chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle tightness, Myalgia, Nausea, Pain, Pain in extremity
Clinical narrative: TIGHTNESS AND CRAMPING IN LEFT LEG AND RIGHT ARM; CONFUSED; GROGGY; TIGHTNESS AND CRAMPING IN LEFT LEG AND RIGHT ARM; TIRED; UPSET STOMACH; HEADACHE; MUSCLE ACHES; SHARP PAIN IN LEFT ARM; SORE ARM; NAUSEA; This spontaneous report received from a patient concerned a 28 year old male. The patient's weight was 205 pounds, and height was 73 inches. The patient's concurrent conditions included irritable bowel syndrome, alcohol user, cigarette smoker, and depression, and other pre-existing medical conditions included patient had no know allergy and no drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced nausea. On 27-MAY-2021, the subject experienced sharp pain in left arm. On 27-MAY-2021, the subject experienced sore arm. On 30-MAY-2021, the subject experienced upset stomach. On 30-MAY-2021, the subject experienced headache. On 30-MAY-2021, the subject experienced muscle aches. On 31-MAY-2021, the subject experienced tightness and cramping in left leg and right arm. On 31-MAY-2021, the subject experienced confused. On 31-MAY-2021, the subject experienced groggy. On 31-MAY-2021, the subject experienced tightness and cramping in left leg and right arm. On 31-MAY-2021, the subject experienced tired. Treatment medications (dates unspecified) included: calcium chloride/glucose/magnesium chloride/potassium chloride/sodium chloride/sodium lactate, and ondansetron. The action taken with covid-19 vaccine was not applicable. The patient recovered from sharp pain in left arm on 27-MAY-2021, had not recovered from sore arm, upset stomach, headache, muscle aches, tightness and cramping in left leg and right arm, tired, confused, groggy, and tightness and cramping in left leg and right arm, and the outcome of nausea was not reported. This report was non-serious.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: TIGHTNESS AND CRAMPING IN LEFT LEG AND RIGHT ARM; CONFUSED; GROGGY; TIGHTNESS AND CRAMPING IN LEFT LEG AND RIGHT ARM; TIRED; UPSET STOMACH; HEADACHE; MUSCLE ACHES; SHARP PAIN IN LEFT ARM; SORE ARM; NAUSEA; This spontaneous report received from a patient concerned a 28 year old male. The patient's weight was 205 pounds, and height was 73 inches. The patient's concurrent conditions included irritable bowel syndrome, alcohol user, cigarette smoker, and depression, and other pre-existing medical conditions included patient had no know allergy and no drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced nausea. On 27-MAY-2021, the subject experienced sharp pain in left arm. On 27-MAY-2021, the subject experienced sore arm. On 30-MAY-2021, the subject experienced upset stomach. On 30-MAY-2021, the subject experienced headache. On 30-MAY-2021, the subject experienced muscle aches. On 31-MAY-2021, the subject experienced tightness and cramping in left leg and right arm. On 31-MAY-2021, the subject experienced confused. On 31-MAY-2021, the subject experienced groggy. On 31-MAY-2021, the subject experienced tightness and cramping in left leg and right arm. On 31-MAY-2021, the subject experienced tired. Treatment medications (dates unspecified) included: calcium chloride/glucose/magnesium chloride/potassium chloride/sodium chloride/sodium lactate, and ondansetron. The action taken with covid-19 vaccine was not applicable. The patient recovered from sharp pain in left arm on 27-MAY-2021, had not recovered from sore arm, upset stomach, headache, muscle aches, tightness and cramping in left leg and right arm, tired, confused, groggy, and tightness and cramping in left leg and right arm, and the outcome of nausea was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Increased bronchial secretion, Irregular breathing
Clinical narrative: Specific sign was of sudden increase in secretions (from eyes, nose, or mouth); allergies ?acting up,?  or a cold; feeling tired. changes in breathing, with  exercises
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Severe rash on shin of both legs (never get rashes) and on both forearms as well as chest.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Bumps( hives) all over the body
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: DVT in Right leg
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac imaging procedure abnormal, Chest X-ray abnormal, Echocardiogram abnormal, Myocarditis, Troponin I
Clinical narrative: Myocarditis
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Product administered to patient of inappropriate age, Tremor
Clinical narrative: Impact was not right away. Patient displayed uncontrollable unilateral leg tremors sporadically (2-3 events) over the course of one day. No prior history. Patient also complains to muscle cramps in his arms and legs 2 weeks after vaccination.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Intracranial mass, Respiratory failure, Thrombocytopenia
Clinical narrative: death D69.6 - Thrombocytopenia, unspecified Respiratory failure Intercranial mass
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Pain in extremity
Clinical narrative: BACK WAS SORE; ARM WAS A LITTLE SORE; CHILLS; ARM FELT TIRED  (WHERE PATIENT GOT THE SHOT OF VACCINE); This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 30-MAY-2021, the subject experienced back was sore. On 30-MAY-2021, the subject experienced arm was a little sore. On 30-MAY-2021, the subject experienced chills. On 30-MAY-2021, the subject experienced arm felt tired (where subject got the shot of vaccine). The action taken with covid-19 vaccine was not applicable. The outcome of the arm was a little sore, arm felt tired (where patient got the shot of vaccine), back was sore and chills was not reported. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hypoaesthesia, Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Nausea, Pyrexia, Rash
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Granuloma annulare, Rash
Clinical narrative: patient developed a rash around 6 weeks post 2nd COVID Vaccine.  5/11/21 was diagnosed with granuloma annulare. Provider unsure if related to covid vaccine
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Systemic: see below for additional details-Medium, Additional Details: expired vial of Moderna Vaccine was given. Vaccine vial was punctured on May 30, 2021 and was not properly strong-pak'd out of system.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: MILD PAIN IN THE SITE OF INJECTION; This spontaneous report received from a consumer concerned a 38 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced mild pain in the site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild pain in the site of injection was not reported. This report was non-serious. This case, from the same reporter is linked to 20210559333.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: SHARP/STABBING PAIN AT INJECTION SITE ON LEFT ARM; This spontaneous report received from a patient concerned a 56 year old male. The patient's weight was 170 pounds, and height was 66 inches. The patient's past medical history included surgery, and concurrent conditions included diabetes mellitus, hypertension, cholesterol, asthma, allergies, non-smoker, and alcohol use, and other pre-existing medical conditions included the patient had no known drug allergies and no drug abuse/illicit use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, and expiry: 23-JUL-2021) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.   On 01-JUN-2021, the subject experienced sharp/stabbing pain at injection site on left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sharp/stabbing pain at injection site on left arm was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Fatigue, Myalgia, Neck pain
Clinical narrative: Received 1st dose of moderna and 2ns dose of J&J vaccine; She felt fatigue; muscle soreness, whole body ache; Arm hurts bad; Severe anxiety; Neck pain; Couldn't really getup; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts bad), ANXIETY (Severe anxiety), NECK PAIN (Neck pain) and ASTHENIA (Couldn't really getup) in a 55-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.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm hurts bad) (seriousness criterion medically significant), ANXIETY (Severe anxiety) (seriousness criterion medically significant), NECK PAIN (Neck pain) (seriousness criterion medically significant), ASTHENIA (Couldn't really getup) (seriousness criterion medically significant), FATIGUE (She felt fatigue) and MYALGIA (muscle soreness, whole body ache). On 14-May-2021, the patient experienced WRONG PRODUCT ADMINISTERED (Received 1st dose of moderna and 2ns dose of J&J vaccine). On 14-May-2021, WRONG PRODUCT ADMINISTERED (Received 1st dose of moderna and 2ns dose of J&J vaccine) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm hurts bad), ANXIETY (Severe anxiety), NECK PAIN (Neck pain), ASTHENIA (Couldn't really getup), FATIGUE (She felt fatigue) and MYALGIA (muscle soreness, whole body ache) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Patient took vaccine on deltoid muscle. On 14May2021 patient received J&J shot.  Concomitant product use was not provided/unknown by the reporter.  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. Treatment for events included pain killer.; 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Wrong product administered
Clinical narrative: Received 1st dose of moderna and 2ns dose of J&J vaccine; She felt fatigue; muscle soreness, whole body ache; Arm hurts bad; Severe anxiety; Neck pain; Couldn't really getup; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts bad), ANXIETY (Severe anxiety), NECK PAIN (Neck pain) and ASTHENIA (Couldn't really getup) in a 55-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.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm hurts bad) (seriousness criterion medically significant), ANXIETY (Severe anxiety) (seriousness criterion medically significant), NECK PAIN (Neck pain) (seriousness criterion medically significant), ASTHENIA (Couldn't really getup) (seriousness criterion medically significant), FATIGUE (She felt fatigue) and MYALGIA (muscle soreness, whole body ache). On 14-May-2021, the patient experienced WRONG PRODUCT ADMINISTERED (Received 1st dose of moderna and 2ns dose of J&J vaccine). On 14-May-2021, WRONG PRODUCT ADMINISTERED (Received 1st dose of moderna and 2ns dose of J&J vaccine) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm hurts bad), ANXIETY (Severe anxiety), NECK PAIN (Neck pain), ASTHENIA (Couldn't really getup), FATIGUE (She felt fatigue) and MYALGIA (muscle soreness, whole body ache) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Patient took vaccine on deltoid muscle. On 14May2021 patient received J&J shot.  Concomitant product use was not provided/unknown by the reporter.  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. Treatment for events included pain killer.; 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: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Tachycardia
Clinical narrative: faster/quicker heartbeat; my heart beating double what it was supposed to be; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (faster/quicker heartbeat) and TACHYCARDIA (my heart beating double what it was supposed to be) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 026B21A) for COVID-19 vaccination.     No Medical History Reported.  Concomitant products included METFORMIN, LISINOPRIL and EMPAGLIFLOZIN (JARDIANCE) for Diabetes, LEVOTHYROXINE for Thyroid disorder, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (faster/quicker heartbeat) (seriousness criterion medically significant) and TACHYCARDIA (my heart beating double what it was supposed to be) (seriousness criterion medically significant). The patient was treated with RIVAROXABAN (XARELTO) ongoing since an unknown date for Anticoagulant therapy, at a dose of 20 mg once a day and METOPROLOL SUCCINATE ongoing since an unknown date for Heart disorder, at a dose of 25 mg once a day. At the time of the report, HEART RATE INCREASED (faster/quicker heartbeat) and TACHYCARDIA (my heart beating double what it was supposed to be) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Emotional distress, Hypersensitivity, Product dose omission issue
Clinical narrative: allergic reaction; patient did not receive the second dose of the vaccine; traumatized by this event; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (allergic reaction) 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 20-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 HYPERSENSITIVITY (allergic reaction) (seriousness criterion hospitalization), PRODUCT DOSE OMISSION ISSUE (patient did not receive the second dose of the vaccine) and EMOTIONAL DISTRESS (traumatized by this event). The patient was treated with EPINEPHRINE for Adverse reaction, at a dose of 5 Epi-Pens. At the time of the report, HYPERSENSITIVITY (allergic reaction) and PRODUCT DOSE OMISSION ISSUE (patient did not receive the second dose of the vaccine) had resolved and EMOTIONAL DISTRESS (traumatized by this event) outcome was unknown.            Concomitant product use was not provided by the reporter.  The father of the patient reported his daughter ended up in the intensive care unit for 2 days on unknown dates. The father stated that while hospitalized, the daughter was treated with  epinephrine "needed 5 epi-pens before it was over with". The father states that his daughter (the patient) was ok now. His daughter was very traumatized by this event and it was difficult for her to talk about it.  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. This report also refers to a case of product dose omission issue for mRNA-1273, lot # unknown, with no associated AEs.; 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. This report also refers to a case of product dose omission issue for mRNA-1273, lot # unknown, with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Right side of face was very swollen; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SWELLING FACE (Right side of face was very swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.   No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 14-Apr-2021, the patient experienced SWELLING FACE (Right side of face was very swollen) (seriousness criterion medically significant). At the time of the report, SWELLING FACE (Right side of face was very swollen) outcome was unknown.  The reporter was the husband of the patient.  The action taken with mRNA-1273 in response to the event was not applicable.  Concomitant medications were not reported. No treatment information was provided.  It was reported that after administration of the second dose of the vaccine (product not specified) on an unspecified date, the patient developed swelling of the right side of her face on 14-Apr-2021.   It was reported that she was sent to the ER (emergency room) by her PCP (primary care physician), where she was given intravenous steroids.  Company Comment: This case concerns a female of unknown age with a serious unexpected event of swelling face. Event latency within 24 hours after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a female of unknown age with a serious unexpected event of swelling face. Event latency within 24 hours after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 70.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Dyspnoea, Fatigue, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: COVID-19; feeling really tired; Having little trouble breathing; brain fog; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (brain fog), FATIGUE (feeling really tired), DYSPNOEA (Having little trouble breathing) and COVID-19 (COVID-19) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product MACITENTAN for Pulmonary hypertension.    Concurrent medical conditions included Primary pulmonary hypertension. Concomitant products included SILDENAFIL for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and MACITENTAN (Oral) 10 milligram. On 04-Nov-2020, the patient experienced FEELING ABNORMAL (brain fog) (seriousness criterion hospitalization prolonged) and COVID-19 (COVID-19) (seriousness criterion hospitalization). On an unknown date, the patient experienced FATIGUE (feeling really tired) (seriousness criterion hospitalization prolonged) and DYSPNOEA (Having little trouble breathing) (seriousness criterion hospitalization prolonged). The patient was hospitalized for 5 days until 05-Nov-2020 due to FEELING ABNORMAL, then until 05-Nov-2020 due to DYSPNOEA and FATIGUE. At the time of the report, FEELING ABNORMAL (brain fog), FATIGUE (feeling really tired), DYSPNOEA (Having little trouble breathing) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2020, SARS-CoV-2 test: positive (Positive) Positive.     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 treatment information was provided.  The patient got first dose of vaccine on March 2021 and second dose on April 2021.  Company comment: Very limited information regarding the events have been provided at this time. Medication Macitentan can be a confounding factor. Based on the mechanism of action of mRNA 1273 and the timing of the event Covid 19 which happened prior to the vaccine schedule, the event is unlikely related to the vaccine. No further information is expected at this time.   This case was linked to MOD-2021-163029 (Patient Link).; Sender's Comments: Very limited information regarding the events have been provided at this time. Medication Macitentan can be a confounding factor. Based on the mechanism of action of mRNA 1273 and the timing of the event Covid 19 which happened prior to the vaccine schedule, the event is unlikely related to the vaccine. No further information is expected at this time.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Deafness transitory, Headache, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: Body pain; Extreme muscle weakness; Night sweats; Headache; Chills; Nausea; Temporary loss of hearing in her right ear; Stiffness in both upper arms and upper legs; This spontaneous case was reported by a health care professional and describes the occurrence of DEAFNESS TRANSITORY (Temporary loss of hearing in her right ear) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness in both upper arms and upper legs). On 19-Apr-2021, the patient experienced DEAFNESS TRANSITORY (Temporary loss of hearing in her right ear) (seriousness criterion medically significant), PAIN (Body pain), MUSCULAR WEAKNESS (Extreme muscle weakness), NIGHT SWEATS (Night sweats), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, DEAFNESS TRANSITORY (Temporary loss of hearing in her right ear), MUSCULOSKELETAL STIFFNESS (Stiffness in both upper arms and upper legs), PAIN (Body pain), MUSCULAR WEAKNESS (Extreme muscle weakness), NIGHT SWEATS (Night sweats), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  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.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Night sweats, Pain
Clinical narrative: Body pain; Extreme muscle weakness; Night sweats; Headache; Chills; Nausea; Temporary loss of hearing in her right ear; Stiffness in both upper arms and upper legs; This spontaneous case was reported by a health care professional and describes the occurrence of DEAFNESS TRANSITORY (Temporary loss of hearing in her right ear) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness in both upper arms and upper legs). On 19-Apr-2021, the patient experienced DEAFNESS TRANSITORY (Temporary loss of hearing in her right ear) (seriousness criterion medically significant), PAIN (Body pain), MUSCULAR WEAKNESS (Extreme muscle weakness), NIGHT SWEATS (Night sweats), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, DEAFNESS TRANSITORY (Temporary loss of hearing in her right ear), MUSCULOSKELETAL STIFFNESS (Stiffness in both upper arms and upper legs), PAIN (Body pain), MUSCULAR WEAKNESS (Extreme muscle weakness), NIGHT SWEATS (Night sweats), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  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: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (anaphylactic reaction) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (anaphylactic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment drug information reported.  Very limited information regarding the event has been provided at this time and is insufficient for causality assessment.; Sender's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: The day after his first Covid-19 shot, patient complaint of itchy face. No swelling, no rashes, no difficulty breathing. Mild and lasted 2 days. On 3rd day after the vaccine, symptoms resolved.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Employee, Medical assistant took Moderna from freezer and without waiting the 2.5 hours, he drew vaccine and injected into patients arm.  I  I have spoke with the patient today after she left to make sure she was not feeling any unusual side effects.  I am not sure of what the proper protocol is for this error is. I called the Moderna hotline and they really could not assist me in this matter.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: near immediate lump at injection site.  minimal bleeding when withdrawing needed.  lump measured at injection site 18 mm x 13 mm.  no active bleeding, no erythema or bruising.  Spoke to patient for 8 minutes during which time no additional signs or symptoms were noted. Discussed next steps.  Will call to check on status in 4-5 hours and again in 20-24 hours.  Advised to contact our clinic or PCP with any additional questions or concerns.   Has appt with PCP 6/3/21 for annual PE.  Advised to monitor site periodically.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patients mother consented patient was 12 years of age at time of vaccination. Mother states pediatrician strongly recommended vaccination due to daughter almost being 12 years of age.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Chills, Confusional state, Headache, Menstruation delayed
Clinical narrative: General: Beginning at 8 hours post vaccination, patient experienced headache and chills. Several times during the night patient woke up to a pounding/racing heart as well as experiencing some confusion/confusing dreams. The following morning, noted experiencing a severe headache (at which time OTC medications were taken to relieve pain) as well as a low-grade fever of 99F (normal body temp of 97.9F). Slight headache continued for a week post vaccination.  Menstrual: Patient experienced a cycle that was 46 days long for the cycle following the date the vaccine was given. Previous four cycles ranged in length from 28 to 34 days. Onset of period was approximately two weeks late.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Palpitations
Clinical narrative: General: Beginning at 8 hours post vaccination, patient experienced headache and chills. Several times during the night patient woke up to a pounding/racing heart as well as experiencing some confusion/confusing dreams. The following morning, noted experiencing a severe headache (at which time OTC medications were taken to relieve pain) as well as a low-grade fever of 99F (normal body temp of 97.9F). Slight headache continued for a week post vaccination.  Menstrual: Patient experienced a cycle that was 46 days long for the cycle following the date the vaccine was given. Previous four cycles ranged in length from 28 to 34 days. Onset of period was approximately two weeks late.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Computerised tomogram, Headache, Magnetic resonance imaging head
Clinical narrative: Elevated blood pressure and headache.  2 mos Blood pressure still elevated and now on bp medicine
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Became Dizzy and was acessed by Nursing staff.  B/P 180\100  p-59 , O2 sat 98%.  Became diaphoretic.  No difficulty breathing no itching.  A&O.  1:17pm B/p 150/90 p-121 O2 sat 100%.  Continued to remain in clinic.  Released at 1:30pm
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Fatigue, Nausea
Clinical narrative: She got her vaccine, she had no symptoms.  The following day had very little soreness and nothing else.  Went to bed, woke up soaking wet, diarrhea, vomiting, dizzy.    She did not have skin feeling funny like with regular flu, but mostly all intestinal.  She changed her clothes and then was shivering and could not get warm, and had hard shaking chills.  She slept very little and has had it continuous since the vaccine.  She has been falling a sleep a lot, day, night and was previously very active and now falls asleep at a drop of a hat.  Over the past week and a half has had the cold chills less, but has awakened moist.   She is having the diarrhea and GI issues less, but feels nauseous at times during the day.   She is still waking up between 11:00 and 2:00 waking up, but falls sleep a lot, does not have a regular schedule as she did before.   It is not debilitating as much but still tired a lot.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Somnolence, Tenderness, Tremor, Vomiting
Clinical narrative: She got her vaccine, she had no symptoms.  The following day had very little soreness and nothing else.  Went to bed, woke up soaking wet, diarrhea, vomiting, dizzy.    She did not have skin feeling funny like with regular flu, but mostly all intestinal.  She changed her clothes and then was shivering and could not get warm, and had hard shaking chills.  She slept very little and has had it continuous since the vaccine.  She has been falling a sleep a lot, day, night and was previously very active and now falls asleep at a drop of a hat.  Over the past week and a half has had the cold chills less, but has awakened moist.   She is having the diarrhea and GI issues less, but feels nauseous at times during the day.   She is still waking up between 11:00 and 2:00 waking up, but falls sleep a lot, does not have a regular schedule as she did before.   It is not debilitating as much but still tired a lot.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis acneiform, Dyspnoea, Hyperhidrosis, Immediate post-injection reaction, Nausea
Clinical narrative: Day of vaccine--immediately after vaccine pt c/o itching of left arm (not vaccinated arm). Pt offered IM benadryl by EMS at the vaccine drive-pt refused. Encouraged to take benadryl and pepcid at home and to f/u with ER if condition worsened. Pt reports her arms, legs, and back began to itch and she developed red splotches over the areas.  She took the Benadryl 50mg at home (did not take pepcid). She took a nap then went to the local ER after she woke up she noticed a pimple-like rash on her face. She states she was given "2" shots and one was a steroid shot. She does not know what the other injection was.  Day 2-Pt states she went fishing (temp 90+ degrees)--pt states she started sweating, became short of breath, nauseated,-felt like she did when she had covid. states rash on body had improved, still had rash on face.  By Saturday states rash on Face was worse, other rash and itching had improved. By 1 wk--rash on face has almost completely resolved.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash macular
Clinical narrative: Day of vaccine--immediately after vaccine pt c/o itching of left arm (not vaccinated arm). Pt offered IM benadryl by EMS at the vaccine drive-pt refused. Encouraged to take benadryl and pepcid at home and to f/u with ER if condition worsened. Pt reports her arms, legs, and back began to itch and she developed red splotches over the areas.  She took the Benadryl 50mg at home (did not take pepcid). She took a nap then went to the local ER after she woke up she noticed a pimple-like rash on her face. She states she was given "2" shots and one was a steroid shot. She does not know what the other injection was.  Day 2-Pt states she went fishing (temp 90+ degrees)--pt states she started sweating, became short of breath, nauseated,-felt like she did when she had covid. states rash on body had improved, still had rash on face.  By Saturday states rash on Face was worse, other rash and itching had improved. By 1 wk--rash on face has almost completely resolved.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Diarrhoea, Headache, Hypoaesthesia, Musculoskeletal stiffness
Clinical narrative: Fingers still numb Heart racing Feels like a 50lb weight in my chest Everything hurts - incredibly hard to move Back feels like a truck hit me Diarrhea ended this morning  Headache gone Nausea almost gone
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Palpitations
Clinical narrative: Fingers still numb Heart racing Feels like a 50lb weight in my chest Everything hurts - incredibly hard to move Back feels like a truck hit me Diarrhea ended this morning  Headache gone Nausea almost gone
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: VACCINE ADMINISTRATION WAS GIVEN WITH A 5/8" NEEDLE.  A 1" NEEDLE SHOULD HAVE BEEN USED.   PATIENT WAS CONTACTED TWO DAYS LATER.  PATIENT HAD NO ADVERSE EFFECTS FROM THE SHORTER NEEDLE.   PATIENT FELT WELL AND HAD NO COMPLAINTS.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Needle issue, Underdose
Clinical narrative: When going to inject vaccine, needle was inserted into arm and when the syringe was depressed the needle retracted immediately, sending most of the vaccine down the patients arm and leaving some in the barrel, it is believed to be less than half the dose administered therefore a second full dose of vaccine was administered in the opposite arm.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass
Clinical narrative: Egg-sized lump remaining at injection site after 4 weeks from initial shot
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pharmacist had many things going on and went to give shot, and afterwards realized the patient was 17 at time of vaccination. The patient and mother both requested Janssen.  The typing technician didn't realize the age.  Patient has had no adverse effects. The patient and state health department have been notified
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Vaginal haemorrhage
Clinical narrative: The morning after receiving the COVID-19 vaccine I began experiencing vaginal bleeding. This lasted approximately 5-6 hours, then started again the following day and lasted overnight, for approximately 12 hours.  I was pregnant at the time of the vaccine being administered, just over 14 weeks.  The day the bleeding stopped (day 3) was the first day of week 15.  I contacted the on call OB who suggested I follow-up with my regular OB on Monday, or to go to the ER if it got worse. During the exam on 5/24/2021 the OB was unable to determine anything wrong with the placenta, baby or my heath and was unable to explain the bleeding other than a potential side effect of the vaccine.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Anxiety, Panic attack, Tinnitus
Clinical narrative: I started having ringing in my left ear (tinnitus) after my first dose. Its been almost a week and the ringing is still present
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Asthenia, Burning sensation, Haematology test abnormal, Idiosyncratic drug reaction
Clinical narrative: Cramping, burning and weakness in my limbs, starting with my thighs. Continued to my upper arms, lower forearms, wrists, fingers. It was debilitating so I wrote to my Healthcare PCP.  There was discussion that it could be from my condition of Fibromyalgia.  No help, there were no appointments available.  Finally, after many days of trying with Skelaxin muscle relaxant, I sought any available doctor at the clinic.  Dr.  suggested I try taking Flexeril.  That did not help.  He very actively sought an immediate appointment with an Immunologist. However, it was over an hour away. We could not make it. I sought an appointment for my own Neurologist of the clinic. I was on Gabapentin sin
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Muscle spasms, Muscular weakness, Neuralgia, Pain
Clinical narrative: Cramping, burning and weakness in my limbs, starting with my thighs. Continued to my upper arms, lower forearms, wrists, fingers. It was debilitating so I wrote to my Healthcare PCP.  There was discussion that it could be from my condition of Fibromyalgia.  No help, there were no appointments available.  Finally, after many days of trying with Skelaxin muscle relaxant, I sought any available doctor at the clinic.  Dr.  suggested I try taking Flexeril.  That did not help.  He very actively sought an immediate appointment with an Immunologist. However, it was over an hour away. We could not make it. I sought an appointment for my own Neurologist of the clinic. I was on Gabapentin sin
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: 6 weeks later got DVT R leg.  pt iwth ulcerative colitis on meds for this.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Condition aggravated, Dizziness, Nervousness
Clinical narrative: After giving vaccine, patient was in observation area and stated he felt light headed. He was nervous about the vaccine and feeling anxious. After speaking with him, he calmed down and stated he normally gets anxious regarding immunizations. He sat for 20 minutes and felt fine enough to go home.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Nausea, Retching
Clinical narrative: He reports getting the first Pfizer shot on 4/30/21. Starting on 5/1/21, he reports feeling fatigue, SOB and cough. These symptoms worsened over the subsequent two days until today when he felt that the cough was so frequent and severe that he couldn't breathe.  No fevers/chills/vomitting. He has felt nauseous and has dry heaved multiple times, mostly in the context of coughing fits. Pt was advised to go to ED for evaluation.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Aldolase, Antinuclear antibody, Anxiety, Asthenia, Blood creatine phosphokinase
Clinical narrative: He developed dullness and numbness in both feet followed by increasing subjective weakness, muscle twitching, intermittent in the legs. Dullness in feet has been constant. This contributed to increasing anxiety about the symptoms.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, C-reactive protein, Electromyogram, Full blood count, Glycosylated haemoglobin
Clinical narrative: He developed dullness and numbness in both feet followed by increasing subjective weakness, muscle twitching, intermittent in the legs. Dullness in feet has been constant. This contributed to increasing anxiety about the symptoms.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Magnetic resonance imaging head, Metabolic function test, Muscle twitching, Muscular weakness
Clinical narrative: He developed dullness and numbness in both feet followed by increasing subjective weakness, muscle twitching, intermittent in the legs. Dullness in feet has been constant. This contributed to increasing anxiety about the symptoms.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Nerve conduction studies, Red blood cell sedimentation rate, Vitamin B12
Clinical narrative: He developed dullness and numbness in both feet followed by increasing subjective weakness, muscle twitching, intermittent in the legs. Dullness in feet has been constant. This contributed to increasing anxiety about the symptoms.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: 3-4 cm circumscribed  indurated area on left upper arm at site of vaccine injection with mild central erythema and surrounding swelling
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Aphthous ulcer, Faeces discoloured, Haemoptysis, Oropharyngeal pain
Clinical narrative: Assumed it was a cold initially, due to sore throat. Sore throat came without other side effects of cold.  Used a flashlight to look at throat. I appear to have developed a canker sore on my tonsil. Because of the location of it, the tonsil is also agitated and has been bleeding leading me to have black stool as well as cough up blood and an upset stomach. This is something I have never experienced before.  It may be unrelated to the vaccine, I am not sure, but I figured it is something worth reporting.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Tonsillar haemorrhage
Clinical narrative: Assumed it was a cold initially, due to sore throat. Sore throat came without other side effects of cold.  Used a flashlight to look at throat. I appear to have developed a canker sore on my tonsil. Because of the location of it, the tonsil is also agitated and has been bleeding leading me to have black stool as well as cough up blood and an upset stomach. This is something I have never experienced before.  It may be unrelated to the vaccine, I am not sure, but I figured it is something worth reporting.