chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blurry vision; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 25Aug2021 (Lot Number: IA7484) as single dose (at the age of 42-years-old) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced blurry vision on an unspecified date. The patient stated that she received her first dose of Comirnaty last week because it was mandated by her workplace. After vaccination she began experiencing blurry vision and an electromagnetic arm where things are sticking to her arm. She was asking what side effects have been reported from Comirnaty and demanding an answer to why her arm is now magnetic. Her concerns as being that last week she had the Pfizer first dose because she is a healthcare worker and obviously it is being mandated and now she is one of those people who is pretty sure that there is metal in her arm because everything magnetic is legit sticking to her and now her vision is getting blurry and she is not too happy. She really doesn't have time to complete a report because she is already on 16 to 18 hour shifts and she is barely going as it is. She is an emergency room technician. Patient stated, "Yeah I am just kind of freaking off that I have noticed over the past weeks almost week, my vision has been getting blurrier like I am having harder timing to see and I am only 42 years old and people help me and then like every time I turn around and I was like wait a minute, what the hell I have got metal that literally sticking to me and I am like what the hell is going on." The outcome of the event was unknown.
pt devel a mild erythematous blochy rash over lt thigh where tetramune immun was given;
(R) forearm pain 9/18/2012. (R) Wrist swelling and numbness. Itching.
positive COVID-19 test with symptom; positive COVID-19 test with symptom; This is a spontaneous report from a contactable consumer (patient's daughter) reported that a 95-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8736) via an unspecified route of administration, administered in Arm Right on 24Mar2021 at age of 95-year-old at single dose for COVID-19 immunisation. Medical history included high blood pressure, Alzheimer's disease, depression and blood clot. Concomitant medications included amlodipine taken for high blood pressure from an unspecified date; apixaban (ELIQUIS) taken as blood thinner from an unspecified date; donepezil hcl taken for Alzheimer's disease from an unspecified date; memantine taken for Alzheimer's disease from an unspecified date; escitalopram oxalate (LEXAPRO) taken for depression from an unspecified date; folic acid taken for an unspecified indication from an unspecified date. The reporter was actually calling how to schedule for the second dose since her mother tested positive second week after getting the first dose (Apr2021) and currently she still didn't have the second dose of shot. It also reported about 2 weeks after she got the first vaccine, she got COVID. She just had a fever for couple of days that was it, the reporter asked when she got the second vaccine. No treatment received for the event. No lab work other than COVID that was positive in Apr2021. The outcome of the events was unknown.
This spontaneous report was received from a healthcare worker referring to a 4 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 26-OCT-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Awoke morning of 9 Sep with intense itching.  The same occurred on the 10th.  Awoke at 0100 on 11Sep to find that the back of my thighs have broken out in hives (no hives in previous 67 years) and a very dark rash w/itch at my waistline.  It appears that I have a mild case of shingles.  No new foods or activity that could be the cause.  In addition to the medications taken at the time of the injection, that same day I started taking amlodipine, Flowmax, and sulfamethoxazole.
MOC called morning after receiving 4 yo vaccine to say Right Thigh was swollen.  Did not resolve for 24 hours and presented to office for evaluation and Right thigh site 3"x2" area of erythema, mild edema and mild tenderness. Slightly warm to touch.     No fever Rx: Benadryl Zyrtec ; ibuprofen prn
1st Dose 19Feb2021/2nd Dose 04Mar2021; COVID-19 positive test results; COVID-19 positive test results; This is a spontaneous report from a contactable consumer.A 58-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: EI9269), via an unspecified route of administration, administered in Arm Left on 04Mar2021 as dose 2, single and first dose via unspecified route of administration, administered in Arm Left on 19Feb2021 (Batch/Lot Number: EL9262) as dose1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not had covid-19 prior to vaccination. Post vaccination the patient was tested for COVID-19. On 01Aug2021, the patient had COVID-19 positive test result and on an unspecified date, there was Inappropriate schedule of vaccine administered. Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The patient underwent lab tests which included rapid result antigen test: positive on 01Aug2021 nasal Swab. The patient had not yet recovered from COVID-19 positive test results.   Follow-up attempts are completed. No further information is expected
vaccine was given to a patient one day passed the expiration date.; Initial information received on 21-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves Adult patient who received expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported.  It was of actual medication error due to expired vaccine used..  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.  List of documents held by sender: none.
Pfizer vaccine was administered outside of clinic- reported by patient- ? NO LOT NUMBER WERE SUPPLIED -----------------------------------------------------------------------------------------------------------------------------------  OBSTRUCTIVE SLEEP APNEA 10/6/2022 CARDIAC ARREST DUE TO UNSPECIFIED CAUSE
Patient when to her doctor with pain and irritation at injection site. Doctor claimed she has "covid arm". Site is hard, red, itchy, and swollen 8 days post vaccine.  Other than these details, she is feeling okay.
Moderna 1st dose given on 3/24/21 and patient subsequently admitted to the hospital on 4/3/21 with COVID-19
Patient developed a fever, after his vaccine which was expected to an extent, he had been diagnosed with breastfeeding jaundice, and developed acid reflux. His cheeks formed a bumpy rash with in a red circular shape, he scratched them constantly and was very uncomfortable. His next set of vaccines were delayed by advise of the Doctor. He was prescribed a steroid cream, and given Eucerin Aquaphor lotions, I was advised to stop breastfeeding him.
Generalized pruritis a few minutes following 2nd dose of Pfizer COVID vaccine; reported having throat fullness for 2 weeks following first dose of vaccine.
Severe nausea after first shot 3 days after 1st Vaccination ~ dizziness, weakness, exhaustion, headaches, using albuterol inhaler in the morning for shortness of breath, bad taste in the mouth and stomach described as the taste of burnt rubber and smell and taste of ignited /lit matches, excessive thirst and dry mouth that has prevented me doing normal activities ~ general malaise and feeling unwell
right arm pain started about 5 hours after vaccines, extended down to hand/fingers. next morning pain had moved down right side causing pain in side and hip. pt unable to walk without her cane and normally doesn't need cane. Heat was helping it feel better. needs to use heat regularly or the pain comes back. arm/side still bothering her today and left side hip started hurting around 11-18-20. still hurts today 11-29-20.
Covid vaccine administration was incorrectly documented. The correct vaccine injection site  that the covid vaccine was administered was the right thigh, but was accidently documented as right buttock. This was a documentation error.  This was not a true adverse event and was directed by the (Privacy) Immunization information system representative to be input in the Vaers system.
Interchange of vaccine product; My tongue was all swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   78-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 78 years intramuscular, in arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 05Oct2023 as unk, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for blood pressure abnormal. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for covid-19 immunization; Moderna covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE), for covid-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Interchange of vaccine product"; SWOLLEN TONGUE (non-serious), outcome "unknown", described as "My tongue was all swollen". The events "interchange of vaccine product" and "my tongue was all swollen" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of interchange of vaccine products, swollen tongue.  Additional information: Patient got vaccinated on saturday morning at 5:30 in the morning, she went to the hospital because her tongue was all swollen, in the hospital she received some medication to bring the swelling of her tongue down: dexamethasone (Intent: Treatment), Benadryl (Intent: Treatment) and Reglan (Intent: Treatment) for her stomach. She didn't take medicines anymore because she did not stay in the hospital. She had 3 Pfizer shots and 1 Moderna shot since the year 2021 and she never had a reaction.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
leg swelling; pain; nausea; This spontaneous report as received from a physician refers to a 15-year-old female patient. The patient had none pertinent medical history, none concomitant medications and none known drug reactions or allergies.    On an unspecified date in May 2019 (reported as 6 months ago), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1614898, expiration date reported as 20-SEP-2021, but upon internal validation established as 15-NOV-2021) (dose and anatomical location were not provided) intramuscularly, for prophylaxis.         On an unspecified date in May 2019 (reported as 6 months ago), the patient experienced leg swelling, nausea and pain for 2 weeks following the injection. No treatment was given for the adverse events, none lab diagnostic studies were performed and the patient did not seek medical attention. The outcome of the events was reported as recovered on an unspecified date in 2019 (reported as 2 weeks after injection).   The relatedness between the event and the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
This spontaneous report as received from a patient's father refers to a currently 7 months old female patient. The reporter was not able to confirm the date of the first or second dose of ROTATEQ. In December 2014, when the patient was 6 months, the patient received the third dose of ROTATEQ oral. On 15-JAN-2015, at the age of 7 months, the patient was vaccinated with ROTATEQ dose 4 (due to physician mistake), oral. The reporter stated that the patient was born very ill, with many unspecified complications, which reportedly "even resulting in the death and resuscitation of the patient" on an unspecified date. The cause of death was reported as unspecified complications. It was unknown whether autopsy was performed. Relatedness between the events and vaccination with ROTATEQ was not reported. Upon internal review, the unspecified complication resulting in death and resuscitation was considered as medically significant. Additional information has been requested.
Erythema, silver dollar size around varicella injection site in (L) upper thigh.
A report was received from a health care professional on 12/11/03 concerning a male vaccinee in his 50's who inadvertently received 1ml of Fluvirin on the same day. On 12/11/03 a vaccinee inadvertently received 1ml of Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 2/10/04: A follow up report was received from a health care professional indicating that the 71 year old vaccinee had not experienced any adverse events at the time of reporting. No follow up pending. All information received.
cough; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (cough). At the time of the report, COUGH (cough) outcome was unknown.            Treatment information was not provided by reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-222917 (Patient Link).
11pm woke up with full body chills, fever, body aches, fatigue. Noticed loss of smell/taste/appetite by morning.
This spontaneous report was received from a registered nurse (R.N.) concerning multiple patients of unknown age and gender. No concurrent conditions or medical history were reported. On 21-SEP-2015, multiple unspecified patients were vaccinated with an improperly stored dose of GARDASIL (Lot # K010215 Expiration date: 05-MAY-2017) (dose, route and anatomical location of administration were not reported). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Swelling; Rashes/ Outbreaks all over my body; Joints are hurting; Paining; Itching; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient reported that patient had taken the shot and on an unspecified date, patient was having swelling, patient was having rashes, outbreaks, and stuff (further not clarified) all over body. Patient joints were hurting. Patient further reported that patient was trying to figure out what patient could do to help with the swelling, paining, and itching. The clinical outcome for the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Nausea, Vomiting, Abdominal Pains, Swollen Lymph Glands. T>103 Onset 6hrs after vaccine
After the vaccine I had chills, fever, shortness of breath and body aches that lasted for a short time. A long term effect that I noticed is a difficulty breathing, heightened allergies (seasonal) and frequent body aches. I also feel tired often. I contacted my doctor a couple of week after my symptoms and as of today we are still trying to do more tests and figure out what options I have. They ran some breathing tests and determined I have some damage in my lungs, which may be from the Moderna or when I had Covid in November.
Outbreak of mouth cold sores; This is a spontaneous report from a contactable pharmacist reporting different events under the same suspect product for 10 patients via medical information team. This is 3rd report.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, on an unknown date, as unknown, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient had an outbreak of mouth cold sores. The clinical outcome of the event was as unknown.   Information about lot/batch number has been requested.
HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine Bivalent.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine Bivalent.) and NO ADVERSE EVENT (No adverse event) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 044H22A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:unknown.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine Bivalent .) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine Bivalent.).    No concomitant medications were reported. HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine Bivalent . HCP mentioned 2 doses were given on 19FEB2023, 1 dose on 20FEB2023, and 1 dose on 10MAR2023. Caller did not specified which date corresponded to patient 3. No treatment medications were reported.  This case pertains to Patient 3.   This case was linked to US-MODERNATX, INC.-MOD-2023-715321, US-MODERNATX, INC.-MOD-2023-715347, US-MODERNATX, INC.-MOD-2023-715325 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715321:Patient 4 case US-MODERNATX, INC.-MOD-2023-715347:Patient 1 case US-MODERNATX, INC.-MOD-2023-715325:Patient 2  case
Client had one varicella vaccine at age 1 yr and at age 12 dx'd with chickenpox.
101-degree fever, body aches, fatigue, mild vertigo, nausea, three bowel movements
Felt nauseous, hot flashes, chills, headache, muscle aches, fatigue, diarrhea, abdominal pain, brain fog and forgetfulness.
Very sore arm for approximately 18 hours after the injection in left arm. Applied ice packs. Soreness completely gone after that timeframe. Have been experiencing tingling in left thumb and hand for past 24 hours. Unsure if related to vaccine.
Patient warned pharmacist before hand that he usually have vagal syncope when getting vaccinations and would need to stay back for several minutes. After administration, patient sat on the floor for about 5 minutes, then he got up and sat in the chair. About 7 to 10 minutes later, he sat on the floor and laid back flat. Within a few seconds, he turned his neck to side like a spasm and locked up his legs. I raised his legs up in the chair and called his name twice and patient responded. He then laid on floor for about 20 minutes or so and we provided him a bottle of water when he asked. We recorded liability form and patient walked out the door.
11/25/22 presents to ED for "shortness of breath and fatigue". PMHx of "stage IV colon cancer with mets to liver on chemo, adenocarcinoma of the prostate"
- Acting delirious - severe headache - memory loss - couldn't speak certain words - couldn't remember words he was trying to say - "kind of out of it".
Seizure occurred at 8:30 - temperature read 100.9.  Had a fever in the 100's most of the night and next day.  In the morning, he woke with a stuffy/runny nose and was very weak.  Weakness improved as the day progressed - but fever stuck around for 28 hours.  He might have already been exposed to the virus prior to the vaccination, but I just wanted to report this.  He is on the mend two days after the shot.  My only concern was this was his H1N1 booster, his first H1N1 shot occurred on 10/24/09 and he had no adverse reaction to it.
numbness below nose, outer upper lip, inner upper lip, tongue. reports symptoms occurred within 30 minutes of receiving vaccine.  Took Benadryl and 40 mg of Pepcid. resolved within an hour.