chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt had appointment 4/27 with PCP who ordered PPSV23 and testosterone injection for same day administration in clinic. Pt received injection and reported back to PCP 4/28 with complaints of rash possibly d/t PPSV23 immunization. PCP advise him to place ice packs on the area, prn ADVIL, and go to the ER if he experienced any further symptoms. Upon telephone f/u with pharmacist on 5/1 pt reported on the afternoon of 4/28 he was dizzy while washing dishes, woke up laying on floor (not sure how long laid there), when woke up so weak couldn't get up, laid for 10 min then was able to get up. After that event he took an ADVIL and was alright the rest of the night. Pt reported using NEOSPORIN and taking ALIEVE on 4/29 and 4/30 with improvement of rash symptoms. On 5/1 pt reported rash had been alleviated. Skin Rash and Rash. Naproxen 500 mg every day, Neomycin/polymyx/pramoxine.
Tightening in her throat area; Hard to swallow; Felt tightening in her throat area/hard to swallow/after the second dose it came on later and lasted longer and was more intense; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EB8737; Expiration date was not reported) on the left arm on 09Apr2021 as a single dose, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store (not a military facility). Medical history included shellfish allergy. The patient had no concomitant medications. The patient had previously receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6205; Expiration date was not reported) on the left arm on 19Mar2021 (when the patient was 40 years old) for COVID-19 immunization, and had felt tightening in her throat area and hard to swallow. On 09Apr2021, after the second dose of vaccination, the patient also had felt tightening in her throat area and hard to swallow; but it came on later and lasted longer, and was more intense. The events were reported to be serious (medically signficant). The patient had received diphenhydramine (BENADRYL) as treatment for the events. The outcome of the events was recovered on 09Apr2021.  Information on lot/batch number was available. Additional information has been requested.
02/07/22 presents to ED for "Dyspnea". PMHx of "severe OSA, history of bronchospasm and reported carcinoid syndrome, type 2 DM, HTN"
very difficult to wake; trouble talking or did not want to talk; legs were very weak and he could not hold himself up; still sluggish; Found him the next morning on the floor/ fell again; this time he scraped his head,; It looked like a carpet burn; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (very difficult to wake), APHASIA (trouble talking or did not want to talk), ASTHENIA (legs were very weak and he could not hold himself up), SLUGGISHNESS (still sluggish) and FALL (Found him the next morning on the floor/ fell again) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04AC21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: flu shot. Past adverse reactions to the above products included No adverse event with flu shot.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (very difficult to wake), APHASIA (trouble talking or did not want to talk), ASTHENIA (legs were very weak and he could not hold himself up), SLUGGISHNESS (still sluggish), FALL (Found him the next morning on the floor/ fell again), HEAD INJURY (this time he scraped his head,) and THERMAL BURN (It looked like a carpet burn). At the time of the report, SOMNOLENCE (very difficult to wake), APHASIA (trouble talking or did not want to talk), ASTHENIA (legs were very weak and he could not hold himself up), SLUGGISHNESS (still sluggish), FALL (Found him the next morning on the floor/ fell again), HEAD INJURY (this time he scraped his head,) and THERMAL BURN (It looked like a carpet burn) outcome was unknown.            The patient got the flu shot 2 weeks prior to the booster.  No concomitant medication details were provided. No treatment medication details were provided.   This case was linked to MOD-2021-370484, MOD-2021-370478 (Patient Link).
No other issues or concerns reported at time of call; Names of vaccines involved (...): ROTATEQ / Temperature: 48.2 F; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 04-OCT-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # T033634, expiration date 16-MAR-2022 for prophylaxis (exact dose and anatomical location were not reported).  The vaccine was stored at the temperature that was reported as 48.2 degrees of Fahrenheit for 5 hours and 19 minutes. It was not reported if there was a previous temperature excursion. No other issues or concerns reported.
My blood pressure had increased to 176 / 102 about 6-8 weeks after Covid-19 Pfizer shot number 2.  I am runner and injured my knee out on a run. My physio therapist had me warming up my knee on a exercise bike, before standing exercises to strengthen my leg muscles. She noticed me begin to pass out, and immediately stopped PT treatment and sat me down and took my BP (176/102). This high BP was extraordinary for me (because I am runner). My BP prior to Pfizer shot 2 was 134 / 89 taken when I donated my blood (which I do 3 or 4 times per year).
Information has been received on 17-JUL-2017 from a licensed practical nurse (LPN) referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 (Lot # M034780, expiration date 15-APR-2019) or RECOMBIVAX HB (Lot # M044032, expiration date 03-JUL-2019) or VAQTA (Lot # N005274, expiration date 03-APR-2018) for prophylaxis. (The doses, routes of administration and sites of administration were not reported.) The excursion information was reported as: The temperature was reported as 9 degrees Celsius (C) to 25 degrees Celsius (C) for the time frame of 13 hours and 47 minutes. There was a previous temperature excursion of 9 degrees Celsius (C) to 25 degrees Celsius (C) for 42 hours 5 minutes. (No dates for the temperatures excursions were reported.) The call was because of a "data logger". Product quality complaint was not involved. No adverse effects reported. No additional information was provided. Additional information has been requested.
At 0913 pt. c/o heart beating fast and dizziness.  Denies taking any routine meds and history of medical conditions.  Denies chest pain or HA. States was nervous about getting the vaccine.  BP 148/82, P 65, R 20, SPO2 100%.  Given bottle of water to drink and resting on exam table.  At 0924 BP 110/72, P 65, R 20 & SpO2 96%.  Pt. reports symptoms resolved upon standing pt. continues to c/o of mild dizziness.  Continues to rest and drink more water.  At 0950 Reports a small amount of dizziness.  At 0950 escorted to car w/husband to drive patient home.
Presented w/ fever, chills, SOB, hypoxia. Tx w/ Decadron, remdesivir for covid+ pneumonia.
10 days after vaccination, I noticed a slight rash and red round mark about 2 inches in diameter on my left upper arm where the injection site was.
8/7/13 Seen in ER for urticaria, achy muscles given BENADRYL IM, Prednisone PO, PEPCID. 8/8/13 ER hives, vomiting, short of breath - BENADRYL IM.
Post vax, the pt experienced systemic reactions of headache, nausea and diarrhea. The pt also experienced a runny nose that lasted one week.
Dizziness began a few hours after the vaccine and hasn?t stopped since. On two separate days since vaccine, I?ve had severe headaches. On and off nausea and appetite tied to dizziness.
Resident received her second vaccination on 2/19/21.  She was sent to the hospital on 2/20/21 for respiratory distress.  We think she aspirated (she has a history of dsyphagia) which caused pneumonia.  However, I am reporting this because it was within 24 hours of receiving her vaccine.
A 17-year-old female patient was given the Moderna Vaccine. the patient should have received a Pfizer
Erythema, Swelling, Tenderness, fevers, Elevated white blood cell count. 6/26/2009 MR received for DOS 6/4-7/2009 with D/C DX: Cellulitis.  Pt presented with fever of 104"F, redness, induration, warm and tenderness at injection site, chills and malaise.  Seen by surgery-nothing to drain.  Tx IV abx. D/C on abx.   ICD9 780.6.
Fever of 104.5; chills; body aches; fatigue; and nausea.
Administer .5ml Fluzone IM Left deltoid. After 15 minutes pt expressed that she was having some itching above the injection site on left arm. Upon observation the upper portion of her arm at the junction of the shoulder was erythematous as well at the inner aspect of the upper arm. The site was not warm to touch and there was noted central clearing with redness only at the inner and upper portion of arm. Pt complained of slight pain.  She stated that she had many allergies and had PO benadryl in purse. She took two 25mg Benadryl by mouth. denies any difficulty breathing or other complaints. Pt observed for 15 additional minutes without incident. redness, pain and itching decreased. Pt released with instruction to seek medical attention if symptoms worsened. PT left Alert and oriented x3.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 29-Mar-2022) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 29-Mar-2022) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Mar-2022 at 11:42 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Mar-2022 at 11:42 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 29-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 29-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 29-Mar-2022) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 29-Mar-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient's ethnicity reported as White. No concomitant medication was provided by the reporter. Vaccine was in thaw state (2 to 8 degree Celsius) from about 24-Dec-2021. Booster dose was given on 29-Mar-2022 at 11:42:49. No treatment medication was provided by the reporter.
Got home from appointment with headache-> 3 tablets MOTRIN at 4:30pm->fell asleep->9pm woke up with worse headache and neck pain and body aches->temp 102F w/neck stiffness and nausea->I instructed patient to visit the ED for evaluation (over the telephone)->patient brought to Hospital via ambulance as patient was too weak to get into car. Vitals: 101.1 degree F, HR 102, RR 20, 100% on room air, BP 138/79, 10/10 pain. Given BENADRYL 50mg IV, REGLAN 10mg IV, 1 liter fluid bolus of normal saline->then later given TYLENOL 650mg PO and MOTRIN 800mg PO->discharged home with stable vitals.
Within 2 days of receiving the vaccine, I developed severe pain and stiffness in both arms.  I could not lift my arms above my head .   Also had pain in my ankles.
22 hours after second injection felt real achy and very dizzy when I got off work and in my car to drive home.  Symptoms occured suddenly.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 17-JUL-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml (lot number and expiration date: K004016 and 08-MAR-2015 respectively; strength, and route of administration were not provided). Nonetheless, no adverse effects were reported. On an unspecified dates, PNEUMOVAX 23 had two temperature excursions; one of 192 hours with a lowest recorded temperature of 34 F (1.111111111 Celsius) and other one of 1164 hours with a lowest recorded temperature of 33 F (0.555555556). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Two days after the vaccination, I developed a rash on the back side of my left thigh. It developed like a rash and I was told to use cortisone cream for four days and it went away.
Pt. states she developed a rash on her face in the evening on 06/15/2004.  On 06/15/2004 she was given Twinrix and a prescription for Flagyl 500 mg for 7 days (had not started Flagyl).  Pt. also had myalgia.
passed away from covid and the doctors did not find any antibodies in his system; passed away from covid and the doctors did not find any antibodies in his system; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (death, medically significant), COVID-19 (death, medically significant), outcome "fatal" and all described as "passed away from covid and the doctors did not find any antibodies in his system". The patient date of death was unknown. The reported cause of death was drug ineffective, covid-19. It was not reported if an autopsy was performed. The reporter asked why did then vaccine fail and wanted to know why this happened and if this had happened to anyone else. The reporter was very angry that believed this vaccine would save lives if ever contracted the virus. Now the reporter's father (patient) was gone. The reporter asked if this was something missed when doing the clinical trials.  The lot number for bnt162b2 was not provided and will be requested during follow up. ; Reported Cause(s) of Death: passed away from covid and the doctors did not find any antibodies in his system; passed away from covid and the doctors did not find any antibodies in his system
Patient received 2nd dose of Pfizer vaccine on 6/10/2021. Initially had typical symptoms of fatigue and arm pain. On 6/13/2021, woke up with  central chest pain and "fluttering" of his heart. Mother read the Agency website concerning possible myocarditis after Covid vaccinations so then took him to the ED.  The chest pain lasted about an hour (resolved in triage in the ED). There he had a normal ECG and chest x-ray. He was referred to see me in clinic on 6/15/2021. He had a normal echocardiogram. Due to the parental concern for possible myocarditis, I recommended a troponin which would show if his chest pain were possibly related to that. It returned mildly elevated at 0.21 ng/mL, prompting me to enter this as a possible mild case of myocarditis after vaccination.
01/05/2023 I started having cough, fatigue; fever muscle ache; joint ache, lost of appetite. After reaching out to urgent care I tested positive for Covid-19 and was prescribed PAXLOVID. Symptoms lasted 3 days.
on 2/1/21 at ~7AM pt was noted by the RN to have rt sided weakness & was sent to Hospital ED for evaluation.  They felt he could have had a TIA, or extension of a prior CVA (nothing new on MRI, has small vessel ischemic disease), or a COVID vaccine reaction. Symptoms have mostly resolved, he is not always cooperative so subtle weakness is difficult to detect. He was hospitalizaed, started on ASA & increased BP meds, and returned to his home, where he has resided for several years.
Hives covering right breast. Hives in areas on both thighs, feet, arms and hands. Chills, dizziness, diarrhea and nausea.
Six hours after shot, itchy skin presented itself throughout body. Continue to have symptoms 8 days later. Have not been able to do daily activities.   Itching increases with heat or clothes touching skin.
Right arm (humerus) swollen and red and feverish and sore at injection site and 1/2 of the humerus ten (10) days after the shot. On Sept 14th the left side of my neck and clavicle broke out with sore and a few on my left arm. Talked to my M.D. on 9/16/16. Symptoms slowly went away by Sept. 20th 2016.
About a week after the injection, I got a red rash that itched around the injection site that lasted about 4 days.
Right after the injection I became acutely lightheaded.  I tried to wait it out and it improved somewhat but not all the way.  I then started to drive home after the 15 min. observation period. About 5 min into my drive home, I developed trouble swallowing/throat tighness and worsened lightheadedness. I called 911 who stayed on the phone with me as I drove back to the hospital. It started to imrpove rather soon and was resolved within 30 min later.
Administered after temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number J7C77, expiry date 26th June 2023) 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 an unknown date, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: GSK receipt date: 17-Jan-2023 Reporter's comment:A nursing director reported that  there was a temperature excursion for several GlaxoSmithKline vaccines (Boostrix, Engerix-B, Havrix and Flulaval quadrivalent) and some of them were administered to patients.  The Fluaval quadrivalent was excursed from 23th August 2022 to 17th November 2022 and the highest temperature reached was 12.5 degree Celsius for 3 months.  Only one Flulaval quadrivalent was administered during this period. There were no other information available at the moment of the call regarding patient´s information. The reporter consented to follow-up via email. This 1 of 3 linked cases reported by same reporter. Additional supportive information: The patient received the Flulaval quadrivalent after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023AMR007425:Same reporter / Boostrix case US-GSK-US2023AMR007430:Same reporter / Engerix-B / Havrix case
Patient began having redness and tenderness at vaccine site 24 November in a.m. Described as being quarter sized. On A.M. of 25 November patient had significant increase in redness, tenderness and heat to the area.
A few minutes after arriving in recovery area, patient began to feel faint. This has happened to her in past with vaccination, she recognized it and laid herself on floor, staff in attendance recommended elevating feet as well, which she did. Reported dizziness, sweaty skin, mild nausea. After approx 15-20 minutes was feeling much better/symptoms resolved. was able to sit and then stand and walk without dizziness. BP 140/90 and 142/70 at 1258pm and 106pm, pulses 86 and 80 respectively. She left the site with her Dad approx 25 min after vaccine. Dad also rec'd vaccine that day. She was instructed to seek medical attention if symptoms returned or new symptoms occurred. Advised for dose #2 to inform staff and consider receiving vaccine lying down.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 28-JUN-2013 (lot # H021608, Expiration Date: 13-AUG-2015). This is one of the report from the same source, linked reports. Additional information is not expected.
I woke up in excrutiating neck, shoulder, and scapula pain. I iced, heated and massaged the area all day to no avail. I finally had to go to the ER on 11/5/2012 about 1:00 AM. They gave me 2 different shots in both arms and oral medication which did not help. Then slowly throughout the day I lost function of my arm. I haven't been able to work since.  I am still in pain and the paralysis is still there.
Patient experienced a medium-size localized rash at the site of injection, for approximately 3-4  days. Patient did not complain of pain or itching.
Received Varicella vaccine (Varivax) on 11/05/06. Around 11/15/06 developed several small non itchy papules on hand, face x2. body x 1 and one on extremity.
Patient received the Janssen COVID vaccination at age 17 years, 11 months. Patient should not have received the vaccination until he was 18 years of age. He reported no adverse reaction to the Janssen COVID vaccination. VAERS report has been completed because the patient was not yet 18 years of age when he received the vaccination.