chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician through a Merck pregnancy registry concerning a 37 year old female with a penicillin allergy who on 05-JUL-2006 was vaccinated subcutaneously with a dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included prenatal vitamins (unspecified). On 27-JUN-2006, the office asked the patient to take a pregnancy test prior to vaccination. The patient did not take a pregnancy test prior to vaccination and was vaccinated on 05--JUL-2006. On 12-JUL-2006, a urine pregnancy test was positive. Unspecified medical attention was sought. At the time of this report, the pregnancy was not confirmed by a blood test. Date of LMP was reported as 01-JUN-2006. Estimated date of delivery is 08-MAR-2007. Follow-up information indicated that on 28-JUL-2006, an ultrasound was performed to confirm the patient's pregnancy. The result of the ultrasound indicated an 8 week EGA. The patient had no previous pregnancies. There was no maternal adverse event to the vaccine. No local reaction at the vaccination site, no chickenpox symptoms post vaccination, and no herpes zoster symptoms post vaccination. It was also reported that the patient was test for varicella antibodies before vaccination, the results were not reported. Further follow-up information was received from the physician and a nurse who reported that the patient underwent a level II ultrasound which revealed pyelectasis but then it resolved. On March 7, 2007, the patient delivered a healthy normal female infant. No Further information is expected.
AFTER RECEIVING VACCINE, PATIENT REPORTED THROAT SWELLING/TIGHTNESS, BROUGHT TO OBS VIA WHEELCHAIR AT 09:10. STATES THROAT SWELLS WITH MOLD AS WELL. VSS THROUGHOUT OBSERVATION. DENIED SOB, EVALUATED BY ON-SITE MD, NO WHEEZING NOTED. COLD WATER GIVEN, PATIENT STATES THROAT SENSATION UNCHANGED AND NOT WORSENED THROUGHOUT MONITORING TIME. INSTRUCTED TO SEEK FURTHER EVAL/TREATMENT IF SYMPTOMS PERSIST/WORSEN. ESCORTED TO EXIT WITH NO FURTHER ISSUES AT 09:30. 09:10 INITIAL BP 116/77; HR 99; SATS 99% RA; 09:17 BP 118/78; HR 85; SATS 97% RA 09:25 BP 135/87; HR 89; SATS 98% RA; 09:30 BP 124/86; HR 90; SATS 99% RA.
Fever more than five degrees above normal with acetaminophen , chills, nausea, headache, light headed, fatigue.
Fevers, myalgias, localized erythema and swelling. Improved with ice and seen by physician on 09/27/16.
Patient c/o left arm pain with swelling and redness. Given 25mg BENADRYL by mouth.
Flushed, itching, Rash on face, neck, chest and back, palpitations and elevated blood pressure; Treatment: oral benadryl and IV drip with benadryl.
She got her vaccine, she did not have any issues.  By the end of the month she was driving and her knees were burning while she was driving back and did let up.  She then went to Dr. (Orthopedic surgeon) in April and he sent her to PT.  The knee began to buckle on her and he felt that it was a meniscal issue.  In the meantime her left breast went numb, her armpit went numb, and he put that on a back burner as he wanted her knee to be addressed.  On 7/16/21 she had a medial meniscal repair.  She went back to him as her knee was still buckling after the surgery, and he watched her walk and said that was her back.  She went to Dr. (orthopedic spine surgeon) and also to Dr. at Medical Center who gives injections in the back and did an MRI to look at her thoracic area, and found lesions on her back . She had a CT scan in 2017 and had nothing in her back at that time.   She went to an MS center and they decide that she has a virus that is causing her issue and they do not believe it's MS due to her age and the clean MRI that she had in 2017.  She had a Rotuxan infusion to slow the lesions down in her spine, 6 hours of infusion in June of 2022.  Now she is due to get one this coming Wednesday 12/14/22.  Her doctor told her to go to the Clinic who had the same symptoms as she had and she went to the Clinic.  They told her that they think it was MS.   This is all after the vaccine, and it's going to limit her from walking.  Her friend has lost her hair due to the vaccine.  Down at s Hospital.  The infusions are scaring her but she does not know what else to do.  MS care center at Hospital is where she has been seen.  She saw Dr. (neurologist).  She saw Medical Center who she went to first who did not think this was MS and needed to go where to go, Dr. at Medical Center Neurology.  They all tell her that COVID could cause the lesions, but she has never had COVID.  She did get her 1st booster on 12/30/21, Moderna, LOT#059H21A.  She retired in 2010 and was healthy and since March of 2021 getting the vaccine her health has been declining.  She is talk to the Clinic in January as to how this infusion is going to go for her, and she does not know what will happen again.  She said that Clinic and Pittsburgh can argue if it is MS or not.  The meds for MS are different than what they are treating her with.  She thinks they will probably do another MRI to keep a look at the lesions in her spine, and if they keep them inactive and does not have more then feels that they may not have to get the Retuxan.  She had bands in her spine to signify MS but she also had them in her blood which is unusual.  She also had 2 spinal taps and said that's when they said that she had gotten a virus which had caused the issues.  IgG bands.
Started Monday afternoon, had a local reaction that has spread down the left arm. Temp has increased 102 for 2 days. States she has somewhat recovered but feels "different."
This spontaneous report was received from a medical assistant concerning 10 unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, via intramuscular, lot # M033583, expiration date: 14-APR-2019, as prophylaxis (Strength and dose were not reported), which experienced a temperature excursion between 47 and 77 Fahrenheit degrees for 2 hours. There were previous temperature excursions. Digital data logger was involved. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
pt recv vax 29JAN97 1012AM;pt devel hives on face, back & arms @ 1020AM;epi given;pt transported to ER by amb;
Palpitations, near syncope Vertigo/dizziness nausea, no vomiting Evaluated in emergency department.  EKG, CT negative. Given IV Fluids, Antivert, phenergan, improved, sent home
Baby was seen on 4/12/19 in AM for vaccines. Next day (Saturday) baby developed hives all over No other changes in diet. Next day (Sunday) went to ER -> given Benadryl. On 4/16/19 was seen in our office, still with same hives; was Rx cetirizine. No changes in diet, no inject site.
Initial tingling in tongue  High heart rate  High blood pressure  Insomnia  Swollen painful lymph node
Vaccine was used past beyond use date.  Beyond use date was 1/23/22, 12:45pm.  Vaccine was used in the morning or 1/24/22.  No adverse event reported.
Head to toe hives. Patient saw a nurse practitioner on 10/19/2015 and was treated with a prednisone decreasing dose pack for 2 weeks.
nephritis; Very very unusual drop in kidney function; Stage 3 kidney disease; This spontaneous case was reported by a consumer and describes the occurrence of NEPHRITIS (nephritis), RENAL IMPAIRMENT (Very very unusual drop in kidney function) and CHRONIC KIDNEY DISEASE (Stage 3 kidney disease) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEPHRITIS (nephritis) (seriousness criterion medically significant), RENAL IMPAIRMENT (Very very unusual drop in kidney function) (seriousness criterion medically significant) and CHRONIC KIDNEY DISEASE (Stage 3 kidney disease) (seriousness criterion medically significant). At the time of the report, NEPHRITIS (nephritis), RENAL IMPAIRMENT (Very very unusual drop in kidney function) and CHRONIC KIDNEY DISEASE (Stage 3 kidney disease) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Glomerular filtration rate: 62 (normal) 62. On 26-Jul-2021, Glomerular filtration rate: 48 (Low) eGFR was down to 48.         No concomitant medical information were reported. No treatment information was reported.  Company Comment: Very limited information regarding these events have been provided at this time. Other factors may have contributed to the low eGFR as 5 months have passed since patient received last dose of vaccine. Further information has been requested.; Sender's Comments: Very limited information regarding these events have been provided at this time. Other factors may have contributed to the low eGFR as 5 months have passed since patient received last dose of vaccine. Further information has been requested.
Pt was given a ZOSTAVAX shot on 12/19/12. She presented today 12/21/12 at counseling window of pharmacy and made employee and I aware of the reaction she had experienced from this vaccine injection. Pt stated that after shot was given that she began to hurt at the injection site. She explained that the pain.
Patient stated that she felt like she was going to pass out and began hyperventilating for roughly 20 seconds. Patient leaned back in chair and closed eyes for about 5 seconds before sitting up straight and stating that she "felt much better." Patient was given a bottle of water and cold compress. Heart rate at that time was 65 bpm. Patient reports severe generalized anxiety, especially to needles. She was observed in waiting area for 30 minutes before leaving with her mother
Reproducible shortness of breath with AVA #1 and #2. 02/03/03: The day of injection he developed a painful knot in the vaccinated arm the size of a quarter. Within 2 days his entire upper arm and left axilla was exquisitely painful and prevented exercising for 2 weeks.  Within 2 days he developed chest pain that increased in severity with taking a deep breath. He felt he could only do "shallow breathing" otherwise the pain would worsen. The pain did not worsen with lying down but he cannot remember the exact location of the pain. He was not involved in any physical training during this time. He had no other systemic symptoms and is unsure as to the specific onset and duration of symptoms.  All symptoms resolved. 02/27/03: Developed more severe local reaction than from previous AVA to include painful swelling. Remembers being unable to exercise for 4 weeks due to arm pain. Within 2 days of shot (but not within the 1st few hours), he experienced chest pain that interfered with his ability to take a deep breath and some shortness of breath significantly greater intensity that with AVA #1; "It scared me". He had shortness of breath at rest as well as during activity. He also developed headache, fever, nasal congestion and some generalized muscle aches but stated this was "different from a cold."  He sought medical attention by the 4th day. He and his crew were grounded for 4 days due to his symptoms.  Systemic symptoms lasted about 1 week, then resolved without sequelae. Others in his unit had some symptoms but not like his and there was no indication of upper respiratory viral infection among his unit.  A medical visit 03/27/03 details service member's concerns about receiving his 3rd AVA due to "localized swelling of the soft tissue in the deltoid areas with significant tenderness...body malaise, generalized weakness, especially of the upper extremities...he also had difficulty of breathing." Following #1 and #2.  He was issued a "deferment of the 3rd shot of AVA."
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of IMMUNE SYSTEM DISORDER (vaccine has turned on my immune system), JOINT STIFFNESS (Joint stifness), OFF LABEL USE (Second dose is 38 days outside the recommended dosing interval), PYREXIA (Fever) and HEADACHE (Headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B210A4 and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Seasonal allergy. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache), ARTHRALGIA (Pain and aching in the leg hip joints and shoulder) and MYALGIA (aching in the leg hip joints, muscles, and shoulder). In April 2021, the patient experienced OFF LABEL USE (Second dose is 38 days outside the recommended dosing interval), FATIGUE (Fatigue) and ARTHRALGIA (Pain and aching in the leg hip joints, muscles, and shoulder). On an unknown date, the patient experienced IMMUNE SYSTEM DISORDER (vaccine has turned on my immune system) and JOINT STIFFNESS (Joint stifness). The patient was treated with IBUPROFEN at a dose of 600 mg every eight hours; IBUPROFEN at a dose of 400 mg four times per day; PARACETAMOL (TYLENOL) at an unspecified dose and frequency; PREDNISONE on 16-Apr-2021 at a dose of 10 mg; 6 days; PREDNISONE at a dose of 40 mg; 5days; PREDNISONE at a dose of 30 mg; 5 days; PREDNISONE at a dose of 20 mg; 5days; PREDNISONE at a dose of 10 mg; 5 days and TRAMADOL at a dose of 50 mg every eight hours. At the time of the report, IMMUNE SYSTEM DISORDER (vaccine has turned on my immune system), JOINT STIFFNESS (Joint stifness), OFF LABEL USE (Second dose is 38 days outside the recommended dosing interval), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Fatigue), ARTHRALGIA (Pain and aching in the leg hip joints and shoulder), MYALGIA (aching in the leg hip joints, muscles, and shoulder) and ARTHRALGIA (Pain and aching in the leg hip joints, muscles, and shoulder) outcome was unknown. Action taken with mRNA-1273 in response to the event was not applicable. This case was linked to MOD-2021-085643. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Added patient's demographic, treatments and events.
Excruciating pain in right arm along with weakness and inability to move arm away from body without extreme pain. Some shooting neurological symptoms in right hand.  And muscle aches along entire arm.
8/30/99 pt got MMR-rt tricep/sc       9/5/99 pt got itchy rash on face, upper trunk, worst at site sc injection.  Seen by dr 9/9/99.
Employee received the flu vaccine on 10/08/2018. On 10/10/2018, employee noticed an itching rash to right upper arm where injection was given. Employee stated rash was from the top of his arm down to his elbow. He was seen in Employee Health on 10/17/2018 and at that time there was a reddened raised area, approximately one inch in diameter, noted to the right upper arm. Employee complained of itching and stated he had not had any pain or fever. He was sent to Dr. and he advised employee to take ZYRTEC OTC.
Received the janssen vaccine at 0930 at a pharmacy. Was invited to play basketball by my colleagues at 1630 and decided to partake. I am very well conditioned, in my mid thirties, and play basketball frequently. I rarely every throw up, have never had a seizure and have never blacked out. We were on our second game and all of the sudden I started feeling my heart race. I couldn?t catch my breath, my stomach began to wrench and I ran to the side of the court and vomited multiple times. I then began to develop tunnel vision, numbness in the right side of my face and top of my head and collapsed. While on the ground I can remember being in and out of consciousness, I was seeing red and black strobes and having uncontrollable movements in all my limbs, I had a seizure. I came back to consciousness only to immediately begin vomiting again and then passed out. My colleagues realized I was in distress and carried me to a building absolutely shocked at the adverse reaction I just endured. I then proceeded to vomit two more times and collapsed again. Three hours later my hands remain numb, the top of my head is still numb, my body is tingling with a pins and needle sensation, I am dizzy, have no appetite and blurred vision and a hellacious  migraine.
Pt stated that she felt cold about 10 minutes after the vaccine administration.  She was anxious before the shot.  Her blood pressure was taken and it was 137/93.  She stated that she had no hx of hypertension.  Since cause of hypertension could not be determined related to vaccine or underlying condition(s), it was recommended that she contact her PCP for evaluation.
Information has been received from a certified medical assistant concerning a 17 year old female with seasonal allergies, glucose intolerance and penicillin allergy who on 06-DEC-2006 was vaccinated IM 0.5 mL, first dose , with Gardasil (lot#653978/0955F). The patient received her second vaccination IM 0.5mL of Gardasil (lot#653978/0955F) on 26-FEB-2007. There was no concomitant medication. On 27-FEB-2007 the patient experienced fatigue and widespread joint pain. No adverse event was reported on the first vaccination. The patient sought unspecified medical attention. Additional information has been requested.
ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 32 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: 25-MAY-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced administered expired vaccine. The action taken with covid-19 vaccine  was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210551574 and 20210554431.
I developed Shingles with the rash on my lower left back and small rash on my stomach
Patient received 4 immunizations on 8/7/98.  Mother called after hours nurse on 8/8 to report her daughter had developed a reaction on her right leg. At the site of the injection was an egg sized swelling that was red and warm to the touch.  Pt. used Ibuprophen and ice to the site
a sore in her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 91-year-old female patient received BNT162b2 (BNT162B2), on 31Mar2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 90 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Pfizer Covid vaccine: 23Jan2021, Lot: EL9262, She read from the vaccine card: , administration date: 23Jan2021, when the patient was 89-year-old, for COVID-19 immunization, reaction(s): "A sore in her arm"; BNT162b2 (Dose 2, Pfizer Covid vaccine: 13Feb2021, Lot: FM9810, She read from the vaccine card:  then something after it but cannot make out what it is, might be a O or Q after MSBI.), administration date: 13Feb2021, when the patient was 89-year-old, for Covid-19 immunization, reaction(s): "A sore in her arm"; BNT162b2 (Dose 3, Pfizer covid vaccine: 25Aug2021, Lot: FA7485), administration date: 25Aug2021, when the patient was 90-year-old, for COVID-19 immunization, reaction(s): "A sore in her arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "a sore in her arm".
complicated by post herpetic neuralgia; diffuse large b cell lymphoma; shingles; suspected vaccination failure/ shingrix vaccine on 13Jun2020, shingles on 29Mar2021; This case was reported by a physician via other manufacturer and described the occurrence of suspected vaccination failure in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included tofacitinib citrate (Xeljanz) tablet for ulcerative colitis.   Concurrent medical conditions included ulcerative colitis.   On 13th June 2020, the patient received Shingrix. On 9th June 2020, the patient started Xeljanz 5 mg twice daily (10 mg daily). On 29th March 2021, 289 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria hospitalization, GSK medically significant and other: Medically significant) and shingles (serious criteria hospitalization and other: Medically significant). On 15th June 2021, the patient experienced diffuse large b-cell lymphoma (serious criteria hospitalization, GSK medically significant and life threatening). On an unknown date, the patient experienced post herpetic neuralgia (serious criteria hospitalization). The patient was treated with prednisone and steroids nos (Steroids). The action taken with Xeljanz was unknown. On an unknown date, the outcome of the vaccination failure and post herpetic neuralgia were unknown and the outcome of the diffuse large b-cell lymphoma was resolved with sequelae and the outcome of the shingles was recovered/resolved.   The reporter considered the vaccination failure, diffuse large b-cell lymphoma and shingles to be related to Shingrix. It was unknown if the reporter considered the post herpetic neuralgia to be related to Shingrix.  Additional details were provided as follows: The reporter was a gastroenterologist. The patient had no history of lymphoma. 445 days after receiving the first dose of Xeljanz, the patient was diagnosed with shingles and 367 days after receiving vaccination and 372 days after receiving the first dose of Xeljanz, the patient had diffuse large b-cell lymphoma. On an unknown date, less than 2 years after Shingrix and Xeljanz, diffuse large b-cell lymphoma was complicated by post herpetic neuralgia. The patient had multiple hospitalization with biopsies, etc. The patient did end up recovering with treatment. The patient was also taking steroids and prednisone but did not felt they were relevant. Medical test results were stated as just pertaining to his diagnosis. The reporter did not wish to provide his complete mailing address. The reporter considered the diffuse large b-cell lymphoma and shingles to be related to Xeljanz. It was unknown if the reporter considered the post herpetic neuralgia to be related to Xeljanz. The reporter consented to follow up. No further details were provided. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.
Patient was given vaccine from a vial that had been punctured for more than 6 hours. Spoke to client 10/14/21 via telephone. Client denied any adverse signs or symptoms besides a sore arm at administration site.
day p/vax unable to move rt leg;one episode of emesis;seen @ clinic given ATB for throat infect;rt leg flaccid would not hold weight on rt leg;felt aseptic meningitis poss r/t leg paralysis;paralysis d/t osteomyelitis or toxic synovitis;