chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am confused; a bit of weakness and felt weak; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 05Apr2021 (Lot number: ER8737) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "asthma" (ongoing), notes: diagnosed when she was a little girl in the 1950's; "COPD" (ongoing), notes: diagnosed just in the past 15 years. The patient's concomitant medications were not reported. Past drug history included: Prednisone, notes: she has been on Prednisone for about a year. The following information was reported: CONFUSIONAL STATE (non-serious) with onset 2021, outcome "unknown", described as "I am confused"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "a bit of weakness and felt weak".  Additional information: I am confused. On 05Apr2021 I received my first Pfizer, COVID-19 vaccine. On 27Apr2021 I received my second Pfizer, COVID-19 vaccine. I received a third Pfizer COVID-19 vaccine on 20Aug2021. I was told it was the Pfizer Booster. Now I am hearing on the news that the Pfizer Booster was just approved and released this week. I do have health issues and I am 73 years old. my question is, did I or did I not received the Booster since the news is saying it was just released. After the 1st dose she experienced a bit of weakness and felt weak. The events did not require a visit to emergency room or physician office.   No follow-up attempts are possible. No further information is expected.
Patient had a episode of brief loss of consciousness, with involuntary twitch/movement of extremities, following administration of 2nd HPV vaccine. Recovered slowly, 30 min. observation.
A report was received from a physician concerning a male patient who was participating in the mRNA-1273 Emergency Use Program and experienced fever, chills, bone crashing body aches (far worse than when he had COVID), shaking that would not let him hold a cup, and heavy sweating at night.   The patient's medical history, as provided by the reporter, included COVID-19. No relevant concomitant medications were reported.   On 29 Dec 2020, approximately 10 hours prior to the onset of the events,  fever, chills, bone crashing body aches (far worse than when he had COVID), shaking that would not let him hold a cup, and 1 day prior to the onset of the event heavy sweating at night, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 30 Dec 2020, the patient was reportedly feeling fine the first 10 hours following vaccine administration, then began to experience fever, chills, bone crashing body aches that were worse than when he had COVID, and shaking that would not let him hold a cup, for another 10 hours. On 30 Dec 2020, the patient reported experiencing heavy night sweating that caused him to change his clothes and sheets 3 times.   Action taken with mRNA-1273 in response to the events was not reported.  The events, fever, chills, bone crashing body aches (far worse than when he had COVID), shaking that would not let him hold a cup, were considered resolved on 30 Dec 2020. The outcome of the event, heavy sweating at night, 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 the events ten hours after vaccination, a causal relationship cannot be excluded. Further information has been requested
I was starting my period (light spotting) and it just stopped after the first dose. That was Mar 9, 2021. I have not gotten my period since. According to the doctors as well as my menstruation cycles prior there were no signs or peri menopause or menopause.  Additional symptoms: After the first dose: (lasted for 3 weeks) Extreme fatigue. (Sleeping 20 hours a day) Swollen joints.  (Radiating pain from the occipital ridge downward through out the spine & the right knee). Constant pain in my neck, shoulders, hips. Brain fog. Blurry vision/vision changes and things looked like they were vibrating/jumping  Numbness in my face  Tasted metal in my mouth  Nausea Diarrhea  Loss of appetite  Depression    After the second dose (lasted 10 days)  Entire left arm was in pain Swollen  and  stiff from left arm, base of my occipital ridge/top of spinal column , neck shoulders, all the muscles between my shoulder blades the day after. Starting on day 3, all the areas up and down my spinal column felt swollen, stiff and in pain.  Dissipated after 10 days.  I lost mobility in my hip joints. Swollen right knee ( I am still experiencing these 2 symptoms, 4/12/21).  Fatigue Brain fog. Diarrhea. Nausea  Loss of appetite
Congestive heart failure; This is a spontaneous report from a contactable consumer (patient).   A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731, expiration date not provided), 1st dose via an unspecified route of administration, administered in Arm Left on 24Apr2021 10:00 at age of 61years old as a single dose for COVID-19 immunisation.  Medical history included congestive heart failure from Mar2013 to an unknown date, Chronic Kidney Disease Stage 2, cured Type 2 Diabetes from Dec2019 to an unknown date. Concomitant medication included losartan. The patient experienced congestive heart failure on 04May2021 12:00 with outcome of recovering. Therapeutic measures were taken as a result of congestive heart failure. The adverse event result in following: Emergency room/department or urgent care. Treatment for the adverse event included LASIK Intravenous (IV). The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0168, expiration date not provided), 2nd dose via an unspecified route of administration, administered in Arm Left on 15May2021 09:30 at age of 61years old as a single dose for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. There had not known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Continued severe migraine/sinus headaches; Continued severe migraine/sinus headaches; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 65-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6203, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 26Feb2021 at 03:00 am (age at vaccination was 65 years) as dose 1, single for COVID-19 immunization. The patient's medical history included HTN (hypertension), GERD (Gastrooesophageal reflux disease), ongoing migraines and known allergy to CT (Computed tomography) dye. Concomitant medication or other medication the patient received in two weeks included galcanezumab gnlm (EMGALITY) injection taken for migraines. The patient previously took compazine [prochlorperazine edisylate], omnicef [cefdinir] and reglan [metoclopramide] and experienced known allergies to it. The facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 27Feb2021, the patient experienced continued severe migraine/sinus headaches. The patient took migraine and sinus meds for the events. The outcome of the events was not resolved.No follow-up attempts are possible. No further information is expected.
Patient was on room air with a baseline issue of apnea where he had been having 1-2 significant apneic events daily requiring moderate stimulation. Within 14 hours of receiving his 2 month immunizations he had 3 very significant apenic events requiring blow-by oxygen and the 3rd event required PPV and intubationd (approximately 22 hours after immunizations ). He remained intubated for approx 35 hours then weaned to CPAP and finally back to RA on 8/8. He is back to his baseline and finally feeding orally as of 8/9.
Metastatic Breast Cancer; This spontaneous case was reported by a patient and describes the occurrence of BREAST CANCER METASTATIC (Metastatic Breast Cancer) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A, 20SL210 and 025B21A) for COVID-19 prophylaxis.     Patient had no known allergies.  The patient's past medical history included COVID-19 in January 2021. Concurrent medical conditions included Breast tumor benign since 2014.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced BREAST CANCER METASTATIC (Metastatic Breast Cancer) (seriousness criterion medically significant). The patient was treated with LETROZOLE at an unspecified dose and frequency. At the time of the report, BREAST CANCER METASTATIC (Metastatic Breast Cancer) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 antibody test: (Positive) Positive.         No concomitant medications were reported. On Dec 2020 the tumor was still benign and on July 2021 was diagnosed with metastatic breast cancer. She was reporting just in case it might have been caused by the Moderna Covid 19 vaccine. The patient did not experienced allergies medications, food and other products. Event all her bones broke subsumed under the event breast cancer metastatic.  Treatment: Breasenial 150 mg 2 tice day.  Company comment: This spontaneous case concerns 53 years old female with Concurrent medical conditions included Breast tumor benign, who experienced the unexpected serious (medically significant) event of breast cancer metastatic, which occurred approximately 3 months after second dose of mRNA-1273 vaccine. Patient was diagnosed with metastatic breast cancer after second primary dose of vaccination. Started on Tablet Breasenial 150 mg 2 times a day. At the time of reporting event outcome is unknown. Concurrent medical conditions included Breast tumor benign is confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns 53 years old female with Concurrent medical conditions included Breast tumor benign, who experienced the unexpected serious (medically significant) event of breast cancer metastatic, which occurred approximately 3 months after second dose of mRNA-1273 vaccine. Patient was diagnosed with metastatic breast cancer after second primary dose of vaccination. Started on Tablet Breasenial 150 mg 2 times a day. At the time of reporting event outcome is unknown. Concurrent medical conditions included Breast tumor benign is confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Initial non-serious case received from a patient on 05 August 2008. A 68-year-old female patient experienced headache, forehead swelling, sleeplessness and irritability on the same day after receiving an intramuscular left deltoid booster dose of IMOVAX on 29 July 2008 (lot number A0484-2, expiration date 02 August 2009) for bat exposure. The patient had received an intramuscular right deltoid tetanus vaccine (trade name, manufacturer, lot number not reported on 26 July 2008. The patient was seen by a physician on 31 July 2008 and received treatment with amoxicillin. The patient reported that she was being treated for sinus infection and ear infection at the time of the vaccination. Patient outcome was reported as 'not recovered'. The patient received a second intramuscular right deltoid booster dose of IMOVAX (lot number A0485-2, expiration date 08 June 2009) on 01 August 2008.
This case was reported by a pharmacist via call center representative and described the occurrence of pustule in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced pustule, blister and rash. On an unknown date, the outcome of the pustule, blister and rash were unknown. It was unknown if the reporter considered the pustule, blister and rash to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) reported that the patient got SHINGRIX last Wednesday from the reporting date and 2 or 3 days later he developed pustules on his chest and HCP also described it as blisters or bumps on his chest.
Left arm large area of induration, erythema, tender to palpater per doctor exam.
Lyph node swollen and tender at 8 days post injection. Shoulder, area of injection, visibly swollen, tight and very warm to the touch.
Pediarix outside of age range; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number A32BB, expiry date 10-AUG-2025) for prophylaxis.   On 22-SEP-2023, the patient received the 1st dose of Pediarix. On 22-SEP-2023, an unknown time after receiving Pediarix, the patient experienced inappropriate age at vaccine administration (Verbatim: Pediarix outside of age range).  The outcome of the inappropriate age at vaccine administration 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: 22-SEP-2023 The nurse called in to request information on how to continue the series after a patient over 12 received first dose of Pediarix. They provided information about vaccine event and patient. The reporter consented to follow up. The patient over 12 years old received a dose of Pediarix, which led to inappropriate age at vaccine administration.
Within minutes of receiving the vaccine the patient suffered a right-sided visual loss consistent with a hemi-anopsia.  She saw an eye specialist the following day and was sent emergently to the hospital where a CT showed a new left occipital lobe CVA
CAN NOT MOVE HIS EYES (LIKE SOMEONE PUT FINGER IN  HIS EYES); BLURRED VISION; FEELING OF ELEPHANT ON HIS HEART; SENSITIVE TO ANY SOUND; CAN NOT SPEAK (LOSING HIS VOICE); SENSITIVE TO LIGHT (CAN'T USE COMPUTER); FEELING DIZZY; FEELING TIRED; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: stomach pain, headache, and increased blood pressure, and other pre-existing medical conditions included: The patient initially visited the ER on 07-Mar-2021 for symptoms of headache, bloated head, high blood pressure and stomach hurting but all this was before receiving the vaccine. The ER stated he was normal. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: 26-MAY-2021) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-MAR-2021, the patient experienced can not move his eyes (like someone put finger in his eyes). On 07-MAR-2021, the patient experienced blurred vision. On 07-MAR-2021, the patient experienced feeling of elephant on his heart. On 07-MAR-2021, the patient experienced sensitive to any sound. On 07-MAR-2021, the patient experienced can not speak (losing his voice). On 07-MAR-2021, the patient experienced sensitive to light (can't use computer). On 07-MAR-2021, the patient experienced feeling dizzy. On 07-MAR-2021, the patient experienced feeling tired. On 07-MAR-2021, the patient experienced headache. Laboratory data (dates unspecified) included: CAT scan (NR: not provided) Not reported, and Magnetic resonance imaging (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from can not move his eyes (like someone put finger in his eyes), blurred vision, feeling tired, feeling of elephant on his heart, sensitive to any sound, can not speak (losing his voice), headache, sensitive to light (can't use computer), and feeling dizzy. This report was non-serious.
Starting around 12 pm, I began to have a headache.  At about 7 pm the headache became a migraine and I decided to take 400 mg of ibuprofen.  Around 8 pm I went to bed as the migraine was not getting any better.  After laying in my bed for a few minutes I began to have nausea and went to the bathroom to see in case I had to vomit or possible have diarrhea.   While sitting on the toilet (and not straining at all), both of my arms started to tingle from the arms to the fingertips.  Several seconds after the tingling began, I began to experience spasticity in both arms so that both arms flexed and both hands closed into fists.  Shortly after I began to feel tingling in my face and realized that I should go to an emergency room.  I attempted to call for my family but was mumbling and had difficulty forming words due to spasticity in my jaw.  They helped dress me since I had zero function in both of my hands and could not stand easily.  We started to walk to the car when I realized that it felt like I was fighting my own legs to get them to move (spasticity in my leg muscles as well).  We arrived at Medical Center.  They ran a CBC with differential, CMP, troponin-I , chest x-ray, and EKG. Everything came back normal except for mild hypokalemia (3.2 mmol/L).  They decided that I had a panic attack and gave me oral potassium and IV lorazepam.  I have no history of any mental health issues and have never had a panic attack before.  I tried to tell everyone at the hospital that I was not in stressed or in fear of anything for entire day including during the episode.  My mind was clear; it was just my body that was behaving abnormally.  I was sent home around 11 pm.  My legs were sore for the next few days due to the sustained contractions.  I feel like it is important to inform you that I am a pharmacist and have encouraged everyone I know to get vaccinated for COVID19.
N & F 48 hours after vaccine about 40. Nausea and fever lasted for four hours. Onset 48 hours after H1N1 vaccine given. No treatment. Unknown temperature.
ADULT DOSE INADVERTENTLY GIVEN TO CHILD.  MOTHER NOTIFIED 12/5/2019.   CALLED MOTHER 12/9/2019, STATES CHILD HAD NO FEVER OR SWELLING AT VACCINE SITE, NO ADVERSE REACTION NOTED.
pt recv vax & had high fever, up to 102 called ER & instructed to apply cold towels to head;p/applying towels, noticed began to sweat as fever dropped then began to shake;chills, sweaty, eye fixed & glassy;t95.6;fell asleep;sz;t99-100;
Around 8pm I began having chills, body aches and SOB that lasted throughout the night. The next day I felt a little better earlier but got very fatigued, had a headache, chills and a large swollen lymph node developed under my left arm and its still there today. And my arm is sore at the injection site.
Left Lymph Node is Very Swollen and painful.  Started 5 fats after shot. It has been the same for 5 days so far
Nausea almost immediately but disappeared shortly, bad headache within a half hour of injection that lasted about 24 hours, low grade fever (100.5), joint pain, and fatigue which lasted about two days and itching at injection sight that has lasted for a week.
Left arm became itchy, red, tender and hard at site. Pt was instructed to use ice packs and take Tylenol.  These symptoms continued for 48 hours.
Fever of 102.5; UTI; Blood in urine; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0171, Expiration Date: not reported), via an unspecified route of administration in left arm on 29Apr2021 10:30 as dose 2, single for COVID-19 immunization (at the age of 25-years-old). The patients' medical history included PCOS (polycystic ovarian syndrome). The patient had no known allergies to medications, food, or other products. There were no concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 08Apr2021 at 8:30 as a single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks prior to the COVID-19 vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced fever of 102.5 (unspecified units) which remained high despite intake of acetaminophen (TYLENOL) and UTI (urinary tract infection) with blood in urine on 29Apr2021 19:00. The events resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included body temperature: 102.5 on 29Apr2021 Fever of 102.5; At 19:00. Therapeutic measures were taken as a result of the events fever and urinary tract infection with blood in urine and included treatment with acetaminophen (TYLENOL) and unspecified UTI antibiotics. The clinical outcome of the events fever of 102.5 and urinary tract infection with blood in urine were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old male patient received BNT162b2 (BNT162B2), on 10Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 25 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Patient had no known allergies. Concomitant medication(s) included: TYLENOL (other medication in 2weeks), start date: 12Aug2022, stop date: 17Aug2022. 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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and treatment included Paxlovid from 12Aug2022 to 16Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient experienced fever (~100 F) and hives/rash on arms and legs. She is not allergic to any medications or food products (eggs, milk). She has never recieved the flu and Pneumo vaccines in the past. Pt was instructed to take Acetaminophen and Diphenhydramine for the reaction. Patient called back the next day (11/5/06 ~10AM) and said that she was doing significantly better.
acute transverse myelitis is reported in a pt who recvd flu vax around 22OCT93; OCT93 exp pain in the back & numbness in rt leg; 26OCT93 devel paralysis in both legs; pt did not have any control over bladder or bowel movements;