chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt is always stable on dialysis.  Pt was 30 min from completing his treatment and he stopped breathing.  Fluid was given, oxygen was placed and sternal rub was performed, pt regained consciousness.
This is a spontaneous case, initially received from a pharmacist on 29-Oct-2018, concerning a 74-year-old elderly female patient. The patient's concomitant medications were unknown. On an unspecified date in Oct-2018 (3 weeks ago as reported), the patient was administered expired FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: 29-Jun-2018]. On an unspecified date in Oct-2018 (within couple of days as reported), after vaccination, the patient experienced tingling and numbness in the left arm. It was reported that the patient could see the stars when touching the shoulder blade. The treatment measures were unknown. At the time of this report, the outcome of the events was not reported. The reporter assessed the case as non-serious.
At 5:34 pm 17 y/o pt. presented to the clinic with mother. Pt was registered and minor consent was signed by parent. Pt received Pfizer booster. Vaccine was administered by the patient?s sister. Although CDC has approved 17 y/o to get a Pfizer booster, this has not been implemented by our location which resulted in this being a medication error. Pt was observed 30 minutes. No signs or symptoms of any adverse reactions noted by the observation nurse.
Patient felt "sick" ( fever, tired, runny nose) the next day after receiving vaccine.
Information has been received from a physician through a Merck pregnancy registry concerning an 18-year-old female, with allergy to IBUPROFEN and a positive family history of hypoplastic left heart, who on 25-JUL-2008 received a dose of VARIVAX (Merck) (lot number, route and injection site unknown) while she may have been pregnant.  Concomitant medication included hormonal contraceptives (unspecified).  The patient had a recent ultrasound done which showed the fetus has a "hypoplastic left heart" (considered as congenital anomaly).  The patient contacted the physician's office for medical attention.  There was no information about her LMP.  Her expected date of delivery was unknown.  Additional information has been requested.
DEEP DRY COUGH; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 15-JUL-2021, the subject experienced deep dry cough. On 15-JUL-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from deep dry cough. This report was non-serious.
No adverse event; Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 47-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.).    No relevant concomitant medications were reported.  No treatment information was provided.
Area of induration and erythema 6cm by 6cm around site of DTaP/IPV upper left arm.
This case involves a 69-year-old female patient who had iron low (blood iron decreased), more tired; fatigued; exhausted (fatigue) and does not feel well; feels like she was hit by a truck (malaise) after receiving INFLUENZA VACCINE and while treated with TREPROSTINIL SODIUM [REMODULIN]. It was unknown if the patient had any medical history, concomitant disease, or risk factor. The patient medical treatment(s), vaccination(s), concomitant medication, and family history were not provided. At the time of the event, the patient had ongoing Pulmonary arterial hypertension. Concomitant medications included BOSENTAN (BOSENTAN); SILDENAFIL CITRATE (REVATIO); BOSENTAN (TRACLEER [BOSENTAN]); and IRON for Iron low. On 10-Feb-2017 REMODULIN (TREPROSTINIL SODIUM) dosage was changed to dosage unknown. On an unknown date, the patient started taking therapy of REMODULIN (TREPROSTINIL SODIUM) formulation unknown dosage unknown iv nos (intravenous not otherwise specified) (with an unknown batch number) for secondary pulmonary arterial hypertension. It was reported that the patient had low iron and had 2 iron infusions on 11- Oct -2021 and 18 -Oct -2021. She had been more tired. On 03-Nov-2021, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination. On 03-Nov-2021, the patient had a flu shot. Thereafter, the patient felt like she was hit by a truck and did not feel well. The patient was very exhausted/fatigued (fatigue previously reported). On an unknown date the patient developed a non-serious iron low (blood iron decreased), more tired; fatigued; exhausted (fatigue) and does not feel well; feels like she was hit by a truck (malaise) (unknown latency) following the first dose intake and (unknown latency) following the last dose intake of TREPROSTINIL SODIUM and following the administration of INFLUENZA VACCINE. Detail of laboratory data were not reported. Action taken with TREPROSTINIL SODIUM (REMODULIN) was unknown. It was not reported if the patient received any corrective treatment for the events. At time of reporting, the outcome was unknown for the events. The reporter did not provide causality for the events of blood iron decreased, malaise and fatigue. There will be no information available on the batch number for this case.
Pain in her arm/still experiencing the pain/It is hurting up to her fingertips/unbearable at times/excruciating pain; Muscle spasms; Got the shot in the middle of her arm not higher up like the first two. It is hurting up to her fingertips/pain in her arm; At night she will feel like a nerve is twitching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in her arm/still experiencing the pain/It is hurting up to her fingertips/unbearable at times/excruciating pain), MUSCLE SPASMS (Muscle spasms), MUSCLE TWITCHING (At night she will feel like a nerve is twitching) and VACCINATION SITE PAIN (Got the shot in the middle of her arm not higher up like the first two. It is hurting up to her fingertips/pain in her arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 040B21A and 202B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SEMAGLUTIDE (OZEMPIC), AZILSARTAN MEDOXOMIL, CHLORTALIDONE (EDARBYCLOR), BUPROPION and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, the patient experienced PAIN IN EXTREMITY (Pain in her arm/still experiencing the pain/It is hurting up to her fingertips/unbearable at times/excruciating pain), MUSCLE SPASMS (Muscle spasms) and VACCINATION SITE PAIN (Got the shot in the middle of her arm not higher up like the first two. It is hurting up to her fingertips/pain in her arm). In December 2021, the patient experienced MUSCLE TWITCHING (At night she will feel like a nerve is twitching). The patient was treated with OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in her arm/still experiencing the pain/It is hurting up to her fingertips/unbearable at times/excruciating pain) and VACCINATION SITE PAIN (Got the shot in the middle of her arm not higher up like the first two. It is hurting up to her fingertips/pain in her arm) had not resolved and MUSCLE SPASMS (Muscle spasms) and MUSCLE TWITCHING (At night she will feel like a nerve is twitching) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: the tests showed nothing (normal) The tests showed nothing. On an unknown date, X-ray: the tests showed nothing (normal) The tests showed nothing.         She has been to her doctor twice and has also visited the emergency room. The Percocet dulls the pain.
MOTHER REPORTS CHILD C/O HEADACHES, BODY ACHES, TEMP ELEVATION TO 102' AND NAUSEA FOR ABOUT 36 HOURS DURATION, WITH DECREASED APPETITE.  GIVEN TYLENOL AND IBUPROFEN AS NEEDED AFTER SYMPTOMS BEGAN.
Swelling of the right foot; joint pain in the right big toe; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9265), via an unknown route of administration on 01Feb2021 at 08:30 (at the age of 76-years old) as a single dose in the right arm for COVID-19 immunization). Medical history included arthritis from an unknown date and unknown if ongoing. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. Concomitant medications included tizanidine hydrochloride (MANUFACTURER UNKNOWN) and naproxen sodium (ALEVE) from an unknown date. The patient did not receive other vaccines within 4 weeks prior to vaccination. On 02Feb2021, the patient experienced swelling of the right foot and joint pain in the right big toe. Therapeutic measures were not taken for the events. The clinical outcome of the events peripheral swelling and arthralgia was recovered on an unknown date in Feb2021.
About one hour after injection, patient experienced overwhelming  fatigue such that he had to lie down in bed. He slept two hours.  Upon awaking, he noticed soreness at the injection site, which has persisted the following day.
Developed 103.9 temp one day following above immuniz. Fussiness and decreased appetite noted. Temp deminished from above max over two days. May have had mouth pain on 2nd day after vacc. Fine macular eruption noted on physical exam 3rd day (8/8/02). Exam otherwise neg.
administered expired doses; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number G3Z3N, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 30th September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 information was provided as follows: The age at vaccination was not reported. The patient received vaccine which was already expired on 30th June 2021. This is 1 of the 5 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021206979:same reporter US-GLAXOSMITHKLINE-US2021AMR207379:same reporter US-GLAXOSMITHKLINE-US2021AMR207380:same reporter US-GLAXOSMITHKLINE-US2021AMR207377:same reporter
Chills; body aches; nausea; vomiting; headache; skin sensitivity; abdominal pain; pain in injection site; pain in neck on side of injection site; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm right on 01Apr2021 at 11:45 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included birth Control Pill, fexofenadine hydrochloride (ALLEGRA), paracetamol (TYLENOL), mefenamic acid (ADVIL). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the arm right on 09Mar2021 at 14:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. The patient previously took Codeine and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 03:15 the patient experienced chills, body aches, nausea, vomiting, headache, skin sensitivity, abdominal pain, pain in the injection site and pain in neck on side of injection site. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visits, and the emergency room/department or urgent care. The clinical outcome of the event chills, body aches, nausea, vomiting, headache, skin sensitivity, abdominal pain, pain in the injection site and pain in neck on side of the injection site was recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
The patient is a 64 y.o. male who presents to the Emergency Department with a few days of right sided neck pain wrapping around to his right upper back. Patient reports a history of similar pain prior to his cervical laminectomy hardware placement. Patient also reports that his sciatica on the right has been exacerbated recently and he is having BLE numbness. He is ambulatory. Patient was seen in the ED for this complaint on 4/5 and was prescribed ibuprofen and Robaxin. He denies any alleviation with these medications. He denies any recent falls, injuries, or other concerning MOI's. Patient notes that he has been trying to get into his PCP, but they are on vacation. He recently quit smoking.
Recvd HIB 5Dec90, started /w T 102-103, next day (had increased T only 1 day)7Dec90 had a red rash (small dots)all over body,lasting for a month. Taken to ER then to Ped Cl.8Dec90 taken to Ped Cl,on 10Dec90 to skin specialist-rxn to vax
5 minutes after I the vaccination I got light headed and heart palpations were felt in my throat, elevated BP of 148/92  which continued to increase to 159/109 which then  Rapid Response was called in and I was transported to ER for about 4hrs.  2 EKGs - done 1st showed PVC, and Cardiac labs were drawn and was continued monitoring with elevated BP.  About 3hrs later ,the 2nd EKG was done which looked better and I was released.  I was advised I could return back to work on 1/1 but I still felt bad and had continued palpations and wasnt able to go bk to wk until 1/5.  I did return to work on 1/5 and at 1:30am I got up and felt lightheaded and the palpations returned.  I went to healthcare facility and got my bp taken which was 174/92 so I went to the ER.  I was given presnisone  and within the next 45min the palpations began to lessen and BP began to decrease. I was also prescribed a 7day course of predinsone and removed from work until 1/9.  I had a virtual visit on 1/7 with my physician in which I showed her the injection site which was still very red, painful and bruised so she prescribed Bactrim and Benedryl causing her to further remove me from work until 1/14.  I had a in person follow up appt on 1/14 which by that time all symptoms had subsided. My BP was back normal at 97/72 and my arm symptoms had subsided as well.  An in office EKG was done which was normal.  But from 1/6-1/14 the heart palpation and elevated BP remained.  Although I will say they did lessened throughtout that time it was extremely hard on me during that time frame .
violently ill; This case was reported by a consumer via interactive digital media and described the occurrence of illness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced illness. On an unknown date, the outcome of the illness was unknown.   The reporter considered the illness to be possibly related to Shingles vaccine.     Additional Information: GSK receipt date: 25-Jan-2023  Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the first shot of two. The patient was violently ill, it was not for everyone. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
The day of the vaccine, I felt flu-like symptoms.  1 day after I received the vaccine, I had deep muscle pain in my armpit (same arm as shot received).  Then 2 days after the vaccine, I developed a rash - red welts surrounding the injection site.  I have had swelling and heat at the injection site for 3 days now.  I didn't have this reaction with the 1st dose - just pain, heat, and swelling at the injection site.
The day after vacination Patient vommited, became further withdraw/autism and within a week or two he developed huge blisters on his ankle/ feet. Due to Covid we  took pictutes/video zoom. The doctor said they were bullous pemphigoid blisters. Patient never had them before/ one was the size of a fifty cent coin. We have photos for you. His dentist and doctor suggested they were from the Covid vaccination. Then this week 2/10/2021 we read an article titled Subepidermal blistering eruptions, including bullous pemphigold, following Covid 19 vaccination. His doctor told us to report his reaction now, so we are reporting it to you.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Adverse event: Rebound Covid; tested negative day after completing treatment with return of symptoms in 2 days and positive test 4 days after treatment; still testing positive at this time.The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results, notes: Rebound Covid; (15Jun2022) negative, notes: tested negative day after completing treatment; (17Jun2022) positive, notes: with return of symptoms in 2 days; (18Jun2022) positive, notes: positive test 4 days after treatment; (2022) positive, notes: still testing positive at this time. Therapeutic measures were taken as a result of covid-19, drug ineffective. Antiviral details. Product: COVID 19 Treatment. Brand: Paxlovid .Treatment start date: 09Jun2022.Treatment stop date: 14Jun2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
became anxious.  c/o SOB, palpitations, dizziness, felt she was going to faint.  Was evaluated in ED, discharged home
Her arm was sore; Had fever; Chills the night after injection; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Her arm was sore), PYREXIA (Had fever) and CHILLS (Chills the night after injection) in a 42-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Her arm was sore), PYREXIA (Had fever) and CHILLS (Chills the night after injection). At the time of the report, PAIN IN EXTREMITY (Her arm was sore), PYREXIA (Had fever) and CHILLS (Chills the night after injection) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient received flu shot in the same arm at the same time. No lot number was provided for Moderna vaccine. She experienced events the night after injection. Treatment information was not reported.
Very sore/tender breasts (both) and experienced what felt like a milk letdown sensation although I have not breastfed in over six years. Symptoms started the Saturday after the vaccination and have persisted since then. I have not yet been relieved of these symptoms but have not taken anything for relief.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date since 08-NOV-2014, an unspecified number of patients were vaccinated with a dose of ROTATEQ (lot #, expiration date and dose were not reported) orally, that was exposed to supported temperature excursions. No adverse experience has been reported. This is one of several reports from the same reporter. Additional information has been requested.
HPV + Fibromyalgia.  1 sexual partner - 3 GARDASIL now + hpv - wow, 1st my Dtr filed 11/2/10. What is FDA/CDC doing, now my cousin!
Fever for 3 days. Emesis (recurrent). Empiric antibiotics.