chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Impaired work ability, Nasal congestion
Clinical narrative: Starting 07/06/2022, I felt fatigued. Either that day or the next day, I felt a stuffy nose and a runny nose (one nostril being runny and one nostril being stuffy). Also, when I drank a glass of orange juice, it hurt my throat as if I was "drinking glass" so I knew something was wrong. I had coughing at night starting that Thursday or Friday (07/07 or 07/08). On 07/08/2022 I did a telehealth visit for a regular visit and I wanted to wait until 5 days post travel (I had returned from overseas) to test myself for COVID-19. After the visit, I did an at-home COVID-19 test the same day (because it was 5 days since I returned home) which was positive. So, I called my doctor back and they wanted confirmation that I was positive. So, I went to urgent care and got a PCR test done. It came back positive on the following Sunday (07/10/2022). I notified my employers on 07/08/2022 and the department of health called me to confirm I was isolating and advised me when to return to work. My symptoms had subsided by Monday (07/11/2022). I went back to one job on 07/12/2022 and then the school job on 07/14/2022 (because I had to wait until I tested negative).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Starting 07/06/2022, I felt fatigued. Either that day or the next day, I felt a stuffy nose and a runny nose (one nostril being runny and one nostril being stuffy). Also, when I drank a glass of orange juice, it hurt my throat as if I was "drinking glass" so I knew something was wrong. I had coughing at night starting that Thursday or Friday (07/07 or 07/08). On 07/08/2022 I did a telehealth visit for a regular visit and I wanted to wait until 5 days post travel (I had returned from overseas) to test myself for COVID-19. After the visit, I did an at-home COVID-19 test the same day (because it was 5 days since I returned home) which was positive. So, I called my doctor back and they wanted confirmation that I was positive. So, I went to urgent care and got a PCR test done. It came back positive on the following Sunday (07/10/2022). I notified my employers on 07/08/2022 and the department of health called me to confirm I was isolating and advised me when to return to work. My symptoms had subsided by Monday (07/11/2022). I went back to one job on 07/12/2022 and then the school job on 07/14/2022 (because I had to wait until I tested negative).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, 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. 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 local dept of health on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Confirmed Breakthrough Case   COVID-19 (Moderna) 1 80 Years 4 Months 04/14/2022 Pharmacy   Moderna   001M21A
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, 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 local Dept. of Public Health and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Local Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case COVID-19 after fully vaccinated with 2 doses Pfizer.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough Case  COVID-19 (Pfizer) 1 74 Years 10 Months 03/02/2021 local Pharmacy  Pfizer EN6202   COVID-19 (Pfizer) 2 74 Years 11 Months 03/23/2021 local Pharmacy  Pfizer EN6204   COVID-19 (Pfizer) 3 75 Years 6 Months 10/05/2021 local Pharmacy  Pfizer FF2588
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Breakthrough case of COVID-19 after fully vaccinated with mRNA vaccine.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, 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. 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. Healthcare is working with the DPHE on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 89.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Patient was hospitalized with COVID-19
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccines given paste beyond use date. no reactions reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Confirmed Breakthrough Case  COVID-19 (Pfizer) 1 66 Years 11 Months 02/12/2021 local County Health Department Pfizer EL9265   COVID-19 (Pfizer) 2 67 Years 03/05/2021 local County Health Department Pfizer EM9810   COVID-19 (Pfizer) 3 67 Years 8 Months 10/25/2021 local County Health Department Pfizer EW0162
Age: 67.0
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. 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. Healthcare is working with the DPHE on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Arthralgia, Asthenia, Dizziness, Gait disturbance
Clinical narrative: Mild Fever, Weakness, Headache, Dizziness, Muscle aches and pains, Upset stomach, Swollen glands, Hip, leg  and neck pain, trouble walking due to weak muscles and pain.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Lymphadenopathy, Muscular weakness, Myalgia, Neck pain
Clinical narrative: Mild Fever, Weakness, Headache, Dizziness, Muscle aches and pains, Upset stomach, Swollen glands, Hip, leg  and neck pain, trouble walking due to weak muscles and pain.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Mild Fever, Weakness, Headache, Dizziness, Muscle aches and pains, Upset stomach, Swollen glands, Hip, leg  and neck pain, trouble walking due to weak muscles and pain.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough Case     COVID-19 (Pfizer) 1 66 Years 11 Months 03/15/2021  Pfizer EP7534   COVID-19 (Pfizer) 2 67 Years 04/05/2021  Pfizer EW0153
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, 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 local Dept. of Health and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Local Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given after Beyond use date. No reactions were reported.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, 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. 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 local dept. of health on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given after beyond use date.  No reactions were reported
Age: 47.0
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 the local Dept. of Public Health and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Local Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given past the beyond use date. no reactions were reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough Case    COVID-19 (Moderna) 1 73 Years 3 Months 01/30/2021 Moderna 007M20A   COVID-19 (Moderna) 2 73 Years 4 Months 02/28/2021 Moderna 031L20A   COVID-19 (Moderna) 3 74 Years 11/01/2021 Moderna 014F21A
Age: 8.0
Sex: F
Vaccine: PNC15
Symptoms: Product administered to patient of inappropriate age, Product administration error, Wrong product administered
Clinical narrative: patient was administered vaxneuvance instead of fluarix in error. reported error to family and pediatrician office. vaccine is indicated for pediatric use but was not requested in this situation. monitoring for potential adverse reactions
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, 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 local Dept. of Public Health and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Local Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chronic inflammatory demyelinating polyradiculoneuropathy, Condition aggravated, Fall, Neurological examination
Clinical narrative: As with prior two doses, this booster dose caused a flare up of symptoms consistent with CIDP exacerbation. This booster dose caused exacerbation of my neuropathy symptoms, balance issues/recurrence of falling, and new occurrence of tremors. The tremors and sensory exacerbations have not fully resolved. After further discussion with my neurologist, it has been concluded that this booster dose likely caused a significant flare up/relapse of my chronic condition resulting in unresolved damage from an episode of demyelination exacerbation.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Tremor
Clinical narrative: As with prior two doses, this booster dose caused a flare up of symptoms consistent with CIDP exacerbation. This booster dose caused exacerbation of my neuropathy symptoms, balance issues/recurrence of falling, and new occurrence of tremors. The tremors and sensory exacerbations have not fully resolved. After further discussion with my neurologist, it has been concluded that this booster dose likely caused a significant flare up/relapse of my chronic condition resulting in unresolved damage from an episode of demyelination exacerbation.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, 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. 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. Healthcare is working with the DPHE on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given past the beyond use date. No reactions were reported.
Age: 12.0
Sex: F
Vaccine: PNC15
Symptoms: Product administered to patient of inappropriate age, Product administration error, Wrong product administered
Clinical narrative: patient was administered vaxneuvance instead of fluarix in error. reported error to family and pediatrician office. vaccine is indicated for pediatric use but was not requested in this situation. monitoring for potential adverse reactions
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, 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. 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 local dept. of health on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given past beyond use date.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Product administration error, Wrong product administered
Clinical narrative: HPV vaccination given in error as parent did not want child to receive.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Breakthrough case of COVID-19 after fully vaccinated with  mRNA vaccine.
Age: 1.08
Sex: M
Vaccine: COVID19
Symptoms: Clumsiness, Coordination abnormal, Gait disturbance, Pyrexia
Clinical narrative: Within 24 hours of receiving his 2nd Covid vaccine dose (Pfizer), our son developed a fever of 102.5. He also displayed some loss of coordination - tripping, and noticeably more unsteady on his feet than he was prior to the vaccine.
Age: 91.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, 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 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. Healthcare is working with the agency on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given after the beyond use date. No reactions were reported.
Age: 69.0
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 the local Dept. of Public Health and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Local Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Confirmed Breakthrough - Mixed Vaccine Manufacturers   COVID-19 (Moderna) 1 71 Years 4 Months 03/04/2021 Hospital Moderna 015M20A   COVID-19 (Moderna) 2 71 Years 4 Months 04/01/2021 Hospital Moderna 002B21A   COVID-19 (Pfizer) 3 72 Years 11/20/2021 Pharmacy Pfizer FF2590
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccine breakthrough infection
Clinical narrative: Breakthrough case COVID-19 after fully vaccinated 3 doses
Age: 43.0
Sex: M
Vaccine: 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. Clinic consulted with the Dept of Public Health 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 on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Pain in extremity
Clinical narrative: Vaccine was placed at 1101. At 1117 when parents was getting up to leave after 15 minute wait period, child started expressing that her arm hurt and started crying. Gave mother an ice pack to apply to site. After about 5 minutes, the mother took the child outside. Child was playing, running around outside with no crying. After a couple minutes, mother brought child back inside due to crying and stating arm hurt again. Child was reassess for site placement and localized reactions. No abnormal findings found. Mother was educated on giving an anti inflammatory to help with pain and to contact the child's pediatrician if in the next hour or so child is still complaining of soreness.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Starting in afternoon after morning vaccine, SOB w use of inhaler to help give relief, pain, redness, swelling, itching at injection site w redness the size of baseball.  Injection site symptoms lasted 1 week, SOB decreased in severity over one week. Client took Benadryl daily, also received one "steroid shot" at PCP office that first week (date unknown).  Symptoms decreased over time the week after vaccination.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Breakthrough case COVID-19 after fully vaccinated with two mRNA vaccines.
Age: 56.0
Sex: F
Vaccine: 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. Medical 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. Medical facility is working with the regulatory authority on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given after beyond use date. no reactions were reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pain, Pyrexia, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough COVID infection. Generalized body aches and fever with unsure onset. Tested positive 08/04/2022.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Cystitis, Malaise, Pneumonia, SARS-CoV-2 test negative
Clinical narrative: On June 12, 2022, I got really sick and had a bladder infection. Two days later, I went to the ER because I thought I was having a heart attack and they diagnosed me with pneumonia. They said that they thought it looked like COVID pneumonia and I've never had pneumonia before. They tested me for COVID-19, and I was negative. My blood oxygen level was also at 90 and they advised that if it got any lower to come back. The bottom of my left lung is missing due to a surgery that I had many years ago, so I believe that I may have been affected more harshly than others may have been. I've been monitored closely by my doctor since these events. As of 08/10/2022, I am still on an antibiotic. I have been prescribed multiple antibiotics over this span of time since none have been able to get rid of the white blood cells that were discovered on a uranalysis that cannot be explained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis abnormal, White blood cells urine positive
Clinical narrative: On June 12, 2022, I got really sick and had a bladder infection. Two days later, I went to the ER because I thought I was having a heart attack and they diagnosed me with pneumonia. They said that they thought it looked like COVID pneumonia and I've never had pneumonia before. They tested me for COVID-19, and I was negative. My blood oxygen level was also at 90 and they advised that if it got any lower to come back. The bottom of my left lung is missing due to a surgery that I had many years ago, so I believe that I may have been affected more harshly than others may have been. I've been monitored closely by my doctor since these events. As of 08/10/2022, I am still on an antibiotic. I have been prescribed multiple antibiotics over this span of time since none have been able to get rid of the white blood cells that were discovered on a uranalysis that cannot be explained.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Confirmed Breakthrough  COVID-19 (Moderna) 1 57 Years 9 Months 03/18/2021 Health Centers Moderna 038K20A   COVID-19 (Moderna) 2 57 Years 10 Months 04/16/2021 Health Centers Moderna 037B21A   COVID-19 (Moderna) 3 58 Years 6 Months 12/03/2021 Health Centers Moderna 065F21A
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Confirmed Breakthrough  COVID-19 (Moderna) 1 57 Years 9 Months 03/18/2021 Health Centers Moderna 038K20A   COVID-19 (Moderna) 2 57 Years 10 Months 04/16/2021 Health Centers Moderna 037B21A   COVID-19 (Moderna) 3 58 Years 6 Months 12/03/2021 Health Centers Moderna 065F21A
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: Patient was to receive Varicalla vaccine on 7/21/22. After the vaccine was administered, the administering nurse realized that the administered vaccine had been expired. The Lot Number for this expired vaccine is unavailable in the patient's chart, but the NDC is : 006-4827-01.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given after the beyond use date. No reactions were reported
Age: 63.0
Sex: U
Vaccine: 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. Consulted with the local Dept. of Public Health and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Local Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Lethargy, Pruritus, Pyrexia, Rash
Clinical narrative: After 7/23/22 COVID vaccine second dose, patient developed fever on 7/24/22 and 7/25/22 with T max 100.1 along with lethargy and loss of appetites. Fever was resolved with as needed acetaminophen and ibuprofen. 7/26 patient back to normal baseline. Rash was noted in afternoon on 7/27/22 located on cheeks, trunk both front and back, bilateral hands/palms, bilateral arms and feet. Rash was not itchy on 7/27/22, noted to be flat, without blister. Rash worsened on 7/28/22 - spread more, more prominent and raised, also itchiness started. Treatment of Zyrtec daily and as needed diphenhydramine started on 7/27/22 and ended on 7/30/22 with resolution of all rash and related symptoms.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Roseola
Clinical narrative: After 7/23/22 COVID vaccine second dose, patient developed fever on 7/24/22 and 7/25/22 with T max 100.1 along with lethargy and loss of appetites. Fever was resolved with as needed acetaminophen and ibuprofen. 7/26 patient back to normal baseline. Rash was noted in afternoon on 7/27/22 located on cheeks, trunk both front and back, bilateral hands/palms, bilateral arms and feet. Rash was not itchy on 7/27/22, noted to be flat, without blister. Rash worsened on 7/28/22 - spread more, more prominent and raised, also itchiness started. Treatment of Zyrtec daily and as needed diphenhydramine started on 7/27/22 and ended on 7/30/22 with resolution of all rash and related symptoms.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient hospitalized with COVID while vaccinated.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given past the beyond use date. no reactions were reported
Age: 38.0
Sex: U
Vaccine: 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. 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. Healthcare is working with the DPHE on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccine breakthrough infection
Clinical narrative: Breakthrough case COVID-19 after fully vaccinated 3 doses
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given after the beyond use date. No reactions were reported
Age: 88.0
Sex: F
Vaccine: 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. 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. Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 66.0
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. 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. Healthcare is working with the DPHE on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, SARS-CoV-2 test, Secretion discharge, Sneezing
Clinical narrative: coughing, sneezing, headache, mucus.  took Paxlovid, lasted around 5 days. Still a little coughing.
Age: 79.0
Sex: F
Vaccine: 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. 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. Healthcare is working with the DPHE on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient hospitalized with COVID while vaccinated.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given after the beyond use date. no reactions were reported.
Age: 34.0
Sex: M
Vaccine: 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. 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 local health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given after the beyond use date. no reactions were reported.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient hospitalized COVID while vaccinated
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test negative, Sinus disorder, Sneezing
Clinical narrative: I think it was around 06/15/2022 that I started out with what I thought was allergy symptoms, like runny nose and sneezing. But it just continued until around 06/18/2022. I took at home COVID-19 tests, but they were negative. I just kept feeling worse, so I went to the local urgent care clinic. They thought that it was a sinus condition, so they gave me a prescription and advised that if I was no better after 4 days to have a second prescription filled. I did end up having to fill the second prescription and still did not feel better. I went back to the urgent care clinic, and they informed me that I had to be on the second prescription for at least 7 days before they would prescribe anything else. They did a second COVID-19 test and it was still negative. After the 7 days, I had begun to feel better, so there was no need for another prescription.
Age: 51.0
Sex: M
Vaccine: 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. 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. Healthcare is working with the public health on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 93.0
Sex: F
Vaccine: 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. Clinic consulted with the Dept of Public Health 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 on a compliance improvement plan and has been reinstated vaccination privileges.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse reaction.  Pt was 4yrs 10months and thought she could get the 5-11 yr dose
Age: 59.0
Sex: M
Vaccine: 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. 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. Healthcare is working with the DPHE on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Dyspnoea, Headache, Oropharyngeal pain
Clinical narrative: It started with was a strange headache for a few days. Then, It felt like I had a slight fever. I had a cough, shortness of breath, sore throat, and joint achiness. I still have the headache and joint aches, but everything else is good. My doctor prescribed PAXLOVID to take if I needed it, but I didn't take it. I was fine without any medication.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: It started with was a strange headache for a few days. Then, It felt like I had a slight fever. I had a cough, shortness of breath, sore throat, and joint achiness. I still have the headache and joint aches, but everything else is good. My doctor prescribed PAXLOVID to take if I needed it, but I didn't take it. I was fine without any medication.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Administration Error: 3 year old female patient receives the first dose of pediatric vaccine from the orange cap presentation authorized for patients aged 5-11 years.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient hospitalized with COVID while vaccinated.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine were drawn up on August 4 and instead of "wasting" the remaining doses CMA placed the vial back in the refrigerator to be utilized the next day.  This does not follow our clinic policies or protocol. The next day, August 5, 2022 -  another CMA went to give a Peds COVID vaccine and utilized the remaining vial from the previous day's doses.  Another nurse later that morning went to give another Covid vaccine and identified that the previous day's supply had been placed back in the refrigerator. Our clinical pharmacist was contacted. The pharmacist contacted the Pfizer Medical Information team and received the following information:  Within the supported 24 hours post-dilution at 2°C to 30°C (35ºF to 86ºF):  o Data supports up to 24 hours storage of diluted vaccine in vials at 2°C to 30°C (35ºF to 86ºF) (this includes 6 hours labeled time described in the Prescribing Information + additional 18 hours excursion time)  o Data supports up to 24 hours storage of diluted vaccine in syringes in the refrigerator (2°C to 8°C [35ºF to 46ºF])  o Data supports up to 6 hours storage of diluted vaccine in syringes at room temperature (8°C to 30°C [46ºF to 86ºF])  o Total cumulative time post-dilution cannot exceed 24 hours, regardless of container.   The error was reported to myself and our policies and procedures will again be reviewed regarding the vaccine storage.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Fall, Interchange of vaccine products
Clinical narrative: Pt with hypertension, hyperlipidemia, type 2 DM, CAD, and obesity, has had a cough and shortness of breath for the past 3 days. She fell and passed out. She has a left-sided pneumonia and requires oxygen and was found to be COVID-19 positive.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Loss of consciousness, Pneumonia, SARS-CoV-2 test positive
Clinical narrative: Pt with hypertension, hyperlipidemia, type 2 DM, CAD, and obesity, has had a cough and shortness of breath for the past 3 days. She fell and passed out. She has a left-sided pneumonia and requires oxygen and was found to be COVID-19 positive.
Age: 48.0
Sex: F
Vaccine: 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 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. Healthcare is working with the Dept of Public Health and Environment on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Asthenia, Blood creatinine increased, COVID-19, COVID-19 pneumonia
Clinical narrative: Presented to ED 7/2/2022 with increasing weakness, poor appetite, congestion.  Antibiotic therapy with IV zosyn, zithromax. Defer IV steroids as patient with no hypoxia. Admitted to Memorial hospital. Previously admitted to the hospital 6/22/2022. Febrile illness was noted without an infectious process identified. He was sent to rehab but has not been participating in rehab. He is increasingly weak and fatigued. Transferred to Hospice on 7/3/2022 and died there on 7/8/2022. Cause of death is listed as Pneumonia due to Covid-19. Submitter does not have access to full medical record. If further information is needed, please contact hospital and hospice records.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Death, Decreased appetite, Fatigue, Lung consolidation
Clinical narrative: Presented to ED 7/2/2022 with increasing weakness, poor appetite, congestion.  Antibiotic therapy with IV zosyn, zithromax. Defer IV steroids as patient with no hypoxia. Admitted to Memorial hospital. Previously admitted to the hospital 6/22/2022. Febrile illness was noted without an infectious process identified. He was sent to rehab but has not been participating in rehab. He is increasingly weak and fatigued. Transferred to Hospice on 7/3/2022 and died there on 7/8/2022. Cause of death is listed as Pneumonia due to Covid-19. Submitter does not have access to full medical record. If further information is needed, please contact hospital and hospice records.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive, Staphylococcus test positive, White blood cell count increased
Clinical narrative: Presented to ED 7/2/2022 with increasing weakness, poor appetite, congestion.  Antibiotic therapy with IV zosyn, zithromax. Defer IV steroids as patient with no hypoxia. Admitted to Memorial hospital. Previously admitted to the hospital 6/22/2022. Febrile illness was noted without an infectious process identified. He was sent to rehab but has not been participating in rehab. He is increasingly weak and fatigued. Transferred to Hospice on 7/3/2022 and died there on 7/8/2022. Cause of death is listed as Pneumonia due to Covid-19. Submitter does not have access to full medical record. If further information is needed, please contact hospital and hospice records.
Age: 70.0
Sex: M
Vaccine: 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. 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. Healthcare is working with the Dept of Public Health and Environment on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 62.0
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. Healthcare facility 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. Healthcare is working with the Dept of Public Health and Environment on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given after beyond use date. No reactions were reported
Age: 3.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient is 3 y/o male given Tdap injection instead of DTaP injection.  This should have been his 4th dose of DTaP
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Emotional distress, Gait disturbance, Pallor, Syncope
Clinical narrative: Pt recieved Tdap and Menveo vaccines during visit with Immunizations Clinic. Upon exiting the clininc Pt attempted to close the office door behind him and stumbled. Pt turned to face door and attempted to pull it closed again. He began to collapse while hanging onto the door handle, at which time staff supported Pt from falling to floor and moved him to exam table within treatment room. Staff memeber notified supervisor near by who alerted nursing staff and provider. Staff memeber stayed with Pt while awaiting provider arrival and monitored for further progression of altered behavior and for signs of allergic reaction. Pt very upset, weak, pale, and faint. Provider and nurse assessed Pt; released to care of parent.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Only one in series  - Breakthrough Case  COVID-19 (Moderna) 1 77 Years 9 Months 01/21/2021  Moderna 027L20A
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given after the beyond use date. no reactions were reported
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Extensive swelling of vaccinated limb, Herpes zoster
Clinical narrative: A little more than 3 weeks after the 4th dose I came down with shingles. No idea if there is any relation to the booster. I have not had the shingles vaccine.
Age: 68.0
Sex: F
Vaccine: 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  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. Healthcare is working with the Dept of Public Health and Environment on a compliance improvement plan and has been reinstated vaccination privileges.