chrisvoncsefalvay/vaers-outcomes huggingface dataset:
visual hallucinations; psychosis; derealization/ depersonalization; fuzzy brain, brain fog, brain feels as though it is stuffed with cotton; severe dizziness; disorientation; This is a spontaneous report from a contactable other health professional (patient). A 55-year-old female patient received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 25Mar2021 at 10:45 (at the age of 55 years) at a single dose in the right arm for COVID-19 immunization. Medical history included depression and post-traumatic stress disorder (PTSD). Concomitant medications included paliperidone palmitate (INVEGA SUSTENNA); vortioxetine hydrobromide (TRINTELLIX); cariprazine hydrochloride (VRAYLAR); levothyroxine sodium (SYNTHROID); clonazepam (KLONOPIN); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); methylphenidate hydrochloride (RITALIN). The patient previously took NSAID, MAOI'S and synthetic progesterone and experienced allergy; and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly, on 04Mar2021 at 01:45 pm in the right arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 25Mar2021 at 18:30, the patient experienced visual hallucinations, psychosis, derealization/ depersonalization, fuzzy brain, brain fog, brain feels as though it is stuffed with cotton, severe dizziness, and disorientation. The patient did not receive any treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: based on the information available, the contributory role of the suspect BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),  to reported events is possible.
Received DTAP on 4/10/02 around 14:00. Mom reported seizure activity on 4/11/02. It started at 03:30 and lasted a minute. Temperature at that time was 104F.
Chest pain, patient was assessed immediately. VS BP 95/69, HR 78, temp 36.6, SPO2 100% on room air.
Post Vaccination Syncopal Episode, occurred during 15 minute waiting period, while standing.  The patient fell to the floor. No head injury occurred per patient and none was observed witnessing the event.  Client laid on the floor for a few minutes until she said she felt better.  We assisted her up to a chair to sit for the remainder of the time and then she had another syncopal episode.  After that, we attempted to get her back to the floor to lay down again and she had another syncopal episode. The patient was pale skin, sweaty and was disoriented for short bursts of time.  During this event, Emergency medical services were called.  Emergency services assessed and determined based on continued disorientation, transporting to the local hospital for follow up was highly recommended.  Patients family accompanied her to the hospital.
Positive result 6 days after completion of medication; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SIMVASTATIN. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine".  The following information was reported: COVID-19 (medically significant) with onset 06Jun2022 at 06:45, outcome "not recovered"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Positive result 6 days after completion of medication". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (06Jun2022) Positive, notes: Positive result. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Where the shot was given the arm swole up the size of a baseball. I could not move it, it had fever in it. Could not move or touch the arm for 4 days. It was extremely painful.
Mixed connective Tissue Disease; Started with a rash on the back and arms in February and and March and then in April I had a Thyroid Ablation; This is a spontaneous report from a contactable nurse (patient). A 40-years-old female patient received bnt162b2 (BNT162B2, brand: Pfizer) at the age of 40-years-old, dose 1 via an unspecified route of administration, administered in Arm Right on 21Jan2021 14:00 (Batch/Lot Number: EL8982) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant. Medical history included Graves Disease. No other vaccine in four weeks. No Covid prior vaccination. Concomitant medication included atenolol (ATENOLOL) taken for an unspecified indication, start and stop date were not reported. Reported adverse event: Started with a rash on the back and arms in Feb and March and then in April in 2021, the patent had a Thyroid Ablation. Developed Mixed connective Tissue Disease on 03May2021. She understand this was not related to the thyroid disorder and was just curious if anyone else has reported a new diagnosis of MCTD. Is very rare and she had no reason to suddenly have it. But its been confirmed through an ANA test for RNP antibody. The patient underwent lab tests and procedures which included ANA test: rnp antibody on 2021. No treatment received. The event outcome was not recovered. The report was provided as serious due to Disabling/Incapacitating. Ae resulted in: Emergency Room Visit/ Physician Office Visit. Covid test post vaccination: Nasal Swab on 05Apr2021 was Negative.
He had shortness of breath and chest pain. He had to go to the emergency room via his wife. When he arrived they performed an EKG and gave him oxygen. He was admitted for 3 days. While there they performed blood tests. They finally treated him on the second day, One doctor thought it was GERD. Another doctor, his cardiologist, thought it was Pericarditis. The first doctor prescribed pantoprazole. The cardiologist prescribed Colchicine. Then he was released from the hospital on June 2nd.
Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 21-APR-2015, the patient was vaccinated with a dose of PEDVAXHIB (lot # K008878) 0.5 ml (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient reported cellulitis in the left arm. Started with a fever the evening of vaccine administration then her arm started swelling. She went to see her doctor and was given cephalexin to treat cellulitis. Swelling has already improved according to patient.
Highly elevated muscle pain levels of fibromyalgia Two severe, lengthy nose bleeds with multiple large blood clots Never had a bloody nose before these two incidents
I have been diagnosed with AFib. I am Now on toprol xl. There is no apparent reason for getting AFib. I have no other underlying conditions.
Headache daily starting 2 days after. Right now it is 8 days later and still having headaches.
The pt experienced a whelp in the are of vax. The pt was scratching site. The parent was informed by the MD what to look for and to let him know of further reactions.
24 hours after administration: localized pain; 48 hours after: Pain went into upper back and left arm across chest; hard time flexing and moving. 1 week later: still having same symptoms as 48 hours
temperature excursion was caused by the door to the refrigerator being left open with no reported adverse event; One patient was administered ACTHIB after not being suitable to use post temperature excursion with no adverse event; Initial information received on 13-Feb-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an unknown age and gender patient who was administered haemophilus type B (HIB) vaccine [ACT-HIB] after not being suitable to use post temperature excursion and reporter reported temperature excursion was caused by the door to the refrigerator being left open with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect haemophilus type B (HIB) vaccine, powder and solvent for solution for injection (lot number: UJ669AAA, expiry date: 07-Apr-2023) (With unknown strength, route and at unknown administration site) for immunization.  On an unknown date, caller reported that temperature excursion was caused by the door to the refrigerator being left open with no reported adverse event (product storage error) (unknown latency) and one patient was administered acthib after not being suitable to use post temperature excursion with no adverse event (poor quality product administered) (latency: same day).  No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Vomiting soon after vaccine. Low temp 96, right listless. Arm developed generalized urticaria about 1 hour after vaccine. Rx with epi 0.12 ml IM. Decaredron 4mg. Benadryl PO 12.5mg.
Within seconds of my first vaccine I had a massive headache. 20 mins later I had brain fog. An hour later I had exhaustion and then injection site arm began hurting. This lasted for 48 hours and then I was fine. It came on fast and stayed. I had difficult time thinking or retaining a memory. Second shot had no instant reaction, injection site just slowly began hurting. An hour later, and very suddenly, brain fog hit me and i lost all short term memory, mid sentence. Similar to what I would consider a form of Alzheimer?s. At the same time I developed a headache, not as severe as the first shot, but I was more exhausted than the first shot. Forming sentences, being able to think was very difficult for 72 hours. I was exhausted, arm hurt. After the 72 hours, I lost my sense to smell. I am in my 96 hour since my second injection and still have no sense of smell. I can taste. Never had a fever but for both shots it felt like it was absorbed by my muscles and was then converted to something else which was then released back into my system. It was like I had sore muscles it was like my muscles became the poison. This effect was grossly more profound  after the second vaccine.  The ability to think was the scariest side effect.
temperature of "100 point something" / her normal temperature is always 97; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 76 year-old female patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 IMMUNIZATION. The following information was reported: BODY TEMPERATURE INCREASED (non-serious) with onset 2021, outcome "recovered" (2021), described as "temperature of "100 point something" / her normal temperature is always 97". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reported that after her second dose, she had a temperature of "100 point something" but it "wasn't a big deal" as she came home and went to bed, and reported that she was good the next morning. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rcvd flu shot from pharmacy 10/17/2013 in rt. arm. During injection, I felt burn and pain and lasting a time after injection told pharmacist. My arm became more sore and red and painful thru day even when lifting arm thumb on rt hand locked up net morning extreme pain could not bend thumb w/o extreme pain. Pain and redness traveled down arm. Became tired and sweating. Since my husband also suffered from flu shot in his right arm with redness, pain and swelling, we both went to hospital emergency ctr for evaluation on Sat 10/19/13. Dr observed severe redness of upper right arm with swelling and pain plus extreme "bruise mark" at injection site. Released and told to follow-up with family physician. Followed up with dr.
09/09/2011: On completion of primary care clinic visit, pt developed sudden stridor and wheezing and started vomiting bilious fluid. Bp was low at 85/55. ? anaphylaxis to flu shot. Gave BENADRYL 25 mg IM and SOLUMEDROL 125 mg IM and EMT called. They gave epi and transported her to ED for further eval and care. Hospital records received: ED course of 9/9, pt was given SOLUMEDROL 125 mg, NS, PEPCID po and albuterol neb; pt cont'd to have slight throat tightness 4 hrs later w/intermittent coughing, so she was admitted for further observation; pt developed tachyarrhythimia (120 bpm) during stay and albuterol dc'd, XOPENEX started instead and pt was changed from LOPRESSOR to verapamil 10 mg IV q8H for better rate control (? beta blocker w/d as atenolol was dc'd due to anaphylaxis); SOLUMEDROL was tapered to oral prednisone; labs all stable (incl TSH and CE); TTE w/minimal MVP w/trace MR, CT angio w/no e/o PE, PERSANTHINS thallium w/normal perfusion and normal LV function; pt c/o ? (L) sided weakness, so neuro was c/s and MRI w/contrast was normal; pt dc'd on 9/18 but no dc summary received.
Atrial Fibrillation (AFib) - Shortness of breath; tightness in chest; high heart rate. ECGs showing AFib  I go into AFib several times per week lasting several hours to several days. I have not history of heart issues prior to receiving the COVID vaccine.  ALSO: I had a low level of Tinnitus prior to first vaccine shot. Three days after the first shot, the volume of the ringing in my ears more than double and still exists today.
Pt was given her 5th dose of COVID vaccine (2nd bivalent booster) on her left arm. She waited in the seating area for 40 minutes. She said she got muscle tightness on the left side of her neck. and it subsided prior to her leaving the pharmacy. She had no other reaction (no hives, no trouble breathing, no itching). She tolerated all her previous doses fine. I advised her to call 911 or seek medical attention if symptoms come back or if she experiences a medical emergency.
off-label use; Inappropriate schedule of drug administered; Inappropriate schedule of drug administered; dry throat; diarrhoea; vomiting; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Dec2021 (Lot number: FD7218) at the age of 38 years as dose 2, single for covid-19 immunisation; janssen covid-19 vaccine (JANSSEN COVID-19 VACCINE), administered in arm left, administration date 07Apr2021 (Batch/Lot number: unknown) as dose 1, single for immunisation. Relevant medical history included: "Aspirin allergy" (unspecified if ongoing); "Interchange of vaccine product" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "off-label use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown" and all described as "Inappropriate schedule of drug administered"; DRY THROAT (non-serious), outcome "recovering", described as "dry throat"; DIARRHOEA (non-serious) with onset 16Mar2022, outcome "recovering", described as "diarrhoea"; VOMITING (non-serious) with onset 16Mar2022, outcome "recovering", described as "vomiting".  Additional information: The reporter's assessment of the causal relationship of the events with the suspect product was reported as Possible at the time of this report.   No follow-up attempts are possible. No further information is expected.
Initial report received on 28 November 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 17-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3879AA received on 02 June 2011, lot number C3879AA received on 25 July 2011 and lot number C4001AA received on 12 March 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms on 23 August 2012, approximately five months after the last dose. On 23 August 2012, the subject developed a cough and paroxysmal cough on 31 August 2012 with a whoop. The subject also experienced apnea and sleep disturbance. Laboratory testing included positive PCR on 03 September 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 03 September 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 06 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Company Medical Assessment: This child had received PENTACEL at 2, 4 and 12 months of age, which is not compliant with the recommended immunization schedule. It is unknown if the alternate dosing regimen resulted in a sub-optimal immune response that left the child susceptible to infection. This is one case out of a cumulative total of 175 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 28 November 2012. These 175 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Itchy rash on arms and legs; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6206), via an unspecified route of administration in the left arm on 13Mar2021 at 10:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included ductal carcinoma in situ (DCIS). The patient had allergies to unspecified medications, food, or other products.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included norethindrone (NORA BE), fish oil (MANUFACTURER UNKNOWN), and vitamins (unspecified) from unknown dates, for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6200) via an unspecified route of administration in the left arm on 20Feb2021 at 12:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 16Mar2021 at 12:00, the patient experienced itchy rash on arms and legs, it began 3 days after second vaccination. The patient did not receive any treatment for the event itchy rash. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event itchy rash was recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
Hospitalization for worsening shortness of breath due to COVID-19 on dates  8/1/2022-8/7/2022.  Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Patient reported reaction to flu vaccine that was given on 10/19/10 - reported raised up et leaked fluid the next day - today 11/16/10 dime sized red area at injection site.
I received PNEUMOVAX in my left deltoid and my seasonal flu vaccine in my right arm on the above day. The next morning my left arm was extremely sore, the right less so. The next morning I performed an aerobic and light weight lifting workout over an hour and a half. About 15 minutes prior to the conclusion of the workout I had an onset of dizziness which was quickly followed by severe myalgias and generalized joint pain. The left deltoid was swollen, acutely painful and firm. The joint symptoms rapidly progressed in severity and persisted for 2 full days, and a circular area of erythema approximately 4 inches wide developed on the left deltoid PNEUMOVAX injection site. The joint pains subsided by day 4, but the injection site on the left arm is still painful to touch and red on day 5. There was no fever.
This is a 83y.o. male with PMH of CAD s/p CABG (1982, redo in 1992), CHF, ICM s/p ICD, T2DM, HLD, hypothyroidism, BPH who presented as a transfer from emergency room for management of NSTEMI and COVID-19 infection. He also has BLE pain after a fall three days prior. Pelvis XR was unremarkable. He tested positive for COVID-19.  Workup revealed NSTEMI with troponin of 2.20. Of note, EKG revealed nonspecific t wave abnormalities however no evidence of St elevations or reciprocals. He received heparin bolus and started on heparin gtt. He was found to be hypoxic on room air which improved to 95% on 2L O2 NC. Patient was transferred to hospital for further management. In the ED, patient noted to be tachycardic in 120s, febrile (Tmax 100.5F), tachypneic, hypoxic in 80s. SpO2 currently maintained on 6L O2 NC. CXR shows mild coarsening of pulmonary interstitium - acute vs chronic. Labs significant for hgb 10.9, lymphocytes 0.8, INR 1.3. troponin 2.20 -- > 4.19. COVID-19 PCR detected. Patient was started on drcadron and remdesevir for 5 days. Patient was weaned off oxygen and passed home oxygen eval. Cleared by endocrine and pulmonary and discharged in a stable condition. Patient lives wife who can assist at home. Resume home Dm regimen per endo and follow up as outpatient. rx sent to pharmacy. Discussed with nursing staff.