chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: diagnosed with Covid-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (diagnosed with Covid-19) 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 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced COVID-19 (diagnosed with Covid-19). At the time of the report, COVID-19 (diagnosed with Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2021, SARS-CoV-2 test: positive (Positive) positive.     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 reported. No treatment information provided.  Company comment: This spontaneous case concerns a patient of an unknown age and gender with no details on relevant medical history, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine. The event occurred approximately 11 days after the first dose of mRNA- 1273 vaccine. Very limited information is available regarding symptoms and clinical course. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender with no details on relevant medical history, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine. The event occurred approximately 11 days after the first dose of mRNA- 1273 vaccine. Very limited information is available regarding symptoms and clinical course. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Product colour issue
Clinical narrative: swelling in the arm after receiving the Moderna Covid-19 Vaccine is a common side effect.; vaccine looks opaque, not white but kind of yellowish; This spontaneous case was reported by a pharmacist and describes the occurrence of PERIPHERAL SWELLING (swelling in the arm after receiving the Moderna Covid-19 Vaccine is a common side effect.) and PRODUCT COLOUR ISSUE (vaccine looks opaque, not white but kind of yellowish) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) 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 20-Dec-2021, the patient experienced PRODUCT COLOUR ISSUE (vaccine looks opaque, not white but kind of yellowish). On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling in the arm after receiving the Moderna Covid-19 Vaccine is a common side effect.). On 20-Dec-2021, PRODUCT COLOUR ISSUE (vaccine looks opaque, not white but kind of yellowish) had resolved. At the time of the report, PERIPHERAL SWELLING (swelling in the arm after receiving the Moderna Covid-19 Vaccine is a common side effect.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were Reported. No Treatments were Reported. Reporter stated that Vaccines from these vials were administered to more than 100 patients Reporter also Stated that after the vaccine was poured into a syringe, inside the syringe the color of the vaccine looked normal, and that the discoloration was only seen in the vial.   Most recent FOLLOW-UP information incorporated above includes: On 22-Dec-2021: Followup received included product quality complaint report received ,QE-013644 updated.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 40 patients were administered expired doses of the Moderna COVID-19 vaccine/ Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients were administered expired doses of the Moderna COVID-19 vaccine/ Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A, 038B21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients were administered expired doses of the Moderna COVID-19 vaccine/ Dose administered after 30-day Use By Date or after manufacturer date of expiry). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (40 patients were administered expired doses of the Moderna COVID-19 vaccine/ Dose administered after 30-day Use By Date or after manufacturer date of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants medications was reported.  No treatments medications was reported.   This case was linked to MOD-2021-424914, MOD-2021-425302, MOD-2021-425118 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Dec-2021: Significant Follow-up added patient details, added 3 doses information.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported. Patient was scheduled to get second dose on 25-Feb-2021 and wanted to know should she get her second dose or whether was allowed to get second dose.  Company comment: This spontaneous case concerns a female patient of unknown age with no details on medical history, who experienced the unexpected non serious event of COVID-19 after mRNA- 1273 Moderna vaccine. The event occurred approximately 8 days after the first dose of mRNA- 1273 vaccine. Very limited information is available regarding symptoms and clinical course. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no details on medical history, who experienced the unexpected non serious event of COVID-19 after mRNA- 1273 Moderna vaccine. The event occurred approximately 8 days after the first dose of mRNA- 1273 vaccine. Very limited information is available regarding symptoms and clinical course. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: About 5-6 hours after injection, I experienced soreness in arm; About 5-6 hours after injection, general fatigue; About 12 hours later, I have a mild headache; About 12 hours later, Mild fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (About 5-6 hours after injection, I experienced soreness in arm), FATIGUE (About 5-6 hours after injection, general fatigue), HEADACHE (About 12 hours later, I have a mild headache) and PYREXIA (About 12 hours later, Mild fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007G21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 50 mcg. In December 2021, the patient experienced PAIN IN EXTREMITY (About 5-6 hours after injection, I experienced soreness in arm) and FATIGUE (About 5-6 hours after injection, general fatigue). December 2021, the patient experienced HEADACHE (About 12 hours later, I have a mild headache) and PYREXIA (About 12 hours later, Mild fever). At the time of the report, PAIN IN EXTREMITY (About 5-6 hours after injection, I experienced soreness in arm), FATIGUE (About 5-6 hours after injection, general fatigue), HEADACHE (About 12 hours later, I have a mild headache) and PYREXIA (About 12 hours later, Mild fever) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 40 patients were administered expired doses of the Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients were administered expired doses of the Moderna COVID-19 vaccine) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A, 003B21A and 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic, Allergy to nuts, Allergy to sting, Clot blood, Hypertension, Gout, Hypertriglyceridemia, Hyponatremia, Blood pressure increased and DVT of legs. Concomitant products included RIVAROXABAN (XARELTO) for Anticoagulant therapy, MULTIVITAMINS [VITAMINS NOS], LOSARTAN, TART CHERRY and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients were administered expired doses of the Moderna COVID-19 vaccine). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (40 patients were administered expired doses of the Moderna COVID-19 vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Date the vial was initially stored in the refrigerator: 09-Nov-2021.  The patient had screening for lung, prostate, skin and colon cancer. The patient had anticoagulant therapy. The patient was in primary hypercoagulable state. The patient had routine physical examination.  No treatment details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Crying, Hypokinesia, Loss of personal independence in daily activities, Nausea, Pain in extremity
Clinical narrative: her is that she reported right away the reaction to the first shot to her provider; then like 2 days later, her right hand started acting up out of nowhere/States it was like in pain anything she tried to grab things; couldn't even do her daily work, take care of kids, try to take coffee, she couldn't use her hand because her hand was in pain; couldn't even use it; crying; Caller states that what she got was nausea; she states she was throwing up; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (her is that she reported right away the reaction to the first shot to her provider), PAIN IN EXTREMITY (then like 2 days later, her right hand started acting up out of nowhere/States it was like in pain anything she tried to grab things), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't even do her daily work, take care of kids, try to take coffee, she couldn't use her hand because her hand was in pain), HYPOKINESIA (couldn't even use it) and CRYING (crying) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced VACCINATION COMPLICATION (her is that she reported right away the reaction to the first shot to her provider), PAIN IN EXTREMITY (then like 2 days later, her right hand started acting up out of nowhere/States it was like in pain anything she tried to grab things), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't even do her daily work, take care of kids, try to take coffee, she couldn't use her hand because her hand was in pain), HYPOKINESIA (couldn't even use it), CRYING (crying), NAUSEA (Caller states that what she got was nausea) and VOMITING (she states she was throwing up). At the time of the report, VACCINATION COMPLICATION (her is that she reported right away the reaction to the first shot to her provider), PAIN IN EXTREMITY (then like 2 days later, her right hand started acting up out of nowhere/States it was like in pain anything she tried to grab things), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't even do her daily work, take care of kids, try to take coffee, she couldn't use her hand because her hand was in pain), HYPOKINESIA (couldn't even use it) and CRYING (crying) outcome was unknown and NAUSEA (Caller states that what she got was nausea) and VOMITING (she states she was throwing up) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided.  Patient received some muscle relaxer pills, nausea and vomiting medications.   This case was linked to MOD-2021-425442 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vomiting
Clinical narrative: her is that she reported right away the reaction to the first shot to her provider; then like 2 days later, her right hand started acting up out of nowhere/States it was like in pain anything she tried to grab things; couldn't even do her daily work, take care of kids, try to take coffee, she couldn't use her hand because her hand was in pain; couldn't even use it; crying; Caller states that what she got was nausea; she states she was throwing up; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (her is that she reported right away the reaction to the first shot to her provider), PAIN IN EXTREMITY (then like 2 days later, her right hand started acting up out of nowhere/States it was like in pain anything she tried to grab things), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't even do her daily work, take care of kids, try to take coffee, she couldn't use her hand because her hand was in pain), HYPOKINESIA (couldn't even use it) and CRYING (crying) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced VACCINATION COMPLICATION (her is that she reported right away the reaction to the first shot to her provider), PAIN IN EXTREMITY (then like 2 days later, her right hand started acting up out of nowhere/States it was like in pain anything she tried to grab things), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't even do her daily work, take care of kids, try to take coffee, she couldn't use her hand because her hand was in pain), HYPOKINESIA (couldn't even use it), CRYING (crying), NAUSEA (Caller states that what she got was nausea) and VOMITING (she states she was throwing up). At the time of the report, VACCINATION COMPLICATION (her is that she reported right away the reaction to the first shot to her provider), PAIN IN EXTREMITY (then like 2 days later, her right hand started acting up out of nowhere/States it was like in pain anything she tried to grab things), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't even do her daily work, take care of kids, try to take coffee, she couldn't use her hand because her hand was in pain), HYPOKINESIA (couldn't even use it) and CRYING (crying) outcome was unknown and NAUSEA (Caller states that what she got was nausea) and VOMITING (she states she was throwing up) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided.  Patient received some muscle relaxer pills, nausea and vomiting medications.   This case was linked to MOD-2021-425442 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Liver function test
Clinical narrative: Patient administered expired doses of the Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered expired doses of the Moderna COVID-19 vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     The patient's past medical history included Fibrocystic breast disease, Cough, Contact dermatitis (Bilateral eyelids), Coccydynia, Viral upper respiratory tract infection, Hearing loss, Vitamin D deficiency, Vitamin B12 deficiency, Unspecified sleep disturbance, Urinary frequency, Anxiety, Mood disorder and Plantar fasciitis. Previously administered products included for Product used for unknown indication: Influenza on 30-Sep-2020 and Influenza on 05-Oct-2021. Past adverse reactions to the above products included No adverse reaction with Influenza and Influenza. Concurrent medical conditions included Hyperlipidemia, Drug allergy (penicillin v potassium tabs (Critical)), Drug allergy (Codeine Sulfate Tabs(critical)), Drug allergy (sulfamethoxazole-trimethoprim tabs(Critical)) and Drug allergy (Levaquin (Moderate)). Concomitant products included CLONAZEPAM for Anxiety, VALACICLOVIR HYDROCHLORIDE (VALTREX) for Cold sores, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), PROBIOTICS NOS, CALCIUM and PANTOPRAZOLE SODIUM for an unknown indication.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered expired doses of the Moderna COVID-19 vaccine). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient administered expired doses of the Moderna COVID-19 vaccine) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Liver function test: abnormal (abnormal) abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient had undergone breast implants, bilateral, travel medicine counseling, lab exam, observation and evaluation of suspected exposure to other biological agent. Patient was also screened for ovarian cancer, lung cancer, breast cancer, cervical cancer, osteoporosis, skin cancer, colon cancer, routine physical examination, and general physical examination. Patient was due to hemoccult or sigmoid, mammogram, breast exam, flu vax, pneumovax, and TD booster.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: contracted COVID after first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted COVID after first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced COVID-19 (contracted COVID after first dose). At the time of the report, COVID-19 (contracted COVID after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by the reporter. No treatment medication was reported by the reporter.  Company comment: This spontaneous case concerns a female patient of an unknown age with no details on medical history, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine. The event occurred approximately 22 days after the first dose of mRNA- 1273 vaccine. Very limited information is available regarding symptoms and clinical course. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of an unknown age with no details on medical history, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine. The event occurred approximately 22 days after the first dose of mRNA- 1273 vaccine. Very limited information is available regarding symptoms and clinical course. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, General physical condition, Liver function test, Physical examination, Serum ferritin increased
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A, 003B21A and 003B21A) for COVID-19 vaccination. The patient's past medical history included Edema legs (Edema right leg), Pain in arm (Pain in left arm), Shoulder pain, Fatty liver (Fatty liver disease), Impaired fasting glucose, Anal fissure, Onychomycosis, Hemorrhoids, Knee pain, Hyperlipidemia, Testosterone deficiency and Hypertriglyceridemia.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, General physical condition: results not provided General physical examination. On an unknown date, Liver function test: abnormal (abnormal) Liver function tests, Abnormal. On an unknown date, Physical examination: results not provided Physical exam  routine. On an unknown date, Serum ferritin increased: high (High) Ferritin elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. Other investigations include Observation and evaluation for suspected exposure to other biological agent, Gastrocnemius partial tear, Screening for prostate cancer, Screen skin cancer, Screen lung cancer, Screen Colon cancer. No Treatment information was reported.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A, 003B21 and 003B21) for COVID-19 vaccination.     The patient's past medical history included Vitamin D deficiency, Tinea cruris, Hypoxemia, Iron deficiency, Gastric volvulus, Mastalgia, Vitamin B12 deficiency, Anemia, Fibromyalgia and Hernia repair. Previously administered products included for Product used for unknown indication: INFLUENZA (SERIES-1) on 18-Sep-2020, INFLUENZA (SERIES-2) on 15-Sep-2021 and Influenza vaccine. Past adverse reactions to the above products included No adverse event with INFLUENZA, INFLUENZA and Influenza vaccine. Concurrent medical conditions included Paroxysmal tachycardia (supraventricular), Postural orthostatic tachycardia syndrome, Urinary tract infection, Rheumatoid arthritis, Hypothyroidism, Hypertension, Depression, Back pain, Anxiety, GERD, Drug allergy (BUPRENORPHINE PTWK ( CRITICAL)) and Allergy to antibiotic (SULFAMETHOXAZOLE-TRIMETHOPRIM TABS (MODERATE0). Concomitant products included OMEPRAZOLE, SODIUM BICARBONATE (OMEPRAZOLE 20MG/SODIUM BICARBONATE 1100MG) for Acid reflux (esophageal), LORAZEPAM for Anxiety, BUPROPION HYDROCHLORIDE and BUPROPION HCL for Anxiety depression, HYDROXYZINE HCL for Dizziness, TRAZODONE HYDROCHLORIDE for Insomnia, SACCHARATED IRON OXIDE (VENOFER) for Iron deficiency, METHOCARBAMOL (ROBAXIN-750) for Muscle spasm, PROMETHAZINE HYDROCHLORIDE for Nausea, CYANOCOBALAMIN for Pernicious anemia, BETAMETHASONE, CLOTRIMAZOLE (CLOTRIMAZOLE AND BETAMETHASONE) for Rash, MIRTAZAPINE (MIRTAZEPINE TEVA) for Sleepy, GABAPENTIN, LEVOTHYROXINE SODIUM, VERAPAMIL HCL, CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]), CERTOLIZUMAB PEGOL and VITAMIN D3 for an unknown indication.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided by the reporter. Patient allergies medical history include hiatal hernia and observation and evaluation for suspected exposure to other biological agent. Concomitant medication include portable oxygen concentrator 1LMP per nasal cannula, hypoxemia. patient services due include HEMOCCULT or SIGMOID, TD BOOSTER BP DIASTOLIC, BP SYSTOLIC, PAP SMEAR,MAMMOGRAM, BREAST EXAM.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Physical examination
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 038B21A) for COVID-19 vaccination.     The patient's past medical history included Myalgia, Fatigue, Pharyngitis, Strain (Strain of the Right Inguinal / Femoral area), Abdominal pain, Lumbar strain, Upper respiratory tract infection, Chest discomfort, Leg pain (leg pain, chronic, left), Knee pain (Knee pain Left,Acute), Synovitis, Eczema, Molluscum contagiosum and Cerumen impaction. Previously administered products included for Drug use for unknown indication: MMR Vaccine on 22-Jan-2010, Inactivated poliovirus vaccine on 22-Jan-2010 and DTAP Vaccine on 22-Jan-2010; for Product used for unknown indication: Influenza Vaccine. Past adverse reactions to the above products included No adverse event with DTAP Vaccine, Inactivated poliovirus vaccine, Influenza Vaccine and MMR Vaccine. Family history included Asthma (Asthma NOS W/ACUTE EXACERBATION) since an unknown date. Concurrent medical conditions included Lumbar strain, GERD, Epigastric pain, Dermatitis (Dermatitis,Peri Oral), Bronchitis (Bronchitis, Acute), UTI, Urticaria, Rhinitis allergic, Hearing disability and Penicillin allergy. Concomitant products included EPINEPHRINE (EPIPEN) for Allergic reaction, LEVOSALBUTAMOL HYDROCHLORIDE (XOPENEX) for Asthma, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR UNSPEC) for Breathing difficult, TRIAMCINOLONE ACETONIDE for Eczema, SALBUTAMOL SULFATE (PROAIR HFA) for Wheezing and Cough, MONTELUKAST SODIUM (SINGULAIR), MONTELUKAST SODIUM from 30-Jul-2020 to an unknown date and METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) from 04-Jun-2020 to an unknown date for an unknown indication.   On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Physical examination: results not reported Results not reported.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other Problems included  H1N1 Vaccine  Other Medications included NEBULIZER DEVICE(Respiratory Therapy Supplies) Use as directed upto four times daily, Last Refill : 30/ Inhalation 3, 18 Dec 2018.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Investigation, Laboratory test, Physical examination, Urogram
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A, 044B21A and 029A21A) for COVID-19 vaccination.     The patient's past medical history included Hematuria, Obstructive sleep apnea syndrome, Barrett's esophagus, Hearing loss (Right ear) and Pain in toe. Concurrent medical conditions included Varicose veins (Right ear), Cervical disc disease, Allergy NOS and GERD. Concomitant products included CETIRIZINE HCL for Allergy NOS, ACETYLSALICYLIC ACID (ASPIRIN 81), PANTOPRAZOLE SODIUM, CYANOCOBALAMIN (VITAMIN B-12), ZINC GLUCONATE (ZINC (GLUCONATE)), VITAMIN C [ASCORBIC ACID], CURCUMA LONGA (TURMERIC [CURCUMA LONGA]), FISH OIL, ROSUVASTATIN CALCIUM (CRESTOR) and UBIDECARENONE (COQ 10) for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Investigation: results not reported (Inconclusive) Results not reported, results not reported (Inconclusive) Results not reported, results not reported (Inconclusive) Results not reported, results not reported (Inconclusive) Results not reported, results not reported (Inconclusive) Results not reported and results not reported (Inconclusive) Results not reported. On an unknown date, Laboratory test: results not reported (Inconclusive) Results not reported. On an unknown date, Physical examination: results not reported (Inconclusive) Results not reported. On an unknown date, Urogram: gross painless hematuria (abnormal) Gross Painless Hematuriaa. On an unknown date, Urological examination: gross painless hematuriaa (abnormal) Gross Painless Hematuriaa.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Lab test included CAD, non obstructive 76 score in the LAD   No treatment medication were provided.  On 11-Nov-2021, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.  Patient had physical therapy evaluation and treated for neck pain due to DJD (Degenerative joint disease). Patient was due for TD booster, hemoccult or sigmoid.  The reporter wanted to know if the 2069 expiration date on the packing slip was a valid expiration date.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Urological examination
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A, 044B21A and 029A21A) for COVID-19 vaccination.     The patient's past medical history included Hematuria, Obstructive sleep apnea syndrome, Barrett's esophagus, Hearing loss (Right ear) and Pain in toe. Concurrent medical conditions included Varicose veins (Right ear), Cervical disc disease, Allergy NOS and GERD. Concomitant products included CETIRIZINE HCL for Allergy NOS, ACETYLSALICYLIC ACID (ASPIRIN 81), PANTOPRAZOLE SODIUM, CYANOCOBALAMIN (VITAMIN B-12), ZINC GLUCONATE (ZINC (GLUCONATE)), VITAMIN C [ASCORBIC ACID], CURCUMA LONGA (TURMERIC [CURCUMA LONGA]), FISH OIL, ROSUVASTATIN CALCIUM (CRESTOR) and UBIDECARENONE (COQ 10) for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Investigation: results not reported (Inconclusive) Results not reported, results not reported (Inconclusive) Results not reported, results not reported (Inconclusive) Results not reported, results not reported (Inconclusive) Results not reported, results not reported (Inconclusive) Results not reported and results not reported (Inconclusive) Results not reported. On an unknown date, Laboratory test: results not reported (Inconclusive) Results not reported. On an unknown date, Physical examination: results not reported (Inconclusive) Results not reported. On an unknown date, Urogram: gross painless hematuria (abnormal) Gross Painless Hematuriaa. On an unknown date, Urological examination: gross painless hematuriaa (abnormal) Gross Painless Hematuriaa.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Lab test included CAD, non obstructive 76 score in the LAD   No treatment medication were provided.  On 11-Nov-2021, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.  Patient had physical therapy evaluation and treated for neck pain due to DJD (Degenerative joint disease). Patient was due for TD booster, hemoccult or sigmoid.  The reporter wanted to know if the 2069 expiration date on the packing slip was a valid expiration date.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Urticaria
Clinical narrative: Second dose received 24 days after the first dose; had a rash from his feet to his neck,stated it was hives./big welts; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received 24 days after the first dose) and URTICARIA (had a rash from his feet to his neck,stated it was hives./big welts) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (had covid some time ago). Concurrent medical conditions included Hearing decreased and Allergy.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced URTICARIA (had a rash from his feet to his neck,stated it was hives./big welts). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received 24 days after the first dose). The patient was treated with PREDNISONE for Hives, at a dose of high dose. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received 24 days after the first dose) and URTICARIA (had a rash from his feet to his neck,stated it was hives./big welts) had resolved.            Caller stated he had covid some time ago. It could not be clarified if it was from before or after the vaccine.  No Concomitant medication information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Nausea, Pyrexia
Clinical narrative: Sick/Illness comes and goes; High fever; Chills; Headache; Nausea; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (Sick/Illness comes and goes), PYREXIA (High fever), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) 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 22-Dec-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced PYREXIA (High fever), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea). On 22-Dec-2021, the patient experienced ILLNESS (Sick/Illness comes and goes). At the time of the report, ILLNESS (Sick/Illness comes and goes), PYREXIA (High fever), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. The patient received booster dose and was sick by 05.00 pm Treatment information was not provided.   This case was linked to MOD-2021-426928 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Disorientation, Headache, Musculoskeletal stiffness, Pain
Clinical narrative: Body aches; Stiffness; Disorientation; Unsteadiness when she stands; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), MUSCULOSKELETAL STIFFNESS (Stiffness), DISORIENTATION (Disorientation), BALANCE DISORDER (Unsteadiness when she stands) and HEADACHE (Slight headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A, 023M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Dec-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 (Body aches), MUSCULOSKELETAL STIFFNESS (Stiffness), DISORIENTATION (Disorientation), BALANCE DISORDER (Unsteadiness when she stands) and HEADACHE (Slight headache). At the time of the report, PAIN (Body aches), MUSCULOSKELETAL STIFFNESS (Stiffness), DISORIENTATION (Disorientation), BALANCE DISORDER (Unsteadiness when she stands) and HEADACHE (Slight headache) outcome was unknown.            Concomitant medications were not provided.  Treatment medication was not provided
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Headache, Mobility decreased, Photosensitivity reaction
Clinical narrative: Didnt have any energy; Light sensitivity; It put me down for 24 hours; Splitting headache like a migraine; Could not get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Could not get out of bed), ASTHENIA (Didnt have any energy), PHOTOSENSITIVITY REACTION (Light sensitivity), FEELING ABNORMAL (It put me down for 24 hours) and HEADACHE (Splitting headache like a migraine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (screwed up patient's sleeping pattern).    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced MOBILITY DECREASED (Could not get out of bed), PHOTOSENSITIVITY REACTION (Light sensitivity), FEELING ABNORMAL (It put me down for 24 hours) and HEADACHE (Splitting headache like a migraine). On an unknown date, the patient experienced ASTHENIA (Didnt have any energy). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. In April 2021, FEELING ABNORMAL (It put me down for 24 hours) had resolved. At the time of the report, MOBILITY DECREASED (Could not get out of bed) and ASTHENIA (Didnt have any energy) outcome was unknown and PHOTOSENSITIVITY REACTION (Light sensitivity) and HEADACHE (Splitting headache like a migraine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medication reported. Patient reported that she might have taken an aspirin for her symptoms, but does not remember.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: After they've taken the first dose of the Moderna COVID-19 vaccine can they get a colonoscopy/Now they only have prostate cancer/has high blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (After they've taken the first dose of the Moderna COVID-19 vaccine can they get a colonoscopy/Now they only have prostate cancer/has high blood pressure) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Prostate cancer.    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 (After they've taken the first dose of the Moderna COVID-19 vaccine can they get a colonoscopy/Now they only have prostate cancer/has high blood pressure). At the time of the report, VACCINATION COMPLICATION (After they've taken the first dose of the Moderna COVID-19 vaccine can they get a colonoscopy/Now they only have prostate cancer/has high blood pressure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.  Patient after they've taken the first dose of the Moderna COVID-19 vaccine can they get a colonoscopy? Ot is going to affetct it in any way? Because they're going to received anesthesia in the process.  Patient father also had high blood pressure and took daily medicines and also have kidney cancer though they do not right now.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: body aches; headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) and HEADACHE (headaches) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070h21a, 026c21a and 007c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, the patient experienced MYALGIA (body aches). 23-Dec-2021, the patient experienced HEADACHE (headaches). At the time of the report, MYALGIA (body aches) and HEADACHE (headaches) had not resolved.            Treatment details include- Pain killers on 23th December. No concomitant drug details were reported.   This case was linked to MOD-2021-426933 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: body aches after booster dose; headaches after booster dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches after booster dose) and HEADACHE (headaches after booster dose) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 103138101) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 50 microgram. In December 2021, the patient experienced PAIN (body aches after booster dose) and HEADACHE (headaches after booster dose). At the time of the report, PAIN (body aches after booster dose) and HEADACHE (headaches after booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.  The patient received 2 doses of the vaccine in another country.  The patient received the first dose of the vaccine on 02-May-2021 and the second dose of the vaccine on 26-May-2021.   Most recent FOLLOW-UP information incorporated above includes: On 24-Dec-2021: Follow up document received on 24-Dec-2021 contains No New Information.