chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Therapy non-responder; Circumstance or information capable of leading to medication error; Drug dose administration interval too short; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a adult female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis, HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B, the 2nd dose of Engerix B, the 3rd dose of Engerix B and Engerix B at an unknown dose. On an unknown date, unknown after receiving Engerix B, Engerix B and Engerix B and not applicable after receiving Engerix B, the patient experienced therapy non-responder, circumstance or information capable of leading to medication error and drug dose administration interval too short. On an unknown date, the outcome of the therapy non-responder, circumstance or information capable of leading to medication error and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Engerix B, Engerix B and Engerix B.  Additional details were provided as follows: The age at vaccination was not reported. The patient was having a negative titer reading after receiving childhood vaccination and hence wanted to complete a second series of Engerix-B. The patient was planning on taking the second dose of the series prior to the 1 month established on the local label due to school requirements and if administered would lead to circumstance or information capable of leading to medication error and shortening of vaccination schedule.      Lab Comments: On an unknown date, the patient's Hepatitis B surface antibody was negative
Pt complains of rash; evidence of reddening of skin on upper extremities. Patient has no complaints of itching, no SOB or difficulty breathing. Patient received 50 mg Benedryl PO with water for reaction. Did not require further intervention. Patient informed to follow-up with primary care physician regarding reaction to determine whether to receive a 2nd dose in 28 days.
Pt. Passed away in her sleep at night following receiving her 2nd Covid vaccination earlier in the day.
Itchy 24 hours after vaccine. Red, dark by Band-Aid area. Started to burn. No fever.
Patient suffered a cardiac arrest and was unable to give details about her symptoms. Per husband, patient did not complain of any symptoms after vaccine administration. She began seizing without warning which was complicated by cardiac arrest of uncertain etiology
Urticarial lesions over abdomen, periorbital edema.  Facial flushing, erythematous back of chest and itching.
covid arm. about a 4 inch red, raised, itchy rash at the injection site of my left upper arm
I experienced heart palpitations immediately after receiving the vaccine (170-180 BPM). I waited the 15 minutes but decided to wait it out at home. Over the next 10 days I experienced 4 episodes of heart palpitations and the last one left me feeling light headed. So, I called EMS and on 04/27/2021 I went to the ER and was diagnosed with SVT. They tried medicine which did not work. So, they had to convert my heart via electrical shock x 2. I was sent home with Metoprolol and told to follow with a cardiologist. I received my second dose of Pfizer on 05/06/2021 with no adverse event. I had another episode of heart palpitations on 06/19/2021 and went back to the ER. They shocked my heart 3 times which did not work. I ended up getting Diltiazem which helped. I was released with that prescription to take regularly (instead of the metoprolol). I continued following up with the cardiologist and ended up having heart ablation surgery on 10/08/2021. During surgery, they diagnosed me with  Belhassen Ventricular Tachycardia (BVT),. I was told to take verapamil for 3 weeks after surgery and then stopped. Since, I have had no issues and did receive my Moderna booster in December with no adverse effects except a slight sore arm.
Headache onset just over an hour after vaccination.  Muscle and joint pain began slowly approx 6 hours after injection and increased to sever muscle and joint pain for 13 more hours.  Disappeared entirely 14 hours after beginning.
Patient complained of severe pain, weakness in upper arm from site of injection to elbow onset immediately post vaccine. Reported 12/15/08, advised to contact us if persistant for one month. 1/7/09, reported no improvement, referred to private physician. Patient stated that she had read on the internet that predinisone was recommended treatment, and would refuse prednisone.
Pt. had a 3 inch erythematous area to (R) upper arm with 0.5 inch hematoma in the center.
Information has been received from a consumer concerning child (sex and age not reported) who was placed on therapy with MMR II (dose number and vaccination date not reported).  The consumer heard about the patient through her sister about 3 years ago.  Subsequently the patient developed an "allergic reaction" after receiving MMR II.  It was unknown whether medical attention was sought.  The patient's out come was not reported.  This is one of two reports from the same source.  Additional information has been requested.
Approximately 5 minuets after administration of vaccines, client reported that his "left arm was itching". Writer noted the client's left upper arm in the deltoid region was edematous, red, and warm to touch with welts. Client who has history of asthma, denied difficulty breathing. Initial vital signs @ 11:38 am B.P. 132/82, Pulse 87, R 21. 50 mg Benadryl given IM, and cold pack applied to the affected extremitie. Client remained alert and responsive throughout treatment.  Client reported that the itching had decrease from a 9 to 4 on a scale of 1-10 prior to discharge.   Vital signs at discharge from clinic at 12:15 P.M. B.P. 120/82, P. 68, R. 24. Upon discharge, client ambulated with assistance and was transported to local hospital in private automobile by parent.  Follow-up  with parent by telephone was unsuccessful.
Patient became limp and unresponsive x 3 minutes, approx 20 minutes after administration.
pneumonia; a little painful in the chest; This is a spontaneous report from a contactable consumer (patient).  This 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 17Feb2021 at a single dose for COVID-19 immunisation. The second shot was planned for 12Mar2021. Relevant medical history included coughing (she had been coughing prior to receiving the dose). No relevant concomitant medications were provided. On 23Feb2021, she went to visit the doctor after it got a little painful in the chest. It was diagnosed as pneumonia for which she was given levofloxacin for 12 days. The outcome of the events was unknown.  Information about batch/lot number has been requested.
6-01-2021  EMS transported Hospital  - Symptoms began as dizziness, speech was slurred, struggled to walk, stiffness behind right thigh and right knee, felt generally wierd, hypotension, and Bradycardia.  Patient stayed one night at Hospital and was released early evening 6-02-2021 after showing great  improvement.  Atorvastatin 20 mg daily, Pantoprazole 40 mg daily, and 325 mg aspirin twice daily prescribed.  Advised to see cardiologist for low heart  6-05-2021  EMS transported patient to Hospital app 6:00 pm- Symptoms were GI Bleed (vomiting black blood), and hypotension.  Patient admitted to Hospital two nights 6-05 and 6-06 and released early afternoon.  6-1 rate.    6-17-2021 pharmacy administered  the second vaccine Pfizer dose EWO217.  6-24-2021  Primary Care Physician prescribed Sucralfate 1 GM as needed for stomach pains after eating.  She, also, directed Patient not to take any further vaccine doses.  8-2021  Cardiologist Dr first prescribed a one month monitor worn externally.  He then had implanted a three year Medtronic Heart Monitor and detected one atrial fibrillation event in Dec 2021.  He prescribed Eliquis 2.5 mg twice daily.
Hot to the touch; Swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th May 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 9th May 2022, 5 hrs after receiving Shingrix, the patient experienced injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site warmth and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth and injection site swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-MAY-2022 Reporter's Comment: The case was reported by the patient. The patient reported that, about 5 hours after receiving the Shingrix vaccine her left arm was hot to the touch and swelling at the injection site.  The reporter did not consent to follow-up.
Patient received Pneumovax 23 vaccine to left deltoid on 10/28/2019 and patient returned to clinic on 10/30/2019 to report having continued severe pain at left arm that is worsened with movement and touch. Patient is able to grasp and flex arm but  flexion is painful. She reports she is taking OTC pain relievers for pain but with limited relief. She denies any current worsening but reports there has barely been any improvement with pain. Encouraged patient to seek follow up care with PCP if any worsening and that she may continue to take OTC pain reliever as the OTC label directions indicated.
I saw bright red dots &dot clusters on both legs; Petechiae; This is a spontaneous report from a contactable consumer reported for herself.  A 58-years-old female patient (not pregnant at the time of vaccination) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL9262, via an unspecified route of administration on 02Feb2021 13:30 in left arm at single dose for covid-19 immunisation.  Medical history included known allergies: Amoxicillin (all penicillin family), she had AT III deficiency (a hereditary blood clotting disorder) that she had been taking warfarin for 23 years never any issues or clots since.  she had never had a reaction to any vaccines before. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  Concomitant medication included warfarin for AT III deficiency and 1 multi vitamin.  The patient previously took amoxicillin and experienced allergies.  On 02Feb2021 the patient got the vaccine at 1:30pm. At 5:30 pm, she saw bright red dots and dot clusters on both legs (not sure when it started, reported as 02Feb2021 05:00 PM) all dots were under the surface of her skin. They didn't itch nor hurt and were not detectable by touch. She took a few pictures. Next day they were still there and hadn't increased or decreased. The next day Thursday, she went to her PCP Dr (Name) got blood work and results came back normal. He thought it to be petechiae but not sure why. Each day the red dot/clusters turned more purple and within 5-7 days had faded away.  Dr. (Name). said if with the second vaccine dose, she got worse dot/clusters that worry her, she was to come back.  On 12Feb2021 she had an appt with her hematologist Dr (Name), after discussing and looking at the pictures (knowing that she had never had this before) she said it was not related to her medical condition-AT3 deficiency, it didn't look like petechiae. She said it was a reaction to the vaccine, to report it and get advice from you folks before got the second dose. There was no treatment received. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolved in Feb2021. The events were reported as non-serious by the reporter.
Febrile sz w/i 24 hours of 1 yr vaccines.  01/14/2008 VAERS report submitted with MR attached for ER visit 12/27 2007 with DX febrile seizure.  Child developed fever night of vax, went limp, vomited , then began shaking which last ~5-10 minutes.  Temp was 104. Returned to hospital with fever again 1/2/08, no seizure activity
Received TWINRIX at about 8:40 A.M. Seemed fine. Talking not dizzy and walked out to waiting rm. Felt thirsty. Was directed to water fountain by CSR. Passed out, hit the wall and slid down about 9:00 A.M. Came to right away. Alert. No problems.
Patient has a h/o HSV. Received zoster vaccine 2/23/16 and developed multiple presumed herpes lesions on gums along with facial swelling/photophobia on 3/8-3/9. HSV culture of lesion negative.
no adverse symptoms were reported; Multiple patients received improperly stored doses of VARIVAX; This spontaneous report was received from a medical assistant referring to multiple patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 30-JUL-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S038700 (expiration date: 01-DEC-2021) for prophylaxis (additional dosage regimen information was not reported). No adverse symptoms were provided.  The vaccine was exposed to a temperature of 6 to 14 Fahrenheit degrees (7.7 Fahrenheit degrees), for a timeframe of 2 hours and 8 minutes. There was no previous excursions and it was found because of a digital data logger.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2008USA010128:Original Case : 2008USA010000 US-009507513-2008USA010124:Original Case : 2008USA010000 US-009507513-2008USA010125:Original Case : 2008USA010000 US-009507513-2008USA010126:Original Case : 2008USA010000 US-009507513-2008USA010127:Original Case : 2008USA010000 US-009507513-2008USA010000:Original Case : 2008USA010000 US-009507513-2008USA010121:Original Case : 2008USA010000 US-009507513-2008USA010123:Original Case : 2008USA010000 US-009507513-2008USA010134: US-009507513-2008USA010135: US-009507513-2008USA010136: US-009507513-2008USA010137:
Information has been received from a health care professional concerning a 63 year old male with no medical history reported, who on 13-FEB-2008 was vaccinated with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (Lot #656233/0200U). There was no concomitant medication reported. Subsequently, in February 2008, the patient reported an injection site reaction after receiving pneumococcal 23v polysaccharide vaccine. The patient stated that his left arm was swollen from the upper shoulder to the elbow and he experienced "sweating" for 3 days. It was reported that the patient called the physician. No diagnostic studies were performed. Subsequently, the patient recovered. No product quality complaint was involved. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
PATIENT HAD GENERALIZED TONIC CLONIC SEIZURES 36 HOURS AFTER VACCINATION
I started smelling a stale water odor, still to this day.  No one else in household smells it.  I have not sought any treatment.  It occurs any time day or night.  I smell it only in our home.  We have had the air ducts, furnace and air conditioner checked and cleaned.  Carpets cleaned and replaced a couple room carpets.  We also installed an air purifier, to no avail.
two minutes after receiving her vaccine she felt light headed, she had nausea and small amount of vomit
Woke up in the morning with her ankle swollen, warm to the touch and in extreme pain. Hurt with movement but not touch. Patient went the the ER a few days later after it didn't go away.  Dr ruled out fracture and blood clot. Dr saw bone spurs on X-ray. Told her to ice, elevate, rest and take aspirin and tylenol. Resolved after 1.5 to 2 weeks.
Within 5 minutes of Imm infant developed maculopapular urticarial rash on face. Patient was alert, oriented with no airway distress. Patient was given 1.25ml of diphenhydramine 12.5mg/5ml (Benadryl generic) po at that time was observed x 30 min in clinic.
Fever 101.4 early this morning ,  head ache,  body aches, nausea. now fever is 100.7 afternoon.
Dehydrated; This case was reported by a physician via(Facebook)interactive digital media and described the occurrence of dehydration in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   On 1st October 2021, the patient received the 1st dose of Shingles vaccine and Influenza vaccine Quadrivalent 2021-2022 season. In October 2021, 1 day after receiving Shingles vaccine and Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced dehydration. On an unknown date, the outcome of the dehydration was unknown.   It was unknown if the reporter considered the dehydration to be related to Shingles vaccine and Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were reported as follows: This case was reported by the physician. The age at vaccination was not reported. The patient had shingles vaccine at clinic. The patient reported that he/she glad its covered by his/her insurance. The patient also received his/her flu shot. At the time of reporting, the patient felt dehydrated and his/her body was in overdrive, but he/she hydrated with water. The patient stated no other side effects whatsoever. The follow-up would not possible as contact details not available.
1.  Migraines began 3 days after the second dose. I have had 1-2 migraines since my vaccination one month ago. (Treatment was sleep and Advil). 2. I had spotting (slight menstruation 10 days after the vaccine). I have been through menopause and not had a period for well over 4 years. 3.  I am very lethargic. I start my day with exercise and energy, but I have to come home and sleep...as in, take a serious nap around 4-5 days per week. This is very uncharacteristic! 4.  My ears are ringing terribly! I'm accustomed to my slight tinnitus. But, on Monday, July 12th, they are ringing exceptionally loud.
12 hrs  after vaccine fever over 100F lasting about 16 hrs, severe headache lasting 24 hrs, muscle, joint and whole body aches lasting 24 hrs, swelling, heat and rash in right arm with pain still ongoing (70 hrs after injection) at injection site
She started breaking out in a red rash and was itching all over within an hour of receiving the vaccine.  Went to see pt next door and she states she could not take Benadryl because she was at work and it would knock her out. Had epipen available and she stated she did not need. However, a couple hours later she felt worse and went home. She had taken Benadryl and took a nap then woke up and her lips were tingling, she decided to seek medical attention, while driving to clinic she had to stop because her tongue was tingling and she had to pull over to take Benadryl she was unable to swallow at this time and administered her epipen. She states she doesn't remember much after this.
Client stated that she had prior history of vaso-vagal response to vaccinations, finger pricks and blood draws, that usually they have her lay down when she gets shots. She also has had nausea and dizziness after other shots. She felt nauseous within 2 minutes and was pale and faint, weak. Checked her bp was between 100/60 and 120/80 pulses 40-60. she was"passing out" between answering questions, called EMS and asked her about what she had eaten this morning. she stated some of a bagel but not all. F/U on 3/12 states she felt better with normal BP/pulse while in ambulance and the EMS released her with out transfer, she sat in her vehicle for 1 hour before driving home. she felt weak with sore shoulder on 3/11
Tremors started one week after initial vaccine; full body - hands, arms, legs. Tremors occurred at rest and continued while extremities were in use. No treatment. Tremors stopped within 48 hours of onset. Neurologist was notified with no recommendation for additional treatment at this time.
Joint pain, swelling, joint stiffness, muscle pain, left arm to wrist pain, neck pain, headache, numbness in fingers on day one of injectionnumbness in left ring and baby finger on day 2 post injection, limited range of motion from day one to day 4 this includes limited flexion, extension, internal and external rotation,
Within 24 hours experienced welp on the entire body, and redness to the administered site, On the 3rd day , right arm swollen lymph nodes
swelling 5cm diameter for 6 days; skin over area peeled; continual muscle pain of about nickle size over area; nausea, fever first 2-3 days
I had gotten the COVID-19 Bivalent vaccine in the morning and around 5PM that night I started not feeling well. I had chills and sweats and I just felt awful, I was incapacitated and in bed so much that I could not even get out of bed to get a thermometer. My back was also really sore, and this was the first thing I had noticed before I started not feeling well. The sweats and chills lasted into Saturday and by that evening they had calmed down, but I still had the back pain and then it dawned on me it was not just back pain, but it was pain in my kidney's. The sweats and chills ended on Monday morning but the pain in my back has lasted, there has been pain on both sides of my back but it has subsided to just the right side and the left side is just a little painful. Every time I urinate, my urine is a dark color. There has not been any blood but is dark and it had a very foul smell as well. I was staying hydrated as I could, so it was also odd that my urine was so dark for the amount of hydration I was having. I ended going to urgent care yesterday and they took a urine sample. There are white blood cells present in my urine which indicates an infection, so they cultured that as well to see what is causing the infection and I am waiting on the results. At this point I cannot do anything for a long period of time without having pain. I cannot sit for too long, or walk, lay down, really anything after a while the pain will get too intense.
Suspected COVID-19; Suspected COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 09Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 03Nov2021 as dose 3 (booster), single (Lot number: 330268d) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: COQ 10; ROSUVASTATIN, stop date: 15May2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Suspected COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 with Paxlovid (Lot number: Fp6522) from 15May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 27-DEC-2015 at 06:29, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 7.5 and 7.0 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.