chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Starting 10/08/2022, I woke up in the morning with terrible chest pain and across my upper back. I didn't know I was positive for COVID and thought I was having a heart attack. I called 911 and went to the ER. They did numerous tests to rule out heart attack and all came back normal and they said I tested positive for COVID. I started remdesivir by IV and almost immediately started feeling better. I got the second dose the next day and then I was discharged. I was feeling much better by then (10/10/2022). I didn't have a cough or fever, just some chest pain. The chest pain resolved after the remdesivir and, when I was discharged, I was just fatigued. I ended up following up with my PCP and cardiologist. The cardiologist did numerous blood tests and scans of the heart to ensure everything was normal. They said there was still inflammation around the heart likely secondary to the COVID-19 infection but it appeared to be healing.
right knee was swollen like there is "water on his knee"; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 21Jan2021 11:00 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he received the COVID-19 vaccine yesterday at 11AM (21Jan2021). This morning (22Jan2021), he woke up and his right knee was swollen like there is "water on his knee". He doesn't know any other problems that may have caused it aside from the vaccine. He was wondering if this is a side effect of the vaccine. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Severe joint pain- sites of previous surgery such as lower back, hip and shoulder showed even worse inflammation and pain. Would rate pain in triage areas at 10/10 or higher  Fever up to 103 degrees F, shivering, unable to sleep due to joint and body pain.   Headache causing dizziness and confusion.   Treated initially with Tylenol but moved up to Oxycodone 7.5/325 that I had from a surgery, took that every 4 hours for next day.   Absolutely horrible 72 hours. Will not take another vaccination. This was mandated by my company.
a case of acute onset of hepatitis and following covid 19 initial vaccine; This is a literature report.  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Patient has never had alcohol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEPATITIS (medically significant), 3 days after the suspect product(s) administration, outcome "recovered", described as "a case of acute onset of hepatitis and following covid 19 initial vaccine". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 446; 622, notes: peaked at day 20; Antibody test: negative; negative; Antinuclear antibody: negative; Aspartate aminotransferase: 212; 232, notes: peaked at day 20; Blood immunoglobulin G: negative; Cytomegalovirus test: negative; Epstein-Barr virus test: negative; Gamma-glutamyltransferase: 101; autoimmune markers: negative; Investigation normal: was positive for hepatomegaly; Viral test: negative.  Clinical course: Case of hepatitis with symptoms lasting for 4-5 weeks following covid 19 initial vaccine and an accidental booster dose.; Sender's Comments: Based on the information available, a possible contributory role of the suspect product cannot be excluded for the reported events 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,Linked Report(s) : US-PFIZER INC-202300197814 Same article/patient/drug and different event/dose;
Vomiting diarrhea nausea fainted shortness of breath 6 hours after vaccination and initial reaction
This is a spontaneous report from a contactable pharmacist via a sales representative. A female patient (Age approximately 66; Unit: Unknown)of an unspecified ethnicity received the first single dose of PREVNAR 13 via an unspecified route of administration on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever, fatigue on an unspecified date (occurred 2 days after vaccination) and other reactions listed in PI Reactions resolved after one week. The outcome of events fever and fatigue was unknown.
Fluvirin from 16/17 season; Fluad for above 65 years of age and instead got this Fluvirin from 16/17 season; This is a spontaneous case initial and follow up received from other health professional (nurse) on 30-Nov-2018 (both the versions being processed together), concerning an 85-year-old, elderly female patient.  It was reported that on September, 3 vials of vaccine under 65 years of age and Fluad for above 65 years of age was ordered and instead got Fluvirin from 2016-2017 season. When the nurse went to record the information from the vial is when it was a different name and was expired.  On 19-Nov-2018, the patient was administered an expired vaccine Fluvirin (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 162030 and expiry date: 31-May-2017) instead of Fluad (explicitly coded as expired vaccine used and wrong vaccine administered) for influenza prophylaxis.  The patient did not experience any adverse events after vaccination.  This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding PTC reference number was 1036115. Based on the QA investigation, it was reported that, the returned sample showed evidence of use and the most likely root cause was a lack of stock inventory management at the complainant resulting in expired material being used. Considering there was no root cause associated with either Seqirus or Agency there was no product impact from this complaint.  The reporter assessed the case as non-serious.  Follow up received from Quality Assurance Department on 11-Jan-2019: The QA investigation report was added. The narrative was amended accordingly.  Non-significant follow up received from other health professional on 18-Feb-2019: The reporter refused to provide the patient details and it was confirmed that the patient had not experienced any adverse events. Med info number was updated in the additional information tab. No changes were made in the narrative.; Reporter's Comments: An 85-yearold, female patient was administered an expired vaccine Fluvirin Thiomersal instead of Fluad (coded as expired vaccine used and wrong vaccine administered). The company assessed the causality of the events as not related to the suspect vaccine considering the events as an accidental nature of the event.
Headache started around 1pm the day after the injection, 1/8.  The headache persistent until I went to bed 1/9.  It was gone in the morning 1/10.
horrible like disgusting like metal taste in my mouth; Dizzy; its like making me sick; Nauseous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05May2021 15:15 (Lot number: ER8735, Expiration Date: 30Jul2021) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "bladder disease" (unspecified if ongoing), notes: Verbatim:  I have a bladder disease. The patient's concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious) with onset 05May2021, outcome "unknown", described as "horrible like disgusting like metal taste in my mouth"; DIZZINESS (non-serious) with onset 05May2021, outcome "unknown", described as "Dizzy"; ILLNESS (non-serious) with onset 05May2021, outcome "unknown", described as "its like making me sick"; NAUSEA (non-serious) with onset 05May2021, outcome "unknown", described as "Nauseous". Therapeutic measures were not taken as a result of dysgeusia, dizziness, illness, nausea.  Additional information: Patient had Pfizer vaccine just a coupe of hours ago and since been home I have those horrible like disgusting like metal taste in my mouth its like making me sick and I am really dizzy and it said it wasnt a common side effect so to call this number if having abnormal side effects. Can taste medicine like metal in my mouth and  know that was like not a common side effect Product details (LOT#, NDC#, UPC# and Expiration Date) and pharmacy details could not be probed over the call as the consumer was unwilling to compete the report.  No follow-up attempts are possible. No further information is expected.
Got jab at 12:15pm.  By 7pm a burning sensation began.  By 9pm nearly my entire body had significant burning neuropathic pain that continues to worsen and has not resolved in 4 weeks.  I had no significant neuropathic pain prior to vaccine and had not taken any medication for neuropathic pain since 2019.    Pain started within hours of the vaccine.  The vaccine was the only new variable in my routine.   Now I'm taking gabapentin 3x daily to help mitigate pain.
Increased temp. 101.5 degrees --> 102 degrees orally, chest heaviness.  Severe muscle & joint pain, tender lymph nodes, sore throat, headache.
I felt as if I was gonna pass out, went to urinate and started cramping. I leaned on the vanity and left arm was hanging on the sink. I starting crying (tears in my eyes) however I wasn't actually crying. Then I stumbled to the bed woke my husband up I couldn't speak. My mouth was circulating and speech wasn't audible. He helped me get into bed started fever for 40 mins and legs was jumping in the air due to shivering. I woke up again around 6am some of my fingertips appeared purple in color. The next day I went to work cause I don't miss any days. I contacted my doctor he thought maybe I had a stroke.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, BrainFog Narrative:
Patient was grey, diaphoretic, and syncopal x2, palpated irregular slow HR - 38.  EMS called arrived at 1011 with ALS and BLS support.  Patient was observed and assessed with 12 led EKG - showed irregular rhythm.  Patient continued to be symptomatic and transported to local ED via EMS.  Patient remained AAO x 3 with notation of transient color changes at time of transport
Prevnar shot in leg caused redness, swelling, hot to touch and pain at injection site
No problems until approximately 2 days later when he broke out in an itchy rash on chest which moved to shoulders then arms and finally the back.  The rash lasted only 2 to 3 days and no fever or other Signs or Sx.
Runny nose; Headache; Left arm hurting; The co-worker said that she "diluted it with sterile water" but caller said "she didn't think it was diluted and that she saw what the co-worker gave her".; The co-worker said that she "diluted it with sterile water" but caller said "she didn't think it was diluted and that she saw what the co-worker gave her".; The co-worker said that she "diluted it with sterile water" but caller said "she didn't think it was diluted and that she saw what the co-worker gave her".; This is a spontaneous report from a Pfizer sponsored program. A contactable 34-year-old female consumer (patient) reported for herself.  A 34-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 22Jul2021 (at the age of 34-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes Indigestion and allergy from an unspecified onset and unknown ongoing and concomitant medications includes Protonix [OMEPRAZOLE] and Acrivastine (BENADRYL ALLERGY RELIEF). On 22Jul2021, patient received first dose of the Pfizer COVID-19 vaccine and patient doesn't think it was diluted at all, Caller said she was given 0.1milliliter of whatever was drawn up. Caller mentioned that after she was given the vaccine, the co-worker said that she diluted it with sterile water, but caller said she didn't think it was diluted and that she saw what the co-worker gave her. It was brought to the caller's attention that the vaccine was supposed to be diluted, and before the shot was administered, the co-worker said you're not supposed to dilute it. Caller mentioned that the "co-worker gave 2 doses of the vial, and caller knows it was supposed to be 6 doses in a vial, and the co-worker had no dosages left and caller was wondering where are the other doses of the vial" Caller wanted to know information on being given an undiluted dose of the vaccine, on whether it is effective. Caller wanted to know what she was supposed to do if the Pfizer BioNTech COVID-19 vaccine dose given to her was diluted with sterile water. On 23Jul2021 patient experienced left arm hurting, on 24Jul2021 patient experienced runny nose and headache. No other vaccines taken within four weeks prior to the first administration date of the suspect vaccine. The outcome of the event Runny nose and headache was recovered on 26Jul2021 and pain in extremity was recovered on 27Jul2021.  No follow-up attempts possible. No further information expected.  Follow-up (PRD/SRD (09Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
LARGE LOCAL REACTION. REDNESS AND SWELLING AT SITE. TYLENOL, ICE TO SITE.
I had Johnson and Johnson on March 11, this was a Moderna booster. Approximately 30 minutes after getting the vaccination I was overcome with an unusual amount of energy as if I had a strong stimulant in my system. This lasted for about 3 hours, and then I crashed hard and was very tired and hungry.  The following morning I had tremors in my right and, and was very sore at the injection site.
Information has been received from a office manager concerning an approximately 3 or 14 years old male patient. The patient's pertinent medical history, drug reactions, allergies and concurrent conditions were not informed. On an unknown date, the patient was vaccinated with GARDASIL (lot #, expiration date and dosage were not provided). administered per intramuscular route. Concomitant therapies were not informed. On unspecified date, the patient's arm became sore after receiving GARDASIL. The outcome of sore arm was unknown at the time of the report. The causal relationship between sore arm and GARDASIL was not reported. No product quality complaint (PQC) was involved. Additional information is not expected as no consent for follow up was given.
Onset of fever evening of vaccinations, 101 degrees. Fever gone by next morning, responded to Tylenol;  c/o achiness that evening, lasted 3-4 days; poor appetite onset that evening, lasted x 1 week;  has been feeling "tired and draggy" ever since evening of vaccinations.  scheduled to see private provider today. P/C from mtoher who states her son saw provate provider yesterday. Per private provider: it is not abnormal to have aching for 2 weeks after immunizations and feel tired 2-3 weeks after immunizations; patient should have : very good immunity" to the diseases for which he was vaccianted. Mom instructed to call health department should there be any new development.
Feeling really bad; Loss of appetize; Diarrhea; Just unable to do anything; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling really bad), DECREASED APPETITE (Loss of appetize), DIARRHOEA (Diarrhea) and FATIGUE (Just unable to do anything) in a male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feeling really bad), DECREASED APPETITE (Loss of appetize), DIARRHOEA (Diarrhea) and FATIGUE (Just unable to do anything). At the time of the report, FEELING ABNORMAL (Feeling really bad), DECREASED APPETITE (Loss of appetize), DIARRHOEA (Diarrhea) and FATIGUE (Just unable to do anything) outcome was unknown.            Concomitants were not provided. No treatment information was reported.
It was reported that a 7 year old male received Fluzone SV '98-'99 USP on 11/3/98, and post vax, the pt experienced a syncopal episode lasting 60 seconds. From additional information received on 11/23/1998, it was reported that the pt recovered from this experience.
After 2 weeks SP immunization Resid - Began to c/o increased weakness & numbness.  Sat -> MD.  Apt with MD.  Started on neurontin 11/20.  Sat on floor.  L/T increased weakness.  11/21 -> hosp with signs & sx of CVA.
This spontaneous report was received from a nurse refers to unspecified patient of unknown age. The patient's medical history, concomitant medication and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of one of the following lots of VARIVAX, but she was not sure the unspecified patient received from which lot. The various lot#s involved (N000681, expiry: 06-JAN-2019) (N012134, expiry: 17-APR-2019), (M048200, expiry: 07-DEC-2018) (M046005, expiry: 05-NOV-2018 (also reported as "18-NOV-2018") (M040138, expiry: 28-SEP-2018) (dosing details not provided), for prophylaxis. No adverse effects were reported. The vaccine lots were exposed to temperature in the range -9 degree Celsius to 8 degree Celsius for 1 hour and 45 minutes. Temperature excursion was detected by digital data logger. No previous temperature excursion occurred. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006789.
Information has been received from a certified medical assistant concerning a male infant who was vaccinated IM with a "full" dose of Zostavax instead a dose of varicella virus vaccine live. The vaccination was reported to be given as a routine vaccination. The event was a result of human error, not product confusion. No symptoms were reported. No diagnostic laboratory procedures were undertaken. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Tachypnea, Tachycardia,   feet, legs felt heavy, shoes felt tight, had chest tightness   Narrative: Had to go to the emergency was discharged the same day  from the emergency department, was not admitted to the hospital, went home and  continued to monitor herself for symptoms, states her legs/feet were numb, tingly,  and felt very heavy, with severe pain (worse pain of her life), it was nerve pain,  legs were twitching, felt like everything on the inside was on fire. Today still feels  feet and toes a bit tingly, face is red from the steroids she was given in the ED.  Had a complete work up in the ED: CXR, blood work, EKG.
I had the shots be fore this last round of the shingles/suspected vaccination failure; I had the shots be fore this last round of the shingles; 2 times and they are Sooo painful; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   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), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient experienced shingles 2 times and they were soo painful. The patient had the shots before this last round of the shingles.  The reporter also said get the shot people. This case was considered as suspected vaccination failure as the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR243350:same reporter
I developed a severe allergic reaction to nail dipping powder. I have been getting my nails done for years and never had any issues. Since getting the Vaccine, even the slightest exposure to the dip powder would cause my neck to itch, severe coughing fits, and complete swelling of my nasal passages. I have always been healthy and continued drinking beverages with vitamin C, turmeric, cayenne pepper, cinnamon and other natural inflammatories but nothing helped so eventually my doctor prescribed steroids which finally alleviated my symptoms.  As I get further away from my vaccination dates, my allergies upon exposure to the dip powder have gotten more and more mild to the point now where I barely have any reaction at all. I have been doing my nails on my own at home and am using the exact same products that I used back when I was getting a reaction. I'm seeing a clear correlation of the allergic reaction with the proximity of the vaccine having been administered. This is obviously not life threatening and has thankfully resolved itself over time but I do believe that it is worth noting.
Very painful menstrual cramps. Far worse than ever experienced. Took 4 ibuprofen to alleviate pain.
This medically confirmed report (initial receipt: 22-Oct-2013) concerns a 47-year old female patient with an allergy to Sulfa. On an unreported date in 2012, the patient received an unspecified influenza virus vaccine (batch number and manufacturer not reported). After vaccination, the arm that it (the vaccine) was administered to became swollen. The patient was hospitalised for two days. Outcome was reported as recovered.
Patient was involved in an MVA post vaccination. Patient stated that he felt "out of it" after leaving the facility and did not register that there was a vehicle in front of him that was stopping. Patient rear ended a vehicle at a stop light and reported that he was very light headed and "out of it". Pt had a fever of 102 degrees x48 hours post vaccination as well.
Developed transverse myelitis following administration of Flu Vaccine in 2003.  Admitted to acute care hospital Nov 2003.  Out of work for 1 month. Discharge summary states parethesia, asthenia. msv
Flashing in right eye on the day adverse event occurred, next day after the event floaters in eye, next day visit to eye doctor, diagnosis torn retina, next day outpatient laser surgery to repair retina, next day neck crepitus, which I have never had before starts and has not gone away to date.