chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a lump at injection site (left arm); patient experienced pain at the injection site; patient has trouble sleeping on the Left side; pain radiates to shoulder; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site lump in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number 2X955, expiry date 31-JAN-2026) for prophylaxis.   On 14-AUG-2023, the patient received Bexsero (left arm). In AUG-2023, an unknown time after receiving Bexsero, the patient experienced injection site lump (Verbatim: a lump at injection site (left arm)), injection site pain (Verbatim: patient experienced pain at the injection site), difficulty sleeping (Verbatim: patient has trouble sleeping on the Left side) and shoulder pain (Verbatim: pain radiates to shoulder).  The patient was treated with nsaid's (Nsaid). The outcome of the injection site lump, injection site pain, difficulty sleeping and shoulder pain were not resolved.   It was unknown if the reporter considered the injection site lump, injection site pain, difficulty sleeping and shoulder pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site lump, injection site pain, difficulty sleeping and shoulder pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 24-AUG-2023 The healthcare professional reported patient received the Bexsero vaccine in left arm and had pain and lump at the injection site in left arm. The pain radiated to shoulder and had trouble sleeping on the left side. The patient took NSAID everyday even the events were not subsided. The reporter consented to follow up via email.
DIZZINESS. LIGHT HEADED.  LOW PULSE  RATE  AND BLOOD PRESSURE
When I would wake up in the morning, right before, I felt like I had the flu and when I was fully awake my body felt like a cold coming on. It started the day after and peaked 3-4 months in and has been downhill since. A week ago would would have ben the last time I felt anything. Last year October I had a really bad ear infection with fluids leaking and ended up in emergency room. I haven't been been back to 100 percent of myself since.
In the morning of 11/02/21, started to feel a headache and joint pains. Then noticed that my left elbow started to swell and so painful to bend. Have to take Tylenol to subside the pain and headache. The swelling gradually spreading towards my wrist. On 11/04/21, decided to have it checked with my doctor and prescribed me with Amoxicillin and Ibuprofen. Was also taken a blood sample for further lab tests. Currently (11/07/21 around 9pm), swelling still continues to spread and have now reached my wrist.
pt was given a vaccine from a vial that had expired 12 hours prior. Vial had been refrigerated the entire time.
The next morning following my second dose of vaccine, I began to have seizures back to back, really bad migraines and restless. I haven't had a seizure out break in months since I been taking my meds on maintenance like I should. I reached out to my Dr. and they told me to come in that morning at 1PM. The Dr. took my vitals and everything seem to be in normal range, except the migraines was still throbbing, felt like my head was about to explode. My provider told me to titrate up on my seizure meds if I experienced another episode. In the meantime, recommended me to alternate Tylenol with ibuprofen. A week after I fully recovered from all symptoms.
This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The medical assistant reported that the vaccine was exposed to temperature of 26F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the medical assistant regarding a 14 years old, male patient with no pertinent medical history reported. On 16-OCT-2012 the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 18-FEB-2013 the patient received another dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
I have had irregular menstrual cycles ever since I got this shot six months ago.  I track my period and am accurate almost to the day for my whole life.  I started late 5 days late after my shot and within 6 months have started my period now within 3 weeks.  I KNOW this is from the shot. I am now having irregular and more frequent periods.  I am not on any prescription medications and nothing has changed the last 6 months in my life since I have got the shot.
varicella type rash over her right eyebrow going up her scalp on right side; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not provided. In or around 19-OCT-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, anatomical location and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), she suffered varicella type rash over her right eyebrow going up her scalp on right side (rash vesicular). As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX) vaccination, the patient's symptoms had resulted in physical limitations not present prior to using the vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the patient had not recovered from the rash vesicular. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Patient was nervous prior to receiving vaccine. After receiving vaccine she stood up from chair and within 2 seconds lost consciousness for less than a second. She slowly began to drop down to the floor while leaning against the wall. Her father was present and held her as she slumped down. She regained consciousness before getting to the floor and began to cry, seemingly scared at what had occurred. She remained sitting on the floor for 5 minutes before moving to the chair for another 15 minutes. Patient was given water. She sat in the waiting area with father and had no changes after that. When asked, she declined having any shortness of breath, itchiness, redness, or swelling.
patient refused to take his bottle, pushing the nipple away with his tongue. Mom has to give the formula drop by drop with syringe for him to eat bacuse he could go hours even 5 hours wihtout wanting his milk. This happened  in the evening of his immunization. Parents were calling the doctor 2x the same week of immunization because of the difficulty of feeding him. This is the 2nd week after the immunization and still showing the feeding difficulty. However, there are no vomiting, diarrhrea, iiritability but just "gassy". This baby has no feeding problem before the immunization and healthy.
horrific pain; pain in left leg, side, mouth, jaw; pain in left leg, side, mouth, jaw; pain in left leg, side, mouth, jaw; pain in left leg, side, mouth, jaw; pressure in head; 1 of your COVID booster shots occurring 21Nov2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 84-year-old female patient received bnt162b2 (BNT162B2), on 21Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 82 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization.  The following information was reported: PAIN (non-serious), outcome "unknown", described as "horrific pain"; PAIN IN JAW (non-serious), PAIN IN EXTREMITY (non-serious), PAIN (non-serious), ORAL PAIN (non-serious), outcome "unknown" and all described as "pain in left leg, side, mouth, jaw"; HEAD DISCOMFORT (non-serious), outcome "unknown", described as "pressure in head"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "1 of your COVID booster shots occurring 21Nov2021".  Clinical course: It was reported that patient requested some retribution for horrific pain and suffering and "run around" following 1 of the COVID booster shots occurring 21Nov2021. Patient reported that she received a government letter stating that she was too late, but patient didn't know. Pfizer sent forms from your (Safety Dept.) which patient documented, all 15+ pages of ER dates & findings, etc. Your forms were sent twice & documented twice, per Pfizer instructions. Nothing has helped, Pfizer never got back to me, (Clinic name withheld) and (Clinic name withheld) Clinics not studying side affects & my Primary Dr. has helped all she can. I'm now walking with a cane, have pain in left leg, side, mouth, jaw & pressure in head. Patient asked to be sent to a clinic doing research on COVID booster residuals, but have found no place, nobody accepting her request/doing such work. Patient mentioned she has been to ER several more times since filling out the forms.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Dizziness, Myalgia, Fever, Diarrhea, NauseaVomiting, chills, lightheadedness Narrative:
On 6-29-11, received Zostavax. On 6-30-11, ct had rash on R arm, R shoulder back, R side of face, states taking Benadryl. Now 11:30 AM, rash is nearly gone.
I received my vaccine and instantly I felt a tickle in my throat.It continued with a sharp headache that lasted for three days after.Right between the eyes.While I waited at the vaccine site I felt my throat tighten and pressure in chest and lungs.I did have swollen lymph nodes throat for 4 days.A swollen lymph nodes under the left arm underarm area and swollen tender breast for 5 days after vaccine.Then I started to experience a sharp pain in my left arm in my veins they would discolor and swell up I would also get fever and headaches.I had issues for 15 days after vaccine.I did not seek medical assistance. I t was manageable from home.I did take tylenol
12/24 ! 13:15 - 15 min after vaccine was administered p t c/o dizziness and shaking. was monitoring for further 15 minutes by vaccine staff. Then apx 06:00 pm that night started c/o chills, N/V, tremors, Fatigue, headache, and feeling flushed. continued thru 12/26. then 12/27 woke up with headache, n/v, chills, tremors and body swelling. 12/28- c/o nausea and headache.  Treated with Tylenol OTC 12/24 and 12/26 only. 12/28 Completed rapid COVID 19 test- results negative.  EDD 07/30/2021.
Canonot move arm/Cannot move fingers; contracture left hand / contracture right hand; terrible pain on shoulder; terrible pain on arms and hands / feels like RSD; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Canonot move arm/Cannot move fingers), MUSCLE CONTRACTURE (contracture left hand / contracture right hand), ARTHRALGIA (terrible pain on shoulder) and PAIN IN EXTREMITY (terrible pain on arms and hands / feels like RSD) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017821A, 027620A and 024M30A) for COVID-19 vaccination.     Concurrent medical conditions included Dust allergy, Allergy to molds, Reflex sympathetic dystrophy (as a chronic illness prior vaccination) and Clot blood. Concomitant products included APIXABAN (ELIQUIS) for Clot blood.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced HYPOKINESIA (Canonot move arm/Cannot move fingers) and MUSCLE CONTRACTURE (contracture left hand / contracture right hand). 27-Oct-2021, the patient experienced ARTHRALGIA (terrible pain on shoulder) and PAIN IN EXTREMITY (terrible pain on arms and hands / feels like RSD). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, HYPOKINESIA (Canonot move arm/Cannot move fingers), MUSCLE CONTRACTURE (contracture left hand / contracture right hand), ARTHRALGIA (terrible pain on shoulder) and PAIN IN EXTREMITY (terrible pain on arms and hands / feels like RSD) had not resolved.            It was reported that the patient received primary series doses on vaccination facility in contact number 2 and booster dose on vaccination facility in contact number 3 of the Moderna Covid-19 vaccine and 1 week after the patient's first booster dose the patient experienced scary things and mentioned all the events.  The patient was never tested positive for COVID-19 and did not receive any other vaccine within one month prior to Moderna Covid-19 vaccine.  It was further mentioned the patient experienced a similar event before 2 times, on 1982 and the other six years after that.  Symptoms were ongoing and the patient was taking Prednisone as treatment, but the patient did not feel much better.
morbilliform rash occurred on torso & neck ~48 hrs after second dose only, persisted for 5 days, antihistamine medication did not resolve rash; slightly itchy & warm. Rash resolved on its own by 1 week post vaccine dose.
COVID-19 Treatment/ positive rapid test; COVID-19 Treatment/ positive rapid test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Lot number: ER8727) at the age of 40 years 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). Concomitant medication(s) included: MONTELUKAST; PSEUDOEPHEDRINE; TYLENOL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; PROBIOTICS daily. Past drug history included: Meloxicam, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Jun2022, outcome "not recovered" and all described as "COVID-19 Treatment/ positive rapid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: tested positive for covid-19 in early June; (Jun2022) Negative, notes: On days 9 and 11 tested negative on rapid tests; (Jun2022) Negative, notes: On days 9 and 11 tested negative on rapid tests; (Jun2022) Positive, notes: tested positive on two rapid tests; (Jun2022) Positive, notes: tested positive on two rapid tests. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient was tested positive for covid-19 in early June. The patient have asthma and his doctor prescribed paxlovid, which he began taking on Day 3 of symptoms (day following positive rapid test). At the time patient had a high fever for two days, but showed steady improvement after starting paxlovid (days 3-7). On days 9 and 11 tested negative on rapid tests, and most of symptoms had improved other than an occasional cough and fatigue. On day 14, the patient began experiencing some a sore throat and mild acheyness. On day 15 my symptoms were more severe including acheyness, mild chills and mild fever, and tested positive on two rapid tests.
Marked erythema, swelling and warmth from site of injection to knee. Minimal tenderness/small raised firm "cystic" mass at site.
Extreme shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received the first dose of bnt162b2 (PFIZER COVID19 VACCINE), via an unspecified route of administration, administered in Arm Right at the age of 31-year-old on 01Oct2021 12:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included none.  The patient's concomitant medications were not reported. The patient experienced extreme shortness of breath on 02Oct2021 12:00 with outcome of not recovered. Event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received the second dose of bnt162b2 on 01Nov2021 covid-19 immunisation.
No additional AE; The vaccine was administered after a temperature excursion/Temperature -14.1 degree Celsius, timeframe 12 minutes; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 14-JAN-2022, the patient was vaccinated with improperly stored (temperature: -14.1 degree Celsius, timeframe: 12 minutes) varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, lot #: U022321, expiration date: 15-JUL-2023 (strength, site and route of administration were not provided) for prophylaxis (product storage error).There was no additional adverse event (no adverse event).
Patient is pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Patient is pregnant) in a 36-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since 2006 and Sjogren's syndrome since 2007. Concomitant products included LEVOTHYROXINE for Hypothyroidism, POTASSIUM for Nutritional supplement.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 01-Oct-2020 and the estimated date of delivery was 09-Jul-2021. On 02-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Patient is pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-sixth week of the pregnancy. The delivery occurred on an unknown date. For neonate 1, Patient Pre pregnancy weight was 130 Pounds and Patient had no maternal history of subfertility. Estimated Date of Conception was reported as 12-Oct-2020. At the time of the report, EXPOSURE DURING PREGNANCY (Patient is pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Oct-2020, Pregnancy test: positive Positive. On 20-Feb-2021, Ultrasound scan: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient already gave birth and currently she is in postpartum.  No treatment medications were provided.  Action taken with mRNA-1273 in response to the events was not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up received on 02-Aug-2021 and included information about patient pregnancy and birth of her child.
Fever on July 6th, 7th and 9th. Rash started on her face the 8th. By the 10th rash was severe and had spread to her chest, neck and back. The 11th rash began to subside.
sore arm; burning sensation at injection site (felt like bee sting); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and VACCINATION SITE PAIN (burning sensation at injection site (felt like bee sting)) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and VACCINATION SITE PAIN (burning sensation at injection site (felt like bee sting)). On 11-Apr-2021, VACCINATION SITE PAIN (burning sensation at injection site (felt like bee sting)) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment information provided.
I had a late dinner and when I stood up, I thought I was going to faint. I didn't faint. I had a hard time seeing. I couldn't see. It was blurry vision. As we were going to ER, it subsided. At the hospital, they hooked me up and said I was in A-fib.They put me on blood thinners there  and a beta blocker - they took me off the blood thinner and sent me home with the beta blocker. I'm still on Metoprolol. Treatment is helping. I have an appt with Cardiologist in August to follow up. (Doctor visit was after the ER in that same week.) I am better but it's unknown if I'm better.
pt recvd vax & 1-3 hrs p/vax exp hives; ea episode of which lasted 10-15 mins; episodes repeated over a 14 hr period, then subsided;
6 hours after shot, arm was in pain where i could hardly move, by morning felt like i had flu, by mon afternoon temperature went up to 101.8 before dropping tues evening.