chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I could taste the medicine in my mouth after about an hour. Then my lips were numb for 5-6 hours... still some tingling the next day.  I felt a little sick the next day. I decided not to get the second shot.
This report was received from Pfizer and was assigned manufacturer report number (2015262159). This was originally reported by a physician concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine (manufacturer unknown), which was administered incorrectly in the triceps tendon (also reported as in the shoulder on deltoid tendon) (Lot. No., dose and route were not reported). No concomitant therapy was provided. On an unknown date, the patient was in a lot of pain and ended up being hospitalized for two days. The shot was administered in a pharmacy. No Product Quality Complaint (PQC) was involved. The outcome of pain was unknown. Additional information has been requested.
none covid 19 vaccine expired  11/22/2022 given 12/7/2022
Patient presented to the ED and was subsequently hospitalized for Abdominal aortic aneurysm (AAA) without rupture within 6 weeks of receiving COVID vaccination.
The day after the vaccine I felt tired and my arm was sore. September 10,  2021 I got tested for covid. The results came back the next day and were positive. I felt like I had allergies and my nose was congested. September 12th 2021 I lost my smell, and I haven't gotten that back yet but everything else is fine.
Headache & Myalgia Narrative: Myalgia 08/25/2021. Headache, fatigue, and injection site pain 08/25/2021 and 08/26/2021. Did not seek medical attention for the symptoms. Resulted in unable to work 08/26/2021.
In the middle of the night, after vaccinations on 7/8/09, patient had a severe bout of projectile vomiting, inconsolable high-pitched crying, and was extrememly irritable.  Tylenol was administered, and the episode lasted approximately 15 minutes.  In the coming weeks, 2-3 similar episodes appeared, fading as quickly as the first.  In August 2009, patient was hospitalized with life-threatening intracranial hemorrhaging.
He said there was an increase in his tinnitus.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 21Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Tinnitus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "He said there was an increase in his tinnitus."  Additional information : Consumer said he received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine and is scheduled to receive the 2nd dose in 2 days, this Sunday. However in the last week, he said he noticed a change in the condition that he had which is tinnitus. He said there was an increase in his tinnitus. He also noted that it is not severe and did not bother him that much. Consumer wants to know if this is related to the vaccine. The patient already received his 1st dose of Pfizer Covid-19 vaccine last March 21 and is scheduled to have his 2nd dose on April 11. However, he had a health issue as there was an increase in his Tinnitus a week ago. He had it previously however he wonders if the increase in his Tinnitus was caused by the vaccine. He would also like to know if there are reports with the Covid-19 vaccine affecting Tinnitus related conditions.   Follow-up(09Apr2021): This is an Spontaneous report from regulatory authority of a contactable consumer. This consumer (patient) reported for himself.  No follow-up attempts are needed. No further information is expected.  Follow-up(13APR2021): This is follow-up spontaneous report from contactable consumer. No  information received.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
R09.02 HYPOXIA 3/25/2023 HX OF ACUTE KIDNEY INJURY
Pt received DTaP, IPV, PPD on 8-2-07. Came to clinic to have PPD read. c/o redness, swelling and pain at injection site.
Employee had recieved two immunizations; Hep B in the right arm, flu shot in the left arm. She began to feel itching on her left arm, redness and swelling beginning. She reported to the LPN there giving the shots, she directed her to go to the New Hire lab where the RN was, EE was stable. 10:35 EE arrived and her left arm was swollen, itching and red.  Medications and allergies assertained. 50mg Benadryl po given as she was not in distress or nor having dyspnea, no difficulty swallowing. Employee sitting with the RN and she began coughing, itching throat, .3mg of Epi delivered to right thigh, EMS called, employee laid down in lounger, reassurred, she continued to cough as her face continued to become red, tongue swelling, speech slurred, chin lift and airway management per RN, Paramedics on site 10:50 AM. O2 Sat 99%. Transferred to ER for observation and further intervention.
moderna booster dose was given 0.5ml instead of 0.25ml. no adverse effect noted
Large welt 2" in diameter, red, raised, painful, still somewhat tender; given ATBs (Amoxicillin) 7 days 500mg/8hrs; swollen glands under left arm;
Chills, achy body swollen arm, achy shoulders, face, neck, joint pain, loss of appetite, fatigue
Swollen painful axillary lymph nodes, runny nose, sneezing, chills, body aches, headaches.
Burning sensation in lower, front left leg. More sensitive to hot and cold. Will sometimes travel to different parts of the lower leg. Blood test and x-ray were done. Nothing showed on the x-ray or blood test. Nothing has been done further. I still experience the burning sensation.
Fatigued, diarrhea, nausea, loss of appetite, general muscle aches, stayed home in bed and hydrated for seven days.
2 1/2 week after Moderna hospitalized for terrible headache, left side weakness,  mental status change,  HTN crisis, TIA suspected, ground glass nodules on CT
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 26-JUN-2015, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX (lot number, dose and route not unknown). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Brain fog/fatigue/headache more than usual since second dose of pfizer vaccine administration one week ago.
Severe shaking, sweating, dizziness and low blood sugar as low as 69... she was given juice and sent home from school on the first day. Next day patient suffered same symptoms. Has been tested for diabetes and sleep apnea, thyroid..all tests are normal.
frozen shoulder, could not move. severe fatigue, no energy to get up and go bathroom or get up in general. nausea, headache. weak muscles. upset stomach, pooping alot
Morbilliform rash generalized initially per pediatrician. Lichen striatus - like eczema right extremity only 10-21-16.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old male patient received BNT162b2 (BNT162B2), on 05Feb2021 at 10:00 as dose 1, single (Lot number: en5318), in right arm, on 26Feb2021 at 12:00 as dose 2, single (Lot number: en6203), in right arm, on 06Oct2021 at 12:00 as dose 3 (booster), single (Lot number: ff8841), in right arm and on 11Apr2022 at 12:00 as dose 4 (booster), single (Lot number: fl3209), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Paxlovid (Lot number: 00069108530) was started on 29Jun2022 and stopped on 01Jul2022 for the treatment of COVID-19. Other medications in 2 weeks was reported to be unknown. There were no known allergies.
12 hours after flu shot developed hives to upper extremities, neck and face. Had lip and tongue swelling, tingling, and numbness. BENADRYL relieved symptoms. Employee reported a reaction 10/11/2018 but didn't provide details until 11/5/2018 after several phone calls.
The first night I had a headache, stuffy nose.  I had a sore arm at the injection site for 3 days.  On day 17, I developed a red rash on my arm around the injection site.
A report has been received from a Health Professional concerning a female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 10-JUL-2014. The patient experienced multiple patients received FLUMIST Quadrivalent and tested positive for Flu A. The outcome of the event of multiple patients received FLUMIST Quadrivalent and tested positive for Flu A is unknown. The report was considered to be non-serious.
NEEDLE MALFUNCTION. PT RECEIVED LESS THAN 50% OF DOSE ADMINISTERED. PT REDOSED W/O ISSUE
Information has been received from a Health Care Professional concerning an 18 year old female patient who on an unspecified date was vaccinated with a dose of GARDASIL. It was reported that on 17-JUL-2009 the patient fainted three times and was ultimately taken to the hospital. The outcome of the patient was unknown. Follow up information was received from a Health Care Professional who stated that the patient received the immunizations in another clinic. It was reported that she was not a patient of the Health Department and she did not have other records. No further information is available.
Immediately felt nauseated, chin fell quickly to my chest, my right arm was stiff, my eyesight was blurred my speech was affected, my head was dizzy. The back of my neck (Left side) was flushed with cerebral fluid. I lost my balance & couldn't walk to another room in the office with out help to lay down for 20 minutes. I got to drink a little water & eat crackers. For 60 days I was like commatoast. Now I sleep 24 & 7 everyday with low energy levels. I can't stop sleeping. I take a shower eat breakfast & fall immediately to sleep 10x a day My mind thinks backwards words are turned around and thoughts now I have very low energy
Incessant crying about 2 hrs after vaccines. Rechecked in our office at 2:00 p.m., examined KUB ordered.
adverse events: pt report event on 11/29/19 at 09:10 am. pt was given first shingrix shot on 07/24/19 no adverse events reported. however, the second shot was administered on 11/20/19 and rash, hives and red bumps appeared all over the body on 11/26/19. pt reported allergy to cold/sinus medications.  Treatment: pt been taking Benadryl. Per indicated it has not been very helpful.  outcomes: Per pt events were not severe enough to go to the urgent care, no trouble breathing or swallowing in tongue reported
After getting the second dose eights days later I insane itching all over my body. The itching stayed for a day or day in a half. Severe muscle pains and fever of 100, headaches. Intensity of the symptoms was maybe 40% of the first dose. Then later on I started on 9/12/2021 feeling a little off. By the 14th was wasn't feeling good at all. Muscle aches, fever 102, lost of smell and taste, diarrhea, nausea, decongestion. On the 09/16/2021 I went to get a COVID test which came back 09/18/2021 as positive for COVID 19 virus. On the 19th I went to get the antibiotic infusion treatment.
Exhaustion, headache, nausea, vomiting, chills. Started at ~12:30 pm on 1/17/21 and continued until 1/18/21.
Today around noonrash/hives appeared at and around injection site. Red, bumpy, hot and itchy.  Took benedryl and itchiness went away. Same symptoms came back again around 6:00 PM.
TIRED; HEADACHE; LIGHT HEADED; HYPERTENSION; HIVES ON CHEST AND NECK; SORE ARM; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included grave's disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 13:30 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included levothyroxine for grave's disease.  On 07-APR-2021, the subject experienced light headed. On 07-APR-2021, the subject experienced hypertension. On 07-APR-2021, the subject experienced hives on chest and neck. On 07-APR-2021, the subject experienced sore arm. Treatment medications included: diphenhydramine hydrochloride. On 08-APR-2021, the subject experienced tired. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headed, and hypertension on 07-APR-2021, hives on chest and neck on 08-APR-2021, sore arm on 10-APR-2021, and tired, and headache on APR-2021. This report was non-serious.
I received the vaccine in the late afternoon and within a few hours I had muscle soreness across my upper back, arms, and legs, as well as widespread joint pain. Later in the evening I had chills. The following day I had stomach cramps. The joint pain lasted for a few weeks.
No additonal AE reported; Improperly stored ROTATEQ was administered to patient; This spontaneous report was received from a medical assistant concerning to a patient of an unknown age and gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.         On 12-NOV-2020, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot number 1660981 and expiration date 13-APR-2021; dose and vaccination scheme were not provided) as prophylaxis. No additional adverse event was reported.  The vaccine underwent a temperature excursion below 36°F (26.2F) for a time frame of 35 hours. There was no previous temperature excursion and it was reported that a data logger was involved.
lower extremities cramping that lasted 5-10mins; elevated blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (lower extremities cramping that lasted 5-10mins) and BLOOD PRESSURE INCREASED (elevated blood pressure) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced MUSCLE SPASMS (lower extremities cramping that lasted 5-10mins) and BLOOD PRESSURE INCREASED (elevated blood pressure). On 20-Jan-2021, MUSCLE SPASMS (lower extremities cramping that lasted 5-10mins) had resolved. At the time of the report, BLOOD PRESSURE INCREASED (elevated blood pressure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported.    No treatment information was provided.
10/18/21 ID physician Dr. note: "Pneumonia due to COVID-19 in vaccinated host- Pfizer in March and April of 2021; with fever and GI symptoms on admit, was stable on RA; rapid strep negative.  Cxray normal - ->now w/ rapid progression since am, bilat infiltrates and markedly increased O2 req's covid hs PCR with cycle number 20 covid inflammatory labs elevated. Started on remdesivir D3/5; dexamethasone D4/10 anticipated; s/p TCZ x1 10/17; remains on BIPAP. S/p ceftriaxone 10/14-10/15".
Patient received expired vaccine. Pfizer recommend revaccination. Patient was contacted to schedule an appointment and declined.
typical sore arm and some fatigue.New symptoms for me with booster- did not have any of this with shot 1 or 2-  raised red injection site started day 3, collarbone lymphnode on left side swollen at day 2, increasing day 3. lymphnode swollen under left armpit on day 4.
diarrhea and itching , started on prednisone to help with itching , pt educated about brat diet for diarrhea which has cleared up
Pt states he developed pustule about 1 week post vaccination. Did not keep area covered to contain drainage. Scratched area. Now has lesion on back of neck, right side of forehead, possible lesions (early) on lower face and chin. No treatment required.
Exhaustion, fever, hacking non productive cough, difficulty breathing. Took Tylenol, Delsym (helped a little) then Mucinex (didn't help), then prescription benzonatate 100 mg (that helped), along with Valerian Root so I could sleep. That helped tremendously. I started feeling better the day after the benzonatate and Valerian Root. probably because I stopped coughing as much and could sleep. After 5 days of the prescription and valerian root  I was almost back to normal except that I am still week and have little stamina.
big red spot 2x4 inches on my arm; This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced localized erythema. On an unknown date, the outcome of the localized erythema was not recovered/not resolved.   It was unknown if the reporter considered the localized erythema to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected an adult as per vaccine indication.  The patient received 1st dose of Shingrix 6 days ago and still have a big red spot 2,4 inches on arm. The reporter was just wondering if this was the normal about the side effects to last this long.
First / dose in 2019 / has not yet received the second / will get / soon; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   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 for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No health care professional information available. The patient would get the second dose soon, and would not restart the vaccine series, per content. Patient did not wish to give complete demographics.  The reporter did not consent to follow up.
Initial information received on 09-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 months old female patient who received vaccine FLUZONE QUADRIVALENT. The patients past medical history and family history were not provided. Concomitant medications included PEDIARIX, PREVNAR, HEPATITIS A and MMRV. On 08-Jan-2019, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ035AB, expiry date 30-Jun-2019 via intramuscular route in the right thigh. It was an actual medication error due to overdose. It was reported that FLUZONE QUADRIVALENT, 0.5 ml was given to 15m old patient. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender- none.
9 days after injection, large well demarcated 6cm diameter reddened circle around injection site.  warm to touch.
Woke up day 9 post vaccination with pain, redness and swelling at site of injection , worsened day 10 and 11, today day 12 it?s improving
Pt. given VARIVAX 3/22/10. Presented to office today with rash (papulovesicular) in dermatomal distribution consistent with shingles. No known exposure to wild-type varicella.
Employee received flu mist 11/18/08. On 11/23 he relates developed symptoms of dry thraot, cough, and sweats. States developed body aches 11/23/08. Reported to EHOS 12/01.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. In approximately August 2015, the patient completed the 3 dose series of GARDASIL (exact dose, lot #, expiration date, route of administration, intervals and anatomical location were not reported). On 22-FEB-2016 (also reported as "18 after the initial 3 dose series was completed"), the patient inadvertently received 4th dose of GARDASIL (exact dose, lot #, expiration date, route of administration and anatomical location were not provided). There were no adverse effects reported. Additional information is not expected as there was no consent for follow up.
This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The patient's pertinent medical history and drug reactions or allergies were not reported. In approximately September 2015 (reported as "approximately 2 months ago"), the patient was vaccinated with the second dose of GARDASIL 9 (lot #, expiry date, dose and route were not reported). Concomitant medications were not reported. In September 2015, immediately after vaccination, the patient became light headed and dizzy. The patient recovered before leaving the office (in September 2015). It was unknown if additional vaccinations took place. The relatedness between the event and GARDASIL 9 was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Patient is only 17 years old and the Moderna COVID 19 vaccine is only recommended for ages 18 and older.
This spontaneous report as received from nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 17-MAR-2016 the patient was vaccinated with expired ROTATEQ suspension 2 lot # K006457, expiry date of 09-MAR-2016, 2 ml, orally. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.