chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received the flu shot on Wednesday afternoon and everything was fine at that point. She started to notice symptoms of 'not feeling well' on Sunday morning. Symptoms listed were increasing nausea with a slight amount of diarrhea. She was not feeling well enough to eat. By Wednesday about 12:00 PM she was 'sweating bullets' and went into the doctors where they had a blood test drawn and an urine analysis completed. Nothing was found according to patient. By Thursday she was feeling well enough to eat and had a large meal and was feeling better. She never had any injection site pain or issues.
pt exp gen hives & inj site rxn consisting of swelling of the entire arm (twice nl size);seen in ER-rx w/DPH;welts (hives bruised p/healing;blood work revealed high Eosinophil count;erythematous irregular hive like rash w/purpuric component
Felt like she was getting the flu; Drowsiness; Headache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like she was getting the flu), SOMNOLENCE (Drowsiness), HEADACHE (Headache), PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like she was getting the flu), SOMNOLENCE (Drowsiness), HEADACHE (Headache), PYREXIA (fever) and CHILLS (chills). At the time of the report, INFLUENZA LIKE ILLNESS (Felt like she was getting the flu), SOMNOLENCE (Drowsiness), HEADACHE (Headache), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            No concomitant information was reported. No treatment information was reported.   This case was linked to MOD-2021-376999 (Patient Link).
This spontaneous report as received from a medical assistant, concerning unspecified patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patients were inadvertently vaccinated improperly stored doses with ROTATEQ orally, lot # N029868 and expiration date 12-MARCH-2019.  Furthermore, on an unknown dates, the patients were vaccinates with RECOMBIVAX HB lot # R006746 and expiration date 09-NOV-2020 and, LIQUID PEDVAXHIB lot # N013293 and expiration date 29-FEB-2020 (doses, frequencies and routes were not provided) for prophylaxis. No adverse effects reported. The vaccines were stored at a temperature of 0 degree Centigrade to 1 degree Centigrade, time frame of 30 minutes with no previous temperature excursion of (0 degree Centigrade for 13 hours 30 minutes). Digital Data logger was involved.
Pt received 1st Moderna vaccine on 3/29. She came to the pharmacy days later and reported mouth ulcers and sore throat appeared 2 days after vaccine.  She stated she had no trouble swallowing but was tingly around mouth and it was difficult to eat. She took tylenol Monday and Tuesday. I counseled her to contact her PCP about incident and concerns of taking 2nd dose, which she stated to not have one.  I showed her benadryl and tylenol and recommended she take them if needed.  There were no apparent mouth ulcers when she showed me on Friday.
I gave the health services phone number because the covid clinic that vaccinated me is now closed and has no phone listed. About a week ago I started getting headaches and dizziness. Now the vertigo is so bad it's hard to stand without staggering - my head is swimming and I am getting severe headaches. I am not sure if I should try to see a doctor, not sure if I should be driving. My second dose is scheduled for May 16th. I have never had a reaction vaccine before and I have no medical conditions or allergies. These are different symptoms from the very mild temporary nausea and arm soreness I felt in the days directly after getting the vaccine.
local rxn to pneumovax x 2-3 days;upper arm from elbow to axilla red, hot & swollen &  very sore;
Slept for 4 hours after shot; Lost ability to walk up stairs normally; Had to two step with cane; Ruined health; Blurred vision; Growths that had gone away are starting again on back; Occasional chills; Joints are all aching; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in the left arm on 17Mar2021 at 13:00 (at the age of 73-year-old), as a single dose for COVID-19 immunisation. Medical history included had to two-step with cane and growths (not specified) on back. The patient had a history of allergy to latex. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 17Mar2021 at 13:00, the patient slept for 4 hours after the shot which had not done that before, extreme fatigue(still had), joints were all aching and lost ability to walk upstairs normally, blurred vision about an hour and the growths that had gone away started again on back and had occasional chills. The patient had to two step with cane and had gotten past that until shot ruined his health and the patient was very healthy before shot. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event slept after shot was recovered on 17Mar2021 at 17:00 after a duration of 4 hours, the event blurred vision was recovered on 17Mar2021 at 14:00 after a duration of 1 hour. The clinical outcome of events extreme fatigue, joints were all aching, lost ability to walk up-stairs normally, had to two-step with cane, ruined health, growths that had gone away started again on back, occasional chills and was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Case number PHEH2012US003537 is an initial spontaneous report received from a consumer and a physician on 09 Feb 2012. This case refers to a 45-year-old female patient. Her medical history included ongoing headache, nerve pain, depression, spasms, tobacco abuse, chronic pain syndrome (continuing: unknown), multiple sclerosis (diagnosed in 2009) and a negative history of cellulitis. Concomitant medications included a TOPAMAX 100mg twice daily for headache, gabapentin 300mg twice daily for nerve pain, ZOLOFT 200mg daily for depression and ZANAFLEX 2mg daily for spasm. She was started therapy with REBIF 44 micrograms three times a week, subcutaneously on 24 May 2011 for multiple sclerosis and it was continuing at the time of this report. On 01 Dec 2011, she went for routine physical examination and was vaccinated with FLUVIRIN (batch number: 1102601 and expiration date: June 2012), and with PNEUMOVAX (batch number: 1138AA and expiration date: 06 Oct 2009). On 02 Dec 2011, she went to the emergency room due to allergic reaction where the arm of the patient swelled in the area of the PNEUMOVAX vaccine and it was hot, red and inflamed. She was admitted to the hospital overnight when the pain was going to her shoulder blade and in her chest. During hospitalization she had laboratory tests which were negative for cardiac issues and blood cultures were negative. She also had an ultrasound of upper right arm that was negative for blood clots. She had serial cardiac and electrocardiogram and they ruled out a myocardial infarction. The symptoms were felt to be non-cardiac in etiology and most likely musculoskeletal in relation to her recent PNEUMOVAX. She received no treatment while in the hospital. On 03 Dec 2011 she was sent back to the emergency room by the physician because the arm was getting worse. She was given intravenous vancomycin in the emergency room for right arm cellulitis. She then had an allergic reaction with hives and her whole body was itching. She was given BENADRYL and antibiotic to prevent her from getting cellulitis. Her top head became spontaneously itchy since the allergic reaction. She stated that she noticed itching of the tip of the head which began in Aug 2011, she continued administration of REBIF. She was discharged from the hospital on 03 Dec 2011 with FIOROCET 50/325 twice daily and VICODIN 10/325 daily as needed for pain. She had recovered from allergic reaction, right arm cellulitis and allergic reaction to vancomycin. The physician assessed the relationship between the allergic reaction and right arm cellulitis and REBIF as suspected and considered PNEUMOVAX vaccine as a suspect causal factor.
Information has been received from a health professional concerning a 24 month old male who was vaccinated with one dose of Varivax. "Within the last month", in August 2006, the patient experienced breakthrough. No product quality complaint was involved. Additional information has been requested.
Patient says her arm hurts when she lifts it; (node)Swollen; (node)itchy; (node)red; (node)hard; (node) tender to touch; felt a nodeabout a size of a baseball at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (felt a nodeabout a size of a baseball at injection site), LIMB DISCOMFORT (Patient says her arm hurts when she lifts it), SWELLING ((node)Swollen), PRURITUS ((node)itchy) and ERYTHEMA ((node)red) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SEMAGLUTIDE (OZEMPIC) and PARACETAMOL (TYLENOL) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Mar-2021, the patient experienced INJECTION SITE MASS (felt a nodeabout a size of a baseball at injection site), SWELLING ((node)Swollen), PRURITUS ((node)itchy), ERYTHEMA ((node)red), INDURATION ((node)hard) and TENDERNESS ((node) tender to touch). On 09-Mar-2021, the patient experienced LIMB DISCOMFORT (Patient says her arm hurts when she lifts it). At the time of the report, INJECTION SITE MASS (felt a nodeabout a size of a baseball at injection site), LIMB DISCOMFORT (Patient says her arm hurts when she lifts it), SWELLING ((node)Swollen), PRURITUS ((node)itchy), ERYTHEMA ((node)red), INDURATION ((node)hard) and TENDERNESS ((node) tender to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes Blood pressure tablets, Cholesterol tablets and stomach tablets. Treatment includes Tylenol.
Information has been received from a physician concerning the experience of another physician's patient. On an unspecified date, a 12 year old female was vaccinated with a dose of Gardasil (yeast). Subsequently the patient developed a rash on her arm. Unspecified medical attention was sought. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
~12 hours after administration patient woke up from sleeping, felt dizzy/nauseous, then fainted. They then waited until symptoms passed, and then went back to bed.
Migraine, chest pain, increased heart rate, pale, diaphoretic, and pain in left arm with erythema and edema.    Employee did receive the egg free influenza vaccination.
Patient stated that three days after receiving second dose of Moderna COVID19 vaccine she woke up with a rash all over her body. She contacted her doctor how instructed her to take Benadryl, apply cold compresses and "wait it out." She also contacted another physician and sent them pictures of her rash.
Info has been received from a physician concerning an 8 year old pt who was vaccinated with a dose of varicella virus vaccine live. "Sometime in 2005", the pt experienced a case of chickenpox that was the worse case the physician had seen in someone who had received varicella virus vaccine live. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Additional info has been requested.
This spontaneous report was received from a nurse regarding a 4 months and 24 days male patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 17-MAY-2018, the patient was vaccinated with a dose of ROTATEQ orally, for prophylaxis, with lot# N026686 and 30-MAR-2019 expiration date (strength and frequency were not reported) at 17 weeks with 5 days old, and was vaccinated again on 06-JUN-2018 with ROTATEQ orally, for prophylaxis with lot# N026663 and 23-FEB-2019 expiration date (strength and frequency were not reported). No adverse effect was reported. No product quality complain was present.
My whole family started testing positive for COVID, several days later on 05/20/2022 I tested myself and I was positive for COVID. My symptoms are a cough with a lot of mucus, and my stomach is very queasy most of the time. I am tired. The arm I received the shot in 6 months ago started to ache. I have no temperature. I called my doctor and she prescribed the PAXLOVID, I am 3 days into taking it.
Patient received Moderna vaccine ~2pm, by the evening, had developed fatigue, with low blood pressure. Patient required admission to the ICU with vasopressor support, which was able to discontinue after ~3 days. Patient reports no other symptoms. Fatigue persisted until mid-March.
Temp 103 - 104 x 2 days; onset at 8 hours after vaccination; no other symptoms except slight erythema at site of Hib vaccine.
Per pt report via phone on 2/25, within a day of administration, the injection site was red and swollen; the redness moved down the arm toward the elbow on the inner aspect of the arm. The patient took Benadryl and the redness resolved by the 23rd.
MODERNA COVID 19 Vaccine EUA   High fever, 101.9 , hardness of left deltoid,headache,
ringing in both ears sonstantly since I received a second dose.  I saw Dr. about 3 weeks after the shot and there was no water in my ears.  She diagnoised it as a side effect of the vaccine and had no other informaiton on how long it would last or if it would go away given the newness of the vaccines.  Unknow if it will result in disability or permanent damage.  I hope not so i am not checkign that box below.  But that could change.
p/vax pt lower lip began to swell & turn outward;also c/o numbness & tightness around mouth;had minimal swelling the next morning;
Patient reports that he received vaccine on 03/17/2021. on 03/19/2021 he started to have a headache on the left side of his head. This is the same side he received his vaccine. He also started having an ear ache on left side starting on 03/20/2021. These symptoms are continued however improved.
Information has been received on 16-JAN-2017 from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was inoculated with ZOSTAVAX vaccine (lot# and route unknown) on or about 22-FEB-2015, administered by a physician, as recommended for routine adult health maintenance, and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 26-JUL-2016, the patient was treated by a physician for the onset of a severe vesicular rash that had spread into the eye, and was diagnosed as herpes zoster, or shingles of the eye. On or about 27-JUL-2016, the patient was treated by the physician for ongoing and worsening symptoms of herpes zoster, or shingles. The physician prescribed erythromycin Ophthalmic Ointment for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review herpes zoster, or shingles of the eye was considered medically significant. Additional information has been requested.
SWOLLEN LEG; BRUISE GREEN PURPLE BRUISE, IT HURTS UPON TOUCHING, ON THE INNER THIGH , LEFT SIDE , BIG SIZE, ABOVE THE KNEE AND ALL THE WAY TO THE TOP; HEADACHE (BUT SHE THINKS IT WAS HANGOVER FROM LAST NIGHT'S DRINKS); FELL DOWN ON BACK NOT RELATED TO SIGHT OF PROBLEM; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known health issue, no known allergies and no drug abuse or illict drug usage, patient was not pregnant at the time of vaccination.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 07:00 for prophylactic vaccination. No concomitant medications were reported. On 02-JUL-2021, the subject experienced fell down on back not related to sight of problem. On 03-JUL-2021, the subject experienced bruise green purple bruise, it hurts upon touching, on the inner thigh, left side, big size, above the knee and all the way to the top. On 03-JUL-2021, the subject experienced headache (but she thinks it was hangover from last night's drinks). On an unspecified date, the subject experienced swollen leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruise green purple bruise, it hurts upon touching, on the inner thigh , left side , big size, above the knee and all the way to the top, and headache (but she thinks it was hangover from last night's drinks), and the outcome of swollen leg and fell down on back not related to sight of problem was not reported. This report was non-serious.
Fever 104 degrees with baths; given Tylenol every 4 hours. Irritable, not sleeping unless held, drooling, vomiting, wouldn't eat but sips for over 48 hours. Per Pediatrician, symptoms due to Hand, Foot, Mouth disease. Had sores on hands, feet, in mouth at 7/8/02 doctor visit.
2 days after dose 2 COVID vaccine, patient started to experience HA, stiff neck/shoulders, lethargy, left arm/hand numbness and tingling. HA improved on 9/2/21. Lethargy improved 9/4/21. All other symptoms resolved.
tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored Program Pfizer First Connect. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number Unknown, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was upset. She was part of the COVID Trial in and this past week (in Dec2020) she started to get sick and tested positive for COVID. They gave her a diary which she had to fill out weekly, so she filled it out and put that she had COVID. She never heard from anyone. She stated the testing site people and snarky attitudes and when they went no one was wearing masks. She was told by the testing site, they couldn't make people wear them. Relayed that she could do an escalation and have someone reach out to her in regards to this. The patient underwent lab tests and procedures which included Covid test: positive on unspecified date in Dec2020. The event outcome was unknown.  Information on the Batch/Lot number has been requested.
Exactly two days after receiving each Covid vaccine I broke out in a swollen blotchy rash on my face, right side of my throat, the back of my neck and on my chest. The reaction after the second dose was more severe than the first. Both times I had to be given a steroid injection in addition to a Benadryl injection for the first vaccine. The rash took several days to clear up. Four months post second vaccine, the same rash randomly appeared in the same locations on my body. I did not seek clinical advice for this event and it cleared up on its own after a few days. Now eight months post second vaccine (today, 10/13/21) the same rash has reappeared in the same spots.
Screaming-inconsolable >3hours. Beginning at 9pm 06/15/2004. Fever 101-102 Ax given Tylenol q4hours.
Had 2nd dose and 3 weeks after had a terrible itching rash behind my legs and groin; Still have rash on whole body; Dose 1 and dose 2 both was administered on same day; Dose 1 and dose 2 both was administered on same day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 (Lot number: ER8732) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Bone degeneration" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL; FISH OIL; POTASSIUM; VITAMIN D [VITAMIN D NOS]. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE  EN6198  Vaccine Location: Left arm), administration date: 08Mar2021, for COVID-19 immunization. The following information was reported: RASH PRURITIC (non-serious) with onset 21Apr2021 08:00, outcome "recovered" (2021), described as "Had 2nd dose and 3 weeks after had a terrible itching rash behind my legs and groin"; RASH (non-serious) with onset 21Apr2021 08:00, outcome "not recovered", described as "Still have rash on whole body"; OVERDOSE (non-serious), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) all with onset 08Mar2021, outcome "unknown" and all described as "Dose 1 and dose 2 both was administered on same day". The events "had 2nd dose and 3 weeks after had a terrible itching rash behind my legs and groin" and "still have rash on whole body" were evaluated at the physician office visit. Therapeutic measures were taken as a result of rash pruritic, rash.  Additional information:Race Information was available. Ethnicity information was available. Facility information was available. Other vaccine in four weeks was unknown. Other medications in two weeks were Adderall, fish oil, potassium, vitamin D. Patient Had 2nd dose and 3 weeks after had a terrible itching rash behind legs and groin. Went to pcp 2x given Prednisone, Zyrtec,  caladryl Then dermatologist was given hydroxyzine, triamcinolone acetonide for the treatment of adverse event. Legs and groin had cleared. Still have rash on whole body. This was going on 5months. AE was resulted in reported as [Doctor or other healthcare professional office/clinic visit].Patient was not recovered. No Known allergies. No covid prior vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. the Pfizer product had a causal effect to the adverse event was reported as No.   No follow-up attempts are possible. No further information is expected.
Developed erythematous streaking, swelling, and worsening pain at injection site. Provided cephalexin  500mg every 6 hours x 5 days w/o improvement. Underwent I&D 08/26/22 due to worsening pain at site. Switched to Bactrim DS BID x 7 days.