chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: injection site warmth; Injection site erythema; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE WARMTH (injection site warmth) and VACCINATION SITE ERYTHEMA (Injection site erythema) 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 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site erythema). On 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (injection site warmth). At the time of the report, VACCINATION SITE WARMTH (injection site warmth) and VACCINATION SITE ERYTHEMA (Injection site erythema) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node on the left side of her neck; This spontaneous case was reported by an other health care professional and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node on the left side of her neck) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (stomach upset), Drug allergy (Hives), Adhesive tape allergy (hives) and Migraine. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy NOS, ALMOTRIPTAN MALATE (AXERT) for Migraine, ESTRADIOL 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 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph node on the left side of her neck). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (MORTIN) for Swollen lymph nodes, at an unspecified dose and frequency. On 31-Jan-2021, LYMPHADENOPATHY (Swollen lymph node on the left side of her neck) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered LYMPHADENOPATHY (Swollen lymph node on the left side of her neck) to be possibly related.    The patient reported lymph node in clavicle area on left side became very enlarged and swollen on the same side as the injection. It got smaller as the weeks went on. She reported the same thing happened with second dose of vaccine. She reported no long term issues at this point. Additional concomitant medication included allergy shots.     This case was linked to MOD-2021-086524 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Patient details, medical history, product details, concomitant medications and event outcome updated
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling, Thermal burn
Clinical narrative: Itching; Burns started appearing; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), THERMAL BURN (Burns started appearing) and SWELLING (Swollen) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PRURITUS (Itching), THERMAL BURN (Burns started appearing) and SWELLING (Swollen). At the time of the report, PRURITUS (Itching), THERMAL BURN (Burns started appearing) and SWELLING (Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not provided. Concomitant 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 events, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: some swelling in her arm at the injection site; sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (some swelling in her arm at the injection site) and VACCINATION SITE PAIN (sore at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concomitant products included ATENOLOL and VITAMINS NOS for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE SWELLING (some swelling in her arm at the injection site) and VACCINATION SITE PAIN (sore at the injection site). On 15-Jan-2021, VACCINATION SITE SWELLING (some swelling in her arm at the injection site) and VACCINATION SITE PAIN (sore at the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not reported. On 15-Jan-2021, the soreness and swelling seemed to be easing a little bit.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: 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 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Fever, at an unspecified dose and frequency. At the time of the report, CHILLS (Chills) and HEADACHE (Headache) had not resolved and PYREXIA (Fever) outcome was unknown. Not Provided      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.    Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2021: No specific follow-up information recorded.; 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: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Swollen like a golf ball; Dissipating but little red; Felt a little bit warm for 2 to 3 days; Itchy in the area of the shot; This spontaneous case was reported by a physician and describes the occurrence of   in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure increased. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF), VITAMIN D [VITAMIN D NOS], PROBIOTICS NOS and RAMIPRIL for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        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 not provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Site of injection reddish; Injection site itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Site of injection reddish) and VACCINATION SITE PRURITUS (Injection site itchy) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 23-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Site of injection reddish) and VACCINATION SITE PRURITUS (Injection site itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (Site of injection reddish) and VACCINATION SITE PRURITUS (Injection site itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: Per MR, the LLT and listing of the events were changed on 22-JUN-2021.; 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: enroll in pregnancy registry; This spontaneous prospective pregnancy case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (enroll in pregnancy registry) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Spontaneous abortion on 13-Apr-2021.    On 12-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 26-Aug-2020 and the estimated date of delivery was 15-Jun-2021. On 12-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (enroll in pregnancy registry). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy.  On 12-Jan-2021, EXPOSURE DURING PREGNANCY (enroll in pregnancy registry) had resolved. Not Provided      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 provided.    Most recent FOLLOW-UP information incorporated above includes: On 13-Jan-2021: Pregnancy update - Added FU AI; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 33-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: Hives that itch on her arm, they started on the shoulder and spread to the arm and still continues; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Hives that itch on her arm, they started on the shoulder and spread to the arm and still continues) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Bipolar disorder (past medical history not provided) and Asthma. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), ATORVASTATIN and MELATONIN for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Hives that itch on her arm, they started on the shoulder and spread to the arm and still continues). At the time of the report, VACCINATION SITE URTICARIA (Hives that itch on her arm, they started on the shoulder and spread to the arm and still continues) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 event, a causal relationship cannot be excluded. Further information has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Dyspnoea, Sleep apnoea syndrome
Clinical narrative: Short of breath; Poor sleep (apnea); Chills; Cough in AIM; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Short of breath), SLEEP APNOEA SYNDROME (Poor sleep (apnea)), COUGH (Cough in AIM) and CHILLS (Chills) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Cough on 07-Jan-2021. Concomitant products included Blood Thinners, DASATINIB MONOHYDRATE (SPRYCEL) and Pacemaker 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 07-Jan-2021, the patient experienced COUGH (Cough in AIM). On 08-Jan-2021, the patient experienced DYSPNOEA (Short of breath), SLEEP APNOEA SYNDROME (Poor sleep (apnea)) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Short of breath), SLEEP APNOEA SYNDROME (Poor sleep (apnea)), COUGH (Cough in AIM) and CHILLS (Chills) 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.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Dizziness; Weakness; Sweating; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness), HYPERHIDROSIS (Sweating) and NAUSEA (Nausea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness), HYPERHIDROSIS (Sweating) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness), ASTHENIA (Weakness), HYPERHIDROSIS (Sweating) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided; 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vertigo
Clinical narrative: Vertigo; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VERTIGO (Vertigo) and NAUSEA (Nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. U25620A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VERTIGO (Vertigo) and NAUSEA (Nausea). At the time of the report, VERTIGO (Vertigo) and NAUSEA (Nausea) 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: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and FATIGUE (tired) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0121.20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 12-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 PYREXIA (Fever) and FATIGUE (tired). On 14-Jan-2021, PYREXIA (Fever) had resolved. At the time of the report, FATIGUE (tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included acetaminophen.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash and redness around the abdomen, both armpits, both shoulders and on back; itchy like mosquito bites on abdomen, armpits, both shoulders, and back.; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of RASH (Rash and redness around the abdomen, both armpits, both shoulders and on back) and PRURITUS (itchy like mosquito bites on abdomen, armpits, both shoulders, and back.) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included 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 07-Jan-2021, the patient experienced RASH (Rash and redness around the abdomen, both armpits, both shoulders and on back) and PRURITUS (itchy like mosquito bites on abdomen, armpits, both shoulders, and back.). At the time of the report, RASH (Rash and redness around the abdomen, both armpits, both shoulders and on back) and PRURITUS (itchy like mosquito bites on abdomen, armpits, both shoulders, and back.) had not 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 relevant concomitant medications reported.  Treatments: hydrocortisone cream and Benadryl.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Myalgia, Pharyngeal swelling
Clinical narrative: a little swelling in throat; Rapid heart rate; Peripheral muscle pain/burning; A spontaneous report was received from a Health Care Professional concerning a 49-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Sore throat , Rapid heart rate, Peripheral muscle pain.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 11 Jan 2021 Monday, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026220A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 11 Jan 2021 Monday , the patient experienced Ongoing Sore throat, Rapid Heart rate, Peripheral muscle pain . No Treatment medication was reported.  Action taken with mRNA-1273 in response to the events was not reported.   The events, Sore throat, Rapid Heart rate, Peripheral Muscle pain, were considered not resolved on 11 Jan 2021.; 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: U
Vaccine: COVID19
Symptoms: Local reaction
Clinical narrative: local reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of LOCAL REACTION (local reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced LOCAL REACTION (local reaction). At the time of the report, LOCAL REACTION (local reaction) 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.   No concomitant medications reported by investigator No treatment medications provided by the reporter.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been  requested.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Blood pressure increased, Blood pressure measurement
Clinical narrative: Blood pressure is extremely high; Blood sugar is extremely high; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure is extremely high) and BLOOD GLUCOSE INCREASED (Blood sugar is extremely high) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure is extremely high) and BLOOD GLUCOSE INCREASED (Blood sugar is extremely high). At the time of the report, BLOOD PRESSURE INCREASED (Blood pressure is extremely high) and BLOOD GLUCOSE INCREASED (Blood sugar is extremely high) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Blood glucose increased: high Blood sugar is extremely high. On 14-Jan-2021, Blood pressure measurement: high Blood pressure is extremely high.     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.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Itchy rash; It is itchy and red; rushes on the back of her neck, then on her breast, then the legs and ended with rush all over body; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash), RASH ERYTHEMATOUS (It is itchy and red) and RASH (rushes on the back of her neck, then on her breast, then the legs and ended with rush all over body) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Medication Allergy (unspecified medications).). Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    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 RASH PRURITIC (Itchy rash), RASH ERYTHEMATOUS (It is itchy and red) and RASH (rushes on the back of her neck, then on her breast, then the legs and ended with rush all over body). The patient was treated with DEXAMETHASONE ongoing since an unknown date at an unspecified dose and frequency and PREDNISONE ongoing since an unknown date at a dose of 40 mg once a day. At the time of the report, RASH PRURITIC (Itchy rash), RASH ERYTHEMATOUS (It is itchy and red) and RASH (rushes on the back of her neck, then on her breast, then the legs and ended with rush all over body) was resolving.        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 these events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, HYDRALAZINE and AMLODIPINE for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced 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.       Patient vaccinated in Left Shoulder.  Laboratory details was not provided. 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; 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: Dry eye, Eye irritation, Headache, Nasal dryness
Clinical narrative: severely eyes burning; eyes were very dry; has headache; nasal cavity dry- felt very dry inside; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (severely eyes burning), DRY EYE (eyes were very dry), HEADACHE (has headache) and NASAL DRYNESS (nasal cavity dry- felt very dry inside) in a 74-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 No adverse event (No medical history reported.).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced EYE IRRITATION (severely eyes burning), DRY EYE (eyes were very dry), HEADACHE (has headache) and NASAL DRYNESS (nasal cavity dry- felt very dry inside). At the time of the report, EYE IRRITATION (severely eyes burning), DRY EYE (eyes were very dry), HEADACHE (has headache) and NASAL DRYNESS (nasal cavity dry- felt very dry inside) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender'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: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus headache
Clinical narrative: Prior to receiving vaccine she had a sinus headache but still has one after getting vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (Prior to receiving vaccine she had a sinus headache but still has one after getting vaccine) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sinus headache.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced SINUS HEADACHE (Prior to receiving vaccine she had a sinus headache but still has one after getting vaccine). At the time of the report, SINUS HEADACHE (Prior to receiving vaccine she had a sinus headache but still has one after getting vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: The event is assessed as unlikely related to mRNA-1273 as was present before vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Nausea
Clinical narrative: Body ache; Chills; Headache; Nausea; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYALGIA (Body ache), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) 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 12-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 MYALGIA (Body ache) and PYREXIA (Fever). 13-Jan-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MYALGIA (Body ache), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Body temperature: 100.7 (Inconclusive) 100.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided 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 these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Body ache; Chills; Headache; Nausea; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYALGIA (Body ache), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) 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 12-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 MYALGIA (Body ache) and PYREXIA (Fever). 13-Jan-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MYALGIA (Body ache), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Body temperature: 100.7 (Inconclusive) 100.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided 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 these events, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin warm, Vaccination site lymphadenopathy
Clinical narrative: Arm was red, itchy, warm; Arm was red, itchy, warm; Arm was red, itchy, warm; swollen lymph node under her injection arm, an axillary node; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm was red, itchy, warm), PRURITUS (Arm was red, itchy, warm), SKIN WARM (Arm was red, itchy, warm) and VACCINATION SITE LYMPHADENOPATHY (swollen lymph node under her injection arm, an axillary node) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-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 LYMPHADENOPATHY (swollen lymph node under her injection arm, an axillary node). On 16-Jan-2021, the patient experienced ERYTHEMA (Arm was red, itchy, warm), PRURITUS (Arm was red, itchy, warm) and SKIN WARM (Arm was red, itchy, warm). On 18-Jan-2021, ERYTHEMA (Arm was red, itchy, warm) had resolved. At the time of the report, PRURITUS (Arm was red, itchy, warm) and SKIN WARM (Arm was red, itchy, warm) had not resolved and VACCINATION SITE LYMPHADENOPATHY (swollen lymph node under her injection arm, an axillary node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jan-2021: Update on AE, additional AEs reported, not pregnant, no treatment, has not seen HCP.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site induration
Clinical narrative: Red hard area a couple of inches below the site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE INDURATION (Red hard area a couple of inches below the site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE INDURATION (Red hard area a couple of inches below the site). At the time of the report, VACCINATION SITE INDURATION (Red hard area a couple of inches below the site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown.; Sender's Comments: Very limited information regarding this event has been provided at this time
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site pain, Panic attack
Clinical narrative: Dizzy like she just got off of a roller coaster; Arm is a little sore; she thinks she is having a panic attack; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy like she just got off of a roller coaster), INJECTION SITE PAIN (Arm is a little sore) and PANIC ATTACK (she thinks she is having a panic attack) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 13-Jan-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced DIZZINESS (Dizzy like she just got off of a roller coaster), INJECTION SITE PAIN (Arm is a little sore) and PANIC ATTACK (she thinks she is having a panic attack). At the time of the report, DIZZINESS (Dizzy like she just got off of a roller coaster), INJECTION SITE PAIN (Arm is a little sore) and PANIC ATTACK (she thinks she is having a panic attack) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was reported to be taken as TYLENOL. Concomitant product use was not provided by the reporter; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Sore arm; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PERIPHERAL SWELLING (Swollen arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and PERIPHERAL SWELLING (Swollen arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) and PERIPHERAL SWELLING (Swollen arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Vaccination site erythema, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Tachycardia; lump is hot, burning, warm to the touch; had a bit lump in the injection site,lump quadrupled its size in 48 hours; swelling in the injection site; had redness in the injection site and lump is red; This spontaneous case was reported by a pharmacist and describes the occurrence of TACHYCARDIA (Tachycardia), VACCINATION SITE WARMTH (lump is hot, burning, warm to the touch), VACCINATION SITE INDURATION (had a bit lump in the injection site,lump quadrupled its size in 48 hours), VACCINATION SITE SWELLING (swelling in the injection site) and VACCINATION SITE ERYTHEMA (had redness in the injection site and lump is red) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.     On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced TACHYCARDIA (Tachycardia), VACCINATION SITE WARMTH (lump is hot, burning, warm to the touch), VACCINATION SITE INDURATION (had a bit lump in the injection site,lump quadrupled its size in 48 hours), VACCINATION SITE SWELLING (swelling in the injection site) and VACCINATION SITE ERYTHEMA (had redness in the injection site and lump is red). On 05-Jan-2021, TACHYCARDIA (Tachycardia) had resolved. At the time of the report, VACCINATION SITE WARMTH (lump is hot, burning, warm to the touch), VACCINATION SITE INDURATION (had a bit lump in the injection site,lump quadrupled its size in 48 hours), VACCINATION SITE SWELLING (swelling in the injection site) and VACCINATION SITE ERYTHEMA (had redness in the injection site and lump is red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication include Birth control pills.  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, SARS-CoV-2 test
Clinical narrative: COVID diagnosis; Soreness in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID diagnosis) and ARTHRALGIA (Soreness in shoulder) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Exposure to COVID-19 and Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, MELATONIN and ACETYLSALICYLIC ACID (ASPRIN) for an unknown indication.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced ARTHRALGIA (Soreness in shoulder). On 01-Jan-2021, the patient experienced COVID-19 (COVID diagnosis). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN (since covid-19 diagnosis)) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID diagnosis) outcome was unknown and ARTHRALGIA (Soreness in shoulder) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Scheduled for 2nd vaccine on 28Jan2021. Information I have researched says you should wait 90 days after COVID to receive the vaccine but no information on if you have received the 1st vaccination already.; Sender's Comments: Due to biological implausibility, the event of COVID-19 is assessed as not applicable to mRNA-1273.  Based on the current available information and temporal association between the use of the product and the start date of the event of Arthralgia, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: Thirsty as a son of a gun; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (Thirsty as a son of a gun) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced THIRST (Thirsty as a son of a gun). At the time of the report, THIRST (Thirsty as a son of a gun) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   no concomitant medicatation and treatment provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia, Vaccination site pain
Clinical narrative: Chills; Muscle soreness; Joint pain; soreness around the vaccine site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness around the vaccine site), CHILLS (Chills), MYALGIA (Muscle soreness) and ARTHRALGIA (Joint pain) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), DIAZEPAM (VALIUM) and QUETIAPINE FUMARATE (SEROQUEL) 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 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness around the vaccine site). On 11-Jan-2021, the patient experienced CHILLS (Chills), MYALGIA (Muscle soreness) and ARTHRALGIA (Joint pain). On 11-Jan-2021, VACCINATION SITE PAIN (soreness around the vaccine site) had resolved. At the time of the report, CHILLS (Chills), MYALGIA (Muscle soreness) and ARTHRALGIA (Joint pain) 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.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: injection site is so painful and it goes down the arm; injection site is so painful and it goes down the arm; experiencing awful headache; joint pain; calf pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site is so painful and it goes down the arm), PAIN (injection site is so painful and it goes down the arm), HEADACHE (experiencing awful headache), ARTHRALGIA (joint pain) and PAIN IN EXTREMITY (calf pain) in a 75-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 COVID-19 on 04-Dec-2020. Concurrent medical conditions included Anxiety, Sulfonamide allergy and Allergic reaction to drug. Concomitant products included LOXAPINE, BUSPIRONE, LEVOTHYROXINE, PROPRANOLOL (PROPANOLOL [PROPRANOLOL]), LOVASTATIN, LISINOPRIL, CLONAZEPAM and ESTRADIOL.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (injection site is so painful and it goes down the arm), PAIN (injection site is so painful and it goes down the arm), HEADACHE (experiencing awful headache), ARTHRALGIA (joint pain) and PAIN IN EXTREMITY (calf pain). At the time of the report, VACCINATION SITE PAIN (injection site is so painful and it goes down the arm), PAIN (injection site is so painful and it goes down the arm), HEADACHE (experiencing awful headache), ARTHRALGIA (joint pain) and PAIN IN EXTREMITY (calf pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: No specific follow-up information recorded.