chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Echocardiogram normal, Electrocardiogram abnormal, Influenza like illness, Laboratory test
Clinical narrative: I had my second vaccine in the series of 2 from Pfizer (mrna). I have tried to complete this form before and the website crashed, so I gave up. After returning home following receiving this vaccine, I began to have pretty severe flu like symptoms about 10 hours post shot. Then I immediately had  an irregular heart rhythm, significant heart palpitations. This continued for weeks and months. I had lab tests, EKGs, echocardiogram, etc on my heart and was given a cardiologist, and have been permanently on propranolol, a beta blocker, to try to calm down the irregular heart rhythm. It have  been on this medication since my second vaccine dose, for about  1 1/2 years and the heart symptoms have never completely improved. They continue. I got my first booster (short 3) in October 2021, and then had more significant heart palpitations. There is no family history of cardiac problems in my family and I had never before had any heart problems, ever. I am healthy, exercise regularly, do yoga, eat healthy, am not overweight, et cetera. I was very shocked to have this adverse reaction and that it has not gone away. I now have been told to not risk my heart my getting a second booster. I really want to get boosted, but I must protect my heart. I need recommendations from experts on what alternatives to the MRNA are there. I know that Novavax also carries potential for cardiac problems and that J and J carries risk of blood clots. I believe in science and vaccines.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Supraventricular extrasystoles
Clinical narrative: I had my second vaccine in the series of 2 from Pfizer (mrna). I have tried to complete this form before and the website crashed, so I gave up. After returning home following receiving this vaccine, I began to have pretty severe flu like symptoms about 10 hours post shot. Then I immediately had  an irregular heart rhythm, significant heart palpitations. This continued for weeks and months. I had lab tests, EKGs, echocardiogram, etc on my heart and was given a cardiologist, and have been permanently on propranolol, a beta blocker, to try to calm down the irregular heart rhythm. It have  been on this medication since my second vaccine dose, for about  1 1/2 years and the heart symptoms have never completely improved. They continue. I got my first booster (short 3) in October 2021, and then had more significant heart palpitations. There is no family history of cardiac problems in my family and I had never before had any heart problems, ever. I am healthy, exercise regularly, do yoga, eat healthy, am not overweight, et cetera. I was very shocked to have this adverse reaction and that it has not gone away. I now have been told to not risk my heart my getting a second booster. I really want to get boosted, but I must protect my heart. I need recommendations from experts on what alternatives to the MRNA are there. I know that Novavax also carries potential for cardiac problems and that J and J carries risk of blood clots. I believe in science and vaccines.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine stored beyond 30 days recommended in the refrigerated state. Event reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. It was recommended repeating this dose. Patient sent a letter to inform them of the need to repeat the dose. We are working on a compliance improvement plan. Reinstated vaccination privileges.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Deep vein thrombosis, Fibrin D dimer, Full blood count, Metabolic function test
Clinical narrative: Syncope, large common femoral deep venous thrombosis
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Troponin, Ultrasound Doppler abnormal
Clinical narrative: Syncope, large common femoral deep venous thrombosis
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Clinic consulted with the health department and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Clinic is working with the health department on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working with a compliance improvement plan and has been reinstated vaccination privileges.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The agency consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The agency is working with the public health dept on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 39.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Administration site cellulitis
Clinical narrative: Cellulitis RUE at site of administration
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working with a compliance improvement plan and has been reinstated vaccination privileges.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working with a compliance improvement plan and has been reinstated vaccination privileges.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The agency consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The agency is working with the public health dept on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The agency consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The agency is working with the public health dept on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Clinic consulted with the health department and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Clinic is working with the health department on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pain in extremity, Ultrasound Doppler abnormal
Clinical narrative: Deep Vein Thrombosis in right calf and right upper leg.  Pfizer booster was on 9-10-2021.  Pain in right calf started 9-13-2021.  Went to emergency room on 9-14-2021 with increasing pain in right calf.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working with a compliance improvement plan and has been reinstated vaccination privileges.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The agency consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The agency is working with the public health on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with the and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Clinic consulted with the health department and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Clinic is working with the health department on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The agency consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The agency is working with public health on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Oral herpes
Clinical narrative: Two huge fever blisters on lower left lip
Age: 6.0
Sex: M
Vaccine: UNK
Symptoms: Discomfort, Erythema, Induration, Loss of personal independence in daily activities, Pain
Clinical narrative: My son received the flu vaccine about 9:30 am on 9/1. A little less than 24 hours later on 9/2 at 7am my son complained of pain and warm to the touch arm. I saw lots of swelling, a hard bump, hot to the touch, redness in a large area of his arm. I gave Motrin. It appeared to help but wore off about 6 hours later and it got bigger and more uncomfortable. I picked him up early from school because teacher reported it getting worse.  As of today 9/4 there is still redness and warmth. It looks like it is improving but still hot to the touch.
Age: 6.0
Sex: M
Vaccine: UNK
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: My son received the flu vaccine about 9:30 am on 9/1. A little less than 24 hours later on 9/2 at 7am my son complained of pain and warm to the touch arm. I saw lots of swelling, a hard bump, hot to the touch, redness in a large area of his arm. I gave Motrin. It appeared to help but wore off about 6 hours later and it got bigger and more uncomfortable. I picked him up early from school because teacher reported it getting worse.  As of today 9/4 there is still redness and warmth. It looks like it is improving but still hot to the touch.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 61.0
Sex: M
Vaccine: UNK
Symptoms: Electromyogram, Laboratory test, Magnetic resonance imaging, Myasthenia gravis
Clinical narrative: New onset Myasthenia gravis
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Healthcare facility consulted with the regulatory authority and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare facility is working with the regulatory authority on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Healthcare facility consulted with the regulatory authority and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare facility is working with the regulatory authority on a compliance improvement plan and has been reinstated vaccination privileges.
Sex: U
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE for this patient.; patient received PROQUAD after a temperature excursion/Temperature 11.5F, Time frame 13 hours; This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant condition, drug reactions/allergies and concomitant medication were not reported.  On 19-AUG-2022, the patient was vaccinated with 1 dose improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status recombinant Human albumin (rHA)) (PROQUAD) (lot # u022729, expiration date: 16-JAN-2022; dose details, strength, route and anatomical location was not provided) for prophylaxis. The vaccines underwent temperature excursion of 11.5 degrees fahrenheit (F) for 13 hours (product storage error). There was no previous temperature excursion. No other adverse event (AE) was reported (no adverse event).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash
Clinical narrative: rash. worst at location site, but also all over body: legs vagina, stomach chest, cheeks, arms
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Night sweats, Pericarditis, Sleep disorder
Clinical narrative: Pericarditis.  Severe chest pains and sweating in the middle of the night.  Woke me up even though I am a very heavy sleeper.   Considered going to emergency room, but research on the internet said that the ER treatment would probably just be giving an anti-inflamatory medicine.  Therefore I a took the maximum dose of Ibuprofen for 24 hours.  Pain subsided within an hour or so and had almost totally gone in about a day and a half.  Sitting up probably helped too.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chest pain, Extra dose administered, Pain, Painful respiration
Clinical narrative: Mild pericarditis.  After having had very painful pericarditis about 10 hours after my first Moderna booster in November 2021 (see separate VAERS report just submitted Temporary Report 882509) which was successfully controlled with a maximum dose of Ibuprofen I took took 200 mg of Ibuprofen prophylactically about 6 hours after my second Moderna booster on April 15, 2022.  I had no adverse reactions to that second booster.   I did the same with this Moderna bivalent (i.e., 200 mg of Ibuprofen 6 hours after the vaccination).  I had no problems during the night by started having chest pains at about 11:30 (about 16 hours after the vaccination).  The pain was most severe when bending over and when breathing deeply.   Taking 200 mg of Ibuprofen made symptoms go away in a couple of hours.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Central nervous system lesion, Dizziness, Headache, Impaired work ability, Magnetic resonance imaging
Clinical narrative: Severe headache, light sensitivity, nausea., changes in the brain  some kind of lesions. Headaches were 24/7 for first 3-4 months.  I couldn?t work at all for almost 6 months. For few months I didn?t get daily 24/7 but I was still suffering with worst headaches when they came very often. Later in December 2021,, Jan 2022 they got more worse  daily.  In February, couldn?t work anymore.  It was like 20 out of scale 1-10. Used topamax initially but after few months headaches got worse so doctor changed to Quilipta . The same thing after sometime, it didn?t help so preventive med is switched to Ajovy now.  Used different triptans, nurtec for pain relief.  Headaches are getting worse day by day.  I fainted in the work place because of severe headache.  I felt  so dizzy sometimes during headaches but that got worse later.