chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; chills; nauseous; did not feel very well at all; diarrhea; hemorrhoid; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient (medical assistant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231) via an unspecified route of administration on 02Jan2021 15:00 (3:00pm) at a single dose on the left deltoid as vaccination. The patient had no medical history. There were no concomitant medications. The patient reported having side effects from her first dose of Pfizer Coronavirus Vaccine administered on 02Jan2021. She tried reporting this information online but has been unsuccessful. Starting the evening of 04Jan2021, she had a headache, chills, felt nauseous, did not feel very well at all, diarrhea, and got a hemorrhoid. She still has a slight headache today; and when she woke up this morning, she felt a little nauseous but that went away; other side effects have improved at this time. Her doctor made her go get a Coronavirus test today in order to go back to work; because he said that the diarrhea and something else of the side effects, she did not remember were not a symptom of the Pfizer Coronavirus Vaccine. She had the Coronavirus test this morning on 06Jan2021 (unknown result); but would not get the results of that test until 48-72 hours after being tested. They would email her those results. Second dose was scheduled for 23Jan2021 at 3:45pm; she still plans to get the second dose. The outcome of the event nauseous was recovered on 06Jan2021 as it already went away while of the remaining events was recovering.
shortness breath, nausea, diarrhea, fatigue.  duration 5 days.  right arm sore, weak days 4-5, and continuing.  Weakness, lightheaded.  Not eat 5 days.
I had a pulmonary embolism with chest pain and shortness of breath beginning on June 21, 2021 and diagnosed with better imaging June 28, 2021. Genetic factors tests were negative. IUD unlikely cause. Possibly hyper-coagulation from Lyme disease. But otherwise no known cause.
2 hrs post DTP/OPV/HIB pt refused to walk or move legs or bear weight;
Fluzone High-Dose was given to a 13 year old/ No AE; Fluzone High-Dose was given to a 13 year old/ No AE; Initial information received on 01-Oct-2019 regarding an unsolicited valid serious case received from a pharmacist.  This case involves a 13 years old male patient who received 0.5 mL dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ232AB, expiry date-10-04-2020 via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  At the time of report no adverse event was reported.  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 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.  Documents held by sender: none.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the unspecified number of patients were vaccinated with ROTATEQ, orally (dose, lot# and expiration date not reported). The patients received a dose of oral, ROTATEQ that was stored improperly, exposed to 34.9F for 4 hours. There was no adverse effects reported. Additional information has been requested. This is one of several reports received from the same reporter.
A 52 year old female pt was started on Oncotice treatment for bladder cancer since July 2005. After an initial induction course, in Nov 2005 monthly instillations were started. After the first and second monthly instillation she experienced burning of the urinary tract, for which Urised was prescribed. On the evening of the second instillation the pt was inadvertently exposed to voided urine. Dysuria, accidental exposure.
Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Swollen hands, joint swelling, generalized body itching-Severe, Systemic: Joint Pain-Severe, Additional Details: Patient did not experience side effects while waiting in store but noticed throat swelling (difficult/painful swallowing) 2 days after vaccine. After visiting with doctor, tested for high body inflammation and started on steroids which are starting to help with symptoms of body swelling/joint pain but have not gone away. Did not experience trouble breathing. Patient already advised by doctor not to complete series.
Arm soreness; Bodyache; Fatigue; Injection site soreness,; Headache; This is a spontaneous report from a contactable consumer. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 03Mar2021 at 13:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation.  Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included ibuprofen (ADVIL) from an unknown date for an unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on an unknown date in 2021 at 13:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. On 04Mar2021, the patient experienced injection site and arm soreness, headache, fatigue, body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site and arm soreness, headache, fatigue, body aches was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
The child experienced an episode of fainting on same day as vaccination. The child has no history of fainting or other vaccine-related adverse events. The child was unconscious but the mother was not present and is unsure of the time of occurrence or duration. According to the mother, the attending pediatrician was not sure if it was a case of vasovagal syncope or a seizure. The child experienced fever, malaise, fatigue, dizziness, nausea, and fall leading to injury. The child underwent EEG but as of 01/06/2010, the report was not available. The child does not have any residual symptoms.
Approximately 9 hours after she experienced nausea, headache and lightheadedness. Treatment of Tylenol and sleep. In the am she states her symptoms had improved end she reported to work as usual. Her symptoms worsened over the morning and she also reports muscle aches and an episode of blurred vision when she stood up. She left work to go home and sleep. She reports all of her symptoms resolved as of 7:00 pm on 10/11/2006.
Patient given expired medication, manufacturer contacted, vaccine maintained the activity necessary to protect against Covie-19 virus at time of administration.
A patient received improperly stored vaccine; No additional AEs were reported; This spontaneous report was received from a medical assistant regarding a 1-year-old patient of unspecified gender. Information regarding medical history, concurrent conditions and concomitant medications was not reported.   On 07-DEC-2021, the patient received an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) as prophylaxis (lot number U024221 and expiration date 04-AUG-2023; both verified as valid (expiration date was reported as 04-OCT-2023)) (no more vaccination details provided). The vaccine had a temperature excursion of 39.5 Fahrenheit (F) for a time frame of 10 hours; there was no previous temperature excursion. No additional adverse events (AEs) were reported, no further information was provided.
Per mom, immediate seizure like activity, eye rolling, rigidity all lasting approx 3 min. Pt was then postictal and developed a fever to 104 F that evening.
Information has been received from the husband of a 70-year-old female with high blood pressure, allergies to tetracycline and ANTIVERT who was vaccinated "11 days ago", on approximately 19-Jul-2007, with a dose of Zostavax (Oka/Merck).  Concomitant therapy included acyclovir and VALTREX.  Subsequently "about 4 days ago", approximately 26-Jul-2007, the patient "broke out in a rash around her ribs that was about a 10 inch area."  Unspecified medical attention was sought.  No laboratory of diagnostic tests were performed.  The outcome is reported as not recovered.  No product quality complaint was involved.  Additional information has been requested.
This spontaneous report was received from a licensed vocational nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot number N002203 and expiration date of 19-JAN-2019 for prophylaxis (dose, route of administration, lot number and expiration date were not reported), while the sterile water diluent was properly stored. The vaccine was exposed to a temperature excursion of  -9°C to 8°C (-3.27°C) with a time frame of 8 hours 10 minutes, There was a previous temperature excursion reported as -14°C to-10°C (-13.27 °C) for 1 Hour 22 Minutes. A "data logger" was involved. There was not product quality complaint involved.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. There was no medical history or concurrent condition reported. On unspecified dates, the patients were administered improperly stored VAQTA (lot # J005010, expiration date: 23-OCT-2015; lot # J014584, expiration date: 16-JAN-2016; lot # K000943, expiration date: 24-SEP-2016; lot # K009506, expiration date: 22-SEP-2016) (dosage, strength and route were not reported). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Urticaria over all body.  Was given Benadryl at home.  Was seen 9/15/15 and given DepoMedrol and instructed to continue Benadryl as needed.  Rash was beginning to fade according to mother when child was seen on 9/15/15.
This is a 21-year-old male who was in his usual health when he received his primary smallpox vaccination on 03/12/2003.  Approximately 2 weeks after receiving vaccination notice swelling in bilateral ankle with no change in respect to duty or posture.  He noticed that the swelling was progressing to his knees bilateral approximately 1 month of vaccination. He had difficulty getting in to his rack on board , which was underway at this time. He reported to medical at approximately 1 month after receiving the vaccination, after developing chest pain (8/10) with out associated shortness of breath. He states he had a sore throat and fever at this time as well. He was told to drink plenty of water, given Motrin®, and returned to work.  Approximately 1-2 days after initial onset of chest pain (10/10), again reported to medical. He was again sent back to work. When he attempted to climb 3 flights of ladders, became short of breath (5/5) and he became dizzy. He was again sent to medical, where he was given intravenous hydration. He was told that his heartbeat was irregular at that time. He was given a diuretic and Motrin® and was again released.   After 3 months had lapsed and his symptoms he was flown from the ship to a hospital. At the hospital, was given medication, had a chest xray and an echocardiogram completed. He was hospitalized for 1 week. He was transferred home via MAC flight. During the flight developed chest pain (10+/10) but did not become short of breath.  He was transferred to medical center via bus.   At hospital he continued to have chest pain and shortness of breath. He was placed on oxygen and placed on bed rest. He was there for 24 hours and then was sent to another hospital via commercial flight. He was admitted for 24 hours and then placed on medical hold from late June to Early September 2003. He then transferred to his current duty station. He states that he has not experienced any further chest pains or shortness of breath since his discharge.
Patient has history of receiving dermal filler 10 months prior to vaccination. Approximately 10 days following receipt of Pfizer/BioNTech COVID-19 Dose 1, she reports swelling of the left side of her face and undereye in the area of her prior dermal filler injection. She took tylenol and benadryl, and the symptoms resolved after 2-3 days.
pt recvd doses of Engerix-B & exp a neg titer result p/3rd dose;
after unknown time of thawing, no less that 15 minutes at room temperature, this vaccine was administered to patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (after unknown time of thawing, no less that 15 minutes at room temperature, this vaccine was administered to patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (after unknown time of thawing, no less that 15 minutes at room temperature, this vaccine was administered to patients). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (after unknown time of thawing, no less that 15 minutes at room temperature, this vaccine was administered to patients) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Acute headache; chills; nausea; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Dec2021 15:30 (Lot number: FJ8757) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA taken for immunisation, administration date 21Nov2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0153, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 13Apr2021, when the patient was 51 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: En6199, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 22Mar2021, when the patient was 51 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021 15:30, outcome "unknown", described as "booster"; HEADACHE (non-serious) with onset 09Dec2021 03:00, outcome "recovered" (Dec2021), described as "Acute headache"; CHILLS (non-serious) with onset 09Dec2021 03:00, outcome "recovered" (Dec2021), described as "chills"; NAUSEA (non-serious) with onset 09Dec2021 03:00, outcome "recovered" (Dec2021), described as "nausea". Therapeutic measures were not taken as a result of headache, chills, nausea.  Additional information: yes patient took other vaccine in four weeks. Other vaccine 4 weeks details: other vaccine 4weeks product was Influenza. The patient did not have covid prior to vaccination and did not covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
suffering from shingles/suspected vaccination failure; suffering from shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. The patient stated he/she still right now was suffering from shingles 5 weeks now. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Pt recv vax on 12/17/98; on 12/19/98 pt exp bullae/ blister on right shoulder w/ erythema; on 12/24/98 area scabbed
The night after my vaccination,  my arm became extremely sore which was expected. I woke up on Saturday morning (two days after injection) and my entire body was covered in a blotchy rash that was warm to touch. No fever, no shortness of breath. Today Day 4 of vaccination my skin is less red but is still itchy and warm to touch and hurts to touch it.
lots of dizziness; more like a brain fog, "she can do stuff but says it felts dizzy"; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lots of dizziness) and FEELING ABNORMAL (more like a brain fog, "she can do stuff but says it felts dizzy") in a female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (lots of dizziness) and FEELING ABNORMAL (more like a brain fog, "she can do stuff but says it felts dizzy"). At the time of the report, DIZZINESS (lots of dizziness) and FEELING ABNORMAL (more like a brain fog, "she can do stuff but says it felts dizzy") outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  No concomitant medications were reported No treatment information was provided   This case was linked to MOD-2021-026107 (Patient Link).
Chills, fever, vomiting, nausea and headaches.  Saw patient on day 3 and still having these symptoms.
pt died at home; no med records; pt had a positive COVID test on 8/14/22, ordering facility: Medical Center; DC sent per request
Itching under both armpits atarted 2 days after injection in left arm.  Then itching (and intensity level) spread over next two days to injection site, left side of lower neck, upper trunk, both arms and wrists accompanied by what appeared to be some redbite marks on  parts of arms and lower backs of legs above ankles.  Also had rash of small bumps (not red) on backs of upper arms.  Legs were itchy in back and above ankles. On fourth day the redness and itching spread to rest of neck area, like a collar.  On fifth day after injection (21st - MONDAY)) I called my family dr. and was prescribed prednisone.   Itching still intense after 3 days of 40 mg. daily.  The injection site also got red next day, an area of 1 and 3/4 inches, and was sore and swollen to the touch but otherwise didn't hurt.  Still red but in broken up patches.  Very itchin at site and more red than other areas.
Died of Acute Hypoxic Respiratory Failure. COVID-19 Pneumonia.
Vaccine was administered and patient was instructed to remain seated to 15 minutes for monitoring.  About 1 minute later, patient fell from seated position, bracing himself against table and wall.  Patient was already regaining his seat when I approached to assess if he had injured himself.  Patient didn't report hitting his head and declined emergency services.  Patient requested water to drink, which was provided as needed.  I remained seated next to patient for about 5 minutes, before having my technician take over monitoring him.  Patient reported that he had been working out and had not eaten anything previous to arriving at pharmacy.  Once patient felt able, he was allowed to move to a chair outside of the vaccination area, where remained seated for another 15 minutes.  It was noted the he was visibly sweating when he moved chairs.  I instructed patient to remain seated as long as he needed.  i periodically checked on him visually while he remained seated for a total of 20 minutes until finally got up to leave.
Vaccine administered at about 6:30. Pt came in store at 10:30 and bought BENADRYL, then went to ER at about 1am.
Complaint of having 4-5 seizure approximately 24 hours after giving MMR and Varivax vaccine. History of seizures but seizure free for 2 weeks before getting MMR and Varivax.
when patient would stand from overnight sleeping, she would have uncontrolled shaking on the left side of the body for 90-120 days starting 2 weeks after the first vaccination, she had normal brain MRI, normal EEG, normal EMG.  Symptoms resolved around 3/20/21 and tapered off at that time.
Central 4cm hard red area in tricep region of R arm with 17x9 cm redness around that. Using OTC hydrocort and ice. Patient does have a fold and hold rx for Keflex in case of worsening symptoms.
PT REPORTED SEVERE PAIN AT INJECTION SITE AND LINGERING MUSCLE STIFFNESS IN SHOULDER AND UPPER ARM. SHE STILL HAS LIMITED MOTION AND STIFFNESS IN THAT UPPER ARM.
Chills and mild's fever for 5.5 hours.   Then threw up a couple of times.  I felt 95% better after throwing up.  Now 5 days later my digestion system is still not back to normal with mild abdominal paisa.
Tested Positive for COVID 19 on 12/24/2021 at my Primary Care Scratchy Throat Headache Tired feeling Dry cough
headache, body ache (primarily back) - started ~ 10 hours after injection; almost fully resolved by day 2 after injection sore injection site, swollen injection site, red injection site - slight improvement 2 days after injection site but not resolved yet
About 5 minutes after injection patient became extremely nauseous. She also felt sweaty and dizzy for about 5 minutes. She was checked EMS and was cleared to go. She waited a little longer than 30 minutes to feel better.