chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer Dose 1 4/16/21 (lot NA) Pfizer Dose 2 5/7/21 (EW0183) Pfizder Dose 3 9/21/21 (lot NA) COVID Positive 1/31/22  1/31/22: The patient known to have lung transplant due to pulmonary fibrosis from fungal infection 2010 immunosuppressive therapy, exposed to COVID patients on Thursday, start on Saturday to have nausea and vomiting and headache with watery diarrhea and shortness of breath with dry cough, episodes of fever and chills with generalized magnus.  No chest pain or dizziness.  She is compliant on her medications.   At emergency she was hypoxic required 2 L of oxygen, her COVID-19 PCR test came back positive, her other labs unremarkable.  Chest x-ray done and show mild bronchial like infiltration without focal consolidations.  At ED she received azithromycin and ceftriaxone.   The pulmonologist at a HCF consulted, Dr. recommend Sotrovimab infusion and dexamethasone, use remdesivir if Sotrovimab not available, the patient accepted at another HCF pending bed availability.  2/3/22: The patient known to have lung fibrosis secondary to chronic fungal infection status post right Last Plantation on immunosuppressive therapy, presented with COVID-19 pneumonitis, she had cough with mild shortness of breath with normal oxygenation room air, chest exam initially mild wheezing then resolved with the therapy, she had nausea and vomiting and diarrhea which improved gradually, her blood pressure was elevated then controlled better.  Her labs show normal inflammatory markers and CBC however she has immunosuppressive therapy, discussed with her pulmonologist/lung transplant team, recommend to monitor her tacrolimus level and the goal between 8 and 10, pending results back, agree on dexamethasone and remdesivir.  The patient currently hemodynamically stable not in distress with normal inflammatory markers, will discharge her today after receiving the 3rd dose of from the severe and follow-up with her pulmonologist next week.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. Patient's medical history, concurrent conditions and concomitant therapy were not reported. On an unknown date, unspecified number of patients were vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot#L008271, Expiry date: 11-MAR-2017 and lot#L005301, Expiry date: 17-Feb-2017) (dose and route were not reported). No adverse symptoms were reported. This is one of two reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a registered pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient received the first dose of VAQTA 50/1.0 U/ml (route of administration, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the patient received the second dose of VAQTA 50/1.0 U/ml, lot number reported as N005605, expiration date 08-APR-2018; 20 months apart which was outside the prescribing information (inappropriate schedule of drug administration). There were no adverse effects reported. Additional information has been requested.
Approximately 3-5 minutes after my second dose of the Pfizer vaccine, I suddenly had a strong burst of energy that was quickly followed by a strange felling in my left arm (the vaccine was injected in my right arm) and extreme difficulty with articulating words. 911 was called. The paramedics noted a slight droop on the corner of my mouth and high blood pressure. It is important to note that my blood pressure is low to normal. I've never had hypertension. The paramedics took me to the hospital. The doctors at the hospital were concerned that I was having a stroke. I was administered tPA. While receiving tPA, the left side of my face was briefly paralyzed. I couldn't use the left side of my face to talk.  After a few minutes of receiving tPA, I regained the ability to talk correctly and the regained control of the left side of my face. I was kept in ICU 24 hours.  I experienced a general numbness on the left side of my body.  After 24 hours in ICU I was discharged.  The ICU doctors, including the neurologist said I didn't have a stroke. The Intensivist said the heightened blood pressure may have caused the stroke-like symptoms. It is important to note that my blood pressure was slightly below normal after tPA treatment while I was monitored in ICU. Again, slightly low to normal blood pressure is normal for me. On 8-12-21, I followed up with my primary doctor who said my blood pressure is normal.
administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 64-year-old female patient who received HAB (Twinrix) (batch number DQ23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th February 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 25th February 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were provided as follows: The patient received an expired dose of Twinrix, which led to expired vaccine used. The reporter consented to follow up.
A few days after receiving my vaccine I started experiencing heart palpitations and increased pulse. On Aug 26, one week after my vaccine I was again having an episode of heart palpitations and racing heart. I took my blood pressure and it was 166/93, pulse 106. My average BP has always been low, in the 115/65 range, so seeing those high numbers was very disconcerting. I monitored my BP for about an hour and it only went down to 157/91.  I called my PCP and spoke to the nurse who asked me if I had had a vaccine recently, and yes I had just had my first dose one week prior.  They advised me to go to the ER.  By the time I got to the ER my BP was about 145/88.  I spent several hours there and had several tests.  Th ER doctor did mention that the high BP may be caused by my immune system response to the vaccine.  A couple days later I had a spike of 194/96, which was scary.  I had blood drawn that day and as the technician was withdrawing the needle, the vein bulged and I had a dark bruise for several days.  During that 1st month I had a follow-up appointment with an orthopedic and when the nurse took my BP, it was 156/87.  She is also an ER nurse and she also told me she has seen others in the ER who were there for high blood pressure after a covid vaccine.  It took a month for my BP to stabilize to acceptable levels and 2-3 months to return to my normal levels
patient stated that close to bedtime he felt ill. shaking , feeling cold and not lucid. this lasted for about 3 hours during night and almost went to the  ER. afterwards unable to sleep well and general exhaustion. At
I will begin by noting that I am known for high pain tolerance and have been a strong, healthy, professional athlete for thirty years. The evening of the vaccination, I went to bed at 9pm feeling odd. By midnight, I became paralyzed with excruciating pain throughout my torso and arms with such an extreme fever that it felt as if my heart was going to stop. I had crushing chest pain which inhibiting my breathing ability in a way that could only be compared to being crushed under a burning truck. The paralyzation was so intense, with pre-existing pain multiplied by a thousand, that I couldn't even speak to alert my husband, who was right beside me. This continued for several hours until it subsided enough for me to pass out from exhaustion. The following day I battled residual aches throughout my torso and arms, accompanied by a mild fever. The trauma of fearing for my life that night and over the past week, exacerbated by the news of this vaccine I received being paused for issues related to my demographic, had made me too afraid to report my extreme side effects until now. With the encouragement and support of my family, I have worked up the courage to do so. It was the scariest, most intense pain and fever I have ever experienced in my life all at once and no one I have described this to has ever heard of the severity of what happened to me.
Rash developed on 9/3/15 appears to be erythema multiforme rashes - no fevers eating well so far.
WEIRD VISION DISTORTION; 9 HOURS LATER I STARTED GETTING WEIRD ACHES AND PAINS. LOCATED AROUND JOINTS IN MY BODY LIKE ANKLES, FINGERS, HIPS, KNEES, ETC; A VERY LIGHT FEVER (MIGHT NOT HAVE HAD A FEVER AT ALL BUT IT FELT LIKE A FEVER); WOKE UP FEELING HUNG OVER; AN HOUR LATER I STARTED TO GET CHILLS; INJECTION SITE BURN/STING AFTER INJECTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown Expiry: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced weird vision distortion, 9 hours later i started getting weird aches and pains. located around joints in my body like ankles, fingers, hips, knees, etc, a very light fever (might not have had a fever at all but it felt like a fever), woke up feeling hung over, an hour later i started to get chills, and injection site burn/sting after injection. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weird vision distortion, a very light fever (might not have had a fever at all but it felt like a fever), woke up feeling hung over, an hour later i started to get chills, and injection site burn/sting after injection, and was recovering from 9 hours later i started getting weird aches and pains. located around joints in my body like ankles, fingers, hips, knees, etc. This report was non-serious.
Swelling and severe pain in left arm where vaccine was administered. T to 102 degrees.
Rash; itchy all over body; This is a spontaneous report from a contactable consumer (patient herself). A 53-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Left on 11Mar2021 15:45 (at the age of 53-years-old) as DOSE 1, SINGLE for COVID-19 immunization. No medical history was reported. Patient's medical history (including any illness at time of vaccination) was none. Family medical history relevant to AE(s) reported as none. Concomitant medication included vitamins (not specified). Additional vaccines administered on same date of the Pfizer suspect was none. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that, patient got her first shot and she developed a rash on the 3rd day afterward. It has been really itchy. On 14Mar2021 the caller noticed the rash and today she still has the rash and it was itchy. Her body has been itchy too. It was explained that the rash was on both elbows but her whole body was also itchy. She was not taking any medication, only vitamins. Caller stated she would contact provider and maybe they could recommend something for the rash and itchiness. She was scheduled for the second on 02Apr2021. Caller would like to know if they were advising people to get the second shot after getting a rash after the first shot. AE(s) did not require a visit to emergency room or physician office. Relevant tests were reported as none. The outcome of all events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Within 24 hrs of vaccine, pt developed multiple facial tics - twitching, almost constant.
Vaccination site warmth; Vaccination site pruritus; Vaccination site erythema; Itching; Vaccination site pain; Red blotches; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red blotches), VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Drug allergy (sulfa, keflex), Drug allergy (keflex), Hypertension, High cholesterol and Hypothyroidism. Concomitant products included METOPROLOL for Blood pressure management, EZETIMIBE and FISH OIL (OMEGA 3 FISH OILS) for Cholesterol, LEVOTHYROXINE for Thyroid disorder, CALCIUM for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced RASH MACULAR (Red blotches), VACCINATION SITE PAIN (Vaccination site pain) and PRURITUS (Itching). On 12-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth). On 28-Mar-2021, RASH MACULAR (Red blotches) and VACCINATION SITE PRURITUS (Vaccination site pruritus) had resolved. At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) outcome was unknown and PRURITUS (Itching) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medication was taken.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Additional adverse event  and outcome with date of recovery for two of the events  Concomitants added and 2nd dose information added, relevant history of the patient added.
Product was admnistered to patient after temperature excursions; This spontaneous report was received from a medical assistant and refers to a 2 year old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.     On 21-JAN-20221, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot number U008180 with expiration date 12-MAR-2023 (dosage [frequency reported as once], route of administration, and anatomical location were not reported) for prophylaxis, which experienced  temperature excursions: 7.4°F for 0 hours, 25 minutes and 0 seconds; 6.4°F for 0 hours, 20 minutes and 0 seconds; and 5.9°F for 0 hours, 15 minutes and 0 seconds. In addition, the vaccine had previous temperature excursions: at 31.3°F for 10 hours,28 minutes and 0 seconds; between range of 6°F to 14 °F (no exact temperature was provided) for 1 hour, 15 minutes and 0 seconds; and 11°F for 4 hours, 6 minutes and 0 seconds.  This is one of several reports received from the same reporter.
Feels like her guts are going to fall out; Vomiting; Feverish; Injection site is the left arm which is swollen; Hurts until today but not as bad as when she got it; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL DISORDER (Feels like her guts are going to fall out), VOMITING (Vomiting), PYREXIA (Feverish), VACCINATION SITE SWELLING (Injection site is the left arm which is swollen) and VACCINATION SITE PAIN (Hurts until today but not as bad as when she got it) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included Cough and Stomach virus.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Injection site is the left arm which is swollen) and VACCINATION SITE PAIN (Hurts until today but not as bad as when she got it). On 02-Apr-2021, the patient experienced GASTROINTESTINAL DISORDER (Feels like her guts are going to fall out), VOMITING (Vomiting) and PYREXIA (Feverish). In April 2021, GASTROINTESTINAL DISORDER (Feels like her guts are going to fall out), VOMITING (Vomiting), PYREXIA (Feverish), VACCINATION SITE SWELLING (Injection site is the left arm which is swollen) and VACCINATION SITE PAIN (Hurts until today but not as bad as when she got it) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.  The patent's second dose was due on 27-Apr-2021.  On 29-Jun-2021, the patient reported that her symptoms lasted 3 weeks and then went away. She felt better and it was all taken care of.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up report received included non-significant information. On 29-Jun-2021: Significant follow up report received included information about the events. Outcome and stop date for the events were updated to recovered/resolved.
Information has been received from a medical assistant referring to a 4 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported)(Incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Rebound symptoms and positive test; Rebound symptoms and positive test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Batch/Lot number: unknown), on 09Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26May2022, outcome "not recovered" and all described as "Rebound symptoms and positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26May2022) Positive, notes: Rebound symptoms and positive test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had no known allergies and she took no other medication in 2 weeks. The patient took COVID 19 Treatment with Paxlovid (Treatment start date=16May2022, Treatment stop date=20May2022).  The lot number for [BNT162b2], was not provided and will be requested during follow up.; Reporter's Comments: ~~~
Several hours after I got my second shot, I began spotting blood even though my period was not expected for another 17 days. Since the vaccine, my periods have been heavier, I've experienced intense nausea, and I have had more painful cramps.
Neck pain after the first dose of COVID-19 (MODERNA) for almost 4 weeks, and after the second dose of MODERNA that I received on May 6 the neck pain was worse.
Information has been recieved from a physician concerning a 15 month old white male with no known medication allergies who on 03/01/2005 at 15:00 was vaccinated in the left arm with the first dose of varicella virus vaccine live. There was no committment therapy.  Illnesses at the time of vaccination included gastroesophageal reflux.  The physiscian reported that on approximately 03/08/2005 the pt developed several vesicular leiosn at the injeciton site and was irritable.  The patient was seen by the physician and no other symptoms were noted. No laboratory/diagnostic tests were performed.  Subsequently the patient recovered from his events.  Additional information is not expected.
fussiness-marked from 1 hr p/vax;fever of 105;some jitteriness & some lethargy (16 hrs p/vax) 24 hrs p/vax doing well
Pt. stated he felt a little dizzy and that is the last thing he remembers.  Patient passed out and was found on the floor.  Denies hitting head. Patient was diaphoretic blood sugar was taken and was 71 . Patient drank juice and ate crackers. Sugar was rechecked and was 101. BP 145/83 HR- 67. Patient was feeling much better and left.
Horrible eye pain / in both eyes / thought that her eyes were going to explode / shooting pain on the inside of the eye; Watering eyes; Beat red eyes; It felt like acid on the front of the eye; Seeing double; shooting pain on the inside of the eye; This case was reported by a consumer via call center representative and described the occurrence of eye pain in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd October 2020, the patient received the 2nd dose of Shingrix (intramuscular). In October 2020, 24 hrs after receiving Shingrix, the patient experienced eye pain, watering eyes, eye red, burning in eyes, double vision and pain. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the eye pain, watering eyes, eye red and double vision were recovered/resolved and the outcome of the burning in eyes and pain were unknown.   It was unknown if the reporter considered the eye pain, watering eyes, eye red, burning in eyes, double vision and pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and reported horrible eye pain. The pain occurred in both eyes and thought that eyes were going to explode.   The pain lasted for 8 hours and then resolved after taking 4 Benadryl.   The patient reported watering eyes, beat red eyes, shooting pain on the inside of the eye and it felt like acid on the front of the eye.   The patient also reported seeing double.   All the symptoms have since resolved. The reporter consented to follow up.
ACUTE RESPIRATORY FAILURE 3/3/2023 ANEMIA ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/2/2023 ANEMIA ACUTE RESPIRATORY FAILURE 3/3/2023 LEFT KNEE JOINT PAIN ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/2/2023 LEFT KNEE JOINT PAIN ACUTE RESPIRATORY FAILURE 3/3/2023 PRESENCE OF GASTROSTOMY ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/2/2023 PRESENCE OF GASTROSTOMY ACUTE RESPIRATORY FAILURE 3/3/2023 SEPSIS WO ACUTE ORGAN DYSFUNCTION ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/2/2023 SEPSIS WO ACUTE ORGAN DYSFUNCTION ACUTE RESPIRATORY FAILURE 3/3/2023 HTN (HYPERTENSION) ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/2/2023 HTN (HYPERTENSION) ACUTE RESPIRATORY FAILURE 3/3/2023 ALTERED MENTAL STATUS, UNSPECIFIED ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/2/2023 ALTERED MENTAL STATUS, UNSPECIFIED