chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Continued mechanical ventilatory support. Consulted Nephrology for dialysis.  Continued tube feedings with Nepro.  Occupational Therapy, Physical Therapy, and Speech Therapy consultations were requested.  Nutrition consult was requested.  Continued IV Avycaz for multidrug-resistant Pseudomonas pneumonia and consulted ID.  Wound Care consult was requested. Colostomy care was ordered.  Continued Protonix. Bilateral lower extremity venous Doppler ultrasound was been ordered and showed new left lower extremity DVT. IVC filter placement was performed by Interventional Radiology. The patient appeaeds to have developed significant debilitation due to his prolonged illness and severe injuries following his motor vehicle accident and episodes of cardiac arrest due to mucus plugging on the 8th August 2022 and another episode of cardiac arrest on the 6th September 2022. He was also diagnosed with severe ventilator associated pneumonia which was treated with a full course of IV antibiotics.  Sputum cultures showed increasingly resistant Pseudomonas species.  Patient had difficulty tolerating weaning trials.  He continues to require mechanical ventilatory support without much progress.  Patient's family were contacted and have brought forward a copy of patient's living well.  They have requested discontinuation of life support measures and focusing on comfort measures only
Within 1 minute post administration of vaccine patient had an onset of ocular migraine which she has a history of.
I started feeling different and hearing voices and was feeling quite unusual where I was tired yet restless, almost zombie-like. Because of this I was dealing with anxiety and depression and thinking suicidal thoughts. Tried some physical working out to kind of sweat it out. Did not help too much. 4 days after the booster, I had started feeling genuinely sick with flu-like symptoms and migraines. I don't normally get migraines, so at that time I went to urgent care and was referred to a neurologist. This required preapproval and only just recently did get approval but have yet to see him.
Customer developed painful red blister on upper right (unilateral) torso which looks like shingles, after few days of getting the shingrix shot
This spontaneous report as received from a nurse refers to 15 patients of unknown age and gender. The nurse stated that on an unknown date, 15 GARDASIL were improperly stored outside of temperature range that was in the prescribing information and those vaccines (dose, route of administration, lot#, expiry date not reported) were administered to unspecified patients (patient information not provided) on an unknown date. No adverse effects were reported. No further information was provided. This is one of several reports from the same source. Additional information has been requested.
Chills/wheezing/coughing/sob/102.8 temp/shallow breathing/tight heavy chest/Hives on forearm and mouth/Abdominal pain, Diharrea, felt like BP was low, O2 sats ranged from 92-93, pounding migraine
Information has been received from a pharmacist concerning a 19 year old male who on 10/24/00 was vaccinated with MMRII and within hours of vaccination, the pt experienced a migraine headache. Unspecified medical attention was sought. Additional information has been requested.
Patient received vaccines on 6/15/17. On 6/16/17 she woke with a rash behind her left knee/leg, the rash darkened  through 6/18/17. ER visit on 6/17/17, told mom it was eczema. On 6/20/17 patient developed a fever. Clinic visit on 6/20/17, looked at rash again and now diagnosed as vascular rash.  Fever continued 6 days until 6/25/17, highest known fever 103.5 F. On 6/26/17 a splotchy rash developed behind patient's ears and in her hairline, spread to torso over the next day. Clinic visit on 6/26/17. Labs were done, mom reports Platelets were in a "Normal" range and liver enzymes were "Slightly Elevated." Rash disappeared by 6/28/17. Per phone call to check back with mom on 7/5/17, vascular rash behind left knee is still visible, is not itchy or bothersome. Patient is feeling well and healthy again.
doing well except after the vaccination, the patient felt nausea and feels dizziness and the skin color turns pale. Mom concerns about the seizure activities after the vaccine because he had a history of seizure when he had fever and after the vaccinations.
Ovulation on October 10 (determined by charting cervical fluid and basal body temperature), received flu vaccine on October 11. First positive urine pregnancy test on October 19. EDD was 07/03/2019. Pregnancy continued on to miscarry with gestational sac only ever growing to 14mm with no yolk sac or fetal pole visible. Bleeding began on November 5 and continued until December 10. Progesterone was low throughout, 5.5 on November 5. Started on PROMETRIUM orally. Miscarriage was complete/bleeding stopped on December 10.
This case was reported by a healthcare professional and described the occurrence of low grade fever in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent medical conditions included premature baby at 29 weeks gestation. Concurrent vaccination included HIB vaccine; manufacturer unspecified; unknown; unknown given on an unspecified date; varicella virus vaccine (non-gsk); non-GSK manufacturer; unknown; unknown given on an unspecified date. Approximately in March 2011, on an unspecified date, when the subject was 4 months old he received unspecified dose of PEDIARIX (unknown). Within 24 hours of receiving the PEDIARIX vaccination, the subject experienced low grade fever. Approximately in May 2011, on an unspecified date, when the subject was 6 months old he received unspecified dose of PEDIARIX (unknown). Within 24 hours of receiving the PEDIARIX vaccination, the subject experienced low grade fever. The healthcare professional who is also the subject's mother, reported the subject had received PEDIARIX at 4 and 6 months of age and had experienced low-grade fever with those vaccinations. She cannot recall what other vaccines he received on those same dates but believed he could have received the Hib and Varicella. Fevers were treated with children's TYLENOL. The fever usually presented within 24 hours. At the time of reporting the low grade fever resolved on unspecified dates. The subject experienced adverse events with INFANRIX, please see case A0988486A.
sleeping unusual amount of time 12-13 hrs & falling asleep again 45mins p/awakening, very irritable but consolable, high pitched cry, t102;
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The pharmacist stated that the patient who was vaccinated with ZOSTAVAX (Lot#, dose/frequency, route unspecified), "2 days ago", on 09-OCT-2012, now(on 11-OCT-2012) had a prescription for Prednisone. The pharmacist believed the Prednisone might have been prescribed for an upper respiratory infection. The pharmacist stated that this was not related to the patient receiving ZOSTAVAX and that she would not provided any additional information unless she knew this situation was related to the administration of ZOSTAVAX. At the time of reporting the outcome was unknown. Additional information is not expected.
Excessive chest pain for 2 days and then chest pain off and on for the next 4 months.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jun2022 at 10:00 as dose number unknown, single (Lot number: FS4991) at the age of 74 years, in left arm and on 17Sep2022 at 15:00 as dose number unknown, single (Lot number: 652524), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was unknown whether the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient had previously received a COVID-19 Vaccine.
I had side effects, very very painful arm stayed painful for months; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.     Additional Information: GSK Receipt Date: 22-MAY-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient received the dose of Shingles vaccine and had side effects such as very painful arm which stayed painful for months.  Additional supportive information: The follow-up would not possible as no contact details were available.
01/14/22 presents to ED for "speech problem, chest pain and shortness of breath". PMHx of "GERD, DM, hypertension, hypothyroidism, scoliosis, sleep apnea on C-PAP, bipolar disorder, ADHD, depression, and anxiety"
Angio Edema in face, hands, feet Urticaria (GIANT  hives)all over body each episode self-resolves within 2 days but continues to reoccur approximately every 2-3 days after last episode resolves.  Treating with anti histamines and cortisone (per doctors instructions) with no permanent resolution
Information has been received from a medical assistant concerning a 22 year old female patient with drug allergy to DURICEF, CECLOR, sulfa and VERSED who on 15-MAY-2012 was vaccinated with her first dose of GARDASIL (lot # not reported) at an unspecified obstetrics and gynecology (OB/GYN) physician's office. Concomitant therapy included ranitidine. On 15-MAY-2012 the patient experienced an itchy rash all over her body within minutes following the vaccination. The patient received BENADRYL at the OB/GYN's office and was referred to another physician, who saw the patient on 17-MAY-2012. The patient was still experiencing the rash and received injections of dexamethasone (manufacturer unknown) and DEPO-MEDROL during that visit. The patient called the practice on 18-MAY-2012 and still complaining of itchy rash and the physician prescribed a MEDROL dose pak to the patient. No lab test was done. At the time of this report, the patient was recovering from the event. Follow up information was received from a medical assistant reporting that the 22 year old female patient with asthma an allergy to DURICEF, CECLOR, sulfa and VERSED, on 15-MAY-2012, had hives and rash on back, trunk and extremities. At the time of the report, the patient had recovered (date not reported). The patient did not seek medical attention. It was stated that they did not administer the vaccine at their office. The patient was only treated for the reaction. Additional information is not expected.
Sever muscle pain in shoulders, neck, and back.  Severe headache and skin was sensitive to touch.  Chills and sweats but no fever. Lasted about 36 hours.  Some slight nausea and fatigue.
patient felt tired/did not want to do anything; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (patient felt tired/did not want to do anything) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (patient felt tired/did not want to do anything). At the time of the report, FATIGUE (patient felt tired/did not want to do anything) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient experienced no side effects after the first Moderna Covid-19 vaccine.   No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.   This case was linked to MOD-2022-535793 (Patient Link).
This patient had an onset of prolonged left sided focal seizure. requiring IV Valium in the ER to stop her seizure. No reoccurrence to date.
Skin welt on injected arm. Hot to touch and some tenderness in under lying muscle.
I had some lightheadedness. I went to my GP and they told me I was in afib. They told me since I was on medications, it was controlled afib. I made an appointment with the cardiologists PA. I wore a heart monitor for 7 days. They said I had an issue where I would stop breathing for periods of time. I was suggested a pacemaker but that is not something I want at this point in my life. I had a sleep study done and was diagnosed with sleep apnea. I slept with a CPAP machine and am working on getting one.
High fever for 3 days, lost of taste.  Stomach pains and heavy menstrual cramps and bleeding. Blood cloths while menstrual cycle.
4 month after completing immunization series patient noted with SMA, SMV, and cerebral venous thrombus. Report from outside hospital show that the SMA had collateralization in August suggestive of a chronic occlusion  s/p thrombectomy with TPA infusion the patient develped ALF and died on 8/23
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  CHRONIC HYPOXEMIC RESPIRATORY FAILURE  9/27/2022,  10/5/2022,  11/2/2022  -  RECURRENCE OF SAME SYMPTOMS
This spontaneous report was received from a nurse and refers to multiple unspecified patient of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # L011080, expiration date 01-OCT-2016, exact doses and route of administration were not provided). It was reported that the vaccines were exposed to temperature of -13.3C for 208 hours before administration. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several received from the same source. Additional information has been requested.
Sudden onset of nausea & dizziness leading to two consecutive falls which resulted in broken ankle.
Information has been received from a physician concerning an 8 week old female who on 17-DEC-2008 was vaccinated with the first dose of ROTATEQ. The physician reported that the patient "choked, was not breathing and became limp for 2 minutes." The patient did not receive the entire dose of the medication. The patient was observed in the office and recovered. Upon internal review, respiratory arrest was considered to be an other important medical event. Additional information has been requested.
Dry cough; a little fever; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), COUGH (Dry cough) and PYREXIA (a little fever) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included prostate medication for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). On 18-Apr-2021, the patient experienced COUGH (Dry cough) and PYREXIA (a little fever). On 25-Apr-2021, OROPHARYNGEAL PAIN (Sore throat), COUGH (Dry cough) and PYREXIA (a little fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
it was rpt fr relative concerning pt who was vax & subsequently pt exp chickenpox & shingles.
Right arm (deltoid) pain\ numbness at site of injection X 20 days after injection, zero redness or warmth.
Swelling, redness, tenderness over most of upper (R) arm, lasting greater than 10 days. Also felt fluish for 48 hours.
Pt received TRUMENBA 6/17/16, developed left knee pain 6/20/16 - woke on 6/21/16 with body aches, joint aches, increased skin sensitivity. Seen in office 6/22 still with body aches.
Reports feeling ill the day of injection. 2-3 days later c/o nausea, dizziness, headache and night sweats.
Hypothermia (lowest temperature was 95°F); Off-label; booster; This is a spontaneous report from a contactable healthcare professional (patient). A 23-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular, administered in deltoid left on 01Oct2021 15:00 (age at vaccination was 23 years) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Medical history was none (Known allergy: NKA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a workplace clinic. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included buspirone taken for an unspecified indication, start and stop date were not reported; and cyanocobalamin (SUBLINGUAL B12) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 on an unspecified date as dose 1, single and on an unspecified date as dose 2, single for COVID-19 immunization The patient experienced hypothermia (lowest temperature was 95°F) on 01Oct2021 22:00 with outcome of not recovered; off-label and booster on 01Oct2021 15:00. No therapeutic measure was taken as a result of hypothermia. The patient underwent lab tests and procedures which included body temperature: 95 fahrenheit on an unspecified date. The event was hypothermia was reported as serious life-threatening, while the other events were assessed as non-serious.  Information about the lot/batch number for the vaccine was not provided and will be requested during follow-up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events hypothermia,; off-label and booster dose   and suspect drug BNT162B2 cannot be excluded 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.
NO ADVERSE EFFECT NOTED, OBSERVED, ASSESSED OR STATED.  AFTER CHILD HAD RECEIVED HIS DOSE OF MCV4 AND FLU, WHICH WERE CONSENTED FOR, I WAS NOTIFIED BY A PARTNER NURSE THAT THIS SAME CHILD HAD RECEIVED A DOSE OF MCV4 ON 12/12/2012, WHICH HAD NOT BEEN CONSENTED FOR AND WAS NOT DOCUMENTED ON THE PREVIOUS CONSENT OR IN CAIR.  CHILD SHOWED NO ADVERSE RESPONSE AND WAS CHECKED ON IN THE CLASSROOM AND WAS WITHOUT NEGATIVE SYMPTOM OR DISTRESS OF ANY KIND, AS WELL.  MOTHER WAS IMMEDIATELY NOTIFIED AND SITUATION WAS EXPLAINED TO HER IN DETAIL AND STATED UNDERSTANDING.  ADVISED HER TO FOLLOW UP WITH THE CHILD'S PMD FOR ANY CONCERNS. COMMUNICABLE DISEASE LEAD NURSE WAS ALSO NOTIFIED FOR FURTHER DIRECTION.
Patient had no adverse effects; vaccine was administered following multiple temperature excursions; This spontaneous report has been received from an office manager, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and previous drug allergies or reactions were not provided. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On 18-JUL-2022, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) at a dose of 0.5 milliliter (ml), once, lot number W006583, expiration date: 23-AUG-2023 (route of administration was not provided) as prophylaxis (product storage error).  The suspect vaccine experienced multiple temperature excursions: on 11-MAY-2022 was stored at a temperature of 5.7 degrees Fahrenheit (F) for 7 minutes, 27-MAY-2022 5.7 F for 5 minutes, 06-JUN-2022 5.9 F for 6 minutes, 09-JUN-2022 5.4 F for 4 minutes, 14-JUN-2022 5.7 F for 7 minutes, 17-JUN-2022 29.1 F for 39 minutes, 20-JUN-2022 7.2 F for 10 minutes, 22-JUN-2022 8.4 F for 15 minutes, and 28-JUN-2022 5.2 F for 3 minutes.   Total excursion time was 96 minutes. No temperature excursion occurred prior to 11-MAY-2022.  No additional adverse events were reported  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA007847: US-009507513-2207USA007928: US-009507513-2207USA007867: US-009507513-2207USA007847: US-009507513-2207USA007985: US-009507513-2207USA007729: US-009507513-2207USA007826: US-009507513-2207USA008018: US-009507513-2207USA008097: US-009507513-2207USA007928: US-009507513-2207USA007847: US-009507513-2207USA007832:
Injection 8-19-11 around 11:20 AM. 8-21-11 woke up and was dizzy. 8-22-11 went to family MD. Pt said MD said too late would not take back. Pt reported to me 8-24-11 dizziness gone.
Rash all over the body, last like 1 day it was a non authorized vaccine, so everything was manage in silence by the hospital until last day, no treatment that I had known
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-JUL-2016, the patient was vaccinated with the improperly stored dose of (wistar 27-3) M-M-R II (lot # L026553, albumin status rHA; dose, route, expiration date were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Narrative:  08/21/2020 COVID swab, result: NOT detected COVID infection following COVID vaccine series 03/13 Janssen, dose #1 (outside facility) 08/06 pt cc: cough, fatigue, loss of taste or smell, dizziness, headache exposure: unknown 08/09 COVID swab, result: detected 08/09 SARS-COV-2 LINEAGE B.1.617.2 08/09 SARS-COV-2 CLADE 21A DELTA 08/10-08/15 PT symptoms continue 08/16 clinically resolved
Huge red rash; The size of a baseball; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS and RASH (The size of a baseball) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021b21a) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included MODAFINIL and BABY ASPIRIN for an unknown indication.    On 27-Apr-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced RASH ERYTHEMATOUS and RASH (The size of a baseball). At the time of the report, RASH ERYTHEMATOUS and RASH (The size of a baseball) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included Cholesterol meds.  No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow-up received on 29 Apr 2021 contains no new information. On 29-May-2021: Reporter contact number added.
Hoarse, loss voice, soreness of throat, redness - voice has change, loss of voice completely at - chest congestion, developed in URI-upper respiratory infection, vomiting - 2 days - heaviness in chest.