chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) 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 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201400:Original Case : US2021201400 US-GLAXOSMITHKLINE-US2021AMR201274:Same reporter.
I cannot say when an "event" occurred but it started the same month as the vaccine was given.  Mouth and lips swelling to fruits (apples, watermelon, peaches, etc).  Increase in eczema as well.  Became much worse after second Gardasil since I didn't realize it was related to the first Gardasil (and chicken pox booster and meningococcal vaccine).  She also developed a different skin issue that caused her skin on her face to look and feel rough (like sandpaper) but without the redness usually associated with her eczema.  She also developed asthma which she had never had before.  She also had GI issues, gas, bloating, gluten and dairy intolerance.
A few hours after vaccines were given at 6 months, min noted intermittent left esotropia. She also started with small tics around the same time and was evaluated by neurologist and found to be of no concern. Still followed by ophthalmology with the potential for needing surgery
Chills, fever (101.3), overall fatique and muscle soreness. Onset 14-16 hours after injection
Since 05/21/23:Lots of fatigue with exertion, Chronic cough, lack of taste or smell, poor sleep, night sweats, nausea, no appetite, intermittent headache, serious brain fog, copious mucus production, trouble breathing,, low grade fever, chills, and more I can't think of right now. 8 or 9 home tests and 2 PRCs over time I have never tested positive for Covid. Blood test shows antibodies for spike protein from vaccine only.
vertigo, nausea, fever, vomiting, chills, migraine, dizziness for 17 hours
picked up COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (picked up COVID) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. In August 2023, the patient experienced COVID-19 (picked up COVID). At the time of the report, COVID-19 (picked up COVID) had not resolved.            No concomitant medication was reported.  Reporter stated that, he/she was fully vaccinated & boosted with Moderna & then two Pfizer vaccinations. Patient picked up COVID in August and still had it.  No treatment information was provided.
Injected with empty syringe/needle, another syringe/needle used to administer vaccine.
Pt w/ hx of Asthma.  Pt c/o left sided headache and dizziness.  BP 128/73, HR 72, RR 18.  Pt given Tylenol 500mg PO.  Pt stable and released from the vaccination site.
Patient presented to office for dose of Tetanus Diptheria vaccine. Dose was administered intramuscularly into the left deltoid. Approximately 5 minutes post administration, patient complained of being hot to MOC, then proceeded to black out. Nurse responded immediately to find pateint in a supine position on the ground. LOC lasted 10-15 seconds. Patient was placed in the recovery position and a blood pressure was recorded as 90/44, and again 5 minutes later as 100/50. Pt recovered in office for about 30 minutes. A nurse escorted patient's mother and patient to their vehicle without incident.
It started with a headache right after the shot around 7:00; continued to feel pain in left arm after the shot and sluggish into the night around 9:00 pm; woke up with chest pains and difficulty walking normally; having significant pain joints, chest and head. Overall body Aches.
The patient was admitted to hospital from 2/24/2021 until 3/6/2021 for AMS, diagnosed with UTI. He had an MRI on 3/3/2021 that incidentally showed a nonocclusive thrombus in the right dural venous sigmoid sinus, which extends to the right jugular vein. He is being treated with apixaban. It is unclear if this is coincidental or somehow related to the vaccine.
got COVID; got COVID; This is a spontaneous report from a Pfizer-sponsored program. This non-contactable consumer reported for patient (reporter's relative). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number and expiry date were not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE; and received dose 1, via an unspecified route of administration on an unspecified date (Batch/Lot number and expiry date were not reported) as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient got COVID. The reporter wanted to know how it was possible that his relative after getting both doses of the COVID-19 vaccine still got COVID. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient presented with sweating and blurred vision 5 to 8 minutes after vaccination. No swelling of lips or tongue observed or shortness of breath reported. Patient reported having anxiety from vaccinations.  Patient was sat down on the ground with her feet elevated, hydrated with water, instructed to take deep breaths, and blood pressure was taken every two minutes.  Vitals will be reported as Time, BP, Pulse: 11:28, 78/62, 60; 11:30, 118/96, 121;  11:32. 107/69, 57; 11:35, 116/88, 65; 11:52, 107/73, 57. A pulse oximeter reading was taken twice reporting 96% and 97%. Patients reported feeling better after 2 minutes (11:30) and was given a glucose tablet at around 11:35, when she reported not having eaten yet. Patient reported feeling better and drove home after contacting family by phone.  Follow-up phone call with patient at 12:10 showed that patient arrived home safely, felt normal. At another follow-up phone call at 5:45 patient reported that she was doing okay and no problems.
Vertigo  Muscles aches exhaustion Day 9 injection site red rash burning seems to getting worse.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Unknown results, notes: COVID 19 Treatment; Positive, notes: rebound infection return symptoms and positive test on day 19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Report about covid treatment reported as Yes. If vaccine received reported as Yes, Other medication in 2weeks reported as No. Antiviral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 22Jun2022, Treatment stop date: 26Jun2022, Indication: Treatment of COVID-19, Administrator route: Oral. Adverse event reported as rebound infection return symptoms and positive test on day 19. Known allergies reported as no.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of COVID-19 and Drug ineffective.
This spontaneous report was received from a physician and refers to a 68-year-old patient of unknown gender. No information regarding the patient's medical history, concomitant medications, concurrent conditions and drug reactions or allergies was provided. On 10-FEB-2017, the patient was vaccinated with a dose of PNEUMOVAX23 injection (route of administration, site, dose, lot number and expiration date were not reported). On 28-MAR-2017, the patient received an additional dose of PNEUMOVAX23 injection (route of administration, site, dose, lot number and expiration date were not reported). No adverse event was reported. Additional information has been requested.
Myalgia, Fever, Fever up to 102.F and severe myalgias Narrative:
After a few minutes tingling in arms, anxious, tongue felt funny. Lasted 10 minutes. Prior medical history of panic attacks.  Normal vital signs , verbal felt better sent to the ED for observation
Patient inadvertently administered the 6-11 year formulation of Moderna rather than the bivalent booster.
Developed rash, Red welts in head, lower back and legs with itching about 10 hours after vaccine given.
Varicella vaccine was administered with a 5/8" needle syringe intramuscularly in the right deltoid rather than subcutaneously. The patient did not experience any adverse effects. The manufacturer was contacted to confirm if series needed to be repeated, which they confirmed that it would not. The patient's guardian was notified of the administration error and recommended to return in the specified timeframe to receive the second vaccine in the series.
No adverse affect.  Mom filled out appointment online for herself because it would not let her book an appointment for anyone under 18.  Then had her son fill out consent form and he came in with her.  She did not get shot but had her son get it.  He is only 17 years old.  We did not realize and gave him the vaccine.  We will contact md and moderna.
Day 1 (March 7)  102.7 fever, severe body aches, headache.  Resolved within  24 hours Day 6 (March 13) full body hives. Resolved with benadryl within 24 hours
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter. No treatment information was provided.  It was reported that Our Moderna vaccine (Lot# 026C21A) was pulled from the freezer on 10/13/2021 with a "use by date" of 11/12/2021 (30 days storage viability in the fridge). The Moderna Vial does not have an expiration date on it. However the Moderna Vail Expiration Date Checker states that this lot number has an expiration date of 10/24/2021.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received-No new information was added.
Chickenpox ( was not diagnosed in hospital, rash did not appear till later) Went to ER w/Kidney stone pain, set hone same day, returned 3days later, went to ICU  with 107temp, diagnosed with Septic Shock,kidney stones, severe kidney infection , acute  renal failure, High Troponin 1 levels,
Injection site warm to touch; Feeling a little itch on the injection site; Half dollar size flatly swollen injection site; Injection site redness; A spontaneous report  was received from a nurse concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) Emergency Use Program and experienced Injection site itching, then she noticed  a half dollar size, flatly swollen Injection site ,Injection site redness and Injection site warmth.  The patient's medical history and concomitant medications not reported.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 04 Jan 2021,  the patient developed Injection site itching, then she noticed  a half dollar size, flatly swollen Injection site ,Injection site redness and,Injection site warmth.   The patient did not have her vaccine administration card with her so she was unable to provide her vaccine Lot number, or the name of the provider who administered the vaccine.  The patient reported that she did not take any medication or notify her doctor of the symptoms at the time of the report.  Action taken with Moderna mRNA-1273 was not applicable.  The outcome of events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I woke up the next morning with sore throat and body aches. I had low grade fever and very tired. It lasted quite a few days so I went into the urgent care on that Tuesday 03/23/2021. It was a week or two of those symptoms did subside. I was not prescribed anything. I went back to work for just 3 days and did recover. I did have a breakthrough case of COVID after my second dose and this January 8, 2021. I did not need doctors care, medications, and just stayed home.
it stung alot when i got the 2nd shot.  like a bee sting.   then after it slowly started to get more irritated,  since yesterday its this big ball of red about as round as an apple or orange, and is hard and itchy.  I read online it may be Covid arm or moderna Arm.  still waiting for it to go down.
Pulmonary embolism; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  An 85-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 as dose 4 (booster), single (Lot number: GJ6738) at the age of 85 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, NDC, LOT, EXP of previous dose: unknown), administration date: 05Feb2021, when the patient was 83-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, NDC, LOT, EXP of previous dose: unknown), administration date: 25Feb2021, when the patient was 83-year-old, for COVID-19 immunization; BNT162b2 (Dose 3, NDC, LOT, EXP of previous dose: unknown), administration date: 29Sep2021, when the patient was 84-year-old, for COVID-19 immunization.  The following information was reported: PULMONARY EMBOLISM (medically significant) with onset Nov2022, outcome "unknown". The event "pulmonary embolism" required emergency room visit.  Clinical Course: There was a correlation between the Bivalent Pfizer COVID 19 vaccine (does not know specific cap color) and blood clots. Caller says and clarifies the patient did not get the vaccine here, the patient's wife was calling in, he got his 4th dose of COVID vaccine on 02Nov2022 and it was the bivalent and then 07Nov2022 he went to the ER and had a pulmonary embolism so the wife was calling today asking if there is a correlation between the two. Doctor wanted to check on giving this patient the COVID vaccine. Patient got the COVID vaccine 02Nov2022. Went to the emergency room 07Nov2022, with pulmonary embolis.  Patient's wife was calling to see if there was a correlation between the COVID vaccine and the pulmonary embolism. Unable to clarify which formulation of the COVID vaccine caller was referring to, stating she only knows it was the Pfizer COVID vaccine. Clarified that patient went to the emergency room 07Nov2022 but unknown if patient was admitted to hospital. Clarified that this COVID vaccine patient received 02Nov2022 was the Bivalent COVID vaccine. When caller looked up patient's vaccine in their system, states that under manufacturer, it states it is unknown but, patient's wife states that it was the Pfizer Bivalent vaccine the patient received. Prior Vaccinations within 4 weeks nothing noted in chart, unless they got it somewhere else. Does not know for sure.; Sender's Comments: Based on the limited information, the serious event Pulmonary embolism cannot be excluded fully for the suspect product BNT162B2, BNT162B2 OMI BA.4-5. 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.
Customer had shot then within 5 minutes became sweating, clammy, dizziness with visual disturbances. She believed she had low blood sugar. 911 called and appeared pt had low blood sugar. She never lost consciousness and was aware at all times.
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Anxiety-Mild, Systemic: Shakiness-Mild, Additional Details: We called 911 the patient was able to walk out with them.  We will call him for follow up.
This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were inadvertently vaccinated with 3 doses of VAQTA injection, intramuscularly, lot # M009377, expiration date: 17-JUN-2017 (dose and anatomical location of administration were not reported), which were improperly stored. It was unknown if a digital data logger was involved. No adverse effects were reported and no product quality complaint was involved. This is one of two cases received from the same source. Additional information is not expected as the reporter did not wish further contact.
Fatigue first day. Felt better for a couple days but then fatigue came back for approx. seven weeks.  I was so fatigued and tired, I thought I had anemia so I called my doctor for blood tests (described below). She said the results showed normal range levels for my hemoglobin, ferritin, and iron.  As of 04/22/2021 I started to feel better, a little less fatigue each day. I can only assume the vaccine caused a longer than normal aftereffect. I'm glad to know that's all it was and not a more serious issue, and I hope the progress contines.
Early cellulitis Rt arm (deltoid) prescribed Keflex 200mg TID x 10 days. Redness and swelling Lt arm (deltoid).
Weight loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4359071-00.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 11Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, Route of Administration : Intramuscular), administration date: 12Feb2021, when the patient was 64-year-old, for COVID-19 immunization, reaction(s): "Covid-19", "Covid-19"; BNT162b2 (Dose 2, single, Route of Administration : Intramuscular), administration date: 11Mar2021, when the patient was 64-year-old, for COVID-19 immunization, reaction(s): "Covid-19", "Covid-19". The following information was reported: WEIGHT DECREASED (non-serious) with onset Mar2022, outcome "unknown", described as "Weight loss". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: It was not known if the patient enrolled in a COVID-19 Vaccine Trial.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Report type updated as spontaneous report.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
This spontaneous report as received from a pharmacist refers to a 60 year old female patient. On 25-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # M037655 for prophylaxis. Other suspect therapies included sterile diluent. On 31-AUG-2017 the patient experienced injection site erythema and injection site pain. On an unknown date the patient experienced injection site warmth and adverse event. The outcome of adverse event was unknown. The outcome of injection site erythema, injection site warmth and injection site pain was reported as not recovered/not resolved.
Information has been received from a certified nurse midwife concerning a female who was vaccinated intramuscularly with a 0.5 ml second dose of GARDASIL. Subsequently the patient developed Bell's palsy. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/15/2008.  Follow up information was received from the C.N.M. who indicated that the patient was not her patient.  The patient just briefly discussed with her and the vaccine was given by someone else.  Additional information has been requested.
Low-grade fever, body aches, chills, headache, and nausea Symptoms subsided after 24 hours