chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Admitted to Medical Center on 11/18/16 with hyponatremia, epigastric pain, UTI, bilateral lower extremity numbness and gait disturbance and generalized weakness. Clt had lumbar puncture and was diagnosed with Guillain Barre Syndrome. Remained in hospital x 10 days and was then transferred to Inpatient rehab at Med Center.
After receiving the 1st dose of Pfizer COVID-19 vaccine, the patient moved to the observation area. After 5 min, patient reported feeling light-headed and tried to stand up. The patient sat down on the floor and leaned against the wall. Patient was able to stand and walk to the provider room for closer observation. Patient felt hot and looked pale. The provider placed a blood pressure cuff on the patient, at which point the patient slumped forward and stopped breathing. A carotid pulse was not able to be appreciated. The patient was pulled to the floor, positioned airway open and was given oxygen. BP was 96/40. Blood sugar was checked (104) and the AED pads were placed. EMS was called. AED advised no shock, patient had a pulse and was breathing. Patient gradually became alert, though reported not feeling well. Patient was disoriented and was not aware of passing out nor the current event. Repeat BP 115/50. Patient began vomiting (~300-400 mL). Patient left with EMS to be evaluated at local Emergency Department.   Of note, patient reports history of vasovagal syncope events 2/2 to various situations.
Where the Pneumonia13 was given turned very red and hot.  This continued and spread over the top part of my arm. It measured nine inches up and about the same around my arm  Went to the DR. and she prescribed an antibiotic and Steroids. This is the 10th day and is still spreading.
pt recv vax 21OCT97 & exp swollen node rt submandibular 26OCT97 & lt groin lump 28OCt;keflex  10 days;rt gone 6NOV;lt groin same 6NOV;
ADMINISTERED VACCINE BEYOND EXPIRATION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 21-MAY-2021, the subject experienced administered vaccine beyond expiration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered vaccine beyond expiration was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Mom states that on the evening of 4/23/07 developed a fever. The next morning she took her temp and it was 104 degrees and she states that her "tongue was hanging out". Mom states that she brought her to urgent care center on 4/24/07. Per record, client had pulse oximetry of 99%, temperature of 104.6, respirations 24 and nonlabored, tongue noted to be a normal color with no swelling. Assessment was fever, bilateral otitis media and questionable swelling of the tongue. Patient was given 80 mg of Tylenol, 400 mg of Rocephin and 1/2 tsp of Benadryl.
swollen mouth; swollen glands; sore throat; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the right arm on 07Jun2021 at 08:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included milk allergy (Dairy allergy), gluten intolerance (Wheat allergy). Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 09Jun2021 at 22:00, the patient experienced swollen glands, sore throat and swollen mouth. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with BENADRYL. On 10Jun2021, the patient underwent COVID-19 virus test (Nasal swab) and the result was negative. The clinical outcome of the events swollen glands, sore throat and swollen mouth was not recovered.  No follow-up attempts are possible. No further information is expected.
Starting 4 days  after second shot, I developed extensive rashes on multiple areas of my body.  The rashes appear to be controlled by Benadryl.  Also started taking Prednisone on 3/22/2021 at 12:30  PM.  At this point (1:00 PM) I have taken 5 doses of Prednisone 10 mg each.  The rashes subside within 2 hours of taking 2 tablets of Benadryl, but reappear around 5 hours of taking Benadryl.  Rashes typically on same body parts, but in different areas.  Rashes still present today.
Immediately after my 2nd dose, I developed a migraine and it not go away. I went to the ER four days later and I was prescribed steroids. I also received Toradol for pain and Compazine for nausea. Since then, I've been experiencing severe headaches, especially in the back of my head, neck, eyes and I've had a lot of nerve pain. Its to the point where I have difficulty brushing my hair, holding my head up straight, or resting my head on a pillow. I also experience numbing sensation - the top layer of my skin feels numb and tingly. Around the end of May, I went to a neurologist and I was prescribed muscle relaxers and other medication. I will continue to see the neurologist for a follow-up.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patients. On an unknown date the patient was vaccinated with ZOSTAVAX (strength, route unspecified) and (Oka/Merck) VARIVAX (strength, route unspecified) concurrently (overdose). No adverse effect reported. No product quality complaint was involved. Additional information is not expected as the reporter refused additional contact.
tested + for covid 6-22-22 , hospitalized 6-22-22 , sx onset 6-19-22, sx at time she was hosp was diarrhea, abd pain ,weakness.  She passed away on 7-13-22;  I have no further information.
7th facial nerve inflammation. Patient woke up and could not close her eye on the right side of face and had facial paralysis on the right side of face in eye brow, cheek, and tongue and facial drooping and can't laugh or whistle. Doctor gave her hydrocortisone 20mg in the morning and at night and artificial tears and will do physical therapy three times a week.
Headache; Chills; Burning in eyes; Body ache; Body stiffness; Painful joints; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 20Mar2021 at 16:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included cholesterol and borderline diabetic. The 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 vaccination. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), acetylsalicylic acid (BABY ASPIRIN), fish oil (MANUFACTURER UNKNOWN) and glucosamine (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. On 11Apr2021 at 09:00, the patient experienced body ache, body stiffness, painful joints, headache, chills and burning in eyes. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body ache, body stiffness, painful joints, headache, chills and burning in eyes was resolved with sequelae (also reported as recovered with lasting effects) on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
pregnant; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (pregnant) outcome was unknown.            No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Lack of effect; He didn't feel well; Patient contracted COVID-19 three months after receiving the Moderna vaccine (felt a tickle in throat); This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION FAILURE (Lack of effect), MALAISE (He didn't feel well) and COVID-19 (Patient contracted COVID-19 three months after receiving the Moderna vaccine (felt a tickle in throat)) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION FAILURE (Lack of effect), MALAISE (He didn't feel well) and COVID-19 (Patient contracted COVID-19 three months after receiving the Moderna vaccine (felt a tickle in throat)). At the time of the report, VACCINATION FAILURE (Lack of effect) and COVID-19 (Patient contracted COVID-19 three months after receiving the Moderna vaccine (felt a tickle in throat)) outcome was unknown and MALAISE (He didn't feel well) had resolved.            No concomitant product was reported. Patient contracted COVID-19 three months after receiving the Moderna vaccine (felt a tickle in throat). He didn't feel well after receiving the Moderna vaccine but it eventually got resolved on its own. No treatment information was reported.  Company Comment: This spontaneous case concerns a male patient (age not specified), with no medical history reported, who experienced unexpected non-serious event of COVID-19 about three months after a dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine. Vaccination failure is also reported. No further information on vaccination details, clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-718095 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718095:Wife case
2-5 minutes after receiving GARDASIL, patient mid sentence, fell back, whole body stiffened, bilateral arms abducted and shaking, eyes rolled backwards. Lasted less than 1 minute. When patient came to, she vomited and had a headache. Patient cannot recall what happened. Pt also lost bladder control. Normal neuro exam except for mild confusion. Cannot remember where she was.
Information has been received from an 81 year old female, with no medical history and no allergies, who on 13-NOV-2007 was vaccinated with a first dose of ZOSTAVAX (Merck). Concomitant therapy included blood pressure pills, osteoporosis pills, and a pill for acid reflux. On 27-NOV-2007 the patient experienced little red rashes around elbow and on legs.  The reporter indicated that the rash felt like wintry itch.  She noted that she usually has a little break out during the winter time.  The patient was applying cortisol cream on it and it was getting better.  There were no laboratory or diagnostic tests performed.  Medical attention was not sought.  No product quality complaint was involved.  No other information was provided.  Additional information is not expected. This is in follow-up to report(s) previously submitted on 3/26/2008. Follow-up information has been received from the physician that the 73 year old female patient with high blood pressure on 17-NOV-2007 was vaccinated with an unknown dose of ZOSTAVAX (Merck) in the right arm. The patient's relevant concomitant medications and past drug history included verapamil 240 mg, lisinopril/hctz 10/12.5 mg, EVISTA, omeprazole 20 mg and diazepam. On 29-JAN-2009 the patient thought that she was having a back pain, so she slept on a heating pad. On 30-JAN-2009 when she woke up, she thought that she had a burn from the heating paid, so she went to see her doctor. The doctor told her that she had shingles on her right side, from her shoulder and wrapping around to the upper part of her back. It was unknown if any laboratory tests were performed. As of 31-JAN-2009, the patient continued to have the shingles which was being treated with 500 mg of VALTREX three times a day. Additional information is not expected.
EXPIRED VACCINE ADMINISTERED TO 9 PATIENTS; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: 23-AUG-2021) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-AUG-2021, the patient experienced expired vaccine administered to 9 patients. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered to 9 patients was not reported. This report was non-serious.
redness in skin around injection site and red patches on upper back and chest lasting <30 min, faded, no shortness of breath, itching or other allergic symptoms. Benadryl liquid administered.
I had a sore arm for about a day after receiving the vaccine. On 11/23/2022, I tripped and fell hitting my head. I had no feeling from my shoulders down and unable to move which lasted about half an hour. Afterwards I had great difficulty walking. I was admitted to the hospital for two days and rehabilitation for twelve days.  I was diagnosed with central cord syndrome.  As of today, I am not able to lift heavy things. I am able to walk and run but I'm not 100% back. The feeling in my hands and feet are different now.
(R) thigh swollen, warm, hard, painful 1 day after vaccinations.
Itching lower half of face, arms (secondary) redness & itching at injection site. Second day, dr prescribed antihistamine.
This spontaneous case was reported by a dentist and describes the occurrence of MYALGIA (body aches) and PYREXIA (fever) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced MYALGIA (body aches) and PYREXIA (fever). On 31-Jan-2021, MYALGIA (body aches) and PYREXIA (fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  Treatment medications was not reported.   This case was linked to MOD-2022-453892 (Patient Link).
Tingling in tongue, felt like tongue was a bit puffy - 5 minutes in.  Lightheaded, dizzy -5-10 minutes in. BP higher than typical for me Given dose of diphenhydramine 50mg and famotidine 40mg and 4oz of juice to stabilize blood glucose (which, by CGM alert, dropped as well).
Left arm where vaccine was given is very red, swollen, painful - about the size of a softball.Advised ice, ibuprofen as needed.  If need be, can be seen by provider.
Stabbing, excruciating pain in lower abdomen.  Reporting this after reading today that the vaccine may affect women?s reproductive organs.  I have never felt such terrible pain in my life and was just about to go to the ER when it faded. Lasted 20 to 30 minutes.  Worst pain of my life and I?ve had two children!
52-year-old male history of idiopathic pulmonary fibrosis who is oxygen dependent who had a series of allergy testing today as well as immunizations who presents and anaphylaxis.  He is in acute respiratory distress in my initial history is therefore limited.  Denies any further exposures but again notes he had multiple immunizations today and allergy testing.  He is overtly tachypneic flushed and in acute distress.
32-year-old female with a history of diabetes presenting to the emergency department complaining of a red rash noted to the left tricep occurring after receiving her yellow fever vaccine last Thursday.  Rash is described as moderate in nature and is itchy and hot.  Patient has no history of the same.  Patient took 2 Benadryl and hydrocortisone cream with no relief.
Throat sore and swollen. By 5:00 PM high fever and chills.
This spontaneous report as received from a pharmacist refers to a multiple unspecified patients of unknown age and gender who were vaccinated with a dose of ZOSTAVAX (lot number, dose, route not reported), that went through an unsupported temperature excursion, on multiple unspecified dates. No adverse effects were reported. Additional information has been requested.
Information has been received from a pharmacist and an LPN concerning a white female with asthma who was vaccinated IM, in the right deltoid, with a 0.5ml dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included a 0.5ml dose in the left deltoid of influenza virus vaccine. Other concomitant therapy included Serevent (2 puffs BID beginning on 10/12/01), Pulmicort, turbohaler (200mg QD beginning 10/12/01) and albuterol inhaler (2 puffs Q4hr PRN beginning 9/24/01. The pt reported that 2 hours after the immunization in her right arm, in the area where the shot was given, began to swell, become red and painful. The pt was seen in the physician's office the next day with a swollen, warm and red upper arm. The pt was treated with (Solu-Medrol) 125mg, prednisone 20mg, po, QD X 2 days, Benadryl 25mg, Q6 hours, PRN and instructed to use over-the-counter ibuprofen 400mg Q6 hours and to call if there was no improvement or if the condition worsened. The pharmacist reported on another pt (WAES 01110662). Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to a unspecified patients of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions and allergies and concomitant therapies was reported. On an unknown dates, multiple doses of improperly stored VAQTA lot # N005274 with expiration date 03-APR-2018 were administered to multiple unspecified patients for prophylaxis. Improperly stored vaccines underwent following temperature excursion: 9 Celsius degrees to 25 Celsius degrees (8.5 Celsius degrees) for 12 hours. Data logger was involved. No adverse event was reported.; Sender's Comments: US-009507513-1708USA000956: US-009507513-1708USA005615: US-009507513-1708USA005616: US-009507513-1708USA005617:
1st vaccination experienced severe painful fatigue 4 hours after vaccine,  lasted 10 hours. Also experienced exasperation of IBS symptoms,  very severe lasting 3 days, with residual problems up 2 weeks.  Finally sought medical attention and got a prescription for hyoscyamine.  2nd dose only mild fatigue noticed but has been continuous, with some weeks more severe than others.
Saturday after the shot I started to have severe abdominal pain. The following day, I have been experiencing muscle spasms and twitching randomly on different areas, such as my calf, back and legs.
Information has been received from a 67 year old Caucasian female with morphine and codeine allergies who on 06Jan04 in the AM was vaccinated IM in the left deltoid with a second booster dose of pneumococcal 23v polysaccharide vaccine. There was no illness at the time of vaccination. The next day the injection site was swollen to twice the normal size, had redness at the site and was hot to touch. She contacted her physician's office. She also had great pain which the physician prescribed ibuprofen and acetaminophen prn. These medications did not reduce her pain. It took about 7 days for the swelling to be reduced. Subsequently, the following events occurred which the pt believes was caused by the pneumococcal 23v polysaccharide vaccine: She had chest and back pain. She visited the ER at the hospital and was discharged from the ER the next day. A myocardial infarction was ruled out. No diagnostic studies were performed. the pt noted that 5 years ago, in 1999, she has tolerated an initial dose of pneumococcal 23v polysaccharide vaccine very well. No product quality complaint was involved. Follow up information received from the pt's physician reported that on 06Jan04  the pt had pain swelling left arm. There were no relevant diagnostic tests performed. Additional information has been requested.
This spontaneous report has been received from a consumer who is the patient's mother referring to a 19 year old female patient. The patient did not have pertinent medical history, drug reactions or allergies, or concurrent conditions. She was taking no concomitant medications. In June 2016, the patient was vaccinated with the first dose of GARDASIL by intramuscular route (strength, dose, anatomical location, lot number and expiration date were not provided) for prophylaxis. She received the vaccine three times at 0, 2 and 6 months. She received her third dose on January 2017. In January 2017, the patient developed strep throat. She also experienced joint pain and could not walk on her legs and had to use crutches. The patient also had tingling and pain in her extremities and sporadic waves of nausea. Additionally, the patient's mother mentioned that "she may have chronic fatigue syndrome." The patient was treated with pain killers and was seen by a pain management doctor. She was tested for Lyme disease (results not specified). At the reporting time, the outcome of all the events was not recovered. The mother felt GARDASIL caused her daughter's health issues. She indicated she had contacted an attorney. Could not walk on her legs, had to use crutches was considered disabling. Additional information has been requested.