chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Headache, MERS-CoV test
Clinical narrative: Experienced side effects; Diarrhea; Dizziness; Headache; Chills; Nausea; I thought my right arm was going to fall off; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Experienced side effects), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), HEADACHE (Headache) and CHILLS (Chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Accident, Squamous cell carcinoma of skin (Stage 1 skin cancer in Sep-2021), Clinical trial participant in 1997, TIA (4 TIAs), MERS and Amputation (On right hand removed) in July 2021. Concurrent medical conditions included Asthma, Cardiac arrhythmia, Seizures (due to car accident) and Allergy (Severe Allergies-with a prescribed epi pen). Concomitant products included EPINEPHRINE (EPIPEN) for Allergy, LEVETIRACETAM (KEPRA), FLECAINIDE, MONTELUKAST SODIUM (SINGULAIR), PANTOPRAZOLE, FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]), ALBUTEROL [SALBUTAMOL], HCTZ and MUPIROCIN for an unknown indication.    On 23-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced DIARRHOEA (Diarrhea). 23-Dec-2021, the patient experienced DIZZINESS (Dizziness), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea). 23-Dec-2021, the patient experienced VACCINATION SITE PAIN (I thought my right arm was going to fall off). On an unknown date, the patient experienced VACCINATION COMPLICATION (Experienced side effects). At the time of the report, VACCINATION COMPLICATION (Experienced side effects), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and VACCINATION SITE PAIN (I thought my right arm was going to fall off) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2003, MERS-CoV test: positive (Positive) Positive, in 2003 was out for 3 weeks with MERS.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was stated that patient had no COVID diagnosis and had received a Tetanus shot 08-Jan-2022 because they cut their finger on a garbage can. Concomitant medication include Ellipta 200 m. No treatment information was reported.   This case was linked to MOD-2022-492034 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination complication, Vaccination site pain
Clinical narrative: Experienced side effects; Diarrhea; Dizziness; Headache; Chills; Nausea; I thought my right arm was going to fall off; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Experienced side effects), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), HEADACHE (Headache) and CHILLS (Chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Accident, Squamous cell carcinoma of skin (Stage 1 skin cancer in Sep-2021), Clinical trial participant in 1997, TIA (4 TIAs), MERS and Amputation (On right hand removed) in July 2021. Concurrent medical conditions included Asthma, Cardiac arrhythmia, Seizures (due to car accident) and Allergy (Severe Allergies-with a prescribed epi pen). Concomitant products included EPINEPHRINE (EPIPEN) for Allergy, LEVETIRACETAM (KEPRA), FLECAINIDE, MONTELUKAST SODIUM (SINGULAIR), PANTOPRAZOLE, FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]), ALBUTEROL [SALBUTAMOL], HCTZ and MUPIROCIN for an unknown indication.    On 23-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced DIARRHOEA (Diarrhea). 23-Dec-2021, the patient experienced DIZZINESS (Dizziness), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea). 23-Dec-2021, the patient experienced VACCINATION SITE PAIN (I thought my right arm was going to fall off). On an unknown date, the patient experienced VACCINATION COMPLICATION (Experienced side effects). At the time of the report, VACCINATION COMPLICATION (Experienced side effects), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and VACCINATION SITE PAIN (I thought my right arm was going to fall off) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2003, MERS-CoV test: positive (Positive) Positive, in 2003 was out for 3 weeks with MERS.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was stated that patient had no COVID diagnosis and had received a Tetanus shot 08-Jan-2022 because they cut their finger on a garbage can. Concomitant medication include Ellipta 200 m. No treatment information was reported.   This case was linked to MOD-2022-492034 (Patient Link).
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Headache, Platelet count, Urticaria
Clinical narrative: all over; Hives; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION ( all over), URTICARIA (Hives) and HEADACHE (Headaches) in an 89-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, the patient experienced CONTUSION ( all over), URTICARIA (Hives) and HEADACHE (Headaches). At the time of the report, CONTUSION (all over), URTICARIA (Hives) and HEADACHE (Headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: abnormal (abnormal) Platelet drop.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicines were reported. No treatment medicines were reported.
Sex: M
Vaccine: COVID19
Symptoms: Scab, Thermal burn, Urticaria
Clinical narrative: Welts; Burns; Scabs; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Welts), THERMAL BURN (Burns) and SCAB (Scabs) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Welts), THERMAL BURN (Burns) and SCAB (Scabs). At the time of the report, URTICARIA (Welts), THERMAL BURN (Burns) and SCAB (Scabs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.   Treatment medications were not reported.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy temporarily  after receiving 1st dose of the Moderna COVID19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of BELL'S PALSY (Bell's Palsy temporarily  after receiving 1st dose of the Moderna COVID19 vaccine) in a 25-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Bell's Palsy temporarily  after receiving 1st dose of the Moderna COVID19 vaccine) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's Palsy temporarily  after receiving 1st dose of the Moderna COVID19 vaccine) 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. Patient wanted to receive a second dose. HCP wanted to know which were the direction on whether the patient should get the second dose. HCP mentioned that the patient received the 1st dose on other facility and that she does not have further information. Patient was about 25 years old. No treatment information was reported.  Company comment: This case concerns a female patient around 25 years old with no medical history provided who experienced serious expected event of Bell's palsy. It was reported that the patient experienced Bell's Palsy temporarily after receiving the fist dose of mRNA-1273. No further information was provided. The precise temporal relationship cannot be determined, having in mind that the exact start date of the reported event was not provided. The outcome of the event was unknown at the time of the report and no information regarding the clinical course of the event was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient around 25 years old with no medical history provided who experienced serious expected event of Bell's palsy. It was reported that the patient experienced Bell's Palsy temporarily after receiving the fist dose of mRNA-1273. No further information was provided. The precise temporal relationship cannot be determined, having in mind that the exact start date of the reported event was not provided. The outcome of the event was unknown at the time of the report and no information regarding the clinical course of the event was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Headache, Heart rate
Clinical narrative: felt pain in the chest; tachycardia; affect his breathing; constant headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (felt pain in the chest), TACHYCARDIA (tachycardia), DYSPNOEA (affect his breathing) and HEADACHE (constant headache) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001j21-2a, 016c21a and 044b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jan-2022, the patient experienced CHEST PAIN (felt pain in the chest), TACHYCARDIA (tachycardia), DYSPNOEA (affect his breathing) and HEADACHE (constant headache). At the time of the report, CHEST PAIN (felt pain in the chest), TACHYCARDIA (tachycardia), DYSPNOEA (affect his breathing) and HEADACHE (constant headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Electrocardiogram: results not provided (Inconclusive) Results not provided. In 2022, Heart rate: abnormal (abnormal) sometimes feel his heart beat fast and other slow. In 2022, Myocardial necrosis marker: results not provided (Inconclusive) Results not provided.         Concomitant medications includes Blood pressure pills. Patient stated that the symptoms worsened. There were no history related to to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. No treatment information details were reported. Lab data includes cardiac test results not provided.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial necrosis marker, Tachycardia
Clinical narrative: felt pain in the chest; tachycardia; affect his breathing; constant headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (felt pain in the chest), TACHYCARDIA (tachycardia), DYSPNOEA (affect his breathing) and HEADACHE (constant headache) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001j21-2a, 016c21a and 044b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jan-2022, the patient experienced CHEST PAIN (felt pain in the chest), TACHYCARDIA (tachycardia), DYSPNOEA (affect his breathing) and HEADACHE (constant headache). At the time of the report, CHEST PAIN (felt pain in the chest), TACHYCARDIA (tachycardia), DYSPNOEA (affect his breathing) and HEADACHE (constant headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Electrocardiogram: results not provided (Inconclusive) Results not provided. In 2022, Heart rate: abnormal (abnormal) sometimes feel his heart beat fast and other slow. In 2022, Myocardial necrosis marker: results not provided (Inconclusive) Results not provided.         Concomitant medications includes Blood pressure pills. Patient stated that the symptoms worsened. There were no history related to to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. No treatment information details were reported. Lab data includes cardiac test results not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site reaction
Clinical narrative: marks where she had the injections / had a mark; had a mark that was itching; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE REACTION (marks where she had the injections / had a mark) and VACCINATION SITE PRURITUS (had a mark that was itching) 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 VACCINATION SITE REACTION (marks where she had the injections / had a mark) and VACCINATION SITE PRURITUS (had a mark that was itching). At the time of the report, VACCINATION SITE REACTION (marks where she had the injections / had a mark) and VACCINATION SITE PRURITUS (had a mark that was itching) 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 medication was not reported. Caller reported that her friend had a mark that was itching. Caller knows her friend had some medical problems. The treatment medication was not reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Urinary incontinence, Vaccination site pain
Clinical narrative: Worsening Urine Incontinence; Worsening weaknes; Soreness at injection site/at the injection sites; This spontaneous case was reported by a consumer and describes the occurrence of URINARY INCONTINENCE (Worsening Urine Incontinence), ASTHENIA (Worsening weaknes) and VACCINATION SITE PAIN (Soreness at injection site/at the injection sites) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Mobility decreased (Not able to lift leg), Fall, Rotator cuff tear and Upper respiratory infection. Concurrent medical conditions included Allergy to antibiotic (Allergy to Cipro), Restless leg syndrome, Urine incontinence, COVID-19, Memory impaired (Memory difficulties), Weakness (Worsening weakness) and Balance difficulty (Worsening balance). Concomitant products included VITAMIN D3, VITAMIN C [ASCORBIC ACID], CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM & VITAMIN D3) and BACLOFEN for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, the patient experienced URINARY INCONTINENCE (Worsening Urine Incontinence), ASTHENIA (Worsening weaknes) and VACCINATION SITE PAIN (Soreness at injection site/at the injection sites). At the time of the report, URINARY INCONTINENCE (Worsening Urine Incontinence), ASTHENIA (Worsening weaknes) and VACCINATION SITE PAIN (Soreness at injection site/at the injection sites) outcome was unknown.            Treatment information was not reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vial was initially stored in the refrigerator on 20-Jan-2022 and was administered more than 30 days after; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 20-Jan-2022 and was administered more than 30 days after) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson & Johnson vaccine (Patient has received a primary Johnson & Johnson vaccine) on 08-Jul-2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson vaccine.    On 22-Feb-2022 at 11:45 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2022 at 11:45 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 20-Jan-2022 and was administered more than 30 days after). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 20-Jan-2022 and was administered more than 30 days after) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient received the booster dose. Vial didn't undergo any temperature excursions. No symptoms were reported.  No medications, treatments, or additional doses had been administered at the time of this report.   This case was linked to MOD-2021-054280, MOD-2021-042747, MOD-2021-060758 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: No menstrual period for month of January after first period/Late Menstrual Period FEB2022; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (No menstrual period for month of January after first period/Late Menstrual Period FEB2022) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced MENSTRUATION DELAYED (No menstrual period for month of January after first period/Late Menstrual Period FEB2022). In February 2022, MENSTRUATION DELAYED (No menstrual period for month of January after first period/Late Menstrual Period FEB2022) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. After the first shot, patient had no  period for the month of JAN-2022. Her menstrual period came at the beginning of FEB-2022. No treatment medications were reported.   This case was linked to MOD-2022-492309 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Menstruation irregular, Pyrexia, Vaccination site pain, Vaginal haemorrhage
Clinical narrative: Fever (did not measure); Vaginal bleeding (off schedule Menstrual period after 2nd shot; 2 Menstrual Periods in FEB2022 Before and after 2nd shot; Sore Left Arm after 2nd shot; Headache after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Vaginal bleeding (off schedule Menstrual period after 2nd shot), MENSTRUATION IRREGULAR (2 Menstrual Periods in FEB2022 Before and after 2nd shot), VACCINATION SITE PAIN (Sore Left Arm after 2nd shot), HEADACHE (Headache after 2nd shot) and PYREXIA (Fever (did not measure)) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding (off schedule Menstrual period after 2nd shot), MENSTRUATION IRREGULAR (2 Menstrual Periods in FEB2022 Before and after 2nd shot), VACCINATION SITE PAIN (Sore Left Arm after 2nd shot) and HEADACHE (Headache after 2nd shot). On 18-Feb-2022, the patient experienced PYREXIA (Fever (did not measure)). At the time of the report, VAGINAL HAEMORRHAGE (Vaginal bleeding (off schedule Menstrual period after 2nd shot), MENSTRUATION IRREGULAR (2 Menstrual Periods in FEB2022 Before and after 2nd shot), VACCINATION SITE PAIN (Sore Left Arm after 2nd shot), HEADACHE (Headache after 2nd shot) and PYREXIA (Fever (did not measure)) outcome was unknown.            Concomitant information was not provided.  Treatment information was not provided.   This case was linked to MOD-2022-492302 (Patient Link).
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced TENDERNESS (Tenderness). On 18-Jan-2021, TENDERNESS (Tenderness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was unknown whether other vaccines were given one month prior to Moderna COVID-19 vaccine. Patient had never been tested positive for or diagnosed with COVID. It was reported that recent change in status such as improvement or worsening of the current condition high blood pressure was unknown. It was unknown whether the patient had sought medical care for the adverse event. It was unknown whether the patient had experienced a similar event in the past.  It was reported that the patient was not under any concomitant or regular medication.  No treatment medications were reported.   This case was linked to MOD-2022-492313, MOD-2022-492314 (Patient Link).
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Experienced tenderness; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Experienced tenderness) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Drug allergy (Allergic to various medications) and Allergy NOS (Allergic to things outside).   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TENDERNESS (Experienced tenderness). On 15-Feb-2021, TENDERNESS (Experienced tenderness) had resolved.            Patient was not under any concomitant or regular medication.  It was reported that the patient experienced tenderness on the day of vaccination, and it lasted for about 1 to 2 days approximately. Patient did not had COVID positive test or diagnosis.  No treatment was given.   This case was linked to MOD-2022-492310, MOD-2022-492314 (Patient Link).
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Tenderness
Clinical narrative: Tenderness; Booster dose administered as a full dose instead half of a dose; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness) and ACCIDENTAL OVERDOSE (Booster dose administered as a full dose instead half of a dose) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013120E, 058E21A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Drug allergy (Various medications and things outside.).   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 03-Sep-2021, the patient experienced TENDERNESS (Tenderness) and ACCIDENTAL OVERDOSE (Booster dose administered as a full dose instead half of a dose). On 05-Sep-2021, TENDERNESS (Tenderness) had resolved. At the time of the report, ACCIDENTAL OVERDOSE (Booster dose administered as a full dose instead half of a dose) outcome was unknown.    Patient was not under any concomitant or regular medication.  Patient never had COVID positive test or diagnosis. It was unknown whether AE caused patient to seek medical care. It was also unknown whether patient experienced a similar event in the past.  No treatment was given.   This case was linked to MOD-2022-492313, MOD-2022-492310 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Limb discomfort, Muscular weakness, Pain in extremity
Clinical narrative: Could not feel the Legs after 2nd shot; Feet hurt constantly after 2nd shot; "My legs get out from under me" after 2nd shot; Muscle Weakness after 2nd shot; Fatigue for 20 hours after 2nd shot; First Moderna COVID-19 dose: on 21MAY2021/2nd Moderna COVID-19 dose on 23JUL2021; This spontaneous case was reported by a consumer and describes the occurrence of SENSORY LOSS (Could not feel the Legs after 2nd shot), PAIN IN EXTREMITY (Feet hurt constantly after 2nd shot), LIMB DISCOMFORT ("My legs get out from under me" after 2nd shot), MUSCULAR WEAKNESS (Muscle Weakness after 2nd shot) and FATIGUE (Fatigue for 20 hours after 2nd shot) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jul-2021, the patient experienced SENSORY LOSS (Could not feel the Legs after 2nd shot), PAIN IN EXTREMITY (Feet hurt constantly after 2nd shot), LIMB DISCOMFORT ("My legs get out from under me" after 2nd shot), MUSCULAR WEAKNESS (Muscle Weakness after 2nd shot), FATIGUE (Fatigue for 20 hours after 2nd shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna COVID-19 dose: on 21MAY2021/2nd Moderna COVID-19 dose on 23JUL2021). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SENSORY LOSS (Could not feel the Legs after 2nd shot), PAIN IN EXTREMITY (Feet hurt constantly after 2nd shot), LIMB DISCOMFORT ("My legs get out from under me" after 2nd shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna COVID-19 dose: on 21MAY2021/2nd Moderna COVID-19 dose on 23JUL2021) outcome was unknown, MUSCULAR WEAKNESS (Muscle Weakness after 2nd shot) had not resolved and FATIGUE (Fatigue for 20 hours after 2nd shot) had resolved.            Concomitant medications was not provided by the reporter. The patient had no  medical history of any disease and was healthy prior to vaccination.  After the second dose vaccination patient experienced fatigue for 20 hours. The patient received a Booster dose of Pfizer COVID-19 vaccine on 21-Feb-2022. It was reported that the muscle weakness did not get any better or worst after the Pfizer dose.   The Patient was prescribed with unknown pain medication which did not work and took ibuprofen on her own.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory loss
Clinical narrative: Could not feel the Legs after 2nd shot; Feet hurt constantly after 2nd shot; "My legs get out from under me" after 2nd shot; Muscle Weakness after 2nd shot; Fatigue for 20 hours after 2nd shot; First Moderna COVID-19 dose: on 21MAY2021/2nd Moderna COVID-19 dose on 23JUL2021; This spontaneous case was reported by a consumer and describes the occurrence of SENSORY LOSS (Could not feel the Legs after 2nd shot), PAIN IN EXTREMITY (Feet hurt constantly after 2nd shot), LIMB DISCOMFORT ("My legs get out from under me" after 2nd shot), MUSCULAR WEAKNESS (Muscle Weakness after 2nd shot) and FATIGUE (Fatigue for 20 hours after 2nd shot) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jul-2021, the patient experienced SENSORY LOSS (Could not feel the Legs after 2nd shot), PAIN IN EXTREMITY (Feet hurt constantly after 2nd shot), LIMB DISCOMFORT ("My legs get out from under me" after 2nd shot), MUSCULAR WEAKNESS (Muscle Weakness after 2nd shot), FATIGUE (Fatigue for 20 hours after 2nd shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna COVID-19 dose: on 21MAY2021/2nd Moderna COVID-19 dose on 23JUL2021). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SENSORY LOSS (Could not feel the Legs after 2nd shot), PAIN IN EXTREMITY (Feet hurt constantly after 2nd shot), LIMB DISCOMFORT ("My legs get out from under me" after 2nd shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna COVID-19 dose: on 21MAY2021/2nd Moderna COVID-19 dose on 23JUL2021) outcome was unknown, MUSCULAR WEAKNESS (Muscle Weakness after 2nd shot) had not resolved and FATIGUE (Fatigue for 20 hours after 2nd shot) had resolved.            Concomitant medications was not provided by the reporter. The patient had no  medical history of any disease and was healthy prior to vaccination.  After the second dose vaccination patient experienced fatigue for 20 hours. The patient received a Booster dose of Pfizer COVID-19 vaccine on 21-Feb-2022. It was reported that the muscle weakness did not get any better or worst after the Pfizer dose.   The Patient was prescribed with unknown pain medication which did not work and took ibuprofen on her own.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Receiving a 100mcg/0.5ml booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Receiving a 100mcg/0.5ml booster dose) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025l21b, 008c21a and 016b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 19-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Receiving a 100mcg/0.5ml booster dose). At the time of the report, ACCIDENTAL OVERDOSE (Receiving a 100mcg/0.5ml booster dose) outcome was unknown.            No concomitant / treatment medication were provided.   This case was linked to MOD-2022-492676.   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2022: Non-significant follow-up received.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021 at 3:55 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Nov-2021 at 3:55 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  It was unknown whether patient was ever diagnosed with COVID-19.  The information about acute illnesses, chronic or long standing health conditions, information about other medications(prescription, OTC, dietary supplements or herbal remedies) at the time of vaccination or at time of reporting were unknown.  The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit.  The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been.  The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna COVID-19 vials went from the super cold freezer to the refrigerator.  The vials were returned to the freezer/refrigerator, or maintained at room temperature.   The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator.  No vaccine state changes were noticed. The vaccine was never refrozen.  None of the vials were punctured. No Previous temperature excursions was reported.  No treatment medications were provided.   This case was linked to MOD-2021-402935 (Patient Link).
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 04 09 2021 & 2nd dose on 05 15 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 04 09 2021 & 2nd dose on 05 15 2021) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008c21a and 016b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 04 09 2021 & 2nd dose on 05 15 2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 04 09 2021 & 2nd dose on 05 15 2021) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-492444 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2022: Non significant follow-up appended contains NNI.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021 at 5:58 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Nov-2021 at 5:58 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  It was unknown whether patient was ever diagnosed with Covid-19. The information about acute illnesses, chronic or long standing health conditions, information about other medications(prescription, OTC, dietary supplements or herbal remedies) at the time of vaccination or at time of reporting were unknown. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported.  No treatment medications were provided.   This case was linked to MOD-2021-402935 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperkeratosis
Clinical narrative: went urgent care, for  calluses on his foot; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERKERATOSIS (went urgent care, for  calluses on his foot) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033h21a) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On 10-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2022, the patient experienced HYPERKERATOSIS (went urgent care, for  calluses on his foot). At the time of the report, HYPERKERATOSIS (went urgent care, for  calluses on his foot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The height of the patient was 5feet 4 inches.  The patient had no allergies to medications, food and other products.  The patient had not tested positive for COVID-19 or diagnosed with it.  The patient did not receive any vaccine 1 month prior to Moderna COVID-19 vaccine.  The patient had not experienced a similar event in the past.  No treatment medications were reported.   This case was linked to MOD-2022-491831 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.    No Medical History information was reported.   On 19-Nov-2021 at 4:52 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021 at 4:52 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The patient was given dose from vial that were stored in an ultracold freezer which was colder than they should have been. The facility had a temperature excursion for the Moderna COVID-19 vaccine and the patient was administered the vaccine underwent temperature excursion.  Excursion duration was 1 month; on 19-Nov-2021, the vial moved from super cold freezer to the refrigerator; 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator; no vaccine state changes were noticed; none of the vials were punctured and no previous temperature excursions.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-402935 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of product storage error (administered vaccine stored at temperature between -80ºF to -84ºF) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 076C21A) for COVID-19 immunization. No medical history reported. On Nov 19, 2021, at 1:06 pm, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 0.25 milliliter. On Nov 19, 2021, patient experienced product storage error (administered vaccine stored at temperature between -80ºF to -84ºF). At the time of the report, product storage error (administered vaccine stored at temperature between -80ºF to -84ºF) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-402935 (patient link).
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Oct-2021 at 4:55 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. Patient were given dose from vial  that were stored in an ultracold freezer which is colder than they should have been. No treatment medication were reported.  This case was linked to MOD-2021-402935 (Patient Link).