chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchy; eruptions of new vesicles; Suspected vaccination failure; symptoms of Shingles/Shingles; This serious case was reported by a nurse and described the occurrence of vaccination failure in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In OCT-2020, the patient received the 2nd dose of Shingrix (left arm). In JUL-2020, the patient received the 1st dose of Shingrix (left arm). On 30-AUG-2023, 3 years after receiving Shingrix and more than 2 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: symptoms of Shingles/Shingles). On an unknown date, the patient experienced pruritus (Verbatim: Itchy) and vesicular eruption (Verbatim: eruptions of new vesicles).The patient was treated with valaciclovir (Valacyclovir) and antivirals nos (Antiviral (Drug Name Unknown)). The outcome of the vaccination failure was unknown and the outcome of the shingles, pruritus and vesicular eruption were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and vesicular eruption to be related to Shingrix and Shingrix.   It was unknown if the company considered the vaccination failure, shingles, pruritus and vesicular eruption to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 06-SEP-2023 and 08-SEP-2023 The reporter was a retired nurse called to report that she developed a significant case of shingles almost three years after receiving her Shingrix. The reporter reported that the shingles were on her left trunk and going around to the back midline. The most outbreak was on the front and just a small outbreak on her back.  The reporter reported that she was on her last dose of antiviral.  The shingles have not resolved, as some areas were still itchy.  She began to have symptoms of Shingles.  It was not a mild case and she continued to have eruptions for the next week.  The patient went on Valacyclovir within 72 hours but it did little to prevent more eruptions. The patient did not believe the reports that the vaccine was 90 percent effective in her age group. It was if it did nothing to reduce the severity or duration of the disease.  The patient was a week out now and she still had daily eruptions of new vesicles. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting.
Within about 1 hr of MMR + Varivax - developed abd pain - redness, swelling, itching of injection site - minimal wheezing, hives on face still. Rx Benadryl, Epi, Orapred, BP.
I have a dermal filler under my eyes and two days after getting the second shot of the Pfizer vaccine I woke up with eyes  very swollen .
can't work; hyperparesthesia; can't sleep; hasn't gotten any sleep for the last 2 nights; suffering; extremely frustrated; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (can't work), PARAESTHESIA (hyperparesthesia), INSOMNIA (can't sleep), SLEEP DEFICIT (hasn't gotten any sleep for the last 2 nights) and PAIN (suffering) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), HYDRALAZINE and LOSARTAN POTASSIUM (LOSARTIN) for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (can't work), PARAESTHESIA (hyperparesthesia), INSOMNIA (can't sleep), SLEEP DEFICIT (hasn't gotten any sleep for the last 2 nights), PAIN (suffering) and FRUSTRATION TOLERANCE DECREASED (extremely frustrated). At the time of the report, FEELING ABNORMAL (can't work), INSOMNIA (can't sleep), SLEEP DEFICIT (hasn't gotten any sleep for the last 2 nights), PAIN (suffering) and FRUSTRATION TOLERANCE DECREASED (extremely frustrated) outcome was unknown and PARAESTHESIA (hyperparesthesia) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: No specific follow-up information recorded. On 13-May-2021: AE start date and outcome, medical records of the pt On 14-May-2021: Email contained response only. On 11-Jun-2021: Non Significant Follow up
Bruising at injection site still remains on 9-26-20 (13 days post injection).
Intense migraine; severe vertigo; stomachache; This is a spontaneous report from a contactable Other HCP (patient herself). A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via intramuscular route, administered in right arm on 09Feb2021 11:00 (age at vaccination: 39-years) as dose 2, single for Covid-19 immunisation. The patient was not pregnant at the time of vaccination. Historical vaccine included first dose of BNT162B2 via intramuscular route, administered in right arm on 19Jan2021 11:00 AM (age at vaccination: 38-years) as dose 1, single for Covid-19 immunisation. Medical history was not reported. Patient had no known allergies. Concomitant medication included Sertraline 100 mg taken for unspecified indication. Facility type Vaccine was workplace clinic. Patient took no other vaccine in four weeks. On 10Feb2021 6:00 A.M patient experienced intense migraine, severe vertigo, stomachache. Patient did not have if Covid prior vaccination. She was tested for covid post vaccination. Patient underwent lab test which included nasal swab test, with unknown results on an unspecified date. No treatment was given for the adverse events. The outcome of events was recovering.   Information on the lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Hives and wheeze, nebulizer and Benadryl, orapred, treated in ER med center.
Patient received influenza vaccine 1/26/20. She reported to the pharmacy that she was still experiencing pain in her shoulder when she lifted her arm in March. She had not been evaluated by a doctor.
I experienced lymph nodes under my left arm, big red spots on my arm, tiredness, weakness and dizziness.
hasn't received a second dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose two years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: hasn't received a second dose yet).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 9-Oct-2023 Pharmacist had no records of the first dose of Shingrix, so no exact vaccination date or lot number was reported. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
vaccine administered to 17.5 year old; A spontaneous report was received from a Healthcare Professional, concerning a patient of 17.5-year-old and was administered the Moderna vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection.   On an unknown date, the pharmacy accidentally vaccinated a 17.5-year-old patient with the first dose of Moderna COVID vaccine.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of event, vaccine administered to 17.5-year-old was considered as resolved on an unknown date.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17.5 year old) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Pt recvd MMR vax on 12AUG91/HIBTITER & on 23AUG91 pt devel a rash; lab eval on 26AUG91 revealed WBC Count 3.5, granulocytes 21, lymphocytes 79, platelet count 248,000; hematocrit 35, hemoglobin 10.9, total lymphocytes 28;
About 10 minutes after receiving vaccine, pt felt tingling in tongue and felt swelling - was gone in 45-60 minutes so pt felt was her imagination - felt pain in shoulder on eve after shot the next day the arm was more painful and hurts in to left neck still painful today - No sign of problem @ injection site.
Vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (Lot number: ER8733) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious) with onset 06Apr2021, outcome "unknown", described as "Vomiting".  Additional information: Reported that she received the Pfizer vaccine today and tonight she was having, she was vomiting and wanted to know vomiting one of the side effects.  No follow-up attempts are possible. No further information is expected.
First night I had soreness where shot was injected; achy bone; cold sweats; fatigue. Second day I was fatigue and had body aches. Third day same symptoms as second day. Fourth day I had shortness of breath, nausea, vomiting, high blood pressure (171/112), headache, stomach cramping, back and chest pains. Went to emergency and Dr. diagnosed hyper-ventilation.  As of today, 11/4/2009, my symptoms still continue with shortness of breath, back and chest pain, and continues headache.
Patient woke up from nap covered in welts.  Reaction started on right quadricept.  He was fussy and refused to eat.
Hives, itchy, throat tightness. Given epinephrine and Benadryl by EMS at scene and transported to hospital for evaluation.
A bandage size bruise was revealed the evening after I received the vaccine and removed the bandage that had been placed over the injection site. My arm felt sore as expected. The odd thing about the bruise is that it stayed the same size and color for at least 3 weeks after the injection. At about the start of the 4th week, the bruise has started to resolve although it is still visible. The initial pain from the first dose was minimal and there was slight swelling that went away in a couple of days. No other remarkable symptoms to report, just a bruise that took a long time to resolve. Size of the bruise was about 3 inches long by 1/2 inch wide.
Pt had sudden onset urinary incontinence beginning the day after vaccination followed a few hours later by a fall and tonic-clonic seizure.  Unclear to wife if he fell first then had sz or starting seizing first and thus fell.  Wife started CPR but had return of spontaneous respirations by the time EMS arrived.  Inpatient for 6 days thereafter recovering from  hypoxia, etc.  DC 6 days later to acute rehab. Does have residual mild decrease in cognition relative to prior baseline.
Patient received a Pfizer second dose vaccine and the first vaccine was moderna. Patient had no symptoms and BP was 114/78 and 15 minutes later was 110/72. pulse was 70 and 15 minutes later 72. patient was kept for 45 minutes to monitor
patient felt fine but was itchy on neck. admistered benadryl and patient decided to leave after 20 more minutes of waiting
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 27-OCT-2015 the patient was vaccinated with an improperly stored dose of Gardasil 9 (0.5 ml; lot # K026247, expiration date: 29-JAN-2017; dose, frequency and route unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion 4 times. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius), Celsius conversion of the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 152, 30, -1.111111111 and R;  184, 29, -1.666666667 and R; 24, 33, .0555555556 and R;  320, 31, -0.555555556 and R; 224, 32, 0 and R. This is one of several reports received from the same source. Additional information has been requested.
Received Tdap IM Right deltoid. Within the hour after vaccine given Right axilla and area began to swell. Area remained swollen for several days. Parent notified health department on day #12 after shot given. Had not seen physician.
PATIENT DEVELOPED ARTHUS REACTION AT SITE OF INJECTION. PATIENT STATED IT IS TENDER AND WARM TO TOUCH AND SWOLLEN. PATIENT STATED THE SWELLING HAS GROWN LARGER SINCE RECEIVING THE VACCINE. VACCINE ALSO APPEARED TO BE GIVEN SUBCUTANEOUSLY RATHER THAN INTRAMUSCULARLY.
This is a spontaneous report from a Pfizer sponsored program "PRIVATE" support. This is a spontaneous report from a contactable consumer. A 78-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date was not reported), via an unspecified route of administration on 13Mar2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had schedule for 2nd dose scheduled on 05Apr2021 but he missed it because he was not feeling well then. Moreover, on 27Mar2021, he said that he was not feeling so good and he was ill for 4 days. He said that he experienced a lack of energy for 4 days. The outcome of the events was unknown. Clinical Course stated by Patient was "he took the first test [shot] and he is looking at the Covid-19 Vaccination Record Card for his first one and it has been a total disaster after the first one. Stated he doesn't want to go through the whole thing but he was ill and didn't feel well at the date of the second one. Reporter stated that was where things went wrong because people have been taking him all over the place trying to get his second shot. Patient stated he was at the point now where he can get the second shot. States his primary doctor went through his entire body looking for everything and he is clear. He stated now that he was clear, he needs to get second shot. Stated he was told to talk to the lady at the hospital and she said that he needs to get the information so that they can set him up for the second shot. Patient clarified that he had the first vaccine and he had no problem with it. States he was scheduled for a number of days after first shot for the second one but at the time the day before that he got sick and he couldn't go to it. States he has been trying to get someone to help him. States he is to the point where he can get an appointment for his second shot. States he has been going through this for 2.5 weeks now. Patient stated he knows where it is located in address. States he needs the phone number to make an appointment for the second dose. Stated this has been really frustrating and usually this is where things go wrong and he doesn't get the help he needs. Stated this was the first time someone has understood what he wants". No follow-up attempts are needed; information about lot/batch number cannot be obtained. Follow-up (21Apr2021): Updated information: Vaccination date and Clinical course of the patient was updated. Additional Information: Vaccination date was changed from 15Mar2021 to 13Mar2021. No follow-up attempts are possible. No further information is expected.
RN assessment: 1 inch swollen and discolored area to the back of arm with large circle of inflammation (approximately 3 inches). Patient reports itching not relieved with diphenhydramine. Pt did stated that she felt like her mouth was a little swollen. She bit the inside of her left lower lip (small whitish area on inside of lip). Pt stated that she feels like she has to chew differently. Pt also stated that last night a stabbing pain started on the inside of her lower forehead above her left eye. Resolved after a few days. Patient continued to use diphenhydramine capsules PRN. Rash and Injection site reaction with itching, possible facial swelling.
Reports shortness of breath BP: 171/86 Sp02: 99% HR: 98 Refused ER transport, seen and cleared by EMS
Very sore arm several days receiving Tdap that required ER visit with resulting antibiotic and anti-inflammatory treatment.
pt recv vax & approx 3-4wk later pt devel joint pain;the most recent info recv on 7JAN98 reports outcome of the pt as ongoing;
Intense muscle pain; excruciating headaches that wouldn't respond to aspirin/caffeine powders; felt feverish, although temperature was normal. Overnight began trembling with cold, despite room temperature above 80 degrees. Felt extremely weak, and occasionally nauseous. Duration approximately 36 hours. Felt absolutely normal by 4:00 am 6/13.
a 16 years old received Flublok Quadrivalent/ no AE; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case was linked to cases 2019SA304486 and 2019SA304487 (same reporter).  This case involves a 16 years old female patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient did not have any concomitant therapy.   On 10-Oct-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via intramuscular route in the left deltoid.  It was of actual medication error case due to inappropriate age at vaccine administration.  It was unknown whether adverse event was experienced or not.  Information on the batch number was requested.  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.
THE PATIENT RECEIVED THIS BIVALENT VACCINE BOOSTER DOSE 1 DAY AFTER THE POSTED EXPIRATION DATE OF THE LOT USED. THERE HAVE BEEN NO ADVERSE REACTIONS REPORTED.
pt recv vax 20OCT97 & exp pain & swelling @ the inj site, fever of 99.8 & had trouble sleeping;
Received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037k20a and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-370033 (E2B Linked Report).; Sender's Comments:  MOD-2021-370033:MOD21-159552 (Original Crosslinked Case)
She had abscess for 7-8 weeks. She couldn't lift her arm. It was sore, swollen, red. She had X-ray exam. She took Naproxen 500mg twice daily for 1 month.
An hour after vaccine high fevers of 103, vomiting, nausea, body aches, and migraines. On 10/8 my feet were really painful, burning and itchy. My toes began to turn red and getting really dry and cracking by my toe nails. I was given medrol steroids which helped symptoms clear, but then symptoms returned with increased sensitivity, pain, swelling, leg cramping and leg spasms, along with the redness.
7cm x 1cm area of erythema, warmth, swelling and tenderness right deltoid.
Patient began receiving chemotherapy for b-cell  lymphoma on 2/10/2021 prior to receiving 2nd dose of covid vaccine on 2/26/2021.  She presented to hospital emergency department with complaints of cough, slight shoortness of breath and intractable nausea and vomiting for 4 days (had received round 5 of 6 six days prior).  She was admitted to the hospital  with pneumonia and neutropenic fever on 5/12/2021.  She also tested positive for COVID-19 on 5/13/2021.
Pt started having fevers and chills. Said temp was up to 101.8 F. Said TYLENOL helped somewhat.
This spontaneous report as received from a Pharmacist refers to a patient of unknown age. The patient was vaccinated with M-M-R II on 09-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced expired vaccine used. No treatment information was reported. The outcome of expired vaccine used is unknown. Expired vaccine used is not related to M-M-R II. From lot 1481Z, which had expired on 11/03/2012. No adverse effect reported. No further information is available. Additional information has been requested.
heart has been racing; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart has been racing) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (heart has been racing). At the time of the report, PALPITATIONS (heart has been racing) outcome was unknown.            Action taken with drug is not applicable. No concomitant medication was reported. No treatment information was provided.