chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow up information has been received from a registered nurse and through a Merck Pregnancy Registry concerning a 22 year old Hispanic female, with an obstetrical history of 0 pregnancies and 0 live births, who on 30-JAN-2008 was vaccinated intramuscularly with a dose of GARDASIL vaccine (yeast), (Lot # 0211U) and a dose of pneumococcal vaccine, polyval (MSD). Concomitant therapy include unspecified iron and vitamins. It was reported that the patient inadvertently received one dose of GARDASIL vaccine (yeast). The patient was suppose to get a hepatitis B virus vaccine rHBsAg (yeast), (manufacturer unknown) vaccine. The nurse said that this was not product confusion. The patient had not been notified at the time of the report. No other details were reported. It was reported that the patient was pregnant and last menstrual period (LMP) was 12-OCT-2007, (estimated date of delivery 19-JUL-2008). The patient had a urine pregnancy test, on 05-MAR-2008 an ultrasound was performed to determine the baby's growth, dates and anatomy. On 17-JUL-2008, 39.5 weeks from LMP, the patient delivered a normal, healthy male baby weighing 6 pounds 2 ounces, apgar 9/9. Additional information has been requested.
Pt reported progressive neuro deficits, was seen by a neurologist and reports a diagnosis of Transverse Myelitis that he reports was attributed to the covid vaccine by his provider.
This spontaneous report was received from a registered nurse regarding another nurse of unknown age and gender. On 07-OCT-2013, when the nurse was administering a patient with a dose of ROTATEQ, orally the patient sneezed. The nurse who was administering the vaccine felt that some of the ROTATEQ may have gotten into her eyes. The nurse flushed her eyes with water. Nurse stated that her eyes were irritated. The outcome of the events were unknown. Additional information has been requested.
3 days post vaccination noted 4inch irregular diameter of erythema and edema.  Are is hot, not tender, and is pruritic.
On March 29, 2021, I woke up at 1:30 AM feeling achy and nauseated.  I remained in bed.  At 7 AM that same morning, I woke up and the aches and nausea had worsened.  I decided to get up to take some Advil.  I walked to the bathroom to obtain the Advil, and I then walked to the kitchen to get some water.  As I was walking back to the bedroom, I became dizzy and increasingly nauseated.  I put my head down on the kitchen counter, and the next thing I remember was waking up (looking at the ceiling) and hearing my husband ask "Are you OK?"  I was on the floor and was sweating profusely.  I had passed out for about 30 seconds.  I was unable to sit up or get up for 10 minutes.  I was finally able to walk to a chair (cont.)
2 days post vax, pt developed bumps around injection site, increased in size, painful, coughing and temperature. Rash approximately baseball size with itch; ? hives. Pt not seen by physician.
Fever, body aches, headache, rapid heart rate, short of breath, sweaty, 3 hour priapism
Patient is 15 years old and received the first dose of the Moderna vaccine. The Moderna vaccine is authorized for people age 18 and older. According to the patient's mother, they did not realize this until after vaccination. Patient was advised not to receive the second dose until 18 years of age. Patient reported redness and swelling at the injection site. No other adverse effects reported.
I received the J & J covid vaccine this morning at 8:30 a.m. At approximately 4:30 p.m a dull headache, nausea and aches in my joints began. About 1/2 hour later I had a brief bout of chills then a fever set in. At 6 p.m. the fever was 100.0.
This spontaneous report was received from a consumer via other company and refers to eighteen patients of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with RECOMBIVAX HB (dose, therapy route and anatomical location were not reported; lot # K011239, exp. date 11-JUN-2016) which was exposed to temperatures outside of the required temperature range. The reporter stated that the efficacy of the product outside the temperature range was not established. The outcome of the event was unknown. Additional information has been requested.
flareup of her guillain-barre; Her eyes, she had the miller fisher variant and her eyes got really wonky again after the first vaccine, her reflexes went away and that was it, balance was off; Has autonomic dysfunction and had an increase of that as well; Her eyes, she had the miller fisher variant and her eyes got really wonky again; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Guillen Guillain-Barre syndrome" (unspecified if ongoing); "Myasthenia Gravis" (unspecified if ongoing); "Hashimoto disease" (unspecified if ongoing); "overweight" (unspecified if ongoing); "Covid", start date: Mar2020 (unspecified if ongoing), notes: Had first symptoms of Covid Mar2020. Concomitant medication(s) included: METHYLPREDNISOLONE taken for guillain-barre syndrome, myasthenia gravis. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "flareup of her guillain-barre"; MILLER FISHER SYNDROME (medically significant), outcome "unknown", described as "Her eyes, she had the miller fisher variant and her eyes got really wonky again after the first vaccine, her reflexes went away and that was it, balance was off"; AUTONOMIC NERVOUS SYSTEM IMBALANCE (non-serious), outcome "unknown", described as "Has autonomic dysfunction and had an increase of that as well"; EYE DISORDER (non-serious), outcome "unknown", described as "Her eyes, she had the miller fisher variant and her eyes got really wonky again". The patient underwent the following laboratory tests and procedures: Full blood count: good, notes: Tests: Had a CBC and CMP panel that came back good, everything was good; Metabolic function test: good, notes: Tests: Had a CBC and CMP panel that came back good, everything was good.  Clinical course: Flareup of Guillain-Barre: Clarified that caller had flare up with each dose of Covid vaccine she received. The Bivalent vaccine was the most minimal reaction of them all. Each reaction lasted a good month or 2. The first experience was the worst. Even her reflexes went out on her. Reflexes reduced and her balance was off. Her eyes, she had the miller fisher variant and her eyes got really wonky again. That hadn't happened in almost 30 years. Clarified that after the first vaccine, her reflexes went away and that was it. That was the only time she lost her reflexes. With the other shots, her reflexes stayed stable. Her eyes are wonky and her balance is wonky. Has autonomic dysfunction and had an increase of that as well. It was the only the first shot, where her reflexes went away, along with the other symptoms. Had first symptoms of Covid Mar2020. Was having a Myasthenia flare up and also getting Guillain-Barre symptoms with it.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Area in arm was red, swollen with fever. Then on Monday the redness had spread down to my elbow. Tingling in fingers, sharp pain would radiate too my elbow and up to my neck. Muscle and body aches with fever.
Patient readmitted due to failure to thrive at home with poor p.o. intake and high output from his ostomy (not taking Imodium, Metamucil as prescribed) complicated by significant hyperkalemia, acute kidney injury, metabolic acidosis, and hyponatremia. The patient was treated with 4 L of IV fluid bolus followed by maintenance fluids with overall improving lab values. Hospital admission within 6 weeks of receiving the COVID vaccine. ED visit encounter for ostomy care education within the same timeframe.
He had a stuffy nose and a lot of nasal discharge. He tested positive on a rapid antigen test for 13 days. The only symptom he presented with was nasal drainage which only lasted for about 5 days. We ended up calling the doctor because his symptoms had resolved but he was still testing positive. She stated that often positive Covid tests after 10 days are due to inactive viral particles still being present in the nasal cavity. Given he had no symptoms and it was past the 10 day mark, he was unlikely to be contagious even with the positive test.
Diagnosed chickenpox 4/13/12 - had vaccine 3/13/02.
After getting the shot, I was monitored at the hospital clinic for 15 minutes at the facility. I did not have the reaction right away not until I got home. I got the vaccine around 9 am for my pre employment requirement and and I got home at 11 am on July 12,2021.  Around 11:30am my left arm where I had the injection is sore, which was expected but the worst was experiencing hives/pruritus for the first time and it was bad.  Thankfully we had some benadryl home medication and calamine lotion and I took bed rest  and hydrated myself and helped by family members who are nurses. I also experienced body malaise. the symptoms eventually improved after day 3.  Currently I feel some heaviness when I take deep breaths and still monitoring.
2/27/19 715p awoke from nap feeling dizzy, nauseated, very weak, muscle aches, Temp 101 degrees, fatigued, unsteady, TYLENOL 500 mg. 2/28/19 symptoms continued. Vomited times 1, shivering and trembling. Right arm sore at injection site R arm, deltoid. Fever controlled w/TYLENOL symptoms waxed and waned. 3/1/19 noticed 2 red swollen areas (R) arm below injection site. The red/swollen areas on right arm were marked with ink along borders to monitor progression of possible inflammation. On 3/1/19 we made a visit to urgent care for evaluation for possible cellulitis. By this time symptoms were beginning to recede. Cephalexin 500mg prescript was given with instructions not to begin unless symptoms progressed. Midnight of 3-1-19, patient awoke profusely perspiring (pajama top soaked wet as well as sheets). His temperature at that time was 98.3 degrees. Patient said he was feeling much better. The fever obviously broke. Patient has been afebrile since his fever broke. Fevers ranged from 101.2 - 99.0 over the 3 days he was ill. (2/27/19 - 3/1/19). He still tires easily but is alert, strong gait, more energy (Sun. 3/3; Mon 3/4). Clinic Dr. is patient's doctor who evaluated him on 2/18 via clinic visit. Blood work (CBC, comprehensive metabolic panel) was included in evaluation. Pulmonary clinic was also notified of possible adverse reaction as patient received #23 pneumococcal polysaccharide valent vaccine, right deltoid on Wed. 2/27 (a day after receiving the SHINGRIX vaccine Tues. 2/26) at pulmonary clinic visit. The swollen/red areas of upper right arm (same arm he received both vaccines) have receded and continues to return to normal as of today 3-4-19. No antibiotic needed. Over last 3 days (3/2, 3/3, 3/4) patient has complained of left side pain at location of waist radiating to lower back and upwards towards chest. Relieved with EXTRA STRENGTH TYLENOL and sitting upright. Pain receding today 3/5 (muscle strain from retching when he vomited 2/28?) kidney injury? After fever broke, patient voided urine had foul odor. That resolved 3/2 with increased fluids and dietary intake. Concerned that this severe reaction might have been caused by having two different vaccines so close. Patient also developed a smattering of small red "pimples" mid anterior chest (breast to breast). Temp at that time was 96.9 degrees, P 72. Denied itching or pain from these "pimples". Monday 3/4 cluster of chest pimples looked like they opened and scabbed over. No visible drainage. Again denies pain, burning or itching of this area. Could this be a subclinical case of shingles? On Sat and Sunday 3/2 and 3/3 patient had multiple small loose stools which subsided by Mon. 3/4. No blood noted in stools. Question: Can we expect another adverse reaction to dose #2 of SHINGRIX scheduled to be given the last week in April? What would be the recommendation to avoid this reaction from happening again? Concern: I am wondering if patient's immune system became overwhelmed by having these 2 vaccines so close together. He has stable metastatic melanoma diagnosed March 2017. Received 14 infusions of Pembrolizumab. Last infusion was March 23, 2018.
Immediately dizzy when I walked out of room and within a few moments felt disoriented. I sat in my car for 20 min and felt ok enough to drive home but was overwhelmed with fatigue. It is 3 hours since vaccine and lethargy is same and am unsteady when walking
Febrile Seizure 8-11-09 Seen in ER and air lifted to Hosp. 8/28/09 MR received for DOS 8/12-13/2009 with D/C DX:  Convulsions NEC. Neurologist dx:  Complicated Febrile Seizures with status epilepticus. Pt presented to ER after several episodes of intermittent extremity twitching which progressed to generalized tonic-clonic seizures in ED. Prior to episode had been fussy and febrile.  Conccern for respiratory compromise resulted in transfer from local hospital to current facility. Pt became responsive on arrival thus no intubation necessary.  No further tonic-clonic seizure activity however parent noted one brief episode of eyes rolled back and R shoulder twitching which lasted ~2 seconds and resolved quickly without intervention. ICD9:  780.39 10/28/09 Additional ICD9 code received: V65.40, 780.32, 345.3, 781.0.
This spontaneous report was received from a Licensed Practical Nurse, via a Pfizer representative (2016046434), referring to a 53 year old female patient. Information about the patient's medical history and concurrent conditions was not provided. On 08-DEC-2015, the patient was vaccinated at a pharmacy, with a dose of ZOSTAVAX, in the deltoid (unsure if left or right arm). At the same time the patient was vaccinated with a dose of PREVNAR in the same deltoid muscle (administration route, lot numbers and expiration dates were not provided for both vaccines). No concomitant therapies were reported. On an unknown date in December 2015, the patient developed cellulitis on the arm that the vaccines were administered in. The cellulitis also went up into her neck. The patient was prescribed an oral antibiotic from the emergency room, as treatment for the cellulitis. The outcome of cellulitis was unknown at the time of this report. The reporter considered cellulitis to be related to ZOSTAVAX. Additional information has been requested.
Chills, fever, extreme body aches, nausea  Ibuprofen 400mg taken every 4-6 hours. Fever broke after 15 hours but returned within 4-6 hours. Easier to manage on second day with ibuprofen. Loss of appetite and nausea. Compazine taken forever nausea.   Currently 50 hours post vaccination, had to miss work due to symptoms. Fever free for 12 hours , co tinge to have loss of appetite and body aches
TOOK AUGMENTIN WHILE ON VIVOTIF THERAPY; This spontaneous case report (PVX2019-2505) was received from a nurse on 07-Oct-2019. It described a female consumer who "took Augmentin while on Vivotif therapy" (PT: Labelled drug-drug interaction medication error). The consumer was receiving oral Vivotif (company suspect) for typhoid fever and oral Augmentin (amoxicillin/clavulanate potassium) (non-company suspect) for an ear infection.  Case report: The consumer took the first dose of Vivotif on 03-Oct-2019. Along with Vivotif, she also started taking Augmentin (twice a day) for an ear infection on 04-Oct-2019, 05-Oct-2019, and 06-Oct-2019. She took two doses of Vivotif and would be taking her third dose on 07-Oct-2019. The nurse reported that she was not sure, when the ear infection started and if it was prior to starting Vivotif or not.  Action taken with Vivotif and Augmentin with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took Augmentin while on Vivotif therapy" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Augmentin while on Vivotif therapy" was considered as not applicable.
Intended to give Influenza and Moderna Booster.  Gave two doses of Influenza vaccine instead.  Discussed with patient and provider and booster Moderna dose administered.  Patient observed with no reaction.
This spontaneous report as received from a pharmacist via company representative regarding a patient of unknown age and gender. No pertinent medical history, drug reactions/Allergies and concomitant medications were reported. On an unspecified date the patient was vaccinated with ZOSTAVAX (lot, expiration date and dosing regimen were unspecified). On an unspecified date, after ZOSTAVAX administration, the patient had a mild case was not provided by the reporter. No product quality complaint was filed. Additional information has been requested.
This spontaneous report as received from a physician refers to a female patient of unknown age with no medical history. The patient had multiple allergies. On 09-JUL-2007 the patient was vaccinated with the first dose of ROTATEQ (lot # unspecified) oral. Other suspect therapies included RECOMBIVAX HB (lot # unspecified). On an unknown date the patient developed irritability, crying, loose and bloody stools after vaccination. The outcome of bloody stools, loose stools, crying and irritability was reported as recovered on an unknown date. No treatment was given. No lab tests were performed. The patient had sought unspecified medical attention. Additional information has been requested.
I received Dose 4 on 04/20/2022, On 04/22/22, I woke up not feeling well. I have lived with this infection for years. I was feeling nauseous, was running a fever, I normally am cathed in the morning, it was a different consistency. After the cath, my husband put a foley in because I could not walk. I needed assistance the entire day. It still comes and goes.
Extreme eczematous rash on neck, chest, breasts, back of shoulders, back of arms, inner forearms, abdomen, waist, thighs front and back, behind knees, sides of knees, inner and outer elbows, buttocks, and tops of hands. Treatment has included a six-day course of Methylprednisolone (21 pills at 4mg each), twice daily application of triamcinolone acetonide ointment 0.1%, Claritin once daily, 50 mg Benadryl daily, three times daily application of itch relief spraydiphenhydramine hydrochloride 2% with zinc acetate0.1%, colloidal oatmeal baths daily. OTC Topical treatments have been ongoing since April 3. Prednisone and Triamcinolone treatment started on April 11. As of today, April 21, symptoms have not changed.
I received the first dose of the COVID 19 (Moderna) on 01/15/2021 in the evening. The next morning I woke up at 05:45am with a sore arm, which I was told was one of the side effect. However I was sore and aching all over my body. As my day continued, I became tired and feeling flushed within the face. I felt my heart rate beating faster than normal. I began having cold chills and the aching within my body progressed through out the day (12 hr shift). When I clocked out at 07:08 pm and got home from work, I was unable to hardly move with out hurting and I felt like I had a fever. My husband checked my temperature and I had a low grade temp of 99.4 with an increase work of breathing and had ,a difficult time catching a breath. My husband took me to the hospital ER and before arriving to the ER I was having a stridor episode and when the nurse checked my temperature it read 102.3. I could not complete a full sentence and began vomiting. I was given epinephrine nebulized, solumedrol, benadryl, zofran, lidocaine nebulized. I had a CT with contrast of my neck and a chest xray. All images came back normal, I had been treated for an allergic reaction from the COVID vaccine and discharged home once the symptoms and stridor subsided.
allergy to vaccine; Initial information received on 20-Aug-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a female patient (age no reported) who experienced allergy to vaccine, while she received vaccine TETANUS TOXOID.  The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  At the time of the event, the patient had ongoing hip dysplasia (right hip) from 16-Jan-1942, obesity from 01-Jan-1973 and allergy to penicillin-hives from 01-Jan-1980.  On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number and expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On 01-Jan-1982, the patient developed an allergy to vaccine (unknown latency) following the administration of TETANUS TOXOID.  Other relevant tests not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the patient had not recovered from allergy to vaccine.  There will be no information on the batch number for this case.
Gardasil booster vaccine was administered to my 14 year old son on 2/21/20 at 8:30 am. 7 am on 2/22/20 he woke up with a fever of 101.5, dizzy, fatigued, sore throat sinus congestion, and closed ears and headache. Returned him to the pediatrician at 11:20am for the symptoms. Saw Dr. at Pediatrics. Assured us that his symptoms were simply a virus and not linked to the vaccine. He was told to drink water and take ibuprofen for the fever, then continue about his day. My son was extremely fatigued all day, falling asleep sitting up, laying down whenever he could. Fever finally broke the morning of 2/23/20. Extreme pain in muscles at the nape of neck, pounding headache, still congested in his sinuses. We will be monitoring him today, but these side effects were not told to us prior to the vaccine, and the pediatrician denies the causation from Gardasil. I am not convinced. After reading the common symptoms online, he seems to have a moderate case.
Patient woke up with red bumpy hives on both arms. No itching, no swelling and no shortness of breath or difficulty swallowing.
1st administration of vaccine on 2/22. Onset of Bell's Palsy on 3/3. Saw primary doctor on 3/4 and neurologist on 3/5 who acknowledged condition and put me on steroids and an antiviral. Rescheduled my second shot which were to be administered on 3/5 as per primary doctor recommendation.
Tightness of throat (oral pharynx) and cough within 3-4 mins and subsided within 5 mins.
SARS-CoV-2 positive with COVID-19 treatment; SARS-CoV-2 positive with COVID-19 treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2022 as dose 2, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: Other medical history: high blood pressure. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "SARS-CoV-2 positive with COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid therapy from 23Aug2022 to 27Aug2022. The patient has no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient with unresponsive, catatonic state, concern for seizures, persisting encephalopathy. Awoke and improved 24 hours later after seizure medications started. Started on Keppra despite negative workup and was awake and alert out of post-ictal state over 24 hours from admission.