chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bad fatigue for 2-3 days; right arm hurts all the time for 1 week; able to stick magnets unto his arm for 4 times; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (bad fatigue for 2-3 days), PAIN IN EXTREMITY (right arm hurts all the time for 1 week) and ADVERSE EVENT FOLLOWING IMMUNISATION (able to stick magnets unto his arm for 4 times) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C214 and 032621A) for COVID-19 vaccination.     The patient's past medical history included Mental disorder NOS (Patient stated that he used to take his mental health medications but has stopped 2-3 months now.). Concurrent medical conditions included Penicillin allergy.   On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced FATIGUE (bad fatigue for 2-3 days), PAIN IN EXTREMITY (right arm hurts all the time for 1 week) and ADVERSE EVENT FOLLOWING IMMUNISATION (able to stick magnets unto his arm for 4 times). At the time of the report, FATIGUE (bad fatigue for 2-3 days) and PAIN IN EXTREMITY (right arm hurts all the time for 1 week) had resolved and ADVERSE EVENT FOLLOWING IMMUNISATION (able to stick magnets unto his arm for 4 times) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported.   This case was linked to MOD-2021-221052 (Patient Link).
Patient reports chills, headache and fever even after taking Tylenol. Soreness and hot to the touch at the injection site - resolved after 24 hours. Swollen gland in neck - still present. Very lethargic for about 20 hours. Rash that started on trunk and moved to legs and arms that is still present. Patient wished all symptoms to be reported even after speaking with staff about how it is all to be expected.
I felt pretty lethargic in the weeks following after the second Pfizer dose and generally felt worse in the gym for several weeks, but I didn't really consider that it could have been the vaccine.  In July, I had palpitations, chest pain, and shortness of breath while at rest at work requiring labetalol and oxygen.  I was seen in an emergency room supposed to be admitted to hospital for cardiology for an echo and cardiac MRI, but I didn't have health insurance and was concerned about the bill.  I've been a paramedic for about six years to put the following statements in context- medical providers make the worst patients.  I didn't get any formal results from the hospital, but my 12-lead was a sinus rhythm with diffuse ST elevation with no reciprocal depression, heart rate around 140. I left the hospital AMA and took high dose aspirin (650mg 3 times per day) for two weeks.  I slept for about two days initially, and then had consistent lethargy to the point of getting out of breath washing the dishes or taking the trash out.  My symptoms were gone after 10 or 11 days and I stopped the aspirin a few days after that.  I have no cardiac history.
achy; tired; sore arm; it takes her system longer to recover from things; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "achy"; FATIGUE (non-serious), outcome "unknown", described as "tired"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; MALAISE (non-serious), outcome "unknown", described as "it takes her system longer to recover from things".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L045954 and expiration date 17-NOV-2017, lot # reported as M000997 and expiration date 07-JAN-2018, exact doses and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccines were exposed to temperature of 8.7 Fahrenheit degrees for 15 hours before administration to the patients. No previous temperature excursion was reported. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
There were no adverse reactions.  Patient denied being pregnant or the possibility of being pregnant on 1/27/10.  Patient then came into the GYN clinic on 2/02/10 for an exam and had a pregnancy test done and found out she was pregnant.  Pt's period was less than 3 days late.
Patient fainted after getting her first dose of covid-19 vaccine Pfizer, pharmacy called paramedic and paramedic informed us that patient had low blood pressure, and needed to be observed for a period of time. Pharmacy called mother and was told that paramedic told her she had anxiety attack due to fear of vaccine but not allergic to covid-19, mother also informed pharmacy there's no medication given to her daughter by paramedic, and patient was doing fine.
Elevated heart rate; that was floating heart that was all over the place it was inconsistent; my heart rate was at 150 and it was bouncing all over the place; white blood cells were high; Fever; temperature was 101; Headache; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program IBCC (Inbound Call Center for HCPs). A 66-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 04May2021 09:45 (Lot Number: ER8736) as second single dose at the age of 66-year-old for covid-19 immunization. Medical history included low thyroid/hypothyroidism. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for low thyroid/hypothyroidism, start and stop date were not reported. No prior vaccination within 4 weeks. The patient previously took BNT162B2 (Lot# EW0150) in left upper arm on 13Apr2021 09:45 am as the first single dose at the age of 66-year-old for COVID-19 immunisation. When after the patient get the second shot (05May2021) he had the fever and headache and held for two days and temperature was 101 Fahrenheit. Two weeks later (May2021), he ended up getting elevated heart rate for about two weeks. That was floating heart, all over the place it was inconsistent. And he had that about two weeks and he finally went to the hospital. The patient ended up in the hospital and they put him in for two weeks his heart rate was at 150 and it was bouncing all over the place and they send him home two days later. The patent still had the elevated heart rate. He was still taking medication for that he was going to back to the doctor for that in three weeks, not the 100 percent cured yet. He was still trying to be better. The patient was hospitalized for the event elevated heart rate from 02Jun2021 to 03Jun2021. Lab test showed the patient had a high rate of white blood cell. His white blood cells were high. Treatment for the event elevated heart rate included: two blood thinners, Eliquis 5mg, Metoprolol Tartrate 50 mg. Outcome of fever and headache was recovered, of heart rate increased was not recoevered, of white blood cells were high was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021660357 same reporter/drug/event, different patient
presented in office w/crops of vesicular lesions to lt arm only extending to hand;herpes zoster;tx w/zovirax, APAP w/codeine;
This case was reported by a consumer via call center representative and described the occurrence of erythema in a 76-year-old female patient who received Shingrix for prophylaxis. On 10th July 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In July 2018, 1 day after receiving Shingrix, the patient experienced erythema, pain, swelling, skin warm and pruritus. On an unknown date, the outcome of the erythema, pain, swelling, skin warm and pruritus were recovered/resolved. It was unknown if the reporter considered the erythema, pain, swelling, skin warm and pruritus to be related to Shingrix. Additional details were reported as follows: The reporter was the patient. She did report this to her pharmacist. The date of vaccination in left arm  was an estimate. She knew it was about 2 months before the date of reporting and could not provide a specific date. The day after the vaccination, a red, hot, itchy patch that was slightly swollen appeared about 3 inches down from the injection site. It was circular and about 3 inches in diameter. Less than a year vaccination, The patient also had some soreness and pain. It lasted about a week and a half to two weeks but had now resolved.
pt devel a rash w/lesions & white bumps following household contact w/another pt who recv varicella vaccine;
Both Lower Legs are swollen, pain below the knee area.  Unable to walk, feet. Boady pain.
Per Patient, was eating supper after receiving vaccination- noted he was having difficulty swallowing so stopped eating. Also noted that injection site was very swollen. Went home and was still having some issues breathing - used his CPAP machine while at home - had issues until about 5 am this morning. Never sought outside medical help. When patient called today (~11 am) he states he is fine now. No issues noted. I did tell the patient he needed to follow-up with his PCP and that in the future if anything like this happened again after a vaccination to seek immediate assistance.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 27-AUG-2015, the patient was vaccinated with improperly stored (Oka/Merck) PROQUAD with lot number: L007230, expiry date: 03-SEP-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Chills; Fever; Back pain reporting severe; This is a spontaneous report from a non-contactable consumer. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the arm left on 01Apr2021 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. It was unknown whether the patient had any allergies to medications, food, or other products. It was unknown whether the patient had received any concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 the patient experienced chills, fever and back pain (reporting severe). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events chills, fever and back pain (reporting severe) was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Early (4 days), heavy, longer then normal (8 days) painful period 2 days after vaccine.  Then another period started on cycle day 12.
@ 1720, while the patient was in her 15-minute post-vaccination waiting period, the patient experienced one episode of vomiting. After that ceased (roughly 15-20 seconds), she instantly self-reported feeling much better. (For context, the patient's mother is a organization member, and both her and the patient's vaccine were being filmed by the local media. Mom reports that her daughter vomits frequently from her undiagnosed neurological condition and feels that with the cameras and all going on around us, that the stress added to the way the patient was feeling). The patient was evaluated by the clinician's onsite (PA & RN); VS were taken, patient was monitored for 25 additional minutes and no further adverse events ever developed in that 25-minute period, including no additional bouts of vomiting.
sore right injection site shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right injection site shoulder) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore right injection site shoulder). At the time of the report, VACCINATION SITE PAIN (sore right injection site shoulder) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-289841 (Patient Link).
1 week after getting the second dose of the GARDASIL vaccine, my feet would go numb as well as my hands. The numbness would spread up and down my arms. I woke up about 2 weeks after the vaccine one night because my right arm had no feeling in it. I couldn't lift it either. It was very frightening. I lost sleep because I was so afraid of that happening to my arm again or that I would stop breathing. I would go entire days with my feet numb after that vaccine. 1 year later, I still wake up with numb hands and now my hands tremble on their own. It's cost me time and money. I've gone to several healthcare providers, including a neurologist. I've had to go to the ER too, twice. This vaccine has ruined my life. I went from no neurological problems to tons with one vaccine. When I told my nurse, they minimized it and said the vaccine didn't cause it. No one reported it or documented it. This vaccine is more insurance crap. It's hurting people. I'm afraid to get something as simple as a flu shot now because I don't know if it will harm me. I was never even told this could be a side effect. I'm very disappointed more action wasn't taken. This vaccine ruins people's lives.
This spontaneous report received from a Physician Assistant (also reported as Nurse Practitioner) refers to a male patient of unknown age. On 13-SEP-2013 the patient was vaccinated with the second dose of GARDASIL (dose, route, site of administration and lot # not provided). The first dose of GARDASIL was administered in 2010 (date unspecified). No adverse effect was reported. Additional information has been requested.
vaccine poured out onto her skin; aCCIDENTAL EXPOSURE / vaccine poured out onto her skin; redness and swelling below the injection site; swelling below the injection site; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 55-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (1st dose received on 28th July 2020, please refer the case US2020AMR197929.).   On 29th September 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season (intramuscular) and the 2nd dose of Shingrix .5 ml. In September 2020, 24 hrs after receiving Influenza vaccine Quadrivalent 2020-2021 season and Shingrix, the patient experienced erythema and swelling. On 29th September 2020, the patient experienced exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the erythema and swelling were not recovered/not resolved and the outcome of the exposure via skin contact and inadvertent exposure to vaccine were recovered/resolved.   It was unknown if the reporter considered the erythema and swelling to be related to Influenza vaccine Quadrivalent 2020-2021 season and Shingrix.  Additional details were provided as follows: The patient reported an accidental exposure from Shingrix.  The patient reported a pharmacist attempting to administer Shingrix, accidentally pulled the plunger out of the syringe, prior to administration and the vaccine poured out onto her skin, which led to exposure via skin contact nd inadvertent exposure to vaccine. The patient reports, the pharmacist proceeded to administer a flu shot to the same arm as well as a Shingrix vaccine. After 24 hours the patient reported redness and swelling below the injection site, which has not resolved.  The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR197929:same reporter
Vocal Fold Paralysis; This is a literature report.  A 45-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "End Stage Kidney Disease" (unspecified if ongoing); "Focal Segmental Glomerulosclerosis" (unspecified if ongoing), notes: 2/2; "kidney transplant" (unspecified if ongoing), notes: failed after 16 years, (on low dose tacrolimus) requiring to start, hemodialysis; "hemodialysis" (unspecified if ongoing). Concomitant medication(s) included: TACROLIMUS taken for renal transplant.  The following information was reported: VOCAL CORD PARALYSIS (hospitalization, medically significant), outcome "recovered", described as "Vocal Fold Paralysis". The event "vocal fold paralysis" required emergency room visit. The patient underwent the following laboratory tests and procedures: Laryngoscopy: widely patent airway with mobile vocal cords, notes: showed widely patent airway with mobile vocal cords bilaterally. Therapeutic measures were taken as a result of vocal cord paralysis.  Clinical Course: Patient had kidney transplant that failed after 16 years (on low dose tacrolimus) requiring to start hemodialysis presented to the ED with complaints of voice hoarseness with dysarthria and throat itching that started 30-45 minutes after patient had the first dose of Pfizer-BioNTech COVID-19 vaccine. She underwent Fiberoptic Indirect Laryngoscopy that showed widely patent airway with mobile vocal cords bilaterally (Vocal Fold Paralysis). Symptoms were thought to be secondary to a reaction to the vaccine vs mild GERD. She received steroids and was discharged home within 24 hours after symptomatic improvement on steroid therapy. Her voice normalized within a week. ; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported event-Vocal  cord paralysis 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.
First, vaccine caused pain. Second vaccine, caused patient pain and  to retain fluid. Patient had an MRI of shoulder and culture of fluid. Fluid tested positive for staph.. Patient was given doxycycline for 10 days. Fluid was drained at hospital. Patient was admitted for overnight stay. Patient has incision in front and back of shoulder. She was diagnosed with tendonitis.
Patient c/o sudden onset of lightheadedness f/b syncopal episode 15 min pta. Rec'd Moderna COVID-19 vacc yesterday. Has h/o HTN but has been refusing meds and chronic clinics since 2018. C/o SOB and upper back tightness. Responding nurse indicates pt's HR was initally irregular. Peripheral pulses thready. Unable to obtain BP.  18g IVs were placed in bilat ACs w/NS running wide open.  EMS was called. On arrival they attempted adenosine 16mg then 8 mg. Then patient was successfully cardioverted and taken to the hospital.
accidentally mixed ActHIB with sterile water instead of the diluent/no AE; Initial information was received on 02-Jan-2020 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to cases 2020SA002455, 2020SA002811, 2020SA002812, 2020SA004004, 2020SA004004 and 2020SA002456 (same reporter).  This case involves a 3 month old patient who received HIB (PRP/T) VACCINE [ACT-HIB] which mixed with sterile water instead of the diluent.  Medical history, medical treatment, vaccination and family history were not provided.  On 17-Dec-2019, the patient received a dose of suspect HIB (PRP/T) VACCINE (lot UJ175AAA, expiry date- 26-11-2020) via unknown route in unknown administration site.  It was a case of actual medication error due to wrong solution used in drug reconstitution.  At the time of report, no adverse event was reported.  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 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.