chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Patient Miscarried; vaccine exposure during pregnancy; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ABORTION SPONTANEOUS (Patient Miscarried) and EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 030m20a) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) (seriousness criterion medically significant). On 30-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Patient Miscarried) (seriousness criterion medically significant). At the time of the report, ABORTION SPONTANEOUS (Patient Miscarried) and EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported.  Action taken with mRNA-1273 in response to the event was Not Applicable   Company Comment:  This case concerns a 25-year-old who experienced vaccine exposure during pregnancy and abortion. Abortion occurred 1 month 8 days post mRNA-1273 use. Although a temporal association exist, there is still not enough information to assess the causal association with the product use.  Critical details such as the obstetric history including the duration of pregnancy, antenatal history and condition at the time of abortion is lacking.  Additional information has been requested.; Sender's Comments: This case concerns a 25-year-old who experienced vaccine exposure during pregnancy and abortion. Abortion occurred 1 month 8 days post mRNA-1273 use. Although a temporal association exist, there is still not enough information to assess the causal association with the product use.  Critical details such as the obstetric history including the duration of pregnancy, antenatal history and condition at the time of abortion is lacking.  Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Magnetic resonance imaging head
Clinical narrative: Permanent hearing loss on left ear; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS UNILATERAL (Permanent hearing loss on left ear) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DEAFNESS UNILATERAL (Permanent hearing loss on left ear) (seriousness criterion disability). At the time of the report, DEAFNESS UNILATERAL (Permanent hearing loss on left ear) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging head: no infections or tumors (normal) No infections or tumors.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  The patient has been evaluated by ENT several times and was given steroid treatment in response to the event.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, a causal relationship cannot be excluded.
Age: 33.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Intentional product misuse, Psoriatic arthropathy
Clinical narrative: Psoriatic arthritis Flare with Humira; Came off Humira because of COVID concerns; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis Flare with Humira) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage form. On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis Flare with Humira) (seriousness criterion medically significant) and INTENTIONAL PRODUCT MISUSE (Came off Humira because of COVID concerns). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis Flare with Humira) outcome was unknown and INTENTIONAL PRODUCT MISUSE (Came off Humira because of COVID concerns) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PSORIATIC ARTHROPATHY (Psoriatic arthritis Flare with Humira) to be unlikely related. No further causality assessment was provided for INTENTIONAL PRODUCT MISUSE (Came off Humira because of COVID concerns).    Concomitant medications were not reported. No treatment information was provided.  Based on the current available, very limited information and temporal association between the use of the product and the start date of the events (Psoriatic arthritis Flare with Humira) a causal relationship cannot be excluded.  However,company causality for (Came off Humira because of COVID concerns) was assessed as not applicable.; Sender's Comments: Based on the current available, very limited information and temporal association between the use of the product and the start date of the events (Psoriatic arthritis Flare with Humira) a causal relationship cannot be excluded.  However,company causality for (Came off Humira because of COVID concerns) was assessed as not applicable.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Hypophagia, Off label use, Pain in extremity
Clinical narrative: numbness in the hand; Headaches; Sore arm; malaise; stressed; not eating very well; Off Label dosing frequency; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (numbness in the hand) and HEADACHE (Headaches) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke (Three years ago patient had a stroke). Previously administered products included for an unreported indication: TDAP, VARICELLA VACCINE and MMR. Concomitant products included VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 29-Mar-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 (numbness in the hand) (seriousness criterion hospitalization), HEADACHE (Headaches) (seriousness criterion hospitalization), PAIN IN EXTREMITY (Sore arm), VACCINATION COMPLICATION (malaise), STRESS (stressed), HYPOPHAGIA (not eating very well) and OFF LABEL USE (Off Label dosing frequency). At the time of the report, HYPOAESTHESIA (numbness in the hand), HEADACHE (Headaches), PAIN IN EXTREMITY (Sore arm), VACCINATION COMPLICATION (malaise), STRESS (stressed) and HYPOPHAGIA (not eating very well) outcome was unknown and OFF LABEL USE (Off Label dosing frequency) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Three years ago patient had a stroke so since it was considered that patient might be having another one given the symptoms, patient went to the hospital where patient head was scanned.  Since patient received other vaccines (Tetanus, diphtheria & acellular pertussis vaccine (TdaP), Measles, Mumps & Rubella (MMR), Varicella) in less than 14 days to the second dose, personnel at the vaccination center told patient that Covid-19 vaccine could not be administered. Patient received some of the vaccines on 12-Apr-2021 and the other a couple of days before.  Patient took Tylenol to treat symptoms.  Company Comment: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, with adverse events of hypoaesthenia, headache, pain in extremity, vaccination -elated malaise and oral intake reduced. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, with adverse events of hypoaesthenia, headache, pain in extremity, vaccination -elated malaise and oral intake reduced. 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: Stress, Vaccination complication
Clinical narrative: numbness in the hand; Headaches; Sore arm; malaise; stressed; not eating very well; Off Label dosing frequency; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (numbness in the hand) and HEADACHE (Headaches) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke (Three years ago patient had a stroke). Previously administered products included for an unreported indication: TDAP, VARICELLA VACCINE and MMR. Concomitant products included VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 29-Mar-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 (numbness in the hand) (seriousness criterion hospitalization), HEADACHE (Headaches) (seriousness criterion hospitalization), PAIN IN EXTREMITY (Sore arm), VACCINATION COMPLICATION (malaise), STRESS (stressed), HYPOPHAGIA (not eating very well) and OFF LABEL USE (Off Label dosing frequency). At the time of the report, HYPOAESTHESIA (numbness in the hand), HEADACHE (Headaches), PAIN IN EXTREMITY (Sore arm), VACCINATION COMPLICATION (malaise), STRESS (stressed) and HYPOPHAGIA (not eating very well) outcome was unknown and OFF LABEL USE (Off Label dosing frequency) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Three years ago patient had a stroke so since it was considered that patient might be having another one given the symptoms, patient went to the hospital where patient head was scanned.  Since patient received other vaccines (Tetanus, diphtheria & acellular pertussis vaccine (TdaP), Measles, Mumps & Rubella (MMR), Varicella) in less than 14 days to the second dose, personnel at the vaccination center told patient that Covid-19 vaccine could not be administered. Patient received some of the vaccines on 12-Apr-2021 and the other a couple of days before.  Patient took Tylenol to treat symptoms.  Company Comment: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, with adverse events of hypoaesthenia, headache, pain in extremity, vaccination -elated malaise and oral intake reduced. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, with adverse events of hypoaesthenia, headache, pain in extremity, vaccination -elated malaise and oral intake reduced. 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: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: diagnosed with COVID; Second dose missed, more than 36 days have passed since first dose; weakness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (diagnosed with COVID) and ASTHENIA (weakness) in a 71-year-old male 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.     The patient's past medical history included No adverse event (No medical history provided).  Concomitant products included AMLODIPINE BESILATE (NORVASC) for Blood pressure, LINAGLIPTIN (TRADJENTA) and PIOGLITAZONE for Diabetes, LEVOTHYROXINE for Thyroid disorder NOS.    On 07-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 COVID-19 (diagnosed with COVID) (seriousness criterion hospitalization). In February 2021, the patient experienced ASTHENIA (weakness) (seriousness criterion disability). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose missed, more than 36 days have passed since first dose). The patient was hospitalized from 13-Jan-2021 to 28-Jan-2021 due to COVID-19. In March 2021, ASTHENIA (weakness) had resolved. At the time of the report, COVID-19 (diagnosed with COVID) and PRODUCT DOSE OMISSION ISSUE (Second dose missed, more than 36 days have passed since first dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, SARS-CoV-2 antibody test: positive (Positive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included plasma and antiviral therapy Patient has past medical history of Diabetes Mellitus, High blood pressure and Hypothyroidism; Sender's Comments: This report also refers to a case of inappropriate schedule of product administration for mRNA-1273 with additional history of AEs of COVID-19 Infection and asthenia following first dose of mRNA -1273 with lot # 037K20A. Based on biological implausibility, the event of COVID-19 infection causality is assessed as not applicable in relation to mRNA-1273. However for the event of Asthenia, 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 This report also refers to a case of intentional product use issue for mRNA-1273,  with no associated AEs.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Road traffic accident
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported by reporter.     On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (blacked out) (seriousness criterion medically significant) and ROAD TRAFFIC ACCIDENT (car accident). At the time of the report, LOSS OF CONSCIOUSNESS (blacked out) and ROAD TRAFFIC ACCIDENT (car accident) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She is taking concomitant medication not otherwise specified.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dyspnoea, Fatigue, Hypoaesthesia, Somnolence
Clinical narrative: mouth was twisted a little bit, did not look good, diagnosed with a mild stroke; hands were numb; shortness of breath; lot of sleepiness; tired all the time; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (mouth was twisted a little bit, did not look good, diagnosed with a mild stroke) and HYPOAESTHESIA (hands were numb) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (mouth was twisted a little bit, did not look good, diagnosed with a mild stroke) (seriousness criterion hospitalization) and HYPOAESTHESIA (hands were numb) (seriousness criterion hospitalization). On an unknown date, the patient experienced DYSPNOEA (shortness of breath), SOMNOLENCE (lot of sleepiness) and FATIGUE (tired all the time). The patient was hospitalized on 25-Apr-2021 due to CEREBROVASCULAR ACCIDENT and HYPOAESTHESIA. At the time of the report, CEREBROVASCULAR ACCIDENT (mouth was twisted a little bit, did not look good, diagnosed with a mild stroke), HYPOAESTHESIA (hands were numb), DYSPNOEA (shortness of breath), SOMNOLENCE (lot of sleepiness) and FATIGUE (tired all the time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment medications were reported  Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities, further information required.   This case was linked to US-MODERNATX, INC.-MOD-2021-101534 (E2B Linked Report).; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities, further information required. US-MODERNATX, INC.-MOD-2021-101534:Wife case
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Gait inability, Hallucination, Hypokinesia, Pyrexia
Clinical narrative: hallucinating; Couln't walk; Can barely move; feels awful; chills; fever; This spontaneous case was reported by an other caregiver and describes the occurrence of HALLUCINATION (hallucinating) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic lymphocytic leukemia.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced HALLUCINATION (hallucinating) (seriousness criterion medically significant), GAIT INABILITY (Couln't walk), HYPOKINESIA (Can barely move), VACCINATION COMPLICATION (feels awful), CHILLS (chills) and PYREXIA (fever). At the time of the report, HALLUCINATION (hallucinating), GAIT INABILITY (Couln't walk), HYPOKINESIA (Can barely move), VACCINATION COMPLICATION (feels awful), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            Concomitant medication was not reported.  Treatment of these events were not reported.  Company comment: 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. The past medical history of Chronic lymphocytic leukemia is a likely confounder the events described   This case was linked to MOD-2021-104070 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The past medical history of Chronic lymphocytic leukemia is a likely confounder the events described
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: hallucinating; Couln't walk; Can barely move; feels awful; chills; fever; This spontaneous case was reported by an other caregiver and describes the occurrence of HALLUCINATION (hallucinating) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic lymphocytic leukemia.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced HALLUCINATION (hallucinating) (seriousness criterion medically significant), GAIT INABILITY (Couln't walk), HYPOKINESIA (Can barely move), VACCINATION COMPLICATION (feels awful), CHILLS (chills) and PYREXIA (fever). At the time of the report, HALLUCINATION (hallucinating), GAIT INABILITY (Couln't walk), HYPOKINESIA (Can barely move), VACCINATION COMPLICATION (feels awful), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            Concomitant medication was not reported.  Treatment of these events were not reported.  Company comment: 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. The past medical history of Chronic lymphocytic leukemia is a likely confounder the events described   This case was linked to MOD-2021-104070 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The past medical history of Chronic lymphocytic leukemia is a likely confounder the events described
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Depression, Headache, Pyrexia, Suicidal ideation
Clinical narrative: Fever after second dose; thought about taking his life; went through an intense depression and started to cry; headaches were intense and extreme; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SUICIDAL IDEATION (thought about taking his life) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced HEADACHE (headaches were intense and extreme). On 10-Apr-2021, the patient experienced SUICIDAL IDEATION (thought about taking his life) (seriousness criterion life threatening) and DEPRESSION (went through an intense depression and started to cry). On an unknown date, the patient experienced PYREXIA (Fever after second dose). On 10-Apr-2021, SUICIDAL IDEATION (thought about taking his life) and DEPRESSION (went through an intense depression and started to cry) had resolved. At the time of the report, HEADACHE (headaches were intense and extreme) had resolved and PYREXIA (Fever after second dose) outcome was unknown.            No adverse event as Medical History was reported. Treatment included acetaminophen.  Concomitant medication was not reported.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable. On 02-Apr-2021, the patient experienced HEADACHE (headaches were intense and extreme). He also described the headaches as a dull, not throbbing pain.  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.   This case was linked to MOD-2021-104303 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown. Not Provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Concomitant medication was not reported. No treatment information was reported.  Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Osteoarthritis, Unevaluable event
Clinical narrative: Osteoarthritis aggravated; Recurred Intestinal tubing; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of UNEVALUABLE EVENT (Recurred Intestinal tubing) and OSTEOARTHRITIS (Osteoarthritis aggravated) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis and Crohn's disease.    Relevant history includes alcohol abstinence and non tobacco user. Osteoarthritis aggravated started at an unknown date in March 2020 and stopped at an unknown in 2020.  The patient's past medical history included Gastric bypass in 2004 and Knee replacement in June 2020. Concurrent medical conditions included Osteoarthritis since 2019 and Gastrointestinal tube insertion since February 2020.   In March 2020, the patient started ADALIMUMAB (HUMIRA) (unknown route) 40 milligram every two weeks. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced UNEVALUABLE EVENT (Recurred Intestinal tubing) (seriousness criterion hospitalization). On an unknown date, the patient experienced OSTEOARTHRITIS (Osteoarthritis aggravated) (seriousness criterion hospitalization). The patient was hospitalized for 2 days due to UNEVALUABLE EVENT. In March 2021, UNEVALUABLE EVENT (Recurred Intestinal tubing) had resolved. At the time of the report, OSTEOARTHRITIS (Osteoarthritis aggravated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Computerised tomogram: recurred intestinal tubing (abnormal) Recurred intestinal tubing.     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.   The patient was hospitalized for two days due to recurred intestinal tubing. She had a laparoscopic procedure to visualized the intestine and it there was no cramping or tumor that was found and the intestine was clear. She was told that it was resolved by itself and no additional treatment or procedure was needed at that time. She was scheduled for an Esophagogastroduodenoscopy to determine the cause of recurred intestinal tubing. The alternative etiology for the event Recurred Intestinal Tubing was reported as could be due to previous gastric bypass surgery.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Ankle fracture, Fall, Loss of consciousness
Clinical narrative: Loss of consciousness; ankle fracture; Fall; This spontaneous case was reported by a physician and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included UPADACITINIB (RINVOQ) from 11-Feb-2021 to an unknown date for Rheumatoid arthritis.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 15-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), ANKLE FRACTURE (ankle fracture) and FALL (Fall). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), ANKLE FRACTURE (ankle fracture) and FALL (Fall) 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.   RINVOQ(UPADACITINIB) is the only concomitant drug reported by the reporter which indicated for sever to moderate rheumatoid arthritis. No tobacco or alcohol use reported. The reporter's causality for the loss of consciousness with the RINVOQ (UPADACITINIB) was no reasonable possibility.The causality of the other reported events was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity, Ultrasound scan, X-ray
Clinical narrative: pain was in back of right leg, up into thigh/Pain in right leg continued to get worse/pain was very excruciating; Developed right leg muscle cramps; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (pain was in back of right leg, up into thigh/Pain in right leg continued to get worse/pain was very excruciating) and MUSCLE SPASMS (Developed right leg muscle cramps) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced PAIN IN EXTREMITY (pain was in back of right leg, up into thigh/Pain in right leg continued to get worse/pain was very excruciating) (seriousness criterion hospitalization) and MUSCLE SPASMS (Developed right leg muscle cramps) (seriousness criterion hospitalization). The patient was hospitalized on 02-May-2021 due to MUSCLE SPASMS and PAIN IN EXTREMITY. At the time of the report, PAIN IN EXTREMITY (pain was in back of right leg, up into thigh/Pain in right leg continued to get worse/pain was very excruciating) and MUSCLE SPASMS (Developed right leg muscle cramps) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2021, Ultrasound scan: (normal) studies were ok. On 02-May-2021, X-ray: ok (normal) studies were ok.         On the evening of 01-May-2021, the patient states he developed cramps and pain in his right leg, which continued to get worse. The patient stated The patient states that the hospital gave him medications to help the pain, and he left the hospital. The patient  took the medicine and it eased for a while, but keeps recurring. The patient stated that he then went to another hospital due to the persistent pain, where he was admitted for observation. The pain is in the back of right leg, up into the thigh. Treatment included pain medicine, Tylenol, Ibuprofen, nerve tablets, and a muscle relaxer. The doctors were trying to find out what the pain was from.  The action taken with mRNA-1273 in response to the event was not applicable.  Company comment Based on the current available information and temporal association between the use of the product  and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product  and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Nodule
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NODULE (knot on the leg) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NODULE (knot on the leg) (seriousness criterion medically significant) and BLOOD GLUCOSE INCREASED (high blood sugar). At the time of the report, NODULE (knot on the leg) and BLOOD GLUCOSE INCREASED (high blood sugar) outcome was unknown. Which was operated on.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: high blood sugar (High) high blood sugar.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had visited the surgeon's office for a knot on her leg and she was operated on.  Company Comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Feeling abnormal, Hallucination, Paranoia
Clinical narrative: hallucinating; started to feel funny/acting weird/feeling weird mentally/no longer himself/didn't feel normal/everything went downhill; Paranoid; acting weird/no longer himself/everything went downhill; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (hallucinating) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (hallucinating) (seriousness criterion medically significant), FEELING ABNORMAL (started to feel funny/acting weird/feeling weird mentally/no longer himself/didn't feel normal/everything went downhill), PARANOIA (Paranoid) and ABNORMAL BEHAVIOUR (acting weird/no longer himself/everything went downhill). At the time of the report, HALLUCINATION (hallucinating), FEELING ABNORMAL (started to feel funny/acting weird/feeling weird mentally/no longer himself/didn't feel normal/everything went downhill), PARANOIA (Paranoid) and ABNORMAL BEHAVIOUR (acting weird/no longer himself/everything went downhill) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided.  On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (hallucinating) (seriousness criterion medically significant), FEELING ABNORMAL (started to feel funny/feeling weird mentally/didn't feel normal/everything went downhill), PARANOIA (Paranoid) and ABNORMAL BEHAVIOUR (acting weird/no longer himself/everything went downhill). At the time of the report, HALLUCINATION (hallucinating), FEELING ABNORMAL (started to feel funny/feeling weird mentally/didn't feel normal/everything went downhill), PARANOIA (Paranoid) and ABNORMAL BEHAVIOUR (acting weird/no longer himself/everything went downhill) outcome was unknown.  Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Retinal haemorrhage, Retinal vascular occlusion, Vision blurred, Visual impairment
Clinical narrative: She is bleeding behind retina so she can't see properly; Clot in retinal branch; She can't see properly; She sees blurry; Light nose bleed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RETINAL HAEMORRHAGE (She is bleeding behind retina so she can't see properly) and RETINAL VASCULAR OCCLUSION (Clot in retinal branch) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced EPISTAXIS (Light nose bleed). On 22-Apr-2021, the patient experienced VISION BLURRED (She sees blurry). On 29-Apr-2021, the patient experienced RETINAL HAEMORRHAGE (She is bleeding behind retina so she can't see properly) (seriousness criterion medically significant), RETINAL VASCULAR OCCLUSION (Clot in retinal branch) (seriousness criterion medically significant) and VISUAL IMPAIRMENT (She can't see properly). At the time of the report, RETINAL HAEMORRHAGE (She is bleeding behind retina so she can't see properly), RETINAL VASCULAR OCCLUSION (Clot in retinal branch), VISUAL IMPAIRMENT (She can't see properly), VISION BLURRED (She sees blurry) and EPISTAXIS (Light nose bleed) outcome was unknown.            Patient started with light nose bleed 2 days after receiving vaccine. Then 2 weeks ago, she developed problem with her eyes. She mentions that she sees blurry. She went to doctor on 29Apr2021 and doctor said that there was a clot in retinal branch and she is bleeding behind retina so she can't see properly.  Treatment medication includes: Vastin Injection for the eyes Concomitant medication includes: BP medicine  Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: End up having a stroke; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-May-2021 and was forwarded to Moderna on 08-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (End up having a stroke) 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 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (End up having a stroke) (seriousness criteria hospitalization and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (End up having a stroke) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and treatment information were not reported.  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   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 event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Osteomyelitis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of OSTEOMYELITIS (Osteomyelitis is acting up again) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Compound fracture - tibia (Bone-setting and skin-grafts were done) in 1975, Compound fracture - fibula (Bone-setting and skin-grafts were done) in 1975, Motor vehicle accident (Bone-setting and skin-grafts were done) in 1975, Osteomyelitis in 1976, Staphylococcus aureus infection in 1976, Bone prosthesis insertion in 1976, Bone graft in 1976 and Bone operation (metal plate removal, with no significant 'osteo' remembered) in 1979. Previously administered products included for Osteomyelitis: Dicloxacillin in 1976, Keflex (In-patient treatment of osteo using Keflex (antibiotic) every four hours and followed by outpatient treatment with oral Dicloxacillin) in 1976. Past adverse reactions to the above products included No adverse reaction with Dicloxacillin and Keflex. Concurrent medical conditions included Osteomyelitis (Dormant case of osteomyelitis for about 47 years).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OSTEOMYELITIS (Osteomyelitis is acting up again) (seriousness criterion medically significant). At the time of the report, OSTEOMYELITIS (Osteomyelitis is acting up again) had not resolved.            No concomitant medication provided.  Description: The patient recently had the first and second shots of vaccine and now patient's osteomyelitis was acting up again. Patient did not see a doctor for this worsening of symptoms because it wasn't yet draining pus and recent problems in patient's lower left leg (redness, pain and change in appearance of the bony looking scar) might go away on their own.   No treatment information reported.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.  Very limited information regarding this events has been provided at this time.  However, the underlying condition in this advanced age patient remains a confounder. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  However, the underlying condition in this advanced age patient remains a confounder. Further information has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Somnolence, Vaccination site pain
Clinical narrative: She is tired/tired was reported as worsened; daily headache; ache to be all over her head, neck, and "everything."; still wants to take a nap when she wakes up; injection site soreness; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3249, Expiration date not reported), via an unspecified route of administration on 19Jan2021 (at the age 45-year-old), as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced injection site soreness for 1-2 days on an unknown date in Jan2021 and has also had a daily headache on 19Jan2021 since received the vaccine. The patient reports that the headache isn't a huge headache, but it is a nuisance. Caller stated that she had a headache within an hour of receiving the vaccine and reports the ache to be all over her head, neck, and everything on an unknown date in Jan2021. Ever since then, she has had this daily mild headache every day. She is wondering if this is normal. On 20Jan2021, she is tired (was reported as worsened) and has a headache. She is a busy mom so it is hard to say if the tiredness is partly from that. It is like if she had a moment to take a nap she will take a nap. She feels like she is getting a good night sleep, but still wants to take a nap when she wakes up on an unknown date in Jan2021. It may not be out of norm. The headache portion is out of the norm. Treatment received with Advil or Excedrin daily once or twice a day for headache. The outcome of the tired, daily mild headache was reported as not resolved and all other events were unknown.  Follow-up (28Jan2021): This is a follow-up spontaneous report from a contactable consumer. No new information was found.  Follow-up attempts are completed. No further information is expected.