chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID Disease after Bivalent Booster; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID Disease after Bivalent Booster) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In November 2022, the patient experienced COVID-19 (COVID Disease after Bivalent Booster). At the time of the report, COVID-19 (COVID Disease after Bivalent Booster) outcome was unknown.            No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2022-673958 (Patient Link).   Reporter did not allow further contact
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Electrocardiogram, Full blood count, Headache, Joint swelling
Clinical narrative: Arm swelling, joint swelling, joint pain, headache
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Peripheral swelling, Troponin, Ultrasound Doppler
Clinical narrative: Arm swelling, joint swelling, joint pain, headache
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction, Blood test, Catheterisation cardiac abnormal, Chest X-ray, Chest pain
Clinical narrative: Chest pain, nausea, lightheaded, shortness of breath led to emergency room visit an hour later.  EKG, Blood tests, chest X-ray, were performed.  Continually elevating troponin.  Cardiac catheterization performed.  Outcome reported as ?Suspected SCAD (spontaneous coronary artery dissection) in OM1 vessel with 60-70% stenosis long diffuse tapering lesion, TIMI III flow, no improvement with nitroglycerin. Otherwise no evidence of epicardial coronary artery disease. ?
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Coronary artery dissection, Coronary artery stenosis, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: Chest pain, nausea, lightheaded, shortness of breath led to emergency room visit an hour later.  EKG, Blood tests, chest X-ray, were performed.  Continually elevating troponin.  Cardiac catheterization performed.  Outcome reported as ?Suspected SCAD (spontaneous coronary artery dissection) in OM1 vessel with 60-70% stenosis long diffuse tapering lesion, TIMI III flow, no improvement with nitroglycerin. Otherwise no evidence of epicardial coronary artery disease. ?
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Troponin increased
Clinical narrative: Chest pain, nausea, lightheaded, shortness of breath led to emergency room visit an hour later.  EKG, Blood tests, chest X-ray, were performed.  Continually elevating troponin.  Cardiac catheterization performed.  Outcome reported as ?Suspected SCAD (spontaneous coronary artery dissection) in OM1 vessel with 60-70% stenosis long diffuse tapering lesion, TIMI III flow, no improvement with nitroglycerin. Otherwise no evidence of epicardial coronary artery disease. ?
Age: 8.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Incorrect dose administered, Pyrexia
Clinical narrative: Adult Pfizer Bivalent dose was given incorrectly to the patient. Patient was put under observation for approximately 45 minutes and no adverse event was reported. Patient was called approximately 3 hours later and mother reported patient had fever and Tylenol was given by the mother but she said her daughter was ok and sleeping.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Periorbital oedema, Pruritus
Clinical narrative: Bilateral periorbital edema, erythema, pruritis.
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Lymphadenopathy, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: Swollen right arm, swollen lymph nodes in armpits (both side), sore and stiff right arm, fatigue
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bell's palsy
Clinical narrative: Systemic: Bell's Palsy-Medium
Age: 19.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Lethargy, Seizure
Clinical narrative: Systemic: Exhaustion / Lethargy-Severe, Systemic: Seizure-Severe
Age: 69.0
Sex: M
Vaccine: FLUA4
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: Patients wife also had injury from injection being given to high. Patient just had mild pain at injection site that has since resolved. No medical treatment was required, and patient does not require a follow up.
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Decreased mobility and pain-Medium, Systemic: Joint Pain-Medium, Additional Details: Patient stated injection was very painful the moment she recieved it. After about a week she followed up with her physician who diagnosed her with joint/shoulder pain due to incorrect injection of a vaccine. Patient has recieved a steroid injection and a medrol dose pack. I will follow up with patient in a few days to see if symptoms have resolved.
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Pain, Product administered at inappropriate site
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Decreased mobility and pain-Medium, Systemic: Joint Pain-Medium, Additional Details: Patient stated injection was very painful the moment she recieved it. After about a week she followed up with her physician who diagnosed her with joint/shoulder pain due to incorrect injection of a vaccine. Patient has recieved a steroid injection and a medrol dose pack. I will follow up with patient in a few days to see if symptoms have resolved.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Confusional state, Dizziness, Injection site pain, Nausea, Syncope
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Presyncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient had two episodes of vasovagal feeling. 911 call was placed, Paramedics came, he felt better soon enough, his vitals were stable, he went home with his mother after eating and drinking Gatorade and water. No fall, no injuries either.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Fall, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt got Moderna COVID-19 bivalent vaccine 1st on left arm. After receiving bivalent booster, pt mentioned gets nervous w/ shots. Has fainted before to flu shot. Immunizer asked if ok to continue w/ flu shot, patient verbalized consent. Immunizer preppred left arm for flu shot about 1in above 1st shot. Administered Flulaval Quad 22-23 vaccine on left arm & as placing bandaid on arm, pt mentioned wanting to lie down then slide off chair & fainted. Recovered after a few seconds. Pt rested for 30min.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Joint injury, Limb injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Condition aggravated, Urticaria
Clinical narrative: Chronic hives were in remission since June. About 24 hours after flu + covid booster hives returned aggressively
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case
Age: 70.0
Sex: F
Vaccine: FLUC4
Symptoms: Wrong product administered
Clinical narrative: Patient is over age 65 years.  Pharmacist gave regular strength Flucelvax rather than adjuvanted or high dose influenza vaccine in error.
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Adm. vaccine that expired on 11-16-22 on 11-17-2022 not knowing the vial had expired at time of adm.  Realized same day after adm the vial lot number  was not in the registry and reviewed the time  vaccine was recieved to date  and noted the vaccine expired 1 day prior.   Notified Vaccine program.  Also notified Pfizer of the incidence and was advised since within 2 days of expire time the vaccine would not have to be readministerd.  An email was sent with the following info to verify that there is 2 additional days for expire time but the vaccine expire date has not had any extention time.   Total Time: 72 days = [10 weeks (70 days) labeled time described in the Prescribing Information plus 2 days excursion time)] No additional excursion time is allowable for vials reduced to 1 week of storage at 2°C to 8°C (35ºF to 46ºF) due to excursions at -50°C to -15°C (-58°F to 5ºF). The vials do not have printed expire dates and when the shipment is recieved the staff have to determine the expire date and then COVID vaccines are constatly having extended  expire dates, making it very confusing for staff to monitor.    No treatment was needed, no injury occured and all staff have met and will place visible expire labels on each box upon recieving and monitor expire dates daily to prevent further occurances.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Moderna 2/19/21, 3/19/21, 10/26/21. Positive on 11/10/22
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given vaccine after BUD
Age: 59.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Lymphadenopathy
Clinical narrative: Severe lymph node swelling left armpit
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD.
Age: 90.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Adm. vaccine that expired on 11-16-22 on 11-17-2022 not knowing the vial had expired at time of adm.  Realized same day after adm the vial lot number  was not in the registry and reviewed the time  vaccine was recieved to date  and noted the vaccine expired 1 day prior.   Notified state Vaccine program.  Also notified Pfizer of the incidence and was advised since within 2 days of expire time the vaccine would not have to be readministerd.  An email was sent with the following info to verify that there is 2 additional days for expire time but the vaccine expire date has not had any extention time.   Total Time: 72 days = [10 weeks (70 days) labeled time described in the Prescribing Information plus 2 days excursion time)] ? No additional excursion time is allowable for vials reduced to 1 week of storage at 2°C to 8°C (35ºF to 46ºF) due to excursions at -50°C to -15°C (-58°F to 5ºF). The vials do not have printed expire dates and when the shipment is recieved the staff have to determine the expire date and then COVID vaccines are constatly having extended  expire dates, making it very confusing for staff to monitor.    No treatment was needed, no injury occured and all staff have met and will place visible expire labels on each box upon recieving and monitor expire dates daily to prevent further occurances.
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Adm. vaccine that expired on 11-16-22 on 11-17-2022 not knowing the vial had expired at time of adm.  Realized same day after adm the vial lot number  was not in the registry and reviewed the time  vaccine was recieved to date  and noted the vaccine expired 1 day prior.   Notified state Vaccine program.  Also notified Pfizer of the incidence and was advised since within 2 days of expire time the vaccine would not have to be readministerd.  An email was sent with the following info to verify that there is 2 additional days for expire time but the vaccine expire date has not had any extention time.   Total Time: 72 days = [10 weeks (70 days) labeled time described in the Prescribing Information plus 2 days excursion time)] ? No additional excursion time is allowable for vials reduced to 1 week of storage at 2°C to 8°C (35ºF to 46ºF) due to excursions at -50°C to -15°C (-58°F to 5ºF). The vials do not have printed expire dates and when the shipment is recieved the staff have to determine the expire date and then COVID vaccines are constatly having extended  expire dates, making it very confusing for staff to monitor.    No treatment was needed, no injury occured and all staff have met and will place visible expire labels on each box upon recieving and monitor expire dates daily to prevent further occurances.
Age: 57.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Bell's palsy, Blood test, Chest X-ray, Computerised tomogram head, Electrocardiogram
Clinical narrative: He got his vaccines, was OK on that day.  2-3 days later his arm on the right side was really sore, and when you rubbed the area close to the shoulder it felt like it pocked out.  Then after that on 11/7/22 he noticed that his mouth was drooping and he did not feel good.  He did not realize that it went to his eye as well.  He was at restaurant and eating lunch and when he was putting food in his mouth and trying to eat he was not able to eat really well, and realized that the food was falling down between his teeth and gums on the right side.   He asked his wife to look at his face and noticed that the right side of his mouth was drooping some.  His eye was very watery.  That evening about 5:30 he did not feel good at all and needed that he had to get some health.  He called a nurse on ask a nurse and explained what his symptoms were and the nurse called back and talked to her what was going on and she said that she felt that he was not having a stroke as he thought, and that he might have Bell's palsy.   On 11/8/22 he went to the ER and did a stroke evaluation and told him that she was 100% sure that he had Bell's palsy.  He had an EKG, a chest x-ray, CAT scan of his brain to rule out the stroke.  She then told him that he needed to see his eye doctor as his eye was involved too and to see his PCP as well.  He got home and the next morning he got his prescriptions filled and he started using that.  Two days later he called his doctors and set up those appointments.  His eye doctor told him that he was progressing well and that it would take some time for his eye to get back to normal.  His PCP also knew what was wrong and said that it was a relaxation to the vaccine, and that one of the side effects was Bell's palsy and that it would go back to normal, and to do some facial exercises to get it back to normal, and has a FU appointment for 6 weeks, and also has a FU appointment with his eye doctor next month too.  His PCP told him to call us and report the reaction.    He went to the ER at Hospital.
Age: 57.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Facial paralysis, Feeling abnormal, Immunisation reaction, Injection site pain, Lacrimation increased
Clinical narrative: He got his vaccines, was OK on that day.  2-3 days later his arm on the right side was really sore, and when you rubbed the area close to the shoulder it felt like it pocked out.  Then after that on 11/7/22 he noticed that his mouth was drooping and he did not feel good.  He did not realize that it went to his eye as well.  He was at restaurant and eating lunch and when he was putting food in his mouth and trying to eat he was not able to eat really well, and realized that the food was falling down between his teeth and gums on the right side.   He asked his wife to look at his face and noticed that the right side of his mouth was drooping some.  His eye was very watery.  That evening about 5:30 he did not feel good at all and needed that he had to get some health.  He called a nurse on ask a nurse and explained what his symptoms were and the nurse called back and talked to her what was going on and she said that she felt that he was not having a stroke as he thought, and that he might have Bell's palsy.   On 11/8/22 he went to the ER and did a stroke evaluation and told him that she was 100% sure that he had Bell's palsy.  He had an EKG, a chest x-ray, CAT scan of his brain to rule out the stroke.  She then told him that he needed to see his eye doctor as his eye was involved too and to see his PCP as well.  He got home and the next morning he got his prescriptions filled and he started using that.  Two days later he called his doctors and set up those appointments.  His eye doctor told him that he was progressing well and that it would take some time for his eye to get back to normal.  His PCP also knew what was wrong and said that it was a relaxation to the vaccine, and that one of the side effects was Bell's palsy and that it would go back to normal, and to do some facial exercises to get it back to normal, and has a FU appointment for 6 weeks, and also has a FU appointment with his eye doctor next month too.  His PCP told him to call us and report the reaction.    He went to the ER at Hospital.
Age: 57.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Loss of personal independence in daily activities, Musculoskeletal discomfort
Clinical narrative: He got his vaccines, was OK on that day.  2-3 days later his arm on the right side was really sore, and when you rubbed the area close to the shoulder it felt like it pocked out.  Then after that on 11/7/22 he noticed that his mouth was drooping and he did not feel good.  He did not realize that it went to his eye as well.  He was at restaurant and eating lunch and when he was putting food in his mouth and trying to eat he was not able to eat really well, and realized that the food was falling down between his teeth and gums on the right side.   He asked his wife to look at his face and noticed that the right side of his mouth was drooping some.  His eye was very watery.  That evening about 5:30 he did not feel good at all and needed that he had to get some health.  He called a nurse on ask a nurse and explained what his symptoms were and the nurse called back and talked to her what was going on and she said that she felt that he was not having a stroke as he thought, and that he might have Bell's palsy.   On 11/8/22 he went to the ER and did a stroke evaluation and told him that she was 100% sure that he had Bell's palsy.  He had an EKG, a chest x-ray, CAT scan of his brain to rule out the stroke.  She then told him that he needed to see his eye doctor as his eye was involved too and to see his PCP as well.  He got home and the next morning he got his prescriptions filled and he started using that.  Two days later he called his doctors and set up those appointments.  His eye doctor told him that he was progressing well and that it would take some time for his eye to get back to normal.  His PCP also knew what was wrong and said that it was a relaxation to the vaccine, and that one of the side effects was Bell's palsy and that it would go back to normal, and to do some facial exercises to get it back to normal, and has a FU appointment for 6 weeks, and also has a FU appointment with his eye doctor next month too.  His PCP told him to call us and report the reaction.    He went to the ER at Hospital.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cyst, Pain
Clinical narrative: Soreness Felt a little ball I bath in alcohol tingling sensation 18 months ago, exams were taken a little cyst.. "something suspicion"
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 86.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Adm. vaccine that expired on 11-16-22 on 11-17-2022 not knowing the vial had expired at time of adm.  Realized same day after adm the vial lot number  was not in the registry and reviewed the time  vaccine was received to date  and noted the vaccine expired 1 day prior.   Notified Vaccine program Administrators.  Also notified Pfizer of the incidence and was advised since within 2 days of expire time the vaccine would not have to be readministered.  An email was sent with the following info to verify that there is 2 additional days for expire time but the vaccine expire date has not had any extension time.   Total Time: 72 days = [10 weeks (70 days) labeled time described in the Prescribing Information plus 2 days excursion time)] ? No additional excursion time is allowable for vials reduced to 1 week of storage at 2°C to 8°C (35ºF to 46ºF) due to excursions at -50°C to -15°C (-58°F to 5ºF). The vials do not have printed expire dates and when the shipment is received the staff have to determine the expire date and then COVID vaccines are constantly having extended  expire dates, making it very confusing for staff to monitor.    No treatment was needed, no injury occured and all staff have met and will place visible expire labels on each box upon receiving and monitor expire dates daily to prevent further occurrences.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: the patient received a monovalent vaccine as a booster not BiValent. However patient told Doctor and her MA that this was her first COVID shot.
Age: 92.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Adm. vaccine that expired on 11-16-22 on 11-17-2022 not knowing the vial had expired at time of adm.  Realized same day after adm the vial lot number  was not in the registry and reviewed the time  vaccine was received to date  and noted the vaccine expired 1 day prior.   Notified state Vaccine programt.  Also notified Pfizer of the incidence and was advised since within 2 days of expire time the vaccine would not have to be readministerd.  An email was sent from Pfizer with the following info to verify that there is 2 additional days for expire time but the vaccine over all expire date has not had any extension time.   Total Time: 72 days = [10 weeks (70 days) labeled time described in the Prescribing Information plus 2 days excursion time)] ? No additional excursion time is allowable for vials reduced to 1 week of storage at 2°C to 8°C (35ºF to 46ºF) due to excursions at -50°C to -15°C (-58°F to 5ºF). The vials do not have printed expire dates and when the shipment is received the staff have to determine the expire date and then COVID vaccines are constantly having extended  expire dates, making it very confusing for staff to monitor.    No treatment was needed, no injury occured  to the vaccine receipent (patient) and all staff have met and will place visible expire labels on each box upon recieving and monitor expire dates daily to prevent further occurances.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Adm. vaccine that expired on 11-16-22 on 11-17-2022 not knowing the vial had expired at time of adm.  Realized same day after adm the vial lot number  was not in the registry and reviewed the time  vaccine was received to date  and noted the vaccine expired 1 day prior.   Notified state Vaccine program.  Also notified Pfizer of the incidence and was advised since within 2 days of expire time the vaccine would not have to be readministered.  An email was sent with the following info to verify that there is 2 additional days for expire time but the vaccine expire date has not had any extension time.   Total Time: 72 days = [10 weeks (70 days) labeled time described in the Prescribing Information plus 2 days excursion time)] ? No additional excursion time is allowable for vials reduced to 1 week of storage at 2°C to 8°C (35ºF to 46ºF) due to excursions at -50°C to -15°C (-58°F to 5ºF). The vials do not have printed expire dates and when the shipment is received the staff have to determine the expire date and then COVID vaccines are constantly having extended  expire dates, making it very confusing for staff to monitor.    No treatment was needed, no injury occured and all staff have met and will place visible expire labels on each box upon receiving and monitor expire dates daily to prevent further occurrences.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Adm. vaccine that expired on 11-16-22 on 11-17-2022 not knowing the vial had expired at time of adm.  Realized same day after adm the vial lot number  was not in the registry and reviewed the time  vaccine was received to date  and noted the vaccine expired 1 day prior.   Notified state Vaccine program.  Also notified Pfizer of the incidence and was advised since within 2 days of expire time the vaccine would not have to be readministered.  An email was sent with the following info to verify that there is 2 additional days for expire time but the vaccine expire date has not had any extension time.   Total Time: 72 days = [10 weeks (70 days) labeled time described in the Prescribing Information plus 2 days excursion time)] ? No additional excursion time is allowable for vials reduced to 1 week of storage at 2°C to 8°C (35ºF to 46ºF) due to excursions at -50°C to -15°C (-58°F to 5ºF). The vials do not have printed expire dates and when the shipment is received the staff have to determine the expire date and then COVID vaccines are constantly having extended  expire dates, making it very confusing for staff to monitor.    No treatment was needed, no injury occured and all staff have met and will place visible expire labels on each box upon receiving and monitor expire dates daily to prevent further occurrences.
Age: 93.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Adm. vaccine that expired on 11-16-22 on 11-17-2022 not knowing the vial had expired at time of adm.  Realized same day after adm the vial lot number  was not in the registry and reviewed the time  vaccine was received to date  and noted the vaccine expired 1 day prior.   Notified state Vaccine program.  Also notified Pfizer of the incidence and was advised since within 2 days of expire time the vaccine would not have to be readministered.  An email was sent with the following info to verify that there is 2 additional days for expire time but the vaccine expire date has not had any extension time.   Total Time: 72 days = [10 weeks (70 days) labeled time described in the Prescribing Information plus 2 days excursion time)] ? No additional excursion time is allowable for vials reduced to 1 week of storage at 2°C to 8°C (35ºF to 46ºF) due to excursions at -50°C to -15°C (-58°F to 5ºF). The vials do not have printed expire dates and when the shipment is received the staff have to determine the expire date and then COVID vaccines are constantly having extended  expire dates, making it very confusing for staff to monitor.    No treatment was needed, no injury occured and all staff have met and will place visible expire labels on each box upon receiving and monitor expire dates daily to prevent further occurrences.
Age: 94.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Adm. vaccine that expired on 11-16-22 on 11-17-2022 not knowing the vial had expired at time of adm.  Realized same day after adm the vial lot number  was not in the registry and reviewed the time  vaccine was received to date  and noted the vaccine expired 1 day prior.   Notified state Vaccine program.  Also notified Pfizer of the incidence and was advised since within 2 days of expire time the vaccine would not have to be readministered.  An email was sent with the following info to verify that there is 2 additional days for expire time but the vaccine expire date has not had any extension time.   Total Time: 72 days = [10 weeks (70 days) labeled time described in the Prescribing Information plus 2 days excursion time)] ? No additional excursion time is allowable for vials reduced to 1 week of storage at 2°C to 8°C (35ºF to 46ºF) due to excursions at -50°C to -15°C (-58°F to 5ºF). The vials do not have printed expire dates and when the shipment is received the staff have to determine the expire date and then COVID vaccines are constantly having extended  expire dates, making it very confusing for staff to monitor.    No treatment was needed, no injury occurred and all staff have met and will place visible expire labels on each box upon receiving and monitor expire dates daily to prevent further occurrences.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna vaccine was administered to patient less than 18 years of age.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Product storage error
Clinical narrative: Adm. vaccine that expired on 11-16-22 on 11-17-2022 not knowing the vial had expired at time of adm.  Realized same day after adm the vial lot number  was not in the registry and reviewed the time  vaccine was received to date  and noted the vaccine expired 1 day prior.   Notified state Vaccine program.  Also notified Pfizer of the incidence and was advised since within 2 days of expire time the vaccine would not have to be readministered.  An email was sent with the following info to verify that there is 2 additional days for expire time but the vaccine expire date has not had any extension time.   Total Time: 72 days = [10 weeks (70 days) labeled time described in the Prescribing Information plus 2 days excursion time)] ? No additional excursion time is allowable for vials reduced to 1 week of storage at 2°C to 8°C (35ºF to 46ºF) due to excursions at -50°C to -15°C (-58°F to 5ºF). The vials do not have printed expire dates and when the shipment is received the staff have to determine the expire date and then COVID vaccines are constantly having extended  expire dates, making it very confusing for staff to monitor.    No treatment was needed, no injury occured and all staff have met and will place visible expire labels on each box upon receiving and monitor expire dates daily to prevent further occurrences.
Age: 90.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Adm. vaccine that expired on 11-16-22 on 11-17-2022 not knowing the vial had expired at time of adm.  Realized same day after adm the vial lot number  was not in the registry and reviewed the time  vaccine was received to date  and noted the vaccine expired 1 day prior.  Notified Vaccine program Administrators.  Also notified Pfizer of the incidence and was advised since within 2 days of expire time the vaccine would not have to be readministerd.  An email was sent from Pfizer with the following info to verify that there is 2 additional days for expire time but the vaccine over all expire date has not had any extension time.   Total Time: 72 days = [10 weeks (70 days) labeled time described in the Prescribing Information plus 2 days excursion time)] ? No additional excursion time is allowable for vials reduced to 1 week of storage at 2°C to 8°C (35ºF to 46ºF) due to excursions at -50°C to -15°C (-58°F to 5ºF). The vials do not have printed expire dates and when the shipment is received the staff have to determine the expire date and then COVID vaccines are constantly having extended  expire dates, making it very confusing for staff to monitor.    No treatment was needed, no injury occured  to the vaccine receipent (patient) and all staff have met and will place visible expire labels on each box upon recieving and monitor expire dates daily to prevent further occurances.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests normal, Anxiety, Blood immunoglobulin A increased, Blood immunoglobulin G decreased, Blood immunoglobulin M decreased
Clinical narrative: Within 8 minutes if getting the vaccine, I had immense pressure in my head and ear, a floating sensation, legs felt like rubber, severe pressure headache with waves of cool and warm sensations throughout my body. I turned extremely pale. My blood pressure was slightly higher than usual. They gave me BENADRYL. The intensity lasted for 2 hours. The next day it started back and never ended. I got vertigo and brain fog on top of everything. Now my immunoglobins are off. My IGG and IGM are low. My IGA is elevated. My kappa Lambda ratios are abnormal. I am high in lambda and have a protein 2M spike of .2 and a protein M1 spike of .1. I have severe panic attacks with depression and anxiety. I have headaches every day. The tingling in my extremities continues in the top and bottom area. I was given steroids with seem to do the best. I was also placed on FLONASE and that has helped with the headache. I am seeing a psychologist for the depression and anxiety. I have declined some treatment because I feel like they are just grasping. Medications that I took prior to the vaccine are not causing anaphylaxis. I ended up in the ER from taking azithromycin which I have taken many times before. I have been following the directions of the COVID-19 clinic. I have had 2 gynecological viral infections that I never had prior to so I know it's doing something to my immune system.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood test abnormal, Bone scan normal, Computerised tomogram head abnormal, Depression
Clinical narrative: Within 8 minutes if getting the vaccine, I had immense pressure in my head and ear, a floating sensation, legs felt like rubber, severe pressure headache with waves of cool and warm sensations throughout my body. I turned extremely pale. My blood pressure was slightly higher than usual. They gave me BENADRYL. The intensity lasted for 2 hours. The next day it started back and never ended. I got vertigo and brain fog on top of everything. Now my immunoglobins are off. My IGG and IGM are low. My IGA is elevated. My kappa Lambda ratios are abnormal. I am high in lambda and have a protein 2M spike of .2 and a protein M1 spike of .1. I have severe panic attacks with depression and anxiety. I have headaches every day. The tingling in my extremities continues in the top and bottom area. I was given steroids with seem to do the best. I was also placed on FLONASE and that has helped with the headache. I am seeing a psychologist for the depression and anxiety. I have declined some treatment because I feel like they are just grasping. Medications that I took prior to the vaccine are not causing anaphylaxis. I ended up in the ER from taking azithromycin which I have taken many times before. I have been following the directions of the COVID-19 clinic. I have had 2 gynecological viral infections that I never had prior to so I know it's doing something to my immune system.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Feeling abnormal, Feeling cold, Feeling hot, Genital infection viral
Clinical narrative: Within 8 minutes if getting the vaccine, I had immense pressure in my head and ear, a floating sensation, legs felt like rubber, severe pressure headache with waves of cool and warm sensations throughout my body. I turned extremely pale. My blood pressure was slightly higher than usual. They gave me BENADRYL. The intensity lasted for 2 hours. The next day it started back and never ended. I got vertigo and brain fog on top of everything. Now my immunoglobins are off. My IGG and IGM are low. My IGA is elevated. My kappa Lambda ratios are abnormal. I am high in lambda and have a protein 2M spike of .2 and a protein M1 spike of .1. I have severe panic attacks with depression and anxiety. I have headaches every day. The tingling in my extremities continues in the top and bottom area. I was given steroids with seem to do the best. I was also placed on FLONASE and that has helped with the headache. I am seeing a psychologist for the depression and anxiety. I have declined some treatment because I feel like they are just grasping. Medications that I took prior to the vaccine are not causing anaphylaxis. I ended up in the ER from taking azithromycin which I have taken many times before. I have been following the directions of the COVID-19 clinic. I have had 2 gynecological viral infections that I never had prior to so I know it's doing something to my immune system.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Immediate post-injection reaction, Immunoglobulins abnormal, Laboratory test abnormal
Clinical narrative: Within 8 minutes if getting the vaccine, I had immense pressure in my head and ear, a floating sensation, legs felt like rubber, severe pressure headache with waves of cool and warm sensations throughout my body. I turned extremely pale. My blood pressure was slightly higher than usual. They gave me BENADRYL. The intensity lasted for 2 hours. The next day it started back and never ended. I got vertigo and brain fog on top of everything. Now my immunoglobins are off. My IGG and IGM are low. My IGA is elevated. My kappa Lambda ratios are abnormal. I am high in lambda and have a protein 2M spike of .2 and a protein M1 spike of .1. I have severe panic attacks with depression and anxiety. I have headaches every day. The tingling in my extremities continues in the top and bottom area. I was given steroids with seem to do the best. I was also placed on FLONASE and that has helped with the headache. I am seeing a psychologist for the depression and anxiety. I have declined some treatment because I feel like they are just grasping. Medications that I took prior to the vaccine are not causing anaphylaxis. I ended up in the ER from taking azithromycin which I have taken many times before. I have been following the directions of the COVID-19 clinic. I have had 2 gynecological viral infections that I never had prior to so I know it's doing something to my immune system.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Light chain analysis abnormal, Magnetic resonance imaging head normal, Muscular weakness, Pallor, Panic attack
Clinical narrative: Within 8 minutes if getting the vaccine, I had immense pressure in my head and ear, a floating sensation, legs felt like rubber, severe pressure headache with waves of cool and warm sensations throughout my body. I turned extremely pale. My blood pressure was slightly higher than usual. They gave me BENADRYL. The intensity lasted for 2 hours. The next day it started back and never ended. I got vertigo and brain fog on top of everything. Now my immunoglobins are off. My IGG and IGM are low. My IGA is elevated. My kappa Lambda ratios are abnormal. I am high in lambda and have a protein 2M spike of .2 and a protein M1 spike of .1. I have severe panic attacks with depression and anxiety. I have headaches every day. The tingling in my extremities continues in the top and bottom area. I was given steroids with seem to do the best. I was also placed on FLONASE and that has helped with the headache. I am seeing a psychologist for the depression and anxiety. I have declined some treatment because I feel like they are just grasping. Medications that I took prior to the vaccine are not causing anaphylaxis. I ended up in the ER from taking azithromycin which I have taken many times before. I have been following the directions of the COVID-19 clinic. I have had 2 gynecological viral infections that I never had prior to so I know it's doing something to my immune system.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paranasal sinus inflammation, Vertigo
Clinical narrative: Within 8 minutes if getting the vaccine, I had immense pressure in my head and ear, a floating sensation, legs felt like rubber, severe pressure headache with waves of cool and warm sensations throughout my body. I turned extremely pale. My blood pressure was slightly higher than usual. They gave me BENADRYL. The intensity lasted for 2 hours. The next day it started back and never ended. I got vertigo and brain fog on top of everything. Now my immunoglobins are off. My IGG and IGM are low. My IGA is elevated. My kappa Lambda ratios are abnormal. I am high in lambda and have a protein 2M spike of .2 and a protein M1 spike of .1. I have severe panic attacks with depression and anxiety. I have headaches every day. The tingling in my extremities continues in the top and bottom area. I was given steroids with seem to do the best. I was also placed on FLONASE and that has helped with the headache. I am seeing a psychologist for the depression and anxiety. I have declined some treatment because I feel like they are just grasping. Medications that I took prior to the vaccine are not causing anaphylaxis. I ended up in the ER from taking azithromycin which I have taken many times before. I have been following the directions of the COVID-19 clinic. I have had 2 gynecological viral infections that I never had prior to so I know it's doing something to my immune system.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case  dose 1 Moderna 2/12/21 015M20A dose 2 Moderna 3/12/21 010A21A
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Adm. vaccine that expired on 11-16-22 on 11-17-2022 not knowing the vial had expired at time of adm.  Realized same day after adm the vial lot number  was not in the registry and reviewed the time  vaccine was received to date  and noted the vaccine expired 1 day prior.   Notified state Vaccine program.  Also notified Pfizer of the incidence and was advised since within 2 days of expire time the vaccine would not have to be readministered.  An email was sent with the following info to verify that there is 2 additional days for expire time but the vaccine expire date has not had any extension time.   Total Time: 72 days = [10 weeks (70 days) labeled time described in the Prescribing Information plus 2 days excursion time)] ? No additional excursion time is allowable for vials reduced to 1 week of storage at 2°C to 8°C (35ºF to 46ºF) due to excursions at -50°C to -15°C (-58°F to 5ºF). The vials do not have printed expire dates and when the shipment is received the staff have to determine the expire date and then COVID vaccines are constantly having extended  expire dates, making it very confusing for staff to monitor.    No treatment was needed, no injury occured and all staff have met and will place visible expire labels on each box upon receiving and monitor expire dates daily to prevent further occurrences.
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Adm. vaccine that expired on 11-16-22 on 11-17-2022 not knowing the vial had expired at time of adm.  Realized same day after adm the vial lot number  was not in the registry and reviewed the time  vaccine was received to date  and noted the vaccine expired 1 day prior.   Notified Vaccine program.  Also notified Pfizer of the incidence and was advised since within 2 days of expire time the vaccine would not have to be readministerd.  An email was sent from Pfizer with the following info to verify that there is 2 additional days for expire time but the vaccine over all expire date has not had any extension time.   Total Time: 72 days = [10 weeks (70 days) labeled time described in the Prescribing Information plus 2 days excursion time)] ? No additional excursion time is allowable for vials reduced to 1 week of storage at 2°C to 8°C (35ºF to 46ºF) due to excursions at -50°C to -15°C (-58°F to 5ºF). The vials do not have printed expire dates and when the shipment is received the staff have to determine the expire date and then COVID vaccines are constantly having extended  expire dates, making it very confusing for staff to monitor.    No treatment was needed, no injury occured  to the vaccine receipent (patient) and all staff have met and will place visible expire labels on each box upon recieving and monitor expire dates daily to prevent further occurances.
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Adm. vaccine that expired on 11-16-22 on 11-17-2022 not knowing the vial had expired at time of adm.  Realized same day after adm the vial lot number  was not in the registry and reviewed the time  vaccine was received to date  and noted the vaccine expired 1 day prior.   Notified Vaccine program.  Also notified Pfizer of the incidence and was advised since within 2 days of expire time the vaccine would not have to be readministered.  An email was sent with the following info to verify that there is 2 additional days for expire time but the vaccine expire date has not had any extension time.   Total Time: 72 days = [10 weeks (70 days) labeled time described in the Prescribing Information plus 2 days excursion time)] ? No additional excursion time is allowable for vials reduced to 1 week of storage at 2°C to 8°C (35ºF to 46ºF) due to excursions at -50°C to -15°C (-58°F to 5ºF). The vials do not have printed expire dates and when the shipment is received the staff have to determine the expire date and then COVID vaccines are constantly having extended  expire dates, making it very confusing for staff to monitor.    No treatment was needed, no injury occured and all staff have met and will place visible expire labels on each box upon receiving and monitor expire dates daily to prevent further occurrences.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Adm. vaccine that expired on 11-16-22 on 11-17-2022 not knowing the vial had expired at time of adm.  Realized same day after adm the vial lot number  was not in the registry and reviewed the time  vaccine was received to date  and noted the vaccine expired 1 day prior.   Notified Vaccine program.  Also notified Pfizer of the incidence and was advised since within 2 days of expire time the vaccine would not have to be readministered.  An email was sent with the following info to verify that there is 2 additional days for expire time but the vaccine expire date has not had any extension time.   Total Time: 72 days = [10 weeks (70 days) labeled time described in the Prescribing Information plus 2 days excursion time)] ? No additional excursion time is allowable for vials reduced to 1 week of storage at 2°C to 8°C (35ºF to 46ºF) due to excursions at -50°C to -15°C (-58°F to 5ºF). The vials do not have printed expire dates and when the shipment is received the staff have to determine the expire date and then COVID vaccines are constantly having extended  expire dates, making it very confusing for staff to monitor.    No treatment was needed, no injury occured and all staff have met and will place visible expire labels on each box upon receiving and monitor expire dates daily to prevent further occurrences.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, COVID-19, Cough, Malaise, Oropharyngeal pain
Clinical narrative: I contracted COVID-19. I had a slightly elevated temperature above 98. I had a sore throat, dry cough, and general malaise. I received PAXLOVID from my doctor.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I contracted COVID-19. I had a slightly elevated temperature above 98. I had a sore throat, dry cough, and general malaise. I received PAXLOVID from my doctor.