chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Injection site itches; Rash at the injection site; Swelling at injection site; Redness around the shot area about the size of 4 quarters; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itches), VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness around the shot area about the size of 4 quarters) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itches), VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness around the shot area about the size of 4 quarters). At the time of the report, VACCINATION SITE PRURITUS (Injection site itches), VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness around the shot area about the size of 4 quarters) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included an ice pack and an anti-histamine. No concomitant medications were provided by reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Product quality issue, SARS-CoV-2 antibody test, Vaccination site pain
Clinical narrative: soreness at injection site; vaccine looked like water/clear and not white to off white color; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT QUALITY ISSUE (vaccine looked like water/clear and not white to off white color) and VACCINATION SITE PAIN (soreness at injection site) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included Ischemic cardiomyopathy and Coronary bypass in 2019. Concurrent medical conditions included Allergy (yellow jacket hornets). Concomitant products included CARVEDILOL (COREG), LOSARTAN, SIMVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 07-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PRODUCT QUALITY ISSUE (vaccine looked like water/clear and not white to off white color). On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site). At the time of the report, PRODUCT QUALITY ISSUE (vaccine looked like water/clear and not white to off white color) had resolved and VACCINATION SITE PAIN (soreness at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, SARS-CoV-2 antibody test: positive (Positive) The Roche Elecsys Anti-SARS-CoV2 S test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment related information has been reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow-up information received contains  lab data - Positive result for test spike Protein antibody test  received after vaccination. On 25-Jul-2021: Follow-up information received contains No new information.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itching at the injection site; Redness on injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE ERYTHEMA (Redness on injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1273011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness on injection site). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE ERYTHEMA (Redness on injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This spontaneous case was reported by non-health care professional and describes the occurrence of Vaccination site pruritus (injection site itching) and Vaccination site erythema (injection site warm) female patient of 74 year of age, who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination     No treatment was reported for the events.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Return of same symptoms as when she had covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Return of same symptoms as when she had covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced COVID-19 (Return of same symptoms as when she had covid). At the time of the report, COVID-19 (Return of same symptoms as when she had covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills
Clinical narrative: little bit of a chill; soreness in shoulder area; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (little bit of a chill) and ARTHRALGIA (soreness in shoulder area) in a 76-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (little bit of a chill) and ARTHRALGIA (soreness in shoulder area). At the time of the report, CHILLS (little bit of a chill) and ARTHRALGIA (soreness in shoulder area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event was not provided. Lab details were not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain in ankle; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain in ankle) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 15-Jan-2021, the patient experienced ARTHRALGIA (Joint pain in ankle). At the time of the report, ARTHRALGIA (Joint pain in ankle) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Light headedness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history was reported.).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced DIZZINESS (Light headedness). At the time of the report, DIZZINESS (Light headedness) 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: little red around the injection site; itching; tenderness in the spot; This spontaneous case was reported by a consumer and describes the occurrence of   in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: horrible pain (whole arm, shoulder, neck); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (horrible pain (whole arm, shoulder, neck)) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Injury (Patient reported a previous injury on her right side.).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (horrible pain (whole arm, shoulder, neck)). At the time of the report, PAIN IN EXTREMITY (horrible pain (whole arm, shoulder, neck)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The Treatment information included muscle relaxer that was prescribed for a previous injury on right side. No relevant concomitant medications were provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event,  a causal relationship cannot be excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Fatigue, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Tingling lip; Numb arm; Weakness; Fever of 101 degrees; Heart racing; Sweating; Diarrhea; Very ill; Completely wiped out; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA ORAL (Tingling lip), HYPOAESTHESIA (Numb arm), ASTHENIA (Weakness), PYREXIA (Fever of 101 degrees) and PALPITATIONS (Heart racing) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 13-Jan-2021, the patient experienced FATIGUE (Completely wiped out). On an unknown date, the patient experienced PARAESTHESIA ORAL (Tingling lip), HYPOAESTHESIA (Numb arm), ASTHENIA (Weakness), PYREXIA (Fever of 101 degrees), PALPITATIONS (Heart racing), HYPERHIDROSIS (Sweating), DIARRHOEA (Diarrhea) and MALAISE (Very ill). At the time of the report, PARAESTHESIA ORAL (Tingling lip), HYPOAESTHESIA (Numb arm), ASTHENIA (Weakness), PYREXIA (Fever of 101 degrees), PALPITATIONS (Heart racing), HYPERHIDROSIS (Sweating), DIARRHOEA (Diarrhea), FATIGUE (Completely wiped out) and MALAISE (Very ill) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Pyrexia: 101 degrees 101 degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment with bupropion and estradiol patch was reported. HCP told the patient to in isolation for 3 days
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Palpitations, Paraesthesia oral, Pyrexia
Clinical narrative: Tingling lip; Numb arm; Weakness; Fever of 101 degrees; Heart racing; Sweating; Diarrhea; Very ill; Completely wiped out; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA ORAL (Tingling lip), HYPOAESTHESIA (Numb arm), ASTHENIA (Weakness), PYREXIA (Fever of 101 degrees) and PALPITATIONS (Heart racing) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 13-Jan-2021, the patient experienced FATIGUE (Completely wiped out). On an unknown date, the patient experienced PARAESTHESIA ORAL (Tingling lip), HYPOAESTHESIA (Numb arm), ASTHENIA (Weakness), PYREXIA (Fever of 101 degrees), PALPITATIONS (Heart racing), HYPERHIDROSIS (Sweating), DIARRHOEA (Diarrhea) and MALAISE (Very ill). At the time of the report, PARAESTHESIA ORAL (Tingling lip), HYPOAESTHESIA (Numb arm), ASTHENIA (Weakness), PYREXIA (Fever of 101 degrees), PALPITATIONS (Heart racing), HYPERHIDROSIS (Sweating), DIARRHOEA (Diarrhea), FATIGUE (Completely wiped out) and MALAISE (Very ill) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Pyrexia: 101 degrees 101 degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment with bupropion and estradiol patch was reported. HCP told the patient to in isolation for 3 days
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pruritus, Vaccination site papule
Clinical narrative: injection site pain; pimple at injection site; itching shoulder up to head; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRURITUS (itching shoulder up to head), INJECTION SITE PAIN (injection site pain) and VACCINATION SITE PAPULE (pimple at injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Depression and Anxiety.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced PRURITUS (itching shoulder up to head). On 08-Jan-2021, the patient experienced INJECTION SITE PAIN (injection site pain) and VACCINATION SITE PAPULE (pimple at injection site). On 09-Jan-2021, INJECTION SITE PAIN (injection site pain) and VACCINATION SITE PAPULE (pimple at injection site) had resolved. In January 2021, PRURITUS (itching shoulder up to head) had resolved.        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.   Patient treatment includes Silver facemask treatment, Cortisone applied QID and Benadryl as treatment medication.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Had a  2 cm erythema at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Had a  2 cm erythema at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history was reported.).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Had a  2 cm erythema at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Had a  2 cm erythema at the 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.   Treatment information was not provided. Concomitant medication was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Fatigue, Headache, SARS-CoV-2 test
Clinical narrative: fatigue over the last few days; loss of sense of taste; Headaches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of sense of taste), HEADACHE (Headaches) and FATIGUE (fatigue over the last few days) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism. Concurrent medical conditions included Seasonal allergy and Hyperlipidaemia. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for High cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Seasonal allergy.    On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced HEADACHE (Headaches). On 14-Jan-2021, the patient experienced AGEUSIA (loss of sense of taste). On an unknown date, the patient experienced FATIGUE (fatigue over the last few days). At the time of the report, AGEUSIA (loss of sense of taste), HEADACHE (Headaches) and FATIGUE (fatigue over the last few days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, SARS-CoV-2 test:.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: sore at the injection site; Fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore at the injection site) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore at the injection site) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE PAIN (sore at the injection site) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided. Concomitant information was not provided.    Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder
Clinical narrative: off balance; Weak legs; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (off balance) and ASTHENIA (Weak legs) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Patient is on medications for blood pressure). Concomitant products included HYDRALAZINE and DILTIAZEM HYDROCHLORIDE (CARTIA XT) for Blood pressure, ROPINIROLE and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Restless legs, VITAMINS [UMBRELLA TERM] for an unknown indication.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 14-Jan-2021, the patient experienced BALANCE DISORDER (off balance) and ASTHENIA (Weak legs). On 14-Jan-2021, BALANCE DISORDER (off balance) and ASTHENIA (Weak legs) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: High fever; Muscle ache; Body aches; A spontaneous report from unspecified location was received from a Nurse concerning a 42-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced high fever, muscle ache and body aches.   The patient's medical history and concomitant medication were not provided.    On 13-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly on right arm for prophylaxis of COVID-19 infection.    On 14-JAN-2021, approximately one day after receiving mRNA-1273, patient started experiencing high fever, muscle ache and body aches. Patient gave consent for safety follow-up with her.  Action taken with mRNA-1273 in response to the events was not reported.    Outcome of the event experienced high fever, muscle ache and body aches were considered unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: felt like a bruise; Vaccination site pain; Vaccination site movement impairment; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (felt like a bruise), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE MOVEMENT IMPAIRMENT (Vaccination site movement impairment) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Psoriatic arthritis. Concurrent medical conditions included BP. Concomitant products included LISINOPRIL for Blood pressure, ETANERCEPT (ENBREL) for Psoriatic arthritis.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 14-Jan-2021, the patient experienced CONTUSION (felt like a bruise), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE MOVEMENT IMPAIRMENT (Vaccination site movement impairment). At the time of the report, CONTUSION (felt like a bruise), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE MOVEMENT IMPAIRMENT (Vaccination site movement impairment) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was provided as she took two ibuprofen tablets 30 minutes before receiving the vaccination and two ibuprofen tablets 6 hours later.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site induration
Clinical narrative: Pale red arm; Bump at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Pale red arm) and VACCINATION SITE INDURATION (Bump at 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 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced ERYTHEMA (Pale red arm) and VACCINATION SITE INDURATION (Bump at injection site). At the time of the report, ERYTHEMA (Pale red arm) and VACCINATION SITE INDURATION (Bump at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment activities for event was unknown.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Rednesss and swelling like a local reaction to a vaccine; Rednesss and swelling like a local reaction to a vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE SWELLING (Rednesss and swelling like a local reaction to a vaccine) and VACCINATION SITE ERYTHEMA (Rednesss and swelling like a local reaction to a vaccine) in a 50-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 reported medical history).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Rednesss and swelling like a local reaction to a vaccine) and VACCINATION SITE ERYTHEMA (Rednesss and swelling like a local reaction to a vaccine). At the time of the report, VACCINATION SITE SWELLING (Rednesss and swelling like a local reaction to a vaccine) and VACCINATION SITE ERYTHEMA (Rednesss and swelling like a local reaction to a vaccine) had not resolved.        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 information was not provided.  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance test, Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 28-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in June 2020 and the estimated date of delivery was 27-Mar-2021. On 09-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-ninth 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 09-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2020, Pregnancy test: positive (Positive) positive. On an unknown date, Glucose tolerance test: inconclusive (Inconclusive) 20 week pregnant. On an unknown date, Ultrasound scan: inconclusive (Inconclusive) 20 week pregnant.     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.   Patient was taking pre natal vitamins. No treatment information was provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 28-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Vaccination site pain
Clinical narrative: Vaccination site pain; Heartbeat felt a little bit faster now feels fine; Slight headache; Tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Heartbeat felt a little bit faster now feels fine), HEADACHE (Slight headache), FATIGUE (Tired) and VACCINATION SITE PAIN (Vaccination site pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Endometrial cancer. Concurrent medical conditions included Plant skin sensitivity (Denies allergies but Paclitaxel caused tachycardia to patient and was told it was plant based.). Concomitant products included VITAMIN D NOS for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced HEART RATE INCREASED (Heartbeat felt a little bit faster now feels fine), HEADACHE (Slight headache) and FATIGUE (Tired). On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, HEART RATE INCREASED (Heartbeat felt a little bit faster now feels fine) was resolving and HEADACHE (Slight headache), FATIGUE (Tired) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment taken by patient is Tylenol.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: Bumps (rash) at the injection site measuring 2 inches wide and 3 inches high; Sore at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore at the injection site) and VACCINATION SITE RASH (Bumps (rash) at the injection site measuring 2 inches wide and 3 inches high) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE PAIN (Sore at the injection site). On an unknown date, the patient experienced VACCINATION SITE RASH (Bumps (rash) at the injection site measuring 2 inches wide and 3 inches high). At the time of the report, VACCINATION SITE PAIN (Sore at the injection site) and VACCINATION SITE RASH (Bumps (rash) at the injection site measuring 2 inches wide and 3 inches high) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment medication included Cortisone.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Vaccination site pain
Clinical narrative: soreness in injection site; muscle pain; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to the company on 15-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in injection site), MYALGIA (muscle pain) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical History Reported).    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 VACCINATION SITE PAIN (soreness in injection site), MYALGIA (muscle pain) and HEADACHE (headache). At the time of the report, VACCINATION SITE PAIN (soreness in injection site), MYALGIA (muscle pain) 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 did not provide any causality assessments.   Treatment information was not provided. Concomitant medication was not provided.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: arm was hurting; Hard lump at the injection site; Injection site was itching; red spot at the injection site; Injection site muscle ached; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was hurting), VACCINATION SITE INDURATION (Hard lump at the injection site), VACCINATION SITE PRURITUS (Injection site was itching), VACCINATION SITE PAIN (Injection site muscle ached) and VACCINATION SITE ERYTHEMA (red spot at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0391Z20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (Injection site muscle ached). On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was hurting), VACCINATION SITE INDURATION (Hard lump at the injection site), VACCINATION SITE PRURITUS (Injection site was itching) and VACCINATION SITE ERYTHEMA (red spot at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) on 14-Jan-2021 at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm was hurting), VACCINATION SITE INDURATION (Hard lump at the injection site), VACCINATION SITE PRURITUS (Injection site was itching), VACCINATION SITE PAIN (Injection site muscle ached) and VACCINATION SITE ERYTHEMA (red spot at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Weakness; Achy; Fever; Headache; Tiredness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), MYALGIA (Achy), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced CHILLS (Chills). On 14-Jan-2021, the patient experienced ASTHENIA (Weakness), MYALGIA (Achy), PYREXIA (Fever), HEADACHE (Headache) and FATIGUE (Tiredness). On 13-Jan-2021, CHILLS (Chills) had resolved. On 14-Jan-2021, MYALGIA (Achy), PYREXIA (Fever) and HEADACHE (Headache) had resolved. At the time of the report, ASTHENIA (Weakness) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication were not reported by the reporter. Treatment details were not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Weakness; Achy; Fever; Headache; Tiredness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), MYALGIA (Achy), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced CHILLS (Chills). On 14-Jan-2021, the patient experienced ASTHENIA (Weakness), MYALGIA (Achy), PYREXIA (Fever), HEADACHE (Headache) and FATIGUE (Tiredness). On 13-Jan-2021, CHILLS (Chills) had resolved. On 14-Jan-2021, MYALGIA (Achy), PYREXIA (Fever) and HEADACHE (Headache) had resolved. At the time of the report, ASTHENIA (Weakness) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication were not reported by the reporter. Treatment details were not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: Numbness on left side of my face; Sore shoulder; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Numbness on left side of my face) and ARTHRALGIA (Sore shoulder) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Numbness on left side of my face) and ARTHRALGIA (Sore shoulder). At the time of the report, VACCINATION SITE PAIN (Numbness on left side of my face) and ARTHRALGIA (Sore shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Heart rate irregular, Palpitations
Clinical narrative: Heartbeat was extremely fast, irregular/Heartbeat reach 188 rpm; Heartbeat was extremely fast, irregular; Felt heart pounding in her chest; This spontaneous case was reported by a nurse and describes the occurrence of HEART RATE INCREASED (Heartbeat was extremely fast, irregular/Heartbeat reach 188 rpm), HEART RATE IRREGULAR (Heartbeat was extremely fast, irregular) and PALPITATIONS (Felt heart pounding in her chest) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sleep apnea.    On 10-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced HEART RATE INCREASED (Heartbeat was extremely fast, irregular/Heartbeat reach 188 rpm), HEART RATE IRREGULAR (Heartbeat was extremely fast, irregular) and PALPITATIONS (Felt heart pounding in her chest). At the time of the report, HEART RATE INCREASED (Heartbeat was extremely fast, irregular/Heartbeat reach 188 rpm), HEART RATE IRREGULAR (Heartbeat was extremely fast, irregular) and PALPITATIONS (Felt heart pounding in her chest) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 188 rpm (abnormal) 188 rpm.     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 product use was not provided by the reporter. No treatment medication was reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.