chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had the Pfizer Covid 19 vaccines and still got Covid.; had the Pfizer Covid 19 vaccines and still got Covid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Batch/Lot number: unknown), on 13Mar2021 as dose 2, single (Lot number: EN6199) and on 15Dec2021 as dose 3 (booster), single (Lot number: EW0191) for covid-19 immunisation. The patient's relevant medical history included: "blood clot" (unspecified if ongoing), notes: at 8:30 she takes a blood thinner because she had a blood clot; "high blood pressure" (unspecified if ongoing), notes: At 9 o'clock she takes her "high blood pressure". The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had the Pfizer Covid 19 vaccines and still got Covid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Caller stated that she and her husband had the Pfizer Covid 19 vaccines and still got Covid. They were both taking Paxlovid. She started it at 10pm last night and would take it again at 10am this morning time and then again at 10pm tonight. It said in the paper that it was supposed to be taken it every 6 hours or do they doing at 10 to 10 and are doing it from 10 to 10. She takes Synthroid at 6 and at 8:30 a blood thinner because she had a blood clot. At 9 her high blood pressure and then she figured at 10 she could take those pills. Caller stated that she had no concerns about interactions and thought it said 6 hours I was supposed to take them.  Patient not taking them every 6 hours.  Patient received it once in the morning and it is not specifying what time of the day to take it. It just said in the morning and at night. Caller stated that about paxlovid mentioned she and her husband had the Pfizer Covid 19 vaccines and both got Covid. They were taking Paxlovid. She was 68-years-old and her husband is 74-years-old. Never got sick off the shots or nothing. Information confirmed as provided. Clarified that they had both Pfizer Covid 19 vaccine shots and the Pfizer Covid 19 booster.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt c/o fatigue, malaise, left arm/injection site soreness, sweats, and dizziness. Decadron 8 mg IM administered. Rx given for Medrol pack.  Rests. Ice and gentle massage to left deltoid recommended. OTC Benadryl and Ibuprofen prn symptoms recommended.
Information has been received from a physician concerning a 22 year old female patient, who on 05-MAR-2010 was vaccinated with the first 0.5 mL dose of GARDASIL (route and lot number not reported). On 05-MAR-2010, the patient experienced syncope after getting the first dose of GARDASIL. It was also reported that the patient visited the office for a "colonoscopy with biopsy". The patient sought unspecified medical attention. The adverse event improved, but the patient's outcome was unknown at the time of reporting. All telephone attempts to contact the reporter have been unsuccessful. Additional information has been requested.
A report was received from a health professional on 30 November 2001 regarding a 97 year old male patient who had received Begrivac on 12 October 2001, and Fluvirin on 20 November 2001.  The reporter stated that while the patient experienced Parkinsonian symptoms beginning in December 2001 this was unrelated to the vaccines and the patient seemed to have suffered no ill effects from having two influenza vaccines.  At the time of reporting the patient had not recovered.  There was insufficient information to determine the reporter's causality assessment.
NAUSEA; This spontaneous case report (PVX2019-1806) was received from a consumer on 13-Jul-2019. It describes a female consumer who felt nausea (PT: Nausea), after administration of Vivotif for an unknown indication.  Case report: The consumer started taking Vivotif and felt nauseous. She took her third dose on 13-Jul-2019 and again felt nauseous.  Action taken with Vivotif was dosage maintained.  The clinical outcome of the event was not resolved.  Company's Comment: In this case, it was reported that a female consumer who felt nausea, after administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, nausea is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that a female consumer who felt nausea, after administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, nausea is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.
headache too on the one side of her head. It was just like migraines; face was swollen started with cheeks and then all over the face; Nausea, felt like throwing up; tiredness; headache too on the one side of her head. It was just like migraines; arm is sore; tingling in mouth; This is a spontaneous report received from a contactable consumer (Patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EW0162, Expiration date: Unknown), via an unknown route of administration on 08Apr2021 10:00 (at the age of 64-year-old) as 1st dose, single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included migraine medication. On 08Apr2021 the patient experienced, tingling in mouth, started when she got into the car after the vaccination. It started a little bit then.  She thought it would go away. She was kind of thinking about it, it was not severe. It was like her mouth is like a little bit swollen but it is nothing like she had a hard time swallowing or anything like that. It was still going on. Her arm was sore. She stated "she knows this is a common side effect. It was still sore. She did a lot of stretching, and it was fine and it is just the usual. On 09Apr2021, at night before she went to bed, she felt some soreness in her face like this morning she woke up and it was swollen, her cheeks were very swollen and her whole face was swollen. Caller read on the information that usually people get side effects right there, but she had a delayed reaction.  The swelling was scary. Caller has a headache too on the one side of her head.  She did take a pain reliever.  The headache was still there. It was like migraines. Usually, she takes a migraine medicine but she took Tylenol for headache but the headache was still there on the right side. Same day, on 09Apr2021 she also experienced nausea, felt like throwing up which started morning, and went away. It was just for the first few minutes this morning; it came and went away. She added she had tiredness. She added that a lot of things happened this morning.  it is like she had a delayed reaction. Caller added her vaccine appointment was 10 o clock 08Apr2021, so she felt side effects around that same time 24 hours later. Patient was worried and asked that she was scheduled in three weeks for the second vaccine, and what should she do at that time.  She wanted to know if her side effects will be more severe and if the amount of vaccination in the second vaccine is the same amount or is it more than the second. Outcome for nausea, felt like throwing up was resolved on 09Apr2021. Outcome for other events it was unknown.  No follow-up attempts are needed. No further information is expected.
Diagnosed with a mild case of COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with a mild case of COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced COVID-19 (Diagnosed with a mild case of COVID-19). At the time of the report, COVID-19 (Diagnosed with a mild case of COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.  The patient wished to know when he would be eligible to receive the Flu vaccine.; Sender's Comments: This case concerns a male patient  of an unknown age with no relevant medical history who experienced non-serious unexpected event of COVID-19. Temporal relationship is unknown since date of vaccination was not provided per SD. The rechallenge was unknown as it was not provided whether the patient received the first or the second dose of the vaccine. Very limited information regarding clinical course of the event has been provided at this time. Based on biological implausibility, causal relationship between the reported event COVID-19 is not applicable. The benefit-risk relationship of Spikevax is not affected by this report.
Cannot even talk; Chills; Nausea; Headache; Fatigue; I can't do anything I am just "lying" on bed; miserable; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had no allergies. The patient reported they couldn't spend on the phone long; they experienced a lot of side effects from their vaccination on "Monday." They reported being vaccinated, first vaccination on "Monday." Tuesday the patient started getting chills and nausea and headache and fatigue and was still in bed. The reporter also stood up and then had a headache and was nauseous; further reporting they had been doing that for 3 days. The reporter inquired when the side effects would stop, further reporting feeling miserable and that they couldn't do anything, just lying on bed, cannot even talk. The clinical outcomes of chills, nausea, headache, fatigue, cannot talk, I can't do anything I am just lying on bed, and miserable were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
sore arm first and second day. exactly one week later i vomited early tuesday morning my dinner and since then i?ve felt nauseous and an off feeling in my stomach. I?ve also been having chest pain.
Had vaccine on 3/3/2021 at approximately 1 PM.  She was found on her couch deceased on 3/8/2021.  Possible death on 3/5/2021.  She called her sister and told sister that back hurt worse than usual and she would lay on the couch and rest.  This is where she was found.  Unknown if from vaccine, but due to vaccination on Wednesday proceeding her death, report is being filed.
Brusing and swelling. Redness over large area. Recommended to patient to be seen by her physician.
pt recv vax 12OCT96 & 22OCT96 pt devel a red gen rash that looked like measles & exp a fever of 102;MD noted that rash persisted for several days but was resolving;
I was very sick which is normal but I woke up this morning, 3/24/2021, and have a red splotchy rash on my neck and forearm. My forearm is very itchy.
1. Loss of mobility, pain 2. Injection administered above deltoid muscle in shoulder joint 3. Saw primary care doctor who suggested seeing a orthopedic doctor and scheduling PT 4. Started PT and made appointment with Orthopedic doctor 5. Had x-rays which were negative and MRI which showed a partial rotator cuff tear 6. Continued PT 7. Saw Orthopedic doctor several times. Doctor prescription Prednisone and pain medication. Pain medication was not helpful. Prednisone was helpful. After 10 days treatment complete. All symptoms returned. 8. Symptoms of loss of mobility and pain not improving 9. Orthopedic suggested surgury 10. Continued PT, with little to no improvement 11. Rotator cuff surgery performed on 4-28-2014 12. Bursectomy and debridement of rotator cuff area performed
This case was reported by a consumer and described the occurrence of swelling injection site in a 2 month old male patient who had received diphtheria and tetanus toxoids and acellular pertussis vaccine for prophylaxis.  A physician or other healthcare professional has not verified this report.  Concurrent vaccinations included IPV, HIB vaccine and Prevnar.  On 04/05/2004 the patient received the first dose of DTPa.  At the time of injection, the patient experienced bleeding that was more than normal.  On the same day that he received vaccination with DTP, the patient experienced swelling around the injection site, crying, and a fever of 100.0 degrees.  The bleeding resolved, the swelling improved, the crying was unresolved, and the outcome of fever was unknown at the time of reporting.
This case meets vaccine breakthrough criteria.  HOME COVID TEST PTA.  SXS COUGH, SOB, FEVER FOR LAST 7 DAYS.
Information has been received from a health authority concerning on 18 month old female patient (also reported as 2.5 year old) with no medical history reported who on 9/25/03 at 8:30 AM was vaccinated IM with a first dose of MMR (lot # 643834/1040M; batch # W9571-5). On 9/27/03 the patient presented with fever 38 degrees C, urticaria, atopic dermatitis, exanthema, lack of appetite, suffering and asthenia and was hospitalized. The outcome was not reported. File to be completed. Follow-up information received from a healthcare professional on 20-Jan-2004, indicated that the child's patients previously reported fever that was as high as was 103 degrees F. and that the patient has recovered.  New information also included county of vaccine administration, verification that no laboratory tests were done, no relevant medical history, no current illnesses and no adverse events following previous vaccine administration.  Information regarding FLUMIST (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding her 9-year-old male child who received a dose on November 26, 2003.  The consumer reported that her son received a dose of FLUMIST on November 28, 2003 and developed "the flu" on November 30, 2003.  Symptoms included:  cough, fever of 103 degrees F., and boday aches.  He was treated with IBUPROFEN.  On 20-JAN-2004, the healthcare professional reported that the child had recovered.
10/17 Fever, fatigue, prod. cough, confusion. Home x 2 weeks. 11/1/09 Called 911 lost consciousness. Extreme BP and pulse spikes. 30# wt loss due to LPR - on 8-9 meds now. Cont. to hypertension, tachycardia, fibromyalgia, reflux (LPR).
Received the 2nd and had an allergic reaction on  eye, it was swollen and has decreased; Received the 2nd and had an allergic reaction on  eye, it was swollen and has decreased; This spontaneous case was reported by a patient family member or friend and describes the occurrence of EYE ALLERGY (Received the 2nd and had an allergic reaction on  eye, it was swollen and has decreased) and EYE SWELLING (Received the 2nd and had an allergic reaction on  eye, it was swollen and has decreased) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EYE ALLERGY (Received the 2nd and had an allergic reaction on  eye, it was swollen and has decreased) and EYE SWELLING (Received the 2nd and had an allergic reaction on  eye, it was swollen and has decreased). At the time of the report, EYE ALLERGY (Received the 2nd and had an allergic reaction on  eye, it was swollen and has decreased) and EYE SWELLING (Received the 2nd and had an allergic reaction on  eye, it was swollen and has decreased) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD21-093411, MOD21-093540, US-MODERNATX, INC.-MOD-2021-162458 (E2B Linked Report).; Sender's Comments:  MOD21-093411:Wife case MOD21-093540: US-MODERNATX, INC.-MOD-2021-162458:Husband's case
Lost all hearing ability in right ear (same side as injection) 24 hrs. after. Treated by a ENT Specialist on Oct 15 and 29. He prescribed Medrol 4mg (21-pack) on Oct 29th.11/4/08-records received for 10/6/08 routine exam.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies and concomitant medications were not reported. On 01-SEP-2016, the patient was vaccinated with improperly stored PROQUAD, lot # M019232, rHA, expiry date 17-OCT-2017, 0.5 ml. Vaccine was exposed to a maximum of 9F and a minimum of 6.8F for a cumulative time frame out of recommended storage range for 23 hours. Data logger in use yes. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Post-vaccination, the patient's medical records were reviewed and notation of previous COVID-19 vaccination series was found. Per website, the patient received Pfizer vaccines on 1/6/2021 and 1/27/2021. The facility Medical Director was notified.
Heart attack; Gastrointestinal Bleed; Gastrointestinal Bleed with a low hemoglobin of 5.8; This is a spontaneous report from a non-contactable consumer. An 80-year-old female patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), at the age of 80 years old, via an unspecified route of administration on 22Jul2021 at single dose for COVID-19 immunisation. The patient was not pregnant at time of vaccination. The patient had no known allergies. Medical history included COVID-19 (prior vaccination). The patient did not receive any other vaccine within four weeks of vaccination. The patient's concomitant medications were not reported. The patient experienced heart attack 16 days after the first administration of vaccine and a gastrointestinal bleed with a low hemoglobin of 5.8 on 07Aug2021. Events resulted in hospitalization for 7 days. The patient had been tested for COVID-19 post vaccination. The patient underwent lab tests and procedures which included hemoglobin: 5.8 (low) on 07Aug2021, COVID-19 test: negative on 07Aug2021. Therapeutic measures were taken as a result of events and included treatment with clopidogrel bisulfate (PLAVIX) and aspirin, blood transfusion and iron. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pfizer 12+ was accidentally administered to this 8yo who should have received Pfizer 5-11yo.
About 24 hours after receiving the fourth COVID vaccine (Pfizer), I started to feel ill. I started to experience flu like symptoms at first. I figured it was because of recently receiving the vaccine. It persisted and I started experiencing tachycardia and chest pains. I went to the ER. I was given two doses of nitroglycerin. There was a cardiac work-up completed and everything came back normal. They attributed my pains to the vaccine. I was kept off of work and strenuous activities for a couple of weeks. It has been six months and I still experience a high heart rate and become out of breath when I try to perform any activities.
Mom reports pt started crying about five hours after vaccine was received. Pt was inconsolable for five hours. Tylenol given at 11pm and 5am. Mom spoke with on call doctor at approx 2am who instructed her to take child to ER if crying gets worse or come into office in the morning. Per mom this morning at 9am, pt is better. Still clingy, and cranky. offered appt, but mom decline at this time.
2" x 2 1/2" cellulitis at vaccine site, right deltoid.
pt recvd vax 21APR93 & pt exp sore arm, h/a & vomiting;
shingles; Information has been received from a lawyer and a female patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported.   On or about 23-FEB-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions.   Subsequent to the inoculation (date not reported), the patient was treated by a physician at a physician office for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.
Rash back, neck, arms and groin w/fever. (Treatment) Loratadine 10 mg 1 tab daily; BENADRYL 25 mg. 1 cap at night #7.
(03/17/2021) Major pain, slept with 2 blocks of ice for 4 mo. was given steroid pack, did not affect problem. Seen by a specialist Orthopedic Surgeon and found it was Subacromial Bursitis in shoulders and wrist. Between two treatments pain was assuaged, but pain in both wrist was increased. Still ongoing pain in the wrists. Opted to use OTC for wrist pain.