chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lost a lot of weight; sick; dry conditions and had a very bad fire with smoke in the air that caused allergy problems; Sinus problem in Aug2022, allergies; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Lot number: GL9694), in left arm for covid-19 immunisation. The patient's relevant medical history included: "sensitive skin" (unspecified if ongoing), notes: has had sensitive skin for years and years and years and doing everything no dyes no perfumes; "sinus", start date: Aug2022 (unspecified if ongoing), notes: has had sensitive skin for years and years and years and doing everything no dyes no perfumes; "allergies" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Pfizer Covid vaccine #1 on 05Jun2021, lot EW0180. Does not have NDC or expiry to provide.), administration date: 05Jun2021, for COVID-19 immunization; BNT162b2 (Pfizer Covid vaccine #2 26Jun2021, lot EW0198. Does not have NDC or expiry to provide.), administration date: 26Jun2021, for COVID-19 immunization; BNT162b2 (Pfizer Covid vaccine booster on 23Dec2021 , lot 330258D. Does not have NDC or expiry to provide.), administration date: 23Dec2021, for COVID-19 immunization; Flu (She had the regular Covid shot and gets a flu shot every year and has never had a reaction in her life). The following information was reported: ALLERGIC SINUSITIS (non-serious) with onset Aug2022, outcome "unknown", described as "Sinus problem in Aug2022, allergies"; HYPERSENSITIVITY (non-serious) with onset 20Sep2022, 8 days after the suspect product(s) administration, outcome "not recovered", described as "dry conditions and had a very bad fire with smoke in the air that caused allergy problems"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "lost a lot of weight"; ILLNESS (non-serious), outcome "unknown", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had a sinus problem in Aug2022, allergies. They have dry conditions and had a very bad fire with smoke in the air that caused allergy problems. Had the Covid outbreak at the facility and tested negative she was out a couple days for safety as she takes care of her mother.
Started complaining of a feeling of "water in both ears" about 2 days after second booster. At times, difficulty hearing. Worse in right ear than in left ear No prior problems with this kind of feeling in either ear.
Information has been received from a pharmacist reported that a patient was believed to received a dose of PNEUMOVAX 23 in April 2009 but no documentation could be produced (immunization status unclear). On approximately 29-MAY-2009 the patient experienced pneumonia and was hospitalized. At the time of reporting, the outcome was unknown. No further information is available.
Mother had child taken to ER in ambulance on 7/9/10 because she noticed a fever of 101.8 at 7 pm that evening. She gave 1/2 dose of Motrin. Pt had severe shaking all over and felt hot per mom. Pt. had vomited X4 since then. It was unclear if shaking was rigors or seizure. Stools were more loose than normal. Pt. has history of UTI's and mom states that "hasn't been right since the MMR".  Pt. was noted to be playing with mother in her room with no evidence of distress and was discharged at 06:50 that morning. Follow up received 7/15/2010: Reaction is per er report.
This case was reported by a consumer and described the occurrence of cough in a 69-year-old male patient who received Influenza vaccine. Co-suspect products included ADVAIR Diskus inhalation powder for asthma and VENTOLIN Hfa inhaler for asthma, wheezing and wheezing. Concurrent medical conditions included COPD from asthma. On an unknown date, the patient received Influenza vaccine at an unknown dose and ADVAIR Diskus (inhaled) at an unknown dose and frequency. On an unknown date, the dose was changed to an unknown dose and frequency. On an unknown date, the patient started VENTOLIN Hfa (inhaled) at an unknown dose and frequency. On an unknown date, the dose was changed to an unknown dose and frequency. On an unknown date, the dose was changed to an unknown dose and frequency. On an unknown date, unknown after receiving Influenza vaccine, ADVAIR Diskus and VENTOLIN Hfa, the patient experienced cough, overdose, sickness and wheezing. The dose of ADVAIR Diskus was increased. The dose of VENTOLIN Hfa was increased. On an unknown date, the outcome of the cough, sickness and wheezing were recovering/resolving and the outcome of the overdose was not recovered/not resolved. The reporter considered the cough, sickness and wheezing to be unrelated to Influenza vaccine and ADVAIR Diskus. It was unknown if the reporter considered the cough, overdose, sickness and wheezing to be related to VENTOLIN Hfa. A patient who has been on unknown doses of ADVAIR and VENTOLIN for a long time has been taking a little more of both ADVAIR and VENTOLIN than usual/as prescribed because he has been sick. Even though he got his flu shot the patient's wife said it was something like the flu not the actual flu. He has been coughing and wheezing more than normal. He is now doing a bit better and not coughing as much.
This is a 21-year-old who received his primary hepatitis B vaccination on 02/03/03. Approximately 1 week later he reports the development of a single "pustule/bump" on his right anterior lateral abdominal area. He did not seek care because he thought that it would to away. He states that it soon became a hole "the size of the end of a Q-tip". He reports that it drained "yellow, green and bloody" pus, but denies any odor to the drainage. On 03/25/03 he sought care at the medical department. Doctor referred him to the emergency department for further evaluation and treatment.  The client was evaluated in the Emergency Department (ED). An incision and drainage procedure was performed on the abscess. He was instructed to pack the wound twice a day with iodophor gauze. He completed the procedure as instructed for 7 to 10 days. He states that the abscess healed without further complication.  On 17 June 2003 the client received his second hepatitis B vaccination. As before, within one week he developed a single pustule/bump on his right upper lateral buttock. He states that he can touch both areas by spreading his hand and reaching from thumb to pink between the two lesion sites. He reports that the pustule progressed, as previously, however this time he did not wait to seek care. The abscess required incision and drainage (I&D), which was done on 30 June 2003. Like before the abscess healed after the I&D procedure without further complication.  The client states that he had never before, or since these two occurrences developed pustules or abscesses. He is a volunteer on a search and rescue team and is concerned that he may not be hepatitis B immune. His other concern is if he continues and takes the third hepatitis B vaccination that he will again develop another abscess. He also states that he did not change detergents, softners, personal hygiene products, living environment or work environment.
Patient came back to flu clinic after 20 minutes and showed pharmacist a rash on upper arm where flu shot was given. Patient stated that she had a slight rash to the flu shot previously that contained egg. Pharmacist gave patient 4-BENADRYL (dye free) and offered a salve for the itching.
On Wednesday before testing positive I was at a my group. On June 19, 2022 I woke up with a headache and congestion used a home COVID 19 Test and it came back positive. I called my doctor on the following Monday to get something for the chronic cough. She prescribed me Robafen with Codeine.  I will be receiving be receiving the monoclonial antibodies June 24/2022.
Sore arm at injection site immediately after injection lasting about 24 hours. Chills starting 12 hours after injection, combined with overall body aches, mild headache, mild nausea.
Very large red, inflamed bump an inch or two below injection site. Then pain in the arm and less mobility ever since. (per patient)
Patient was scheduled to for a Pediatric Pfizer Booster instead was given Pfizer Booster Adult dose his right arm.
25FEB92 swelling of lymph nodes head & neck, sore throat; Seen by MD dx viral illness; 5MAR92 joints of wrists & fingers swollen & stiff; 16MAR started coughing; dx pneumonia 17MAR92; also erythema over thumb joints;
3/14/2023 that night I had a tickly and funny feeling in my throat. Throughout the night, I woke up with a very dry throat and stuffy. I woke up multiple times. I felt heart palpitations. I took FLONASE. This did not clean up my stuffy nose. The next afternoon, I had bad stomach problems. I took an at home COVID test and tested positive, 3/15/23. My nose started to run pretty bad that day and I had a dry cough. I started taking ibuprofen. On 3/16/23 I could not sleep at all, I was so congested and could only breathe through my mouth. I was not hungry. I had a high fever; I did not take my temperature. I felt very hot and had chills. My lips began to swell that evening and progressively got worse. My eyes were swollen. I took hydroxyzine and that brought the swelling down. On 3/17/23 I lost my sense of taste and smell. I still was very stuffy and breathing through my mouth. I checked my vitals. My blood pressure was a little high and my pulse was normal. I had a telehealth appointment and was prescribed PAXLOVID and began taking it that day. The next day, 3/18/23,the inside of my nostrils were burning. I was able to sleep fine. My saliva had a bitter taste. My nostrils were burning inside and I still had stuffiness. I feel asleep and when I woke up my oxygen level was 87. My blood pressure was elevated. I took another at home COVID test and it was positive. 3/19/23 A layer of skin fell of my top lip. My oxygen level was 92 and my heart rate was at 124. I had diarrhea and more stuffiness. On 3/19/23 My ears were clogged and was stuffy. I had a positive COVID test. On 3/20/23 I had a stuffy nose, headache and sweats. My stuffy nose was able to clear. 3/21/23 My vitals were better. The first day my smell was coming back. 3/22/23 the final day on PAXLOVID. Positive COVID test. 3/25/23 I still had congestion, sense of smell and taste still gone and I had a bad cough. Still testing positive for COVID. 3/26/23 I had more coughing fits and took albuterol. I am getting out of breath when moving. My heart rate jumps while sitting into the 100's. 3/29/23 I began to smell again, still coughing and out of breath. 4/1/23 I had uncontrollable cough. 4/2/23 I tested negative with an at home COVID test. I continued to cough and have heart palpitations. Sense of smell and taste returning. On 4/4/23 I called the doctor because I still had symptoms. I was prescribed cetirizine, azelastine and prednisone. I completed prednisone and are still taking the other two prescriptions.
No other AE; A dose was administered to a patient after a temperature excursion; This spontaneous report was received from nurse practitioner and refers to a patient on unknown age or gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unspecified date, the vaccine was under temperature excursion with a temperature of 0.5°C for 168 hours. Previous to this, there was no temperature excursion.   On 24-JAN-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose administered for prophylaxis (strength, and route of administration were not provided; lot #U008315 with an expiration date of 15-AUG-2023). No adverse events were reported.; Sender's Comments:  US-009507513-2202USA003842: US-009507513-2202USA003818:
pt. reports feeling lightheaded with mild diaphoresis after vaccination, pt . placed in a supine position, vital signs stable, pt. given a bottle of water and then discharged to home with boyfriend
This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, route, lot # and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Abnormal eye movements (multiple an hour) the following day (12/19). He was taken to local emergency room and admitted to neurology for continuous video EEG, sedated for brain MRI, ophthalmology exam. All tests were normal, but movements have continued. He saw ophthalmology for a dilated exam today, 1/6/2020, and they referred us to neuro ophthalmology.
Patient is a 30 year old female who presents following administration of a first dose of Pfizer COVID19 vaccine in the right deltoid.  She states that about 15 minutes following administration of the vaccine that she started to experience intermittent numbness/tingling in her right arm and hand.  She denies history of a similar episode.  She denies decreased range of motion, muscle weakness, and pain.  She relates past medical history of ankylosing spondylitis and Crohn?s disease of which she is controlling with diet/exercise.  She is not currently taking any medications.  She denies history of Guillain-Barre Syndrome.  Confirms allergies to shellfish.  She otherwise denies chest pain, difficulty breathing, swelling of the face/lips/tongue/throat, skin rash/itching, cramping abdominal pain, nausea, and vomiting.    GEN: Alert and oriented x 4, NAD. HEAD: NCAT EYES: PERRL, EOMI ENT: Ears normal, Nose normal, OP normal, no evidence of angioedema NECK: Supple, without LAD.  CV: RRR, no m/r/g PULM: Clear to auscultation bilaterally, no accessory muscle use ABD: Soft, no tenderness. SKIN: No rashes, skin warm and dry.  Injection site present in the correct anatomical position.  No erythema or edema of the injection site. MSK: FROM, MS 5/5, brisk capillary refill at the distal digits bilaterally NEURO: decreased touch sensation in the right arm, consistent with radial nerve distribution.   Alert and oriented x 4, CN 2-12 grossly intact, no ataxia, gait steady  Paresthesias following vaccine administration.  Patient demonstrated full range of motion, 5/5 muscle strength of the bilateral arms.   Recommended patient to seek medical attention should she develop severe right arm pain, right arm muscle weakness, or loss of range of motion.  Also explained signs/symptoms of Guillain-Barre Syndrome to patient and instructed her to seek medical attention should she develop any. Reiterated to patient to continue using her right arm and that she may take NSAIDs for arm discomfort as needed.   Instructed patient to consult their PCP regarding the post-vaccination reaction.  Patient instructed to go to emergency department should she develop chest pain, difficulty breathing, swelling of the face/lips/mouth/tongue/throat, or cramping abdominal pain with nausea/vomiting.  Patient demonstrated understanding of post-vaccination instructions.
Information has been received from a nurse practitioner concerning a 7 year old Caucasian female pt who on 22Sep1997 at 12 months of age was vaccinated in the left arm with a first dose of varicella virus vaccine live (lot 623655/0807E). On 08Apr04, the pt developed a breakthrough rash of 50 to 100 pox with an infected vesicle. On 09Apr04, the pt was seen for a doctor visit with more than fifty papular and vesicular lesions on the face, neck, trunk and arms. Some of the lesions were crusted over. There was one yellow crusted lesion in the lower abdominal area with an approx 3cm diameter of erythema. The pt was afebrile. The diagnosis was varicella with an infected lesion. The pt was administered cephalexin (Keflex). Subsequently, the pt recovered.  A product quality complaint was not involved. Additional information is not expected.
Received vaccine 5/16/15. Next day experienced redness, itching, swelling. Resolved after 2 days. Then on 5/29 began to swell, become hot and cause arm pain. Tx with XYZAL for allergic response. Tx cellulitis with BACTRIM. Pt then went out of town.
On 10/29/2004 total body aches, swollen hands: sore, HA. So sore she couldn't get out of bed. By 11/1 she was better. Better, but not quite himself.
Information has been received from a consumer concerning a child who was vaccinated with a dose of MMR II. The consumer reported that the pt developed the symptoms of autism shortly after vaccination, including "flapping his hands and going into his own world." Unspecified medical attention was sought. Upon internal review, symptoms of autism was determined to be an other important medical event (OMIC). The consumer also reported that her nephew developed a similar reaction following vaccination with MMR II (WAES0305USA02300). Further info is not available.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Batch/Lot number: unknown), on 16Feb2021 as dose 2, single (Batch/Lot number: unknown), on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 09Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "psoriasis" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; HCTZ; AMLODIPINE; LIPITOR. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
The mother of the patient relates that the day after the vaccination, when the child went back to school, she noticed that his left arm was red with an edema and hot to the touch at the site where the vaccine was administered the day before. The mother takes the patient to the primary physician Dr to get an evaluation of the affected area. Dr prescribe oral Benadryl and children Tylenol.
Extreme fever (103) Tuesday morning, horrible aches and chills, migraine. Didn't eat for 24 hours (7 pm Monday to around 7 pm Tuesday). Slept 18+ hours Tuesday (normally 6-7 hours a night). Nausea all morning. Bruising (size of an orange) at injection site), as well as swelling (normally doesn't happen when I get vaccinated).  Very sore joints and muscles (hard to stand, rotate, or walk) from late Monday night (11 pm) to Wednesday morning (8 am).
Information has been received from a licensed practical nurse concerning an 82 year old female with no known allergies, hypertension, type II diabetes mellitus, rhinitis allergic and supraventricular tachycardia who on 29-MAY-2007 was vaccinated SC "in the right deltoid muscle" with a single dose of Zostavax (Oka/Merck) (lot # 652965/0622F).  Concomitant therapy included cyanocobalamin, CARDIZEM CD, LANOXIN, GLUCOPHAGE, ALLEGRA, calcium (unspecified), aspirin and FLONASE.  On 30-MAY-2007, the day after the administration of Zostavax (Oka/Merck) (lot # 652965/0622F), the patient developed "flu-like symptoms" including a low-grade fever and widespread body aches.  Unspecified medical attention was sought.  No labs were performed.  At the time of the report the patient had not recovered.  There was no product quality complaint involved.  No further information was provided.  Additional information has been requested.
This spontaneous report has been received from a registered nurse referring to a male patient of unknown age. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 04-APR-2018, the patient was vaccinated with an expired and improperly stored dose of VAQTA lot # M031806 with expiration date of 30-MAR-2018 (strength, route, dose, and anatomical location were not provided) for prophylaxis. No adverse events were reported. The vaccine was exposed to a temperature range between 9°C to 25°C, during a time frame of 1.25 hours, which was called by a data logger. No previous temperature excursions were reported.
Within 2 minutes of patient receiving shot his eyes started to cross and his hands formed a fist and he tensed up and brought them towards his chest. His head rolled back and his eyes started to rolled back. His wife was next to him and held his neck. the pharmacist administered an Epi-pen into his left thigh and 911 was called. He became conscious within seconds of receiving the Epi-pen. He was able to verbally communicate and was able to tell us his age. He was very thirsty & became very sweaty in the minutes after he came to. He said he's never had a severe reaction after vaccines, never gets the flu shot and doesn't have history of seizures. Paramedics came immediately and took him to the Hospital.
Patient suffered a heart attack within 2 weeks of receiving vaccine. Patient had 99% blood clotting in his artery.
Temp 101, chills, body aches fatigue, nausea x 3 days  arm soreness @ inj site
Spot on arm, just below injection site. Red, warm, tender, round with irregular border. In first 48hrs after second vaccine, sane arm was sore and stiff. No other side effects/reactions noticed until red spot.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In November 2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster also known as shingles and other complications. On an unknown date, the patient was treated at a hospital emergency room for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.