chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: U
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Vaccine received age 14; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of OFF LABEL USE (Vaccine received age 14) in a 14-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Vaccine received age 14). At the time of the report, OFF LABEL USE (Vaccine received age 14) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Possibly given the vaccine subcutaneously; Crosslinked with cases MOD21-078849,  MOD-2021-087892  The caller was a registered nurse that called several times to Moderna Medical Information. The caller said that called asking for information because was not sure if a direct relative had received the dose on the deltoid muscle or subcutaneously. The caller denied consent for a report or a follow up as only wanted medical information. The safety consent for follow up was denied by the caller. at that time.   The caller received several emails and called in 2 more different times and this morning woke up with an email from a regulatory authority with the ID number MOD-2021-087892. The caller stated again that was just looking for information and didn't wanted to report anything.    The caller wanted someone from safety to call them by the end of this day or if not is going to have to take this further because can't have regulatory authority keep asking for information. and stated that is not very happy with this. The caller said that has nothing on writing saying that Moderna not going to harass it anymore and that this handling is not giving a lot of confidence in MODERNA. The caller said that it has no other choice but to contact the CEO of MODERNA, and that the next thing is to call to corporate office or the FDA because they might want to know how it is being handled.  The caller wasn't clear on a further follow up, when the agent asked if further follow up was rejected said that doesn't want a safety follow up nor receiving emails anymore but also said that the only follow up that wants is from safety, not from a regulatory authority.  Consent not collected as caller was unclear on future contact; Reporter's Comments: This case concerns a female patient of unknown age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting incorrect route of product administration without any associated adverse events.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: delayed reaction itchy left arm; delayed reaction warmth; delayed reaction red area, area is 3 inches in diameter; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (delayed reaction itchy left arm), VACCINATION SITE WARMTH (delayed reaction warmth) and VACCINATION SITE ERYTHEMA (delayed reaction red area, area is 3 inches in diameter) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (delayed reaction itchy left arm), VACCINATION SITE WARMTH (delayed reaction warmth) and VACCINATION SITE ERYTHEMA (delayed reaction red area, area is 3 inches in diameter). At the time of the report, VACCINATION SITE PRURITUS (delayed reaction itchy left arm), VACCINATION SITE WARMTH (delayed reaction warmth) and VACCINATION SITE ERYTHEMA (delayed reaction red area, area is 3 inches in diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided. treatment to the events not reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Big Red Spot on arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Big Red Spot on arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Big Red Spot on arm). At the time of the report, RASH (Big Red Spot on arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided. treatment to the events not provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: Heart Palpitations; Injection site pain/tenderness; Fatigue; headache; muscle pain; Joint pain; chills; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart Palpitations), INJECTION SITE PAIN (Injection site pain/tenderness), FATIGUE (Fatigue), HEADACHE (headache) and MYALGIA (muscle pain) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PALPITATIONS (Heart Palpitations), INJECTION SITE PAIN (Injection site pain/tenderness), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (Joint pain), CHILLS (chills), PYREXIA (fever) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 10-Feb-2021, PALPITATIONS (Heart Palpitations) had resolved. On 13-Feb-2021, INJECTION SITE PAIN (Injection site pain/tenderness), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (Joint pain), CHILLS (chills), PYREXIA (fever) and NAUSEA (nausea) had resolved. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 100 degree Celsius (High) fever is recovered after three days..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Nausea, Palpitations, Pyrexia
Clinical narrative: Heart Palpitations; Injection site pain/tenderness; Fatigue; headache; muscle pain; Joint pain; chills; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart Palpitations), INJECTION SITE PAIN (Injection site pain/tenderness), FATIGUE (Fatigue), HEADACHE (headache) and MYALGIA (muscle pain) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PALPITATIONS (Heart Palpitations), INJECTION SITE PAIN (Injection site pain/tenderness), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (Joint pain), CHILLS (chills), PYREXIA (fever) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 10-Feb-2021, PALPITATIONS (Heart Palpitations) had resolved. On 13-Feb-2021, INJECTION SITE PAIN (Injection site pain/tenderness), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (Joint pain), CHILLS (chills), PYREXIA (fever) and NAUSEA (nausea) had resolved. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 100 degree Celsius (High) fever is recovered after three days..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: pain in same arm of injection; Patient started having fever >101; headache; chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in same arm of injection), PYREXIA (Patient started having fever >101), HEADACHE (headache) and CHILLS (chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in same arm of injection), PYREXIA (Patient started having fever >101), HEADACHE (headache) and CHILLS (chills). On 26-Feb-2021, PAIN IN EXTREMITY (pain in same arm of injection), PYREXIA (Patient started having fever >101), HEADACHE (headache) and CHILLS (chills) had resolved.            Patient took 2nd dose on 25Feb2021 on left arm. On same day(25Feb2021)she started having fever >101, headache and chills and pain at same arm as injection site for 24 hours.
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: red blotchy area at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (red blotchy area 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 20-Feb-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 (red blotchy area at the injection site). At the time of the report, INJECTION SITE RASH (red blotchy area at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient received the dose of the vaccine on 20Feb2021 and she developed 3 inches red blotchy area at the injection site
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) 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 01-Mar-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 (arm soreness). At the time of the report, PAIN IN EXTREMITY (arm soreness) outcome was unknown.            Caller received 2nd shot of vaccine yesterday 01Mar2021, caller enquired if she can take Advil for his Arthritis Pain.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Myalgia, Pyrexia, Vaccination site movement impairment
Clinical narrative: difficult to lift arm; cloudy brain; soreness at the injection site; body aches; fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (difficult to lift arm), FEELING ABNORMAL (cloudy brain), VACCINATION SITE PAIN (soreness at the injection site), MYALGIA (body aches) and PYREXIA (fever) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included CITALOPRAM for Anxiety, CETIRIZINE for Seasonal allergy, CELECOXIB (CELEXA [CELECOXIB]) and ROFLUMILAST (ADAIR) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced HYPOKINESIA (difficult to lift arm), FEELING ABNORMAL (cloudy brain), VACCINATION SITE PAIN (soreness at the injection site), MYALGIA (body aches), PYREXIA (fever) and HEADACHE (Headache). On 27-Feb-2021, VACCINATION SITE PAIN (soreness at the injection site), MYALGIA (body aches), PYREXIA (fever) and HEADACHE (Headache) had resolved. On 28-Feb-2021, HYPOKINESIA (difficult to lift arm) and FEELING ABNORMAL (cloudy brain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Additional info received,event added, concomitant medications added
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: difficult to lift arm; cloudy brain; soreness at the injection site; body aches; fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (difficult to lift arm), FEELING ABNORMAL (cloudy brain), VACCINATION SITE PAIN (soreness at the injection site), MYALGIA (body aches) and PYREXIA (fever) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included CITALOPRAM for Anxiety, CETIRIZINE for Seasonal allergy, CELECOXIB (CELEXA [CELECOXIB]) and ROFLUMILAST (ADAIR) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced HYPOKINESIA (difficult to lift arm), FEELING ABNORMAL (cloudy brain), VACCINATION SITE PAIN (soreness at the injection site), MYALGIA (body aches), PYREXIA (fever) and HEADACHE (Headache). On 27-Feb-2021, VACCINATION SITE PAIN (soreness at the injection site), MYALGIA (body aches), PYREXIA (fever) and HEADACHE (Headache) had resolved. On 28-Feb-2021, HYPOKINESIA (difficult to lift arm) and FEELING ABNORMAL (cloudy brain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Additional info received,event added, concomitant medications added
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Rash
Clinical narrative: 5 cold sores on bottom lip; Breaking out in neck area; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (5 cold sores on bottom lip) and RASH (Breaking out in neck area) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ORAL HERPES (5 cold sores on bottom lip) and RASH (Breaking out in neck area). At the time of the report, ORAL HERPES (5 cold sores on bottom lip) and RASH (Breaking out in neck area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received Covid vaccine on 20feb2021. Patient is breaking out in neck area, 5 cold sores on bottom lip.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance test, Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan normal
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 40-year-old female patient (gravida 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included Crohn's disease (In remission), Abortion (spontaneous abortion) on 13-Apr-2018, Induced abortion on 13-Nov-2018 and Subfertility (IVF because of diminished ovarian reserve.). Concurrent medical conditions included Diabetes and Toxemia of pregnancy. Concomitant products included INSULIN for Diabetes, ACETYLSALICYLIC ACID (ASPIRIN) for Eclampsia, antepartum, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS) and IRON for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 05-Jun-2020 and the estimated date of delivery was 12-Mar-2021. On 08-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 08-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jul-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Glucose tolerance test: gestational diabetis (High) Gestational diabetes. On an unknown date, Ultrasound scan normal: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information reported.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; A spontaneous report was received from a consumer concerning a male patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event of fever.  The patient's medical history was not reported.  Concomitant products information was not reported.  On  27 Jan 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (batch number:09L20A) for prophylaxis of COVID-19 infection.   On 28 Jan 2021 after receiving vaccine the patient experienced the event of fever.  Action taken with mRNA-1273 in response to the event was not provided.   Treatment information was not provided.  On 02 Feb 2021 the outcome of the events  fever was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-047944:Crosslinked (MOD21-018124) US-MODERNATX, INC.-MOD-2021-022474:Crosslinked (MOD21-018124)
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular
Clinical narrative: arm started to itch again and was red again; small little red itchy spots; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (small little red itchy spots) and PRURITUS (arm started to itch again and was red again) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 02-Feb-2021, the patient experienced RASH MACULAR (small little red itchy spots). On 08-Feb-2021, the patient experienced PRURITUS (arm started to itch again and was red again). The patient was treated with PARACETAMOL (TYLENOL) at a dose of unknown and IBUPROFEN at an unspecified dose and frequency. At the time of the report, RASH MACULAR (small little red itchy spots) and PRURITUS (arm started to itch again and was red again) 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.   Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2021: treatment medication has been updated.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching at the lower extremities; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching at the lower extremities) in a female patient of an unknown age who received mRNA-1273 (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history Provided.).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching at the lower extremities). At the time of the report, PRURITUS (itching at the lower extremities) outcome was unknown.       No treatment information was reported. The action taken with mRNA-1273 (Unknown) was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: develop a pretty significant rash; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (develop a pretty significant rash) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-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 RASH (develop a pretty significant rash). The patient was treated with METHYLPREDNISOLONE (MEDROL DOSEPAK) for Generalized rash, at an unspecified dose and frequency. At the time of the report, RASH (develop a pretty significant rash) 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.   Patient takes several medications for several conditions (24 medications, PA offered to fax it; no new medications, all prior to the rash except the COVID-19 vaccine). It was a generalized rash, not only on the injection site. Treatment activities for event was done with Medrol Pak.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea, Headache, Myalgia
Clinical narrative: diarrhea; dry cough; headache; muscle aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), COUGH (dry cough), HEADACHE (headache), MYALGIA (muscle aches) and CHILLS (chills) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced DIARRHOEA (diarrhea), COUGH (dry cough), HEADACHE (headache), MYALGIA (muscle aches) and CHILLS (chills). At the time of the report, DIARRHOEA (diarrhea), COUGH (dry cough), HEADACHE (headache), MYALGIA (muscle aches) and CHILLS (chills) 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 medication details were not reporter by the reporter. Treatment details was not was reported by the reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Asthenia, Bedridden, Chills, Fatigue
Clinical narrative: Lot of side effects; I was in bed for 36 hours; Muscle pain; Chills; Fever; Nausea; Headache; Body was aching; fever continued till next day; Feeling tired; Weak; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Lot of side effects), BEDRIDDEN (I was in bed for 36 hours), MYALGIA (Muscle pain), CHILLS (Chills) and PYREXIA (Fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, LISINOPRIL and METOPROLOL for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Lot of side effects), BEDRIDDEN (I was in bed for 36 hours), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache), MYALGIA (Body was aching), PYREXIA (fever continued till next day), FATIGUE (Feeling tired) and ASTHENIA (Weak). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, ADVERSE EVENT (Lot of side effects), BEDRIDDEN (I was in bed for 36 hours), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache), MYALGIA (Body was aching), PYREXIA (fever continued till next day), FATIGUE (Feeling tired) and ASTHENIA (Weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Lot of side effects; I was in bed for 36 hours; Muscle pain; Chills; Fever; Nausea; Headache; Body was aching; fever continued till next day; Feeling tired; Weak; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Lot of side effects), BEDRIDDEN (I was in bed for 36 hours), MYALGIA (Muscle pain), CHILLS (Chills) and PYREXIA (Fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, LISINOPRIL and METOPROLOL for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Lot of side effects), BEDRIDDEN (I was in bed for 36 hours), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache), MYALGIA (Body was aching), PYREXIA (fever continued till next day), FATIGUE (Feeling tired) and ASTHENIA (Weak). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, ADVERSE EVENT (Lot of side effects), BEDRIDDEN (I was in bed for 36 hours), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache), MYALGIA (Body was aching), PYREXIA (fever continued till next day), FATIGUE (Feeling tired) and ASTHENIA (Weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vaccination site pain
Clinical narrative: a little sore arm; lightheadedness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Feb-2021 and was forwarded to Moderna on 17-Feb-2021.    This spontaneous report from was received from a 67 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lightheadedness and sore arm.  The patient's concomitant medications included unspecified medication for blood pressure, cholesterol and acid reflux.  On 09-Feb--2021 the patient received his dose of mRNA-1273 (Lot number: 015M20A) solution injection  intramuscularly in his arm for  prophylaxis of COVID-19 infection.   On 12-feb-2021, the patient started experiencing this lightheadedness. Now it was mild but it was still there. The patient said that the vaccination was well executed. The patient had a little sore arm.  Treatment information was not provided.  Action taken with the suspect drug mRNA-1273 was unknown.  The outcome of the event of lightheadedness was recovering and that of event of sore arm was not recovered /not resolved.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Vaccination site erythema, Vaccination site mass, Vaccination site swelling
Clinical narrative: arm was blown up; sore; lumpy; swollen; hot; looked a little red; A spontaneous report was received from a Nurse concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lumpy, swollen, hot and red reaction at injection site, arm was blown up and sore in arm.  The patient's medical history was not provided. Concomitant medications reported were Calcium, Vitamin D, Vitamin B12, Zinc, Vitamin C, Metoprolol, Boniva for drug use for unknown indication.  On 5 Feb 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 deltoid for prophylaxis of COVID-19 infection.  On 15 Feb 2021, the patient experienced lumpy (vaccination site mass), swollen (vaccination site swelling), hot (vaccination site warmth) and it looked a little red (vaccination site erythema). On 16 Feb 2021, the arm was blown up (swelling arm) and was sore (pain).  Treatment details included Ice pack.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: arm was blown up; sore; lumpy; swollen; hot; looked a little red; A spontaneous report was received from a Nurse concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lumpy, swollen, hot and red reaction at injection site, arm was blown up and sore in arm.  The patient's medical history was not provided. Concomitant medications reported were Calcium, Vitamin D, Vitamin B12, Zinc, Vitamin C, Metoprolol, Boniva for drug use for unknown indication.  On 5 Feb 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 deltoid for prophylaxis of COVID-19 infection.  On 15 Feb 2021, the patient experienced lumpy (vaccination site mass), swollen (vaccination site swelling), hot (vaccination site warmth) and it looked a little red (vaccination site erythema). On 16 Feb 2021, the arm was blown up (swelling arm) and was sore (pain).  Treatment details included Ice pack.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: low grade fever; A spontaneous report was received from a Healthcare Professional concerning a 65-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events low grade fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 15 Feb 2021, the patient experienced the events low grade fever.  Treatment details included Tylenol  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, low grade fever was not reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site pruritus, Vaccination site rash
Clinical narrative: arm was itching below the injection site - left arm; rash where the shot was administered - left arm - It's about 6 inches long, 5 inched across; red rash - area has grown to 6 inches across the bottom of the arm past the top of the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash - area has grown to 6 inches across the bottom of the arm past the top of the injection site), VACCINATION SITE PRURITUS (arm was itching below the injection site - left arm) and VACCINATION SITE RASH (rash where the shot was administered - left arm - It's about 6 inches long, 5 inched across) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced RASH ERYTHEMATOUS (red rash - area has grown to 6 inches across the bottom of the arm past the top of the injection site) and VACCINATION SITE RASH (rash where the shot was administered - left arm - It's about 6 inches long, 5 inched across). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (arm was itching below the injection site - left arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Itching, at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (red rash - area has grown to 6 inches across the bottom of the arm past the top of the injection site), VACCINATION SITE PRURITUS (arm was itching below the injection site - left arm) and VACCINATION SITE RASH (rash where the shot was administered - left arm - It's about 6 inches long, 5 inched across) 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 medication details were not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: red rash on arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (red rash on arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (red rash on arm). At the time of the report, RASH (red rash on arm) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Rash - Near Injection Site; Redness - Near Injection Site; Arm Pain; Itchy Sensation - Near Injection Site; Swelling - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE PAIN (Arm Pain), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.  On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE PAIN (Arm Pain), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site). At the time of the report, VACCINATION SITE RASH (Rash - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE PAIN (Arm Pain), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - 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 relevant concomitant medications were reported.  Treatment details included Benadryl (diphenhydramine HCL) - Advised by their HCP to try to alleviate the symptoms as well as Cortizone-10.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives; rashes on her back of her neck,rash on arm and tights; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) and RASH (rashes on her back of her neck,rash on arm and tights) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), OLMESARTAN MEDOXOMIL (BENICAR), LEVOTHYROXINE SODIUM (SYNTHROID), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMINS NOS for an unknown indication.  On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced URTICARIA (Hives) and RASH (rashes on her back of her neck,rash on arm and tights). At the time of the report, URTICARIA (Hives) and RASH (rashes on her back of her neck,rash on arm and tights) 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.   Treatment details included Benadryl and Zyrtec + concomitant.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hypoglycaemia, Injection site erythema, Injection site pain
Clinical narrative: headache; dizziness that is very bizzare; like having hypoglycemia; very tender and very painful; swollen; red, swollen, very tender and very painful; super sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (super sore), DIZZINESS (dizziness that is very bizzare), HYPOGLYCAEMIA (like having hypoglycemia), INJECTION SITE PAIN (very tender and very painful) and HEADACHE (headache) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (super sore). On 15-Jan-2021, the patient experienced INJECTION SITE PAIN (very tender and very painful), INJECTION SITE SWELLING (swollen) and INJECTION SITE ERYTHEMA (red, swollen, very tender and very painful). On 04-Feb-2021, the patient experienced DIZZINESS (dizziness that is very bizzare) and HYPOGLYCAEMIA (like having hypoglycemia). On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (super sore), DIZZINESS (dizziness that is very bizzare), HYPOGLYCAEMIA (like having hypoglycemia), INJECTION SITE PAIN (very tender and very painful), HEADACHE (headache), INJECTION SITE SWELLING (swollen) and INJECTION SITE ERYTHEMA (red, swollen, very tender and very painful) 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 product include Exedrin OTC.  Treatment details include that the patient may have taken Naproxen 400mg and applied heat.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: headache; dizziness that is very bizzare; like having hypoglycemia; very tender and very painful; swollen; red, swollen, very tender and very painful; super sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (super sore), DIZZINESS (dizziness that is very bizzare), HYPOGLYCAEMIA (like having hypoglycemia), INJECTION SITE PAIN (very tender and very painful) and HEADACHE (headache) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (super sore). On 15-Jan-2021, the patient experienced INJECTION SITE PAIN (very tender and very painful), INJECTION SITE SWELLING (swollen) and INJECTION SITE ERYTHEMA (red, swollen, very tender and very painful). On 04-Feb-2021, the patient experienced DIZZINESS (dizziness that is very bizzare) and HYPOGLYCAEMIA (like having hypoglycemia). On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (super sore), DIZZINESS (dizziness that is very bizzare), HYPOGLYCAEMIA (like having hypoglycemia), INJECTION SITE PAIN (very tender and very painful), HEADACHE (headache), INJECTION SITE SWELLING (swollen) and INJECTION SITE ERYTHEMA (red, swollen, very tender and very painful) 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 product include Exedrin OTC.  Treatment details include that the patient may have taken Naproxen 400mg and applied heat.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Diarrhoea, Headache, Hypoaesthesia oral
Clinical narrative: lips and tongue got numb; lost taste; diarrhea; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (lips and tongue got numb), AGEUSIA (lost taste), DIARRHOEA (diarrhea) and HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), CLONAZEPAM, CITALOPRAM, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), PREDNISONE and HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (ANTIBIOTIC EAR) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA ORAL (lips and tongue got numb), AGEUSIA (lost taste), DIARRHOEA (diarrhea) and HEADACHE (headache). At the time of the report, HYPOAESTHESIA ORAL (lips and tongue got numb), AGEUSIA (lost taste), DIARRHOEA (diarrhea) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HYPOAESTHESIA ORAL (lips and tongue got numb), AGEUSIA (lost taste), DIARRHOEA (diarrhea) and HEADACHE (headache) to be possibly related.    No treatment information was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Intervertebral disc degeneration, Magnetic resonance imaging, Osteoarthritis
Clinical narrative: discogenic marrow changes; degenerative disc disease; osteoarthritis; chills; low grade fever; Severe backache/Severe low back pain that radiated to right hip; A spontaneous report was received from a consumer concerning a 80 year old, female patient who developed Severe backache/Severe low back pain that radiated to right hip, discogenic marrow changes, degenerative disc disease, osteoarthritis, fever, and chills.     The patient's medical history included blood clots, hypertension and anxiety.  Products known to have been used by the patient, within two weeks prior to the event, included clonazepam, apixaban, lisinopril, and oxycodone hydrochloride/oxycodone terephthalate.     On 28-JAN-2021, approximately four days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. It was planned for patient to receive their second dose on 03 Mar 2021.   On an unspecified date post vaccination, patient developed low grade fever and chills. On 01 Feb 2021, four days post vaccination, the patient developed severe backache described as severe low back pain that radiated to right hip. An ambulance was called and patient was transported to an emergency room (ER) where an X-ray was done. Patient was then sent home and told to follow-up with her primary care physician (PCP) who referred to a pain clinic. A magnetic resonance imaging (MRI) revealed osteoarthritis, degenerative disc disease and discogenic marrow changes. The patient is unable to have steroid injections because of her use of an anticoagulant.  Treatment information was unknown.    There was no change planned to the dosing schedule of mRNA-1273 in response to the event(s).  The events Severe backache/Severe low back pain that radiated to right hip, discogenic marrow changes, degenerative disc disease, and osteoarthritis were considered not recovered/not resolved.   The outcome of events fever and chills, was unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.