chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I STARTED HAVING PAIN IN MY UPPER LEFT LEG AROUND 12/31 ..THE PAIN HAS WORSEN TODAY AND THE PAIN IS CAUSING ME TO LOSE MY BALANCE. IT FEELS LIKE ITS GOING TO GIVE OUT WHILE WALKING.  THE PAIN TRAVELS DOWN MY WHOLE LEG.  IF I STAND STILL OR SIT FOR A WHILE ITS HARD FOR ME TO PUT WEIGHT ON MY LEG.  I HAVE NEVER HAD PAIN IN MY LEG LIKE THIS BEFORE.  I WAS TOLD TO LET VSAFE KNOW DURING MY CHECK IN AND WILL  CALL THE NURSE ON DUTY TONIGHT.  IT'S BECOMING UNBEARABLE.  I AM DUE FOR MY 2ND DOSE ON THE 8TH .
had worsening vision loss in her eye; had worsening vision loss in her eye; This is a spontaneous report from a contactable consumer (patient) based on the information received by Pfizer. An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation; pyrimethamine (Tablet, Lot Number: AM0737A; Expiration Date: 31Jul2022) via an unspecified route of administration from an unspecified date and ongoing at 25 mg once daily for toxoplasmosis retinitis. Medical history included toxoplasmosis retinitis (eye infection toxoplasmal), vision loss (Blindness), and an allergy to sulfa medications. Concomitant products were not reported. On an unspecified date, the patient had a second dose of the Covid vaccine. On an unspecified date in Feb2021 (over the last month of 01Mar2021), after starting the products, the patient had worsening vision loss (visual impairment) in her eye within one month of receipt of the second dose of the COVID-19 vaccine. The patient felt the only thing that was new was she had just received the second dose of the Covid vaccine. As of 01Mar2021, the statuses of treatment with pyrimethamine and the worsening of vision loss in her eye were ongoing. An association with pyrimethamine cannot be ruled out. However, the event is confounded by toxoplasmosis retinitis, vision loss, and receipt of the COVID-19 vaccine, which the reporter notes was the only new occurrence. The action taken in response to the events for pyrimethamine was dose not changed. Therapeutic measures were taken as a result of had worsening vision loss in her eye. The outcome of the events was unknown. The reported was considered as other serious (important medical events).  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recv dtp/opv on 8-15-90.  pt devel. fever of 106 degF and convulsions.  pt hospitalized.
27 weeks and 6 days pregnant received dose of Gradasil 9 on 01/10/2019; no adverse effect; This spontaneous prospective pregnancy report was received from a nurse regarding a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not reported. The nurse described that a 27 weeks and 6 days pregnant vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (exposure during pregnancy) on 01-OCT-2019, lot # 1621934 and expiry date 29-JAN-2022 (strength, dose, route were not reported) for prophylaxis. The nurse stated that it was not product confusion and no adverse effects reported. The patient became pregnant with last menstrual period (LMP) of 20-MAR-2019 and estimate date of delivery 25-DEC-2019. The pregnancy outcome was pending.
broke out in hives, hives, upper back, ears-given DPH + epi;MD ordered prednisone syrup-hives cont;
expired ACTHIB diluent being administered to a patient with no reported adverse event; Initial information received on 14-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp(healthcare professional).  This case involves Adult and unknown gender patient to whom expired Haemophilus type B (HIB) vaccine [ACT-HIB] administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Dec-2022, the patient received a dose of suspect Haemophilus type B (HIB) vaccine(with unknown formulation, frequency, strength,  route and at administration site) for immunization.  On 13-Dec-2022 the patient received an expired Haemophilus type B (HIB) vaccine with no reported adverse event (expired product administered)(latency: same day) following the administration of Haemophilus type B (HIB) vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
This is a spontaneous report from a contactable nurse based on information received by Pfizer from Merck National Services Center. Service request ID #: 1-6628038210. A 17-year-old patient of unknown gender and ethnicity received the full series of PREVENAR on unknown dates. Relevant medical history and concomitant medications were not reported. The patient developed diabetes on an unknown date. No patient demographics were available and no other information was reported.
Airway began to constrict, chest tightened, patient seized. Epinepherine given, transported to hospital by EMT's.
UTI symptoms started on 11/7/21 evening, diagnosed UTI on 11/8/21, 11/9/21 blood in urine and flank pain started in late evening, early morning 11/10/21 diagnosed pyelonephritis.
Patient reported following his immunization he became short of breath, tired, weak, joint pain, headache, recommended go to emergency room, resulting Hospitalization 1/20-22/2021 dx Acute Hypoxic Respiratory Failure secondary to Acute on Chronic Diastolic Heart Failure exacerbation, currently patient remains on home oxygen
pneumonia; arm swelled up; pocket fuid in her left arm; turned red; the injection, "the second" hurt a little more but not a big deal; This spontaneous report was received from a female patient via Pfizer (MFR# 2021616142) concerning   herself. Patient stated she was not a healthcare professional, but was a caregiver to some older people. The patient's medical history, concurrent conditions and concomitant therapies were not provided.           On an unspecified date, she was administered with the first dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, route, lot# and expiration date were not provided) for pneumonia prophylaxis and "ended up in the emergency room (ER) twice". the patient stated she states she had quite a reaction.   On an unspecified date approximately in 2018 (reported as "2 or 3 years ago") (conflictive information), she went to a health conference center and it was set up so people were 6 feet apart and masked. She talked to the "same doctor before" and the second time. They told her which station she would go to. She talked to the nurse, told her the reactions she had had in the past and the nurse asked her if she was allergic to any of the items, she had no idea as she had no idea what was in the vaccine so the nurse explained what they usually are in and asked again, this time she answered she was not allergic. After a while talking the patient was vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23). She stated the injection, "the second" hurt a little more but not a big deal (vaccination site pain). A couple months later, she went to the doctor because her chest was tight, she worked all week. She had a chest x-ray, and the doctor said she had "waking" pneumonia.  She added that with the Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) her arm swelled up (peripheral swelling) and she had a pocket of fluid in her left arm (oedema peripheral), it turned red (unspecified date). She went to the ER and they gave her unspecified medication. They sent her home and said if it gets worse, she had to come back. On "sunday morning", she got up and she did not believe it, it was worse than ever. She went back to the ER and said it was getting worse. She stated it was terrible. She stated she had it back right around 2017 or 2018 also, but she was not sure (conflictive information). She ended up telling the doctor she would never take that one again, never ever. The doctor said she would not have to.         At the time of the report, the outcome of pneumonia and vaccination site pain was unknown.  The causal relationship between the event and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not provided.  Upon internal review, pneumonia was considered a medically significant event.
Upper right leg became red and swollen after DTaP on 2/26/03. Seen by an MD in urgent care 2/28/03. Tx with Benadryl.
Pt reported a rash on her torso, and itching as well (she does have prior history of itching and rash X 2 years)
See attached. Received FLUZONE Pres-Free injection on August 28, 2012, in the left deltoid area. On Tues, August 29 had quarter size swollen area, with about half dollar size red area, low grade fever of 100.5. Wed, August 30 woke up with hives everywhere. Neck and face were bright red just about purple looking. Started taking BENADRYL when that did not work was told to try Cetirizine came to see dr on August 31, he had her stop the Cetirizine and put her on Hydroxyzine 50 mg three times a day. After two days on medication hives resolved. Then on Sept 10 the itching started again. She was in to see dr on Sept 11, and was treated with Hydroxyzine 50 mg again. Patient stated that 24hrs after being on Hydroxyzine hives and itching gone. See it to follow up with allergist.
Patient presenting to Medical Center with progressive vision loss on 5/17/21, day prior to admission patient endorsing complete right eye vision loss and progressive left eye vision impairment. Prior to admission, she had presented to hospital for progressive right eye vision loss. Had right eye tonometry and ultrasound performed, pressure 24, ultrasound overall unremarkable. ESR and CRP normal limits. Referred for outpatient evaluation by ophthalmology and neuro-ophthalmology. Neuro-ophthalmologist referred her for IV steroids due to concern for ischemic optic neuropathy. She was started on IV solumedrol 1g daily for 5 days, with stabilization of her vision loss. No improvement in right eye vision loss, no worsening of left eye vision loss. Per patient, left eye vision blurriness able to see shapes and colors. Discharged on 5/21/21 on prednisone 60 mg until follow up with neuro-ophthalmology on 5/27/21.
Initial HCP report received on 04 Dec 2009: This patient under the age of four years was vaccinated with FLUVIRIN on 04 Dec 2009. No other adverse event was reported.
have a headache from the base of my neck up; felt nauseous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "have a headache from the base of my neck up"; NAUSEA (non-serious), outcome "recovered", described as "felt nauseous". Additional information: nausea subsided at the end of the 15-minute wait at the vaccination clinic, but still has the headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Headache-Mild
Patient was given Flucelvax instead of Spikevax on accident. Patient stated he had already received flu vaccine in October of this month
Patient states that two hours after receiving the vaccine she developed a mild rash. It was not bad enough that she felt she needed to be seen by her physician. She is only taking BENADRYL and rash has not yet fully resolved but isn't worse.
Few of his immunocompromised patients (unknown #) who previously received the Janssen vaccine, received an additional dose of the moderna vaccine with a 0.5mL; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Few of his immunocompromised patients (unknown #) who previously received the Janssen vaccine, received an additional dose of the moderna vaccine with a 0.5mL) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Janssen (Few of the patient previously received the Janssen vaccine and). Past adverse reactions to the above products included No adverse event with Janssen. Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Few of his immunocompromised patients (unknown #) who previously received the Janssen vaccine, received an additional dose of the moderna vaccine with a 0.5mL). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Few of his immunocompromised patients (unknown #) who previously received the Janssen vaccine, received an additional dose of the moderna vaccine with a 0.5mL) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter stated that few of their immunocompromised patients who previously received the Janssen vaccine, received an additional dose of the Moderna vaccine with a 0.5mL dose. The reporter who was an HCP stated that some of their patients got 0.5mL of Moderna vaccine 3rd dose and reported that they do not want to call it as them receiving the booster dose of Moderna with 0.5mL dose but termed it as an additional dose.   No Concomitant product use was reported. No treatment information was provided.
A PEDIATRIC DOSE OF PFIZER VACCINE WAS ACCIDENTALLY ADMINISTRED TO HIM /NO ADVERSE EVENT REPORTED
Noticed on Saturday later in the day at around 12pm 8/1/2020 a knot and its warm to the touch and it itches and is a little sore
Sore arm and sleepiness within 2-3 hours after shot. Body aches within 24 hours, lasting 24-48 hours.
This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported). Concomitant products included MORPHINE for an unknown indication. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness). At the time of the report, PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided. Company Comment: This case concerns a 74-year-old female who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: Sender's Comments: This case concerns a 74-year-old female who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report was received from a 65 year old female patient regarding herself. medical history included thyroid disease. The patient was allergic to TYLENOL with Codeine. On 20-APR-2016, the patient was vaccinated with one shot of ZOSTAVAX and PNEUMOVAX 23 each in the same left arm. The ZOSTAVAX was given in the fatty back part in the arm by the elbow and the PNEUMOVAX 23 was administered in the left arm up by the shoulder area. On an unknown date in 2016 a few days after receiving the two vaccines, the patient experienced cellulitis. The symptoms started with swelling on her left arm into her chest area up to her face which also got swollen and the swelling continued more, especially if she felt warm. Patient said she felt pains and aches when she would stand up and her body in general felt swollen. Patient also mentioned that she got an eruption which was a red rash that developed around her lower legs into her calves and the rash would look like it was healing and then the rash would suddenly flare up again around her lower legs. The patient also felt exhausted and fatigued. The patient stated that when she got the PNEUMOVAX 23, the clinic where she got both vaccines told her apparently the PNEUMOVAX 23 had touched her bone or nerve possibly and a few days later, she experienced a fever and cellulitis as well, which she was given an unknown antibiotic as treatment however the antibiotic made her very light sensitive in her eyes and face to the extent that she couldn't see in the light very well and after 3 days she had to stop taking the antibiotic. On an unknown date in 2016, her throat became hoarse and she felt breathlessness. The patient was prescribed an unknown anti-histamine to help treat some of her side effects. Lab data included blood tests, pulmonary test, lung X-ray. The patient went to see several Internist doctors and an immune disorder specialist but none of them could diagnose exactly why she was having numerous side effects or what specifically was causing her adverse reaction. The outcome of cellulitis, photophobia, dyspnoea and dysphonia was reported as not resolved. Causality was not reported. Upon internal review cellulitis was determined to be medically significant. Additional information has been requested.
The patient informed me before giving the second dose of Moderna that she has fainted for every single vaccine she has ever been given including the first dose of Moderna. She stated it usually happens one to two minutes after receiving the vaccine and that she comes to within 10-15 minutes. Her father has been with her for every vaccination, and she just rests her head on his stomach. I informed the other pharmacist on duty of this and had EpiPen and smelling salts on hand just in case. We were all ready to react in case of any emergency. The patient did faint after sitting for a couple of minutes. She knew it was about to happen and her father stepped in to let her rest her head. We had her feet raised on a chair. She was still breathing the entire time, so we used smelling salts to bring her to which worked. She was out for close 10 minutes, but still breathing normally. The smelling salts enabled her to respond and nod that she was okay. When she came to, she asked for water and a sticker, which we gave her, and she acted as if nothing had happened and was all smiles. We did get a member of management to come fill out a report.
administered expired TENIVAC with no adverse event; Initial information received on 17-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 60 years old female patient who was administered expired Diphtheria-2/Tetanus-5 Adsorbed Toxoids no Preservative Adult [Tenivac] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown expired dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids no Preservative Adult Suspension for injection of lot U7189AA and expiry: 30-Sep-2023 via unknown route in unknown administration site for Immunization, with no adverse event (expired product administered) (latency: same day).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was 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 Directive and Regulatory Authority 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.
Swelling, itching (slight), and pain area raised slightly. No cellulitis. No erythema tender to touch. First time obtaining tDap.
12/30/2020 Covid 19  vaccine Pfizer Lot # EK9231 01/20/2021 Covid 19 vaccine Pfizer Lot # EL3247 04/02/2020 Covid exposure to daughter 4/06/2021 Covid exposure to husband 4/07/2021 texted positive for covid with PCR test 4/19/2021 potential to return to work
My Brother also and he was sick for 16 days; My Brother also and he was sick for 16 days; My Brother also and he was sick for 16 days; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2 NOS), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), ILLNESS (non-serious), outcome "unknown" and all described as "My Brother also and he was sick for 16 days".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a nurse practitioner refers to a 18 year old female patient. On 24-APR-2014 the patient was vaccinated with GARDASIL injection, dose 3 (dose and route unspecified). Other suspect therapies included VAQTA dose 3 (dose and route unspecified). No concomitant medication was reported. On an unknown date medication error was reported that the patient was in the office today on 24-APR-2014 to receive her third dose of GARDASIL and her booster dose of VAQTA later than the recommended dosing schedule. Patient was given her first dose of GARDASIL (0.5mL dose) on 03-NOV-2009 and second dose of GARDASIL on 30-JUL-2010; Patient was given her first dose of hepatitis a vaccine, inactivated (0.5 ml (milliliters) dose) on 30-JUL-2010. No adverse effects reported. 1 Nurse called to inquire if a patient is late in getting their scheduled third dose of GARDASIL and booster dose of VAQTA, would vaccination series need to be restarted or could proceeding dose be given. There was no product quality complaint involved. The outcome of the medication error was unknown. Additional information has been requested.