chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Extra dose administered
Clinical narrative: extra dose administered; very weak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (very weak) and EXTRA DOSE ADMINISTERED (extra dose administered) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery on 19-Feb-2021. Concurrent medical conditions included Colon cancer since 13-Feb-2021.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced ASTHENIA (very weak). On 18-Mar-2021, the patient experienced EXTRA DOSE ADMINISTERED (extra dose administered). On 18-Mar-2021, EXTRA DOSE ADMINISTERED (extra dose administered) had resolved. At the time of the report, ASTHENIA (very weak) outcome was unknown.            On 18MAR2021, the rehab facility made a mistake to give her a third dose claiming that the 2nd dose she received was not documented.  Concomitant product use was not provided by the reporter. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not Applicable.  Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: Significant blood that came out from the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Significant blood that came out from the injection site) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Significant blood that came out from the injection site). On 21-Apr-2021, VACCINATION SITE HAEMORRHAGE (Significant blood that came out from the injection site) had resolved. Not Provided          Concurrent medication details not provided.  Treatment details were not provided. Patient stated that vaccination provider cleaned the site and put band aid on it.
Sex: M
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED (Blood work showed low platelets) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PLATELET COUNT DECREASED (Blood work showed low platelets). At the time of the report, PLATELET COUNT DECREASED (Blood work showed low platelets) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) On an unknown date, Platelet count: Low and normal. Prior vaccination the patient went for physical exam and his blood work showed low platelets and he never had low platelets before. Doctor told patient to come back with in one month for a recheck and on unknown date  blood work showed normal platelet levels. No treatment medication provided by reporter. No concomitant medication provided by reporter.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: injection site burning, Pain in arm; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE PAIN (injection site burning, Pain in arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.    Co-suspect products included non-company products RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis and ADALIMUMAB (HUMIRA) for an unknown indication.    Concurrent medical conditions included Plaque psoriasis (moderate to severe, chronic).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced INJECTION SITE PAIN (injection site burning, Pain in arm). At the time of the report, INJECTION SITE PAIN (injection site burning, Pain in arm) 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.   No concomitant medicines were reported. No treatment information were reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Terrible headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Hypertension and Eye disorder NOS. Concomitant products included VITAMINS NOS for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced HEADACHE (Terrible headache). At the time of the report, HEADACHE (Terrible headache) had not resolved. Not Provided          Concomitant medications included blood pressure medicine and eye medicine. .  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Mouth haemorrhage
Clinical narrative: Bleeding from mouth; Chest pain; Could not breath; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), DYSPNOEA (Could not breath) and MOUTH HAEMORRHAGE (Bleeding from mouth) 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 was reported.).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced CHEST PAIN (Chest pain) and DYSPNOEA (Could not breath). On 11-Apr-2021, the patient experienced MOUTH HAEMORRHAGE (Bleeding from mouth). On 10-Apr-2021, CHEST PAIN (Chest pain) and DYSPNOEA (Could not breath) had resolved. On 11-Apr-2021, MOUTH HAEMORRHAGE (Bleeding from mouth) had resolved.        This case was linked to MOD-2021-073072 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Diarrhoea, Hypersensitivity, Sneezing, Throat irritation
Clinical narrative: Diarrhea; Throat irritation; Sneezing; Allergy; This spontaneous case was reported by a physician and describes the occurrence of THROAT IRRITATION (Throat irritation), SNEEZING (Sneezing), HYPERSENSITIVITY (Allergy) and DIARRHOEA (Diarrhea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 22-Mar-2021, the patient experienced THROAT IRRITATION (Throat irritation), SNEEZING (Sneezing) and HYPERSENSITIVITY (Allergy). On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, THROAT IRRITATION (Throat irritation), SNEEZING (Sneezing) and HYPERSENSITIVITY (Allergy) had not resolved and DIARRHOEA (Diarrhea) 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 medication was reported.  Treatment medication was not provided by the reporter.   Reporter did not allow further contact
Age: 31.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Headache, Vaccination site pain, X-ray
Clinical narrative: Headache; Pain in arm; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Pain in arm) and HEADACHE (Headache) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 006B21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    The patient's past medical history included Kidney stones (Hospitalized. Recovered 14-Jan-2021; also reported at the beginning of February 2021, his kidney stones were removed) from 28-Dec-2020 to February 2021 and Stent placement (Stent placed to remove the kidney stones.  Stent was removed on 11-Jan-2021) on 11-Jan-2021. Previously administered products included for Kidney stones: Keflex from 28-Dec-2020 to 06-Jan-2021. Past adverse reactions to the above products included No adverse reaction with Keflex. Concurrent medical conditions included Kidney stones (Recurring issues with kidney stones), Non-tobacco user, Abstains from alcohol, Attention deficit disorder, Asperger's syndrome, Scoliosis, Obsessive-compulsive disorder and Crohn's disease (Moderate to severe). Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Attention deficit disorder.   On 08-Aug-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain in arm). On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (Pain in arm) had not resolved and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2020, X-ray: kidney stones (abnormal) Showed that he had 2 kidney stones..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE PAIN (Pain in arm) to be possibly related. No further causality assessment was provided for HEADACHE (Headache).    Treatment of the events were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow-up information received on 24-MAY-2021 contains no new information. On 01-Jun-2021: Follow up report received on 01-JUN-2021 included additional events.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site itching; injection site swelling; injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (injection site redness) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Herpes zoster.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (injection site redness). At the time of the report, VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (injection site redness) outcome was unknown.            she recently got a Shingles shot No Concomitant medications were provided No treatment information provided   Reporter did not allow further contact
Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Body temperature increased, Headache, Myalgia, Pyrexia
Clinical narrative: Headache; body ache; temperature elevation from 100.4-101.8F till 102 degrees Fahrenheit; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MYALGIA (body ache) and PYREXIA (temperature elevation from 100.4-101.8F till 102 degrees Fahrenheit) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 040A21A) for COVID-19 vaccination.    Co-suspect product included non-company product NAPROXEN SODIUM (ALEVE) for an unknown indication.    No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE, ATORVASTATIN and HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN-HYDROCHLOROTHIAZIDE) for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started NAPROXEN SODIUM (ALEVE) (unknown route) at an unspecified dose. On 21-Apr-2021, the patient experienced HEADACHE (Headache), MYALGIA (body ache) and PYREXIA (temperature elevation from 100.4-101.8F till 102 degrees Fahrenheit). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), MYALGIA (body ache) and PYREXIA (temperature elevation from 100.4-101.8F till 102 degrees Fahrenheit) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Body temperature increased: 100.4-101.8f till 102 100.4-101.8F till 102.         Treatment drugs included Tylenol and Aleve.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Extremely tired and fatigue; He had headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (He had headache) and FATIGUE (Extremely tired and fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced HEADACHE (He had headache). On 08-Apr-2021, the patient experienced FATIGUE (Extremely tired and fatigue). At the time of the report, HEADACHE (He had headache) had resolved and FATIGUE (Extremely tired and fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: Arm felt like a rock; Redness; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Arm felt like a rock), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy, Allergy to chemicals (Formaldehyde) and Sulfonamide allergy (All sulfa drugs). Concomitant products included SERTRALINE for Anxiety, OMEPRAZOLE for Hiatal hernia.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Arm felt like a rock), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling). At the time of the report, VACCINATION SITE INDURATION (Arm felt like a rock), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-084745 (E2B Linked Report). This case was linked to MOD-2021-019243 (Patient Link).; Sender's Comments:  MOD-2021-084745:crosslinked, Husband of MOD-2021-019243
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: periods are longer and heavier; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (periods are longer and heavier) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (periods are longer and heavier). At the time of the report, HEAVY MENSTRUAL BLEEDING (periods are longer and heavier) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. Her period lasted more than 14 days.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Jaw disorder
Clinical narrative: patient had to go to the emergency room because her jaw locked up after receiving first COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of JAW DISORDER (patient had to go to the emergency room because her jaw locked up after receiving first COVID-19 vaccine) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM for Pulmonary arterial hypertension.    The patient's past medical history included Serotonin syndrome. Concurrent medical conditions included Pulmonary arterial hypertension since 29-Nov-2020. Concomitant products included MACITENTAN, TADALAFIL and WARFARIN SODIUM for an unknown indication.   On 19-Nov-2020, the patient started TREPROSTINIL SODIUM (Intravenous) .09 microgram/kilogram. 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 JAW DISORDER (patient had to go to the emergency room because her jaw locked up after receiving first COVID-19 vaccine). At the time of the report, JAW DISORDER (patient had to go to the emergency room because her jaw locked up after receiving first COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included Treprostinil sodium (IV) (TREPROSTINIL SODIUM) (Continued).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: chills; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headache) and PYREXIA (fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), HEADACHE (headache) and PYREXIA (fever). At the time of the report, CHILLS (chills), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy, Allergy to chemicals (formaldehyde) and Drug allergy (All sulfa drugs).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment was provided.    This case was linked to MOD-2021-084638 (E2B Linked Report).; Sender's Comments:  MOD-2021-084638:crosslinked, Wife of the patient (second dose)
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Dyspnoea, Headache, Lymph node pain
Clinical narrative: Stomach issue\pain in the right quadrant which she describes as intermittent pain; musculoskeletal pain; Joint issue; pain in the lymph node of the arm; nauseated; headache\intermittent pain in back of her head; feels like hit by a truck; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), ABDOMINAL DISCOMFORT (Stomach issue\pain in the right quadrant which she describes as intermittent pain), MUSCULOSKELETAL PAIN (musculoskeletal pain), ARTHRALGIA (Joint issue) and LYMPH NODE PAIN (pain in the lymph node of the arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Primary biliary cholangitis (Autoimmune disorder).    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced DYSPNOEA (shortness of breath). On 21-Apr-2021, the patient experienced LYMPH NODE PAIN (pain in the lymph node of the arm), NAUSEA (nauseated), HEADACHE (headache\intermittent pain in back of her head) and MYALGIA (feels like hit by a truck). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Stomach issue\pain in the right quadrant which she describes as intermittent pain), MUSCULOSKELETAL PAIN (musculoskeletal pain) and ARTHRALGIA (Joint issue). At the time of the report, DYSPNOEA (shortness of breath), LYMPH NODE PAIN (pain in the lymph node of the arm) and MYALGIA (feels like hit by a truck) outcome was unknown, ABDOMINAL DISCOMFORT (Stomach issue\pain in the right quadrant which she describes as intermittent pain), MUSCULOSKELETAL PAIN (musculoskeletal pain), ARTHRALGIA (Joint issue) and HEADACHE (headache\intermittent pain in back of her head) had not resolved and NAUSEA (nauseated) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.  No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Significant FU. Medical history added. New events added and outcomes updated for previous events.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal pain, Myalgia, Nausea
Clinical narrative: Stomach issue\pain in the right quadrant which she describes as intermittent pain; musculoskeletal pain; Joint issue; pain in the lymph node of the arm; nauseated; headache\intermittent pain in back of her head; feels like hit by a truck; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), ABDOMINAL DISCOMFORT (Stomach issue\pain in the right quadrant which she describes as intermittent pain), MUSCULOSKELETAL PAIN (musculoskeletal pain), ARTHRALGIA (Joint issue) and LYMPH NODE PAIN (pain in the lymph node of the arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Primary biliary cholangitis (Autoimmune disorder).    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced DYSPNOEA (shortness of breath). On 21-Apr-2021, the patient experienced LYMPH NODE PAIN (pain in the lymph node of the arm), NAUSEA (nauseated), HEADACHE (headache\intermittent pain in back of her head) and MYALGIA (feels like hit by a truck). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Stomach issue\pain in the right quadrant which she describes as intermittent pain), MUSCULOSKELETAL PAIN (musculoskeletal pain) and ARTHRALGIA (Joint issue). At the time of the report, DYSPNOEA (shortness of breath), LYMPH NODE PAIN (pain in the lymph node of the arm) and MYALGIA (feels like hit by a truck) outcome was unknown, ABDOMINAL DISCOMFORT (Stomach issue\pain in the right quadrant which she describes as intermittent pain), MUSCULOSKELETAL PAIN (musculoskeletal pain), ARTHRALGIA (Joint issue) and HEADACHE (headache\intermittent pain in back of her head) had not resolved and NAUSEA (nauseated) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.  No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Significant FU. Medical history added. New events added and outcomes updated for previous events.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Chills, Dizziness, Gout, Vaccination site pain
Clinical narrative: Adverse reaction; Very light headedness; Chills; Vaccination site pain; the gout flared up; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse reaction ), DIZZINESS (Very light headedness), GOUT (the gout flared up), CHILLS (Chills) and VACCINATION SITE PAIN (Vaccination site pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Inflammation.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 15-Jan-2021, the patient experienced GOUT (the gout flared up). On 12-Feb-2021, the patient experienced ADVERSE REACTION (Adverse reaction ), DIZZINESS (Very light headedness), CHILLS (Chills) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, ADVERSE REACTION (Adverse reaction ), DIZZINESS (Very light headedness), GOUT (the gout flared up), CHILLS (Chills) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.            No concomitant medication was reported by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-029162 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Swelled up; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelled up) 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 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelled up). At the time of the report, VACCINATION SITE SWELLING (Swelled up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.   This case was linked to US-MODERNA TX, INC-MOD-2021-084890 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Headache, Myalgia
Clinical narrative: Headache; Body ache / generalized aching; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (Headache) and MYALGIA (Body ache / generalized aching) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Articular calcification, Joint range of motion decreased and Ankylosing spondylitis.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 20-Mar-2021, the patient experienced HEADACHE (Headache) and MYALGIA (Body ache / generalized aching). At the time of the report, HEADACHE (Headache) and MYALGIA (Body ache / generalized aching) 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 considered HEADACHE (Headache) and MYALGIA (Body ache / generalized aching) to be possibly related.    No treatment and concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up information received on 21-MAY-2021 and contains no new information.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site bruising, Vaccination site irritation, Vaccination site pain
Clinical narrative: Really sore arm where it hurt to lift it or sleep on; Feeling of slight soreness or bruising feeling, slight burning sensation just below where the needle went; Irritation just below where the needle went; Feeling of slight soreness or bruising feeling, slight burning sensation just below where the needle went; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Really sore arm where it hurt to lift it or sleep on), VACCINATION SITE BRUISING (Feeling of slight soreness or bruising feeling, slight burning sensation just below where the needle went), VACCINATION SITE IRRITATION (Irritation just below where the needle went) and VACCINATION SITE PAIN (Feeling of slight soreness or bruising feeling, slight burning sensation just below where the needle went) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Really sore arm where it hurt to lift it or sleep on), VACCINATION SITE BRUISING (Feeling of slight soreness or bruising feeling, slight burning sensation just below where the needle went), VACCINATION SITE IRRITATION (Irritation just below where the needle went) and VACCINATION SITE PAIN (Feeling of slight soreness or bruising feeling, slight burning sensation just below where the needle went). At the time of the report, PAIN IN EXTREMITY (Really sore arm where it hurt to lift it or sleep on), VACCINATION SITE BRUISING (Feeling of slight soreness or bruising feeling, slight burning sensation just below where the needle went), VACCINATION SITE IRRITATION (Irritation just below where the needle went) and VACCINATION SITE PAIN (Feeling of slight soreness or bruising feeling, slight burning sensation just below where the needle went) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was unknown.  Patient stated that he use daily and does workout.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (vaccination site pain). At the time of the report, VACCINATION SITE PAIN (vaccination site pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up reported: NNI
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: ache; tiredness; This spontaneous case was reported by a physician and describes the occurrence of PAIN (ache) and FATIGUE (tiredness) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ADALIMUMAB (HUMIRA) for Crohn's disease.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (ache) and FATIGUE (tiredness). At the time of the report, PAIN (ache) and FATIGUE (tiredness) 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.   On an unknown date, bloodwork was done, results unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: Injection site was soaked in blood and fluid, with a ring under the skin around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Injection site was soaked in blood and fluid, with a ring under the skin around the injection site) in a 76-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 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Injection site was soaked in blood and fluid, with a ring under the skin around the injection site). At the time of the report, VACCINATION SITE HAEMORRHAGE (Injection site was soaked in blood and fluid, with a ring under the skin around the injection site) outcome was unknown. Not Provided       Concomitant medications were not reported. The patient did not received treatment medications.   Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-084818 (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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pruritus, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: Itching at vaccination site; Hive-like raised area at injection site; Swelling at vaccination site; Mild myalgia; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at vaccination site), VACCINATION SITE URTICARIA (Hive-like raised area at injection site), VACCINATION SITE SWELLING (Swelling at vaccination site) and MYALGIA (Mild myalgia) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 26-Mar-2015 and Osteoporosis since 08-May-2017. Concomitant products included MIRTAZAPINE (REMERON) from 30-Mar-2021 to an unknown date, TELMISARTAN from 30-Mar-2021 to an unknown date, AZELASTINE from 22-Oct-2020 to an unknown date, COLECALCIFEROL (VITAMIN D3 1000) from 30-Sep-2020 to an unknown date, CICLOSPORIN (RESTASIS) from 26-Mar-2015 to an unknown date, CALCIUM from 26-Mar-2015 to an unknown date, MULTIVITAMIN [VITAMINS NOS] from 09-Feb-2012 to an unknown date, MAGNESIUM, OMEGA-3 NOS, CURCUMIN (TURMERIC MERIVA), ASCORBIC ACID, BIOTIN, COPPER, RETINOL, ZINC (HAIR SKIN NAILS) and ZINC for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at vaccination site), VACCINATION SITE URTICARIA (Hive-like raised area at injection site), VACCINATION SITE SWELLING (Swelling at vaccination site) and MYALGIA (Mild myalgia). On 30-Jan-2021, VACCINATION SITE PRURITUS (Itching at vaccination site), VACCINATION SITE URTICARIA (Hive-like raised area at injection site), VACCINATION SITE SWELLING (Swelling at vaccination site) and MYALGIA (Mild myalgia) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication list also include tums extra strength smoothies 300 mg (750 mg) chewable tablet. Treatment information was not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Contrast media allergy, Dermatitis allergic, Diarrhoea, Scan, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of CONTRAST MEDIA ALLERGY (Contrast media allergy), DIARRHEA (Diarrhea), DERMATITIS ALLERGIC (Allergic rash all over her body) and PERIPHERAL SWELLING (Arm swelling) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphocytic leukemia and Malignant neoplasm of central portion of female breast. Concurrent medical conditions included Chronic lymphocytic leukemia (Symptomatic chronic lymphocytic leukemia of B-cells reported.), Allergy to antibiotic (Allergy to sulfa-antibiotics reported.), Iodine allergy, Malignant neoplasm of central portion of female breast and Estrogen receptor positive breast cancer. Concomitant products included ANASTROZOLE (ARIMIDEX), VITAMIN D3, CYANOCOBALAMIN, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), PROBIOTICS NOS and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication. On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and IBRUTINIB (IMBRUVICA) (Oral) 420 milligram. On an unknown date, the patient experienced CONTRAST MEDIA ALLERGY (Contrast media allergy), DIARRHOEA (Diarrhea), DERMATITIS ALLERGIC (Allergic rash all over her body) and PERIPHERAL SWELLING (Arm swelling). At the time of the report, CONTRAST MEDIA ALLERGY (Contrast media allergy) and DIARRHOEA (Diarrhea) outcome was unknown and DERMATITIS ALLERGIC (Allergic rash all over her body) and PERIPHERAL SWELLING (Arm swelling) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Scan: n/a No results reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medications were provided by the reporter. This case was linked to MOD-2021-086818, MOD-2021-086711, MOD-2021-086996, MOD-2021-087217, MOD-2021-087097 (E2B Linked Report).; Sender's Comments:  MOD-2021-086818:Case received in same source doc email; MOD-2021-086711:Case received in same source doc email MOD-2021-086996:Case received in same source doc email; MOD-2021-087217:Case received in same source doc email; MOD-2021-087097:Case received in same source doc email.
Age: 61.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Blood pressure measurement, Dizziness, Fatigue, Feeling abnormal, Rash
Clinical narrative: dizziness; Foggy feeling in head; facial rash; fatigue; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (dizziness), FEELING ABNORMAL (Foggy feeling in head), RASH (facial rash) and FATIGUE (fatigue) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Hypertension.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In March 2021, the patient experienced DIZZINESS (dizziness), FEELING ABNORMAL (Foggy feeling in head), RASH (facial rash) and FATIGUE (fatigue). At the time of the report, DIZZINESS (dizziness), FEELING ABNORMAL (Foggy feeling in head), RASH (facial rash) and FATIGUE (fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood pressure measurement: 150/95 (High) Elevated. On an unknown date, Blood pressure measurement: 115 to 130 (Inconclusive) 115 to 130 and 70 to 80 (Inconclusive) 70 to 80.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included anti-hypertensive medication. Treatment information was not provided.  The action taken with mRNA-1273 in response to the event was not applicable.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: covid vaccine made arm sore; sore joints; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Apr-2021 and was forwarded to the company on 20-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (covid vaccine made arm sore) and ARTHRALGIA (sore joints) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO medical history information reported.  Concomitant products included ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (covid vaccine made arm sore) and ARTHRALGIA (sore joints). At the time of the report, VACCINATION SITE PAIN (covid vaccine made arm sore) and ARTHRALGIA (sore joints) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information reported.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Myalgia, Neuralgia, Pain
Clinical narrative: numbness and tingling; low back pain; prickling sensation; cervogenic headaches; muscle pain; nerve pain; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (numbness and tingling), NEURALGIA (nerve pain), BACK PAIN (low back pain), PAIN (prickling sensation) and MYALGIA (muscle pain) in a female patient of an unknown age 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 Cervical discectomy (Disc replacement in cervical small annular tear in C4).   On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced NEURALGIA (nerve pain) and MYALGIA (muscle pain). On an unknown date, the patient experienced PARAESTHESIA (numbness and tingling), BACK PAIN (low back pain), PAIN (prickling sensation) and HEADACHE (cervogenic headaches). The patient was treated with GABAPENTIN at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (numbness and tingling), NEURALGIA (nerve pain), BACK PAIN (low back pain), PAIN (prickling sensation), MYALGIA (muscle pain) and HEADACHE (cervogenic headaches) outcome was unknown.            No concomitant medications were reported.  Action taken with mRNA-1273 in response to the event was not applicable.