chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Could not get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Could not get out of bed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BEDRIDDEN (Could not get out of bed). At the time of the report, BEDRIDDEN (Could not get out of bed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported No treatment information was provided.   This case was linked to MOD-2021-194149 (Patient Link).
within a short  period of injection: low grade fever, chills, extreme muscle soreness, swelling at injection site (hardness of area too), redness, itching, swelling/pain of armpit, headache, lethargic, some insomnia, inability to move arm without significant discomfort. after 72 hours fever, chills, extreme soreness abated. It is now 120 hours (5 days), I STILL have redness, itching, swelling/mild pain of armpit, occasional headaches, still sore at injection site. please note I do not know the brand of the vaccine, only that it was a Tdap vaccine
Left arm hurt a lot for the first 4 days, all the way down my arm, past my elbow, then it went away. Still felt tender. Then around a week ago I started to feel weird tenderness around my elbow and now the whole arm is starting to go numb down to my fingers.
Case number PHEH2015US024109 is an initial spontaneous report received from a health care professional on 16 Nov 2015. This report refers to a 65 year old female patient. Medical history and concomitant medications were not reported. Her vaccination history included administration of FLUVIRIN (batch number: not reported) on an unknown date which was well tolerated. The patient was vaccinated with FLUVIRIN (batch number: 1516901) intramuscularly on 10 Nov 2015. On 12 Nov 2015, the patient experienced radiating pain into underarm and felt like lymph-nodes were swelling. Outcome of the events was not reported. Seriousness of the events was unknown. Causality was not reported.
Patient felt burning in left arm, and said he felt flushed approximately 15 minutes after receiving 1st dose of the vaccine. Patient refused transport to nearby hospital. He waited an additional 10 minutes before leaving.
Symptoms started 2 weeks after receiving the 2nd dose of the vaccine. The symptoms started as heart palpations that occurred at least once a day. The palpations have progressively become more frequent till they were occurring about 30-40 times a day. The palpations seem to occur more often with position changes but can, and do happen at any time. They occur when standing, walking, sitting, or laying.
Pain, swelling at inject site, l/deltoid, no fever, no abscess, no rash, adenopathy, hives.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.   Additional details were provided as follows:  The age at vaccination was not reported.  The patient received Shingrix about 3 months ago and experience a little bit of arm soreness.  The reporter did not want to provide the contact information for the pharmacy and did not want to answer any further questions.  The reporter did not want to provide personal address.  The reporter provided limited information.  For tolerances of 2nd dose, refer case US2020227529, reported by same reporter for same patient.   Sender's Comments: US-GLAXOSMITHKLINE-US2020227529: same patient.
I received my first Shingrix shot on Dec 30, 2019, and a few adys later started getting hives across my whole body.   The itching, and size of the hives, was not getting better, and I went to the doctors office after about 3 weeks later.  I was told it is unliekly that the Shingrix caused the hives (I was seen by Dr.), and to take OTC antihistamines.  I started taking approximately 1 Benadryl pill/day, and the hives were getting progressively better.  I received my 2nd dose this morning, and the hives have flared up significatly.  Both vacciens were administeted in my left arm.
Shingles; This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (Shingles) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  The patient enquired whether Is it safe to receive the second dose during a course of antivirals for shingles No treatment information provided.
ear pain; warm ear; she feels like it has some liquid; This case was reported by a consumer via call center representative and described the occurrence of ear pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th May 2020, the patient received the 2nd dose of Shingrix. On 9th May 2020, less than a day after receiving Shingrix and less than a week after starting Sudafed Expectorant, the patient experienced ear pain, skin warm and ear discharge. The patient was treated with pseudoephedrine, guaiphenesin (Sudafed Expectorant). On an unknown date, the outcome of the ear pain, skin warm and ear discharge were not recovered/not resolved.   It was unknown if the reporter considered the ear pain, skin warm and ear discharge to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 50 or 51 year. The patient reported that she had the second dose of Shingrix on Saturday.  That same day at night she started experiencing ear pain. The patient said  that she took Sudafed and felt better.  On Monday she had two doses of Sudafed instead of 3 and hear ear pain came back. The patient said that the first day it was a piercing ear pain.  Patient also said that her ear was also warm sometimes and she feels like it had some liquid. The patient did not want to share any information. In the source document the outcome of the events were reported as recovering but as per narrative it was captured as not recovered.
Information has been received from an office manager concerning a female registered nurse who is an employee in the office, who on 08-MAY-2009 lacerated her fingers of her right hand when she removed a broken vial of MMR II (Lot: 663766/0035Y) from the carton. The nurse did not have exposure to the vaccine. The nurse irrigated the lacerations, applied bandage and at the time of reporting was recovering. The office manager also reported 2 vials broken (two at the neck and one vial in the bottom) in 10 package carton, the location of the broken vials was in the middle and not in the corner of the carton. There was no damage to the carton. Additional information has been requested.
Flushing/sweating, dizziness, chest tightness. BP 162/110 (pulse 76). Final BP 153/104 (pulse 80). O2 sats 99%-100%. Apple juice and water given.
Developed new onset unilateral facial drooping, difficulty with eyelid closure, loss of nasolabial fold, and loss of forehead furrow on 3/7/2021 diagnosed as Bell's palsy
Server migraine, lost of appetite, nausea, vomiting, and muscle pain and aches
Big knot that was red, hard and warm to the touch that started 24 hours after the vaccine. He went to ER and was treated with cephalexin and hydroxyzine. The redness and warmth are gone. The knot is still there (8/12/13).
given the vaccine with wrong diluent with no reported adverse event; Initial information received on 07-Jul-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a patient of an unknown  age and gender and was given the vaccine with wrong diluent with no reported adverse event , while receiving vaccine YELLOW FEVER VACCINE - [YF-VAX].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received an unknown  dose of suspect YELLOW FEVER VACCINE - (with an unknown strength, formulation and route)  ( lot number and expiry date: not reported) for immunization.  The reporter informed that  immunization nurses called regarding the potential use of YF-VAX using a different diluent. Upon inventory, they found extra diluent without its corresponding vaccine and they are assuming that maybe it was given with saline water.  They were not sure who of the 11 patients that received the vaccine that day were given the vaccine with wrong  diluent.  On an unknown date the patient was given the vaccine with wrong diluent with no reported adverse event (product preparation error) (unknown latency) . The reporter claimed to have found an article stating that the vaccine is stable in sterile water for 1 hour and wanted to know if there was any  information that correlates to that.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (given the vaccine with wrong diluent with no reported adverse event).  Outcome: unknown.  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 guidelines. 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.
5min p/vax c/o light headed, h/a, ears & eye pain resolved completely p/10 min;
This spontaneous report as received from a consumer refers to herself, a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (frequency, route, lot # and expiry date were not reported) for prophylaxis. She reported that after receiving ZOSTAVAX, in June (year unspecified), that she came down with the shingles. She stated that this was "sheer suffering, the air hurt and spent days in agony". She noted that her blisters would weep fluid and she would have to put pads under her breast to absorb the fluid. She noted that some of her blisters were 2 inches by 4 inches and they did not resolve until February the following year. She states that she now has scars from the blisters. No treatment was given to adverse events. The outcome of herpes zoster was reported as recovered. The outcome of vaccination failure and emotional distress was unknown. The outcome of scar was considered to be not recovered. Causality assessment was not provided. No further information was obtained. No PQC filed. Therefore no VZV packet sent.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown date unspecified number of patients were vaccinated with a dose of PROQUAD (Merck) (lot number, expiration date, dose, route were not reported) that underwent a supported temperature excursion. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Case number PHEH2016US028148, is an initial spontaneous report received from a nurse on 24 Oct 2016. This report refers to a female patient of an unknown age. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with Influenza Virus Vaccine Unknown INN (manufacturer unknown, batch number: not reported) on an unknown date. The patient experienced vaccination site reaction. The outcome of the event was reported as completely recovery. Seriousness of the event was reported as non serious and causality of the event was not reported.
Patient hospitalized for complete AV block and bradycardia on 3/3/2021. Patient presented to the ED on 3/4/2021 for pacemaker failure and was subsequently hospitalized. these visits are within 6 weeks of receiving COVID vaccination.
Seizure, twitching, foaming at mouth, for 30 seconds. Tx: ED visit, saline IV, blood/urine test, EKG.
Immunization took place Wednesday, 26 Oct 2005 approx 5:30 PM. I felt fine during the rest of the evening. By early Thursday morning (27 Oct 05)I noticed my bottom lip seemed to be swollen as if I had a hive on it then at about 9:00 AM my voice became very hoarse which I thought was very strange, then my voice faded in and out,also with increased asthma difficulties. My voice is still raspy and fades in and out. My asthma is still troublesome as of todays date is 1 Nov 05. I felt that since the hoarseness is still me and asthma difficulties, I felt it was best that I contact your office about it. I do't have any idea how much longer this will last I'm hoping it goes away soon? I did not go to a doctor for it, I have been taking Benadryl to counter the reaction from it and primateen for the asthma.  I have had Flu Immunizations for years and this is the first time I have had any kind of reaction to it,which was another odd thing about this. My lip still is swollen but not big enough to create attention to it.
3DEC98 nausea/vomiting & h/a;4DEC98 mom related had a virus;
Reported that 11-year old male patient received the vaccines below. Presented to physician office today c/o bilateral weakness in both upper and lower extremities. Diagnosed as possible GBS and sent to hospital. 12/29/2008 MR received from PCP which include hospital records for DOS 12/17-20/2008 with D/C DX: weakness in limbs. Admitted from PCP office to r/o GBS due to onset of weakness 3 weeks ago which required help with ambulation and 1 episode of bladder incontinence. Some resolution on it's own, but still with intermittent episodes of weakness, requiring help with ambulation. Now with h/A, persistant pain in knees, legs and thighs and mild SOB.  PE (+) for decreased strength, borderline patellar reflexes.    F/U visit to PCP on 12/24/08-no muscle weakness. 1/15/2009 MR received for DOS 12/17-20/08 with D/C Dx: Weakness in limbs. Pt presented with intermittent weakness and pain. W/U (-).  Pain much improved.  Weakness unchanged. D/C to f/u with PCP.
Swollen itchy eyelids with slight watering eyes Benedryl tablets helped ease symptoms
Initial case received on 26 January 2010 from a healthcare professional.  At 12 years of age, a female patient received an injection (site and route unknown) of ADACEL, lot number AC52B077AA (not valid Sanofi Pasteur lot number) on 25 January 2007. The patient at 15 years of age, was diagnosed with pertussis by PCR positive test on 08 January 2010. She required a doctor's visit, but no further information was provided. The outcome of the event was unknown.  The reporter in this case also reported a similar event for another patient; this event is captured in case number 2010-00704.  Documents held by sender: none.
I had a case of shingles when I visited my primary physician for an annual check up on February 24.
2 days post  vaccination and every day since having headache, congestion, and soreness in joints
This spontaneous report was received from a nurse and health professional and refers to a year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 04-NOV-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck), lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
(L) deltoid red & itchy (5 1/4" x 5 1/2" area) warm to touch. The night of the vaccine date, the area was smaller. It continued to get larger and showed up today for us to look at it (6/9/11).
developed painful adenopathy in my neck and armpit at 5 days post vaccine (same side as shot) and a large local reaction at injection site at 7 days.
Pt complaining of very painful arm and numbness; pain is also radiating into neck. Pain started within a couple hours of the shot and is still persisting a month later. She saw her doctor and he told her the shot hit her radial nerve, and has recommended physical therapy and referred her to a neurologist.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for sleep apnea, pleural effusion, chronic systolic heart failure, esrd, diastolic heart failure, ckd stage 5, dyslipidemia , anemia, renal failure, obesity. Patient was on palliative care. Per note 5/7 "He was hospitalized in hospital 4/13-4/14/21 due to a non-functioning dialysis catheter. He has been sick much of the time since his IJ catheter was placed 9/22/20 and has not had a dialysis fistula placed. He has had multiple issues with his dialysis catheter due to clogging, including needing 3 ED visits, and had the clog dissolved most of the time. Nephrology successfully completed a dialysis session on 4/14 with removal of 7 pounds. He is being scheduled for an outpatient Vascular Surgery appointment to begin fistula creation. He was hospitalized in hospital 4/25-4/27/21 for management of volume overload. he was dialized on 4/26 and 4/27 without issues of catheter clogging. He had been planned for evaluation of his catheter but chose to return home and have the procedure as an outpatient. He was noted to have a R pleural effusion, but workup was deferred to PCP. He was discharged home after his volume status improved. His R IJ dialysis catheter was replaced 5/4/21. Per patient, it is now functioning normally. He met with his PCP on 5/6/21 for a followup. His wife reported concerns about his oxygen level, 92%. He does not use CPAP and sleeps when sitting rather than in bed. He is also craving salt and eating salt packets. He is not eating due to anorexia and he is not drinking supplements." Deceased 5/12 with no cause of death listed.
The patient was given a dose of Moderna 6 years - 11 years instead of a Bivalent booster
Acute neuropathy/GBS (357.OAP)/Rash mild form GBS, did not required treatment or hospitalization.
Pt recvd vax & seemed fine, however, approx 15 hrs later woke up w/tingling her lips, hands & feet; This condition progressively got worse w/light-headedness, dizziness, ringing in the ears, h/a, & burning in the feet, legs & buttock;
HCP calling to report AE for patient that received VARIVAX and then developed a rash/rash on both shoulders and arms and it was diagnosed as contact dermatitis/rash, contact dermatitis versus chicken pox; erythematous macules, likely varicella/rash, contact dermatitis versus chicken pox; This spontaneous report was received from a nurse and refers to an approximately 18-month-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. No known allergies reported.  On 06-OCT-2023, the patient was vaccinated with varicella virus vaccine live (OKA/MERCK) (VARIVAX) injection, valid lot #W034708, expiration date: 01-NOV-2024, administered in left thigh for prevention of varicella (strength, and route of administration were not provided).  On an unknown date in October 2023, the patient developed a rash. His mother, a 6-month pregnant female was exposed to the "varicella-like" rash (she had not received any company product). On 19-OCT-2023, the patient was seen in doctor's office for a rash on both shoulders and arms and it was diagnosed as contact dermatitis. On the same date, the patient then saw another provider in the same healthcare system, who noted it was "erythematous macules, likely varicella". The patient was seen again in the first office on 20-OCT-2023 and the provider's note stated "rash, contact dermatitis versus chicken pox". The patient was placed in varicella isolation and was prescribed diphenhydramine (BENADRYL) and a cream of unknown name. On 23-OCT-2023, a physician from the first office ordered a varicella antibody test for the patient which had yet to result. No other medical information was known. At the reporting time, the rash was still present. No side effects were reported for the mother.  The causal relationship between the events and varicella virus vaccine live (OKA/MERCK) (VARIVAX) was unknown.
she had a 103.5 temperature and her reaction was severe; This is a spontaneous report from a contactable consumer (patient's friend).   A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 10Apr2021 at age of 62 years old (Batch/Lot number was not reported) at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  Reporter stated that My friend received the Pfizer/Biontech COVID-19 vaccine yesterday, 10Apr2021. Today(11Apr2021) she sent me a text message saying she had a 103.5 temperature and her reaction was severe. Outcome for event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a office manager concerning a 13 month old female patient who on 08-FEB-2010 was subcutaneously vaccinated in the right arm with the first dose of VARIVAX (Merck) (Lot#665201/1294Y) 0.5 mL and concomitantly received a dose of PREVENAR vaccine on the same day. The office manager reported that on 23-FEB-2010, the patient presented to the doctor office with redness, blister like lesions and swelling at the injection site that looked like the bottom of a soup can. It was unspecified if lab tests were performed. The patient was treated with triamcinolone cream and would have the follow up visit on 09-MAR-2010. At the time of the report the patient was unknown. A lot check has been initiated. Follow up information has been received from a medical assistant who reported that the patient was vaccinated in the right leg (previously reported as right arm) with a dose of VARIVAX (Merck) (Lot#665201/1294Y) and was vaccinated with PREVENAR (Lot E07228) (previously reported as PREVENAR in the left leg. On 09-MAR-2010, the patient was seen by the physician, the patient had a rash on her right leg. The patient's parents were instructed to contact the physician if the rash worsened. It was noted that the patient had a follow-up appointment with the physician scheduled for 19-APR-2010. At the time of the report the patient outcome was unspecified. Additional information has been requested. This is one of several cases reported by the same source.
Within minutes, developed palpitations, got extremely dizzy and light headed, nauseated. Pulse was found to be irregular.  Within few hours developed fever, chills, headache, muscle aches.   Today is day 2, still having chills, headache, weakness, muscle pain and palpitations still ongoing. Light headed on sitting up  Right arm extremely sore,   Taking tylenol and motrin (1g and 800 q8hr)