chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Not adverse effect. The pt has h/o recurrent zoster with Zostavax didn't help. he came back with another episode of zoster
Immediately after vaccination, a small, hard knot began to form underneath the skin at the injection site. At 1 minute, it was noticeable by touch. At 10 minutes, it was about the size of a golf ball. At 15 and 20 minutes, it was still the size of a golf ball. Patient stated that he was slightly nauseated and a bit dizzy, but was okay otherwise. Patient wanted to go home after the 20 minute mark and left at that time. Nothing else was significant enough to report.
The evening when I had the vaccination when I went to bed, I had extreme pain going down through my whole body. My muscles and bones all the way down to my toes. I've never had anything like that before except when I had COVID-19, but it wasn't as severe at the time. This was a severe pain. This went on for 8-10 hours that evening. I have arthritis on the right side of my body with my right hip. I was walking with a limp at the time, and that has gotten worse. I wasn't sure if this was in relation to the vaccine or not. It's gotten to the point where by the end of September, I could hardly walk due to the problems with my right side. I was walking with a cane and it was still difficult to walk. I finally went to an orthopedic doctor and he prescribed physical therapy and it has helped, but it's still painful to walk. The only thing that changed was getting the vaccine prior to these health events occurring. I would say it has gotten a bit better, but I still have a ways to go with recovery.
Severe urticaria starting within 2 hrs. Treated with oral Benadryl and Prednisone.
concerned with the size of blood clots that were occurring; I started my menstrual cycle 25 days early; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Sep2021 12:45 (Lot number: ec3183) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: shell fish" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ew0169, Location of injection: Arm Left, Vaccine Administration Time: 10:45 AM), administration date: 02Sep2021, when the patient was 36 years old, for Covid-19 Immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 01Oct2021 16:15, outcome "recovered" (2021), described as "concerned with the size of blood clots that were occurring"; POLYMENORRHOEA (non-serious) with onset 01Oct2021 16:15, outcome "recovered" (2021), described as "I started my menstrual cycle 25 days early". Therapeutic measures were not taken as a result of menstrual disorder, polymenorrhoea.  Additional Information: It was reported that, Two days after my second dose, I started my menstrual cycle 25 days early. I had completed my previous menstrual cycle on 23Sep. This has never happened to me, i was also concerned with the size of blood clots that were occurring, as this was not normal for me. Patient was not diagnosed with COVID-19 prior vaccination. Patient has not been tested for COVID-19 after post vaccination. The patient received treatment for adverse events was no. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Follow-Up (27Oct2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
1) Rosacea - took oral and topical antibiotics & it cleared up 2) Frozen Shoulder - took x-rays, MRI & am now doing physical therapy 3) Period - had to go back to dr for an ultrasound which were negative
Tightness in chest, pain across chest and shoulders, hard to get a deep breath, and fatigue. Because I have had two past blood clots I decided I should get checked and I had heard about the possibility of clots with that particular vaccine. Dr. determined because of my past history I needed a D-Dimmer if that was elevated I would need an x-ray and CTA. The result was elevated so I did the other test. CTA was clear, but the x-ray found a small nodule on left lung.  I was told to start an aspirin regimen every day and take Ibprophen 4 times a day for a week to help inflammation in the lungs. After a week my breathing did improve. I still become winded at times. I was told to check on lung nodule again in 6 months.
got shingles years after the first shot,; Very very painful; got shingles years after the first shot,; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got shingles on the lower vaccination protection).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles, pain and incomplete course of vaccination. On an unknown date, the outcome of the shingles, pain and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient reported that, the very very painful,  get the vaccination he/she recommend it over being miserable with shingles. The patient stated that, he/she got shingles on the lower vaccination protection now this vaccination was higher protection for you 2 shots the old one was just one. The patient got shingles years after the first shot, because people come into grocery stores with everything all the time. Till the time of reporting, the patient did not receive the 2nd dose of Shingles vaccine, which led to incomplete course of vaccination.
Mom states pt had prolonged crying for 6 hrs p/DTP, starting 1.5 hrs p/inject; Mom reported this to MD, same PM; Seen by MD next day; MD prescribed DT injects;
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 78-year-old male patient who received SHINGRIX (batch number LT533, expiry date 10th November 2020). The patient's past medical history included shingles. On 10th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 10 days after receiving SHINGRIX, the patient experienced shingles, skin tightness, pruritus, boil and pain. On an unknown date, the outcome of the shingles, skin tightness, pruritus, boil and pain were unknown. It was unknown if the reporter considered the shingles, skin tightness, pruritus, boil and pain to be related to SHINGRIX. Additional details were provided as follows: About ten days later, the patient developed a case of shingles on my left forehead and scalp. The first symptom was an unusually feeling of tight skin and some itching in that area followed by an outbreak of boils. The patient received a prescription of VALTREX from the physician and the boils and scalps disappeared at the end of ten days. At no point was the condition particularly painful although the area was somewhat tender if I pressed it or slept with that side of my side on the pillow. The pharmacist told me that the 1st shot offered no protection and that the 2nd shot on schedule.
pt recv vax;devel swelling & red spots on rt hand;lab eval showed pt was neg for antibodies;f/u: second dose given w/ no problems;reporter felt sx must not be related to shot;
Patient is historian, called Clinic to report symptoms. Per patient, patient received Moderna vaccine on Thursday, 01/21/2021 in left deltoid, localized reaction of redness at around 5 pm on Friday with "bubbly blisters" similar to herpetic blisters at sight, heat, itchiness, and hard induration red in color with white rim about the size of her palm. Per patient, blisters were gone in the morning on Saturday with continuation of other symptoms. Per patient, she did take Benadryl every 12 hours until 2/8/2021 and in addition used topical cortisone anti-itch cream. Patient reports today, 02/11/2021 that the sight is not back to normal but the symptoms of itchiness, redness, heat, and induration are resolved.
103.1 fever, nausea, vomiting, total body ache/pain, fatigue lasting multiple days,   Fever broke with chills and cold sweat but then returned later. Neck has been sore and is still sore three days later. No stamina three days later.
Hospitalized (9.12.21);  COVID-19 positive (9.9.21);  fully vaccinated  History of Present Illness Patient is a 79 y.o. female with a PMHx of DM2, HTN,  who presents to hospital with shortness of breath.  The patient states that about a week ago she started having some sore throat and fevers and chills.  Patient reports some body aches.  About 3-4 days after that she started having some cough and shortness of breath.  Patient went to get tested for COVID and her test was positive.  It took about 3 days for her test results to come back, and by the time she got her test results she was having significant shortness of breath, continued fevers, and severe cough.  Patient denies any sick contacts, does not know where she contracted COVID from.  Patient denies any vomiting, but has had some diarrhea.  Her appetite has been poor.  Patient states she has had fever every single day at home.  Patient states that given her positive test and her worsening trouble breathing, she came to the ER for evaluation.  Patient is fully vaccinated. In the ER the patient was found to be tachypneic, weak, and hypoxic.  Chest x-ray was performed and showed bilateral diffuse infiltrate of disease consistent with COVID-19 pneumonia.  Patient was placed on high-flow nasal cannula with improvement in her overall work of breathing.  Given her significant hypoxic respiratory failure the patient was admitted the hospital for further treatment. Assessment and Plan   Acute hypoxic respiratory failure secondary to COVID-19 pneumonia -on HFNC 50% FiO2 -Symptom started on 9/5, day 7 of illness -Hypoxic -received decadron day 1/10 in the ER -remdesivir day 1/5 -would meet criteria for Tociluzumab, but not available -No MAB therapy -patient did receive Moderna x2 back in March/April -VItamin D 10,000 units now  - vitamin C 1.5g TID -zinc -wean O2 as able Notes from 9.17.21:  Chief complaint Pneumonia due to COVID-19 virus  Subjective 08:30 a.m. Patient seen and examined. Patient states she is feeling a lot better today on the nasal canula. Says her shortness of breath seems to be greatly improving.
Onset last pm with raised red rash on trunk. Has gotten worse today with areas the size of quarters with white "dots" in middle. Father says there are many varied sizes from small the quarter size. He says child is alert, active, and in no distress other than the rash. Was taken to pediatrician this am. Doctor feels that the rash is due to an allergic reaction to an immunization and placed the child on steroids.
Increased nasal congestion; mucous production; nasal mucous requiring frequent and productive nose blowing; It is an almost constant irritant; This is a spontaneous report from a contactable nurse, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL1283) via an unspecified route of administration in the left arm on 10Jan2021 at 12:15 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis (MS), gastroesophageal reflux disease (GERD) and seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received an unspecified medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH9899) via an unspecified route of administration in the left arm on 12Dec2020 at 00:15 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. On 17Jan2021 at 12:00, the patient experienced increased nasal congestion and mucous production which had continued for more than six weeks, with no other symptoms, no illness with just excessive nasal mucous requiring frequent and productive nose blowing and was almost constant irritant. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events increased nasal congestion, mucous production, nasal mucous requiring frequent and productive nose blowing, constant irritant were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Injected arm swollen, red, hot. Pt experienced light fever the night of injection.
Itching neck and shoulders. Hives neck, chin and posterior shoulder area and erythema. TX ER BENADRYL and steroid Rx.
Patient has a pea size nodule inferior to his clavicle on the right side. It appears to be a swollen lymph node but he will be seen by a MD for confirmation. He woke up the next AM with this present. It is painful to touch.
Numbness in the tongue; Numbness of the face; Headache; Numbness in the arm; A spontaneous report was received from a consumer concerning a 45-years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events numbness in the arm, numbness of the face, numbness in the tongue.  The patient's medical history was not provided. Concomitant medications was not reported.  On 20 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031L20A) via intramuscular route in his left arm for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient experienced the events numbness in the arm, numbness of the face, Headache. On 23 Feb 2021 she experienced event numbness in the tongue. Treatment included ibuprofen was provided by the reporter.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, numbness in the arm, numbness of the face, headache, numbness in the tongue were unknown at the time of this report.
Massive headaches, sore muscles, fatigue, nausea, Occasionally dizzy spells.
Exactly 12 hours after administration I experienced these symptoms: Exploding headache, nausea, vomiting, chills, fever, dizziness, unable to stand up I had a partial loss of consciousness with the exploding headache.  This lasted for 6 1/2 hours.  Then the headache diminished to that of a severe migraine and I regained full consciousness.  Over the course of another 12 hours I gradually improved so that 24 hours after onset of severe reaction I could stand up, move around, and eat a little.  Some symptoms such as extreme fatigue and brain fog lasted for another week.     I have never had a headache like that and I hope I would never experience anything like that again.
Rash and itching first at the injection site and then over most of body- still itching after 2nd dose on 2/23/21
fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included TOFACITINIB CITRATE (XELJANZ) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown.            No treatment information was provided   Reporter did not allow further contact
painful muscle spasms; prevent from walking; knee pain; chills; back pain moved down into groin and then into thigh; back pain moved down into groin and then into thigh; back pain moved down into groin and then into thigh; This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th July 2019, the patient received Shingrix (intramuscular). On 20th July 2019, less than a day after receiving Shingrix, the patient experienced chills, back pain, pain in thigh and groin pain. On an unknown date, the patient experienced muscle spasm, unable to walk and knee pain. On an unknown date, the outcome of the chills was recovered/resolved and the outcome of the back pain, pain in thigh, groin pain, muscle spasm and unable to walk were not recovered/not resolved and the outcome of the knee pain was unknown.   It was unknown if the reporter considered the chills, back pain, pain in thigh, groin pain, muscle spasm, unable to walk and knee pain to be related to Shingrix.  Additional details were provided as follows: The patient was the reporter's husband. The reporter reported that, when the patient came back to home, experinced chills and back pain. The chills resolved after 24 hours, but the back pain moved down into his groin and then into his thigh. The patient had painful muscle spasms, that prevent him from working.
On 3/14/08 AM noted L arm had redness, warmth & swelling.  Child had difficulty raising arm.  Taken to ER 3/14 PM.  Area of redness measured 3" wide x 6" long.  Child was given Benadryl and put on prednisone x 4 days.  Talked with pt on 3/17 & child doing okay now.  Maybe a little swelling left in arm.
Pt recv vax on 10/28/98; on 11/2/98 pt exp swelling on left side of lip, unable to blink or close left eye, increased left side facial droop; dx=Bell's Palsy
cold sensation in back of head; trouble breathing; lightheadedness; racing heart; anxiety; This is a spontaneous report from a contactable nurse (patient).  A 35-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231, expiry date: unknown), via an unspecified route of administration on 09Jan2021 10:00 at single dose (Left arm) for COVID-19 immunization. Medical history included Infertility, IVF, known allergies: Penicillin. Patient is not pregnant. There were no concomitant medications.  Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. While driving home the patient experienced cold sensation in back of head, trouble breathing, lightheadedness, and racing heart. Paramedics called. Patient was better after 30minutes. They thought it was anxiety. They were asking if it was safe to get 2nd vaccine. The patient did not receive any treatment. Patient experienced the events on 09Jan2021 10:30.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included heart rate: racing heart on 09Jan2021. Outcome of the events was recovered on an unspecified date.
Patient got her COVID Vaccine on 2/9, on 2/13 she started having nausea, diarrhea, bad back pain, fever, chills, and a stuffy nose. Patient was on her way to the ED when we spoke 2/15. Patient was going to have them look at her because of her sx. Patient started with chills and diarrhea throughout the night.  Fever went up to 100.2 seem to break a little with Tylenol. Still warm to the touch.  Achy, diarrhea,  nausea, headache, dizzy. Had 2nd shot Tuesday night 2/9 no apparent symptoms.  Just tender at injection went away in 12 hours.
pain in my neck; neck there was a swollen, reddish lump near the chest bone on the right side; neck there was a swollen, reddish lump near the chest bone on the right side; neck there was a swollen, reddish lump near the chest bone on the right side; fever; sleepy; pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy), PAIN IN EXTREMITY (pain in arm), NECK PAIN (pain in my neck), SWELLING (neck there was a swollen, reddish lump near the chest bone on the right side) and ERYTHEMA (neck there was a swollen, reddish lump near the chest bone on the right side) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced SOMNOLENCE (sleepy), PAIN IN EXTREMITY (pain in arm) and PYREXIA (fever). On 16-Mar-2021, the patient experienced NECK PAIN (pain in my neck), SWELLING (neck there was a swollen, reddish lump near the chest bone on the right side), ERYTHEMA (neck there was a swollen, reddish lump near the chest bone on the right side) and MASS (neck there was a swollen, reddish lump near the chest bone on the right side). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. On 15-Mar-2021, PYREXIA (fever) had resolved. At the time of the report, SOMNOLENCE (sleepy), PAIN IN EXTREMITY (pain in arm), NECK PAIN (pain in my neck), SWELLING (neck there was a swollen, reddish lump near the chest bone on the right side), ERYTHEMA (neck there was a swollen, reddish lump near the chest bone on the right side) and MASS (neck there was a swollen, reddish lump near the chest bone on the right side) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use included unspecified high blood pressure medication.  Reportedly, next to the patient's lump, she has a ball that upon touching moves inside. The patient stated that she is not going for the second dose.
This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. Past medical history and concurrent conditions were not reported. On unspecified dates in 2013, the patient received complete set of 3 doses of GARDASIL 1 vial of 1. intramuscular route (dose, strength, vaccination site. #lot, expiry date unspecified). Concomitant medications were not provided. On 31-DEC-2015, the patient received another dose of GARDASIL 1 vial of 1, intramuscular route (dose, strength, vaccination site, #lot, expiry date unspecified). No product quality complaint (PQC) was reported. There was no known adverse effects. No further information was provided. Additional information has been requested.
Woke up the next morning (Saturday) with extreme localized pain at the base of my spine. As I got up and moved around, the pain spread laterally. Pain increased during the day to the point that unnecessary moving wasn't really an option. I finally went to the ER on Monday because the pain had not abated and nothing I did (pain reliever, ice/heat) reduced it. I got an MRI in the ER which showed some swelling but no damage or explanation for the pain. I was prescribed something which I started  taking immediately.  By Tuesday evening things had improved, but the pain didn't go away completely until Friday.