chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CC: patient was watching TV as reported by his mother. started seizing and having difficulty breathing. EMS was called for transport. On arrival to ED, patient was breathing 60-70 BPM, tachy at 135-140 sinus rythym. B/P stable at 140's/90's. his pupils were equal and reactive to light. no response to aggressive sternal rub. slight seizure like activity with arm and leg jerking. Ativan IVP given Patient is on non-rebreather sao2 at 90-100 fluctuating. IV established. he desats to 80-85 on room air. Has frothy sputum from mouth. RSI performed with succs and versed to secure airway and ventilate patient. 7.5 tube placed with one attempt at 27/teeth. verified via direct auscultation and capnography. Tube secured. maintanence medications given to ensure sedation. transfer initiated and airmed launched. Dr. accepted. patient left building at 1940 via airmed. Patients labs (electrolytes WNL) normal wbc. D-dimer at 1500. suspect for PE or flash pulmonary edema although his breathsound are clear bilateral.  18:10 03/27/21.  BP: 124/89. MAP: 100. HR: 135. RR: 54. O2 saturation: 94%. Temp: 99.2 F. Pain level now unable to obtain due to patient condition.  --20:05 3/27/21    Weight: 81.6 kg estimated
She had an "episode" on 11/2/13 from 0803-0815 her mother found her gagging in bed and carried her downstairs. She did not respond to questions and voided all of her urine. There were no tonic-clonic movements. She was seen at ED.
States received Flu vaccine at Ashe Tuesday and then few hours after exp whole body soreness, vomiting, fever.
Pt. goes to pharmacy to be oriented about the discomfort that she was presenting in her left arm since the day she was vaccinated (August 19). Upon inspection, the area was red, hot, hard and covered most of the muscle, plus the area was quite porous and hard to the touch. Patient identified Doctor G. as her main provider. I contacted him, explained the situation and he let me know the course to follow, in this case is to send her with antibiotics since she may be presenting an infection in the area. Doxycycline 100mg was given twice per day for 7
Patient developed rash/itching to back. Received Benadryl 25mg po with good effect. Discharged in stable condition.
I developed a blistering and scabbing rash on the palms of my hands shortly after my second dose.  I also was very sick after my second dose - intense chills and body aches for about 10 hours the day after I received the second shot.  The blisters and rash have not subsided for an entire month, and I was recently diagnosed with dyshidrotic hand eczema / Chronic Vesicular Hand Dermatitis and was prescribed Clobetasol 0.05% topical ointment.
upper rt thigh @ area of vax;swollen, reddened w/small knot;Md instructed warm clothes & APAP;
very fatigue and sore arm, headache,  the night of the shot. 01/06/2021, Very fatigue, chills, fever, body aches, red spot where shot was given, slight headache,  01/07/2021 cough, sob, asthma like symptoms, headache, body aches, slight fever. 99.9, loose stools,   01/08/2021
Day after: fever, chills, headache, nausea. Still going on: headaches (bad) lasting all day and night, no matter how much Tylenol I take
Receive second dose of SHINGRIX on 12/28/18. Next day I got pain, swelling, headache, muscle pain, belly pain and rash look like shingles.
Stroke; This is a spontaneous report from a contactable consumer (patient). A 74-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the left arm on 15Apr2021 at 13:45 (Batch/Lot Number: ER8733) as DOSE 1, SINGLE (at the age of 74-years-old) for COVID-19 immunisation. Medical history included Type 2 diabetes mellitus and Chronic Obstructive Pulmonary Disease (COPD), high blood pressure (BP) and Covid-19 from an unknown date and unknown if ongoing. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received several normal prescriptions and supplements within 2 weeks of vaccination. The patient had unspecified concomitant medications. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had a stroke on 05May2021 at 13:30 and was ambulanced to the hospital where he had vascular carotid artery surgery. The patient was hospitalized from 05May2021 to an unknown date for 9 days. The second dose was set for 06May2021. The event resolved with sequel. The event resolved with sequel on an unspecified date in 2021. This report is serious (caused / prolonged hospitalization, disabling / incapacitating). The event required Emergency room/department or urgent care.
Patients wife described rash on extremities of arms and lower abdomen. However, No rash or redness around injection site.
Information has been received from a physician concerning a patient who was vaccinated IM with a second dose of measles virus vaccine live (Endera-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process). Subsequently the patient developed varicella. The lesions were tested and they were negative for the vaccine strain. The physician felt that the varicella infection was unrelated to vaccination. There was no product quality complaint involved. Additional information is not expected.
Has developed rash around injection site about 5 inches in diameter and it is red at the injections site.  Patient reports not feeling well in general.  Sent picture to his provider and left message with provider.
Redness and induration over ~ 10 x 10 cm area of upper outer arm around site of Pneumovax injection, occurring within 24-48 hours of injection.
8 months later shingles /Suspected Vaccination Failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 8 months after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: 8 months later shingles /Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 24-JUL-2023 This case was reported by a patient via interactive digital media. The patient got both shingle shots and 8 months later shingles. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting.
got a flu shot twice and was sick both times for 3 weeks; Initial information received on 16-Dec-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient).   This case involves a patient of an unknown demography who was sick (illness) for 3 weeks, after receiving INFLUENZA VACCINE both the times.   The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received two doses of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site.  On an unknown date, the patient was sick (illness) for 3 weeks, unknown latency following the administration of INFLUENZA VACCINE both the times.  No laboratories details reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information about batch number for this case.
Nose started bleeding last night at around 12:00am after receiving Flumist earlier in the day.  It stopped bleeding only to start again about an hour later.
C/o chest pain & in left shoulder. No radiate. Paramedics on scene to evaluate.
Information has been received from a pharmacist concerning a 51 year old female with sinus disorder and sulfonamide allergy who on 29-MAR-2008 was vaccinated SQ into the right arm with a dose of pneumococcal 23v polysaccharide vaccine (Lot# 658200/0804U). On 31-MAR-2008, the patient developed lymphadenitis. Unknown medical attention was sought via telephone. The patient's lymphadenitis persisted. No product quality complaint was involved. In follow up, the healthcare worker asked for information to identify the patient in the adverse reaction. No further information reported. Additional information has been requested.
pt recv vax 22MAR96 & expose to varicella 10 days prior to outbreak;pt & sibling devel varicella 27 lesions, face, chest, back, buttocks;sibling did not recv vax;
pt recv vax & 10SEP97 pt exp a sudden onset of a fever of 106;pt was taken to ER & pt mom was uncertain if pt was adm;6hr later pt recovered w/o an prescription or OTC med given;
Case number PHEH2014US003958 is an initial spontaneous reprot received from a pharmacist on 24 FEB 2014 with a follow-up received on 01 APR 2014. This report refers to a 14-year-old male patient. His medical history and concomitant medications was not reported. He was vaccinated with 0.5 ml of FLUCELVAX (batch number: 004011A/006001A, expiry date JUN 2014) intramuscularly into left deltoid on 31 DEC 2013 at 6:40 PM. No adverse event ws reported following this administration error (inappropriate age at vaccine administration).   Follow-up received from a pharmacist on 01 APR 2014. Site and time of vaccinatiion updated.   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 01 APR 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
The patient is also "a cancer patient in remission".; had pneumonia about 5 or 6 years ago; had a mild reaction; This spontaneous report as received from a patient's husband refers to a female of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On an unknown date in 1992, the patient was vaccinated with a dose of unspecified pneumococcal vaccine (manufacturer unknown) (dose, route of administration, lot number and expiration date were not provided) for prophylaxis. On an unknown date in 1992, the patient experienced mild reaction (unspecified). In approximately 2013 (reported as about 5 or 6 years ago), the patient experienced pneumonia. On an unknown date, the patient was diagnosed with a cancer (unspecified). It was reported that, the cancer was in remission, at the time of the report. The outcome of the events was not provided.  The reporter considered mild reaction to be related to pneumococcal vaccine (manufacturer unknown). The relatedness between cancer and pneumonia and pneumococcal vaccine (manufacturer unknown) was not provided.  Upon internal review, the events of cancer and pneumonia were determined to be medically significant.
Pt describes getting a vaccine on 3/5, then on 3/8 woke up in the morning and was very confused and disoriented.  This was experienced by her significant other.  She went to bed again immediately and then woke up later at 3 PM.
Fever; Nausea; Vomiting; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Apr2021 at 14:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication included cetirizine hydrochloride (ZYRTEC) from an unknown date for an unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 09Apr2021 at 14:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 01May2021 at 03:00, the patient experienced fever, nausea, vomiting, body aches. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient underwent SARS-CoV-2 test (Nasal swab) and the result was negative. The clinical outcome of the events fever, nausea, vomiting, body aches was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Tonic clonic activity-see ER note for 4/11/2015. PT had same type of problem after receiving vaccines on 2/10/2015.
It was gradual change and I am not sure if it was after my 1st or 2nd shot, or when I actually noticed it, but my sense of taste and smell has drastically changed.  Everything has a similar odor, where good things smell more mediocre, and bad things smell "less bad" if that makes sense. Everything is taking on the same sense and smell, but not 100%. I can still smell peanut butter or a rose and tell what it is, but it is drastically different and can be unpleasant. Food is not as enjoyable and neither are smells. All my foods are taking on the same smell and taste.
neuralgia; severe headache; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of neuralgia in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced neuralgia (Verbatim: neuralgia) and headache (Verbatim: severe headache). The outcome of the neuralgia and headache were unknown.   It was unknown if the reporter considered the neuralgia and headache to be related to Shingrix.     It was unknown if the company considered the neuralgia and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-OCT-2023 The reporter did not consent to follow-up.
Hives within 24 hours of vaccine, localized injection/redness at site where vaccine given.
Swollen Lymph nodes at neck Red rash on arm at site of vaccination and up to the neck Painful arm
This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a adult female patient who received SHINGRIX for prophylaxis. On 26th January 2019, the patient received the 1st dose of SHINGRIX. In January 2019, less than a day after receiving SHINGRIX, the patient experienced itchy rash, unwell, chills, diarrhea, general body pain, joint pain and mass. On an unknown date, the outcome of the itchy rash, unwell, chills, diarrhea, general body pain, joint pain and mass were unknown. It was unknown if the reporter considered the itchy rash, unwell, chills, diarrhea, general body pain, joint pain and mass to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however; it could be 62 or 63 years. The patient preferred not to give any more personal information. The patient received SHINGRIX on Saturday and had been ill ever since (2nd day) chills, diarrhea, aches (even in joints in my back) and woke up with a large lump on her face. It looks like a rash and itches terribly. The patient was surprised to wake up am to this lump on her cheek. The patient planned to call her dermatologist this am on the date of reporting. The patient might receive a letter from safety department.
APPROXIMATELY 20 MINUTES AFTER RECEIVING THE VACCINE HE SAID HIS TONGUE WAS SWELLING. HE THEN TOOK A BENADRYL WHILE STILL AT THE PHARMACY.  HE SAT AND WAITED SO WE COULD MONITOR HIM. HE NOTICED IMPROVEMENT IN THE SWELLING OF HIS TONGUE AND IT WAS RETURNING BACK TO NORMAL. WE HAD RECOMMENDED THAT HE COULD VISIT THE EMERGENCY ROOM, BUT HE OPTED TO WAIT HERE SINCE  HE WAS IMPROVING AND NOT HAVING ANY DIFFICULTY BREATHING.
Pt recvd 2 doses of Engerix-B & 12 days p/2nd dose exp erythema around the torso; reporter states that pts clinical picture was most consistent w/bug bites & seemed to be temporally related to recent walk in woods;
This spontaneous report was received from a health care worker refers to a patient of unknown demographics. On 28-JAN-2014 the patient was vaccinated with PNEUMOVAX23, injection, 0.1 ml (millilitres), intradermal (dosing regimen unspecified). On 28-JAN-2014 the patient experienced accidentally administered with PNEUMOVAX23, the patient received 0.1 ml intradermally (underdose). She reports that a patient was due to receive a tuberculin skin test, but was accidentally administered PNEUMOVAX23 due to product confusion. She stated that the patient received 0.1 ml intradermally. She stated that no adverse reactions reported at this time. The outcome of the medication errors and underdose were unknown. Additional information has been requested.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown demographics. On an unspecified date, since 05-MAY-2014, an unspecified number of patients were vaccinated with VARIVAX (Merck). The reproter stated that on 05-MAY-2014 onwards her refrigerator and freezer units began to have temperature excursions and VARIVAX (Merck) was improperly exposed to temperatures above 5F as listed in the following sentences. VARIVAX (Merck) Lot # J009727 (expiration: 07-AUG-2015) was improperly exposed to 22F for 4224 hours. All of the data listed here was reconfirmed with the reporter. No further information was available at the time of this report. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unspecified dates, the unspecified number of patients received improperly stored doses of ROTATEQ, orally, (lot#, expiration date, dose and indication were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
pulled the needle out, it was dripping on her hand, her shoulder was wet and after 30 minutes, her Band Aid was full of blood; pulled the needle out, it was dripping on her hand, her shoulder was wet and after 30 minutes, her Band Aid was full of blood; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 68-years-old female patient received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 22Jan2021 (age at vaccination was 68 years) as dose number unknown, single for COVID-19 immunization. The patient's medical history included diabetes mellitus from 2000 and ongoing. Concomitant medications included insulin lispro (HUMALOG) taken for diabetes mellitus from 2020 to an unspecified stop date and insulin glargine (LANTUS) taken for diabetes mellitus, start and stop date were not reported. On 22Jan2021, the patient informed that she noticed when operator pulled the needle out, it was dripping on her hand, her shoulder was wet, and after 30 minutes, she had to wait to be sure she had no reaction, and her Band Aid was full of blood, so she was wondering whether or not she received the shot, or did it come out of her arm when she pulled the needle out. She gives herself shots twice a day, she knows how a shot was supposed to be, how liquid was supposed to stay in the arm, not get all over her arm and hand, if you have a Band Aid from a shot, and have blood in the Band Aid, it was most likely the fluid in your arm that came out with the blood (as reported). At the time of reporting, the outcome of the event vaccination site haemorrhage was unknown.  Information on the lot/batch number has been requested.  Amendment: This follow-up is being submitted to add vaccination site bleeding as event.  Follow-up (22Apr2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  The batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for COVID-19 immunization. The patient experienced erythema (left arm; warm red patch), warm skin, lymphadenopathy (lymph nodes swollen underneath my left arm), and breast swelling (breast is really swollen), with outcome of unknown. Additional information: Patient had side effects from her second shot. Her right arm was fine when she got her first shot (not clarified further). On her left arm, she had a red patch where it was warm. Her lymph nodes were swollen underneath her left arm. Her breast was really swollen. This follow-up submitted to notify the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Patient developed an injection site reaction to the Zostavax vaccine. The administration site became red, hard, and swollen.
05/19/2022, I tested positive for COVID-19. Symptoms were a deep cough, congestion, general bad feeling, chills but not fever. They gave me Paxlovid over the phone, all symptoms have evaded at this point.