chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Arthritis reactive, Laboratory test
Clinical narrative: REACTIVE ARTHRITIS (SEVERE PAIN); This spontaneous report received from a patient concerned a patient of unspecified age, sex, unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: UNKNOWN) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date in JUL-2021, the patient was diagnosed with reactive arthritis. The patient is still in severe pain after three weeks. Laboratory data included: Lab test (NR: not provided) diagnosed with Reactive Arthritis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from reactive arthritis (severe pain) This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210822977-Covid-19 vaccine ad26.cov2.S-Reactive arthritis (severe pain).This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Experienced a little soreness in his arm after the injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Experienced a little soreness in his arm after the injection) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol and Diabetes. Concomitant products included EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE (SYNJARDY) for Diabetes, ROSUVASTATIN for High cholesterol, ASPIRIN [ACETYLSALICYLIC ACID].    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced INJECTION SITE PAIN (Experienced a little soreness in his arm after the injection). At the time of the report, INJECTION SITE PAIN (Experienced a little soreness in his arm after the injection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Company Comment: 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.; 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
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Redness and itchiness; Redness and itchiness; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Redness and itchiness), PRURITUS (Redness and itchiness) and delayed reaction to the vaccine in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012120A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness and itchiness), PRURITUS (Redness and itchiness) and delayed reaction to the vaccine. At the time of the report, ERYTHEMA (Redness and itchiness) and PRURITUS (Redness and itchiness)  delayed to the vaccine utcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea
Clinical narrative: Nausea; Little Headache; Sore Arm; A spontaneous report was received from a (Reporter like Consumer) concerning a  65 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (Nausea, Little Headache and Sore Arm) list.      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: 006M20A) intramuscularly for prophylaxis of COVID-19 infection.    On 15-FEB-2021, The patient experienced the events list (Nausea, Little Headache and Sore Arm).     Laboratory details was not provided.    No treatment information was provided.     Action taken with mRNA-1273 in response to the events was not reported.     At the time of this report, the outcome of the event(s) (Nausea, Little Headache and Sore Arm) was unknown.    The reporter assessed the event(s), [Nausea, Little Headache and Sore Arm], as related to study drug.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Rash
Clinical narrative: Body ache; Fever; Rash (on her trunk-front and back); Chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Body ache), RASH (Rash (on her trunk-front and back)) and CHILLS (Chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced PAIN (Body ache), RASH (Rash (on her trunk-front and back)) and CHILLS (Chills). At the time of the report, PAIN (Body ache), RASH (Rash (on her trunk-front and back)) and CHILLS (Chills) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD21-033093 (E2B Linked Report).; Sender's Comments:  MOD21-033093:
Sex: M
Vaccine: COVID19
Symptoms: Antibody test negative
Clinical narrative: had 0 antibodies on a test after getting 2 vaccine; A spontaneous report was received from a consumer concerning a male patient who developed had 0 antibodies on a test after getting 2 vaccine/ drug ineffective.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.      The patient received their first of two planned doses of mrna-1273 (Batch number : 012L20A) on 12 Jan 2021. On 09 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mrna-1273 (Batch number: 012M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 12 Jan 2021, patient received first dose and on 09 Feb 2021, patient received second dose of vaccine.  On 11 Feb 2021, the patient reported having no antibodies on a test after getting 2 vaccine/ drug ineffective.   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 events had 0 antibodies on a test after getting 2 vaccine/ drug ineffective were not reported.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Still getting sick with COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Still getting sick with COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Still getting sick with COVID). At the time of the report, COVID-19 (Still getting sick with COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Illness, Nausea
Clinical narrative: soreness; dizziness; diarrhea; felt sick; Tired; nausea; had a robust reaction to first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), DIZZINESS (dizziness), DIARRHOEA (diarrhea), ILLNESS (felt sick) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-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 PAIN (soreness), DIZZINESS (dizziness), DIARRHOEA (diarrhea), ILLNESS (felt sick), NAUSEA (nausea) and FATIGUE (Tired). At the time of the report, PAIN (soreness), DIZZINESS (dizziness), DIARRHOEA (diarrhea), ILLNESS (felt sick), NAUSEA (nausea) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not provided. Concomitant medication not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination complication
Clinical narrative: soreness; dizziness; diarrhea; felt sick; Tired; nausea; had a robust reaction to first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), DIZZINESS (dizziness), DIARRHOEA (diarrhea), ILLNESS (felt sick) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-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 PAIN (soreness), DIZZINESS (dizziness), DIARRHOEA (diarrhea), ILLNESS (felt sick), NAUSEA (nausea) and FATIGUE (Tired). At the time of the report, PAIN (soreness), DIZZINESS (dizziness), DIARRHOEA (diarrhea), ILLNESS (felt sick), NAUSEA (nausea) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not provided. Concomitant medication not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: injection site arm warm; A spontaneous report was received from a 72-years-old  female patient concerning herself who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event injection site arm warm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On an unknown date in Feb 2021, the patient experienced the event injection site arm warm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, injection site arm warm was not recovered.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid-19) in an 86-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 (No medical history reported).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced COVID-19 (tested positive for Covid-19). At the time of the report, COVID-19 (tested positive for Covid-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of   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 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.            No concomitant medication was reported.  No treatment medication was reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: hives; severe rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) and RASH (severe rash) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) 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 23-Feb-2021, the patient experienced URTICARIA (hives) and RASH (severe rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (hives) and RASH (severe rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment medications included 2 IM steroids injection, oral steroids.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: arm hurt; "felt tired"; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt), FATIGUE ("felt tired") and CHILLS (chills) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt), FATIGUE ("felt tired") and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (arm hurt), FATIGUE ("felt tired") and CHILLS (chills) outcome was unknown.            No concomitant medication and treatment information were reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Nausea, Pruritus, Pyrexia
Clinical narrative: left arm red; left arm itchy; vomiting two times; slit rash over her body, pink, little thing in the skin; Nausea; Chills; feverish; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 08-Feb-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 08-Feb-2021.    A spontaneous report was received from a consumer concerning herself, who is a 81-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events left arm red, left arm itchy, vomiting two times, slit rash over her body, pink, little thing in the skin, chills, nausea, feverish.  The patient's medical history was blood pressure, also allergic to panicillin. Concomitant medications reported were blood pressure medicine.  On 29 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) through unknown route in the unknown location for prophylaxis of COVID-19 infection.  On an unknown date, 8 days later after first dose the patient experienced the events left arm red and itchy , color, collapse two times, slit rash over her body, pink, little thing in the skin. After taking paracetamol patient experienced chills, nausea and feverish.  Treatment details included paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events left arm red, left arm itchy, vomiting two times, slit rash over her body, pink, little thing in the skin, chills, nausea, feverish was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vomiting
Clinical narrative: left arm red; left arm itchy; vomiting two times; slit rash over her body, pink, little thing in the skin; Nausea; Chills; feverish; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 08-Feb-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 08-Feb-2021.    A spontaneous report was received from a consumer concerning herself, who is a 81-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events left arm red, left arm itchy, vomiting two times, slit rash over her body, pink, little thing in the skin, chills, nausea, feverish.  The patient's medical history was blood pressure, also allergic to panicillin. Concomitant medications reported were blood pressure medicine.  On 29 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) through unknown route in the unknown location for prophylaxis of COVID-19 infection.  On an unknown date, 8 days later after first dose the patient experienced the events left arm red and itchy , color, collapse two times, slit rash over her body, pink, little thing in the skin. After taking paracetamol patient experienced chills, nausea and feverish.  Treatment details included paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events left arm red, left arm itchy, vomiting two times, slit rash over her body, pink, little thing in the skin, chills, nausea, feverish was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Arm was itchy and she started scratching it; Red; Swollen under the skin at the injection site; Swollen circle the size of a tennis ball; Tender; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 08-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tender), VACCINATION SITE PRURITUS (Arm was itchy and she started scratching it), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE SWELLING (Swollen under the skin at the injection site) and VACCINATION SITE MASS (Swollen circle the size of a tennis ball) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced TENDERNESS (Tender). On 07-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swollen under the skin at the injection site) and VACCINATION SITE MASS (Swollen circle the size of a tennis ball). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Arm was itchy and she started scratching it) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, TENDERNESS (Tender), VACCINATION SITE PRURITUS (Arm was itchy and she started scratching it), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE SWELLING (Swollen under the skin at the injection site) and VACCINATION SITE MASS (Swollen circle the size of a tennis ball) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications used were not reported. No treatment information were reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (Fatigued) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O12MZ0A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (Fatigued). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (Fatigued) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications includes blood pressure.  treatment information includes allergy meds and vitamins.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain, Rash
Clinical narrative: Rash spread on back and neck; Rash on her chest; Soreness; Chills; soreness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Feb-2021 and was forwarded to Moderna on 08-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on her chest), MYALGIA (Soreness), CHILLS (Chills), PAIN (soreness) and RASH (Rash spread on back and neck) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced RASH (Rash on her chest), MYALGIA (Soreness), CHILLS (Chills) and PAIN (soreness). On 05-Feb-2021, the patient experienced RASH (Rash spread on back and neck). At the time of the report, RASH (Rash on her chest), MYALGIA (Soreness), CHILLS (Chills), PAIN (soreness) and RASH (Rash spread on back and neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Benadryl.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: fell shouldn't drive car; body ache; chills; maybe fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (fell shouldn't drive car), MYALGIA (body ache), CHILLS (chills) and PYREXIA (maybe fever) in a 68-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 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced FEELING ABNORMAL (fell shouldn't drive car), MYALGIA (body ache), CHILLS (chills) and PYREXIA (maybe fever). At the time of the report, FEELING ABNORMAL (fell shouldn't drive car), MYALGIA (body ache), CHILLS (chills) and PYREXIA (maybe fever) outcome was unknown.            No concomitant medications and treatment information were reported.   This case was linked to MOD-2021-024150 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Dyspnoea, Fatigue, Hypoaesthesia
Clinical narrative: Shortness of breath; Fatigued; Left face numbness that lasted 20 minutes/left hand numbness that last 20 minutes; Slurred speech for 20 minutes; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Left face numbness that lasted 20 minutes/left hand numbness that last 20 minutes), DYSARTHRIA (Slurred speech for 20 minutes), DYSPNOEA (Shortness of breath) and FATIGUE (Fatigued) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 26-Dec-2020 and Transient ischaemic attacks. Concurrent medical conditions included Colon cancer and Diabetes.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced HYPOAESTHESIA (Left face numbness that lasted 20 minutes/left hand numbness that last 20 minutes) and DYSARTHRIA (Slurred speech for 20 minutes). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath) and FATIGUE (Fatigued). At the time of the report, HYPOAESTHESIA (Left face numbness that lasted 20 minutes/left hand numbness that last 20 minutes), DYSARTHRIA (Slurred speech for 20 minutes), DYSPNOEA (Shortness of breath) and FATIGUE (Fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications includes Blood thinners.  No treatment information were reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Headache, Hypertension, Nasal congestion, Nausea
Clinical narrative: Congestion; Elevated blood pressure; nausea; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congestion), HYPERTENSION (Elevated blood pressure), NAUSEA (nausea), HEADACHE (Headache) and PYREXIA (Fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (Congestion), HYPERTENSION (Elevated blood pressure), NAUSEA (nausea), HEADACHE (Headache) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, NASAL CONGESTION (Congestion), HYPERTENSION (Elevated blood pressure), NAUSEA (nausea), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure increased: elevated (High) elevated blood pressure.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes use of blood pressure medications (not further specified).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Congestion; Elevated blood pressure; nausea; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congestion), HYPERTENSION (Elevated blood pressure), NAUSEA (nausea), HEADACHE (Headache) and PYREXIA (Fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (Congestion), HYPERTENSION (Elevated blood pressure), NAUSEA (nausea), HEADACHE (Headache) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, NASAL CONGESTION (Congestion), HYPERTENSION (Elevated blood pressure), NAUSEA (nausea), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure increased: elevated (High) elevated blood pressure.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes use of blood pressure medications (not further specified).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Vaccination site erythema
Clinical narrative: Body aches; Itchiness at the injection site; redness on injection site; fatigue; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE ERYTHEMA (redness on injection site), FATIGUE (fatigue) and CHILLS (Chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced MYALGIA (Body aches), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE ERYTHEMA (redness on injection site), FATIGUE (fatigue), CHILLS (Chills) and HEADACHE (Headache). 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, MYALGIA (Body aches), FATIGUE (fatigue), CHILLS (Chills) and HEADACHE (Headache) had resolved and VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE ERYTHEMA (redness on injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Body aches; Itchiness at the injection site; redness on injection site; fatigue; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE ERYTHEMA (redness on injection site), FATIGUE (fatigue) and CHILLS (Chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced MYALGIA (Body aches), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE ERYTHEMA (redness on injection site), FATIGUE (fatigue), CHILLS (Chills) and HEADACHE (Headache). 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, MYALGIA (Body aches), FATIGUE (fatigue), CHILLS (Chills) and HEADACHE (Headache) had resolved and VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE ERYTHEMA (redness on injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyskinesia, Injection site pain, Jaw disorder
Clinical narrative: weak; problem with his jaw/muscle related; unable to open his mouth all the way; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm), ASTHENIA (weak), JAW DISORDER (problem with his jaw/muscle related) and DYSKINESIA (unable to open his mouth all the way) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced INJECTION SITE PAIN (sore arm), ASTHENIA (weak), JAW DISORDER (problem with his jaw/muscle related) and DYSKINESIA (unable to open his mouth all the way). At the time of the report, INJECTION SITE PAIN (sore arm), ASTHENIA (weak), JAW DISORDER (problem with his jaw/muscle related) and DYSKINESIA (unable to open his mouth all the way) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment information were reported.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Vaccination site pain
Clinical narrative: chills; Arm sore; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 08-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and VACCINATION SITE PAIN (Arm sore) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included NAPROXEN, LEVOTHYROXINE SODIUM (SYNTHROID), NAPROXEN, DOXYLAMINE SUCCINATE (UNISOM 2), MELATONIN and ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced CHILLS (chills) and VACCINATION SITE PAIN (Arm sore). At the time of the report, CHILLS (chills) and VACCINATION SITE PAIN (Arm sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose increased, Blood pressure fluctuation, Headache, Increased viscosity of upper respiratory secretion
Clinical narrative: mucus build-up; elevated glucose; fluctuated BP; Bad Headache; This spontaneous case was reported by a consumer and describes the occurrence of INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (mucus build-up), BLOOD GLUCOSE INCREASED (elevated glucose), BLOOD PRESSURE FLUCTUATION (fluctuated BP) and HEADACHE (Bad Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (mucus build-up), BLOOD GLUCOSE INCREASED (elevated glucose), BLOOD PRESSURE FLUCTUATION (fluctuated BP) and HEADACHE (Bad Headache). At the time of the report, INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (mucus build-up), BLOOD GLUCOSE INCREASED (elevated glucose), BLOOD PRESSURE FLUCTUATION (fluctuated BP) and HEADACHE (Bad Headache) outcome was unknown.            No concomitant medications and treatment information were reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Covid arm 1st dose-left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Covid arm 1st dose-left arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included LITHIUM CARBONATE, INSULIN GLARGINE, INSULIN ASPART (NOVOLOG), BENZTROPINE [BENZATROPINE], DOCUSATE, VITAMIN C [ASCORBIC ACID], ZINC and MELATONIN for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION COMPLICATION (Covid arm 1st dose-left arm). On 30-Jan-2021, VACCINATION COMPLICATION (Covid arm 1st dose-left arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient was prescribed an unspecified antibiotic for the adverse event.   This case was linked to MOD-2021-024410 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up information received provided concomitant and treatment medications.
Sex: M
Vaccine: COVID19
Symptoms: Injection site warmth, Pruritus, Swelling, Vaccination site erythema
Clinical narrative: arm was itching; swelling there's a liquid, red, hot, and now it has travelled all over his elbow to his wrist; Vaccination site erythema; hot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Feb-2021 and was forwarded to Moderna on 07-Feb-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (arm was itching), SWELLING (swelling there's a liquid, red, hot, and now it has travelled all over his elbow to his wrist), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and INJECTION SITE WARMTH (hot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047620A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PRURITUS (arm was itching), SWELLING (swelling there's a liquid, red, hot, and now it has travelled all over his elbow to his wrist), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and INJECTION SITE WARMTH (hot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency. At the time of the report, PRURITUS (arm was itching), SWELLING (swelling there's a liquid, red, hot, and now it has travelled all over his elbow to his wrist), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and INJECTION SITE WARMTH (hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Insomnia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Arm swells; Arm hurts; I didn't sleep last night; Uncomfortable; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Feb-2021 and was forwarded to Moderna on 25-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Arm swells), VACCINATION SITE PAIN (Arm hurts), INSOMNIA (I didn't sleep last night) and DISCOMFORT (Uncomfortable) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Arm swells), VACCINATION SITE PAIN (Arm hurts), INSOMNIA (I didn't sleep last night) and DISCOMFORT (Uncomfortable). At the time of the report, VACCINATION SITE SWELLING (Arm swells), VACCINATION SITE PAIN (Arm hurts), INSOMNIA (I didn't sleep last night) and DISCOMFORT (Uncomfortable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Concomitant medication was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Lymph node pain, Nipple pain, Rash, Rash erythematous
Clinical narrative: Rash all over the body/Severe rash; feeling miserable for several days; few spots on left arm; Itched; red; nipples were very tender; lymph glands in the breast area and under the armpits responded; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 08-Feb-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash all over the body/Severe rash), FEELING ABNORMAL (feeling miserable for several days), RASH MACULAR (few spots on left arm), RASH PRURITIC (Itched) and RASH ERYTHEMATOUS (red) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. LOT# 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included SIMVASTATIN.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash all over the body/Severe rash), FEELING ABNORMAL (feeling miserable for several days), RASH MACULAR (few spots on left arm), RASH PRURITIC (Itched), RASH ERYTHEMATOUS (red), NIPPLE PAIN (nipples were very tender) and LYMPH NODE PAIN (lymph glands in the breast area and under the armpits responded). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH (Rash all over the body/Severe rash), FEELING ABNORMAL (feeling miserable for several days), RASH MACULAR (few spots on left arm), RASH PRURITIC (Itched), RASH ERYTHEMATOUS (red), NIPPLE PAIN (nipples were very tender) and LYMPH NODE PAIN (lymph glands in the breast area and under the armpits responded) outcome was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Rash macular, Rash pruritic
Clinical narrative: Rash all over the body/Severe rash; feeling miserable for several days; few spots on left arm; Itched; red; nipples were very tender; lymph glands in the breast area and under the armpits responded; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 08-Feb-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash all over the body/Severe rash), FEELING ABNORMAL (feeling miserable for several days), RASH MACULAR (few spots on left arm), RASH PRURITIC (Itched) and RASH ERYTHEMATOUS (red) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. LOT# 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included SIMVASTATIN.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash all over the body/Severe rash), FEELING ABNORMAL (feeling miserable for several days), RASH MACULAR (few spots on left arm), RASH PRURITIC (Itched), RASH ERYTHEMATOUS (red), NIPPLE PAIN (nipples were very tender) and LYMPH NODE PAIN (lymph glands in the breast area and under the armpits responded). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH (Rash all over the body/Severe rash), FEELING ABNORMAL (feeling miserable for several days), RASH MACULAR (few spots on left arm), RASH PRURITIC (Itched), RASH ERYTHEMATOUS (red), NIPPLE PAIN (nipples were very tender) and LYMPH NODE PAIN (lymph glands in the breast area and under the armpits responded) outcome was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: headache; Cough; SARS-COV-2 test positive; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 08-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), COUGH (Cough) and SARS-COV-2 TEST POSITIVE (SARS-COV-2 test positive) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Tremor. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) 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 29-Jan-2021, the patient experienced HEADACHE (headache), COUGH (Cough) and SARS-COV-2 TEST POSITIVE (SARS-COV-2 test positive). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), COUGH (Cough) and SARS-COV-2 TEST POSITIVE (SARS-COV-2 test positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication includes medicine for her cholesterol and for her tremors.   This case was linked to US-MODERNATX, INC.-MOD-2021-029065, US-MODERNATX, INC.-MOD-2021-029065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-029065: US-MODERNATX, INC.-MOD-2021-029065: