chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, C-reactive protein increased, Echocardiogram, Electrocardiogram, Grip strength decreased
Clinical narrative: Initial reaction 10/28/21  Severe joint pain, elevated heart rate, elevated blood pressure, severe swelling of hands and knuckles.  Second Reaction 12/1 Severe joint pain, elevated heart rate, elevated blood pressure, severe swelling of hands and knuckles. Subsequent steroid treatment did not improve blood inflammatory levels (3, 3 week steroid treatment cycles) Heart rate increased further after second dose, saw Cardiologist 1/11/22, cardio echo-sound performed 1/27, heart rate 150+, Atrial Flutter discovered on echo-sound/EKG, did not exist previously. Severe ongoing joint pain ? travelling throughout body with different location every few days (hands , wrist, elbows, knees, feet, chest) Repeated blood tests during steroid treatment cycles reflect elevated blood inflammatory levels continuing (as of 2/26/22). Doctor has recommended Cardiac Catheter Ablation procedure (to be scheduled on 2/28/22). Reaction has required 15+ office/ blood test visits and cardiac catheter procedure is pending. Joint pain, elevated heart rate and atrial flutter remain unresolved. Severe ongoing daily joint pain. Inflammatory Blood test levels remain high after 2 full 3-week steroid treatment cycles. (CRP Non-Cardiac 2.12mg/dl on 2/22 after 6 weeks total of Prednisone, currently on third 3-week cycle). Note I had a full physical in September 2022, No Atrial Flutter at that time, full blood panel, all blood test results were normal except slightly high cholesterol levels.  Reaction condition remains unresolved, high blood inflammatory levels, elevated heart rate and constant joint pain in new locations every day (Left hand, knuckles, wrist, left elbow is primary, with other joints variable). Rapidly losing hand strength in left hand and ability to grasp / twist objects (i.e., doorknob twist is not possible every day)
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Peripheral swelling
Clinical narrative: Initial reaction 10/28/21  Severe joint pain, elevated heart rate, elevated blood pressure, severe swelling of hands and knuckles.  Second Reaction 12/1 Severe joint pain, elevated heart rate, elevated blood pressure, severe swelling of hands and knuckles. Subsequent steroid treatment did not improve blood inflammatory levels (3, 3 week steroid treatment cycles) Heart rate increased further after second dose, saw Cardiologist 1/11/22, cardio echo-sound performed 1/27, heart rate 150+, Atrial Flutter discovered on echo-sound/EKG, did not exist previously. Severe ongoing joint pain ? travelling throughout body with different location every few days (hands , wrist, elbows, knees, feet, chest) Repeated blood tests during steroid treatment cycles reflect elevated blood inflammatory levels continuing (as of 2/26/22). Doctor has recommended Cardiac Catheter Ablation procedure (to be scheduled on 2/28/22). Reaction has required 15+ office/ blood test visits and cardiac catheter procedure is pending. Joint pain, elevated heart rate and atrial flutter remain unresolved. Severe ongoing daily joint pain. Inflammatory Blood test levels remain high after 2 full 3-week steroid treatment cycles. (CRP Non-Cardiac 2.12mg/dl on 2/22 after 6 weeks total of Prednisone, currently on third 3-week cycle). Note I had a full physical in September 2022, No Atrial Flutter at that time, full blood panel, all blood test results were normal except slightly high cholesterol levels.  Reaction condition remains unresolved, high blood inflammatory levels, elevated heart rate and constant joint pain in new locations every day (Left hand, knuckles, wrist, left elbow is primary, with other joints variable). Rapidly losing hand strength in left hand and ability to grasp / twist objects (i.e., doorknob twist is not possible every day)
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autoimmune hepatitis, Biopsy liver abnormal, Blood test abnormal, Fatigue, Hepatic enzyme increased
Clinical narrative: On Dec 26, 2021 I started to feel sick. I was so fatigued I could barely get out of bed. On Dec 29, 2021 I went to the urgent care and I was swabbed for COVID and flu. Both were negative. My blood pressure was extremely low so I went to the emergency dept at a local hospital. I was hospitalized until January 1, 2022 with extremely elevated liver enzymes. It was thought that I had autoimmune hepatitis but bloodwork was taking a long time to come back. I was discharged with instructions to see a hepatic specialist. It took 3 weeks for bloodwork to come back. I then got a liver biopsy on January 19, 2022. It was determined I did have autoimmune hepatitis. My liver was very necrotic so I began treatment with a high dose of Prednisone.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hepatic necrosis, Hypotension, Influenza virus test negative, Malaise, Mobility decreased
Clinical narrative: On Dec 26, 2021 I started to feel sick. I was so fatigued I could barely get out of bed. On Dec 29, 2021 I went to the urgent care and I was swabbed for COVID and flu. Both were negative. My blood pressure was extremely low so I went to the emergency dept at a local hospital. I was hospitalized until January 1, 2022 with extremely elevated liver enzymes. It was thought that I had autoimmune hepatitis but bloodwork was taking a long time to come back. I was discharged with instructions to see a hepatic specialist. It took 3 weeks for bloodwork to come back. I then got a liver biopsy on January 19, 2022. It was determined I did have autoimmune hepatitis. My liver was very necrotic so I began treatment with a high dose of Prednisone.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: On Dec 26, 2021 I started to feel sick. I was so fatigued I could barely get out of bed. On Dec 29, 2021 I went to the urgent care and I was swabbed for COVID and flu. Both were negative. My blood pressure was extremely low so I went to the emergency dept at a local hospital. I was hospitalized until January 1, 2022 with extremely elevated liver enzymes. It was thought that I had autoimmune hepatitis but bloodwork was taking a long time to come back. I was discharged with instructions to see a hepatic specialist. It took 3 weeks for bloodwork to come back. I then got a liver biopsy on January 19, 2022. It was determined I did have autoimmune hepatitis. My liver was very necrotic so I began treatment with a high dose of Prednisone.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood test normal, Dizziness, Electrocardiogram, Fatigue
Clinical narrative: Dizzy, sweats, two lumps at injection site, fatigue, almost fainted. We called 911 and they did an EKG and took to emergency room. Blood pressure was high.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Injection site mass, Presyncope
Clinical narrative: Dizzy, sweats, two lumps at injection site, fatigue, almost fainted. We called 911 and they did an EKG and took to emergency room. Blood pressure was high.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Troponin increased
Clinical narrative: Patient presented with chest pain 48 hours after received dose #1 of Pfizer vaccines. Found to have transiently elevated troponins. Diagnosed with myopericarditis.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Injection site pain, Musculoskeletal stiffness
Clinical narrative: -Some chest discomfort and stiffness near the area of the chest above the heart -Soreness at the site of injection even after 1 week  -Tightness in the chest when breathing (not frequently, but maybe 2-3 days in a week)
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicectomy, Appendicitis, Bladder disorder, Blood test, Computerised tomogram abdomen abnormal
Clinical narrative: Around 7pm on 3/13/21 I went to use the restroom to urinate when I felt a severe pain that felt like my bladder and uterus wanted to fall out. I could hardly stand to get help. I took Ibuprofen to try to relieve the pain so I could care for my injured toddler. The severe pain lasted most of the night with little relief. In the morning I went to the emergency room where they ran labs and did a CT scan. I had slightly elevated white blood cells and the CT scan showed a possible appendicitis. The appendix wasn?t presenting with the normal signs of appendicitis but it was inflamed. I had surgery to remove my appendix that evening at 9pm 3/14/22. The resident surgeon mentioned she believes the vaccine was causing appendicitis in some patients but at that time there was little information on this. Now it has been listed as an adverse side effect and I believe this is what caused mine. I?ve had reactions such as lip and tongue swelling/ tingling, brain fog and vertigo after my 1st and 3rd Pfizer vaccines. I had the normal side effects such as sore arm, swollen lymph nodes and fatigue from each dose of vaccine as well.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Fatigue, Lymphadenopathy, Pain, Pain in extremity
Clinical narrative: Around 7pm on 3/13/21 I went to use the restroom to urinate when I felt a severe pain that felt like my bladder and uterus wanted to fall out. I could hardly stand to get help. I took Ibuprofen to try to relieve the pain so I could care for my injured toddler. The severe pain lasted most of the night with little relief. In the morning I went to the emergency room where they ran labs and did a CT scan. I had slightly elevated white blood cells and the CT scan showed a possible appendicitis. The appendix wasn?t presenting with the normal signs of appendicitis but it was inflamed. I had surgery to remove my appendix that evening at 9pm 3/14/22. The resident surgeon mentioned she believes the vaccine was causing appendicitis in some patients but at that time there was little information on this. Now it has been listed as an adverse side effect and I believe this is what caused mine. I?ve had reactions such as lip and tongue swelling/ tingling, brain fog and vertigo after my 1st and 3rd Pfizer vaccines. I had the normal side effects such as sore arm, swollen lymph nodes and fatigue from each dose of vaccine as well.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pathology test, Uterine disorder, White blood cell count increased
Clinical narrative: Around 7pm on 3/13/21 I went to use the restroom to urinate when I felt a severe pain that felt like my bladder and uterus wanted to fall out. I could hardly stand to get help. I took Ibuprofen to try to relieve the pain so I could care for my injured toddler. The severe pain lasted most of the night with little relief. In the morning I went to the emergency room where they ran labs and did a CT scan. I had slightly elevated white blood cells and the CT scan showed a possible appendicitis. The appendix wasn?t presenting with the normal signs of appendicitis but it was inflamed. I had surgery to remove my appendix that evening at 9pm 3/14/22. The resident surgeon mentioned she believes the vaccine was causing appendicitis in some patients but at that time there was little information on this. Now it has been listed as an adverse side effect and I believe this is what caused mine. I?ve had reactions such as lip and tongue swelling/ tingling, brain fog and vertigo after my 1st and 3rd Pfizer vaccines. I had the normal side effects such as sore arm, swollen lymph nodes and fatigue from each dose of vaccine as well.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test negative, Pruritus, Urticaria
Clinical narrative: Exactly 2 weeks after my booster shot, my skin became extremely itchy with hives that covered my entire body. The hives continued for an entire month. I visited urgent care who assured me It was something I was eating or putting on my skin that I was allergic to. I was prescribed steroids for a week. By day 3 of my steroid treatment, the hives returned. I was then told to visit an allergist. The allergist tested me for food allergens and environmental allergens -- which came back negative for all. She mentioned she had several patients come in with the same issue from the Moderna booster. She administered a steroid injection and prescribed me a higher dose of steroids for 22 days. It is now a week and 3 days since my steroid injection and the hives are back.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient received first dose in December, 7 months ago; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient received first dose in December, 7 months ago) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient received first dose in December, 7 months ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient received first dose in December, 7 months ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose was given outside of the 12 hour mark/ Doses were administered greater than 12 hours post the initial vial puncture; Moderna Covid-10 vaccine was left at room temperature for 24 hours/The vial was kept at room temperature after first puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given outside of the 12 hour mark/ Doses were administered greater than 12 hours post the initial vial puncture) and PRODUCT STORAGE ERROR (Moderna Covid-10 vaccine was left at room temperature for 24 hours/The vial was kept at room temperature after first puncture) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K212A and 084J4A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 13-Feb-2022 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2022 at 11:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given outside of the 12 hour mark/ Doses were administered greater than 12 hours post the initial vial puncture). In February 2022, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-10 vaccine was left at room temperature for 24 hours/The vial was kept at room temperature after first puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given outside of the 12 hour mark/ Doses were administered greater than 12 hours post the initial vial puncture) and PRODUCT STORAGE ERROR (Moderna Covid-10 vaccine was left at room temperature for 24 hours/The vial was kept at room temperature after first puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there were no known symptoms after vaccination. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 to 25 degree celsius) was less than 24 hours. On 13-FEB-2022 a vial of Moderna COVID-19 vaccine was left at room temperature for 24 hours and was used outside of the 12 hour limit for puncturing, though only punctured 3 times total.   Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2022: Significant Follow Up appended. Batch/Lot No added. Update received states the expired vaccine was administered to 2 patients. Drug Start date obtained. On 24-Feb-2022: Follow up received contains patient initials, first dose information were added and second dose information, event start date was updated. The LLT of product storage error was added. On 24-Feb-2022: Narrative was updated contains non-significant information.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Underdose
Clinical narrative: received her first dose (0.5 ml) of Moderna COVID19 Vaccine on 03Mar2021 and second dose (0.5 ml) on 31Mar2021 and third dose (0.25 ml) on 23Sep2021.; immunocompromised individual received 0.25 ml as third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (immunocompromised individual received 0.25 ml as third dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her first dose (0.5 ml) of Moderna COVID19 Vaccine on 03Mar2021 and second dose (0.5 ml) on 31Mar2021 and third dose (0.25 ml) on 23Sep2021.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included ETANERCEPT (ENBREL) for Immunocompromised.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 23-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 23-Sep-2021, the patient experienced UNDERDOSE (immunocompromised individual received 0.25 ml as third dose). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her first dose (0.5 ml) of Moderna COVID19 Vaccine on 03Mar2021 and second dose (0.5 ml) on 31Mar2021 and third dose (0.25 ml) on 23Sep2021.). At the time of the report, UNDERDOSE (immunocompromised individual received 0.25 ml as third dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her first dose (0.5 ml) of Moderna COVID19 Vaccine on 03Mar2021 and second dose (0.5 ml) on 31Mar2021 and third dose (0.25 ml) on 23Sep2021.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient who received their first two doses and a third dose as a booster back before the guidelines were updated, at the time of reporting want to get the fourth dose. The pharmacist wanted to know if this fourth dose should be considered as the booster or the third dose. The pharmacist states that it was not really an error because the guidelines changed after the patient received their vaccines.  No treatment information provided.   This case was linked to MOD-2022-493745 (Patient Link).
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     Concomitant products included CYANOCOBALAMIN (VITAMIN B-12) for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in the arm). At the time of the report, PAIN IN EXTREMITY (pain in the arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medications were provided.   This case was linked to MOD-2022-494221, MOD-2022-494249 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Follow-up received contains no new information.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Gait disturbance, Pain, Pain in extremity, Suicidal ideation
Clinical narrative: pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     Concomitant products included CYANOCOBALAMIN (VITAMIN B-12) for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in the arm). At the time of the report, PAIN IN EXTREMITY (pain in the arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medications were provided.   This case was linked to MOD-2022-494221, MOD-2022-494249 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Follow-up received contains no new information.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 041B21A) for COVID-19 vaccination.     Concomitant products included CYANOCOBALAMIN (VITAMIN B-12) for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-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 PAIN IN EXTREMITY (Pain in the arm). In 2021, PAIN IN EXTREMITY (Pain in the arm) had resolved.            Treatment information was not provided.   This case was linked to MOD-2022-494221, MOD-2022-494240 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Follow-up received does not contain any new information.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Gait disturbance, Pain, Pain in extremity, Suicidal ideation
Clinical narrative: Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 041B21A) for COVID-19 vaccination.     Concomitant products included CYANOCOBALAMIN (VITAMIN B-12) for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-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 PAIN IN EXTREMITY (Pain in the arm). In 2021, PAIN IN EXTREMITY (Pain in the arm) had resolved.            Treatment information was not provided.   This case was linked to MOD-2022-494221, MOD-2022-494240 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Follow-up received does not contain any new information.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  The vial was initially stored in the refrigerator on 17-Dec-2021. The vial did not undergo any temperature excursions and vaccine beyond use date was 16-Jan-2022.   No Treatment medications were reported.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives all over the body after booster/Hives Unresponsive to medications after booster; Itching all over the body after booster/Hives & Itching Unresponsive to medications after booster; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over the body after booster/Hives Unresponsive to medications after booster) and PRURITUS (Itching all over the body after booster/Hives & Itching Unresponsive to medications after booster) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 002A21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, the patient experienced URTICARIA (Hives all over the body after booster/Hives Unresponsive to medications after booster) and PRURITUS (Itching all over the body after booster/Hives & Itching Unresponsive to medications after booster). The patient was treated with PREDNISONE at a dose of 9 days; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 10 milligram, 4 tabs daily. At the time of the report, URTICARIA (Hives all over the body after booster/Hives Unresponsive to medications after booster) and PRURITUS (Itching all over the body after booster/Hives & Itching Unresponsive to medications after booster) outcome was unknown.            Concomitant medications was not provided by the reporter.  Patient experienced symptoms 13 days after the booster he had hives, and Itching all over the body. His Doctor prescribed 9 days of Prednisone which did not help. He took Benadryl on his own. The allergist prescribed Zyrtec 10mg 4 tablets daily.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Pyrexia, Vaccination site erythema
Clinical narrative: Redness at injection site a week after injection; Fever; Chills; Felt like death for 24 hours after dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt like death for 24 hours after dose), VACCINATION SITE ERYTHEMA (Redness at injection site a week after injection), PYREXIA (Fever) and CHILLS (Chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Felt like death for 24 hours after dose), VACCINATION SITE ERYTHEMA (Redness at injection site a week after injection), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, FEELING ABNORMAL (Felt like death for 24 hours after dose) had resolved and VACCINATION SITE ERYTHEMA (Redness at injection site a week after injection), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: give 4 patient booster doses, with more than 30 days refrigerated stored vial; Expired Booster Doses Administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Booster Doses Administered) and PRODUCT STORAGE ERROR (give 4 patient booster doses, with more than 30 days refrigerated stored vial) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007J21-2A, 036C21A and 036C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Booster Doses Administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (give 4 patient booster doses, with more than 30 days refrigerated stored vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Booster Doses Administered) and PRODUCT STORAGE ERROR (give 4 patient booster doses, with more than 30 days refrigerated stored vial) outcome was unknown.        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: 21 Jan 2022 6 am No concomitant medications were provided. No treatment medications were provided.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: received shots after the 30-day use by date; received shots after the 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received shots after the 30-day use by date) and PRODUCT STORAGE ERROR (received shots after the 30-day use by date) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received shots after the 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (received shots after the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received shots after the 30-day use by date) and PRODUCT STORAGE ERROR (received shots after the 30-day use by date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The vial was initially stored in the refrigerator on 17-Dec-2021. Beyond use date of the vaccine was 16-Jan-2022. The vial did not undergo any temperature excursions.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Doses administered after 30-day use by date; Doses administered after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) and PRODUCT STORAGE ERROR (Doses administered after 30-day use by date) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) and PRODUCT STORAGE ERROR (Doses administered after 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Number of doses/vials - 23 doses.  Date the vial was initially stored in the refrigerator - 17 Dec 2021. BUD date reported as 16 Jan 2022.  Vial did not undergo any temperature excursions.  Treatment medication was not provided by the reporter.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Doses administered after 30-day use by date; Doses administered after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) and PRODUCT STORAGE ERROR (Doses administered after 30-day use by date) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) and PRODUCT STORAGE ERROR (Doses administered after 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. The vial was initially stored in the refrigerator on 17-Dec-2021. The vial did not undergo any temperature excursions. BUD for the vaccine was on 16-Jan-2022. Treatment information was not provided.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  Nurse said that 23 patients received shots. Doses administered on 21 Feb 2022, after 30-day Use By Date with Beyond use date (BUD) of 16 Jan 2022. The vial was initially stored in the refrigerator on 17 Dec 2021. Not undergone temperature excursions.  Treatment information was not provided.
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: employees gave someone expired Tenivac with no reported adverse event.; Initial information received on 21-Feb-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age male patient who reported employees gave someone expired tenivac with no reported adverse event. while receiving vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [tenivac].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 21-Feb-2022, the patient received a  dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult lot U6922AA via unknown route in unknown administration site for immunization..  On 21-FEB-2022 the patient developed a non-serious employees gave someone expired tenivac with no reported adverse event. (expired product administered) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (Latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event employees gave someone expired tenivac with no reported adverse event.  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: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Product storage error; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Product storage error) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 16-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient had NKDA(no known drug allergies).  Concomitant medication information was not provided by the reporter.  Moderna vaccine was pulled from  freezer on 16 Dec 2021. Beyond use date of 15 Jan 2022 was printed in red and taped to the top of boxes. On 26 Jan 2022, Staff noticed that vaccine was still in the fridge and expired and 5 doses had been given at that point. On 31 Jan 2022, Moderna confirmed that revaccination was not required. Patient notified of error and that a repeat vaccine was not required. Patient denied any adverse effects.  Treatment information was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vacccine was left at room temperature 24 hours,and was outside of the 12 hrs limit for puncturing; vacccine was left at room temperature 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vacccine was left at room temperature 24 hours,and was outside of the 12 hrs limit for puncturing) and PRODUCT STORAGE ERROR (vacccine was left at room temperature 24 hours) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2022 at 10:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vacccine was left at room temperature 24 hours,and was outside of the 12 hrs limit for puncturing) and PRODUCT STORAGE ERROR (vacccine was left at room temperature 24 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vacccine was left at room temperature 24 hours,and was outside of the 12 hrs limit for puncturing) and PRODUCT STORAGE ERROR (vacccine was left at room temperature 24 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Vial was first punctured on 12-FEB-2022 at 11:45 am and was left at room temperature for 24 hours on 13-Feb-2022. The vial was used outside of the 12 hour limit for puncturing. The patient experienced no adverse events from the immunization.  No treatment medications were reported.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided.  It was reported that vial was initially stored in the refrigerator on 17-Dec-2021. It was stated that vial did not undergo an temperature excursions. The BUD was on 16-Jan-2022.  Treatment information was not provided.
Sex: U
Vaccine: FLUX
Symptoms: Pneumonia
Clinical narrative: Pneumonia; Initial information received on 22-Feb-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who had pneumonia while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In 1980, the patient received a  dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunization.  In 1980 the patient developed a serious event pneumonia (unknown latency) following the administration of Influenza Vaccine.   It was reported that got a flu shot in 1980, forced by the military, and three days later had pneumonia what's the connection, I don't know, but I won't take a flu shat again.  Action taken : Not applicable.  Corrective treatment : No corrective treatment reported for the event.  Event outcome : Unknown for the event.  Seriousness criteria : This event(pneumonia) was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 28-Feb-2022:This case involves an unknown age and unknown gender patient who had pneumonia while receiving vaccine Influenza Vaccine. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses, and concomitant medications. The role of the vaccine cannot be assessed this.
Sex: U
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: 16 vials of Menactra that were our of range for 21 hours reaching a maximum temperature of 52.3 degrees F, due to the refrigerator door accidentally being left ajar; Initial information received on 21-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient with unknown demographics who had 16 vials of menactra that were our of range for 21 hours reaching a maximum temperature of 52.3 degrees f, due to the refrigerator door accidentally being left ajar while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE with unknown dose lot U70878AA (6 vials) via unknown route in unknown administration site for immunization.  On 20-JAN-2022 the patient had 16 vials of menactra that were our of range for 21 hours reaching a maximum temperature of 52.3 degrees f, due to the refrigerator door accidentally being left ajar (product temperature excursion issue) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (16 vials of Menactra that were our of range for 21 hours reaching a maximum temperature of 52.3 degrees F, due to the refrigerator door accidentally being left ajar).  At time of reporting, the outcome was Unknown for the event 16 vials of menactra that were our of range for 21 hours reaching a maximum temperature of 52.3 degrees f, due to the refrigerator door accidentally being left ajar.   Additional information was received on 23-Feb-2022 from a other health professional:Case updated from non case to valid case.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Heart rate increased, Injection site erythema, Injection site pain
Clinical narrative: Sore injection site 2/26-2/28. Red/swelling injection site 2/26-2/28, Fever 2/27, Nausea 2/26, Muscle aches 2/26-2/27, Brain fog 2/26-2/28, Fatigue 2/27, Fast heart rate 2/26-2/28.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Myalgia, Nausea, Pyrexia
Clinical narrative: Sore injection site 2/26-2/28. Red/swelling injection site 2/26-2/28, Fever 2/27, Nausea 2/26, Muscle aches 2/26-2/27, Brain fog 2/26-2/28, Fatigue 2/27, Fast heart rate 2/26-2/28.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Pain in extremity, Rash
Clinical narrative: Burning sensation in right upper arm for 1 hour after injection. Pain in right under arm began 2 days after injection. Redness/rash on right arm began 3 days after injection.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Hot flush, Nightmare, Pain, Taste disorder
Clinical narrative: Nightmares, impending doom, hot flashes, change in taste, body aches, no treatment through doctor
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Chills, Confusional state, Feeling abnormal
Clinical narrative: Site: Swelling at Injection Site-Medium, Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Confusion-Medium, Systemic: Fever-Severe, Systemic: brain fog, left eye spasms, severe headache. swollen left armpit lymph node-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Severe, Systemic: Lymph Node Swelling-Severe, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: Patient had a virtual consult with provider on February 23rd at 11:52am.   Was instructed to rest, take acetaminophen for fever and report any additional symptoms that persist/worsen. Pateint also reports he had similar adverse effects after the 2nd vaccination but did not report to pharmacy or provider at that time (mainly severe headache, fever/chills, brain fog and tender left armpit lymphnode).