chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site urticaria
Clinical narrative: itchy hives at the injection site; severe pain at the injection site; episodes of chills; felt feverish; her highest measured; nausea; muscle and joint pain; muscle and joint pain; fatigue; injection site swelling; limits the mobility of that [right] arm; migraine headache; 3" x 3" patch of itchy, painful hives on her right thigh; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (limits the mobility of that [right] arm), MIGRAINE (migraine headache), URTICARIA (3" x 3" patch of itchy, painful hives on her right thigh), VACCINATION SITE URTICARIA (itchy hives at the injection site) and VACCINATION SITE PAIN (severe pain at the injection site) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 14-Jan-2019, the patient experienced MIGRAINE (migraine headache) and URTICARIA (3" x 3" patch of itchy, painful hives on her right thigh). On 14-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (limits the mobility of that [right] arm), VACCINATION SITE URTICARIA (itchy hives at the injection site), VACCINATION SITE PAIN (severe pain at the injection site), CHILLS (episodes of chills), PYREXIA (felt feverish; her highest measured), NAUSEA (nausea), MYALGIA (muscle and joint pain), ARTHRALGIA (muscle and joint pain), FATIGUE (fatigue) and VACCINATION SITE SWELLING (injection site swelling). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (limits the mobility of that [right] arm), MIGRAINE (migraine headache), URTICARIA (3" x 3" patch of itchy, painful hives on her right thigh), VACCINATION SITE URTICARIA (itchy hives at the injection site), VACCINATION SITE PAIN (severe pain at the injection site), CHILLS (episodes of chills), PYREXIA (felt feverish; her highest measured), NAUSEA (nausea), MYALGIA (muscle and joint pain), ARTHRALGIA (muscle and joint pain), FATIGUE (fatigue) and VACCINATION SITE SWELLING (injection site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment related information has been reported.; 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased, Hyperarousal
Clinical narrative: Felt very dizzy; felt a rush of adrenaline for 2-3 minutes; my HR was 125 at rest for more than a few hours; A spontaneous report (United States) was received from a Health Care Professional concerning a 50 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Dizziness, Norepinephrine increased, and Heart rate increased.  The patient's medical history was provided as allergies to preservatives. Relevant concomitant medications were reported as CLARITINE, MUCINEX, ADVAIR, SINGULAIR, TURMERIC, IMMUNE BOOST, NAPROSYN E.  On 08 JAN 2021, prior to the onset of event, the patient received their first dose of two planned doses of mRNA-1273 (lot/batch: unknown) in left arm for prophylaxis of COVID-19 infection.  On 08 JAN 2021, the patient experienced Dizziness, Norepinephrine increased, and Heart rate increased.  Laboratory details was provided as Heart rate 125, which was increased in that time. Treatment information was provided as albuterol and Benadryl.  Action taken with mRNA-1273 in response to the events was unknown.  On 08 JAN 2021, the outcome of the event's Norepinephrine increased, and Heart rate increased was considered as resolved. At the of this report, the outcome of the event's Dizziness was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: A red circle 2.5 to 3 inches across; it's itchy, not pain, right where the shot was; Big area which was large swollen and red; Itchy area at the injection site; Minimal soreness at site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Itchy area at the injection site), VACCINATION SITE PAIN (Minimal soreness at site), VACCINATION SITE ERYTHEMA (A red circle 2.5 to 3 inches across; it's itchy, not pain, right where the shot was) and VACCINATION SITE SWELLING (Big area which was large swollen and red) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0146204) for COVID-19 vaccination.     No Medical History information was reported.    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 (Minimal soreness at site). On 18-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy area at the injection site). On 19-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (A red circle 2.5 to 3 inches across; it's itchy, not pain, right where the shot was) and VACCINATION SITE SWELLING (Big area which was large swollen and red). On 25-Jan-2021, VACCINATION SITE PRURITUS (Itchy area at the injection site), VACCINATION SITE PAIN (Minimal soreness at site), VACCINATION SITE ERYTHEMA (A red circle 2.5 to 3 inches across; it's itchy, not pain, right where the shot was) and VACCINATION SITE SWELLING (Big area which was large swollen and red) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information included Benadryl. Patient visited Emergency Room on 21 Jan 2021. Concomitant medications were not provided.   This case was linked to MOD-2021-093957 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Patient demographics and event stop date changed. Follow-up received on 16-may-2021 contains no new information
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: Itchiness at the injection site; Hardness at the injection site; Redness at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE INDURATION (Hardness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE INDURATION (Hardness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE INDURATION (Hardness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) 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.   Treatment for the events included acetaminophen, ibuprofen and diphenhydramine.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: NNI
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: pain in my (left) arm; fever of 101 degrees (Fahrenheit) in one ear and 102 degrees in the other; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in my (left) arm), PYREXIA (fever of 101 degrees (Fahrenheit) in one ear and 102 degrees in the other) and CHILLS (Chills) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020.    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 PAIN IN EXTREMITY (pain in my (left) arm), PYREXIA (fever of 101 degrees (Fahrenheit) in one ear and 102 degrees in the other) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in my (left) arm) and CHILLS (Chills) outcome was unknown and PYREXIA (fever of 101 degrees (Fahrenheit) in one ear and 102 degrees in the other) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  The patient was treated with Tylenol (paracetamol).; 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: debilitating intermittent headaches that comes and goes; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (debilitating intermittent headaches that comes and goes) in a 44-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 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (debilitating intermittent headaches that comes and goes). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (debilitating intermittent headaches that comes and goes) 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 were reported. Patient needs to be in a dark room to help herself feel better. Patient had taken Tylenol (paracetamol) and Motrin (ibuprofen), as treatment medication.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever @ 100.7; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever @ 100.7) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013J201A) for COVID-19 vaccination.     The patient's past medical history included Erdheim-Chester disease (Treated with Tafinlar 200mg a day.) and UTI. Concomitant products included DABRAFENIB MESILATE (TAFINLAR), APIXABAN (ELIQUIS), ASPIRIN [ACETYLSALICYLIC ACID], ROSUVASTATIN CALCIUM (CRESTOR), MANNOSE, D- and PREDNISONE for an unknown indication.    On 11-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 PYREXIA (Fever @ 100.7). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 milligram. At the time of the report, PYREXIA (Fever @ 100.7) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.7 (High) 100.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter stated the patient normally runs a fever due to an UTI  but was aware that it was not the case in this matter.   This case was linked to MOD-2021-074374 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Reporter contact information, event outcome updated.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: Receive vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a physician assistant and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Receive vaccine while pregnant) in a 32-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (1 drink /month) on 01-Mar-2021 and Spontaneous abortion (Blighted ovum diagnosed at 10 weeks) on 10-Jul-2020. Previously administered products included for an unreported indication: MARIJUANA (5mg edible every 1-2 times per year) until 01-Mar-2021. Concurrent medical conditions included Asthma (Abuterol inhaler PRN for exacerbation only). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 22-Aug-2020 and the estimated date of delivery was 29-May-2021. On 10-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Receive vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 10-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Receive vaccine while pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Sep-2020, Pregnancy test: positive (Positive) Positive. On 20-Nov-2020, Blood test: other (abnormal) The risk of Down syndrome is less than the screeningcut-off. (Maternal Serum Screen- PAPP-A and NT test). On 20-Nov-2020, Human chorionic gonadotropin: other (abnormal) The risk of Down syndrome is less than the screeningcut-off. On 08-Jan-2021, Ultrasound scan: normal (normal) Fetal anatomy scan is normal (OB complete single or first gestation ultrasound). On 22-Feb-2021, Glucose tolerance test: 93 (normal) No evidence of gestational diabetes. (Gestational Diabetes Screening test).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had no maternal history of subfertility. The number of fetuses was reported as 1 and had established prenatal care. There was no complications or acute illness during this pregnancy to date.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Live follow up received on 16-Apr-2021: Added HCP contact information, patient's medical historical conditions, current pregnancy details, laboratory tests, second dose information. The action taken changed (from unknown to not applicable).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: felt tingling in my hands; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (felt tingling in my hands) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.  Concomitant products included ALPRAZOLAM (XANAX) and TRAMADOL for an unknown indication.    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 PARAESTHESIA (felt tingling in my hands). At the time of the report, PARAESTHESIA (felt tingling in my hands) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance test, Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 039J20A) for COVID-19 vaccination.     Concurrent medical conditions included Alcohol use (1 drink per week). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 08-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 05-Feb-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 02-Jul-2021. On 08-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 08-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Oct-2020, Pregnancy test: positive (Positive) Positive. On 25-Mar-2021, Glucose tolerance test: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   Moderna COVID-19 Vaccine formulation administered by Subcutaneous route as per source document.  Patient had Ultrasound on 15FEB2021 and had no concerns, Genetic Screen on DEC2020  No concerns, Glucose Tolerance on 25MAR2021 which was Normal.  Patient had Pregnancy previously and the end date was  where the outcome was Live, full term birth.   No treatment information is provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15JUL2021 and has new information about Patient demographics, Lab details, Pregnancy details, Moderna vaccine Dose details and Concomitants. On 02-Aug-2021: NNI.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Fatigue, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: the exact same shape red, swelling came back; swelling and itching at the injection site; tired; swelling and itching at the injection site; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), ERYTHEMA (the exact same shape red, swelling came back), VACCINATION SITE PRURITUS (swelling and itching at the injection site), FATIGUE (tired) and VACCINATION SITE SWELLING (swelling and itching at the injection site) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 06-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 DIZZINESS (dizzy), VACCINATION SITE PRURITUS (swelling and itching at the injection site), FATIGUE (tired) and VACCINATION SITE SWELLING (swelling and itching at the injection site). On 14-Jan-2021, the patient experienced ERYTHEMA (the exact same shape red, swelling came back). On 09-Jan-2021, VACCINATION SITE PRURITUS (swelling and itching at the injection site) had resolved. At the time of the report, DIZZINESS (dizzy), ERYTHEMA (the exact same shape red, swelling came back) and FATIGUE (tired) outcome was unknown and VACCINATION SITE SWELLING (swelling and itching at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain
Clinical narrative: continued discomfort and sharp pain in the abdomen; sharp severe stabbing pain in my stomach at central midline; This spontaneous case was reported by a nurse and describes the occurrence of ABDOMINAL PAIN (sharp severe stabbing pain in my stomach at central midline) and ABDOMINAL DISCOMFORT (continued discomfort and sharp pain in the abdomen) in a 53-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 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced ABDOMINAL PAIN (sharp severe stabbing pain in my stomach at central midline). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (continued discomfort and sharp pain in the abdomen). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (MORTIN) at a dose of 200mg 2 times. At the time of the report, ABDOMINAL PAIN (sharp severe stabbing pain in my stomach at central midline) and ABDOMINAL DISCOMFORT (continued discomfort and sharp pain in the abdomen) had not 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.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2021: No significant information was received.
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Musculoskeletal stiffness, Pain in extremity, Vaccination site pain
Clinical narrative: stiffness in legs; Pain in both thighs, they were achy; It was hard to stand up from seated position; some soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in both thighs, they were achy), DYSSTASIA (It was hard to stand up from seated position), MUSCULOSKELETAL STIFFNESS (stiffness in legs) and VACCINATION SITE PAIN (some soreness in her arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 (some soreness in her arm). On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in both thighs, they were achy) and DYSSTASIA (It was hard to stand up from seated position). On 16-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness in legs). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK, qd. At the time of the report, PAIN IN EXTREMITY (Pain in both thighs, they were achy), DYSSTASIA (It was hard to stand up from seated position), MUSCULOSKELETAL STIFFNESS (stiffness in legs) and VACCINATION SITE PAIN (some soreness in her arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Event outcome updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Pyrexia
Clinical narrative: diarrhea; fever of 102 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and PYREXIA (fever of 102 degrees Fahrenheit) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea) and PYREXIA (fever of 102 degrees Fahrenheit). At the time of the report, DIARRHOEA (diarrhea) and PYREXIA (fever of 102 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up received on 08.JUN.2021 contain no new information; 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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain, Pruritus, Vaccination site reaction
Clinical narrative: red welts about an inch near injection location; itching; sorenes, and achiness; muscle ache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (red welts about an inch near injection location), PRURITUS (itching), PAIN (sorenes, and achiness), MYALGIA (muscle ache) and FATIGUE (fatigue) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O11L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (red welts about an inch near injection location), PRURITUS (itching), PAIN (sorenes, and achiness), MYALGIA (muscle ache) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE REACTION (red welts about an inch near injection location), PRURITUS (itching), PAIN (sorenes, and achiness), MYALGIA (muscle ache) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO concomitant medications provided by the reporter. Treatment medication includes Tylenol.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Outcome of events updated.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: received vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (received vaccine while pregnant) 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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 15-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (received vaccine while pregnant). On 15-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (received vaccine while pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.  Caller stated had  first dose in January and the second dose in February.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Updated the dose number to 1st dose; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event following immunisation
Clinical narrative: adverse outcome; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT FOLLOWING IMMUNISATION (adverse outcome) 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 an unknown date, the patient experienced ADVERSE EVENT FOLLOWING IMMUNISATION (adverse outcome). At the time of the report, ADVERSE EVENT FOLLOWING IMMUNISATION (adverse outcome) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: No significant information was received.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: This spontaneous case reported by a pharmacist (subsequently medically confirmed), describes the occurrence of fatigue (generalized fatigue), myalgia (muscle ache), pain, pyrexia (fever) and nausea in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced fatigue (generalized fatigue), myalgia (muscle ache), pain, pyrexia (fever), nausea and vomiting. At the time of the report, fatigue (generalized fatigue), myalgia (muscle ache), pain, pyrexia (fever), nausea and vomiting outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments. Treatment and concomitant medications not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This spontaneous case reported by a pharmacist (subsequently medically confirmed), describes the occurrence of fatigue (generalized fatigue), myalgia (muscle ache), pain, pyrexia (fever) and nausea in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced fatigue (generalized fatigue), myalgia (muscle ache), pain, pyrexia (fever), nausea and vomiting. At the time of the report, fatigue (generalized fatigue), myalgia (muscle ache), pain, pyrexia (fever), nausea and vomiting outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments. Treatment and concomitant medications not provided.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Fatigue
Clinical narrative: confused; weak; fatigued; This spontaneous case was reported by an other caregiver and describes the occurrence of CONFUSIONAL STATE (confused), ASTHENIA (weak) and FATIGUE (fatigued) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced CONFUSIONAL STATE (confused), ASTHENIA (weak) and FATIGUE (fatigued). At the time of the report, CONFUSIONAL STATE (confused), ASTHENIA (weak) and FATIGUE (fatigued) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment of these events were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow up received on 15APR2021 included no new information.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Malaise, Myalgia, Pyrexia
Clinical narrative: no energy to get up, not even to lift a cup; feeling low and low; pain in her whole body; fever; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (no energy to get up, not even to lift a cup), MALAISE (feeling low and low), MYALGIA (pain in her whole body), PYREXIA (fever) and HEADACHE (headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 39K20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure. Concomitant products included INSULIN for Diabetes.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced ASTHENIA (no energy to get up, not even to lift a cup), MALAISE (feeling low and low), MYALGIA (pain in her whole body), PYREXIA (fever) and HEADACHE (headache). At the time of the report, ASTHENIA (no energy to get up, not even to lift a cup), MALAISE (feeling low and low), MYALGIA (pain in her whole body), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient treated her symptoms with acetaminophen   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Follow up received on 14APR2021 included no new information.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Decreased immune responsiveness, Diarrhoea, Dizziness
Clinical narrative: "believes that the vaccine decreased her immune system"; Fatigue; Diarrhea; Loss of smell; loss of taste; feeling; headache; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED IMMUNE RESPONSIVENESS ("believes that the vaccine decreased her immune system"), DIZZINESS (dizzy), DIARRHOEA (Diarrhea), ANOSMIA (Loss of smell) and AGEUSIA (loss of taste) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037k20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced DIZZINESS (dizzy), FEELING ABNORMAL (feeling) and HEADACHE (headache). On 08-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), ANOSMIA (Loss of smell), AGEUSIA (loss of taste) and FATIGUE (Fatigue). On an unknown date, the patient experienced DECREASED IMMUNE RESPONSIVENESS ("believes that the vaccine decreased her immune system"). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency. At the time of the report, DECREASED IMMUNE RESPONSIVENESS ("believes that the vaccine decreased her immune system"), DIZZINESS (dizzy), DIARRHOEA (Diarrhea), ANOSMIA (Loss of smell), AGEUSIA (loss of taste), FEELING ABNORMAL (feeling), FATIGUE (Fatigue) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2021: Follow up received on 19-Jan-2021, Contains non significant information
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, SARS-CoV-2 test
Clinical narrative: "believes that the vaccine decreased her immune system"; Fatigue; Diarrhea; Loss of smell; loss of taste; feeling; headache; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED IMMUNE RESPONSIVENESS ("believes that the vaccine decreased her immune system"), DIZZINESS (dizzy), DIARRHOEA (Diarrhea), ANOSMIA (Loss of smell) and AGEUSIA (loss of taste) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037k20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced DIZZINESS (dizzy), FEELING ABNORMAL (feeling) and HEADACHE (headache). On 08-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), ANOSMIA (Loss of smell), AGEUSIA (loss of taste) and FATIGUE (Fatigue). On an unknown date, the patient experienced DECREASED IMMUNE RESPONSIVENESS ("believes that the vaccine decreased her immune system"). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency. At the time of the report, DECREASED IMMUNE RESPONSIVENESS ("believes that the vaccine decreased her immune system"), DIZZINESS (dizzy), DIARRHOEA (Diarrhea), ANOSMIA (Loss of smell), AGEUSIA (loss of taste), FEELING ABNORMAL (feeling), FATIGUE (Fatigue) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2021: Follow up received on 19-Jan-2021, Contains non significant information
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: headache; injection site itching/started itching; injection site swelling/again was swollen; injection site redness/again was red; injection site heat/again was hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site itching/started itching), VACCINATION SITE SWELLING (injection site swelling/again was swollen), VACCINATION SITE ERYTHEMA (injection site redness/again was red), VACCINATION SITE WARMTH (injection site heat/again was hot) and HEADACHE (headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itching/started itching), VACCINATION SITE SWELLING (injection site swelling/again was swollen), VACCINATION SITE ERYTHEMA (injection site redness/again was red) and VACCINATION SITE WARMTH (injection site heat/again was hot). On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, VACCINATION SITE PRURITUS (injection site itching/started itching), VACCINATION SITE SWELLING (injection site swelling/again was swollen), VACCINATION SITE ERYTHEMA (injection site redness/again was red), VACCINATION SITE WARMTH (injection site heat/again was hot) and HEADACHE (headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information provided. Treatment included cortisone cream and cold washrag.   This case was linked to US-MODERNATX, INC.-MOD-2021-083158 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received on 07-JUN-2021 included updated AE information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083158:dose 1
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) 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 event, a causal relationship cannot be excluded.  Further information have been requested
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Incomplete course of vaccination, Product dose omission issue, Urticaria
Clinical narrative: advised not to take second dose of vaccine; cancelled the second dose; big red whelps on front and back of thighs, appeared on arms; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (big red whelps on front and back of thighs, appeared on arms), INCOMPLETE COURSE OF VACCINATION (advised not to take second dose of vaccine) and PRODUCT DOSE OMISSION ISSUE (cancelled the second dose) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to venom (insect venom), Dust allergy (dust), Pollen allergy (pollen), Allergy to molds (mold), Asthma and Heart disease, unspecified. Concomitant products included ALBUTEROL SULFATE, ACETYLSALICYLIC ACID (ASPIRIN), ATORVASTATIN, BIOTIN, FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA), CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM CARBONATE AND VITAMIN D3), CENTRUM SILVER, DILTIAZEM HYDROCHLORIDE (DILTIAZEM CD), EPINEPHRINE, ESTRIOL SUCCINATE (ESTRIOL), POLYCARBOPHIL CALCIUM (FIBERCON), FLUTICASONE PROPIONATE, LEVOTHYROXINE, MONTELUKAST SODIUM (MONTELUKAST), MIRABEGRON (MYRBETRIQ), SALBUTAMOL SULFATE (PROAIR HFA), DENOSUMAB (PROLIA), TOBRAMYCIN, PARACETAMOL (TYLENOL), VITAMIN C [ASCORBIC ACID] (VITAMIN C), CETIRIZINE HYDROCHLORIDE (ZYRTEC) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced URTICARIA (big red whelps on front and back of thighs, appeared on arms). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (advised not to take second dose of vaccine) and PRODUCT DOSE OMISSION ISSUE (cancelled the second dose). The patient was treated with METHYLPREDNISOLONE at a dose of 4 mg. On 21-Jan-2021, URTICARIA (big red whelps on front and back of thighs, appeared on arms) had resolved. At the time of the report, INCOMPLETE COURSE OF VACCINATION (advised not to take second dose of vaccine) and PRODUCT DOSE OMISSION ISSUE (cancelled the second dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       One of the treatment medication included Dospak 215   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: No specific follow-up information recorded. On 08-Jun-2021: No significant information was received.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Menstruation irregular, Skin burning sensation, Vaccination site erythema, Vaccination site induration
Clinical narrative: Face numbness of unknown origin lately; an extremely heavy period that not only came two weeks early but still has yet to end; knot was red; burning feeling; knot was itchy; arm hurt; had a knot; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Face numbness of unknown origin lately) and MENSTRUATION IRREGULAR (an extremely heavy period that not only came two weeks early but still has yet to end) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Face numbness of unknown origin lately) and MENSTRUATION IRREGULAR (an extremely heavy period that not only came two weeks early but still has yet to end). At the time of the report, HYPOAESTHESIA (Face numbness of unknown origin lately) outcome was unknown and MENSTRUATION IRREGULAR (an extremely heavy period that not only came two weeks early but still has yet to end) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received on 07-JUN-2021 included additional AE information.; 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.