chrisvoncsefalvay/vaers-outcomes huggingface dataset:
approx 10 mins p/receiving immun, pt was observing sibling received vax; pt fell to floor, observed only by father who stated looked weak; was immed picked up & began crying; appeared pale & sl cyanotic; VS nl w/o dyspnea; No further faint;
I was unable to sleeep most of the night. I was kept awake by being very restless and could not hold still or get comfortable. I was tossing and turning between 11:00 PM and 5:00 AM when I finally got up. This feeling lasted until about 8;00 AM. I do not have a history of this condition at all and usually sleep very well.
Information has been received from a physician and registered nurse concerning a 78 year old female with hypertension and osteoporosis and a history of cold sores who on 20-FEB-2007 was vaccinated SC with a 0.65 ml dose of Zostavax (lot # 654604/1406F). Concomitant therapy included SYNTHROID, atenolol (manufacturer unknown), lisinopril (manufacturer unknown) and alendronate sodium. On 22-FEB-2007, two days after vaccination, the patient developed 4 areas of rash with itching on her back. No lesions or vesicles were noted by the patient. She applied hydrocortisone lotion to the rash. On 24-FEB-2007 the patient began developing pain in her chest and back. She also had pain under her arm, through the breast area and to her waist. As of 26-FEB-2006 the rash was diminishing and the tenderness continued. On 02-MAR-2007 the patient was seen by the physician and she had 4 lesions on her right upper back with looks to be a case of shingles and the patient has pain. She was treated with FAMVIR 500 mg TID for 5 days, MEDROL dosepack and VICODIN. No laboratory tests were performed. At the time of the report, the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
There were two rounds of symptoms that happened: On 2/19/21, I experienced a red rash around the injection site.  2/20/21:  I had a televisit with Dr. and she recommended ice and Tylenol for the rash.  I also applied hydrocortisone cream.  On 3/3/21, I experienced severe range of motion decrease as well as increased pain in my shoulder joint.  I went to see my PCP and then to another Dr.  I was diagnosed with Bursitis leading to a Frozen Shoulder due to the improper location for the COVID vaccine, given a Cortisone shot, and referred to complete 6-12 weeks of Physical Therapy.  I completed 6 weeks and then had two follow up appointments with Dr. office.  My range of motion has increased and is nearly back as of 7/3/21.
Expired Havrix administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 55-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 30-MAR-2023, the patient received Havrix. On 30-MAR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Havrix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date:03-APR-2023. Pharmacist reporting having administered an expired dose of Havrix. Adverse event contained all reported information. HCP gave consent for safety team follow up. Patient received an expired dose, which led to expired vaccine used.
Fever, muscle aches, headache, chills, nausea  all on 1st day after. On the 2nd day after, the fever broke, but I still had muscle aches and was exhausted.
Pt complaining of rash on extremities, hot to touch, itchy, and bumpy liquid filled pustules 1-2mm in diameter. Rash is clustered and confined to the extremities. It has been evident for approximately 1 year following initial Anthrax IZ. Rash is intermittent and varying in severity.
Received Moderna vaccines on 2/4/21, 3/5/21; tested positive for COVID-19 by PCR on 7/29/21. Admitted to Hospital on 7/27/21. History of duodenal cancer. Appears to be asymptomatic for COVID, admitted for bowel obstruction.
Positive test result to COVID-19 and developed symptoms; Positive test result to COVID-19 yesterday morning and developed symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 64-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 22Dec2021, outcome "not recovered", described as "Positive test result to COVID-19 and developed symptoms"; COVID-19 (medically significant) with onset 22Dec2021, outcome "not recovered", described as "Positive test result to COVID-19 yesterday morning and developed symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Dec2021) positive, notes: In the morning. The reporter reported that the patient was vaccinated and got a positive test result to COVID-19 in the morning of 22Dec2021 and developed symptoms.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I experienced left sore arm after my Pfizer vaccine.  I had two episodes and I do not know if they are related to the Pfizer vaccines.  Feb 28,2021 @ 10pm, severe onset vomiting.  March 15, 2021 @9:45am had a mild stroke.  I was in ICU, CT scans, MRI, echocardiogram, extensive blood work done. They also put in a heart monitor.
Hives/welp left axilla with burning, itching at site, flu like symptoms.
This spontaneous report was received from a physician via company representative refers to a 23 year old female patient. The information was reported to the physician by the patient's mother who was also a nurse. The patient's medical history and concurrent conditions were unspecified by reporter. On an unknown date the patient was vaccinated with first dose of GARDASIL (dose, route of administration, anatomical location and lot number was unknown). It was reported that the patient completed all the 3 doses of GARDASIL. Concomitant medications were not reported. On an unknown date, between the patient's second and third dose, the patient began to experience abdominal cramping, nausea and chest pain. No product quality complaint was reported. The patient sought medical attention by visiting to an unspecified neurologist and gastrointestinal specialist. The outcome of abdominal cramping, nausea and chest pain was unknown. The causal relationship between the events and GARDASIL was unknown. Additional information is not expected as reporter was not willing to be contacted.
Patient notified immunization clinic on 10/11/04 that immediately after receiving flu shot on 10/7/04 she felt pain radiating down her right arm to her elbow. She did not complain to immunization staff at that time. She has since seen a family practice physician on 10/08/04 and an orthopedic surgeon on 10/25/04, who administered a cortisone injection into her right arm to relieve the discomfort.
5/6/2021 after vaccine s/o sore arm. (5/7/2021 nausea) 5/8/2021 :L deltoid swelling & red,                tired/ new fatigue & headache. 5/10  L deltoid warm to touch.
Dizziness, Arthralgia, UrticariaPruritus, Chills Narrative:
Daily low grade fever followed by sweating. Ongoing cycles of this multiple times each 24 hour span. Also lack of energy and feeling achy
Pt came in with redness and burning at the injection site. Size was about the size of a tennis ball.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: On 14Jul2022, he started Paxlovid for COVID-19 Treatment and stopped on 19Jul2022. On 24Jul2022, he had rebound of Covid 5 days after treatment end. It was unknown if treatment received for AE or not. He was recovering from AE.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
WE RECEIVED A CALL ON TUESDAY AFTERNOON THE 13TH OF APRIL FROM THE MEDICAL EXAMINER REQUIRING INFORMATION ON HOW TO CONTACTB THE PATIENT'S DOCTOR. WHEN ASKED AS TO WHAT HAPPENED WE WERE TOLD THAT THE PATIENT WAS FOUND DEAD IN HER APARTMENT ON TUESDA.Y.  WE DID INFORM THEM THAT THE PATIENT HAD  RECEIVED THE JANSSEN VACCINE AT THE PHARMACY ON FRIDAY THE 9TH. WE DONT KNOW  THE CAUSE OF ADVERSE EVENT.
Information has been received from a RN concerning a 4 month old female with no known medical history or allergies who on 10Jul06 was vaccinated with a PO dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) (lot653981/0411F). Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, poliovirus vaccine, pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar) and Hib conj vaccine (manf unk). While being administered rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) (lot 653981/0411F) the pt began to gag and vomit. Subsequently on 10Jul06, the pt recovered. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/10/2006.
This spontaneous report as received from a health care worker refers to about 25 patients of unknown age and gender. No information about medical history, concurrent conditions and concomitant medications were reported. The reported stated that on unspecified dates between 26-SEP-2014 and 07-OCT-2014 (Merck) VARIVAX was improperly exposed to -10 degrees C for short (unspecified) time frames, and however the average temperature has been kept in the correct range of < -15 degrees C. It was also reported that about 25 patients received one of these vaccines (related case 1410USA005552) approximately on an unknown date in 2014 (reported as unspecified dates during this time frame of 26-SEP-2014 to 07-OCT-2014). No know adverse effects. The outcome of events reported is unknown. No product quality complaint was involved. This case is linked to the case 1410USA005552 via same reporter link. Additional information has been requested.
Red rash at injection site; Itchy at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red rash at injection site) and VACCINATION SITE PRURITUS (Itchy at injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0181321A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red rash at injection site) and VACCINATION SITE PRURITUS (Itchy at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (Red rash at injection site) and VACCINATION SITE PRURITUS (Itchy at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Pt had pain and swelling within hours, has marked induration and erythema. Skin indurated especially at elbow.
Red bumps turned into rash then then 2 days ago achy pain from right shoulder blade.  Swelling, red warm arm, shoulder pain. Restricted rom.
freezing, absolutely freezing, he couldn't get warm; all his muscles ached; major headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06May2021 11:15 (Lot number: EW0175) at the age of 57 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Lot: EW0162 , Time- 09:30, Anatomical location: Left arm), administration date: 15Apr2021, for COVID-19 immunization. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 15May2021 19:00, outcome "recovered" (16May2021), described as "freezing, absolutely freezing, he couldn't get warm"; MYALGIA (non-serious) with onset 15May2021 19:00, outcome "recovered" (16May2021), described as "all his muscles ached"; HEADACHE (non-serious) with onset 15May2021 19:00, outcome "recovered" (16May2021), described as "major headache".  Additional information: The patient experienced AE 9.5 days after his second dose. Nasopharyngitis and myalgia lasted for all by about 12 hours after onset and major headache lasted about 24 hours after onset. No Investigation Assessment done. No vaccines administered on the same date of the Pfizer suspect. No prior vaccinations (within 4 weeks) was administered. No AE following prior vaccinations.  No follow-up attempts are possible. No further information is expected.
Shortly after the 1st dose, I developed moderate/severe hip pain, bilaterally. Hip pain keeps me up at night, it disturbed my sleep. I can't sit for a prolonged time due to hip pain. It makes walking difficult, especially up and down the stairs. The pain didn't go away 4 months later and it didn't get better. My 1st vaccination was in April 2021;  it is August 2021, when I write this report and hip pain is still present.
Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: pt reports itching and rash within 15 mins after vaccine is given. Benadryl was given and feeling better but emotionally overwhelm due to possibly unable to receive 2nd shot
stomach has been upset; had diarrhea and had 2 loose stools; Queasy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administration date 27Feb2021 (Batch/Lot number: unknown) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 01Mar2021, outcome "unknown", described as "stomach has been upset"; DIARRHOEA (non-serious) with onset 01Mar2021, outcome "unknown", described as "had diarrhea and had 2 loose stools"; NAUSEA (non-serious) with onset 01Mar2021, outcome "unknown", described as "Queasy".  Additional Information: The patient was taking unspecified medication but she did not think anything would be related. The patient's next appointment/ second dose was scheduled on 31Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Large 2x3 in raised redden area on left arm at site of injection.  Iced area took tylenol
Extreme lethargy, swelling and pain at the injection site. Pt stated flu like symptoms.
Initial report was received from a health care professional on 18 November 2011. An 88 year-old female patient with an unknown past medical history had received on a Friday an intramuscular injection of FLUZONE HIGH-DOSE (lot number, site and date of administration not reported) and by that evening, complained of arm and shoulder pain. The patient was evaluated by a physician on Monday and had 60 cc of non purulent, viscous, amber colored fluid from the shoulder joint. The patient had an MRI and was found to have joint effusion and degenerative joint disease. Treatments were not reported. No further information was available at the time of the report. Outcome was not recovered. Documents held by sender: none.
Information has been received from a physician concerning a 23 year old female who was vaccinated with a first dose of GARDASIL 0.5ml IM. Subsequently the patient experienced "seizure like reaction", the patient was shaking and passed out shortly after receiving the dose of GARDASIL 0.5ml IM. After receiving her vaccination the patient became responsive again within 1-2 minutes and noted that the injection was very painful. The patient was in the office when the event occurred. It was noted that the patient had since returned to receive the second dose of GARDASIL 0.5ml IM with no problems. Upon internal review seizures like reaction was determined to be an other medical event. Additional information has been requested.
from chart: "Pt reports arm really hurt yesterday after injection. After coming home from work yesterday, felt so cold. Sat in hot tub - felt cold and hot after. Woke in middle of the night w/ fever, vomiting and diarrhea. Fever did not go over 101. States fever is gone now. Has had 3 episodes each of vomiting and diarrhea. Last vomited 1 hour ago. Still nauseated. Has some abd pain prior to vomiting/diarrhea that resolves after. Drinking water which is staying down. Is tired, has been sleeping. Head is killing her but not the worst HA ever - feels like it's turning into a migraine. Did not have her coffee this morning. Arm still hurts, aches, is uncomfortable. Denies dizziness, lightheadedness, body aches or any other sxs. "
pt recvd vax;broke out in hives eve of inject;to MD,was given a kenalog inject & po atarax;sxs persistant;back to MD again;was given medrol dose pk pf prednisone;this drug effective p/ 2nd dose
arm is a little sore and starting to hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A female patient received BNT162B2 OMI BA.4-5, on 17Nov2022 as dose number unknown (booster), single (Lot number: Gh9694) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Nov2022, outcome "unknown", described as "arm is a little sore and starting to hurt".  Additional information: Patient reported that the nurse came in about an hour ago and gave her the booster shot that was supposed to help prevent the new variant. She said she can't read what the nurse wrote. She got a code but doesn't know which one is the Pfizer bivalent booster. She provided 2 lot numbers, fj5682 she got in June and Gh9694 the one she received today. She wanted to know if the booster she got today was the bivalent. She also mentioned that her arm was a little sore and starting to hurt.  No follow-up attempts are possible. No further information is expected.
PFIZER BIONTECH COVID 19 VACCINE: ADMINISTRATION ERROR- EXTRA DOSE  PATIENT VACCINATED AT NORTHWAY HEALTH AND REHAB ON 4/1/21 AND 4/22/21 WITH WHAT WAS BELIEVED TO BE 1ST AND 2ND DOSES RESPECTIVELY.  IT WAS UNKNOWN THAT THE PATIENT HAD ALREADY RECEIVED A 1ST DOSE AT A DIFFERENT NURSING FACILTY.  NO ADVERSE REACTIONS REPORTED.    1ST DOSE 2/19/21  2ND DOSE 4/1/21  3RD DOSE 4/22/21
HIVES ON HIS LEGS, ABDOMEN, AND ON RT DELTOID WHERE VACCINE WAS ADMINISTERED. HAS REDNESS & SWELLING ON RT ARM.
103 degree fever; deep cough; chills; body aches; nasal congestion; loss of taste; loss of smell; as well as an earache; Despite receiving both vaccine doses, I tested positive for COVID-19 on 6/16.; Despite receiving both vaccine doses, I tested positive for COVID-19 on 6/16.; inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient). This 30-year-old male patient received bnt162b2 (brand: Pfizer), dose 1 via an unspecified route of administration, administered in arm left on 27Feb2021 (Batch/Lot Number: EN6205) as dose 1, single; dose 2 via an unspecified route of administration, administered in arm left on 16Mar2021 (Batch/Lot Number: EN6207) as dose 2, single for covid-19 immunisation at the age of 30-year-old. The patient medical history and concomitant medications were not reported. The patient previously took buspirone cox and experienced drug allergy. It was unknown that if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Facility type vaccine: Hospital. Despite receiving both vaccine doses, patient tested positive for COVID-19 on 16Jun2021. Patient had somewhat severe symptoms; 103 degree fever, deep cough, chills, body aches, nasal congestion, and loss of taste and smell, as well as an earache. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19: covid test type post vaccination: Nasal Swab on 17Jun2021 (as reported) with result positive. No treatment for events. The outcome of event was recovering.
Narrative: Pneumonia vaccination today states swelling, redness to site, itching, pain to left upper arm, no fever, no n/v, no other complaints. Symptoms: Erythema Multiform and Urticaria Pruritus.
transverse myelitis, abrupt onset about 90 min p/vax;paresthesias, hypesthesias & bilat lower extremity paresis;tingling;progressive numbness lower extremities;walking difficult;dizziness;polyradiculitis or myelitis;leg weakness;GBS;
"vaccine arm" -- swelling, heat, redness, tightness at and around the site of the injection. Extends about 6" down from injection and approx 3" wide.
Report A0369578A describes an anaphylactic reaction in a male vaccinee of unspecified age who received Hep B vaccine recombinant (Engerix-B). Medical history, concurrent conditions, and concurrent medications were not specified. The vaccinee had an unspecified reaction to "pertussis" as a child. He received measles, mumps, and rubella vaccine and meningococcal vaccine at unspecified times without reaction. On an unspecified date, the vaccinee received an injection of Engerix-B; it was not known if he had received previous injections of Engerix-B. Subsequently, he experienced an anaphylactic reaction. As of 5/22/02, the anaphylactic reaction had resolved. Anaphylactic reaction is considered GSK medically serious.