chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of pain in arm in a 61-year-old female patient who received SHINGRIX (batch number FJ575 ?, expiry date 30th January 2020). On 1st March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st March 2018, immediately after receiving SHINGRIX, the patient experienced pain in arm. On 2nd March 2018, the patient experienced heart disorder, chest discomfort, tiredness, headache, queasy and troponin increased. The patient was treated with Aspirin. On an unknown date, the outcome of the pain in arm, chest discomfort, tiredness, headache and queasy were recovered/resolved and the outcome of the heart disorder and troponin increased were unknown. The reporter considered the pain in arm, chest discomfort, tiredness, headache and queasy to be probably related to SHINGRIX. It was unknown if the reporter considered the heart disorder and troponin increased to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient had family history of heart attack and stroke. On 1st March 2018, at 15:35, the patient received SHINGRIX on right deltoid. The patient experienced something (discomfort) she had never felt before in her chest just below the breast and at the top of rib cage. The patient was concerned about her heart. The patient went to a clinic on 2nd March 2018, (Friday) afternoon and was taken to the emergency room and was there for 3 hours. On 2nd March 2018, the patient went to a clinic and then the patient undergone electrocardiogram, blood test and a chest x-ray which were resulted unknown and troponin test resulted elevation. The patient wanted to speak with someone about this event. The reported batch number FJ575, did not exist in sales database.
Fainted during the mandatory 15 minute evaluation period post vaccination. Sat with patient who returned to  and refused medical transport and color returned was with wife who will watch him today. Recommended a meal with rapid, intermediate, and long acting carbohydrates. Reported once started drinking water again he felt better. Monitored patient for additional 20 minutes to observe. Stood up without assistance but was carefully monitored. Then left with wife for lunch since hungry.
expired IPOL was accidentally given with no reported adverse event; Initial information received on 28-Jul-2022 regarding an unsolicited valid  non-serious case received from a nurse.  This case is linked to case 2022SA311619.  This case involves a 8 years old female patient to whom  expired IPV (VERO) [IPOL] was accidentally given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) and varicella zoster vaccine (varicella vaccine) for Immunization.  On 27-Jul-2022, the patient received 0.5ml  dose of suspect IPV (VERO) once, suspension for injection, (strength: unknown) (lot T1D482M and expiration date: 25-Jul-2022) via unknown route in the left deltoid for immunization was accidentally given with no reported adverse event (expired product administered) (latency: same day).  Action taken : not applicable.  Outcome: unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Narrative:  A 77yo male with PMH of Hypothyroid, Automatic Implantable Cardiac Defibrillator,Systolic Heart Failure, Gouty Arthritis, Depression, OA, OSA, Chronic Kidney Disease Stage III, Cholelithiasis, Pulmonary Arterial HTN, Heart Failure, HTN, Paroxysmal A-fib and Acute Renal Failure He received Pfizer Covid-19 vaccine per policy and protocol without complication No ADE reported Home Hospice patient with recent hospitalization and multiple medical problem He presented to the ED on February 28, with nose bleed (Epistaxis) that would not stop and was admitted His medication included apixaban and aspirin - was stabilized. CHF exacerbation ( EF of 20%-25% in September of 2020), BNP = 30000 on 02/20, Ches X- ray w/mild Pulmonary Edema, AKI with a Cr of 4.6, bilateral lower extremities Edema, data system showed the patient passed away on March 16, 2021
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: HOT FLASH TIMES A ZILLION-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Evening of shot day (2 of 2 ) arm a little sore then progressed to being light headed  and sweating, hot flash times a zillion, next day was still dizzy in morning, all cleared up by  end of day on 3-30-2022 . Patient reports much worse on second shot (first shot arm sore only)
It started with pain in the right arm, the pain was increasing and it never went away. It burn, I haven't had fever. The pain continued in the right leg, next to the knee and I started to limb (it started 1 month later) I can't walk, the pain is strong. The spine in the lower zone, and one day I woke up and couldn't move or get up. After I had pain in the clavicle left side. Pain in both thumbs like jerking. Pain started to change from the lumbar zone to the feet. Same sensation from hand went to my feet. I couldn't take it anymore and went to the doctor. I had test done and now taking pills for pain.
On July 8, 2022 I had congestion in my left nostril, the nest day it moved to the right nostril, a headache that has not went away, fatigue, shortness of breath, sore throat. I used my home COVID-19 test that came back positive on July 9, 2022, I went to an urgent care on July 10, 2022 to have PCR COVID-19 test done, they called me July 12, 2022 with a positive result. I was prescribed FLONASE nasal spray. I still have congestion and a headache I am getting better and I can work.
shingles; pain in her lower back; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Mar2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Three days after, on 10Mar2021, the patient experienced pain in her lower back. On 21Mar2021, she had shingles breakout. They suspected that the vaccine shot was bringing out shingles. They would like to confirm if it would be fine to not let the patient take the 2nd dose. Outcome of the events was unknown.    Information on the lot/ batch number has been requested.
2 days after the shot my tongue became red, swollen, and burned on the tip area.  After 5 days the tongue  was normal again. But any long term issues are not known at this time
This spontaneous  report as received from a registered nurse refers to an unspecified number of patients unknown age and gender. On an unknown date the patients were vaccinated with RECOMBIVAX HB (dose, route of administration, lot# and expiry date were not reported) that improperly stored. No adverse symptoms was reported. It was reported that the temperature excursion was unsupported with in-house stability data. This is one of several reports received from the same reporter. Additional information has been requested.
first dose / on 5/26/21 / not received any further doses; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 26th May 2021).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. No additional information provided. The reporter did not consent to follow up.
Tested positive on 25th of March; Nerve pain in her back; Shingles; This is a spontaneous report received from a Pfizer sponsored program and Pfizer COVID-19 Vaccine Call Center via medical information team. A contactable female consumer of an unspecified age reported for herself that received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 17Mar2021 to 17Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the caller had the 1st dose on 17Mar2021 and has been tested positive on 25Mar2021 (which was after the 1st dose). She also experienced nerve pain in her back the day after the 1st dose and it lasted for 5 days, she thought she had shingles on Mar2021. She would like to confirm if there was a time period before she can take the 2nd dose. Provided PMI phone and hours of operation, since she called outside of PMI operating hours. The Pfizer-BioNTech COVID-19 Vaccine does not contain SARS-CoV-2 and cannot give you COVID-19. The vaccine should be offered even if you had symptoms or no symptoms of COVID-19 infection. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 25Mar2021. The outcome of event "nerve pain in her back" was recovered and other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
4 hours of inconconsolable screaming, full body shivers, full body rigidity, ruddy skin from crying, sob from crying ... followed by 4 hours of unarousable sleep .... then he never slept longer than 2 hours at a time for the next three years .... sleep 2 hours, up for 6, nap 2 hours, up for 8 ... needed deep pressure to fall asleep (heavy bouncing or swinging).  01/06/2010 Neurological consulation records received. Service dates 11/20/02 to 9/3/09. Assessment: Autism. Patient presents with poor eye contact, texture sensitivity, motor stereotypies, abnormal social responses, toe walking, lack of speech, lacks pincer grasp, developmental delay. Hyperactivity. remaining asleep (excessive), tantrums.
Pt had burning hot redness over the bilateral bicep area spreading to the upper extermities.
24 hours after the vaccine injection I had severe chest and abdominal pain along with nausea and vomiting. I went to the ER where they did blood work, an ekg, and a chest xray, all of which were within normal limits. I was give IV morphine for the pain and IV pepcid. The symptoms went away after a couple of hours and I was released. The symptoms did not return.
85 recruits were vaxed w/Td & Yellow @ the same time; pts exp swelling & erythema surrounding vax site to a greater extent than was previously exp;
As per MD who administered vaccines, pt fainted ~1 minute after 3 vaccines had been administered.  MD called for me and I saw the patient who was in a chair.  Her back arched back.  Eyes open & rolled back was unresponsive & noted tonic posturing of her left hand.  PT became awake & oriented after being assisted to floor.  Episode lasted <1 minute.  Pt was given soda (had no breakfast) and released to mother's care upon becoming fully awake\alert\oriented.  Mom reported patient had headache x24H following the incident (follow-up phone call x 9 days after).
This spontaneous report as received from an unknown reporter refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of incorrect storage GARDASIL (lot # J003727, Expiration date 07-NOV-2015) (dose and route unspecified). This is one of several reports received from the same source. Additional information has been requested.
This spontaneous consumer report (initial receipt 15-Jan-2013) concerns a 73 year old female patient. On 23-Dec-2012, the patient received a flu vaccine (batch and manufacturer unspecified). On 25-Dec-2012, the patient developed aplastic anemia and has been in the hospital since being admitted on 25-Dec-2012. The patient has had several blood transfusions while in the hospital and her white blood count was as low as 0.4. The patient had blood drawn frequently. The event outcome was recovering. Reporter's comments: The reporter considered events serious due to hospitalisation.
Swelling, hot, redness. Pt had no fever mother stated she did not discover it till 2 days ago, pt was with baby sitter seen by physician, given Keflex antibiotics and instructed to use hot and cold compresses.
All 4 doses were administered to both of them, and got covid after that; All 4 doses were administered to both of them, and got covid after that; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), 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. 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), outcome "unknown" and all described as "All 4 doses were administered to both of them, and got covid after that". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: All 4 doses were administered to both of them, and got covid after that. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: He was not able to swallow the pill as it is too big, he did not chew it, his wife was taking the medication (PAXLOVID), she did not experienced any symptoms. All 4 doses were administered to both of them, and got covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201198093 same reporter/drug/event, different patient;
Chills, total body soreness, sweating, bad headache, tireness,  Ended about 9pm after breaking out in a wet sweat
Rash; Itching all over; Skin was red; This is a spontaneous report from a contactable pharmacist. A 52-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on May2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. In May2021, the patient experienced rash, itching all over and skin was red. He says she got the first dose on a Friday and on Sunday was when she got the side effect. He wants to know was she should be able to get the second dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
The very worst of the headaches was a week after shot, with very bad total body muscle aches for one day.; Bad headaches started the next day.  I have continued to have the painful headaches most of the days since getting the 1st dose of pfizer vaccine, including today, about 3 weeks later. The very worst of the headaches was a week after shot; This is a spontaneous report from a contactable consumer, the patient. An adult non-pregnant female patient of unspecified age received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: EN6205) via an unspecified route of administration in the left arm on 18Mar2021, as a single dose for COVID-19 immunisation. The patient had no medical history and did not receive any concomitant medications. The patient had no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 19Mar2021, the patient experienced bad headaches that started the next day. The patient continued to have the painful headaches most of the days since getting the first dose of Pfizer vaccine, including the day of reporting, about 3 weeks later. The very worst of the headaches was a week after shot, with very bad total body muscle aches for one day on 25Mar2021. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the event bad headaches that started the next day was not recovered while that of very bad total body muscle aches for one day was recovered on 26Mar2021.   No follow-up attempts are needed. No further information is expected.
Persistent nose bleeds for over a week that are difficult to stop. Sometimes several in a day.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 20-DEC-2015 at 17:35, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 8.8 (for 24 hours) and 8.2 (units unspecified) respectively. There were no product quality complaints (PQC) involved No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
2 days after vaccine: Intense nausea, hot flashes (never had hot flashes before), increased sense of smell triggering vomiting (like when pregnant), Vertigo, vaginal spotting. Blurry vision Still have all symptoms (except spotting) just are more mild, going on 3 weeks.
Fever; chills; soreness/body aches; muscle aches; feeling tired; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL9261) via unknown route at left arm on 27Jan2021 06:45 at single dose for covid-19 immunization. Medical history reported as none. Concomitant medication included pregabalin; cetirizine hydrochloride (ALLERTEC). The patient had no allergy. the patient not-receive any other vaccines within 4 weeks prior to the COVID vaccine. other medications the patient received within 2 weeks of vaccination includes Pregabalin, Allertec. On 27Jan2021, patient had fever, chills, soreness, muscle aches, body aches, feeling tired. There was no treatment received for the adverse events. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
1/6/2021 local reaction at time of vaccine of itching, soreness; resolved 2-3 days. 1/14/2021 local reaction returns, red, hot, indurated, and itching >10 cm (size of hand) with area of increased redness at center.
1 of 2 pts who devel a local react exp a react described as red, warm, 10 x 5 cm in diameter;
1.  09/03/2020; 17:00 Severe shoulder pain and limited range of motion (<30 deg) 2. 09/03/2020 19:30 took 200 mg ibuprofen 3. 09/03/2020 20:00 went to bed; pain required repositioning every few minutes 4. 09/03/2020 23:30 got up for more ibuprofen, stopped to urinate, felt dizzy and hot, tried to sit on the floor but lost consciousness and landed hard. Loss of consciousness lasted about 5-10 seconds. My wife came to help and said I was only able to provide limited responses to her questions, and my skin was clammy. Note: the dizziness, loss of consciousness, and clammy skin is what I experience when I ingest MSG. 5. 09/03/2020 23:40 While I was sitting on the floor, my wife gave a sip of water to me and I got dizzy and lost consciousness again, hitting my head on the sink pedestal as I fell. Loss of consciousness lasted about 5-10 seconds. 6. Called the Hospital System nurse on call and she recommended a trip to the ER. Checked in to the ER and waited for about 30 minutes. 7. 09/04/2020 00:41 Left the ER when they said it would be about a 6 hour wait.  8. Slept upright on the sofa because it caused less shoulder pain. 9. 09/04/2020 03:30 Got up to go to the bathroom, felt dizzy and hot, sat down, and lost consciousness again. Loss of consciousness lasted about 5-10 seconds.  10. 09/06/2020 15:00 As of this date and time, no more fainting spells, gradual lessening of shoulder pain, and slowly regaining range of motion and strength.
the patient was administered improperly stored VARIVAX; This spontaneous report was received from a medical assistant and refers to a 3-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 10-AUG-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # S025608, expiry date 18-AUG-2021 (dose, route of administration and anatomical location were not provided), which was reconstituted with properly stored sterile diluent (lot # S037030, expiry date 05-JUL-2022), for prophylaxis. The vaccine experienced temperature excursion of -12.5 Celsius degrees (range of temperature -14 to -10 Celsius degrees) for 1 minute and temperature excursion of -14 Celsius degrees (range of temperature -14 to -10 Celsius degrees) for 1 minute (there were multiple excursions). There was no previous temperature excursion. Digital data logger was involved.
Dizzy spells, extreme fatigue, increased heart rate, leg pain all starting about one month after vaccination. Diagnosed as Postural Orthostatic Tachycardia Syndrome (POTS) on January 19, 2023.