chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started screaming episode the day pt had 2nd DTP/HIB/OPV; lasted 6 hrs used APAP;
I had a breakthrough Covid infection after last booster. On Friday May 27, 2022, I noticed I was feverish on the way home. I had sniffles, sore throat, funky taste in my mouth and throat and very lethargic. I went to bed the next day early and slept for almost 12 hours. I have been staying at home and taking it easy.
ER VISIT C/O VOMITING NAUSEA ALSO REPORTING SIMILAR SYMPTOMS INTERMITTENTLY OVER PAST THREE DAYS-DISCHARGED HOME AFTER UNEVENTFUL ER WORK UP. RETURNED TO CLINIC FOR FOLLOW UP 11/14 AND REPORT OF INCREASING FATIGUE AND SIMILAR SYMPTOMS OVER PREVIOUS THREE WEEKS. ADMITTED TO HOSPITAL. RAPID DETERIORATION AND EMERGENCY XFER BY LIFE FLIGHT TO HIGHER LEVEL OF CARE> MULTIPLE ORGAN FAILURE > LIFE SUPPORT > SUBSEQUENT DEMISE 11/29 AT OTHER HOSP.
liquid adjuvant only used; administered liquid adjuvant only; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2022, the patient received Shingrix. On 11th November 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14 NOV 2022 Reporter's comment: Pharmacist called to inquire how to proceed. Should the patient be revaccinated. Reported they inadvertently administered the Shingrix liquid adjuvant component only without the lyophilized powder to a patient. The pharmacist confirmed vaccine was administered in their facility.  Additional supportive information: Reported they inadvertently administered the Shingrix liquid adjuvant component only without the lyophilized powder to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
at 4pm the same day my stomach was really hurting  and I was really tired with severe diarrhea. I went to bed at 8pm and woke an hour later at 9pm with a high fever of 102.2 I was shivering,  I was convulsing and hyperventilating so I was having trouble breathing. I was unable to take any medication because I wasn't fully alert at the time my husband got my to take chewable Tylenol my fever broke at about 2am. the next day I had a severe headache and muscle aches and bad back pain and still had diarrhea. It is not the 24th and my back is still hurting and my stomach hurts I'm still having diarrhea and am breathing like I ran a marathon.
Adverse Event - 2nd Injection Shot given 12N 02/24/2021 02/25/2021 Awoke 2AM - my entire body hurt with intense pain which lasted and slowly decreased during the day. Slept thru the night - still hurt but not as bad. Some tightness in my chest thru the day. Pain slowly lessened to achiness. I had lingering pain in my hands and achiness in my muscles. Saturday 2/27 Continued to feel off Evening - Pain under injection arm - worse in evening Sunday - No fever. Some nausea with food No fever Some nausea with food lasted for at least 2 weeks more Some tightness in my chest persisted. Have been using Advair HFA inhaler 2xday
Slight tingling sensation and slight tension of the upper lip that resolved  after 10 minutes.
urticaria, angioedema, joint pains, difficulty breathing; 2 wks p/post exposure dose pt hospitalized & given Epi;
Woke up the day after the vaccine with a buzzing in my head. It?s been two weeks and buzzing hasn?t subsided.  Refuse to get the second dose. Afraid the buzzing will get worse and louder.
Body pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body pain) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MYALGIA (Body pain) and PYREXIA (Fever). At the time of the report, MYALGIA (Body pain) and PYREXIA (Fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported   No treatment information was provided   This case was linked to MOD-2022-441951, MOD-2022-441961 (Patient Link).
After administration of PREVNAR 13, a pneumococcal immunization, patient became extremely lethargic, left eyelid was drooping, severe pain in legs and white count increased to 19,000. The immunization PREVNAR 13, was administered June 11, 2014 and as of July 16, 2014, the patient is starting to recover. This event was reported to Immunologist, whose practice administered the vaccine. A message was left for the manufacturer of PREVNAR 13, Wyeth Pharmaceuticals. Please note the lot number of the PREVNAR 13 was H45391, expiration, May 31, 2015.
Patient is fully vaccinated as on 02/03/2021 with Pfizer and contracted COVID, tested positive on 9/15/2021.
Fever 103, chills, feel very hot and very cold at the same time, no sting to get up, dizziness. This is a booster #3 and already happen with the second booster on 03/03/2022.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 55-year-old male patient who received SHINGRIX for prophylaxis.  Previously administered products included Tetanus vaccine with an associated reaction of lymphadenopathy (approximately 30 years ago, he got a Tetanus shot (unknown manufacturer)) and SHINGRIX with an associated reaction of influenza like illness (For the tolerability of 1st dose, refer case US2018188644 reported for same patient). On 11th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In October 2018, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms, hot flashes, chills, enlargement of lymph nodes and tingling sensation. On an unknown date, the patient experienced pain. The patient was treated with paracetamol (Tylenol). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the influenza-like symptoms, hot flashes, chills and pain were recovered/resolved and the outcome of the enlargement of lymph nodes and tingling sensation were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, hot flashes, chills, pain, enlargement of lymph nodes and tingling sensation to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in right arm and experienced flu-like symptoms, hot flashes, chills, and aches. The patient stated that he took Tylenol for these symptoms. The patient stated that 2 days after receiving the 2nd dose, he noticed that the lymph nodes under his right armpit were swollen.  The patient also noticed a tingling sensation from his right elbow to his right shoulder.
Likely kidney stone, intermittent severe pain in left flank, cleared up in three weeks.
4/8/2021- red, warm, and swollen injection site, slightly itchy, acetaminophen taken for pain. 4/9/2021- picture evidence, slightly more itchy this day. Days since, swelling has gone down, still slightly warm, no longer painful.
Severe whole body rash with intense itching. Deep red coloration. Peeling skin. Torso, thighs, back, buttocks, arms hands and face. Rash and itching began on day 4 after second Moderna shot. Peeling of skin started on or about day 8 or 9.
Patient reported fever, chills, body aches, fatigue and dizziness within one hour of receiving the flu shot. No redness or swelling at injection site.
Shortness of breath in the early morning, and lasted about 3 hours. The symptom woke me up from sleep, and it's pretty intense that I was gasping for air at some point.
Tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for Covid-19) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011I20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Dyslipidemia.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for Covid-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, COVID-19: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: addt'l info uploaded
At 4am this morning woke up with headache, chills, nausea, slight fever, joint pain, muscle pain.   Had COVID and bacteria pneumonia back in October   Spoke with doctor this morning and said the symptoms were not unexpected. Doctor encouraged to file VAERS report.
EXPIRED VACCINE ADMINISTERED FROM THE VIAL AFFECTED DUE TO TEMPERATURE EXCURSION; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 71 year old male. 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: 1808986, expiry: 02-OCT-2021) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-JUN-2021, the patient experienced expired vaccine administered from the vial affected due to temperature excursion. On 21-JUN-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine administered from the vial affected due to temperature excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915719, 20210915661, 20210916715, 20210917163, 20210916907, 20210916553, 20210916768, 20210917515, 20210917226, 20210916697, 20210916910, 20210915852, 20210915646, 20210916965, 20210915623, 20210915731, 20210916228, 20210916312, 20210916697, 20210915748, 20210916415, 20210916455, 20210916520, 20210916584, 20210916658, 20210916808, 20210916811, 20210916849, 20210916959, 20210916465 and 20210916300.
HPI: Mother called last night. She said that child developed Mother reports he has rashes on lower back and legs. She noticed the rash yesterday morning at around 8 am. She reports that BENADRYL (4ml) has helped slightly. ROS: Reports itchiness. Denies fever. Denies swelling or pain at injection site (left deltoid). Denies vomiting, nausea, and diarrhea. No eruption near injection site. PE: Well-appearing well-hydrated patient in NAD. 3 cm x 6 cm ovoid red lesion on posterior lateral left thigh. Partially blanching with slightly raised border but not scaly. Proximal lower extremities and lower trunk have scattered red, ovoid lesions. Lesions are blanching, slightly raised, and 6x9 mm to 1.2 cm in longest dimension. These are not obviously aligned with Blaschko's lines. A/P: Pityriasis rosea (L42): Red ovoid, slightly raised lesions on trunk and lower extremities. Herald lesion on lateral left thigh indicates rash is possibly pityriasis rosea. Adverse reaction caused by viral vaccines. Can't ignore the coincidental timing. But also can't find a report of Pityriasis Rosea associated with flu vaccine.
This spontaneous report as received from a pharmacist refers to a patient who was administered an expired dose of PNEUMOVAX 23 (Lot # 672781/1706AA and expiration date 03-OCT-2013) on 06-NOV-2013. No adverse effects reported. Additional information has been requested.
Left arm started to itch on Friday night (1 week after vaccine).  Nothing was noticeable at that time.  Next morning around 9 am there was a red rash about 2" x 2" visible and it was itchy.  It lasted about 3 days and has now gone.
Information has been received regarding a case in litigation. A 39 year old female with no known allergies reported that on an unspecified date she was vaccinated with the second dose of GARDASIL. After receiving the second dose she broke out in a rash. In June 2007, the patient was vaccinated with the third dose of GARDASIL. After receiving the third dose, she broke out in a rash again and it was much worse. Also after the third dose, she started having recurring urinary track infection, nausea and headache. And she also reported she was having diarrhea and pains. At the time of this report, the patient's symptoms persisted. She sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.  1/23/09 Reviewed ER medical records of 5/24/2007. FINAL DX: Urinary anomaly Records reveal pt experienced frequency, pressure & rgency x 2 days.
swelling under eyes; This spontaneous case was reported by a health care professional and describes the occurrence of EYE SWELLING (swelling under eyes) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EYE SWELLING (swelling under eyes). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, EYE SWELLING (swelling under eyes) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   patient took ibuprofen as treatment and with in one week the event is resolved.
Developed altered mental status 2 hours post-vaccination, along with tachycardia/tachypnea.  Was seen in ED at Medical Center, found to be febrile.  Symptoms resolved with anti-pyretics.  Found to be positive for covid the following day
The patient was given a flu shot right near shoulder joint which was above the deltoid muscle on left arm. Even after 3-4 weeks, patient came to the pharmacy complaining about shoulder pain.
Small painful bruised, mild edematous nodule size of a dime to the left deltoid area.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 4:24 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 4:24 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Age of patient was reported as 42.11 for dose administered on 20-Mar-2021.  Batch number 031A21A underwent temperature excursion on 20-Mar-2021 with temperature 34 and 37 degrees Fahrenheit at 9 am to 10 am. This vial was moved to fridge on 09-Mar-2021 and beyond use date for the vial was reported as 08-Apr-2021. Product moved to clinic on 20-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degrees Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
PATIENT RECEIVED MORE THAN THE RECOMMENDED DOSES OF COVID-19 VACCINE. THE MODERNA SERIES WAS ADMINISTERED ON 3/20/2021 AND 4/17/2021, THEN THE PFIZER SERIES WAS ADMINISTERED ON 4/20/2021 AND 5/11/2021.
Information has been received from a paramedic concerning a patient who on an unspecified date was vaccinated with a first dose of ROTATEQ vaccine live (human-bovine) at 14 weeks of age. There was no adverse event reported. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
I had a Covid vaccine on 1/10/21 and mammogram on 1/15/2021. The technical called on 1/22/21 to make another appointment for 2nd mammogram on Feb 5, 2021. I was told that something was found on my left breast near the nipple. I realized I had pain in the area and it didn?t go away.  I had the Covid vaccine shoot in my left arm.  I as terrified and went to the appointment on 2/5/21 and the doctors told me I had a benign cyst under the skin on my left breast that hurt a lot. I went for 2nd vaccine even though I still had a cyst on my left breast. The cyst was under the skin. The cyst finally went away 2/14/21, today. I realized on 2/5/21 when I went to for the 2nd mammogram, I was confused and told the technicians I had it for a while but actually the cyst started after I had the first vaccine.
No additional AEs were reported; The nurse stated that a patient received an expired PROQUAD on 06/16/2022; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 16-JUN-2022, the patient was vaccinated with the expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (therapy type was recombinant Human albumin) subcutaneous injection, 1 dosage form for prophylaxis (lot #T034828, expiration date: 11-APR-2022, strength and route of administration were not provided) (expired product administered). The sterile diluent (manufacturer unknown) that was reconstituted with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot#T036815, expiration date 29-MAR-2023) was not expired. No additional adverse events were reported (not adverse event).
Myalgia, Fever, at injection site soreness, reddness, and warmth. c/o chills, fatigue,sob. Told to follow up with primary care physician. Narrative:
Feels like there are sand in her eyes; Eyes are burning, irritated every waking moment; Nose burning, irritated every waking moment; Tongue felt like it was burnt; Tongue started tingling; A spontaneous report was received from a consumer who was also a 75-years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who felt like there are sand in her eyes/foreign body sensation in eyes, eyes are burning; irritated every waking moment/eye irritation, nose burning; irritated every waking moment/nasal discomfort, tongue started tingling/paraesthesia oral, and tongue felt like it was burnt/tongue discomfort.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Fexofenadine hydrochloride.  On 05 Mar 2021, approximately couple of hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number: 027A21A) via unknown route for COVID-19 infection prophylaxis.  On 05 Mar 2021, couple of hours after receiving the vaccine patient's tongue started tingling all evening and the next day it felt like tongue was burnt. Patient's eyes and nose were burning every waking moment and were irritated. Patient also felt like there were sand in eyes.  Patient was eating the same thing and medications and detergent had not changed. The patient believed this was not an allergic reaction. Treatment for the event included benadryl for three nights but this was not working.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, felt like there are sand in her eyes, eyes are burning; irritated every waking moment, nose burning; irritated every waking moment, tongue started tingling and tongue felt like it was burnt was unknown at the time of this report.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Approximately 30 minutes after injection I had a metallic taste.  It lasted for about hour and half.  Also experienced a sensation of body flushing.  Kind of like when you receive a pain shot at the hospital, you feel the flushing sensation. That lasted about the same amount of time.  Slight sense of dizziness or spaced our with the body flushing.  The flush felt from my arms to legs.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Oct2021 at 13:15 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 06Apr2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: "High blood pressure controlled" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing); "mild asthma" (unspecified if ongoing); "Known allergies: All penicillin types" (unspecified if ongoing). Concomitant medication(s) included: VALSART, start date: 01Feb2017. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300251633 same patient, different drug/AE.;