chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Leukemia.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm). At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter. A laboratorian called regarding a leukemia patient who reportedly did not present antibodies for the COVID-19 virus upon undergoing an antibody test   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: discomfort at the site of injection for short period of time; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (discomfort at the site of injection for short period of time) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concomitant products included PREDNISONE, LISINOPRIL, ALLOPURINOL, CLOTRIMAZOLE and HYDROCHLOROTHIAZIDE, TRIAMTERENE (HYDROCHLOROTHIAZIDE WITH TRIAMTERENE) for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOMFORT (discomfort at the site of injection for short period of time). At the time of the report, VACCINATION SITE DISCOMFORT (discomfort at the site of injection for short period of time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include Paradoxical. No treatment was reported for the events.   This case was linked to MOD-2021-244832 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Ear pain, Musculoskeletal chest pain, Tremor
Clinical narrative: Pain going down in the rib area and around her back; symptoms of Tremors that are constantly coming and going/Tremors are so bad that she cant even proper step; tremors are coming in different varieties and sometime she has pain in her ear.; Pain going down in the rib area and around her back; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (Pain going down in the rib area and around her back), TREMOR (symptoms of Tremors that are constantly coming and going/Tremors are so bad that she cant even proper step), EAR PAIN (tremors are coming in different varieties and sometime she has pain in her ear.) and BACK PAIN (Pain going down in the rib area and around her back) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event. Concomitant products included PREDNISONE, LISINOPRIL, ALLOPURINOL and CLOTRIMAZOLE for an unknown indication.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL CHEST PAIN (Pain going down in the rib area and around her back), TREMOR (symptoms of Tremors that are constantly coming and going/Tremors are so bad that she cant even proper step), EAR PAIN (tremors are coming in different varieties and sometime she has pain in her ear.) and BACK PAIN (Pain going down in the rib area and around her back). At the time of the report, MUSCULOSKELETAL CHEST PAIN (Pain going down in the rib area and around her back), EAR PAIN (tremors are coming in different varieties and sometime she has pain in her ear.) and BACK PAIN (Pain going down in the rib area and around her back) outcome was unknown and TREMOR (symptoms of Tremors that are constantly coming and going/Tremors are so bad that she cant even proper step) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included Paradoxical, Hydrochlorothiazide - trimipramine 50/70 mg QD.  'Patient said that day after the administration of the vaccine no symptoms occurred. However, a day later she started experiencing pain going down in the rib area and around her back.Then month later she has started experiencing symptoms of Tremors'  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. Further information has been requested   This case was linked to MOD-2021-244827 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Mobility decreased, Myalgia, Neuralgic amyotrophy
Clinical narrative: diffuse inflammation of the brachial plexu; loss of range of motion,  loss of strength in abduction and his external humerus, and his other systems are mildly weak.; loss of strength in abduction and his external humerus; after the 2nd dose, 8 hours later his arm started to hurt a lot, like someone had put an ice pick in his shoulder.; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIC AMYOTROPHY (diffuse inflammation of the brachial plexu), MOBILITY DECREASED (loss of range of motion,  loss of strength in abduction and his external humerus, and his other systems are mildly weak.), ASTHENIA (loss of strength in abduction and his external humerus) and MYALGIA (after the 2nd dose, 8 hours later his arm started to hurt a lot, like someone had put an ice pick in his shoulder.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 025320A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN for Cholesterol, NADOLOL and MAGNESIUM for Long QT syndrome.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEURALGIC AMYOTROPHY (diffuse inflammation of the brachial plexu), MOBILITY DECREASED (loss of range of motion,  loss of strength in abduction and his external humerus, and his other systems are mildly weak.), ASTHENIA (loss of strength in abduction and his external humerus) and MYALGIA (after the 2nd dose, 8 hours later his arm started to hurt a lot, like someone had put an ice pick in his shoulder.). At the time of the report, NEURALGIC AMYOTROPHY (diffuse inflammation of the brachial plexu), MOBILITY DECREASED (loss of range of motion,  loss of strength in abduction and his external humerus, and his other systems are mildly weak.), ASTHENIA (loss of strength in abduction and his external humerus) and MYALGIA (after the 2nd dose, 8 hours later his arm started to hurt a lot, like someone had put an ice pick in his shoulder.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: bad taste in her mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (bad taste in her mouth) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Atopic dermatitis. Concomitant products included DUPILUMAB (DUPIXENT) for Atopic dermatitis.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. In March 2021, the patient experienced DYSGEUSIA (bad taste in her mouth). At the time of the report, DYSGEUSIA (bad taste in her mouth) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       In February 2019, Patient started taking dupilumab 300 mg every other week subcutaneous, strength: 300mg/2ml (with an unknown formulation, expiry date- 30-Sep-2023). Pharmacist advised there were no Interactions with dupilumab and the covid Vaccine. This was not a listed side effect of dupilumab. Patient was going to see her md office that day.  No treatment information was provided the reporter
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine as a 1st dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine as a 1st dose) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine as a 1st dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine as a 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Patient received Moderna and Pfizer vaccine3; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Patient received Moderna and Pfizer vaccine3) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2020, the patient experienced PRODUCT ADMINISTRATION ERROR (Patient received Moderna and Pfizer vaccine3). At the time of the report, PRODUCT ADMINISTRATION ERROR (Patient received Moderna and Pfizer vaccine3) 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 provided by the reporter. no treatment information provided by the reporter
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Dizziness, Dry mouth, Dysgeusia, Paraesthesia oral
Clinical narrative: very similar reaction/second time the onset was much quicker; dizzy; extremely dry mouth; taste of metal; tingling on the side of my tongue; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (very similar reaction/second time the onset was much quicker), DIZZINESS (dizzy), DRY MOUTH (extremely dry mouth), DYSGEUSIA (taste of metal) and PARAESTHESIA ORAL (tingling on the side of my tongue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (very similar reaction/second time the onset was much quicker), DIZZINESS (dizzy), DRY MOUTH (extremely dry mouth), DYSGEUSIA (taste of metal) and PARAESTHESIA ORAL (tingling on the side of my tongue). At the time of the report, ADVERSE EVENT (very similar reaction/second time the onset was much quicker), DIZZINESS (dizzy), DRY MOUTH (extremely dry mouth), DYSGEUSIA (taste of metal) and PARAESTHESIA ORAL (tingling on the side of my tongue) outcome was unknown.            No concomitant medications reported.  Treatment information not reported.   This case was linked to MOD-2021-027491 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: Caller received the 1st dose on 27May2021 and was in contact with her daughter who was diagnosed with Covid on 29Jun2021; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Caller received the 1st dose on 27May2021 and was in contact with her daughter who was diagnosed with Covid on 29Jun2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 27-May-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 EXPOSURE TO SARS-COV-2 (Caller received the 1st dose on 27May2021 and was in contact with her daughter who was diagnosed with Covid on 29Jun2021). At the time of the report, EXPOSURE TO SARS-COV-2 (Caller received the 1st dose on 27May2021 and was in contact with her daughter who was diagnosed with Covid on 29Jun2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported. she is scheduled to receive her 2nd dose
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Mobility decreased, Somnolence, Vaccination site pain
Clinical narrative: Mobility decreased; Vaccination site pain; very sleepy; headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (very sleepy), MOBILITY DECREASED (Mobility decreased), HEADACHE (headache) and VACCINATION SITE PAIN (Vaccination site pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD (worsened after shot given) since August 2010, Chronic bronchitis (have more incidenses) since 1966, Drug allergy (Allergic to steroids), Depression, Acid reflux (esophageal), Heart disorder (unspecified) and Bone disorder. Concomitant products included FAMOTIDINE for Acid reflux (esophageal), CALCIUM CARBONATE (CALTRATE [CALCIUM CARBONATE]) for Bone disorder (NOS), BUPROPION HYDROCHLORIDE (WELLBUTRIN) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for Depression, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Heart disorder.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced SOMNOLENCE (very sleepy) and HEADACHE (headache). On 24-Apr-2021, the patient experienced MOBILITY DECREASED (Mobility decreased) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, SOMNOLENCE (very sleepy), MOBILITY DECREASED (Mobility decreased), HEADACHE (headache) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information  was provided.   This case was linked to MOD-2021-187185 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: lip swelling or inflammation; 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 LIP SWELLING (lip swelling or inflammation) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 immunization.     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 LIP SWELLING (lip swelling or inflammation). At the time of the report, LIP SWELLING (lip swelling or inflammation) outcome was unknown.            No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Unevaluable event
Clinical narrative: two other adverse events; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (two other adverse events) and MYALGIA (muscle aches) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced UNEVALUABLE EVENT (two other adverse events) and MYALGIA (muscle aches). The patient was treated with PARACETAMOL (TYLENOL) for Myalgia, at a dose of 1 dosage form. At the time of the report, UNEVALUABLE EVENT (two other adverse events) and MYALGIA (muscle aches) had resolved.            No concomitant information was reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: eczema; This spontaneous case was reported by an other health care professional and describes the occurrence of ECZEMA (eczema) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ECZEMA (eczema). At the time of the report, ECZEMA (eczema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information, if any, was not provided by the reporter. Treatment information, if any, was not provided
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Achy; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), PANTOPRAZOLE and ZOLPIDEM for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 MYALGIA (Achy). At the time of the report, MYALGIA (Achy) had resolved.            No treatment medications were provided.   This case was linked to MOD-2021-042699 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Shoulder injury related to vaccine administration
Clinical narrative: Injection site pain; SIRVA; This spontaneous case was reported by a consumer and describes the occurrence of SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (SIRVA) and INJECTION SITE PAIN (Injection site pain) in a 71-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) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (SIRVA) and INJECTION SITE PAIN (Injection site pain). At the time of the report, SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (SIRVA) had not resolved and INJECTION SITE PAIN (Injection site pain) outcome was unknown.            No concomitant medication were provided by the reporter. No treatment information were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Additional information received for the case: MOD-2021-028253 on 02-07-2021 new event and second dose information were added.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Magnet stick to her injection arm in the left upper arm; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Magnet stick to her injection arm in the left upper arm) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0090T1A and 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Jun-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 03-Jun-2021, the patient experienced UNEVALUABLE EVENT (Magnet stick to her injection arm in the left upper arm). At the time of the report, UNEVALUABLE EVENT (Magnet stick to her injection arm in the left upper arm) outcome was unknown.            No treatment and concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Patient second name is updated.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: Pain in their legs; Pain in their knees; Constant muscular pain from their waist down; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in their legs), ARTHRALGIA (Pain in their knees) and MYALGIA (Constant muscular pain from their waist down) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026021a) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-2021, the patient experienced PAIN IN EXTREMITY (Pain in their legs). 29-Jun-2021, the patient experienced ARTHRALGIA (Pain in their knees) and MYALGIA (Constant muscular pain from their waist down). The patient was treated with ACETAMINOPHEN for Pain, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) for Pain, at a dose of 15 milligram. At the time of the report, PAIN IN EXTREMITY (Pain in their legs), ARTHRALGIA (Pain in their knees) and MYALGIA (Constant muscular pain from their waist down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that she was not taking any concomitant medications.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Pain, Product dose omission issue, Pyrexia, Vaccination site pain
Clinical narrative: the next day he started experiencing symptoms of little bit sick; pain; too much sick with fever; arm pain at the site of injection for 3-4 weeks; 1st dose of Moderna COVID-19 vaccine on 14May2021 , second dose not taken; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (the next day he started experiencing symptoms of little bit sick), PAIN (pain), PRODUCT DOSE OMISSION ISSUE (1st dose of Moderna COVID-19 vaccine on 14May2021 , second dose not taken), PYREXIA (too much sick with fever) and VACCINATION SITE PAIN (arm pain at the site of injection for 3-4 weeks) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose of Moderna COVID-19 vaccine on 14May2021 , second dose not taken). On 15-May-2021, the patient experienced ILLNESS (the next day he started experiencing symptoms of little bit sick), PAIN (pain), PYREXIA (too much sick with fever) and VACCINATION SITE PAIN (arm pain at the site of injection for 3-4 weeks). On 14-May-2021, PRODUCT DOSE OMISSION ISSUE (1st dose of Moderna COVID-19 vaccine on 14May2021 , second dose not taken) had resolved. At the time of the report, ILLNESS (the next day he started experiencing symptoms of little bit sick), PAIN (pain), PYREXIA (too much sick with fever) and VACCINATION SITE PAIN (arm pain at the site of injection for 3-4 weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeding disorder, Feeling abnormal, Nausea, Pyrexia
Clinical narrative: can't eat anything; "losing myself"/"inside pressure"; nausea; vomiting; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (can't eat anything), FEELING ABNORMAL ("losing myself"/"inside pressure"), NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jun-2021, the patient experienced FEEDING DISORDER (can't eat anything), FEELING ABNORMAL ("losing myself"/"inside pressure"), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever) and CHILLS (chills). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, FEEDING DISORDER (can't eat anything), FEELING ABNORMAL ("losing myself"/"inside pressure"), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            The caller did not report his Age/DOB or concomitant medications.   The  patient used to drink a lot of water to feel better.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: can't eat anything; "losing myself"/"inside pressure"; nausea; vomiting; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (can't eat anything), FEELING ABNORMAL ("losing myself"/"inside pressure"), NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jun-2021, the patient experienced FEEDING DISORDER (can't eat anything), FEELING ABNORMAL ("losing myself"/"inside pressure"), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever) and CHILLS (chills). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, FEEDING DISORDER (can't eat anything), FEELING ABNORMAL ("losing myself"/"inside pressure"), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            The caller did not report his Age/DOB or concomitant medications.   The  patient used to drink a lot of water to feel better.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Oligomenorrhoea
Clinical narrative: Menstrual cycle prolonged; Heavy menstrual bleeding; This spontaneous case was reported by a consumer and describes the occurrence of OLIGOMENORRHOEA (Menstrual cycle prolonged) and HEAVY MENSTRUAL BLEEDING (Heavy menstrual bleeding) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OLIGOMENORRHOEA (Menstrual cycle prolonged) and HEAVY MENSTRUAL BLEEDING (Heavy menstrual bleeding). At the time of the report, OLIGOMENORRHOEA (Menstrual cycle prolonged) and HEAVY MENSTRUAL BLEEDING (Heavy menstrual bleeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were provided.   This case was linked to MOD-2021-245561 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient given dose 2 weeks after vial puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given dose 2 weeks after vial puncture) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given dose 2 weeks after vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient given dose 2 weeks after vial puncture) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Interchange of vaccine products
Clinical narrative: I got Moderna as my 1st dose and Pfizer as my 2nd dose; having headaches on and off still; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (I got Moderna as my 1st dose and Pfizer as my 2nd dose) and HEADACHE (having headaches on and off still) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (I got Moderna as my 1st dose and Pfizer as my 2nd dose) and HEADACHE (having headaches on and off still). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 20-Jun-2021, INTERCHANGE OF VACCINE PRODUCTS (I got Moderna as my 1st dose and Pfizer as my 2nd dose) had resolved. At the time of the report, HEADACHE (having headaches on and off still) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported accidentally administered the Pfizer vaccine instead of the Moderna COVID-19 vaccine. Dose 2 Pfizer (non-Moderna) information : Lot #: EW0182 Date administered: 20JUN2021.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: Patient hasn't received 2nd dose yet; 5 days after receiving 1st dose, she contracted with covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (5 days after receiving 1st dose, she contracted with covid) and PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced COVID-19 (5 days after receiving 1st dose, she contracted with covid). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet). At the time of the report, COVID-19 (5 days after receiving 1st dose, she contracted with covid) and PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include blood pressure. No treatment medication was reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Heavy Menstrual bleeding after both Covid-19 vaccines; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Heavy Menstrual bleeding after both Covid-19 vaccines) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 049C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (Heavy Menstrual bleeding after both Covid-19 vaccines). At the time of the report, HEAVY MENSTRUAL BLEEDING (Heavy Menstrual bleeding after both Covid-19 vaccines) outcome was unknown.            no concomitant was provided no treatment medication was provided   This case was linked to MOD-2021-245555 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chest discomfort, Hypoaesthesia, Muscular weakness
Clinical narrative: experiencing numbness; It feels like on the side he took the shot, it feels like the muscles are falling asleep, like he is put under sedation; chest feels like he pulled something; feels weak; a lingering ache in his top shoulder; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (experiencing numbness), MUSCULAR WEAKNESS (It feels like on the side he took the shot, it feels like the muscles are falling asleep, like he is put under sedation), CHEST DISCOMFORT (chest feels like he pulled something), ASTHENIA (feels weak) and ARTHRALGIA (a lingering ache in his top shoulder) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. 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 HYPOAESTHESIA (experiencing numbness), MUSCULAR WEAKNESS (It feels like on the side he took the shot, it feels like the muscles are falling asleep, like he is put under sedation), CHEST DISCOMFORT (chest feels like he pulled something), ASTHENIA (feels weak) and ARTHRALGIA (a lingering ache in his top shoulder). The patient was treated with PARACETAMOL (TYLENOL) for Shoulder pain, at a dose of 1 dosage form. At the time of the report, HYPOAESTHESIA (experiencing numbness), MUSCULAR WEAKNESS (It feels like on the side he took the shot, it feels like the muscles are falling asleep, like he is put under sedation), CHEST DISCOMFORT (chest feels like he pulled something), ASTHENIA (feels weak) and ARTHRALGIA (a lingering ache in his top shoulder) outcome was unknown.            No concomitant medications reported.   This case was linked to MOD-2021-245747 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza like illness, SARS-CoV-2 antibody test negative
Clinical narrative: flu like virus; may have got a bad lot from the pharmacy or maybe it is just my body; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Jul-2021. The most recent information was received on 26-Jul-2021 and was forwarded to Moderna on 27-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like virus) and FEELING ABNORMAL (may have got a bad lot from the pharmacy or maybe it is just my body) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 002B21A) for COVID-19 vaccination.     The patient's past medical history included Flu like symptoms.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like virus) and FEELING ABNORMAL (may have got a bad lot from the pharmacy or maybe it is just my body). At the time of the report, INFLUENZA LIKE ILLNESS (flu like virus) and FEELING ABNORMAL (may have got a bad lot from the pharmacy or maybe it is just my body) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 antibody test negative: negative (Negative) negative.         On an unknown date, post vaccination, the patient reported that he experienced symptoms of flu like symptoms.   No treatment information was provided  No Concomitant information was provided   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Significant : Patient Details provided
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Swelling
Clinical narrative: Red swelled; Red swelled; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red swelled) and SWELLING (Red swelled) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Red swelled) and SWELLING (Red swelled). At the time of the report, ERYTHEMA (Red swelled) and SWELLING (Red swelled) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea
Clinical narrative: headache; nausea; fatigue; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), NAUSEA (nausea), FATIGUE (fatigue) and MYALGIA (muscle pain) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced HEADACHE (headache), NAUSEA (nausea), FATIGUE (fatigue) and MYALGIA (muscle pain). At the time of the report, HEADACHE (headache), NAUSEA (nausea), FATIGUE (fatigue) and MYALGIA (muscle pain) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Red rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Red rash at injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No specified medical history has been 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 VACCINATION SITE RASH (Red rash at injection site). At the time of the report, VACCINATION SITE RASH (Red rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.    This case was linked to MOD-2021-187577 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: NNI FU - No new information was provided
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Sedation, Therapeutic response unexpected
Clinical narrative: Light headed immediately after the shot; No energy; Feels sedated; Vaccine has made him calm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed immediately after the shot), ASTHENIA (No energy), SEDATION (Feels sedated) and THERAPEUTIC RESPONSE UNEXPECTED (Vaccine has made him calm) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CLONAZEPAM (KLONOPIN) for an unknown indication.    On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-2021, the patient experienced DIZZINESS (Light headed immediately after the shot), ASTHENIA (No energy), SEDATION (Feels sedated) and THERAPEUTIC RESPONSE UNEXPECTED (Vaccine has made him calm). At the time of the report, DIZZINESS (Light headed immediately after the shot), ASTHENIA (No energy), SEDATION (Feels sedated) and THERAPEUTIC RESPONSE UNEXPECTED (Vaccine has made him calm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This patient reported he doesn't need clonopin after this vaccine because it has made him so calm down and he feels off. These symptoms started right away and he is still feeling them, but not quite as bad as the day after the vaccine.  Treatment information was not provided by the reporter.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue
Clinical narrative: Got sick; Passed 48 days without second dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick) and PRODUCT DOSE OMISSION ISSUE (Passed 48 days without second dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Passed 48 days without second dose). On an unknown date, the patient experienced ILLNESS (Got sick). On 14-May-2021, PRODUCT DOSE OMISSION ISSUE (Passed 48 days without second dose) had resolved. At the time of the report, ILLNESS (Got sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.   Treatment information was not provided.     Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Additional information received and New event "Got sick"was added
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-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 VACCINATION SITE SWELLING (swelling). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE SWELLING (swelling) outcome was unknown.            No concomitant medications were not reported.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: severe allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (severe allergic reaction) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced ALLERGY TO VACCINE (severe allergic reaction). At the time of the report, ALLERGY TO VACCINE (severe allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.