chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very stiff fingers, toes; Very stiff fingers, toes and other joints immediately after waking up; like arthritis; This is a spontaneous report from a contactable consumer or non health care professional reported for himself. A 58-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262 and Expiration date was not reported), via an unspecified route of administration, administered in left arm, at 03:00 PM on 24Jan2021 (at the age of 58 years-old) as a first dose, single for covid-19 immunization at Public Health Clinic/Veterans Administration facility. The patient's medical history and concomitant medications were not reported. The patient past drug event included levoquin (allergies to medications, food, or other products). Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 31Jan2021, the patient had experienced very stiff fingers, toes, very stiff fingers, toes and other joints immediately after waking up, and like arthritis and patient got a little better during the day. The patient did not received any treatment for reported events. Seriousness reported as No. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Left thigh injection site erythema, non-tender.  Prescribed Augmentin; Zyrtec.
This is a spontaneous report from a contactable medical assistant calling on behalf of a physician. A 17-year-old female patient received TRUMENBA (Lot# L13515, Exp date Jul2016, NDC 0005010010), intramuscular in the left arm, on 29Apr2016, at 0.5 ml single. The patient's medical history was unknown. Concomitant medication included CYCLAFEM tablet, oral, from an unspecified date and ongoing, at 1 DF daily (1 mg (dot) 35 mcg), as birth control pill. On 29Apr2016 and for three days it was red and swollen on the upper arm and it was tender. The reporter considered the adverse events as related to meningococcal group b rlp2086. The events recovered. Follow-up (18JUN2016): Follow-up attempts are completed. No further information is expected.
Fully vaccinated patient who tested positive for COVID during routine admission testing at hospital.  Patient admitted through ED for hypoglycemia (30's) and hypoxia (84% on room air).  Patient does use O2 at home, but only when he sleeps.  Other than hypoxia no other s/s COVID.  Discharged home on day 3.
Information has been received from a physician concerning a 75 year old retired male who at 9:am on 5/30/06 was vaccinated, route unknown, in the right deltoid with a second dose of Pneumococcal 23v polysaccharide vaccine (lot 651322/1044P). Subsequently, onset date not specified, the pt developed right arm deltoid erythema, edema and pain on flexion and extension. On 6/3/2006 the pt recovered. It was reported that the pt was in for a routine physical exam. Ice and acetaminophen Tylenol were administered and a CBC was performed. It was noted that the pt did not experience any adverse events following the prior vaccination. The physician indicated that medical intervention was required (OMIC). Additional information is not expected.
Patient given the HPV9 vaccine #2 on 9/25/17 at 11 AM. Patient complained his (R) arm was sore, showed his mother on 9/27/17. He came into office at 11:00 AM on 9/28/17, was given MOTRIN and monitored for 15 mins before leaving.
Severe headaches, fever, lethargy, blurry vision, loss of appetite, rash.   Visit to Urgent Care advised to monitor closely and cease medications and vaccinations, control fever etc.  Patient has ongoing headaches, itchiness, blurry vision which weren't present prior to vaccination.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was reported as follows: The healthcare professional reported, that almost all of her patients she vaccinated with SHINGRIX complained about soreness in the arm where the vaccine was given and the symptoms lasted for up to 1 week. No further information was provided about each specific patient since it was too many to capture. This case was linked to case US2018106485, reported by the same reporter.
PT FELL TO THE FLOOR, DIZZINESS, PALE LIPS, C/O  CHEST TIGHTNESS. EMT CALLED, SYMPTOMS IMPROVED, REFUSED TRANSPORT, LEFT WITH DAD.
Patient called the Facility COVID-19 Nurse Holtline with post-dose vaccine related symptoms or guidance. He stated he just received the J&J covid vac Pt msg re: pause which prompted him to think of ongoing sx he has been experiencing after covid vac.  ?sob few days after vaccine, nausea, vomiting, fatigue, congestion, muscle aches (sx on/off since 4/1/2021)
3/20/21: Pt bib Medical Center via helicopter with c/o headache/ seizure. Per FR, pt was driving when she was witnessed by friend having a possible seizure. Upon arrival to ED, pt had second episode of possible seizure. Pt given Ativan, Keppra and thiamine in ED. Pt is AAOx4 upon arrival, speech mildly delayed. VSS at this time. Pt reports drinking a bottle of liquor everyday and states a PMH of alcohol withdraw. Progress note from 3/25/21: Neurological examination at this time continues stable. Patient underwent DSA yesterday with findings of left frontal lobe cortical vein thrombosis with hemorrhagic conversion. Documented that given timing of events, a consideration should be given to possible COVID vaccine related thrombosis and may advise against second dose of vaccine. EEG with no evidence of epileptiform discharges. Continues with intermittent word finding difficulties/confusion, but continues following all commands consistently. Possible that some component is also related to longstanding ETOH abuse? Pending discussion of findings with NES, apparently patient was reported to have episodes of irregular heartbeat during DSA?
This case was reported by a pharmacist via call center representative and described the occurrence of unresponsive to stimuli in a 3-year-old female patient who received ENGERIX B adult. On 19th June 2017, the patient received the 3rd dose of ENGERIX B adult 1 ml. On 19th June 2017, immediately after receiving ENGERIX B adult, the patient experienced unresponsive to stimuli (serious criteria GSK medically significant), limping, sweating, injection site pain, overdose and adult product administered to child. On an unknown date, the outcome of the unresponsive to stimuli, limping, sweating, injection site pain, overdose and adult product administered to child were unknown. The reporter considered the unresponsive to stimuli, limping and sweating to be almost certainly related to ENGERIX B adult. It was unknown if the reporter considered the injection site pain to be related to ENGERIX B adult. Additional details were provided as follows: The patient received the adult dose of the ENGERIX B at an age of 3 years, which led to overdose and adult product administered to child. The patient received ENGERIX B adult in the right arm. Within 40 seconds after the onset of limp and unresponsive, the physician was able to arouse the patient and found a heart rate. She was sweaty. The patient went home with mother. Less than a day after receiving ENGERIX B adult, the patient experienced sweating and injection site pain. The patient's mother called health care professional (HCP) and stated that the patient's right arm hurt and was laying around. The healthcare professional did not have details of vaccine batch number.
Initially, the first day as with the first dose, my left arm ached but this time it lingered for about 4 days. I was working a job that requires heavy lifting and at first thought it was the work, but after not working at all for about 3 days, my body would start aching all over. This is approximately 10 days after my second dose of Phizer. My bones ached, sort of like getting the flu. Late in the afternoons is when this pain would begin and by 7-8 at night, all I wanted to do was sleep. Each day, when waking most all the aching would be gone only to start up again about the same time in the afternoon/early evening. Last night, I went to bed about 7 pm and slept up until 6 am. As I am writing this, the aching is beginning in my arms again and I have tons of tiredness. It is 4:25 pm. and day 12 after the 2nd dose of Phizer.
24 hours after receiving #4 dose Anthrax, developed oral sores, perhaps Lichen planus or candidiasis.
Patient was given 0.2mL more than the ordered dose. Patient was seen by onsite NP. Patient asymptomatic. No negative outcome.
This spontaneous report as received from a healthcare worker refers to a 11 year old male patient. None of pertinent medical history and drug reactions/allergies reported. On 20-MAY-2014 the patient was vaccinated with a dose of GARDASIL lot # J011960, Exp date 08-JUN-2015, intramuscularly (dose unspecified). The patient was vaccinated with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and MENACTRA during the same visit on 20-MAY-2014 (dose and route unspecified). On 20-APR-2014 the patient reported that the injection stung. On 20-MAY-2014 the patient experienced redness and swelling in his lymph nodes in the axilla region of the arm in which he received GARDASIL. On 22-MAY-2014, the patient's arm is hurting so that he cannot move it and he was going to be examined by physician on the same day, the healthcare worker recommended that ice be applied to the patient's arm of discomfort, and no other treatment had been given at the time of this report. No laboratory tests were performed. The outcome of events were reported as not recovered/not resolved. Additional information has been requested.
I had Pfizer Booster shot and next I got Bells Palsy. Now my face is paralyzed one sided.
Information has been received from a Nurse Practitioner concerning a 12 year old female on 18-FEB-2008 was vaccinated with the first dose of GARDASIL (lot # not reported). The patient also received MENACTRA (lot # not reported) and ADACEL (lot # not reported) "at the same time." On 18-FEB-2008, "shortly after receiving GARDASIL", the patient "was pale and felt lightheaded." On 19-FEB-2008, "the day after receiving the vaccines, she blacked out while taking a shower and was still very pale. She did not hurt herself when she blacked out." The patient sought unspecified medical attention. Additional information has been requested.
2/10 ER note, 2nd covid vax on 1/7. Diagnosed with Covid on 1/9 after outbreak at mother's work. Nasal congestion/fatigue, recovered quickly. Began 2/4 with daily fever and fatigue, abdominal pain, reddened eyes and neck pain/tenderness upon palpation. Rash began today, 2/10.  MIS-C vs meningitis/encephalitis. Inflammatory markers significantly elevated, concerning for MIS-C, hemodynamically stable. Admitted. Urine & blood cultures ordered.   Work up confirms diagnosis of MIS-C, initiated treatment. He received IVIG, and IV steroids. Infectious disease was consulted forrecommendations,[SB.3] a[SB.4]nd followed along throughout hospitalization. Pediatric cardiology was also consulted per protocol.    With clinical improvement and improving inflammatory markers, he was transitioned to oral steroids with taper to complete his course for MIS?C treatment. To remain on ASA, prednisone until coronary arteries are reassessed, and he has normalization of platelets. Discharged home with planned cardiology follow-up.
Patient gave history of pain and swelling at injection site noticed 5 days after injection was given; did not return to me for evaluation, but reported reaction on next scheduled visit. Pain and swelling resolved without treatment but a 3 x 3 cm mass remains at the left deltoid injection site.
Swollen eyelids and lips starting about 1 hour after the vaccine, lasted about another hour
pt called office 23OCT96 stating arm red, swollen, & very painful pt instructed to call on 24OCT report progress if not improved to come to office;
Injection site erythema; Injection site swelling; Injection site inflammation; Vaccine Administered at Inappropriate Site; This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site inflammation and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site inflammation and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site inflammation to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received the Shingrix vaccination subcutaneously in left arm, which led to intramuscular formulation administered by other route. The patient experienced erythema, swelling, and inflammation at the injection site. The reporter was unable to provide any additional information. The reporter indicated that this case was initially presented by someone during a conference.  The reporter followed up to get the details and obtained the details at the time of reporting.  The adverse event was already reported to VARS (vaccine adverse event reporting system) as described by the reporter.  The reporter provided the patient's email address and was told she gave permission to be contacted. The reporter granted consent to follow up.
arm was on fire; She started to itch and got this big baseball size, a baseball or softball, whichever is the bigger ball, under her arm where the pharmacist gave her the injection.; She started to itch and got this big baseball size, a baseball or softball, whichever is the bigger ball, under her arm where the pharmacist gave her the injection.; This spontaneous report was received from a 74 year old  female patient via Pfizer with bronchiectasis and atypical mycobacterial infection.      On an unknown date, the patient was vaccinated with zoster vaccine live(manufacturer unknown) (strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis.    On an unknown date, the patient experienced her arm was on fire (feeling hot). She started to itch and got this big baseball size, a baseball or softball, whichever was the bigger ball, under her arm where the pharmacist gave her the injection (vaccination site mass and vaccination site pruritus). She went back to the pharmacy showed her arm and the pharmacist said that was not normal.  At the time of the report, the outcome of feeling hot, vaccination site mass and vaccination site pruritus was unknown.        The patient did not mention the causality assessment between the events and zoster vaccine live(manufacturer unknown) vacciantion.
The area of erythema measuring 13 cm long and 11 cm wide over the right deltoid with accompanying warmth and mild induration. Benadryl recommended with close follow up for progression.
pt recvd flu vax & devel an area of erythema & edema 1 1/2" in diameter 2 days later;
it started off with a light fever / then turned into a red mark on my arm! is now larger then the original day
Sore arm, 3:00 pm date of vaccine, mild soreness remains 2 days later; chills and fever began approx. 11:00 pm date of vaccine (T 99.8), fever 101.2 and 101.3, down to 99.5 with 2 Tylenol day after vaccine; chills lasted an hour; fever broke about 1:30 am 2nd day after vaccine. Temp normal 2nd day after vaccine. Mild fatigue 2nd day after vaccine.
patient received their first dose of MENQUADFI in October 2022, and then inadvertently received another dose of MENQUADFI early with no reported adverse event; the patient was supposed to receive the HPV vaccine, but she was inadvertently administered a second dose of MENQUADFI with no reported adverse event; Initial information received on 21-Apr-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 12 years old female patient who received their first dose of menquadfi in october 2022, and then inadvertently received another dose of menquadfi early and the patient was supposed to receive the hpv vaccine, but she was inadvertently administered a second dose of meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi] with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.   On 17-Apr-2023, the patient received  suspect meningococcal a-c-y-w135 (t conj) vaccine Solution for injection lot dose number 2 at dose of 0.25 ml (batch number: U7449AA, Expiry date: 23-Sep-2024) via intramuscular route in the left arm for prophylactic vaccination (immunization) and TB skin test (skin test)  On 17-Apr-2023 , patient received their first dose of menquadfi in october 2022, and then inadvertently received another dose of menquadfi early (incorrect dose administered) , patient was supposed to receive the hpv vaccine, but she was inadvertently administered a second dose of menquadfi (wrong product administered) (same day latency) with no reported adverse event.  Action taken was not applicable.   At time of reporting, the outcome was Unknown for both events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
V. high fever >104, Labored breathing, Decreased responsiveness, Excessive sleepiness.
Pt recv vax on 2/26/99; on same day pt exp inconsolable crying x 3 days
Ear infection; shingles; Dose 1 vaccination date 02Jul2021, Dose 2 vacciantion date 16Aug2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received bnt162b2 (BNT162B2), on 16Aug2021 as dose 2, single (Lot number: FC3182) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cold sores" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/lot number: FA6780, Location of Injection: Arm Left), administration date: 02Jul2021, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 16Aug2021, outcome "unknown", described as "Dose 1 vaccination date 02Jul2021, Dose 2 vacciantion date 16Aug2021"; EAR INFECTION (non-serious) with onset 01Sep2021, outcome "not recovered"; HERPES ZOSTER (non-serious) with onset 01Sep2021, outcome "not recovered", described as "shingles". The events "ear infection" and "shingles" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of ear infection, herpes zoster.  Amendment: This follow up report is being submitted to amend previously reported information: To update Events and letter.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300360474 Same product, patient, different AEs, different dose;
Less than 3 hours after 2nd Pfizer vaccination headache, chest pain, fatigue and ringing in the ears occurred.  Headache went away after 1 hour.  Fatigue and ringing of ears persist.  GP doctor prescribed asteroids  for ringing in ears and fatigue.  as of 4/29/2021 currently taking MethyIPREDNISolone tablets.
patient received her second shingrix immunization on 3/10. On 3/20 she called and expressed her concern for some possible side effects which she had been having since the vaccine. She said that the next day her right arm ( arm of administration) was swollen and red down to her elbow and that a few days later that her neck on that side was swollen in the area of her lymph nodes and that in the groin area that she also experienced what appeared to be a swollen lymph node. She also said that the area around her nipples became reddened and tender . She said all of this had gone away but that last night 3/19 that her eyes started itching profusely and were red at the corners. She said it felt lie pink eye; however , she went to eye doctor 3/20 and he said it was not pink eye (thought possibly allergies) but for her to watch it to see if it worsened. She was concerned as to whether these were side effects of the vaccine. I told her the localized reaction on her arm definitely was, and that possibly the others could be a reaction of her body trying to mount an immune response. She said she felt fine besides her eyes. I told her we would report to VAERS.
3/05 @ 9pm - pain on right shoulder (about a 4 for pain). 3/06 @ 4am - diarrhea that lasted until next morning. 3/06 @ 9am - pain on right shoulder, armpit, and back (about 8 for pain); chills, fever (98-99), and headache. 3/06 @ 6pm - pain on right shoulder, armpit, and back (about 6 for pain); chills, cold sweats, and fever (98-99). 3/06 - 3/07 - during the night a had fever, cold sweats, and chills. All my clothing, pillow, and bed sheets were wet on the morning. 3/07 @ 9am - pain on shoulder only (about 4 for pain), chills, and headache. 3/07 @ 9pm - pain on shoulder (about 2 for pain), chills, and headache. 3/08 @ 5am - pain on shoulder almost gone. Just tender to touch. Some chills still persist.
Within 10 minutes of walking my dog, my heart would start palpitating and beating to the point where I had shortness of breath and had to bend over...until it subsided.    Every day for 6-8 weeks straight my heart would start beating within 10 minutes of my walk beginning. We live on flat land so there was no extra effort required to walk and no other conditions. CAlled my doctor and he said it's probably nothing to worry about and keep an eye on it if if lasts another 4 weeks or so...by that time I stopped walking...and the palpitations eased as time grew between my vaccine and my condition so  I  didn't think anything of it...until I got my booster...then a couple weeks later...same thing happened...
Woke up with sever headache middle of forehead, never had a headache like this in my life.  Took Tylenol and seemed to help. Experiencing  extreme fatigue today (12/31/2020) and headache continues, not as severe as alternating Tylenol and ibuprofen  for the headache.