chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SIDE EFFECTS HAVE DEFINITELY BEEN KICKING MY BEHIND; ACHES; CHILLS; NAUSEA; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a female 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, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced side effects have definitely been kicking my behind, aches, chills, nausea, headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the side effects have definitely been kicking my behind, nausea, headache, aches, chills and fatigue was not reported. This report was non-serious.
Mom reports pt had been cranky but no fever to touch on 18SEP91; pt became lethargic; had sz, vomited & aspirated; Pt was taken to HOsp by ambulance; hospitalized x 5 days;
Pt has a large bruise on arm where he received flu shot. Arm is sore as well.
Soreness in upper left arm. Ice and Ibuprofen (800 mg) relieved pain for a short time, but never completely. Alternated TYLENOL (2-650 mg) first few days patient could not elevate arm without severe pain. Got better, but not completely.
Information has been received from a health professional concerning a 5 year old female who on 16-JUL-2001 was vaccinated with VARIVAX (Oka/Merck) (lot# 638647/0232L). Concomitant therapy included ENGERIX-B and PREVNAR. On 29-AUG-2005 the patient developed zoster, vomiting and diarrhoea. The patient was placed on therapy with Acyclovir for the treatment of zoster. Additional information is not expected.
Cold sore on lip; This spontaneous case was reported by a consumer and describes the occurrence of LIP PAIN (Cold sore on lip) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027O21A, 012M20A and 014M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced LIP PAIN (Cold sore on lip). The patient was treated with LYSINE at an unspecified dose and frequency. At the time of the report, LIP PAIN (Cold sore on lip) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-392147, MOD-2021-391952 (Patient Link).; Sender's Comments: Non-serious Case
red blisters on my bilateral tongue /red blisters on my bilateral inner cheek; This spontaneous case was reported by an other health care professional and describes the occurrence of BLISTER (red blisters on my bilateral tongue /red blisters on my bilateral inner cheek) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced BLISTER (red blisters on my bilateral tongue /red blisters on my bilateral inner cheek). At the time of the report, BLISTER (red blisters on my bilateral tongue /red blisters on my bilateral inner cheek) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.     No concomitant medications were reported.  Treatment information was not provided.
C/o generalized weakness/dizziness/headache after receiving vaccine.  Was seen in the ED on 1/6/21.  Feeling weak and unable to stand up.  ER labs unremarkable.  Admitted to hospital.   After received Azithromycin and Rocephin patientt reports feeling much better.   Following day reports feeling symptom free.
Administered PEDIARIX and Hep B, so patient received two Hep B's. Called father on 3-15-16 and he stated that she was fine and was at day care.
Following second dose: - Pain at injection site - Redness - Tiredness (after 18 hours, ok after 48 hours) - Chills (after 18 hours, ok after 48 hours)
I did not have a reaction to the vaccine. I tested positive for COVID-19 in 12/2022. I got a prescription for PAXLOVID.
This case was reported by a physician via sales rep and described the occurrence of shingles in a 57-year-old female patient who received Shingrix for prophylaxis. On 25th May 2018, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In May 2018, 1 day after receiving Shingrix, the patient experienced shingles, fever, foggy feeling in head, disorientation, stinging, rash, burning skin, lethargy, dizziness and inability to work. The patient was treated with Valtrex. On an unknown date, the outcome of the shingles, fever, foggy feeling in head, disorientation, stinging, rash, burning skin, lethargy and dizziness were recovered/resolved and the outcome of the inability to work was unknown. The reporter considered the shingles, fever, foggy feeling in head, disorientation, stinging, rash, burning skin, lethargy, dizziness and inability to work to be related to Shingrix. Additional details were provided as follows: The physician was the patient's (reporter's wife) husband who reported the case. The age at vaccination was not reported. The patient received Shingrix on an unknown deltoid and the patient experienced a temperature of over 100 degrees. She also had a foggy head, disorientation, dizziness and lethargy. The patient experienced rash on her lower leg and burning and stinging accompanied the rash. The patient had medical attention and a fellow physician in his practice confirmed that she had shingles. In 2018, Valtrex was administered and all her side effects had resolved. The patient's side effects significantly impacted her ability to drive and work.
This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy skin), SLEEP APNOEA SYNDROME (INCREASED SLEEP APNEA) and MYALGIA (MUSCLE ACHES with HUMIRA) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis. NO KNOWN ALLERGIES.  Concurrent medical conditions included Rheumatoid arthritis. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PRURITUS (Itchy skin), SLEEP APNOEA SYNDROME (INCREASED SLEEP APNEA) and MYALGIA (MUSCLE ACHES with HUMIRA). At the time of the report, PRURITUS (Itchy skin), SLEEP APNOEA SYNDROME (INCREASED SLEEP APNEA) and MYALGIA (MUSCLE ACHES with HUMIRA) had not resolved.    The patient did not receive any concomitant drugs. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter causality for the events of ITCHY SKIN, INCREASED SLEEP APNEA and MUSCLE ACHES with HUMIRA was not provided. No treatment drug details was reported.
Systemic: Dizziness/Lightheadedness-Medium, Systemic: Patient returned 8/19/2022 to state her lightheadedness was due to anemia. She received fluids at ER and given iron to restart. No issue with vaccine. Mild. Additional details: Patient returned on 8/19/2022, after discussing her visit to the ER, she stated the MD diagnosed her symptom from anemia, not due to vaccine. She was given fluids and iron to resume.
Red rash on vaccination site; Rash has spread into a circle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SCAR (Rash has spread into a circle) and VACCINATION SITE RASH (Red rash on vaccination site) 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 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE SCAR (Rash has spread into a circle). On an unknown date, the patient experienced VACCINATION SITE RASH (Red rash on vaccination site). At the time of the report, VACCINATION SITE SCAR (Rash has spread into a circle) and VACCINATION SITE RASH (Red rash on vaccination site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Pt c/o dizziness and dry throat cause discomfort when swallow. Vital was taken BP: 126/90, HR: 69, Oxygen: 96.  Patient did not eat breakfast and feel better after eating crackers. No EMS. Patient was observed longer and cleared by nurse.
Client reports running errands on 1/6/23 and suddenly feeling "winded and exhausted". Since that time she has felt lethargic stating, "I have no energy to keep doing what I do in a normal day." Also reports having a runny nose since this time. Client reported occurrence on 1/20/23.
Reported soreness in the arm from Immunization. Had x-rays done where it showed some inflammation.
after a very painful injection, pt has not been able to raise her right arm above her head or reach outward with extreme pain or assistance from her other hand to move her arm
Patient states that she had arm pain after receiving vaccine. After the pain at injection site dissipated, she has had pain in her upper arm and should that has increased in intensity and persists to this day.  The patient was counseled to seek help from her physician.
The patient received the Pneumovax and HD Fluzone vaccines on 11/05/21.  She called to ask questions and report adverse events beginning at 5:00 a.m. on 11/06/21.  The patient woke up with severe pain in each arm.  She then fainted.  She came to and sat on the side of her bed and fainted again.  This time hitting her head and nose on the night stand.  She was wanting to know if she should not have received both vaccines together.  She took some ibuprofen and drank some water and is feeling much better now as of 12:30 p.m. today.  I advised her to seek medical care but she was going to message her Doctor. Will be following up with the patient.
approx 1 hour after he received the booster dose of Moderna, he began to lose focus in his eye, fuzzy peripheral vision and he was unable to work at his computer.  He stopped working and within 1 hour his visual symptoms resolved.  He then developed a dull headache which has persisted daily for 6 weeks.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL9261), in right arm, on 17Feb2021 as dose 2, single (Lot number: EN9581), in right arm and on 22Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 47 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "LPR (silent reflux)" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: Known allergies: No; "chronic sinusitis" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE, start date: 01Jan2020; CLARITINE, start date: 01Oct2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Dec2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: tested negative twice; (unspecified date) Negative, notes: tested negative twice; (29Dec2022) Positive, notes: positive on day 9; (20Dec2022) Positive, notes: Positive test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Anti-viral details included Paxlovid from 20Dec2022 till 25Dec2022 for treatment of COVID-19. This was a report about covid treatment. Other medication in 2weeks product: Flonase with start date 01Oct2022. Adverse event: Covid rebound after finishing 5 day dose of Paxlovid. Sinus congestion, sore throat, problems breathing in both airways due to inflammation. Chills, low grade fever tested negative twice then positive on day 9 of positive test on 20Dec2022 Nausea. No appetite. Adverse event start date: 29Dec2022, start time: 01:15 PM. AE resulted in: [None of the above]. If patient recovered: Not recovered. If treatment ae: No.
28jul90 pt vax 2nd hepta B.  pt devel generalized urticaria.
Pain in left arm at and around injection site since day after immunization on 11/28/06.
This is a 74y.o. female with a medical history of breast cancer, bipolar disorder, hypothyroidism, Parkinson's disease, COPD, history of DVT and Eliquis who presented to the emergency department secondary to a fall. She states that she has been feeling ill and having significant body aches and myalgias over the past 7-10 days. She says that she was attempting to ambulate around her house when she fell. She states that her cough has been worsening over the past week. Patient states that she was vaccinated for COVID however her sister recently tested positive for COVID.    On presentation, patient was found to be positive for COVID 19. CT of the head and neck showed no acute process
2 hr p/vax pt devel fever of 103; APAP had been given prior to vax & 2 hrs later; fever, irritability, high pitched cry lasted for 3-4 days; pt had vomiting for 2 days; fever relieved somewhat by Motrin; pt had inflammation @ site of inj;
Pt got flu shot on 10/14/23.  On 10/15/23 pt began experiencing vision disturbances.  Pt is having double vision.  He has no pain or headache.  He thinks it may be caused by the vaccination he got.
Patient describes a red looking welt form at injection site the next day after shot, pt also said the main symptom she is experiencing is itching and it has continued every day since. Pt said she put  NEOSPORIN on it with a Band-Aid a few days later, and then tried hydrocortisone/applied to site to help with the itching. When patient presented to the pharmacy on, she showed me the site which looked like a healing sore, some dry skin, slightly red and said it mainly just itches every day.
This spontaneous report as received from a pharmacist via a company representative refers to a 71 year old female patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided. In approximately October 2017 (reported as October or November 2017, "after the hurricane"), the patient was vaccinated with PNEUMOVAX 23 (lot number, expiration date, dose, route and site of administration were not reported) for prophylaxis. In 2017, the patient experienced redness, but not in the vaccination area. The redness was closer to the elbow. The patient self-treated with ice. The outcome of redness was reported as resolved in approximately 2017. The relatedness between the event and PNEUMOVAX 23 was not reported. This is one of two reports received from the same reporter.
This spontaneous report as received from a healthcare worker refers to a 2 year old patient of unknown gender. On 19-JUN-2014, the patient was vaccinated with a dose of VAQTA, strength: 50/1.0 U/mL 1.0 ml, intramuscular (lot#, expiration date and indication not reported). The reporter stated that the patient received an adult dose of VAQTA today (19-JUN-2014). No adverse effect reported. Additional information has been requested.
Pain and Throbbing in the legs, feet and hands Tingling sensation through out feet, legs and hands Bruising in the back of calves Loss of posterior tibial pulse  in the right  ankle
Chest pain, flushing of face.  No sob, no edema, BP and HR stable,  ASA 325mg given po and 911 called
Fever, migraine , chills, swollen arm and red all around the vaccine site, very weak,
2nd day post vaccination on arm began to swell, ache with pain in upper arm and shoulder caused sleep interference. Pt used ice and heat alternating and dosed with ibuprofen, Tylenol and ASA with no relief. MD visit on 1/20/05 for eval. To ER via ambulance after passing out on 1/22. 2nd MD office visit scheduled 1/24. Still has severe pain from Left collarbone down to fingertips with burning, throbbing, tingling and numbness.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other medication in two weeks. The patient received Paxlovid for COVID 19 Treatment, Treatment start date is 17Aug2022, Treatment stop date is 19Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recvd 3 doses of Hep B vax on 24AUG92 & devel sore arm @ inject site w/minimal swelling No further details were provided;
On April 10, I began to have confusion and nausea.  My confusion lasted all day and I have absolutely no memory of about 10 hours of that day.  I only know about the confusion from my husband and two friends that I texted since I knew something was wrong.  I underwent a stroke work-up in the ER which was all negative other than some scattered nonspecific foci of T2 signal prolongation in the subcortical and deep white matter of the cerebral hemispheres bilaterally for which my neurologist said is most likely normal but the amount is a little unusual for somebody who is as healthy as I am.  The working diagnosis when I was discharged from the ER was global transient amnesia but I was told to f/u with a neurologist.  The neurologist performed an EEG that was normal and agreed with the diagnosis of GTA.
THE PATIENT DIED (THE PATIENT SURVIVED 2 WEEKS IN ICU BEFORE SHE PAST 2); This spontaneous report received from a patient via a company representative via social media concerned a 3 decade old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: stage 4 colon cancer, and kidney stone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry : unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient died (the patient survived 2 weeks in icu before she past 2 ) and was hospitalized in ICU (date unspecified). Laboratory data (dates unspecified) included: CT scan (NR: not provided) kidney stone, clear. On an unspecified date, the patient died from unknown cause of death. It was unknown if an autopsy was performed The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211104964-Covid-19 vaccine ad26.cov2.s - The patient died (the patient survived 2 weeks in icu before she past 2 ). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
This spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients medical history and concurrent conditions were not provided. Since 01-NOV-2016, an unknown number of patients were vaccinated with improperly stored doses of ROTATEQ lot number not reported. Other vaccines improperly stored included VAQTA, RECOMBIVAX HB, GARDASIL 9, M-M-R II, and PEDVAX HIB. No adverse effects reported. No further information provided. No contact information was provided. This is one of several reports from the same source. Additional information is not expected.
Fluarix on Oct2021 and a dose of FluLaval on Jan2022; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 12-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number 42M9S, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUARIX QUADRIVALENT 2021-2022 SEASON).   On 4th January 2022, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 4th January 2022, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device and an unknown time after receiving FLUARIX QUADRIVALENT 2021-2022 SEASON, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient received a dose of Fluarix Quadrivalent on 26th October 2021 and then received a dose of FluLaval Quadrivalent on 04th January 2022, which led to extra dose administered. The reporter consented to follow up. This case was reported by a medical assistant.