chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it)/Swell occurred 5 days post injection and remained for several days; Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it) with corresponding ear ache and rough throat; Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it) with corresponding ear ache and rough throat; Small hives on bottoms of feet and on hands; This is a spontaneous report from a contactable consumer (patient herself). A 51-year-old female patient received the first dose of bnt162b2 (formulation: solution for injection), via an unspecified route of administration in right arm on 30Jan2021 at 08:00 as single dose for COVID-19 immunization. The patient's medical history included psoriasis, psoriatic arthritis and lupus, and was allergic to Benzodiazepines. Concomitant medication included guselkumab (TREMFYA). The patient was not pregnant at the time of vaccination. Prior to the COVID vaccine, the patient did not receive any other vaccines within 4 weeks and was not diagnosed with COVID-19. On 03Feb2021, the patient experienced very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it) with corresponding earache and rough throat. Swell occurred 5 days post injection and remained for several days. The patient also experienced small hives on bottoms of feet and on hands (the patient had psoriatic arthritis and lupus, so it was not unexpected). The patient was nervous, so underwent a COVID test on the sixth day (negative). The patient underwent lab tests and procedures on 05Feb2021 which include Qualitative PCR: negative and nasal swab: negative. 11 days out and the patient still have some lymph node swelling, but its nearly gone. The patient did not received treatment for the adverse event. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Strange sensation something crawling on my skin; This spontaneous case was reported by a consumer and describes the occurrence of FORMICATION (Strange sensation something crawling on my skin) in a patient of an unknown age and gender 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 was reported.). Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FORMICATION (Strange sensation something crawling on my skin). At the time of the report, FORMICATION (Strange sensation something crawling on my skin) outcome was unknown.            Treatment information was not provided for this event. It was reported that the patient felt this sensation basically on trunk and head.
Warm reticular pattern exanthem that blanches on face and tv wrk, upper arms and thighs, no treatment just watch and if worse EM.
He presented with garbled speech and left-sided weakness, the provider notified, and the patient was sent to ER.  Hospital records indicate the patient's symptoms resolved prior to the EMS arriving; however, the patient was transported for evaluation.   His presentation was consistent with a TIA. He was continued on dual antiplatelet therapy with aspirin and Plavix.2. Bilateral carotid artery stenosis was noted. The patient has a history of symptomatic carotid stenosis, hyperlipidemia, hypertension, Carotid artery syndrome, and ischemic stroke.   V
Patient received the Pfizer COVID-19 vaccine on 12/23/20 and 1/13/21, so was fully vaccinated when she tested positive for COVID-19 on 8/14/21.
COVID-19 VACCINE-INDUCED THROMBOTIC THROMBOCYTOPENIA; COVID-19 VACCINE-INDUCED THROMBOTIC THROMBOCYTOPENIA; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested.  On an unspecified date, the patients experienced covid-19 vaccine-induced thrombotic thrombocytopenia,  On an unspecified date, the patient died from covid-19 vaccine-induced thrombotic thrombocytopenia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20211034157.; Sender's Comments: V0: 20211034195-COVID-19 VACCINE AD26.COV2.S-COVID-19 vaccine-induced thrombotic thrombocytopenia. This event(s) is labeled per RSI and is therefore considered potentially related.; Reported Cause(s) of Death: COVID-19 VACCINE-INDUCED THROMBOTIC THROMBOCYTOPENIA; COVID-19 VACCINE-INDUCED THROMBOTIC THROMBOCYTOPENIA
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: ER8131), in left arm, on 30Mar2021 as dose 2, single (Lot number: EW0175), in left arm, on 11Nov2021 as dose 3 (booster), single (Lot number: FH8020), in left arm and on 14Jul2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 64 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CALCIUM CITRATE; CHONDROITIN; FISH OIL OMEGA 3; GLUCOSAMINE; VITAMIN D3. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had no known allergies. He received other medication in two weeks as Multivitamin. Patient was treated with Paxlovid (anti-viral) for covid-19 from 11Oct2022 to 16Oct2022.
This spontaneous report was received from a healthcare worker and refers to a 13 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 30-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # L011846 and expiration date 16-JUN-2017) (dose and route of administration were not provided). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Patient was administered flu shot 10 days after 1st dose of Pfizer COVID-19 Vaccine
20 cm area of red itchy skin on left upper arm. Cool compress and loratadine.
This  75 year old white male received the Covid shot on 3/27/21    and went to the Edand admitted on 4/13/21  with the following diagnoses listed below. CEREBROVASCULAR ACCIDENT I63.9 - Stroke (CMS/HCC) N17.9 - Acute kidney failure, unspecified R29.810 - Facial weakness
Onset of high fever that spiked at 103F, and has continued thru the second day
AIRWAY IRRITATION; HIVES; This spontaneous report received from a physician concerned a 48 year old male. 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 was not reported, administered on 25-JAN-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 5 decade old. No concomitant medications were reported. On an unspecified date, the patient experienced airway irritation, and hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hives and airway irritation was not reported. This report was non-serious.
Drug exposure during pregnancy; No adverse event; This spontaneous retrospective pregnancy case was reported by a patient family member or friend and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU and ASKU) for COVID-19 prophylaxis.     No medical history/conditions, allergy, concomitant diseases and risk factor.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) and NO ADVERSE EVENT (No adverse event). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) had resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy).    No concomitant and treatment medications were reported.  Reporter stated that the daughter in law was given 2 Moderna Covid-19 shots plus. Patient was pregnant in Mar 2021 and did not exactly know which dose was given at the time. The specific dates when these were administered, and the corresponding lot numbers were not known. The patient gave birth to a baby who was then 18 months old and who had dermatitis that never got away. This report was for the daughter in law.  Company Comment: This is a spontaneous case concerning an adult female patient, exact age unknown with no reported medical history and maternal exposure during pregnancy, who did not experience any adverse event. Patient received a dose of mRNA-1273 vaccine during pregnancy, gestation age at the time of vaccination was unknown. The baby was reported to have experienced dermatitis. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-716868 (Parent-Child Link).   See case US-MODERNATX, INC.-MOD-2023-716868 for details regarding the child case.
This is a spontaneous report from a contactable nurse reporting on behalf of a physician. This nurse reported similar events for 3 patients. This is the 2nd of 3 reports. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration in the arm, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced severe arm pain following the injection on an unspecified date with outcome of unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016503342 Same reporter/drug/event, different patient; US-PFIZER INC-2016503348 Same reporter/drug/event, different patient.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 12 years old adolescent patient and unknown gender. On 09-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (PFIZER COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 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 had no relevant medical history. No known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jun2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid. Clinical course: Paxlovid rebound infection. Tested negative on rapid home test day 5 (same day completed paxlovid). On day 10/11 started feeling symptomatic again - congestion, cough, headache.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Myocarditis; strong pain/pangs in chest at middle of the night; This is a spontaneous report received from a contactable consumer (patient). A non-pregnant 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 at the age of 64-years-old via an unspecified route of administration, administered in Arm Left on 06Apr2021 (Lot Number: EN6208) as 2nd dose, single for covid-19 immunisation.  Medical history included mitral valve prolapse, seasonal allergy, hypotension. No other vaccine in four weeks. No covid prior vaccination.  No covid tested post vaccination.  The patient's concomitant medications were not reported.  The patient previous took fist dose of BNT162B2 on 16Mar2021 at the age of 64-years-old administered in Left arm (Lot number: EL9262) for covid-19 immunisation and experienced chest pains/soreness/pangs. The patient experienced strong pain/pangs in chest at middle of the night of the vaccine. Since then she still had chest pains/soreness/pangs, what she now think is myocarditis. Adverse event start date was 16Apr2021. No treatment was received. The event outcome was not recovered.
swelling in throat glands; red eyes; face swelling; scaling on her eye lashes; Initial information was received on 27-Jan-2021 regarding an unsolicited valid non-serious case from a consumer or consumer or other non-professional (patient).  This case involves a 82 year old female patient who experienced red eyes (ocular hyperaemia), swelling in throat glands (pharyngeal swelling), face swelling (swelling face) and scaling on her eye lashes (eyelid exfoliation), after she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  In 2017, patient was taking the FLUZONE QUADRIVALENT as previous vaccination with no side effects.  Medical history, medical treatment, family history and concomitant medication were not provided.  On 08-Oct-2017, the patient received a first dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UI840AA, 04-Jun-2018] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious red eyes (ocular hyperaemia), swelling in throat glands (pharyngeal swelling), face swelling (swelling face) and scaling on her eye lashes (eyelid exfoliation), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data not reported.  It was reported at the time of reporting that, patient looked Asia and she is Irish.   It was also reported that, patient was not wanting to take the COVID vaccine but wanted to know if she would have the same side effects as the FLUZONE HIGH-DOSE and her physicians suggested her, not take the COVID vaccine due to  FLUZONE HIGH-DOSE side effects.   It was not reported if the patient received any corrective treatment.  At the time of reporting, event outcome was reported as unknown for all the reported events.   At the time of reporting, the result of assessment reported as not reported.
very ill; Initial information received  on 13-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves a patient of unknown age and gender who got very ill after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient had received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, route, formulation, batch number and expiry date: unknown) in unknown administration site for flu.   On an unknown date, the patient got very ill (illness) (latency: unknown) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (very ill).  At time of reporting, the outcome was Unknown for the event very ill.
ATRIAL FIBRILLATION; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer through a company representative concerned a male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total, for prophylactic vaccination (dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected Covid-19 infection due to which he almost died (bad Covid-19 infection) (suspected clinical vaccination failure) and atrial fibrillation. He was fully vaccinated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from atrial fibrillation, and the outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211245023 and 20211245964. This report was associated with a product quality complaint: 90000207820.; Sender's Comments: V0: 20211245900- COVID-19 VACCINE AD26.COV2.S- Atrial fibrillation. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20211245900- COVID-19 VACCINE AD26.COV2.S- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
The first thing was that I had a very red swollen arm. It was very swollen, hot, and painful. The next thing was nausea, and I was unable to eat. I had no interest in eating and had a severe migraine-like headache. It hurt to have my eyes open, and I stayed in bed and didn?t get up for 3 days. I ached all over and had a temperature over 100 degrees. Those were the main symptoms. After, I also developed very achy joints which was painful. I started having irregular heart beats and palpitations. I don?t know if it?s in relation to COVID, but they are monitoring my heart and I?m currently on a monitor. They?re trying to figure out why my heart is racing, fluttering, heart palpitations, and dizziness. I had a really bad episode 6 weeks ago and figured I would go check this out. I also had some nerve tinges in my face and watering of my left eye. This is all on the left side which is where I got my shot. I?m unsure if this is in relation to the vaccine or COVID. It comes and goes, but I?m not sure if they?re related. I also did get shingles after the 2nd vaccine as well, before my third shot. I think it?s probably related to the whole COVID experience. I have also gotten COVID before the vaccine was available twice. Within 3 months of getting COVID the first time, I got it again. I had to get over the symptoms before receiving the vaccine. Some things I'm recovered from, but with the heart issues and nerve issues, I'm not recovered from yet. I'm unsure if they're in relation. One other thing to mention was that after the 3rd dose, I also had swollen lymph nodes in my neck and underneath my arms in the armpits.
The next day she said her left arm hurt really bad, more than she was expecting and she felt under the weather.
Reporting administration error as per immunization system. We contacted Pfizer for expiration dates, pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only include manufactuarer dates on the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from them.  No adverse reaction reported from the patient at the time of the vaccination. No adverse reaction reported since the administration of vaccine.
Redness at the site of injection. Antihistamine and Hydrocortisone ointment.
Initial medication error report received on 09 December 2013 from nurse. A patient whose age, gender, medical history and concomitant medications were not reported, received a dose of FLUZONE (route, lot number and site of vaccination was not reported) on an unknown date. Reporter stated that adult consumer received 0.25 ml. Patient did not have any adverse events. List of documents held by sender: none.
A week after my second dose for Covid 19 I started have diarrhea and it continued for days and I still have it. I am concerned because it won't stop. I am drinking lots of fluids so as not to dehydrate. I will call my Doctor if it does not stop after 7 days. I hope this is a minor side effect of a good vaccine.  Thanks
Chest tightness, anxiety. BP 119/66 (pulse 81), 100% O2 sat. Given water and graham crackers.
Within 2 hours of receiving the injection the patient experienced swelling, redness, itching and was warm to touch with a temperature of 101F. The patient was treated with a steroid injection and antibiotics for an acute inflammatory reaction.
Initial misuse report received from a healthcare professional on 23 September 2013. A 02-year-old patient had received 0.5 ml of FLUZONE. It's an over dose. No adverse event was reported. List of documents held by sender: none