chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site is red, has a rash, is warm to the touch; Injection site is red, has a rash, is warm to the touch; Injection site is red, has a rash, is warm to the touch; Fingers feel a little pricky; has the vaccine it was tender to the touch; It itches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Aug2021 10:30 (Lot number: FC3183) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart condition" (unspecified if ongoing), notes: Has a heart condition she takes medicine for; "A-fib" (unspecified if ongoing), notes: Had this for a few years. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE RASH (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 2021, outcome "not recovered" and all described as "Injection site is red, has a rash, is warm to the touch"; PARAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "Fingers feel a little pricky"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "has the vaccine it was tender to the touch"; PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "It itches".  Additional information: Injection site was red, had a rash, was warm to the touch: When patient first had the vaccine it was tender to the touch. It was not tender now. Did not pay much attention to it. Been a couple days and noticed the rash, patient did not notice it before. It itches. It was warm to the touch and there was a round circle located where the vaccine was injected at. Should have been administered higher, but because of her blouse sleeve, they could not get it up high enough. States maybe it was given a little lower. Patient did not feel sick. Fingers feel a little pricky: It comes and goes. It was a little bit strange. No prior vaccinations within four weeks to the first administration date of the suspect vaccine. Never received a Flu vaccine.  No follow-up attempts are possible. No further information is expected.
Severe body aches, chills, sweating the day following the vaccine on 12/27/20. Proceeded by hives starting on 12/31/20.  Hives were mainly on neck and face.
3 days after vaccine, I had a high fever and then went into Afib and was rushed to hospital. Hospitalized for 4 days. Then when released he started developing a lot of Ulcers in mouth and throat. It got so severe that he had a hard time eating. Went to PCP and was given an anti-inflammatory and Oxycodone and advised to use Miracle Mouth Wash. These treatments helped a little but was eventually admitted to the hospital again for 5 days and was given Dilaudid, Prednisone, and Oxycodone.  Doctors attributed that I am having these problems as it was an Autoimmune response. Referred to a Rheumatologist, Dermatologist and Gastroenterologist. Mouth ulcers eventually went away. Then 2 weeks later I started having heart problems again and an ambulance took me to the hospital for Afib. After being released, I got COVID, which made his ulcers come back. From there he was put on a heavy dose of Prednisone. After finishing his Prednisone, he developed heart problems again and was rushed to the hospital as he went back into Afib. I was in the ER for 4 hours then had Cardioversion performed. After being released, I saw my Cardiologist and had an Echo Stress test and an Electrophysiology test. After testing, I was rushed to the hospital again where he was Cardioverted and Defibrillated. Since then, I was prescribed Metoprolol, Flecainide 50mg and advised to take baby Aspirin 81mg. He's been on these meds since 3/3/2022. Currently waiting to see if I need Heart Surgery and Ablation Surgery.
lt arm inj site red, swollen, febrile, tender to touch; tx DPH;
It is 5 days after the vaccine was administered. The back of patient's arm is red and swollen and warm. She says the arm is still sore.
3 day after my vaccine I got a hard bump on the back of my ear; right lymph nodes is swollen from the inside; This is a spontaneous report from a contactable Healthcare Professional, the patient. A 26-year-old female patient started to receive the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via intramuscular route in the right arm on 13Jan2021 12:15 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient did not have any allergies to medications, food, or other products. On 15Jan2021 12:00 AM, after receiving her vaccine she got a hard bump on the back of her ear and her right lymph nodes was swollen from the inside. No treatment was received for the events. Since the vaccination the patient had not been tested for COVID-19. The clinical outcome of the event hard bump and lymph node swollen was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Six days post vax, the pt's mother said the pt developed a quarter sized red, hot mark on front of right thigh.
shoulder pain; Neck pain; vertigo; fatigue; muscle weakness; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12May2021 at 09:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient previously took montelukast sodium(SINGULAIR) on an unknown date for unknown indication and experienced drug allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levocetirizine dihydrochloride (XYZAL), fluticasone propionate (FLONASE) and nortriptyline hydrochloride (NORTRIPTYLINE); all on an unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12May2021 at 10:00 the patient experienced Neck and shoulder pain, vertigo, fatigue, muscle weakness. The event resulted in doctor or other healthcare professional office/clinic visit. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event Neck and shoulder pain, vertigo, fatigue, muscle weakness was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up
expired ACT-HIB was administered to a patient/no AE; Initial information was received on 25-Jun-2021 regarding an unsolicited valid non-serious case received from a physician via MI (Medical Information- 00657177).  This case involves a 1 year-old female patient who was vaccinated with expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (Expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  On 11-Jun-2021, the patient received fourth dose 0.5 mL (once) fourth dose of suspect HIB (PRP/T) VACCINE (lot UJ266AA and expiry date 05-Jun-2021) via an intramuscular route at the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired product administered (latency was on same day).  At the time of report, no adverse event reported.  Result of assessment was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pericarditis. Burning and stabbing pain in chest, pain shot down into left arm. Lasted days.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in an unspecified number of patients who received SHINGRIX. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable for this report. The healthcare professional (HCP) stated that, some patients experienced mild fever after receiving a dose of SHINGRIX vaccine. This case was one of the 3 cases reported by the same reporter.
urinary urgency, lumbar pain, leg paresthesia, arthralgia, gonalgia, genital area paresthesia, urine retention
Guillain Barre syndrome; paralysis; weakness; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (unknown). On an unknown date, unknown after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), paralysis (serious criteria hospitalization and GSK medically significant) and weakness (serious criteria hospitalization). On an unknown date, the outcome of the guillain barre syndrome, paralysis and weakness were unknown.   It was unknown if the reporter considered the guillain barre syndrome, paralysis and weakness to be related to Shingrix.  Additional information: The following receipt of the Shingrix vaccine injections, the patient suffered significant weakness to the point of paralysis, diagnosed by his treating neurologist as Guillain-Barre Syndrome following administration of the shingles medication Shingrix. As a result the patient had undergone substantial hospitalizations and extensive testing and was permanently restricted from receiving any other vaccines.
FEELING A LITTLE SHAKY; NAUSEA; HEADACHE; MUSCLE ACHES ON THE LEFT SIDE OF THE BODY; VOMITING; SHAKINESS; HOT FLASHES; DIZZINESS; This spontaneous report received from a patient concerned a 28 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced shakiness. On 08-APR-2021, the subject experienced hot flashes. On 08-APR-2021, the subject experienced dizziness. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced muscle aches on the left side of the body. On 10-APR-2021, the subject experienced feeling a little shaky. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, shakiness, hot flashes, dizziness, nausea, and muscle aches on the left side of the body on 09-APR-2021, and had not recovered from headache, and feeling a little shaky. This report was non-serious.
Had the MODERNA vaccine for all three shots.  After the booster I have had Palpitations, Heart beating hard, blood pressure up and down
Patient arrived to clinic to receive Janssen COVID-19 vaccine. Patient was accompanied by father. After consenting to receive vaccine, vaccine was given to left deltoid muscle. After about eight minutes, patient started to express feeling strange, reporting that she felt like she was going to pass out. Patient became clammy and pale. Clinic MD was called for assistance. After a few minutes, patient started yawn, with head nodding back. Patient was slow to respond for approximately 30 seconds during syncope. There was no loss of pulse or no s/s of trouble breathing. In clinic emergency response called, along with 911. Paramedics arrived to clinic, received report from MD and nurse about situation. Patient was assessed by paramedics, EKG done and was NSR, blood glucose done, and VS several times throughout incident. Patient was initially hypotensive with BP 80s/60s, with BP returning to 116/62 within a few minutes. Patient was taken home by parents following incident, electing not to go to hospital with paramedics. Patient was in good condition when leaving clinic with directions from clinic staff and paramedics to seek emergent care if needed.
Patient began to have metallic taste in mouth - felf like "he had braces on again." Also felt slight tightness in his cheeks.  Dispensed 1 loratadine per patient request (his allergist told him to take one when he has signs of reaction), and shortly after administered 50mg benadryl liquid to the patient. Sat with patient for 45 minutes after administration, to which all symptoms resolved and patient stated they were ready to go, and they left.
sweating; muscle pain on his back and wrist; sore, muscle ache, pain; joint pain/ pain on his wrist; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), BACK PAIN (muscle pain on his back and wrist), MYALGIA (sore, muscle ache, pain), ARTHRALGIA (joint pain/ pain on his wrist) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced HYPERHIDROSIS (sweating), BACK PAIN (muscle pain on his back and wrist), MYALGIA (sore, muscle ache, pain), ARTHRALGIA (joint pain/ pain on his wrist) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (sweating), BACK PAIN (muscle pain on his back and wrist), MYALGIA (sore, muscle ache, pain), ARTHRALGIA (joint pain/ pain on his wrist) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Noproblemwithinjection.Painthenestdaywhichisunremitting.
I had a scratchy throat at 7:30AM and was shivering by 3PM. That's when my fever started. I had a headache, and I went in the next morning to get my COVID-19 test which came back positive. I had head congestion and when my ears were clogged, I could not taste. My sense of smell was enhanced. I drank more water and orange juice. I did not think that I was sick enough to get the prescription that the doctors office prescribed so I did not take it. My teeth started to ache after my 2nd shot and now if I drink something cold, it hurts my teeth. The dentist indicated that there was nothing wrong with my teeth. My entire family had the same illness. My daughter tested positive as well. Her symptom severity was the same as mine, but she was not vaccinated.
Shortness of breath, if moving, breathing, or talking lungs hurt and it got severe on July 6th.  Given dexamethasone 10 milligram(s)  IntraMuscular to help. Shortness of breath is still there, but can do minimal movement or talking but chest pain begins if too much breathing, talking, or moving.
got lightheaded; hot flashes; the hours of sleep I get are less and less/I cannot sleep; I am living miserable since; hot flashes along with migraines are an every day and night thing; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date in 2021 as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration in arm right on 11May2021 at 22:45 (at the age of 29-year-old) as a dose 1, single for COVID-19 immunization and experienced migraine, patient felt lightheaded, got hot flashes, the weeks that passed the symptoms grew stronger and more frequent and on came the sleepless nights with an outcome of not recovered. 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, has the patient been tested for COVID-19 was reported as no. It was reported that, after getting her second dose, on an unspecified date in 2021, she again got lightheaded and hot flashes a few moments later. Stated that, it has now been weeks and the hours of sleep she get are less and less. Stated that, she cannot sleep and hot flashes along with migraines are an every day and night thing. The patient was been tested like a rat in a lab by doctors and they have no answers. She understood this was all new and there wasn't much research but she need help. Stated that, a mother of 2 experiencing this was not ideal. The patient need answers as fast advice on what to do. Stated that, was this happening to anyone else or just her. Stated that, she cannot comfortably recommend to others to get the vaccine when she was living miserable since. Stated that, the patient wanted help and any feedback would be greatly appreciated. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment was not received for the events. The device timestamp was on 28Jun2021. On an unspecified date in 2021, the patient underwent lab tests and procedures which included tested like a rat in a lab (Laboratory test), resulted as unknown results, they have no answers. The outcome of the events was not recovered.  Information related to batch/Lot no. was requested.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 20-JAN-2015, the patient was vaccinated with first dose of GARDASIL (dose, route of administration, site, lot# and expiry date were not reported). On 23-MAR-2015, the patient received the second dose of GARDASIL (dose, route of administration, site, lot# and expiry date were not reported). The patient was in the office at the day of the report (on 23-JUL-2015), to receive the last third dose in the series. The patient would be getting for the third dose GARDASIL 9 (dose, route of administration, site, lot# an expiry date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish the further contact.
On the afternoon of the day of vaccination (2/6/21) I have developed a skin rash on my chest and neck, but it went away after few hours.  On Sunday I felt a strong pain in my right arm. In the afternoon (2/7/21) I developed a severe headache, started to feel chest pain, a bit of nausea, flushed skin on my cheeks. By about 5:00 pm I felt really bad and I checked my blood pressure- using electronic meter. The reading was 171/105 with pulse 91. I have no history of high blood pressure. I called my physician but there was only recorded message to go to ER in case of emergency. I didn't feel that urgent need so I called my friend who is a nurse and she advise me to take aspirin. I did not have one on hand so my husband went to the store and I took it (325mg) after 6 pm. By 5:50 pm my blood pressure went up to 181/108, with pulse 98. At 6:54 pm it went down to 148/95 with pulse 91. The headache was becoming dull and I started to feel a bit better. This morning my blood pressure continues to be high- 149/95 with pulse 70.
she has had unspecified " left arm problems"; her ''hands are tingling and white all the time"; her ''hands are tingling and white all the time"; on an unspecified date, she got shingles; This spontaneous report was received from a consumer referring to herself, an adult female patient.   The patient's current condition included: High blood pressure and breast cancer. The patient's medical history included: ankle surgery.  The patient's previous drug allergies or reactions included: acetaminophen allergy, acetaminophen (+) hydrocodone bitartrate (VICODIN) allergy, and hydrocodone allergye. The patient's concomitant therapies included: bromelains (+) capsicum (+) choline (+) chondroitin (+) chymotrypsin (+) ginger (+) ginkgo (+) guar gum (+) hawthorn (+) inositol niacinate (+) lecithin (+) levocarnitine (+) papain (+) phytosterols (+) taurine (+) trypsin (+) ubidecarenone (LABS LIPOTROL), metoprolol, losartan potassium manufacturer unknown, calcium (unspecified), vitamin d (unspecified), choline bitartrate (+) inositol (+) minerals (unspecified) (+) rutin (+) vitamins (unspecified) (ORTHO MOLECULAR ALPHA BASE WITHOUT IRON) vitamin b (unspecified), sertraline hydrochloride (ZOLOFT)  methadone hydrochloride, misoprostol, and gabapentin.   On 13-DEC-2013 the patient was vaccinated with zoster vaccine live (ZOSTAVAX) 19400 plaque-forming units (PFU) vial, administered subcutaneous, for prevention of shingles (prophylaxis) (dosage regimen and anatomical site of vaccination were not reported) ; lot number J007301, which has been verified to be valid, expiration date reported and validated as 20-SEP-2014.  In approximately April 2014 (also reported as "four months later, on an unspecified date"), she got shingles (herpes zoster).  On an unknown date, the patient reported she had unspecified left arm problems (Limb discomfort). At the reporting time, the patient also stated that her hands were tingling and white all the time  (paraesthesia and pallor).   The patient sought medical attention, and called the physician, the treatment provided was aciclovir cream for herpes zoster (also reported as "was treatment given for AE?: No" conflicting information). The patient did not received treatment for the paraestheria, pallor nor the limb discomfort.   The outcome of herpes zoster and limb discomfort was reported as recovering. At the time of the report, the outcome of paraesthesia and pallos was determind to be not recovered (also reported as "present status: recovering"). The causal relationship between the suspect vaccine regarding the herpes zoster and the limb discomfort was not provided, and the patient attributed the paraesthesia and the pallor to be related to the zoster vaccine live (ZOSTAVAX).