chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported in a literature article and described the occurrence of Guillain Barre syndrome in a 40-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included small temporal epidural hematoma, nondisplaced right temporal skull fracture and zygomatic arch fracture due to a fall from a secondary story roof. His neurological examination was normal. On an unspecified date, the subject received unspecified dose of BOOSTRIX (route and injection site unknown). One week after vaccination, he was discharged home. Less than one month after vaccination with BOOSTRIX, few days after his discharged, the subject experienced weakness and numbness in his legs which progressed to involve his arms. The subject was hospitalised 3 weeks after his initial fall. The subject's examinations showed muscle strength was 2/5 in his lower extremities and 3/5 in his upper extremities. His deep tendon reflexes were absent at his ankles and knees and were diminished in his upper extremities. There was bilateral peripheral facial paresis, bulbar weakness and impaired gag reflex. He had diminished touch and pin prick sensation in a stocking glove distribution. His vital capacity was reduced to 1.4 liters. Magnetic resonance imaging of his brain and spinal cord were unremarkable. A lumbar puncture revealed a cerebrospinal fluid protein of 790mg/dL and one white blood cell. Guillain-Barre Syndrome was diagnosed. Nerve conduction studies revealed prolongation of the upper and lower motor action potential latencies, reduced motor conduction velocities and reduced amplitude. Median and ulnar nerves sensory action potentials were absent. The subject was treated with normal immunoglobulin and his muscle strength improved. 3 months later he continued to have tingling in his hands and feet and use a walker. At the time of reporting, limb weakness was improved and the outcome of the other events was unspecified.
The first dose given on 09/21/2021 and the second dose given on 09/24/2021. ON 09/21 second dose was given at approximately 12pm. Child observed at clinic observation site immediately after administration and transferred to onsite clinic at 1pm for continuous observation.  No s/s of distress.   Findings per clinician  : Pt denies any symptoms, denies HA, ST, abd pain, cough, body aches, chills, fever. EOMI, PERL, LS clear, HEENT exam neg. Reflexes are good. Pt is asymptomatic.
My periods have been very irregular since I?ve received my vaccination. Not only do they last significantly longer (10+ days when they would originally go 5 or 6 days), I?ve had heavy mensural bleeding and blood clots. I?ve been filling one super+ tampon every 2 hours for at least 5 days of my period. I wear pads every day because I have continuous bleeding throughout the month.  This has impacted my quality of life.
Within 1 hour of receiving vaccine felt dizzy, lightheaded, "like a cloud over" him. Then w/in 2 hrs nausea, respiratory congestion, yellow mucous, nausea, no appetite, diarrhea, and total body aches which continued into the next day (11/9/17).
Patient is homebound, vaccinator did not verify her CDC card and administered what he thought was her second dose of Moderna on 4/28/2021.  On 6/7/2021 it was found that her first vaccine was in fact Pfizer. This was not found until the family presented the card to a medical professional associated with the company that has been carrying out the homebound vaccinations. Family only presented care to this medical professional because the card had not been fully filled out and the patient had a routine surgery, which she needed proof of vaccination.  Patient did not have any side effects or any adverse effects, reported to be in fine health.
achiness; light red area below the injection site; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (light red area below the injection site), FATIGUE (tiredness) and MYALGIA (achiness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 040A21A) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis and Osteoarthritis. Concomitant products included RITUXIMAB (RITUXAN), METHOTREXATE, METOPROLOL, VALSARTAN, AMLODIPINE, FOLIC ACID and Nolaxican.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced ERYTHEMA (light red area below the injection site) and FATIGUE (tiredness). On an unknown date, the patient experienced MYALGIA (achiness). On 26-Feb-2021, ERYTHEMA (light red area below the injection site) and FATIGUE (tiredness) had resolved. At the time of the report, MYALGIA (achiness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Rheumatologist stated it would be okay to get revaccinated because their Antibody test (SARS COvid-2 IG antibody) shows negative.   Treatment information was unknown   This case was linked to MOD-2021-169526 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Live follow up, medication history added , second dose added
I suddenly experienced what I guess is called a visual aura - seeing shimmery zig zag lines out of my right eye along with a blank spot.  I also had a headache that started at the same time and lasted most of the day.  I did not see my physician for this and I wasn't sure if it should be reported as a possible side effect of the shingles vaccine, but I have not ever had this type of visual aura/headache happen before.
This spontaneous report as received from a physician via company representative refers to "possible few hundred of patients" of unknown age and gender. The patients' concurrent conditions, drug allergies or reactions, pertinent medical history and concomitant therapies were not reported. Since approximately 2013 (reported as for about 3 to 3 1/2 years) the patients had been receiving ZOSTAVAX (19400 PFU) intramuscularly (dose, lot # and expiration date were not reported). The physician also reported that there have been no additional Adverse Events reported regarding "the efficacy of administering ZOSTAVAX (19400 PFU) intramuscularly with these patients." No treatment was given. The patients did not seek medical attention. No product quality complaint was involved. Additional information has been requested.
VACCINES GIVEN, WHILE PARENT PUTTING CHILD INTO CAR SEAT, INFANT STARTED TO VOMIT, VOMITED LARGE AMOUNT CLEAR FLUID. MOTHER STATES CHILD COMPLETELY ACTING HER NORMAL SELF.
Severe chest and back muscle spasms that seized up and would not release, similar in feeling to a "charley horse". The first series of these spasms began the day after vaccination at 5:00 pm and lasted for an hour, and then a second series began around 6:30 pm and also lasted for an hour. I took 400mg of ibuprofen at 5:30 pm with no results. There was no change in heart rate and no feelings of heart spasms. This also happened during my second COVID vaccination with the same timing, but I did not think it was related to the vaccine until it happened during the same time frame this time around. I have not experienced these symptoms at any other time in my life.
Body aches, chills, approx. 8 cm x 8 cm redness, site warmth, unknown fever, soreness to site.
Pt was being treated for frozen shoulder, 2 weeks after pt began to have abduction problems again.
got the first dose of shingrix, 2.5 yrs ago , never went back for the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received Herpes zoster (Shingrix).   Previously administered products included Shingrix (received 1st dose two and half years before reporting day).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The pharmacist reported that patient never went back for the 2nd dose. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient received first dose in another state.  The patient wanted to know if he need to start over the vaccination series. No other information of vaccine available . The reporter consent to follow up. This case is linked with case US2021097929, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021097929:SAME REPORTER
When my symptoms started, I read about "COVID Arm", which I believe relates to my delayed experience.  On 3/12, day 8 after the initial vaccine, the injection site became very itchy, formed a red oval, hard, hot, swollen area.  On 3/13 it was a bit worse.  On 3/14 the arm was a bit better, but there was a lot of itchiness to my back and abdomen.  On 3/15, the arm redness was still visible but fading, but the itchiness to my back remained to a lesser degree. The injection site was no longer hard or swollen. On 3/16  there was some redness to the arm still visible.  Itching has improved. Today, there is faint redness still visible, minimal itching.
Numbness; Pain; Swelling; skin discoloration; Left arm injection site swelled like a Popeye muscle and was down to elbow; Temperature; A rash; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Temperature), HYPOAESTHESIA (Numbness), PAIN (Pain), SWELLING (Swelling) and SKIN DISCOLOURATION (skin discoloration) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A and 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided.  Concomitant products included METOPROLOL, AMLODIPINE, EZETIMIBE (ZETIA), LEVOTHYROXINE, NITROFURANTOIN, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (PROAIR BRONQUIAL), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) and VITAMINS NOS for an unknown indication.   On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jul-2021, the patient experienced BODY TEMPERATURE INCREASED (Temperature) and RASH (A rash). On 09-Jul-2021, the patient experienced HYPOAESTHESIA (Numbness), PAIN (Pain), SWELLING (Swelling), SKIN DISCOLOURATION (skin discoloration) and VACCINATION SITE SWELLING (Left arm injection site swelled like a Popeye muscle and was down to elbow). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, BODY TEMPERATURE INCREASED (Temperature), HYPOAESTHESIA (Numbness), PAIN (Pain), SWELLING (Swelling), RASH (A rash) and VACCINATION SITE SWELLING (Left arm injection site swelled like a Popeye muscle and was down to elbow) had resolved and SKIN DISCOLOURATION (skin discoloration) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jul-2021, Body temperature: abnormal (abnormal) abnormal.         The patient also took heating pad, and cold compress as treatment medication.
Reported "tingling and numbness" in anterior neck, jaw, face and tongue during observation period. No rash, hives observed. 50 mg Diphenhydramine IM administered. Patient had similar event after first dose of Moderna Covid vaccine.
Initial spontaneous case received from a consumer, who is also the patient, on 20 November 2014. A female patient received an INFLUENZA VACCINE (manufacturer, lot number, and administration details not reported) on an unspecified date "26 years ago", and subsequently developed an autoimmune disease. No additional details were reported, and the patient did not provide contact information for follow-up. Outcome was unknown. Documents held by sender: None.
Moderna 025L20A Ten days after received the 1st Moderna vaccine this patient had a paretic rash on arms and legs. Around that same time the patient sprayed his home with pest control. Patient called his PCP and reported that they could not tell if the rash was from the bug spray or the Moderna vaccine. The patient's PCP advised him it would be fine for him to receive his second vaccine, but to take Zytec 10mg x1 the day of his second vaccine and to observed for 30 minutes after that vaccine was given. Patient did not have any problems immediately after the second moderna vaccine on 2/1/2021.
Initial and follow up information has been received from a registered nurse (previously reported as a licensed practical nurse) concerning a 13 year old female patient, who in late December 2007 ("right before Christmas") was vaccinated with the first dose of Gardasil (lot # not reported).  The patient did not receive a concomitant vaccine (previously reported that patient received influenza virus vaccine on same day).  Within 15 minutes of the vaccination, the patient experienced "a whoosh/warm feeling going through her upper leg, the shot felt uncomfortable and the area was tender."  The nurse added that the patient had flu-like symptoms, including body aches and malaise, as well as nausea.  The symptoms lasted for 1 1/2 days.  It was reported that there were flu symptoms going around the town.  No further information was provided.  It was reported that another patient experienced symptoms after receiving the Gardasil.  (WAES # 0801USA02289).  Additional information is not expected. 04/07/2008 Initial and follow up information has been received from a registered nurse (previously reported as a licensed practical nurse) concerning a 15 year old female student patient who in late December 2007 ("right before Christmas") was vaccinated with the first dose of GARDASIL (lot # not reported). The patient did not receive a concomitant vaccine (previously reported that patient received influenza virus vaccine on same day). Within 15 minutes of the vaccination, the patient experienced "a whoosh/warm feeling going through her upper leg, the spot felt uncomfortable and the area was tender". The nurse added that the patient had flu-like symptoms, including body aches and malaise, as well as nausea. The symptoms lasted for 1 1/2 days. It was reported that there were flu symptoms going around the town. No further information was provided. In follow-up it was reported that on 21-DEC-2007, the patient a 15 year old female student with no illness at the time of vaccination and no pre-existing allergies, birth defects or medical conditions was vaccinated intramuscularly into the "LT" with the first dose of GARDASIL, (Lot # 658563/106U). It was reported that the patient felt injection: immediate warmth throughout, became sick later in the day i.e. body aches, nausea, tired and no appetite. It was reported that another patient experienced symptoms after receiving the GARDASIL, (WAES # 0801USA02289). Additional information is not expected.
Initial and follow-up information has been received from a registered nurse concerning female patients in the age range of 14-17 who were vaccinated with Gardasil vaccine (Lot# 057868/0523U, 657622/0388U, or "0398U"). Subsequently, all of the patients in her office, experienced injection-site pain. At the time of the report the patients outcomes were unknown. Additional information has been requested.
0730 pm  itchy mouth and swelling of tongue took 20 mg prednisone, 50 mg Benadryl, 20 mg famotidine  7:50 pm short of breath, oxygen saturation at 73%, wheezing  8:00 pm  numbness hands and feet, grey skin, 911 called  8:12 pm paramedics arrived, 10 L via non rebreather.  Transferred to ED  monitored for 5 hours/ NS given EKG normal tiponin normal chest xray negative for PE  prednisone x 3 days 20 mg famotidine am AND pm Benadryl 50 mg HS Zyrtec AM  itching resolved   22 October follow up
Metallic taste in mouth immediately following injection.  Taste did not subside and made food taste bad. Tingling in lips started 12 hours after shot. Chest pain.  Have been taking Tylenol and Benadryl and symptoms have not resolved but have not gotten worse
Systemic: Hypertension-Medium, Systemic: Hypotension-Medium, Additional Details: Patient states he has had an erratic blood pressure ever since he received his 1st COVID vaccine - his dr told him to report to us
skin with 1 1/2 cm x 4 cm erythema/induration mid upper (L) arm
Fever of 100.6. Body aches. Flu like symptoms. Extreme swelling and redness/tenderness at injection site.
After injection started with rash on chest and felt tired with chills and feverish. Complained of back pain with increased shortness of breath by afternoon. Seen in ED around 6:30 PM on 8/23/01.
Patient was diagnosed with COVID-19 on December 1.  Her symptoms began a day or 2 after Thanksgiving with nonproductive cough shortness of breath.  After the finding of of the Covid she had contacted the hospital to set up an IV infusion of antibodies, but when she arrived for the infusion today they found that she was hypoxemic so they presented her to the emergency department and she was placed on supplemental oxygen.  Patient has had exertional dyspnea and nonproductive cough
0.1 mL was initially administered instead of 0.2 mL. This was noticed by another staff. Patient was still in the office, and they were able to administer the second half of the dose. The patient ultimately received the full first dose
killed all those 5 people; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "killed all those 5 people". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: This has killed the most people out of any other drugs since any drug has came out. I've had friends who had strokes, heart attacks, lost their babies. There will be lots of people like me calling. It takes me 2 buttons and funny sounds to be able to get to you. Do you want everybody to do that to your phone system? I can share it with 100 million people. There's only one punishment for what you're doing. You put that man's daughter in a coma. This is an experiment on people. You cant go around killing people. This stuff is made to make people sterile. We don't need sterility right now. We have an inverted triangle. Because we're losing that many people. It's about people not being born, not people dying. We have 700,000 people who have just been grilled and dawned through. I don't want anybody to get hurt. How do you sleep at night knowing that you supported this. You guys loosely call this a vaccine when you don't have a Comirnaty. I don't see labels for Comirnaty and any of that. I see EUA vaccines, and over the holiday, it went bivalent. It's still twice the dosage of the original. You're saying that it's 2 variants, but it's not. In 49 out of 50 states, you have to pass 2 different things legally to go from a jab to go to a vaccine. Therefore, your vaccine will never get there. In order for it to be a vaccine, it needs to be made from the virus. It wasn't. 2nd, it's supposed to get rid of the virus. It doesn't. It's just straight mRNA. It killed all those 5 people. We weren't told the truth. We weren't given a choice. Companies are saying you have to get the shot. Is that even legal? CDC finally admitted PCR is not a test. PCR is an amplification for DNA. It's used in law enforcement. If you test for something with, you will find it 97 times out of 100 that it's there or not. It will give you a false positive every time almost. That's why your company picked this test for COVID. You sure you're testing for COVID Not SARS-COV 2 Have you tried to test for something else 97 out of 100 will show up small pox. How many people have you killed Millions. How many more people are going to die? Billions. People are dying because of the shot. Not because of COVID."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: killed all those 5 people
Fever; chills; headache; muscle pain; vomiting; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself). A 46-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in arm right on 11Feb2021 at 13:15 (01:15 PM) (at the age of 46-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no known allergies. The patient did not receive any other vaccine within four weeks. Patient was not diagnosed with COVID prior vaccination. Patient has not been COVID tested post vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in arm right on 21Jan2021 at 01:15 PM (at the age of 46-year-old) as dose 1, single for COVID-19 immunization. On 12Feb2021 at 02:30 AM, the patient experienced fever, chills, headache, muscle pain, vomiting. The patient did not receive any treatment for the events. Outcome of the events was recovering.  Follow-up (PRD/SRD 11May2021): Follow-up attempts completed. No further information expected.
This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 71-year-old, elderly patient of an unspecified gender. It was report that, the FLUAD TIV vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 12-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250795, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805526 was crossed linked to original case 201804863 due to same reporter.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. Pertinent medical histories, current conditions and concomitant medications were not reported. On 12-NOV-2016 date, the patient was vaccinated therapies included M-M-R II (dosage regimen were not reported) and on 19-NOV-2016 patient was again vaccinated with ZOSTAVAX (dosage regimen were not reported). The minimum spacing between the M-M-R II and ZOSTAVAX was too short. No adverse effects were reported. No further information was provided. Let number M034765 has been verified to be a valid lot number for ZOSTAVAX. Lot number M016233 has been verified to be a valid lot number for M-M-R II. Additional information is not expected as the reporter did not give is consent to contact.