chrisvoncsefalvay/vaers-outcomes huggingface dataset:
about 3 weeks later, I noticed about the 28th of the month, I noticed that her speech started slurring, and it didnt get better, or worst. And that was the sign of a hemorrage (stroke) With in a few days later, the right one was totally paryalized and she couldnt make a fist. Her right leg started turning inward, she could not raise her leg. She took a fall a few days later, and ended up with a fracture in her leg. Her right side of the body was effected. The Neurologist showed the effects of the brain. A year later, shes making progress, but she still has effects from the stroke. MRI showed stroke as a 5 on a scale of 1 - 10. Her speech is not all the way back. She is a fall risk. I have had to spend 1000.00 out of pocket for someone to help with her. She has had falls due to this.
rotator cuff tendonitis is reported in a pt receiving 1 dose of fluogen; pt exp upper lt arm pain which was dx on 28OCT93 as tendonitis; pt was treated w/ a support sling, ice & non-steroidal anti-inflammatory meds; still pain limited ROM;
No discomfort noted at injection. Usual discomfort (mild) on the next day. Then as days passed, pain in left deltoid became worse with weakness noted because of intense pain at injection area.
Patient broke out is small bumps on her hands and legs same day August 27th. August 28th  she got an enormous lump at the vaccination point that was large red and warm. it was about a 3" round circle. lasted for days.  she got a fever of 103 plus with no other symptoms for 6 days after that. Took her to the Dr the next week because her fever wouldn't let up with both tylenol and motrin on board. The dr said if her fever didnt go down over the weekend- she would need to be brought back in for blood work. luckily her fever broke on day 8. she still has a very small lump present to this day that she scratches and says hurts every day and night- some days she makes it bleed.
Entire arm swollen up to neck, hurt to move, tingling and sensitive to touch, headache, nausea and flu like symptoms.
Information has been received from a physician concerning a 62-65 year old female with a history of breast cancer four to five years ago with local resection, radiation and chemotherapy and no known drug reactions or allergies who on 09/19/2006 was vaccinated SC with 0.65 ml dose of varicella zoster virus vaccine live (lot 652965/0622F). Concomitant therapy included Tamoxifen citrate. On 9/27/06 the pt developed lesions and painful pustules on one side of her abdomen and back, diagnosis was possible shingles. The pt was scheduled to be seen dermatologist on 9/28/06 for diagnosis and possible treatment. At the time of the report, pt had not recovered. No lab studies were performed. There was no product quality complaint involved. Additional information has been requested.
MenA Lyophilized Conjugate Component mixed with just plain sterile water; MenA Lyophilized Conjugate Component mixed with just plain sterile water; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 13-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA908A, expiry date 30-APR-2024) for prophylaxis.   On 14-AUG-2023, the patient received Menveo (left deltoid). On 14-AUG-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: MenA Lyophilized Conjugate Component mixed with just plain sterile water) and inappropriate dose of vaccine administered (Verbatim: MenA Lyophilized Conjugate Component mixed with just plain sterile water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-AUG-2023 The Menveo was reconstituted improperly with sterile water instead of provided liquid conjugate component, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter called to report an administration error for the Menveo Vaccine and he gave only the MenA Lyophilized Conjugate Component mixed with just plain sterile water to a patient in the left deltoid (Inappropriate Reconstitution Technique). The reporter consented to follow-up.
Initial report received on 28 July 2010 from another manufacturer, Merck, under service request 1-3630816675. The reporter was a pharmacist. An infant patient, whose medical history was not reported, received an unspecified Pertussis vaccine (manufacturer and lot number not reported) on an unspecified date over 15 years ago. The patient was reported to have had a severe reaction to the pertussis vaccine. No other information was available. Follow-up information received from a pharmacist on 07 September 2010. Due to the following information, this case was upgraded to serious. The patient's date of birth was provided as 08 January 1988. The patient is a female. It was unknown if the patient had any concurrent illnesses at the time of receiving the Pertussis vaccine, and an additional polio vaccine (trade name, manufacturer name, lot number, route and site of administration  were unknown) over 15 years ago. It was reported the patient experienced a seizure after administration of the vaccines and recovered (date not reported). Time and course of the seizure were unknown. No other information was provided. Documents held by sender: None.
resp distress & generalized swelling & urticarial rash noted by mom approx 1 hr p/leaving office; instructed via phone to give DPH & Ventolin & go to nearest ER;
It was reported that a 21 year old female pt received Menomune A/C/Y/W-135 vaccination administered on 30-OCT-2001. Approximately 4 days after vaccination the pt developed ringing in her ears. She was seen by general practitioner no infection was found. Pt was also seen by ENT specialist, a hearing test was done, results, significant amount of hearing loss noted. Pt to be seen by MD for evaluation, date of appointment not specified.
These symptoms included fever, fatigue, malaise, and joint pain/Has had over a month of fever; These symptoms included fever, fatigue, malaise, and joint pain; These symptoms included fever, fatigue, malaise, and joint pain; These symptoms included fever, fatigue, malaise, and joint pain; This is a spontaneous report from a contactable physician reported for patient. This is 1 of 2 reports. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), via an unspecified route of administration, administered at unspecified anatomical location on 14Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced fever/has had over a month of fever in Apr2021, these symptoms included fever, fatigue, malaise, and joint pain in 2021. The patient underwent lab tests and procedures which included antinuclear antibody: normal, polymerase chain reaction: normal, sars-cov-2 test normal. The reporter asked regarding two of his patients and seek any medical information to help him better make his decisions in providing treatment. HCP states that his first patient received the Pfizer COVID 19 vaccine on 14APR2021 and developed adverse effects beginning the following day and states that this has been ongoing with symptoms for a month and that he has seen the patient around 4 times since then which the last visit being 10MAY2021. The patient continues to have daily elevated temperatures throughout the day, but the other symptoms have started to decrease. Reporter have run tests to rule out other things such as ANA, PCR flu, covid, body temperature: daily elevated etc. and they have all resulted normal. The reporter asked are there been reports of ongoing fevers like this. The reporter wants to know is there any information on the efficacy of the Pfizer COVID 19 vaccine when the doses are given longer than 21 days apart. The reporter reported that he wanted to see if Pfizer has any information regarding patients running fevers for an extended period following the Covid-19 vaccine and declined to complete safety report. Report filed with minimal information provided. Reporter provided with phone number, and reportum reference number, JPVY58TK, prior to transfer. The outcome of the event was unknown  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
extreme pain in upper arm & down arm to thumb, upper arm still has pain 4 days later, especially when arm is raised,pain not just in the area the shot was given, also pain in trapezius
The injection site has hardened creating a raised, red circle approximately 3 inches in diameter that radiates heat to the touch, is extremely sore, and occasionally itchy.
No adverse events occurred. The patient was administered a Pfizer Pediatric Covid vaccine that was stored in the refrigerator for 17 days beyond what is approved by the manufacturer.
?Pfizer lot #FJ6369 with temp excursion. Reported to Pfizer company and ok?d for use. Instructed by their staff to report each dose given in this system.?
Head feels heavy inside and have brain fog, forgetful, headaches atleast 4 times a week and causes base of head to hurt and neck- achy feeling. I take Aleve daily for this
Patient described a swollen, painful, warm to the touch rash about 3-4 inches below her injection site. The rash began to appear the evening after her injection and was still present 4 days later.  Patient believes it may have improved slightly.
Patient came in to get her first shingles shot and was given a covid -19 (Pfizer) shot in error. She began to think about the timeline the technician gave her for the next shot and then thought she may have been given a covid-19 shot. Upon verification she was correct. They administered the wrong shot. She was concerned because she had already received her covid-19 vaccinations (moderna ) in January and February 2021.  She stated she has had no adverse reactions. We have been checking on her and continues to report no adverse events.
Patient reported to COVID Vaccine administration site two days post vaccination for Pfizer COVID vaccine to report an itchy red, raised bump/hard nodule at the vaccine site. Vitals were as follows: BP 137/74 O2 Sat on RA 99.9% HR 93 Physician evaluated the patient and instructed to apply compress and report to ER if symptoms worsen.
Pale, shaking, red spots/welting up all over and fussy. Parents were advised to take the child to the nearest ER. On follow-up, they did not take the child for treatment and "he is fine" per dad.
Case number PHEH2014US024274, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up received from nurse on 21 Jan 2015. This report refers to a 56 year old  female patient. Medical history was not reported. Concomitant medications were none. She was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly into the right deltoid at a dose of 0.5 ml on 21 Nov 2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hours and 15 minutes. The patient did not experience any adverse reaction due to the maladministration. No further information was provided. Follow up received from nurse on 21 Jan 2015: updated site of vaccination and reporter comment.
High temp 105.4 nauseated, anorexic, couldn't walk; out of balance; Legs hurt;
SORE ARM; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-MAY-2021, the subject experienced sore arm. The action taken with covid-19 vaccine was not applicable. The patient recovered from sore arm on 05-MAY-2021. This report was non-serious.
AXILLARY NEUROPATHY (PATIENT STATEMENT)am now far enough along in the progression of this injury where my neurologist is recommending nerve transposition.
Fever of 100.3° which lasted for 14 hours beginning at 11:00PM that evening. Fever was reduced to 99.4° with 400mg acetaminophen orally taken. Fever has not returned since.
AT 4PM ON DAY OF VACCINATION, DEVELOPED DROWSINESS AND FATIGUE
PATIENT WAS GIVEN 0.2ML OF THE 30MCG FORMALA INSTEAD OF 0.2ML OF THE 10MCG FORMULA
Skin rashes; This is a spontaneous report from a contactable consumer (patient) reported that a 23-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number and Expiration Date unknown) via an unspecified route of administration on 26Dec2020 at single dose for covid-19 immunisation.  Medical history included on ongoing birth control.Concomitant drug included ethinylestradiol, norelgestromin (XULANE,Patch) for Birth control.Patient had the first shot of COVID vaccine (later confirmed) on 26Dec2020 and think, she was not exactly sure if it's exactly a side effect from the vaccine but patient just having like skin rashes and wondering if other people have been reporting that as a common side effect. Second dose is coming on Saturday, 16Jan2021.The outcome of event skin rash was unknown without treatment receiving.  Information about Lot/Batch number is requested.
Developed mild pain in the chest the day following the first vaccine dose, painful muscle cramps at arm/injection site, muscle cramps in feet, and very painful colon inflammation which made it difficult to move around.  Also felt feverish for two nights after the injection but did not take temperature to confirm. All other symptoms and body inflammation appeared to have resolved with the exception of painful inflammation in the knees which appeared after all other inflammation symptoms at various other body sites dimminished.
pt recvd vax 5JAN95 & then suffered from 3 days of persistent crying & low grade fever; 5cm area of induration @ inj site;
Rash after starting antibiotic (ZITHROMAX) and recurring flu vaccine and HPV rash - raised red lesions and surrounding erythema on face and upper extremities and around site of influenza vaccine (R) deltoid.
Bells palsy on right side of face for four hours and went away; Tingling sensation that went down the right side of her arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), on 17Apr2021 as dose 2, single (Lot number: EW0158) at the age of 46 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (COVID-19 Vaccine: Dose 1: , Manufacturer: Pfizer, Date: 27Mar2021 , LOT: ER2613, NDC/EXP: Unknown, Dose: Unknown, Route: Intramuscular injection to left arm), administration date: 27Mar2021, when the patient was 46-year-old, for COVID-19 immunization. The following information was reported: BELL'S PALSY (medically significant), outcome "recovered", described as "Bells palsy on right side of face for four hours and went away"; PARAESTHESIA (non-serious), outcome "not recovered", described as "Tingling sensation that went down the right side of her arm". Additional information: Bells palsy on right side of face for four hours and went away. Tingling sensation that went down the right side of her arm. Positive COVID-19 virus on 16May2022 after receiving three Pfizer COVID-19 Vaccines.   No follow-up attempts are possible. No further information is expected.
Pt's right arm was hot to touch and very sore shoulder and arm. She had several red, blotchy areas and spreading.
Proquad expired on 9/16/2020, but was administered on 10/12/2020. No adverse reactions were reported. Patient was scheduled to repeat the vaccine in 3 months. Mother verbalized understanding.
Local reaction right arm. Erythematous wheal like lesion 2 x 1.5 inches and 2 other lesions 1" x 1" HPV Varicella. Arthus Phenomenon.
Vaccine was given 1 day past expiration date.  Did not realize it was short dated when rec'd so we were going by the 10 week BUD.  Patient did not experience any side effects.
Tired; Nausea; Headache; Body ache; A spontaneous report was received from a consumer who is 38-year-old female patient that received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced headache, feeling tired, body ache, and nausea. Patient was breastfeeding but this was reported as a separate case.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28-Dec-2020, the patient received the first of two planned doses of mRNA-1273 (Lot number: 039K-202A) in the left deltoid for COVID-19 for infection prophylaxis.  On 28-Dec-2020, the patient reported she had a bad headache, was tired, had body ache, and nausea. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, headache, tired, body ache, and nausea was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
patient was inadvertently vaccinated with an expired vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 23-Aug-2021 from a Physician via Agency (Reference number- 00740074) and transmitted to Sanofi on 23-Aug-2021.  This case involves a 39-year-old male patient who was inadvertently vaccinated with an expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] with no adverse event (Expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Aug-2021, the patient received a 0.5 mL (total) dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot number not reported and expiry date 08-Aug-2021] via intramuscular route in left deltoid for prophylactic vaccination.  It was reported, "A patient was inadvertently vaccinated with an expired dose of Adacel and requested guidance on how to proceed".   It was a case of actual medication error due to expired vaccine used (latency was on the same day).  At the time of reporting, patient had no adverse event.  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.  There will be no information available on batch number for this case.
Patient has severe anxiety when getting vaccines per Dad. Patient did eat before vaccine at around 10am. He stayed conscious the entire time, but had trouble standing and said he felt like he could not breathe.
The patient was given the Bivalent instead of the Monovalent COVID vaccine for the first does.
3 days after my first dose, my left arm became very tight. 7 days after my first dose I tried a very light workout to try and stretch out the tightness, I did not exert myself very much. The next day my entire arm was so tight that I couldn't move it easily, and had constant tingling in my fingers. for the next week (7-14 days after the shot) the arm stayed very tight. At 14 days my shoulders and back became very tight as well, and by 3 weeks I was having back spasms. I did no heavy lifting or physical activity during this time other than normal day to day household activities.  On 29 July it became completely unbearable, and I went to a military medical clinic in and was placed on 10mg of cyclobenzaprrine (1xday), 500mg of naproxen(2xday), and 325mg of acetaminophen(5xday). I experienced uncontrolled back spasms for the next 4 days and couldn't get out of bed. After those 4 days, while I was in pain and still having spasms I could get out of bed and function a limited amount. By 14 August I was feeling better but still sore and having some spasms.  At this time I am still having some spasm activity in my shoulders but it has subdued substantially.  I have a high pain tolerance and it is rare for me to seek prescription medication because I cannot do my job while on them.
Within a couple days after the shot my right eye was very irritated, I knew it wasn't pink eye though. I called the eye Dr. on the Friday after my shot, and I got in there and he said I developed corneal ulcers in my right eye. They gave me a couple different eye drops and a gel. Then I had to start buying single packet eye drops and get that every month. They put plugs in my eye, and they said they didn't know how I had lasted those few days without help. Then I was sent to an eye specialist, and they said my immune system was attacking itself. Then it finally starting correctly (get better) with more treatment. My vision is still not completely back, and I will have to continue to do the gel drops and the eye drop packets every month.
Major change in the monthly cycle after 25+ years of cycle routine. Major PMS enhancement; Major PMS enhancement.; A normal headache changed to major migraines and cramping for each cycle since the Vaccine.; A normal headache changed to major migraines and cramping for each cycle since the Vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an intramuscular route of administration in the left arm on 25Feb2021 at 12:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient included was allergic to sulfa drugs. The patient did not take any concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an intramuscular route of administration in the left arm on 04Feb2021 at 15:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 12Mar2021, the patient experienced major change in the monthly cycle after 25 plus years of cycle routine, major PMS enhancement. A normal headache changed to major migraines and cramping for each cycle since the vaccine. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events major change in the monthly cycle after 25 plus years of cycle routine, major PMS enhancement. A normal headache changed to major migraines and cramping for each cycle since the vaccine. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events major change in the monthly cycle after 25 plus years of cycle routine, major PMS enhancement was, a normal headache changed to major migraines and cramping for each cycle since the vaccine was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
I took a 27hr flight and a 24hr boat ride, and somehow along the way I caught COVID. I was able to test 4-5 days after first noting the symptoms. I took an Antigen COVID test and it was positive. There I stayed and quarantined in my hotel for 7 days. I got a negative test later that allowed me to go home. During my "stay" my doctor issued an antibiotic and  prednisone.