chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient reported itchy/puffy eyes about 15minutes after vaccination.  I gave the patient a dose of liquid benadryl. The patient was monitored for an additional wait time before stating she felt okay and wanted to go home.
2/07/08 @ 7:40 a.m. reported pain in lower ribs bilaterally, took 2 Tylenol.  At noon, she stated she had pain radiated to upper chest, said pain subsided, but still present.  She stayed in school with nurse monitoring her.  B/P 98/60, P-80, Temp 98.2F at room per school nurse.
I had a fever, chills, body aches, and it was the first time in my life I had a migraine in my life that sounds and lights were triggering me. And about a month and half or 2 months later, I started getting really dizzy. I thought it was stress, and a month after I went to the doctor. My ears started ringing really bad on April 15th and has not stopped. I had a hearing exam for that and I am seeing an EMT for that now. Some of the doctors do believe this is vertigo from the vaccine due to the amount of patients they are seeing now that have the vaccine in common before they meet with them.
Did not use diluent in the box; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's comment: The reporter reported that someone at their clinic had given a Menveo vaccine without using the diluent in the box. The reporter assuming they used sterile diluent that they kept on the counter. The reporter asked for guidance to know how that affects the individual receiving it. Additional supportive information: The patient had Menveo reconstituted with sterile diluent, instead of the supplied diluents, which led to wrong solution used in drug reconstitution. The follow-up could not be possible as no contact details were available. This is 1 of 4 linked cases reported by same reporter for different patients. Conservatively case was processed with event wrong solution used in drug reconstitution considering the sterile diluent was used in vaccine reconstitution.; Sender's Comments:  US-GSK-US2023AMR032664:Same reporter US-GSK-US2023AMR032665:Same reporter US-GSK-US2023AMR032666:Same reporter
Information has been received from a physician concerning a female with Addison's disease and a history of bulimia who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot# 646494/1201N). The physician reported that the pt was seen in the office "falling over in pain". At the time of this report, the outcome was unknown.  The physician also reported that 2 other pt's developed adverse events after being vaccinated with pneumococcal 23v polysaccharide vaccine (WAES # 0405USA00961 & 0405USA01170).  Additional information has been requested.
2-3 hours, post vax, upper outer left arm had pain, redness and swelling. Parent gave Tylenol every 4 hours but pt didn't sleep. On 9/29/00, same symptoms persisted. Pt went to school. Parent picked up child from school at 15:15. Swelling was below the elbow on left side which continued up the left side of her face and feverish. She complained of left eye, ear and throat had pain. Pain intensified through 9/30/00 when pt couldn't stop crying and went to hospital at 12:00. Doctor at hospital treated with prednisone (4 days) and Tylenol with codeine and also amoxicillin. Symptoms persisted 3 days after hospital visit. On the 4th day, no symptoms. No problems with respirations. Child feels better.
2nd dose more than a year after 1st dose; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date, 1 year ago).   In August 2022, the patient received the 2nd dose of Shingles vaccine. In August 2022, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 25-OCT-2022 Reporter's comment:  This case was reported by a consumer via interactive digital media. The patient got his/her second shingles vaccination 2 months prior to the reporting.  That was over a year after he/she got first dose.  The reporter asked did he/she still need a booster. Additional supportive information:  The patient received 2nd dose of Shingrix that was over a year after first dose, which led to lengthening of the recommended interval between vaccine doses.
First, extreme tiredness, left arm muscles weak.  Sunday, generally not feeling well - tired, sore, achy.  Monday - sore throat, achy, tired, Tuesday - sore throat, achy, tired, fever under 100, no appetite, nauseous, Wednesday - too ill to get out of bed - chills, fever, pain, exhaustion, weakness, Thursday, muscle weakness, fatigue, fever - under 99 - sore throat better, muscle pain; Friday, tired, sore throat better, chest hurts, mild dry cough, low temp, muscle pain still
Mother reports that client broke out in a rash on the face, arms and chest then it went to the back and legs also. Child was taken to ER that same day after mother noticed that he did not respond fast to OTC allergy medication. Dr. at ER was unclear to what was the cause of the rash. Client was treated for allergy at Hospital and released after the rash resolved.
Became very sick on Friday with flu symptoms. Fever 101.8, body aches, chills, runny nose, dizzy, very tired, headache,
Information has been received from a consumer concerning her daughter who on an unspecified date was vaccinated with a dose of MERUVAX II (Lot number unspecified). Secondary suspect vaccinations included ATTENUVAX, MUMPSVAX II and other unspecified vaccines (manufacturer unspecified). Subsequently the patient experienced fever and a welt on her arm. At the time of the report the status of the patient was unspecified. It was unspecified if the patient sought medical attention. Additional information has been requested.
This spontaneous report was received from an vaccine coordinator referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 30-DEC-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # U016065, expiration date 20-MAY-2023) 0.5 mL (route, anatomical location and frequency not reported) for prophylaxis. The vaccine was stored at 8.1 degrees Celsius (C) for 2 hours, 58 minutes and 0 seconds. No previous temperature excursion were reported and it was unknown is a digital data logger was involved. No additional adverse events (AEs) were reported.
In the first 2 days (probably a couple of hours after the shot) I felt achiness, and it got worse body pains, joint pains and fatigue. Almost a week after I started getting sick, aches, shore throat, headache and fever (101.5F) that is when I went to the ED and it lasted about 2 days and then it went away. At the ED they did COVID and strep tests both negative. This was with my first dose and my second one the same thing happened.
Seen in Emergency room on for redness/raised area that measured 3x2cm. Diagnoses with cellulitis of L upper arm.
In 2 hours-runny nose-sneezing-chest congestion-dry mouth-chills-fever-massive headache-sinus ache-tooth ache- heavy head- miserable! Some less miserable by 10:00 PM. Next day- weak-asthma-phlegm-cough.
The pt experienced a maculo-papular rash and then vaccine related measles developed 9 days post vax.
Starting the morning after vaccination patient reports injection arm pain, stiffness, and loss of function that has not subsided. No visible injury or redness. She had been to two doctors and both prescribed steroids. No imaging was done yet based on patient report.
Case number PHEH2014YS003782 is an initial spontaneous report from the pharmacist received on 21 FEB 2014. This report refers to a 11-year-old female patient who was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) at a dose of 0.5 ml intramuscularly on 26 NOV 2013. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration).   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "adult product administered to child".
The client reported that 3 days after receiving the vaccine, they developed chest pressure, tachycardia, and mild shortness of breath. The client also reported feeling, "like I wanted to get out of my body" and stated her body felt uncomfortable. The client described these symptoms as "anxiety," but denied any history of anxiety or these symptoms prior to receiving the vaccine. The symptoms lasted 1.5 days. The client didn't take any medications or follow up with any providers.
COVID 19 Treatment; COVID 19 Treatment; Moderna; Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 21Jul2021 as dose 2, single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) and on 01Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Jan2022, outcome "unknown", described as "Moderna; Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative after 5 days of COVID and taking paxlovid; Positive, notes: Symptoms returns 6 days later and tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Yes patient received vaccine. No other medication was taken in 2weeks. No Known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Case number PHEH2014US017500 is an initial spontaneous report received from a medical assistant on 27 Aug 2014. This report refers to an 86 year old male patient. His medical history and concomitant medications were not reported. It was reported that unopened FLUVIRIN MDVs reached 50.7. F for 4 hours. Reported as one time excursion. The patient was vaccinated with FLUVIRIN (batch number: 1410801 at a dose of 0.5 ml intramuscularly on 25 Aug 2014, from the MDV after the excursion. No adverse event was reported. No further information was provided.
Pain and weakness in right thigh. Area numb to being touched, but touch is painful in the muscle.
No additional AE or PQC reported; VARIVAX was administered to a patient after a temperature excursion; This spontaneous report was received from a licensed vocational nurse (LVN) and refers to a patient of unknown age and gender. The pertinent  patient's medical history, drug reactions and allergies and concomitant therapies were not reported.  On 15-NOV-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #W005206, expiration date: 14-FEB-2024, administered for prophylaxis (anatomical location and route of administration were not provided), after the vaccine underwent a temperature excursion in a temperature of -13.7 Celsius degrees for a time frame of 5 hours and 15 minutes (Product storage error). There was no previous temperature excursion. No additional adverse event (AE) or product quality complaint (PQC) reported (No adverse event).
Soreness in upper right arm. Can be sharply painful on certain activity such as opening door.
Having physical and vocal tics; Stutter; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Lot number: ER8730) at the age of 18 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: TIC (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Having physical and vocal tics"; DYSPHEMIA (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Stutter".  Additional information: Patient was reported to be weighing 270 (units not reported). Patient stated she was having a severe reaction to Pfizer vaccine and stated she was having vocal and physical tics and stutter very often.  No follow-up attempts are possible. No further information is expected.
the patient experienced no symptoms; first dose ofGARDASIL 9 on 10/30/2018 and a second dose ofGARDASIL 9 on 1/18/2019; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 30-OCT-2018, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly (strength, lot# and expiration date were not provided) for prophylaxis. On 18-JAN-2019, the patient received second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, lot# and expiration date were not provided) for prophylaxis. The patient experienced no symptoms. No further information provided.
Area where she had the injection was red; Tender rash; A lump; It was Itchy; It was hard; Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurt), VACCINATION SITE ERYTHEMA (Area where she had the injection was red), INJECTION SITE RASH (Tender rash), VACCINATION SITE SWELLING (A lump) and VACCINATION SITE PRURITUS (It was Itchy) in a 75-year-old female 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 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm hurt). On 20-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Area where she had the injection was red), INJECTION SITE RASH (Tender rash), VACCINATION SITE SWELLING (A lump), VACCINATION SITE PRURITUS (It was Itchy) and VACCINATION SITE INDURATION (It was hard). On 10-Feb-2021, VACCINATION SITE PAIN (Arm hurt) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Area where she had the injection was red), VACCINATION SITE SWELLING (A lump), VACCINATION SITE PRURITUS (It was Itchy) and VACCINATION SITE INDURATION (It was hard) outcome was unknown.        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.   Treatment and concomitant medications were not provided by reporter.
On 8/27/02-45 mins later after receiving the shot, I experienced blurred vision, nausea, dizziness, and restless. On 8/28/02 about 9:15am I felt sick to the stomach and had to vomit, headaches.
Had both vaccines and died from COVID-19 afterwards; Had both vaccines and died from COVID-19 afterwards; This is a spontaneous report from a contactable nurse. A 42-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 and dose 2; both via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had both vaccines and died from COVID-19 afterwards on an unspecified date. The patient did not have any known underlying health conditions or issues. The patient died on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Had both vaccines and died from COVID-19 afterwards; Had both vaccines and died from COVID-19 afterwards
Rash; Pain on the lower side of the belly; This case was reported by a consumer via call center representative and described the occurrence of rash in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. In November 2019, less than 4 months after receiving Shingrix, the patient experienced rash and lower abdominal pain. On an unknown date, the outcome of the rash and lower abdominal pain were unknown.   It was unknown if the reporter considered the rash and lower abdominal pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not provided but the patient could be 79 to 80 years. About a week before the time of reporting, the patient broke out with rash and pain on the lower left side of the belly.  The patient had gone to see his physician the day before reporting and had been prescribed medication for it. The reporter consented to follow up.
Rash developed on upper body, on arms ,neck, and, around the injection site. I had a tele-heath appointment with my doctor unfortunately, the medication did not help the rash it spread so I visited the Urgent Care to receive medical help.
Information has been received from an office manager at the physician's office concerning a female consumer who on 31-OCT-2007 was vaccinated with a first dose of GARDASIL (lot # 657736/0389U). It was reported that "after the 1st dose", the patient has her period in November and December; however she did not have it in January, February and March. On 06-MAR-2008 the patient received her second dose of GARDASIL (lot # 659655/1486U). It was reported that the patient was not pregnant. Additional information has been requested.
I had a low-grade fever, a painful arm, and fatigue within 24 hours of receiving the vaccine. On 3/7/2021, I felt this weird burning/sensitivity/tingling sensation around the trunk of my body. I also experience nervousness. On 3/10/2021 the area around my trunk started to have patches of bumpy red rashes.
Loose stools 4-5 times/day. Started day after ROTATEQ.
Pt became shaky, with hives on left arm at injection site and spread to R arm and chest.
Headache, Arthralgia, Fever, Jaundice, body aches Narrative:
This spontaneous report was received from a licensed practical nurse and refers to a 6-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 26-SEP-2016, the patient was vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered dose of vaccine experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916.
Immediately after receiving vaccine, client closed eyes & had several mild jerky motions as she slid down the chair. Mother caught her arm, at which time, she opened her eyes & stated that "I felt like I was having a dream & I just woke up". Client became pale (very) immediately after injection. BP about 90-100/70 (noisy/hard to hear)/reg pulse about 80/min after. Approx - 15 minutes of resting, completely recovered. Color - pink, W/D; BP 120/70, advised to inform PCP of incident. Patient denies any previous allergies or neurological problems.
Several minutes after the vaccine was given the patient started to experience pruritis, initially at the site of the injection, but it began to become more generalized.  She started to feel warm and flushed, and observed that her skin was starting to become red and flushed (no hives or other rash was apparent).  She then noticed that her throat was itchy, and she was having difficulty swallowing.  She denied cough, dyspnea, chest tightness.  She said she felt "funny", but did not have any near syncopal events.  She denied GI symptoms.  On observation, there was obvious flushing of her skin and her right eye was hyperemic (she said that the sensation of itching was more prominent on the right side).  She was initially hypertensive, with a BP of 171/97, HR of 133, respiratory rate of 18 and SaO2 99%.  She was treated with 0.3mg epinephrine IM, and was transferred to the ER.  She states that several minutes after receiving the EpiPen, she began to feel better with regards to her throat globus and pruritis.  Patient was nonetheless transferred to the ER for further evaluation and observation.
Acute left basal ganglia  ischemic stroke confirmed on MRI.  Presented with slurred speech and ataxia.  Woke up the morning of 9/16/21 with symptoms after going to bed normal the night before.
Myalgia, Arthralgia, Fever & Tachycardia Narrative:
pt recvd vax 13OCT92; 25OCT92 deel numbness in legs & pain in low back extending down legs; seen by MD dx GBS; devel body wide parasis but not intubated; had 4 total plasma exchange
Initial report from the via call center received on 02 Dec 2009: The patient had received FLUVIRIN (Batch no: 960232P) on 09 Oct 2009. On 16 Nov 2009, the patient began experiencing tingling on the left side of her face and loss balance. The patient went to her primary care physician but treatment medication was not prescribed. Symptoms of tingling and loss of balance were continuing at the time of the report. No further information reported at the time of the report.
Adverse, bad taste when drinking fluids, no change in taste regarding solid foods. Started a few hours after vaccination, started subsiding 4 days after vaccination.