chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; A spontaneous report  was received from a consumer concerning a 86years old male patient who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced events(rash).  The patient's medical history was not provided. Relevant concomitant medication was reported i.e., heart failure medication.  On 20jan2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot/batch: unknown) intramuscularly in the anatomical location for prophylaxis of COVID-19 infection.  Laboratory details not provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event was resolved.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination complication
Clinical narrative: feeling bad; chills; A spontaneous report  was received from a consumer concerning a 77 year old female patients who received   Moderna's  Covid 19 vaccine(mRNA1273) experienced chills and  feeling bad.  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 Amlodipine and Valacyclovir.  The patient received second of two planned dose of mRNA-1273 (Batch Number 012M20A) intramuscularly  in right arm on 03-FEB-2021  for prophylaxis of Covid 19 infection.  On 03-FEB-2021, the patients experienced chills since night of vaccination  and was feeling bad. The treatment information was not provided.  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. The outcome of the event s chills and feeling bad were considered as unknown.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Oral discomfort, Oral pain, Pain in extremity, Pruritus
Clinical narrative: Felt like it was burning; Flu-like symptoms; Body felt itchy/tops of his hands felt itchy; Arms were sore; Roof of his mouth hurt and was red in color; Bumps on his thighs; Little bumps all from within a red ring of where his injection site was; A spontaneous report was received from a consumer concerning a 54-years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events arm were sore/pain in extremity, flu-like symptoms/influenza like illness, body felt itchy/tops of his hands felt itchy/pruritus, roof of his mouth hurt and was red in color/oral pain, felt like it was burning/oral discomfort, bumps on his thighs/urticaria and little bumps all from within a red ring of where his injection site was/vaccination site abscess.   The patient's medical history was not provided. No relevant concomitant product use was reported.  On 25 Jan 2021, prior to the onset of the events, the patient received their dose of mRNA-1273 (lot/batch: unknown) in the anatomical location for prophylaxis of COVID-19 infection. The route of administration was unknown.    On an unknown date, after receiving the vaccine, the patient experienced arm sore and flu-like symptoms. He started to feel better on the 29 Jan 2021. On 02 Feb 2021, the patient felt body itchy, top of the hands felt itchy. On the same day, patient reported that, roof of his mouth hurts and it was red in color, felt like burning and a burning itchiness, bumps on his hands, bumps on his thighs and there was little bumps within red rings on the injection site.  Treatment details included some sort of creams and benadryl.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events arm sore, flu like symptoms, felt body itchy, tops of the hands itchy, roof of his mouth hurt and was red in color, felt like burning, burning itchiness, bumps on his hands, bumps on his thighs and little bumps all from within a red ring of where his injection site was, were not recovered/not resolved.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site abscess
Clinical narrative: Felt like it was burning; Flu-like symptoms; Body felt itchy/tops of his hands felt itchy; Arms were sore; Roof of his mouth hurt and was red in color; Bumps on his thighs; Little bumps all from within a red ring of where his injection site was; A spontaneous report was received from a consumer concerning a 54-years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events arm were sore/pain in extremity, flu-like symptoms/influenza like illness, body felt itchy/tops of his hands felt itchy/pruritus, roof of his mouth hurt and was red in color/oral pain, felt like it was burning/oral discomfort, bumps on his thighs/urticaria and little bumps all from within a red ring of where his injection site was/vaccination site abscess.   The patient's medical history was not provided. No relevant concomitant product use was reported.  On 25 Jan 2021, prior to the onset of the events, the patient received their dose of mRNA-1273 (lot/batch: unknown) in the anatomical location for prophylaxis of COVID-19 infection. The route of administration was unknown.    On an unknown date, after receiving the vaccine, the patient experienced arm sore and flu-like symptoms. He started to feel better on the 29 Jan 2021. On 02 Feb 2021, the patient felt body itchy, top of the hands felt itchy. On the same day, patient reported that, roof of his mouth hurts and it was red in color, felt like burning and a burning itchiness, bumps on his hands, bumps on his thighs and there was little bumps within red rings on the injection site.  Treatment details included some sort of creams and benadryl.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events arm sore, flu like symptoms, felt body itchy, tops of the hands itchy, roof of his mouth hurt and was red in color, felt like burning, burning itchiness, bumps on his hands, bumps on his thighs and little bumps all from within a red ring of where his injection site was, were not recovered/not resolved.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Vaccination complication
Clinical narrative: not feeling well; headache; CHILLS; myalgia; A spontaneous report was received from a consumer concerning a 48years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (chills, myalgia, headache, vaccination complication).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3feb2021, prior to the onset of the events, the patient received their first of second dose of mRNA-1273 (lot/batch: 007M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  Laboratory details not provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: She woke up with a fever; Bad headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Bad headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 039k20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included LOSARTAN, ATORVASTATIN, ESCITALOPRAM OXALATE (LEXAPRO) and AMITRIPTYLINE for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced HEADACHE (Bad headache). At the time of the report, HEADACHE (Bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (Inconclusive) Fever of 100.         Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2021: Follow-up received included updated verbatim (low fever and very bad headache over eyes, lasted half a day).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, C-reactive protein, Full blood count, Headache, Hypertension
Clinical narrative: high blood pressure; Extremely severe headache which is relentless; fever; A spontaneous report was received from  a health care professional concerning a 61 years male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like  high blood pressure 160/100 ,fever and persistent headache.  The patient's medical history  provided confirms that the patient was tested positive for COVID-19 on 08 Nov 2020. The concomitant medications taken by the patients included Losartan which is used for unknown indication.  On29 Dec 2020,prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273(Batch number- unknown) for prophylaxis of COVID-19 infection.  On 26 Jan 2020,prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273(Batch number- unknown) for prophylaxis of COVID-19 infection.  On an unspecified date the patient  experienced high blood pressure 160/100,fever and persistent headache. On 12 Jan 2021 tests like CMP,CBC,C-reactive, TSH, Vitamin d were performed ath result was all normal. Treatment medications included losartan , amlodipine  and metoprolol to keep his blood pressure under control.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events headache, high blood pressure 160/100. fever and persistent headache is considered to be unknown.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test, Pyrexia, Vitamin D
Clinical narrative: high blood pressure; Extremely severe headache which is relentless; fever; A spontaneous report was received from  a health care professional concerning a 61 years male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like  high blood pressure 160/100 ,fever and persistent headache.  The patient's medical history  provided confirms that the patient was tested positive for COVID-19 on 08 Nov 2020. The concomitant medications taken by the patients included Losartan which is used for unknown indication.  On29 Dec 2020,prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273(Batch number- unknown) for prophylaxis of COVID-19 infection.  On 26 Jan 2020,prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273(Batch number- unknown) for prophylaxis of COVID-19 infection.  On an unspecified date the patient  experienced high blood pressure 160/100,fever and persistent headache. On 12 Jan 2021 tests like CMP,CBC,C-reactive, TSH, Vitamin d were performed ath result was all normal. Treatment medications included losartan , amlodipine  and metoprolol to keep his blood pressure under control.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events headache, high blood pressure 160/100. fever and persistent headache is considered to be unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Fear, Illness, Impaired work ability
Clinical narrative: diarrhea; weakness; sick ever since; can't do anything; scared to receive the 2nd dose; vomiting; arm was sore; A spontaneous report was received from a consumer concerning a 78-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm sore, vomiting, diarrhea, weakness, sickness, inability to do anything and fear for the second dose.  The patient's medical history includes allergies for codeine and morphine, high blood pressure, high cholesterol and open-heart surgery. Concomitant medications include high blood pressure medicine, high cholesterol medicine and blood thinners.  On 21 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 0416204) in the left upper arm for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient experienced soreness in arm. On 23 Jan 2021, the patient experienced vomiting, diarrhea, weakness, sickness, inability to do anything and fear for the second dose.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event, arm sore, vomiting, diarrhea, weakness, sickness, inability to do anything and fear for the second dose, was considered unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: diarrhea; weakness; sick ever since; can't do anything; scared to receive the 2nd dose; vomiting; arm was sore; A spontaneous report was received from a consumer concerning a 78-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm sore, vomiting, diarrhea, weakness, sickness, inability to do anything and fear for the second dose.  The patient's medical history includes allergies for codeine and morphine, high blood pressure, high cholesterol and open-heart surgery. Concomitant medications include high blood pressure medicine, high cholesterol medicine and blood thinners.  On 21 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 0416204) in the left upper arm for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient experienced soreness in arm. On 23 Jan 2021, the patient experienced vomiting, diarrhea, weakness, sickness, inability to do anything and fear for the second dose.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event, arm sore, vomiting, diarrhea, weakness, sickness, inability to do anything and fear for the second dose, was considered unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: It was a solid red surface, today now more like a rash and not as itchy; Itching really bad around the injection site; Became very red around the injection site; Slightly raised, 2inch diameter around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching really bad around the injection site), VACCINATION SITE ERYTHEMA (Became very red around the injection site), VACCINATION SITE SWELLING (Slightly raised, 2inch diameter around the injection site) and VACCINATION SITE RASH (It was a solid red surface, today now more like a rash and not as itchy) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) for Acid reflux (oesophageal), HYDROCHLOROTHIAZIDE for Blood pressure, NADOLOL (CORGARD), VITAMIN B COMPLEX and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching really bad around the injection site), VACCINATION SITE ERYTHEMA (Became very red around the injection site) and VACCINATION SITE SWELLING (Slightly raised, 2inch diameter around the injection site). On 04-Feb-2021, the patient experienced VACCINATION SITE RASH (It was a solid red surface, today now more like a rash and not as itchy). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. On 04-Feb-2021, VACCINATION SITE PRURITUS (Itching really bad around the injection site) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Became very red around the injection site), VACCINATION SITE SWELLING (Slightly raised, 2inch diameter around the injection site) and VACCINATION SITE RASH (It was a solid red surface, today now more like a rash and not as itchy) 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.   Treatment for the event included Ibuprofen, cetirizine and diphenhydramine cream.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm was sore at the injection site; A report was received from a consumermber concerning a  65 years old, female patient was participating in the mRNA-1273 Emergency Use Program and experienced arm was sore at injection site.  No relevant concomitant medications were reported.  On 18Jan2021,prior to the onset of the event(s), the patient received their first shot of two planned doses of mRNA-1273 (LOT/BATCH 030L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event(s) was not reported. The outcome of the event(s) was/were unknown/not reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: at the injection site it is feeling really itchy; A spontaneous report was received from a reporter like consumer concerning a  unknown Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events vaccination site itching and it hurts once in a while.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 27-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 29-JAN-2021, The patient experienced the events vaccination site itching and it hurts in a while.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events vaccination site itching and it hurts in a while  was unknown.  The reporter assessed the events vaccination site itching and it hurts in a while as related to study drug.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Injection site pain, Insomnia, Myalgia
Clinical narrative: Body Aches Mild-Moderate; Headache Mild-Moderate; Joint Pain Mild-Moderate; Feeling Queasy; Pain Injection Site; Difficulty Sleeping; A spontaneous report (US)  was received from a 76-years-old male consumer, who received Moderna's COVID-19 vaccine (mRNA-1273)  and experienced Mild-Moderate body aches, Headache, joint pain, feeling queasy, Injection site pain and difficulty sleeping.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 02-FEB-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 029K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 02-FEB-2021, the patient experienced difficulty sleeping. On 03-FEB-2021, the patient experienced mild-moderate body aches, headaches, joint pain, feeling of queasy and injection site pain.  Laboratory details was not provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events was unknown.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Body Aches Mild-Moderate; Headache Mild-Moderate; Joint Pain Mild-Moderate; Feeling Queasy; Pain Injection Site; Difficulty Sleeping; A spontaneous report (US)  was received from a 76-years-old male consumer, who received Moderna's COVID-19 vaccine (mRNA-1273)  and experienced Mild-Moderate body aches, Headache, joint pain, feeling queasy, Injection site pain and difficulty sleeping.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 02-FEB-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 029K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 02-FEB-2021, the patient experienced difficulty sleeping. On 03-FEB-2021, the patient experienced mild-moderate body aches, headaches, joint pain, feeling of queasy and injection site pain.  Laboratory details was not provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events was unknown.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; A report was received from a consumer 79 year old, male patient was participating in a program and experienced headache No relevant concomitant medications were reported.   While participating in this program, and preceding this event, the patient experienced the serious adverse event of special interest of headache (MOD-2021-06313) Approximately 2 weeks a go prior to the onset of the event(s), the patient received their first of two planned doses of mRNA-1273 ([LOT/BATCH # 027L20A ]) intramuscularly  for prophylaxis of COVID-19 infection.   Patient received 1st shot of Moderna COVID Vaccine few weeks ago, may be 2 weeks a go but he does not remember the date and he has headache from the day of injection. Patient  enquired can he take aspirin as he knows aspirin will causes low B.P. No treatment information was provided. Consent to FU with him and his HCP.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Injection site rash, Nausea
Clinical narrative: shortness of breath; COVID arm; headache; nausea; A spontaneous report was received from a Consumer concerning a 25-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, nausea, COVID arm, shortness of breath.  The patient's medical history, was not  provided by the reporter.  On 26thJAN2021, approximately one day  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) for prophylaxis of COVID-19 infection.   On 27thJAN2021 has had: Headache and nausea, and "COVID arm". On 3rd FEB2021 "COVID arm" came back. And also felt shortness of breath so she went to the Emergency room local facilities for a quick check.    Action taken with mRNA-1273 in response to the events was not reported.   The events,  headache, nausea, COVID arm, shortness of breath was resolved on 28/Jan/2021.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: throw up; FEVER; headache; A spontaneous report was received from a consumer concerning herself, a female patient of 80-years-old who received Moderna (mRNA-1273) vaccine and experienced headache, she threw up (vomiting) and had a fever(pyrexia).  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first dose of Moderna COVID-19 vaccine on 19-JAN-2021, and the second dose on 16-FEB-2021 intramuscularly in the left arm for the prophylaxis of COVID-19 infection.  On 17-FEB-2021, the patient started to have headache at the night. On 18-FEB-2021, the patient threw up and had a fever.  The laboratory details was not provided. The patient took Tylenol to subside the symptoms.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, headache, vomiting, and fever was not recovered/ resolved.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Injection site pain
Clinical narrative: face turned flushed/a reddish color; Injection site hurt; A spontaneous report was received from a HCP concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced face turned flushed/a reddish color, Injection site hurt.  The patient's medical history, was not provided by the reporter, included . Concomitant medications reported included Losartan, Atorvastatin.   On 6/Jan/2021 patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20-2A) intramuscularly in the for prophylaxis of COVID-19 infection.   On 3/Feb/2021patient received their first of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly.  Action taken with mRNA-1273 in response to the events was not reported.   The events, face turned flushed/a reddish color, Injection site hurt and recovery was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ears started ringing really loud/ aggravating her tinnitus; A spontaneous report was received from a Consumer concerning a 71- year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event ears started ringing really loud(tinnitus).   The patient's medical history was not provided. Concomitant medications reported included, alprazolam, albuterol inhaler, levothyroxine and zetia.  On an unspecified date in JAN 2021, approximately few hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 032L20A) via unknown route for prophylaxis of COVID-19 infection.  On an unspecified date in JAN 2021, it was reported that on the same night the mRNA-1273 vaccine got administered, the patient experienced the event "ears started ringing really loud" and since the day it happened off and on. The patient reports "she might be experiencing tinnitus". As per the report, the patient usually takes medication but stopped taking them because she thought they may be aggravating her tinnitus.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event(s) was unknown.  At the time of this report, the event ears started ringing really loud were considered not resolved.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site discolouration, Injection site rash, Tenderness
Clinical narrative: now purplish in color and 6 inches across; soreness; injection site rash; Tenderness; A Spontaneous report was received from a consumer concerning 78 years old, female patient who was administered with Moderna's COVID-19 vaccine and experienced tenderness, soreness/arthralgia , injection site discolouration, and injection site rash.  On 21Jan2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.   On 21 Jan 2021, the patient started experiencing symptoms of tenderness, soreness, at the time of this report purplish in color and 6 inches across with rash around the injection site. The patient took two Tylenol on the first day for symptoms and still experiencing some soreness.  The outcome of the event tenderness, soreness, injection site discolouration, and injection site rash was not reported.; Reporter's Comments: This case concerns a 78 Y/O F with nonserious unexpected tenderness, injection site discoloration and expected injection site rash, arthralgia.  Event onset the same day as first dose mRNA-1273. Event outcomes unknown. 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle pain up to shoulder and neck; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain up to shoulder and neck) in a 69-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 21-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 MYALGIA (Muscle pain up to shoulder and neck). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and GABAPENTIN at an unspecified dose and frequency. At the time of the report, MYALGIA (Muscle pain up to shoulder and neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: strange body rash on her left arm; Perfect little circles of red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (strange body rash on her left arm) and VACCINATION SITE ERYTHEMA (Perfect little circles of red) 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.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE RASH (strange body rash on her left arm) and VACCINATION SITE ERYTHEMA (Perfect little circles of red). At the time of the report, VACCINATION SITE RASH (strange body rash on her left arm) and VACCINATION SITE ERYTHEMA (Perfect little circles of red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow-up information received on 16-Apr-2021 does not contain any new information.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Arm sore; Redness at injection site; Itchiness at injection site; Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm sore). On 28-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). The patient was treated with IBUPROFEN at an unspecified dose and frequency; CORTISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 23-Jan-2021, PAIN IN EXTREMITY (Arm sore) had resolved. At the time of the report, VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination complication
Clinical narrative: Developed symptoms/symptoms were very mild; SARS CoV-2 tested positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (SARS CoV-2 tested positive) and VACCINATION COMPLICATION (Developed symptoms/symptoms were very mild) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (SARS CoV-2 tested positive). On an unknown date, the patient experienced VACCINATION COMPLICATION (Developed symptoms/symptoms were very mild). At the time of the report, SARS-COV-2 TEST POSITIVE (SARS CoV-2 tested positive) had not resolved and VACCINATION COMPLICATION (Developed symptoms/symptoms were very mild) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, SARS-CoV-2 test: Negative. On 05-Feb-2021, SARS-CoV-2 test: (Positive) On 02 Feb 2021, the patient developed symptoms..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient treated with BAM Infusion on 10Feb2021   This case was linked to MOD21-033291 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Injection site discomfort, Injection site erythema, Injection site pain
Clinical narrative: Fever of 100F; Chills; muscle and joint aches; red spot on the injection; sore injection site; tender injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 100F), CHILLS (Chills), MYALGIA (muscle and joint aches), INJECTION SITE ERYTHEMA (red spot on the injection) and INJECTION SITE DISCOMFORT (sore injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (red spot on the injection), INJECTION SITE DISCOMFORT (sore injection site) and INJECTION SITE PAIN (tender injection site). On 25-Jan-2021, the patient experienced PYREXIA (Fever of 100F), CHILLS (Chills) and MYALGIA (muscle and joint aches). At the time of the report, PYREXIA (Fever of 100F), CHILLS (Chills), MYALGIA (muscle and joint aches), INJECTION SITE ERYTHEMA (red spot on the injection), INJECTION SITE DISCOMFORT (sore injection site) and INJECTION SITE PAIN (tender injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Body temperature: 100 (Inconclusive) 100F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever of 100F; Chills; muscle and joint aches; red spot on the injection; sore injection site; tender injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 100F), CHILLS (Chills), MYALGIA (muscle and joint aches), INJECTION SITE ERYTHEMA (red spot on the injection) and INJECTION SITE DISCOMFORT (sore injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (red spot on the injection), INJECTION SITE DISCOMFORT (sore injection site) and INJECTION SITE PAIN (tender injection site). On 25-Jan-2021, the patient experienced PYREXIA (Fever of 100F), CHILLS (Chills) and MYALGIA (muscle and joint aches). At the time of the report, PYREXIA (Fever of 100F), CHILLS (Chills), MYALGIA (muscle and joint aches), INJECTION SITE ERYTHEMA (red spot on the injection), INJECTION SITE DISCOMFORT (sore injection site) and INJECTION SITE PAIN (tender injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Body temperature: 100 (Inconclusive) 100F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site joint movement impairment
Clinical narrative: pain on the arm where she got vaccine; Movement in arm is limited; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on the arm where she got vaccine) and VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Movement in arm is limited) 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 21-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain on the arm where she got vaccine) and VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Movement in arm is limited). At the time of the report, PAIN IN EXTREMITY (pain on the arm where she got vaccine) and VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Movement in arm is limited) outcome was unknown.            Concomitant medication was not reported. Treatment medication was not reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: body temperature rising; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (body temperature rising) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PYREXIA (body temperature rising). At the time of the report, PYREXIA (body temperature rising) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Body temperature: rising (High) rising.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not receive any treatment medication. No relevant concomitant medications were reported.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Headache, Pain in extremity
Clinical narrative: Mild nosebleed; Mild headache; Soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Mild nosebleed), PAIN IN EXTREMITY (Soreness of arm) and HEADACHE (Mild headache) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01120MA) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness of arm). On 18-Feb-2021, the patient experienced EPISTAXIS (Mild nosebleed) and HEADACHE (Mild headache). At the time of the report, EPISTAXIS (Mild nosebleed), PAIN IN EXTREMITY (Soreness of arm) and HEADACHE (Mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: felling fatigue (for almost three weeks); This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felling fatigue (for almost three weeks)) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (felling fatigue (for almost three weeks)). At the time of the report, FATIGUE (felling fatigue (for almost three weeks)) outcome was unknown.            Concomitant medication was reported as "Adviril" for high blood pressure and to treat high cholesterol. Treatment medication was not used.; Sender's Comments: Based on the current available information although temporal association between the use of the product and the start date of the event is unknown, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Dizziness, Headache, Joint swelling, Pyrexia
Clinical narrative: swelling left elbow and knee; pain on the entire left half of body especially her hip, elbow and knee; Fever; Headache; Dizziness; Rapid Heart rate; A spontaneous report was received from a consumer  concerning  herself, a female patient who experienced Dizziness/Dizziness, Rapid heart rate/Tachycardia, Fever/Pyrexia, Headache/Headache, Pain on the entire left half of her body especially her hip, elbow and knee/Arthralgia,  Swelling left elbow and knee/ Joint swelling.   The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, was not provided by the reporter.   On 29-JAN-2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly at an unspecified site  for prophylaxis of COVID-19 infection.    After few hours the vaccination on 29-JAN-2021, she had dizziness with rapid heart rate, fever, headache and on 31-JAN-2021 she had  pain on the entire left half of her body especially her hip, elbow and knee with swelling left elbow and knee. Laboratory information at the time of events was not provided. She reported that she was in lot of pain when she called.  Treatment information included Tylenol and Ibuprofen, but the events didn't respond to the medicines.    Action taken with mRNA-1273 in response to the events were unknown.  The events, dizziness with rapid heart rate, fever, headache and pain on the entire left half of her body especially her hip, elbow and knee with swelling left elbow and knee were considered  as unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: swelling left elbow and knee; pain on the entire left half of body especially her hip, elbow and knee; Fever; Headache; Dizziness; Rapid Heart rate; A spontaneous report was received from a consumer  concerning  herself, a female patient who experienced Dizziness/Dizziness, Rapid heart rate/Tachycardia, Fever/Pyrexia, Headache/Headache, Pain on the entire left half of her body especially her hip, elbow and knee/Arthralgia,  Swelling left elbow and knee/ Joint swelling.   The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, was not provided by the reporter.   On 29-JAN-2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly at an unspecified site  for prophylaxis of COVID-19 infection.    After few hours the vaccination on 29-JAN-2021, she had dizziness with rapid heart rate, fever, headache and on 31-JAN-2021 she had  pain on the entire left half of her body especially her hip, elbow and knee with swelling left elbow and knee. Laboratory information at the time of events was not provided. She reported that she was in lot of pain when she called.  Treatment information included Tylenol and Ibuprofen, but the events didn't respond to the medicines.    Action taken with mRNA-1273 in response to the events were unknown.  The events, dizziness with rapid heart rate, fever, headache and pain on the entire left half of her body especially her hip, elbow and knee with swelling left elbow and knee were considered  as unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Dizziness, Fall, Gait disturbance, Headache
Clinical narrative: swelling left elbow and knee; pain on the entire left half of body especially her hip, elbow and knee; Fever; Headache; Dizziness; Rapid Heart rate; A spontaneous report was received from a consumer  concerning  herself, a female patient who experienced Dizziness/Dizziness, Rapid heart rate/Tachycardia, Fever/Pyrexia, Headache/Headache, Pain on the entire left half of her body especially her hip, elbow and knee/Arthralgia,  Swelling left elbow and knee/ Joint swelling.   The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, was not provided by the reporter.   On 29-JAN-2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly at an unspecified site  for prophylaxis of COVID-19 infection.    After few hours the vaccination on 29-JAN-2021, she had dizziness with rapid heart rate, fever, headache and on 31-JAN-2021 she had  pain on the entire left half of her body especially her hip, elbow and knee with swelling left elbow and knee. Laboratory information at the time of events was not provided. She reported that she was in lot of pain when she called.  Treatment information included Tylenol and Ibuprofen, but the events didn't respond to the medicines.    Action taken with mRNA-1273 in response to the events were unknown.  The events, dizziness with rapid heart rate, fever, headache and pain on the entire left half of her body especially her hip, elbow and knee with swelling left elbow and knee were considered  as unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Joint swelling, Myalgia, Pain, Pyrexia
Clinical narrative: swelling left elbow and knee; pain on the entire left half of body especially her hip, elbow and knee; Fever; Headache; Dizziness; Rapid Heart rate; A spontaneous report was received from a consumer  concerning  herself, a female patient who experienced Dizziness/Dizziness, Rapid heart rate/Tachycardia, Fever/Pyrexia, Headache/Headache, Pain on the entire left half of her body especially her hip, elbow and knee/Arthralgia,  Swelling left elbow and knee/ Joint swelling.   The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, was not provided by the reporter.   On 29-JAN-2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly at an unspecified site  for prophylaxis of COVID-19 infection.    After few hours the vaccination on 29-JAN-2021, she had dizziness with rapid heart rate, fever, headache and on 31-JAN-2021 she had  pain on the entire left half of her body especially her hip, elbow and knee with swelling left elbow and knee. Laboratory information at the time of events was not provided. She reported that she was in lot of pain when she called.  Treatment information included Tylenol and Ibuprofen, but the events didn't respond to the medicines.    Action taken with mRNA-1273 in response to the events were unknown.  The events, dizziness with rapid heart rate, fever, headache and pain on the entire left half of her body especially her hip, elbow and knee with swelling left elbow and knee were considered  as unknown.