chrisvoncsefalvay/vaers-outcomes huggingface dataset:
doesn't remember anything; muscle spasms in back and legs; very tired; very sore; fever; grand mal seizures; sweating and being soak and wet; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (grand mal seizures) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Epilepsy (The patient has a history of grand mal, petit mal and stress seizures. Patient stated that he has at least one minor seizure once a month and the last seizure he had with this great intensity was about 3 to 4 months ago.) and Drug allergy (aspirin). Concomitant products included MIDAZOLAM for Seizure, CLOBAZAM (ONFI), ESLICARBAZEPINE ACETATE (APTIOM) and TOPIRAMATE (TOPAMAX) for an unknown indication.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (grand mal seizures) (seriousness criterion medically significant). 04-May-2021, the patient experienced HYPERHIDROSIS (sweating and being soak and wet) and PYREXIA (fever). On 05-May-2021, the patient experienced MEMORY IMPAIRMENT (doesn't remember anything), MUSCLE SPASMS (muscle spasms in back and legs), FATIGUE (very tired) and MYALGIA (very sore). On 05-May-2021, GENERALISED TONIC-CLONIC SEIZURE (grand mal seizures) had resolved. At the time of the report, HYPERHIDROSIS (sweating and being soak and wet), MEMORY IMPAIRMENT (doesn't remember anything), MUSCLE SPASMS (muscle spasms in back and legs), FATIGUE (very tired), MYALGIA (very sore) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Blood test: unknown (Inconclusive) Result not provided.         It was reported that the patient took midazolam and swiped his magnet across his vagus nerve stimulator (VNS) for treatment.  Action taken with mRNA-1273 in response to the event was Not Applicable   It was reported that the patient was asymptomatic after first dose and experienced symptoms on 04May2021 at midnight after second dose of vaccine.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The medical history of epilepsy was assessed as strong cofounder.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The medical history of epilepsy was assessed as strong cofounder.
It felt like the flu. Tired, chills, low grade fever, dizzy, nauseous. Headache. Lasted about 24 hours.
Injection site was inflamed and arm below injection site was swollen and had a big knot. Overnight Friday Nov.21-Saturday Nov.22 my left arm was painful, numb and tingling from shoulder to fingertips, which persisted into the following day but not with the severity of the night. Went to emergency since clinic was closed. Was treated, released and given RX for antibiotics.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 77-year-old male patient who received Shingrix for prophylaxis. On 5th June 2018, the patient received the 1st dose of Shingrix. On 5th June 2018, couple of hours after receiving Shingrix, the patient experienced injection site pain. On 9th June 2018, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Shingrix. Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported, but it could be 76 or 77 years. The patient experienced soreness at the injection site within a few hours and persisted for 3 to 4 days. The event was resolved without sequelae. The patient denied permission to contact their physician. The patient declined to provide any contact information for follow-up including date of birth. The patient did not have lot number or expiry date of the vaccine. This case was one of the 2 cases, reported by the same reporter.
Patient is a paraplegic female who complained of worsening tone/rigidity in bilateral lower extremities after receiving an influenza vaccination 11/12/07.  There was no pain due to hemiparalysis, but a therapist suggested possible adverse event.  The patient has received other vaccinations at this location with no reported complications.
syringe leaked as it was being administered, then administered using new prefilled syringe; Syringe leaked as it was being administered; Product Complaint; This case was reported by a other health professional via call center representative and described the occurrence of accidental under dose in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXC05AA, expiry date 31st March 2023) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced accidental underdose, syringe leak and pharmaceutical product complaint. On an unknown date, the outcome of the accidental underdose, syringe leak and pharmaceutical product complaint were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-May-2022 Reporters comment: The Health care professional (practice manager) was the reporter. Neither she nor anyone else has previously reported this complaint to our company. The reporter stated that the syringe leaked between the needle and the syringe's luer lok tip as it was being administered. The reporter stated that the leak occurred after the needle was inserted into the patient's skin and as the plunger was being depressed. The reporter stated that the experienced nurse felt the patient didn't receive much of the dose (related adverse event: partial dose).  The reporter stated that the dose was then administered using a new prefilled syringe. The reporter confirmed all operations were performed appropriately before defect discovered. The following questions were asked. The reporter asked where did it leak, at the luer lok tip, between needle and syringe. Was the syringe pre-assembled with needle some time before administration: NO, just prior to administration. What size gauge needle was used: 25Gauge. Was the blister and/or carton damaged: No. If leaking from plunger stopper, are there any liquid traces observed on the plunger stopper rings: n/a. Was the luer lok damaged: No. Was the needle which was used, available: Yes. Will return to GlaxoSmithKline with syringe. Was there any damage/breakage on the syringe barrel: No. The suspect product was available and the doctor's office will return the syringe with needle and the box to GlaxoSmithKline. Reporter requested to send return shipping label/packaging to Health care professional (reporter). The reporter consented to follow up with Health care professional. Additional Supportive Information: The patient did not receive the full dose of Bexsero, which led to accidental underdose.
Late menstrual cycle (3weeks), chills, body ache, sore throat, running nose.
Sedation, Myalgia, Fever, Chills Narrative:  On 1/27/21, 12-13 hours after 2nd dose, awoke with myalgias, feeling cold/shivers, fever up to 101. Symptoms lasted until 1900 on 1/27/21. Left work early on 1/2721 due to worsening fatigue and myalgias. No known prior COVID infection.   Other Relevant History:
This spontaneous report was received from a nurse regarding an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date in December 2015, the patient was vaccinated with 1st dose of GARDASIL 9 (dosing details not known) and then received the 2nd dose of vaccine in July 2016; this is outside the recommendations per the GARDASIL 9 prescribing information. No adverse effects reported. No Product Quality Complaint (PQC) involved. Additional information has been requested.
Condition with dementia has gotten worse; Could not walk straight; A spontaneous report was received from a consumer concerning a 73-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and noted that her conditions with dementia has gotten worse/dementia aggravated and could not walk straight/gait disturbance.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter. Her current condition included dementia.  On 07 Mar 2021, the patient received her first of the two planned doses of mRNA-1273 (batch number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On 07 Mar 2021 conditions with dementia has gotten worse and the patient can't walk straight.  Treatment information was not provided.  The action taken with mRNA-1273 in response to the events was unknown.  The outcomes of the events were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
patient already got the first and second dose of the vaccine and that tested positive to Covid-19 weeks ago; patient already got the first and second dose of the vaccine and that tested positive to Covid-19 weeks ago; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A 14 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) at the age of 14 years (as reported) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "patient already got the first and second dose of the vaccine and that tested positive to Covid-19 weeks ago". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The reporter wanted to know if the patient could receive the booster dose of the vaccine.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Rotarix third dose given; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 6-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 47YIA) for prophylaxis.   On 27-MAR-2023, the patient received the 3rd dose of Rotarix lyophilized formulation. On 27-MAR-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced extra dose administered (Verbatim: Rotarix third dose given). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-MAR-2023 The reporter called and reported that a third dose of Rotarix was administered to a patient, which led to extra dose administered. The reporter consented to follow up via mail. No expiry date reported date reported by health care professional
Patient developed redness in neck and chest area about 2 minutes after receiving the Moderna vaccine. Slight swelling was observed in neck area and throat dryness was mentions. Patient displayed no issues with breathing. Patient was observed for 30 minutes with symptoms diminishing to very little redness.
This spontaneous case, received on 15-Oct-2018 from a pharmacist (initial and follow-up 1 combinedly processed), concerns a 37-year-old, adult male patient. On an unspecified date, FLUCELVAX QIVc vaccine reached maximum temperature of 56 Fahrenheit and was out of the recommended storage conditions for 8 hours, which was reported to be the first excursion. On 13-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: 30-Jun-2019] which was stored inappropriately. At the time of this report, no adverse events were reported. The reporter assessed this case as non-serious. This case 201804540 was cross-linked to source case: 201804533 due to same reporter.
Side Effects: Headaches, Dizzness/ Syncope, Opposite arm pain, wrist pain,  (R) shoulder blade pain and stiffness. Painful non healing rash on buttocks, Rash on (L) arm, large lump on (R) side lower back of head DR's Visit ER Visit
5 days p/vax adm noticed itching, then redness & edema;has inc past 2 days;feels warm to touch @ inj site
10/30/2021 I began having a migraine., that latest for off and on till Nov 3rd when it turned into Vertigo.  I have dizzy spells off and on. I went to the ER on Nov 7th.  The ER gave me a migraine cocktail that latest till today on Nov 19th, 2021, also they gave me a patch behind my ear and that lasted for 3 days. The Vertigo still comes and goes but the migraine I have not had since Nov 7th. On Nov 9th went to see a doctor she gave me medication for the Vertigo.
One week after the second vaccine I developed Bell's Palsy; This is a spontaneous report from a contactable other health professional reported for himself. A 30-year-old male patient received second dose of bnt162b2, via an unspecified route of administration in left arm on 11Jan2021 11:00 at single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included terbinafine, cetirizine hydrochloride (ZYRTEC), multivitamin. The patient previous received first dose of bnt162b2, via an unspecified route of administration in right arm on 21Dec2020 11:00 for covid-19 immunization. The patient experienced one week after the second vaccine, he developed bell's palsy on 18Jan2021 with outcome of not recovered. The event was reported as non-serious. The adverse event result in a visit to emergency room/department or urgent care. Treatment Prednisone, valacyclovir was received for the adverse event. Facility where the most recent COVID-19 vaccine was administered: School or Student Health Clinic. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported event Bell's palsy. 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.
Upon leaving the store approximately 15 minutes after receiving vaccination, patient told her father that she felt she was having an issue with her vision and was feeling faint.  Her father was able to support her as she fainted and was lowered gently to the ground in front of the store.  A pharmacy technician was leaving the store simultaneously and upon witnessing the event ran back to the pharmacy to tell me I was needed to assist.  When I arrived, the patient was alert and breathing and able to answer questions regarding personal information, date, time and location.  Patient stated she felt normal other than some tingling sensation in her hands.  Patient reported that she hadn't eaten anything since waking up that morning.  EMS was already en route, and I observed the patient until they arrived.  Patient has since been transported to the hospital and is currently reported in stable condition.
This patient had a severe headache, fever to 104 and lethargy beginning approximately 24 hours to 36 hours after Typhoid immunization was administered. On exam, no other illnesses were obvious.
Information has been received from a certified nurse practitioner (C.N.P.) concerning an 18 year old female with asthma who on 21-OCT-2009 was intramuscularly vaccinated with the second dose of 0.5 ml GARDASIL (lot # 0702X/ exp. 08-SEP-2010) in left deltoid.  Concomitant therapy included albuterol.  The patient received the first dose and the second dose at the university where the patient was a student.  No other vaccine was given at the time of the second dose on 21-OCT-2009.  ADACEL was to be administered, but it was not given due to the patient's events immediately following the GARDASIL dosing.  The reporter stated that the patient experienced syncope and tonic-clonic like seizure activity after receiving her second dose of GARDASIL on 21-OCT-2009 (date of dose 1 was unspecified).  The patient reported that she remained in the provider's (unspecified) office until she recovered from her adverse effects.  On 21-OCT-2009, the patient had recovered from syncope and tonic-clonic like seizure activity.  Upon internal review, tonic-clonic like seizure activity was determined to be an other important medical event.  No further information is available.
subjective fever, myalgias, arthralgias, weakness, fatigue, nausea.
Student had varivax immunization and had clinical varicella 11/24/03-went to MD 11/25/03 with diagnosis with varicella.
Patient is a 95 y.o. female patient of MD with history of HTN, HLD, Afib, UTI who presented to Hospital with lethargy, poor intake in the setting of recent COVID diagnosis. Family ultimately decided to change to DNRCC on 1/3 and pursue Hospice.    Goals of care Comfort care Discussion at bedside with 2 children on 1/3 They have noticed a severe decline in function, nutrition and quality of life since her hip fracture in 11/2022 Had been getting oxycodone at ECF prior to admission -- currently complaining of "pain all over" Family desired change to DNR-CC  Hospice has accepted and will provide services at LTC once able to return out of COVID isolation Discontinued most medications including remdesivir as pt wants to limit pills Added oxycodone and anxiolytics PRN (OK for no IV) Palliative care consulted for assistance with hospice diagnosis  Discharge to ECF with hospice    Covid-19 Virus Infection Date of onset of symptoms: circa 12/31 Symptoms present on admission: poor appetite, decreased LOC Date of covid positive test: 1/1 at SNF (unable to obtain test result electronically to scan into chart) -- > repeat COVID test positive (1/3)  Vaccination status: vaccinated Imaging: CXR "vascular congestion" Oxygen requirements on admission: RA Current oxygen requirements: 94% RA Medical therapy: Remdesevir started per ID -- > stopped 1/3 End isolation on 1/11   Fall, initial encounter Inpatient fall on 1/6 from bed with +head trauma Complaining of R shoulder pain and with small forehead hematoma Shoulder XR -- non-acute Will hold on CT head given DNRCC and not going to change management Fall precautions, pain control as above   Acute UTI Candiduria Significant pyuria noted with many bacteria and rare yeast Pt denies urinary sx but is confused and unreliable Ucx with >100 candida albicans Stopped ceftriaxone Discussed with pharmacy -- start fluconazole for now given this may be contributing to her discomfort   Dysphagia Severe protein calorie malnutrition with cachexia Appears cachectic with muscle wasting, underweight on admission Did not tolerate recent mirtazapine per son Noted dysphagia for last month or so per family and currently tolerating little to no PO intake Should qualify for Hospice on this alone Will give gentle D5 gtt for now Family opting for DNRCC so hold on SLP consult and provide MDD diet   Acute metabolic encephalopathy Decreased responsiveness, arouses but oriented x 0 Normally conversant per son but has been steadily declining since hip fracture with poor nutrition Due to COVID, UTI, dehydration Family states she was doing well after recent sx for hip fracture, but got worse after Remeron was started for appetite, which has happened to her before Remeron added to allergy list due to worsening confusion with medication
Large red swelling of arm/upper arm 12x10 cm in diameter at site of injection.
2 days after vaccine, rash described as large mosquito bites will occure anywhere on her body resolve within 24 hours only to return in a different area.  have occurred on palms and head  as well as most other areas
received one dose of Shingrix / intramuscularly in the gluteal area; This case was reported by a nurse via call center representative and described the occurrence of vaccine administered at inappropriate site in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix (intramuscular). In October 2020, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the vaccine administered at inappropriate site was unknown.  Additional details were provided as follows: The age at the vaccination was not reported. The patient received 1st dose of Shingrix in the gluteal area, which led to vaccine administered at inappropriate site. No adverse event was reported. The reporter did not consent to follow up.
(L) upper arm pain, swelling and decrease ROM. Left shoulder began 3 day after injection. Pt has been going to physical therapy.
The primary reporter is the pharmacist. She reported that M-M-R II (dose, strength, route and lot # was unknown) had been exposed to 48F for 48 hours, and was unsure if it had been administered to any patients. Additional information is not expected.
Second Dose of Pfizer exactly 48 hours later I had really bad joint pain in the hands and feet. The feet pain did go away pretty quickly., however, my hands have remained with pain since. I went to my pcp first and then was sent to a rheumatologist for further investigation. I did have an MRI on my hands and also had many blood tests as well. The findings stated that there was no visible damage to joints and bones and did not find any inflammation markers in blood as well. The pain is typically worse at night and if I am sitting and reading it would flare up in pain.  It would also wake me up in the middle of the night if I was moving around at all in my sleep.  I did have reconstructive surgery on my right wrist with no prior pain  and the pain is mainly located in my fingers.  The main hand with the most pain is my right hand while my left hand's pain level has gone down significantly. My pain level on my left hand would be around 1-2 and my right hand is around a 3-4. I was prescribed Gabapentin for the pain however it doesn't seem to help at all and the only recommendation was to use a a compression wrap as well.  No visible signs of inflammation from skin level when flare ups occur.  I did receive Johnson & Johnson vaccine for my booster and had only flu like symptoms occur for a few days.