chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Interchange of vaccine products; fainted; broke out in a full body rash/terrible rash; 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 66-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose 1, Single), for COVID-19 immunisation; Moderna (Dose 2, Single), for COVID-19 immunisation; Moderna (Dose 3 (Booster), Single), for COVID-19 immunisation; Moderna (Dose 4 (Booster), Single), for COVID-19 immunisation. The following information was reported: RASH (non-serious) with onset Sep2023, outcome "unknown", described as "broke out in a full body rash"; SYNCOPE (medically significant) with onset Sep2023, outcome "unknown", described as "fainted"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Sep2023, outcome "unknown". Clinical course: Caller calling about new Pfizer vaccine, she broke out with full body rash and fainted she's asking if these are side effect and what to do. Patient trying to figure out if she should go to the emergency room and patient have a terrible rash from the vaccine. Advised caller to contact the emergency her doctor or go room if experiencing severe allergic reactions to the vaccine. Caller stated that she called about the new Pfizer Vaccine. Had the vaccine last night. Just broke out in a full body rash about 06:00pm. Wanted to know if this a side effect and what to do. Had the other vaccine for Moderna and this was her first Pfizer. Mentioned that she also fainted today and was tried to find out if she should be going to the emergency room. Does not have the product name as it appears on the label or the lot number this was her first Pfizer and had the four others of Moderna.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Denies any adverse reactions. FLUMIST expired on 12/3/12 & was given on 12/10/12.
pt recvd vax; 8 days later, exp fever to 104; also has sz; tx in er;
Day of vaccine and day after: high fever, chills, headache, body aches, vomiting, and diarrhea.  April 13: food smelled rancid.  April 17:  certain foods smell and taste rancid.  Everyday, more foods smelled/tasted rancid.  4/20/21: Symptoms improved, but several foods have a rancid aftertaste.
I had nerve pain on the back left of my head. Going from the back to the top of my head. It lasted a couple days, I treated it with vitamins and minerals and interferential therapy. I did this for two days. Occipital Neuropathy
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium
Myalgia, malaise/fatigue, dizziness, nausea x 8 h, starting approx. 24 h after administration of vaccine Sx improved with ibuprofen and rest
Patient finished two series last year. I administered one dose  on 04/08/23 then realized patient already finished the series
developed itchy red welt like hives at injection site (L deltoid) from L shoulder to elbow. also c/o nausea. no breathing problems. this reaction occurred approx 17 hours after injection. child never had a reaction to flu or any vaccine in the past. no allergies to anything. 3/4 family members received their flu shot at this same clinic on different days/times. Mother was told day before due to her documented latex allergy that there is a rubber stopper in the vial, but Mother choose to proceed with vaccine. There was no mention of rubber stopper with her son, but he has no documented latex allergy. child went to school nurse at 11am on Fri 10/1 and had to be sent home due to symptoms. 10/2 child developed cold symptoms and was covid neg. child missed school 10/4 and 10/5 due to cold symptoms. child missed 2.5 days of school total.
20OCT93 onset head cold (dimetapp); 24OCT93 chest (lung) involvement; h/a, stiff neck, equilibrium disturbance 2-3 wks duration; bad cough & congestion w/above sx; generic ATB prescribed by MD;
Patient came into the pharmacy today to speak with the pharmacist.  I was working today.  She said she had itching that started on Monday February 1st followed by a rash on that area of the arm. She received her vaccine on Saturday January 23, 2021.  She did not notice rash or itching until February 1, 2021. She said she also had some tenderness in her arm as well.  The rash had gotten much better since Monday when she came into the store today to show me.  It was a light pink color and just in a small area on her left arm.  She just wanted to let us know.  So, I told her I would report it. She still has a little bit of itching and redness, but it was not really bothering her much anymore.
Burning sensations in head; metal/chemical taste in mouth; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 01Apr2021 at 14:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis and high blood pressure. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C), vitamin d (MANUFACTURER UNKNOWN), paracetamol (TYLENOL) and multivitamins (MANUFACTURER UNKNOWN), all taken from unknown dates for unspecified indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, immediately after vaccination, the patient experienced metal/chemical taste in mouth. On 01Apr2021 at 21:00, in the evening, the patient experienced burning sensations in head which was ongoing at the time of this report. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the events. The clinical outcome of the events metal/chemical taste in mouth and burning sensations in head were not resolved at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
First dose on Aug/2021, 2nd dose not administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first dose in August 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's Comment: The reporter request information if the series should be restarted in case the 2nd dose was not administered yet. The reporter asked if the patient repeat both dose or only get 2nd dose. Since there was not contact with healthcare professional directly, request of follow up was not gathered. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose which led to incomplete course of vaccination.
Fever blister on her lip; This is a spontaneous report from a contactable pharmacist from a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 12Jan2021 at a SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got the vaccine yesterday and woke up this morning with a fever blister on her lip on 13Jan2021 . She was asking if it was okay for her to take Valtrex and if it would affect the efficacy of the vaccine. The patient was also asking if patients can take Tylenol prior to the shot as preemptive measures for side effects like fever. She also mentioned that she heard from somewhere that there were reports regarding infertility with the vaccine. She was confirming if this was true. She stated, "I get that there's still limited information, with this being all new in all, but it is kind of worrisome on our part as well because we just don't want to mess up administration of this vaccine." She mentioned that she heard from somewhere that there were reports regarding MS (Multiple Sclerosis) side effects with the vaccine. She was also confirming if this was true. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Itchy, swollen, hot, red rash area. Expanded in size on second day, by third day swelling began to subside and itch was less persistent. Look changed from red bump to red ring with bruise-like area inside. Heat dropped significantly after first day.
severe chills; severe headache; very tired; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 09Apr2021 at 09:00 (at the age of 68-year-old), as single dose for COVID-19 immunisation. Medical history was reported as none and the patient did not have a history of allergies to any food or medications or other products. The patient did not receive any other medications within two weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 19Mar2021 at 09:00 (at the age of 68-year-old), as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 09Apr2021 at 21:00, the patient experienced severe chills, severe headache and very tired for 2 days. No therapeutic measures were taken for the events. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events severe chills, severe headache and very tired were recovered on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Extreme tiredness; Sore on mouth; Difficulty in breathing; Chills; This is a spontaneous report from a contactable consumer (the patient). A female patient of an unspecified age (approximately age 76) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included Asthma, Type 2 diabetes, Client's esophagus and Several nodules on her right lung. The patient concomitant medications were not reported. On an unspecified date, several days after the first dose of vaccine, the patient experienced extreme tiredness, sore on mouth, difficulty in breathing, and chills. The outcome of the events was unknown. All the events were reported as non-serious.   Information related lot/batch number has been requested.
Sunday evening 04/24/2022, I noticed some head cold like symptoms with minor stuffiness and headache. I did an at home COVID-19 test the next morning on 4/25/2022 which was negative. The cold symptoms remained and got a bit worse. I was experiencing fatigue and headache so I was sleeping a lot for the next few days. On Thursday, I tested again and it came back positive. So I called the doctor who prescribed antivirals and advised that I increase my vitamin D and water intake and lowered my recommended blood pressure medication dosage. Overall it has been a mild case, perhaps a 6 on a scale of 1 to 10.
Severe local reaction left arm diffusely tender, red, warm, edematous down to forearm.  Slight swelling of neck/throat.  Patient Afebrile but with myalgias, fatigue.
Severe headache; chills; Fatigue/tiredness; dizziness; nausea; vomit; This is a spontaneous report from a contactable Pharmacist. An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and expiry dates were not reported) via an unspecified route of administration on an unknown date in Feb2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in Feb2021 the patient experienced with severe headache, chills, Fatigue/tiredness, dizziness, nausea and vomit. Patient received treatment with acetaminophen.  Patient whether tested for COVID-19 post vaccination was unknown. The outcome of the events was recovered on an unknown date in Feb2021.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Three days after receiving dose 1 of the Moderna COVID 19 vaccine, I was contacted by the deceased daughter who indicated she could not get her mother out of bed.  She was subsequently placed in Hospice Care due to global decline, never experienced any significant improvement, and expired 30 days later.    Vaccine related adverse effect global debilitation after receiving vaccine.
nurse gave Dtap  without the hib portion from  Pentacel, no AE; Initial information received on 22-Jul-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a patient (unknown demographics) to whom nurse injected 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] while reconstituting only Dtap  without the hib portion was given (lot UJ2598A, Expiry date 14-May-2021, route and site of administration were not reported) for prophylactic vaccination on 22-Jul-2020.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to Inappropriate reconstitution technique.  At the time of reporting, no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Patient received expired MODERNA vaccine. The vaccine expired 7/13/2022. Patient was contacted on 7/29/22 and stated no adverse reaction.
No menstral period since 27May2021; No menstral period since 27May2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 (Lot number: ER8729) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VIT D [VITAMIN D NOS]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6204, Location of injection: Arm Left), administration date: 19Mar2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: AMENORRHOEA (non-serious), MENSTRUAL DISORDER (non-serious), outcome "unknown" and all described as "No menstral period since 27May2021". Therapeutic measures were not taken as a result of amenorrhoea, menstrual disorder.  Additional information: Patient received Covid-19 vaccine from School or Student Health Clinic facility. Patient does not received any other vaccine within 4 weeks of Covid-19 vaccination. Patient received Multivitamin & Calcium w/ Vit D within 2 weeks of Covid-19 vaccination. Patient does not have any prior vaccination. Patient was not tested for Covid-19 since vaccination. Patient does not have any known allergy.  No follow-up attempts are possible. No further information is expected.
Vaccinated patient with the wrong medication. patient was supposed to receive Pfizer Primary dose 6 month - 4 year and instead received Pfizer Bivalent 6 months - 4 years due to incorrect vial placed in the wrong basket. Was not notified about situation until 12/28/2022.
Pt developed a papular rash on the site of injection (left thigh) which progressed over the thigh, left arm and left temple over the next three days.
Information was received from a nurse practitioner via company representative concerning a female patient of unknown age. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, in approximately September 2014, reported as one or two years ago, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, anatomical location, lot number, expiration date were not reported). Concomitant therapy was not reported. On an unspecified date after receiving the vaccination, the patient experienced swelling from the elbow to the shoulder. The outcome of the event was not reported. The causality between the event and ZOSTAVAX was not reported. Additional information has been requested.
Shingrix 1st dose - 10/18/20 Left shoulder and arm sorness. All joints in body became sore. Sore for aprox 48-72 hours. Symptoms resolved naturally.  Shingrix 2nd dose - 11/19/20 Left hip/shoulder/collarbone/shoulderblade sore . 1/2" red ring around left arm below vaccination site. Lasted aprox. 2 days. Symptoms naturally resolved.   Did not seek medical attention.
Patient presented to pharmacy on 10/12/2018 describing an adverse reaction to the vaccine. She claimed to experience shivering/chills and a fever, followed by dizziness and vomiting. Later she broke out in blisters under the breast area on the trunk of her body. The blisters are starting to heal, but are still present.
Cellulitis 5" x 3" Skin hot to touch. Placed on antibiotics as a precaution.
Patient complained of itching which started and remained mainly in face, then progressed to limbs. Symptoms started within 1 - 2 hours after receiving the vaccine.
At hour 30, fever of 101.4, resolved with tylenol.   Mild soreness  at injection site.
Pt recvd vax & devel erythema, swelling, & small amount of induration @ inject site;
I had vaccination on 02/22/2022. I started to experience with heart palpitations and atrial fibrillation in 07/2022 and monitored vitals with watch. I contacted my primary doctor who referred me to a cardiologist. I went to the emergency room on 10/17/2022 for atrial fibrillation. I wore a Holter monitor for two weeks and was seen by cardiology 02/7/2023. I have a follow up appointment on March 7th 2023 for possible pacemaker.
I received my first Pfizer booster for COVID on 9/22/2021. On 2/1/2022, I started to have a runny nose and a low-grade fever. I took 2 ALEVE, and the fever went away within an hour. On 1/31/2022, some friends had called to let us know they had tested positive, so I tested myself for COVID with an at-home test that day. That test yielded a negative result. After I started having symptoms on 2/1/2022, I decided to go to a a local pharmacy to undergo a rapid test; this time, I got a positive result. My symptoms weren't severe, so I didn't see a doctor, and I just treated my symptoms with OTC medicines like ALEVE, cough drops, and CORICIDIN HPB. The symptoms lasted maybe 2-3 days, then I improved and felt normal again after 4-5 days. We isolated for 5 days and wore masks (sometimes double masks) for about a week afterwards. At the time of this writing, we still mask if we are in large crowds or significant gatherings.
symptoms started 8/26/21 with congestion, runny nose, body aches and headache.  Covid positive 8/30/21   Symptoms improving 8/30/21
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 5:07 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 5:07 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    No concomitant medications were reported. Batch number 031A21A underwent temperature excursion on 20-Mar-2021 with temperature 34 degrees Fahrenheit from 09:00 AM and at 10:00 AM with temperature 37 degrees Fahrenheit . The vial was initially moved to the fridge on 09-Mar-2021 and proposed beyond use date was 08-Apr-2021. Product moved to clinic on 20-Apr-2021. 20 vials were sent to clinic. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.