chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt stopped at pharmacy at about 3 pm and told me that he started feeling like he had a heartburn-like feeling about 20 minutes after receiving the shot. That would have been around 12:35. He didn't tell me about it until about 2:45 pm. I asked if he had any difficulty breathing or feelings of swelling in his mouth, lips, throat. He denied having any such symptoms. I showed him diphenhydramine (Benadryl) OTC and instructed him to take 50 mg every 4 hours until him symptoms subsided and to seek immediate medical attn if he noticed any difficulty breathing and to please follow up with me in an hour to let me know how he was doing. The patient took the 50 mg diphenhydramine. He stopped by the pharmacy again at around 3:15 pm and said that he felt like the heartburn had stopped but he felt like he had a small lump in his throat. He was somewhat worked up and was nervous. He did not say he was having any difficulty breathing, just that he felt he had a lump in his throat. I offered to call 911 for him but he said he would rather have a friend drive him to an ER just to be safe. He left the pharmacy with myself under the assumption that he was heading to the ER.
About 20min p/MMR shot c/o runny eyes, SOB, sneezing, just not feeling well; R-20, BP 130/90, p68; Resp shorten wheezes, eyelids swollen, eyes red; Given EPI, felt better but c/o itchy skin;
taking Metoprolol, for blood pressure and his heart; taking Metoprolol, for blood pressure and his heart; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EW0164 or EW0184, Expiration date: 31Aug2021), via an unspecified route of administration on 22Apr2021 as DOSE 1, 0.3ML SINGLE for covid-19 immunisation. Medical history included allergies. Concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY, Batch/lot number: 1771730) via unspecified route of administration on 13May2021 as 10 mg, daily for allergies, fluticasone propionate via unknown route on 13May2021 as usually one puff, sometimes two puff in each nostril. Patient received first COVID-19 Vaccine on 22Apr2021. Patient was taking metoprolol, for blood pressure and his heart on 13May2021. Patient wants to know if it is ok to get his second COVID-19 Vaccine today since patient took Zyrtec and Flonase nasal spray this morning. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a physician concerning an 46 years old male patient, without pertinent medical history or drug reaction / allergies. The physician reported that on 24-AUG-2012, the patient was vaccinated subcutaneously with the first dose of VARIVAX (Merck) (dose was not reported). No other co-suspects were reported. No concomitant medications were reported. On 15-SEP-2012, the patient developed a varicella like rash, and dermatomal pain following the administration of his first dose of VARIVAX (Merck). The patient came down with 15 chicken pox like blisters last week. The patient was treated with an unspecified antihistamine. There was not laboratory test performed. The patient sought medical attention as office visit. At the time of report, the patient had not recovered. Additional information has been requested.
first dose of BNT162B2 on 27Jan2021 14:00  and second dose on 10Feb2021(range 15 days); first dose of BNT162B2 on 27Jan2021 14:00  and second dose on 10Feb2021(range 15 days); dizziness followed by blackout; dizziness followed by blackout; This is a spontaneous report from a contactable consumer(patient himself).  A 69-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm left on 10Feb2021 14:00 (at age of 69-year-old)  (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. Medical history included Penicillin allergy. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 27Jan2021 14:00 (at age of 69-year-old)  in left arm for COVID-19 immunisation. The patient experienced dizziness followed by blackout on 10Feb2021 15:00. There was no treatment received for the events. There was no Covid prior vaccination or Covid tested post vaccination. The outcome of events dizziness followed by blackout  was resolved on unknown date.  Information on the lot/batch number has been requested.
She had a period after 2 yrs, after she got her booster of Moderna; This spontaneous case was reported by a patient family member or friend and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (She had a period after 2 yrs, after she got her booster of Moderna) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2022, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (She had a period after 2 yrs, after she got her booster of Moderna). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (She had a period after 2 yrs, after she got her booster of Moderna) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
The defect was discovered after administration; white powder in the antigen vial/pqc filed; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 67-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7K545, expiry date 22-OCT-2024) for prophylaxis. This case was associated with a product complaint.   On 30-AUG-2023, the patient received Arexvy (intramuscular). On 30-AUG-2023, an unknown time after receiving Arexvy, the patient experienced underdose (Verbatim: white powder in the antigen vial/pqc filed). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: The defect was discovered after administration).  The outcome of the underdose and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt date: 31-AUG-2023 Pharmacist reported that a colleague had administered Arexvy to two patients and after the patients had left the pharmacy, the reporter noticed that retained white powder in the antigen vial.  The powder was described as partially pill-like and partially like powdered sugar.  They did not know which of two patients received the underdose.  The reporter I reviewed the reconstitution instructions, and received the following information prior to transferring the call to the medical information department for further instruction. All operations were performed appropriately before defect was discovered.  The defect was discovered after administration. The mixing was performed gently. The vial was held upside-down while being withdrawn. The product was administered. The health care professional was experienced in vaccine administration. The antigen component was the component in question. The health care professional was not able to email a picture. No liquid, only powder was left in the affected vial/s.  Yes the stopper was pierced in the circular area dedicated to perforation.  It was unknown if air was injected into vial. The reporter will call them back with wholesaler information for credit when they locate this information. The reporter consented to follow up. This is 1 of 2 linked report, reported by same reporter. The patient received Arexvy and later it was noticed that retained white powder in the antigen vial, which led to underdose.; Sender's Comments:  US-GSK-US2023119233:Same reporter
Client felt dizzy after injection. Laid on cot , had gatorade and felt better. B/P 108/58, 99% O2sat, HR 78. Left under Mother's care, to call 911 or go to ER is new symptoms occur.
Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a health professional, Nurse. This case involves a 19 months old female patient who received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DAPTACEL (lot number: C5254AB) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation, both in right thigh. On 21-Sep-2018 at 09 AM, the patient received a 0.5 ml single first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT5899MA via intramuscular route in the right thigh. It was a case of actual medication error due to overdose. It was unknown whether adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt devel clinical chickenpox 1 1/2 yr p/vax;dx confirmed in sib pt broke out 1 to 2 wk later;no complications;
Pt with seizure-like activity noted x2 by her husband, with symmetric jerking of legs, loss of responsiveness, loss of bowel/bladder function.
12/2/09 Received H1N1 vaccine by mouth/no preservatives. Within 7 days of vaccine, lower back pain. 12/25/09 low grade fever 100-102 degrees and night sweat. Night sweat continued for additional 5 days.  Coughing ensued.  Then fatigue with pins & needles/tingling/numbness in both thighs first, then both feet.  Could not stand in the on feet first thing in the morning.  When eventually able to stand, had difficulty walking (only able to take small steps).  Pins & needles/tingling/numbness ascended to both arms/hands.  On 1/29/10 pins & needles/tingling/numbness reached face and tongue.  Checked into Hospital Emergency at approx. 10pm that night.  Series of tests were done- including spinal tap and CAT Scan. On 1/30/10 admitted hospital for inpatient treatment of 4 cycles of IVIG.  Discharged from hospital on 2/3/10.  Currently undergoing home physical therapy.  Prescribed for outpatient nurse visits.  Taking prescriptive pain killer (morphine).  Vomiting.
pt recv vax & exp sneezing, pruritus both feet;12-13hr later awoke w/h/a face flushed, nausea, felt shaky, hands tremulous, gen feeling out of it;also c/o rapid heart rate w/each dose;
GARDASIL 9 series was delayed a month; 9 series was delayed a month for her second dose due to COVID. Caller refused demographics. No additional AE details or PQC.  First dose: 05/06/2022 Second dose: 08/01/2022; This spontaneous report was received from a consumer referring to a 32 years old female patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 06-MAY-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis.         On 01-AUG-2022, the patient received the second dose, and the series was delayed a month due to COVID (inappropriate schedule of product administration). The outcome of COVID was reported as recovered. The causality assessment was not reported.
pt recv vax 11MAR96 & 18DEC97 pt exp more than 25 pruritic varicella-like lesions over this body;
On about 9/17/2022, I went to a party and came into contact with someone who later tested positive for COVID-19. On 9/22/2022, I had body aches and a runny nose. I work at a nursing home, so I requested a COVID-19 test. The result was negative, but the following morning of 9/23/2022, I still felt ill. When I tested again on that day, I got a positive result. On the first day, I had a low-grade temperature of 99.9; my baseline temperature is usually 97.6 or lower, so it felt like a fever. After the first day of my illness, though, I didn't get another fever. My doctor prescribed me a Z-Pak (250 mg) on 9/23/2022, which I took for five days, and a four-day supply of prednisone (10 mg).  The main symptoms I experienced were sinus congestion, a constantly runny nose, and body aches. My symptoms lasted for maybe five days. While I was taking my medications, though, I felt better after the second day and was cleaning. I also never lost my appetite.
I was just kind of mopey; This is a spontaneous report from a Pfizer Sponsored Program via a contactable consumer (patient). A 76-years-old patient of an unspecified gender received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient just wanna thank you for the vaccine, got em both and feeling very safe. Just on the second shot patient was just kind of mopey but other than that was wonderful. Event outcome was unknown.  No follow-up attempts are needed. No further information is expected.
Left ear hearing loss and tinnitus bilaterally. Still present and has ben present for 4 months. Broke out into immediate flushing, heart rate went up to 132, and severe nausea following vaccine. Had to stay at clinic for 90 minutes to recover.
C/O lightheaded and dizzy vital signs monitored, given food and juice and water  Patient felt better and left clinic on own
STRANGE FORMATION ON THE INNER UNDERSIDE OF ARM WHERE VACCINE WAS ADMINISTERED LEFT ARM THAT TURNED YELLOW; DIZZINESS; FOOT ACHE; MUSCLE ACHES UNDERNEATH LEFT ARM; NOT FEELING WELL SINCE RECEIVING THE VACCINE; FALL; FEELING WOBBLY; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced feeling wobbly. On MAY-2021, the subject experienced fall. On 14-MAY-2021, the subject experienced not feeling well since receiving the vaccine. On an unspecified date, the subject experienced strange formation on the inner underside of arm where vaccine was administered left arm that turned yellow, dizziness, foot ache, and muscle aches underneath left arm. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from strange formation on the inner underside of arm where vaccine was administered left arm that turned yellow, feeling wobbly, not feeling well since receiving the vaccine, and muscle aches underneath left arm, and the outcome of dizziness, foot ache and fall was not reported. This report was non-serious.
Dizziness; Nausea. BP 96/58; HR 69; RR 18. Pt has history of anxiety with blood draws & shots.  Pt feeling better BP 101/60; HR 70; RR 18
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (dose, frequency and route of administration were not provided) lot# N017700 and expiration date: 09-JUN-2019. The VARIVAX was reconstituted with properly stored dose of sterile diluent (manufacturer unknown). No adverse effect was reported. The vaccine was stored in between 15 degrees Fahrenheit (F) to 46 F for 1 hour and 9 minutes. Previous temperatures excursions were in between 6 F 14 F for 76 minutes and in between 15 F to 46 F for 1 hour and 23 minutes. The digital data logger was involved in recording the temperature excursion. Sender's Comments: US-009507513-1711USA002012.
Stiffness started in neck and between shoulder blades 3 hours after dose.  Soon entire body was stiff/achy. Laid down and fell asleep for 5 hours. Continued to have body aches and headaches for two more days. Took Tylenol to ease symptoms (it was helpful).
Initial c/o shakes, bodyaches, sweats. Pt later said shakes are normal for him. Pt instructed to take Advil 800mg q 8hrs prn and to go to ED prn worsening symptoms.
Around 4PM my arm started to ache - i didn't give it much thought.  As the evening went on, the discomfort radiated to my axilla and down the left arm with occasional shooting pain from the injection site down my arm.  I woke up during the night with severe muscle pain.  I feel like someone has used a club on my entire body.  I also have a headache.  Tylenol and ibuprofen do nothing.
Waking up the next morning: Extreme fatigue (slept for two straight days) (2 days) Swollen lymph nodes (throat was sore and had ear ache) (2 days) Headache (1day) Body Aches (1 day) Red and swollen and itchy at injection site that lasted 5 days
1st 3 days sore arm and red area about inch wide. This went away now day 9 large swollen red hard area making whole arm hurt
Information has been received from a nurse concerning a female who was vaccinated with GARDASIL. The registered nurse reported that the patient had a syncopal episode. This is one of two reports from the same source.
April 13, 2022 After a nearby lightning strike I found myself in Afib and went to the ER. I was given an IV medication to stabilize my heart rate around 05:00AM April 14th, 2022. I was admitted to the hospital on the 13th and then later the morning of April 14th I had an echo done that showed my efficiency factor was at 33%. Previous echos June 2021 showed 45% efficiency factor. I have been in touch with my doctors and have seen both PCP and cardiologists as well. For the time being I am treating this medicinally with Eliquis, spironolactone, and we will be doing a repeat echo and  from there checking on efficiency factor if there is no improvement we will be discussing implantable devices.
pt. vax'd /w 3rd dose of hepatitis B vaccine in Nov '89, subsequent lab evaluation revealed liver function "twice normal".
Patient is a 58-year-old female who works as a child day care worker. Patient received government-mandated TWINRIX vaccine on 3 April 2014 as part of her employment. Patient notes she received this vaccine high on the left shoulder (approximately 1 inch below the acromion process) and shortly after vaccination develop significant discomfort/pain within hours of vaccination which has since persisted for several months. She denies any systemic symptoms such as hives, or other dermatitis, lip swelling, tongue swelling, throat tightness, or any airway or vascular compromise. She denies any diffuse arthralgias or myalgias. However, she does endorse chronic left shoulder pain and somewhat limited range of motion of her left arm. She states this pain is lifestyle limiting and prevents her from sleeping on her left side. She states the pain has minimally improved. She describes the pain as a chronic aching pain, and estimates it severity is 5/10. She denies any previous shoulder injuries or orthopedic problems. She is otherwise in good health with no other chronic medical problems. She does not take any medications. She does describe occasional doses of ibuprofen to help with her shoulder pain with little relief. She denies any other symptoms or complications. She specifically denies any left shoulder/arm weakness or paresthesias. She denies any local site reactions other that mid swelling for a couple of days after vaccination.
Sore arm; Nausea; Fatigue; Muscle aches; Fever; Sore throat; Headache; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the arm right on 19Apr2021 at 14:45 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included crohn's disease, panic disorder and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ustekinumab (STELARA), alprazolam (XANAX) and ritual vitamins (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received clindamycin palmitate hydrochloride (CLINDAMYCIN) and ceftriaxone sodium (ROCEPHIN) and experienced drug allergy. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 24Mar2021 at 15:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 19Apr2021 at 16:00, the patient experienced sore arm, nausea, fatigue, muscle aches, fever, sore throat, headache and dizziness. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm, nausea, fatigue, muscle aches, fever, sore throat, headache and dizziness was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Rash on face, trunk, back and a few on arms and legs, pink 2-3mm papular lesions on erythematous base starting one week post immunizations; fever started one day post (103 deg F). By 3rd day of rash noticed some in hairline and 3 in oral pharyngia
pt recvd vax under no distress; mom returned stating pt was in trouble; CNS intact, pulse 58; cold compress applied; pt reported falling on concrete beside car; mom took pt home; pt vomited later @ home (contained some blood), h/a;
rash at the site of the injection that has not increased or decreased in size, it's the size of my palm; This is a spontaneous report from a contactable consumer (patient). A 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and Expiration Date was not reported) via an unspecified route of administration on 02Feb2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced rash at the site of the injection that has not increased or decreased in size, it's the size of her palm on an unspecified date. Patient was asking if her symptom following administration of the second dose of the covid vaccine was normal and asking what she should do about it. Seriousness was reported as non-serious. The outcome of the event was unknown.  Information about lot/batch has been requested.  Follow-up attempts are completed. No further information is expected.
Pt has red whelps on arms, legs, back, neck. No problems breathing, no swelling to limbs, face or neck. Instructed to follow up with MD.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL dose 3, intramuscular. The patient received an improperly stored dose of GARDASIL (lot K010574, expiration 04/08/2017). The patient received her dose, which was her third in the series, on 04/14/2015. No adverse effect reported. No additional information provided. This is one of two reports from the same reporter. Additional information has been requested.
Irritability, fever, R leg injection site erythema, induration with PEDIARIX 1st dose (pertussis component).