chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very sore arm; Chills/had four blankets and space heater but still shivering uncontrollably; Numbness; Tingling in hands and feet; Hands crapped up into lobster claws ended up at ER; Never was so cold in my life-had four blankets and space heater but still shivering uncontrollably; Very scary experience; This is a spontaneous report from a contactable consumer or other non hcp. A 56-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0161), dose 2 via an unspecified route of administration, administered in the left arm on 07May2021 at 18:00 (at the age of 56-year-old) as dose 2, single for covid-19 immunisation. The patient's medical history was not reported. The patient had no known allergies. Concomitant medications the patient received within 2 weeks of vaccination included levothyroxine; estrogens conjugated, estrogens esterified (MENEST); progesterone and duloxetine. Historical vaccine included bnt162b2 (Lot number: ER8737) dose 1 via an unspecified route of administration, administered in the left arm on 13Apr2021 at 18:45 for covid-19 immunisation. On 08May2021 at 18:00, the patient experienced very sore arm, chills/had four blankets and space heater but still shivering uncontrollably, numbness, tingling in hands and feet, hands crapped up into lobster claws ended up at ER, never was so cold in my life-had four blankets and space heater but still shivering uncontrollably and very scary experience. Patient was not dehydrated. Facility where the most recent COVID-19 vaccine was administered was a pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event resulted in Emergency room/department or urgent care. Since the vaccination, the patient had not tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Device timestamp was provided as 04Jun2021. Treatment for the events was given with Tylenol and fluids. Outcome of the events were recovered on an unspecified day in 2021.   Follow-up attempts are completed. No further information is expected.
Light-headed, dizzy, weak - felt like legs would not hold me up, fluttery sensation in body, high blood pressure.  45 minute duration with gradual recovery. Mild pain at injection site, head and neck pain, fatigue -3 day duration.
MA mistakingly gave a pregnant patient preservative free Flublok in stead of preservative free Fluzone Quad/no AE; MA mistakingly gave a pregnant patient preservative free Flublok in stead of preservative free Fluzone Quad/no AE; Initial pregnancy information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA266136, 2019SA266138 and 2019SA266137 (same reporter).  This case involves a 23 years old female patient who was mistakenly exposed to preservative free vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of preservative free INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] while she was pregnant.  Patient's gestation period at onset and gestation period at exposure was not reported, the date of last menstrual period was not reported, the estimated due date is 16-DEC-2019.  The patient's past medical history, previous pregnancy/ies, medical treatment(s), vaccination(s) and family history were not provided.  Patient was not on any concomitant therapy.  On 20-Sep-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number 16-DEC-2019 via unknown route in the right deltoid.  It was a case of actual medication error due to wrong vaccine administered (Wrong product administered).  It was reported that patient did not experience any adverse event at the time of reporting.  Additionally, at time of reporting, the outcome of the pregnancy was unknown because patient's delivery due date is on 16-DEC-2019.  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.
Dizziness, cold and clammy, BP 85-50, HR 68, RR19, given apple juice and water. 10 minutes later, BP 88/57, HR 76, pt states BP normally low around 90s. Released in stable condition
I had prior health issues and when receiving the second dose all my prior health issues resurfaced. I am now seeing a foot doctor for my plantar fasciitis. I went also to the hospital to have an endoscopy due to my GERD symptoms. I am also seeing a chiropractor for my hip and back pain. My symptoms are still present today.
9 1/2 X9 1/2 cm area of erythema, warmth tenderness, swelling @ injection site
24 hours after injection, patient developed low grade fever, body aches, muscle pain and headache. Still present after 1 wk. Rapid Flu test done and is negative.
diarrhea; weakness; sick ever since; can't do anything; scared to receive the 2nd dose; vomiting; arm was sore; A spontaneous report was received from a consumer concerning a 78-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm sore, vomiting, diarrhea, weakness, sickness, inability to do anything and fear for the second dose.  The patient's medical history includes allergies for codeine and morphine, high blood pressure, high cholesterol and open-heart surgery. Concomitant medications include high blood pressure medicine, high cholesterol medicine and blood thinners.  On 21 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 0416204) in the left upper arm for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient experienced soreness in arm. On 23 Jan 2021, the patient experienced vomiting, diarrhea, weakness, sickness, inability to do anything and fear for the second dose.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event, arm sore, vomiting, diarrhea, weakness, sickness, inability to do anything and fear for the second dose, was considered unknown.
I got swelling in the glands around my neck and under my chin. It is so painful and i was not told about the adverse events at the time of vaccination.
Presented with SOB, DX Covid PTA 9/7; admitted with Covid PNA; TX with Maxipime, steroids, remdesivir, vancomycin, Vit C, Zithromax, rocephin, Vit D3, Singulair, zinc, plasma x2; intubated 9/13; + BLD CX due to bolus pemphigoid; AKI- TX to alternate Medical Center for CRRT.
On April 9th, 2021 I received my second Moderna Vaccine. I started feeling sick early morning of April 10th, 2021. Have been sick since then. Migraine headaches, fever, chills, stiff neck, painful ear aches, body aches, exhaustion, severe night sweats, etc.
Excruciating headaches, nausea, insomnia lasting 3 days following 2nd dose of Pfizer Covid19 vaccine. On  the afternoon of Sunday, January 31, 2021, I began having intense back and chest pain that lasted approximately 5 hours.  I went in to the Emergency Department for a series of tests and it was undetermined at that time what the cause was of the chest pain.
swelling in the arm, pain extending from shoulder to fingers, extreme redness around the site,noticable induration at site, redness and induration of 6cm or more at site
Mild flu like symptoms; Mild discomfort; incorrectly administered Infanrix instead of Boostrix to a 48 years old patient; This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a 48-year-old male patient who received DTPa (Infanrix) (batch number D2KX9, expiry date 26th November 2021) for prophylaxis.  On an unknown date, the patient received Infanrix. On an unknown date, unknown after receiving Infanrix, the patient experienced adult use of a child product and wrong vaccine administered. On an unknown date, the outcome of the adult use of a child product and wrong vaccine administered were unknown.  Additional details were provided as follows: A health care provider called reporting that they incorrectly administered Infanrix instead of Boostrix to a 48 years old patient, which led to  adult use of a child product and wrong vaccine administered.   Follow up information received from other health professional on 5th May 2020: The patient demographics details were updated. On 24th February 2020, the patient received the 1st dose of Infanrix intramuscularly. Less than 3 months after the patient experienced influenza-like symptoms and discomfort. The patient was due for Tdp vaccine the medical assistants misunderstood directions of physician and drew up and administered Dtap to the patient. This could had been prevented should the MA had used critical thinking as well as educational regarding age range on Dtap vs Tdap. In speaking with the patient, he did not express any adverse events abnormal to any other vaccine he had. Reported very mild flu-like symptoms. The reporter spoke directly with patient who reported that he did know if he was experiencing adverse reactions because of similar reactions to vaccine in past. Mild discomfort and flu like symptoms. The reporter advised the patient to notify immediately should any additional or abnormal  symptoms present themselves. Till 17th April 2020 nothing additional had been reported. The VAERS details were updated. It was unknown if the reporter considered the influenza-like symptoms and discomfort to be related to Infanrix.
Patients received expired moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received expired moderna Covid-19 vaccine) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received expired moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received expired moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. It was reported that the vial did not undergo temperature excursion. The vial was initially stored in the refrigerator on 04-Apr-2022. Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow-up received contains non-significant information: updated reporter contact details.
Medication Administration Error The patient was to receive her second primary dose of Covid-19 Pfizer vaccine but was accidentally given the Pfizer bivalent vaccine instead. The clinical pharmacists were notified and the patient was contacted. Any further Covid-19 vaccinations will follow booster protocols.
Patient stated he went to ER in late evening presenting with swollen throat area. ER stated they gave him IV Solu-Medrol. Wrote prescriptions for prednisone, Benadryl and Ventolin which patient filled on 6/26/14 in the morning.  Patient stated that he felt better this morning but decided to fill his prescriptions to follow MD's orders.
arm started hurting, nausea and fatigue/malaise, headache within first 24 hours - that's all very expected, and was much less severe than with the 2nd base shot and 1st booster (I had Pfizer for all 3 prior doses).  I took Advil a few times to reduce the arm pain and headache. HOWEVER, today even though I was starting to feel better, after eating a late lunch, I had sudden, severe (ie shat the bed) diarrhea. I took Imodium after cleaning up, and have "Liquid IV" drink powder on hand for rehydration, so I am still treating at home. Please note that I was advised NOT to get the flu shot at the same time, so I only got this one.
The patient received Pfizer vaccine in his left arm, then we reivewed his administration form about his flu shot and I gave the Flucelvax vaccine in his right arm.  As soon as I pulled the needle out and reached for the band aid, he lost conciousness.  A caretaker of the center called him by name many times and he was unresponsive for 15-20 seconds.  She said he was having a seizure.  She said he has had them in the past, but it has been a very long time since his last eipsode.  He regained conciousness after 15-20 seconds and he was warm to the touch.  He cough several times as if he was going to vomit, but he never did.  We called 911. The patient insisted that he was fine and he did not want to go to the ER and did not want to lay down.  Paramedics came and evaluated the patient.  His BP was 110/70, Pulse of 76, and had an oxygen sat of 97. They waited until about 1:10 and then they left when they felt he was stable. The patient left with a caretaker.
Patient described that on 9/12/2020 (day after vaccine administration) left arm was red and swollen. She has experienced congestion, cough, muscle aches, diarrhea, and general fatigue since 9/12/2020. She is still experiencing these symptoms 9/21/2020.
pt recv vax ID 12AUG94 & devel a rash @ the inj site on lt forearm which was 1 1/2inches in diameter; w/in hr pt recovered;
Positive Influenza B test result, severe headache, body aches, chills, fever, fatigue, dizziness, sore throat, cough
about 8 am the day after shot, left eye had blurry periphery vision for about 15 minutes, slight headache in right hemisphere for about 15 minutes afterwards.  blood pressure during this time was about 160/90 taken by nurse at work.  Symptoms went away about 8:30 am
Patient should have received the second dose as Pfizer, not Moderna. Nurse vaccinator inadvertently gave incorrect 2nd dose vaccine. Follow up with patient today (4/20/21) reports no adverse events other than the expected reaction after 2nd dose.
Vaginal bleeding one week post partum. Due date 4/6/2021. Delivered on 4/11/2021. Healthy boy, 7 lbs 6 oz. Forecept-assisted delivery.  Bleeding started one week later. Large amount of bleeding. Three units of blood transfused. In ER/ICU for approximately 40 hours.
Fever 104.7 with febrile seizures.  9/25/2008 MR received for DOS 9/5-7/2008 with D/C DX:  Febrile Illness likely 2' to Pediarix immunization.  Questionable seizure. 30 wk premie.  Mild dehydration. Pt presented to ER with fever of 104'F, loose stools, spitting up and questionable seizure. Sepsis w/u (-). Given IVF and abx until cx were  (-). D/C home.
This is a spontaneous report from a contactable medical assistant reporting on behalf of a medical practice. This medical assistant reported similar events for 3 patients. This is the 1st of 3 reports.  A 65-year-old male patient received PREVNAR 13) Lot # N34935, Expiry Date Oct2017) via an unspecified route of administration at 0.5 ml, single at left deltoid on 09Dec2016 for immunization, at physician office. Relevant medical history (including any illness at time of vaccination) were none. The reporter did not wish to share his concomitant medications or other medical conditions. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the suspect. Prior Vaccinations (within 4 weeks) were none. No AEs were reported as following prior vaccinations. In Dec2016, about 2 days after the injection, he began to experience redness, swelling, heat and pain at the injection site.  He went back into the office and was treated for cellulitis. His side effects lasted about 2 weeks, and he has completely recovered in Dec2016. He had no relevant investigations done.; Sender's Comments: A causal relationship between the administration of PREVNAR 13 and the occurrence of the reported events cannot be excluded based on the temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2017005458 Same reporter/product/events, different patients;US-PFIZER INC-2017005460 Same reporter/product/events, different patients.
Administration error: An 8 year old male patient receives his first dose of the Pfizer-BioNTech gray vaccine, Which is licensed for patients 12 years of ae and older.
J96.00 ACUTE RESPIRATORY FAILURE 7/23/2021 UNSPECIFIED DEMENTIA, UNSPECIFIED SEVERITY, WO BEHAVIORAL DISTURBANCE J96.00 ACUTE RESPIRATORY FAILURE 7/23/2021 UTI (URINARY TRACT INFECTION)
Immediately after receiving my vaccination for the second dose my arm began to be in pain. I cannot even pick my arm up and if I put any pressure on the arm I can feel the pain permeating from the vaccination site. The pain is continuing since the second shot and is causing issues with work and quality of life. I have talked with my physician and have been referred to a neurologist.
On 2/19/21, patient was 17 years old and was vaccinated with covid 19,  vaccine was indicated for 18 years old.   Neither patient nor parent reported any adverse events, signs and symptoms after dose was administered.  Patient came back and received 2nd dose on 03/17/21.
facial twitching on the left side of the face which started with her lip which lasted for a couple of hours and moved to her left cheek the next day. These were resolved until she noticed left lower eyelid twitching last Sunday night; left lower eyelid twitching; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported to have received the first dose of the vaccine almost 3 weeks ago and it will be exactly 3 weeks on Monday. Last week on possibly Friday (Jan2021), she noticed facial twitching on the left side of the face which started with her lip which lasted for a couple of hours and moved to her left cheek the next day. These were resolved until she noticed left lower eyelid twitching last Sunday night which had happened about 30 times with durations of about 4 seconds until now since Sunday. She is asking if this was reported and if she was to proceed with 2nd dose. The patient recovered from facial twitching on the left side of the face which started with her lip which lasted for a couple of hours and moved to her left cheek while did not recover from left lower eyelid twitching.  Information about Lot/Batch number has been requested.
The adverse outcome was a miscarriage. The due date was the 12th of July 2022 based on my last period of October 5th. At the time of injection, I was not aware I was pregnant. I took a pregnancy test November 23rd and found out I was pregnant. The next day I suspected a miscarriage when I started bleeding in the afternoon.   Previously I had a healthy pregnancy with delivery on April 1, 2020. No previous miscarriages.
Email from patient today: "I just wanted to let you know I had a terrible reaction to the shingles vaccine I received. I had horrible nausea, fever, chills, and my arms, neck, shoulders and back were clenched and totally locked up so that my arms were behind me and my head was pulled back. Today, the nausea, fever and chills are gone but I feel like I was hit by a truck, my entire body aches. I would greatly appreciate it if you report this reaction to the necessary parties (drug manufacturer and/or CDC). If that is not something you do, please let me know and I will look into it."
pneumonia; pulmonary embolism; This serious case was reported by a physician via call center representative and described the occurrence of pneumonia in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   Concurrent medical conditions included asthma and chronic obstructive pulmonary disease.   On an unknown date, the patient received RSV vaccine and Flu vaccine. On an unknown date, less than 2 weeks after receiving RSV vaccine and Flu vaccine, the patient experienced pneumonia (Verbatim: pneumonia) (serious criteria hospitalization and GSK medically significant) and pulmonary embolism (Verbatim: pulmonary embolism) (serious criteria GSK medically significant).  The outcome of the pneumonia and pulmonary embolism were unknown.   It was unknown if the reporter considered the pneumonia and pulmonary embolism to be related to RSV vaccine and Flu vaccine.     It was unknown if the company considered the pneumonia and pulmonary embolism to be related to RSV vaccine and Flu vaccine.   Additional Information: GSK receipt date: 21-SEP-2023 The Reporter was a GSK employee who was reporting on behalf of an HCP (MD).  The health care professional (HCP) had a patient who received dose of RSV vaccine unknown if Arexvy or Abrysvo.  Patient had a history of Chronic obstructive pulmonary disease (COPD) and asthma.  The patient received another vaccine at the same time as the RSV vaccine which was potentially a flu vaccine. 2 weeks after receiving the RSV vaccine, the patient was hospitalized with pneumonia, duration unknown.  The patient also recently present to the emergency room with pulmonary embolism. The reporter consented to follow up. Note: As vaccine was unknown if AREXVY or ABRYSVO but reported received dose of RSV vaccine so suspect coded as per generic name.
After ZOSTAVAX was administered, patient experienced wheezing and difficulty breathing (approximately 15 minutes later). BENEDRYL 50 mg was given to her. Blood pressure measurements showed increase in blood pressure. Patient had rapid relief of wheezing/breathing and went home after 30 minutes.
Vaccine given incorrectly in only one nostril. To be revaccinated 11/6/09. There was no adverse event. Patient was just given 1/2 dose of Flumist and was later revaccinated.
Tested positive for Covid 19; Experiencing symptoms of COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for Covid 19) and COVID-19 (Experiencing symptoms of COVID-19) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COVID-19 on 27-Jan-2021.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for Covid 19). On an unknown date, the patient experienced COVID-19 (Experiencing symptoms of COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for Covid 19) and COVID-19 (Experiencing symptoms of COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, COVID-19: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported by the reporter. Treatment details was not reported by the reporter.
before the shot, the patient reported that he has a history of fainting. Patient fainted shortly. was given ice pack, and recovered over about 20 minutes.