chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He subsequently tested positive for COVID-19 on nasal quantitative reverse transcriptase polymerase chain reaction RT-PCR; He subsequently tested positive for COVID-19 on nasal quantitative reverse transcriptase polymerase chain reaction RT-PCR; This is a literature report from a sales representative for the following literature source(s):   A 63-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetes mellitus" (unspecified if ongoing); "hospitalization" (unspecified if ongoing); "tachycardia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with latency 2 days after the suspect product(s) administration, outcome "recovering" and all described as "He subsequently tested positive for COVID-19 on nasal quantitative reverse transcriptase polymerase chain reaction RT-PCR". The patient underwent the following laboratory tests and procedures: Brain natriuretic peptide (2-100): less than 35.0; Computerised tomogram: demonstrating bilateral pulmonary emboli, notes: without evidence of parenchymal involvement from SARS-CoV-2; Electrocardiogram: without changes to suggest ischemia, notes: or right ventricular strain; Fibrin D dimer: 2.26 ug/ml, notes: was 4.5 times above the upper normal limit. Reference range less than or equal to 0.48; Haemoglobin: 11.8 %; Oxygen saturation: 91 %; Polymerase chain reaction: Positive, notes: On day 2; Positive, notes: On day 8 Repeat Test; Pulmonary embolism: demonstrating bilateral pulmonary embol, notes: without evidence of parenchymal involvement from SARS-CoV-2; Troponin T: less than 2.50, notes: High Reference range: less than or equal to 39.0. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug Ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
I experienced bad headaches and a 101-102 fever within the first day or so. I also experienced abdominal pain and arm pain that was so severe that it make me sick to my stomach accompanied by vomiting and diarrhea. I felt weakness in my legs to the point that I felt shaky. I had blurred vision. Everything subsided except for fatigue and I was having trouble breathing with pain in my lungs. At first I thought it was my asthma flaring up, but ultimately I realized it wasn't that. Shortly after that, my heart started beating wrong and my blood pressure shot up to 153/123 for around a week. Headaches persisted and I got severe joint pain. It felt as though that my elbow would break if I lifted something. My resting heart rate would get up to 160BPM. I would get fever spikes of 102-103 that would last a day and then drop and my body could not regulate the temperature properly. Since then, I have experienced excessive sweating. I began having a serious head fog with memory issues. Every time I would walk into a room I would forget what I was doing and had trouble keeping up with conversation. I was going through periods of vomiting and diarrhea that would last for days at a time. I have had a lot of hive and rashes as well and my hands will actually turn purple. I began to hear ringing and tonal sounds in my ear and at one point I went completely deaf in my right ear, it switched to my left ear for a day. My hearing has recovered at this point. I've seen many doctors including neurologists and infectious disease doctors with no explanation to what I'm experiencing.
Received vaccine on 1.6. 2021.  Arm muscle was sore and "thicker". the rest of that day.  DId not take any NSAID or acetaminophen. Awoke on 1.7. 2021 and arm muscle was still "thick" but not quite as sore.  However, muscle was red, warm to touch and intensely pruritic. about the size of a golf ball. Tried not to scratch. Took no NSAID, tylenol or antihistamine.  Awoke on 1.8. 2021 and arm thickness almost gone and about 50% of itching gone.  Took no otcs. awoke on 1.9. 2021, thickness and itching gone until awoke on 1.14. 2021. on 1.14. 2021 arm was slightly thick. Definitely warm to touch, red and intensely pruritic. Size of a baseball. On 1.15. 2021 still itching but not as warm or red or thick.  on 1.16. 2021 most of these had dissipated. On 1.17. 2021 all were gone.
At the 4th hour I started feeling nausea, headache, chills, stiff neck, and dizziness.  At the 5.5 hour I am still feeling the same with the headache and dizziness getting worse
03/10/2021 early morning I started experiencing terrible cramps and I thought I just had to use the bathroom that didn't produce anything and the pain intensified throughout the night. Around 11 AM the next morning I called into work and went to the bathroom and passed blood and that's when I called my doctor and he told me to go to the hospital and I went to the hospital and waited for 5 hours before being taken to the ER. They did vitals and my blood pressure was skyrocket and they did a cat scan which showed I had colitis. At that point I had nothing to eat or drink and was on an IV drip and they gave me morphine to relieve the pain. They kept for a week and during that time I see infectious disease, gastroenterology, and my PCP. Besides IV drip I was on antibiotics and no food. When I was discharged I ate rice and nothing with fats and was on a specific diet for a month and then followed up with my doctors and had my colonoscopy which was clear. I never had stomach problems before and I always said I had a stomach of steel because I could eat anything.
within minutes after my shot, I started to have difficulty swallowing. i was monitored for 30 minutes at the vaccine site before being escorted to the medical observation area. While in the medical observation area I tried to take a sip of water but could not swallow it. At that moment I began having a tight feeling in my chest. I began to hyperventilate followed by difficulty breathing or talking. This was accompanied by feelings of impending doom, and uncontrollable trembling and inability to concentrate on what the medical observation area Doctor was saying. The time from the drink of water until I was able to breathe, speak, and concentrate normally was about 20 minutes. Tightness in my chest has improved but not fully recovered. General malaise and headache have developed.
Swelling started up where vaccines were administered, now moved down arm now, tender, only a little sore now.
Moderna CoVid 19 vaccine given to patient 16 years old, when indicated only for patients 18 years and above.
Phone call from client's mother injection site is fine, it underneath arm that is bruised 2 inch area with 5 cent size lump. 3/4/08 lump gone, bruise fading-yellowish this am per mom.
an expired Quadracel was given to a patient yesterday with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 4 years old male patient who was given an expired quadracel yesterday with no reported adverse  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Prophylactic vaccination.  On 18-Apr-2023, the patient received a suspect diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine at dose of 0.5 ml Suspension for injection dose series 5 lot C5851AA via intramuscular route in the left thigh for prophylactic vaccination (immunization).  On 18-APR-2023 the patient was given an expired quadracel was given to a patient (expired product administered) same day latency with no reported adverse event.  Action taken was not applicable.  At time of reporting, the outcome was Unknown    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 the 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.
Pt received shot around 6:30pm on 01-12-22. Saw signs of rash around 8:30pm same night. Rash covered most her body on 01-13-22. Pt took Benadryl throughout the day. Pt noticed rash started getting worse late that night. Took more Benadryl, went to bed. Woke up on 01-14-22, lips, hands, and feet were swollen and rash covered entire body.
Pt called, stating that he had a fever of 101.3 with vomiting and diarrhea. Normal boold sugar spiked to 379, and he had chills.  Once fever reached 103.5, pt went to the ER.  He was discharged after several hours with no admitance.  Pt "feels fine" 09/09/2022
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE PULMONARY EMBOLISM W INFARCTION, UNSPECIFIED
Child stated fear/dizzy following FLUVIRIN. Pulse weakened, legs elevated with 1 l po water. BP monitored & normal at 35 min. No wheal/flare neck-face-arms. Eyes red from crying.
20APR rash, itchy, sore throat-DPH; 21APR t101, welts came up DPH given; 22APR rash gone, fever 98, sore throat; rash;
About 8 or 10 hours later, I woke up during the night with severe chills and a fever. I was taking Tylenol every four hours, but it wasn't helping at all. I was also nauseous. All of that lasted for about 21 hours, then they decreased and lasted like another day. I was having hot flashes. My left knee randomly gave out a few weeks after that and my left armpit was really itchy. It was the sickest I've felt in my entire life. I spoke with my doctor and she prescribed nausea meds.
Experiencing some stool that had a little bit of blood and kind of mucus; Experiencing some stool that had a little bit of blood and kind of mucus; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received first dose of BNT162B2 via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. This past Friday, so on the 18Dec2020 got the first shot of the COVID 19 Vaccine and starting yesterday (19Dec2020), the patient started experiencing some stool that had a little bit of blood and kind of mucus. So, patient just wanted to know if that is a side effect of the vaccine that could happen or if anyone else have also reported symptoms like that. Events outcome was unknown.  Information about lot/batch number has been requested.
PATIENT RECEIVED INFLUENZA, BIVALENT COVID AND SHINGRIX VACCINE ON SAME DATE, STATED THAT WHEN HE WENT TO ROUTINE MD VISIT NEXT DAY HE HAD DIFFICULTY WALKING AND SPEAKING, MD SENT PATIENT TO HOSPITAL TO BE EVALUATED. ACCORDING TO PATIENT THEY TOLD HIM HIS SYSTEM WAS "OVERWHELMED" BY RECEIVING 3 VACCINES AT ONCE. RELEASED SAME DAY NO TREATMENT. PT BACK TO NORMAL NEXT DAY.
About 72 hours after the 1st dose, I experienced a fullness in the left ear accompanied with a low frequency, low volume buzzing or humming . These symptoms persisted over the next week, but would switch from left to right ear or occasionally in both. At the end of the first week I experienced two episodes of mild  vertigo lasting for about 3 or 4 hours on two separate days & then stopped. The fullness & humming persisted until about 14 days after vaccination & then cleared & have not returned. The symptoms seem to stop when I went to bed at night.
Day after injection given pt noticed knot in his upper arm. Arm was also red, swollen and tender. Today arm is slighly red and tender, swelling and knot are gone.
she's been tested positive 6 days after her first dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (Patient herself) reported that an unspecified aged female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On unspecified date it was reported as patient got the first dose. The second dose of the vaccine is scheduled tomorrow (05Mar2021). She has been tested positive 6 days after her first dose. She would like to confirm if she can take the second dose scheduled for tomorrow. Outcome of event was unknown.  No follow up attempts are possible; information about Lot/batch number cannot be obtained.
Feels run down - can't get out of bed; barely can talk; Arm was hurting; Fever; Headache; A spontaneous report (United States) was received from a consumer concerning a 40-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever, pain in arm, headache, felt run down - can't get out of bed and could barely talk.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient experienced  fever, pain in arm and headache. On 28 Jan 2021, the patient experienced the events feels run down - can't get out of bed and could barely talk. No lab data was provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, fever, pain in arm, headache, felt run down - can't get out of bed and could barely talk was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Since first shot, she had sinus problems and tired progressively getting worse.  After second dosage, she started sleeping 18 to 20 hours a day, passed out and lost feeling in her legs and arms, unable to walk and had 3 IVIG treatments, 72 hour steroid blast, shock testing and sleep study, spinal tap, 12 days in the hospital and more to come.
I was extremely tired, achy all over and had a very bad headache that started about 14 hours after the shot and lasted 30 hours.  The next day was a little tired but no other symptoms have occurred after that.
Parent reported event to Health Center 12/1/2022. Parent reports child had "head to toe" rash with onset approximately 3 days post vaccination and resolved 1 week post vaccination. The parent also reports the child was lethargic and spiked high fever 3 days post vaccination and resolved 7 days post vaccination. Parent did not specify that she notified healthcare provider after the incident. Parent reported to me today "the same events occurred with vaccinations received 3/22/18, 5/10/18, 7/19/18, and 5/8/19." However in all encounters with the parent consent, the parent said "no" to questions "does your child have allergies to medications, food, a vaccine component or latex" AND "has your child had a severe allergic reaction to a vaccine in the past."
This spontaneous report as received from a Licensed Practical Nurse refers to unspecified group of unknown age and gender. Information about patients' medical histories were not provided. On an unknown date, the patients were vaccinated with doses of GARDASIL (dose, frequency, route of administration, indication and lot # were not provided) which possibly were improperly stored. No adverse effects were noted. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
I was lethargic off and on and had nausea for 3 weeks after 1st vaccine I developed Oral Lichen Planus about 2 wks after 1st injection  I did not have 2nd vaccine because of my reactions to the 1st one!
101.5 fever. Nausea. Chills. Fatigue. Headache.
I have currently been having problems with both of my knees and also my elbows.  I've had both of my knees drained numerous times and have seen two different orthopedic surgeons and both of them have referred me to a rheumatologist.  They believe I have rheumatoid arthritis, but I haven't been officially diagnosed.  I have a consult with a rheumatologist on the 19th of March.  I believe these adverse side effects are from the Anthrax vaccine which I believe contained the substance Squalene.
3/3/21 2nd shot 3/25/21 started a cough and runny nose, asked Dr. for cough medication due to chronic coughing causing rib pain 4/3/21 woke up with both ears plugged. Called Dr and over the phone he said it sounds like an allergy which caused  blocked eustachian tube and prescribed nasal spray and allergy medication with instruction to immediately stop blowing my nose. 4/19/21 left ear worse and could barely hear anything at work so drove to Urgent Care to get it looked at. Dr. there said since there is liquid behind the ears it is Acute serous Otitis and to continue taking the meds my Dr. prescribed. 4/25/21 L ear is no better and unable to hear from it, today woke up with R ear getting plugged. Also, before the hearing problem, I woke up with a rash on the entire front of my neck that itched, lasted for a week with minimal rash around my eyes and ear area.
Swelling in face and throat; Swelling in face and throat; Laryngitis; Widespread pain; This is a spontaneous report from a contactable healthcare professional (patient) received via Regulatory Authority. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm, on 19Dec2020 at 05:15 PM (Batch/Lot Number: Ej1685) (at the age of 41 years old) as dose 1, single for COVID-19 immunisation in a hospital. Medical history included chronic allergies and endometriosis. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included omalizumab (XOLAIR); montelukast sodium (SINGULAIR); cetirizine hydrochloride (ZYRTEC); duloxetine hydrochloride (CYMBALTA); vitamin B complex; lansoprazole (PREVACID). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swelling in face and throat, laryngitis, and widespread pain on 07Jan2021. The events resulted to physician office visit. The patient received prednisone as treatment for the events. The patient did not recover from the events on the time of the report. The patient was administered the second dose of BNT162B2 on 09Jan2021, single (at the age of 41-years-old) (Batch/Lot Number: Ej1686) in the right arm for COVID-19 immunisation in a hospital.  No follow-up attempts are needed. No further information is expected.
Suspected Vaccination Failure; I got the shingles vaccine! / still had shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The reporter stated that sorry he/she did received shingles vaccine and still had shingles but shingles was worse and stated never another vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Patient had sore right arm next day after immunization and was unable to lift his arm. As of the day of this report the inability to raise the arm still persists.