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced DIZZINESS (Dizziness), FATIGUE (Fatigue), HEADACHE (Headache), PAIN IN EXTREMITY (Arm pain) and DYSPNOEA (Shortness of breath). At the time of the report, DIZZINESS (Dizziness), FATIGUE (Fatigue), HEADACHE (Headache), PAIN IN EXTREMITY (Arm pain) and DYSPNOEA (Shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Hypertension, Pain
Clinical narrative: blood pressure is higher than normal; heart rate is higher than normal; mild headache; soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (soreness), HYPERTENSION (blood pressure is higher than normal), HEART RATE INCREASED (heart rate is higher than normal) and HEADACHE (mild headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event and COVID-19 in September 2020. Concomitant products included ERGOCALCIFEROL (VITAMIN  D) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN (soreness) and HEADACHE (mild headache). On 02-Feb-2021, the patient experienced HYPERTENSION (blood pressure is higher than normal) and HEART RATE INCREASED (heart rate is higher than normal). At the time of the report, PAIN (soreness), HYPERTENSION (blood pressure is higher than normal), HEART RATE INCREASED (heart rate is higher than normal) and HEADACHE (mild headache) 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.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Fatigue
Clinical narrative: Loss of taste; loss of smell; Fatigued; A spontaneous report  was received from a healthcare professional concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fatigued, loss of taste and smell.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Not available) via unknown route for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the events  fatigued. On 16 Feb 2021, the patient experienced the events  loss of taste and smell.  Treatment details included Not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, fatigued, loss of taste and smell was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Tinnitus
Clinical narrative: tinnitus; fever; on and off headache; A spontaneous report was received from a Pharmacist  concerning a 43-years-old Female  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tinnitus, fever, on and off headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Jan 2021, patient received first of two planned doses of mRNA-1273 (lot/batch: unknown). On 17 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the event tinnitus. On 17 Feb 2021, the patient experienced the events  fever. On and off headache.  Treatment details included For the symptoms: Tylenol, 19Feb2021.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, action taken with the drug in response to the events is not applicable.   On 18 Feb 2021 the outcome of event(s), fever was resolved. The outcome of events, tinnitus, on and off headache was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chilling; A spontaneous report was received from a consumer concerning himself, a male patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills.  The patient's medical history was not included. Concomitant products was not included.  On 19 Feb 2021, prior to the onset of events the patient received dose of their two planned doses of mRNA-1273 (Batch N0: unknown) intramuscularly for prophylaxis of covid 19 infection.  On 19 Feb 2021, the patient experienced chills.   Treatment information was not included.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, chills was resolved on an unknown date.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events usual, some soreness in the arm, a little bit more than the flu shot.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 028L20A) via unknown route for prophylaxis of COVID-19 infection. On 19 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 016M20A) via unknown route for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient experienced the event(s) usual, some soreness in the arm, a little bit more than the flu shot.  Treatment details included Not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), usual, some soreness in the arm, a little bit more than the flu shot was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye irritation, Headache, Pyrexia
Clinical narrative: A spontaneous report (United States) was received from a consumer concerning a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, fever of 101.9F/pyrexia, headache, eyes are burning/ Eye irritation.  The patient's medical history reported included anxiety and  allergy to meperidine and venlafaxine . Concomitant medications reported were Ativan(lorazepam), trazodone, lorazepam for drug use for unknown indication.  On 18 Feb 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 011M20A) in the right arm for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient experienced the events chills, fever of 101.9F, headache, eyes are burning.   Treatment information provided was took paracetamol 2 hours prior to this report . Laboratory details were not provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events, chills, fever of 101.9F, headache, eyes are burning were unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Skin burning sensation
Clinical narrative: Burning sensation underneath the skin of her left face and nostril; A spontaneous casewas reported by a consumer  concerning about  his friend, 41 years old female patient and describes the occurrence of burning sensation underneath the skin of her left face and nostril  who received mRNA-1273 (Moderna COVID-19 Vaccine) injection for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27 Jan,2021 the patient started mRNA-1273  COVID-19 Vaccine at an unspecified dose. On the same day after one hour,  the patient experienced burning sensation underneath the skin of her left face and nostril.   At the time of the report, burning sensation underneath the skin of her left face and nostril had not resolved.  Action taken with mRNA-1273 in response to events was not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Peripheral swelling, Sinus pain
Clinical narrative: Sore arm; It was so bad that she couldn't even put deodorant on; Upper arm was also swollen; Couldn't raise her arm; could hardly straighten her arm; Sinuses also hurt and this pain comes and goes; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021. The most recent information was received on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN IN EXTREMITY (It was so bad that she couldn't even put deodorant on), PERIPHERAL SWELLING (Upper arm was also swollen), LIMB DISCOMFORT (Couldn't raise her arm) and LIMB DISCOMFORT (could hardly straighten her arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PAIN IN EXTREMITY (It was so bad that she couldn't even put deodorant on), PERIPHERAL SWELLING (Upper arm was also swollen), LIMB DISCOMFORT (Couldn't raise her arm), LIMB DISCOMFORT (could hardly straighten her arm) and SINUS PAIN (Sinuses also hurt and this pain comes and goes). At the time of the report, PAIN IN EXTREMITY (Sore arm), PAIN IN EXTREMITY (It was so bad that she couldn't even put deodorant on), PERIPHERAL SWELLING (Upper arm was also swollen), LIMB DISCOMFORT (Couldn't raise her arm), LIMB DISCOMFORT (could hardly straighten her arm) and SINUS PAIN (Sinuses also hurt and this pain comes and goes) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Updated the outcome of the events ( Pain in extremity, Peripheral swelling, Limb discomfort, Sinus pain) from unknown to recovered.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Right arm warm to touch; Right arm itchy; Right arm rash; Right arm swollen; Right arm redness of 2-4 inches; Sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Right arm warm to touch), VACCINATION SITE PRURITUS (Right arm itchy), VACCINATION SITE RASH (Right arm rash) and VACCINATION SITE SWELLING (Right arm swollen) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided y the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN LOW) and LEVOTHYROXINE for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 19-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Right arm warm to touch), VACCINATION SITE PRURITUS (Right arm itchy), VACCINATION SITE RASH (Right arm rash), VACCINATION SITE SWELLING (Right arm swollen) and VACCINATION SITE ERYTHEMA (Right arm redness of 2-4 inches). At the time of the report, PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE PRURITUS (Right arm itchy) had resolved and VACCINATION SITE WARMTH (Right arm warm to touch), VACCINATION SITE RASH (Right arm rash), VACCINATION SITE SWELLING (Right arm swollen) and VACCINATION SITE ERYTHEMA (Right arm redness of 2-4 inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Right arm warm to touch; Right arm itchy; Right arm rash; Right arm swollen; Right arm redness of 2-4 inches; Sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Right arm warm to touch), VACCINATION SITE PRURITUS (Right arm itchy), VACCINATION SITE RASH (Right arm rash) and VACCINATION SITE SWELLING (Right arm swollen) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided y the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN LOW) and LEVOTHYROXINE for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 19-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Right arm warm to touch), VACCINATION SITE PRURITUS (Right arm itchy), VACCINATION SITE RASH (Right arm rash), VACCINATION SITE SWELLING (Right arm swollen) and VACCINATION SITE ERYTHEMA (Right arm redness of 2-4 inches). At the time of the report, PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE PRURITUS (Right arm itchy) had resolved and VACCINATION SITE WARMTH (Right arm warm to touch), VACCINATION SITE RASH (Right arm rash), VACCINATION SITE SWELLING (Right arm swollen) and VACCINATION SITE ERYTHEMA (Right arm redness of 2-4 inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.