chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash head to toe. Not sleeping or eating. - Maculopapular rash, condense together in big patches, not sick, no cough, no URI c/o, measles-like rash.
1 day after receiving Pneumo 13 he experienced pain in (R) shoulder that continued to increase. Shoots into neck and biceps. (+) associated headache. A week later pain is beginning to subside.
I had the shot and got shingles twice/Suspected vaccination failure; Got shingles twice; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. Rechallenge with Shingles vaccine was negative. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles 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 had shingles shot and got shingles twice. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Dec2021 at 12:00 as dose 3 (booster), single (Lot number: FL3197) at the age of 61 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: BUSPAR oral, start date: 01Jan2012; MYRBETRIQ oral, start date: 01Jan2017; PAXIL CR oral, start date: 01Jan2012; ZYPREXA oral, start date: 01Jul2021. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received treatment with Paxlovid Treatment start date- 14Jul2022, Treatment stop date- 19Jul2022. Follow-up attempts are completed. No further information is expected.
Patient received influenza vaccine at his MD office on 1/22/18. He also received a steroid injection in his back on the same day but writer unable to get any specifics about steroid injection from patient and MD office had no record of this injection. Pt started to experience symptoms approximately 2/4/18 of:  hand and foot parathesias. He was evaluated in the ED and workup non revealing. He became progressively weaker and started to experience numbness of face and tongue on approximately 2/11/18. He also had blurred vision, sweating, feeling of coldness in body, and started to feel difficulty breathing.. Pt  was admitted to the hospital on 2/11/18. Neurology was consulted and their note stated EMG findings confirmed Guillian Barre Syndrome/acute demyelinating inflammatory polyneuropathy-with Miller Fisher Syndrome variant. He received IVIG 50g iv daily x 5 days with improvement of his symptoms. Plan is for discharge to inpatient rehab or home based on his functional status.
Intense pain and discomfort within 12 hours of receiving vaccine accompanied by severely limited range of motion in left shoulder, unable to lift arm up to or above shoulder level, significant impairment in ADLs. Started taking OTC NSAIDs and using ice/heat to the affected area to relieve discomfort. Made appointment with PCP for left shoulder evaluation on 11/23/2021. Determined that injection was given too high on the left shoulder, missing the deltoid muscle and injuring the infraspinatus tendon causing acute inflammation. Prescribed Prednisone 10mg x 9 days and Mobic 15mg for pain relief, and authorized referral to Orthopaedic shoulder specialist if symptoms persisted.
my right foot started to feel weird- felt wet or tingly sometimes; my first menstruation after vaccinehad many small blood clots, which isnot normal for me; This is a spontaneous report from a contactable consumer, the patient. A 40 -year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6206) via an unspecified route of administration in the right arm on 04Mar2021 at 18:30 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history included patient was allergic to shellfish. No concomitant therapies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The. Three days after the vaccine, on 07Mar2021 at 11:00 the patient experienced right foot started to feel weird and felt wet or tingly sometimes however the foot was not swollen. The patient still had those sensations 18 days after vaccine. Also, the patient first menstruation after the vaccine had many small blood clots, which was not normal for her. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of tingling foot and small blood clots in menstruation was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Severe exacerbation of TINNITUS, both ears.  She had pre-existing tinnitus for many years, rated 1-2/10.  Following vaccination, became much louder and disruptive to daily functioning and falling asleep at night.  Rated as 8-9/10.
I felt soreness and pressure build up in my arm starting a few hours after the receiving the dose. The soreness and pressure got progressively worse over the course of two days. It wasn't unbearable, just uncomfortable. The second day after the vaccine I had stretched my arm pretty good for minute, when I released the stretch I felt a rush of something for from my arm into my torso. I got really dizzy and passed out, my wife was in the room at the time and said I never closed my eyes; but I had completely blacked out. My wife had woken me up and I wasn't sure what had happened, it took me about 30 seconds to realize I had passed out after stretching that arm. My arm had felt better after waking up from passing out, and soreness had passed a couple days later. I didn't get checked out,  after I woke up I started feeling fine.  I'm honestly not sure if it's directly related to the vaccine or not, I just thought I should let someone know just in case.
Two days, I had extreme tiredness. Mild headache. Extreme muscle pain.  Moderate chills. Mild Fever. Nauseous.  Mild vertigo.
When I got the shot, moderately severe pain immediately radiated down my arm and into my last two fingers on my left arm as well as up into my shoulder blade area. It was a lot more painful than I expected based on previous shots. I went to bed with only arm pain and a small headache. Around 11pm that night I woke up in severe pain that was much worse than my chronic pain. I have prescription narcotic pain medication and that did not help. I was unable to leave bed and called my doctor at his home around 7am. I had a very bad headache (and I am used to headaches) and all of the areas of my body that normally hurt hurt much worse. My fingertips started tingling. I was miserable and in bed for about 3 days before starting to feel better, at which point I noticed that my arms and hands were off. The last two fingers on my left hand lost grip strength for about a week. The muscles In my arms kept getting weak. My fingers and the palms of my hands continue to tingling uncomfortably but the weakness is improving.
I do not believe that this recent event is connected with the vaccine. I have a history of a cavernoma resection approximately 1 1/2 years ago and then for the last month I have been experiencing postural headaches, balance issues, insomnia, and slow cognition (I forget words, what I'm saying, etc).
started to cough after second dose; hand numb in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (started to cough after second dose) and INJECTION SITE HYPOAESTHESIA (hand numb in injection arm) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Exposure to COVID-19 (Relatives tested positive for COVID today) since 07-Apr-2021.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced COUGH (started to cough after second dose) and INJECTION SITE HYPOAESTHESIA (hand numb in injection arm). At the time of the report, COUGH (started to cough after second dose) had resolved and INJECTION SITE HYPOAESTHESIA (hand numb in injection arm) outcome was unknown.            No concomitant medications were provided No treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10-MAY-2021, contains information such as event outcome has changed.
This non-serious spontaneous case, initially received from other non-health professional on 14-Nov-2018, concerning a female patient of unspecified age. On an unspecified date, the FLUCELVAX QIVc vaccine underwent first temperature excursion with maximum temperature (Tmax) 8.2 degree Celsius for 4 minutes. On 22-Oct-2018, vaccine underwent second temperature excursion with Tmax 9.8 degree Celsius for 23 minutes. On an unspecified date, two temperature excursions were identified after an audit. On 24-Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 252672 and expiry date: 30-Jun-2019) which underwent temperature excursion. The patient did not experience any adverse effect after the vaccination. This case is linked to 201805262 (same reporter).
Chills; Fever; Sweating; Severe headache; Nausea; Lethargy; Dizziness; This is a spontaneous report from a non-contactable consumer (patient). An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 22Feb2021 (Lot Number: EL3247) as dose 2, single for COVID-19 immunization. Medical history included was not reported. Patient had known penicillin allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 22Feb2021 (Lot Number: not reported) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced chills, fever, sweating, severe headache, nausea, lethargy, dizziness on 23Feb2021. The patient received paracetamol (TYLENOL). The outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Information has been received from a physician concerning a 24 month old female who was vaccinated with MMR. Concomitant therapy included VARIVAX (Merck). It was only known that they received MMR and VARIVAX (Merck). It was not certain if they were administered concomitantly or in what order. Subsequently, the patient experienced rash and fever of 101 degrees F. This is one of several reports from the same source. Additional information has been requested.
Tested positive for COVID on 01Nov2023. Sore throat, runny nose, cough; Tested positive for COVID on 01Nov2023. Sore throat, runny nose, cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the parent.  A 15-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Dec2022 as dose 5 (booster), single (Lot number: GJ6742) at the age of 14 years, in right 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. Patient received bivalent Pfizer COVID-19 vaccine in Pharmacy or Drug Store. The patient's relevant medical history included: "Lactose intolerance" (unspecified if ongoing). No covid prior vaccination. Patient had no allergies. There were no concomitant medications. No other vaccine in four weeks, no other medications in two weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Oct2023, outcome "recovering" and all described as "Tested positive for COVID on 01Nov2023. Sore throat, runny nose, cough". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Nov2023) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Adverse event start date was 28Oct2023.  No follow-up attempts are possible. No further information is expected.
breast are hurting; arm sore; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiry date were not reported) via unspecified route of administration on an unknown date (age at vaccination: 68-year-old) as 2nd dose, single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Previously patient took first dose of bnt162b2 (Lot number EDOR76) via unspecified route for COVID-19 immunisation. The patient experienced breast was hurting and arm sore on 08Jun2021. Reporter states she took the shot yesterday and her breast are hurting. Would it make her breast hurt? she stated the second one. She had to look at the paper. It's got her arm sore and her pain in her breast. It was stated breast was hurting today, this morning it was hurting now the 8th. It keeps on hurting. she took two Tylenol as treatment for breast pain. The outcome of event was not resolved.  PSCC Communication: Provided caller with report reference. The caller was provided with phone number for safety if she would like to call back at a later time, option 3 for safety, and hours of operation.   No follow-up attempts are possible. No further information is expected.
This case was retrieved via a search of scientific literature on 11 November 2011. The reporter for this case is the same as in case numbers: 2011-11264, 2011-11265, 2011-11271, 2011-11272 and 2011-11371. Verbatim form the abstract: "Background: Tdap vaccine was not licensed for use in adults aged greater than or equal to 65 years due to lack of sufficient efficacy and safety data. Objective: To characterize reports to the Vaccine Adverse Event Reporting System (VAERS) among adults aged greater than or equal to 65 years who received Tdap vaccine 'off-label' to assess for potential vaccine safety concerns. Methods: We searched VAERS for reports of adverse events (AEs) in subjects aged greater than or equal to 65 years who received Tdap vaccine from 9/1/2005 to 9/08/2010. Medical records were requested for all reports coded as serious (death, hospitalization, prolonged hospitalization, permanent disability, life-threatening illness). Proportional reporting ratio (PRR) was used to assess for higher proportionate reporting for AEs after Tdap compared with Td reports in subjects aged greater than or equal to 65 years. Results: VAERS received 243 reports following Tdap administered to persons aged greater than or equal to 65 years. Eleven (4.5%) reports were serious, including two deaths. Most common AEs were local reactions in 100 (41.2%) reports. Seventy-eight (32.1%) reports contained coding terms that denoted inappropriate administration of vaccine. 'Cough' was the only term associated with disproportionately higher reporting after Tdap compared with Td. Six of seven Tdap reports containing the term 'Cough' were non-serious. Clinical review of serious reports identified no unusual patterns of AEs. Conclusion: Our VAERS review of the 'off-label' use of Tdap vaccine in adults greater than or equal to 65 years did not find any safety concerns that warrant further study. These data will provide useful baseline information to assist CDC and FDA with monitoring efforts as permissive recommendations for Tdap in older persons are adopted." A 71-year-old male who had received Tdap (manufacturer, lot number route site and date of administration not reported) and PPV (manufacturer, lot number route site and date of administration not reported) and 34 days later had the onset of symptoms for GBS (Guillain Barre Syndrome). No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
Vomiting, Nausea, EXTREME Headache, EXTREME Pain in my left shoulder joint. Like a HOT SHARP  knife. Low fever, chills.  NOTE: i had bad pain in my left shoulder before the covid vaccine. after the extreme pain for 19 hours, my previous shoulder pain is gone. As the vaccine may have helped resolve that.
swelling at injection site Narrative: Per supervisor report:  " stated right arm swollen after second immunization. ... She further stated that she was out four days with the first injection after having a fever."
Pt reports LA began hurting the evening of injection 10/16/2023. She calls stating that arm is still hurting as of today 11/20/2023. She reports that arm is very sore and has a knot at injection site. She states that LA has slight bruising, and she sometimes experiences pain that will shoot down her arm into wrist.
pt recv vax 22MAY95 & pt devel chicken pox on 19MAY95; On 28MAY95 pt devel chicken pox; No further details were provided;
Itchiness; General body pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), PAIN (General body pain) and CHILLS (chills) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 048a21a) for COVID-19 vaccination.     Concurrent medical conditions included Asthma since 20-Jul-1990.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced PRURITUS (Itchiness), PAIN (General body pain) and CHILLS (chills). On 20-Feb-2021, PAIN (General body pain) and CHILLS (chills) had resolved. At the time of the report, PRURITUS (Itchiness) had not resolved.            Concomitant medications were not reported. Treatment information in response to events was not provided.   This case was linked to MOD-2021-102185, MOD-2021-102185 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Updated Patient details, demographics,Medical History, 2nd dose details, updated outcome of the event chills from Not recovered to Recovered. new event Body Pains added. updated action taken from Unknown to Not applicable and Reporter casualty to Possible
previously received a complete series of COVID-19 vaccine; Administration date of Moderna vaccine past the BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration date of Moderna vaccine past the BUD) and INTERCHANGE OF VACCINE PRODUCTS (previously received a complete series of COVID-19 vaccine) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration date of Moderna vaccine past the BUD). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (previously received a complete series of COVID-19 vaccine). On 13-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administration date of Moderna vaccine past the BUD) had resolved. At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (previously received a complete series of COVID-19 vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-320876.
Patient was in perfect health never got sick and was a college student who did ballet every day since she was three- years-old.  From the day she received the Gardasil vaccine she became tired and got aches and pains throughout her body.  The pain started with her hands then moved to her arms and spine.  Patient was diagnosed with three forms of arthritis and a heart murmur. Patient has been in pain every single day of her life and frequents the emergency room from the arthritis pain.
Pt received her vaccine at 1725 and proceeded to the monitoring area for her 30 minutes of monitoring. At 1755 pt c/o to RN of feeling itchy all over body. RN provided pt with diphenhydramine 25mg PO x 1 with water. No other c/o offered and pt's symptoms improved after taking diphenhydramine. Pt feeling better and discharged home at 1825.
Fever began at 7:00pm, started at 100.8 and crept up and down all night. Pain at injection site began immediately following vaccination, redness extending from site began at 12 hour mark and continued spreading. Hard lump formed by 24 hour mark. Redness still increasing at 48 hour mark, fever persists and congestion in nose and chest began.
fatigue; Muscle aches; headache; sore throat; chills; low grade fever; This is a spontaneous report from a contactable consumer. A 47-year-old female consumer received second dose of BNT162B2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection, Lot number: EM9810) via an unspecified route of administration on Left arm on 09Feb2021 at 04:00 PM for COVID-19 immunization. Medical history included uterine tumors. Patient had no known allergies. Concomitant medication was not reported. Historical vaccine included first dose of BNT162B2 (Pfizer-Biontech COVID-19 vaccine, lot number: EL3247 at 04:00 PM on Left arm) and experienced muscle ache on injection site. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 10Feb2021 at 06:00 AM, patient experienced muscle aches, headache, sore throat, chills, low grade fever and fatigue. No treatment was provided for the events. Outcome of the events was recovering.