chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I've had a persistent cough since I had COVID-19 and I waited a few months for vaccine and 2-3 days after vaccine I started getting much worse sore throat and clogged sinuses. I went to see asthma Doctor and she treated me for sinus infection with rounds of amoxicillin and prednisone. I started spitting out blood from nasal passages which worried me. I went to ENT and had chest x-ray and CT scan of sinuses and I was subjected to more antibiotics including clindamycin and prednisone. I was shortness of breath, I had difficulty swallowing, and there was no more bleeding but I did have mucous in sinuses. The ENT sent me to get biopsy done 06/23/22 and that biopsy showed cancerous tumor by nasal pharynx region where nasal passages meet. I have a cancerous tumor and it's being sent to the hospital to see if it's localized or spread. This week I'm going to have another CT of throat because of difficulty swallowing and that's where we are up to this point. I'm not 100% sure it's because of vaccine because November of last year I got my first booster and didn't have those subsequent symptoms and I got COVID-19 in late January and had a bad sore throat, tiredness, achiness, and that was it and I didn't lose taste and smell.
I woke up with loud ringing in my ear and I couldn't hear with that ear. a week or so later when it didn't stop I went to my doctor who sent me to an otolaryngologist.  Her associate did a hearing test and I was sent for a MRI of head/ brain A couple of weeks later my hearing seemed a bit better(confirmed by another hearing test), so I was told to check back in about 6 months to see if hearing continued to improve. Hearing did improve.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 at 10:30 as dose 1, single (Batch/Lot number: unknown), in right arm and on 26Dec2021 at 19:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Apr2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). 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 "Treatment of COVID-19". The patient underwent laboratory test: SARS-CoV-2 test: Positive. 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.
Patient reported DOE March 4, 2021, was subsequently diagnosed with pulmonary embolism, hospitalized and treated with Xarelto. He is currently recovering and will continue with Xarelto as an outpatient.
Swelling, warmth, erythema in area of vaccination 2 days after it was placed, placed on KEFLEX 5/27/11.
I developed Shingles 3 days after my 2nd Moderna vaccine.  Thigh became numb and had intense hip pain starting 4/11/21.  Had a previously scheduled doctor's visit on 4/12/21.  He thought I may have pinched/compressed a  in my hip.  Gave me Gabapentin for the pain.  The next day, April 13, 2021, the rash started to appear across my lower back, hip area and lower front of my body.  He gave me a prescription for 7 days of Valacylcovir which is ending today.  Still have pain, so I'm still taking the Gabapentin
Hives on forehead, head and trunk.  Mild headache.  Used Benadryl over the counter.
About two hours after receiving flu vaccine employee complained of throat tightness, nausea and redness and itching of face, arms and chest. follow up: Pt seen inER and treated for acute allergic reaction. Information from medical records states allergic reaction. msv
3/27/2022-Presents to ER, accompanied by Police under 941 custody for suicidal ideation and trying to purchase weapon. Covid - test. Psychiatric admit for safety, stabilization and medication  management. 4/1/2022- Covid + test, asymptomatic, other then sore throat.  4/6/2022- Asymptomatic. Discharged home out of state with his mother.
Symptoms first occurred approximately 26 hours after injection (4:30 pm following day).  Initial symptom was mild headache progressively increasing in severity with pain between the eyes and at top of left eyeball. Pain in both shoulder joints, swollen fingers, inability to sleep, dry throat, abdominal pain in liver & spleen, pain in mouth, nausea, vomiting. Symptoms lasted approximately 14 hours until 6 am.
AFTER RECEIVING MIST, PATIENT COMPLAINED OF CHEST PAIN, SHORTNESS OF BREATH, WAS SHAKEY, COMPLAINED OF HER THROAT BEING "SORE", AND HER EAR BEING HOT. SHE BEGAN COUGHING IMMEDIATELY AFTER THE MIST WAS ADMINISTERED.
Pt. received H1N1 flumist.  Mother states pt. is terrified of shots and has passed out before, so she chose mist. Flumist administered without problems.  Brother in same room received injection. After the brother received his shot the patient stood up and started to fall. She was assisted to the floor.  While she was starting to fall, she started to pass out and her color got pale. Assisted to elevate her feet and applied cool cloth to her forehead. BP is 140/80, pulse 60, pt was aroused easily, alert and oriented and responsive. After a few minutes she was assisted to sitting position, BP rechecked 114/80.  Pt up to chair and given Sprite and crackers. Pt. stated she felt fine and wanted to go to school. Instructed to wait 20 minutes before leaving. Pt color back to normal. Telephone call later at 1:40 PM stating she had passed out at school and could not feel her hands.  Mother was instructed to go to the ER or MD for evaluation.  Followed up with mother the next morning.  She stated she did not take the child to the doctor because it would cause more anxiety for the child and she seemed to be doing fine. The child was playing outside in the yard and is doing fine per mom.
I95.9 HYPOTENSION 4/11/2023 HEMATEMESIS J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/12/2023 HEMATEMESIS
This spontaneous report as received from a pharmacist refers to a 77 year old patient of unknown gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. In 2015, the patient was vaccinated with two separate injections of ZOSTAVAX (dose, route, lot number and expiration date were not reported) for prophylaxis (extra dose administered). No adverse events were reported. It was reported that the patient did not receive treatment.
Bladder cancer; Humira was fail medication for patient; This is a solicited report from FACILITATED COLLECT received by a contactable consumer (patient) based on information received by Pfizer. (MFR Control No. # 21K-163-4125619-00).  A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via intramuscular, on 05Aug2021 at single dose for COVID-19 immunisation. Co-suspect drug included subcutaneous adalimumab (HUMIRA, 40MG/0.4ML) taken from an unknown date at dose of 40 mg cyclic (1 in 14 D), CF (citrate free) for psoriatic arthritis/moderate to severe chronic plaque psoriasis. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) administered on unknown date for COVID-19 immunisation. Apart from underlying disease, no additional medical history was provided. No relevant concomitant medications were provided. On an unknown date, HUMIRA was fail medication for patient. On 04Oct2021, the patient diagnosed with bladder cancer. HUMIRA as a prior failed medication with reason for discontinuing was bladder cancer. She was switched to apremilast (OTEZLA). The last action taken with HUMIRA in response to the events was permanently discontinued on unknown date.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient had not recovered from bladder cancer while the outcome of the remaining event was unknown.  Reporter's Causality for HUMIRA 40MG/0.4ML (ADALIMUMAB) and Bladder cancer: The reporter's causality for the event of Bladder cancer with HUMIRA 40mg/0.4ml (ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of HUMIRA was fail medication for patient was not provided. Reporter's Causality assessment for HUMIRA 40MG/0.4ML (ADALIMUMAB) and Lack drug effect: not reported.  Pfizer statement: The reporter's assessment of the causal relationship of the event with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. RA's opinion is that the event of Bladder cancer is not assessable.RA's opinion is that there is no reasonable possibility that the event of HUMIRA was fail medication for patient is related to HUMIRA 40mg/0.4ml (ADALIMUMAB).   No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be established.
General body aches started 9/4, note patient was using excavator starting 9/3  thru 9/7.  Body aches and head ache continued through 9/7.  Reported sx 9/8.  9/8 mild sore throat and temp  99.6, continued body aches and malaise, chest hurts with cough.  Per MD doubtful reaction to vaccine, ordered COVID testing, patient will consider testing but  insists "reaction to pneumonia vaccine".  Advised patient will complete VAERS.
On 12/16/04, called to report swelling from shoulder to elbow where received pneumococcal vaccine on 12/15/04. Visited ER on 12/16/04 as swelling increased to wrist area, no pain reported. Ice and Motrin recommened by physician.
got Covid/She tested positive for SARS-Cov-2 04JAN2021; got Covid; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient indicated she received her first dose of vaccine 21Dec2020.  She tested positive for SARS-Cov-2 04Jan2021.  She was asking how she "got Covid" and if she should receive the second dose. The outcome of the event was unknown.   Information on Lot/Batch number has been requested.; Sender's Comments: The reported tested positive for SARS-Cov-2 after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
-Eye: dry eye, swelling with discharge in both eyes. Doctor verified it was not conjunctivitis. -Chills, fever (no temp provided), sweating, headache, fatigue -Hands and wrists swollen/red, unable to rotate wrists with trouble lifting arms
Muscle and joint pain; Muscle and joint pain; Headache; Fatigue; Flucelvax Quadrivalent and COVID-19 Vaccine were administered on the same date, in the same arm; This spontaneous case was received on 03-Nov-2022 from other health professional via Regulatory Communications (reference number: SEQW22-05366) and concerned a 36-year-old, male patient.  The patient's concurrent condition included diabetes, gout, hypertension, obesity. The patient's historical drug included unspecified drug after which the patient experienced allergic reaction (reported as 'allergic reaction to an unnamed drug in the past'). The patient's concomitant medications were not reported.  On 18-Oct-2022, the patient received a non-company, co-suspect COVID-19 vaccine (brand not specified; anatomical location: left arm, dose: reported as 'four', route of administration, and indication: not reported. The batch number reported was 6J259.  On the same date, the patient was vaccinated with Flucelvax Quadrivalent (influence vaccine inact sag 4v; anatomical location: left arm; dose: 0.5 ml; route of administration: not reported) (explicitly coded as 'Product administration error') for prevention of influenza disease caused by influenza virus subtypes A and B. The batch number reported was 942431.  On 19-Oct-2022, one day after receiving Flucelvax Quadrivalent and COVID-19 vaccine, the patient experienced a severe headache along with fatigue, severe muscle and joint pain. No treatment was received for the events.  At the time of initial reporting, on 03-nov-2022, the patient had not recovered from the events.  The reporter did not provide causality assessment.   The case was assessed as non-serious.  Company comment: The events of muscle pain, joint pain, fatigue and headache are assessed as possibly related to Flucelvax Quadrivalent due to plausible temporal relationship. Product administration error is assessed as not related to Flucelvax Quadrivalent as per company conventions.; Sender's Comments: The events of muscle pain, joint pain, fatigue and headache are assessed as possibly related to Flucelvax Quadrivalent due to plausible temporal relationship. Product administration error is assessed as not related to Flucelvax Quadrivalent as per company conventions.
its bluish in color and it looks like there is bleeding under the skin; noticed his reaction/an area on the inside of his right thigh that looks like a hematoma; he has like a hematoma almost like a discoloration of the skin on the inside of his thigh/purplish color, like a bluish reddish but it is not red.; rash on the inside of his thigh. He clarifies well it is not a rash it is more like a hematoma; This is a spontaneous report from a contactable consumer (patient himself). An 83-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EN6198), via an unspecified route of administration on the left arm, first dose at age 83 years, on 25Feb2021 at single dose for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. Patient stated that he got the Pfizer COVID 19 Vaccine yesterday (25Feb2021) at noon and this morning (26Feb2021), he has a rash on the inside of his thigh. He clarifies well it is not a rash it is more like a hematoma, almost like discoloration of the skin, it doesn't hurt but he wants to see if this is something that normally occurs. He showered last night and didn't notice it until this morning. He only noticed it about a half hour ago so he is not sure if there is any difference. He clarifies the area on the inside of his thigh is a purplish color, like a bluish reddish but it is not red. It looks like a hematoma, like bleeding under the skin. There is no swelling, it is not raised and it doesn't hurt to touch, just there. He didn't call his primary about this. He got this information so his doctor does not know anything about it. If it is something to be concerned about he will run down to the emergency room but he will see if he can find the office contact info. Outcome of the events was not recovered. Case was reported as non-serious.
Headache; Hives all over/tachycardia hives; tachycardia hives; Lost a lot of weight; Cannot concentrate at school; His hands are swollen; hands are swollen and he can't use them; Passed out and blacked out; This is a spontaneous report from a contactable consumer (patient's mother). A 12-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 15May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history included asthma (the asthma had been dormant for 2 years, he had asthma before he had the vaccine/was given an inhaler for asthma); epilepsy that is under control, but his immune system is low because of the seizures he gets); and had COVID in Oct2020. Concomitant medications included he was given an inhaler (unspecified) for asthma. On 17May2021 (2 days after he got his vaccine), he started getting headache and hives all over. The doctor called it "tachycardia hives". In May2021, her son lost a lot of weight and she took him to karate and he passed out and blacked out. Doctor (pediatric doctor) told her son not to get the 2nd dose right now and recommended to cancel the second dose. The reporter stated that she was stressing out from it because her son could not concentrate at school. His hands were swollen and he could not use them. After receiving the shot he got tachycardia Hives and passed out, blacked out and doctor told her to call Pfizer before he received his 2nd shot. The patient underwent lab tests and procedures which included Covid: positive in Oct2020. The outcome of the events was unknown. The reporter assess the events as non-serious.  Information about batch/lot number is requested.
Hot, sore, turgid area (about 6 cu inches) at site of shot extending seemingly to the bone; Painful when using arm to pull up out of a chair; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Apr2021 (at the age of 77-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high (well controlled) and sulfa allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and acetylsalicylic acid (BABY ASPIRIN) for unspecified indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Jul2021 at 18:00 the patient experienced hot, sore, turgid area (about 6 cu inches) at site of shot extending seemingly to the bone and was painful when she used the arm to pull herself up out of a chair. Patient thought it was cellulitis. On 27Jul2021 patient saw the doctor and the doctor confirmed that it was not cellulitis. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with amoxicillin (MANUFACTURER UNKNOWN) 1000 mg thrice daily. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event hot, sore, turgid area (about 6 cu inches) at site of shot extending seemingly to the bone and painful when she used the arm to pull herself up out of a chair were not recovered at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Flu; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) on 03-Dec-2020.  This case involves a patient with unknown demographics who experienced flu (Influenza), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concurrent conditions were not provided.  Concomitant medications were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number, expiry date and other dosing details were not reported) for prophylactic vaccination  On an unknown date, (unknown latency) the patient reported that every time he/ she got flu (Influenza), the patient would be down for 5 to 7 days, following the administration of INFLUENZA VACCINE. The patient had also gotten the shot in over 20 years but not the flu.  Relevant laboratory test was not reported.  It was not reported if the patient received a corrective medication.  The outcome of the event was recovered, at the time of this report.   There will be no information available on batch number for this case.
Transverse myelitis involving the conus medullaris and cauda equina with MRI demonstrating enhancement of the distal thoracic spinal cord and the cauda equina
CLIENT WAS GIVEN A PEDIATRIC DOSE OF HEP A VACCINE. HE THEN NEEDED TO BE CONTACTED TO COME BACK TO THE OFFICE TO GIVE A SECOND PEDIATRIC DOSE TO = ADULT DOSING FOR VACCINE SCHEDULE.
CHEST PAINS; IRRITABLE BOWEL SYNDROME FLARE-UP; NAUSEA FLARE UP; FEVER; PAIN IN THE BACK OF THE HEAD; INFLAMED TISSUES IN THE NOSE; INFLAMED TISSUES IN THE EAR SINUSES; EAR PAIN; SINUS PRESSURE; FELT LIKE PASSING OUT; This spontaneous report received from a parent concerned a 24-year-old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, irritable bowel syndrome, penicillin allergy, sulfas allergy, peanuts allergy, grapes allergy, and cephalosporin allergy, and other pre-existing medical conditions included no prior reactions to vaccination in the past, no vaccination in the month before Janssen covid-19 vaccination. The patient experienced drug allergy when treated with topiramate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. Concomitant medications included fluticasone propionate for asthma, salbutamol for asthma, diphenhydramine hydrochloride for drug used for unknown indication, cyproheptadine for ibs, famotidine for ibs, lansoprazole for ibs, and ondansetron for ibs. On 2021, the subject experienced ear pain. On 2021, the subject experienced sinus pressure. On 2021, the subject experienced felt like passing out. On 2021, the subject experienced inflamed tissues in the nose. On 2021, the subject experienced inflamed tissues in the ear sinuses. On 2021, the subject experienced pain in the back of the head. Laboratory data included: Blood test (NR: not provided) No abnormalities, CAT scan (NR: not provided) no abnormalities, and Nasoendoscopy (NR: not provided) inflamed tissues in the nose/ear sinuses. On APR-2021, the subject experienced irritable bowel syndrome flare-up. On APR-2021, the subject experienced nausea flares up. On APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. On 11-MAY-2021, the subject experienced chest pains. Treatment medications (dates unspecified) included: ketorolac tromethamine, meclozine, hydrocortisone, azithromycin, prochlorperazine, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on APR-2021, had not recovered from pain in the back of the head, ear pain, sinus pressure, felt like passing out, chest pains, nausea flare up, and irritable bowel syndrome flare-up, and the outcome of inflamed tissues in the nose and inflamed tissues in the ear sinuses was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Fever-102.7, nausea, diarrhea, fatigued, headache, loss of appetite, chills, dizziness, sore sight of injection, heart palpitations
I contracted COVID-19 2/25/22 with symptoms of fatigue, cough, fever, chills, abdominal pain, diarrhea, headache, sore throat, shortness of breathe, chest tightness/pain, body aches, and congestion. I was prescribed prednisone and an inhaler. I still have chest tightness, shortness of breathe, and I need to use the inhaler frequently.
This spontaneous report as received from a registered nurse refers to a 2 year old patient. On 02-OCT-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # H018014, expiry date: 01-OCT-2014), 0.5 ml, subcutaneous. The (Oka/Merck) VARIVAX had expired on 01-OCT-2014. No adverse effects were reported. The outcome of the event was unknown. Additional information is not expected since the reporter could not be contacted.
p/vax pt exp inj site soreness; redness, hardness, warmth;