chrisvoncsefalvay/vaers-outcomes huggingface dataset:
64 yo M with prior h/o GBS, presenting with rapidly progressing generalized weakness. For the past week patient has been having nausea vomiting . He was tested for Covid which was negative. Symptom eventually resolved by Thursday. Friday night he started complaining of some heaviness in his legs, but still was able to ambulate on his own. Saturday morning became much more weaker all over, needed some help from his wife to get into the car. He initially presented to ED on Saturday, it was felt that his weakness was due to dehydration, he was discharged home. However after getting home he became much weaker all over, and was unable to walk at all. He was brought back to ED, and subsequently transferred to ICU. On admission to ICU here, per H&P, he was still able to speak in full sentences, swallow, shrug shoulders. He had CTA, MRI C spine w/wo contrast, MRI T spine w/o contrast (unable to tolerate further), which were all unremarkable. LP was obtained which showed 9 nucleated cells, 48 protein, 74 glucose, neg meningitis/encephalitis panel. Today, he has significant bulbar weakness, but was mouthing words and responding appropriately and consistent on my initial evaluation. But toward end of my evaluation, he became obtunded and very labored breathing. He was intubated emergently. Of note, patient had GBS in 2001 after Giardia infection. He received PLEX, and recovered completely. Prior to current presentation, in mid Feb, he had received his Shingles vaccine, did not have any symptoms after, until NV started a week ago.
3 days after mist, increased T 102.9, cough, H/A, vomiting, increased HR to 120-140, went to ER for IVF. Fever last for 2 days, now with residual cough.
The day after the vaccination I was violently ill with nausea, vomiting, diarrhea, and massive body aches. These subsided about 24 hours post injection. Six weeks after injection I began have dizzy and fainting spells. I went to my PCP and was referred to a neurologist. After many tests I was diagnosed with Steroid-Responsive Encephalopathy Hashimoto.
Headache at night / with disrupted sleep (08/25/14) following vaccine admin. Awoke next AM with sore throat/nausea (08/26/14) parent gave patient TUMS PO.
Mild fatigue starting around 3 hours later and lasting 1 day. 2 days later rash around injection sight with no itching, and lymph node under armpit right side sore.
Lapses in mental acuity and memory.  I did not recall an event that occurred less than one month prior associated with the purchase of a stock.
This person was given a second bivalent booster dose.  The patient didn't remember getting the first one, did not bring her card with and the nursing home where she lives signed her up to have this shot and didn't realize she already had a bivalent booster dose.  The person has had no side effects and has not had any problems since receiving this vaccine.  This is being reported as an administration error.  There are NO adverse side effects.  The other bivalent booster dose was given on 10-13-2022.
Could not move from the neck to just below hips. I continue with residual pain in the left hip.
Started as a skin itch at wrists, neck and around hairline of face.  Then as weeks passed it moved to include my thighs, shins and arms.  Not at first, but eventually, small bumps appeared (almost indiscernible).   About a week ago, for one day, my body got hot as if my skin was reacting to niacin, (underlying burning sensation but not painful).  It felt like my immune system was reacting and fighting back.
she stated she had arm pain that night, unable to sleep well due to arm pain, unable to lay on that side and it continued.  On 10/16/2018 she stated it was difficult to lift her arm above her head, and difficult to dress.  She was offered P.T., but declined.  Stated she has been taking Ibuprofen and doing stretches.
shoulder muscle pain occurs when patient rotates and/or lifts arm beyond certain points. Per patient, started after having the vaccine and has not subsided
No adverse event; We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) 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 EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    No relevant concomitant medications were reported.  2 administrations of 17 Jun 2023 and thaw date was 10 Jun 2023. No treatment medication reported.    This case was for the 14th patient out of 30 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live Follow-up received include Vaccine information reported and inarrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (Patient 1)
lyophilized powder of menveo was reconstituted with sterile water and administered to a patient; lyophilized powder of menveo was reconstituted with sterile water and administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 13-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: lyophilized powder of menveo was reconstituted with sterile water and administered to a patient) and inappropriate dose of vaccine administered (Verbatim: lyophilized powder of menveo was reconstituted with sterile water and administered to a patient).The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 18-AUG-2023 The reporter called to report that the lyophilized powder of Menveo was reconstituted with sterile water and administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. More details were asked but reporter declined because event happened at a different facility, so no information was available. The reporter consented to follow up via email.
I woke up the next morning with COVID-19 like symptoms, respiratory, headache, fever, chills and my arm was really sore, and I could not move it very well. Three days later, all of the symptoms were gone except the arm pain. It has remained consistent for the last year. I can move it, but I can't reach up over my shoulder height. I can barely lift it at all or reach behind me. Couldn't turn it. Very restricted range of motion. I was just living with it waiting for it to go away until I finally decided to talk to someone about it because it wasn't going away. My doctor referred me to  Orthopedics. And I had a chance to see Doctor I saw him on March 23, 2022. Finally got around to doing something about it. He gave me a cortisone shot after he indicated it was rotator cuff impingement and he noted that he' s seen this before and its an inflammation that can happen from vaccinations. And it doesn't go away unless you do something about it. He gave me the options of using ibuprofen over time or a cortisone shot, so I chose the cortisone shot and it helped quite a bit then referred me to physical therapy with. The physical therapy should be able to restore most if not all my range of motion. It's still painful but were working on it. I still have a restricted range of motion, but ill work through it. They said it was stiff tendons and muscles, but there's nothing wrong with me, just need to do repetition exercises to get the range of motion back.
Rash (raised, red dots) on leg at injection site and low grade fever, fussy for a few days, mom has now noticed a café au lait spot that she hadn't noticed before.
No adverse events. Patient was given a DT vaccine instead of a DTaP vaccine. Parents were notified and mother brought her daughter in the office for the DTaP.
Vaccine administered 3 days after puncturing the vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 3 days after puncturing the vial) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 3 days after puncturing the vial). On 20-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 3 days after puncturing the vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up contains updated event verbatim.
following vaccine administration, patient verbalized dizziness and became pallor. rapid response team notified for further disposition. patient denies chest pain, SOB, N/V. patient remain AAOX3 with no LOC. treatment resolved with no ED escalation. Patient exited vaccination area ambulatory with no concerns.
Pulmonary embolism causing acute cor pulmonale causing syncope and resulting in ankle fracture Treated with heparin and transitioned to Eliquis Discharged to rehab and now doing better at home
Acute superficial vein thrombosis.  Nodule formed  on the back of the right leg which decreased in size after 2 days after initial symptoms. A bruise was formed in the surrounding  area the next day. Four days later the bruise became larger so I decided to go to the ER where they did an ultrasound. Deep vein thrombosis was ruled out. I was sent home and recommended to wait for the symptoms to go away, no medications were given. I?m still recovering.
no adverse effects; the patient was administered expired MMR II; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 29-JAN-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # R000555 and expiration date 08-JAN-2020 (expired product administered), for prophylaxis (dose strength, frequency, and route of administration were not reported). Sterile diluent, lot# N032755 and expiration date 04-AUG-2020 was used to reconstitute the vaccine.  The patient experienced no adverse events.
COVID 19 Treatment; COVID 19 Treatment; brand=Pfizer / BioNTech, brand other=Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Jun2023 as dose 6 (booster), single (Lot number: gl2042) at the age of 71 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Nov2022 as dose 5 (booster), single (Lot number: 052d22a) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "glaucoma" (unspecified if ongoing), notes: other medical history: glaucoma; "prostatectomy" (unspecified if ongoing), notes: other medical history: prostatectomy. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Jun2023, outcome "unknown", described as "brand=Pfizer / BioNTech, brand other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received other vaccination and did not receive any other medication in 2 weeks. Paxlovid was given as treatment for COVID-19 from 24Aug2023 to 29Aug2023. The event was reported as Covid rebound. Positive covid test, very runny nose, persistent cough. No fever or achey leg muscles like the first go-around. Patient did not have any known allergies
UKNOWN - SAW ON SOCIAL MEDIA THAT PATIENT PASSED AWAY ON 4/1/2021
FEVER, CHILLS, BODY ACHES, LEFT KNEE PAIN AND EFFUSION
VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9/.12.23 LATE AFTERNOON.
Pt reports broke out in small blisters on abdomen 2 days after receiving varicella immunization. Stated blisters itched but no fever noted. Today in clinic noted scabbed areas on abdomen.
patient was supposed to have Tdap, but instead received Tenivac, with no reported adverse event; Initial information received on 25-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 68 years old female patient who was supposed to have tdap, but instead received tenivac, with no reported adverse event ,while receiving vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past vaccination(s) included DAPTACEL in 2013. The patient's past medical history, medical treatment(s) and family history were not provided.   On 09-Aug-2022, the patient received a total dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT( lot U7183AA and expiration date: 24-Sep-2023) at a dose of 0.5ml via unknown route at an unknown administration site for immunization.  On 09-Aug-2022 (Latency: same day), the patient was supposed to have tdap, but instead received tenivac, with no reported adverse event (wrong product administered) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  Action taken:not applicable  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.
hearing loss; vision issues; neurological issues; pain; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a currently 76-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 17-FEB-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as subsequently, the patient was treated for the following injuries resulted from zoster vaccine live (ZOSTAVAX) use: hearing loss, vision issues, neurological issues and pain. The outcome of deafness, visual impairment, nervous system disorder and pain was reported. The reporter considered deafness, visual impairment, nervous system disorder and pain to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, deafness  was determined to be a medically significant event.
Fever 100.5F; Lymph node severe pain under arm; Pain under arm; Upset stomach; Body hurts; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 14Apr2021 at 13:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included ANA (anti-nuclear antibodies) and ankylosing spondylitis. The patient did not receive any concomitant medication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021, 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 COVID vaccine. On 15Apr2021 at 12:45, the patient experienced fever 100.5 Fahrenheit (F), lymph node severe, pain under arm, upset stomach, body hurts. On 15Apr2021, the patient underwent body temperature and the result was 100.5 Fahrenheit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events of fever 100.5F, lymph node severe, pain under arm, upset stomach, body hurts were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Arm soreness with no resolved 24 hours later; This is a spontaneous report from a non-contactable consumer. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 04Mar2021 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 04Mar2021, the patient experienced arm soreness with no resolved 24 hours later. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arm soreness was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 66-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site rash and injection site warmth. On an unknown date, the outcome of the injection site rash and injection site warmth were unknown. It was unknown if the reporter considered the injection site rash and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported patient had a localized rash and warm for 3 days after receiving a dose of SHINGRIX on an unknown arm. Lot number and expiration date of the vaccine were unknown.
Constant tinnitus which started March 24 and has not gone away.   At times it is extremely loud and hard to focus on other things other times low buzz/hissing lie noise. Attempting to get appt with ENT but currently have appt next week with primary care Dr.
My father awoke the day after vaccine with a fever of 100 and his blood oxygen level at 82, he was shaking, weak.  We called 911 and he was taken to hospital, he was given oxygen in er and then transferred to a room.  On Friday he suffered a heart attack and was put on life support .  On Tuesday, April 6th we discontinuing all life saving measures and my father died.
Syncope Resulting in major concussion 90-year-old female with past medical history significant for hypertension, type 2 diabetes, osteoarthritis, dementia who presented to the emergency room by EMS after having a ground-level fall at nursing home. Does have mild dementia per the facility report. The patient does not remember the fall. EMS did report that the patient was ambulatory upon their arrival to the facility. The patient is alert and oriented x3. She does complain of a headache and bilateral knee pain. She denies any vision changes. She denies any fever, chills, shortness of breath, chest pain, nausea or vomiting. During my bedside evaluation I observed patient resting no distress. She appears very fatigued and complains of pain at the site of her scalp laceration in the occipital area. Daughter who is a retired nurse present at bedside supplemented the history. Patient does not recall the event. Daughter was in patient's room when she fell. Patient was walking back eating dinner to her room. She ambulates without assistance. Nothing similar to this has happened before. Daughter stated she was on the ground 10 seconds approximately before she woke up. Daughter clarified that patient is a DO NOT RESUSCITATE/allow natural death
Patient was given MENACTRA and Tdap in right deltoid 5/4/11. This morning 5/6 awoke with large amount of swelling and redness in bicep and deltoid.
Information has been received from a pharmacist via a company representative to three patients of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On an unknown date the patients were vaccinated with doses of ZOSTAVAX (dose and route unspecified). Other suspect and concomitant therapies were not reported. On an unknown date the patient contracted shingles. The outcome of the event was unknown. Additional information has been requested.
Information has been received from a physician concerning a male (age not reported) who in 2007 was vaccinated with three doses of Rotateq, oral. Following the first and third doses (not the second), the patient experienced "extreme voluminous vomiting". The above reaction followed a similar pattern during each of the above episodes. The patient sought unspecified medical attention. Subsequently on an unspecified date, the patient recovered from extreme voluminous vomiting approximately 28 hours post dose. No product quality complaint was involved. Additional information has been requested.