chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe fatigue; nausea; sweats; tinnitus; This is a spontaneous report from a contactable other hcp.  A 76-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6201), dose 1 intramuscular, administered in Deltoid Left on 09Feb2021 (Age at vaccination: 76 years) as DOSE 1 SINGLE, dose 2 intramuscular, administered in Deltoid Left on 04Mar2021 (Batch/Lot Number: EN6205) as DOSE 2 SINGLE for covid-19 immunisation. Medical history included HTN from 20Jun2018 and was ongoing, Afib from 07Jun2021 and was ongoing, PVC, PVD, DM (Diabetes) from 14Jan2019 and was Ongoing, cataracts, diverticulosis, depression was Ongoing, polyneuropahty, COPD, insomnia, Chronic kidney disease (CKD - 3) from 24Feb2021 and was Ongoing . Patient was known to allergies which included amlodipine, codeine, cipro, losartan, MS, PCN, ACE inhibitors. It is unknown whether the patient tested for covid prior to vaccination. Post vaccination, patient was not tested for covid. It is unknown whether the patient taken any medication within four weeks prior to vaccination. Concomitant medication(s) included asa (ASA) taken for an unspecified indication from 12Jun2018 and ongoing; Duloxetine; evolocumab (REPATHA) taken for an unspecified indication from 02Jun2020 and ongoing; gliclazide (MICROZIDE [GLICLAZIDE]); metoprolol tartrate (LOPRESSOR); omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]) taken for an unspecified indication from an unspecified start date and ongoing; biotin, cyanocobalamin, folic acid (MVI 3) taken for an unspecified indication, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication from 02Jun2020 and ongoing; HCTZ taken for blood pressure measurement from Jun2020 and ongoing; metoprolol succinate (TOPROL) taken for blood pressure measurement from Jun2020 and ongoing; ondansetron (ZOFRAN [ONDANSETRON]) taken for nausea from 24Feb2021 to an un-specified stop date. On 09Feb2021, the patient experienced severe fatigue, nausea, tinnitus, sweats. Therapeutic measures were taken which included zofran, gas x labs. The patient underwent lab tests and procedures which included blood creatinine: 1.10 on 24Feb2021 High , blood glucose: 148 on 24Feb2021 High , coagulation time: 34  on 24Feb2021 High , glomerular filtration rate: 49 on 24Feb2021 Low , haematocrit: 47.3 on 24Feb2021 High , haemoglobin: 16.3 on 24Feb2021 High. The Outcome of the events was recovered in 2021.  Follow-up (02Apr2021): This is a follow up-spontaneous report from a contactable other HCP. This other HCP reported for the patient in response to Non-HCP letter [sent to Non-HCP] via follow-up letter which included that: Updated Suspect drug(Dosing regimen),event updated, patient (RMH added, narrative amended.   No follow-up attempts are needed. No further information is expected.
Pt as she as about to be released from observation stated that she did not feel normal and that she felt dizzy. shortly afterwards she stated she had chest pain .Vitals were taken BP  160/90  HR 73  R 20  Pulse Ox 99 .  Pt was observed and Paramedics were called. Pt was evaluated and paramedics felt it was not necessary for pt to go to hospital.   Repeat BP was 180/90 Pt advised by me to have relative to take to ER for evaluation.  Relative(sister) picked up pt at d/c from vaccine site
Information has been received from a mother concerning her 27 month old male son with a history of two episodes of "foot and mouth disease." On 08/23/2000 the pt was SC vaccinated with one dose of varicella vaccine. Concomitant therapy included Rexan acyclovir. It was noted that the "child became sick almost immediately and then was sick for 82 days." It was reported by the mother that the pt developed diarrhea, volitile personality "became very strong" and "pulled lamps off tables," cring all day, wheezing, fever and little dots then rash within one week. The mother reported that at two weeks the pt developed lesions on his legs and arm, vomited and was lethargic. He was treated with Benadryl and was seen by a pediatrician. Unspecified blood work was done. The mother reported that one physician suggested that the pt had "foot and mouth disease."  Another physician saw the pt and confirmed that the pt had chicken pox. The mother reported, "it had gone down the child's throat, he had diarrhea and his tongue looked like it was burned with acid." It was noted by the mother that "since then, the child has serious bouts with outbreaks of herpes in mouth and penis region, almost monthly along with the diarrhea, fever, tongue looking to be burned with acid." The mother also noted that her son's intellect was affected. Follow-up info from a physician noted that he had not seen this child consistently and that the mother of the child has not been complaint in having the child seen or healthy visits and vaccinations. It was noted that the pt was seen by an infectious disease physician. It was noted that this physician saw that child in 1999 and has seen the child in the past for various colds. He most recently saw the child on 04/16/2001 and the child was healthy and obviously recovered from all of the adverse events. He did state that the mother of the child has reported prior to and post-vaccination with varicella vaccine that the pt was very volitile in his personality. It was noted that the child was referred in 1999, prior to vaccination with varicella vaccine, to another physician for possible esophagitis. It was noted that the pt has had atypical blood work in the past but it was not known if an immune work up was done. The physician stated that he did not really believe that the child had all of the symptoms reported by the mother but was unable to comment further since he did not see the child regularly. It was noted that the mother, who has a past medical history of fibromyalgia, practices homeopathic medicaine. The physician did noted that on 04/16/2001, the pt was well. Additional info has been requested.
The most recent third dose caused redness, swelling, warmth, hardness, itchiness and discomfort around the site of injection which quickly spread to a welt 4inches by 3 inches and growing.
Janssen COVID-19 Vaccine EUA.  Approximately 15 hours after the vaccine the left eyelid began swelling.  the swelling has lasted for 36 hours
PATIENT CAME INTO THE PHARMACY ON 05/23/2022 AND STATED THAT HE HAD ISSUES WITH HIS ARM AFTER HIS SHOT.  HE STATED THAT HIS ARM WAS RED AND HAD STREAKS GOING DOWN HIS ARM.  HE SAID THAT HIS ARM WAS RAW, SORE AND INFLAMMED.  PATIENT SHOWED ME WHERE THE INJECTION OCCURED WHICH WAS APPROXIMATELY  3 INCHES ABOVE THE ELBOW.  I EXPLAINED THAT WE DO NOT GIVE SHOTS THAT LOW AND MAYBE IT COULD BE A SPIDER BITE OR OTHER ISSUE.  I ADVISED PATIENT TO GO TO THEIR DR FOR A DIAGNOSIS.
Back side of arm has been progressively getting redder; Swollen; Painful; A big raised lump on back of her arm; Thinks she received the vaccine subcutaneously; A spontaneous report was received from a pharmacist concerning a female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and thinks she received the vaccine subcutaneously, back side of arm has been progressively getting redder, swollen, and painful and a big raised lump on back of her arm.  The patient's medical history was not provided. Concomitant product use was not provided.  On 08 J an 2021 The patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection Lot # 012L20A.   On an unknown date the patient's back of arm was progressively getting redder, swollen and painful. The pharmacist stated, "it looks like a big raised lump on back of her arm". Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The event, thinks she received the vaccine subcutaneously, was considered resolved on 08 Jan 2021.  The events, back side of arm has been progressively getting redder, swollen, and painful and a big raised lump on back of her arm, was considered unknown.; Reporter's Comments: This regulatory report concerns a female patient who experienced thinks she received the vaccine subcutaneously (inappropriate route of vaccine administered), back side of arm has been progressively getting redder, swollen, and painful and a big raised lump on back of her arm.  The event occurred following the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: 012L20A, expiration date-unknown). Treatment administered was not reported and outcome was unknown. Based on the information provided which includes a strong temporal association and the absence of any other etiology,  the events of  back side of arm has been progressively getting redder, swollen, and painful and a big raised lump on back of her arm, a causal association with the vaccine administration cannot be excluded.  The event of inappropriate route of vaccination is considered not applicable.
Chest pains that started during rest, and fatigue, lasting until ibuprofen treatment. Visited the Dr for suspected pericarditis, who prescribed 3 weeks of ibuprofen regimen and administered tests.
BODY ACHE; FEELING TIRED; This spontaneous report received from a consumer concerned a 40 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 08-APR-2021, the subject experienced body ache. On 08-APR-2021, the subject experienced feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body ache, and feeling tired. This report was non-serious. This case, from the same reporter is linked to 20210435771.
After two individual Prevnar 13 shots, a toddler experienced foul-smelling poop and diarrhea and a very bad diaper rash with red raised bumps for 5 days. A previously unvaccinated, breastfed girl was given 2 doses of Prevnar13 (a full series of two shots since it was delayed). The first was at age 12 months (10/30/15), and the second was at age 15 months (01/22/2016).  Her health and temperature at both visits were normal, and there were no diet or diapering changes before or after either visit. About one day after the 10/15 shot, she experienced foul-smelling poop. There were about 2 poops in one day that had less water than usual, then later that day or the next day there were about 3 soft (but not fully runny) foul-smelling poops every 2-3 hours. The parents believed it was a coincidence, and the girl showed no other symptoms apart from slight tiredness, that may have been unrelated. She was treated at home with almond oil, A&D, baths, air drying, and Triple Paste. While the rash was painful and bright red the first day, the next day it turned into red raised bumps from anus to genitals that lasted about 2-3 days. As it showed improvement and seemed to not be painful after the first day of discovery, she was treated at home, and the rash was fully gone at the end of a week. The same symptoms (but with more severity) happened after her 1/22 shot. This time, the foul-smelling runny poops started the morning of the 23rd, and there were about 4-5 of them, one every 2 hours. The rash this time, however, was more severe. After the first runny poop (the morning of the 23rd), a larger diaper area turned bright solid red, and she screamed and cried when it was touched. By the 24th, the rash again turned into bright red raised bumps (very numerous and close together) from anus to genitals, spreading out to inner thigh, but there was no more diarrhea or signs of her discomfort. The bright red color was gone by the morning of the 27th, and the rash was gone fully by the 28th. Again, she showed slight signs of tiredness, but no other symptoms. Lastly, the parents primarily cloth diaper, and the father reported that his clothes severely itched him on the 26th. They wondered if this was because the clothes he was wearing were washed in a separate load after a diaper load from the 25th. However, they do not know if the itchy clothes are related directly to Prevnar 13, as it could easily be unrelated.
Headache, Myalgia, lethargic, eyes hurting, right arm swollen/painful Narrative:
Fever, vomiting, diarrhea. Subsequently found to be rota positive on testing performed 1/5/16.
Patient's wife reported at 3:30 PM (about 1.5 hours after vaccination) that patient described having weakness in the right side of his body.     Patient described as "stroke symptoms".  Patient was transported by ambulance to Hospital.  MRI performed at 10 PM that night.  Told that brain and carotid scans were fine.  Patient's wife told me that ER department ruled as a light stroke, but dissolved by itself.  Patient was allowed to leave hospital due to no beds available.
hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair loss) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included Ankle injury (Bad ankles), Knee replacement and Shoulder replacement. Concomitant products included LISINOPRIL, ACETYLSALICYLIC ACID (BABY ASPIRIN), METOPROLOL and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ALOPECIA (hair loss). At the time of the report, ALOPECIA (hair loss) had resolved.            No treatment medication details was reported.   This case was linked to MOD-2021-006473 (Patient Link).
started swelling in face ,hands, eyes; started swelling in face ,hands, eyes; started swelling in face ,hands, eyes; having arrhythmias and blood pressure issues; having arrhythmias and blood pressure issues; have continued to have. Cardiac issues; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), on 28Dec2020 06:30 PM into right arm at single dose for COVID-19 immunization in Hospital. Medical history included Migraines, high blood pressure that was controlled. Patient was not Pregnant at the time of vaccination. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No allergies to medications, food, or other products. Concomitant medication (medications the patient received within 2 weeks of vaccination) included hydrochlorothiazide and furosemide (LASIX [FUROSEMIDE]). patient took injection and started swelling in face, hands, eyes. Then started having arrythmias and blood pressure issues. She has continued to have. Cardiac issues as well as blood pressure problems. ill was hospitalized. Duration of hospitalization was 2 days. blood pressure and arrythmias. Patient was currently seeing cardiologist on April 14th to see what can be done. events start date and time was 28Dec2020 06:45 PM. It was unknown if the adverse event result in doctor or other healthcare professional office/clinic visit or Emergency room/department or urgent care. "Location of injection information is available for all vaccines received on the same date". Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Lab test included Nasal Swab on 23Jan2021 with negative result. Treatment for the events included medication, in process of seeing a Cardiologist. Outcome of the events was not recovered. Serious criteria is hospitalized and life threatening.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of swelling in face, hands, eyes, arrhythmias, cardiac issue and blood pressure issues cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Temperature of 102.0 started around 9am on Friday. Tylenol was given and temperature decreased to 101.1. The temperature continued to fluctuate over the next day ending Saturday afternoon. Saturday night around 8PM he developed small red dots not raised, non blanchable over his trunk and leading out his limbs with some around his neck and ears. The small red dots continued until Wednesday without apparent pain or itching. Each day the dots began to fade.
No additional AEs or PQC reported; Caller reported expired dose of PNEUMOVAX 23 was administered.  No other information is provided.  No additional AEs or PQC reported.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On 30-SEP-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)  0.5 mL, intramuscularly, lot # T040202 wth expiration date 11-SEP-2022, for prophylaxis (strength and anatomical location were not reported). No other information was provided. No additional adverse events (AEs) were reported.
Began having tachycardia on 10/27/2021, no previous issues before that. Had to go to ER several times. Was referred to heart valve clinic.  Completed cardiac stress test and echo. Cause of tachycardia was never found, was put on bisoprolol beta blocker and it has controlled my symptoms.  report this possible adverse  medical event due to covid vaccine
he asked for the Janssen covid 19 and wrote on his consent form that he was 18. He was 2 months shy of 18 years of age at time of vaccination
Upper arm and shoulder pain and stiffness since vaccination. Also, shooting pain in forearm when using it.
Itchiness/rash on upper left thigh began on 1/31/2021 and then increased to tops of both thighs, back of both thighs, down the back of left thigh as well as, tops of fingers on right hand, stomach, left arm, and back. Additionally, injection site is red, raised and warm to the touch in a circle roughly 2.5 inches in diameter.
Summary: between 12-26 hours after shot, flu-like symptoms. 4 rounds of vomiting + headache.  Monday night ~10:00 p.m.: random, mild pain in chest; feels like a needle is poking into my heart. More wiped out than usual, go to bed 1-2 hours earlier than normal. Monday night-Tuesday morning, ~12 hours after shot: ~1:40 a.m. Wake up with chills & apparent fever; didn't have thermometer ~2:02 a.m. Nausea quickly turns to vomiting. Headache begins. ~3:30 a.m. 2nd round of vomiting. Dry heaves. Muscle contractions are longer & more severe than typical for me. ***Unable to sleep much. Fever apparently breaks. Headache, overall fatigue.*** ~7:30 a.m. 3rd round of vomiting. Dry heaves. Muscle contractions are longer & more severe than typical for me. ~10:00-10:30 a.m. Drive to pharmacy; buy thermometer and aspirin. Thermometer reads 97.4º, then 96.7º, so the fever is long gone. ~11:00-12:30 p.m. Take one tablet (81 mg) of aspirin every 30 minutes with a couple of ounces of water. That's all the water I can drink. ~12:40 p.m. 4th round of vomiting; lost the water. Muscle contractions wouldn't stop; I felt dizzy at the end. ~2:10 p.m. Wake up feeling slightly better; last 30 minutes on the computer for work. Go back to sleep. ~4:15 p.m. Wake up feeling much better; last ~1 hour on the computer. ~10:00 p.m. start eating again. First time in 24 hours.
On March 19, baby threw up (only time in her life, and the nights of March 19 and 20, cried a lot more than usual and cries weaker than usual. Measured temperature under arm pit on March 20: 100 degrees F. She seemed better by night of March 21, but still had temp of 100F, measured daily by forehead strip, until day she died.   Nurse follow up on 07/13/04 states: pyelonephritis w/abcesses, E. coli sepsis.
After the first dose, it hit me at 3pm with flu like symptoms and sore arm. That remained through the weekend. It had somewhat subsided prior to my second dose. However after the second dose again I had flu like symptoms. but all my symptoms increased and became worse. I had increased migraines, dizzy spells, diarrhea, excruciating pain, numbness on the right side of my face, sensitivity to noise, increased vertigo, ringing in my ears, nausea, rash, shortness of breath, sensitivity to light and smells along with brain fog. I have lost 15 pounds over the last 7 months. At times I have shooting pain up either side of my neck into my eye. Bright lights cause flare ups of these symptoms. All of this I have had EVERY SINGLE DAY FOR THE LAST 7 MONTHS.  Following the second shot, I went back to my doctor around April 26th because I had become so sensitive to noise along with ringing in my ears and wanted to get my hearing checked. I was refer for PT as my balance was really affected. I had weekly visits between May and August  There were times they would touch my neck that would cause me to go into an excruciating flare-up. On June 22, 2021 I went to the ER because I was in excruciating pain. I had multiple blood test done which were unremarkable, as well as a UA.  I went again on July 8th, 2021 and they diagnosed me with vertigo and wanted to give me valium, which I declined. In July I went to a hearing and balance specialist, and was told that the vaccine had caused my  immune system to go into overdrive and attack the vestibular of my right ear at 33% . Overall impressions was unilateral weakness of 33% indicative of right peripheral deficit. A hearing test on 10/29/21 noted slight hearing loss in my right ear. In August I was referred  to an upper cervical chiropractor who I am still seeing with 3 visits remaining. I also was place on a heart monitor for 3 days - those results are not in my chart at this time.
Woke 8 hours after the vaccine to excruciating right ear pain, nausea, aches.  Weakness, aches, general flu like symptoms for all of the next day (Sunday).  Woke up Monday feeling much better but not 100%.  Felt worse Tuesday with muscle weakness.   Tuesday night lymph nodes in neck were very enlarged.  Approximately baseball size.  Weakness, fever, malaise all day Wednesday.