chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of lyme disease in a male subject aged between 50 and 59 years old (age 60 at the time of reporting) who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included quadruple heart bypass. Concurrent medical conditions included complains of decrease in mental sharpness, decreased strength, irregular heartbeat and joint arthritis. Concurrent medications included Doxycycline, Simvastatin, PLAVIX, FUROSEMIDE, Aspirin, Metoprolol tartrate, TRAMADOL and PARACETAMOL. On an unspecified date (date not known, but the subject reports receiving the vaccine soon after it was on the market) the subject received unspecified dose of LYMERIX (unknown). In 2004, at an unspecified time after vaccination with LYMERIX, the subject started feeling symptoms of arthritis, irregular heartbeat and weakness (also reported as medical history). The subject reported Lyme disease beginning 20 May 2011 with a "positive blood test" on 20 May 2011. This was considered to be vaccination failure. The report was considered to be medically serious by GlaxoSmithKline. At the time of reporting the outcome of the events was unspecified.
Patient received DTaP #4 in left thigh, our office, on 5/29/03 as well as PPD test in left forearm. Parents contacted our after hours service to report body rash and redness on thigh at injection site on 6/5/03. Patient seen in our office 6/6/03 for treatment.
Very red swollen at injection site its been getting worse not better very painful tingling in my hand fingers and arm losing sensation to finger tips at time
12/23 vaccine' 12/27/2020  lower abdominal pain, woke up with symptoms, severe. vomited 1x. Sharp pain. Intermittent.  12/28/2020 pain got less 12/29/2020 referred to pcp. Thought possible ovarian cyst.  12/30 Pain continued, lower abdominal.
2/25/2010 fever, chills, joint pain. 2/26/2011 Injection site red swollen and tender to the touch.  Arm pain. Underarm tenderness.
Patient had known vagal reaction to first shot and alerted team at registration. Patient was taken to separate classroom to receive shot but insisted on receiving it standing up. After administration patient sat on EMS stretcher in case of adverse event. Patient then began reporting lightheadedness and and nausea. Symptoms subsided 10 minutes later. Patient refused transport via EMS and left shortly after symptoms subsided.
received vaccine past published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received vaccine past published expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050e21a) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine past published expiry). On 30-Nov-2021, EXPIRED PRODUCT ADMINISTERED (received vaccine past published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter   This case was linked to MOD-2021-403113 (Patient Link).
Aching, chills, lethargic. Patient is seeking treatment. Outcome to be determined.
Systemic: vaginal bleeding-Mild, Additional Details: patient called pharmacy 6/17 to ask if a side effect of the moderna shot was vaginal bleeding. she was upset as she had a hysterectomy many years ago (leaving one ovary and her cervix intact) and had began spotting bright red blood on 6/17, attributing it to the immunization. informed her of s/s of an emergent situation if it progresses, and the need to mention it to her pcp/obgyn
Patient developed nausea, poor oral intake, dehydration and hyponatremia. This resulted in encephalopathy, falls, and  spinal compression fracture
A company representative reported that a pt received an injection of Prevnar and subsequently, developed a fever. The pt recovered within 1 day. This is 1 of 2 pts from this facility who had an adverse experience following receipt of Prevnar.
Started out with bad chills and a fever. Whole Body ache. Around 9-10am I broke out in hives all over my body that lasted all day. Now they are coming and going
After both 2nd & 3rd dose my period came the next day after several months of not getting a period; This is a spontaneous report from a contactable consumer.  A 53-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on 12Oct2021 11:00 (at the age of 53 years) (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient had no medical history. Concomitant medication included estradiol cipionate; progesterone (PROGESTIN). The patient previously took BNT162B2 DOSE 1 on 17Feb2021 16:30 (lot: EN6201) and DOSE 2 on 10Mar2021 16:30 (lot number: EN6206); at the age of 52 years both in the right arm for COVID-19 immunization; Flu vaccine on 23Sep2021 (at the age of 53 years) for immunization. It was reported that the patient's period came the next day after several months of not getting a period (postmenopausal haemorrhage) on 13Oct2021 04:00. The event was assessed as serious (medically significant). The patient did not received treatment for the event. The outcome of the event was recovered on an unspecified date.
Received the vaccine on a Wednesday afternoon. That evening I developed body aches, which got progressively worse over the course of the following day. I developed a persistent headache on Thursday that stuck around until Sunday. On Saturday morning I woke up feeling ok, still had the dull headache, but was ok enough to be up and around. At approximately 10:30 Saturday morning I was hit with stroke symptoms. I had weakness in my left hand, tunnel vision, couldn?t understand words that were spoke to me and was aphasic with garbled speech.  Went to local ER and was worked up for stroke. Symptoms resolved Within approximately  45 minutes. All tests, lab results ok.
Within 15 seconds of injection, the arm began to itch. Within 30, my whole body was itching. It still has not stopped two days later, after use of Benadryl, a steroid shot, and Pepcid.
She passed out and fell; She passed out and fell; blood pressure was low; This is a spontaneous report from a contactable pharmacist. A 23-years-old female patient received first doe of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on 14Sep2021 (at age of 23-years-old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient had recently received a hepatitis B vaccine for work. Patient participate in annual vaccinations such as the flu vaccine and never had a reaction. On 14Sep2021, she passed out and fell and blood pressure was low. patient administered the epi pen due this incident occurring for the second time back to back. The event she passed out and fell (fall) resulted in visit to emergency room visit. The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on strong temporal relationship, a possible causal association between the event Loss of consciousness and the suspect drug BNT162B2 cannot be excluded. 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.
Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of Zostavax (Merck). Subsequently the patient developed a small rash on her arm. Unspecified medical attention was sought and the patient improved on unspecified therapy. The rash went away after approximately 24 hours and the patient recovered. There was no product quality complaint involved. Additional information has been requested.
3 days after vaccination with inlfuenza vaccine, to right deltoid, noticed itching, then redness around vaccination site.  Upon examination today, redness about size of quarter, still complains of itching, small amount induration at injection site size of quarter.  Patient states redness is worsening over last few days.  Called primary physician, suggested cortisone cream over night.  Patient to call in morning if worse.
Headache swollen glands neck and sore throat Narrative:  Other Relevant History:
Immediately post vaccination pt c/o Nausea Vitals: 10:50 121/88, 86, 12, SpO2 100%, 98.2F -- > 10:59 109/78, 84, 12, 100% -- > 11:10 118/85, 86, 12, 100% -- > 113/75, 77, 12, 100% -- > 11:16 113/75, 77, 12, 100% Pt stable and released from the vaccination site. On 11/9 pt's family reported hip pain to RA.  Hip pain resolved by the evening of the 9th.  NO additional reaction noted.
This spontaneous report was received from a nurse regarding a patient of unknown age and gender. There was no information on medical history and drug reactions or allergies. On 20-NOV-2014, the patient was vaccinated with second dose of RECOMBIVAX HB strength reported as 10 units reported as Y (unspecified units), product lot # H010965, dose, route not reported that expired on 01-JUN-2014. The RECOMBIVAX HB did not have any previous temperature excursions. The RECOMBIVAX HB was found to be supported with post expiry data. No adverse symptoms were reported. There was no product quality complaint involved. The outcome of the events was unknown. Additional information has been requested.
On 12/1/21 I had my first seizure, unfortunately I was outside and I fell on the concrete and subsequently suffered a skull fracture that required a craniotomy. No prior history of seizures. I was taken by ambulance to the hospital where they did a CT test and sent me home with a concussion. Two days later after being completely incoherent, sleeping constantly, and vomiting I went back to the hospital where they performed another CT. They found a bleed and took me into surgery for the craniotomy. We later found out the bleed was visible on the CT from 12/1/21 but it was incorrectly read by the radiologist. He made an addendum to his notes 9 days after the fact. I was in the hospital until 12/8/21. This injury caused me to need physical therapy, occupational therapy, and speech therapy. I'm now on an anti-seizure medication called Keppra and I have a 6 month driving restriction.
chills; had a temp of 104.2; diarrhea; dry cough; This is a spontaneous report from a contactable Nurse.  A 65-years-old male patient (Reporter's Husband) received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) first dose on 12Jan2021 as a single dose for covid 19 immunization. The patient experienced chills on 3Feb2021 09:00, had a temp of 104.2, diarrhea on 03Feb2021, dry cough on Feb2021. Reporter stated that patient had the vaccine three weeks ago on 12Jan2021 and did okay. he had the other one at 6pm on Tuesday. Stated that yesterday at 9:00 that he had class in morning, is a teacher and had chills and wore a coat all day. Stated that when he got home that he went to bed. Stated that he was under three velour blankets and when she came home that she could feel the heat through blankets. Stated that he had a temp of 104.2. Wanted to know if they have seen anything like this or is this something different. Stated that he had slept all night and ran a low-grade temp of 99.1. Stated that he is running the same today. Stated that he had diarrhea that started last night. Stated that she is a retired nurse. Stated that she called the site that he went to get the vaccine and asked them about it and was told that if she was concerned that she should bring him in. Stated that she monitored and watched him all night and gave him fluids. The patient underwent lab tests and procedures which included body temperature was 104.2, 99.1 on 03Feb2021, body temperature was 99.1 on 04Feb2021. The patient received treatment of two extra strength Tylenol and within 45 minutes it was down to 99.1, had a cough and had some Tussin pearle drops, Fluids. The outcome of events was unknown.   Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Information was received 30-JUN-2017 via a phone call from a nurse practitioner who reported that an unspecified patient possibly received VARIVAX and PROQUAD during the same appointment which was "4 days ago". No symptoms were reported. Lot numbers, expiration dates for the VARIVAX, PROQUAD and sterile diluent were unknown. No further information was provided regarding the patient. The nurse also reported that another unspecified patient had received VARIVAX and PROQUAD during the same appointment, but that incident had occurred "a long time ago". No symptoms had been reported and the nurse practitioner stated she had already reported this incident to Merck. The nurse practitioner did not wish to answer further questions and reported she did not wish to be contacted. Additional information is not expected as the reporter did not wish to be contacted.
pt experienced eye itching and swelling about 20min after vaccination and within an hour had hives to body - was taken to the ER and received steroids and Benadryl .
Heart Palpitations and chest tightness.  It was a dull ache it felt like someone was "squeezing my heart gently".  Heart felt like it was skipping a bit or a heavy beat once a minute felt mostly at night lying down.   I have been seeing articles lately about myocarditis with Moderna vaccine and felt like it was my duty to report this.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 67-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    There was no reported medical history.  Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE ).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In May 2022, the patient experienced COVID-19 (COVID-19). In 2022, COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant medication information was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The formulation for Humira was reported as Solution for injection in pre-filled pen. Reporter causality was not reported for the event COVID-19 with respect to Humira.  Treatment information was not provided by the reporter. Company comment: This spontaneous case concerns a 67-year-old female patient, with no relevant medical history, who experienced the unexpected and non-serious AESI of COVID-19. Vaccination date was not reported; hence latency to a dose of mRNA-1273 vaccine, cannot be properly assessed. No information on previous Covid-19 vaccination available. No further details on clinical course, lab test results or treatment were reported. The outcome of the event was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 67-year-old female patient, with no relevant medical history, who experienced the unexpected and non-serious AESI of COVID-19. Vaccination date was not reported; hence latency to a dose of mRNA-1273 vaccine, cannot be properly assessed. No information on previous Covid-19 vaccination available. No further details on clinical course, lab test results or treatment were reported. The outcome of the event was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Day 1 just minor arm pain; Day 2 arm pain and flu-like symptoms, chills, minor headache and fatigue with slightly larger area of redness on right arm where shot was administered, Day 3, flu-like symptoms gone but redness on arm and pain persists and area of redness a bit bigger; Day 4 redness on arm seems to have grown to cover an area at least 5x5 inches and there is some swelling as well as persistent low-level soreness. The area also feels warm to the touch.
Patient was given Shingrix in RA in deltoid region. As soon as immunization given there was blood, and a hematoma started to develop above injection site. A bandaid was applied, and patient was asked to sit for 15 minutes to monitor for severe reaction. I checked patient's arm after 15 minutes and hematoma had subsided and there was only the original drop of blood on bandaid. I asked the patient if there would be someone at home with her when she left and she stated yes. I told her to expect a bruise and if anything besides bruising/sore arm occurs to call her physician. Event Details
Patient spoke to the pharmacist regarding  whether it was possible to have a delayed reaction to the vaccines she received a week prior and stated that she woke up that morning with a large, red itchy rash at the injection site that was becoming larger and itchier as the morning progressed. When pharmacist looked at rash around 11:15am, she observed a large raised rash that covered the patient's entire bicep area. Patient took 25mg  Benadryl tablet approximately 12:05pm to help with the itchiness. Pharmacist advised patient to contact her primary physician regarding the reaction. Patient showed pharmacist the rash again at 4:35pm and the rash area had decreased in radius but was still red and raised. Patient stated rash was no longer itchy.
Initial report was received on 09 July 2013 from a non health care professional. A female patient (date of birth not reported) with a history of depression, had received on 07 July 2013 IMOVAX (sanofi pasteur lot number and site of administration not reported) and IMOGAM (sanofi pasteur lot number and site of administration not reported) and on the way home from the ER (date not reported) felt nauseous, vomited and became confused on directions home. "Over the weekend" experienced body aches, concentration issues and auditory hallucinations. The patient heard water running and continued to hear brother's voice after hanging up phone. Concomitant medication included CELEXA (antidepressant) and tramadol. Relevant diagnostic test/laboratory data was unknown. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
My left arm felt heavy, which I thought was probably normal. Then I felt as if the heaviness  moved up to my shoulders, neck, and jaw muscles. I kept telling myself it was all in my head. I'm a RN and tried to rationalize the heavy feelings. Then my facial muscles started to feel heavy, with my right side feeling a bit heavier that the left. I received my vaccination. So I was sitting in a car for 15 minutes. I didn't notify healthcare workers because I thought it was psychosomatic and I could move my facial muscles. I drove away and ended up switching drivers with my partner who was with me. The facial numbness continued. After about 30 minutes the sensation of numbness went away.
Tinnutis in both ears-can be consistent or will occur every other day. It will be going on 3 weeks! Also, ears sometimes hurt.  I?ve been to ENT AND primary care-no infection or hearing issues.
Date and time adverse event started: 26th March, Monday evening, had stroke-like symptoms. Went to hospital on the 27th, dx of  a stroke.    Patient has a dx of a stroke, went to hospital, since d/c'd to home with residual.   patients reports no changes, was diagnosed with a TIA and pending follow ups with heart doctor & neurologist. Q99- asked if she should take the 2nd dose. recommended she follow up with her PCP and neurologist to discuss risks and benefits of the 2nd dose, patient verbalized understanding.
headache; fatigue; muscle aches; This is a spontaneous report received from contactable consumer, the mother of the patient. A 29-year-old adult male received the second dose of BNT162b2 (solution for injection; Lot EN6200 expiry not provided) as a single dose via unspecified route on 19Feb2021 (at the age of 29-years-old) for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications reported. The patient previously received COVID-19 immunisation with BNT162b2 (first dose; Lot EL9262 expiry information not provided) on 29Jan2021 (at the age of 29-years-old). The consumer reported that the patient had not received any other vaccinations within four weeks prior to the COVID vaccine. The consumer also reported that the patient had no known allergies and was not diagnosed with COVID prior to the vaccination. On 20Feb2021 after his second injection, the patient experienced a headache, fatigue and muscle aches. There was no laboratory testing reported. There was no treatment received for the events. The outcome of the events, headache, fatigue and muscle aches was recovered on 21Feb2021.
The patient warned that she has a tendency to pass out with immunizations. Immediately after the immunization she said she thought she would be fine but just a moment later she said she was feeling faint with some ringing in her ears. I gave her a glass of water, she took a sip then asked to put her head between her knees. She was still feeling woozy and asked to lie on the floor.  She laid down on the floor and put her feet on the chair.  I gave her a mini Snickers.  She continued to lie on the floor until she felt better. After about 10 minutes she left with her mother and said she was feeling better.
allerg rxn @ site of inj, red & swollen 2mm lump, lt arm deltoid, afeb