chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bruise in the injection site; Hard lump; redness at either side of the injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE BRUISING (Bruise in the injection site), INJECTION SITE MASS (Hard lump) and VACCINATION SITE ERYTHEMA (redness at either side of the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE BRUISING (Bruise in the injection site), INJECTION SITE MASS (Hard lump) and VACCINATION SITE ERYTHEMA (redness at either side of the injection). At the time of the report, INJECTION SITE BRUISING (Bruise in the injection site), INJECTION SITE MASS (Hard lump) and VACCINATION SITE ERYTHEMA (redness at either side of the injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
fever; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Regulatory authority (Reference number- 00690450) and transmitted to Sanofi on 20-Jul-2021.  This case involves a 16 year old male patient who had fever (pyrexia) after receiving MENINGOCOCCAL VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV (Human papillomavirus) VACCINE [HPV VACCINE].  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL VACCINE produced by unknown manufacturer (lot number: AMAA521A4 and expiry date: not reported) by unknown route, in an unknown administration site for prophylactic vaccination .  On an unknown date the patient developed a non-serious fever (pyrexia) (unknown latency) following the administration of MENINGOCOCCAL VACCINE.  It was reported, "Caller has had a fever for 6 days. Caller wanted to know if that was normal after taking Vaccine. Caller did not want to provide demographics. Caller was warm transferred to ask about a fever for 6 days after getting Menactra. Explained the side effects on the package insert to him and when obtaining the lot number he states that he received a meningitis vaccine but was not sure which one he received at the pharmacy. Explained to him that his pharmacy would know which brand he received if he called them. Caller states he also received the HPV vaccine the same day."  No laboratory data was received.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.
This case was reported by a consumer via call center representative and described the occurrence of pain in extremity in a 56-year-old female patient who received Shingrix for prophylaxis. On 12th July 2018, the patient received the 1st dose of Shingrix (intramuscular). On 13th July 2018, 1 days after receiving Shingrix, the patient experienced pain in extremity, nausea, exhaustion, erythema, dizziness and arm discomfort. In July 2018, the patient experienced upset stomach and headache. On an unknown date, the outcome of the pain in extremity, nausea, erythema, dizziness and arm discomfort were recovered/resolved and the outcome of the upset stomach, exhaustion and headache were not recovered/not resolved. It was unknown if the reporter considered the pain in extremity, nausea, upset stomach, exhaustion, headache, erythema, dizziness and arm discomfort to be related to Shingrix. Additional details were received as follows: In the evening, the patient received a dose of Shingrix. The patient was fine at the night of vaccination, but woke up in the middle of the night with extreme pain and discomfort in her arm and redness. In the next night, after vaccination, the patient experienced nausea, dizziness and absolute exhaustion. Most of the symptoms were resolved, but the patient still had the severe exhaustion that prevents her from doing all her usual activities, along with headaches and an upset stomach. The patient reported that nausea was resolved but upset stomach was a separate problem for her.
Patient required hospitalization due to breakthrough infection. She received Pfizer vaccine last dose in series on 03/27/21. Hospitalized from 07/22/21 - 08/01/21. Below is copied from the discharge summary:   Patient is a 92 y.o. female with a history of coronary artery disease, diabetes mellitus, hypertension, hypothyroidism and congestive heart failure presented to the emergency department with complaints worsening bilateral lower extremity times two days.  CT head negative for any acute findings.  Chest x-ray resolved small left pleural effusion without any other significant changes.  BNP 1315, troponin 90, 81, delta 0, creatinine 2.36, hemoglobin 9.9.  WBC within normal limit.  COVID-19  Bilateral LE Weakness Improved - Currently at room air - Likely bodyaches related to covid  - Venous doppler negative for DVT - No neurological deficits or trauma - PT/OT and CM consult for STR - CRP 15, 14 and D-Dimer: 1,404  Dispo: awaiting SNF
BRUISE ON THE CALF MUSCLE; LUMPS ON THE CALF MUSCLE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unknown) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced bruise on the calf muscle. On APR-2021, the subject experienced lumps on the calf muscle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bruise on the calf muscle and lumps on the calf muscle was not reported. This report was non-serious.
Within a few seconds of vaccination patient (before the Band-Aids could even be applied) he had a 15-20 second episode of upper body stiffening and reduced level of consciousness. Patient reports that he felt "dizzy" just prior to the episode and recalls events both before and after the episode. There were no tonic/clonic movements reported. Based on history I suspect this falls under the category of stress-related response with possible convulsive vasovagal syncope. Additional specialty consultation pending to rule-out any other issues or contraindications to future vaccination with these products.
Changes in a normally very regular menstrual cycle.  Spotting has been occurring between menstruations almost weekly for a day or two. This has occurred every period since receiving the second vaccination.; Changes in a normally very regular menstrual cycle.  Spotting has been occurring between menstruations almost weekly for a day or two. This has occurred every period since receiving the second vaccination.; This is a spontaneous report from a contactable nurse, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the arm left on 30Jan2021 at 08:00 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included ADHD (Attention Deficit-Hyperactivity Disorder) and low vitamin d levels. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) 40 mg daily and colecalciferol (VITAMIN D3) 5000 units daily for unknown indication from an unknown date. The patient had no known allergies to medications, food or other products (reported as NKA/NKDA). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284) via an unspecified route of administration in the arm left on 09Jan2021 at 08:00 (at the age of 32-year-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 08Feb2021 at 07:00, the patient experienced changes in a normally very regular menstrual cycle. Spotting had been occurring between menstruations almost weekly for a day or two. This occurred every period since receiving the second vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event changes in a normally very regular menstrual cycle, Spotting occurring between menstruations almost weekly for a day or two was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
My son was sitting in a chair eating. He out of no where began grabbing his leg at 8:30 PM and saying "owwww" repeatedly. I picked him up and he started crying when his leg moved. After I calmed him about five minutes later I put him down to walk and he started crying and was not willing to walk on his leg that received the vaccine. It hurts to move his leg at all.
CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: gluten allergy, crohn's disease, and depression. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered at left arm on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 34 years old. On 29-OCT-2021, the patient received non-company suspect vaccine included: Moderna/ spikevax (elasomeran) (dose number in series 2) (form of admin and route of admin were not reported, batch number: unknown and expiry: unknown) dose was not reported, administered at left arm for prophylactic vaccination. Age at time of vaccination 34 years old. It was unknown whether patient had any adverse events following vaccination with Moderna/ spikevax (elasomeran) (dose number in series 2). On 25-MAR-2022, the patient received additional non-company suspect vaccine included: Moderna/ spikevax (elasomeran) (dose number in series 3) (form of admin and route of admin were not reported, batch number: unknown and expiry: unknown) dose was not reported, administered at left arm for prophylactic vaccination. Age at time of vaccination 35 years old. Concomitant medications included bupropion for antidepressant.  On an unspecified date, the patient had covid infection (dose number in series 3). The patient took non-company drug Paxlovid (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered first dose on 28-MAY-2022 and last dose on 01-JUN-2022 for treatment of covid 19 and was recovered. On 25-MAY-2022, the patient underwent COVID-19 virus (initial) test which was positive that led to confirmed clinical vaccination failure (dose number in series 1). On 08-JUN-2022 at 07:00, the patient experienced confirmed covid-19 infection and return of symptoms which includes mostly congestion and extreme fatigue (dose number in series 3). On 08-JUN-2022 the patient again underwent Laboratory data included: COVID-19 virus test which was positive (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and elasomeran was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported.  This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000236609.; Sender's Comments: V0: 20220634514 -Covid-19 vaccine ad26.cov2.s -CONFIRMED CLINICAL VACCINATION FAILURE . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Lethargic, then mild appeared to be getting a fever treated with Tylenol (7.5mg) at temp of 99.5at 3pm. Later around 8:30pm he started to shake and shiver saying he was cold, temperature check not fever level (98.6) used oximeter to check oxygen it indicated it was low of 77 and heart rate 91. Called nurse line to describe symptoms and she had use recheck temperature which had went up to 99.8 and heart rate of 160. She advised me to take him to ER. Within an hour. We took him to local hospital where at that time he had a temperature over 100 F. and an alarming heart rate of 150-160 for over an 1.5 time period. They have him ibuprofen and monitored heart rate. Today he is high energy (more than usual), no fever appetite, has not fully returned but was able to eat some. No appeared fever.
red sore at site of injection; red sore at site of injection; This is a spontaneous report from a contactable healthcare professional (patient). A 72-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration (administered on the left arm) on 11Feb2021 14:00 (at the age of 72-years-old) as 1st dose, single dose for COVID-19 immunisation. Medical history included low thyroid from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient has no known allergies. The patient has no other medications in two weeks. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. The patient experienced red sore at site of injection on 11Feb2021 15:00 (with reported adverse event date: 12Feb2021). It was reported that the patient still has redness and slight sore. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Within one day or so after receiving my 3rd dose I started to experience extreme body pain. From head to toe the pain was so unbearable I could barely move without the pain increasing. I also experienced a horrible migraine the Friday after my vaccine, I was in bed for two days with the lights out. A week or two later I started experiencing an itch on both of my feet, later that night I woke up in the middle of the night scratching. I had a few hives on the back of my neck. The next day I was hospitalized because my entire body was covered in hives. At the same time my left eye was swollen shut and they gave me some kind of steroid to bring the inflammation down. The eye did get better after a few days, but the rest of my body took about two months to get resolution. The doctors said the chemical levels in my body were very high. Late January I noticed a spot on my left nipple, and it was a little tender too touch. I started to experienced nipple discharge and pain around that area and that lasted throughout the month of February. My doctors are not allowing me to get another vaccine.
Information has been received from a Certified Medical Assistant (C.M.A.) referring to unspecified patients. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. On unspecified dates, the patients were administered GARDASIL (L039066, Expiration Date 19-MAR-2017; K011562, Expiration Date 08-APR-2017; dose, frequency and route unspecified). The GARDASIL had been exposed to temperature of 1 degree Centigrade, coldest temperature (incorrect product storage). The total cumulative time was unspecified. The reporter was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
30 S/P Administration of deployment vaccination patient began to feel lethargy, fatigue, HA, Mild vague abdominal pain, hoarseness, and diffuse trunk hive like rash. Transfers via POV to nearby clinic where monitor shows HOTN, Mild Hypoxia which continued to worsen which prompted Epi Pen Admin x1 at 0.3. EMS was consulted and he was transferred to ED where he was put under further observations and discharged 2 hours later. Dx w/ Anaphylaxis due to Vaccine, though unsure which one.
Twenty four hours after the vaccine developed chills, fever, nausea with vomiting severe fatigue with dizziness, joint pains, headache for 28 hours.
Patient stated she developed a circular rash at the site of injection evening post-injection. There were no additional symptoms to the rash (not itchy or painful). Rash slowly expanded the following day, Thursday 5/18/17, and felt warm on Friday 5/19/17. No additional symptoms upon report date of 5/20/17.
Discomfort; General body pain/Hurt all over body; Vaccination site pain/Arm hurt after covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Discomfort), PAIN (General body pain/Hurt all over body) and VACCINATION SITE PAIN (Vaccination site pain/Arm hurt after covid vaccine) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free, Solution for injection in pre-filled pen. On an unknown date, the patient experienced DISCOMFORT (Discomfort), PAIN (General body pain/Hurt all over body) and VACCINATION SITE PAIN (Vaccination site pain/Arm hurt after covid vaccine). At the time of the report, DISCOMFORT (Discomfort) outcome was unknown and PAIN (General body pain/Hurt all over body) and VACCINATION SITE PAIN (Vaccination site pain/Arm hurt after covid vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   On unknown dates, the patient experienced hurt all over body after covid vaccine, arm hurt after covid vaccine, discomfort a week before next injection and lack of ffect. On unknown dates, hurt all over body after covid vaccine and arm hurt after covid vaccine resolved. Moderna vaccine was also considered suspect.   It was unknown if patient was enrolled in a COVID-19 vaccine trial.   No treatment medication was provided.  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.
first dose 04Mar2018, has not received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 04th April 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. No vaccine details were provided. The reporter consented to follow up. This was one of 4 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019194737:same reporter US-GLAXOSMITHKLINE-US2019194733:same reporter US-GLAXOSMITHKLINE-US2019178991:same reporter
8/13/21:  20 min after injection, tingling, heavy, left arm, face, jaw, eye, congestion into left nostril, then into right nostril, left lateral calf tight.  Resolved about 2 hours later.  8/14/21:  awoke with right arm & fingers heavy, numb; pumped & moved fingers and arm with resolution in 15 minutes.  8/14-8/17 mild shortness of breath, contacted MD.  Deemed allergic reaction; used EPI Pen injection, started oral prednisone, benadryl.  8/22 not improved and went to hospital ER.  Had battery of tests with no result besides allergic reaction and referred to allergist.  Allergist consulted same week.
After 2 days 9/15/12 after school, had rash on knees, inner thigh & lower back (size of oatmeal grain) & small rash over all body. Pt went to the MD 9/17/12 MD confirm possible reaction on vaccine. Pt if followed up by MD right now, given prednisone.
Patient had headache, body aches, left arm pain, chills, fever (101 degrees) and fatigue for 2 days. Onset of symptoms were about 8 hours after the dose. He took Tylenol and symptoms improved.
Blue blotches over body, especially elbows, knees and hands with swelling and redness within 5 hrs of vaccination.
Rash to Upper Arms and Legs, pain to the touch, warm, red, sore, fever, seem to spread, sore under arm pits. Started Friday and is continuing today 08/31/2020, left arm does feel better. Patient had similar for 1st Shingrix shot but this is more severe.
arm swelled, big patch; broke out with all body rash; a lot of swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swelled, big patch), RASH (broke out with all body rash) and VACCINATION SITE SWELLING (a lot of swelling at the injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm swelled, big patch), RASH (broke out with all body rash) and VACCINATION SITE SWELLING (a lot of swelling at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (arm swelled, big patch), RASH (broke out with all body rash) and VACCINATION SITE SWELLING (a lot of swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
LESS THAN 5 MINUTES AFTER RECEIVING THE VACCINE, PATIENT FELT VERY LIGHT HEADED. SHE SAW BLACK SPOTS & HER HEARING WAS MUFFLED. SHE SAT BACK DOWN IMMEDIATELY. HER SKIN WAS WHITE WITH A GREEN TONE. BLOTCHY IN SOME SPOTS. SHE WAS ALSO SWEATING WITH CHILLS.  WE GAVE HER WATER & RICE CAKES THEN A PEDIALYTE POP. PATIENT FELT BETTER AFTER 3 GLASSES OF WATER AND AFTER 15 MINUTES HAVE PASSED. WE MONITORED HER FOR AN ADDITIONAL 15 MINUTES.  SHE LEFT THE PHARMACY WITH COLOR BACK IN HER FACE AND SWEATING HAD STOPPED ADVISED HER TO STAY HYDRATED & SEEK MEDICAL ATTENTION IF NECESSARY
Stabbing pains in right ear first; then, approximately 2 days later, stabbing pains in left ear.