chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Chest pain, Differential white blood cell count normal, Dizziness, Electrocardiogram normal, Full blood count normal
Clinical narrative: About 1.5 hours after I received both vaccines, my heart rate spiked, I got extremely dizzy and thought I was going to pass out and was rushed the the hospital.  I felt like I was having a heart attack because of the chest pains, muscle spasm and inability to talk.
Age: 37.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Heart rate increased, Muscle spasms, Speech disorder, Troponin normal
Clinical narrative: About 1.5 hours after I received both vaccines, my heart rate spiked, I got extremely dizzy and thought I was going to pass out and was rushed the the hospital.  I felt like I was having a heart attack because of the chest pains, muscle spasm and inability to talk.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Breast pain, Breast swelling, Breast tenderness, Diarrhoea, Dizziness
Clinical narrative: Per employee in her own word on reporting documentation (Fridays date was 11/18/2022):  went to bldg 2nd floor for covid booster on friday 11/19/2022, over the weekend i felt dizzy headache body aches chills diarrhea and nausea and left arm and side all the way to breast swollen tender and pain full. came to work Monday to advise supervisor and to see what I need to do .had to have my husband dress and drive me to work. nothing just resting and keeping my arm from not touching my body due to the extreme pain . Taking over the counter tylenol and ibuprofren. had the covid booster
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Feeling cold, Headache, Impaired driving ability, Loss of personal independence in daily activities, Nausea
Clinical narrative: Per employee in her own word on reporting documentation (Fridays date was 11/18/2022):  went to bldg 2nd floor for covid booster on friday 11/19/2022, over the weekend i felt dizzy headache body aches chills diarrhea and nausea and left arm and side all the way to breast swollen tender and pain full. came to work Monday to advise supervisor and to see what I need to do .had to have my husband dress and drive me to work. nothing just resting and keeping my arm from not touching my body due to the extreme pain . Taking over the counter tylenol and ibuprofren. had the covid booster
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Peripheral swelling
Clinical narrative: Per employee in her own word on reporting documentation (Fridays date was 11/18/2022):  went to bldg 2nd floor for covid booster on friday 11/19/2022, over the weekend i felt dizzy headache body aches chills diarrhea and nausea and left arm and side all the way to breast swollen tender and pain full. came to work Monday to advise supervisor and to see what I need to do .had to have my husband dress and drive me to work. nothing just resting and keeping my arm from not touching my body due to the extreme pain . Taking over the counter tylenol and ibuprofren. had the covid booster
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: I have had mild and apparently typical adverse reactions to all four Moderna Covid vaccines - which lasted less than a day each time. I contracted Covid on 16Oct22. I called my doctor and they set up a Telehealth consultation . We discussed my symptoms and status to determine if an anti-viral medication was warranted. Ultimately I did not get the medicine and got better myself after about two weeks. I do not seem to have any lasting issues. I am very happy to have gotten the vaccines!
Age: 55.0
Sex: F
Vaccine: PNC20
Symptoms: Dizziness, Feeling hot, Headache, Nausea
Clinical narrative: Patient complained of dizziness, feeling hot, headache and nausea
Age: 22.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: patient received a .25ml dose when they should've received a .5ml dose.  I've worked with our local health department and will be contacting the patient to inform them and encourage another .5ml dose 8 weeks after the .25ml dose was given.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt received novavax booster too early based on CDC guidance on novavax boosters. Pt had received J&J on 7/26/22.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: patient received a .25ml dose when they should've received a .5ml dose.  I've worked with our health department and will be contacting the patient to inform them and encourage another .5ml dose 8 weeks after the .25ml dose was given.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in jaw, Paranasal sinus discomfort, Paranasal sinus hypersecretion, Sinus pain
Clinical narrative: Headache, onset evening of 11/05/2022, and daily after vaccination, with increased sinus pressure and pain over sinuses, including right temple and to teeth and jaw, with clear nasal drainage, on approx. 11/12/2022. on a.m. of 11/13/2022, oral temperature 99.6F. Initiated "e-visit" for care (virtual visit.) Assessed by MD for SINUS PAIN and SINUSITIS. Treatment: Doxycycline Monohydrate 100mg oral tabs, 1 q12 hours for SINUSITIS, started on 11/13/2022, completed 11/18/2022. Also, OTC Afrin nasal decongestant (one day) and acetaminophen 500mg oral tabs prn. As of 11/20 and 11/21/2022, temperature normal. Facial sinus pain and clear drainage continues as of 11/21/2022, somewhat improved.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis, Toothache
Clinical narrative: Headache, onset evening of 11/05/2022, and daily after vaccination, with increased sinus pressure and pain over sinuses, including right temple and to teeth and jaw, with clear nasal drainage, on approx. 11/12/2022. on a.m. of 11/13/2022, oral temperature 99.6F. Initiated "e-visit" for care (virtual visit.) Assessed by MD for SINUS PAIN and SINUSITIS. Treatment: Doxycycline Monohydrate 100mg oral tabs, 1 q12 hours for SINUSITIS, started on 11/13/2022, completed 11/18/2022. Also, OTC Afrin nasal decongestant (one day) and acetaminophen 500mg oral tabs prn. As of 11/20 and 11/21/2022, temperature normal. Facial sinus pain and clear drainage continues as of 11/21/2022, somewhat improved.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: patient received a .25ml dose when they should've received a .5ml dose.  I've worked with our state health department and will be contacting the patient to inform them and encourage another .5ml dose 8 weeks after the .25ml dose was given.
Age: 92.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: patient received a .25ml dose when they should've received a .5ml dose.  I've worked with our local health department and will be contacting the patient to inform them and encourage another .5ml dose 8 weeks after the .25ml dose was given.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Diarrhoea
Clinical narrative: Pt received bivalent booster on 11/3/22. Called hospital call ceneter on 11/8/22 to report diarrhea since 11/5/22. Tried antidiarrheals but has not helped.  Pt denies any changes to diet. Pt recommended by RN to go to urgent care or see PCP for further evaluation.
Age: 44.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt does not have any adverse symptoms. Pt was given an expired vaccine with no adverse reactions. physician and patient was notified. reached out to manufacturer and they suggested to revaccinate in 28 days. Pt is aware of this and decided that she will get the vaccine in 28 days at her local pharmacy
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Pruritus, Urticaria
Clinical narrative: Woke up with hives less than 12 hours after vaccination and itchiness
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This 9-year-old female received adult dose of 100 mcg in October and in November. It was found when auditing records on 11/15/2022. Parents have been notified. They deny any adverse side effects, no fever, no body aches, no fatigue after receiving her injections.
Age: 96.0
Sex: U
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Asymptomatic
Age: 27.0
Sex: F
Vaccine: ANTH
Symptoms: Syncope
Clinical narrative: Fainted followed by a possible seizure three days later (no family history of seizures)
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Malaise, Pain, Pyrexia
Clinical narrative: On 10/11/2022 I started feeling COVID-19 symptoms. I developed body aches; headache; nasal drip; sneezing; and 102.0 fever for 2 -3 days. Tested positive on 10/12/2022 and was prescribed a 5 day course of PAXLOVID. I also noticed that once I completed the medication I started getting light headaches.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sneezing, Upper-airway cough syndrome
Clinical narrative: On 10/11/2022 I started feeling COVID-19 symptoms. I developed body aches; headache; nasal drip; sneezing; and 102.0 fever for 2 -3 days. Tested positive on 10/12/2022 and was prescribed a 5 day course of PAXLOVID. I also noticed that once I completed the medication I started getting light headaches.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Feeling abnormal, Gait disturbance, Influenza like illness, Pain in extremity
Clinical narrative: PATIENT REPORTED TWO EPISODES OF FAINTING WITHIN 24 HOURS OF RECEIVING HER 4TH DOSE (2ND BOOSTER) OF COVID VACCINE. SHE RECOUNTED THAT SHE WAS WALKING DOWN THE STAIRS TO HER BASEMENT, WHEN SHE SUDDENLY FELT WOOZY, AND BRIEFLY FAINTED, STUMBLING DOWN THE LAST FEW STEPS. SHE RECOVERED, THEN WENT TO THE BATHROOM, ONLY TO FAINT AND COLLAPSE FULLY ON THE WAY THERE. AFTER SHE RECOVERED, SHE WENT BACK TO BED, FEELING OFF THE REST OF THE DAY. SHE STATES THAT BLOOD SUGAR WAS NOMINAL AT THE TIME, AND THAT THIS DID NOT FEEL LIKE PAST LOW-BLOOD SUGAR FAINTINGS SHE HAS HAD.   SHE WENT TO A FACILITY TO CHECK HER KNEE, WHICH WAS FINE, BUT SHE BELIEVES SHE BROKE A TOE ON ONE OF THE FALLS. IT IS UNKNOWN IF THIS WAS CONFIRMED BY HEALTHCARE TEAMS. SHE REPORTED THAT SHE DID HAVE SIDE EFFECTS FOLLOWING HER OTHER COVID SHOTS, BUT THEY WERE TYPICAL (FLU-LIKE SYMPTOMS, ARM HURTING, ETC). PT HAD A PACEMAKER CHECK LATER THAT WEEK WHICH NOTED NO CARDIAC ABNORMALITIES UP TO OR AFTER THE EVENT. ADVISED PATIENT TO DISCUSS WITH MD AND TO WEIGH BENEFIT/RISK OF FUTURE MRNA-BASED COVID VACCINES. PATIENT HAS SINCE RECOVERED AND "FEELS FINE," BUT PRESENTED TO SITE OF VACCINATION TO MAKE US AWARE, AND TO SEE IF THIS WAS A REPORTED ADE IN OUR LARGER PATIENT POPULATION.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Syncope
Clinical narrative: PATIENT REPORTED TWO EPISODES OF FAINTING WITHIN 24 HOURS OF RECEIVING HER 4TH DOSE (2ND BOOSTER) OF COVID VACCINE. SHE RECOUNTED THAT SHE WAS WALKING DOWN THE STAIRS TO HER BASEMENT, WHEN SHE SUDDENLY FELT WOOZY, AND BRIEFLY FAINTED, STUMBLING DOWN THE LAST FEW STEPS. SHE RECOVERED, THEN WENT TO THE BATHROOM, ONLY TO FAINT AND COLLAPSE FULLY ON THE WAY THERE. AFTER SHE RECOVERED, SHE WENT BACK TO BED, FEELING OFF THE REST OF THE DAY. SHE STATES THAT BLOOD SUGAR WAS NOMINAL AT THE TIME, AND THAT THIS DID NOT FEEL LIKE PAST LOW-BLOOD SUGAR FAINTINGS SHE HAS HAD.   SHE WENT TO A FACILITY TO CHECK HER KNEE, WHICH WAS FINE, BUT SHE BELIEVES SHE BROKE A TOE ON ONE OF THE FALLS. IT IS UNKNOWN IF THIS WAS CONFIRMED BY HEALTHCARE TEAMS. SHE REPORTED THAT SHE DID HAVE SIDE EFFECTS FOLLOWING HER OTHER COVID SHOTS, BUT THEY WERE TYPICAL (FLU-LIKE SYMPTOMS, ARM HURTING, ETC). PT HAD A PACEMAKER CHECK LATER THAT WEEK WHICH NOTED NO CARDIAC ABNORMALITIES UP TO OR AFTER THE EVENT. ADVISED PATIENT TO DISCUSS WITH MD AND TO WEIGH BENEFIT/RISK OF FUTURE MRNA-BASED COVID VACCINES. PATIENT HAS SINCE RECOVERED AND "FEELS FINE," BUT PRESENTED TO SITE OF VACCINATION TO MAKE US AWARE, AND TO SEE IF THIS WAS A REPORTED ADE IN OUR LARGER PATIENT POPULATION.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Product administration error
Clinical narrative: ADMINISTRATION ERROR: Gave High Dose Influenza vaccine to a client under 65 years of age.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient was given beyond-use date pfizer bi-variant vaccine. Vial was opened on 11/18/2022.
Age: 1.33
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Gave Boostrix  for ages 7 years and up instead of  Infanrix DTaP ages 6 mos to 6 yrs the appropriate vaccine for his age. The patient did not suffer any adverse symptoms. No adverse reaction occurred-discovered error when looking at billing information
Sex: U
Vaccine: COVID19-2
Symptoms: Bradycardia, Echocardiogram, Electrocardiogram, Heart rate irregular
Clinical narrative: Bradycardia as low as 36 beats per minute and erratic heartbeat began October 13,2022 and worsened to the point that I went to the ER on October 16, 2022. I was transferred by ambulance for observation and monitoring through October 17, 2022. Bradycardia and erratic heart-rate were confirmed and I was discharged to follow up with cardiologist at a later date.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: Error between State system and clinic system mirroring information.  State system only listed one PCV13 vaccine.  When reconciled, clinic system showed two additional pneumonia vaccines (after administration).  Patient should not have received pneumonia dose today.  Patient was up to date previously.  Patient was called and she is doing well.  She states she feels fine.  Patient was told if she started to feel unwell in any capacity to please return to clinic, go to the nearest hospital, or dial EMS.  VAERS report will be submitted.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy lung abnormal, Blood cholesterol, Computerised tomogram coronary artery abnormal, Computerised tomogram thorax abnormal, Neuroendocrine tumour of the lung
Clinical narrative: I went to my regular doctor visit for my cholesterol, and I did a calcium scoring test. They found neuroendocrine tumor in my left lung. I also had all my COVID-19 vaccines in my left arm. On the 24th I had CT scan on the chest, and they saw the same neuroendocrine tumor. I was schedule for a lung biopsy, and it was determined that I had a rare tumor. I referred to a cardiothoracic surgeon 09/20/2022 and she did a breathing test. Then the surgery was scheduled on the 09/29/2022 and they removed all the tumors.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary function test, Tumour excision
Clinical narrative: I went to my regular doctor visit for my cholesterol, and I did a calcium scoring test. They found neuroendocrine tumor in my left lung. I also had all my COVID-19 vaccines in my left arm. On the 24th I had CT scan on the chest, and they saw the same neuroendocrine tumor. I was schedule for a lung biopsy, and it was determined that I had a rare tumor. I referred to a cardiothoracic surgeon 09/20/2022 and she did a breathing test. Then the surgery was scheduled on the 09/29/2022 and they removed all the tumors.
Age: 58.0
Sex: F
Vaccine: PNC20
Symptoms: Allergy to vaccine, Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The evening of the vaccine, my left deltoid we sore.  It stayed sore for 5 days and also was red and swollen.  On the 5th day I developed a red, itchy rash over my anterior neck X 2 days.  The next day my eyelids were swollen and I had a red rash on my face.    I saw Dr. on Nov 17th and she felt this was an allergic reaction to the Prevnar 20.  The face and neck rash were gone on that date, but the arm rash was still present, although faint, and resolved by the next day.  I took pictures and showed the rash pictures to Dr.
Age: 58.0
Sex: F
Vaccine: PNC20
Symptoms: Rash, Rash erythematous, Rash pruritic, Swelling of eyelid
Clinical narrative: The evening of the vaccine, my left deltoid we sore.  It stayed sore for 5 days and also was red and swollen.  On the 5th day I developed a red, itchy rash over my anterior neck X 2 days.  The next day my eyelids were swollen and I had a red rash on my face.    I saw Dr. on Nov 17th and she felt this was an allergic reaction to the Prevnar 20.  The face and neck rash were gone on that date, but the arm rash was still present, although faint, and resolved by the next day.  I took pictures and showed the rash pictures to Dr.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt received primary series dose of pfizer instead of bivalent booster.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Moderna monovalent was given instead of bivalent
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Eye swelling, Nodule, Pain in extremity, Rash, Skin warm
Clinical narrative: Rash along arm, swelling,  hot to touch, lump in arm,  pain in arm, right eye swollen
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Swelling
Clinical narrative: Rash along arm, swelling,  hot to touch, lump in arm,  pain in arm, right eye swollen
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Moderna monovalent was given instead of bivalent
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Condition aggravated, Herpes zoster reactivation
Clinical narrative: I received the Moderna Bivalent booster and a flu vaccination on 11/8/2022. On the morning of 11/12/2022, I went to the bathroom as soon as I got out of bed. When I was in the bathroom, I noticed that I had experienced an outbreak of herpes simplex. This is unusual for me, because as I have had more than one outbreak in my life, they have always been sporadic and then dormant for 30 years. The 30-year period of dormancy came to an end between 2/25/2021 and 3/25/2021, which were the dates of my first two Moderna vaccinations for COVID-19. I didn't really associate the outbreak with the vaccine, as I was going through a very stressful period then. However, just 4 days after receiving the Moderna Bivalent booster, I had yet another outbreak. The timing of both occurrences makes me wonder if there is a connection between the shots and the outbreaks. Have the shots affected my immune system in a way that is conducive to an outbreak occurring? During the outbreak in either February or March 2021, I saw a doctor, who prescribed me valacyclovir. After this latest outbreak, I spoke to a nurse at the clinic I previously went to, and I was again prescribed valacyclovir. The lesions were gone within 48 of my taking the medication. In addition to this information, I would also like to add that I also received Pfizer boosters for COVID-19 on 11/7/2021 and 4/29/2022, and I did not experience any outbreaks afterwards. The only issues I had with those boosters were fatigue and diarrhea. Not only that, but I also want to mention that I have not been sexually active for 4 years, so it's not as if the outbreaks were triggered in any way by a new exposure.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Feeling abnormal, Paraesthesia, Swollen tongue
Clinical narrative: Patient received vaccine and was monitored for 15 minutes, about 10 minutes in during monitoring patient reported tongue "swelling" and funny feeling/tingling. No dyspnea, chest pain, wheezing, lip swelling or change in vital signs. Patient was treated with 50 mg Benadryl and monitored for 1 hour until 1030. Patient's symptoms did not change after Benadryl, did not improve or worsen. Patient provided with contingency to call our office with any changes, continue Benadryl as needed and ultimately follow up with Emergency care as needed.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Headache, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: I tested positive for Covid on 11/14/2022.  high fever, body aches, headache, congested
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I tested positive for Covid on 11/14/2022.  high fever, body aches, headache, congested
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: pt was to receive dose 3 of primary series but received bivalent booster instead..
Age: 63.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Bladder catheterisation, Gait inability, Urinary retention
Clinical narrative: Urinary retention, foli, could not walk
Age: 63.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Confusional state, Dehydration, Dysuria, Gait inability, Headache
Clinical narrative: Urinary retention, foli, could not walk
Age: 63.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Lung infiltration
Clinical narrative: Urinary retention, foli, could not walk
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Decreased appetite, Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea, and moderate-severe abdominal  pain for six hours, followed by  five days of loss of appetite, mild abdominal pain, and diminishing diarrhea. Self-treated  with Pepto-Bismol, famotidine,and  ginger tea.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: Went on cruise 11/06 felt sick began feeling sick 11/05 took home test 11/08 morning with positive result of covid, 11/08 went to minute clinic prescribed Lagevrio,  11/14 symptoms subsided.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Product administration error
Clinical narrative: ADMINISTRATION ERROR We had a drive through influenza clinic.  We had volunteers helping.  This 62 year old was given the High Dose Influenza vaccine meant for 65 and older.
Age: 86.0
Sex: M
Vaccine: FLU4
Symptoms: Electrocardiogram, Loss of consciousness, Pulse abnormal, Syncope
Clinical narrative: Patient received vaccine and was fine afterwards. Pharmacist had a conversation with the patient for about 5 minutes after the vaccine was administered. Patient was NOT slow to get up after vaccine. About ten minutes later the patient was walking down the aisle of the store, and an employee saw patient stretch his arm completely out. Patient continued walking and about 30 feet later the patient collapsed and Emergency was called. Patient was breathing but not conscience and a faint pulse was observed.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age, Product administration error
Clinical narrative: ADMINISTRATION ERROR We had our drive through influenza clinic.  We had volunteers helping in many spots. We administered a High Dose influenza vaccine to this 57 year old.  On 10-03-2022, she denied any adverse events or reactions.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Extra dose of varicella immunization was given to patient. Primary care provider was notified.
Age: 63.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Inflammation, Joint swelling, Pruritus
Clinical narrative: PATIENT HAS A SWOLLEN, RED, ITCHY ELBOW. VACCINE SITE LOOKS FINE JUST LOTS OF INFLAMMATION IN THE ELBOW AREA AND VERY RED. HE WENT TO THE URGENT CARE  AND HAD TO HAVE A STEROID SHOT. HE SAID THE PROVIDER THERE ALSO TOLD HIM TO TAKE BENADRYL.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Product administration error
Clinical narrative: ADMINISTRATION ERROR We had our drive through influenza clinic at our hall.  We utilize volunteers throughout, including volunteer nurses. We administered the High Dose influenza vaccine meant for 65 and older to this 61 year old.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Periorbital swelling, Rash, Rash pruritic, Rhinorrhoea
Clinical narrative: 1-2 days after vaccination patient started with erythema around the nose, rhinorrhea and itchy rash of nose. Then on 11/20-11/21 noted some slight facial swelling, cheeks and below the eye. Seen at PCP office 11/21/2022 noted to have mild facial edema without angioedema. No diffuse urticaria, airway not compromised. given antihistamines and topical steroid cream for rash.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Swelling face
Clinical narrative: 1-2 days after vaccination patient started with erythema around the nose, rhinorrhea and itchy rash of nose. Then on 11/20-11/21 noted some slight facial swelling, cheeks and below the eye. Seen at PCP office 11/21/2022 noted to have mild facial edema without angioedema. No diffuse urticaria, airway not compromised. given antihistamines and topical steroid cream for rash.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Product administration error
Clinical narrative: ADMINISTRATION ERROR We had our drive through influenza clinic at our hall.  We utilize volunteers throughout, including volunteer nurses. We administered a High Dose influenza meant for 65 and over to this 58 year old.  10-03-2022  Client reports on adverse effects.
Age: 21.0
Sex: M
Vaccine: TDAP
Symptoms: Confusional state, Fatigue, Somnolence
Clinical narrative: severe fatigue, drowsiness, confusion state
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal distension, Bladder pain, Micturition urgency
Clinical narrative: Pain and bloating in the bladder area. Feel a need to use the bathroom.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Product administration error
Clinical narrative: ADMINISTRATION ERROR We had our drive through influenza clinic at our hall.  We utilize volunteers throughout, including volunteer nurses. We administered the High Dose influenza meant for 65 and older to this 58 year old.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Product administration error
Clinical narrative: ADMINISTRATION ERROR We had our drive through influenza clinic at our hall.  We utilize volunteers throughout, including volunteer nurses. We administered a High Dose influenza meant for 65 and older to this 64 year old.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Vertigo
Clinical narrative: Vertigo...lasted 11 hours
Age: 20.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood pressure increased, Dizziness, Dysphagia, Heart rate increased, Oropharyngeal discomfort
Clinical narrative: Approximately 10 minutes after vaccine administration, patient complained of dizziness, and remained seated in the pharmacy vaccine area to wait for improvement.  The patient was checked on a few minutes later, where her symptoms had worsened to include an elevated heart rate.  A blood pressure was checked and found to be elevated.  Patient remained stable but developed some throat discomfort and a slight difficulty in swallowing.  Patient reported no itching, rash, swelling or difficulty breathing.  Symptoms did not improve, and EMS was called.  Patient's pulse was 89 and oxygen saturation was steady at 99% when checked by first responders.  The patient decided to leave under her own power with paramedics for further evaluation.  Upon follow up with the patient later the same day, she reported an improvement in her condition.
Sex: M
Vaccine: FLUC4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This RN injected the Influenza vaccine (adult) into a Newborn baby boy's R Thigh, by error. Error was not noted until at approximately 5:10 PM & injection was given at approx 1:38 PM on same date(11/21/2022).
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received one dose of 0.2 adult pfizer by accident at 11 AM. Person who administered did not notice until she was documenting vaccine. Individual informed me what had happened. I called parents at 11:43 PM to see how patient was doing. First, I spoke to mother who states patient was acting like his normal self.  About 1 hour later I received call from father who was concerned. Explained to him what had happened. Father also informed me patient was well. Explained to him that since his it is his first vaccine the most important thing to monitor is for and acute allergic reaction to vaccine.  Father states patient did not have SOB, hives, angioedema or other symptoms. Informed dad that if he noticed any new symptoms arise to bring patient back into clinic. Father understood and had no additional questions or concerns.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: THE PATIENT INCORRECTLY RECEIVED THE MONOVALENT COVID VACCINE AS A THIRD DOSE INSTEAD OF THE BIVALENT COVID VACCINE.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Incorrect route of product administration, Pain
Clinical narrative: Patient called the pharmacy on 11/21/2022 and stated that he has been in pain since he got the shot last year. He stated that the pharmacist may have gave him the shot between the shoulder and joint. He complains of numbness and serious pain which he has seen a doctor for. He claimed an EMT was done and that his PCP recommended rehab.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion
Clinical narrative: patient developed a bruise under bandage
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inflammation, Injection site pain, Muscle swelling, Myalgia, Pain
Clinical narrative: Developed a sore and swollen left deltoid about 4-5 days after the injection. About a 3 x 3" area at least..  The injection site was sore the first 2 days and went away.  Came back on day 4-5. I also had bumped up against the corner of the wall while walking but I do that often.  Never got this reaction.  I was worried it could be a blot clot so on the 9th day I went to urgent care.  The PA said it was inflammation from the vaccine.  Post-injection inflammatory reaction.  Put heat on it .  Treat as normal. No massaging.  She said it could go away in a couple of weeks.  If it got red to call doctor for ultrasound orders.  This is day 17 and the arm is still sore.  The swelling is going down slowly. Usually I have a sore arm for days after injections but this time it was  one or two days and then it quit but came back. It is sore  to stretch my arm across my chest.  Used to be sore when I would stretch the arm straight out.  That has subsided. Still tender to lay on it.  I try not too. It doesn't hurt just sitting and doing normal activity.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Developed a sore and swollen left deltoid about 4-5 days after the injection. About a 3 x 3" area at least..  The injection site was sore the first 2 days and went away.  Came back on day 4-5. I also had bumped up against the corner of the wall while walking but I do that often.  Never got this reaction.  I was worried it could be a blot clot so on the 9th day I went to urgent care.  The PA said it was inflammation from the vaccine.  Post-injection inflammatory reaction.  Put heat on it .  Treat as normal. No massaging.  She said it could go away in a couple of weeks.  If it got red to call doctor for ultrasound orders.  This is day 17 and the arm is still sore.  The swelling is going down slowly. Usually I have a sore arm for days after injections but this time it was  one or two days and then it quit but came back. It is sore  to stretch my arm across my chest.  Used to be sore when I would stretch the arm straight out.  That has subsided. Still tender to lay on it.  I try not too. It doesn't hurt just sitting and doing normal activity.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dry mouth
Clinical narrative: Dry mouth x5 weeks
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: the Bivalent vaccine was inadvertently given as dose #2 in the series instead of the original Pfizer vaccine
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Tinnitus
Clinical narrative: chronic bilateral tinnitus immediately beginning after second dose and continuing currently
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dysphagia, Ear pain, Insomnia
Clinical narrative: Severe sore throat.  Unable to swallow food or liquids including water.   By the next day I couldn't even swallow tylenol pills.   Constant cough throughout the night approximately 3 times a minute.  Unable to sleep due to this.  Spread to ears approx 14 hours later.  Very painful.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test positive, Streptococcus test negative
Clinical narrative: Severe sore throat.  Unable to swallow food or liquids including water.   By the next day I couldn't even swallow tylenol pills.   Constant cough throughout the night approximately 3 times a minute.  Unable to sleep due to this.  Spread to ears approx 14 hours later.  Very painful.
Age: 1.25
Sex: F
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hives and fever later that day
Sex: U
Vaccine: COVID19-2, FLU4
Symptoms: Extra dose administered
Clinical narrative: Recd High Dose Flu 10/18/22 then 11/7/2 - Notified 0 adverse effects - Asked for Flu shot
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood alkaline phosphatase increased, Full blood count, Immature granulocyte count
Clinical narrative: immature granulocytes on CBC on 5/2/2022 and again on 11/7/2022.  Alkaline phosphatase 155 on 5/2/2022 and 158 on 11/7/22
Age: 94.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dysarthria, Facial paralysis, Posture abnormal, Speech disorder
Clinical narrative: RESIDENT UNABLE TO SIT UPRIGHT IN CHAIR, NOTED FACIAL DROOP, SLURRING OF WORDS AND MUBBLING, POA ELECTED HOSPICE SERVICES AND REQUESTED NO FURTHER TREATMENT
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Blood creatinine increased, Blood potassium increased, Blood sodium decreased, Blood urea increased
Clinical narrative: Had covid booster, then started feeling unwell a couple days later. Continued to have severe fatigue, decreased appetite, cough, decreased urination. Seen on 10/17/22 and found to have creatinine 6.47, BUN 71, Sodium 128, potassium 5.6. Was hospitalized. Had AKI, biopsy revealed acute interstitial granulomatous glomerulonephritis, felt to be due to covid vaccine. Treated with steroids and improving.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Fatigue, Glomerulonephritis acute, Granuloma
Clinical narrative: Had covid booster, then started feeling unwell a couple days later. Continued to have severe fatigue, decreased appetite, cough, decreased urination. Seen on 10/17/22 and found to have creatinine 6.47, BUN 71, Sodium 128, potassium 5.6. Was hospitalized. Had AKI, biopsy revealed acute interstitial granulomatous glomerulonephritis, felt to be due to covid vaccine. Treated with steroids and improving.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Malaise, Urine output decreased
Clinical narrative: Had covid booster, then started feeling unwell a couple days later. Continued to have severe fatigue, decreased appetite, cough, decreased urination. Seen on 10/17/22 and found to have creatinine 6.47, BUN 71, Sodium 128, potassium 5.6. Was hospitalized. Had AKI, biopsy revealed acute interstitial granulomatous glomerulonephritis, felt to be due to covid vaccine. Treated with steroids and improving.
Age: 36.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Burning sensation, Fatigue, Pain, Vaccination site pain, Vaccination site urticaria
Clinical narrative: Pain at injection site, itchy welt developed after 2 days the size of a baseball, general fatigue (grade 1 at most), all resolved within a few days.
Age: 36.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Fatigue, Injection site pain, Pruritus, Urticaria
Clinical narrative: Pain at injection site, itchy welt developed after 2 days the size of a baseball, general fatigue (grade 1 at most), all resolved within a few days.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Blindness unilateral, Bone erosion, Burning sensation, Central nervous system lesion
Clinical narrative: 2 days after patient received initial moderna vaccine she developed numbness in her hands and feet, and generalized tingling, she developed decreased L eye vision, and a tight sensation on torso, pressure behind eyes, vertigo, trouble walking. Was seen in the ER at Hospital. Patient was not admitted, but was evaluate, she was sent to PCP who sent to neurology. Patient had MRIs that were consistent with multiple sclerosis.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Demyelination, Erythromelalgia, Eye pain, Gait disturbance
Clinical narrative: 2 days after patient received initial moderna vaccine she developed numbness in her hands and feet, and generalized tingling, she developed decreased L eye vision, and a tight sensation on torso, pressure behind eyes, vertigo, trouble walking. Was seen in the ER at Hospital. Patient was not admitted, but was evaluate, she was sent to PCP who sent to neurology. Patient had MRIs that were consistent with multiple sclerosis.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal, Multiple sclerosis
Clinical narrative: 2 days after patient received initial moderna vaccine she developed numbness in her hands and feet, and generalized tingling, she developed decreased L eye vision, and a tight sensation on torso, pressure behind eyes, vertigo, trouble walking. Was seen in the ER at Hospital. Patient was not admitted, but was evaluate, she was sent to PCP who sent to neurology. Patient had MRIs that were consistent with multiple sclerosis.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal chest pain, Nerve conduction studies, Ocular discomfort, Pain, Peripheral swelling
Clinical narrative: 2 days after patient received initial moderna vaccine she developed numbness in her hands and feet, and generalized tingling, she developed decreased L eye vision, and a tight sensation on torso, pressure behind eyes, vertigo, trouble walking. Was seen in the ER at Hospital. Patient was not admitted, but was evaluate, she was sent to PCP who sent to neurology. Patient had MRIs that were consistent with multiple sclerosis.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash macular, Rheumatoid arthritis, Skin lesion, Spinal osteoarthritis, Vertigo
Clinical narrative: 2 days after patient received initial moderna vaccine she developed numbness in her hands and feet, and generalized tingling, she developed decreased L eye vision, and a tight sensation on torso, pressure behind eyes, vertigo, trouble walking. Was seen in the ER at Hospital. Patient was not admitted, but was evaluate, she was sent to PCP who sent to neurology. Patient had MRIs that were consistent with multiple sclerosis.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray abnormal
Clinical narrative: 2 days after patient received initial moderna vaccine she developed numbness in her hands and feet, and generalized tingling, she developed decreased L eye vision, and a tight sensation on torso, pressure behind eyes, vertigo, trouble walking. Was seen in the ER at Hospital. Patient was not admitted, but was evaluate, she was sent to PCP who sent to neurology. Patient had MRIs that were consistent with multiple sclerosis.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Gait disturbance, Hypoaesthesia, Laboratory test, Magnetic resonance imaging head abnormal
Clinical narrative: 2 days after patient received initial moderna vaccine she developed numbness in her hands and feet, and generalized tingling, she developed decreased L eye vision, and a tight sensation on torso, pressure behind eyes, vertigo, trouble walking. Was seen in the ER at Hospital. Patient was not admitted, but was evaluate, she was sent to PCP who sent to neurology. Patient had MRIs that were consistent with multiple sclerosis.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging spinal abnormal, Multiple sclerosis, Ocular discomfort, Paraesthesia, Vertigo
Clinical narrative: 2 days after patient received initial moderna vaccine she developed numbness in her hands and feet, and generalized tingling, she developed decreased L eye vision, and a tight sensation on torso, pressure behind eyes, vertigo, trouble walking. Was seen in the ER at Hospital. Patient was not admitted, but was evaluate, she was sent to PCP who sent to neurology. Patient had MRIs that were consistent with multiple sclerosis.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: 2 days after patient received initial moderna vaccine she developed numbness in her hands and feet, and generalized tingling, she developed decreased L eye vision, and a tight sensation on torso, pressure behind eyes, vertigo, trouble walking. Was seen in the ER at Hospital. Patient was not admitted, but was evaluate, she was sent to PCP who sent to neurology. Patient had MRIs that were consistent with multiple sclerosis.
Sex: U
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; expired product administered to a patient; ONE of TEN vials has a different lot/expiration date/The affected VARIVAX with LOT S020464, EXP Jul 2, 2021, was administered to a patient; expired product administered to a patient/ONE of TEN vials has a different lot/expiration date/The affected VARIVAX with LOT S020464, EXP Jul 2, 2021, was administered to a patient; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-OCT-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, one vial, lot #S020464, expiration date: 02-JUL-2021, administered for prophylaxis (strength, dose, dose number and route of administration were not provided) (expired product administered).  The nurse reported that the other 9 doses matched the carton, which was sealed/intact/free from damage or physical defects, however this issue was not discovered until the product was used. She investigated the issue at the day of this report with another nurse and identified that the one vial had a different lot/expiration date compared to the remaining vials in package. The nurse practitioner confirmed that she had never carried varicella virus vaccine live (oka/merck) (VARIVAX) with lot #S020464. The lot # had no prior temperature excursions. No additional adverse event (AE) reported.
Age: 66.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Asthma, Cough, Loss of personal independence in daily activities, Pulmonary function challenge test abnormal
Clinical narrative: Asthma/ cough got worse after she got the Moderna bivalent booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ASTHMA (Asthma/ cough got worse after she got the Moderna bivalent booster dose) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     The patient's past medical history included TIA. Previously administered products included for Product used for unknown indication: Pfizer (Dose 1,Lot number EL9267) on 13-Feb-2021, Pfizer (Dose 2,Lot number EN6202) on 05-Mar-2021, Pfizer (1st booster dose,Lot number FF8839) on 05-Oct-2021, Pfizer (2nd booster dose and Lot number FK9729) on 27-Apr-2022. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Cough, Hypertension, Hypercholesteraemia, Sulfonamide allergy (Sulfa), Allergy to antibiotic (Quinolone) and Adhesive tape allergy (adhesive of bandages). Concomitant products included IRBESARTAN (AVAPRO), HYDRALAZINE, ATORVASTATIN CALCIUM (LIPITOR) and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 07-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHMA (Asthma/ cough got worse after she got the Moderna bivalent booster dose). At the time of the report, ASTHMA (Asthma/ cough got worse after she got the Moderna bivalent booster dose) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Other relevant medical history information included breast and stomach ca that was taken cared last year. The patient received flu vaccine on 18-OCT 2022. On Unknown date, Laboratory test included Metacholine test with result reported as Positive. Patient was told that a positive test would mean that she had asthma so she was going to follow up with her pulmonologist. Patient was scheduled to have an endoscopy to see if it was GERD (Gastroesophageal reflux disease) or EOE (eosinophilic esophagitis). Treatment medications included Trelegy inhaler, Fluticasone inhaler which was not started on yet and patient planned to start with them  after her endoscopy.
Age: 66.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Asthma
Clinical narrative: Asthma/ cough got worse after she got the Moderna bivalent booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ASTHMA (Asthma/ cough got worse after she got the Moderna bivalent booster dose) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     The patient's past medical history included TIA. Previously administered products included for Product used for unknown indication: Pfizer (Dose 1,Lot number EL9267) on 13-Feb-2021, Pfizer (Dose 2,Lot number EN6202) on 05-Mar-2021, Pfizer (1st booster dose,Lot number FF8839) on 05-Oct-2021, Pfizer (2nd booster dose and Lot number FK9729) on 27-Apr-2022. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Cough, Hypertension, Hypercholesteraemia, Sulfonamide allergy (Sulfa), Allergy to antibiotic (Quinolone) and Adhesive tape allergy (adhesive of bandages). Concomitant products included IRBESARTAN (AVAPRO), HYDRALAZINE, ATORVASTATIN CALCIUM (LIPITOR) and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 07-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHMA (Asthma/ cough got worse after she got the Moderna bivalent booster dose). At the time of the report, ASTHMA (Asthma/ cough got worse after she got the Moderna bivalent booster dose) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Other relevant medical history information included breast and stomach ca that was taken cared last year. The patient received flu vaccine on 18-OCT 2022. On Unknown date, Laboratory test included Metacholine test with result reported as Positive. Patient was told that a positive test would mean that she had asthma so she was going to follow up with her pulmonologist. Patient was scheduled to have an endoscopy to see if it was GERD (Gastroesophageal reflux disease) or EOE (eosinophilic esophagitis). Treatment medications included Trelegy inhaler, Fluticasone inhaler which was not started on yet and patient planned to start with them  after her endoscopy.