chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bladder infection; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was getting her second dose on Saturday (20Feb2021) and thinks she was getting a bladder infection (unspecified date). The patient was not sure yet but is going to get a test kit today (16Feb2021) and will find out. The patient has already gotten the first dose of the COVID-19 vaccine. The patient wanted to know if she will be able to get her second dose of the COVID-19 vaccine if they put her on antibiotics. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown.), for Covid-19 immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "massive blood clot in left leg around knee in calf area that later moved to abdomen"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "arm was burning at the site"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "something was squeezing so hard on the right side of chest it was taking my breath"; VOMITING (non-serious), outcome "unknown", described as "threw up"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; HEADACHE (non-serious), outcome "unknown", described as "blasting headache"; ASTHENIA (non-serious), outcome "unknown", described as "so weak"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "couldn't hardly walk". Clinical course of the events: After receiving the 2nd Covid vaccine the Pfizer, within mins after taking the shot, patient arm was burning at the site and something was squeezing so hard on the right side of chest it was taking breath, threw up, diarrhoea, blasting headache, and was so week that patient could not hardly walk. 3 weeks to the day patient was diagnosed with massive blood clot in left leg around knee and calf area that later moved to abdomen where patient had to have a venous wall stent. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt recv vax on 11/16/98; on same day pt exp soreness of vax site w/ redness & hot. Follow up: No additional information.
Pfizer-BioNTech COVID -19 Vaccine EUA Administered on 7/14/22 - reported hive like rash on 07/14/22 at 1:53 pm on chest, abdomen and back.
3/24/08 VZV administered in L arm.  Mom called 3/25/08 stated injection site had dime size redness & swelling and later on went to quarter side.  3/26/08 patient came in and redness is size of tennis ball.  Instructed mother to give MOTRIN for swelling and discomfort.  If redness swelling, and pain persist to go to PCP for further evaluation.
Vertigo, felt as if she would pass out, unusual heart beat, heart beat has pauses and has since had irregular heart beat
The medical assistant gave the wrong meningococcal vaccine, I ordered MCV4 for 14 year old patient and MA accidently have Men B vaccine.   The patient has not reported any adverse events/signs or symptoms.
Headache, Myalgia, Arthralgia, Fever & NauseaVomiting Narrative: Employee went with symptoms after 2nd dose to her personal physician and was treated with prednisone and methocarbamol, losing work days.
Fever, chills; decreased appetite; fatigue; injection site pain Narrative: Tylenol as needed for fever
pain; swelling; lump on collar bone; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd October 2019, the patient received the 1st dose of Shingrix. On 22nd October 2019, less than a day after receiving Shingrix, the patient experienced pain, swelling and mass. On 26th October 2019, the outcome of the pain, swelling and mass were recovered/resolved.   It was unknown if the reporter considered the pain, swelling and mass to be related to Shingrix.  Additional details were provided as follows: The patient experienced pain, swelling and lump on collar bone. The reporter was left a sticky note from another pharmacist. The pharmacist stated that, she did not normally work at that particular store The reporter consented to follow up
Severely swollen lymph nodes. Very painful to swallow, difficult to sleep comfortably.
pt recv vax 2OCT96 & w/in a few min of vax pt devel swelling, urticaria, & redness @ inj site, reporter stated pt had no rxn p/vax;
Information has been received from a physician concerning a 12 weeks old male patient who on 27-OCT-2008 was vaccinated with a dose of ROTATEQ (lot # 660682/0574X) 2cc orally. At the same visit 2 month old vaccines were administered (vaccines unspecified). The physician reported that on approximately 03-NOV-2008, the patient developed an ear infection. "Yesterday" on 05-NOV-2008 the patient started vomiting. The physician advised the parents to take the patient to the ER where he was admitted to the hospital. At the time of the report, the patient was in surgery for intussusception. At the time of the report, the patient had not recovered. The physician considered the intussusception and ear infection to be life threatening and other important medical events. A priority lot check has been requested. Additional information has been requested.  11/25/08 Reviewed hospital medical records of 11/5-11/8/2008. FINAL DX: Ilecolic intussusception, s/p exp lap reduction Records reveal patient experienced reduced oral intake, sleepy, vomiting.  Had recently been on antibiotics for croup.  Seen in ER, labs WNL & d/c to home.  At home had bloody stool & returned to ER.  IS confirmed & taken to OR when enema failed to reduce.  Progressed well & d/c to home on oral antibiotic.
Got really ill; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of illness in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced illness (Verbatim: Got really ill).  The outcome of the illness was not reported.   The reporter considered the illness to be possibly related to Shingles vaccine.     The company considered the illness to be possibly related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported by a patient's brother/sister via interactive digital media. The patient got really ill from the Shingles shot. This case had been linked with US2023AMR038235 by same reporter for different patient.  Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR038235:Same reporter
hasn't slept all night; temperature started coming on/temperature went to 102 Fahrenheit; whole body aches; headache; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (hasn't slept all night), PYREXIA (temperature started coming on/temperature went to 102 Fahrenheit), MYALGIA (whole body aches), HEADACHE (headache) and NAUSEA (nausea) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 013M20A and 027L02A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Hypertension (High blood pressure) and Hypercholesteraemia (High cholesterol).   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Dec-2021, the patient experienced INSOMNIA (hasn't slept all night), PYREXIA (temperature started coming on/temperature went to 102 Fahrenheit), MYALGIA (whole body aches), HEADACHE (headache), NAUSEA (nausea) and CHILLS (chills). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 30-Dec-2021, INSOMNIA (hasn't slept all night), PYREXIA (temperature started coming on/temperature went to 102 Fahrenheit), MYALGIA (whole body aches), HEADACHE (headache), NAUSEA (nausea) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2021, Body temperature: 102 fahrenheit (High) 102 Fahrenheit.         Concomitant medication includes: Many medications The patient though of having COVID infection but realized that the events were common from the vaccine, later took medicine and was symptoms free.   This case was linked to MOD-2021-434890 (Patient Link).
5 days after the injection (April 12) I noticed pain/tingling in both hands and both feet. In addition, some places on hands and feet were very sore to the touch. Symptoms increased over the next week; visited primary care Dr on April 21. Symptoms escalated and visited ER on April 24. Consulted with pain specialist May 4, neurologist May 6 and had nerve conductivity tests May 13.
Chills, pain at injection site, headache, dizziness, body aches began at 1600 on 2/4/21 and subsided at 1400 on 2/6/2021.
Patient tested positive for COVID on 09/01/2021. Did have increased oxygen needs. She was started on dexamethazone 6mg PO x10 days on 09/04/2021.
Patient was given Pfizer booster shot. Boosters approved for only 16+ at time. Mistake was not caught at registration before vaccine administered.
Patient came into the pharmacy on 4/10/19 and reported a rash all over her body - red with raised areas similar to hives. She said it started on 4/9/19, the day after she received her first dose of SHINGRIX. BENADRYL was recommended and patient was referred to her physician.
SOB, CP, myalgias, arthralgias, upper extremity rash, tachycardia, HTN
chest pain; arm pain; This is a spontaneous report from a contactable other HCP (patient). A 52-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 18Aug2021 at 08:00 (at the age of 52-years-old) as dose 2, single for COVID-19 immunisation. The patient previously received the first dose of bnt162b2 (lot number er8731) on an unspecified date in Jul2021 for Covid-19 immunisation. Medical history included schizoaffective disorder and allergies to compazine. Th epatient did not have COVID prior vaccination. Concomitant medications included olanzapine and melatonin, bot taken for an unspecified indication, start and stop date were not reported. On 18Aug2021 at 08:00 the patient experienced chest pain and arm pain. Th patient stated that she had stabbing pain in chest right and left side. The events resulted in Emergency room/department or urgent care and were treated with rest in bed. The patient was not COVID tested post vaccination. The outcome of events was not recovered.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Spotting vaginal bleeding; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 13May2021 01:30 (at the age of 50-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient had no took any past drug. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 13May2021 13:30, the patient experienced spotting vaginal bleeding. The outcome of event was not recovered.  Information on the lot/batch, further information has been requested.
Administered Hep A vaccination #1 on 6/30/08; on 7/01/08 pt mother called pt woke up with chest pain at 9am, the repeated fever at 930 am with possible wheezing per local average Dr advised mother to take pt to Emer RM for further evaluation.
After injecting the vaccine by 2 minutes while I was monitoring the patient, I noticed a small, hard lump at the injection site. The patient said he doesn't feel any pain and while monitoring the patient, I noticed it was getting smaller. Kept monitoring the patient for 20 minutes and he said he is feeling well and he doesn't have any pain or discomfort at the injection site and left.
Large growth under armpit the 2nd morning after the 2nd dose.  Two days later, growth has spread down side
Based on information received on 15 Nov 2017, the following information has been amended: vaccine preferred name changed from "INFLUENZA QUADRIVALENT RECOMBINANT VACCINE" to "INFLUENZA VACCINE". Initial unsolicited case received from a consumer (patient wife) via other company Astellas Pharma under the MFR control number: 2016US015482 on 15 Nov 2017. This case involves 67-year-old male patient who was vaccinated with a dose of INFLUENZA VACCINE and a dose of PNEUMOCOCCAL VACCINE (Batch numbers, expiry date, dose, dose in series, route and site of administration were not reported for both the vaccines) on 07 Nov 2016. The patient also started treatment with 160 mg and 120 mg dose of XTANDI (Manufacturer: Astellas Pharma) (Batch numbers reported as 1539683PC and 1543982PC, expiry date not reported) daily once orally from an unknown dates for prostate cancer with metastasis and metastatic castrate resistant prostate cancer. (It was reported as patient had no changes after starting the drug and patient was enrolled in patient support program). Patient current condition was reported as pain. Other medical history was not reported. Concomitant medications were not reported. On an unknown date, after receiving the treatment with XTANDI, patient developed first episode of fatigue. On an unknown date in Jul 2016 and Oct 2016, after receiving the treatment with XTANDI, patient developed fatigue (second and third episode). On an unknown date in Nov 2016, following the vaccination and after the administration of XTANDI patient developed soreness in the arm and achiness at injection sites. On an unknown date, following the vaccination and after the administration of XTANDI, patient developed bruising, depression, hot flashes, loss of appetite, joint aches and headache. On an unknown date, following the vaccination and after the administration of XTANDI, patient died due to unknown cause. Patient relevant lab tests and corrective treatment were not reported. The outcome of the events fatigue, Hot flashes, soreness in the arm and achiness at injection sites were reported as not recovered and the outcome of all the other events were not reported. It was not known, whether autopsy was performed to the patient. The patient wife assessed the causal relationship between the suspect drug XTANDI and with the event soreness in arm as not related. List of documents held by sender: none. Sender's Comments: The patient died post vaccination with influenza vaccine (Mfr Unk) and Pneumococcal vaccine. Time to onset was not reported. Patient had an ongoing medical condition of prostate cancer with metastasis and metastatic castrate resistant prostate cancer for which he was being treated with XTANDI. No autopsy results were available. Reported events may be related to preexisting medical condition which could have as well resulted in death. Based upon reported information the role of the vaccine cannot be established. Autopsy report confirming the cause of death is required to further assess the case. Reported Cause(s) of Death: Deceased.
DEATH; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 02-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date in MAY-2021, she died from unknown cause of death. It was reported that, patient's obituary news was on paper on 17-MAY-2021. It was unspecified that if the autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0- 20210634485- Covid-19 vaccine ad26.cov2.s-Death.This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
On 03-27-2021, did not feel well. I thought it was something I ate, felt very gassy. It progressed by Tuesday night, I was up all night with pain and cramping.  I also noticed since receiving my Moderna vaccine I have noticed my arthritis flare up, my finger joints and hands tend to be more irritated and painful.  I continue to have joint pain and stomach cramping .  I also visited my PCP who gave me medication, Cipro and Flagil medication.  I feel side effects are being under reported.
The evening of the same day the pt received the shot she noticed a rash. The next day the rash was worse and she had a fever, the following day she went in for treatment, MD suspected cellulitis.
2JUN97 strep ATB-amoxicillin x 10days;18JUN97 fever to 102 & vomitting 1x episode;exposed @ church nursery-25JUN97 break through chicken pox started 9 pox all but 2 crusted over by 2JUL97 confirmed by MD 30JUN97;
A legal complaint was received from an attorney concerning a male child who received HibTiter on an unspecified date (s) "in or about" 1994. Relevant medical history was not provided. Additional suspect vaccines included Acel-Imune and Engerix B administered on unspecified date (s) "in or about" 1994. Concomitant medication were not reported. It is alleged that as a result of cumulative of mercury in the thimerosal containing vaccine (s), the child developed "toxic" neurological effects of mercury poisoning including but not limited to autism. The reporter indicated that the "first onset of symptoms of the minor plaintiff's vaccine-related injuries occurred prior to 36 months from 2/17/03." The legal complaint states that "the last significant aggravation on the minor plaintiff's vaccine-related injuries occurred prior to 36 months from 2/17/03." Mercury poisoning and autism were considered medically important (OMIC). No additional info was available at the time of this report.
Sinus infection; blood coming out of her nose; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection), EPISTAXIS (blood coming out of her nose), PYREXIA (Fever) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concomitant products included LISINOPRIL, ATORVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 08-Feb-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills).   On 22-Feb-2021, the patient experienced SINUSITIS (Sinus infection) and EPISTAXIS (blood coming out of her nose).   At the time of the report, SINUSITIS (Sinus infection) and EPISTAXIS (blood coming out of her nose) outcome was unknown and PYREXIA (Fever) and CHILLS (Chills) had resolved.      No treatment information was provided.
This is a continuation of worsening conditions since last report on October 12,2021. I have increased blindness of my right eye. I had consultation with nerve disease specialist. I met with the Optical specialist on October 16, 2021 doctor diagnosed me with post vaccination uveitis with possible herpetic opportunistic infection of the right eye.
After injection patient became pale, diaphoretic, and hypotensive.  Patient placed on gurney in Trendelenburg position. Serial vitals taken as patient recovered.  Water given.  When recovered patient went home with family.
8/6/18 Patient went to an urgent care facility complaining of painful rash on face and scalp which began 8/3/18. Attending physician diagnosed her with shingles after completing physical exam and prescribed Valtrex and Folgard Rx.
Information has been received from a licensed practical nurse (LPN) concerning a retired 77 year old female with asthma, aortic stenosis, paroxysmal atrial fibrillation, left ventricular hypertrophy, coronary artery disease, and elevated cholesterol, who was vaccinated with Zostavax (Oka/Merck) (lot#"6743U"). The patient developed a mild case of shingles after having been vaccination with Zostavax (Oka/Merck). The patient was seen in the office and ordered valacyclovir hydrochloride (VALTRIX). Additional information received from a nurse practitioner reported that the patient developed a rash on 04-SEP-2007, and was seen on 07-SEP-2007 for shingles. Treatment included famiciclovir (FAMVIR) and deltasone (PREDNISONE). It was reported that the patient had recovered. No product quality complaint was reported. No further information was available. The patients shingles were considered to be an other important event by the reporter. Additional information is not expected.
Psoriasis/SEVERE Psoriasis covering her entire body from her Toes to the Scalp; This is a spontaneous report from a contactable consumer (patient's daughter/caregiver). An 88-year-old female patient received bnt162b2 (BNT162B2, Lot number was not reported), dose 2 via an unspecified route of administration in Mar2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 in Feb2021 as single dose for COVID-19 immunization. In Apr2021 the patient was diagnosed with Psoriasis (which she had never had prior) this subsequently went to severe psoriasis covering her entire body from her toes to the scalp. The outcome of the event was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.