chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine given 10/6. Onset of progress neuologic sx starting 10/18. Initially sensory loss w/ T6 level progressed to motor loss LE w/loss of bladder control. Transferred to hosp. 11/15. Current working diagnosis is Neuromyelitis Optica. 12/29/08-records received for DOS 11/15/08-presented with C/O bilateral lower extremity weakness with T4 down decreased feeling and electric pins in her back when trying to move. Bladder incontinence and bowel constipation times 2 weeks. All symptoms began on 1025/08 with bilateral foot numbness slowly went up her legs and subsequent fall. Assessment: plantar neuropathy. Hyperglycemia steroid induced.  Gait disturbance. Deficits of activities of daily living.  Loss of vision in left eye. 4/8/09-DC Summary 11/26-12/17/08-DC DX:Transverse myelitis. Paraplegia. Neuropathic pain. Urinary tract infection with Klebsiella pneumoniae. Urinary rentention/neurogenic bladder. Neurogenic bowel. Spasticity. Treated with plasmapheresis.
SWELLING TO EYES; RED ITCHY BLISTER LIKE RASH; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's past medical history included muscle ache, and concurrent conditions included high blood pressure, high cholesterol, thyroid disease, horseradish allergy, and cataract. The patient experienced drug allergy when treated with rosuvastatin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included amlodipine, ezetimibe, levothyroxine sodium, lisinopril, and rosuvastatin calcium.  On MAR-2021, the subject experienced swelling to eyes. On MAR-2021, the subject experienced red itchy blister like rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling to eyes on 2021, and was recovering from red itchy blister like rash. This report was non-serious.
fever; slight headache; This is a spontaneous report from a contactable consumer or other Non-HCP (patient's son).   Follow-up (16Mar2021) received from contactable consumer via from a Pfizer Sponsored Program was processed together with initial information.   A 56-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 01Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  On an unspecified date after the vaccination the patient had no symptoms however had a slight headache one day which went away. On 12Mar2021 the patient started having fever (around 100F). On an unspecified date the patient got tested for COVID-19, but it was negative. The patient was referred to their HCP. The patient's HCP told him that event was probably from covax. Patient asked if it was correct as he just started with a fever 4 days ago. Outcome of headache was resolved. Outcome of fever was not resolved.   Information on the lot/batch number has been requested.
pt said her arm was swollen and red with a tingling pain- she went to her doctors office and got a shot of steroid. Her arm is still swollen at this time.
The injection site, (left arm) is still sore and has occasional pain in it. was told that it would be a few days, is now a few months.  no treatment yet... hopefully this pain in the arm will go away, will mention it to my doctor next time I have an appointment. Worried about why there is still arm pain?
Initial unsolicited report received from a nurse on 15 JULY 2015. A female patient has received a dose of INFLUENZA QUADRIVAL A-B (batch number U5101FA, expiry date: 30 JUNE 2015, dose, dose in series and route of administration were not reported. in left deltoid on 22 JUNE 2015 at 12:37 hours. The patient was vaccinated at private doctors office/hospital. Patient's illness at the time of vaccination, pre-existing physician-diagnosed allergies, birth defects, medical condition and other medications were denied by reporter. On an unknown date, after vaccination, the patient developed pain in left shoulder (since three months) and there was no  swelling or redness. Laboratory  investigations and corrective treatments were not reported. At the time of this report, the outcome of the event was unknown. Documents held by sender: none. Follow-up report received from a physician on 18 AUGUST 2015. The patient's date of birth was updated (born on 31 DECEMBER 1992). It was reported that patient did not state that pain in shoulder was a pre-existing condition. Other vaccination within four weeks and other medications was reported as none. Illness at the time of vaccination was none. It was also reported that patient had received dose 7 of influenza vaccine. Laboratory investigations was reported as none. Final outcome was not reported as the patient did not respond event after leaving three messages.
SEVER pain lasting and still counting 4+ days.  Forgot to tell administrator that I previously had a left total TSA .
This case was reported by a healthcare professional and described the occurrence of hives in a 31-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). The subject's medical history included bee sting allergy. Concurrent medical conditions included asthma. Concurrent vacciantion included seasonal influenza vaccine (non-GSK manufacturer); typhoid vaccine (non-GSK manufacturer; oral) given on the same date as suspect vaccine. On 27 March 2014 the subject received 1st dose of TWINRIX (unknown route, right deltoid). On 29 March 2014, 2 days after vaccination with TWINRIX, the subject experienced hives and itching. The events resolved within 24 hours. On 30 March 2014, the events were resolved. After the next vacciantion with TWINRIX the events recurred. On 29 April 2014 the subject received 2nd dose of TWINRIX (unknown route, left deltoid). On 29 or 30 April 2014, 11 hours after vaccination with TWINRIX, the subject experienced hives and itching. The subject was treated with antihistamine. At the same time of reporting, the events were resolved. Follow up infromation received on 28 March 2014 from the healthcare professional: On 27 march 2014 the subject received 1st dose of TWINRIX (intramuscular, right deltoid). On 27 March 2014, less than one day after vaccination with TWINRIX, the subject experienced hives and itching. On 30 March 2014, the events were resolved. On 29 April 2014 the subject received 2nd dose of TWINRIX (intramuscular, left deltoid). On 29 April 2014, 11 hours after vaccination with TWINRIX, the subject experienced hives and itching. On 30 April 2014, the events were resolved. This case has been reported to regulatory authority.
pain in arm; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and influenza-like symptoms. On an unknown date, the outcome of the pain in arm and influenza-like symptoms were unknown.   It was unknown if the reporter considered the pain in arm and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not applicable for this report. The age group was not reported but was selected adult as per vaccine indication. The reporter stated that she knew other patients who received the Shingrix vaccine. After receiving the Shingrix vaccine, those patients experienced flu like symptoms and pain in the arm. The reporter did not provide any additional details regarding the other patients.
Initial report received from healthcare professional on 05 March 2014. A male patient (date of birth and age at the time of event were not reported), whose medical history was unknown and concomitant medication were not reported, had received intramuscular dose of FLUZONE , batch number: UH908AA (dose number was not reported) in left arm on 30 January 2014. It was reported that on an unspecified date, after receiving FLUZONE , the patient experienced pain at injection site while he was driving and has hands on the wheel. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was not recovered. Documents held by sender: none
Resident returned from her medical appointment and relayed d/t cold symptoms her PCP tested her for Covid and it was positive
22OCT91 low grade fever, 23OCT91 2PM-t105; Taken to ER 4PM t105.6-106;
Within 9 hours of receiving the vaccination, I noticed that my hands started hurting and my scalp itching.  I took a 25 mg. Benadryl tablet.  Hives were developing on my wrists and forearms.  Welts were forming in my scalp.  I rushed to the emergency room where at that time, I was developing large welts on my wrists, arms and forehead.    I was given 60 mg. of Predisone and an epinephrine shot (subcutaneous).  I was observed for about two hours and released home after the hives went away.  Upon returning home, I immediately went to bed.  It was about 10:45 p.m.  At 12:30 a.m. I woke up with severe itching on my fore arms, buttocks, rear thighs, waist, and scalp.  I immediately took a 25 mg. Benadryl and drove to the emergency room - a second time.    I arrived at 1:00 a.m.  I was escorted to a room where I was in a full blown allergic reaction.  My body was completely covered in rash/hives and welts formed in my head, neck, and back areas.  An intravenous line was started in my left hand, and I was given an i.v. push of pepcid.  I was also given an epinephrine shot in my left arm.  I was monitored for two hours and then they released me home.  I was prescribed a weeklong series of Pepcid (oral) and a three-day dose of Prednisone in case I experienced further problems.
This spontaneous report was received from a registered nurse and refers to a 19 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. It was reported that the patient received his first pediatric dose of VAQTA 25/0.5, on 16-NOV-2016 at age 17 years (route, frequency, lot/batch # and expiration date were not reported) and received the second pediatric dose of VAQTA lot# N023953 with expiration date of 05-NOV-2018 (route and frequency were not reported) on 12-JUL-2018 at the age 19 years old. No adverse effect was reported.
initially soreness @ site w/welt 24hrs later: sore throat, dizziness, drowsiness & body aches duration 1 wk;
Patient sat down to receive vaccination, no signs of nervousness and watched while the intern give the vaccination to him and then watched while the intern gave his sister the vaccination. Shortly after patient said he could not see very well and his face felt hot and funny. He started to cry and freak out a bit so he set him down in the chair and told him to breathe slowly and deeply.  The patient went limp, did not lose consciousness. We got the patient some water and some peanut butter crackers. The symptoms only lasted a few minutes but we had the patient stay for 30 minutes so we could observe him. Patient felt better and went home.
vaccine-related measles infection.   Patient was seen 4/8/2019, about 2 days after rash appeared, no fever.  She had a rash that had started on the scalp, was maculopapular and extended to her upper diaper area.  Rash was becoming confluent, no vesicles.  She also had watery eyes and erythematous papules on the soft palate.
For several weeks, starting on the day of the vaccine, I have been immobilized and barely able to walk. I have pain in my bones in my back and my legs, and my arms. Much pain in my neck and shoulder.
became unresponsive & no radial pulse;responded to precordial thump & subcutaneous epi;adm for overnoc monitoring;no cardiac or resp complication;appears to have complete recovery
The patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (The patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (The patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (The patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (The patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.).    No concomitant medications were reported.   It was reported that, nurses had no Standing orders other than what they had for the second booster, when first administering Bivalent boosters. So, they assumed the same dose as the second booster, hence they were administering 0.25 ml instead of 0.5 ml to uncompromised adults.  It was reported that approximately 100 patients were administered an invalid dose of the Moderna COVID-19 bivalent booster.  No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Master case
Scratchy throat, mild fever (100 degrees), vomiting, nausea, headache, diahrrea
reconstituted the Imovax vaccine; drawing it with a syringe the vial leaked/ leaking was coming through the previously pierced hole in the septum and that the cause was most likely because the needle guage provided in the kit with the Imogam was too large; Initial information received on 02-May-2019 regarding an unsolicited valid non-serious case received from a pharmacist by phone. This case involves a 20 years old female patient who was vaccinated with third dose of RABIES (HDC) VACCINE [IMOVAX RABIES] (Batch number: P1C851M and expiry date: 25-Sep-2020, dose, route and site of administration were not reported) on an unknown date.   The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   It was a case of potential medication error due to inappropriate reconstitution technique.  It was also a case of syringe leak.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.   Documents held by the sender: none.
sinus infection; COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report received from a contactable other healthcare professional (patient, physician assistant) reported for a 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiration date not provided), via intramuscular, in left arm, on 23Dec2020 (at the age of 48-year-old), at single dose, for COVID-19 immunization; and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiration date not provided), via intramuscular, in arm left, on 12Jan2021 09:30 (at the age of 48-year-old), at single dose, for COVID-19 immunization. Medical history included regional lymphadenopathy (on the left side where vaccine received), lymphadenopathy of the axillary and groin. She had to have lymph node biopsy. Patient reported she had a COVID 19 antibody test before she received the COVID 19 vaccine and it was negative. So she did have a baseline. Concomitant medications were not reported. The patient previously took flu vaccine (one flu shot, a long time ago). Patient had her second COVID 19 vaccine on 12Jan2021 and tested positive for the COVID 19 virus on 09Mar2021. She reported she was symptomatic but with the COVID 19 vaccine probably did not get as sick as she could have. She felt like she had a sinus infection (visit physician office) but never had a fever. She was seen at an Ear, Nose, and Throat doctor who diagnosed her with a sinus infection. The doctor prescribed a methylprednisolone (MEDROL DOSE PACK) and cefdinir 300mg one tablet twice daily for 14 days. She lost her taste and smell only after she started feeling better. The patient underwent lab tests and procedures, which included COVID 19 rapid test was positive on 09Mar2021 and an unknown date, COVID-19 PCR test was positive on three unknown dates. She had her blood drawn for a viral load. Event was reported as non-serious. The causality assessment between event "tested positive for COVID 19 virus" and vaccine was provided as "unrelated". The outcome of the event "sinus infection" was unknown; of other events was recovering.; Sender's Comments: Based on the available information, a causal relationship between the event vaccination failure with COVID-19 and probably associated sinus infection and the suspected vaccine BNT162B2 cannot be completely excluded. However, given the current SARs-COV-2 pandemic in country of incidence, there is an inherently higher risk of COVID-19 infection; and the efficacy of the vaccination may be affected by multiple factors.  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.
Pfizer-BioNTech COVID-19 Vaccine EUA: Vaccine recipient has a history of losing consciousness after administration of injections and drawing blood for laboratory work. He stated that he did not have issues after his recent seasonal flu vaccine. After administration of the COVID-19 vaccine, the vaccine recipient drank some orange juice. The APN who was monitoring him after vaccination watched him become unresponsive shortly after. The APN raised his legs in an attempt to stimulate him and check his pulse. A CODE-10 (Medical emergency for outpatient, visitors, and employees) was called. Vaccine recipient regain consciousness and refused to go to the emergency room for follow-up. The vaccine recipient felt better, checked out of the vaccine clinic, and walked out on their own.
PARTIAL DOSE ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 09-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-OCT-2021, the patient experienced partial dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose administered was not reported. This report was non-serious.
Numbness in right side of face. Tingling in both hands. Very sore muscles in shoulders and neck. Getting better as of 09/24/2011. Treatment was Advil every four hours or as needed.
Received Pfizer COVID-19 Vaccine and developed an for first-time a diagnosed skin auto-immune disease called Bullous Pemphigoid. This has damaged my skin with painful and itchy skin blister on my entire face, body, and extremities. This is negatively impacting my mental health. I received the Pfizer COVID-19 Vaccine from Hospital. I never had this skin issue and it started shortly after receiving Pfizer COVID-19 vaccine. Dermatologist performed Biopsy of Skin Blisters which confirmed the diagnosis of Bullous Pemphigoid. I have been taking months of oral prednisone & mycophenolate & topical clobetasol ointment to suppress the Bullous Pemphigoid. I am now immunocompromised and recently been experiencing falls and difficulty walking. I was hospitalized 2 weeks ago at Hospital and currently in a skills nursing facility receiving rehabilitation services.