chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe headache  16-18 hours after vaccine- cleared up Cold sore on lip - I am susceptible to cold sores- cleared up Welt on arm above injection (about 1 inch long 1/4 inch wide- cleared up Itching on back shoulder blade in exact site where I had shingles in 2004.  Discovered after scabs appeared from scratching  roughly 17 days after.  Increased tiredness accompanies this 18 days after. No sensitive nerves on site, only itching.  Still present
I noticed on 27MAR2023 I had a cough.  28MAR2023 I had flu like symptoms mainly aches, diarrhea, fever, chills, very exhausted, this continued until my Paxlovid stared kicking in. 30MAR2023 I started Paxlovid. I seemed to improve then 08APR2023 the congestion started hitting me and today I sound worse that I have for two weeks.
Covid 19-I tested positive on May 6, 2022 the night before i had an itchy throat, and was hoarse and wasn't able to clear my throat later on that day i ran a fever of 101.0 for about 2 hours I was prescribed Paxlovid for my symptoms after taking Paxlovid my symptoms subsided after 5 days of taking Paxlovid i tested positive again on May 17th.
BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a 30 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced body aches. On 11-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and chills on 12-APR-2021. This report was non-serious.
A non-serious spontaneous report of "29 patients received expired FLUMIST" was received form a physician concerning a seven-year-old male. The patients' medical history included no history of asthma. Concomitant medications were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Sine the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications). There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events with the medication error.
Recently paralyzed for a few days; Dripping urine from penis, had no control of urine; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (Recently paralyzed for a few days) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARALYSIS (Recently paralyzed for a few days) (seriousness criterion medically significant) and URINARY INCONTINENCE (Dripping urine from penis, had no control of urine). At the time of the report, PARALYSIS (Recently paralyzed for a few days) and URINARY INCONTINENCE (Dripping urine from penis, had no control of urine) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.  COMPANY COMMENT: This is a regulatory case concerning a 74-year-old male patient with no clinical history who experienced the unexpected events of PARALYSIS and URINARY INCONTINENCE The events occurred unknown days after third dose of mRNA-1273. The rechallenge was not applicable since only information about third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is a regulatory case concerning a 74-year-old male patient with no clinical history who experienced the unexpected events of PARALYSIS and URINARY INCONTINENCE The events occurred unknown days after third dose of mRNA-1273. The rechallenge was not applicable since only information about third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
no adverse event reported; parent gave incorrect date of birth, which caused this vaccine error (Pfizer COVID vaccine administered to child younger than 5 years old)
This spontaneous report was received from a registered nurse regarding an unspecified patients of unknown age and genders. The patients' medical history or concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # reported as M00311, expiration date 15-NV-2017, dose, route od administration and anatomical location were not provided). Concomitant medications were not provided. There were no adverse effects reported. Temperature and time were reported as 0 degrees C for 160 hours. Previous temperature excursion was reported as 9C for 10 hours and 30 minutes. This is one of several reports from the same source (MARRS #160USA017128, 1604USA017912, and 1604USA017914). Additional information has been requested.
tested positive for Covid 19 vaccine; tested positive for Covid 19 vaccine; This is a spontaneous report from a contactable consumer (patient) and other healthcare professional.   A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: EL9269 or EI9269 or E19269), dose 2 via an unspecified route of administration, administered in Arm Right on 12Feb2021 around 7:00pm (at the age of 45 years old) as 2nd dose, single dose for COVID-19 immunization. Medical history included high prolactin, former smoker. No family medical history relevant to adverse events. Concomitant medication(s) included gabapentin (GABAPENTIN) taken for an unspecified indication, gabapentin 300mg, 3 times per day and stopped taking it because she got tired of it and didn't see any improvement. She stopped taking it maybe 2 months ago and had only been taking it not even 3 months, start and stop date were not reported; bromocriptine (BROMOCRIPTINE) taken for high prolactin, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. No additional vaccines administered on same date of the Pfizer suspect. No adverse events following prior vaccinations. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: EL3249, or EI3249, or E13249), dose 1 via an unspecified route of administration, administered in Arm Right on 20Jan2021 around 12:00am as 1st dose, single dose for COVID-19 immunization and experienced pain in arm, dry mouth and little headache. It was reported that patient tested positive for Covid 19 after having both doses of the Covid 19 vaccine. She got vaccinated with first dose on 20Jan2021 and had the second dose on 12 Feb 2021. She got Covid, tested positive for COVID, 24 May 2021. She went back for a test again this Monday, 7 Jun 2021 and it was negative. The patient stated that she went to see her primary care doctor and they told her to report about the vaccine. She stated there was nothing after the second dose. Adverse event did not require a emergency room/physician office visit. Investigation Assessment: Yes. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 24May2021, sars-cov-2 test: negative on 07Jun2021. The clinical outcome of the event tested positive for covid 19 vaccine was recovered on 07Jun2021 and vaccination failure was unknown.  Information about Lot/Batch number requested, additional information requested.
pt recv vax & devel an inj site rxn;this is 1 of 6 pt from this facility to devel an inj site rxn p/vax;
CONFUSION, MEMORY LOSS, ANXIETY, UNSTABLE GAIT.  EXAM SHOWS DECLINE IN SHORT TERM MEMORY AND COGNITIVE FUNCTION WHICH WAS RAPID FROM PRIOR VISITS WHERE NEUROCOGNITIVE FUNCTION WAS COMPLETLEY NORMAL.  GAIT  IS SLIGHTLY ATAXIC
Swelling of right thigh began on 9/9/03 (3.5 moles x 3.5 moles). There was no induration or tenderness. Pt was active and afebrile, no pain at swelling. Pt attended school on 9/9/ and 9/10/03. Pt brought back to Dr's office on 9/10/03 (PM) because swelling was 7" x 6". Still no discomfort, no fever. Pt active and playful. Benadryl 25mg/BID Rx.
VOMITING; STOMACH PAIN; BACK PAIN; MOANING; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAR-2021, the subject experienced vomiting. On 07-MAR-2021, the subject experienced stomach pain. On 07-MAR-2021, the subject experienced back pain. On 07-MAR-2021, the subject experienced moaning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, stomach pain, and back pain, and the outcome of moaning was not reported. This report was non-serious.
About one week after first vaccine shot, blood test showed very high level of inflammation (Crp) that led to Double Vision.  I was put on Prednisone (60  mg/day) .  In the past few weeks, I've had several more blood tests, a brain MRI, surgery to perform biopsies on both eyes (biopsies tested positive for both eyes), and a current plan to involve a Rheumatologist.
got the vaccine within the past 24 hours and resulted positive for the test; got the vaccine within the past 24 hours and resulted positive for the test; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on an unspecified date in 2020 at a single dose for COVID-19 immunization. There were no medical history or concomitant medications. The patient got the vaccine within the past 24 hours and resulted positive for the test, the patient took 48 hours ago like was that going to some adverse reaction like patient had the positive results before knowing the result patient got the vaccine so at present patient was just kind of anxious about what going to happen. Next shot will be due on 20Jan2021. The outcome of events was unknown.
Too ill to function--I had Covid-19 in November, and my response was worse than my worse day of the two week illness. I was literally green in the face, faint-ish and quite nauseous. I am a healthy person and am quite active. I was in bed unable to do anything for about 12 hours.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On an unknown date, an expired dose of M-M-R II (rHA, lot # K010319, expiration date 22-JUL-2016; dose and route were unknown) was inadvertently administered to the patient. No adverse effect was reported. Additional information has been requested.
loc >2 MIN, SIEZURE LIKE ACTIVITY < 1 MIN, PT. SENT TO ER VIA EMS AFTER MD EVAL.
local react 12 cm x 15 cm induration, erythema w/vesicles;
states "Last May 1st I got my 1st dose of the covid vaccine... on May 4th, when I woke up, I couldn't see  well. Blurry vision on my right eye, I couldn't even read even with my glasses on.  When I blinked I could see big blobs of different colors, black, blue, green, red, yellow... I made an appointment with an ophthalmalogist (May 7) and was told there was bleeding at the back of my eye and referred to a retina doctor. May 12, I saw a retina doctor and was given 2 shots right into my eye. Now I could still see black blobs but much smaller and wherever I look I could see like white clouds with sparkling tiny lights of different colors, even if my eyes are closed. "
lumbar injection for pain; neck is stiff; terrible head ache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (neck is stiff), HEADACHE (terrible head ache) and VACCINATION SITE PAIN (lumbar injection for pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009021A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CARBAMAZEPINE (CARBATROL), PRAVASTATIN, LEVOTHYROXINE SODIUM (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]), ACETYLSALICYLIC ACID (BABY ASPIRIN) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (neck is stiff) and HEADACHE (terrible head ache). On an unknown date, the patient experienced VACCINATION SITE PAIN (lumbar injection for pain). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) for Headache, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (neck is stiff), HEADACHE (terrible head ache) and VACCINATION SITE PAIN (lumbar injection for pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment- Excedrin Migraine yesterday and today (June 17th and 18th) The patient also mentioned that last Monday had a lumbar injection for pain.
Patient presented to pharmacy 1 week after injection with a circular rash on arm that itched, patient had been applying rubbing alcohol, told patient to use hydrocortisone cream and/or BENADRYL, patient stated rash was starting to look better.
hoarse voice, throat tightness Narrative:  Patient received his 1st COVID shot 3/11/21. Ten minutes later he developed intense itching, a horse voice, and felt itching in his throat stating " I feel like my throat was getting tight". Spoke in full sentences without difficulty, O2 sat 98% on RA, denied chest pain or shortness of breath. Denied throat or facial swelling or n/v. Denied any prior similar reaction except for pruritus from opiates. Admitted to ER. IV Diphenhydramine and dexamethasone were administered with 1L of normal saline. Observed for 2 hours and discharged as symptoms resolved, no longer flushed, and voice returned to normal. Advised not to have second COVID vaccine administered due to concerns of increased reaction with second dose.
trouble lifting things like my tea kettle; lot of pain in right elbow; bad neck and shoulder pain; bad neck and shoulder pain; sore right arm similar to after a tetanus shot; This is a spontaneous report from a non-contactable nurse (patient).  A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number: EL1284, intramuscular on right arm from 05Jan2021 09:45 to 05Jan2021 09:45 as single dose (first dose) for COVID-19 immunisation.  Medical history included none.  The patient's concomitant medications were not reported. On 05Jan2021 at 03:00pm, the patient experienced sore right arm similar to after a tetanus shot. On 06Jan2021, the pain in upper arm gone but by afternoon but the patient got bad neck and shoulder pain on right side that she treated with heat and Advil. On 07Jan201, neck pain still present and by late afternoon, the patient got a lot of pain in right elbow. On 08Jan2021, the patient still have the neck to shoulder pain in addition to the right elbow pain. It feels like she sprained her elbow and was having trouble lifting things like my tea kettle. The outcome of the event sore right arm/pain in upper arm was recovered on 06Jan2021; having trouble lifting things like my tea kettle was unknown; while the other events were not recovered. Treatment has been given for the event bad neck and shoulder pain. Since the vaccination, the patient has not been tested for COVID-19.   No follow up attempts are possible. No further information is expected.
Wrong formulation administered. Patient received 0.25mcg. Correct dose for patient age is 0.5mcg. Spoke to Private. Private advised to repeat same dose again same day. Parent notified and patient was brought back to the clinic for remaining dose of 0.25mcg. No adverse effect noted or reported by patient parents.
This is a spontaneous report from a contactable other hcp (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Er8731), dose 2 via an unspecified route of administration, administered in arm right on an unspecified date as 2nd dose, single for covid-19 immunisation. Concomitant medications included metformin; insulin glargine (TOUJEO); lisinopril; atorvastatin calcium; piroxicam (FARXICAN). Medical history included ongoing diabetes mellitus. The patient previously took Ibuprofen and experienced allergy to Ibuprofen. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ep7534,) administered in right arm on 24Mar2021 10:30 for COVID-19 Immunization. The patient had a mini stroke on 25Apr2021 20:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.; Sender's Comments: Based on the limited available information, the reported event I had a mini stroke is assessed as unlikely related to the suspect product BNT 162b2 (PFIZER-BIONTECH COVID-19 VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Information has been received from a nurse concerning a post partum female patient who on 21-DEC-2010 was vaccinated with the first dose of VARIVAX (Merck) (lot # not reported). On 21-DEC-2010 or 22-DEC-2010 the patient experienced a rash on her wrist where the hospital name band had been. She had no history of irritation or rash when previously wearing a hospital name band. At the time of reporting, the patient's rash on her wrist persisted. The patient had sought unspecified medical attention. Additional information has been requested.
pt recv vax 5NOV96 & 7NOV96 pt had trouble swallowing;next day exp SOB & throat was constricting;pt returned to MD office & was given adrenalin & DPH;rx pred;pt recovered;
This spontaneous case was reported by a consumer and describes the occurrence of MOUTH SWELLING (After I had taken 2.5 packs of the Paxlovid I had an adverse event in which my mouth swelled), SWOLLEN TONGUE (After I had taken 2.5 packs of the Paxlovid I had an adverse event in which my mouth swelled and tongue swelled) and TRISMUS (Felt like my mouth could not open far enough for me to be comfortable) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication. The patient had no allergy. Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (BLISOVI 24 FE) for Birth control, FLUOXETINE HYDROCHLORIDE (PROZAC), BUSPIRONE and MONTELUKAST for an unknown indication. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 2.5 packs. On 12-May-2022, the patient experienced MOUTH SWELLING (After I had taken 2.5 packs of the Paxlovid I had an adverse event in which my mouth swelled), SWOLLEN TONGUE (After I had taken 2.5 packs of the Paxlovid I had an adverse event in which my mouth swelled and tongue swelled) and TRISMUS (Felt like my mouth could not open far enough for me to be comfortable). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in May 2022 at a dose of 1 dosage form. On 12-May-2022, MOUTH SWELLING (After I had taken 2.5 packs of the Paxlovid I had an adverse event in which my mouth swelled), SWOLLEN TONGUE (After I had taken 2.5 packs of the Paxlovid I had an adverse event in which my mouth swelled and tongue swelled) and TRISMUS (Felt like my mouth could not open far enough for me to be comfortable) had resolved. An unknown drug was taken as COVID-19 treatment with start date on 10-MAY-2022 and end date on 12-May-2022. It was reported that after patient took 2.5 packs of the Paxlovid, patient had an adverse event on 12-May-2022 in which mouth swelled and tongue swelled. Patient felt like mouth could not be opened far enough to be comfortable. Patient needed to take Benadryl and contact the doctor for a care plan. The Device Date  was reported as 13-May-2022.
anaphylactic shock and was transported to hospital ER/swollen lips and throat; This is a spontaneous report from a contactable consumer. An adult female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation at a clinic. Medical history included allergic to penicillin and history of previous anaphylaxis reactions. The patient has no covid prior to vaccination. The patient's concomitant medications were not reported. The patient previously took IV iron and experienced allergy. The patient received the vaccine at clinic and within 10 minutes, the patient experienced swollen lips and throat like anaphylactic shock and was transported to hospital ER. The patient received IV benadryl and Pepcid as treatment. The outcome of the events was recovered on an unspecified date.  Information on the lot/batch number has been requested.