chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It began with funny sensations, paresthesias in the saddle area. They were occassional and brief, almost felt like muscle twitches or a buzzing electric shock (hit your funny bone) feeling. That progressed a bit. After several weeks I noticed that it occurred predictably with neck flexion. Also over the time period of late October 2013 to late November, the paresthesias worsened, and I also developed weakness and mild dyscoordination in my legs bilaterally. Overall the symptoms were very disturbing, but I could still walk.The symptoms gradually improved over the next 10 months. Currently I am about 80% better but still notice some dyscoordination and my gait is permanently altered. I can run, but have trouble playing sports as my agility is reduced. The subjective feeling of leg movement is noticeably altered and this is unpleasant. I received a full work up and my neurologist diagnosed me with "post-viral syndrome". He did not think the symptoms were related to the vaccine. I had also had a brief but bad viral infection in early September 2013, which was initially diagnosed as Lyme Disease, but retrospectively as a viral syndrome, probably aseptic menengitis or possibly a mild viral encephalitis. That viral episode resolved withing 1 week though, and there was about 6 weeks between recovery from that and the development of these neurologic symptoms, and I was feeling normal in between. In summary, I think there is a good chance my symptoms are from the vaccine. I am a board certified psychiatrist, and a full-time faculty member at a university.
Dizziness, NauseaVomiting, vertigo, blurred vision Narrative:  53-year-old female vaccinated Janssen COVID-19 March 31, 2021. She has been doing poorly since 3 days post vaccination and remains unable to work. Slow progressive recovery began April 5, 2021. History provided by employee and medical records were not available to review. Onset April 3rd with severe dizziness, nausea, vomiting, blurred vision. Progressively worsened to severe vomiting, blurred vision, and she was unable to independently complete ADLs. Attempted self treatment migraine PRN med. Presented to Hospital, evaluated in ER on rule out stroke protocol. CT, MRI, labs, EKG obtained and normal. At that time also mild UTI, started course of Keflex, and resolved. Discharged April 4 with diagnosis of labyrinthitis, likely secondary to a viral infection, and benign positional vertigo. Treating with mescaline, Zofran and exercises for vertigo and gradually increasing her walking distance. Presented for follow-up audiology last week, evaluated by ENT and PCP this week same working diagnosis. Denies headache, new symptoms, and reports progressive improvement in vertigo and visual acuity to the point she is able to read on 4/14/2021. Past medical history significant for overweight, hypertension, heart disease and diabetes. She has had 2 migraine type headaches in her lifetime, both head pain with nausea and no aura. Both occurring in 2020, and the diagnosis of migraine was made in urgent care. Full med list not obtained but includes aspirin 81 mg daily.   Other Relevant History:
A report was received from a health care professional on 10/30/2003, concerning an unspecified number of vaccinees under 4 years of age who inadvertently received Fluvirin on an unspecified date. No adverse effects had occurred at the time of report. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/01/03: Follow up information received from a health care professional indicated that an 18 month old female vaccinee inadvertently received Fluvirin on 10/18/03 and had no experienced any adverse event at the time of the report. No follow up pending, all information received. Cross reference with: PJP200300957, PJP200400013, PJP200400015, PJP200400016, PJP200400017, PJP200400018, PJP200400019, PJP200400020, PJP200400021, PJP200400022, PJP200400023 and PJP200400024.
Injection site became pink, 3X5 inches, the day following the shot.  On 2.11.2021, about 55 hours after vaccination #2, pt developed generalized weakness, nausea, and then vomited.  She was taken to bed, where she rested poorly and only dozed off for 1-2 minutes at a time and was mumbling words.  She  continued with generalized weakness, nausea with dry heaves, a sensation of marked shortness of breath, and inability to stand without support.  Complained of feeling hot and then cold.  Appeared pale and lethargic, skin clammy and complained of difficulty breathing and was irritable. Lung sounds -clear, no wheezing despite being unable to speak more than a few words at time. Vitals at 10:00pm:  HR 62, pulse weak, O2 sat 92% (normal for her), temp 101.7F (her normal temp is 95-96).  Given a Tylenol extra strength 500mg, 2.5 mg Prednisone, increased O2 nasal canula to 3-4 L/min, and cold compresses to reduce fever and discomfort.   Vitals at 10:15p:  HR 93, O2 sat 92%, BP 131/59. Discussed going to the ER, but decided to wait until the morning if not better. Symptoms continued until ~ 2am, when she was able to fall deep asleep for 4 hours.  Awoke and felt better, able to walk, but still a bit weak and short of breath.  By noon Feb 12 she felt mostly back to normal.
Clients son called today to report that client was found deceased in his home this am.  His son reported knowing his father received vaccines to go overseas and wanted to make sure Health Department was aware.  His son reported that his father had been feeling fine, only had "sore arm" after shots but no other side effects reported.  Wife of deceased reported to his son that client was fine this morning.  Son was very calm and felt like it would be good to let us know if anything was related.  He knows that HD can't confirm seeing his father.   11/30/06 Received death certificate from coroner.  Also received v/m from coroner that no autopsy was performed. COD stated as probable acute myocardial infarction due to atherosclerotic cardiovascular disease & hyperlipidemia per death certificate. 1/2/07 Received medical records from PCP which consisted only of a visit of 8/1/06 for ear wax removal.  CXR done 11/13/06 was WNL.  WBC 7.9, H/H 16.4/47.5, plts 252.  Slightly elevated cholesterol at 163 & low HDL of 34.  Globulin elevated at 3.6.  PSA 2.37 is WNL.  T/C to PCP office to determine is any other visit made in 2006.  Stated that patient was scheduled to return to PCP the day after he died & had gotten his labs & CXR in preparation for that visit for a complete PE.  Stated that patient was essentially in very good health when last seen in 8/01 & that labs were WNL.  Requested that they at least send the most current med list. 1/2/07 Received patients med list which included only Pravachol, Zyrtec D & tetracycline for folliculitis. 1/12/06 Received EKG from PCP.  States the only EKG they have was done 11/13/06 & revealed normal sinus rhythm, rate 70.
Information has been received from a consumer concerning her daughter a 23 year old female with a history of eczema and Dairy allergies (cause of the eczema) who completed vaccination series of GARDASIL "just about a year ago". Concomitant therapy included omega-3 marine triglycerides, proboitics, and pure essential brand (Dr. Ashes Brand). The patient didn't experience any symptoms after the first or second dose of GARDASIL. Two days after the third dose the patient developed a vaginal rash during her menstruation the rash became worse. The patient also had "abscesses" that had developed on the outside of the vagina. She stated that the abscesses were caused from an e-coli bacteria. The patient had been test for sexually transmitted diseases, skin cultures, abscess cultures, and biopsies all of which had been negative. The mother also stated her daughter has not engaged in any sexual activity and could not identify a source for rashes. The patient had been placed on antibiotics that do not provide relief and was last prescribed a cortisone cream that states "has settled things a little bit this week during her period." The mother and her daughter believed in "doing everything natural and only received GARDASIL after it was highly recommended by a physician who is a friend of the family." The office manager at the gynecologist explained the patient didn't receive her vaccinations at their office and speculated that the vaccines were given either at school or by the patient's father, who is a physician. The patient was now visiting her physician about two times a week due to "flare ups" and was going to be seeing an infectious disease physician. The patient was not recovered. Additional information has been requested.
patient was supposed to receive hepatitis A and influenza vaccines. Instead, a flu shot was given along with Pentacel and Prevnar 13. / no AE; The patient received the fourth dose of Pentacel on 01Jul2019. The dose that was given in error today was therefore an extra dose/ no AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an 18-month-old patient who was supposed to receive HEPATITIS A VACCINE and INFLUENZA VACCINEs Instead, a flu shot was given along with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) [PREVNAR 13] (lot number, exp date, dosing details not reported on 03-Oct-2019.  Past vaccination included fourth dose of Pentacel on 01Jul2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to wrong vaccine administered and extra dose administered.   It was reported that The patient had received the fourth dose of Pentacel . The dose that was given in error today was therefore an extra dose.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Patient complains of numbness and burning at injection site. Doctor prescribed antibiotics for cellulitis.
Severe acute immune thrombocytopenia, now refractory to steroids and IVIG developed 10 days after second dose of vaccine. Patient developed spontaneous wet purpura, petechiae and vaginal bleeding on 3/19/2021. CBC showed undetectable platelet count. Normal hemoglobin and platelets. Did not respond to dexamethasone 40md daily x 4 or multiple IVIG doses. Started romiplostim on 3/25/21 and is currently on dose escalations with platelets persisting undetectable.  On 3/28 developed acute anemia with a 2 to 3 g/dL hemoglobin drop and was found to have a spontaneous hemoperitoneum . Treated with tranexamic acid, multiple platelet transfusions and an additional dose of romiplostim. Bleeding has since resolved but platelets remain undetectable.
101 fever, severe arm pain, swollen lymph nodes armpit of left arm, headache
arm swelled up really bad; arm hot to the touch; arm was red; arm was very itchy; She received her second dose on Tuesday, 28/SEP/2021, lot 061E21A, no expiration date reported; injection site was hard; injection site was a little hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site was a little hot), PERIPHERAL SWELLING (arm swelled up really bad), FEELING HOT (arm hot to the touch), ERYTHEMA (arm was red) and PRURITUS (arm was very itchy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A and 00VF21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced VACCINATION SITE WARMTH (injection site was a little hot), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She received her second dose on Tuesday, 28/SEP/2021, lot 061E21A, no expiration date reported) and VACCINATION SITE INDURATION (injection site was hard). On 02-Oct-2021, the patient experienced PERIPHERAL SWELLING (arm swelled up really bad), FEELING HOT (arm hot to the touch), ERYTHEMA (arm was red) and PRURITUS (arm was very itchy). At the time of the report, VACCINATION SITE WARMTH (injection site was a little hot), PERIPHERAL SWELLING (arm swelled up really bad), FEELING HOT (arm hot to the touch), ERYTHEMA (arm was red), PRURITUS (arm was very itchy) and VACCINATION SITE INDURATION (injection site was hard) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She received her second dose on Tuesday, 28/SEP/2021, lot 061E21A, no expiration date reported) had resolved.            No Concomitant medications were reported. No treatment medications were reported.
12:49 Patient approached RN stating she has slight expiratory wheezing. Taken to observation for assessment.  12:50 vitals BP 149/58 HR 112 o2 100% Denies pain   Patient denies difficulty breathing and states she has anxiety as a baseline condition. Patient appears calm and is cooperative. Patient states she has history of asthma so RN instructed her to use her inhaler. Wheezing diminished immediately.   13:00 vitals BP 162/99 HR 89 o2 98% Denies pain    Patient states she feels light headed and instructed to lie down on gurney  (HOB elevated). Patient no longer has wheezing. Patient currently drinking coconut water and states she did not eat much today.   13:15 vitals  BP 157/86 HR 73 o2 100% Denies pain   Patient states she still feels a little light headed but overall feels better. No difficulty breathing and no expiratory wheezing. Patient states she still feels slightly anxious.   13:23 Symptoms have subsided and husband states he can drive patient home. RN educated patient and husband if any symptoms return to go directly to the ER and use inhaler if wheezing returns on the way to the ER. Both patient and husband agree with this plan and patient left nursing care without distress.   Electronically signed by: RN 2/18/2022 1:30 PM
3 days after 1st dose-  discharge from left nipple.    2nd dose vaccination: muscle pain and chills, memory loss, brain fog and (hallucinations, behaving like a 1o year old as per family)
30 minutes after receiving the vaccine I started with a severe headache, which continued to get worse in the next 24 hours, as well as a sensation of my throat closing up, which lasted for a little over the next 24 hours after injection. I have not felt right since getting the vaccination. Tired and needing to sleep a lot, now having a scratchy throat and cough.
she felt sick approximately during 1 week; squamous cell carcinoma; This spontaneous case was reported by a patient and describes the occurrence of SQUAMOUS CELL CARCINOMA (squamous cell carcinoma) in an 83-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia (when she was little but got all their shots later.) and Infusion. Concurrent medical conditions included Allergy NOS.   On an unknown date, the patient received second dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2023, the patient experienced SQUAMOUS CELL CARCINOMA (squamous cell carcinoma) (seriousness criterion medically significant). On an unknown date, the patient experienced ILLNESS (she felt sick approximately during 1 week). At the time of the report, SQUAMOUS CELL CARCINOMA (squamous cell carcinoma) had not resolved and ILLNESS (she felt sick approximately during 1 week) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Oct-2023, Biopsy: squamous cell carcinoma in the wrist.         No concomitant medication was reported.  Patient will undergo a surgery next week. No treatment information was reported.  Company comment: This spontaneous case concerns an 83-year-old, female patient with no medical history information reported, who experienced the unexpected serious (medically significant) event of squamous cell carcinoma and non serious event of illness (occurring for 1 week after 2nd dose). The event of squamous cell carcinoma occurred after the third dose of SPIKEVAX 2023-2024. Temporal relation is unclear. As reported patient received three doses of Moderna vaccine and was diagnosed by biopsy with squamous cell carcinoma in the wrist. The patient had a scheduled surgery and was wandering whether it is recommended to receive Spikevax if surgery is scheduled. No further information about the event was provided. Considering the nature of event, lack of biological plausibility for causality and patient's advanced age as risk factor, causality for the event of squamous cell carcinoma is assessed as not related. The benefit-risk relationship of SPIKEVAX 2023-2024 is not affected by this report.
Shoulder pain in arm vaccinated, have not been able to wear a handbag on that shoulder since. Occasional tingling in fingers of same arm. Grasp & strength of hand significantly & surprisingly weakened. Difficult to sleep on that side.
No symptoms reported; a patient received a dose of improperly stored dose; This spontaneous report was received from a nurse and refers to a 12-week-old male patient. No information regarding patient's concurrent conditions, past medical history, concomitant medications, drug reactions or allergies was provided.  On 09-JAN-2020, the patient was vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, intramuscular, lot number S006470, expiration date 15-JAN-2022 (exact dose was not provided) for prophylaxis. There was no adverse effect reported.  Administered dose of vaccine experienced the temperature excursion of 35.2 degrees Fahrenheit for 24 minutes. There was no previous temperature excursions. Data logger was involved.
This spontaneous report was received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 12-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L007578 with an expiration date on 05-MAR-2017; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.
Started with a headache and tiredness on Friday evening. Then Saturday strong body aches  and mild headache. Sore arm
Initial report received from a pharmacist on 15 Jan 2010: This patient was vaccinated with FLUVIRIN an unknown batch number, 0.5 ml on an unknown date with a vaccine stored at temperatures as low as 34 F and 35 F. No adverse event was reported.
Patient said she developed a ball under her left armpit next day (She noticed it at night) after she got the vaccine. It was painful at that time. Bump became smaller in two days but there is a bruise around the bump now. It's not painful.
Abscess of pancreas, Paroxysmal atrial fibrillation, Hypertension, Acute hypoxemic and hypercapnic respiratory failure, Hypothyroidism, Severe protein-calorie malnutrition, Septic shock, Abdominal abscesses, Encephalopathy, Acute kidney injury on HD, Necrotizing pancreatitis,  pAFib  Pt remains critically ill, on maximal norepinephrine along with vasopressin. Worsening renal function, however at this time the wife does not want to transfer back to ICU and consider CRRT. On 7/21/2022,  NP called to bedside after wife arrived to discuss goals of care and potential terminal extubation. NP sat with wife for about 35 minutes discussing his care and overall condition. At this point, she has decided that she has given him the opportunity to improve and he continues to decline. Wife requests that we transition him to comfort measures and requests terminal extubation at this time. Pronounced deceased.
Patient presented to emergency department on 1/10/2022 with worsening shortness of breath. Patient was found to be COVID-19 positive. She was treated with supplemental oxygen and decadron. Her symptoms improved and she was discharged with home healthcare on 1/19/2022.
Pt received second dose moderna vaccine. Did not bring first dose vaccine card, unable to obtain first dose lot number and date of vaccination from patient. Pt left facility and upon approaching stop light in front of building, pt began to experience SOB with fast heart rate and mouth dryness. Pt returned to facility to seek medical attention. Brought to med obs #1 via wheelchair by staff for evaluation. Reports mild improvement of symptoms upon arrival to med obs. No s/s of distress noted upon pt arrival. Pt reports taking prescribed lisinopril PTA this AM. Upon assessment of VS, BP elevated. Pt states he occasionally has SBP 200+/DBP 100+. Denies s/s of anxiety at present and denies headache/vision changes. VS are as follows: 1314: BP 187/107 (RUE), rechecked on LUE 233/134, HR 75, RR 17, O2 sat 98% on RA. 1319: BP 233/118 (LUE), rechecked on RUE 242/122, HR 104, RR 16, O2 sat 99% on RA. Per VS parameters, pt qualifies for EMS transport for ER evaluation of elevated BP. Notified in-house PA of need for assessment and confirmation of EMS need for transport as well as notification to lead supervisor. Constable at employee entrance notified to assist in arriving EMS. Upon assessment of pt by PA, pt disclosed he is non-compliant with prescribed lisinopril at home and will occasionally use medication PRN or double/triple his dosage based on symptoms. PA provided education on proper use of lisinopril and confirmed need for higher level of care. Pt agreeable to EMS transport for further evaluation. 9-1-1 called. While awaiting EMS arrival, pt reported sweating of hands and shallow breathing, stating, "I feel like I have to concentrate on my breathing now." Pt not in distress. EMS arrived to transport pt to Hospital. Pt alert and oriented x4 and ambulatory from stretcher to EMS gurney upon transfer.  VS while awaiting EMS arrival are as follows: 1324: BP 249/126, HR 83, RR 17, O2 sat 100% on RA 1329: BP 247/109, HR 85, RR 18, O2 sat 100% on RA 1336: BP  243/112, HR 84, RR 20, O2 sat 100% on RA 1347: BP 245/144, HR 87, RR 18, O2 sat 100% on RA
left thigh was diffusely erythematous and edematous down to just above the knee. Warm to touch, slightly indurated.  Mother reported the patient had been itching the area a lot.  Outside of the area of primary erythema, there was several surrounding wheal-like erythematous areas to the left thigh concerning for urticaria.  Mother initially reported he seemed to have pain when walking on the leg, however on exam the area seemed nontender (although difficult to communicate as the patient is nonverbal, he is autistic). Patient was also jumping up and down in exam room and did not show signs of discomfort.
Received Varicella Vax 5/30/07 LA, child developed rash and redness at injection site.