chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: Diarrhea; Horrible stomach problems; This spontaneous case was reported by an other caregiver and describes the occurrence of DIARRHOEA (Diarrhea) and ABDOMINAL DISCOMFORT (Horrible stomach problems) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 025G20-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced DIARRHOEA (Diarrhea) and ABDOMINAL DISCOMFORT (Horrible stomach problems). At the time of the report, DIARRHOEA (Diarrhea) and ABDOMINAL DISCOMFORT (Horrible stomach problems) outcome was unknown.            Reportedly, the dentist wanted to make a canal in the tooth, it was not possible, so they pulled the tooth. The doctor put him on antibiotic and then the diarrhea started. The reporter stated that they filled the cadaver bone with plastic.  No relevant concomitant medications were reported.  Treatment information was not provided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Vaccination site pain
Clinical narrative: Body aches; headache; tender around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), HEADACHE (headache) and VACCINATION SITE PAIN (tender around the injection site) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced MYALGIA (Body aches), HEADACHE (headache) and VACCINATION SITE PAIN (tender around the injection site). The patient was treated with PARACETAMOL (TYLENOL) in March 2021 for Headache, Myalgia and Vaccination site tenderness, at a dose of 1000 mg once a day. On 19-Mar-2021, MYALGIA (Body aches), HEADACHE (headache) and VACCINATION SITE PAIN (tender around the injection site) had resolved. Not Provided          No relevant concomitant medication was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Event outcome was updated.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pruritus, Urticaria
Clinical narrative: Hives all over his body except the lower limbs; Itching; Feeling body is hot; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over his body except the lower limbs), PRURITUS (Itching) and FEELING HOT (Feeling body is hot) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced URTICARIA (Hives all over his body except the lower limbs), PRURITUS (Itching) and FEELING HOT (Feeling body is hot). At the time of the report, URTICARIA (Hives all over his body except the lower limbs), PRURITUS (Itching) and FEELING HOT (Feeling body is hot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment information was not provided.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Incomplete course of vaccination
Clinical narrative: Turned away for second dose due to being on a steroid regimen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INCOMPLETE COURSE OF VACCINATION (Turned away for second dose due to being on a steroid regimen) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (Turned away for second dose due to being on a steroid regimen). At the time of the report, INCOMPLETE COURSE OF VACCINATION (Turned away for second dose due to being on a steroid regimen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products known to have been used by the patient, within two weeks prior to the event, included steroids.    Treatment of the event not reported.  This report refers to a case of incomplete course of vaccination for mRNA-1273, lot # unknown  with no associated AEs.; Sender's Comments: This report refers to a case of incomplete course of vaccination for mRNA-1273, lot # unknown  with no associated AEs.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Injection site red; Puffy rash around the injection site bigger than a quater; Swollen around the injection site; Itchy around the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site red), VACCINATION SITE RASH (Puffy rash around the injection site bigger than a quater), VACCINATION SITE SWELLING (Swollen around the injection site) and VACCINATION SITE PRURITUS (Itchy around the injection site) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included VITAMINS NOS for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site red), VACCINATION SITE RASH (Puffy rash around the injection site bigger than a quater), VACCINATION SITE SWELLING (Swollen around the injection site) and VACCINATION SITE PRURITUS (Itchy around the injection site). The patient was treated with HYDROCORTISONE (topical) in March 2021 for Vaccination site erythema, Vaccination site rash, Vaccination site swelling and Vaccination site pruritus, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) in March 2021 for Vaccination site pruritus, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (Injection site red), VACCINATION SITE RASH (Puffy rash around the injection site bigger than a quater), VACCINATION SITE SWELLING (Swollen around the injection site) and VACCINATION SITE PRURITUS (Itchy around the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional treatment information included breast milk, on the injection site to treat adverse event.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm/Arm pain; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm/Arm pain) and HEADACHE (slight headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm/Arm pain) and HEADACHE (slight headache). At the time of the report, PAIN IN EXTREMITY (sore arm/Arm pain) and HEADACHE (slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment medications was not provided by the reporter
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown. Not Provided          No concomitant medication were reported.  No Treatment information was reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: Sore arm around the injection site; Rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm around the injection site) and VACCINATION SITE RASH (Rash around the injection site) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01020A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-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 15-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm around the injection site) and VACCINATION SITE RASH (Rash around the injection site). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Sore arm around the injection site) and VACCINATION SITE RASH (Rash around the injection site) had resolved. Not Provided          No relevant concomitant medications were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Outcome of the event was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: pain in shoulder iridin to back; had sore arm that 3 or 4 days more chronic pain in left arm (injection); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (had sore arm that 3 or 4 days more chronic pain in left arm (injection)) and ARTHRALGIA (pain in shoulder iridin to back) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's medical history was not reported.  Concomitant products included LEVETIRACETAM (KEPPRA), AMLODIPINE, PRAVASTATIN, PARACETAMOL (TYLENOL REGULAR) and IBUPROFEN for an unknown indication.    On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE PAIN (had sore arm that 3 or 4 days more chronic pain in left arm (injection)). On an unknown date, the patient experienced ARTHRALGIA (pain in shoulder iridin to back). The patient was treated with PREDNISONE at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and LIDOCAINE, PRILOCAINE (COMPOUND LIDOCAINE) for Pain, at a dose of UNK, bid. At the time of the report, VACCINATION SITE PAIN (had sore arm that 3 or 4 days more chronic pain in left arm (injection)) and ARTHRALGIA (pain in shoulder iridin to back) outcome was unknown.            Additional treatment medication included unspecified muscle relaxing.   This case was linked to US-MODERNATX, INC.-MOD-2021-048391 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Her arm is very painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm is very painful) 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 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Her arm is very painful). At the time of the report, PAIN IN EXTREMITY (Her arm is very painful) outcome was unknown.            No relevant concomitant medications were reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (little bit of arm soreness) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history information reported. On Mar 5, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 5, 2021, patient experienced vaccination site pain (little bit of arm soreness). On Mar 7, 2021, vaccination site pain (little bit of arm soreness) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant product use and treatment information not provided by the reporter. The patient had the second dose and had no issues. Reporter did not allow further contact. Most recent follow-up information incorporated above includes: On May 7, 2021: Action taken and consent updated.
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Device connection issue
Clinical narrative: Vaccine was being administered but it spilled out, so they ended up administering an other dose.; Vaccine was being administered but it spilled out, so they ended up administering an other dose.; WARNING: THE STUDY CONFIGURATION IS MISSING THE STUDY PHASE. PLEASE UPDATE THE STUDY PHASE AND RE-GENERATE THE NARRATIVE AGAIN.    This     The subject received mRNA-1273 (Moderna COVID-19 Vaccine). The report describes a case of DEVICE CONNECTION ISSUE (Vaccine was being administered but it spilled out, so they ended up administering an other dose.) and ACCIDENTAL OVERDOSE (Vaccine was being administered but it spilled out, so they ended up administering an other dose.).     The patient's past medical history included No adverse event (No adverse event history).  On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (Vaccine was being administered but it spilled out, so they ended up administering an other dose.) and ACCIDENTAL OVERDOSE (Vaccine was being administered but it spilled out, so they ended up administering an other dose.). At the time of the report, DEVICE CONNECTION ISSUE (Vaccine was being administered but it spilled out, so they ended up administering an other dose.) and ACCIDENTAL OVERDOSE (Vaccine was being administered but it spilled out, so they ended up administering an other dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator.  Treatment of this event was not provided.  Company comment: This report refers to a case of syringe connection issue and accidental overdose for mRNA-1273, lot # unknown  with no associated AEs   Reporter did not allow further contact
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Ocular hyperaemia, Pruritus
Clinical narrative: Eyes were very red; her shoulder to elbow on arm was red and very itchy; her shoulder to elbow on arm was red and very itchy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (her shoulder to elbow on arm was red and very itchy), ERYTHEMA (her shoulder to elbow on arm was red and very itchy) and OCULAR HYPERAEMIA (Eyes were very red) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (her shoulder to elbow on arm was red and very itchy), ERYTHEMA (her shoulder to elbow on arm was red and very itchy) and OCULAR HYPERAEMIA (Eyes were very red). At the time of the report, PRURITUS (her shoulder to elbow on arm was red and very itchy) and ERYTHEMA (her shoulder to elbow on arm was red and very itchy) had resolved and OCULAR HYPERAEMIA (Eyes were very red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment medication were over-the-counter (OTC) anti itching cream and eye drops.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: No new information reported.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details not provided.  concomitant details not provided.    This case was linked to MOD-2021-009003 (Patient Link).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever ( 101 ° F-102 ° F); This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever ( 101 ° F-102 ° F)) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-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 PYREXIA (Fever ( 101 ° F-102 ° F)). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever ( 101 ° F-102 ° F)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 ° f to 102 ° f 101 ° F to 102 ° F sometimes goes down to 98 ° F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included 3 unspecified medicines for the convulsion and to treat reflux acid.  Treatment medications included paracetamol  (Tylenol).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of herpes zoster (shingles) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine), batch# 012A21A) for COVID-19 immunization. The patient's past medical history included bone fracture bone in 2020. Concomitant products included levothyroxine for an unknown indication. On Mar 3, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 12, 2021, patient experienced herpes zoster (shingles). At the time of the report, herpes zoster (shingles): resolving. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments. The treatment for the shingles event included antiviral medication and Advil.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Rash, Urticaria
Clinical narrative: Problems in her back / pain in the back; rash on her arm, like hives; Rash on her arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Problems in her back / pain in the back), URTICARIA (rash on her arm, like hives) and RASH (Rash on her arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced URTICARIA (rash on her arm, like hives) and RASH (Rash on her arm). On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (Problems in her back / pain in the back). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Problems in her back / pain in the back) was resolving and URTICARIA (rash on her arm, like hives) and RASH (Rash on her arm) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.     Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Reporter contact information and patient initials updated
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Pain in extremity, Vaccination site urticaria
Clinical narrative: Pain in arm/injection arm was sore; headache; Fatigue; welt at injection site; Lack of appetite; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Lack of appetite), PAIN IN EXTREMITY (Pain in arm/injection arm was sore), VACCINATION SITE URTICARIA (welt at injection site), HEADACHE (headache) and FATIGUE (Fatigue) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 032M204) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 13-Feb-2021, the patient experienced DECREASED APPETITE (Lack of appetite) and VACCINATION SITE URTICARIA (welt at injection site). On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm/injection arm was sore), HEADACHE (headache) and FATIGUE (Fatigue). At the time of the report, DECREASED APPETITE (Lack of appetite), PAIN IN EXTREMITY (Pain in arm/injection arm was sore), VACCINATION SITE URTICARIA (welt at injection site), HEADACHE (headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was given.  No treatment information was given.   This case was linked to MOD-2021-101624 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Email Updated and 2nd dose of vaccine information provided
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Anxiety, Arthralgia, Dysgeusia, Gait disturbance
Clinical narrative: joints would start hurting; tingling on the back sides in the rear of his tongue; recurring and metallic taste in his mouth; terrible headach; going to come down with the flu for several hours; mental agitation with anger, or not feeling well; erratic performance, described as breathing sometimes like having run three miles after climbing; walking; extraordinarily high level of anxiety; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (recurring and metallic taste in his mouth), PARAESTHESIA (tingling on the back sides in the rear of his tongue), HEADACHE (terrible headach), ARTHRALGIA (joints would start hurting) and ANXIETY (extraordinarily high level of anxiety) in a 66-year-old male 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.     The patient's past medical history included Deep vein thrombosis in 2017, Atrial fibrillation (With cardioversion), Sleep apnea and Knee replacement (Double knee replacement.). Concomitant products included ROSUVASTATIN, RIVAROXABAN (XARELTO), LISINOPRIL, HCTZ, CURCUMIN (TURMERIC MERIVA), ACETAMINOPHEN and METOPROLOL SUCCINATE for an unknown indication.    On 21-Feb-2021 at 5:10 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced ANXIETY (extraordinarily high level of anxiety). On 26-Feb-2021, the patient experienced GAIT DISTURBANCE (walking). On 01-Mar-2021, the patient experienced AGITATION (mental agitation with anger, or not feeling well) and HYPERVENTILATION (erratic performance, described as breathing sometimes like having run three miles after climbing). On an unknown date, the patient experienced DYSGEUSIA (recurring and metallic taste in his mouth), PARAESTHESIA (tingling on the back sides in the rear of his tongue), HEADACHE (terrible headach), ARTHRALGIA (joints would start hurting) and INFLUENZA (going to come down with the flu for several hours). On 04-Mar-2021, ANXIETY (extraordinarily high level of anxiety), GAIT DISTURBANCE (walking), AGITATION (mental agitation with anger, or not feeling well) and HYPERVENTILATION (erratic performance, described as breathing sometimes like having run three miles after climbing) outcome was unknown. At the time of the report, DYSGEUSIA (recurring and metallic taste in his mouth), PARAESTHESIA (tingling on the back sides in the rear of his tongue), HEADACHE (terrible headach), ARTHRALGIA (joints would start hurting) and INFLUENZA (going to come down with the flu for several hours) 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.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperventilation, Influenza, Paraesthesia
Clinical narrative: joints would start hurting; tingling on the back sides in the rear of his tongue; recurring and metallic taste in his mouth; terrible headach; going to come down with the flu for several hours; mental agitation with anger, or not feeling well; erratic performance, described as breathing sometimes like having run three miles after climbing; walking; extraordinarily high level of anxiety; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (recurring and metallic taste in his mouth), PARAESTHESIA (tingling on the back sides in the rear of his tongue), HEADACHE (terrible headach), ARTHRALGIA (joints would start hurting) and ANXIETY (extraordinarily high level of anxiety) in a 66-year-old male 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.     The patient's past medical history included Deep vein thrombosis in 2017, Atrial fibrillation (With cardioversion), Sleep apnea and Knee replacement (Double knee replacement.). Concomitant products included ROSUVASTATIN, RIVAROXABAN (XARELTO), LISINOPRIL, HCTZ, CURCUMIN (TURMERIC MERIVA), ACETAMINOPHEN and METOPROLOL SUCCINATE for an unknown indication.    On 21-Feb-2021 at 5:10 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced ANXIETY (extraordinarily high level of anxiety). On 26-Feb-2021, the patient experienced GAIT DISTURBANCE (walking). On 01-Mar-2021, the patient experienced AGITATION (mental agitation with anger, or not feeling well) and HYPERVENTILATION (erratic performance, described as breathing sometimes like having run three miles after climbing). On an unknown date, the patient experienced DYSGEUSIA (recurring and metallic taste in his mouth), PARAESTHESIA (tingling on the back sides in the rear of his tongue), HEADACHE (terrible headach), ARTHRALGIA (joints would start hurting) and INFLUENZA (going to come down with the flu for several hours). On 04-Mar-2021, ANXIETY (extraordinarily high level of anxiety), GAIT DISTURBANCE (walking), AGITATION (mental agitation with anger, or not feeling well) and HYPERVENTILATION (erratic performance, described as breathing sometimes like having run three miles after climbing) outcome was unknown. At the time of the report, DYSGEUSIA (recurring and metallic taste in his mouth), PARAESTHESIA (tingling on the back sides in the rear of his tongue), HEADACHE (terrible headach), ARTHRALGIA (joints would start hurting) and INFLUENZA (going to come down with the flu for several hours) 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.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: The injection site is itchy.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (The injection site is itchy.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M209) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (The injection site is itchy.). At the time of the report, VACCINATION SITE PRURITUS (The injection site is itchy.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications include Diabetes medications  Patient used alcohol as treatment to get some relief.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Parosmia, Taste disorder
Clinical narrative: Foul taste; Foul smell; Feeling horrible; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Foul taste), PAROSMIA (Foul smell) and MALAISE (Feeling horrible) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE and DULAGLUTIDE (TRULICITY) for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced TASTE DISORDER (Foul taste), PAROSMIA (Foul smell) and MALAISE (Feeling horrible). At the time of the report, TASTE DISORDER (Foul taste), PAROSMIA (Foul smell) and MALAISE (Feeling horrible) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Pyrexia
Clinical narrative: Coughing; 103.2 degree fever; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing) and PYREXIA (103.2 degree fever) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Adrenal insufficiency. Concomitant products included HYDROCORTISONE for Adrenal insufficiency, ESTRADIOL for an unknown indication.    On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced COUGH (Coughing) and PYREXIA (103.2 degree fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Coughing, at an unspecified dose and frequency. At the time of the report, COUGH (Coughing) and PYREXIA (103.2 degree fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Body temperature: 103.2 degree (High) 103.2 degree.         Other concomitant medication included gastrointestinal medication.   This case was linked to MOD-2021-048503 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Movement disorder, Pain in extremity
Clinical narrative: Arm is sore/pain in arm; Numbness in the arm; Lost feeling in the arm, difficulty moving arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is sore/pain in arm), HYPOAESTHESIA (Numbness in the arm) and MOVEMENT DISORDER (Lost feeling in the arm, difficulty moving arm) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 immunisation.     Concurrent medical conditions included Adrenal insufficiency. Concomitant products included HYDROCORTISONE for Adrenal insufficiency, ESTRADIOL for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm is sore/pain in arm), HYPOAESTHESIA (Numbness in the arm) and MOVEMENT DISORDER (Lost feeling in the arm, difficulty moving arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm is sore/pain in arm), HYPOAESTHESIA (Numbness in the arm) and MOVEMENT DISORDER (Lost feeling in the arm, difficulty moving arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Other concomitant medication included gastrointestinal medication.   This case was linked to MOD-2021-048486 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) 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 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided. Treatment information was not reported.    Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: No new information reported
Sex: M
Vaccine: COVID19
Symptoms: Sluggishness, Vaccination site pain
Clinical narrative: Sluggish; pain on the left arm, feels as if some one punched; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Sluggish) and VACCINATION SITE PAIN (pain on the left arm, feels as if some one punched) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced SLUGGISHNESS (Sluggish) and VACCINATION SITE PAIN (pain on the left arm, feels as if some one punched). At the time of the report, SLUGGISHNESS (Sluggish) and VACCINATION SITE PAIN (pain on the left arm, feels as if some one punched) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included unspecified medicines for heart conditions. Treatment information was not reported.   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pyrexia
Clinical narrative: nausea; fatigue; fever/high fever; This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (nausea), FATIGUE (fatigue) and PYREXIA (fever, high fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to medicines).    On 07-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 10-Mar-2021, the patient experienced NAUSEA (nausea) and FATIGUE (fatigue). On an unknown date, the patient experienced PYREXIA (fever, high fever). At the time of the report, NAUSEA (nausea), FATIGUE (fatigue) and PYREXIA (fever, high fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information reported. Treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Non-Significant follow up appended to MOD-2021-048530
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included PREDNISONE for an unknown indication.    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 FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Skin irritation
Clinical narrative: irritation all over the body; redness on the arm; rash on the arm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (irritation all over the body), ERYTHEMA (redness on the arm) and RASH (rash on the arm) 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 02-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced SKIN IRRITATION (irritation all over the body), ERYTHEMA (redness on the arm) and RASH (rash on the arm). At the time of the report, SKIN IRRITATION (irritation all over the body), ERYTHEMA (redness on the arm) and RASH (rash on the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Clumps of hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Clumps of hair loss) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Clumps of hair loss). At the time of the report, ALOPECIA (Clumps of hair loss) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue
Clinical narrative: sore arm; felt fatigue/little tired; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (sore arm) and FATIGUE (felt fatigue/little tired) 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 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 24-Feb-2021, the patient experienced AXILLARY PAIN (sore arm) and FATIGUE (felt fatigue/little tired). At the time of the report, AXILLARY PAIN (sore arm) and FATIGUE (felt fatigue/little tired) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Event information details.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Induration, Irritability, Mass, Pain in extremity
Clinical narrative: big bump similar to that when you get a bite and the area gets hard; area gets hard; feels irritated; the injection site started to itch; feels extremely tired; injection site swelled up; arm soreness the day of which went away the next day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness the day of which went away the next day), MASS (big bump similar to that when you get a bite and the area gets hard), INDURATION (area gets hard), IRRITABILITY (feels irritated) and VACCINATION SITE PRURITUS (the injection site started to itch) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Leg pain. Concomitant products included IBUPROFEN from 16-Mar-2021 to an unknown date for Leg pain, HYDROCHLOROTHIAZIDE for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness the day of which went away the next day). On 16-Mar-2021, the patient experienced MASS (big bump similar to that when you get a bite and the area gets hard), INDURATION (area gets hard), IRRITABILITY (feels irritated), VACCINATION SITE PRURITUS (the injection site started to itch), FATIGUE (feels extremely tired) and VACCINATION SITE SWELLING (injection site swelled up). On 09-Mar-2021, PAIN IN EXTREMITY (arm soreness the day of which went away the next day) had resolved. At the time of the report, MASS (big bump similar to that when you get a bite and the area gets hard), INDURATION (area gets hard), IRRITABILITY (feels irritated), VACCINATION SITE PRURITUS (the injection site started to itch), FATIGUE (feels extremely tired) and VACCINATION SITE SWELLING (injection site swelled up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient tried putting something cold against injection site area for a few minutes but trying not to touch the area.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: big bump similar to that when you get a bite and the area gets hard; area gets hard; feels irritated; the injection site started to itch; feels extremely tired; injection site swelled up; arm soreness the day of which went away the next day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness the day of which went away the next day), MASS (big bump similar to that when you get a bite and the area gets hard), INDURATION (area gets hard), IRRITABILITY (feels irritated) and VACCINATION SITE PRURITUS (the injection site started to itch) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Leg pain. Concomitant products included IBUPROFEN from 16-Mar-2021 to an unknown date for Leg pain, HYDROCHLOROTHIAZIDE for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness the day of which went away the next day). On 16-Mar-2021, the patient experienced MASS (big bump similar to that when you get a bite and the area gets hard), INDURATION (area gets hard), IRRITABILITY (feels irritated), VACCINATION SITE PRURITUS (the injection site started to itch), FATIGUE (feels extremely tired) and VACCINATION SITE SWELLING (injection site swelled up). On 09-Mar-2021, PAIN IN EXTREMITY (arm soreness the day of which went away the next day) had resolved. At the time of the report, MASS (big bump similar to that when you get a bite and the area gets hard), INDURATION (area gets hard), IRRITABILITY (feels irritated), VACCINATION SITE PRURITUS (the injection site started to itch), FATIGUE (feels extremely tired) and VACCINATION SITE SWELLING (injection site swelled up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient tried putting something cold against injection site area for a few minutes but trying not to touch the area.