chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After Dose 1 08/26/2021 was in menopause and she noticed that she had some bleeding after Dose1, biopsy for two weeks later and informed that it was a side effect of the vaccination. Felt like a rod went down her spin Really bad head ache and numbness with feet. Hot flash like fever, warm and flush and numbness tingled, short of breath like a wait on her and numbness and hands and body aches and computer work was getting worst and saw a occupational health and primary health provider and did not miss work but felt miserable and upcoming Neurology test coming up. 10/07/2021 appoint with PA and urgent care on the Saturday 09/25/2021 Urgent care visit.
A swollen gland in the left underarm. Tenderness for approximately 48 hours.
doctors administered Flublok Quadrivalent to a 16 year old female patient with no reported adverse event; Initial information received on 19-Oct-2023 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 16 years old female patient and Nurse reported that the doctors administered Influenza Quadrivalent Recombinant Vaccine [Flublok Qiv] to a 16 year old female patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the 16 year old female patient received a unknown dose of suspect Influenza Quadrivalent Recombinant Vaccine (strength, expiry date and lot number not reported) via unknown route in unknown administration site as Prophylactic vaccination (immunization) (product administered to patient of inappropriate age) (same day latency). Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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 the 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.
I was at a regular doctor visit we noticed that my blood pressure was elevated. We increased my Losartan and tried Nifedipine and then removed Nifedipine. I am now on Metoprolol. I am currently waiting to see if this medication will lower my blood pressure.
This case was reported by a other health professional via sales rep and described the occurrence of feeling bad in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was recovered/resolved. It was unknown if the reporter considered the feeling bad to be related to SHINGRIX. Additional details were provided a follows: The age at the vaccination was not reported. The reporter reported the patient felt like they were hit by a truck for 2 days. This case was linked with the cases US2018GSK204598 and US2018GSK205480, reported by the same reporter.
This literature marketed report as received from the author refers to a 28 year old male patient with asplenia. This is case 1 of 5 reports. Patient's medical history was not reported. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose and frequency unknown) in the arm. Other suspect therapies included influenza virus vaccine (unspecified). Both the vaccination were received in the same arm. Patient's concomitant medication was not reported. On an unknown date the patient experienced large local inflammatory reactions (erythema, oedema and warmth) (hospitalization), fever (hospitalization), leucocytosis (hospitalization) presumed cellulitis (hospitalization) and vomiting (hospitalization). The patient's laboratory results included WBC 29.7K/microliter, and maximum temperature of 104.5 degree F. The patient sought care within 2-3 days of vaccination and was admitted to the hospital for observation. Patient received full courses of antibiotics to cover for common skin flora as well as methicillin-resistant staphylococcus aureus. Within 5-7 days, the patient experienced improvement in the skin findings and resolution of the systemic symptoms. From the records available, it appeared that only patient 1 had received (manufacturer unknown) PS23 vaccine prior to this reaction. The indication for prior (manufacturer unknown) PS23 vaccination was the patient's asplenia. The date of this prior vaccination was not available as it occurred prior to the patient's enrollment in the healthcare system. The outcome of the events localized inflammation, injection site erythema, warmth and edema and presumed cellulitis was considered as resolving and outcome of fever, leucocytosis and vomiting was considered as resolved. The reporter considered the events to be related to Pneumococcal vaccine, Polyvalent (23-valent) (manufacturer unknown). This case is linked to case # 1405USA008574, 1405USA008573, 1405USA008575 and 1405USA008576 (same reporter link). Additional information has been requested.
Client received the COVID vaccine (Pfizer, lot # ER8731, expiration date 7/2021) at 11:15. Client  walked up to the EMT desk and reported dizziness and blurry vision, EMT and RN responded at 11:28. The client returned to her seat, ambulating with a steady gait, no visible distress, color normal. Vital signs obtained: blood pressure 122/78, heart rate 88, respiratory rate 12, O2 level 99%. Client stated she experiences these symptoms before she gets a migraine. The client stated that migraines are her only medical condition, she has no prescribed medications and no allergies. The client was alert and oriented and had no difficulty breathing. The client stated she hadn't eaten yet and just had a drink of water at 0740. She refused water and benadryl. At 1133, the client stated that she felt "totally fine" and wanted to leave. Encouraged the client to stay for 30 minutes from her symptom onset but she deferred. Education provided regarding mobile reporting system, emergency management and AMR activation, and primary care follow up. Client denied questions and left at that time, ambulated with a steady gait to her car.
fungal infection in the groin; This is a spontaneous report from a contactable other-HCP (healthcare professional) and contactable consumer. A 48-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical drugs included patient reported that, she missed her doses of tofacitinib citrate (XELJANZ) for approximately two months since Nov2020 due to her asthma worsened and she was on prednisone for her asthma. The patient experienced fungal infection in the groin on an unspecified date. The patient stated that she used jock itch ointment and it gets better but never really goes away for the event. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
COUGH, Fatigue, Muscle or body aches, Headaches, Congestion or runny nose, Nausea or vomiting and Diarrhea
Patient became weak and unable to hold his head up one day following injection. Following day, low appetite. Day 2, had vomiting and unable to take in any PO. Day 3, was able to start eating. Day 4 and 5, he had improvement of neck pain. Day 5, had drop in blood pressure into the 70-80s systolic and 40-50s diastolic at home and then again in the clinic with no other signs of illness.  Day 6, found to have Acute Kidney Injury on his CKD with creatinine rising into the 5's with baseline creatinine of 1.4-1.6. His liver function was abnormal also with elevated bilirubin to 6 (baseline normal 1), Alk Phos 522. He was hospitalized 2/25-2/28/2021 for these issues.
Lower lip swelling and tongue burning on 2/13/2021, responded to benadryl 25mg  Lower lip swelling recurred on the opposite side 3/1/2021, responded to benadryl 25mg
Pain started in afternoon which I thought was normal. by the next day arm was excruciating, so swollen that I couldn't bend it. Looked like, huge red, inflamed arm from armpit to elbow. Took ice packs, and Motrin - discoloration is ever so slight today 7/31/07
This COVID booster (#2) was given SQ instead of IM. I had no reaction as I had with previous vaccines (flu-like symptoms) and I have a swollen, tender, itchy area where the vaccine was given subcutaneously.  I called Allergy dr and the message sent to me was that Dr said I would have an immune response anyway. Nothing else. It is too early to know if there will be other issues with this medication error.
15 minutes after the vaccination, I fainted. Had already left Pharmacy and was unconscious for about 20 minutes.
It was reported that a 31 year old female patient received a Yellow Fever vaccination (lot #UB077AA) and a Hepatitis A (lot # 0863L) administered on 10/16/01. Reportedly the next day a rash developed on the patient's face--unresolved. Patient will be seen by her family practitioner, date not specified.
upon receiving the vaccine, a large amount of blood squirted out. the patient passed out after a few seconds of bleeding. we elevated the patients legs were elevated and she was given water. Emergency was called and the patient was evaluated. bp and pulse were okay. patient elected to go home rather than the hospital.
Per EMS report, approximately 5 minutes after vaccination, client reports dizziness, and numbness to the lips and tongue, denies any other symptoms, client taken to observation area, vital signs checked BP 132/76, HR 81, 02 Sat 96%,  Client states had Benadryl tabs in purse but preferred liquid Benadryl, Given 25 mg  Children's Benadryl PO, client was monitored for 45 minutes and reports symptoms resolved and return to baseline. Client departed using rideshare Lyft without further incident
Fever about 6 hours after. 103 2 days later. Headache worse 1 day later. Sore throat worse 1 day later. Dizzy 1 day later.
Information has been received from a nurse concerning a 13 year old female patient who on 04-JAN-2008, was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 657006/0188U) IM, on 19-MAR-2008 was vaccinated with the second dose of GARDASIL vaccine (yeast) (lot # 659657/1487U) IM and on 09-JUL-2008, was vaccinated with the third dose GARDASIL vaccine (yeast) (lot # 660553/0070X) IM. The nurse reported the patient developed hives, arthralgia and swollen knees and ankles after administration of her first dose of HPV vaccine in January-2008. The patient experienced the symptoms intermittently through receiving her HPV vaccine series. Medical attention was sought. The laboratory diagnostics studies performed were sedimentation rate, CBC and rheumatoid factor were negative. The patient's hives and arthralgia and swollen knees and ankles persisted. The patient is being treated with ibuprofen (motrin) and cetirizine (Zyrtec). Additional information has been requested.  10/08/2008 PCP office records received. 13 yr WCC 1/4/08.  PE WNL except nevus noted on neck, wart on finger. Seen 5/19/08 for worsening joint pain, constant x 2 weeks-5 months duration. Pain ankles, knees, hips and back. One time ankle swelling. Sent for labs. DX: Joint pain-unspecified. Seen 7/9/08 for spreading rash and joint pain. PE (+) for wheal and flare lesion on knee and shoulder. Pediatric Rheumatology consult 8/21/08 with Impression: Arthralgia associated with mild joint hypermobility. Urticaria. Pt reports transient joint swelling as well. Tx with Aleve.
?Pfizer-BioNTech COVID-19 Vaccine EUA"  Fever of 101, generalized myalgias, injection site swelling and pain
minor headache to start, but unrelieved 4 days later even with use of Excedrin.  On 31 Jan dizziness began, becoming persistent on 1 February.  Mental fatigue.
This was my second SHINGRIX vaccine. The first time I only had redness and soreness at the injection site. After the second one, in addition to the former I experienced muscle aches, headache, chills and dizziness.
Immediately after vaccine was administered 05/02/2015 the patient started experiencing chronic gastrointestinal issues to include IBS-D, chronic abdominal pain, as well as a slight sensitivity to certain foods. Immediately following the 2nd vaccine administered 09/10/2018, all outstanding health issues caused by initial vaccine were exacerbated causing chronic pancreatitis, chronic abdominal pain, insomnia, inability to consume solid foods and continues to be an issue to this date.
Admission 7/29/2021 Medical Center 4E Active Problems - documented as of this encounter (statuses as of 07/31/2021) Problem Noted Date COVID-19 virus detected 07/31/2021 Last Assessment & Plan:    Formatting of this note might be different from the original. Asymptomatic COVID-19 infection Chest x-ray does not show any acute findings Patient does not have any fever or chills or nausea or diarrhea or shortness of breath or cough Vaccinated in the past No treatment indicated at this time Advice self quarantine at home for 2 weeks   Near syncope 07/29/2021 Last Assessment & Plan:    Formatting of this note might be different from the original. Patient with 3 episodes of near-syncope while at rest today and presently NIH 0 with no focal deficits and denies vertigo. Patient has been on Eliquis thus should have CT head rule out pathology such as subdural or infarct despite Eliquis therapy. Will monitor on telemetry to rule out for arrhythmia such as paroxysmal atrial fibrillation or bradyarrhythmia and will monitor hemodynamics as patient may have either elevation or low blood pressure as partial etiology for her dizziness as well. She does have T-wave inversion inferior leads and troponin undetectable patient denies chest pain. Case reviewed with Cardiology will trend troponins give single dose aspirin 81 mg and stress test in a.m.. 7/30- Improved symptomatically. Vitals stable. No significant arrhythmia on monitor. CT head no acute CVA. Echo- normal LV size, function and EF 60%. No regional wall motion abnormalities and Carotid ULS -no significant stenosis.  MRI of the brain negative finding Negative for orthostatic hypotension Status as per patient's request Patient's symptoms of dizziness has resolved   History of pulmonary embolism 07/29/2021 Last Assessment & Plan:    Formatting of this note might be different from the original. Patient states she has been on Eliquis for years for paroxysmal atrial fibrillation and had episode of DVT pulmonary embolism over 10 years ago. She denies shortness of breath or chest discomfort and has been continued on Eliquis Continue Eliquis
hives on torso and back,  bilateral hands, bilateral Lower extremity , history of dermal fillers in december 2021
Right arm swelling at injection site, redness/rash at injection site. Localized to right arm injection site.
Initial report received on 1/27/2006 from an investigator participating in the above mentioned trial under the reference number FID02. A 61 year old female subject received an intradermal injection of either study article influenza virus vaccine USP trival A and B high dose, Subvirion U or study article influenza virus vaccine USP trival A and B Subvirion U on 9/27/2005. On that day she developed redness at the injection site which resolved over the next nine days. Twenty one days post vaccination, she had no complaints and was administered an intramuscular injection of Fluzone SV 2005-2006, lot number not reported. Approximately ten days following that vaccination, she was hospitalized with neurological complaints and diagnosed with transverse myelitis. A MRI showed subtle findings in the spinal cord. She was treated with steroids and fully recovered. Per the reporter, the subject is now (date not reported) readmitted with an exacerbation of the disease, and the neurologist believes this is a form of acute disseminated encephalomyelitis. The MRI findings are extensive in the posterior cord although her clinical symptoms are not as bad. She also has CSF pleocytosis with 100 cells/cu mm. Per the reporter, the subject may have had subtle neurological symptoms for years that had not been reported for medical attention. With exacerbation and remissions, it may be the start of multiple sclerosis. At the time of this report, the subject had not recovered. The causality of the event is reported as associated. Follow up information received on 2/3/2006. The onset date for the second episode of transverse myelitis is reported as 1/27/2006. At the time of this repot, the subject had not recovered. According to the investigator, the event is related to the study, product.
Red swollen right thigh warm to touch. Rx: moist heat, Benadryl and Augmentin ES
very spotted and almost look like blood clotting under the skin; Headache; Bruising from her waist all the way down to her ankles; She has a low, lower immune system.; She actually lost a few pounds just a couple weeks after; She started feeling tired; Two days later the bruising started swelling up; She wasn't feeling good.; This is a spontaneous report received from a contactable consumer (parent).  A 16-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) age at vaccination of 16-years-old, as single dose, for covid-19 immunisation.  Medical history included narcolepsy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, about four days later vaccination, the patient had like bruising from her waist all the way down to her ankles. It was unknow if it was clotting or if it was bruising but they were all over her legs. So, patient went to the hospital because mother didn't know it looks really odd. It was very spotted and almost look like blood clotting under the skin, not like typical bruising. She has a low, lower immune system. Patient weight was about 100 pounds but she actually lost a few pounds just a couple weeks after because she wasn't feeling good since the first shot. So, she is down to like 96 right now and ever since that we have this. The patient started feeling tired and headache and everything probably within the day and then about two days later the bruising started swelling up and then three and four days and five days just the bruises kept coming. So, they were it was like a couple of new bruises on her legs everyday and then about the fifth day the bruising stop and kind of just kind of disappear it from there. No treatments were administered for the events. Outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Syncope; Psychosis; Encephalopathy; This is a spontaneous report from a contactable physician. A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in arm left on 18May2021 12:00 at the age of 59-years-old (Batch/Lot Number: EW0176) as single dose for COVID-19 immunization. Relevant medical history and concurrent conditions included hypertension (HTN), overactive bladder, benign prostatic hyperplasia (BPH). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered on 22Apr2021 at the age of 59-years-old (Batch/Lot Number: ew0164) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included amlodipine, lisinopril, oxybutynin, tamsulosin, hydroxyzine. The patient experienced syncope, psychosis/encephalopathy within 2 hours at 18May2021 14:00. Duration of hospitalization was 2. AE treatment included antipsychotics. The patient underwent lab tests and procedures which included Nasal Swab: negative on 20May2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of events was not recovered.; Sender's Comments: Based on temporal association, a causal association between the reported events and BNT162B2 cannot be fully excluded. Case will be reassessed when additional information is available.   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 RAs, Ethics Committees, and investigators, as appropriate.
No adverse event. Vaccine was reconstituted with bacteriostatic sodium chloride contrary to manufacturer's instructions.
Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 031M20A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy (mastectomy in the left side in the past.). Concomitant products included LEVOTHYROXINE, LISINOPRIL, MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) and VITAMINS NOS for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (Shortness of breath). On 09-Mar-2021, DYSPNOEA (Shortness of breath) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Heart rate increased: increased (High) heart was beating real fast for 15 minutes..   After the second dose, while returning home from the vaccinations site, after waiting the recommended 15 minutes. patient experienced the events.  Treatment medications were not provided.   This case was linked to MOD-2021-396109 (Patient Link).
This case was reported by a physician via sales rep and described the occurrence of felt faint in a 62-year-old male patient who received Shingrix (batch number 4LP5Y, expiry date unknown) for prophylaxis. On 6th September 2018, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, less than a month after receiving Shingrix, the patient experienced felt faint, low blood pressure, fever, tremor, chills and myalgia. On an unknown date, the outcome of the felt faint, low blood pressure, fever, tremor, chills and myalgia were unknown. It was unknown if the reporter considered the felt faint, low blood pressure, fever, tremor, chills and myalgia to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix on the left deltoid. The patient had very high fever, shaking, chills, myalgia, went to emergency room (ER) because blood pressure low and he thought he was going to pass out. The reporter agreed to be contacted on follow up. Lab Comments: On an unknown date, the patient blood pressure was measured.
Parents brought child in for vaccination and completed consent and had child's birthdate at 11/09/2016. After vaccination given, parents said they would get the second dose in where they reside, but they had been unable to get it before coming for visit. When we tried to submit administration to insurance it was denied as the child was 4 years old. Called mother to talk with her, explained what insurance said. Mother confirmed DOB, and said she were traveling and were scared.