chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pulmonary Embolism Narrative: Patient was hospitalized with acute pulmonary embolis on 2/12/2021. Was started on Eloquis and discharged on 2/15/2021, with primary diagnosis of acute PE and BLE DVT. Secondary diagnosis of acute systolic heart failure with bilateral pleural effusions. On 2/17 we got notification that patient was placed on hospital.
red, painful, inflamed face. Started 6/11/20 afternoon. Pt states he was in a house working 6/10/20-6/11/20 and out of the sun. Patient states rash got progressively worse. Patient is still experiencing symptoms. He wakes up due to pain, showers, exfoliates face and has not been using lotion. Pain has not improved.
The day after the vaccine I got the usual symptoms for 36 hours. Four days after the vaccine I developed a slight cough. The cough got worse, and I had green sputum. After ten days I contacted my doctor and he prescribed antibiotics. It cleared up a little, but it was persisting. I was tested for Covid-19 and the test was negative. I had the cough for almost three weeks. I developed a weird bruise on my right forearm the size of a silver dollar. It was round and it took a couple of weeks to go away. My arthritis in my hands was also worse than normal for the three weeks.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 24-MAY-2018, the patient was vaccinated for prophylaxis with M-M-R II lot number N014482, expiration date 10-MAY-2019 (strength, dose number, anatomical location, route of administration) and VARIVAX lot number N028715, expiration date 13-OCT-2019 (strength, dose number, anatomical location, route of administration). Both vaccines were reconstituted with 2 separate MENACTRA instead of Merck diluent.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 24-JUL-2017, the patient was vaccinated with a dose of VARIVAX as prophylaxis and a dose of PROQUAD as prophylaxis (Strength, dose, route, lot numbers and expiration dates were not reported). The patient's concomitant medications included sterile diluent (manufacturer unknown). No adverse symptoms were reported.
not sure how much the patient got; This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 3-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number Z3Mk7, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th September 2021, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On 14th September 2021, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received Flulaval quadrivalent in left thigh. The licensed practical nurse called in to reported that, they administered Flulaval to a 3 year old patient getting a booster for new flu season. The reporter ststed tah, the patient moved during administration of vaccine and they were not sure how much of the vaccine the patient got. It leaked out due to patient moving and jerking leg, not due to syringe, which led to  incomplete dose administered. The reporter did not consent to follow up.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 11-FEB-2019, the patient was vaccinated with improperly stored PEDVAXHIB (1 injection, via intramuscular, lot # reported as: R0123571, expiration date: 19-MAR-2021; strength and anatomical location were not reported) for prophylaxis. No adverse effect was reported. The PEDVAXHIB was exposed to 0 degree Celsius for 45 minutes. There was no previous temperature excursion. The data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA008818: US-009507513-1903USA006922: US-009507513-1903USA006923: US-009507513-1903USA006924: US-009507513-1903USA006925: US-009507513-1903USA006926: US-009507513-1903USA006927: US-009507513-1903USA006928: US-009507513-1903USA006929: US-009507513-1903USA006930: US-009507513-1903USA006931: US-009507513-1903USA006932: US-009507513-1903USA006933: US-009507513-1903USA006934: US-009507513-1903USA006935: US-009507513-1903USA006936: US-009507513-1903USA006937: US-009507513-1903USA006938: US-009507513-1903USA006939: US-009507513-1903USA006940: US-009507513-1903USA006941: US-009507513-1903USA006942: US-009507513-1903USA006943: US-009507513-1903USA006944: US-009507513-1903USA006945: US-009507513-1903USA006946: US-009507513-1903USA006948: US-009507513-1903USA006949: US-009507513-1903USA006950.
Caller diagnosed with a UTI following first vaccine dose; This is a spontaneous report from a Pfizer Sponsored Program from contactable female consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date were not reported) via unspecified route of administration on an unknown date as 1st dose single dose for Covid-19 immunization. Medical history and concomitant medication were not reported. On an unspecified date, consumer reported that she was diagnosed with a UTI following first vaccine dose of Pfizer COVID-19 Vaccine and placed on an antibiotic. Her second covid vaccination dose was scheduled for next Wednesday on 10Feb2021 and she was worried about a possible interaction when taking the antibiotic and the covid vaccine together and asked should she stop her antibiotic or do she reschedule the second dose of the vaccine. Also Stated that the fact sheet said do not take any other vaccinations, but her doctor put her on this antibiotic. She had to go to the doctor because she had a UTI. She was starting on antibiotic Cefuroxime 500mg for 10 days for the UTI. The lady where they are having the vaccinations told patient that she could put her second dose of Pfizer COVID-19 Vaccine off until the 15th; that they had gotten something from Pfizer or CDC or somewhere that said the second dose of Pfizer COVID-19 Vaccine could go 5 days longer than the 21 days if necessary. She asked if that information was correct and will be taking her second dose of the vaccine next Wednesday.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
This is a former 26 weeker by dates male infant in an open crib in RA.  The infant has been nippling all feedings for 7 days.  Theophylline has been discontinued since 7-16-03.  The infant has a history of apnea/bradycardia  X 1 event/day.  The infant received immunizations on 7-25-03 at 1500.  At 2000 on 7-25-03 the infant was noted to be fussy with poor feeding.  At 2400 7-26-03 the infant did not feed well and had 2 bradycardic episodes and emesis.  The infant continued to have multiple bradycardic episodes with oxygen required.  On on 7-26-03 at 2420 a CBC was ordered along with Tylenol(not given).  At 0125 a NC was started and at 0200 a CBG, blood culture and urine culture were obtained.  Antibiotics were started.  At 0225 NCPAP of 6cm was started at 21-30%.  At 0245 a OGT was placed.  At 0250, a PIV was started for antibiotic administration.  The infant began to receive gavage tube feedings.  At 0850, the infant was weaned to NC and a CXR was obtained.  The infant remained on a NC X 2 days.  On 7-27-03 at 1200 pm, the infant received a dose of lasix.  On 7-28-03 the NC was discontinued, as well as the antibiotics.
Following discharge, after 15 min monitoring, pt. c/o dizziness.  B/P was taken 124/64, monitored further until 12:40 PM.  No further issues.
02/01/22 presents to ED for "Shortness of Breath,  Leg Swelling". PMHx of "significant for right hip arthroplasty (1/11/22)"
Black out like feeling; Sweating; Bad adnominal pain; Felt double over pain in stomach; Thirstiness; Fatigue; Headache; Nausea; Blurry Vision; Moody; Swelling in left armpit; This spontaneous report was received from a consumer concerning a female patient (age not provided) who experienced black out like feeling (feeling abnormal), blurry vision (vision blurred), moody (mood altered), swelling in left armpit (peripheral swelling), sweating (hyperhidrosis), bad abdominal pain (abdominal pain), felt double over pain in stomach (abdominal pain upper), thirstiness (thirst), fatigue, headache and nausea.  The patient's medical history includes allergies. No concomitant medications were indicated.  On 13-Jan-2021, at 9:30 AM, this patient received the first planned doses of mRNA-1273 (Lot/Batch number: Not reported) intramuscularly to the right arm for prophylaxis of COVID-19 infection.   On 13-Jan-2021, later that afternoon after her vaccination, this patient felt fatigue, blurry vision, headache, thirstiness, moody, swelling in left armpit and nausea. On 14-Jan-2021, at 2:00 AM, the patient had bad abdominal pain, nausea, sweating, black out feeling and felt double over in pain in stomach. A couple of days later all symptoms went away, except for swelling in left armpit. Her HCP (Health Care Professional) said it's okay for her to get the second dose.   Action taken with mRNA-1273 in response to the events was not provided/unknown.  The outcome for the events, black out like feeling, blurry vision, moody, sweating, bad abdominal pain, felt double over pain in stomach, thirstiness, fatigue, headache and nausea, is recovered. The outcome for the event, swelling in left armpit (peripheral swelling), is not recovered.; Reporter'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.
Developed chicken pox 07/02/2002, Diagnosis by PCP, Mom states @ least 150 lesion's on child's chest.
After she got vaccinated two days after that 14 Dec 2021, she got her labs done. Her sugar was high. This spontaneous case was reported by a patient and describes the occurrence of BLOOD GLUCOSE INCREASED (After she got vaccinated two days after that 14 Dec 2021, she got her labs done. Her sugar was high.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 prophylaxis.     Patient reported she had some other allergies too (Extensive list that is too long to report). The patient did not had COVID positive test or diagnosis.  Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE (She always gets the flu shot every year and and she never has a problem). Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE. Concurrent medical conditions included Diabetes (But her A1C is mostly under 7percent. She did not have to take diabetes medicine.), Drug allergy (Phenobarbital), Drug allergy (Dilantin), Allergy to antibiotic, Food allergy (Chamomile tea), Ragweed allergy and Blood pressure high.    On 14-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021, the patient experienced BLOOD GLUCOSE INCREASED (After she got vaccinated two days after that 14 Dec 2021, she got her labs done. Her sugar was high.). At the time of the report, BLOOD GLUCOSE INCREASED (After she got vaccinated two days after that 14 Dec 2021, she got her labs done. Her sugar was high.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Dec-2021, Blood glucose: high She got her labs done. Her sugar was high.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was provided by reporter. Treatment information was not provided.   This case was linked to MOD-2022-586371 (Patient Link).
administered a extra dose of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number J44K5, expiry date 30-NOV-2024) for prophylaxis.   Concomitant products included MENVEO.   On 29-SEP-2023, the patient received the 2nd dose of Menveo. On 29-SEP-2023, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: administered a extra dose of Menveo).  The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 29-SEP-2023 The nurse reported that 11 year old male patient was administered a dose of Menveo on and afterwards they realized that he had just received a dose on 31 August 2023 which led to extra administered. The nurse did not have lot number information for the first dose. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
Anthrax vaccine administerd 3/27/03.  Macular papular rash develop 3/29/03 on trunk, face and extremities.  Patient returned 4/7/03 with c/o erythema and severe itching on entire trunk and extremities. Also presented with flaking and peeling of skin at site of anthrax vaccination.  Patient referred to dermatology that day to r/o erythema multiforme.
temp of 99.2; feeling unwell; cold like symptoms; This is a spontaneous report from a contactable consumer(patient). A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date was not provided), via an unspecified route of administration on 05Mar2021 as 1 ST DOSE, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient stated that she has been feeling unwell, cold like symptoms and a temperature of 99.2. The outcome of the events was reported as unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Narrative: Pt convinced ADR is due to the vaccine. That nausea and excess salivation, started 6 months after Pfizer vaccine 3/21. Most likely due to semaglutide as no nausea on low dose but nausea following dose increase.
flu-like symptoms; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Positive) on 12-Dec-2020 and Transplant.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms) and PYREXIA (fever). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Tylenol.
Pt had a renal transplant in January 2022.  Pt has had ongoing issues with rejection and other medication adjustments.  Pt arrived to ER due to arthralgias, but denies any other COVID symptoms.  Pt was COVID-19 positive.
pt recv 2 doses of vax 8APR96 & 8JUN96 & lab eval 5AUG96 revealed a lack of seroconversion;
Dizziness, faint feeling, visited ER confirmed a tumor on the brain, referred to cardiologist.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Nausea-Mild, Systemic: Tachycardia-Mild, Additional Details: Upon administration of the vaccine, the patient expressed difficulty breathing, nausea and tachycardia. The pharmacy team prepared to adminsiter epinephrine and benadryl, however, upon speaking with the husband and the patient, it appeared to be more of an anxiety-related symptom. The patient refused to take benadryl due to concerns about breastfeeding. The patient stayed in the pharmacy for observation. Symptoms resolved within 30 minutes after sitting down and drinking water.
injection site itching; injection site redness; injection site hot to touch; injection site hardness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number GX25K, expiry date 30th November 2021) for prophylaxis.   On 28th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 29th June 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site warmth and injection site induration. On 1st July 2019, the patient experienced injection site itching. On 1st July 2019, the outcome of the injection site induration was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site induration and injection site itching to be related to Shingrix.  Additional details were received as follows: The patient received Shingrix on the left deltoid. Mention descipency regarding outcome.
Patient here for varicella vaccine to satisfy requirements. Patient informed me today that he DID in fact have chicken pox as a child, but denied having the disease at the first appointment.
Severe heart palpatations, occasionally my lips/hands would begin to turn blue, and experience pain for upwards of 3 minutes, and shortness of breath with minimal exertion.
rash at the injection site; diarrhea; fever blister in the left upper arm which erupted; felt very sick; arm was uncomfortable; arm pain; upper arm was swollen; itching across her chest and general back of the shoulder area; rash and itching across her chest and general back of the shoulder area; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th June 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site rash, diarrhea, pruritus, rash, fever blister, pain in arm, swelling arm, sickness and arm discomfort. On an unknown date, the outcome of the injection site rash and sickness were unknown and the outcome of the diarrhea, pruritus, rash, fever blister, pain in arm, swelling arm and arm discomfort were recovered/resolved.   It was unknown if the reporter considered the injection site rash, diarrhea, pruritus, rash, fever blister, pain in arm, swelling arm, sickness and arm discomfort to be related to Shingrix.  Additional details were provided as follows: The patient received shingrix in her left deltoid and had a terrible reaction. The patient experienced left whole arm pain for a week and the upper arm was swollen and the arm was uncomfortable for 1 week. There was rash at the injection site. The rash and itching across her chest and general back of the shoulder area for 1 week or longer and she had fever blister in the left upper arm which erupted and took longer to heal. The patient felt very sick. She had diarrhea for 1 and half days. The patient has never had chicken pox before. The reporter consented to follow. This case had been linked to the case US2020187097 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020187097:same reporter
when he got the initial Covid dose and the booster dose; when he got the initial Covid dose and the booster dose; noticed the levels going down twice when he got the initial Covid dose and the booster dose; PSA level went down substantially for no other reason of why it happened twice, his levels went down at least 40%; This is a spontaneous report from a contactable physician (patient). A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single and received second dose of BNT162B2 (lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single and received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 3, single for covid-19 immunization. The patient medical history included prostate cancer. Concomitant medications were not reported. It was reported that, patient states he has had prostate cancer and has been on treatment on that. Wants to report an unusual thing the the Pfizer covid shot. His PSA was going up when on treatment and he stopped that because it kept going up. He noticed the levels going down twice when he got the initial Covid dose and the booster dose, his PSA level went down substantially for no other reason. He was on a chemotherapy treatment and had stopped it because it wasn't working, not for a period of time, but after he got the vaccines his levels went down at least 40%. Does not know the basis for this, but it's easy data to obtain. If Pfizer could get with the oncologists they can easily follow the data and do not have to draw bloodwork but complete a chart review on those who got the shot and compare data. Knows that there are some cancer treatments that are mRNA treatments and this struck up to be so unusual and weird to him. Thinks this would be a cheap study and be of benefit and be helpful if done. Clarifies he had prostate cancer prior, way before getting the vaccine. Has had it a few years. Again, mentions his PSA went down for no other reason of why it happened twice and it was weird to him since he had the vaccine. Wants Pfizer to do a therapy study. The patient underwent lab tests and procedures which included PSA (prostatic specific antigen): went down at least 40% on an unspecified date. The outcome of the events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and unknown gender. On an unknown date, the unspecified number of patients were vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse effects were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.