chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Dyspnoea
Clinical narrative: Blood clots in the legs; Had shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (Blood clots in the legs) and DYSPNOEA (Had shortness of breath) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (Blood clots in the legs) (seriousness criterion medically significant) and DYSPNOEA (Had shortness of breath) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (Blood clots in the legs) and DYSPNOEA (Had shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment details were reported.  Company comment: This case concerns a 66-year-old male patient, with no medical history reported, who experienced the serious unexpected ADR of deep vein thrombosis and serious unexpected event of dyspnoea after dose of mRNA-1273. Very limited information regarding date of vaccination, date of the events, clinical evolution, complementary studies and treatment was provided at this time. The re-challenge is unknown since no information regarding dose number was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report   This case was linked to MOD-2021-403940 (Patient Link).; Sender's Comments: This case concerns a 66-year-old male patient, with no medical history reported, who experienced the serious unexpected ADR of deep vein thrombosis and serious unexpected event of dyspnoea after dose of mRNA-1273. Very limited information regarding date of vaccination, date of the events, clinical evolution, complementary studies and treatment was provided at this time. The re-challenge is unknown since no information regarding dose number was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Extrasystoles, Palpitations
Clinical narrative: heart issues/a fluttering heart; palpitations; heart skipping a beat; This spontaneous case was reported by a non-health professional and describes the occurrence of CARDIAC DISORDER (heart issues/a fluttering heart), PALPITATIONS (palpitations) and EXTRASYSTOLES (heart skipping a beat) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (heart issues/a fluttering heart), PALPITATIONS (palpitations) and EXTRASYSTOLES (heart skipping a beat). At the time of the report, CARDIAC DISORDER (heart issues/a fluttering heart), PALPITATIONS (palpitations) and EXTRASYSTOLES (heart skipping a beat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  No treatment medication information was given. Patient did not see a doctor about his symptoms.   This case was linked to MOD-2021-404352 (Patient Link).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Lymphadenopathy
Clinical narrative: got "pretty sick" (after 2nd dose); swollen lymph nodes (after 2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got "pretty sick" (after 2nd dose)) and LYMPHADENOPATHY (swollen lymph nodes (after 2nd dose)) in a 35-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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (got "pretty sick" (after 2nd dose)) and LYMPHADENOPATHY (swollen lymph nodes (after 2nd dose)). At the time of the report, ILLNESS (got "pretty sick" (after 2nd dose)) and LYMPHADENOPATHY (swollen lymph nodes (after 2nd dose)) outcome was unknown.            No Concomitant medication was reported.     No treatment medications were reported.   This case was linked to MOD-2021-404744, MOD-2021-404759 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: slightly swollen at injection site; itchy at injection site; small rash on back of neck; This spontaneous case was reported by a non-health professional and describes the occurrence of RASH (small rash on back of neck), VACCINATION SITE SWELLING (slightly swollen at injection site) and VACCINATION SITE PRURITUS (itchy at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 138124 and 138124) for COVID-19 vaccination.     Concurrent medical conditions included Hypersensitivity reaction, Hives, Penicillin allergy (which cause rash on use) since 1960, Drug allergy (which causes disorientation on use.) since 1990, Shellfish allergy (which cause itchy throat on use.) since 1980, Hypothyroidism since 1985, Pancreatitis since 2020, Constipation chronic since 2021, Curvature of spine since 2010 and Food allergy (allergic to chocolate which cause rash.) since 1965. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.   On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Sep-2021, the patient experienced RASH (small rash on back of neck). On 20-Sep-2021, the patient experienced VACCINATION SITE SWELLING (slightly swollen at injection site) and VACCINATION SITE PRURITUS (itchy at injection site). On 25-Sep-2021, RASH (small rash on back of neck) had resolved. At the time of the report, VACCINATION SITE SWELLING (slightly swollen at injection site) and VACCINATION SITE PRURITUS (itchy at injection site) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided.   This case was linked to MOD-2021-304188 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue after the first dose) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced FATIGUE (Fatigue after the first dose). At the time of the report, FATIGUE (Fatigue after the first dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were provided.  No treatment information were provided.   This case was linked to MOD-2021-406418 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: bad side effects from both of my doses/awfully to both dose; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (bad side effects from both of my doses/awfully to both dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (bad side effects from both of my doses/awfully to both dose). At the time of the report, VACCINATION COMPLICATION (bad side effects from both of my doses/awfully to both dose) outcome was unknown.        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.   No concomitant and treatment medications was reported. The patient got a really bad side effects from both of doses and thinking about getting the third shot.   This case was linked to MOD-2021-406484 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Proteinuria, Urine analysis
Clinical narrative: traces of protein in urine; This spontaneous case was reported by a consumer and describes the occurrence of PROTEINURIA (traces of protein in urine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059E21A and 066D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PROTEINURIA (traces of protein in urine). At the time of the report, PROTEINURIA (traces of protein in urine) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Oct-2021, Urine analysis: abnormal (abnormal) traces of protein in urine.         Concomitant medication was not reported. Treatment information was not reported. Patient reports that she is healthy,does not have kidney problems and traces of protein  has never shown before in her urine.   Reporter did not allow further contact
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin, Rash
Clinical narrative: rash is all over his torso; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash is all over his torso) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to animal (Allergy to cat), Allergy to animal dander (allergy to dog dander) and Glycosylated hemoglobin abnormal. Concomitant products included IRBESARTAN for Glycosylated haemoglobin, METFORMIN for Glycosylated hemoglobin.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced RASH (rash is all over his torso). The patient was treated with PREDNISONE for Rash, at an unspecified dose and frequency; PREDNISONE for Rash, at a dose of 665544332211 and PREDNISONE for Rash, at a dose of 5544332211. At the time of the report, RASH (rash is all over his torso) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Glycosylated haemoglobin: 5.8-6.0 5.8-6.0 percent.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient visited primary care doctor and received 3 courses of prednisone.1st course was dosed in 5544332211. 1-2 months later, rash did not go all the way, so he took 665544332211 in middle of summer. In September, it came back again, so he took 5544332211.  Even with the prednisone, it keeps coming back. Medical conditions is having A1c 5.8-6.0 percent for years and he takes metformin and Irbesartan.
Sex: M
Vaccine: COVID19
Symptoms: Eructation, Taste disorder
Clinical narrative: After 7 hours he developed funny taste out of stomach when he belches; developed funny taste out of stomach when I belche; This spontaneous case was reported by a consumer and describes the occurrence of ERUCTATION (After 7 hours he developed funny taste out of stomach when he belches) and TASTE DISORDER (developed funny taste out of stomach when I belche) 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 08-Dec-2021 at 11:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced ERUCTATION (After 7 hours he developed funny taste out of stomach when he belches) and TASTE DISORDER (developed funny taste out of stomach when I belche). At the time of the report, ERUCTATION (After 7 hours he developed funny taste out of stomach when he belches) and TASTE DISORDER (developed funny taste out of stomach when I belche) outcome was unknown.            No Concomitant medication was reported.     No treatment medications were reported.   Reporter did not allow further contact
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: she was in bed with cold symptoms; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (she was in bed with cold symptoms) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A, 010A21A and 077C21B) for COVID-19 vaccination.     Concurrent medical conditions included Menopause. Concomitant products included LEVOTHYROXINE for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced NASOPHARYNGITIS (she was in bed with cold symptoms). At the time of the report, NASOPHARYNGITIS (she was in bed with cold symptoms) outcome was unknown.            No treatment was received.   This case was linked to MOD-2021-406538, MOD-2021-406647 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Movement disorder
Clinical narrative: Hardly been able to move; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (Hardly been able to move) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MOVEMENT DISORDER (Hardly been able to move). At the time of the report, MOVEMENT DISORDER (Hardly been able to move) outcome was unknown.            No concomitant medication was reported.  No treatment medication use was reported.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: Sore arm after each dose; very mild flu like symptoms after each dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after each dose) and INFLUENZA LIKE ILLNESS (very mild flu like symptoms after each dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 009C21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm after each dose) and INFLUENZA LIKE ILLNESS (very mild flu like symptoms after each dose). At the time of the report, PAIN IN EXTREMITY (Sore arm after each dose) and INFLUENZA LIKE ILLNESS (very mild flu like symptoms after each dose) outcome was unknown.            Concomitant medication information was not reported. Treatment information was not reported.   This case was linked to MOD-2021-406661, MOD-2021-406670 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered >12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) had resolved.        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.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered greater than 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.  The patient received dose from vial that was first punctured on 30 Nov 2021 and put on the refrigerator since then.It was reported that, date the vial was initially stored in the refrigerator was 30 Nov 2021. Date the vial was first punctured was on 30 Nov 2021 time was assumed around 8 AM.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered >12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported. No Treatment medications were provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Peripheral swelling, Pyrexia, Vaccination site pain
Clinical narrative: my armpit is all swollen; low grade fever; A lot of pain in some of my joints, like my toes & knees; My arm is sore arm at injection site.; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (my armpit is all swollen), PYREXIA (low grade fever), ARTHRALGIA (A lot of pain in some of my joints, like my toes & knees) and VACCINATION SITE PAIN (My arm is sore arm at injection site.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B and 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, the patient experienced PERIPHERAL SWELLING (my armpit is all swollen), PYREXIA (low grade fever), ARTHRALGIA (A lot of pain in some of my joints, like my toes & knees) and VACCINATION SITE PAIN (My arm is sore arm at injection site.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (my armpit is all swollen), PYREXIA (low grade fever), ARTHRALGIA (A lot of pain in some of my joints, like my toes & knees) and VACCINATION SITE PAIN (My arm is sore arm at injection site.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Dec-2021, Body temperature: high (High) HIGH.         Concomitant medication use was unknown Tylenol was taken between 6 and 7 am.   This case was linked to MOD-2021-406730, MOD-2021-406735 (Patient Link).
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered greater than 2 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 2 hours post puncture) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 2 hours post puncture). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 2 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Alternative email. 2 vials that were first punctured on 30-Nov-2021 and put on the refrigerator since then.  Concomitant medications were not provided.  Treatment information was not provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered >12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) had resolved.        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
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered >12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Laryngitis, Sinusitis
Clinical narrative: Sinus infection; Laryngitis; This spontaneous case was reported by a nurse and describes the occurrence of LARYNGITIS (Laryngitis) and SINUSITIS (Sinus infection) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 008B21A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Cholesterol.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced LARYNGITIS (Laryngitis). On 04-Dec-2021, the patient experienced SINUSITIS (Sinus infection). At the time of the report, LARYNGITIS (Laryngitis) and SINUSITIS (Sinus infection) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 02Dec2021, the nurse reported the patient got sick and was diagnosed with laryngitis and placed on "steroids" and an antibiotic. The nurse reported over the weekend, the patient was still sick and went to an Facility and was diagnosed with a sinus Infection. The nurse reported that the patient was not given another antibiotic from facility because the Facility reported they could not give an antibiotic to a patient until 2 weeks out from the Moderna booster dose. The nurse reported the patient takes medications daily to treat diabetes (past medical history) and cholesterol (past medical history)  No Concomitant medications were reported.  Treatment information included steroids and an antibiotic (unspecified).  The nurse reported that the patient was not given another antibiotic from facility because the Facility reported they could not give an antibiotic to a patient until 2 weeks out from the Moderna booster dose.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Patient felt like patient had the flu; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (Patient felt like patient had the flu) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Patient felt like patient had the flu). At the time of the report, INFLUENZA LIKE ILLNESS (Patient felt like patient had the flu) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.  The reporter reported that after 20 hours of receiving the second dose, the patient felt like the patient had the flu.   This case was linked to MOD-2021-406574 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: gave a dose of the Moderna Covid-19 vaccine to a patient from a vial which has been punctured for more than 12 hours.; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave a dose of the Moderna Covid-19 vaccine to a patient from a vial which has been punctured for more than 12 hours.) 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 08-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave a dose of the Moderna Covid-19 vaccine to a patient from a vial which has been punctured for more than 12 hours.). On 08-Dec-2021, EXPIRED PRODUCT ADMINISTERED (gave a dose of the Moderna Covid-19 vaccine to a patient from a vial which has been punctured for more than 12 hours.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered greater than 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017f21a) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided by the reporter. No treatment information provided. The vial was initially stored in the refrigerator on 30-Nov-2021. The vial was first punctured on 30-Nov-2021.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Overdose, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 22-years patient administered  FLUZONE QUADRIVALENT HIGH-DOSE /no AE; 22-years patient administered  FLUZONE QUADRIVALENT HIGH-DOSE /no AE; receiving FLUZONE QUADRIVALENT HIGH-DOSE on accident due to the administrator not verifying the product prior to administration, original order was not for a high dose but a standard flu vaccine with no adverse event; Initial information received on 01-Dec-2021 regarding an unsolicited valid non-serious case from other health professional via Agency (under the reference: 00880548).  This case involves a 22-year-old female patient receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] on accident due to the administrator not verifying the product prior to administration, original order was not for a high dose but a standard flu vaccine with no adverse event (wrong product administered, product administered to patient of inappropriate age, overdose).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 01-Dec-2021, the patient received a 0.7 mL total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [frequency: once, strength: high dose, lot UJ763AA, expiry date: 30-Jun-2022] via intramuscular route in the left arm for prophylactic vaccination.  It was a case of an actual medication error due to wrong vaccine administered, inappropriate age at vaccine administered, overdose (latency same day).  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Interchange of vaccine products
Clinical narrative: I did not have any adverse reactions to the moderna vaccine except localized pain at injection site. I wanted to let you know because I had such a horrible reaction to the Pfizer second shot. I chose this because that have the original dose for the booster.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ageusia, Cough, Decreased appetite, Fatigue, Headache
Clinical narrative: Ongoing side effect day 3 now after third dose.  Severe non-stop cough, nasal and chest congestions, lots of mucus production,  severe headache,  fever, fatigue, not able to sleep. Lost sense of taste and appetite, muscle weakness.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscular weakness, Nasal congestion, Pyrexia, Respiratory tract congestion, Secretion discharge
Clinical narrative: Ongoing side effect day 3 now after third dose.  Severe non-stop cough, nasal and chest congestions, lots of mucus production,  severe headache,  fever, fatigue, not able to sleep. Lost sense of taste and appetite, muscle weakness.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sleep disorder
Clinical narrative: Ongoing side effect day 3 now after third dose.  Severe non-stop cough, nasal and chest congestions, lots of mucus production,  severe headache,  fever, fatigue, not able to sleep. Lost sense of taste and appetite, muscle weakness.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deafness, Disorientation, Ear discomfort, Erythema, Injection site discomfort
Clinical narrative: hearing loss at low frequency with severe distortion and  pressure.  1+ week duration, then respite 2-3 days, then scheduled office visit, then reoccurred for about 10 days then over for about 10 days as of this entry.  physician noted redness upon ear inspection and prescribed antibiotics  - 2 courses - symptoms had cleared by the time second course arrived and began.  comment - this was very unusual and not experienced before - the audio distortion was very unique. a bit of disorientaation but no fever, pain or imbalance.  injection site discomfort/pain after second  - about 4 days
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site pain
Clinical narrative: hearing loss at low frequency with severe distortion and  pressure.  1+ week duration, then respite 2-3 days, then scheduled office visit, then reoccurred for about 10 days then over for about 10 days as of this entry.  physician noted redness upon ear inspection and prescribed antibiotics  - 2 courses - symptoms had cleared by the time second course arrived and began.  comment - this was very unusual and not experienced before - the audio distortion was very unique. a bit of disorientaation but no fever, pain or imbalance.  injection site discomfort/pain after second  - about 4 days
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Joint injury, Limb injury, Pain, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Pain
Clinical narrative: Systemic: Body Aches Generalized-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient got dizzy within 3 minutes after receiving her Moderna booster, had to sit on ground, 911 came and took her to hospital, patient was fine after 1 hour.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Tenderness
Clinical narrative: Developed a spongy "water bubble" in right armpit.  Was slightly tender when pressed and had no noticeable lumps or nodules.  Slowly dissipated over the following 7 days.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Hypertension, Interchange of vaccine products
Clinical narrative: Systemic: Chest Tightness/Heaviness/Pain-Medium, Systemic: Hypertension-Medium, Additional Details: Patient got a booster of Moderna. His first 2 doses were Pfizer. After the booster was administered he experienced chest tightness, which he described as feeling like having anxiety but he was not anxious. His blood pressure was 146/97. He said his baseline is high but was not sure of the level. He experienced this for about 2.5 hours and is now completely back to normal everyday activities.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint injury, Limb injury, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Oligomenorrhoea
Clinical narrative: My menstrual cycle began 13 days late and I believe it may be connected to the vaccine booster, as I have been very regular for the past several years. My last period began on 10/27 and, although feeling symptoms around a month later such as cramping, I did not start my next cycle until 12/10.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Joint injury, Pain, Paraesthesia
Clinical narrative: Error: Shoulder joint injury (prolonged pain, tingling, etc.).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: syncope x3 and hyptotensive event after injection, 911 was called for evaluation, was taken to local hospital, followed up with patient 12/9/21 and patient states he is fine and no longstanding issues.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Dizziness/Lightheadedness-Mild, Systemic: Flushed/Sweating-Mild, Additional Details: Patient felt faint and was slightly sweating with a feeling of dizziness. She never went unconscious. She was given water and food to help with uneasiness. After a 15-minute period, she felt better and has reported no other difficulties.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Nausea, Pain, Vomiting
Clinical narrative: Systemic: Abdominal Pain-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Medium
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face, Swelling of eyelid
Clinical narrative: Moderate facial swelling including eye lids, upper lip
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Hypotension, Incorrect route of product administration
Clinical narrative: Systemic: Dizziness/Lightheadedness-Severe, Systemic: Flushed/Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Mild, Additional Details: Some bleeding at injection site indicating that needle hit capillary. This compounds injection difficulty with heart complications as some portion of injection is not completely IM but IV (via capillary) also. This moves the vaccine more rapidly into the volume of distribution of the patient. Aspiration of the syringe at the injection site is not required for COVID-19 vaccinations, perhaps it should be.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site haemorrhage, Nausea
Clinical narrative: Systemic: Dizziness/Lightheadedness-Severe, Systemic: Flushed/Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Mild, Additional Details: Some bleeding at injection site indicating that needle hit capillary. This compounds injection difficulty with heart complications as some portion of injection is not completely IM but IV (via capillary) also. This moves the vaccine more rapidly into the volume of distribution of the patient. Aspiration of the syringe at the injection site is not required for COVID-19 vaccinations, perhaps it should be.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Sore at injection location, chills, fever, body aches, headache.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Magnetic resonance imaging normal, Nausea
Clinical narrative: Initially was believed to be pancreatitis or a pancreas problem and had an MRI scan done and it found no issues anywhere but i still have extreme nausea waking up in the mornings and diarrhea that still hasnt really stopped since
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: Patient said both arms hurt now. second dose on 10/23/21 was moderna lot 939901, rx 1543991, opposite arm as the first one.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 35.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Episcleritis, Ophthalmological examination, Vaccine positive rechallenge
Clinical narrative: Recurrence of episcleritis that had occurred after the second dose of the vaccine.  Symptoms started approximately one week after the third dose of the vaccine and have persisted despite steroid eye drops for over 6 weeks.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: She received a full dose for her booster, instead of the half dose.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Confusional state, Disorientation, Dizziness, Fall
Clinical narrative: Systemic: Abdominal Pain-Mild, Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Severe, Additional Details: PT IS 6 YEAR OLD CHILD, HAD HER SECOND DOSE AND WAS TOLD TO SIT AND WAIT FOR HER OBSERVATOIN PERIOD. THE NEXT PATIENT WAS HER SISTER, AND WAS SCREAMING AND SCARED DURING HER APPOINTMENT. PT GOT UP AND WALKED OVER TO SEE, AND FELT DIZZY AND FAINTED AGAINST A STAND. SHE RECOVERED AND FELT DISORIENTED AND HAD STOMACH PAIN. PT RECOVERED AND WAS ABLE TO LEAVE AFTER HER OBSERVATION PERIOD WITH HER FATHER
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Abdominal Pain-Mild, Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Severe, Additional Details: PT IS 6 YEAR OLD CHILD, HAD HER SECOND DOSE AND WAS TOLD TO SIT AND WAIT FOR HER OBSERVATOIN PERIOD. THE NEXT PATIENT WAS HER SISTER, AND WAS SCREAMING AND SCARED DURING HER APPOINTMENT. PT GOT UP AND WALKED OVER TO SEE, AND FELT DIZZY AND FAINTED AGAINST A STAND. SHE RECOVERED AND FELT DISORIENTED AND HAD STOMACH PAIN. PT RECOVERED AND WAS ABLE TO LEAVE AFTER HER OBSERVATION PERIOD WITH HER FATHER
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injection site pain, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: Patient (12YO Male) reported severe pain at site of injection beginning immediately after injection that radiated down his arm, causing him to have restriced movement from shoulder to fingers. Ice was applied and after consultation with mother, weight-appropriate OTC ibuprofen was administered approx. 10-15 min post-injection.  Patient reported that upper arm was feeling better but lower arm was feeling worse.  No respiratory symptoms were noted and patient was alert and able to communicate.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Non-severe allergic reaction, rash, itching in arms and legs
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Urticaria
Clinical narrative: Hives.  First appearance was on her stomach/front torso at 4:00am on 12/5/21.  Cleared up with Benedryl, but reappeared later in the day (12/5/21) on her back.  Have continued to appear and move around her torso on each subsequent day.  The patches of hives appear to be getting smaller each time they reappear and they are managed with Benedryl and hydrocortisone 1% cream.  Had to leave school on 12/6/21 but the rest of the week she?s been able to stay at school.  Had a  consult with her pediatrician  on 12/6/21 and she felt the hives were likely due to the recent vaccine, but there is no way to link the hives to the vaccine for certain.  No other exposures that could have caused the hives are thought to have occurred.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Diabetes mellitus, Dizziness, Feeling abnormal, Mobility decreased
Clinical narrative: PATIENT AND FAMILY MEMBER INDICATE THAT SINCE FRIDAY IN THE EARLY MORNING, HE GAVE HIM CHILLS FEVER AND DID NOTE THAT HE HAD AN EASY PARALYSIS WHILE SLEEP. SATURDAY AND SUNDAY HE WAS WITHOUT GETTING UP FROM THE BED, HE DIDN'T GO TO THE DOCTOR UNTIL MONDAY MORNING. IT INDICATES THAT THE DAY THE VACCINE WAS ADMINISTERED HAD DIZZINESS AND HE FEELS BAD, BUT I DO NOT COMMENT ANYTHING TO ANYONE
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Paralysis, Pyrexia
Clinical narrative: PATIENT AND FAMILY MEMBER INDICATE THAT SINCE FRIDAY IN THE EARLY MORNING, HE GAVE HIM CHILLS FEVER AND DID NOTE THAT HE HAD AN EASY PARALYSIS WHILE SLEEP. SATURDAY AND SUNDAY HE WAS WITHOUT GETTING UP FROM THE BED, HE DIDN'T GO TO THE DOCTOR UNTIL MONDAY MORNING. IT INDICATES THAT THE DAY THE VACCINE WAS ADMINISTERED HAD DIZZINESS AND HE FEELS BAD, BUT I DO NOT COMMENT ANYTHING TO ANYONE
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase normal, Anion gap, Aspartate aminotransferase increased, Blood albumin normal, Blood alkaline phosphatase normal
Clinical narrative: My S/S occured <24hrs, right breast doubled in size. Hot to the touch with erythema, fever 101.6 and chills lasting 24 hours. Pain in chest/right breast not relieved by 800 mg motrin and Tylenol.  On 8/21/21 at 8am, went to ER.  At ER given IV cefazolin and ketorolac, and sent home with Norco and Naproxen. Referred to breast surgery for screening.  Ingredients in shot attacked a cyst in the right breast. The cyst was documented in imaging years prior, never problems noted with it. Pain lasted >1mo. Missed school, work, clinical and spent much time in bed due to pain that only Norco was helping.