chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pruritus, Scab
Clinical narrative: itchiness on her neck, stomach and legs/Itchiness on her legs; scabs on her neck and stomach; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness on her neck, stomach and legs/Itchiness on her legs), SCAB (scabs on her neck and stomach) and FATIGUE (feeling tired) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced PRURITUS (itchiness on her neck, stomach and legs/Itchiness on her legs), SCAB (scabs on her neck and stomach) and FATIGUE (feeling tired). At the time of the report, PRURITUS (itchiness on her neck, stomach and legs/Itchiness on her legs) and SCAB (scabs on her neck and stomach) had resolved and FATIGUE (feeling tired) 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 for the event included diphenhydramine, rubbing alcohol, and hydrocortisone cream.  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.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jan-2021: No specific follow-up information recorded.; 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.
Age: 25.0
Sex: U
Vaccine: COVID19
Symptoms: Eye swelling, Lymphadenopathy, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Arm being itchy at the injection site; Swollen lymph nodes in her arm and shoulder; Whole upper arm looked like there was red dye under the skin in an oval shape; Whole upper arm is sensitive; Eye started to swell up; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eye started to swell up), LYMPHADENOPATHY (Swollen lymph nodes in her arm and shoulder), VACCINATION SITE PRURITUS (Arm being itchy at the injection site), VACCINATION SITE ERYTHEMA (Whole upper arm looked like there was red dye under the skin in an oval shape) and VACCINATION SITE PAIN (Whole upper arm is sensitive) in a 25-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2021, the patient experienced EYE SWELLING (Eye started to swell up). On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes in her arm and shoulder), VACCINATION SITE PRURITUS (Arm being itchy at the injection site), VACCINATION SITE ERYTHEMA (Whole upper arm looked like there was red dye under the skin in an oval shape) and VACCINATION SITE PAIN (Whole upper arm is sensitive). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, EYE SWELLING (Eye started to swell up), LYMPHADENOPATHY (Swollen lymph nodes in her arm and shoulder), VACCINATION SITE PRURITUS (Arm being itchy at the injection site), VACCINATION SITE ERYTHEMA (Whole upper arm looked like there was red dye under the skin in an oval shape) and VACCINATION SITE PAIN (Whole upper arm is sensitive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications 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 event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011320A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    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 CHILLS (Chills) and PYREXIA (Fever). At the time of the report, CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Body temperature: 101.2 (Inconclusive) Degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  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.; 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.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection site swelling; Redness at injection site; Tenderness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Tenderness at the injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE for Hypertension.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Tenderness at the injection site). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at a dose of unknown. At the time of the report, VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Tenderness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was 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: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Injection site rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Injection site rash) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE RASH (Injection site rash). At the time of the report, VACCINATION SITE RASH (Injection site rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.  Treatment medication 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: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort
Clinical narrative: Chest tightness; Anxiety; This spontaneous case was reported by a health care professional and describes the occurrence of CHEST DISCOMFORT (Chest tightness) and ANXIETY (Anxiety) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 11-Jan-2021, the patient experienced CHEST DISCOMFORT (Chest tightness) and ANXIETY (Anxiety). The patient was treated with CETIRIZINE HYDROCHLORIDE (CETRIZINE) at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (Chest tightness) had not resolved and ANXIETY (Anxiety) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ANXIETY (Anxiety) to be not related. No further causality assessment was provided for CHEST DISCOMFORT (Chest tightness).    No concomitant medications were reported.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: fever; ache; leg started to hurt; nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), PYREXIA (fever), PAIN (ache) and PAIN IN EXTREMITY (leg started to hurt) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025l00a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no adverse event). Concomitant products included THYROID for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced NAUSEA (nausea) and PAIN IN EXTREMITY (leg started to hurt). On 18-Jan-2021, the patient experienced PYREXIA (fever) and PAIN (ache). At the time of the report, NAUSEA (nausea), PYREXIA (fever), PAIN (ache) and PAIN IN EXTREMITY (leg started to hurt) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment 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 events, a causal relationship cannot be excluded
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Rash, Unevaluable event
Clinical narrative: Toughness; A rash that develop in chest, shoulder and mainly in chin, jaw and ear and somewhat on the face; Felt mild flushing (like a warm and flushing through the body); This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Felt mild flushing (like a warm and flushing through the body)), UNEVALUABLE EVENT (Toughness) and RASH (A rash that develop in chest, shoulder and mainly in chin, jaw and ear and somewhat on the face) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy (Sulfa) and Drug allergy. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), LETROZOLE and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced FLUSHING (Felt mild flushing (like a warm and flushing through the body)). On 08-Jan-2021, the patient experienced UNEVALUABLE EVENT (Toughness) and RASH (A rash that develop in chest, shoulder and mainly in chin, jaw and ear and somewhat on the face). At the time of the report, FLUSHING (Felt mild flushing (like a warm and flushing through the body)), UNEVALUABLE EVENT (Toughness) and RASH (A rash that develop in chest, shoulder and mainly in chin, jaw and ear and somewhat on the face) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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.; 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site pain) in a 65-year-old female 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 (No medical history provided).    On 09-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (Injection site pain). At the time of the report, VACCINATION SITE PAIN (Injection site pain) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   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.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Feeling abnormal
Clinical narrative: Weak; Brain felt foggy; Tenderness in her arm; Headache; Chills; Achy joints(wrist, knuckles, and knees); Extremely fatigued; This spontaneous case was reported by a nurse and describes the occurrence of ASTHENIA (Weak), FEELING ABNORMAL (Brain felt foggy), TENDERNESS (Tenderness in her arm), HEADACHE (Headache) and CHILLS (Chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) 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 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced ASTHENIA (Weak), FEELING ABNORMAL (Brain felt foggy), TENDERNESS (Tenderness in her arm), HEADACHE (Headache), CHILLS (Chills), ARTHRALGIA (Achy joints(wrist, knuckles, and knees)) and FATIGUE (Extremely fatigued). At the time of the report, ASTHENIA (Weak), FEELING ABNORMAL (Brain felt foggy), TENDERNESS (Tenderness in her arm), HEADACHE (Headache), CHILLS (Chills), ARTHRALGIA (Achy joints(wrist, knuckles, and knees)) and FATIGUE (Extremely fatigued) 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.   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'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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Tenderness
Clinical narrative: Weak; Brain felt foggy; Tenderness in her arm; Headache; Chills; Achy joints(wrist, knuckles, and knees); Extremely fatigued; This spontaneous case was reported by a nurse and describes the occurrence of ASTHENIA (Weak), FEELING ABNORMAL (Brain felt foggy), TENDERNESS (Tenderness in her arm), HEADACHE (Headache) and CHILLS (Chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) 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 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced ASTHENIA (Weak), FEELING ABNORMAL (Brain felt foggy), TENDERNESS (Tenderness in her arm), HEADACHE (Headache), CHILLS (Chills), ARTHRALGIA (Achy joints(wrist, knuckles, and knees)) and FATIGUE (Extremely fatigued). At the time of the report, ASTHENIA (Weak), FEELING ABNORMAL (Brain felt foggy), TENDERNESS (Tenderness in her arm), HEADACHE (Headache), CHILLS (Chills), ARTHRALGIA (Achy joints(wrist, knuckles, and knees)) and FATIGUE (Extremely fatigued) 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.   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'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: Pruritus
Clinical narrative: Itchiness around neck; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness around neck) 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 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced PRURITUS (Itchiness around neck). At the time of the report, PRURITUS (Itchiness around neck) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   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.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Jaw clicking, Pain in extremity, Pain in jaw, Trismus
Clinical narrative: Jaw clicks; Lock jaw; Slight pain upon opening her mouth; Arm sore; This spontaneous case was reported by a health care professional and describes the occurrence of JAW CLICKING (Jaw clicks), TRISMUS (Lock jaw), PAIN IN JAW (Slight pain upon opening her mouth) and PAIN IN EXTREMITY (Arm sore) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Thyroid disorder NOS and Fibromyalgia. Concomitant products included AMITRIPTYLINE for Fibromyalgia, AMLODIPINE for Hypertension, VITAMIN C [ASCORBIC ACID] for Immunodeficiency, VITAMIN D NOS for Immunodeficiency NOS, LEVOTHYROXINE for Thyroid disorder NOS.    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced JAW CLICKING (Jaw clicks), TRISMUS (Lock jaw), PAIN IN JAW (Slight pain upon opening her mouth) and PAIN IN EXTREMITY (Arm sore). On 09-Jan-2021, PAIN IN EXTREMITY (Arm sore) had resolved. At the time of the report, JAW CLICKING (Jaw clicks), TRISMUS (Lock jaw) and PAIN IN JAW (Slight pain upon opening her mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment related information has been reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 symptoms; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine and experienced COVID-19 symptoms.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.   On Unknown date, after receiving the vaccine, the patient experienced COVID-19 symptoms. Upon follow up call, the patients symptoms were fever, vomiting, nausea, headache fatigue, body ache, chills, have sneezing, stuffiness, loss of taste and smell.   She also tested positive for COVID-19.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the event was recovered.; Reporter's Comments: Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of COVID-19 symptoms and mRNA-1273 use is assessed as unlikely.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: hard time sleeping/Patient has been sleeping from 3am to 7am; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (hard time sleeping/Patient has been sleeping from 3am to 7am) in a 91-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 Cardiac operation. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), TAMSULOSIN, FUROSEMIDE, METOPROLOL SUCCINATE (METROL [METOPROLOL SUCCINATE]) and PANTOPRAZOLE for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced INSOMNIA (hard time sleeping/Patient has been sleeping from 3am to 7am). At the time of the report, INSOMNIA (hard time sleeping/Patient has been sleeping from 3am to 7am) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication details was reported.; Sender's Comments: Very limited information regarding this event has been provided at this time. The event is probably related to the patient's comorbidities
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: swollen lymph nodes; lymph nodes that were slightly tender; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes) and LYMPH NODE PAIN (lymph nodes that were slightly tender) 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 No adverse event (No reported medical history).   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes) and LYMPH NODE PAIN (lymph nodes that were slightly tender). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes) and LYMPH NODE PAIN (lymph nodes that were slightly tender) 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.   Company Comment: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swollen at the site of injection; Left arm was slightly pink and had oval redness of 5in in height and 3in width; Little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen at the site of injection), VACCINATION SITE ERYTHEMA (Left arm was slightly pink and had oval redness of 5in in height and 3in width) and VACCINATION SITE PAIN (Little sore) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swollen at the site of injection), VACCINATION SITE ERYTHEMA (Left arm was slightly pink and had oval redness of 5in in height and 3in width) and VACCINATION SITE PAIN (Little sore). At the time of the report, VACCINATION SITE SWELLING (Swollen at the site of injection), VACCINATION SITE ERYTHEMA (Left arm was slightly pink and had oval redness of 5in in height and 3in width) and VACCINATION SITE PAIN (Little sore) 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. 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 dates of the events, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Round knot at the injection site; Injection site is warm to touch; Round knot at injection site that is itchy; Round knot at the injection site that is red; Round knot at injection site that is tender; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Round knot at the injection site), VACCINATION SITE WARMTH (Injection site is warm to touch), VACCINATION SITE PRURITUS (Round knot at injection site that is itchy), VACCINATION SITE ERYTHEMA (Round knot at the injection site that is red) and VACCINATION SITE PAIN (Round knot at injection site that is tender) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder NOS (autoimmune disease).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE MASS (Round knot at the injection site), VACCINATION SITE WARMTH (Injection site is warm to touch), VACCINATION SITE PRURITUS (Round knot at injection site that is itchy), VACCINATION SITE ERYTHEMA (Round knot at the injection site that is red) and VACCINATION SITE PAIN (Round knot at injection site that is tender). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Round knot at the injection site), VACCINATION SITE WARMTH (Injection site is warm to touch), VACCINATION SITE PRURITUS (Round knot at injection site that is itchy), VACCINATION SITE ERYTHEMA (Round knot at the injection site that is red) and VACCINATION SITE PAIN (Round knot at injection site that is tender) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Nausea, Pyrexia
Clinical narrative: Feeling uneasy; Nausea; Chills; General fatigue; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (Feeling uneasy), NAUSEA (Nausea), CHILLS (Chills), FATIGUE (General fatigue) and PYREXIA (Fever) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No medical history reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced MALAISE (Feeling uneasy), NAUSEA (Nausea), CHILLS (Chills), FATIGUE (General fatigue) and PYREXIA (Fever). On 10-Jan-2021, MALAISE (Feeling uneasy), NAUSEA (Nausea), CHILLS (Chills), FATIGUE (General fatigue) and PYREXIA (Fever) 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.   Concomitant product use was not provided by the reporter. Treatment medications included paracetamol and ibuprofen.   This case was linked to MOD-2021-004601 (Patient Link).; 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: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Hypertension
Clinical narrative: High blood pressure; Dizziness; Fatigue; Chills; A spontaneous report was received from a healthcare professional concerning a 80 years old, male patient who experienced fatigue/PT: fatigue, chills/PT: chills, dizziness/PT: dizziness and high blood pressure/PT: hypertension.   The patient's medical history included COVID-19 since an unknown date in Jul 2020 and double pneumonia since an unknown date.  Products known to have been used by the patient, within two weeks prior to the event, included Allopurinol 300 mg, Levothyroxine 88 mg, Amlodipine 10 mg, Potassium 99 mg, Vitamin B12 250 mg, Zinc 50 mg, Vitamin C 500 mg, Tamsulosin Hel .4 mg and Finasteride 5 mg all since an unknown date for an unknown indication.  On 07 Jan 2021, prior to the onset of the symptoms, the patient received their first/second (not specified) of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.    The patient experienced fatigue, chills, dizziness as well as high blood pressure all since 07 Jan 2021.  Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events fatigue, chills, dizziness as well as high blood pressure were unknown.; Reporter'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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Dry mouth, Fatigue
Clinical narrative: very hard to walk; sick for 3 days; achiness; sick feeling; nauseous; fever 102F; chills; dizzy; dry  mouth; tired; achy joints; headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for 3 days), GAIT DISTURBANCE (very hard to walk) and MYALGIA (achiness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Itching and Cataract operation. Concomitant products included DUPILUMAB from 06-Dec-2018 to an unknown date for Eczema.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick for 3 days), GAIT DISTURBANCE (very hard to walk) and MYALGIA (achiness). At the time of the report, ILLNESS (sick for 3 days), GAIT DISTURBANCE (very hard to walk) and MYALGIA (achiness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: Positive. On an unknown date, X-ray: (Inconclusive) no improvement on the chest x-ray.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-188550 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: reporter details, lab data, vaccination information , even t were updated; 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Illness, Malaise, Myalgia
Clinical narrative: very hard to walk; sick for 3 days; achiness; sick feeling; nauseous; fever 102F; chills; dizzy; dry  mouth; tired; achy joints; headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for 3 days), GAIT DISTURBANCE (very hard to walk) and MYALGIA (achiness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Itching and Cataract operation. Concomitant products included DUPILUMAB from 06-Dec-2018 to an unknown date for Eczema.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick for 3 days), GAIT DISTURBANCE (very hard to walk) and MYALGIA (achiness). At the time of the report, ILLNESS (sick for 3 days), GAIT DISTURBANCE (very hard to walk) and MYALGIA (achiness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: Positive. On an unknown date, X-ray: (Inconclusive) no improvement on the chest x-ray.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-188550 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: reporter details, lab data, vaccination information , even t were updated; 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test positive, X-ray
Clinical narrative: very hard to walk; sick for 3 days; achiness; sick feeling; nauseous; fever 102F; chills; dizzy; dry  mouth; tired; achy joints; headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for 3 days), GAIT DISTURBANCE (very hard to walk) and MYALGIA (achiness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Itching and Cataract operation. Concomitant products included DUPILUMAB from 06-Dec-2018 to an unknown date for Eczema.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick for 3 days), GAIT DISTURBANCE (very hard to walk) and MYALGIA (achiness). At the time of the report, ILLNESS (sick for 3 days), GAIT DISTURBANCE (very hard to walk) and MYALGIA (achiness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: Positive. On an unknown date, X-ray: (Inconclusive) no improvement on the chest x-ray.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-188550 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: reporter details, lab data, vaccination information , even t were updated; 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: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Cold-stimulus headache, Insomnia
Clinical narrative: brain freeze/shooting pain headache similar to brain freeze after you get ice cream; to help her sleep she took a sleeping pill; This spontaneous case was reported by a consumer and describes the occurrence of COLD-STIMULUS HEADACHE (brain freeze/shooting pain headache similar to brain freeze after you get ice cream) and INSOMNIA (to help her sleep she took a sleeping pill) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced COLD-STIMULUS HEADACHE (brain freeze/shooting pain headache similar to brain freeze after you get ice cream) and INSOMNIA (to help her sleep she took a sleeping pill). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Brain freeze, at an unspecified dose and frequency. At the time of the report, COLD-STIMULUS HEADACHE (brain freeze/shooting pain headache similar to brain freeze after you get ice cream) had not resolved and INSOMNIA (to help her sleep she took a sleeping pill) outcome was unknown.            Patient reported that she took a sleeping pill to help her sleep. In concomitant medications blood pressure medication was reported. Patient reported that she received second shot of Moderna and did not have any reaction. Patient reported that the shooting pain headache made her think as if she was having a stroke.   Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2021: Follow-up information received on 17 APR 2021 contains Added historical condition, concomitant medications and treatment . Updated patient demographics, re-challenge date and event outcome. On 11-Jun-2021: No new information was updated.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: 6 inch wide rash on the opposite side of the L elbow (volar area); Itchy on the area of the injection; Painful bump/swelling at the injection site; Difficulty moving his L arm up and down; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Difficulty moving his L arm up and down), VACCINATION SITE PRURITUS (Itchy on the area of the injection), VACCINATION SITE SWELLING (Painful bump/swelling at the injection site) and VACCINATION SITE RASH (6 inch wide rash on the opposite side of the L elbow (volar area)) in a male 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 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Difficulty moving his L arm up and down) and VACCINATION SITE SWELLING (Painful bump/swelling at the injection site). On 10-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy on the area of the injection). On 11-Jan-2021, the patient experienced VACCINATION SITE RASH (6 inch wide rash on the opposite side of the L elbow (volar area)). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 milligram. On 09-Jan-2021, VACCINATION SITE MOVEMENT IMPAIRMENT (Difficulty moving his L arm up and down) and VACCINATION SITE SWELLING (Painful bump/swelling at the injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itchy on the area of the injection) and VACCINATION SITE RASH (6 inch wide rash on the opposite side of the L elbow (volar area)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: Dizziness; Nausea; Vomiting; Headache; This spontaneous case was reported by a health care professional and describes the occurrence of DIZZINESS (Dizziness), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter. .     On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Jan-2021, the patient experienced DIZZINESS (Dizziness), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications included an unspecified medication for nausea.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itching around the injection site; Redness around the injection site; Around the injection site is swollen; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PRURITUS (Itching around the injection site), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE SWELLING (Around the injection site is swollen) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Intraocular pressure high. Concomitant products included DORZOLAMIDE HYDROCHLORIDE (DORZOLAMIDE [DORZOLAMIDE HYDROCHLORIDE]) and BIMATOPROST (LUMIGAN PF) for Intraocular pressure high, VITAMIN D NOS and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching around the injection site), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE SWELLING (Around the injection site is swollen). At the time of the report, VACCINATION SITE PRURITUS (Itching around the injection site), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE SWELLING (Around the injection site is swollen) 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.   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 onset date of the reported events, a causal relationship cannot be excluded.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Diarrhoea, Myalgia, Oropharyngeal pain
Clinical narrative: This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ARTHRALGIA (joint ache), MYALGIA (muscle ache), DIARRHOEA (diarrhea), COUGH (slight cough) and OROPHARYNGEAL PAIN (sore throat) in a 55-year-old male 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 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced ARTHRALGIA (joint ache), MYALGIA (muscle ache), DIARRHOEA (diarrhea), COUGH (slight cough) and OROPHARYNGEAL PAIN (sore throat). On 10-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID -19 test positive). The patient was treated with NAPROXEN SODIUM (ALEVE) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (joint ache), MYALGIA (muscle ache), DIARRHOEA (diarrhea), COUGH (slight cough), OROPHARYNGEAL PAIN (sore throat) and SARS-COV-2 TEST POSITIVE (COVID -19 test positive) 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.; Sender's Comments: Very limited information regarding this event has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.