chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient filled out their paperwork and included a history of seizures but was said they did not have known history of seizures related to vaccines. The patient was advised to wait in our waiting room for 15 minutes after the administration.  As they were standing up to leave after 15 minutes she started seizing.  As I, the pharmacist, ran out to help, her friend and an observer assisted in slowly lowering her to the floor.  She was lowered without injury and turned onto her side.  As this was occurring a pharmacy team member called 911, even though the friend denied service as "she has had seizures for over 20 years". I informed them we had to call 911 but they had the right to deny transport. The seizure lasted maybe less than 1 minute, stopped for about 30 seconds but patient was unresponsive but with pulse and then another seizure occurred lasting maybe less than 1 minute.  The patient then regained consciousness but was confused. I directed her to remain laying down, but she slowly sat into a sitting position. She almost immediately grabbed her chest and complained of severe chest pain.  She then also complained of jaw pain and shook her arm and complained of right sided arm pain when asked. I asked a pharmacy team member to get 4 chewable baby aspirin (81mg x4) as these are signs of a heart attack. The friend stated she has a long history of heart issues but in the adrenaline of the moment I do not remember what issues she stated.  As the staff member was getting the Aspirin EMS arrived and agreed to administer the 325 mg total of chewable aspirin.  The EMS assisted the patient in taking the aspirin and helped her off the floor onto their gurney.  I gave as much detail in my report to EMS as possible and they took the patient out of the store to the hospital. At the time of transport she was alert and still complaining of chest pain.
Information has been received from a nurse practitioner concerning a female patient who on an unspecified date was vaccinated with the three dose series of RECOMBIVAX HB when she was in elementary school (lot number not provided). Post vaccination the patient developed gastrointestinal upset and lost 30 pounds. This occurred years ago and the patient has recovered. It was unspecified if the patient sought medical attention. No further information is available.
Approximately 8 days after 1st Covid 19 ( Moderna) vaccination,  patient developed a large red area around injection site. she came by the pharmacy 7 days after this started and  first informed the pharmacy.  The patient commented the area has been getting larger each day. We measured the red area; the dimensions were 3.5" x 3".  It was warm and hard.  It was recommended to her to take diphenhydramine.
3NOV92 swelling began in rt big toe progressed upward to joints mainly in rt side of body; had some numbness tingling lt hand; swelling not excessive; was seen in ER 4NOV92; for arthritis;
Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked to cases 2018SA279742, 2018SA279748, 2018SA279744, 2018SA279745, 2018SA279746, 2018SA279747, 2018SA279740, 2018SA277209 and 2018SA279741 (same reporter). This case involves a 64  years old male patient was vaccinated with a 0.5 ml dose of FLUBLOK QIV lot QFAA1829; expiry date;30-Jun-2019  via intramuscular route in the left deltoid on 02-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccination included a dose of HEPATITIS A VACCINE on an unspecified date (reported as same visit). It was a case of actual medication error due to incorrect product storage (It was reported that shipment was sent to her clinic on 27sep2018 and was received on 01oct2018 and administered to 10 patients). No follow up treatment/symptoms reported. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. List of documents held by sender: none
Information has been received on 16-JAN-2017 from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was inoculated ZOSTAVAX vaccine (lot# and route unknown) on or about 01-NOV-2013, administered by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 26-JAN-2015 the patient was treated by a physician for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster inducing migraines. The patient has been prescribed morphine injections, acyclovir, DEMEROL injections, promethazine injection for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
7/20 - 7/22: 43-year-old G4P1021 at 37w4d presenting to triage for scheduled repeat C-section (elective). 7/20 delivered baby. Seen and evaluated 7/22. Patient examined and note addended as indicated. Doing well POD 2. Pain controlled, tolerating PO, ambulating, bleeding minimal. Recovering from COVID-19. Tested positive last week. Stable for d/c home. Follow-up 2 weeks.
Headache, body aches, joint pain, LARGE SWOLLEN LYMPH NODE IN LEFT ARMPIT
woke up the night of my vaccine with pain in my left eye and significant itching and tearing.  The pain went away in a couple of hours but the itching continued for 3 days. It woke me up from sleep 3 nights in a row. I took Zatidor eyedrops and Allegra with very little improvement.   I get similar eye symptoms with seasonal allergies but this was the worse I have ever experienced and was not accompanied by runny nose, sneezing or coughing which I usually get with seasonal allergies and this is not a typical season for my allergies this may be just a coincidence but since I have read that Covid 19 can give similar ocular symptoms I am concerned about my second dose.  I got a COvid test 2 days ago (no other symptoms) and do not yet have the results
fever of 103deg; stomach cramps; cold sweats; nausea; diarrhea; extreame cold chills; headaches; indigestion; This is a spontaneous report from a contactable consumer. A adult 43 year old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Left on 14Apr2021 09:00 (Batch/Lot Number: EW0158) as SINGLE DOSE for covid-19 immunisation. The patient medical history included overweight. Concomitant medication(s) included valacyclovir [valaciclovir] (VALACYCLOVIR [VALACICLOVIR]), paracetamol (TYLENOL), loratadine (CLARITINE) and multivitamins taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 administered in Arm Left on 24Mar2021 09:00 (Lot Number: ER8727). The reporter stated that the day after the second dose he had a fever of 103deg, stomach cramps, cold sweats, nausea, diarrhea, extreme cold chills and headaches on 15Apr2021 18:00 and indigestion on 15Apr2021. These lasted until the fourth day. he started feeling better but almost every night since the vaccine I have had a little headache, and nausea. he thought it was going away until last night 20Apr2021 the headache has returned worse and he had a low grade fever along with indigestion. As he was writing this he have cold sweats and a headache. The patient did not receive any treatments for the events. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks and prior to the COVID-19 vaccine. The outcome of the events fever of 103deg, stomach cramps, cold sweats, nausea, diarrhea, extreame cold chills, headaches was reported as not recovered and indigestion was reported as unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Severe rash forehead and eyes numbness dropping in face swelling throat tingling itching. High dose steroids and antihistamine for 7 days.
Severe vertigo episode 12.5 hours after receiving 1st dose of COVID-19 vaccine. Intermittent episodic dizziness which resolved by week three.  Upon second dose, within 48 hours experienced a major episode of vertigo. Thereafter daily episodes of vertigo and dizziness lasting up to three minutes without warning. Experienced severe stomach pains and indigestion. Symptoms resolved by the end of July.
I am having redness and itchiness on the injection site; I am having redness and itchiness on the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: 0H9702) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, I had all my injections (clarified as Pfizer Covid-19 vaccine), all the booster and everything), for Covid-19 immunization; Bnt162b2 (Dose 2, I had all my injections (clarified as Pfizer Covid-19 vaccine), all the booster and everything), for Covid-19 immunization. The following information was reported: VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "I am having redness and itchiness on the injection site". The events "i am having redness and itchiness on the injection site" required physician office visit.  Additional information: Consumer stated, "I had all my injections (clarified as Pfizer Covid-19 vaccine), all the booster and everything and on Wednesday I got the latest the omicron Covid Pfizer (Clarified as Covid 19 vaccine Bivalent). What I wanted to know because I never had this reaction before I am having redness and itchiness on the injection site. Consumer stated, "I do not think this is anything abnormal. I just decided to check because I am 77 years old."  No follow-up attempts are possible. No further information is expected.
Consumer will be completing their dose of Vivotif during the travel; Spontaneous report received on 06FEB2020.  A pharmacist reported that a "consumer will be completing their dose of Vivotif during the travel" (PT: Inappropriate schedule of product administration). The consumer was receiving Vivotif for immunisation. It was reported that the consumer had only one dose of Vivotif left to take. The consumer will take the last dose during the travel. The pharmacist did not provide the date of travel for the consumer. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer will be completing last dose of Vivotif during the travel (Inappropriate schedule of product administration). Vivotif course should be completed one week prior to the travel. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer will be completing last dose of Vivotif during the travel (Inappropriate schedule of product administration). Vivotif course should be completed one week prior to the travel. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.
Same evening when I got the vaccine my arm started hurting from the shoulder to the elbow it was an intense pain I couldn't out my hand up because it will hurt it felt so heavy, I also felt fatigue & my body started hurting. The next day when I woke up I had a headache I felt space out  I didn't feel myself I also got diarrhea & the diarrhea lasted until 2/10/2021.
pain migraine, throbbing, pressure, headache; excruciating pulsating headache/ hurting headache; pulsating migraine, with pressure; pulsating migraine, with pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Sep2021 (Lot number: FC3181) at the age of 64 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose: 26Aug2021, injection in left arm, between 1000am to 1100am, Lot: FC3180, First dose was good.), administration date: 26Aug2021, when the patient was 64 years old, for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 16Sep2021, outcome "not recovered", described as "excruciating pulsating headache/ hurting headache"; HEAD DISCOMFORT (non-serious), MIGRAINE (non-serious) all with onset 16Sep2021, outcome "not recovered" and all described as "pulsating migraine, with pressure"; HEADACHE (non-serious) with onset 09Oct2021, outcome "not recovered", described as "pain migraine, throbbing, pressure, headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, head discomfort, migraine, headache.  Additional information: Caller states to me that she knows that headache is a common side effect but she is wondering if the shot has the effect of giving you a pulsating migraine, with pressure, hurting headache in your whole head, excruciating migraine as being a side effect that she is experiencing three weeks after her second dose? . She is upset and nervous and hurting. The day of the second shot about two and a half hours later she started experiencing an excruciating headache, pulsing pressure in head like the shot went to her head and it lasted the whole day, it was an excruciating migraine pain and pressure. Last Saturday she started experiencing the same excruciating pain migraine, throbbing, pressure, headache. She is being told that she can get a headache. The severity of her headache is more than a headache. Asking if high blood pressure would have anything to do with pulsating migraine/headache. Thinks she had too much when talking about the dose and it was not pretty. First dose was good but the second dose caught her. she called the doctor and is taking ibuprofen for her headaches. No vaccination within 4 weeks prior vaccinations. No AE following prior vaccinations.  No follow-up attempts are possible. No further information is expected.
Patient reported swollen and painful arm, fluid drained from shoulder, 2 days in hospital.
The lymph nodes under my left arm swelled -- some are the size of walnuts.  They are painful and achy.  Managed with Tylenol.  I've heard from friends that it's a common occurance, but I'm not reading about it in the media as a side affect.
Reported by pediatrician office: visit on 6/8 symptoms started 6/7, fussy, crying, abdominal pain, bloody stool; suggested to visit ER, then admitted. Ultrasound, lower and upper GI fluoroscopy with enema. Discharged 6/9. Follow up with pediatrician on 6/11, states "doing well. Feeding and active as usual. No concern at present". Pediatrician visit 6/13 with complaint of "super fussy off and on". History reports no fever, vomiting, diarrhea, or blood in stool; acting normal in office. Progress notes state plan "Observational instructions given. Call if any concern." No follow-up visits noted after this.
Vaccine placed on 4/25/06. ACP and IPV on left arm MMR on Right arm SQ. Mom noticed 9:00am on 4/26/06 child complaining of itching notably swollen and warm to the touch. left arm only. Itch, rash and swelling resolved on day 5.
mom noticed pt scratching inject site & had welts @ inject site; welts would disappear & then reoccur not sure how often this happened; being treated for bronchitis & viral infect since 23OCT92; fever 104 x 3 days starting 24OCT92;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: En6199), on 01Apr2021 as dose 2, single (Lot number: En6199) and on 03Oct2021 as dose 3 (booster), single (Lot number: EW0183) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 including PAXLOVID given from 25Aug2022 to 29Aug2022.
hives-arms & back lasted 24hr-did go away;mom informed reporter of rxn 1mo later during office visit;
I took my dog out for a walk and when walking the dog I collapsed, I later determined my blood pressure was low at 110/69. My Neurologist had me go to the emergency room. TIA was determined by the attending physician who happened to be my Neurologist.
Patient received Anthrax #1 and typhoid vaccines on 10 Jan and smallpox vaccine on 11 Jan'11. On 12 Jan (1 day post vaccine) he reports he developed a rapid heart rate, cold sweats in night and felt like he was being punched in the chest. He described the pain in the middle of the chest as a sharp pressure. He also had SOB, no energy, and that it was worse when lying down and thus interfered with sleep but improved if he was up and moving around. The pain was continuous and he couldn't keep up in PT during the following week. He states he didn't worry about it since had been briefed that these sxs might occur after receiving the SPV. He also states he 'got sick that week' after receiving the vaccines with a fever and runny nose. He sought medical tx on 18 Jan where he had an EKG performed and blood work. EKG was apparently normal (no copy available) and troponins negative, but CKMB positive at 30 (0-5 ng/mL). (Repeat on eval at medical center on 15 Feb was normal). The pain was constant and still is present continuously (one month later) with intermittent twinges of sharper pain, although he states overall the intensity is lessening. He states he can press in on the right side of the bone in middle of the chest next to his ribs and feel pain. He reports he had no viral illnesses in the weeks prior to receipt of the vaccine.
I have become weaker. My muscles hurt now. All the time. Just from regular things. Like cleaning the house.  I have gotten weaker from this vaccine.
My 3 year old son was hospitalized due to DKA and diagnosed as type 1 diabetes on 11/14/2022. He had 3 doses covid vaccines (COVID-19, mRNA, LNP-S, PF, 3 mcg/0.2 mL dose, tris-sucrose) on 08/11/2022, 09/01/2022, 10/27/2022.
- Slight dizziness upon injection and immediately after - Pain in shoulder on vaccine site - Nausea about 7-8 hours post vaccination - Physical and mental exhaustion 10 hours post vaccination - Dizziness again about 22 hours post vaccination - Consistent nausea and exhaustion
Miscarriage.  First day of last menstrual cycle was March 30, 2021. Pregnancy was confirmed through home test on May 7, 2021 and with doctor on May 10th, 2021. The doctor referred me to OBGYN and first appointment was on June 9th, 2021. Expected delivery date was January 4, 2022. The first ultrasound occurred on June 10th, 2021. This ultrasound showed concerns of development as I was measuring 6 weeks and should have been at 10 weeks based on the previous dates. A follow-up ultrasound occurred on June 25th and confirmed the baby was not viable. My body was not recognizing the miscarriage and therefore had to go in for a D&C on June 30, 2021.
I had a rash on my forehead break out, no change of face creams, soaps, shampoos etc.  I still experience this rash from time to time - on line Dr consultation on 1.26.2022.. Dr. advised to take general allergy tab and use Cortizone cream.  Had a Chalazion on my left eye, never had one before in my life and I'm 58 years old.  Face-to-face Doctor visit on 3.23.22.  Treatment is prescription eye anti-biotics and warm compress to the eye.  I thought it worth mentioning to you as I have never had either of these issues in my life. Just in case others have reported the same things.
L arm pain and swelling. She also had a neck mass develop. Resolved but still having residual pain
Patient signed up for a booster moderna shot. Right before we gave her dose she said she was wanting the 3rd dose for immune compromised. Her card only showed 2 doses and the booster had already been approved on insurance, therefore we didn't think it was an issue to go to the 0.5ml dose from the 0.25ml. We reprocessed later and it flagged it for 4th dose.
Swelling if R thigh 2nd day post vax. R thigh diam 12.5' vs L thigh diam of 10 3/4".
Nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06May2021 (Lot number: EW0171) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (ongoing), notes: States she was diagnosed 7 years ago. . Concomitant medication(s) included: BABY ASPIRIN taken for hypertension. The following information was reported: NAUSEA (non-serious) with onset 06May2021, outcome "unknown", described as "Nausea".  Additional Information: The patient stated for concomitant Product baby aspirin she did not took one every day, she just took it sometimes. She did not had high blood pressure all the time. She stated there was times it flares up. concomitant Products baby aspirin took for blood pressure. she called because she got her first dose of the COVID-19 vaccine yesterday and had nausea on and off since then. The caller was wondering how long the nausea would last and when could she take aspirin again. she was wondering when she could take anything over the counter medications or her prescription medication she had for nausea. She stated she had Reglan and Zofran and wanted to know if she could take any of those. Caller stated that the nausea started around 5 or 6 pm on the 06May2016 and had experienced it off and on since then. She stated that when she first made this phone call, she was experiencing nausea and now she was not. She states that she had a prescription medication for it and wanted to know if she could take it and when could she start taking aspirin again for her blood pressure. She stated that she takes the low dose aspirin from time to time. She also wanted to know if there were any other products she shouldn't be taking, because she did not want to decrease the effectiveness of the vaccination. she stated that she could not take a narcotic medication. No prior vaccination within 4 weeks No AE(s) following prior vaccinations.  No follow-up attempts are possible. No further information is expected.