chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Episodic cyanosis, gray, pale,lethargy, intermittent, Episodic tachypnea, coughing. Normal exam x 2.
Pt into office 10-14-19 0921AM - Given Influenza High Dose Trivalent vaccine 0.5mL IM 10:00AM. Pt Returned to office 10-14-19 1422 c/o feeling like a lump was in his throat becoming difficult to swallow. Admin 0.3 mL Epi 1mg/mL. Prednisolone 60mg, Albuterol Neb 2.5mg/3mL, EKG and transported to ED via EMS
Red, raised welt to right thigh. Pt medicated with BENADRYL 25 mg PO.
I administered the patient's 1st Moderna dose in our vaccination room.  The patient was not showing any signs of reaction. The patient then went to our observation area in front of the pharmacy. Five minutes after vaccination, he presented to the pharmacy window stating that he felt faint. A pharmacy technician immediately opened the pharmacy door and put a chair under the patient, as he passed out into it.  I instructed another technician to call 911. I ran to the patient who then stopped breathing.  I grabbed an Epi-pen off the pharmacy shelf and was about to administer it when the patient regained consciousness.  The patient was very pale, but oriented to person, place and time. EMS arrived, gathered information, and left with the patient.
vaccine [Pentacel] reconstituted with an unknown diluent, without the dtap-ipv component with no adverse event.; Initial information received on 12-Jan-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 6-month-old male patient (76 cm and 16 kg) who experienced vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] reconstituted with an unknown diluent, without the dtap-ipv component with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine suspension for injection (strength, expiry date: unknown) (lot: UJ678AAA) via unknown route in unknown administration site for Childhood vaccination.  On an unknown date the patient had a non-serious event vaccine [pentacel] reconstituted with an unknown diluent, without the dtap-ipv component with no adverse event (product preparation issue) (unknown latency) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine.  Action taken with diphtheria, tetanus, AC pertussis, IPV AND HIB vaccine (pentacel) was 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.;
Chills, shaking, low grade fever. Coughing--onset 9/17/13.
Hives & fever 100.4F (R); Seen by MD, not hospitalized;
SHE WAITED 15 MINUTES AFTER IMMUNIZATION. WHEN HER 15 MINUTES WAS UP, SHE MENTIONED THAT SHE FELT DIZZY AND NAUSEATED. SHE HAD JUST BEGUN FEELING THAT WAY. SHE ALERTED A FRIEND AND BOTH MONITORED HER. SHE ALSO SAID SHE WAS HAVING TROUBLE CATCHING HER BREATH.  WE GAVE HER A SIP OF WATER, THEN A SIP OF 7-UP. AFTER A COUPLE MINUTES, SHE WAS FEELING A LITTLE BETTER. BUT THEN SHE SAID NO, SHE WASN'T FEELING BETTER. WE CALLED 911 AND MONITORED HER. WE TRIED TO TAKE HER BLOOD PRESSURE, BUT IT WAS HURTING HER ARM. THE AMBULANCE ARRIVED ABOUT 8 MINUTES LATER AND HAD HER LAY ON THE GURNEY AND TOOK HER TO THE AMBULANCE TO MONITOR. WE HAVE TRIED TO CALL HER SINCE THEN AND HER PHONE IS GOING TO VOICEMAIL.
Pt started having soreness in his arm starting 3 days after the vaccine and progressed to muscle weakness and trouble lifting his arm.
MOM CALLED AND STATED CHILDS LT WAS RED,SWOLLEN, AND HOT TO THE TOUCH ON TUESDAY EVENING. SHE GAVE MOTRIN AND A BATH. CHILD DOING FINE TODAY. AGH.
After administration of shots, he said he is not feeling well and feeling neck tightening or something happening in body. Called 911 and paramedics arrived.
4/14/2021  Two weeks after the 2nd Covid-19 vaccine,,about 11 PM.  patient, developed a sudden numbness in his right are, hand & right side of the face.  He had no sensation and could not feel anything.  He immediately was taken to the emergency room at Hospital.  They began testing and suspected a blood clot.  They administered blood thinners, TPA by injection into the port, performed many tests including Ct scan, chest Xray, blood tests, EKG etc.  He was being monitored & hooked up to various scanners.  They decided to move him by Ambulance to the ICU Unit at Medical Center .  He was in the neurology emergency room there for several hours & then moved the Neurology ICU. They kept him there, doing various testing, until Friday 4/16/2021 When they moved him to a regular Neurology floor.  Staff neurologists continued to monitor his condition.  On Saturday, 4/6/2021, an MRI showed a small blood clot in the Thalamus of the brain, which they believe caused the lack of sensation  on the right arm, hand & face.    He was discharged & went home on Monday 4/18/2021.  New medication was prescribed, Physical therapy and was told to make an appointment with a Neurologist.  On Thursday, 4/22/2021 patient had an appointment with his Cardiologist, Dr. the Dr gave him an examination & told him to proceed with the neurologist, etc.  Patient has an appointment at PT in on Wed. April 28, 2021.  He is waiting for an appointment with Dr. Neurologist at Neurology Group
fever-felt hot up to 105 but temp not actually taken by father;crying inconsolably;father reported eyes rolling back in head-sz;
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Apr2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Apr2023, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid on 20Apr2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300165872 Same patient, different product, different event;
got diagnosed with Covid19 afterwards; got diagnosed with Covid19 afterwards; This is a spontaneous report from a non-contactable consumer.  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient and had the first shot (unclear if Pfizer or Moderna) and got diagnosed with Covid-19 afterwards (dates unspecified). The outcome of the event diagnosed with Covid-19 was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
sore arm started immediately, extreme fatigue started the day after. Headaches started intermittently, but by the 2nd week were occurring daily, and would wake up with abd pain/nausea feeling. difficulty focusing, thinking straight. saw doctor 10/7/21: BP 80/50.  increased salt / protein / fluids in diet. 10/8/21:  BP 77/45, 84/50, 10/10:  76/45 10/11: 77/51, 10/12: 75/43. 10/13: 81/48, 10/14/21: 72/46, 80/45. starting electrolyte replacement per MD, re-checked - 95/52. later 104 systolic when in office lying down at MD 10/14/21 (do not recall diastolic reading). 10/15/21 83/49 (have not taken electrolyte replacement yet today). persistent fatigue, low BP, difficulty focusing / thinking clearly, headaches daily.
Pt. had body aches, headache - felt very feverish for about 48 hours after getting the vaccine.
lnadvertenly adminstered expired vaccine; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions or allergies were not reported.  On 09-OCT-2020, the patient was vaccinated with second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (strength, frequency, dose and route of administration were not reported; lot # R028381, expiration date was reported as 03-OCT-2020) for prophylaxis. This was an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), which was inadvertently administered to the patient (expired product administered). No previous temperature excursions. The outcome of the event was unknown.
she was going to pass out; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; Weakness; Dizziness; Throwing up; Fever; abdominal pain; she didn't go back to work until 24Sep2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 09Aug2021 (Lot number: EW0179) at the age of 56 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 27Aug2021, outcome "recovered" (24Sep2021), described as "she was going to pass out"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 27Aug2021, outcome "unknown" and all described as "positive COVID-19 test with symptoms"; ASTHENIA (non-serious) with onset 27Aug2021, outcome "recovered" (24Sep2021), described as "Weakness"; DIZZINESS (non-serious) with onset 27Aug2021, outcome "recovered" (24Sep2021), described as "Dizziness"; VOMITING (non-serious) with onset 27Aug2021, outcome "recovered" (24Sep2021), described as "Throwing up"; ABDOMINAL PAIN (non-serious) with onset Aug2021, outcome "not recovered", described as "abdominal pain"; JOB DISSATISFACTION (non-serious) with onset Aug2021, outcome "recovered" (24Sep2021), described as "she didn't go back to work until 24Sep2021"; PYREXIA (non-serious) with onset 27Aug2021, outcome "recovered" (24Sep2021), described as "Fever". The events "she was going to pass out", "positive covid-19 test with symptoms", "positive covid-19 test with symptoms", "weakness", "dizziness", "throwing up", "abdominal pain", "she didn't go back to work until 24sep2021" and "fever" were evaluated at the physician office visit and emergency room visit.   The patient underwent the following laboratory tests and procedures: pyrexia: (27Aug2021) 102; sars-cov-2 test: (27Aug2021) positive; ultrasound scan: (unspecified date) unknown results.   Therapeutic measures were taken as a result of loss of consciousness, covid-19, asthenia, vomiting, abdominal pain, job dissatisfaction, pyrexia. Therapeutic measures were not taken as a result of dizziness.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101851769 same patient/product, different dose/events.
BELLS PALSEY ,FACIAL PARALYSIS, MY DOCTORS ARE SAYING THAT I HAVE PERMANENT DAMAGE  AND WILL NEVER FULLY RECOVER FROM THIS ISSUE THAT AFFECTS MY ABILITY TO TALK, EAT ,INTERACT WITH OTHER PEOPLE. CONSTANT FACIAL MUSCLE PAIN ALMOST DAILY MUSCLE CRAMPING IN MY FACE AND OR NECK DEPRESSION ASSOCIATED WITH THE STIGMA OF HAVING DISTORTED FACE
tingling in face, arms, hands, legs, right foot, knees; burning in face, arms, hands, legs, right foot, knees; numbness in face, arms, hands, legs, right foot, knees; This spontaneous case was reported by a physician and describes the occurrence of PARAESTHESIA (tingling in face, arms, hands, legs, right foot, knees), BURNING SENSATION (burning in face, arms, hands, legs, right foot, knees) and HYPOAESTHESIA (numbness in face, arms, hands, legs, right foot, knees) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESTRADIOL (ESTROGEN) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 06-Jan-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced PARAESTHESIA (tingling in face, arms, hands, legs, right foot, knees), BURNING SENSATION (burning in face, arms, hands, legs, right foot, knees) and HYPOAESTHESIA (numbness in face, arms, hands, legs, right foot, knees). The patient was treated with PREGABALIN (LYRICA) for Adverse event, at a dose of UNK dosage form and BACLOFEN for Adverse event, at a dose of UNK dosage form. At the time of the report, PARAESTHESIA (tingling in face, arms, hands, legs, right foot, knees), BURNING SENSATION (burning in face, arms, hands, legs, right foot, knees) and HYPOAESTHESIA (numbness in face, arms, hands, legs, right foot, knees) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that around 5 PM left arm started tingling and burning then it went to right arm, then hands, felt numbness, tingling, burning, then to the knees, right foot, the face, had numbness in eat, forehead, chin. At the time of reporting, the patient still has all the symptoms, numbness and burning in arms, face, legs. After 3 and a half weeks, arms were a little bit better, they were not as tight, they were not burning that much, but her hands are, in the thumb, has no feeling in that part of her hand. Felt tingling, numbness, whole face feels like some had given her lidocaine, legs were numb.   Patient was treated with 3 doses of high IV (intravenous) steroids.
This spontaneous report was received from a pharmacist and refers to a 5 month old patient of unknown age. Concurrent conditions, medical history, historical and concomitant drugs were not reported. The pharmacist informed that on 09-JUN-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 Injection, for prophylaxis (strength, dose, route, anatomical location, lot # and expiration date were not reported) instead of PREVNAR 13. No adverse effect reported.
Initial and follow up information has been received from a pharmacist, concerning a 65 year old male patient, with benign prostatic hypertrophy and a seizure disorder, who on 08-JUN-2007, at approximately 8:25am, received two doses, of PNEUMOVAX 23; he was vaccinated IM in the left deltoid with one 0.5ml dose and also IM in the right deltoid with one 0.5ml dose of PNEUMOVAX 23 (Lot #655291/0985F) (previously reported as lot #655289/0958F).  Concomitant therapy included FLOMAX, phenytoin and finasteride (manufacturer not specified).  The pharmacist confirmed that there were no adverse events noted, and the patient was considered "recovered" on the same day, 08-JUN-2007.  The patient sought unspecified medical attention.  No additional information is expected.
Patient reported having "normal" injection site reactions but with hives covering entire body. Pt saw PCP who gave her prednisone taper dose.
Patient got up from the seat where he received his vaccine and was walking to the back to be seated and monitored. He past out once he got to the back. He hit the right side of his head. As he came too he reported mild nausea. He denied any pain or vision changes.  He then reported a history of diabetes. He stated he had dialysis this morning and took insulin prior to coming to vaccine clinic but did not eat anything. He took a few sips of juice. He was diaphoretic and clammy. Pulse was 46, SPO2 was 96%. He had a mild audible murmur. Lung sounds: wheezing and crackles. There was a small area of swelling noted to the right side of his head. EMS was called for transport due to hitting his head and history of taking blood thinners.
INJECTION SITE LUMP; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-MAR-2021, the subject experienced injection site lump. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site lump. This report was non-serious.
16 year old patient was inadvertently administered FLUBLOK QUADRIVALENT/ no AE; Initial information received on 21-Sep-2021 regarding an unsolicited valid non-serious case received from a pharmacist and consumer/non-healthcare professional via call center via Agency (Reference number- 00779084).  This case involves a 16-year-old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Product administered to patient of inappropriate age).  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  On 17-Sep-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: QFAA2103 and expiry date: 25-May-2022) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration (latency: same day).  It was reported "Call received from Pharmacist reporting a 16 year old patient was inadvertently administered FLUBLOK QUADRIVALENT. Caller with question on whether we have any safety information on administering FLUBLOK QUADRIVALENT to a pediatric patient."  At the time of reporting, 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.
This spontaneous report was received from a medical assistant regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 27-APR-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L004014, expiry date 04-MAR-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to first temperature excursion of 47 F for a time frame of 48 hours form 04-APR-2016 to 06-APR-2016. It was also subjected to second temperature excursion of 72 hours from 19-APR-2016 to 22-APR-2016. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient received vaccine on 3/16/21 and developed a sore, hot, red whelp about 3 inches below where shot was given (right arm). She is not having any anaphylactic issues.  She will keep an eye on and discuss with her doctor.
got the flu; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 06-Dec-2020.  This case involved female patient who got the flu (influenza) while received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect Influenza Vaccine (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, unspecified time after receiving the vaccine, it was reported that patient was one of them, her husband insisted, got the flu(influenza) and had not had it since patient had not had a shot, might be it was a coincidence, could not convince patient  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.  The reporter assessed the causal relationship with suspect vaccine as related.
1st dose of Shingrix on 18Nov2019 / is late for the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18th November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 2nd dose of shingrix, which led to incomplete course of vaccination. The reporter did not had lot or expiration date. The reporter consented to follow up.
Swelling, redness and tenderness 5cm X 5.5cm area on left upper arm.
Patient presented 6/24/19 and stated his arm turned red swelled and had severe itching at the injection site.
Large swollen red area pt. had fever, chills and generalized myalgia - state felt like flu symptoms.
T78.40XA ALLERGIC REACTION, INIT 1/19/2023 COLON POLYP
death Narrative: Patient received COVID vaccine #1 on 12/30/20 and #2 on 2/1/21. He was an inpatient in the facility and had been under hospice care since 12/9/20. No adverse events to vaccine found per notes. On 2/27/21, he began to have short and rapid respirations and was unresponsive. He was given morphine, atropine sublingual, lorazepam and nebulizers per hospice care orders and was determined to be imminent. On 2/28/21 at 2230, he passed. No autopsy results available. 27 days from date of vaccination to date of death.
Tinnitus with continued buzzing sound starting 2 days after the injection. This continues at all times and seems constant.   Shoulder Pain - Beyond initial pain following injection, I have experienced arthritis like pain developing in my right shoulder joint.
Patient reported a history of anxiety related to vaccine injections and a history of fainting post vaccination. Patient was brought to a private room for the vaccination and did faint about 5 minutes post vaccination. Patient was brought to the ground. Patient was able to respond to questions and only lost full consciousness for about 10 seconds. Patient recovered from the event after about 15 minutes and waited at our clinic 30-40 minutes post vaccination. By the time the patient left, he had fully recovered.