chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient had a first time seizure a few minutes after having the vaccine; This is a spontaneous report from a contactable physician. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number: unknown), dose 1, intramuscularly on 25Apr2021 at 12:00 PM (at the age of 17-years-old) as a single dose for covid-19 immunisation. The patient's medical history was reported as none. Concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. No other medication was received within 2 weeks of the vaccination. On an unspecified date, the patient had a first time seizure a few minutes after having the vaccine. No therapeutic measures were taken as a result of the event. The event seizure did result in an emergency room/department or urgent care visit. Clinical outcome of the event first time seizure a few minutes after having the vaccine was resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   Follow up attempts needed. Further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of seizure  due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including EEG and Head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Post vax, the pt became diaphoretic, clammy, dizzy, decreased blood pressure, and decreased pulse. Pt was put in supine position and vitals taken every 5 minutes for 15 minutes until stable. Monitored for 1/2 hour and released with family.
Vomiting, no other symptoms... after vomiting he was hungry and wanted to eat again also wanted to play, was laughing and seemed fine.
This case was reported by a nurse via call center representative and described the occurrence of vomiting in a 20-year-old female patient who received BEXSERO (batch number 16D501, expiry date 31st March 2019) for prophylaxis. On 27th June 2018, the patient received the 2nd dose of BEXSERO .5 ml. On 27th June 2018, less than a day after receiving BEXSERO, the patient experienced vomiting, chills, headache, pain in arm, skin warm, injection site swelling, nausea, fever, injection site pain and injection site induration. On 28th June 2018, the patient experienced erythema of extremities and dizziness. On an unknown date, the outcome of the vomiting was recovered/resolved and the outcome of the chills, pain in arm, erythema of extremities, skin warm, injection site swelling, nausea, dizziness, fever, injection site pain and injection site induration were unknown and the outcome of the headache was not recovered/not resolved. It was unknown if the reporter considered the vomiting, chills, headache, pain in arm, erythema of extremities, skin warm, injection site swelling, nausea, dizziness, fever, injection site pain and injection site induration to be related to BEXSERO. Additional details were provided as follow: The patient received BEXSERO in right deltoid. The patient had a horrible headache and severe sore arm that was painful and hot to touch and was larger the 50 cent piece and was getting larger. The patient had fever and chills all night. The patient had nausea and vomiting all day and a severe headache that was rated as a 5 or 6. On 28th June 2018, 1 day after receiving vaccination, she woke up with dizziness and redness on arm. The patient had increasing arm pain, redness and tenderness. She was fine and drinking water on the reporting date with no vomiting. The headache was persists and the injection site was swollen, hard and painful. The patient was not experiencing confusion or light sensitivity.
No additional AE; reported lot #W025277 and exp 8/10/2024. Valid lot number in datebase with exp. date assigned as 28-SEP-2022; Patient was administered VARIVAX that went Temperature Excursion; This spontaneous report was received from an other health professional refers to a patient of unknown age and gender. No information on medical history, current condition and concomitant medications was provided.      On 10-APR-2023 the patient was vaccinated with dose of improperly stored and expired varicella virus vaccine live (oka/merck) (VARIVAX) lot # W025277 and exp. Date 28-SEP-2022 for prophylaxis (exact dose and route of administration were not provided) (experienced product storage error, no adverse event and expired product administered).
Patient stated that after two hours of administration, she felt that her tongue and lips were tingling. Her throat felt tight and scratchy. She felt that she was having a tough time swallowing. We gave her 10ml of Benadryl liquid 12.5mg/5ml. She left the pharmacy against the pharmacist's recommendation. She was advised to come back, but she said she will be fine, so she stayed home. Informed patient to call EMS if symptoms worsen or have trouble breathing.
Red, swollen arm around the injection site.  Extended around the arm and about 3 inches long.  Warm to the touch.  Painful.  She called me at the pharmacy the day after getting the injection.  She said it had stopped hurting now but did mention previous pain.
Body aches, fatigue, nausea, headache, lymph node above collarbone swollen.
muscle aches, cough, sore throat, h/a, fatigue, fever 100, sx began on 8NOV96 have cont 19NOV96, also back pain;pain in inj site & entire rt arm;saw MD who states pt had a virus;
Initial report received from a healthcare professional on 05 November 2013. A 47-year-old patient received 0.5ml FLUZONE. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
My lymph nodes and my breast are very enlarged; My lymph nodes and my breast are very enlarged; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), BREAST ENLARGEMENT (non-serious), outcome "unknown" and all described as "My lymph nodes and my breast are very enlarged".  Additional Information: It was reported that the patient had vaccine on Tuesday and lymph nodes and breast were very enlarged and patient wanted to know what should be done or should go to a doctor for this because it was now 4 days, 5 days after the vaccine, 4 days after the vaccine and it had not gone away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
CHANGE IN LIVES; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced change in lives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of change in lives was not reported. This report was non-serious.
This spontaneous report as received from a pharmacy technician concerning a currently 16 years old adolescent. Gender was not reported. Medical history and concurrent conditions were not reported. On 01-MAY-2014, the patient was vaccinated with VARIVAX (Merck) lot # J009165; expiration date: 24-JUL-2015, (dose, strength and route not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reports from the same reporter. Additional information has been requested.
Fluarix exposed to freezing temperature was administrated; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 27-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: The health care professional called and reported that a Fluarix QIV that was exposed to freezing temperature was administrated to a patient, which led to incorrect storage of drug. No symptoms or further details were reported. The reporter agreed to follow-up. This case was 1 of 8 case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR215097:Different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215096:Different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215095:Different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215094:Different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215093:Different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215098:Different patient, same reporter US-GLAXOSMITHKLINE-US2021214412:Different patient, same reporter
Patient was hospitalized with Delirium on 5/16/21 - 5/18/21. Lab, imaging and EEG did not reveal any definitive etiology for delirium
Felt soreness at injection sight almost immediately after. Then felt extreme fatigue followed by chills and fever around hour 6, at about hour 12 had nausea and vomiting then woke up Saturday morning feeling achy but no more nausea. Felt fine during the day, but closer to the being extreme fatigue and a fever occurred again. Woke up Sunday feeling almost completely back to normal, just itchiness and ?COVID arm? at the sight of injection
headache; aches; injection site soreness; This is a spontaneous report from Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included knee pain and nausea. Concomitant medication(s) included paracetamol (TYLENOL) taken for knee pain. Patient was told to take Tylenol. She had issue with her knee. She wanted to know if she can take any other pain reliever. She has had knee issue prior to getting vaccinated. She had been having nausea as well. She had experienced headache, aches, and injection site soreness on unspecified date. But it has gone away. The event outcome for events was unknown.  No follow-up attempts are possible. No further information is expected.
45 minutes, post vax, pt began having difficulty with speech. Speech was slurred and she said she didn't feel right. BP 104/70 (normal for pt is 130/90); Pulse 104. No difficulty breathing. Had some dizziness. Notified pt's MD who ordered 50 mg of Benadryl. Pt refused to go to ER.
Lethargy, excessive sleepiness, stomach cramps, low grade fever over the course of 3 days.
Patient reports red, bumpy, itchy rash that appeared on her abdomen from her breast to her belly button on 10/7/21. Patient reported negative for new soaps, detergents or medications. She also stated that she had a similar reaction with her Clindamycin allergic reaction. Rash resolved in 2-3 days after patient took benadryl. Patient has never had a reaction to a Flu shot in the past and does not think that the reaction is from the Flu shot.
Information has been received from a licensed practical nurse concerning a 17-week-old male who during June 2008, was vaccinated with the first oral dose of ROTATEQ (human-bovine). It was reported that the patient threw up immediately upon administration of the vaccine. Unspecified medical attention was sought in the doctor's office. No product quality complaint was involved. Additional information has been requested.
By Wed night, pt was feverish (unk temp warm to touch) and had some swelling, Thursday woke up vomited slept additional . When seen Friday am 10/20, right upper arm was swollen, skin flushed (pink) entire right upper arm warm to the touch. Sent to comprehensive health center. After awaiting for many hours, mother called pediatrician was told was given IM antibiotics and oral Keflex. Has return appt 10/26.
Tightness of right side of jaw. Difficulty chewing and pain when light pressure is applied. Pain extends along jaw to right ear
Pain at injection site that persisted followed by numbness and tingling down medial aspect of arm for approximately 24 hours after the injection, upper extremity and neck ache, headache with associated eye pain, fatigue
Significant swelling began around 5 am the day after my shot. Not just around the injection area, but around my whole upper arm. About 5 inches in diameter. The injection site was warm to the touch for about 3-4 days after. Pain in both my muscle and on the skin surface lasted for about a week after the shot. I could not easily move, touch or use my left arm the day after. My shot arm had a very noticeable lump for a few days. Flu-like symptoms began exactly at the 24 hour mark after the vaccine shot. Body ache all over (especially in my lower back and down my legs) paired with nausea, dizziness and fatigue lasted until I went to bed that night (9/14). When I woke up the next day most the symptoms were gone. I have had a sporadic headache ever since the shot, however.
Immediately after receiving injections, pt developed head to toe hives & a cough Tx: Benadryl, prednisone, albuterol, epi Jr.  outcome: Sent to ER
Pt woke up the day after the vaccination and had hives on her arms and face. She went to her medical doctor where they prescribed her a prednisone taper, daily cetirizine and an antibiotic because she had scratched some open. She did not call us until today, 10/21/19. Documented in her profile her allergic reaction to the specific vaccine received.
Left eye developed a Central Retinal Venous Occlusion which was diagnosed on 16 February 2022.  As a result, I have experienced a significant permanent degradation in my visual acuity as a result, now less than 20/200 in that eye.  I have been under the care of a retinal specialist and treated with VEGF intraocular injections monthly since diagnosis.  Despite this treatment, I subsequently developed a retinal artery occlusion which has worsened my visual acuity in the affected eye. I have undergone extensive workup to determine the cause of this problem, including blood labs to rule out coagulopathies, carotid doppler, echocardiogram, holter and MRI/MRA of the head and neck that have not determined a cause.
Information has been received from a nurse referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 22-MAY-2015 the patient was inadvertently vaccinated with GARDASIL (lot # 0636AE, 0.5 ml, intramuscularly (IM)) that had expired on 09-JAN-2015. No adverse effects were reported. Additional information is not expected as the physician is not allowed to be contacted.
This is a spontaneous report obtained from a contactable physician (Pediatrician) through a Pfizer sales representative. A female patient of an unspecified age, race and ethnicity received the first dose of TRUMENBA on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced muscle pain and pins and needles. The patient stated she was feeling as if she was unable to move arms and legs for 4 days, like she couldn't walk or move. Physician stated she was in fact able to move and walk but she had muscle pain. The patient refused second dose on 20Mar2018. Clinical outcome was unknown at time of this report.
Numbness/tingling in left arm and hand (near pinky finger). Chest pain on left side - sharp, stabbing, nerve-like pain deep in chest cavity (under pectoral muscles) Neck/shoulder tension on left side - range of motion very limited, painful to move Small bump and swelling above collarbone on left side  Symptoms began the morning after vaccination upon waking (~8am). The chest pain subsided gradually after I got up. Same thing the next day. On the 3rd morning post-vaccination, chest pain did not subside and began moving throughout my chest. I went to my doctor (PRIVACY) and he determined I was experiencing thoracic outlet syndrome symptoms due to swelling reaction from my booster shot.  He advised me to notify him if symptoms get worse or persist after 3-5 days.
p/vax pt devel high fever; joint pain;spine & leg pain; extreme muscle weakness & inability to concentrate
Headache, Fever, NauseaVomiting, chills, sweats, no appetite Narrative: Nausea, fatigue, fever 100.1, chills, sweats, headache, no appetite; tylenol taken
Fri - 4-3-09 - School nurse phoned HD and stated that student's L upper arm was somewhat red with some swelling. Client c/o nausea and L arm pain. Referred to PMD. Mother phoned HD today to say she took student to Express Care. Told no PE x 1 week, TYLENOL q4-6h prn and cold compresses.
extra dose of fluzone qiv np was inadvertently administered,with no reported adverse event; extra doses of the vaccine was administered as it was the wrong child,with no reported adverse event; Initial information received on 01-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 months old male patient who had extra dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] was inadvertently administered, with no reported adverse event and extra doses of the vaccine was administered as it was the wrong child, with no reported adverse event.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination; and HEPATITIS A VACCINE INACT (VAQTA) for Prophylactic vaccination.  On 28-Oct-2022, the patient received a 0.5ml QY dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7701NA and expiry date:30-Jun-2023) via intramuscular route in unknown administration site for prophylactic vaccination.  On 28-Oct-2022 the patient developed a non-serious event of extra dose of fluzone qiv np was inadvertently administered, with no reported adverse event (extra dose administered) (Latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On 28-OCT-2022 the patient developed a non-serious extra dose of the vaccine was administered as it was the wrong child, with no reported adverse event (wrong patient received product) (Latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken: not applicable.  Outcome: Unknown  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 guidelines. 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.
Pt developed red, swollen and hard area at injection site measuring 6.5cm X 9cm, with a red streak 8cm X 4cm at upper arm. Symptoms started (achy and feverish) on 10/18/01 with localized reaction beginning on 10/19/01.
Fever 103.6 intermittently for 3 days; red raised rash in diaper area, mom had just changed brands of diapers; devel diarrhea 9AUG91; tx fever w/APAP x 3 days, rash w/Nystatin;
Mailed correspondence received on 06/04/01: "A nurse reported that a 4month old male ,with a medical history of possible latex allergy, received his first doses of Prevnar (Lederle Labs), Hibtiter (Lederle), IPOL (Aventis Pasteur SA) and DTaP (Acel-Imune, Lederle labs) vaccines on 01/24/01. On 03/19/01, when he was 5 month old, the infant's mother reported to the pediatrician that the infant developed "respiratory difficulty', wheezing and oral thrush.
Per MD vote "Veteran recounts that she received her first Pfizer vaccination on May 3rd and had "anaphylactic reaction". She was transported by ambulance to a local ER, given epipen injection in the ambulance and then treated at the ER. She adds that she was 'wiped out" for a couple of weeks with little energy. She is feeling "more normal now".
did not mix the powder & liquid together and Patient was given just the liquid dose; did not mix the powder & liquid together and Patient was given just the liquid dose; Arm is hurting / Pain in arm / soreness in the arms/pain has been excruciating in left arm; muscle pain/pain has been excruciating; back pain / back pain is excruciating; pain/ affecting her joints/pain has been excruciating; fever after partial dose; This case was reported by a consumer and described the occurrence of pain in arm in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th January 2021, the patient received Shingrix. On 13th January 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. In January 2021, the patient experienced pain in arm, fever, muscle pain, back pain and joint pain. On an unknown date, the outcome of the pain in arm, muscle pain, back pain, joint pain, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the pain in arm, fever, muscle pain, back pain and joint pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported that received the adjuvant suspension component of the Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient stated that the nurse did not mix the two components together and only administered the liquid component. The patient experienced a fever for 2 days, joint pain, muscle pain, back pain, and arm pain that started on the same night she received the adjuvant component (less than a day after vaccination). The patient came back to physician office to get the full complete dose on 22nd January 2021, for tolerance refer case US2021016994.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021016994:same patient (FU2 and 1st dose case)- Case for dose received on 22Jan2021- full dose