chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After getting the second dose of Moderna he complained it was painful more than his first dose. I asked if he was ok and he said he didn't feel good at all. So I watched him and said let me know I am right here as I was watching him. He said he didn't feel good and wanted to lie down. I look at the patient he was leaning back on his chair, I felt his pulse was fast and he was pale and sweating. I told my technician to call 911 for help and came on tapping on his shoulder calling out for his name. He didn't response to my call so I gave him an EpiPen (0.3 mg). After getting the EpiPen he came back responsive I could tell because he was looking at me when I tapped his shoulder and call his name out. I asked if he felt better and can hear me he signal yes. A few minutes later he was able to speak in short sentences and able to give us his wife phone number (she was in her car waiting in the parking lot) to come inside. Paramedic came and took over the case and getting all the information from me
Information has been received from a physician concerning a 17 month old female who on 13-NOV-2006 was vaccinated SC with first 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot # 653973/0798F). On 02-MAY-2007, the physician diagnosed the patient was a breakthrough case of chickenpox and reported that the patient had chickenpox all over her body, including in the ear canal. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Fever; fatigue; headaches; dizziness; major soreness in arm; lack of focus; blurry vision. Adverse events still continuing by late evening, despite medication.
I was travelling out of state. A few days before that, I noticed being short of breath and I had some coughing. After around 3 days of that getting worse, I wound up going to the emergency room. The doctor asked all the right questions, and the D-Dimer test came back with some concerns. They did a CT scan with contrast and came back with some indication of blood clots. The next day, the informed me that I did have blood clots that began in my legs and travelled to my lungs. I spent 3 days in the hospital on a Heparin I.V. I was release and was still on oxygen. I was informed that had I not come in, it could have been life threatening. They advised that we travel home very slowly. We only did 3 hours of driving a day and stopped frequently. I am now on Eliquis for the next 6 months.
COVID-19 virus test positive / SARS-CoV-2 test positive; First dose administered janssen and second dose Moderna administered; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 virus test positive / SARS-CoV-2 test positive) and INTERCHANGE OF VACCINE PRODUCTS (First dose administered janssen and second dose Moderna administered) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for Prophylactic vaccination.     Previously administered products included for Prophylactic vaccination: JANSSEN COVID-19 VACCINE (COVID-19 VACCINE AD26.COV2.S) (Dose 1 vaccinated on left arm and unknown route of administration. Batch number: 1808609 & Expiry date:07-sep-2021.) on 22-Mar-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE (COVID-19 VACCINE AD26.COV2.S).    On 15-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (First dose administered janssen and second dose Moderna administered). On an unknown date, the patient experienced COVID-19 (COVID-19 virus test positive / SARS-CoV-2 test positive). At the time of the report, COVID-19 (COVID-19 virus test positive / SARS-CoV-2 test positive) and INTERCHANGE OF VACCINE PRODUCTS (First dose administered janssen and second dose Moderna administered) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Polymerase chain reaction: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive and positive (Positive) Rapid test was positive.         No concomitant medications were reported  No treatment medications were reported  Lab data given as lab test Rapid test was conducted on unknown date with Positive as result.  company comment: This spontaneous case concerns a 60 year old, male patient with no relevant medical history reported, who experienced the unexpected nonserious AESI event of COVID-19 (SARS-CoV-2 test positive) which occurred unspecified days after receiving the booster dose of mRNA-1273 vaccine. The patient had received initial schedule of vaccination with Janssen COVID-19 Vaccine (interchange of vaccine products). The current pandemic situation of COVID 19 may remain as confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 60 year old, male patient with no relevant medical history reported, who experienced the unexpected nonserious AESI event of COVID-19 (SARS-CoV-2 test positive) which occurred unspecified days after receiving the booster dose of mRNA-1273 vaccine. The patient had received initial schedule of vaccination with Janssen COVID-19 Vaccine (interchange of vaccine products). The current pandemic situation of COVID 19 may remain as confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 15-JUN-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (dose and route not reported, lot # J004332 and expiration date 26-SEP-2014). No adverse effects were reported. Additional information has been requested.
Psychosis,  Ataxia, Confusion, headache, mental fog, tremulousness, muscle twitching, muscular weakness 4 days after the second dose of the Pfizer vaccine was given
Very itchy on neck, chest, trunk, back and arms . Fatigue and severe body aches the following day. Benadryl helped w/ itching.
Expired Bexsero administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 7-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB39AB, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st August 2022, unknown after receiving Bexsero and Bexsero 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 Information: GSK receipt date: 9-Aug-2022 Reporter's comment: The healthcare professional (HCP )reported that on 1st August 2022 a patient received a dose of Bexsero that expired on 31st July 2022. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Patient reported "not feeling right", throat is tight, hard to swallow, light headed. Patient was put in the exam room at 6:00pm VS take, WNL. Doctor examined patient, lungs clear, airway clear. No swelling, redness, rash. Patient was given 25mg cap of Benadryl, monitored for 25min. Repeat vitals taken, improvement in HR, otherwise WNL.  Patient given prescription for Albuterol inhaler, Benadryl, Loratadine.  ER precautions advised to parent
Headaches; Chills; Lethargy; Nausea; Nosebleeds; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 05Apr2021 at 14:15 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included fish oil (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 15Mar2021 at 14:15 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 04:00, the patient experienced headaches, chills, lethargy, nausea, nosebleeds. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events headaches, chills, lethargy, nausea, nosebleeds was recovered with sequelae.   No follow-up attempts are needed. No further information is expected.
Ever since then he's been having pain on that's developed in the opposite shoulder and but its been a week; This is a spontaneous report from a contactable consumer. A 54-year-old male patient (reporter's husband) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 21May2021, as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously had first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, on an unknown date for COVID-19 immunization. Reporter stated her husband received the Pfizer second shot Covid 19 immunization on 21May2021 and ever since then he's been having pain on that's developed in the opposite shoulder and but it's been a week, a day and a week after the immunization and they were playing golf today and he was in excruciating a pain and he equivalates it to be broken, like a broken arm but it was his shoulder and we have tried phoning, several different places all they say is if you want Covid vaccine we can help you but they cannot help us with the side effect and so this is extremely alarming to us and we want to know what's going on. Was this something to be concerned about. He was a healthy in shape and a 54 year old man and never had any issues with his shoulder until after the shot and we were just trying to see what was going on. Outcome of the event was reported as not recovered.  Information about batch/lot number has been requested.
RED CIRCLE AROUND INJECTION SITE, ITCHING. TENDERNESS/LUMP LASTING LONGER THAN 3 WEEKS (SO FAR.)
Immediately after administering HPV vaccine in (R) deltoid, patient experienced loss of color, and loss of consciousness. Event lasted about 20 seconds and pt experienced slight tremors of extremities when regaining consciousness. Patient immediately became responsive when mother splashed water on face and called name. No period of confusion following event. Vital signs within normal limits. Some nausea and dizziness. Likely syncopal episode
1 week after receiving the vaccine, i developed redness, hot to the touch, and swelling at the vaccine site
sudden pain injection site, dizziness with things spinning, light headed with pressure in head and nausea
Pt came to the clinic to get her Flu & Covid Bivalent vaccines.  Immediately after the administration of the 1st vaccine (Flu), pt. started to feel lightheaded and nauseous.  She was transferred to a wheelchair and then to a cot to lay down.  She was offered water/snack and vitals monitored.  She advised she felt a bit anxious before coming in for the vaccines.  Pt wanted to proceed with her 2nd vaccine (Pfizer Bivalent).  That was administered at 1455 with no troubles.  Pt was monitored for approximately 25 minutes after her last vaccine, and she advised she was feeling back to normal.  Vitals all were within normal limits during the duration.
Pt recv vax on 9/3/98; on 9/10/98 pt exp tingling in feet &hands, numb left foot,blurry eyes, blocked ears; pt to M.D.; refer to neurologist 11/3.  Dx=optic neuritis. Per HCP follow up report-10/7/98 1 week after 1st Hep B patient started having neurological symptoms. To see neurologist. Will get written statement from neurologist if ok to get more Hep B. Mom stated that in the past two years, patient has had ongoing symptoms that have prompted seeing a large number of specialist but to date, has not been diagnosed with any specific condition. Initially, the symptoms began with muscle weakness and severe fatigue which mimicked multiple sclerosis. These symptoms subsided but then a Lupus type rash appeared and has continued to appear on her face. In more recent months, patient has had symptoms that have been similar to Crohn's disease (i.e. mouth/tongue sores, severe diarrhea, vomiting). A detailed list of physicians and summary can be requested through the parent (from Blue Cross and Blue Shield) to assist with further investigation.
had anxiety reactions after receiving their Moderna Covid- 19 vaccinations; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (had anxiety reactions after receiving their Moderna Covid- 19 vaccinations) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANXIETY (had anxiety reactions after receiving their Moderna Covid- 19 vaccinations). At the time of the report, ANXIETY (had anxiety reactions after receiving their Moderna Covid- 19 vaccinations) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2022-546517, MOD-2022-546518 (Patient Link).
Sleepy/ SLEEPIER THAN NORMAL; Stiffness/ STIFF; Sores mouth/ DEVELOPED SORES IN MOUTH; Headache; Fever; Pain/ Aches and Pains/ Sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain/ Aches and Pains/ Sore), SOMNOLENCE (Sleepy/ SLEEPIER THAN NORMAL), MUSCULOSKELETAL STIFFNESS (Stiffness/ STIFF), STOMATITIS (Sores mouth/ DEVELOPED SORES IN MOUTH) and HEADACHE (Headache) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis, Ulcerative colitis and Plaque psoriasis.    Concurrent medical conditions included Rheumatoid arthritis, Ulcerative colitis and Plaque psoriasis.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced PAIN (Pain/ Aches and Pains/ Sore), HEADACHE (Headache) and PYREXIA (Fever). On an unknown date, the patient experienced SOMNOLENCE (Sleepy/ SLEEPIER THAN NORMAL), MUSCULOSKELETAL STIFFNESS (Stiffness/ STIFF) and STOMATITIS (Sores mouth/ DEVELOPED SORES IN MOUTH). At the time of the report, PAIN (Pain/ Aches and Pains/ Sore), SOMNOLENCE (Sleepy/ SLEEPIER THAN NORMAL), MUSCULOSKELETAL STIFFNESS (Stiffness/ STIFF), STOMATITIS (Sores mouth/ DEVELOPED SORES IN MOUTH), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported.  The patient had covid vaccine issues such as headache, fever, aches and pains with booster. It was unknown if she was enrolled in a covid 19 vaccine trial.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2022: Significant Live Follow Up received included events were added.
This spontaneous report was received from a nurse practitioner via a company representative and refers to a 18 year old male patient. The patient's concurrent conditions, pertinent medical history and drug reactions or allergies were unknown. The patient's concomitant therapies included TRUMENBA and MENACTRA. Approximately on 03-AUG-2016 (reported as "approximately 6 weeks ago") the patient was vaccinated with the first dose of GARDASIL 9 (dose, frequency, route, lot number and expiration date were unknown). The reporter stated that the patient experienced dizziness approximately on 04-AUG-2016 (reported as "24 hours after receiving the first dose of GARDASIL 9") It was also reported that the patient recovered approximately on 18-AUG-2016, as her symptoms lasted approximately for two weeks. The patient sought medical attention by speaking to the nurse practitioner. The reporter stated that the patient received an unspecified treatment for the event. It was unknown if the patient had laboratory diagnostic studies performed. Additional information has been requested.
Full body welts and swelling. Feet swollen. Face, arms, trunk, legs, back, neck all with welts. Looked bruised as they faded. Lasted 7 days.
Fever, cold chills, fatigue, aching legs 1 1/2 hrs after receiving injection.
2 dasys after receiving the dose developed herpetic rash on left side small area 2.5 by 1.25 inches red warm raised painful -burning and itching  intolerant to  touch by fabric or dressing 4/8- current - now rough only itching as of 4/14/2021
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 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Jul2022 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 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's relevant medical history included: "Asthma" (unspecified if ongoing); "Pneumonia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: If vaccine received: Yes. Patient not received other medication in 2 weeks. Patient not had any known allergies. Anti viral details: [{product COVID 19 Treatment, brand Paxlovid , treatment start date was 21Dec2022, treatment stop date was 26Dec2022, indication was Treatment of COVID-19).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 15-NOV-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # M022947 with an expiration date 12-NOV-2017 for prophylaxis (dose and route of administration were not reported). There was no adverse effect reported.
First two days, high fevers, chills, migraine.  Got better for three or four days then,  At first, dizziness and lightheadedness upon standing up, nearly fainting.    Within another week, intermittent heart racing, elevated blood pressure episodes followed by headaches.    By three weeks out from second dose my headaches became constant, some devolving into migraines, relegating me to my bed.  Headaches are now constant, from morning until night, intermittent heart racing and bouts of light headedness are nearly every day.
Patient stated he took the vaccine on Thursday 5/13, he felt fatigued the same night but on Saturday started to feel numbness in legs and forearms but comes and goes. He also stated his face felt hot and tingly but still had sensation in it. He also felt a slight headache but that subsided on 5/21/21 when patient went ER. No c/o fever, body aches, sob, cough. Patient took ibuprofen to help with the headache and it helped. He stated what he felt started with tingling and then joint pain and numbness but no exact time how long it lasts, he stated sometimes it lasts a few minutes and sometimes as long as an hour but it comes and goes, he states he feels the sensation almost every day. He states he switches between the ibuprofen and the Tylenol and he does feel a little relief from taking either or.
This is in follow-up to report(s) previously submitted on 7/16/2007. Information has been received from a licensed practical nurse concerning a 26 year old female (weight 148#, height 66") who on 22-NOV-2006 was vaccinated with the first dose of GARDASIL. The patient was vaccinated with the second dose of GARDASIL (Lot #653937/0637F) on 22-JAN-2007 and the third dose (Lot #657622/0388U) on 21-MAY-2007 at 2:00 pm in the right deltoid. Concomitant therapy included LEXAPRO. No illness was reported at the time of vaccination. On 21-MAY-2007, the patient was vaccinated and developed a quarter-sized knot around the injection site. On 13-JUN-2007, the patient was seen by her physician and was diagnosed with a sterile abscess at the injection site which was not being treated (previously reported as being treated with antibiotics). As of 14-JUN-2007, the patient had not recovered. On an unspecified date, the area resolved and the patient recovered from the injection site abscess. Additional information has been requested.