chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: UNK, DTAPHEPBIP
Symptoms: Rash erythematous, Rash macular, Swelling face, Urticaria, Vomiting
Clinical narrative: My son started to throw around 3pm on 9/2/22. He vomiting ended  by the time we went to bed around 9p and woke up the next morning, 9/3/222 with diarrhea that lasted till 9/6. A rash started the morning of 9/4 on the outside of his thighs and buttox.  It was a blotchy red rash that looked like large patches of dry skin. We gave him benadryl for the rash 9/4-9/6/22. Monday when he woke up the rash moved to several areas of his body including his arms, torso, legs, hands and feet and then after his nap Monday afternoon his rash turned into hives, his face was very swollen & hands and feet and he had a fever 102.5. I callled his doctors office after hours and they highly suggested I take him to the ER. The Emergency Room I took him to ran a series of blood tests to rule things out. They gave him tylenol for his fever and sent us home around 10:30pm 9/5/2022. I tried to get him seen the next day, 9/6/2022 by his primary care physician or another provider in the office that administeredd the vaccine and they had no availailble opened appointments. They then set me up with a virtual appointment Telemedicine with another doctor at 3pm. Suggested I take patient back to the Emergency Room and ask for Steroids as his hives did not improve and kept coming back.  He fever adn hives returned once again so  At 7pm on 9/6/2022 Patient father took him to the Urgent Care and they gave him a dose of a steroid and called in a presciption for Prednisolone, 15MG/5ML SOLN. On the bottle it reads give 5 ML by mouth once daily for 4 days. After they came home from the Urgent Care I gave him more benadryl and around 2am, 9/7/2022 Patient woke me up asking me for a drink and he was covered in sweat. This is when I feel the fever finally left his body and when he woke up at 8am his skin was clear from all hives and the swelling on his face had dramatically reduced only leaving red marks under his eyes. The swelling from his hands and feet had gone down and he seemed like the child he was before I  brought  him in to get this vaccine.
Age: 3.0
Sex: M
Vaccine: UNK, DTAPHEPBIP
Symptoms: Diarrhoea, Lethargy, Pyrexia, Rash, Swelling face
Clinical narrative: My son started to throw around 3pm on 9/2/22. He vomiting ended  by the time we went to bed around 9p and woke up the next morning, 9/3/222 with diarrhea that lasted till 9/6. A rash started the morning of 9/4 on the outside of his thighs and buttox.  It was a blotchy red rash that looked like large patches of dry skin. We gave him benadryl for the rash 9/4-9/6/22. Monday when he woke up the rash moved to several areas of his body including his arms, torso, legs, hands and feet and then after his nap Monday afternoon his rash turned into hives, his face was very swollen & hands and feet and he had a fever 102.5. I callled his doctors office after hours and they highly suggested I take him to the ER. The Emergency Room I took him to ran a series of blood tests to rule things out. They gave him tylenol for his fever and sent us home around 10:30pm 9/5/2022. I tried to get him seen the next day, 9/6/2022 by his primary care physician or another provider in the office that administeredd the vaccine and they had no availailble opened appointments. They then set me up with a virtual appointment Telemedicine with another doctor at 3pm. Suggested I take patient back to the Emergency Room and ask for Steroids as his hives did not improve and kept coming back.  He fever adn hives returned once again so  At 7pm on 9/6/2022 Patient father took him to the Urgent Care and they gave him a dose of a steroid and called in a presciption for Prednisolone, 15MG/5ML SOLN. On the bottle it reads give 5 ML by mouth once daily for 4 days. After they came home from the Urgent Care I gave him more benadryl and around 2am, 9/7/2022 Patient woke me up asking me for a drink and he was covered in sweat. This is when I feel the fever finally left his body and when he woke up at 8am his skin was clear from all hives and the swelling on his face had dramatically reduced only leaving red marks under his eyes. The swelling from his hands and feet had gone down and he seemed like the child he was before I  brought  him in to get this vaccine.
Age: 3.0
Sex: M
Vaccine: UNK, DTAPHEPBIP
Symptoms: Urticaria, Vomiting
Clinical narrative: My son started to throw around 3pm on 9/2/22. He vomiting ended  by the time we went to bed around 9p and woke up the next morning, 9/3/222 with diarrhea that lasted till 9/6. A rash started the morning of 9/4 on the outside of his thighs and buttox.  It was a blotchy red rash that looked like large patches of dry skin. We gave him benadryl for the rash 9/4-9/6/22. Monday when he woke up the rash moved to several areas of his body including his arms, torso, legs, hands and feet and then after his nap Monday afternoon his rash turned into hives, his face was very swollen & hands and feet and he had a fever 102.5. I callled his doctors office after hours and they highly suggested I take him to the ER. The Emergency Room I took him to ran a series of blood tests to rule things out. They gave him tylenol for his fever and sent us home around 10:30pm 9/5/2022. I tried to get him seen the next day, 9/6/2022 by his primary care physician or another provider in the office that administeredd the vaccine and they had no availailble opened appointments. They then set me up with a virtual appointment Telemedicine with another doctor at 3pm. Suggested I take patient back to the Emergency Room and ask for Steroids as his hives did not improve and kept coming back.  He fever adn hives returned once again so  At 7pm on 9/6/2022 Patient father took him to the Urgent Care and they gave him a dose of a steroid and called in a presciption for Prednisolone, 15MG/5ML SOLN. On the bottle it reads give 5 ML by mouth once daily for 4 days. After they came home from the Urgent Care I gave him more benadryl and around 2am, 9/7/2022 Patient woke me up asking me for a drink and he was covered in sweat. This is when I feel the fever finally left his body and when he woke up at 8am his skin was clear from all hives and the swelling on his face had dramatically reduced only leaving red marks under his eyes. The swelling from his hands and feet had gone down and he seemed like the child he was before I  brought  him in to get this vaccine.
Age: 35.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site mass
Clinical narrative: It?s been over three weeks since my first injection and I still have a large lump and the injection site.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Malaise, Pain in extremity, Pyrexia
Clinical narrative: I tested positive for COVID-19 on 6/24/22. I had a bad fever and a sore arm after my shot and I was sick for about a week. I was very tired as well.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I tested positive for COVID-19 on 6/24/22. I had a bad fever and a sore arm after my shot and I was sick for about a week. I was very tired as well.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abnormal loss of weight, Blood test, Computerised tomogram thorax, Discomfort
Clinical narrative: Right ear pain, tinnitus, head pressure tremors, paresthesias , numbness on right side of body from toes to hands.Abdomial pain, waves of constriction and swelling across diaphragm. periods of shortness of breath, unintended wt loss periodic blurred vision PCP visits 2/23/21, 6/21/21 and others rec short steroid course, Neurology, MD rec steroids and Gabapentin MD ENT Ophthalmologist
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Ear pain, Head discomfort, Hypoaesthesia, Paraesthesia
Clinical narrative: Right ear pain, tinnitus, head pressure tremors, paresthesias , numbness on right side of body from toes to hands.Abdomial pain, waves of constriction and swelling across diaphragm. periods of shortness of breath, unintended wt loss periodic blurred vision PCP visits 2/23/21, 6/21/21 and others rec short steroid course, Neurology, MD rec steroids and Gabapentin MD ENT Ophthalmologist
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Tinnitus, Tremor, Ultrasound abdomen, Vision blurred
Clinical narrative: Right ear pain, tinnitus, head pressure tremors, paresthesias , numbness on right side of body from toes to hands.Abdomial pain, waves of constriction and swelling across diaphragm. periods of shortness of breath, unintended wt loss periodic blurred vision PCP visits 2/23/21, 6/21/21 and others rec short steroid course, Neurology, MD rec steroids and Gabapentin MD ENT Ophthalmologist
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Gave booster vaccine after 8/31/2022.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: MODERNA monovalent 2nd booster dose  given to the patient on Wednesday, 8/31/2022.
Age: 35.0
Sex: M
Vaccine: COVID19-2
Symptoms: Computerised tomogram abdomen abnormal, Full blood count, Lipase, Metabolic function test, Pancreatitis
Clinical narrative: Pancreatitis which was found on 9/4/22 with CT scan of abdomen; mild case - resolved with 24 h liquid diet with 72 hrs of soft diet
Age: 35.0
Sex: M
Vaccine: COVID19-2
Symptoms: Ultrasound abdomen, Urine analysis
Clinical narrative: Pancreatitis which was found on 9/4/22 with CT scan of abdomen; mild case - resolved with 24 h liquid diet with 72 hrs of soft diet
Age: 42.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Erythema, Pain
Clinical narrative: Red painful
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was administered 0.5mL instead of 0.25mL.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Moderna monovalent 2nd booster dose administered to the  patient on Wednesday, 8/31/2022.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Dyspnoea, Vomiting
Clinical narrative: 2nd hand, after pt had left vaccine site and returned to work they experienced trouble breathing. and ambulance was called. pt told them they had asthma and they did start breathing better but then began vomitting so they were transported to the hospital. current condition unknown
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received Bi Valent form instead of gray cap as fist dose. note Manufacture will be DC old form and Have 2nd short set as bivalent. Second dose given as Bivalent form by Nurse.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Facial paralysis
Clinical narrative: 4/9/2022 Developed Bells Palsy - right side facial paralysis the day after receiving the Pfizer booster 4/8/2022. Lasted for a little over a month.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: The patient received Moderna monovalent 2nd booster dose on Wednesday, 8/31/2022
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, C-reactive protein increased, Joint swelling
Clinical narrative: Pain and swelling in joints of feet,  hips and shoulders with a settling into hands as time went on.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine expiration date was identified to expire on June 22, 2021, but the manufacturer expiration date was February 25, 2021. Based on the information learned, County Health took the following steps: Covid-19 Response Unit Pharmacists contacted Moderna for guidance and based on Moderna data, the Moderna Medical Information team provided the following information: The vaccine administered on March 4, 2021 through March 10, 2021 from lot number 025J20-2A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. A county medical director was contacted and based on this information from Moderna, no re-vaccination is needed.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Incident details: Per Dr. email sent out on 9/1/22-"the monovalent mRNA COVID-19 vaccines are not authorized as booster doses for individuals 12 years of age and older. Any patients that are currently scheduled to receive a booster should wait until we have the bivalent booster on hand."- The patient was seen in office on 9/1/22 and received a booster dose of the monovalent mRNA COVID-19 vaccine (pfizer) in error as patients are now only supposed to receive the bivalent booster per Dr.  email. Pt was due for booster at the time they received it, however the bivalent booster was not yet stocked. Possible Cause: Possible cause of the incident is that an email was sent out regarding the discontinuation  of monovalent covid boosters receives the bivalent booster doses. This was overlooked by management and staff, as previous changes to clinic processes is usually discussed in a meeting. Also monovalent and bivalent are new terms that have not previously been used when discussing booster vaccines. Corrective Action: Corrective action included notifying staff and providers of the recent change regarding COVID vaccines and were notified to stop giving COVID booster doses until the Clinic receives the bivalent vaccines. Staff and providers were notified via email, skype, and verbally. Incident reported to VAERS.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine expiration date was identified to expire on June 22, 2021, but the manufacturer expiration date was February 25, 2021. Based on the information learned, County Health took the following steps: - Covid-19 Response Unit Pharmacists contacted Moderna for guidance and based on Moderna data, the Moderna     Medical Information team provided the following information:  - The vaccine administered on March 4, 2021 through March 10, 2021 from lot number 025J20-2A maintained the     activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. -  A county medical director was contacted and based on this information from Moderna, no re-vaccination is needed.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: The patient received monovalent 2nd booster dose on Wednesday, 8/31/2022.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Fatigue, Influenza like illness, Neuralgia, Pain in extremity
Clinical narrative: Electric shock through my whole body. I have had nerve pain in my arms and extreme fatigue since then. Every day I feel like I'm coming down with the flu.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Incident details: Per Drs. email sent out on 9/1/22-"the monovalent mRNA COVID-19 vaccines are not authorized as booster doses for individuals 12 years of age and older. Any patients that are currently scheduled to receive a booster should wait until we have the bivalent booster on hand". The patient was seen in office on 9/1/22 and received a booster dose of the monovalent mRNA COVID-19 vaccine (Pfizer) by RN in error as patients are now only supposed to receive the bivalent booster per Drs. email. Patient was due for booster at the time they received it, however the bivalent booster was not yet stocked. Possible Cause: Possible cause of the incident is that an email was sent out regarding the discontinuation of monovalent Covid boosters until Private receives the bivalent booster doses. This was overlooked by management and staff, as previous changes to clinic processes is usually discussed in a meeting. Also 'monovalent' and 'bivalent' are new terms that have not previously been used when discussing booster vaccines.  Corrective Action: Corrective action included notifying staff and providers of the recent change regarding COVID vaccines and were notified to stop giving COVID booster doses until the Clinic receives the bivalent vaccines. Staff and providers were notified via email, skype, and verbally. Incident reported to VAERS.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine expiration date was identified to expire on June 22, 2021, but the manufacturer expiration date was February 25, 2021. Based on the information learned, County Health took the following steps: Covid-19 Response Unit Pharmacists contacted Moderna for guidance and based on Moderna data, the Moderna Medical Information team provided the following information: The vaccine administered on March 4, 2021 through March 10, 2021 from lot number 025J20-2A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. A county medical director was contacted and based on this information from Moderna, no re-vaccination is needed.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Incident details: Per Dr. email sent out on 9/1/22-"the monovalent mRNA COVID-19 vaccines are not authorized as booster doses for individuals 12 years of age and older. Any patients that are currently scheduled to receive a booster should wait until we have the bivalent booster on hand." The patient was seen in office on 9/1/22 and received a booster dose of the monovalent mRNA COVID-19 vaccine (pfizer) in error as patients are now only supposed to receive the bivalent booster per Dr. email. Pt was due for booster at the time they received it, however the bivlalent booster was not yet stocked . Possible Cause: Possible cause of the incident is that an email was sent out regarding the discontinuation  of monovalent covid boosters receives the bivalent booster doses. This was overlooked by management and staff, as previous changes to clinic processes is usually discussed in a meeting. Also monovalent and bivalent are new terms that have not previously been used when discussing booster vaccines.  Corrective Action: Corrective action included notifying staff and providers of the recent change regarding COVID vaccines and were notified to stop giving COVID booster doses until the Clinic receives the bivalent vaccines. Staff and providers were notified via email, skype, and verbally. Incident reported to VAERS. Recommendation: I would recommend holding a meeting to notify Leads/Supervisors/Managers of any changes regarding COVID vaccine administration, rather than sending out an email that may not be read by all staff. If an email is needed to be sent, I recommend making it clear that a process is being changed.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine expiration date was identified to expire on June 22, 2021, but the manufacturer expiration date was February 25, 2021. Based on the information learned, County Health took the following steps: Covid-19 Response Unit Pharmacists contacted Moderna for guidance and based on Moderna data, the Moderna Medical Information team provided the following information: The vaccine administered on March 4, 2021 through March 10, 2021 from lot number 025J20-2A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration.  A county medical director was contacted and based on this information from Moderna, no re-vaccination is needed.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on upper left and right arms, shoulder, left and right ankles. Prednazone .  Hives slowly went away but areas itched.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine expiration date was identified to expire on June 22, 2021, but the manufacturer expiration date was February 25, 2021.  Based on the information learned, County took the following steps: ? Covid-19 Response Unit Pharmacists contacted Moderna for guidance and based on Moderna data, the Moderna Medical Information team provided the following information:  o ?The vaccine administered on March 4, 2021 through March 10, 2021 from lot number 025J20-2A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration.?  o A county medical director was contacted and based on this information from Moderna, no re-vaccination is needed.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Incident details: Per Dr's email sent out on 9/1/22-"the monovalent mRNA COVID-19 vaccines are not authorized as booster doses for individuals 12 years of age and older. Any patients that are currently scheduled to receive a booster should wait until we have the bivalent booster on hand." The patient was seen in office on 9/1/22 and received a booster dose of the monovalent mRNA COVID-19 vaccine (pfizer) by employee in error as patients are now only supposed to receive the bivalent booster per Dr's  email. Pt was due for booster at the time they received it, however the bivlalent booster was not yet stocked at office. Possible Cause: Possible cause of the incident is that an email was sent out regarding the discontinuation  of monovalent covid boosters until office receives the bivalent booster doses. This was overlooked by management and staff, as previous changes to clinic processes is usually discussed in a meeting. Also ?monovalent? and ?bivalent? are new terms that have not previously been used when discussing booster vaccines.  Corrective Action: Corrective action included notifying staff and providers of the recent change regarding COVID vaccines and were notified to stop giving COVID booster doses until the Clinic receives the bivalent vaccines. Staff and providers were notified via email, skype, and verbally. Incident reported to VAERS.
Age: 0.83
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine
Age: 67.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Extra dose administered, Tinnitus
Clinical narrative: approximately 70 minutes after my vaccine , I experienced sudden onset of ringing, (Tinnitu?s)  in my ears. This is the first time I have experienced this after a covid vaccine or booster.
Age: 67.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Immunisation, Off label use, Tinnitus
Clinical narrative: approximately 70 minutes after my vaccine , I experienced sudden onset of ringing, (Tinnitu?s)  in my ears. This is the first time I have experienced this after a covid vaccine or booster.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Incident details: Per Drs. (Medical Director) email sent out on 9/1/22-"the monovalent mRNA COVID-19 vaccines are not authorized as booster doses for individuals 12 years of age and older. Any patients that are currently scheduled to receive a booster should wait until we have the bivalent booster on hand". The patient was seen in office on 9/2/22 and received a booster dose of the monovalent mRNA COVID-19 vaccine (Pfizer) by RN in error as patients are now only supposed to receive the bivalent booster per Drs. email. Patient was due for booster at the time they received it, however the bivalent booster was not yet stocked.  Possible Cause: Possible cause of the incident is that an email was sent out regarding the discontinuation of monovalent Covid boosters until Private receives the bivalent booster doses. This was overlooked by management and staff, as previous changes to clinic processes is usually discussed in a meeting. Also 'monovalent' and 'bivalent' are new terms that have not previously been used when discussing booster vaccines.   Corrective Action: Corrective action included notifying staff and providers of the recent change regarding COVID vaccines and were notified to stop giving COVID booster doses until the Clinic receives the bivalent vaccines. Staff and providers were notified via email, skype, and verbally. Incident reported to VAERS.
Age: 1.58
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired vaccine.  No reaction
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, COVID-19, Decreased appetite, Fatigue, Mobility decreased
Clinical narrative: On 05/11/2022  around 05:00PM I started getting fever.   I tested positive for COVID-19. It was over 100 degree. My husband is a doctor so  he was COVID-19 positive.  The home Nurse came and gave my husband infusion at the same time they also signed me up for the infusion. I received it the same day.  On 05/12/2022 I was  extremely tired, no appetite and low energy. I felt like I wanted to just stay in bed. I drank a lot  of liquid.  For about a week or so I felt tired but I started  healing slowly.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: On 05/11/2022  around 05:00PM I started getting fever.   I tested positive for COVID-19. It was over 100 degree. My husband is a doctor so  he was COVID-19 positive.  The home Nurse came and gave my husband infusion at the same time they also signed me up for the infusion. I received it the same day.  On 05/12/2022 I was  extremely tired, no appetite and low energy. I felt like I wanted to just stay in bed. I drank a lot  of liquid.  For about a week or so I felt tired but I started  healing slowly.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Incident details: Per Drs. (Medical Director) email sent out on 9/1/22- 'the monovalent mRNA COVID-19 vaccines are not authorized as booster doses for individuals 12 years of age and older. Any patients that are currently scheduled to receive a booster should wait until we have the bivalent booster on hand'. The patient was seen in office on 9/2/22 and received a booster dose of the monovalent mRNA COVID-19 vaccine (Pfizer) in error as patients are now only supposed to receive the bivalent booster per Drs. email. Patient was due for booster at the time they received it, however the bivalent booster was not yet stocked.  Possible Cause: Possible cause of the incident is that an email was sent out regarding the discontinuation of monovalent Covid boosters until Private receives the bivalent booster doses. This was overlooked by management and staff, as previous changes to clinic processes is usually discussed in a meeting. Also 'monovalent' and 'bivalent' are new terms that have not previously been used when discussing booster vaccines.  Corrective Action: Corrective action included notifying staff and providers of the recent change regarding COVID vaccines and were notified to stop giving COVID booster doses until the Clinic receives the bivalent vaccines. Staff and providers were notified via email, skype, and verbally. Incident reported to VAERS.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Endolymphatic hydrops, Magnetic resonance imaging normal, Tinnitus
Clinical narrative: Low frequency hearing loss with tinnitus right ear; endolymphatic hydrops
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired vaccine/ no reaction
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired vaccine.  No adverse reactions
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Per the recommendations of our local health jurisdiction, we are reporting this as an adverse event as the booster was given after unauthorized  the use of  monovalent vaccines as booster doses for individuals 12 years of age and older.
Age: 0.92
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine given/ No adverse reactions.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient (DOB 10/11/2019) received the Pfizer 6m-4y (Maroon cap) vaccine from facility for his second dose, following a first dose of Moderna 6m-5y (Blue cap, magenta label). Vaccine info chit was marked as 'Pfizer', we verbally confirmed a Pfizer dose of the vaccine with patient's father and the dose was administered with no issue. Patient's father noted after vaccination the discrepancy between the dose stickers and brought the issue to the attention of staff. The discrepancy was brought to the attention of pharmacist, and confirmation was made that the vaccine administered was Pfizer. Pharmacist then spoke with patient's father regarding the error, the CDC recommendation in this situation, and next steps for the patient. Patient's father expressed understanding, and patient has an appointment for a third dose in 8 weeks, in accordance with Appendix D of the CDC's clinical recommendations.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE.
Age: 1.25
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired vaccine. No adverse reaction.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Per the recommendations of our local health jurisdiction, we are reporting this as an adverse event as the booster was given after unauthorized  the use of  monovalent vaccines as booster doses for individuals 12 years of age and older.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired vaccine / no adverse reactions
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Didn't realize we were supposed to be moving on to giving bivalent boosters and mistakenly administered the monovalent shot in its stead.  The bivalent shots were not in stock at the time.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient was observed for 15min because of their claim of having no known allergies. After the 15 minute observation, I (the pharmacist) cleared her since she did not appear to have any side effects. It was not until later in the evening when I realized that the protocol for the COVID vaccine had changed, and I proceeded to report the event to VAERS.
Age: 15.0
Sex: F
Vaccine: FLUR4, HEPA, IPV, MNQ
Symptoms: Hyperhidrosis, Nausea, Pallor
Clinical narrative: A 15 yrs 11 month old female student looked pale, sweating, felt nauseous after receiving the four vaccines. She is assisted to lay down on the floor with her feet elevated. O2 5 liters given. Vital signs taken: 2:35pm: BP 122/85, HR 84, RR 16,O2 sat 100% 2:37pm: BP 121/91, HR 93, RR 16, O2 sat 99%, Color pink, no nausea or dizziness, no shortness of breath 2:40pm: BP 121/84, HR 84, RR 20, O2 sat 99% 2:42pm:BP (sitting) 101/66, HR 87, RR 20, O2 sat 100%, denied dizziness 2:45pm:BP (sitting) 118/66, HR 64, RR 20, O2 sat 100% on room air. 2:50pm: BP(Sitting) 103/67, HR 68, RR 20, O2 sat 98% 2:55pm BP(Sitting) 107/64, HR 69, RR 16, O2 sat 99% 3:00pmBP(Standing) 97/61, HR 81, RR 16 O2 sat 100%, denied dizziness 3:05pm BP (Standing) 113/69, HR 69, RR 16, O2 sat 100% She is awake and responds to verbal stimuli the whole time. Student went home with her mother and guardian. Refer to seek medical care for difficulty breathing  and chest tightness. Mother and guardian understand the instructions.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Per the recommendations of our local health jurisdiction, we are reporting this as an adverse event as the booster was given after the FDA  unauthorized  the use of  monovalent vaccines as booster doses for individuals 12 years of age and older.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Per the recommendations of our local health jurisdiction, we are reporting this as an adverse event as the booster was given after the FDA  unauthorized  the use of  monovalent vaccines as booster doses for individuals 12 years of age and older.
Age: 3.0
Sex: F
Vaccine: IPV
Symptoms: Blood test, Cardiac dysfunction, Cardiac failure, Cytogenetic analysis, Dyspnoea
Clinical narrative: After reciev5the first dose I noticed two weeks later she was breathing hard and not eating I took her to her physician who stated he thought it was just a cold. Came back 2 weeks later for 2nd dose and ended up on the er with heart failure and trouble breathing was transferred and are currently  still here. The doctors are talking heart transplant from a virus that has effected her heart function
Age: 3.0
Sex: F
Vaccine: IPV
Symptoms: Echocardiogram, Hypophagia, Inappropriate schedule of product administration, Respiration abnormal, Viral infection
Clinical narrative: After reciev5the first dose I noticed two weeks later she was breathing hard and not eating I took her to her physician who stated he thought it was just a cold. Came back 2 weeks later for 2nd dose and ended up on the er with heart failure and trouble breathing was transferred and are currently  still here. The doctors are talking heart transplant from a virus that has effected her heart function
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received expired vaccine/ no adverse reactions
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Didn't realize we were supposed to be moving on to giving bivalent boosters and mistakenly administered the monovalent shot in its stead.  The bivalent shots were not in stock at the time.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Upon completing his 15 min observation time, patient stood and started walking away. After several meters he complained of light headedness, wooziness, and dizziness. He reports eating a good lunch but his mother stated that he is always starving after school, He was brought back to a room. He denied lip swelling, tongue swelling, shortness of breath, wheezing, coughing, nausea or vomiting. His temp was 99F temporal, HR 76, RR 24, BP 112/76, SpO2 95%. Exam was unremarkable without urticaria, edema of the lip or tongue, pharyngeal erythema, tonsillar edema, wheezing, increased respiratory effort, rales. Belly was benign. Extremities were warm and well perfused. He was given 250 mL of water and a Pedialyte popsicle. After 25 minutes of observation, his symptoms improved. He walked out of clinic with complaints of arm soreness.
Age: 1.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired vaccine. No adverse reaction.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: RPh didn't realize we were supposed to give bivalent boosters. Mistakenly administered the monovalent shot instead. The bivalent shots were not in-stock at the time.
Age: 1.58
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired vaccine. no reaction.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: The RPh didn't realize we were supposed to be moving on to giving bivalent boosters and mistakingly administered the monovalent shot in its stead.  The bivalent shots were not in stock at the time.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired vaccine. No adverse reaction.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired vaccine. No adverse reaction
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE.
Age: 1.58
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received  expired vaccine. no adverse reactions
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired vaccine no reaction
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Per the recommendations of our local health jurisdiction, we are reporting this as an adverse event as the booster was given after the FDA  unauthorized  the use of  monovalent vaccines as booster doses for individuals 12 years of age and older.
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Administered orange cap (5-11yrs) Pfizer dose rather maroon (6m-4yrs). No s/sx at this time, will follow up with mother in a couple days to confirm child doing fine.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Catheterisation cardiac abnormal, Myocardial infarction
Clinical narrative: 2 myocardial infarctions in June 2022
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired vaccine. no reaction
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Per the recommendations of our local health jurisdiction, we are reporting this as an adverse event as the booster was given after the FDA  unauthorized  the use of  monovalent vaccines as booster doses for individuals 12 years of age and older.
Age: 1.5
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired immunization. no adverse reaction
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Immediate pain in arm, sore to touch and movement. Unable to use for days.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was administered after 10 week received date
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired vaccine, No adverse reaction
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired vaccine. No adverse reaction.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Per the recommendations of our local health jurisdiction, we are reporting this as an adverse event, since the booster was given after the FDA unauthorized the use of monovalent vaccines as booster doses for individuals 12 years of age and older.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Heart valve incompetence
Clinical narrative: Mitral valve leak.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Development of large welps/hives covering both arms and both legs. They range in size from adult pinkie nail to the size of a quarter. The larger ones appear to be hard and peak in height in the center. Daughter is scratching them; not sure if due to them being there or if they actually itch.  Provided cortisone to all of the welps, put bandaids on to prevent scratching and also gave Benedryl in case they do itch. the welps appeared at daycare today, likely after nap time, but daycare staff not sure of the exact time. They were not there this morning.
Age: 32.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Amnesia, Anxiety, Eye movement disorder, Loss of consciousness, Posture abnormal
Clinical narrative: pt came in anxious/frazzled due to hx of not liking shots. she received both shots and seemed to be handling things well. while husband was given his covid shot, patient was noticed to be observing and then began to slump and waiver in her chair. husband noticed her eyes were rolling back/up and she eventually fainted/passed out as she did not recall several minutes of events that took place. 911 was called and emt's evaluated her and determined she was ok to go home with husband.
Age: 32.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Syncope
Clinical narrative: pt came in anxious/frazzled due to hx of not liking shots. she received both shots and seemed to be handling things well. while husband was given his covid shot, patient was noticed to be observing and then began to slump and waiver in her chair. husband noticed her eyes were rolling back/up and she eventually fainted/passed out as she did not recall several minutes of events that took place. 911 was called and emt's evaluated her and determined she was ok to go home with husband.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Eczema, Miliaria, Skin disorder
Clinical narrative: Patient had a rash in May and June that his dr said was probably heat rash. It continued and appeared to get worse in June and July after the vaccination. It was just diagnosed as excema or a related skin condition by his doctor in late August.
Age: 27.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Dizziness, Dry skin, Feeling hot, Hyperhidrosis, Lethargy
Clinical narrative: Patient received Dose #1 of JYNNEOS intradermally. Lead RN was approached by patient who said he was "not feeling well" Lead RN noted that patient looked diaphoretic and lethargic. Auxiliary RNs came to assist patient to seated position on floor with back against wall. Patient stated that he felt very tingly all over and warm. "Seeing stars". "Like I'm going to pass out". Patient stated experience was first time. Incident protocol activated.  1428: BP 115/70; HR 56; RR 22; Diaphoretic; Lung Sounds Bilateral Clear; Able to drink a cup of water sans emesis. 1433: BP 124/84; HR 64; Skin Dry; Skin Tone Normal; Patient reports vision normal again. Patient stated he felt normal again.  Patient observed for another 30 minutes and discharged from field clinic.
Age: 27.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Malaise, Paraesthesia, Visual impairment
Clinical narrative: Patient received Dose #1 of JYNNEOS intradermally. Lead RN was approached by patient who said he was "not feeling well" Lead RN noted that patient looked diaphoretic and lethargic. Auxiliary RNs came to assist patient to seated position on floor with back against wall. Patient stated that he felt very tingly all over and warm. "Seeing stars". "Like I'm going to pass out". Patient stated experience was first time. Incident protocol activated.  1428: BP 115/70; HR 56; RR 22; Diaphoretic; Lung Sounds Bilateral Clear; Able to drink a cup of water sans emesis. 1433: BP 124/84; HR 64; Skin Dry; Skin Tone Normal; Patient reports vision normal again. Patient stated he felt normal again.  Patient observed for another 30 minutes and discharged from field clinic.
Age: 24.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Anxiety, Hyperhidrosis, Nausea, Nervousness, Vomiting
Clinical narrative: Patient received Dose #2 of JYNNEOS intradermally. Lead RN noticed patient was seated in tripod position over side of chair. Lead RN approached patient, and patient said he was feeling anxious and nauseated. Lead RN encouraged him to vomit if he was feeling the need. Patient was given a receptacle and vomited liquid only. Patient stated he did not have much fluid or food before vaccination. Also, the vaccination process made him nervous.  1205: BP 130/80; HR 92; RR 18; Diaphoretic; Subjective Warm; Lung Sounds Bilateral Clear 1210: BP 125/90; HR 70; Skin Dry; Skin Tone Normal; Patient Conversational; AOX4; Went to bathroom to wash face.  Patient observed for another 30 minutes & discharged from field clinic.
Age: 36.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Anxiety, Dizziness, Feeling hot, Hyperhidrosis, Pallor
Clinical narrative: Patient started to feel anxious and dizzy during observation period.  Stated that the bubble on his arm "freaked him out".  Assisted to seated position on floor with back against wall.  1140: BP 130/80; HR 82; pulse strong; sweaty; hot; started yawning a lot; pale; blurry vision 1145 - BP 120/80; HR 82; difficulty speaking 1150 - BP 120/80;  HR 68; patient stated he?s starting to feel better; stopped sweating; color is coming back to skin.  Held in observation for another 30 minutes then released from field clinic.
Age: 36.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Speech disorder, Vision blurred, Yawning
Clinical narrative: Patient started to feel anxious and dizzy during observation period.  Stated that the bubble on his arm "freaked him out".  Assisted to seated position on floor with back against wall.  1140: BP 130/80; HR 82; pulse strong; sweaty; hot; started yawning a lot; pale; blurry vision 1145 - BP 120/80; HR 82; difficulty speaking 1150 - BP 120/80;  HR 68; patient stated he?s starting to feel better; stopped sweating; color is coming back to skin.  Held in observation for another 30 minutes then released from field clinic.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Pain in extremity, Peripheral swelling, Thrombosis, X-ray abnormal
Clinical narrative: Blood clot in left leg.  Left leg was extremely swollen and in pain.  Initially admitted into Hospital.  The hospital administered and IV and took X-rays to verify the blood clot.  The doctor advised it was a ?very rare blood clot? and was further told I ?should never have gotten this blood clot? and there was ?no reason?.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Per the recommendations of our local health jurisdiction, we are reporting this as an adverse event as the booster was given after the FDA  unauthorized  the use of  monovalent vaccines as booster doses for individuals 12 years of age and older.
Age: 68.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Incorrect dose administered, Needle issue
Clinical narrative: Patient was at the pharmacy to receive her Havrix and Engerix vaccines on Wednesday 9/7/22.  I noticed that the Havrix vaccine started leaking from the needle while the medication was being administered and the patient and I noticed that it started leaking down her arm.  I stopped administering the dose to see what the next step should be.  I contacted the manufacturer and the representative advised that according to guidance that the dose should be repeated since there is uncertainty if the dose would be effective.  I informed the patient of the recommendation and she accepted my apology and the dose was administered.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Per the recommendations of our local health jurisdiction, we are reporting this as an adverse event, since the booster was given after the FDA unauthorized the use of monovalent vaccines as booster doses for individuals 12 years of age and older.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was given Fluzone HD instead of Fluarix.