chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PSORIASIS FLARE UP/ BREAK OUT ON LEFT BUTTOCKS; SORE ARM; This spontaneous report received from a patient via other manufacturer concerned 6 decade old adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis, and moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, 1 total administered on 10-APR-2021 for prophylactic vaccination. Age at time of vaccination 53 years old. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On an unspecified date, the patient experienced psoriasis flare up/ break out on left buttocks and sore arm (dose number in series 1). The patient received non-company suspect vaccine included Pfizer Biontech covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin unknown, intramuscular, batch number: unknown and expiry: unknown) dose not reported, (1 in once) administered on an unspecified date for prophylactic vaccination. No concomitant medications were reported. The patient received non-company suspect drug Humira (adalimumab) (solution for injection in pre-filled pen, subcutaneous, batch number: unknown and expiry: unknown) dose and frequency were not reported from 27-OCT-2017 for psoriatic arthritis and moderate to severe chronic plaque psoriasis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; action taken with tozinameran was not reported; and dose of adalimumab was not changed. The patient had not recovered from psoriasis flare up/ break out on left buttocks, and the outcome of sore arm was not reported. This report was non-serious. This case, involving the same patient is linked to 20220625171.
Case number PHEH2014US003756 is an initial spontaneous report received from a pharmacist on 20 FEB 2014. This report refers to 17 years old female patient. Past medical history and concomitant medication were not reported. She vaccinated with FLUCELVAX (batch number: 004001A) intramuscularly on 07 NOV 2013. No adverse event was reported following this administration error.  Following an internal review on 18 AUG 2014, a significant correction wad done for the information received on 20 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
After shot, felt ok. Going to bed, had chills, was feverish and didn't sleep well. Sleeping heart rate was high. Pre vaccine resting heart rate ranged 71-75. Day after climbed to 75(from 72) to 86 by January 18. Contracted covid about that time. Didn't seem to have any symptoms. Did have a runny nose I blamed allergies and tested negative. Positive test was when I felt better on that Friday so quarantined from then. Heart rate stayed high.
about 2 hours post dose pt developed itchy raised rash on one arm.  Saw MD 2d later, was determined to have herpes zoster rash, treated with valacyclovir.
Skin is warm. Capillary refill takes less than 3 seconds. Blanchable, erythematous lesion that is 6 cm in greatest diameter noted overlying the left anterior thigh. Increased warmth and swelling but no fluctuance. No streaking or purulent drainage. No tenderness with palpitation.
Patient developed hives/rash on arms and back post vaccination. Patient was given benadryl 25 mg and Epi pen was administered 0.3 mg. Patient's hives improved, denied any shortness of breath or difficulty breathing. Patient's vitals were checked Q10 mins, remained stable throughout encounter. SpO2 remained in the 98-99% range.
This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with GARDASIL 9 injection, lot number M011117, expiration date 07-DEC-2017 (dose, route and anatomical location of administration were not reported), which were improperly stored at 60 F for 1 hour and 30 minutes. There was no previous temperature excursion. Digital data logger and product quality complaint were not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Diffuse urticarial rash over entire body, within hours, post vax. (Note: there may have been small urticarial skin rash prior to IZ). Rx'd Benadryl.
A vaccine was given  that had been expired by 4days .Pt was informed. Charge Nurse informed  to  reached out to Pfizer and was referred to agency.
Started experiencing shortness of breath a couple of hours after.  Thought it was asthma (which is normally triggered by dander and I hadn't been around dander) so I used my inhaler.  Next morning I woke up and my face was very puffy on the left side (vaccine was in left arm).  I am still having visible swelling almost 24 hours later.
Had the first COVID vaccine on 1/8 and did a hike on 1/9 that was about 2-3 miles and did fine and then developed severe exhaustion on 1/10 while hiking 2-3 miles and had trouble getting back due to exhaustion. She then had to stay in bed due to exhaustion for about 2 weeks. Also developed 2 days after the vaccine, symptoms of nausea, shakiness and sweating.  Brain fog, decreased short term memory loss/trouble with word finding with tachycardia started about 10 days after the vaccine. Baseline, has a mild stutter which she does not think worsened with her symptoms, but was not sure. Difficulty with word finding and memory most unusual for patient that she is a scientist and a poet. She developed symptoms of dysuria and incomplete bladder emptying on January 13. I saw her for a telephone visit on January 20, ordered urine tests and empirically treated for UTI with Augmentin.
Patient was given 2nd dose of Shingrix within 4 weeks of receiving the 1st dose.  Per product guidelines, that dose is considered invalid and patient is to receive a valid 2nd dose again in 2 months from this invalid dose.
Information has been received from a consumer concerning her 7 year old daughter with "a severe egg allergy" who "a while back" was vaccinated with a dose of MMR II. Subsequently (a while back), the patient had severe reaction. At the time of this report, the patient's outcome was unspecified. It was unknown if the patient has sought medical attention. No further information is available.
This spontaneous report as received from a office manager (other health professional) refers to a patient of unknown age. Pertinent medical histories, current condition, reactions and allergies were not reported. On 31-OCT-2016, the patient was received an improperly dose of ZOSTAVAX (Dosage regimen were not reported) (lot # M028798, expiration date: 18-AUG-2017), intramuscular. Following temperature of 8.1 F for 43 minutes with data logger. Concomitant medications were not reported. No adverse effects were reported (no adverse event). No further details were provided. No Product quality complaint (PQC) was involved. Additional information has been requested.
Intense, incapacitating  flu-like symptoms starting approx. 12 hours after injection, lasted for 24 hours
Fever starting 10 hours after second dose of vaccine that lasted for about 24 hours; severe sore throat started about 48 hours after injection and lasted until steroid injection during second visit to urgent care. Three days after sore throat started, went to urgent care and was prescribed antibiotics for strep. Antibiotics had no effect.  At second visit to urgent care I was given a steroid shot, which resolved the problem
She is very itchy since day 3, severe joint pain starting day 4 in shoulder, elbow and scapula, started on 1000mg/day NAPROXEN
fever of 102 the morning after receiving the vaccine, severe headache, severe eye pain, diarrhea, weakness, bone pain, abdominal cramps, loose stool--that had mucous and blood in it.  Also had a small amount of vaginal bleeding/spotting not associated with her period.  Multiple days of these symptoms.
This case was considered medically important. Information regarding PREVNAR was received from a physician via GlaxoSmithKline, regarding a 2-month old male patient who experienced hypotonia, refusal to eat, pallor and inconsolable crying. The patient received the first dose on 21-Jul-2008. The patient also received the first dose of DIPHTHERIA (manufacturer unknown) and the first dose of PEDIARIX (GlaxoSmithKline) on 21-Jul-2008. The patient experienced hypotonia, refusal to eat, pallor and inconsolable crying and 21-Jul-2008, three to four hours after vaccinations. This was considered to be systemic reaction. Hours later the issue resolved, however, the patient was taken to a hospital Emergency Room for evaluation. Diagnostic tests were performed (see test results). All test results were normal. The physician considered the event of hypotonia to be possibly related to treatment with PEDIARIX. The physician questioned a specific lot of PEDIARIX, because she had another patient who had experienced adverse events after receiving the same lot of PEDIARIX. No additional information was available at the time of this report.
R thigh became red and warm after immunization.  Fever spiked to 102 48 hours after immunization.  72 hours after immunization blister appeared and popped.  4 days after immunization child was brought to clinic.  Drained abcess and cultured, began Augmentin.
Given vaccine 6/3/09. Fever 101 degrees 6/4/09. 101 degrees-103 degrees 6/5/09. Pain at vaccine site.
Pt developed increasing pain and stiffness in left shoulder over the course of month after vaccination and developed adhesive capsulitis of left shoulder.
I have heard, and saw recently that a small group of primarily male adolescents and young adults have developed difficulties with their hearts after taking the vaccine. I am also having this problem. I am an athlete with a resting heart rate of around 55-65. Now my resting is 75-90. When I went on a light jog; it reached 210. I received the COVID vaccine. I don?t know exactly who to contact for this, or if you guys need to know this. I just knew they were looking into/ researching people with this rare affect. Have a nice day!
This spontaneous report was received from a other health professional via a company representative refers to a 14 year old female patient. Concurrent condition included: very emotional and crying. On 14-OCT-2014 the patient was vaccinated with GARDASIL dose 1, (dose, route and frequency unspecified) intramuscular. No concomitant medications were reported. On 14-OCT-2014, the patient experienced syncopal episode. It was reported that after receipt of this dose, patient had a syncopal episode in the office and was slumped over in the chair - although she was easily aroused and sent home with her mother (this was considered resolved). The reporter stated that on 15-OCT-2014, the patient came back to the office along with her mother. The mother reported to the reporter that her daughter (the patient) has been very emotional and crying since receipt of the vaccine, although patient states she has been emotional and crying for one week (which began prior to receipt of the vaccine). Treatment given was none. On 14-OCT-2014, the outcome of syncopal episode was reported as resolved. Causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
within 1 hour of receiving the 2nd vaccine both of my cheeks went completely numb. within 24 hours there was some restoration of feeling however to this day it is not fully gone. I can bite on my cheek on the inside and feel pressure but no pain. I can smile.. pucker, blink move my eyebrows.. talk normal. just still don't have full feeling back in cheeks.
Breakthrough COVID-19 case with symptom onset 8/19/2021: Cough. Hospitalized 8/19/2021 for unknown duration. Death 8/26/2021. Vital records COD = ACUTE HYPOXIC RESPIRATORY FAILURE, COVID-19. Per vital records, COD ICD Codes include: Not yet coded ; Other Significant Conditions include: BRONCHIECHIECTASIS PULMONARY EMBOLUS;  Place of death: HOSPITAL;
The patient received the Pfizer vaccination and had filled out their consent form having everything checked no. After given their immunization they were instructed to sit for the required 15 minutes. The patient got (Name's) attention he went out immediately. The patient's forehead/torso was sweating immensely. She was asked how she felt and if her breathing was ok. She was breathing fine. While talking to her she stated that her hands were starting to tingle.  911 was called. They evaluated her and released at the pharmacy.  (Name) called on 4/14 and talked with the patient and she said that she was completely fine and thanked him for calling and asking.
Neck pain left side that night. Ongoing. Severe headache day 2-5 after.  Muscle spasm day 5 am.
Patient had high fever of 103 degrees the night of the vaccination. She also woke up the next morning with a really sore and swollen arm. The symptoms went away on its own after 2 days.
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Concurrent medical conditions included Allergy to antibiotic (allergy to erythromycin).  In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 22-May-2022 to 26-May-2022 for COVID-19 treatment, at a dose of 1 dosage form. At the time of the report, COVID-19 (COVID-19) had resolved.  No concomitant medication was reported. It was unknown whether the patient received any medications/products within 2 weeks of starting COVID-19 treatment. After paxlovid treatment on 22-May-2022, the patient again had COVID-19 rebound with horrible taste in mouth, upset stomach, diarrhea, which recovered later on unspecified date. The device date was reported as 05-Jun-2022.  Company comment: This spontaneous case reported by a patient, concerns a 65-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious of COVID-19 infection, on an unknown date after receiving the 3rd dose of mRNA-1273 vaccine. Latency between vaccination and onset of the event could not be assessed. It was reported that the patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) from 22-May-2022 for COVID-19 treatment for 5 days. The same date that the patient started with Paxlovid, he had horrible taste in mouth, upset stomach, diarrhea, COVID-19 rebound which got resolved later on. Details of the onset date, lab results and symptoms of this initial COVID-19 infection was not reported. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This spontaneous case reported by a patient, concerns a 65-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious of COVID-19 infection, on an unknown date after receiving the 3rd dose of mRNA-1273 vaccine. Latency between vaccination and onset of the event could not be assessed. It was reported that the patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) from 22-May-2022 for COVID-19 treatment for 5 days. The same date that the patient started with Paxlovid, he had horrible taste in mouth, upset stomach, diarrhea, COVID-19 rebound which got resolved later on. Details of the onset date, lab results and symptoms of this initial COVID-19 infection was not reported. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
4/17/23   I sitting at my desk and grabbed a drink and I noticed I had a feeling over my body, that was like a tingling. I checked my pulse, and I was skipping beats.  My blood pressure cuff detected the irregular heartbeat. I went to the doctor and had an EKG and was diagnosed with premature ventricular contractions.  There were no other symptoms.  I have an appointment with a cardiologist on 5/8/23.
Fever and vomiting within 24 hours. By day 5 post-vaccination fever and vomiting have resolved but decreased appetite has persisted.
Soon after administration of vaccine, pt experienced left shoulder pain, numbness and tingling with the inability to mover her arm at full ROM. Pt sent to ED for follow-up after hours and has been referred to Orthopedics for further evaluation.
Fairly strong injection site pain for several days (unusual for me as I normally have no problems with past vaccines).  102.8 fever 12hrs after 2nd dose.  Severe chills/shaking.  Fever dropped to slightly over 100 from dose plus 17hrs through 63hrs, prior to dropping rapidly to normal.  During duration of fever: headache, muscle aches, digestive tract gas and loose stools, weakness, lack of mental focus, tired, and general feeling of heaviness with  some feeling of heart palpitations (not normal for me).   Post fever, minor headache, weakness, and lack of mental focus continued through present (Dose plus 80hrs), but now almost totally gone.  Appear to be starting Moderna/COVID arm with 4in diameter, round, itchy red spot on just at and below injection site  on right bicep.
Patient received shot at 12:45 pm and at about 12:55 pm the patient became semi-conscious and rigid and was helped to the floor where he was placed in the recover position. After about 2 -3 minutes the patient began to respond to stimuli and answer questions. 911 had been called at the time of the event and showed up about 10 minutes later and attended to the patient. About 30 minutes from the event occurring the patient walked out with the fire department and it was suggested he went to the Emergency room to be evaluated. EKG was done at the hospital as well as a wellness exam and nothing remarkable was found. The patient has a follow-up June 1st with a neurologist
Patient presented to the ED on 11/4/21 for cate bite. Patient presented to the ED and was subsequently hospitalized on 11/14/21 for closed fracture of sacrum d/t motor vehicle collision. These visits are within 6 weeks of receiving covid vaccination.
pt recv vax 5JAN96 & pt exp a severe local rxn including tingling & numbness of hand & arm;nurse reported that the rxn was not accompanied by resp distress or a change in BP;
On the date of the vaccine that night my blood pressure went up to 143/130 which is higher than it has ever been. My blood pressure the bottom number would not go under 100. The entire night my head felt like I was in a tunnel and my heart and chest felt tight. I was unable to work the following day due to not getting any sleep out of fear of something tragic happening to me. In addition last night or early this morning at 3 AM I woke up and my body was itching all over. The palms of my hands were itching my gums were itching I had red marks on my body and had Not done anything out of the ordinary or eight anything out of the ordinary. I took two Benadryl?s and was able to fall back to sleep for a little while and now the itching has stopped but my eyes are swollen.
Patient developed severe diarrhea within hrs of vaccine needing ER rehydration. Six days later returned to ER for abnormal movements and admitted for work-up for possible seizures.
Arm started itching and is warm, almost like a mosquito bite, at the site of my injection
patient experienced swollen tongue and throat. Also onset headache. Given DiphenHydramine with good effect. No breathing difficulty.
Itchiness at site of injection; Red rash at site of injection; Swelling at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at site of injection), VACCINATION SITE RASH (Red rash at site of injection) and VACCINATION SITE SWELLING (Swelling at site of injection) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at site of injection), VACCINATION SITE RASH (Red rash at site of injection) and VACCINATION SITE SWELLING (Swelling at site of injection). On 08-Mar-2021, VACCINATION SITE PRURITUS (Itchiness at site of injection), VACCINATION SITE RASH (Red rash at site of injection) and VACCINATION SITE SWELLING (Swelling at site of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment medications were not reported. Patient declined to give information for further follow up.   Reporter did not allow further contact
Red raised lump on arm at injection site  , now red ring around injection site , heart palpitations
Patient received second dose of Moderna on 4/16/2021. approximately 6 hours later began having bilateral leg weakness and numbness which worsened requiring her to come to ED for evaluation.
There is no adverse event noted at this time as the patient is doing well as of now since receiving the vaccine. This is a report documenting that patient was administered a bivalent Pfizer-BioNTech COVID19 vaccine inadvertently as his first dose of the primary COVID19 vaccine series. The patient was monitored for 30 minutes in the doctor's office with no immediate adverse reaction noted and later he was contacted by phone and was found to be doing well without side effects. This was the first dose of his primary series (i.e. his first ever covid vaccine) so monovalent Pfizer BioNTech vaccine would have been recommended. Per CDC guidelines, in this situation, since the primary and booster dosages are the same the bivalent Pfizer BioNTech COVID19 vaccine can be counted as a primary series dose. It is recommended that the patient complete the vaccination schedule (i.e. complete the primary series) with a monovalent Pfizer-BioNTech COVID19 vaccine in 3-8 weeks. Patient was advised of this and all further recommendations and all of his questions were answered. He was advised to contact his local health department for subsequent doses of his COVID19 vaccination due to office not having monovalent Pfizer-BioNTech COVID19 vaccine available.
Patchy localized erythema and tenderness at injection site. Total size 12x15cm.
TWO MINUTES AFTER THE MEMBER RECEIVED THE FLU MIST, HE HAD A LUMP IN HIS THROAT, DIAPHORETIC, HOT BODY.