chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2/28/2021 patient was admitted for rectal bleeding while taking apixaban Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine. This hospitalization does not appear to be related to the vaccine.
After few days of second dose of COVID vaccine,  right cheeks was noted to be swollen and tender to touch upon waking in the morning as if someone placed an apple inside the cheek. Swelling progressed to up to eyes, below lower jaw and near nose. Swelling and pain persisted for 3-4 days and disappeared on its own,  I was advised to take only Tylenol and nothing else. After swelling and inflammation on cheeks resolved then occasionally and randomly rashes, redness, small tiny skin eruptions with itching appear above the skin or even under the skin  then resolves on their own.  Now symptoms are progressing affecting vision and hearing . I could watch TV without glasses but now suddenly they appear blurred. For the last three days, right ear has echo of external sound such as if I am sitting in front of TV it appears sound is echoing in right ear, which is annoying and discomforting.
Headache; Tiredness; Weakness; Shortness of breath; This case was reported by a consumer via call center representative and described the occurrence of headache in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th January 2023, the patient received the 1st dose of Shingrix. On 11th January 2023, less than a day after receiving Shingrix, the patient experienced headache, tiredness and weakness. On 13th January 2023, the patient experienced shortness of breath. Shingrix was discontinued. On an unknown date, the outcome of the headache, tiredness, weakness and shortness of breath were recovered/resolved.   It was unknown if the reporter considered the headache, tiredness, weakness and shortness of breath to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-JAN-2023 Reporter's Comments: The patient reported case for herself. The patient stated that she received her first dose of Shingrix and experienced headache, tiredness, weakness that was resolved.  The patient stated that two days after the dose she began to experience periods of shortness of breath that would come and go but resolved after about a week.  She would not be getting the second dose based on the recommendation of the pharmacy. The reporter consented to follow up.
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 47-year-old male patient received BNT162b2 (BNT162B2), on 30Nov2021 as dose 3 (booster), single (Lot number: FK5618) at the age of 47 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, but mild and under control" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Montelukast, start date: 01Oct2018, for Drug allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jul2022) positive, notes: first day of symptoms and positive covid test; (28Jul2022) negative, notes: On Day 9 I tested negative on the antigen test; (30Jul2022) positive, notes: Day 11 I took the antigen test and got positive results (immediate and bright red on the test). Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
PATIENT HAD A REALLY BAD REACTION TO FIRST SHINGRIX (IRREGULAR HEARTBEAT, HIGH BLOOD PRESSURE, BRUISING, SORE ARM LASTING FOR DAYS, CHEST PAIN, AND RAIDIATING PAIN TO THE OTHER ARM) - UNSURE IF HE WILL GET 2ND DOSE
inconsolable crying for over 5 hrs; began w/in an hr of vax; did not sleep for 12 hrs;
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2009, the patient was inoculated with ZOSTAVAX, by a physician, as recommended for routine adult health maintenance and for prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated at a healthcare facility/nursing facility for a severe vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
This is a spontaneous report from a contactable physician via Pfizer sales representative. A 18-month-old patient of an unspecified gender received four doses of PREVNAR 13, each one on an unspecified date at single dose for immunisation. Medical history included Jacobsen Syndrome. The patient's concomitant medications were not reported.  Physician ran titers on several vaccines due to the nature of the syndrome, and only pneumococcal 13-val conj vaccine did not demonstrate an immune response in this patient after all 4 doses were administered. Physician felt that lack of response was due to the patient's condition.
This case was reported by a pharmacist via call center representative and described the occurrence of general body pain 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, less than a year after receiving SHINGRIX, the patient experienced general body pain, performance status decreased and bone pain. On an unknown date, the outcome of the general body pain, performance status decreased and bone pain were recovered/resolved. It was unknown if the reporter considered the general body pain, performance status decreased and bone pain to be related to SHINGRIX. Additional information was reported as follows: The exact age at vaccination was not provided. However, the patient was over 50 years old. After vaccination with SHINGRIX, the patient experienced systemic pain, inability to function and bone pain for a period of three days. The pharmacist did not have any other information at the time of reporting. The reporting pharmacist had not vaccinated the patient. No address was provided, as the reporting pharmacist she was not working at the time of reporting. This case was linked with case US2018GSK138588 (wife's case), reported by the same reporter.
Missing period.  I have not had my period, which was supposed to start on 1/30.  I took a pregnancy test yesterday, which was negative.
Vaccine reaction, initial encounter Assessment & Plan: Patient received Shingrix vaccine on 9/12 and was fine when she left. Reaction started the following day.   Plan Conservative management OTC Anti-inflammatory such as ibuprofen PRN Ice compress prn The reaction was marked with a marker and explained to the pt to monitor if the redness and size increased Advise to let us know if symptoms worsens
Information has been received from a nurse concerning unspecified number of patients of unknown age. The patients' medical history and concurrent condition were not reported. On an unknown date, an unspecified number of patients were administered improperly stored PROQUAD (Lot# N010247, expiration date 25-SEP-2018) (dose, frequency and route were not reported) that was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot# and expiration date unknown).  The vaccine was exposed to temperature excursion of 6 Fahrenheit (F) to 14 F for 15 hours and the data logger was not involved. The vaccine was previous exposed to a temperature excursion of 6 F to 14 F for 164 hours. No adverse effects reported.
Pt was covered head to toe with red spots. She was not feverish and did not seem bothered by it. It took 3 days for patient to recover fully and the spots to go away.
Ultrasound to R/O DVT; Severe arm swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Oct2021 11:00 (Lot number: 301358A) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergy- cigarette smoke" (unspecified if ongoing); "Known allergy- Adhesive" (unspecified if ongoing). No covid prior vaccination. The patient's concomitant medications were not reported. Facility type vaccine: pharmacy or drug store. No other vaccine in four weeks. Past drug history included: Atropine, reaction(s): "Known allergies: Atropine". Vaccination history included: Bnt162b2 (Dose 2, lot number: EL8982, administration time: 12:00 pm), administration date: 08Feb2021, when the patient was 68 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, lot number: EL8982), administration date: 18Jan2021, when the patient was 68 years old, for COVID-19 immunization.  The following information was reported: PERIPHERAL SWELLING (medically significant) with onset 08Oct2021, outcome "not recovered", described as "Severe arm swelling"; DEEP VEIN THROMBOSIS (medically significant), outcome "unknown", described as "ultrasound to R/O DVT". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10May2021) negative; ultrasound scan: (unspecified date) unknown results.  Clinical course: Severe arm swelling of several months duration. Event treatment reported as ultrasound to R/O DVT.   Follow-up attempts are completed. No further information is expected.
After receiving the Covid19 shot, patient was sitting down, approximately 7-10 later patient passed out for approximately 30-60 seconds. Patient was laid on the ground where he regained consciousness. 911 was called, while waiting for paramedics, BP was checked and was normal, paramedics checked patients blood sugar which was normal . paramedics took patient to Hospital ER at patients request
C/o allergic reaction to influenza vaccine at 3:20 pm 10/7/19. S/s right ear burning and itching, right eye itching and swollen and lower bottom of face itching. C/o wheezing.
This case was reported by a physician via call center representative and described the occurrence of intussusception in a 4-month-old male patient who received ROTARIX lyophilized formulation) (batch number 2J475, expiry date 14th February 2020) for prophylaxis. Co-suspect products included HIBERIX for prophylaxis, PEDIARIX for prophylaxis and PREVNAR 13 for prophylaxis. On 1st October 2018, the patient received the 2nd dose of ROTARIX lyophilized formulation (oral), HIBERIX, PEDIARIX and PREVNAR 13. On 2nd October 2018, 1 days after receiving ROTARIX lyophilized formulation, HIBERIX and PEDIARIX, the patient experienced intussusception (serious criteria hospitalization and GSK medically significant), fever (serious criteria hospitalization), vomiting (serious criteria hospitalization) and lethargy (serious criteria hospitalization). On an unknown date, the outcome of the intussusception, fever, vomiting and lethargy were unknown. It was unknown if the reporter considered the intussusception, fever, vomiting and lethargy to be related to ROTARIX lyophilized formulation, HIBERIX and PEDIARIX. Additional details reported as follows: The physician initially left a voice mail on 4th October 2018 and requested a callback. The physician reported that the patient experienced intussusception, 24 hours after the second dose of ROTARIX. GlaxoSmithKline response center called back and obtained further details from nurse. Nurse reported that the mother of the patient called back the next morning after receiving ROTARIX stated that the patient had fever, felt lethargic and vomited twice. The patient came into the office on that same day and was diagnosed with intussusception.  The patient was hospitalized and had surgery. It was unknown if the reporter considered the fever,vomiting, intussusception and lethargy to be related to PREVNAR 13 as well.
headache; fatigue; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (fatigue) and MYALGIA (muscle pain) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 28-Sep-2023, the patient experienced HEADACHE (headache), FATIGUE (fatigue) and MYALGIA (muscle pain). At the time of the report, HEADACHE (headache), FATIGUE (fatigue) and MYALGIA (muscle pain) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Suspect product batch number reported as either 25E23A or 2ZE23A. Patient queried that if patient could take treatment medication Tylenol.
This is a spontaneous report from a contactable consumer who reported for his 2 daughters. These patients experienced the same events after first and second dose of vaccine. This is the second of 2 reports for patient 1. A 20-year-old female patient received on 04Aug2015 at 3:30 pm a single dose of TRUMENBA. The patient had ongoing asthma chronic and allergy for entire life. Concomitant medications included birth control pills and inhaler as needed for asthma. The patient received the first dose on 05Jun2015 intramuscular and experienced minimal pain at the injection site. No other vaccines were administered on the same date or within 4 weeks. Immediately after second vaccination, the patient felt tingling throughout the body like someone was sticking needles in it. The event lasted for 2 hours then went away on 04Aug2015. No treatment was provided. Laboratory tests were not performed. The same reactions occurred to her sister after first and second vaccination with TRUMENDA performed respectively on 05Jun2015 and 04Aug2015. Follow-up (24Aug2015): Follow-up attempts completed. No further information expected.
Abnormal menstrual bleeding and spotting. Unpredictable gushes of vaginal bleeding (fresh/red blood) daily but not continuous.  My normal cycle is at the same time every month and I rarely spot/bleed between cycles. I now have cramps and blood/spot daily which is extremely uncharacteristic. This has been a horrible experience and there does not seem to be an end in sight.
Information has been received regarding a case in litigation, from a lawyer concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2012, the patient was vaccinated with a dose of ZOSTAVAX as permanent prevention and protection against shingles and zoster-related injuries (prophylaxis). (Strength, dose, route of administration, anatomical location, lot # and expiration date were not reported) due to a health care professional recommendation. On an unknown date, the patient experienced shingles (herpes zoster) and other zoster-related injuries despite being inoculated with the ZOSTAVAX vaccine (vaccination failure). On an unspecified date in 2016, the patient was treated by it's health care provider for shingles. It was also reported that the patient suffered serious physical, emotional and economic damages as a result. In addition, the patient would continue to suffer ongoing injuries, included but not limited to: mental and physical pain and suffering (Emotional distress and pain), extensive medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of pre-existing conditions and activations of latent conditions, lost wages, loss of earning capacity and other losses and damages. At the time of report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and  the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Temperature 104,7 began 4 days after vaccinations.  Also mild cellulitis/infectious wound right upper arm.  6/19/08 treatment: Keflex.  On Tylenol PRN.  Rec Ibuprofen PRN.
Two hours after FLUZONE HD administered, felt feverish approximately equal to 100 degrees F, chills, pain at injection site, very sore arm - unable to move arm around. Got shot around 3 PM, symptoms subsided around 10-11 PM. Next day felt weak but able to move arm around. Acute event. Pt took an anti-inflammatory for pain sore arm. Symptoms resolved.
Received both doses of Moderna Covid vaccine (2/22021 &3/2/2021) and had breakthrough covid symptoms (congestion, runny nose, loss of taste and smell) on 4/17/2021.  Tested positive with PCR testing on 4/21/2021
Next day post vax, the pt awoke with a headache. She also felt spinny and then things started to go black and she passed out a little bit. When she awoke, she couldn't see or hear anything. She had a second episode of this when she tried to get back up. She also had a temperature of 101.5.
Initially started with the common known left underarm lymph node pain and mild swelling. After a couple of weeks the lymph node pain continued and intensified with additional pain radiating up and around the entire left shoulder for about two more weeks. Then at about 4 weeks later, the ongoing pain continued, with an additional burning nerve pain and numbness radiating down the upper arm, across the elbow and down the lower arm into the wrist. No relief of pain, now at 11 weeks post second vaccination.
long term weakness and pain at injection site ( tricep ) beginning week after shot and still present 80 days later
Slight rash at injection site; Warmth at injection site; Flu-like symptoms; This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2019, the patient received Shingrix. On 10th September 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms. On 13th September 2019, the patient experienced injection site rash and injection site warmth. On an unknown date, the outcome of the influenza-like symptoms, injection site rash and injection site warmth were unknown.   It was unknown if the reporter considered the influenza-like symptoms, injection site rash and injection site warmth to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication. On 13th September 2019, 4 days after receiving Shingrix, the patient had slight rash and warmth at injection site. The adverse event was captured via webchat and visitor didn't respond after chat opened and initial question received from visitor. Chat visitor indicated that they were a pharmacy technician. The reporter denied permission to follow up.
Mother calls and reports patient that on evening of administration of flu vaccine (12/06/17)  patient began throwing up at 1130PM and at 530 AM 12/7/17 had a witnessed febrile seizure. Per mother patient does have a h/o one former febrile seizure. Per Pediatrician, report needed to be placed through VAERS.
noticed a change after the first dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (noticed a change after the first dose of the Moderna COVID-19 vaccine) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Epilepsy since 1995. Concomitant products included LEVETIRACETAM (KEPRA) for Seizure.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VACCINATION COMPLICATION (noticed a change after the first dose of the Moderna COVID-19 vaccine). At the time of the report, VACCINATION COMPLICATION (noticed a change after the first dose of the Moderna COVID-19 vaccine) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-363263 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Follow up received on 27-OCT-2021,contains patient demographic details, medical history and concomitant medication.
Anthrax vaccine administered Friday, July 31st, 2009 normal burning sensation, discomfort experienced immediately. Next day, Saturday AUG 1st, noticed mosquito bite sized mark, still burning sensation. As of Monday, AUG 03, burning, pain, and large rash, lump at injection site.
Patient became dizzy/lightheaded six minutes post injection. She was ambulating to the front desk and instead sat in a chair in the lobby. This nurse observed her to be pale and clammy, placed a chair under her feet to elevate her legs, she was coherent and continued to articulate, blood pressure was obtained in her left arm at 98/68. Within three minutes of feeling faint, the patient stated she felt well enough to leave and refused additional care.
On January 22 my left arm at the injection site began to itch.  There was a welt approximately 3" long and 2 1/2 " wide very red and hot to the touch   I am using Benadryl Itch cooling gel to stop the itch.
I felt sick after I got the shot, 5-6 months later, May 10, I developed necrotic seizures, in the abdominal area. For 2-3 days I had pain, I went to ER and did CT scan, found necrotic tissue, they operated on May 13th, and they removed. I was discharged the following day.
Slightly feverish & tired. Second day left foot turned bright red, very warm & itchy.  Gone by next morning. No other issues.
On Jan 26 of this year I weighed 158 In a orthopedic office.  March 3. COVID Moderna 012421A March 31 COVID Moderna 008821A On April 8 I weighed 156. On July 29 in a orthopedic office I weighed 151. On August 25 In a orthopedic office I weighed 149. Today at home I weighed 147.  In all cases I was dressed about the same, jeans, t-shirt, socks and shoes . That's about 11 pounds in 7 months. I am NOT trying to lose weight.
Temp of 99.2 and red raised itchy rash on neck and upper back.
h/a w/increasing intensity;took usual meds w/o relief;nausea now;no fever, but very tired;will send to neuro for exam;