chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2, solution for injection), on 15Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Coconut" (unspecified if ongoing), notes: Known allergies: Coconut. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patients adverse events are Vomiting, Metal odor in taste, Harsh xerostomia, Difficulty swallowing on 17Jun2022.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out.
BP DROP 78/53 HR 36-37 WENT TO ER CARE 11:30 PM TIL 10:00 AM WAS TOLD HAD A STROKE TRANSFERRED TO ER 12 NOON TIL 7:30 PM DOCTOR TOLD HER NO STROKE RELEASED NEXT DAY BP REBOUND TO 170/101 HR 73 STILL RUNNING HIGH 7/20/2021 TOLD TO CHECK WITH CARDIOLOGIST
Chills started at 7pm the day of vaccine,.  Epic Headache. Fever 99.8  and high pulse 120, the next morning
Patient received vaccines, contracted viral illness 5/21/14. Diagnosed w/GBS on 6/11/14.
began with low grade fever going up to 100.6, body aches, nausea, vomiting , diarrhea, dry heaves, maintained fever 48 hours, vomiting 12+ hours, diarrhea 24 hrs
pt sent to ED by home health on 8/5/21 with hypotension, AMS, and SOB ;found to be positive for COVID; O2 supplementation; emaciated appearance; given ABX, Decadron, Vitamins C and D and zine; convalescent plasma; dc'd 8/23/21 to the nursing home where she passed away on 8/24/21
got covid probably omicron 2.1 with 2 pfizer and booster; got covid probably omicron 2.1 with 2 pfizer and booster; I was so sick my world imploded; coughing up blood; severe headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovered" and all described as "got covid probably omicron 2.1 with 2 pfizer and booster"; ILLNESS (non-serious), outcome "recovered", described as "I was so sick my world imploded"; HAEMOPTYSIS (non-serious), outcome "recovered", described as "coughing up blood"; HEADACHE (non-serious), outcome "recovered", described as "severe headache". The events "got covid probably omicron 2.1 with 2 pfizer and booster", "i was so sick my world imploded", "coughing up blood" and "severe headache" required emergency room visit. Therapeutic measures were taken as a result of covid-19, drug ineffective, illness, haemoptysis, headache.  Clinical course: Patient got covid probably omicron 2.1 with 2 pfizer and booster. In one day patient was so sick patient world imploded. patient was coughing up blood severe headache no idea what was going on. Went to ER and got paxlovid and nebulizer. In 12 hours patient felt a little better. 24 almost better and day 3 almost symptom free. This was the best thing ever. Thank you1,000,000 times over as patient really thought it was over. So much for a mild disease.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received vaccination 10/07/02 in right arm, C/o pain, swelling and warmth of right arm around injection site, later that day, Pt seen 1/09/02 and  post right arm edematous, erythematous and warm, Full ROM
knee joint infection; This is a spontaneous report from a contactable consumer (patient's wife) via the Pfizer-sponsored program. A male patient of an unspecified age received the first dose of received bnt162b2 (BNT162B2, Solution for injection, lot number was not reported), via an unspecified route of administration on 22Apr2021 as 1ST DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter called for her husband who got the first dose already and is due for the next day (13May2021). However, in between the doses he got a knee joint infection, so he is taking antibiotics. The second dose of vaccine was scheduled a day after the report, on 13May2021. The knee joint infection, she believes, was diagnosed this past Saturday (unspecified date). The antibiotic given was Keflex, 500 mg 4 times a day. The reporter added that she called because her mother-in-law (patient's mother) was on an antibiotic and was told to not get the vaccine until after. The reporter was trying to figure out if it is okay for her husband to take the second dose of the vaccine since he is on an antibiotic. Therapeutic measures were taken as a result of knee joint infection. Outcome of the event was unknown.   Information on batch number has been requested.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; BRAIN FOG; FATIGUE; STABBY BONE PAIN IN HER ARMS AND LEGS; MUSCLE WEAKNESS IN THE ARMS AND LEGS; This spontaneous report received from a patient concerned a 59 year old female. The patient's height and weight were not reported. The patient experienced drug allergy when treated with ciprofloxacin/fluoroquinolones and levaquin (levofloxacin). She had stabby bone pain in her arms and legs when she took ciprofloxacin/fluoroquinolones. She had lost a tendon 10 years ago in the back of her calf muscle (she believed it was her left leg). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978 and expiry: unknown) dose was not reported, frequency time 1 total administered on 23-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the patient experienced muscle weakness in the arms and legs. On 07-APR-2021, she experienced a lot of stabby bone pain in her arms and legs. On 10-APR-2021, she experienced fatigue. On 29-AUG-2021, she experienced brain fog and began having symptoms such as a pain in her right sinus and felt sweaty. She thought that, she had a sinus infection. Eventually, on 01-SEP-2021 (Wednesday), she had fever of 101 F (fahrenheit) (ranging from 100-100.5 on average). On 02-Sep-2021 (Thursday), she also had a severe headache. She went through Rapid Covid-19 test and the results were positive for Covid-19. The above symptoms were diagnosed as part of being the break through covid-19 infection (suspected covid-19 infection and suspected clinical vaccination failure). She treated her own symptoms with sinus medication and Tylenol (paracetamol). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stabby bone pain in her arms and legs, and fatigue on 15-MAY-2021, and muscle weakness in the arms and legs on 10-APR-2021, was recovering from suspected covid-19 infection, had not recovered from brain fog, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000193677.; Sender's Comments: V0:20210932343 - covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS
24 hours after the second COVID-19 vaccine dose: chills, body aches, joint pain,  fatigue, migraine. Symptoms resolved within 48 hours. Patient was breast feeding during both time that she received the vaccine doses. At the time of the second dose, the baby was 4 months old. He developed symptoms also 24 hours later: fussy, crying, decreased appetite.
Information has been received from a pharmacist concerning a 70 year old male with hypertension and allergic to morphine and tramadol hydrochloride who on 04-FEB-2009 was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX (lot # 663672/1709X). Concomitant therapy included alendronate sodium (MSD), lisinopril (manufacturer unknown) and atenolol. On 04-FEB-2009 the patient experienced a drop in blood pressure, nausea, dizziness and a tingling/cold in hands approximately one hour after the vaccination. The patient presented to the emergency room for evaluation and it was noted that the patient self administered a dose of epinephrine prior to arriving at the emergency room. Subsequently, the patient recovered on 05-FEB-2009. Upon internal review, the patient's experiences were determined to be other important medical events as the patient received treatment with epinephrine. Additional information has been requested.
At injection site approximately equal to 2 X 2" red swollen, hot to the touch, raised area.  The next day injection has gotten approximately 1 " bigger than before.  Pt has been taken MOTRIN 94-6 hours BENADRYL 98 hours.  No improvement.   Injection site left thigh will give ORAPREDOCT today with BENADRYL to see if any improvement.
She got her vaccine she was fine.  She felt soreness in the arm that night, but it was Saturday, she felt really weird.  She was light headed, nauseous and her arm was sore.  Then later on in the day she started getting pain on the bone underneath her armpit near her chest.  She felt weird inside of her, going into her lymph glands to her legs.  She has a pain going up her jaw on the left side of her neck.  The pain was there and it stayed there for a second and then disappeared, sharp pain up her jaw.  She has never weird pains in her body before.   The symptoms then disappeared and felt in her body.  Then underneath her arm came up, has a redness around the area where she got the vaccine.  She still has the soreness on the chest/boob area.
This spontaneous report as received from a 64 years of female patient with drug allergy/reaction to amoxicillin. On 18-AUG-2014 the patient was vaccinated with ZOSTAVAX (dose, frequency and route of administration were not provided). Concomitant therapy was blood thinner (unspecified) medication. On 19-AUG-2014 (also reported as about 24  hours after receiving ZOSTAVAX vaccination), the patient experienced lump and redness at injection site. Action taken with respect to ZOSTAVAX was not applicable. Product quality complaint (PQC) was not involved. The outcome of lump and redness at injection site was unknown. Causality was not provided. Caller did not want to provide any contact information. Additional information is not expected.
In November of 2021, I began to notice fluid build up in my lungs. It became progressively worse so I went to the doctor who put me on LASIX in December. In November, I also had an echocardiogram done on my heart and was advised that my ejection fraction was at 25%. In January of 2022 I contracted Covid. Since then, I have had problems keeping the fluid out of my body with LASIX. I have been to an emergency clinic a few times to receive I.V. diuretics. I have had to double my LASIX and have had to take metolazone twice a week as a booster. I ended up with two blood clots in my right leg which gave me a P.E. in my left lung and required hospitalization for 3 days at the hospital. They have done another echocardiogram and found my ejection fraction even lower at 20%. My cardiologist has begun me on a process to speak about a heart transplant. I have had heart failure since I was young, but this fluid build up is new and my heart failure has maintained its levels for years, but now my ejection fraction continues to go down and I have this fluid build up that I cannot control.
14 year old male was given an injection of Bexsero, however, he should have received Menveo; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 14-year-old male patient who received Men B NVS (Bexsero) (batch number 25db5, expiry date 31-JUL-2025) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: 14 year old male was given an injection of Bexsero, however, he should have received Menveo).  The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-AUG-2023 The patient was given an injection of Bexsero; however, he should had received Menveo, which led to wrong vaccine administered. The reporter consented to follow up. No further information was known.
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the unspecified number of patients were vaccinated with RECOMBIVAX HB (dose, route of administration, lot# and expiration date not reported). The patients received a dose of RECOMBIVAX HB that was stored improperly. There was no adverse effects reported. Additional information is not expected. This is one of several reports received from the same reporter.
Fever (low, 100 degrees) for day and a half, chills, sweats, lighheadedness followed by hives/rash on arm (but not at injection site). Saw Dr. He prescribed an antibiotic and a cortisone cream. Suggested followup in four days unless there wasimprovement. Immediate contact if worse. I slowly got better and I canceled followup appointment. There is still some residucal redness  and swelling in rash area.
Lips were swollen when she woke up and continued getting worse; This is a spontaneous report from contactable consumer. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 21Apr2021 as a single dose for COVID-19 immunisation. The patients' medical history was not reported. It was unknown if the patient was pregnant at the time of vaccination. It was unknown if the patient received any medications within two weeks prior to the COVID-19 vaccination. It was unknown if the patient received any other vaccines within four weeks prior to the COVID-19 vaccination. On 22Apr2021, the patient lips were swollen when she woke up and continued getting worse. The event resulted in emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of the event lips were swollen when she woke up and continued getting worse was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
8 days p/vax pt devel fine rash & fever;mom made MD appointment then remembered immun & re-read literature &decided was probably a rxn to MMR;cancelled Md appt;22SEP97 high fever was 101 ear;pt rubbed vax site;
Initially had flushing and shortness of breath.  Had an immediate chest pain in the center of chest a little below the breast bone.  The flushing and shortness of breath only lasted a minute or two but the chest pain remained strong  for 20 minutes.  The patient also complained of a numbness in hand of injection arm after 10 minutes.  We gave her a bottle of water and checked her blood pressure. Her BP was 138/90 and pulse of 85.  Patient did not want to go to hospital to be checked. After 30 minutes the chest pain was resolved.
Breakthrough case admission after 2 vaccines Pfizer 4/20/21 lot# Ew0164;  Pfizer 5/11/21 lot# EW0179
Developed varicella mild case. (rash, itches) about 10 lesions. Treatment: Benadryl, calamine lotion.
Fever; headache; joint pain; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 27-year-old female patient received unspecified dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fever, headache, and string joint pain. The patient has No health issues, no medications. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
THE PATIENT IS HAVING SEVERE PAIN AT THE INJECTION SITE, AND JOINT PAIN, UNABLE TO LIFT LEFT ARM. RATING PAIN 10/10 AT TIME OF ASSESSMENT.
After receiving 1st dose covid vaccine patient became lightheaded and nauseated. Laid Patient on cot. Vitals stable. Pt evaluated by Dr . Patient felt better after eating crackers and was discharged with family member
Covid-19 virus; Covid-19 virus; This is a spontaneous report from a Pfizer sponsored program regulatory authority Support from a contactable consumer reported for a male patient (father). A male patient of an unspecified age received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date of Jan2021 as dose 1, single, dose 2 via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter's daddy got vaccines same date as reporter's mama did and his positive Covid test was done the night of the 20Aug2021. Reporter's daddy was getting a monoclonal antibody infusion at this moment. She declined to complete report for her daddy. The patient was doing ok; and they know that the vaccine was not going to stop you from doing it, it's just supposed to stop you from being hospitalized. They called reporter's Daddy in from the parking lot and tested him for Covid. They told him it would be a couple of hours before they got the results; so, he told them to just put it in his chart. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 20Aug2021. The outcome of the events was unknown.  Information about lot/batch number has been requested.
10/4/20212:46 pm called patient, no answer left message to return call.  10/18/21 1:42 pm called patient, does not receive incoming calls. Text message and email sent via vaccine portal.  12/23/21 Called patient, this phone does not accept incoming calls. Message posted in vaccine portal client need a full dose of Moderna at next vaccination.
Expiration date was 5/31/2022, but beyond use date was 3/17/2022.
Admitted for hyperglycemia and found to have covid infection; fully vaccinated. No specific treatment required, asymptomatic. Discharged home.
floaters; achy all over; Exhausted; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 77-year-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Expiry Date: unknown, Batch/Lot number: EL9267), via an unspecified route of administration, administered in arm right on 19Feb2021 11:00 (at the age of 77years) as single dose for covid-19 immunisation. Medical history included gluten allergy from 2009 to an unknown date, lesion in pancreas from 2009 to an unknown date. The patient's concomitant medications were not reported.  Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot number: EL8982), via an unspecified route of administration, administered in the right arm on 29Jan2021 14:00 (at the age of 77years) as single dose for COVID-19 immunisation. No additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations (within 4 weeks). On 19Feb2021 at 15:00, the patient experienced exhausted, floaters, achy all over. No physician room or emergency room visits. The outcome of events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.
Patient complained of tingling to his hands 15 minutes post-vaccination. Patient had no other s/sx of reaction. Patient observed for another 15 minutes and tingling did not worsen. Patient left observation area and returned to work. Patient returned to observation area around 4:40 p.m. and complained that tingling to hands was still present and he felt tightness in his forearms. Patient is a coach for the children and was outside in the 90+ degree heat during the afternoon. Patient came into observation area to cool down. Patient's blood pressure taken and was elevated, although patient stated that he had HTN. Paramedics called on site to evaluate patient. Patient began to complain of dizziness and was transported to local hospital. On the way to the hospital, the patient developed chest pain and shortness of breath. Patient was diagnosed with a non-STEMI at the hospital and transferred to higher level of care. The patient is currently undergoing observation and tests to determine the cause of the MI. The patient received epinephrine 0.5 ml at the hospital to cover any underlying vaccine reaction.
person reported feeling lightheaded. It was right before lunch. Accucheck was done by EMS and person was able to ambulate out of clinic.
At 2:42 pm on 07.10.22, client received second booster dose and reported "feeling a little dizzy" approximately 5 minutes after vaccine administration in left arm.  Client was  offered cracker snacks, juice, and water.  Client reports feeling "a little better" after eating snacks.  Client reported that she "did not eat anything all day".  Client rested in anti-gravity chair for 30 minutes and denied feeling any dizziness after 30 minutes.  All vital signs were within normal limits during observation period and client was picked up by her father to go home.  Client was observed to leave vaccination site with her father, walking with a steady gait and balance.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 35-year-old female. Neither medical history nor concomitant medications were reported. On an unspecified date in Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.
Arm was really sore, could hardly move it.  Later in the day it moved up to my head and neck.  I can't move my neck and I have a really bad headache.