chrisvoncsefalvay/vaers-outcomes huggingface dataset:
became incoherent for 2.5 days after Booster 1/could not talk or form thoughts; major reaction to Booster 1/ very very ill; nor walk w/o help; had fever; did not eat/drink for 2 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 70-year-old patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "chronic kidney patient Lev. 2" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization; Bnt162b2 (Dose: 2), for Covid-19 Immunization, reaction(s): "fever". The following information was reported: INCOHERENT (non-serious) with onset Oct2021, outcome "unknown", described as "became incoherent for 2.5 days after Booster 1/could not talk or form thoughts"; EATING DISORDER (non-serious) with onset Oct2021, outcome "unknown", described as "did not eat/drink for 2 days"; PYREXIA (non-serious) with onset Oct2021, outcome "unknown", described as "had fever"; ILLNESS (non-serious) with onset Oct2021, outcome "unknown", described as "major reaction to Booster 1/ very very ill"; GAIT DISTURBANCE (non-serious) with onset Oct2021, outcome "unknown", described as "nor walk w/o help".  Additional information: Patient was fairly active and had major reaction to booster 1 vaccine in Oct2021. With 2nd vaccine had fever, then patient was okay. With Booster 1, patient was very ill. Patient had a chronic kidney Lev. 2 under care of Dr. Normally, patient was doing well and functioning within normal range. Patient became incoherent for 2.5 days after booster 1, had fever and could not talk or form thoughts, nor walk w/o help. Patient did not eat/drink for 2 days.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202200544435 same patient/ reporter, different product/ AE
05:35PM STATES 'FEELS LIKE SHE WILL PASS OUT, NAUSEA & HAS CHEST PAIN'. PLACED ON COT AND CARDIAC MONITOR. A/O, PINK, W/D, RESP WITH EASE, NO DIAPHORESIS, NO DECREASED LOC.  SINUS TACH ON MONITOR. 5:49PM ASA P.O./CHEWED.  IV STARTED PER SQUAD. SMALL AMT EMESIS (APROX 2 TSP). TRANSPORTED TO ER PER SQUAD.
Had a seizure: some memory loss, bit tongue very severely, possible broken or dislocated bone in her shoulder. (She has an appointment with a orthopedic specialist).
Knee swelling then swelling of other joints followed by severe pain & immobility. Hoping disablility will not be permanent but has now been going on for several months.
Arm soreness at injection site after second dose; Vomiting (four sessions of vomiting after midnight); Felt nauseous; Red blotches on my face; My face got red; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red blotches on my face), ERYTHEMA (My face got red), VACCINATION SITE PAIN (Arm soreness at injection site after second dose), VOMITING (Vomiting (four sessions of vomiting after midnight)) and NAUSEA (Felt nauseous) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced FATIGUE (Extreme fatigue). On 16-Mar-2021, the patient experienced RASH MACULAR (Red blotches on my face), ERYTHEMA (My face got red), VOMITING (Vomiting (four sessions of vomiting after midnight)) and NAUSEA (Felt nauseous). On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm soreness at injection site after second dose). On 16-Mar-2021, ERYTHEMA (My face got red) had resolved. At the time of the report, RASH MACULAR (Red blotches on my face), VACCINATION SITE PAIN (Arm soreness at injection site after second dose), VOMITING (Vomiting (four sessions of vomiting after midnight)), NAUSEA (Felt nauseous) and FATIGUE (Extreme fatigue) outcome was unknown.            No treatment information was reported.   This case was linked to MOD-2021-047947 (Patient Link).
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On unknown dates, the patients were vaccinated with improperly stored M-M-R II (dose and route unspecified, lot # reported as L007578 with expiration date of 05-MAR-2017, lot # reported as L003859 with expiration date of 25-FEB-2017). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Mild soreness injection site Slight swelling of 3-4 cm diameter at injection site with little or no redness. Lasted 48-72 hour as it tapered off
Pt came to clinic with temp 104.5, mild runny nose and no other symptoms, exam was WNL and fever attributed to vaccines. Pt went to ED 3/14 again with high fever and was admitted for 10 days with intermittent high fever, no other symptoms, extensive work up for infection was negative. Vitals were always stable and pt appeared clinically well except for high fevers.
Three days after receiving my first Pfizer shot, I started having chest pain and shortness of breath. I ended up being off of work for 9 days. During that time, I have had an echo, holter monitor placed, chest xray, blood work, a covid test which was negative, fever 102 on and off for the 9 days I was off of work. Nausea, vomiting, diarreah, and my blood pressure resting is 150/108 and I am a healthy person and is never sick. Headaches as well. My heart now has irregular beats and I am being referred to a cardiologist.
The patient experienced mild systemic symptoms but they were not reported until the following week. On 09/18 the patient feverish. On 09/20/2001 the patient experienced lower extremity stiffness, soreness and swelling. On 09/21/2001 the patient developed a raised, red, painful rash on the palms of her hands. On 09/24/2001 the patient called to report her symptoms. The patient Health Dept called. The patient was excluded from work until 10/03/2001. The patient went to an infectious disease Dr on 10/02/2001.
Palpitations  Increased tachycardia  Elevated ESR Elevated CRP Flare of dysautonomia requiring multiple medication adjustment Continuing for months after vaccination
Bad headache; Fever; Flu like symptoms; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 10Mar2021 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included covid-19 from Dec2020 to an unknown date COVID in Dec2020. The patient's concomitant medications were not reported. The patient experienced bad headache on 11Mar2021, fever on 11Mar2021, flu like symptoms on 11Mar2021.  The patient underwent lab tests and procedures which included influenza virus test: negative. The outcome of event flu like symptoms was not recovered, all other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
~ 1 week after injection arm began to feel sore again. The next day, a rectangular rash patch ~ 4in x 5in appeared around injection site.  The rash was very sore, slightly raised, red, hard, and very hot to the touch. Much hotter than surrounding arm without rash. The soreness lasted for ~ 4.5 days, the rash lasted ~ 4 days. By Tuesday, 6 April 2021 in the evening everything seemed fine.
Report symptoms of dry mouth 2 days post vaccination.  Treatment: drinking water. Outcome: Report increase urination due to drinking water.
Swelling of arm, soreness and headache, 14w pregnant EDD 3/24/21
11am - noon: nausea Noon - went to bed at 10pm: red, swollen, sore at site; very tired, sore muscles especially shoulders/neck, headache  - would classify all as moderate  Did not take any meds  6:30 am: woke up with only mild redness, swollen and sore at site
TASTE HAS CHANGED; FEELING SICK; CHILLS; FEVER; NAUSEA; EXHAUSTION; This spontaneous report received from a patient concerned a 70-year-old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no other medical history reported. The patient experienced drug allergy when treated with codeine, and levofloxacin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-MAY-2021, the subject experienced taste has changed. On 18-MAY-2021, the subject experienced feeling sick. On 18-MAY-2021, the subject experienced chills. On 18-MAY-2021, the subject experienced fever. On 18-MAY-2021, the subject experienced nausea. On 18-MAY-2021, the subject experienced exhaustion. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and nausea on MAY-2021, was recovering from chills, and had not recovered from exhaustion, taste has changed, and feeling sick. This report was non-serious.
Noticed Petechiae, bruising and blood blisters in mouth 6/15/21.  Went to urgent care and had CBC done and platelets were at 2,000 and was instructed to go to ER.  Got second opinion from primary care physician an instructed to go to ER.  Went to ER on 6/15/21 and was immediately admitted to hospital.  Began steroid IV treatment and had completed blood profile done.  Underwent bone marrow biopsy and abdominal ultrasound 6/18/21 - all normal.  Was given platelet infusion and human immune globulin infusions.  Release from hospital on 6/21/21 with platelet count at 32,000.  Continued steroid treatment and regular CBC tests.  Platelet count dropped to 6,000 on 7/2/21 and was readmitted to hospital.  Given steroid infusions and began 1 of 4 Bitruxan treatments. Released from hospital on 7/5/21.  Continuing steroid treatment and Bitruxan  treatments with regular CBC tests.  Outcome to be determined
Pt states that her right arm was swollen and ached all the way down to her fingertips, itched all over body, jaw hurt to open/close, no fevers but had a little nausea/bowel issues (after gas bout she had a lot of pus coming out of anus), states her arm is really red at injection site and now it's hot and swollen about teh size of a quarter then around that about the size of a half dollar. It's welted with white patches at teh lower border. Pt also states her whole head is itchey but she states that her swelling is more localized.
Rash at injection site followed by rash under the elbow, both arms and spreading up the arms; taking antihistamine, anti-itch cream
Swollen lymph node under arm the size of a tennis ball for 6 days now, extreme pain throughout arm down to the fingertips with tingling, extreme pain into scapula, neck pain and migraine for 6 days  Taken 600 mg advil every 6 hours as needed for pain
the evening of her vaccine, she developed muscle aches, joint pain,  fever and headache. She took tylenol and used a cool compress. Symptoms improved within the next two days except the joint pain. Pt reports joint pain-finger, wrists, ankles and knees has continued. Pain has improved but not back to normal. She has not tried any further medication. Will try ibuprofen and monitor.
numbness in my right hand; This case was reported by a consumer via call center representative and described the occurrence of numbness in hand in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2020, the patient received Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced numbness in hand. On an unknown date, the outcome of the numbness in hand was unknown.   It was unknown if the reporter considered the numbness in hand to be related to Shingrix.  Additional details were reported as follows: The patient got the Shingrix shot in his left deltoid and experienced numbness in his right hand. The patient wanted to know whether numbness in hand could be caused by the vaccine and also whether there were other side effects of the Shingrix vaccine.
Aches beginning ~6 hours after injection. Extreme chills about two hours later followed by fever, nausea, extreme fatigue, slight headache, slight pain at injection site. Symptoms began easing about 26 hours after injection and were mostly gone a few hours later. About 46 hours after injection (upon awakening), I saw a small red rash at the injection shot (about the size of a half dollar). The site was sore and glands under my arm were swollen and sore. Those symptoms subsided about 24 hours later.
Sore arm for more than 5 days and swollen hard skin around the injection area.
Pt has a history of COPD, schizophrenia, and polysubstance abuse, and currently lives in a facility. He suffered a ground level fall and was noted to have a subdural hematoma. He was awaiting transfer to hospital care at the facility when his COVID test came back positive.
Patient was admitted to the hospital with COVID symptoms and was treated with typical COVID medications. Patient was discharged home with hospice.
shoulder and injection site pain of both shoulders/ right shoulder he notices pain 40-50% of time/ pain comes and goes; shoulder and injection site pain of both shoulders; awkward movement of shoulder aggerate the pain; This spontaneous case was reported by a consumer and describes the occurrence of shoulder and injection site pain of both shoulders, right shoulder he notices pain 40-50% of time, pain comes and goes, shoulder and injection site pain of both shoulders, and awkward movement of shoulder aggerate the pain in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. not provided) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced shoulder and injection site pain of both shoulders/ right shoulder he notices pain 40-50% of time/ pain comes and goes, shoulder and injection site pain of both shoulders and awkward movement of shoulder aggerate the pain. The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and TYLENOL for Adverse event, at an unspecified dose and frequency. At the time of the report, shoulder and injection site pain of both shoulders, right shoulder he notices pain 40-50% of time, pain comes and goes, shoulder and injection site pain of both shoulders, and awkward movement of shoulder aggerate the pain outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was mentioned. Treatment also includes Ice and heat alternation.   This case was linked to MOD-2021-314534 (Patient Link).
Client was inadvertently given a booster too early.  His second dose in the primary series was given 3/3/2023, his booster was given 3/28/2023.  Dr. was notified, as well as nursing staff, LPN at Center.  LPN was asked to notify the client and to reach out to me with any concerns or if the client had any problems for follow up with our physician.
THIS WAS THE DATE OF MY SECOND MODERNA COVID 19 VACCINATION, ONE MONTH AFTER MY FIRST.  INITIALLY I ONLY FELT SORENESS AT THE INJECTION SITE ALONG WITH SOME SWELLING.  HOWEVER, 3 DAYS LATER I DEVELOPED AN ITCHY RASH AT THE INJECTION SITE.  I ALSO NOTICED A SMALL HIVE ON THE UNDERSIDE OF MY UPPER ARM.  I AM APPLYING A TOPICAL ANTIHISTAMINE GEL WHICH WAS HELPED EASE THE ITCH AND THE RASH HAS DIMINISHED SOMEWHAT.  I GUESS THIS IS CALLED ?COVID / MODERNA ARM??
pt recv vax FEB96 & MAY97 pt devel mild case of chickenpox w/approx 50 or fewer lesions, none of which went to vesicular stage;chickenpox were accompanied by sl fever;
Patient was administered a dose from an expired vial.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial.) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial.). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications are provided by the reporter. Patient reported that there was a transcription error when taking notes of the expiration dates of the lot  for the vials they have at their facility. They've mistakenly administered expired vials to 10 patients.   This case was linked to MOD-2021-366918, MOD-2021-366925 (Patient Link).
Information has been received from a Licensed Practical Nurse (L.P.N) who inquired if patients who have had pneumonia were at a greater risk to experience injection site reactions or systemic adverse effects after receiving PNEUMOVAX 23. Attempts are being made to verify the existence of identifiable patients. Follow-up was received from a licensed practical nurse who reported that the patient had pneumonia before and when he was vaccinated on an unspecified date with a dose of PNEUMOVAX 23 (Lot# not reported), on an unspecified date, he had arm redness, it was extremely swollen, hot and feverish at the injection site and his whole arm. At the time of the report the patient's outcome was unknown. It was unknown if the patient sought medical attention. This is one of several cases from the same source. Additional information is not expected.
tendonitis/tendonitis aggravated; shoulder impingement/shoulder impingement aggravated; arthritis aggravated; This case was reported by a other health professional via call center representative and described the occurrence of tendonitis exacerbated in a 63-year-old patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   The patient's past medical history included chickenpox (but no shingles at the time of reporting). Previously administered products included Zostavax (received few years ago). Concurrent medical conditions included tendonitis, impingement syndrome shoulder and arthritis (which were well managed at the moment).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced tendonitis exacerbated, impingement syndrome shoulder and arthritis aggravated. On an unknown date, the outcome of the tendonitis exacerbated, impingement syndrome shoulder and arthritis aggravated were unknown.   It was unknown if the reporter considered the tendonitis exacerbated, impingement syndrome shoulder and arthritis aggravated to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows:  The age at vaccination was not reported. After vaccination with Influenza vaccine Quadrivalent unspecified season, the pre-existing condition of the patient was easily aggravated for months following vaccinations in either shoulder. The patient's orthopedist recently at the time of reporting, confirmed this to be not uncommon.  He suggests, in the future, the patient would ask for such vaccinations below the belt (in the buttocks or thigh), so as not to exacerbate the shoulder issues.  According to the reporter's internist the patient should receive Shingrix.  He asked, administration procedures suggest Shingrix should be injected in the Deltoid.  The patient asked, could Shingrix be injected elsewhere with equal or near equal effectiveness.
received adult dose instead of pediatric; received adult dose instead of pediatric; This case was reported by a pharmacist and described the occurrence of overdose in a 19-year-old female patient who received HBV (Engerix B adult) (batch number P4DJ5, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd March 2022, the patient received the 1st dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 23rd March 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and adult use of a child product. On an unknown date, the outcome of the overdose and adult use of a child product were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-APR-2022 Reporter's Comments: The case was reported by patient's parent. The patient received ENGERIX-B VACCINE adult dose instead of the pediatric dose. The reporter would like to know what she should do. The reporter did not have expiry date of vaccine. The reporter consented to follow up. Additional Supportive Information: The patient received adult dose instead of the pediatric dose which led to overdose and adult use of a child product.
Simple febrile seizure, crying, twitching, stiffening 2-3 minutes, fever, ER-observation -> Resolution. Chief Complaint: Seizure-like activity. This morning, just before 8:00 a.m., the dad heard the patient crying, went into the room, and then saw the patient stiffen up, had twitching of his hands, eyes were fluttering and some slight extension of his neck. He then fell asleep afterwards. Dad estimated that the twitching episode happened for approximately 2-3 minutes. He did not pay attention to how long he was sleepy after, but he kind of got sleepy. He sat up then and then drank some water and then wanted to go back to sleep. The parents are telling me that leading up to today, he has not been having any URI symptoms. He has been happy, playful, tolerating good amounts of oral intake, making appropriate amounts of urine output. He did get his immunizations earlier in the week and the mother stated that last time he got his immunizations, he did not spike a fever until the end of the week, so she says that she was expecting it. She felt that he was tactilely warm yesterday, so she did start rotating MOTRIN and TYLENOL for him. He had a slight decrease in his oral intake yesterday and was a little bit crankier than usual, but otherwise, he was fine. They deny any trauma. They deny any falls. They did give him TYLENOL at 8:00 a.m. after he had had the episode and they had last given him MOTRIN last evening. He has tolerated oral intake, but he continued to be somewhat decreased in his activity level. He still feels febrile to the parents. They did not measure it. They brought him immediately into the Emergency Room because of the shaking episode. No sick contacts that they are aware of. Again, no difficulty in breathing. He has been making good urine output until today. No other medications being given other than the MOTRIN and TYLENOL. No other aggravating or relieving factors for the chief complaint.