chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arthritis; This is a spontaneous report received from a contactable Other HCP reported for himself. This 62-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 23Mar2021 13:00 (Batch/Lot Number: ER2613) as single dose for covid-19 immunisation. Medical history included have been recovering from reactive arthritis since very late 2016, had Still's disease in 1989 and had allergy to lisinopril. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen; losartan; alfuzosin; lansoprazole. A couple of days after the vaccination on 26Mar2021, his arthritis (primarily, but not entirely joints related to the reactive arthritis rather than the Still's) started becoming much more painful. This grew quite intense about 10 days after the vaccination. At that time he increased hgis daily intake of ibuprofen from two 200 mg pills per day to four 200 mg pills (two pills twice per day). This has stabilized the condition. When the reactive arthritis began several years ago, he was taking eight pills per day and had gradually brought it down to two pills, and he had no real discomfort at the time of vaccination and was planning to drop the dose again. The patient have never had to increase the dosage in the past except for cases when he was slowly reducing the dose, would try a new lower dose and would decide he was not quite ready. The patient have never before had to increase the dose from a stable level. The event result in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Set you back, misery; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling miserable in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of feeling abnormal (on an unknown date patient received 1st dose refer link case US2023AMR034523).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling miserable (Verbatim: Set you back, misery). Rechallenge with Shingles vaccine was positive. The outcome of the feeling miserable was not reported.   It was unknown if the reporter considered the feeling miserable to be related to Shingles vaccine.     It was unknown if the company considered the feeling miserable to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR034523   Additional Information: GSK Receipt Date: 01-MAR-2023 This case was reported by a patient via interactive digital media. The patient just had second of two shots and they set you back a couple days, but patient never want to be in that kind misery again. Follow-up would not possible as no contact details were available. This case had been linked with US2023AMR034523 by same reporter for same patient.; Sender's Comments:  US-GSK-US2023AMR034523:Same reporter
DISTURBED SLEEP; BAD HEADACHE; CHILLS; MILD FEVER; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, the patient experienced chills. On APR-2021, the patient experienced mild fever. On an unspecified date, the patient experienced disturbed sleep, and bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and mild fever, and the outcome of disturbed sleep and bad headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210925695.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case was assessed as non-serious.
I did not personally witness the patient's reaction, so everything that follows was reported by another patient sitting next to him.  We heard that he briefly lost consciousness and possibly had a seizure.  Possibly muscle "twitching".    A few moments later we attended to the patient and he was fully conscious and alert.  Said that he hadn't eaten yet today and that it might be related.  He was sitting upright in a chair and said that he had no seizure history.  The patient received water and power bars during observation.  He did express that he was nervous about getting a shot.  Another patient called emergency services and they took him outside of the building for assessment.  He did not appear to be in any distress at the time he left our facility.
SI joint pain   left hip and back pain  pain medication  gabapentin  joint pain worsen - may have to do an injection to the SI joint.
Suspect Breakthrough Case  Ascorbic acid, Tylenol, Zinc  Inpatient
Information has been received from a physician concerning a 22 year old female with no medical history who was vaccinated with her first (lot# 658222/0927U), second (lot# 658222/0927U) and third (lot# 659964/1978U) dose of GARDASIL on 22-AUG-2007, 08-SEP-2007 and 19-MAR-2008, respectively. On 04-MAY-2009 the patient was diagnosed with high grade squamous intraepithelial lesion carcinoma in situ after a PAP test. The patient had a LEEP Procedure done on 15-MAY-2009. The patient sought unspecified medical attention. Additional information received via telephone from a medical assistant on 19-MAY-2009. Medical assistant reported that the patient's second dose of GARDASIL was administered on 08-NOV-2007 (not 08-SEP-2007 as previous reported). There were no concomitant vaccines administered with GARDASIL vaccinations. The medical assistant confirmed that the patient had a PAP smear test on 04-MAY-2009 and had a LEEP on 15-MAY-2009. The reporter did not know the patient's recovery status. The patient did not have a scheduled follow up visit with physician at the time. The reporter considered high grade squamous intraepithelial lesion carcinoma in situ to be an other important event and disabling. Additional information has been requested.
In the evening the day "I" received the vaccine "I" felt itchy all over "my" body; Since then, "my" neck continues to be itchy and "I" have developed a rash; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 08Apr2021 at 08:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included abdominal adhesions and related pain, and allergy to avocado. 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 did not receive concomitant medication. On 08Apr2021 at 17:00, in the evening of the day of vaccination, the patient had felt itchy all over her body. Since then, her neck continued to be itchy and she developed a rash. 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 outcome of the events felt itchy all over body; since then, neck continued to be itchy and developed a rash was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
I woke up with a swollen and red and itching around the injection site one week after getting the Moderna COVID 19 Vaccine .  I'm taking Benadryl, icing the area, and using benadryl gel.  I read online that this is considered COVID arm and is "delayed cutaneous hypersensitivity" according to what I've read.  Supposedly this should subside within 2 days....
Moderna Arm: Patient's left arm below the injection site became very swollen, red and hard to the touch. This did not resolve after 10 days. Patient went to doctors office and back here to the pharmacy to show us her arm. She was treated for an allergic reaction with possible cellulitis.
Generalized rash; Red, hard, circle approximately 3 inches in diameter at injection site; Red, hard, circle approximately 3 inches in diameter at injection site; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6201; Expiration date were not reported), via unspecified route of administration in the left arm on 26Feb2021 as first dose, single dose for COVID-19 immunisation at a Pharmacy or Drug Store. Medical history included glaucoma, hypertension (HTN), mild COPD and Penicillin (PCN) allergy; all from an unknown date and unknown if ongoing. Concomitant medications included aliskiren fumarate (TEKTURNA) taken for an unspecified indication, start and stop dates were not reported. The patient previously took vancomycin and experienced drug allergy. The patient was not pregnant at the time of vaccination. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. On an unspecified date (reported as one week after the injection), the patient experienced generalized rash. On 12Mar2021 07:00 AM (reported as two weeks after injection), the patient also experienced red, hard, circle approximately 3 inches in diameter at injection site occurred on left arm. No treatment was taken for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse concerning a 19 year old female patient with a history of mononucleosis at age of 15 who on 16-MAR-2009 was vaccinated with her first dose of GARDASIL (lot # unknown). The patient experienced soreness at the injection site the day the vaccine was administered on 16-MAR-2009. The patient was experiencing difficulty breathing, hear rate of 90-100, flushed face, weakness, fatigue, "air hunger" or claustrophobic feeling and severe headache on 25-MAR-2009 9 days after her vaccination. The patient had visited the physician's office for medial attention. The only medication the patient was on was ZOVIA (manufacturer unspecified) for the completion problems and painful menstrual cycles. The patient never had any heart rate problems or headache before. At the time of reporting the patient's difficulty breathing and heart rate of 9--100 and flushed face and weakness and fatigue and "air hunger" and claustrophobic feeling and soreness at the injection site and severe headache persisted. Additional information has been requested
Information has been received from a physician concerning a 15 week old male who on 31-MAY-2007 was vaccinated with Rotateq (Lot# 656833/0407U). Concomitant therapy included Pediarix, Hib conj vaccine (unspecified carrier) and Prevnar. The physician reported that the child was vomiting profusely on the morning of 09-JUL-2007 and was taken to the hospital. The physician reported the child was transferred to another hospital. The child was found to have an intussusception. The physician reported that the patient sought medical attention to prevent serious criteria and was hospitalized because of the experience. Additional information has been requested. 8/8/07-records received from transferring facility for DOS 7/9/07-C/O vomiting.  8/24/07-records received for DOS 7/10-7/20/07-DX: Intussusception. Pyelonephritis. E.coli sepsis/bacteremia. Small bowel-small bowel intussuception noted not reducible by hydrostatic enema. Small bowel resection with anastomosis and incidental appendectomy. Post operative day 2 high fevers noted and urinalysis revealed urinary tract infection. 8/8/07-records received from transferring facility for DOS 7/9/07-C/O vomiting. HX reflux. 8/24/07-records received for DOS 7/10-7/20/07-DX: Intussusception. Pyelonephritis. E.coli sepsis/bacteremia. Gastrographin enema: intussusception. Small bowel-small bowel intussuception noted not reducible by hydrostatic enema. Small bowel resection with anastomosis and incidental appendectomy. Post operative day 2 high fevers noted
pt recvd vax;devel fever,muscle aches & redness at inject site;devel sore arm w/o swelling or erythema;fatigue;
No adverse effect; Expired vaccine used; This spontaneous report was received from a nurse refers to a 18 years old patient. The patient's concurrent condition, pertinent medical history, drug reactions/allergies were not reported.    On 27-JUN-2019, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA), vial (strength, dose was unknown) via intramuscular route, lot # r013858, expiration date of 27-JUN-2019 for prophylaxis. On 27-JUN-2019, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) (expired product administered). No adverse events were reported. No product quality complaint was involved. The outcome of expired product administered was unknown.  Lot No. r013858 has been verified to be a valid lot number for [hepatitis a vaccine, inactivated], expiration date reported as 27-JUN-2019, but upon internal validation established as 12-JUN-2019.
Lt arm 3x3in induration. Itchiness, swelling, pain. Improved with MOTRIN.
not feeling right.; Vertigo; Motion sickness; dizzy; 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 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 (Lot number: ER8730) at the age of 80 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "vertigo" (unspecified if ongoing); "headache" (unspecified if ongoing); "Parkinsons" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 30Mar2021, outcome "recovering", described as "dizzy"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "not feeling right."; VERTIGO (non-serious), outcome "unknown", described as "Vertigo"; MOTION SICKNESS (non-serious), outcome "unknown", described as "Motion sickness". Therapeutic measures were taken as a result of dizziness, vertigo, motion sickness.  Additional Information: Action(s) taken with drug was Unknown. None history of all previous immunization with the Pfizer vaccine considered as suspect. None additional vaccines administered on same date of the Pfizer suspect. Any AE(s) doesn't required a visit to Emergency Room or Physician Office. None prior Vaccinations (within 4 weeks). None AE(s) following prior vaccinations. No Patient's Medical History (including any illness at time of vaccination. No Relevant Tests.  No follow-up attempts are possible. No further information is expected.
Immediate pain & redness at injection site, worsening over 48 hours; body aches and fatigue within 24 hours; fever and headache within 36 hours and other symptoms persisted. Patient saw doctor at Clinic on 6/3/18...prescribed ibuprofen, fluids, rest. Symptoms persisted through 6/3/18 and patient woke much better on 6/4/18. Possible cellulitis at injection site and headache are still persistent.
This spontaneous report as received from a physician refers a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 21-OCT-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (dose, frequency and route were not reported) lot # L002213, expiration date 21-JUL-2016. No adverse effects have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Whole body aches, anxiety, high Cholesterol, concentration difficulty, constipation, cramps arms, depression, digestive problems, dry mouth, energy loss, muscle fatigue and pain, fever, headaches continuous, impotence, sleep insomnia, joint pain strong, hepatitis (liver enzymes), memory loss, mood; anxious, nervousness (anxiety), numbness and tingling: fingers, arms, legs and abdominal, lower back pain (scale 10), pain: knees, ankles, muscle and joint, sensitivity to chemicals, sinusitis, skin discoloration, sleep problems, suicide attempt, TENS needed for pain control (I have one), vision problems, weakness.   2/27/09 MR received for multiple visits 2006-2008. DX:  Hypercholesterolemia, Microhematuria, Accident caused by burning materials, substance use and abuse, redness or d/c of eye, pinguecuela, opiod dependance, nicotine dependance, cocaine dependance, cannabis dependance, alcohol abuse, anxiolytic dependance, substance induced, mood d/o, Hep B, Hep C, knee arthralgia, conductive hearing loss. Head injury 2003 and 2008 with infected scalp lac-abscessed. DX with Bipolar d/o 1/2008 with visual hallucinations and fear of being persecuted. HIV (+) 1/2008. Hearing eval for conductive hearing loss due to impacted cerumen.  Headache, kidney problems, stomach pain, articulation bursitis, no sleep, depression, anxiety, back pain, shoulder bursitis, arthryty. The anthrax have at least 250 condition, please focus on this event, because I had to many friend (soldiers) with a lot of disease, thank you.
Rash on neck advised to use hydrocortisone. On 9/1/15 presents with Herpes zoster to right flank and right upper thigh. Treated with Zovirax  800mg 5X day for 7 days and medrol pack.
Eight days post vax, this pt experienced a seizure, low grade fever of 99.7, vomiting. Blood tests were conducted and he was observed for a couple of hours. Testing revealed a viral infection. Parent also stated that he has a seizure disorder which is being controlled with Dilantin.
13.5 hrs after infection chills began.  Fever developed and lasted about 9-10 hrs.  Headache started after fever started and lasted about 20 hrs
About 1 month after 4th dose vaccine, I began having a sore throat, sinus congestion and headache. Later that evening, I began having chills. I woke up the next morning with a headache, sore throat, loss of appetite, fatigue, cough and chills. I did a home Covid test on 5-16-2022 and it was positive. I had a telehealth visit to notify the doctor that I tested positive. She prescribed me Paxlovid and I started it last night on 5-18. My headache is gone but I still have a sore throat and feel that I am starting to get better. The oxygen levels are normal at this time. I am reporting a breakthrough case of Covid, no reaction to the vaccine.
Woke up 0n 4/22 /2021 with eyes blood red, headaches, chills . Called eye doctor and was given different medication for glocoma. It made eyes swell and itch . Patient was taken off that med. and pit back on the original. Patient is still having chills and cough and headaches
Mild Shortness of breath for about 24hrs. Swollen lip from about 4:15pm into next morning until about 8:00 am. Sore throat for about 24 hrs. All treated with Benadryl from home.
HAD WITHIN A MINUTE TINGLING AND NUMBNESS OF THE LEFT SIDE OF THE FACE AND LEFT ARM. MORE PRONOUNCED LEFT SIDE OF THE FACE, NUMBNESS LIKE I WAS GIVEN LOCAL TO THE LEFT SIDE OF MY FACE. COULD BARELY FEEL MY FACE ONLY LEFT SIDE. FELT I WAS DROOPING. TEETH WAS TINGLING. MY LEFT ARM GOT BETTER IN 2 HOURS. THERE WAS NO WEAKNESS. HOWEVER MY LEFT SIDE OF THE FACE WAS NUMB AND TINGLING LASTED APPROXIMATELY  2 DAYS.  INTENSITY OF THE NUMBNESS GOT BETTER BY THE EVENING OF THE SHOT. I TOOK 325 MG OF ASPIRIN WITHIN 15 MIN OF THE EPISODE .  MY PULSE, BP AND OTHER VITALS NORMAL. MAIN WAS MY LEFT SIDE OF THE FACE .
came down with Covid; came down with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing); "immune impaired" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "came down with Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: came down with Covid (self-test). The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
numbness and tingling in shoulder worked up to back and front of head then to face and lips lymphnode swollen in armpit
The pt experienced a rash. It was noted that the lesions were not fluid filled. It in unknown whether the pt sought medical attention. Additional information has been requested.
Burning (sunburn-like) all over body starting 2 days after vaccine. Hasnt taken anything for it.
Patient called the pharmacy this morning claiming to have experienced light headedness, sweating and tiredness before passing out on the floor of her kitchen trying to get a drink of water. She has no memory of passing out or how long she was on the floor! Said she had a sore arm from the shot but felt fine last night. Advised patient to seek medication attention as she had a bump on the back of her head. She was feeling better when she called but told her I would report adverse event online and as well as to my management team.