chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: FLUA4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient came in to pharmacy on 10/6/22 and asked for flu shot.  He received FluAD Lot 346336 in left arm billed through his insurance.  Upon filing his flu forms later in the evening, we realized he had already received a flu shot this year from our facility, Fluzone High Dose 0.7ml Lot UJ875AB on 9/8/22, also billed through the same insurance.  The plan accepted and paid for both shots, it never gave us any rejections.  No adverse event that we know of has taken place other than receiving 2 flu vaccines one month apart.  Patient is hard of hearing, does not speak well, and not sure if he is able to read.  He has only used our pharmacy for vaccines so we are not sure of his primary care physician.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest discomfort, Eye pruritus, Lacrimation increased, Periorbital oedema, Throat irritation
Clinical narrative: periorbital edema, itchy watery eyes, throat irritation, chest tightness
Age: 39.0
Sex: F
Vaccine: UNK
Symptoms: Incorrect product formulation administered
Clinical narrative: I drew up the wrong Moderna Booster Vaccine for Employee Health for herself and 2 staff nurses to give for Employee Health.  This nurse obtained the vaccine from the pharmacy looked at the label saw it said Moderna while drawing was the 5 dose vial but did not look at close enough to realize it did not say Bivalent.  When one of the other staff realized we would need more drawn as we had 1 dose left she went to draw more and discovered the vaccine vial that was drawn from was Moderna but it did not say Bivalent and showed this to me after she had started to draw doses. Immediately we realized the error together and contacted the other nurse to not give any more of the pre-drawn vaccine doses that I had drawn up for them to administer.  We determined that 4 employees had received the CoVid Moderna Booster and not the Bivalent Booster.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthritis, Joint injury, Massage, Mobility decreased, Pain in extremity
Clinical narrative: Patient explained that about an hour after receiving the vaccine she had a lot of pain in her arm. By the next morning she could not move her arm. She went to Urgent care on 10/01/22. There they took an x-ray and told her it was damage to the joint and she had inflammation there.  She has been using OTC ibuprofen, ice, and massage to help alleviate the pain.  She is still having a lot of pain and is following up with her PCP. She has since regained some range of motion in the arm.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: X-ray limb abnormal
Clinical narrative: Patient explained that about an hour after receiving the vaccine she had a lot of pain in her arm. By the next morning she could not move her arm. She went to Urgent care on 10/01/22. There they took an x-ray and told her it was damage to the joint and she had inflammation there.  She has been using OTC ibuprofen, ice, and massage to help alleviate the pain.  She is still having a lot of pain and is following up with her PCP. She has since regained some range of motion in the arm.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Glycosylated haemoglobin increased, Paraesthesia
Clinical narrative: In May of 2022 I noticed tingling in my feet especially when I was in bed.  In August 2022 I noticed my A1C and it was 8.2 which was high.  Three months before that it was 6.8.  I got another glucose monitor and began to check daily.  Average daily is 189.  Mine for about the last month and every morning it is 180 or so constantly high.  I have an appointment with an endocrinologist at the end of Halloween.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Headache, Pain in extremity, Rash, Urticaria
Clinical narrative: Soreness in upper arm for 48 hours with a rash and hives.  Had a bad headache the night and morning after the vaccine was given.  Rash on arm is persisting.
Age: 32.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: The intern, administered the Moderna Bivalent Vaccine.  Part of the vaccine solution leaked out of the syringe.  It was determined by the intern and patient that more that 50% of the vaccine was administered.  Moderna and CDC were both contacted and it was not recommended to revaccinate since more than 50% was received.   Case was submitted to Moderna by both the patient and intern.
Age: 32.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: The intern, administered the Moderna Bivalent Vaccine.  Part of the vaccine solution leaked out of the syringe.  It was determined by the intern and patient that more that 50% of the vaccine was administered.  Moderna and CDC were both contacted and it was not recommended to revaccinate since more than 50% was received.   Case was submitted to Moderna by both the patient and intern.
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient received Flu vaccine on 09/22/2022 and believed it was a COVID vaccine. He attended a Flu clinic and received a Fluava; Quad Lot # K7752 Exp. 06/30/2023 vaccine because he did not realize he had already had a 2022 Flu vaccine administered.
Age: 73.0
Sex: M
Vaccine: FLUA4
Symptoms: Rash
Clinical narrative: Patient went to ER shortly after receiving vaccine. Had rash up arm and across chest. Thought could be related to vaccine.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Wrong vaccination administered
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Atrial flutter, Chest X-ray, Electrocardiogram abnormal
Clinical narrative: atrial flutter several hours resolved on its own
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: I have had a metalic tatse in my mouth ever since the booster shot i got in june. and its constant. has not gone away at all.
Age: 14.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Fall, Loss of consciousness, Syncope
Clinical narrative: Patient received a flu shot initially, then shortly after received a COVID Pfizer bivalent vaccine, then he fainted, fell off his chair, then regained conscious right after, seemed okay, left the facility walking,
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Loss of consciousness, Nausea, Syncope
Clinical narrative: 15 minutes after vaccination the patient was by the reception area and started to feel feint. A nurse nearby guided her to a chair. Patient lost consciousness for a few seconds. EMS was called. Patient's breathing remained normal and pulse was at 60 normal quality. Patient stated she was going to vomit, but did not. Patient stated she has feinted 4 or 5 times related to blood draws. EMS arrived at approx. 2:50PM. Patient refused transport and stayed for approximately 40 minutes. She stated she was now feeling fine and left.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Device dislocation, Incorrect dose administered, Syringe issue
Clinical narrative: Patient was receiving Moderna Bivalent Booster vax. While getting the vaccine, the needle dislodged from syringe.  Shot giver inserted the needle into pt's arm. At the time of pushing the plunger, shot giver and pt felt being splashed by the vaccine. The needle was on pt's arm and syringe was empty on shot giver's hand. Shot giver removed needle from pt's arm. Shot giver and pt are not sure on how much vaccine was injected.  Patient described as she heard a pop when it happened and then felt the splash on her face and dripping on her arm. Pt. stayed at observation for 15 minutes, she was feeling fine before leaving.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypersensitivity, Injection site mass, Injection site pain, Injection site swelling, Neck pain
Clinical narrative: patient came to pharmacy with her left arm swollen in several places below  the injection site in a non-uniform manner.  her arm was warm to the touch and she complained that it "felt weird".  the pain was up to her neck and down to past her elbow.  the swelling was in lumps.  she said her arm started to hurt the evening of getting her shot and continued to ache.  We had told her she should get that looked at by a physician.  I spoke with the  patient after she went to see a doctor.  they told her to take benadryl and ice the area down stating it was an allergic rxn.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity, Sensory disturbance, Skin warm
Clinical narrative: patient came to pharmacy with her left arm swollen in several places below  the injection site in a non-uniform manner.  her arm was warm to the touch and she complained that it "felt weird".  the pain was up to her neck and down to past her elbow.  the swelling was in lumps.  she said her arm started to hurt the evening of getting her shot and continued to ache.  We had told her she should get that looked at by a physician.  I spoke with the  patient after she went to see a doctor.  they told her to take benadryl and ice the area down stating it was an allergic rxn.
Age: 11.0
Sex: F
Vaccine: UNK
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was given the incorrect pfizer bivalent 12+ vaccine while being 11 years old.  Mop and PCP were informed.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, SARS-CoV-2 test positive, Sepsis, Systemic inflammatory response syndrome
Clinical narrative: Patient received Moderna COVID vaccine on 2/11/21, 3/11/21, and 11/2/21. On 10/1/22, patient admitted to our inpatient facility (med/surg unit) with COVID infection, SIRS/sepsis, and generalized weakness. Patient was discharged home on 10/5/22.
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Patient came to pharmacy on 10/4 after receiving vaccine to complain of severe arm pain with a picture of supposed location of immunization taken by patient. I had a conversation with him about the staff member who administered the vaccine and asked about his present symptoms. Reassured patient that staff member would immediately be re-trained and patient asked to be updated after.
Age: 14.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Product administered to patient of inappropriate age
Clinical narrative: The immunizer gave patient Moderna Bivalent per dad's request without verifying eligibility. Pharmacist called to follow up with dad. Per dad, pt was feeling fine, just a little tired. Dad was counseled to monitor patient closely and notify doctor if any abnormal symptoms. Dad did not us to notify doctor.
Age: 25.0
Sex: F
Vaccine: COVID19-2
Symptoms: Loss of consciousness, Seizure like phenomena
Clinical narrative: Patient blacked out and appeared to have a seizure, 911 was called and evaluated patient. Patient recovered and did not go to hospital.
Age: 21.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Pfizer monovalent was given beyond 72 days from the time the vaccine was transferred by original box of Pfizer to the pharmacy refrigerator.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, COVID-19, Chills, Cough, Headache
Clinical narrative: Contacted Covid19.  High Temp, Sore Throat, Chills, Aches, General Not Feeling  Well, Sneezing (significant), Dry Cough, Headache
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Oropharyngeal pain, Pain, SARS-CoV-2 test positive, Sneezing
Clinical narrative: Contacted Covid19.  High Temp, Sore Throat, Chills, Aches, General Not Feeling  Well, Sneezing (significant), Dry Cough, Headache
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: patient developed a rash below injection site day after injection
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Blood culture positive, COVID-19, Pneumonia bacterial, SARS-CoV-2 test positive
Clinical narrative: Patient received Pfizer COVID vaccine on 2/27/21, 3/19/21, 8/31/21, and 3/23/22. On 10/2/22, patient admitted to our inpatient facility (med/surg unit) with acute hypoxic respiratory failure and sepsis secondary to COVID infection and bacterial PNA (during hospitalization, blood culture was positive for strep pneumo). Patient was discharged home on 10/5/22.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Sepsis, Streptococcus test positive
Clinical narrative: Patient received Pfizer COVID vaccine on 2/27/21, 3/19/21, 8/31/21, and 3/23/22. On 10/2/22, patient admitted to our inpatient facility (med/surg unit) with acute hypoxic respiratory failure and sepsis secondary to COVID infection and bacterial PNA (during hospitalization, blood culture was positive for strep pneumo). Patient was discharged home on 10/5/22.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nervous system disorder, Pain
Clinical narrative: constant pain, tightness, and nerve reaction in arm where shot was given
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pfizer dose was given beyond 72 days.  Pharmacist is waiting from the response of the Supply Chain Quality Team on the stability of the Pfizer vaccine lot # FP7139
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Ketoacidosis, Metabolic encephalopathy, SARS-CoV-2 test positive
Clinical narrative: Patient received Pfizer COVID vaccine on 3/3/21, 3/25/21, 8/23/21, and 3/30/22. On 10/2/22, patient was admitted to our inpatient facility (med/surg unit) with COVID-19 infection, acute metabolic encephalopathy, and ketoacidosis. As of today (10/6/22), patient is still admitted in the med/surg unit.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient was administered 0.2ml of the Pfizer pediatric dose.  However, the vaccine given had expired 5 days prior.  the lot number expired 09/30/2022 and the vaccine was given 10/05/2022.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: patients rt arm became swollen, red, hot, and painful Tues night after getting the fluzone HD. Symptoms did not subside by Wed night so patient was seen and prescribed keflex
Age: 15.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Endotracheal intubation, Intensive care, Pyrexia, Tachycardia, Unresponsive to stimuli
Clinical narrative: SUDDEN FEVER, UNRESPONSIVE, TACHYCARDIA. ER ARRIVAL 10/4/2022@ 0345. PT TRANSFERED TO ICU HOSPITAL 10/4/2022@0850. PT INTUBATED AT TIME OF TRASFER.
Age: 35.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Deafness bilateral
Clinical narrative: Loss of hearing in both ears.
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 10yo (nearly 11yo) received 12+ Pfizer vaccine
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Tenderness
Clinical narrative: Lymphadenopathy on ipsilateral size in a axillary and infraclavicle site. Size 2-3 inches. No tender at first them tenderness from compression on other tissues. None
Age: 40.0
Sex: M
Vaccine: UNK
Symptoms: Headache, SARS-CoV-2 test negative
Clinical narrative: Monkey Pox vaccine given 9/24/22. 2 days later he started having headaches. Not severe but persistent going going on for 11 days.  No other neurological concerns No viral illesses  Seems related to vaccine but seemed to have lasted longer than expected
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, COVID-19, Chest pain, Chills
Clinical narrative: Vaccination received 8:15PM 4/13/22 at pharmacy.  Onset of symptoms at 10:30PM  ? Onset of pronounced fatigue and mild soreness at injection site. Went to bed with a mild headache.  4/14/22: Pt tested positive for COVID-19 this day. Pain at injection site. Woke with nausea, diarrhea, post nasal drip and sinus congestion, moderate headache; severe low back pain, diffuse joint pain, and muscle aches at 9/10 on VAS. Restlessness, tachycardia, sharp chest pains, profound fatigue, very cold with chills, temp 97.3.   4/15/22: Pain at injection site. Restlessness, nausea, headache and chills resolved. Diarrhea, post nasal drip and sinus congestion; low back pain, diffuse joint pain, and muscle aches at 8/10. Periodic tachycardia and sharp chest pains, very tired.  4/16/22: Soreness at injection site. Restlessness, nausea, headache, chills, diarrhea, tachycardia and sharp chest pains resolved. Post nasal drip and sinus congestion; low back pain, diffuse joint pain, and muscle aches at 3/10 on VAS. Still very tired.  4/17/22: Mild soreness, itching, swelling, and redness at injection site. Post nasal drip and sinus congestion; low back pain, diffuse joint pain, and muscle aches at 2/10 on VAS. Still very tired.  4/18/22: Mild soreness, itching, swelling, and redness at injection site. Post nasal drip and sinus congestion; fatigue, low back pain, diffuse joint pain, and muscle aches resolved.    4/19/22: All symptoms resolved. No use of Bactroban.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Feeling cold, Headache, Injection site erythema
Clinical narrative: Vaccination received 8:15PM 4/13/22 at pharmacy.  Onset of symptoms at 10:30PM  ? Onset of pronounced fatigue and mild soreness at injection site. Went to bed with a mild headache.  4/14/22: Pt tested positive for COVID-19 this day. Pain at injection site. Woke with nausea, diarrhea, post nasal drip and sinus congestion, moderate headache; severe low back pain, diffuse joint pain, and muscle aches at 9/10 on VAS. Restlessness, tachycardia, sharp chest pains, profound fatigue, very cold with chills, temp 97.3.   4/15/22: Pain at injection site. Restlessness, nausea, headache and chills resolved. Diarrhea, post nasal drip and sinus congestion; low back pain, diffuse joint pain, and muscle aches at 8/10. Periodic tachycardia and sharp chest pains, very tired.  4/16/22: Soreness at injection site. Restlessness, nausea, headache, chills, diarrhea, tachycardia and sharp chest pains resolved. Post nasal drip and sinus congestion; low back pain, diffuse joint pain, and muscle aches at 3/10 on VAS. Still very tired.  4/17/22: Mild soreness, itching, swelling, and redness at injection site. Post nasal drip and sinus congestion; low back pain, diffuse joint pain, and muscle aches at 2/10 on VAS. Still very tired.  4/18/22: Mild soreness, itching, swelling, and redness at injection site. Post nasal drip and sinus congestion; fatigue, low back pain, diffuse joint pain, and muscle aches resolved.    4/19/22: All symptoms resolved. No use of Bactroban.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Myalgia, Nausea
Clinical narrative: Vaccination received 8:15PM 4/13/22 at pharmacy.  Onset of symptoms at 10:30PM  ? Onset of pronounced fatigue and mild soreness at injection site. Went to bed with a mild headache.  4/14/22: Pt tested positive for COVID-19 this day. Pain at injection site. Woke with nausea, diarrhea, post nasal drip and sinus congestion, moderate headache; severe low back pain, diffuse joint pain, and muscle aches at 9/10 on VAS. Restlessness, tachycardia, sharp chest pains, profound fatigue, very cold with chills, temp 97.3.   4/15/22: Pain at injection site. Restlessness, nausea, headache and chills resolved. Diarrhea, post nasal drip and sinus congestion; low back pain, diffuse joint pain, and muscle aches at 8/10. Periodic tachycardia and sharp chest pains, very tired.  4/16/22: Soreness at injection site. Restlessness, nausea, headache, chills, diarrhea, tachycardia and sharp chest pains resolved. Post nasal drip and sinus congestion; low back pain, diffuse joint pain, and muscle aches at 3/10 on VAS. Still very tired.  4/17/22: Mild soreness, itching, swelling, and redness at injection site. Post nasal drip and sinus congestion; low back pain, diffuse joint pain, and muscle aches at 2/10 on VAS. Still very tired.  4/18/22: Mild soreness, itching, swelling, and redness at injection site. Post nasal drip and sinus congestion; fatigue, low back pain, diffuse joint pain, and muscle aches resolved.    4/19/22: All symptoms resolved. No use of Bactroban.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Restlessness, SARS-CoV-2 test positive, Sinus congestion, Tachycardia, Upper-airway cough syndrome
Clinical narrative: Vaccination received 8:15PM 4/13/22 at pharmacy.  Onset of symptoms at 10:30PM  ? Onset of pronounced fatigue and mild soreness at injection site. Went to bed with a mild headache.  4/14/22: Pt tested positive for COVID-19 this day. Pain at injection site. Woke with nausea, diarrhea, post nasal drip and sinus congestion, moderate headache; severe low back pain, diffuse joint pain, and muscle aches at 9/10 on VAS. Restlessness, tachycardia, sharp chest pains, profound fatigue, very cold with chills, temp 97.3.   4/15/22: Pain at injection site. Restlessness, nausea, headache and chills resolved. Diarrhea, post nasal drip and sinus congestion; low back pain, diffuse joint pain, and muscle aches at 8/10. Periodic tachycardia and sharp chest pains, very tired.  4/16/22: Soreness at injection site. Restlessness, nausea, headache, chills, diarrhea, tachycardia and sharp chest pains resolved. Post nasal drip and sinus congestion; low back pain, diffuse joint pain, and muscle aches at 3/10 on VAS. Still very tired.  4/17/22: Mild soreness, itching, swelling, and redness at injection site. Post nasal drip and sinus congestion; low back pain, diffuse joint pain, and muscle aches at 2/10 on VAS. Still very tired.  4/18/22: Mild soreness, itching, swelling, and redness at injection site. Post nasal drip and sinus congestion; fatigue, low back pain, diffuse joint pain, and muscle aches resolved.    4/19/22: All symptoms resolved. No use of Bactroban.
Age: 3.0
Sex: M
Vaccine: UNK
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: His arm became swollen to tennis ball size off center from injection site. It was warm and hard to the touch about an inch below the injection site
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site red, swollen and itchy
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: Rash all over body
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Malaise, Tremor
Clinical narrative: Woke up with chills, shaking, overall malaise that I had never experienced before.  Took 30 minutes to get out of bed and take Extra Strength Tylenol.  Symptoms dissipated in about 30 minutes.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site nodule, Injection site warmth
Clinical narrative: nodule at injection site, warm sensation at injection site
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received expired dose of Pfizer monovalent
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product preparation error
Clinical narrative: Patient was given pediatric pfizer 10MCG/0.2ML that was undiluted.  Patient's father was notified asked to watch for any adverse events such as sore arm, tiredness, fever.  Told father than if a severe reaction such as anaphylaxis occur to call 911.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Influenza virus test negative, Oropharyngeal pain, Pyrexia
Clinical narrative: started with a sore throat... throat condition worsened... was in undisclosed location, went to urgent care, they indicated results from flu, strep, and covid were negative... started a slight fever, tired.. returned home. took a covid home test two days after urgent care and results were positive.. contacted my dr. who then prescribed paxlovid and z pak...   My throat was the worse that happened.. was over within 5 days.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: started with a sore throat... throat condition worsened... was in undisclosed location, went to urgent care, they indicated results from flu, strep, and covid were negative... started a slight fever, tired.. returned home. took a covid home test two days after urgent care and results were positive.. contacted my dr. who then prescribed paxlovid and z pak...   My throat was the worse that happened.. was over within 5 days.
Age: 11.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Anxiety, Fall, Hypotonia, Loss of consciousness, Memory impairment
Clinical narrative: Patient came in with her mother and her sister for two vaccines. She was hesitant (anxious) to receive her vaccines, but eventually agreed. She received her Tdap in her left arm first, then we stood her up to flip the chair around and she sat down to receive her flu shot in her right arm.  A few seconds after she received her flu vaccines she lost consciousness for a few seconds which caused her to slump into the chair. I was able to place my hand  under her neck to support it. A second later she opened her eyes - they dilated and she arched her back out of the chair, fell forward and shook for a few seconds as I tried to lay her on the ground. She became alert immediately as I laid her on the ground and asked what happened. After that she was alert and oriented and had no other symptoms. Mom stated she has passed out from a vaccine before but she didn't shake in the past. She sat on the ground with her head between her legs as I administered her mom's and sister's vaccines. After that she was steady enough to leave. I called the mother a couple of hours later to check in and she said she was fine, no swelling at the injection site and no other adverse events after leaving the pharmacy.
Age: 11.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Mydriasis, Tremor
Clinical narrative: Patient came in with her mother and her sister for two vaccines. She was hesitant (anxious) to receive her vaccines, but eventually agreed. She received her Tdap in her left arm first, then we stood her up to flip the chair around and she sat down to receive her flu shot in her right arm.  A few seconds after she received her flu vaccines she lost consciousness for a few seconds which caused her to slump into the chair. I was able to place my hand  under her neck to support it. A second later she opened her eyes - they dilated and she arched her back out of the chair, fell forward and shook for a few seconds as I tried to lay her on the ground. She became alert immediately as I laid her on the ground and asked what happened. After that she was alert and oriented and had no other symptoms. Mom stated she has passed out from a vaccine before but she didn't shake in the past. She sat on the ground with her head between her legs as I administered her mom's and sister's vaccines. After that she was steady enough to leave. I called the mother a couple of hours later to check in and she said she was fine, no swelling at the injection site and no other adverse events after leaving the pharmacy.
Age: 37.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: Muffled hearing , increased sensitivity, louder tinnitus in left ear.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy bone, Biopsy uterus, Colonoscopy, Computerised tomogram, Endoscopic retrograde cholangiopancreatography
Clinical narrative: I don't know if this event and the vaccine are related, but I had a menstrual period that started 8/7/21 and lasted about 10 days. This resulted in 6 months of cancer screening including 12 procedures over 6 months, including 3 biopsies.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Magnetic resonance imaging, Scan with contrast, X-ray
Clinical narrative: I don't know if this event and the vaccine are related, but I had a menstrual period that started 8/7/21 and lasted about 10 days. This resulted in 6 months of cancer screening including 12 procedures over 6 months, including 3 biopsies.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Basedow's disease
Clinical narrative: Graves Disease
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: The pfizer covid-19 vaccine 12+ gray cap was pulled from the fridge instead of the pfizer covid-19 Bivalent 12+ gray cap vial.  This was not noticed until pharmacist on duty was reporting waste report into the pharmacy computer system and the lot# and vial information did not match the Pfizer Bivalent vaccine.  Patient was called the phone number on file did not work.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: The pfizer covid-19 vaccine 12+ gray cap was pulled from the fridge instead of the pfizer covid-19 Bivalent 12+ gray cap vial.  This was not noticed until pharmacist on duty was reporting waste report into EPRN and the lot# and vial information did not match the Pfizer Bivalent vaccine.  Patient was called and voice message was left. They are eligible get the new booster in 2 months time.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Incorrect product formulation administered
Clinical narrative: The pfizer covid-19 vaccine 12+ gray cap was pulled from the fridge instead of the pfizer covid-19 Bivalent 12+ gray cap vial.  This was not noticed until pharmacist on duty was reporting waste report into EPRN and the lot# and vial information did not match the Pfizer Bivalent vaccine.  Patient was called and left a voicemail. They could get the new booster in 2 months time.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blister, Facial discomfort, Headache, Herpes zoster
Clinical narrative: Five days after the vaccine (8/20) I started having a headache but didn't realize what was going on.  I also had a SEVERE ache in my left shoulder and back so bad that I could not sleep. Seven days after the vaccine (8/22) I had a very red eye and strange feelings in my face.  Symptoms started getting worse and worse but I was unable to get to urgent care until 8/28 when I was diagnosed with shingles in my face and left eye.  I had blisters on the left side of my face, could not sleep , blisters in my eye socket and eyeball.  I began steroids and anti-viral meds immediately and symptoms began to subside within four days.  Today I just have some residual discomfort in my face, occasional shooting pains in my head, and scarring between my eyes.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Insomnia, Ocular hyperaemia, Pain, Scar
Clinical narrative: Five days after the vaccine (8/20) I started having a headache but didn't realize what was going on.  I also had a SEVERE ache in my left shoulder and back so bad that I could not sleep. Seven days after the vaccine (8/22) I had a very red eye and strange feelings in my face.  Symptoms started getting worse and worse but I was unable to get to urgent care until 8/28 when I was diagnosed with shingles in my face and left eye.  I had blisters on the left side of my face, could not sleep , blisters in my eye socket and eyeball.  I began steroids and anti-viral meds immediately and symptoms began to subside within four days.  Today I just have some residual discomfort in my face, occasional shooting pains in my head, and scarring between my eyes.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: Five days after the vaccine (8/20) I started having a headache but didn't realize what was going on.  I also had a SEVERE ache in my left shoulder and back so bad that I could not sleep. Seven days after the vaccine (8/22) I had a very red eye and strange feelings in my face.  Symptoms started getting worse and worse but I was unable to get to urgent care until 8/28 when I was diagnosed with shingles in my face and left eye.  I had blisters on the left side of my face, could not sleep , blisters in my eye socket and eyeball.  I began steroids and anti-viral meds immediately and symptoms began to subside within four days.  Today I just have some residual discomfort in my face, occasional shooting pains in my head, and scarring between my eyes.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: The pfizer covid-19 vaccine 12+ gray cap was pulled from the fridge instead of the pfizer covid-19 Bivalent 12+ gray cap vial.  This was not noticed until pharmacist on duty was reporting waste report into EPRN and the lot# and vial information did not match the Pfizer Bivalent vaccine.  Patient was called and he states he would return in in 2 months time to get the Bivalent vaccine.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Wrong product administered
Clinical narrative: The pfizer covid-19 vaccine 12+ gray cap was pulled from the fridge instead of the pfizer covid-19 Bivalent 12+ gray cap vial.  This was not noticed until pharmacist on duty was reporting waste report into EPRN and the lot# and vial information did not match the Pfizer Bivalent vaccine.  Patient was called she appreciated the call to let her know what happened.  She plans to call her provider in the morning. She can get the new booster in 2 months time.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Severe bloody nose multiple times today. Gushing blood from the nasal cavity. Bled through everything we tried to use to stop it including a tampon in a matter of less than a couple minutes.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Product availability issue
Clinical narrative: gave monovalent moderna covid booster. The state had not yet issue vs the bivalent covid vaccine.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Product availability issue
Clinical narrative: gave monovalent moderna covid booster. The state had not yet issued us the bivalent covid vaccine.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Incident: Patient was given Monovalent vaccine on 9/28/22 after the CDC update recommendation to the Bivalent Booster dose.
Age: 1.5
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received second influenza vaccine this season. First dose: 10/3/2022. Second dose 10/6/2022. No adverse reaction after immunizations given. Parent advised to monitor for increased soreness, fever or other adverse reaction.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: Patient received Monovalent COVID-19 vaccine. Recommendations from ACIP/CDC updated on 9/2/22 to discontinue Monovalent COVID-19 Boosters and to begin using BIVALENT COVID-19 Boosters.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: Patient received Monovalent COVID-19 vaccine. Recommendations from ACIP/CDC updated on 9/2/22 to discontinue Monovalent COVID-19 Boosters and to begin using BIVALENT COVID-19 Boosters.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: Patient received Monovalent COVID-19 vaccine. Recommendations updated on 9/2/2022 to discontinue Monovalent COVID-19 Boosters and to begin using BIVALENT COVID-19 Boosters.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: Patient received Monovalent COVID-19 vaccine. Recommendations updated on 9/2/22 to discontinue Monovalent COVID-19 Boosters and to begin using BIVALENT COVID-19 Boosters.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: Patient received Monovalent COVID-19 vaccine. Recommendations updated on 9/2/22 to discontinue Monovalent COVID-19 Boosters and to begin using BIVALENT COVID-19 Boosters.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: Patient received Monovalent COVID-19 vaccine. Recommendations updated on 9/2/22 to discontinue Monovalent COVID-19 Boosters and to begin using BIVALENT COVID-19 Boosters.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: Patient received Monovalent COVID-19 vaccine. Recommendations updated on 9/2/22 to discontinue Monovalent COVID-19 Booster and to begin using BIVALENT COVID-19 Boosters.
Sex: U
Vaccine: COVID19
Symptoms: Nasal congestion, Vaccination site pain
Clinical narrative: tenderness/soreness at the injection site; mild nasal congestion; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), 12 hrs after the suspect product(s) administration, outcome "unknown", described as "tenderness/soreness at the injection site"; NASAL CONGESTION (non-serious), 12 hrs after the suspect product(s) administration, outcome "unknown", described as "mild nasal congestion". The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 4.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pfizer BioNTech Covid 19 Vaccine, Bivalent EUA given to 4-year-old, not approved for emergency use at this age group. Only approved for 12 years of age and older. Received full dose for 12 years of age and older.
Age: 4.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect dose administered, Incorrect product formulation administered, Product administered to patient of inappropriate age
Clinical narrative: Pfizer BioNTech Covid 19 Vaccine, Bivalent EUA given to 4-year-old, not approved for emergency use at this age group. Only approved for 12 years of age and older. Received full dose for 12 years of age and older.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: no adverse event; HCP reported that a patient missed a dose of VARIVAX; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 30-AUG-2022, the patient missed a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dosage regimen, lot #, and expiry date were not provided) since the pharmacist was out of sterile diluent to reconstitute the vaccine. The reporter stated that it was unknown if it was the 1st or the 2nd dose for the patient. No adverse event was reported.  This is a non-valid case due to lack of patient's identifiers.  Follow-up information has been received from the pharmacist on 03-OCT-2022.  This case was previously considered non-valid due to lack of patient's identifiers, but after follow-up information, the case is now valid.   This case was regarding a female patient of unknown age.
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: MMR II that had undergone temperature excursion was administered; No additional AE reported; This spontaneous report was received from a physician's office manager and refers to a male patient, who would be 5 years old at the reporting time. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) subcutaneous injection, lot # T034388 was confirmed to be valid, expiration date 08-OCT-2022, administered for prophylaxis (dose, route of administration, and anatomical location were not reported). Administered dose of the vaccine was stored in temperature of 54.7 degrees Fahrenheit for 58 minutes.  There were no previous temperature excursions reported. There was no additional adverse event reported (No adverse event).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA002449:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE details available; Improperly stored vaccine administered / temperature above 46F (62.8F); This spontaneous report was received from an unspecified reporter and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions or concomitant therapies were not reported.  On 07-SEP-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #1879864, expiration date: 19-OCT-2023; route of administration defaulted to oral, dose was not reported), that was improperly stored.  Storage and temperature excursion details: Temperature: above 46 degrees Fahrenheit (62.8 degrees Fahrenheit) Time frame: 8 hours 0 minutes and 0 seconds Previous temperature excursion? No  No additional adverse event (AE) details available.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: NO additioanll AE details available; improperly stored vaccina administered/ temperature above 46 F (62.8 F); This spontaneous report was received from an unspecified reporter and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions or concomitant therapies were not reported.  On 06-SEP-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #1879864, expiration date: 19-OCT-2023; route of administration defaulted to oral, dose was not reported), that was improperly stored.  Storage and temperature excursion details: Temperature: above 46 degrees Fahrenheit (62.8 degrees Fahrenheit) Time frame: 8 hours 0 minutes and 0 seconds Previous temperature excursion? No  No additional adverse event (AE) details available.
Age: 3.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; Patient is three years and three months old and was not yet due for second dose of PROQUAD.; This spontaneous report was received from a nurse practitioner referring a 3 years and 3 months old patient of unknown gender. The patient's historical vaccines included measles mumps rubella vaccine and varicella vaccine (both manufacturer unknown). Pertinent medical history, drug Drug reactions, allergies and concomitant medications were not reported.  On 06-SEP-2022, the patient was accidentally vaccinated earlier than indicated with a second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) subcutaneous injection, once, lot number W012739 with expiration date 16-OCT-2023, administered for prophylaxis (strength, dose, anatomical location, and route of administration not provided) (product administered to patient of inappropriate age).  No adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; expired dose of PROQUAD was administered to a patient on 7SEP2022; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 07-SEP-2022, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA) subcutaneous injection, 0.5 ml, for prophylaxis (anatomical location, and route of administration were not provided), lot # U007504 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA), expiration date upon internal validation established as 04-SEP-2022 (the same as reported) (expired product administered). Administered vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) was not involved in temperature excursion through the date of administration.  There were no adverse events reported (no adverse event).
Sex: M
Vaccine: HPV9
Symptoms: Off label use
Clinical narrative: Consumer's husband has had unspecified polyps removed from his throat "multiple times."  His physician has recommended GARDASIL 9 in hopes of preventing the polyps from coming back. Consumer reported that the physician referenced an unspecified rese; This spontaneous report was received from consumer's wife and refers to a male patient of unspecified age. The patient's medical history included unspecified polyps, and throat polyps removal. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient's physician has recommended hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection for preventing the polyps from coming back (dose, strength, lot #, expiry date, and route of administration were not provided) (off label use).
Sex: F
Vaccine: HPV4
Symptoms: Colonoscopy, Human papilloma virus test positive
Clinical narrative: Caller reported a patient who was fully vaccinated with GARDASIL as an adolescent is now positive with HPV.; patient required a colposcopy; This spontaneous report was received from physician via a company representative and refers to a 29-year-old female. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, when the patient was an adolescent, was fully vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot #, and expiry date were not provided) for prophylaxis.  On an unknown date (also reported as now), the patient was positive with Human papillomavirus (HPV). On an unknown date, she required a colposcopy, but the reporter did no had any more information on this event. The outcome of both events was unknown.  The causal relationship between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Endotracheal intubation, Seizure
Clinical narrative: Specialist transferred physician who is requesting guidance on use of MMRII after an unspecified patient experienced a seizure that resulted in intubation. She states that earlier in the day the patient had received MMRII, VARIVAX and an unspecified; This spontaneous report was received from a physician and refers to a male patient of an unknown age. The patient's medical history was not reported. Concomitant therapies were not reported. On 21-SEP-2022, the patient was vaccinated with non-merck hepatitis A vaccine, with varicella virus vaccine live (oka/merck) (VARIVAX) and with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, lot #, expiry date, and route of administration were not provided for all) all for prophylaxis. On the same day, he experienced seizure, that resulted in intubation. He sought medical attention. The outcome of the event was unknown. Relatedness between the event and suspect vaccines was not reported.  Upon internal review, the event of seizure was considered to be medically significant.