chrisvoncsefalvay/vaers-outcomes huggingface dataset:
las year I get the shots, 3 weeks ago another episode/suspected vaccination failure; another episode; more painful then ever.; 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.   The patient's past medical history included shingles (had mild case about 10 years ago, with just few rashes, then 3 years later got again with horrible pain).   On an unknown date, the patient received Shingles vaccine. In November 2021, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that 3 years later of first outbreak got it again and had no rash, just the horrible pain, which lasted for few weeks. The patient was getting shingles every 2 or 3 years, no rash, just the horrible back pain and had feeling that something was crawling on back.  The patient reported that last year from reporting date his/her physician insisted to get the Shingle shots and the patient got it. 3 weeks ago, from reporting date, the patient experienced another episode of Shingles more painful than ever. The patient really believed if you never had the shingles, the shot was good, but for people that kept having it, it was not worth it, because the virus was in your body already, received shots or not. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting.
Pt here with mother who was not aware that pt had had H1N1 intranasal at school a few days prior and mother permitted pt to receive FLUMIST not knowing about prior H1N1 intranasal.
Child developed edematous, warm to touch & tender left leg from hip to knee. Started approximately 24hrs after immunizations given. Child required MD visit where mother reports he was given Benadryl, & a 7 day course of medicine. Mother believed the medicine was Amoxicillin. The leg had decreased swelling starting on 5/2/04
PATIENT NOTICED SWOLLEN LIPS DURING THE EVENING THE SAME DAY PATIENT RECEIVED VACCINE. PATIENT TOOK BENADRYL WHICH HELPED BUT WHEN PATIENT WOKE UP THE NEXT MORNING SWELLING WAS BACK. PATIENT CALLED PHARMACY TO REPORT REACTIONS, SHE WAS ADVISED TO REPEAT BENADRYL AND CALL HER DOCTOR. PATIENT WAS ABLE TO MAKE APPOINTMENT WITH DOCTOR THAT DAY TO BE SEEN. ANY FURTHER OUTCOME IS UNKNOWN.
Day 2 tired, Day 3 and 4 headache, Day 5 and 6 - intermittent eye twitch with ocular migraine symptoms in right eye.
Dizzy spells; Cold chills; Muscle aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy spells), CHILLS (Cold chills), MYALGIA (Muscle aches) and PYREXIA (Fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 026B21A) for COVID-19 vaccination.     The patient's past medical history included Muscle ache (muscle ache due to past accident).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced DIZZINESS (Dizzy spells), CHILLS (Cold chills), MYALGIA (Muscle aches) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency; GUAIFENESIN (MUCINEX) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 08-Mar-2021, CHILLS (Cold chills), MYALGIA (Muscle aches) and PYREXIA (Fever) had resolved. On 15-Mar-2021, DIZZINESS (Dizzy spells) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, SARS-CoV-2 test: negative (Negative) tested negative for covid-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications provided ice pack was used for treatment.   This case was linked to MOD-2021-116387.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Added demographic details(DOB), Added event(pyrexia), treatment drug and updated event stop date
On Wednesday 13Apr I took a home covid test and tested positive for covid.; On Wednesday 13Apr I took a home covid test and tested positive for covid.; This is a spontaneous report received from a contactable reporter (Other Health Professional). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. Patient had no known allergies. There were no concomitant medications in two weeks. Prior to vaccination patient was not diagnosed with COVID-19.  Patient has not received other vaccine in four weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Apr2022 at 16:45, outcome "recovering" and all described as "On Wednesday 13Apr I took a home covid test and tested positive for covid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Apr2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment with home rest and over the counter medication.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information  a causal relationship between the reported events and suspected drug BNT162B2 cannot be excluded
I woke up the morning after my shot with the "typical" symptoms after my previous 3 shots: achy, chills, a little soreness in injection site.  Just overall felt crappy.  By mid-afternoon my gut and bladder discomfort started.  I ate a light meal with little roughage.   The majority of my diet is usually plant based.  By the next morning my pain in my gut and bladder woke me up early.  The night before I had to get up and urinate a lot (the urge to urinate, but not a lot of urine came out:  my bladder felt really irritated, but not like a true bladder infection.  It hurt to bear down to urinate, not the gripping pain at the end of voiding.  My gut was really distended, I had a lot of gas.  Burping, passing gas, and bowl movements helped alleviate the pain temporarily.  The pain was all anterior and below the umbilicus, in both the gut and the bladder, and very sharp.  No nausea, vomiting, nor diarrhea.  My stools were normal consistency, but lower in volume because I could not even look at any raw fiberous food.  My fever was 100.3.  By day 4 (yesterday), my fever was coming down and the sharpness was lessening.  My fever broke last night, and all symptoms are gone except mild discomfort in  my gut and bladder.
Case number PHEH2011US009469 is an initial spontaneous report received from a consumer on 11 Nov 2011: This case refers to unknown age and gender patient. This patient was vaccinated with MENVEO (batch number: unknown) intramuscularly on unspecified date in Aug 2011. Few days later patient experienced darker, discolored at injection site that was three to four inches in circumference. At the time of reporting discolored area still persists but faded to some degree. Outcome reported as ongoing.
UTI symptoms developed a few days later. Problems when urinating. Started drinking cranberry juice and contacted my doctor via message board. She didn't think it was an adverse reaction to the vaccine even though I haven't had a UTI in over a decade and prescribed a three day regiment of antibiotics which ended last Wednesday.   Symptoms have gone away and am currently monitoring it.
Information has been received from a registered nurse referring to unspecified patients of unknown ages and genders. Since October 2014 the patients were vaccinated with doses of improperly stored ROTATEQ (oral, lot#, dose and frequency were unknown). No adverse effects were noted. It was unspecified if the patients sought medical attention. This is one of the several reports received from the same reporter. Additional information has been requested.
Elevated adverse reaction; This spontaneous case was reported by a pharmacist and describes the occurrence of ADVERSE REACTION (Elevated adverse reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Elevated adverse reaction). At the time of the report, ADVERSE REACTION (Elevated adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication use was provided by the reporter.  Treatment of events was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Non significant follow up received on 25-06-2021. contact information provided.
No menstrual cycle bleeding for two months after first vaccination.  Now irregular cycles (5/26/2021 and 6/15/2021.  Had previously been regularly experiencing menstrual cycles (28 day interval with 3-5 days typically of menstruation, last 2 menstruations prior to vaccination 1/27/2021 and  3/2/2021) after birth of second child and continuously taking progesterone only OCP.
Once I received the shot and went to my car I noticed I had a rash on my face so I immediately took benadryl. When I woke up the next morning I was extremely dizzy and fell in the shower.  It was more than just being dizzy it was like I couldn't see and it was hard to pick myself up.  I may have fainted because I didn't recall falling just noticed I was on the shower floor.  I thought I had gotten up but then again I was still on the floor.  I made it back to bed and slept for a few hours.  After that I seemed fine.
Within a couple of minutes of getting the booster, I began developing hives on my neck and my face. My doctor gave me some Benadryl. It subsided after 2hrs. The itching lasted a couple of days. I went back to the doctor 3 days later because of the itching. The itching cleared up within 2 weeks.
24 hrs after receiving INFLUENZA vaccine, around 7 pm, (L) arm was swollen, red, hives, hot to touch. Dizziness and SOB.
Hives on neck, back, R arm approx 25 minutes after shot given. No difficult breathing or facial swelling. Hives stabilized after about 30 minutes and still present at time of reporting at 90 minutes post injection.
Passed out after leaving immunization clinic room.  BP check 5:35 96/58; 5:40 104/64; 5:45 106/70; Sitting position 5:50 110/62; 5:55 104/62
Terrible headache, advised to take Tylenol or ibuprofren if not allergic to same- unknown outcome at this time.
45min of inconsolable, high pitched crying secondary to DTAP given earlier;local rxn w/tender, erythematous knot lt thigh;
0.1cc IM partial dose administered. Within minutes pt complained of throat tightness & breathing difficulty. Administered Epinephrine 1:1000 0.5cc IM x 1, BENADRYL, ZANTAC & prednisone. Sx slowly resolved & pt was discharged in good condition without rest of flu shot.
Patient came in for 2nd IPOL vaccination. About 1 week after injection patient noticed itchy rash on arm. Informed the pharmacy another week later 7/19/2018 and said that it has not gotten any better and has spread down leg. No pain or inflammation-Just itchy rash.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from License Party. Other Case identifier(s): US-BRISTOL-MYERS SQUIBB COMPANY-2023-099919 . Information was received from a Consumer/other non-health professional concerning an 82 Year(s) old Male patient, who received Suspect product APIXABAN (Tablet) via Oral (5 milligram(s) 2 every 1 Day) for prophylaxis stroke, lot number: Unknown; Suspect product COVID-19 VACCINE for Product used for unknown indication, lot number: Unknown. The patient received apixaban with strength of 5 mg. On 06-Sep-2022, the patient had covid-19 (covid-19), which was considered non-serious. Treatment was not provided. The outcome of the covid-19 was unknown. The patient died on 01-Oct-2022. It is unknown if an autopsy was performed. The action taken with APIXABAN medication was unknown. The action taken with COVID-19 VACCINE medication was unknown. Medical history and concurrent conditions included clot blood, fall, neck injury and atrial fibrillation. Past therapy included Warfarin. Concomitant medications were not reported. Relevant Laboratory and amp; other Diagnostic Tests On an unknown date, EKG: Diagnosed blood clots, MRI: Diagnosed blood clots. The reporter did not provide a causality assessment for event covid-19 to APIXABAN. The reporter did not provide a causality assessment for event covid-19 to COVID-19 VACCINE. The following Case IDs are linked to this patient: 2022-129212. Tracking of Changes: 10-Jul-2023: Initial information was received.   Eliquis is under agreement. Sender's Comments:Causality Assessment: COVID-19 was related to Apixaban and COVID-19 VACCINE..  Pfizer Comment: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Linked Report(s) : US-PFIZER INC-202201273191 Same reporter, Same patient, different events. Reported Cause(s) of Death: Clot blood.
3/16/21 @ 1600 Diarrhea  3/17/21 @ 0300 - 0330 Woke up with body shaking uncontrollably. Teeth Chattering. Jaw started to Lock. Shortness of breath. Body and joint aches. Face started to get numb. Self administered Tylenol, Albuterol inhaler, and alprazolam. Called 911 around 0345-0400, to report and get help. While on the phone with 911 operator, body started to calm down and shaking subsided. Shortness of breath still present. Notified operator that I will wait, and if symptoms become worse then I will call back for help to Hospital. 03/17/21 temperatures 100.8 to 101.0 throughout the day. Tylenol taken 650 mg every 4-6 hours. Also body and joint aches. Headaches. Difficulty walking. Fatigue.  03/18/21 0600 body aches, fatigue, and headache. No Fever.
The symptoms started immediately as far as the pain in the upper arm muscle. I tried to work it out and it got worse in the evening. Next morning i was achy all over and with a low grade fever, had soaking wet sweats at night as I was perimenopause. Hip and back pain but I'm also arthritic so I guess that's all part of it. I saw the Endocrinologist and was told that I have Levaquin syndrome and not to get an antibiotic in that category and to add that as a severe allergy.
she says it started getting pale; warm to the touch; red circle about 5 cm from injection site; one edge was swollen; bruise on the arm; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PALLOR (she says it started getting pale), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE BRUISING (bruise on the arm), MYALGIA (sore arm) and VACCINATION SITE ERYTHEMA (red circle about 5 cm from injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DILTIAZEM, LISINOPRIL, LEVOTHYROXINE, ACETYLSALICYLIC ACID (BABY ASPIRIN) and ATORVASTATIN for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE BRUISING (bruise on the arm) and MYALGIA (sore arm). On 23-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE ERYTHEMA (red circle about 5 cm from injection site) and VACCINATION SITE SWELLING (one edge was swollen). On 24-Feb-2021, the patient experienced PALLOR (she says it started getting pale). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. On 12-Feb-2021, VACCINATION SITE BRUISING (bruise on the arm) and MYALGIA (sore arm) had resolved. On 24-Feb-2021, VACCINATION SITE SWELLING (one edge was swollen) had resolved. On 25-Feb-2021, PALLOR (she says it started getting pale), VACCINATION SITE WARMTH (warm to the touch) and VACCINATION SITE ERYTHEMA (red circle about 5 cm from injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: On 02-JUN-2021, follow up document was attached which contains Outcome of event
SLOWLY STARTED LOSING TASTE /  TASTE DISAPPEARING QUITE A BIT / LOST TASTE OF SOME THINGS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient's smell was okay. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included amlodipine, atorvastatin, irbesartan, and metoprolol. On 2021, the patient experienced slowly started losing taste / taste disappearing quite a bit / lost taste of some things. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from slowly started losing taste / taste disappearing quite a bit / lost taste of some things. This report was non-serious.
a little bit of itching; kind of hives; uncomfortable at times, at his feet, and ankles; he has rashes; terrible skin; This is a spontaneous report from a contactable consumer (reporting for himself). A 79-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiration date: unknown), via an unspecified route of administration from 09Jan2021 to 09Jan2021 at single dose for COVID-19 immunization. The patient's medical history Ablation surgery. The patient's concomitant medications were not reported. On an unspecified date, the patient had a little bit of itching, kind of hives, he did not break out, he was uncomfortable at times, at his feet, and ankles. The patient has rashes, and terrible skin. The outcome of the events was unknown.
After my 2nd shot I got covid19 for the 2nd time; After my 2nd shot I got covid19 for the 2nd time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "After my 2nd shot I got covid19 for the 2nd time".  Clinical course: Patient reported covid-19 vaccine don't work very well just over 2 years since patient had covid-19. A year later patient got vaccine. Within 6 or 8 months after patient's 2nd shot patient got covid19 for the 2nd time. Not really happy about it.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No adverse effect reported.; a patient was administered a dose of improperly stored MMRll that was reconstituted with Merck DILUENT that did not undergo an excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, concurrent condition, drug reaction/allergy and concomitant medication was not provided.  On 06-NOV-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # S005249, expiration date 20-FEB-2021; vaccine dosage detail was not reported) subcutaneously for prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was reconstituted with properly stored sterile diluent. The storage temperature of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was above 47 Fahrenheit (46.9 Fahrenheit) for 37 minutes. There was no previous temperature excursion. No adverse effects reported. Data logger was involved.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 58-year-old female patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 27Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "lactose intolerant to ice cream" (unspecified if ongoing). Concomitant medication(s) included: ALKA SELTZER [ACETYLSALICYLIC ACID], start date: 07Jun2022, stop date: 19Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: previously tested negative on Day 7; Positive, notes: Paxlovid Rebound; Tested Positive again on Day 10. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: COVID 19 Treatment: Paxlovid, treatment start date-06Jun2022 and stop date-10Jun2022. On 16Jun2022, Paxlovid Rebound; Tested Positive again on Day 10 and symptoms appeared again and they were not mild; previously tested negative on Day 7 and had started to improve. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.