chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Starting 11/1/2022, child developed an increasing area of redness around the vaccination site, to 10 x 12 cm circular area with intense redness, warmth, no induration.  This progressed despite starting Amoxicillin for her right otitis media on the same day the redness started. The area was itchy, only painful if prodded. It was treated with a combination of Benadryl orally and topical antibiotic.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine vial stored for longer than recommended time post puncture (up to 28 days) No adverse effects
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Adverse event, Blood test, Computerised tomogram, Renal infarct
Clinical narrative: Several adverse events have occurred since 3rd dose (Moderna)-Lot number 039d21A) on 10/28/21- March 2022 Heart attack. March 2022, Stroke 3 weeks after heart attack. On 10/18/22 received the Pfizer BV-lot number6J6665 at  Pharmacy.  On 10/29/22 Arrived at the Emergency Department at Hospital with an admission to Hospital. Discharge date 11/1/2022 medical determination of Renal Infarction. Doses received  1st Moderna-027A21A on 3/5/21 2nd Moderna- 039A21A on 4/2/21 3rd Moderna- 039d21A on 10/28/22 4th Pfizer- 6J6665 on 10/18/22
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Pt was given vaccine from a bottle that was in the refrigerator on day 31. Moderna was notified and they returned information stating the the vaccine should be fine and it should still be effective, but patient may get another if they feel it is necessary, attempted to call Pt left Voice messages on his phone will information and call back #'s
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: I had my vaccination on 10/29/2021. On 04/010/2022 I was exposed to COVID and took tests daily. I tested COVID-19 Positive on 04/12/2022. I began isolation with over-the-counter medication to include Tylenol Motril Tea and Mucinex. I tested COVID-19 Positive for 15 days.  I did have a lingering cough for months but it could have been due to reflux or COVID-19.
Age: 7.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product preparation error
Clinical narrative: Pt reported no adverse event at contact time of informing pt's family of administering increased concentration of vaccine
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine vial store for longer than recommended post puncture of vial (potentially up to 28 days) no adverse reaction
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Chills, Cough, Dyspnoea, Headache
Clinical narrative: On September 23, 2022, I had a very bad headache followed by body aches, cough, and runny nose. Most of my pain is in my back area near my lungs and shoulders.  I have breathing issues.  I now must use my inhaler almost 4 hours a day.  My cough has gotten better but I still have the runny nose.  I have not had a fever, but I did experience chills and sweaty spells mostly at night.  Since September 20th, I have seen my asthma doctor and my regular doctor.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hyperhidrosis, Pain, Rhinorrhoea
Clinical narrative: On September 23, 2022, I had a very bad headache followed by body aches, cough, and runny nose. Most of my pain is in my back area near my lungs and shoulders.  I have breathing issues.  I now must use my inhaler almost 4 hours a day.  My cough has gotten better but I still have the runny nose.  I have not had a fever, but I did experience chills and sweaty spells mostly at night.  Since September 20th, I have seen my asthma doctor and my regular doctor.
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pharyngeal swelling
Clinical narrative: I have never had a problem before, and I asked If I could just leave after the vaccine. When I was driving down the road, I started noticing swelling in my throat about 15 minutes after receiving my vaccine. I went to urgent care, and they told me to take BENADRYL, and to come back if things got worse. The BENADRYL cleared it up and I didn't have any other issues.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Atrial fibrillation, Cardiac ablation, Cardioversion, Chest discomfort, Chest pain
Clinical narrative: She got her vaccine, didn't have any problems for the first 3 days.  Then on Thursday she started having some swelling in her left ankle  Friday night she felt a little different, a little off, could not sleep and could not tell what the issue was.  On Saturday night she did an EKG on her apple watch and it was all over the place and it told her that she was in A-fib and her heart rate was 164.   She called her daughter who was downstairs and told her what was wrong, her color was really bad, and she told her that she had such pain in her chest, but it was letting up a bit and that it felt like somebody was sitting on her chest.  They did another EKG and hear rate which was down to 152, and the EKG showed squiggly line and very close together.   She is a retired nurse.  She asked if she wanted to go to the hospital and she decided to wait and see if it was better as the pressure was not as bad.  Her son-in-law is a doctor who informed them to get her dressed and take her to the hospital.  She went to the ER and when she got there she her heart rate was between 150-162, they gave her a Digitalis and put her on a drip of that as well.   They hoped that within a few hours to a day that it would come down, but she still had the drip on Monday, and did let her go home on Monday.  They were talking about doing a Cardioversion and it would be another doctor that was not her doctor, so they agreed and discharged her home.   She had an ablation and saw her Cardiologist, this was on 2/8/22 after her first COVID vaccine, she was in Atrial fibrillation and her rate was 179, 162, did go down to 117 on 2/9/22  She saw Dr. on 2/14/22 and had the ablation on 2/28/22 and had a cardioversion following that.  She went into A-fib several different times, after the 1st and 2nd vaccines and kept watching for it and then when she had the 1st booster in October of 2021  things got bad, and had this vaccine and now they want to possibly do another cardioversion and a pacemaker.    She was in the Hospital for 2 days.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Condition aggravated, Electrocardiogram abnormal, Feeling abnormal, Heart rate increased, Insomnia
Clinical narrative: She got her vaccine, didn't have any problems for the first 3 days.  Then on Thursday she started having some swelling in her left ankle  Friday night she felt a little different, a little off, could not sleep and could not tell what the issue was.  On Saturday night she did an EKG on her apple watch and it was all over the place and it told her that she was in A-fib and her heart rate was 164.   She called her daughter who was downstairs and told her what was wrong, her color was really bad, and she told her that she had such pain in her chest, but it was letting up a bit and that it felt like somebody was sitting on her chest.  They did another EKG and hear rate which was down to 152, and the EKG showed squiggly line and very close together.   She is a retired nurse.  She asked if she wanted to go to the hospital and she decided to wait and see if it was better as the pressure was not as bad.  Her son-in-law is a doctor who informed them to get her dressed and take her to the hospital.  She went to the ER and when she got there she her heart rate was between 150-162, they gave her a Digitalis and put her on a drip of that as well.   They hoped that within a few hours to a day that it would come down, but she still had the drip on Monday, and did let her go home on Monday.  They were talking about doing a Cardioversion and it would be another doctor that was not her doctor, so they agreed and discharged her home.   She had an ablation and saw her Cardiologist, this was on 2/8/22 after her first COVID vaccine, she was in Atrial fibrillation and her rate was 179, 162, did go down to 117 on 2/9/22  She saw Dr. on 2/14/22 and had the ablation on 2/28/22 and had a cardioversion following that.  She went into A-fib several different times, after the 1st and 2nd vaccines and kept watching for it and then when she had the 1st booster in October of 2021  things got bad, and had this vaccine and now they want to possibly do another cardioversion and a pacemaker.    She was in the Hospital for 2 days.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Joint swelling, Skin discolouration
Clinical narrative: She got her vaccine, didn't have any problems for the first 3 days.  Then on Thursday she started having some swelling in her left ankle  Friday night she felt a little different, a little off, could not sleep and could not tell what the issue was.  On Saturday night she did an EKG on her apple watch and it was all over the place and it told her that she was in A-fib and her heart rate was 164.   She called her daughter who was downstairs and told her what was wrong, her color was really bad, and she told her that she had such pain in her chest, but it was letting up a bit and that it felt like somebody was sitting on her chest.  They did another EKG and hear rate which was down to 152, and the EKG showed squiggly line and very close together.   She is a retired nurse.  She asked if she wanted to go to the hospital and she decided to wait and see if it was better as the pressure was not as bad.  Her son-in-law is a doctor who informed them to get her dressed and take her to the hospital.  She went to the ER and when she got there she her heart rate was between 150-162, they gave her a Digitalis and put her on a drip of that as well.   They hoped that within a few hours to a day that it would come down, but she still had the drip on Monday, and did let her go home on Monday.  They were talking about doing a Cardioversion and it would be another doctor that was not her doctor, so they agreed and discharged her home.   She had an ablation and saw her Cardiologist, this was on 2/8/22 after her first COVID vaccine, she was in Atrial fibrillation and her rate was 179, 162, did go down to 117 on 2/9/22  She saw Dr. on 2/14/22 and had the ablation on 2/28/22 and had a cardioversion following that.  She went into A-fib several different times, after the 1st and 2nd vaccines and kept watching for it and then when she had the 1st booster in October of 2021  things got bad, and had this vaccine and now they want to possibly do another cardioversion and a pacemaker.    She was in the Hospital for 2 days.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: no symptoms at time of information given to parents about undiluted vaccine given to patient
Age: 50.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired dose given 12 hours after expiration. Vaccine never left out long the 1 minutes to draw up the dose. No complaint of any adverse reactions form the patient. Patientt notified and offered to repeat the dose.
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Cough
Clinical narrative: Chronic cough
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: patient was given a vaccine from a bottle that was 31 days in the refrigerator.  Moderna was notified and they replied statign there should be no problem vaccine should be active But Pt may get another if they choose to., Pt was notified of this event.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Cardiac monitoring, Dyspnoea, Electrocardiogram, Heart rate decreased
Clinical narrative: Trouble breathing, heart rate really high then would drop really low, had a full blown asthma attack, had to go get nebulizer treatment, inhaler and steroids. Was put on heart monitor, had heart sonogram, EKG.  Heart rate is still messed up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Ultrasound scan
Clinical narrative: Trouble breathing, heart rate really high then would drop really low, had a full blown asthma attack, had to go get nebulizer treatment, inhaler and steroids. Was put on heart monitor, had heart sonogram, EKG.  Heart rate is still messed up.
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Infection, Nasal congestion, Oropharyngeal pain, Pyrexia, Upper respiratory tract congestion
Clinical narrative: Breakthrough infection confirmed by antigen test, sore throat, stuffy nose, fever, upper respiratory congestion,.
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Viral test positive
Clinical narrative: Breakthrough infection confirmed by antigen test, sore throat, stuffy nose, fever, upper respiratory congestion,.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Feeling cold, Headache, Muscle spasms, Myalgia
Clinical narrative: chills muscle aches cramps headache burning hip joints
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Delirium, Hypersomnia, Incoherent
Clinical narrative: Patient has been incoherent and showed increased delirium all day and has had difficulty staying awake that has persisted into the evening
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine vial store for longer than recommended post puncture of vial (potentially up to 28 days) no adverse reaction
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: no symptoms
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Diarrhoea, Headache, SARS-CoV-2 test positive
Clinical narrative: I felt drained of energy for two weeks and experienced diarrhea on a daily basis and had mild headaches as well.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a 3rd dose of the Shingrix vaccine. Prior two doses administered in 2019. patient was not experiencing any side effects.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypertension
Clinical narrative: high blood pressure
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Dizziness, Nausea, Oropharyngeal pain
Clinical narrative: Tested positive on 10/25/2022 - Symptoms; sore throat;cough;dizziness nausea body aches and had to sit for the dizziness water. Continued coughing for 5days. Prescribed Paxlovid
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, SARS-CoV-2 test positive
Clinical narrative: Tested positive on 10/25/2022 - Symptoms; sore throat;cough;dizziness nausea body aches and had to sit for the dizziness water. Continued coughing for 5days. Prescribed Paxlovid
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine vial store for longer than recommended post puncture of vial (potentially up to 28 days) no adverse reaction
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Shivering for two hours
Age: 58.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Unevaluable event
Clinical narrative: unknown, could not get ahold of patient despite trying multiple times and multiple phone numbers
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event.  Patient recieved Flu shot by mistake and requested a COVID booster instead.
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Lip swelling, Swelling face
Clinical narrative: Facial and lip swelling
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: Swollen right Calf, right ankle and top of right foot, Symptoms have persisted for 4 weeks.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Asthenia, Bone pain, Brain neoplasm, Fatigue
Clinical narrative: I started experiencing adverse events almost immediately following the vaccine (1st & 2nd dose of Moderna). It started with extreme fatigue, debilitating bone pains and night sweats. After months of tests, they discovered the vaccine gave me a pituitary brain tumor.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Laboratory test, Magnetic resonance imaging head abnormal, Night sweats, Pituitary tumour
Clinical narrative: I started experiencing adverse events almost immediately following the vaccine (1st & 2nd dose of Moderna). It started with extreme fatigue, debilitating bone pains and night sweats. After months of tests, they discovered the vaccine gave me a pituitary brain tumor.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Inflammation, Injection site nodule
Clinical narrative: I had a knot and soreness on injection site. The next day I had a lot of joint pain and swollen in my right hand, fatigue, and headache. The joint pain stayed around for a couple days. I touch my right hand and it was sore. I got to work the next day and my hand was still sore. It was pain shooting through my thumb and wrist. It was nonstop pain to where I got nauseous. I took meds for the pain, but I still had pain all night. I went to my doctor, and she did an x-ray to see if my hand was broken but it was not. She did find inflammation in my hand and wrist.  She prescribed me steroids and gave me a brace so I cannot move it. My arm is getting better now. I can move my wrist now but still a little pain.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Nausea, Orthosis user, Pain, Pain in extremity
Clinical narrative: I had a knot and soreness on injection site. The next day I had a lot of joint pain and swollen in my right hand, fatigue, and headache. The joint pain stayed around for a couple days. I touch my right hand and it was sore. I got to work the next day and my hand was still sore. It was pain shooting through my thumb and wrist. It was nonstop pain to where I got nauseous. I took meds for the pain, but I still had pain all night. I went to my doctor, and she did an x-ray to see if my hand was broken but it was not. She did find inflammation in my hand and wrist.  She prescribed me steroids and gave me a brace so I cannot move it. My arm is getting better now. I can move my wrist now but still a little pain.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, X-ray limb normal
Clinical narrative: I had a knot and soreness on injection site. The next day I had a lot of joint pain and swollen in my right hand, fatigue, and headache. The joint pain stayed around for a couple days. I touch my right hand and it was sore. I got to work the next day and my hand was still sore. It was pain shooting through my thumb and wrist. It was nonstop pain to where I got nauseous. I took meds for the pain, but I still had pain all night. I went to my doctor, and she did an x-ray to see if my hand was broken but it was not. She did find inflammation in my hand and wrist.  She prescribed me steroids and gave me a brace so I cannot move it. My arm is getting better now. I can move my wrist now but still a little pain.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Pruritus, Superficial inflammatory dermatosis, Urticaria
Clinical narrative: Have been battling CHRONIC hives since 1st Pfizer Covid booster.  4 Zyrtec per day has helped suppress this, but still have incidents of itchy hives that appear to be heat/pressure induced.  Early on I used OTC cortisone.  Eased itching, but did NOT eliminate hives.  After seeing dermatologist used Halobetasol Propionate Cream 0.05 % which eliminated itch and hives, but did not prevent additional hives from occurring.  Used Prednisone prescription when hives began appearing after the bi-valent vaccine.  Hives temporarily eliminated, but have returned, occurring sporadically, despit.  Had NO such problems until having the Pfizer Covid vaccine.  Am completely convinced this now chronic condition was caused by vaccine/vaccine booster ingredient.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Lacrimation increased, Oropharyngeal pain
Clinical narrative: Came down with COVID, tested positive 10/31/22. Began Paxlovid evening of 11/1/22. Sore throat, cough, runny nose, teary eyes, tired. Feeling somewhat better 11/2/22, but symptoms continue.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Came down with COVID, tested positive 10/31/22. Began Paxlovid evening of 11/1/22. Sore throat, cough, runny nose, teary eyes, tired. Feeling somewhat better 11/2/22, but symptoms continue.
Age: 7.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Erythema, Fall, Syncope
Clinical narrative: Patient received both vaccines and after 10 minutes she fainted on the floor.  Was transferred to gurney and patient was noted to be awake after she fell, accompanied by mother. Vital signs were stable (BP 91/60, HR 106, T 98.7, O2sat 99%).  Ice pack was applied to redness on forehead. Patient is alert and oriented. Denied pain. Was monitored for 20 more minutes. Cleared by MD to be sent home.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Tinnitus
Clinical narrative: Constant ear ringing.    All day  - 24/7
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product preparation error
Clinical narrative: The pharmacist administered an 0.2 mL of undiluted Pfizer Bivalent Booster for 5-11 years old to the patient at 2 PM on 11/2/22. The pharmacist called the parent the same day at 3:30pm and told her about the incident. She was gracious and understanding of the situation. No adverse effects had been seen in the patient at the time of this call.
Age: 98.0
Sex: F
Vaccine: COVID19-2
Symptoms: Aggression, Altered state of consciousness, Seizure, Troponin increased
Clinical narrative: Seizure activity, aggressive behavior, change in LOC, sent to hospital via EVAC for evaluation and treatment
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: Patient stated she had pain in shoulder, arm and neck after vaccination.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulation drug level below therapeutic, Atelectasis, Bronchiolitis, COVID-19, Cardiac failure congestive
Clinical narrative: Per web report received by local county Public Health Department and per local Immunization Registry.   PFIZER 3/24/2021  ER2613 PFIZER 4/14/2021  EW0158  PFIZER  11/24/2021  FJ1620 PFIZER BLVNTBSTR 6/16/2022 FM7553   The patient presented to the Hospital ED with pre-hospital reported hypoxemia and a COVID-19 diagnosis and hypoxemia with symptoms of increased trouble breathing; she was noted to be 69% saturation on 2L at her facility and had a positive COVID-19 test 10/16/2022. She stated she has felt unwell for quite some time but that symptoms worsened yesterday, prompting the test. She denies severe chest pain. She does have wheezing and a cough. She has lower extremity s welling. She has no severe abdominal symptoms. Patient?s work-up was consistent with worsening congestive heart failure in addition to her COVID-19 diagnosis. She had only borderline oxygen saturations in ED, with reports of respiratory distress prior to arrival and it was determined that the patient was at significant risk of decompensation. She was given diuresis in the ED and given decadron as well for COVID-19 with borderline saturations and pre-hospital low O2 readings. She was admitted to hospital for further management. Web-report stated the patient did not have signs of bacterial infection and she is was noted to be on coumadin for atrial fibrillation, but level was noted to be sub-therapeutic. Patient had an elevated D-Dimer. CT was obtained from the ED for inpatient follow-up and report stated no pulmonary embolism. Interval development of small bilateral pleural effusions and associated consolidation/atelectasis. This is most severe on the left. Bronchiolitis characterized by a background of mild increased ground glass opacity. Local County public Health department has no further information regarding this patient?s hospital course or outcome. Please contact the hospital for further information.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Computerised tomogram thorax abnormal, Condition aggravated, Cough, Diuretic therapy
Clinical narrative: Per web report received by local county Public Health Department and per local Immunization Registry.   PFIZER 3/24/2021  ER2613 PFIZER 4/14/2021  EW0158  PFIZER  11/24/2021  FJ1620 PFIZER BLVNTBSTR 6/16/2022 FM7553   The patient presented to the Hospital ED with pre-hospital reported hypoxemia and a COVID-19 diagnosis and hypoxemia with symptoms of increased trouble breathing; she was noted to be 69% saturation on 2L at her facility and had a positive COVID-19 test 10/16/2022. She stated she has felt unwell for quite some time but that symptoms worsened yesterday, prompting the test. She denies severe chest pain. She does have wheezing and a cough. She has lower extremity s welling. She has no severe abdominal symptoms. Patient?s work-up was consistent with worsening congestive heart failure in addition to her COVID-19 diagnosis. She had only borderline oxygen saturations in ED, with reports of respiratory distress prior to arrival and it was determined that the patient was at significant risk of decompensation. She was given diuresis in the ED and given decadron as well for COVID-19 with borderline saturations and pre-hospital low O2 readings. She was admitted to hospital for further management. Web-report stated the patient did not have signs of bacterial infection and she is was noted to be on coumadin for atrial fibrillation, but level was noted to be sub-therapeutic. Patient had an elevated D-Dimer. CT was obtained from the ED for inpatient follow-up and report stated no pulmonary embolism. Interval development of small bilateral pleural effusions and associated consolidation/atelectasis. This is most severe on the left. Bronchiolitis characterized by a background of mild increased ground glass opacity. Local County public Health department has no further information regarding this patient?s hospital course or outcome. Please contact the hospital for further information.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram, Fibrin D dimer increased, Hypoxia, Laboratory test
Clinical narrative: Per web report received by local county Public Health Department and per local Immunization Registry.   PFIZER 3/24/2021  ER2613 PFIZER 4/14/2021  EW0158  PFIZER  11/24/2021  FJ1620 PFIZER BLVNTBSTR 6/16/2022 FM7553   The patient presented to the Hospital ED with pre-hospital reported hypoxemia and a COVID-19 diagnosis and hypoxemia with symptoms of increased trouble breathing; she was noted to be 69% saturation on 2L at her facility and had a positive COVID-19 test 10/16/2022. She stated she has felt unwell for quite some time but that symptoms worsened yesterday, prompting the test. She denies severe chest pain. She does have wheezing and a cough. She has lower extremity s welling. She has no severe abdominal symptoms. Patient?s work-up was consistent with worsening congestive heart failure in addition to her COVID-19 diagnosis. She had only borderline oxygen saturations in ED, with reports of respiratory distress prior to arrival and it was determined that the patient was at significant risk of decompensation. She was given diuresis in the ED and given decadron as well for COVID-19 with borderline saturations and pre-hospital low O2 readings. She was admitted to hospital for further management. Web-report stated the patient did not have signs of bacterial infection and she is was noted to be on coumadin for atrial fibrillation, but level was noted to be sub-therapeutic. Patient had an elevated D-Dimer. CT was obtained from the ED for inpatient follow-up and report stated no pulmonary embolism. Interval development of small bilateral pleural effusions and associated consolidation/atelectasis. This is most severe on the left. Bronchiolitis characterized by a background of mild increased ground glass opacity. Local County public Health department has no further information regarding this patient?s hospital course or outcome. Please contact the hospital for further information.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Lung consolidation, Lung opacity, Malaise, Oxygen saturation decreased, Peripheral swelling
Clinical narrative: Per web report received by local county Public Health Department and per local Immunization Registry.   PFIZER 3/24/2021  ER2613 PFIZER 4/14/2021  EW0158  PFIZER  11/24/2021  FJ1620 PFIZER BLVNTBSTR 6/16/2022 FM7553   The patient presented to the Hospital ED with pre-hospital reported hypoxemia and a COVID-19 diagnosis and hypoxemia with symptoms of increased trouble breathing; she was noted to be 69% saturation on 2L at her facility and had a positive COVID-19 test 10/16/2022. She stated she has felt unwell for quite some time but that symptoms worsened yesterday, prompting the test. She denies severe chest pain. She does have wheezing and a cough. She has lower extremity s welling. She has no severe abdominal symptoms. Patient?s work-up was consistent with worsening congestive heart failure in addition to her COVID-19 diagnosis. She had only borderline oxygen saturations in ED, with reports of respiratory distress prior to arrival and it was determined that the patient was at significant risk of decompensation. She was given diuresis in the ED and given decadron as well for COVID-19 with borderline saturations and pre-hospital low O2 readings. She was admitted to hospital for further management. Web-report stated the patient did not have signs of bacterial infection and she is was noted to be on coumadin for atrial fibrillation, but level was noted to be sub-therapeutic. Patient had an elevated D-Dimer. CT was obtained from the ED for inpatient follow-up and report stated no pulmonary embolism. Interval development of small bilateral pleural effusions and associated consolidation/atelectasis. This is most severe on the left. Bronchiolitis characterized by a background of mild increased ground glass opacity. Local County public Health department has no further information regarding this patient?s hospital course or outcome. Please contact the hospital for further information.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pleural effusion, Respiratory distress, SARS-CoV-2 test positive, Wheezing
Clinical narrative: Per web report received by local county Public Health Department and per local Immunization Registry.   PFIZER 3/24/2021  ER2613 PFIZER 4/14/2021  EW0158  PFIZER  11/24/2021  FJ1620 PFIZER BLVNTBSTR 6/16/2022 FM7553   The patient presented to the Hospital ED with pre-hospital reported hypoxemia and a COVID-19 diagnosis and hypoxemia with symptoms of increased trouble breathing; she was noted to be 69% saturation on 2L at her facility and had a positive COVID-19 test 10/16/2022. She stated she has felt unwell for quite some time but that symptoms worsened yesterday, prompting the test. She denies severe chest pain. She does have wheezing and a cough. She has lower extremity s welling. She has no severe abdominal symptoms. Patient?s work-up was consistent with worsening congestive heart failure in addition to her COVID-19 diagnosis. She had only borderline oxygen saturations in ED, with reports of respiratory distress prior to arrival and it was determined that the patient was at significant risk of decompensation. She was given diuresis in the ED and given decadron as well for COVID-19 with borderline saturations and pre-hospital low O2 readings. She was admitted to hospital for further management. Web-report stated the patient did not have signs of bacterial infection and she is was noted to be on coumadin for atrial fibrillation, but level was noted to be sub-therapeutic. Patient had an elevated D-Dimer. CT was obtained from the ED for inpatient follow-up and report stated no pulmonary embolism. Interval development of small bilateral pleural effusions and associated consolidation/atelectasis. This is most severe on the left. Bronchiolitis characterized by a background of mild increased ground glass opacity. Local County public Health department has no further information regarding this patient?s hospital course or outcome. Please contact the hospital for further information.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: pt incidently recieved  the Pfizer bivalent for their Primary Covid dose instead of the monovalent . no adverse reaction happened
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product preparation issue
Clinical narrative: The pharmacist administered an 0.2 mL of undiluted Pfizer Bivalent Booster for 5-11 years old to the patient (Brody Tarin) at 2 PM on 11/2/22. The pharmacist called the parent the same day at 3:30pm and told her about the incident. She was gracious and understanding of the situation. No adverse effects had been seen in the patient at the time of this call.
Age: 9.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product preparation error
Clinical narrative: The pharmacist administered an 0.2 mL of undiluted Pfizer Bivalent Booster for 5-11 years old to the patient at 1 PM on 11/2/22. The pharmacist called the parent the same day at 3:30pm and told her about the incident. She was gracious and understanding of the situation. No adverse effects had been seen in the patient at the time of this call.
Age: 9.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: 5-11yr vaccine was diluted prior to admin.  In doing so, patient was given 20mcg booster dose instead of the appropriate 10mcg dose.
Age: 72.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Shots given in same arm at patient request, 1 inch apart. Arm is swollen from shoulder down to elbow, red, and warm to the touch.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine vial store for longer than recommended post puncture of vial (potentially up to 28 days) no adverse reaction
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cerebrovascular accident, Facial paralysis, Hemiparesis, Low density lipoprotein decreased
Clinical narrative: PATIENT'S WIFE CALLED US ON 11/2/22 AND REPORTED THAT AFTER 3 DAYS OF HIM RECEIVING THE VACCINE HE HAD A STROKE ON 9/15/22.  I CALLED HER BACK AND SPOKE TO HER FOR AWHILE.  THEY DON'T KNOW IF THE STROKE IS RELATED TO THE PFIZER BIVALENT VACCINE OR NOT, BUT I WANTED TO REPORT IT.    HE HAD DROOPY MOUTH AND 911 WAS CALLED.  HE SPENT A WEEK IN THE HOSPITAL THEN REHAB FOR ONE WEEK AND ANOTHER WEEK IN REHAB.  NO OTHER SYMPTOMS REPORTED CURRENTLY, SEEMS LIKE FULL RECOVERY.    PER HIS VISIT TO NEUROLOGY TODAY, HE IS ABLE TO DRIVE, AND DOCTOR INSTRUCTED HIM TO  STOP LIPITOR DUE TO LOW LDL AND CONTINUE ON ASPIRIN.   HE WAS WEAK ON LEFT SIDE, BUT TOTALLY RECOVERED.    DOCTOR DOESN'T SEEM CONCERNED IT IS VACCINE RELATED, BUT FELT OBLIGED TO REPORT.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Peripheral swelling, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Arm swollen and 2in area around vaccine site red and hot to touch
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: 5-11yr vaccine was diluted prior to admin.  In doing so, patient was given 20mcg booster dose instead of the appropriate 10mcg dose.
Age: 66.0
Sex: F
Vaccine: HEPAB
Symptoms: Rash, Urticaria
Clinical narrative: Patient received vaccine on 10/29/2022 then on 10/30/2022 she noticed a rash/hives on the upper portion of her body/chest and down one arm along with a smaller spot on her leg.  Patient did not take any over the counter medications before coming to the pharmacy to report on 11/2/2022.  Patient was advised to take benadryl and follow up with her provider that had recommended her to get the Twinrix due to liver disease.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: NO adverse reaction or treatment needed.  Patient received the monovalent pfizer dose instead of the bivalent booster.   The patient has been notified to return 2 months from this dose to receive the bivalent booster.
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: 5-11yr vaccine was diluted prior to admin.  In doing so, patient was given 20mcg booster dose instead of the appropriate 10mcg dose.
Age: 7.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: 5-11yr vaccine was diluted prior to admin.  In doing so, patient was given 20mcg booster dose instead of the appropriate 10mcg dose.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Gave Patient a primary dose, when she should have received a bivalent dose.
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient was here to get 3rd dose of the Pediatric Pfizer Covid 19 for under age 5 y.o. Patient received the Pediatric Pfizer Covid 19 Bivalent vaccine for children ages 5 y.o. - 11 y.o. I spoke to mom at 4:30pm today, and she reports that he is tolerating the dose fine so far.
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Physician incorrectly administered vaccine. Instead of receiving the second dose Pfizer monovalent she gave me bivalent
Age: 11.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Incorrect dose administered
Clinical narrative: 5-11yr vaccine was diluted prior to admin.  In doing so, patient was given 20mcg booster dose instead of the appropriate 10mcg dose.
Age: 9.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: Pt receiving bivalent booster.  During admin, pt moved away at the end causing about 1/4th of the dose not being administered.  Provider recommended revaccination, however parent decline re-administration at this time.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Patient called to report that she took her bandaid off on 11/2/2022 after her vaccine that was received on 10/31/2022. She said that the injection site looked pink and like a blister that had popped. She said there was no fluid and it was not warm to the touch or red, like it might be infected. I recommended that she monitor the site and seek evaluation at an urgent care if the site does not get smaller or stays the same. Also recommended that she apply Neo-sporin to reduce chance of infection. She did mention that she had an allergy to latex. I verified that the bandages are "not made from natural latex" but it is possible that she may be allergic whatever fabric the bandages are made from.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Dehydration, Disorientation, Foreign travel, Head discomfort
Clinical narrative: On 10/17/2022 I woke up with a lot of head congestion. We returned that day from an extended vacation. On the flight my symptons became worse; headache, sore throat and very congested.I became slightly fevered and disoriented as well as dehydrated. I assumed it was a sever head cold and it did not get down into my lungs. I took two home tests as noted in section 19 and contaced my doctor after the second test. She provided instruction for dealing with the COVID as well as a perscription. By the weekend (Oct 22-23) I was for the most part recovered but continued my isolation until the 10th day.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Oropharyngeal pain, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: On 10/17/2022 I woke up with a lot of head congestion. We returned that day from an extended vacation. On the flight my symptons became worse; headache, sore throat and very congested.I became slightly fevered and disoriented as well as dehydrated. I assumed it was a sever head cold and it did not get down into my lungs. I took two home tests as noted in section 19 and contaced my doctor after the second test. She provided instruction for dealing with the COVID as well as a perscription. By the weekend (Oct 22-23) I was for the most part recovered but continued my isolation until the 10th day.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine vial store for longer than recommended post puncture of vial (potentially up to 28 days) no adverse reaction
Age: 42.0
Sex: M
Vaccine: UNK
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Left arm numbness and hand pain
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No Adverse event or treatment needed.  patient received the monovalent pfizer instead of the bivalent pfizer booster
Age: 66.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient presented to medical clinic for his scheduled second dose of vaccine. Vaccine administered was the expired vaccine that was not pulled from the vaccine fridge after Saturday clinic on 10/8/22. Dose was expired by 4 days. Manufacturer instructed clinic to administer a third dose as soon as possible. Patient still deciding if he wants a third dose. Patient had no adverse reactions to expired second dose. Patient was instructed to call if he experienced and adverse events or side effects. Patient has been in several times since that administration and has had no side effects.
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness
Clinical narrative: Patient reported dizziness.  Examined patient, states she did not eat breakfast nor water.  Patient had some chicken and rice for lunch.  Gave patient  water and patient rested on bed in Nurses Room at School for 10 minutes.     Patient stands after resting and denies dizziness but c/o dizziness with sitting.   Patient is left in stable condition with school nurse.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Customer called for a temperature excursion in case 02261220. Caller reported that PROQUAD that had undergone temperature excursion was administered to a patient. No additional AE reported. No PQC reported. No further information was provided.    ?; This spontaneous report was received from nurse, concerning to patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-SEP-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) product quantity 1, (lot #W012743 has been verified to be a valid lot for PROQUAD, expiration date: 16-OCT-2023) for prophylaxis (strength, dose regimen, route of administration and anatomical location were not provided). In addition the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) underwent to temperature excursion of -11-8 degree Celsius for 1 hour and 45 minutes. (product storage error).  It was also mentioned that previously temperature excursion happened. No additional adverse event was reported.; Sender's Comments:  US-009507513-2210USA001209: US-009507513-2210USA000872:
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Maternal exposure before pregnancy, No adverse event
Clinical narrative: No adverse event; patient that received an unknown varicella vaccine 3 weeks before becoming pregnant.; This spontaneous prospective pregnancy report has been received from a nurse practitioner, regarding a 19-years-old female patient. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 12-JUL-2022, reported as 3 weeks before becoming pregnant (last menstrual period reported as 23-JUL-2022, with and estimated date of conception on 29-APR-2022 (conflicting information)), the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection (caller did not know if this was the first or the second does) as prophylaxis (lot number: U029621, which was determined to be valid, with an expiration date on 22-SEP-2023) (dose, route and anatomical location of administration was not reported) (maternal exposure during pregnancy).  The pregnancy outcome was not reported at the time of the report therefore, the fetal outcome was unknown. No additional adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Cervical dysplasia
Clinical narrative: The patient completed the gardasil 9 series at 10 years old was known to have cervical intra-epithelial neoplasia; This spontaneous report has been received referring to a female patient of unknown age. The patient's concurrent conditions, medical history, and concomitant medications were not provided.   On an unknown date, the patient was vaccinated with the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) series (strength, dose, frequency, route of administration, anatomical location, lot number, and expiration date were not reported) for prophylaxis.  On an unknown date, the patient experienced cervical intra-epithelial neoplasia (CIN).  The outcome of the event was not provided.  The causality assessment was not reported.
Sex: U
Vaccine: MMRV
Symptoms: Accidental underdose
Clinical narrative: child kicked the administrating medical assistant which resulted in a smaller than recommended dose of PROQUAD being administered; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 27-OCT-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, lot #, expiration date and route of administration were not provided) for prophylaxis. It was reported that a child kicked the medical assistant, which resulted in a smaller than recommended dose being administered (Accidental underdose).
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Haemorrhage, Immediate post-injection reaction, Urticaria
Clinical narrative: Patient immediately bled and developed localized hives. Benadryl given within 5 minutes and patient felt better 15 minutes after medication
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Iridocyclitis, Ophthalmological examination abnormal
Clinical narrative: anterior uveitis left and right eyes, treated with prednisolone acetate eye drops for ~5 months, symptoms resolved but began again after next COVID vaccine and continue
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event or treatment needed.  On 09/27/2022 our organization did not yet have the bivalent booster, so this patient was given the monovalent dose.   They have been contacted and instructed to get the bivalent booster 2 months after their last dose.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Feeling hot, Rash
Clinical narrative: rash, heat, redness, cellulitis
Age: 0.5
Sex: F
Vaccine: HPV9
Symptoms: Wrong product administered
Clinical narrative: Pt was given the wrong shot in office, was suppose to get a PCV (Prevnar13) instead of HPV. So far no adverse reaction, called the hotline and was advised that there was no need to worry unless child had a life threatening reaction.
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, Product administered to patient of inappropriate age
Clinical narrative: Patient, 11 years, was given Pfizer Bivalent 12 and up.
Age: 12.0
Sex: F
Vaccine: COVID19-2, FLUC4, FLUC4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Given 2 flu shots. No immediate ADRs
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Condition aggravated, Cough, Fatigue, Headache
Clinical narrative: I had a non stop cough, really tired, and headache. I already had a chronic cough and COVID-19 made it way worse. I tested positive for COVID-19 at home on 08/29/2022. I called my doctor through telehealth the same day and she prescribed me symbicort and to take mucinex. It has been 2 months and I still have the cough.