chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1515-pt presented with complaints of being shaky after having blood drawn in the lab. I administered the flu vaccine im and pt reported he was fine but then experienced syncope so we had him recline with knees up until he had recovered.
Started with a *really* itchy thumb.  Itching kept up & would not dissipate.  Rash started & looked like tiny welts/boils, etal. As of this date I still have the rash (4/12/2012)... As one area 'heals' you can look and see another row of the bumps already having formed; the rash radiates outward and has taken up about half of my palm; has only gone up to the base of the pointer finger; has covered my entire thumb and destroyed my thumbnail.  I've had a nurse friend tell me it sounds like eczema but the doctors office not tell me a thing except that I must have come in contact with *something* - I am not allergic to anything and have never had eczema in my life and was healthy when I went in for the checkup/shot...
intense itching of toes enough to wake up from sleep; Rash on tops on toes and upper part of foot; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 20Apr2021 at 16:00 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included fexofenadine hydrochloride/pseudoephedrine hydrochloride (ALLEGRA D 12HR), ascorbic acid/ pyridoxine hydrochloride/ biotin/  tocopheryl acetate/ folic acid/ thiamine/ nicotinic acid/ colecalciferol/ cyanocobalamin/ retinol/ pantothenic acid/ riboflavin/ phytomenadione/ iron/ sodium/  copper/ zinc/ calcium/ iodine (FLINTSTONES COMPLETE) and malus spp. vinegar extract (APPLE CIDER VINEGAR) ACV Gummies; all for unknown indications from unknown dates and unknown if ongoing. On 25Apr2021 at 18:00, the patient experienced intense itching of toes enough to wake up from sleep and rash on tops on toes and upper part of foot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events intense itching of toes enough to wake up from sleep and rash on tops on toes and upper part of foot was not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
Patient is an employee at Health Center. She was given the vaccine approx 3:30 pm on 1/28/2021 in the left deltoid. Patient was monitored for 15 minutes after receiving the vaccine without incident. The following is a written statement from patient describing events: "About 30 minutes after vaccine, I felt like I had hit my elbow on something. Discomfort radiated from left elbow to wrist- I did have pain around injection site. About 8:30pm on 1/8/21, area around injection site became more painful. Gradually pain increased radiating down to finger tips and up to left side of neck, stopped right below ear. Neck and shoulder muscles felt really tight- uncomfortable ache. Also got extremely tired- left side of face felt numb- left eye slightly blurry- I fell asleep about 10pm. Woke up a few hours later drenched in sweat. Face numbness gone, eyesight normal.? Patient reports the following day 1/9/2021 @ 2pm: ?All of a sudden I started to sweat all over. I didn?t feel hot, only last about 30 minutes.? Patient reports on Sunday 1/10/2021: ?Woke up feeling okay. Left arm and neck still ached but not as bad. Got fatigued around 10am. I got a headache that became really bad. Dizzy, nauseous- no relief from OTC meds. Headache went away after a few hours.? Patient reports today 1/11/2021: ?Today I am still very tired. My left arm, fingertips, shoulders and neck still ache. Face is flushed.? Patient does state previous reactions to prior vaccines: ?TdaP about 7 years ago made me have joint pain for months. Last flu shot received was about 9 years ago, had flu like symptoms x12 hours.? Patient did not seek any medical care for the reaction described above. Patient?s PCP has been also been made aware of her reaction.
Seriousness criteria other medically significant (OMIC). Initial report received on 05 December 2006 from a health care professional. A 47 year old female patient, with a history of food induced anaphylactic reactions, and who was taking Prednisone, Albuterol and Zyrtec, had received a dose of Fluzone on 27 November 2006 at 11:00 pm. The lot number, route and site of administration were not reported. Twenty minutes post immunization, at 11:20 pm, the patient experienced chest tightness, shortness of breath, and spasmodic coughing. The patient was administered Adrenalin, and transported to the emergency room via rescue EMS where she was treated and released. Treatments received, and diagnostic tests performed were not reported. At the time of this report, the patient had not recovered. A corrective version (1), (with the same latest received date as the previous version), was generated in order to amend the category in this case as serious, category II, for reporting purposes.
This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient had flu like symptoms for a few days. The patient refused to get a second dose of SHINGRIX. The reporter did not agree to follow up from GlaxoSmithKline.
Patient went to a pharmacy offsite clinic at a company to get dose 1 of Pfizer. The parents put patient DOB with an age of 12 on the VAR form. Based on the age, the patient is only 11 years old at the time of the vaccination. Patient received COVID Pfizer vaccine outside of the age guidelines.
flu; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 03-Dec-2020.  This case involves a patient of unknown demographics who had flu (influenza), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, past vaccinations, family history and concomitant medications were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient had flu (influenza), (non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Shingles; This is a spontaneous report from a contactable consumer (patient). A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), dose 1 via an unspecified route of administration on 02Mar2021 as single dose, dose 2 via an unspecified route of administration on 26Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient got the first dose and she was diagnosed with shingles on 22Mar2021. She got her second dose and she was better with the shingles but now she had shingles again and stated that she was 42 and she never had shingles in her entire life. She just thought she wanna call and let them know. The patient was under doctor's care at that time. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Rash - swollen- itchy - red -- at injection site- 3-4 inches diameter - very red for 48 hours-  after 48 hours, better , getting  back to normal slowly-    No pain- no fever
This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On 13-SEP-2013 the patient was vaccinated with PNEUMOVAX23 (lot# 0087AE, expiration date 18-AUG-2013) 0.5 ml, intramuscular. The patient received a dose of expired dose PNEUMOVAX23. No adverse effects were reported. Additional information is not expected.
About 3 weeks after my vaccine I started hearing a noise in my ear that sounded like air coming out. I also felt pressure. It prevented me from sleeping/working. I went to the doctor and they attributed it to the vaccine. They ran multiple tests and all were normal. I started getting frequent headaches in August. Since September I have had headaches with aura every day. I had an EEG and they found I have mild seizures. Sometimes when I get the headaches my face goes numb. I have had a number of imaging done including chest X-ray, MRI's and EEG. I have also had blood work done.
10/25/19@1:45PM: patient called and reported swelling on her right arm. Has started taking tylenol since yesterday (10/24) and has taken 3 doses total until the phone call. - patient spoken to the pharmacist and was advised to continue taking tylenol and usually takes a few days to resolve.
Blurry vision in my right eye; Influenza: 2Nov2022 / Pfizer Bivalent: 2Nov2022; Influenza: 2Nov2022 / Pfizer Bivalent: 2Nov2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 at 19:15 as dose 4 (booster), single (Lot number: 6H9702) at the age of 33 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA), on 02Nov2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Epilepsy" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing), notes: High Blood Pressure; "Known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: DAYQUIL. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 02Nov2022, outcome "unknown" and all described as "Influenza: 2Nov2022 / Pfizer Bivalent: 2Nov2022"; VISION BLURRED (non-serious) with onset 03Nov2022 at 06:45, outcome "unknown", described as "Blurry vision in my right eye". It was unknown if therapeutic measures were taken as a result of vision blurred.
Patient parent called and notified office of seizure 05/25/2022. Went to outside ER for treatment 05/25/2022. Positive for Covid 05/25/2022. Sent home. Told to give Tylenol and Ibuprofen rotating.
A few minutes after the vaccine was administered the patient felt hot, lightheaded, dizzy and had to sit down.  While sitting down his eye rolled back and he passed out.  His spouse said his body was shaking.  She lowered him to the floor and he awoke.  Paramedics were called and determined his blood pressure was very low. They tried to stand the patient up to take another blood pressure reading, but the patient had to sit down as he became dizzy and lightheaded again.  The paramedics took him to the ER where the doctor said he was fine and discharged him.
had Moderna for 1st and 2nd doses; given Pfizer as booster dose; This spontaneous case was reported by a health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (had Moderna for 1st and 2nd doses; given Pfizer as booster dose) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (had Moderna for 1st and 2nd doses; given Pfizer as booster dose). On 07-Oct-2021, INTERCHANGE OF VACCINE PRODUCTS (had Moderna for 1st and 2nd doses; given Pfizer as booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.   This case was linked to MOD-2021-345542 (Patient Link).
DIED OF COUGHING; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnic origin 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 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient died of coughing. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20230756395-Died of coughing. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: DIED OF COUGHING
Developed itchy, red , painful rash   2.5 inch width  3 inch length, very hot to touch Each day increased in size to max of  3 inch width 6 inch length Redness decreasing  day 4-5  still present but seems to be resolving as of today 8/26/21
Pt had vaccines on 10/16/01; mom brought pt to clinic on 10/17/01 with a complaint of tremor and shaking. 911 was called.
Patient has been admitted to the hospital with pleural effusion, possible pericarditis and is positive for coronavirus, ongoing workup unclear if pleural effusion is secondary to covid 19 as this is atypical.
Initial unsolicited report received from other healthcare professional on 08 July 2016. This case involves a 42-year-old female patient who was vaccinated with a dose of TENIVAC (batch number: U5411AA, expiry date, site and route of administration not reported) on 16 June 2016. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as allergies: none known as per reporter; Medical History: none as per reporter. Concomitant medications were not reported. Any other vaccinations within 4 weeks of vaccinations was not reported. On 30 June 2016, 14 days following the vaccination, it was reported that the patient did not have any reactions at that time. Then stated they heard from another patient that, later that night of 30 June 2016, the patient had passed away. Relevant diagnostic tests/laboratory data was not reported. The patient's corrective treatment was not reported. On 30 June 2016, the patient had died. List of documents held by sender: none. Sender's Comments: This case concerns a death in a patient who was vaccinated with DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT and two other products. This case is not sufficiently documented. More information including and not limited to detailed Autopsy report and patient's medical history, laboratory tests are needed to further assess this case. Based on the information provided; the role of vaccine cannot be assessed. Reported Cause(s) of Death: passed away.
Parent noticed redness and swelling in left deltoid the day after vaccination was given.  The day after parent reports to clinic for with more swelling, blisters begin to form with drainage.
Client (DOB: 8/22/2018) received second dose of Moderna 6 months to 5 years COVID vaccine lot # AR9237B  today in left arm at 11:18 am. At 11:40 am client stated his "toe was itchy." PHN and RN approached client in the observation area, sitting upright in the chair next to his father. PHN lifted client's shirt to observe skin. No rashes or hives observed on trunk, chest, neck, arms, legs, feet, or toes. Skin dry and appropriate to Ethnicity. Client's father reported a history of eczema and peanut allergies. Client has his own epi-pen and reported having rash on chest, shoulders, and back and threw up when ate peanut butter as an infant. Client not taking any medications. Vitals taken at 11:43 am, when client reported "itchiness is gone: "BP 90/60, HR 106 bpm, SPO2 97%, RR23. No difficulty breathing noted, client talking and playing on IPAD. At 11:49 am client confirmed itchiness had not returned. PHN educated father to remain in observation for 30 more minutes to monitor. At 11:59 am PHN called Clinical Project Coordinator. Per Coordinator, if itchiness returns at all, to call 9-1-1 and continue to monitor for 30 minutes. At 12:06 pm, PHN observed no rashes on skin and client denied itching. PHN educated father to follow up with primary care provider in 24 hours, and reviewed signs and symptoms of an emergency and when to call 9-1-1. Client left with father at 12:18 pm with steady gait, no concerns.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2021 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Low WBC" (unspecified if ongoing); "Idiopathic" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) negative; (09Jun2022) positive, notes: tested positive; White blood cell count: (unspecified date) Low. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid was used for the treatment of covid-19 from 01Jun2022 to 05Jun2022, lot number: FX2741. Did not experience any known allergies. The patient did not received other medication in 2weeks. The patient has no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates (reported as since 31-DEC-2015), the patients were vaccinated with improperly stored doses of PROQUAD (lot # L026728, expiration date 15-JAN-2017, exact doses and route of administration were not reported). It was reported that the vaccines were exposed to the temperature of 8F for an unspecified time frame. A defrost cycling was considered. The reason of the report was data logger. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Pt with history of recovered Covid, developed sudden absominal pain, distention, emesis, diagnosed with bowel infarct and pneumonia, one day after 1st covid vaccine.  Died 1/5/21 in hospice.
Flu like symptoms; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and HEADACHE (Headache). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and HEADACHE (Headache) had resolved.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up received on 21-May-2021 and included significant information Outcome of all the events were updated to resolved.
Fever, Nausea, chest pain beginning evening of shot, through next day.  Waned evening of 2d day.
Hives (itchy, red, upraised) started to appear first on scalp, hands, groin area. Within 24 hours of first appearing. moved to all areas of body. They would first burn and then become very itchy. Would be intense for 15-30 minutes and then move to another spot on the body and be intense 15-30 minutes. This lasted for 24 hours for 9 days. Went to Urgent Care on 1/19 because also had chest pain / heart burn, which is abnormal for me. Urgent Care ran all of the tests (EKG, CT scan, etc.) and heart and lungs were fine. I have no known allergies and no new food introduction or skin products introduced in environment. Nothing new with environment at all. Doctor prescribed a 5-day tapered prednisone for hives. The Prednisone did not offer any relief. I took Benadryl every 5-6 hours along with the prednisone prescription. The Benadryl provided minor itching relief. After 9 days of Hives 24/7, I reached out to Doctor again and she consulted with allergy team. They believe that I was having a delayed-immune response to Booster shot I received on 1/5. Told me to take Zyrtech (one or two tablets, twice daily). I had immediate relief once I started taking Zyrtech. I am taking 1 tablet, twice a day. Hives still come and go but they aren't itchy or upraised. Just red splotches in random places. It is 2/3 and I am still having to take Zyrtech.
He has been having postnasal drip, runny nose, deep coughing for a month, trouble sleeping. All this has led to both a sinus and ear infection. I made an appointment to see his pediatrician, who upon examination referred him to an ENT to try and determine what is causing these events as both the ear infections and sinus infections are reoccurring.