chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 49 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 21Dec2021 (Lot number: FF8841) at the age of 49 years as dose 3 (booster), single, intramuscular, administered in arm right, administration date 10Feb2021 (Lot number: EL3248) as dose 2, single and intramuscular, administered in arm right, administration date 22Jan2021 (Lot number: EL3248) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 02Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 02Apr2022, outcome "recovering" and all described as "Contracted Covid-19 on 02Apr2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Apr2022) positive. Therapeutic measures were not taken as a result of vaccination failure, Covid-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Pyrexia, Sinus disorder, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP) for a Pfizer sponsored program. The reporter is the patient. A 64 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster dose), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis w rheumatoid factor multiple site w/o org/sys involvement" (unspecified if ongoing); "Emphysema" (unspecified if ongoing). Concomitant medication(s) included: Albuterol [Salbutamol]; Anoro Ellipta; Caltrate 600+D3; Carvedilol; Epinephrine; Folic Acid; Furosemide; Isosorbide Dinitrate; Lipitor; Loratadine; Meloxicam; Methotrexate; Potassium; Synjardy XR; Triamterene and Hydrochlorothiazide; Vitamin C [Ascorbic Acid]; Xeljanz XR. Past drug history included: Aspirin, reaction(s): "Allergies: Aspirin"; Demerol, reaction(s): "Allergies: Demerol"; Lisinopril, reaction(s): "Allergies: Lisinopril". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had corona virus"; PYREXIA (non-serious), outcome "unknown", described as "low-grade fever twice"; SINUS DISORDER (non-serious), outcome "unknown", described as "sinuses were attacked". Patient said she had corona virus, low-grade fever twice, sinuses were attacked. She said she had Pfizer COVID vaccine and booster and still got corona virus. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). A 28 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "Patient developed myocarditis after receiving COVID-19 vaccine he was 28 years old". Event took place after use of product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4339756-00 (RA). A 43 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation; Risankizumab (SKYRIZI [RISANKIZUMAB]) (ongoing) (Batch/Lot number: unknown) for psoriasis, psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for Covid-19 Immunization. The following information was reported: VACCINATION COMPLICATION (medically significant) with onset 2021, outcome "unknown", described as "had a serious reaction to the second Covid vaccine". The action taken for Risankizumab was dosage not changed. Additional Information: The patient had Covid. He had first two doses of vaccine but not booster and in 2021, he had a serious reaction to the second vaccine. It was unknown if patient was enrolled in a Covid-19 vaccine trial. The reporter's assessment of the causal relationship of the [Vaccination adverse reaction] with the suspect product [Skyrizi (Risankizumab)] was not provided at the time of this report and the reporter's assessment of the causal relationship of the [Vaccination adverse reaction] with the suspect product bnt162b2 (BNT162B2) was not provided at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on available information and the drug temporal relationship, the causality between the event "vaccination complication" and the suspect drug "BNT162B2" cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: medication error due to accidentally administering expired IPOL to a patient with no Adverse event; Initial information received on 05-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional via call center.  This case involves a 5 years old male patient who had experienced medication error due to accidentally administering expired ipol to a patient with no adverse event while receiving vaccine ipv (vero) [Ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) for Prophylactic vaccination; and measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination.  On 05-Apr-2022, the patient received a 0.25 mL to 2 mL dose of suspect ipv (VERO) lot R1F973M frequency: once (strength, formulation and expiry date: unknown)  via intramuscular route in the left deltoid for prophylactic vaccination.  On 05-APR-2022, the patient developed a non-serious event medication error due to accidentally administering expired ipol to a patient with no adverse event (expired product administered) (latency: same day) following the administration of ipv (VERO).   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (expired product administered).  At time of reporting, the outcome was Unknown for the event expired product administered.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: administered ACT-HIB to a patient using an alternate diluent with no reported adverse event.; Initial information received on 06-Apr-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 1 years old male patient who was administered act-hib using an alternate diluent with no reported adverse event. while receiving vaccine hib (prp/t) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 13v (CRM197) (Prevnar 13) for Prophylactic vaccination; hepatitis a vaccine (Hepatitis a) for Prophylactic vaccination; and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) for Prophylactic vaccination.  On 10-Mar-2022, the patient received a 0.5 ml dose of suspect hib (prp/t) vaccine lot UJ579AAA frequency: once (dose, route, strength: unknown) in unknown administration site for Prophylactic vaccination.  On 10-MAR-2022 the patient developed a non-serious event administered act-hib to a patient using an alternate diluent with no reported adverse event. (Wrong diluent used) following the administration of hib (prp/t) vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (Wrong diluent used).  At time of reporting, the outcome was Unknown for the event Wrong diluent used.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Injection site pain, Limb discomfort
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: Patient came into the pharmacy picking up his regular medication, while chatting about getting his second shingrix vaccine, he mentioned that he has been experiencing mild, non-debilitating, but noticeable discomfort on his left arm where the first injection occurred.  After talking to him, I suggested he should talk to his doctor during his next office visit in May to discuss if this was indeed an related to the shingrix vaccine.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: Was in menopause for a year Now get my period every 26 days
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Urticaria
Clinical narrative: Chills, mild headache, and hives covering my neck, my front and back torso.  On 8Apr, I woke up feeling okay but by 1p I was getting chills.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Severe, Additional Details: Patient received his second Moderna booster (0.25ml) around 12 noon on 3/31/22. Patient said he experienced "bad" chest pain that started later that night and into the next day (4/1/22) and resolved on 4/2/22. He said the chest pain on 4/2/22 was mild. Patient said he spoke to his primary prescriber via phone.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electrocardiogram abnormal
Clinical narrative: Developed Paroxysmal AFib
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Myalgia, Oropharyngeal pain
Clinical narrative: Arthritic pain in ankles and wrists Febrile (low grade) Muscle aches Dizziness Sore throat Fatigue
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Arthritic pain in ankles and wrists Febrile (low grade) Muscle aches Dizziness Sore throat Fatigue
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Thirst, Vertigo
Clinical narrative: moderate fever that comes down with Tylenol  body aches vertigo which is slowly resolving excessive thirst even with increased intake
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: Muscle and body pain
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Immediate post-injection reaction, Neurological symptom, Road traffic accident
Clinical narrative: Immediately after the injection experienced mental confusion which lasted for ~3 hours. During that time she was involved in a MVA which totaled her car. She experienced similar neurologic sx's after the second dose of Pfizer which was administered on 4/13/21.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient received 1st Dose Covid 19 vaccine Janssen Lot # 1805018.   04/01/2021 patient returned  to  Vaccine clinic 04/22/2021 received a 2nd dose of Pfizer Lot # ER8731.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: administration error. Patient was given 0.25 ml rather than 0.5 ml as a first dose.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: syncope and collapse
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chest pain, Chills, Condition aggravated, Dyspnoea
Clinical narrative: I went to the Health Clinic and as soon as I got my shot I started feeling bad I started having Asthma issues. I was having difficulty breathing. I went home and it got worst. I sat up for about 5 minutes at home and I could not breath. My chest was hurting, had chills, and I could not reach my doctor. I went to bed and was covered in 4 blankets my significant other came into the room and I was barely breathing. I got out of bed I started throwing up. I was not able to maintain anything down. I was like this for weeks. I was barely able to walk. I got in contact with my doctor and he said not to do the 2nd shot. I was able to finally go see my doctor where he gave me a lot of  medicine. I had a bump in my arm. It took about 6 months for the allergic reaction go away. I am doing much better now.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait disturbance, Hypersensitivity, Peripheral swelling, Vomiting
Clinical narrative: I went to the Health Clinic and as soon as I got my shot I started feeling bad I started having Asthma issues. I was having difficulty breathing. I went home and it got worst. I sat up for about 5 minutes at home and I could not breath. My chest was hurting, had chills, and I could not reach my doctor. I went to bed and was covered in 4 blankets my significant other came into the room and I was barely breathing. I got out of bed I started throwing up. I was not able to maintain anything down. I was like this for weeks. I was barely able to walk. I got in contact with my doctor and he said not to do the 2nd shot. I was able to finally go see my doctor where he gave me a lot of  medicine. I had a bump in my arm. It took about 6 months for the allergic reaction go away. I am doing much better now.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test positive, Raynaud's phenomenon, Scleroderma
Clinical narrative: Raynaud?s. Scleroderma antibodies later discovered
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Condition aggravated, Gait disturbance, Hypoaesthesia, Paraesthesia
Clinical narrative: After the first one I had slight thinning, I didn't think anything of it. After the second shot I was in the shower and clumps of my hair were falling out like crazy and from there I started seeing the doctor an dermatologist. My feet then started to go numb the feeling was completely gone. I have had problems walking ever since. The dermatologist had me try Rogaine for men, collagen, biotin, then they were gonna do injections but I refused It took about 7 months for my hair to grow back. My feet took about a year to get feeling back and they are still tingling until this day.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitis
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Listless, Memory impairment, Respiratory symptom, Sleep attacks
Clinical narrative: Listless, Continually falling asleep, Sudden memory difficulty, Breathing changes,
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Chest pain, Dyspnoea, Erythema, Extra dose administered
Clinical narrative: Patient's sister called on Sat, 4/9/22 around 9:15am.  She reported that patient had an adverse reaction to her second booster given on 4/8/22.  Patient was given the vaccne around 11:30am on 4/8/22.  Sister stated that patient felt flush (red in the face), chest pain, shortness of breath, "didn't feel good", palpitations, difficulty breathing, slight to moderate tongue swelling.  EMS was called an patient was given a HD of Benadryl IM.  Pt was taken to a hospital and IV fluids were given.  Patient was discharged and sent home.  This information was provided by patients Sister via her call the  pharmacy on 4/9/22.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Flushing, Palpitations, Swollen tongue
Clinical narrative: Patient's sister called on Sat, 4/9/22 around 9:15am.  She reported that patient had an adverse reaction to her second booster given on 4/8/22.  Patient was given the vaccne around 11:30am on 4/8/22.  Sister stated that patient felt flush (red in the face), chest pain, shortness of breath, "didn't feel good", palpitations, difficulty breathing, slight to moderate tongue swelling.  EMS was called an patient was given a HD of Benadryl IM.  Pt was taken to a hospital and IV fluids were given.  Patient was discharged and sent home.  This information was provided by patients Sister via her call the  pharmacy on 4/9/22.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient was administered the moderna covid 19 vaccine on 3/30/22. The vaccine had expired on 3/27/22 per the moderna website.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Dizziness, Fatigue, Pain
Clinical narrative: Severe diarrhea  Fever Severe body pain Severe tiredness Chest pains Dizziness
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Severe diarrhea  Fever Severe body pain Severe tiredness Chest pains Dizziness
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered the Moderna COVID-19 vaccine on 3/30/2022. The vaccine expired on 3/27/2022 per the Moderna website. Patient administered a booster dose  of 0.25mL.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bone pain, Cardiac disorder, Condition aggravated, Dizziness, Loss of consciousness
Clinical narrative: My heart condition, the dizzy spells and black outs returned after being dormant for over 20 years. More bone pain as well.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Condition aggravated, Headache, Immunisation reaction, Magnetic resonance imaging normal
Clinical narrative: Severe tinnitus
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Neurological examination normal, Tinnitus
Clinical narrative: Severe tinnitus
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Pyrexia, Swelling
Clinical narrative: Moderna arm - swelling and fever,
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Inadvertent vaccination with Pfizer vaccine who's "good for Use' date was 10 days expired. Vaccine itself was still within expiration date.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Inadvertent vaccination using Pfizer vaccine whose "good to use" date was exceeded by 10 days. Vaccine still good within expiration window.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Inadvertent administration of Moderna Vaccine past expiration and "good to use by" date.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Expired product administered, Headache, Pain, Pain in extremity
Clinical narrative: Inadvertent administration of Moderna Vaccine past expiration and "good to use by" date.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Dizziness, Expired product administered
Clinical narrative: Inadvertent administration of Moderna Vaccine past expiration and "good to use by" date.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: I mistakenly gave the patient a 4th dose of the Pfizer vaccine.  Per our EHR,  she was vaccinated on 6/27/2021 and 3/7/3022 per the Immunization registry.  I read the 2022 vaccine as 2021 by mistake and told her and her Mom that she needed a booster.  After giving the booster, my staff alerted me that she had received her last dose one month prior and was not due for a booster.  I let Mom and the patient know immediately. I spoke to Mom about 2 hours later. Her daughter was fine but she gave me dates from their vaccine card which were different.  The first dose was on 6/26/2021 and not 6/27/2021 and she received a second dose on 7/17/2021 that was not in the registry.  So, this was a fourth covid vaccine.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal uterine bleeding, Biopsy, Intrauterine contraception, Laboratory test normal, Uterine dilation and curettage
Clinical narrative: I had no prior uterine bleeding issues. No history of gynecological issues. I got the 1st dose of the vaccine and started having uterine bleeding. It subsided. I got the second dose and a month later the uterine bleeding restarted. Since that time, in has been an excess of daily uterine bleeding to where I've had to have a DNC which is a gynecological procedure and an IUD device placed to try and stop the bleeding. I have received medication and it continues. I'm planning in the next several months to remove my uterus to try to resolve the issue. Its daily without stopping.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Wrong dose was administered 0.5mls versus 0.3mls
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: wrong dose was administered 0.5mls versus 0.3mls
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dehydration, Diarrhoea, Headache, Lethargy
Clinical narrative: Headaches, pain in the head and neck, joint pain, muscle ache, lethargic. Diarrhea, nauseous, vomiting, dehydration. I went to the urgent care locally. I was given medication.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Neck pain, Vomiting
Clinical narrative: Headaches, pain in the head and neck, joint pain, muscle ache, lethargic. Diarrhea, nauseous, vomiting, dehydration. I went to the urgent care locally. I was given medication.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Decreased appetite, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Fever of 102.   Complete fatigue.   I slept for 18 out of 24 hours.   Every joint in my body hurt.  I could not lie on my right side because the pain in my right arm.   I had no appetite.   The fever lasted 28 hours as well as the sore joints. Took ibuprofen on a 4 hour basis.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: Fever of 102.   Complete fatigue.   I slept for 18 out of 24 hours.   Every joint in my body hurt.  I could not lie on my right side because the pain in my right arm.   I had no appetite.   The fever lasted 28 hours as well as the sore joints. Took ibuprofen on a 4 hour basis.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Wrong dose administered 0.5mL versus 0.3mL.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis
Clinical narrative: Severe headache - attempted to treat at home with OTC Tylenol Extra Strength x 2 and Maxalt 10 mg x 2. I took the Maxalt?s 2 hours apart. After no relief and sweating and committing due to severe headache called primary care office. The got me in and gave me a shot of Toradol. A couple  hours later my headache pain/symptoms improved.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein normal, Chest X-ray normal, Chest discomfort, Chest pain, Electrocardiogram normal
Clinical narrative: Chest pain started within days to weeks after 2nd dose. Didn't realize it was a concern until it kept happening. Told PCP at her physical a couple months later. Pain is brief, intermittent, sometimes stabbing, dull, or like pressure. She is not an active person so she couldn't give an acceptable description of when it happens so Cardiologist said it didn't fit "pericarditis" but more recently she has noticed that when she does try to do something active she notices the chest pain which then resolves after a brief episode.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer, Pain, Red blood cell sedimentation rate normal, Troponin T normal
Clinical narrative: Chest pain started within days to weeks after 2nd dose. Didn't realize it was a concern until it kept happening. Told PCP at her physical a couple months later. Pain is brief, intermittent, sometimes stabbing, dull, or like pressure. She is not an active person so she couldn't give an acceptable description of when it happens so Cardiologist said it didn't fit "pericarditis" but more recently she has noticed that when she does try to do something active she notices the chest pain which then resolves after a brief episode.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: wrong dose was administered 0.5mls versus 0.3mls
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Culture urine positive, Pseudomonas infection, Pseudomonas test positive, Urinary tract infection
Clinical narrative: Complicated UTI from pseudemonas. Risk of sepsis and adrenal crisis.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: wrong dose was administered 0.5mls versus 0.3mls
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: On 5/15/21 I started to get a rash that was the size of a grapefruit and I had to take Benadryl and steroids to get it to stop growing and it started out the size of a nickel. It lasted for 6 days till I had all of those medications in my system to get it to stop.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Somnolence, Tremor
Clinical narrative: Chills, shakes
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchiness started on scalp, then down to neck, back of neck and ears covered in hives, then down to back of body
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: wrong dose was administered 0.5mls versus 0.3mls
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: wrong dose was administered 0.5mls versus 0.3mls
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Extra dose administered, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: REACTION STARTED THE NIGHT OF THE ADMINISTRATION. PATIENT HAD SEVERE REDNESS OF UPPER ARM. REDNESS WAS FROM SHOULDER TO ELBOW. RED AND PAINFUL.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Thyroid cyst, Ultrasound thyroid
Clinical narrative: Was diagnosed with large thyroid cyst.  May have been there previous to vaccination.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: Pain in shoulder & when lifting arm.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose in the series was given on 6/21/2021. Second dose given early on 7/2/21. Patient experienced more fatigue, muscle soreness and chills than on the first dose.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd Moderna vaccine 7 days before the recommended time between the 1st and 2nd dose. P
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Booster given 2 months early.  No symptoms present at the time of administration. Pt will wait to determine if symptoms present. If symptoms present themselves, pt will immediately seek medical assistance from medical professionals.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given her 2nd Moderna vaccine 7 days before the recommended time between the 1st and 2nd dose. Per CDC, doses administered with an interval error after October 25, 2021
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Grip strength decreased, Immediate post-injection reaction, Joint range of motion decreased, Muscular weakness
Clinical narrative: Assuming SIRVA - immediate arm/shoulder soreness which then developed into pain & reduced range of motion which still continues today.  There was also nerve pain that existed for some of this past year.  Also reduced muscle strength (sometimes very difficult to reach & hold dinner plate from cabinet & even hold a hair dryer, put on a car seat belt, etc.).  Medicine (acetaminophen, ibuprofen & aspirin) doesn't relieve pain.  Symptoms continued to worsen; therefore, Dr. appt on 10/19/21 - physical exam was done which then led to 6 weeks of physical therapy.  Continued with pain & range of motion wasn't restored.  Therefore, another Dr. appt - Xray to confirm no tears and an ultrasound was done.  Received a steroid shot on 12/13/21 & again on 2/23/22 but continue with pain & reduced range of arm/shoulder motion.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain in extremity, Ultrasound scan, X-ray normal
Clinical narrative: Assuming SIRVA - immediate arm/shoulder soreness which then developed into pain & reduced range of motion which still continues today.  There was also nerve pain that existed for some of this past year.  Also reduced muscle strength (sometimes very difficult to reach & hold dinner plate from cabinet & even hold a hair dryer, put on a car seat belt, etc.).  Medicine (acetaminophen, ibuprofen & aspirin) doesn't relieve pain.  Symptoms continued to worsen; therefore, Dr. appt on 10/19/21 - physical exam was done which then led to 6 weeks of physical therapy.  Continued with pain & range of motion wasn't restored.  Therefore, another Dr. appt - Xray to confirm no tears and an ultrasound was done.  Received a steroid shot on 12/13/21 & again on 2/23/22 but continue with pain & reduced range of arm/shoulder motion.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pallor, Syncope
Clinical narrative: post vaccine client fainted did not hit head, skin pale (history of fainting), light headed. Client awake and talking  lay down with feet elevated, water and OJ given. No improvement  offer to call 911 sent to ER
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fear, Vision blurred
Clinical narrative: The next day after the booster when I woke up , went to the bathroom and  put the light on, the room seems full of fog, very scary! it dissipated after a few minutes Since then it is much lighter but in the 1st minutes I put the lights in the morning, there is a slight foggy look in the room. I did not have any after effect after the 1st 2 shots of the Pfizer vaccine And now I am concerned about having a second booster,  what is your suggestion?  I did have Covid  in October 2011, had some fever under 100 for 2 days
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus of the right ear.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Blood test, Dizziness, Dysstasia, Impaired work ability
Clinical narrative: Suddenly without any warning the room started spinning and I could not stand up and could not safely get to the floor. I had to hold onto the kitchen counter to keep from falling. My head was spinning and I was nauseous. My husband rushed me to the ER where they diagnosed vertigo and treated it with medication. The dizziness and nausea lessened over the next few weeks but took more than a month to go away. After my second Covid 19 shot on 3/19/2021 a similar reaction occurred on March 22. However I did not go to the doctor or hospital at that time. It took a day or so to lessen enough so that I could go back to work. Again, it occurred less and less frequently and severely over the following weeks.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Laboratory test, Nausea, Urine analysis, Vertigo
Clinical narrative: Suddenly without any warning the room started spinning and I could not stand up and could not safely get to the floor. I had to hold onto the kitchen counter to keep from falling. My head was spinning and I was nauseous. My husband rushed me to the ER where they diagnosed vertigo and treated it with medication. The dizziness and nausea lessened over the next few weeks but took more than a month to go away. After my second Covid 19 shot on 3/19/2021 a similar reaction occurred on March 22. However I did not go to the doctor or hospital at that time. It took a day or so to lessen enough so that I could go back to work. Again, it occurred less and less frequently and severely over the following weeks.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Autoimmune disorder, Bedridden, Dysphonia, Nervous system disorder
Clinical narrative: Complete loss of speech within two days after vaccination. The day after the vaccine, I was only able to speak for about 20-30 minutes before my voice tired-out. The day after, I was completely mute. To this day, my speech has still not returned. In addition to loss of speech, I have had a series of severe and debilitating neurological and autoimmune type issues that have grown in number and severity over time and still continue to this day. This left me completely bedridden.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: chronic back pain without sciatica
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Hyperaesthesia, Hyperhidrosis, Ophthalmic migraine
Clinical narrative: Skin sensitivity Diaphoresis Diarrhea Visual migraine
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Injection site erythema, Injection site pruritus
Clinical narrative: Reddened skin at point of injection with itching
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered vaccine that was past beyond use date. No s/sx toxicity occurred.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dental care, Oral lichen planus
Clinical narrative: Severe outbreak of Oral Lichen Planus... ..Dental treatment   (MethylPrednisolone Tablets USP 4mg dose pack)    Regular use of Magic Mouth Wash,  Contains  ( Lidocaine, Benadryl, Maalox, Nystatin)      Dental Cleaning are on regular 4 month intervals.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine. Repeat dose administered.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pt received expired vaccine. Re-dosed appropriately
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles virus developed approximately 48 hours after Pfizer injection four
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Bundle branch block right, Chest X-ray normal, Chest pain, Echocardiogram abnormal, Electrocardiogram abnormal
Clinical narrative: Beginning on 1/17/22, approximately four weeks after my vaccine, I began to experience mild, intermittent chest soreness. By 1/20/22, the soreness was persistent and moderate, which led me to go to urgent care. At urgent care, my heart rate and blood pressure were high. The urgent care EKG was normal aside from an incomplete right bundle branch block. The urgent care chest xray was normal. The attending doctor at urgent care ruled out heart attack, prescribed 600 mg ibuprofen 3x per day for 7 days to treat possible costochondritis or pericarditis, and instructed to follow up with PCP as soon as possible. The ibuprofen reduced the symptoms. On 1/24/22, saw a PCP, who took another EKG with similar findings, though with normal heart rate and blood pressure. The opinion of the PCP was possible costochondritis and provided a referral to a cardiologist. On 1/26/22, saw cardiologist (listed as doctor to contact in this report), who repeated the EKG with similar findings, and ordered an echocardiogram due to suspecting pericarditis. On 2/11/22, echocardiogram found mild inflammation. As of today, 4/9/22, the symptoms are almost entirely gone. In total, they lasted approximately 8 weeks, first appearing on 1/17/22, worsening through 1/22/22, substantially improving during the 7 days of ibuprofen, with mild occasional symptoms continuing to improve through mid-late March.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Hypertension, Inflammation, Pericarditis
Clinical narrative: Beginning on 1/17/22, approximately four weeks after my vaccine, I began to experience mild, intermittent chest soreness. By 1/20/22, the soreness was persistent and moderate, which led me to go to urgent care. At urgent care, my heart rate and blood pressure were high. The urgent care EKG was normal aside from an incomplete right bundle branch block. The urgent care chest xray was normal. The attending doctor at urgent care ruled out heart attack, prescribed 600 mg ibuprofen 3x per day for 7 days to treat possible costochondritis or pericarditis, and instructed to follow up with PCP as soon as possible. The ibuprofen reduced the symptoms. On 1/24/22, saw a PCP, who took another EKG with similar findings, though with normal heart rate and blood pressure. The opinion of the PCP was possible costochondritis and provided a referral to a cardiologist. On 1/26/22, saw cardiologist (listed as doctor to contact in this report), who repeated the EKG with similar findings, and ordered an echocardiogram due to suspecting pericarditis. On 2/11/22, echocardiogram found mild inflammation. As of today, 4/9/22, the symptoms are almost entirely gone. In total, they lasted approximately 8 weeks, first appearing on 1/17/22, worsening through 1/22/22, substantially improving during the 7 days of ibuprofen, with mild occasional symptoms continuing to improve through mid-late March.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Pruritus, Quality of life decreased, Rash, Rash pruritic
Clinical narrative: Site: Itching at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Rash/lesions that is painful, itching, weaping-Severe, Additional Details: Rash started about 4 days after the shot. Initally rash started on back, but spread to sides, arms, legs. Rash was initally itchy. Became painful, itchy, 'ugly' and weaping lesions formed. Patient has tried antihistamines (hydroxyzine, allegra), creams (triamcinolone, mupirocin). Nothing has helped and he states that this shot has changed his life.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Rash vesicular
Clinical narrative: Site: Itching at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Rash/lesions that is painful, itching, weaping-Severe, Additional Details: Rash started about 4 days after the shot. Initally rash started on back, but spread to sides, arms, legs. Rash was initally itchy. Became painful, itchy, 'ugly' and weaping lesions formed. Patient has tried antihistamines (hydroxyzine, allegra), creams (triamcinolone, mupirocin). Nothing has helped and he states that this shot has changed his life.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea, Thinking abnormal
Clinical narrative: Initial Nausea - lasted for about 2-3 hours  Brain Fog (fuzziness, not thinking clearly) - lasted 1.5 days
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site pain, Throat irritation
Clinical narrative: Pain and redness in shot area for 2 days, redness moving to another area lower on the arm on day three. On the evening of third day developed tickle in throat that could not be stopped for 30 mins. Lower arm redness still there on day four.
Age: 66.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Acoustic stimulation tests abnormal, Blood test, Dizziness, Dysphagia, Hypoacusis
Clinical narrative: Tennitus, hearing issues, trouble swallowing, diziness.  Tennitus HAS NOW BECOME CONSTANT.  Prednisone, antihistamine, PT.  Vertigo was ruled out
Age: 66.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Tinnitus
Clinical narrative: Tennitus, hearing issues, trouble swallowing, diziness.  Tennitus HAS NOW BECOME CONSTANT.  Prednisone, antihistamine, PT.  Vertigo was ruled out
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: Upset Stomach
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Nurse inoculates patient with second booster without realizing that she still did not meet the minimum required time of 4 months.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: At 7 hours after injection, mild headache on Day 1.  Slightly worse headache on afternoon of Day 2.  This is not unusual.  On Day 3, severe intermittent throbbing headache, especially on exertion or standing, left temple.  Pain was 8.5 out of 10.  1000 mg Tylenol did not help.  Lasted about 6 - 10 hours.  Consulted with health insurance nurse on call and was advised could go to nearest hospital if desired.  Day 4 (today) I feel fine.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: 3/24:  8 hrs after shot,  Injection site pain minor Fatigue moderate Headache moderate Feelings of fever minor  Recovered 3/27/2022
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, Hypersomnia, Impaired work ability
Clinical narrative: On 1/10/2022, I had an excruciating headache, a runny nose, and extreme fatigue. I work at a facility, so I went to the nurse, who did a rapid COVID-19 test, and the result was negative. As the day progressed, I became more tired. I took 2 Advil for my headache, which helped. After work, I took a PCR test at the community lab. On 1/11/2022, I called in sick to my workplace. That day, I had a runny nose, sore throat, extreme sinus pressure, and extreme fatigue. I slept for most of that day. On 1/14/2022, I finally got my PCR results back, and they were positive. My doctor recommended that I take Mucinex-D, DayQuil, and NyQuil. She also recommended another OTC medicine, but I don't remember the name. She then provided me with a sick note for work and instructed me to stay at home and recuperate. I then returned to work on 1/17/2022.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Paranasal sinus discomfort, Rhinorrhoea, SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: On 1/10/2022, I had an excruciating headache, a runny nose, and extreme fatigue. I work at a facility, so I went to the nurse, who did a rapid COVID-19 test, and the result was negative. As the day progressed, I became more tired. I took 2 Advil for my headache, which helped. After work, I took a PCR test at the community lab. On 1/11/2022, I called in sick to my workplace. That day, I had a runny nose, sore throat, extreme sinus pressure, and extreme fatigue. I slept for most of that day. On 1/14/2022, I finally got my PCR results back, and they were positive. My doctor recommended that I take Mucinex-D, DayQuil, and NyQuil. She also recommended another OTC medicine, but I don't remember the name. She then provided me with a sick note for work and instructed me to stay at home and recuperate. I then returned to work on 1/17/2022.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Slowly developed Tinnitus
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Product use issue
Clinical narrative: The patient received Prevnar 13 and the recommended vaccine was the newer PCV20.  The pharmacy had not received that vaccine and was not available yet in the store.  The patient was contacted but did not answer the phone.  They are due for PCV 23 in 1 year
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: A 49-year-old patient was vaccinated but wasn't eligible at this time
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Food poisoning, Injection site pain, Nausea
Clinical narrative: This is my first booster shot, and it was in my right arm. My right armpit got very swollen in about 24 hours, with a soft pear-shaped swelling 4x2x1" and a mild burning sensation. This didn't happen during my first two shots.  Other side effects: fatigue, very sore arm at the injection site.  During the first evening after my shot, I also experienced intense nausea and vomiting every other 10-15 min for about 3 hours, very likely because of food poisoning from takeout food.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vomiting
Clinical narrative: This is my first booster shot, and it was in my right arm. My right armpit got very swollen in about 24 hours, with a soft pear-shaped swelling 4x2x1" and a mild burning sensation. This didn't happen during my first two shots.  Other side effects: fatigue, very sore arm at the injection site.  During the first evening after my shot, I also experienced intense nausea and vomiting every other 10-15 min for about 3 hours, very likely because of food poisoning from takeout food.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Red itchy rash on neck and chest. One course of cortisone after and inital cortisone injection. 24 hour allegra-twice a day for 2 months.  Oral Pepcid to refuce histamine.  Started a low histamine diet which I believe made a difference.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Nasal congestion, Rhinorrhoea
Clinical narrative: I had a stuffy nose, slightly runny and I took a shower and I noticed I did not smell and taste. My taste came back gradually after a couple days.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I had a stuffy nose, slightly runny and I took a shower and I noticed I did not smell and taste. My taste came back gradually after a couple days.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Axillary lymphadenopathy on the same side as vaccine was given