chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Vomiting
Clinical narrative: nauseous; Vomiting; Chills; Headache; A spontaneous report was received from a Consumer concerning a 30 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nausea ,vomiting ,chill, headache.  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 their first of two planned doses of mRNA-1273 (lot/batch:011LZ0N) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.  Laboratory details are not provided. He took Ibuprofen to treat his symptoms.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events nausea, headache, vomiting, chills, which events were ongoing.  The reporter assessed the events, nausea, vomiting, headache, chills as related to study drug.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: A spontaneous report  was received from a consumer concerning fea 51-year-old, female patient, participating in the Moderna's COVID-19 vaccine (mRNA-1273) Emergency Use Program  who and experienced Injection site pain. The patient's medical history, was not provided by the reporter. Concomitant medical conditions were reported included  Liver enzymes elevated, pancreatitis - doesn't feel symptoms,in menopause - has hot flashes. Concomitant Product Code were reported amlodipine 10 mg atenolol Bayer aspirin, vitamin supplements. The patient received their first of two planned dose of mRNA-1273 on 22 Jan 2021. Prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 in(Lot number: unknown) in the left, non-dominant upper arm at a Walmart Pharmacy for prophylaxis of COVID-19 infection. Experienced injection site pain.  On the morning of 23 Jan 2021, after receiving mRNA-1273, the patient felt "pain" in the arm. Treatment for the pain included with ice and cold packs and took one hydrocodone. No relevant lab data was reported by the reporter. Action taken with mRNA-1273 in response to the events was not reported. The outcome of Injection site pain was unknown. The reporter did not provide an assessment for the Injection site pain. Patient gave consent for Safety to follow-up with them if necessary. Since no Seriousness criteria is reported , hence the case is considered to be Non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Hyperhidrosis, Malaise
Clinical narrative: Sweating around neck; Wasn't feeling good on Sunday; Chills; Joint pain; Muscle pain; Nausea; Feeling tired; A spontaneous report from unspecified location was received from a consumer concerning a 66 year elderly male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like chills, joint pain, swelling, muscle pain, nausea, sweating around neck area, Wasn't feeling good on Sunday achy all over and tired.  The patient medical history was not provided.  No relevant concomitant medications were reported.  On 07-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the anatomical location for prophylaxis of COVID-19 infection.  As a effect of first dose as per the patient statement he experienced chills, joint pain, swelling, muscle pain, nausea, sweating around neck area, Wasn't feeling good on sunday achy all over and tired still feeling side effects till 23-JAN-2021.  No laboratory details are provided.  No treatments received details provided.  As per the patient statement till now he experienced all the mentioned adverse events so none of them is get resolved.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: Sweating around neck; Wasn't feeling good on Sunday; Chills; Joint pain; Muscle pain; Nausea; Feeling tired; A spontaneous report from unspecified location was received from a consumer concerning a 66 year elderly male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like chills, joint pain, swelling, muscle pain, nausea, sweating around neck area, Wasn't feeling good on Sunday achy all over and tired.  The patient medical history was not provided.  No relevant concomitant medications were reported.  On 07-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the anatomical location for prophylaxis of COVID-19 infection.  As a effect of first dose as per the patient statement he experienced chills, joint pain, swelling, muscle pain, nausea, sweating around neck area, Wasn't feeling good on sunday achy all over and tired still feeling side effects till 23-JAN-2021.  No laboratory details are provided.  No treatments received details provided.  As per the patient statement till now he experienced all the mentioned adverse events so none of them is get resolved.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Abdominal discomfort, Constipation, Discomfort, Dizziness, Dyspepsia
Clinical narrative: felt faint; stomach was bothering him; nauseous; constipated; felt terrible; didn't sleep well; indigestion; fatigue; A spontaneous report was received from a Consumer concerning a 77 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue, dyspepsia, abdominal discomfort, nausea, constipation, discomfort, poor quality sleep, dizziness.  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: 025L20A)  for prophylaxis of COVID-19 infection.  On 21-JAN-2021, The patient experienced fatigue, On 22-JAN-2021, patient experienced indigestion. on 24-JAN-2021, the patient experienced stomach bothering, stomach feeling tight, nausea, constipation, felt terrible, didnt sleep well  and felt faint.  Treated with Rolaids .   Action taken with mRNA-1273 in response to the events was not reported.    At the time of this report, the outcome of the events were unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue, Nausea, Poor quality sleep
Clinical narrative: felt faint; stomach was bothering him; nauseous; constipated; felt terrible; didn't sleep well; indigestion; fatigue; A spontaneous report was received from a Consumer concerning a 77 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue, dyspepsia, abdominal discomfort, nausea, constipation, discomfort, poor quality sleep, dizziness.  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: 025L20A)  for prophylaxis of COVID-19 infection.  On 21-JAN-2021, The patient experienced fatigue, On 22-JAN-2021, patient experienced indigestion. on 24-JAN-2021, the patient experienced stomach bothering, stomach feeling tight, nausea, constipation, felt terrible, didnt sleep well  and felt faint.  Treated with Rolaids .   Action taken with mRNA-1273 in response to the events was not reported.    At the time of this report, the outcome of the events were unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Sore Arm; A spontaneous report was received from a consumer concerning a 69 year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed a sore arm/injection site pain.  The patient's medical history was not provided.  No relevant concomitant medications were reported.   On 25 Jan 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 013L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   The patient experienced pain in her right arm on 26 Jan 2021.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event sore arm was not reported.  Reporter causality for the event was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness
Clinical narrative: A Spontaneous case report was received from a consumer who was a female patient who has received first dose of Moderna COVID-19 Vaccine (mRNA-1273) on 22-JAN-2021.She experienced her feet was really cold.Past medical history was not provided.Treatment wa unknown.The outcome of the patient is unknown.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pain
Clinical narrative: Body Aches; Dizziness; Chills; A spontaneous report was received from a consumer concerning a 77 year old male patients who received   Moderna's  Covid 19 vaccine(mRNA1273) experienced chills, dizziness, body aches. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.    The patient received first of two planned dose of mRNA-1273 intramuscularly on 02-FEB-2021  for prophylaxis of Covid 19 infection.  On 03-FEB-2021 patient had chills. The patient also developed dizziness and body aches. The treatment information was not provided.  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the event were unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Arm is numb; Arm is sore; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness and numbness in her vaccinated arm.  The patient's medical history was not reported. Concomitant medication was not reported.  19-JAN-2021, prior to the onset of the events, the patient received their first planned dose of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  Same day patient was experiencing soreness and numbness in her vaccinated arm. Soreness went away after a few days.    No Laboratory details provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event hypoaesthesia is Unknown.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: fatigue; chills; headache; A spontaneous report () was received from a consumer concerning 27-year-old,male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient experienced FATIGUE (fatigue), CHILLS (chills) and HEADACHE (headache). The patient's medical history was not provided by the reporter.  On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.  On an unknown date, the patient experienced FATIGUE (fatigue), CHILLS (chills) and HEADACHE (headache). At the time of the report, FATIGUE (fatigue), CHILLS (chills) and HEADACHE (headache) outcome was unknown.    Action taken with the drug in response to the event is not applicable. The out come of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Sinusitis
Clinical narrative: Sinus infection; Arm Pain; Headache; A spontaneous report was received from a Consumer concerning 43 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events- positive COVID test, arm pain, headache and sinus infection.  There was no relevant medical history for the patient.  No relevant concomitant medications were provided.    On 5/Jan/2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch no- 039A20A) intramuscularly for prophylaxis of COVID-19 infection.  On 18 Jan 2021, the patient experienced positive COVID test and was recovered on 24th Jan. on an unknown date, the patient also experienced events- arm pain, headache, and sinus infection.  No Lab details were provided for the patient  No Treatment details were provided. Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event- tested positive for COVID was resolved, but the outcome of events- arm pain, headache and sinus infection were unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: left arm sore; A spontaneous report was received from a HCP and a Consumer concerning 60 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event pain in extremity.  The patient's medical history was type II diabetes and 2 stent in her heart. No relevant concomitant medications were reported.    On 23JAN2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection  Treatment details patient took Tylenol 500 mg before and after the shot.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event, which event is being referenced here was unknown.  The reporter assessed the event left arm sore as related to study drug.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Swelling
Clinical narrative: Bump; Redness; Pretty warm; Itchy; A spontaneous report  was received from a consumer concerning a 36-year-old, female patient, participating in the Moderna's COVID-19 vaccine (mRNA-1273) Emergency Use Program who had red bump and a pretty good sized ark, and it's pretty warm , itching.  The patient's medical history, is not provided by the reporter.   Concomitant medications were not reported.   The patient received their first of two planned dose of mRNA-1273 on 15/Jan/2021. On prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 in(Lot number: 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    Experienced had red bump and a pretty good sized ark, and it's pretty warm , itching.   No lab data is reported bye the reporter.   Action taken with mRNA-1273 in response to the events was not reported.     The outcome of events, had red bump and a pretty good sized ark, and it's pretty warm , itching were unknown.   The reporter did not provide an assessment for the events, had red bump and a pretty good sized ark, and it's pretty warm , itching.  Since no Seriousness criteria is reported , hence the case is considered to be Non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: symptoms came back, also itchiness; Redness; Swelling; A spontaneous report was received from a Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swelling, erythema, pruritis.   The patient's medical history was not provided. No relevant concomitant medications were reported.     On 16-JAN-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 16-JAN-2021, The patient experienced swelling and   redness. Treated with antibiotics.  Action taken with mRNA-1273 in response to the events was not reported.   On 20-JAN-2021 swelling and redness were resolved on 20-JAN-2021 and came back with itching on 24-JAN-2021. At the time of this report, the outcome of the event not resolved.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: the injection site is warm to touch; soreness at the injection site; area of a few mm surrounding the injection site-no erythema; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE ERYTHEMA (area of a few mm surrounding the injection site-no erythema) and VACCINATION SITE WARMTH (the injection site is warm to touch) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20a) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE ERYTHEMA (area of a few mm surrounding the injection site-no erythema) and VACCINATION SITE WARMTH (the injection site is warm to touch). At the time of the report, VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE ERYTHEMA (area of a few mm surrounding the injection site-no erythema) and VACCINATION SITE WARMTH (the injection site is warm to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided Treatment information was not provided
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Limb discomfort
Clinical narrative: sore right arm; warm to touch at the injection site; redness at the injection site; little swollen at the injection; hurting around the injection site; itchy right arm; A spontaneous report was received from a consumer concerning a 71-years-old, female patient who experienced itchy right arm, hurting around the injection site, redness at the injection site, sore right arm, warm to touch at the injection site and little swollen at the injection.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 16 Jan 2021, approximately nine days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 037K20A] intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 24 Jan 2021, the patient experienced her right arm itching and hurting around the injection site.  On 25 Jan 2021, the patient experienced redness, soreness, warm to the touch and swelling at the injection site  Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events itchy right arm, hurting around the injection site, redness at the injection site, sore right arm, warm to touch at the injection site and little swollen at the injection were unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: sore right arm; warm to touch at the injection site; redness at the injection site; little swollen at the injection; hurting around the injection site; itchy right arm; A spontaneous report was received from a consumer concerning a 71-years-old, female patient who experienced itchy right arm, hurting around the injection site, redness at the injection site, sore right arm, warm to touch at the injection site and little swollen at the injection.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 16 Jan 2021, approximately nine days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 037K20A] intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 24 Jan 2021, the patient experienced her right arm itching and hurting around the injection site.  On 25 Jan 2021, the patient experienced redness, soreness, warm to the touch and swelling at the injection site  Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events itchy right arm, hurting around the injection site, redness at the injection site, sore right arm, warm to touch at the injection site and little swollen at the injection were unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Red mark about the size of a 50 cent piece; Itching; A spontaneous report was received from a consumer concerning a, female patient, participating in the Moderna's COVID-19 vaccine (mRNA-1273) Emergency Use Program  who had experienced Red mark about the size of a 50 cent piece,  Itching.  The patient's medical history, is not provided by the reporter.  Concomitant medications were not reported.   The patient received their first of two planned dose of mRNA-1273 on 12Jan2021. On prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 in(Lot number: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  Experienced Red mark about the size of a 50 cent piece, Itching.   No lab data is reported by the reporter.   Action taken with mRNA-1273 in response to the events was not reported.     The outcome of events,Red mark about the size of a 50 cent piece,  Itching were unknown.   The reporter did not provide an assessment for the events Red mark about the size of a 50 cent piece,  Itching.  Since no Seriousness criteria is reported , hence the case is considered to be Non-serious.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site pain
Clinical narrative: slightly tender; half dollar size purple mark around injection site; A spontaneous report was received from a consumer concerning an 87 year old female patient who developed/experienced half dollar size purple mark around injection site.   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 baby aspirin, venlafaxine, pregabalin, cefalexin and lisinopril.   The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on 21-JAN-2021. The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.    The patient's husband called in to report side effects from first dose of vaccine. The patient received the vaccine on 21-Jan-2021. On 25-Jan-2021 the patient noticed that there was a purple mark around the injection site about the size of a half dollar coin.  The patient reported that there was no pain, but the area was slightly tender. Treatment information was not provided/unknown.    Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The events vaccination site discoloration and vaccine site pain were considered not recovered/not resolved. The outcome of the events was unknown/not reported.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dyspnoea, Feeling abnormal, Flushing, Heart rate increased
Clinical narrative: Shortness of breath; Fast heart rate; blood pressure was at 180; chest flushed; started to feel funny; A spontaneous report was received from a consumer concerning a female patient of unknown age ,who was administered with Moderna's covid-19 vaccine and experienced faster heart rate,increased blood pressure at 180,shortness of breath,chest flushing,feeling funny and pale look.  Parient's medical history was not provided.No relevant concomitant medications were mentioned.  On 21-JAN-2021,prior to the onset of events,the patient received the first of two planned doses of mRNA-1273(Lot number:unknown)for prophylaxis of covid-19 infection.  On 21-JAN-2021,after administering mRNA-1273 vaccine ,the patient was told to sit down to be monitored for 15 minutes.After 3 minutes,patient started feeling funny.Patient started to feel heart pound out of chest and going really fast along with shortnes  of breath.Nurse told the patient that she looked pale and her chest was flushed.After an hour and half of monitoring blood pressure and heart went down.Patient scheduled for second dose on 15-FEB-2021.Patient was put on oxygen by nurse ,after an hour heart rate and blood pressure went down.  There was no change planned to the dosing schedule of mRNA-1273 in response to the events.  Outcome of events were considered unknown.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Itchiness; Redness; Swelling; A spontaneous report was received from a consumer concerning a female patient (age: unknown), who received Moderna's COVID-19 vaccine (mRNA-1273) experienced redness, swelling and itchy.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 16 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: unknown) for prophylaxis of COVID-19 infection along with her husband and two coworkers.  On 16 Jan 2021, the patient experienced redness and swelling which was resolved on 20 Jan 2021. Again, on 24 Jan 2021 the patient's hand was red and itchy. Treatment for itchiness include Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of events, redness, swelling and itchy was not resolved.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Neck pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck), NECK PAIN (pain in the neck), MUSCULOSKELETAL STIFFNESS (stiff shoulder plates) and ARTHRALGIA (pain in shoulder plates) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Cholesterol and Blood pressure. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck), NECK PAIN (pain in the neck), MUSCULOSKELETAL STIFFNESS (stiff shoulder plates) and ARTHRALGIA (pain in shoulder plates). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 24-Jan-2021 at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff neck), NECK PAIN (pain in the neck), MUSCULOSKELETAL STIFFNESS (stiff shoulder plates) and ARTHRALGIA (pain in shoulder plates) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Insomnia; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Insomnia) 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.    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 INSOMNIA (Insomnia). At the time of the report, INSOMNIA (Insomnia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: she had been feeling dizzy "like if she had been drinking" and lightheaded,  and today this symptoms are more intense than yesterday; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (she had been feeling dizzy "like if she had been drinking" and lightheaded,  and today this symptoms are more intense than yesterday) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004m20a) for COVID-19 vaccination.     Concomitant products included CLONAZEPAM for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced DIZZINESS (she had been feeling dizzy "like if she had been drinking" and lightheaded,  and today this symptoms are more intense than yesterday). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, DIZZINESS (she had been feeling dizzy "like if she had been drinking" and lightheaded,  and today this symptoms are more intense than yesterday) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: Dizziness; Fatigue; A spontaneous report  was received from a consumer , concerning a female patient of unspecified age, who received Moderna Covid- 19 vaccine and  experienced dizziness and fatigue and received a Intramuscular injection who has an appointment to get a Prolea injection tomorrow and doubt whether will there be a drug interaction with the Covid-19 Vaccine.  The patients medical history and  Concomitant medication  was not provided.  Patient received her Moderna Covid-19 vaccine 1st dose of  vaccine on  22 JAN 2021 and experienced Dizziness and Fatigue .   The action taken to the events ere not applicable.  Treatment information was not provided.  Outcome of the events Dizziness and Fatigue was not considered to be resolved  at the time of this report.; 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: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration
Clinical narrative: Red rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOLOURATION (Red rash at injection site) in an 82-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 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 INJECTION SITE DISCOLOURATION (Red rash at injection site). At the time of the report, INJECTION SITE DISCOLOURATION (Red rash at injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Herpes dermatitis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HERPES DERMATITIS (Herpes Outbreak) 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 HERPES DERMATITIS (Herpes Outbreak). At the time of the report, HERPES DERMATITIS (Herpes Outbreak) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. Treatment details were not reported by the reporter
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Tendonitis
Clinical narrative: headache; at wrist, 4 little bumps coming up/ inflammation of the tendons.; The injection site is very tender; This spontaneous case was reported by a consumer and describes the occurrence of TENDONITIS (at wrist, 4 little bumps coming up/ inflammation of the tendons.), INJECTION SITE PAIN (The injection site is very tender) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE PAIN (The injection site is very tender). On 23-Jan-2021, the patient experienced TENDONITIS (at wrist, 4 little bumps coming up/ inflammation of the tendons.). On an unknown date, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 25-Jan-2021, INJECTION SITE PAIN (The injection site is very tender) had resolved. At the time of the report, TENDONITIS (at wrist, 4 little bumps coming up/ inflammation of the tendons.) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported included Cholesterol. Treatment details also included ice.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash
Clinical narrative: Rash; Swollen lymph node in armpit of the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and LYMPHADENOPATHY (Swollen lymph node in armpit of the injection site) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash) and LYMPHADENOPATHY (Swollen lymph node in armpit of the injection site). At the time of the report, RASH (Rash) and LYMPHADENOPATHY (Swollen lymph node in armpit of the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication information was provided. Treatment details was not reported by the reporter.   This case was linked to MOD21-023053 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Injection site rash, Peripheral swelling
Clinical narrative: swollen arm; Rash on Arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm) and INJECTION SITE RASH (Rash on Arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced PERIPHERAL SWELLING (swollen arm) and INJECTION SITE RASH (Rash on Arm). On 12-Feb-2021, PERIPHERAL SWELLING (swollen arm) and INJECTION SITE RASH (Rash on Arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Oropharyngeal pain, Poor quality sleep, Pruritus
Clinical narrative: Immediately after shot the back of the hand got a little red, but was fine; skin feels itchy, it´s a mild itchiness, no rash; The entire body itches, including skull and face, inside vagina; "It bothers me", didn't sleep very well; the throat is a little sore; pain in injection site; felt fatigue yesterday; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Immediately after shot the back of the hand got a little red, but was fine), PRURITUS (skin feels itchy, it´s a mild itchiness, no rash), PRURITUS (The entire body itches, including skull and face, inside vagina), POOR QUALITY SLEEP ("It bothers me", didn't sleep very well) and OROPHARYNGEAL PAIN (the throat is a little sore) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Cholesterol, Arthritis, Osteopenia and Dry skin. Concomitant products included NAPROXEN for Arthritis, ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) for Cholesterol, AVENA SATIVA, MELALEUCA ALTERNIFOLIA OIL (AVENO [AVENA SATIVA;MELALEUCA ALTERNIFOLIA OIL]) for Dry skin, ATENOLOL for Hypertension, VITAMIN D2 for Osteopenia.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced ERYTHEMA (Immediately after shot the back of the hand got a little red, but was fine), PRURITUS (skin feels itchy, it´s a mild itchiness, no rash), PRURITUS (The entire body itches, including skull and face, inside vagina), POOR QUALITY SLEEP ("It bothers me", didn't sleep very well), OROPHARYNGEAL PAIN (the throat is a little sore), VACCINATION SITE PAIN (pain in injection site) and FATIGUE (felt fatigue yesterday). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. On 25-Jan-2021, FATIGUE (felt fatigue yesterday) outcome was unknown. At the time of the report, ERYTHEMA (Immediately after shot the back of the hand got a little red, but was fine), PRURITUS (skin feels itchy, it´s a mild itchiness, no rash), PRURITUS (The entire body itches, including skull and face, inside vagina), POOR QUALITY SLEEP ("It bothers me", didn't sleep very well), OROPHARYNGEAL PAIN (the throat is a little sore) and VACCINATION SITE PAIN (pain in injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications also included multivitamin B complex and gyngko.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Immediately after shot the back of the hand got a little red, but was fine; skin feels itchy, it´s a mild itchiness, no rash; The entire body itches, including skull and face, inside vagina; "It bothers me", didn't sleep very well; the throat is a little sore; pain in injection site; felt fatigue yesterday; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Immediately after shot the back of the hand got a little red, but was fine), PRURITUS (skin feels itchy, it´s a mild itchiness, no rash), PRURITUS (The entire body itches, including skull and face, inside vagina), POOR QUALITY SLEEP ("It bothers me", didn't sleep very well) and OROPHARYNGEAL PAIN (the throat is a little sore) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Cholesterol, Arthritis, Osteopenia and Dry skin. Concomitant products included NAPROXEN for Arthritis, ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) for Cholesterol, AVENA SATIVA, MELALEUCA ALTERNIFOLIA OIL (AVENO [AVENA SATIVA;MELALEUCA ALTERNIFOLIA OIL]) for Dry skin, ATENOLOL for Hypertension, VITAMIN D2 for Osteopenia.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced ERYTHEMA (Immediately after shot the back of the hand got a little red, but was fine), PRURITUS (skin feels itchy, it´s a mild itchiness, no rash), PRURITUS (The entire body itches, including skull and face, inside vagina), POOR QUALITY SLEEP ("It bothers me", didn't sleep very well), OROPHARYNGEAL PAIN (the throat is a little sore), VACCINATION SITE PAIN (pain in injection site) and FATIGUE (felt fatigue yesterday). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. On 25-Jan-2021, FATIGUE (felt fatigue yesterday) outcome was unknown. At the time of the report, ERYTHEMA (Immediately after shot the back of the hand got a little red, but was fine), PRURITUS (skin feels itchy, it´s a mild itchiness, no rash), PRURITUS (The entire body itches, including skull and face, inside vagina), POOR QUALITY SLEEP ("It bothers me", didn't sleep very well), OROPHARYNGEAL PAIN (the throat is a little sore) and VACCINATION SITE PAIN (pain in injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications also included multivitamin B complex and gyngko.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: experienced a big red, tender rash at the injection site; big red, tender rash at the injection site.; big red, tender rash at the injection site.; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE RASH (experienced a big red, tender rash at the injection site), INJECTION SITE PAIN (big red, tender rash at the injection site.) and INJECTION SITE ERYTHEMA (big red, tender rash at the injection site.) 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 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE RASH (experienced a big red, tender rash at the injection site), INJECTION SITE PAIN (big red, tender rash at the injection site.) and INJECTION SITE ERYTHEMA (big red, tender rash at the injection site.). At the time of the report, INJECTION SITE RASH (experienced a big red, tender rash at the injection site), INJECTION SITE PAIN (big red, tender rash at the injection site.) and INJECTION SITE ERYTHEMA (big red, tender rash at the injection site.) outcome was unknown. Not Provided      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 relevant concomitant medications was reported. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Overtired; Pain at the injection site; Chills; Body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site), CHILLS (Chills), MYALGIA (Body aches), PYREXIA (Fever) and FATIGUE (Overtired) 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.   On 25-Jan-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) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site), CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Fever). On 26-Jan-2021, the patient experienced FATIGUE (Overtired). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site), CHILLS (Chills), MYALGIA (Body aches), PYREXIA (Fever) and FATIGUE (Overtired) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Itchy Sensation - Near Injection Site; Swelling - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Swelling - Near Injection Site) and INJECTION SITE PRURITUS (Itchy Sensation - Near Injection Site) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-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 INJECTION SITE SWELLING (Swelling - Near Injection Site) and INJECTION SITE PRURITUS (Itchy Sensation - Near Injection Site). At the time of the report, INJECTION SITE SWELLING (Swelling - Near Injection Site) and INJECTION SITE PRURITUS (Itchy Sensation - Near Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications are reported. No treatment medication has been provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm to the touch; Large red rash, almost 6 inches long, 3 inches wide; Little swollen; Large red rash, almost 6 inches long, 3 inches wide; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE SWELLING (Little swollen) and VACCINATION SITE RASH (Large red rash, almost 6 inches long, 3 inches wide) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 626L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-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 VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE SWELLING (Little swollen) and VACCINATION SITE RASH (Large red rash, almost 6 inches long, 3 inches wide). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE SWELLING (Little swollen) and VACCINATION SITE RASH (Large red rash, almost 6 inches long, 3 inches wide) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Treatment Cold compress, hydrocortisone, Benadryl
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: itchiness on the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness on the injection site.) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included POTASSIUM for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021 at 2:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchiness on the injection site.). At the time of the report, VACCINATION SITE PRURITUS (itchiness on the injection site.) outcome was unknown.            other concomitant medications were reported are fluid pill and blood pressure medicine for an unknown indication.  No treatment information provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: TCR-NNI(NO NEW 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.