chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 16 month old female with a pcn allergy, amoxicillin allergy and a diptheria toxoid vaccine allergy who on 05/17/1993 was vaccinated with a dose of hep b vaccine recombinant IM. Several hours after receiving the vaccine, the pt developed hives. The pt sought unspecified medical attention. Additional info has been requested.
On the next day I experienced a very severe migraine headache with nausea and vomiting. I had to throw up almost every 30 minutes. After calling urgent care, I was advised to visit the nearest emergency room where I was given an IV with pain and anti-nausea medication.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No medical history provided. The reporter stated that improperly M-M-R II (Indication: vaccination) may have been administered. No concomitant medications were provided. No adverse event was reported. Additional information is not expected.
Patient broke out in hives at school.  She was sent home.  We called the doctor and was told to give her Benadryl.
Pt c/o Alopecia, First noticed approx 2-3 wks post HBV #1. Pt under increased stress (1st year med. student) Also concerned about past episodes, Will f/u as needed.
This case was reported by a nurse via call center representative and described the occurrence of injection site redness in an 18-year-old female patient who received BEXSERO (batch number 157101A, expiry date 31st AUGUST 2017). Concomitant products included BEXSERO. On 8th AUGUST 2016, the patient received the 2nd dose of BEXSERO (intramuscular). On 10th AUGUST 2016, 2 days after receiving BEXSERO, the patient experienced injection site redness, injection site warmth, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site redness, injection site warmth, injection site pain and injection site swelling were not recovered/not resolved. The reporter considered the injection site redness, injection site warmth, injection site pain and injection site swelling to be almost certainly related to BEXSERO. Additional details were provided as follows: This case was reported by a licensed practical nurse. On 6th JUNE 2016, the patient received 1st dose of BEXSERO and there were no reports of adverse events after. The patient received 2nd dose of BEXSERO at 15:59 in left arm. The case is one of the three cases reported by the same reporter.
At  night he is really sweating.; that night he got really bad chills; Fever; Came home feeling delirious; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273), and who came home feeling delirious, that night he got really bad chills, fever, and at night he was really sweating.   The patient's medical history was not provided.  Concomitant medications were not provided.   On 13 Jan 2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number 027L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 13 Jan 2021, the patient came home feeling delirious after he had received the COVID -19 vaccine.  That night, he developed real bad chills with a fever.  O  On 17 Jan 2021, his temperature worsened and was 100.8 degrees Fahrenheit (F).  At night he was really sweating.   Treatment for the events were not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, came home feeling delirious, that night he got really bad chills, fever, and at night he was really sweating, were not resolved.; Reporter's Comments: This spontaneous report refers to a case of a male patient who experienced a serious event of feeling delirious and non-serious event of he got really bad chills, fever, and was really sweating.  The events developed on the same day after the administration of the mRNA-1273 vaccine (lot # 027L20A, expiration date-unknown). No treatment was reported, and outcome is unknown.  Based on the information provided which includes a temporal association, a causal association cannot be excluded.
Patient received 1st dose of Moderna vaccine while she was 17 and did not meet eligibility criteria. No adverse event or reaction was reported by the patient.
About 2 hours after the shot i started have chills and shaking. I went to bed around noon, next thing around 6pm my husband called 911. I was being unresponsive, yelling and screaming it hurts and i am stuck on the 2nd floor. Earlier that day i was yelling make it stop and when my sister came in i was sitting on the bed saying i had to go to the bathroom but i'm afraid because i am on the second floor and afraid to get down. She helped me up and literary had to move my feet, needless to say i did not make it. From noon to 6Pm i do not remember anything at all, other than what i was told.
Patient reports vaccination stung her upon administration, the stinging is felt off and on, once in a while..patient also reports pain and tenderness, and numbness of entire arm, down to hand.
Pt presented to the clinic for a covid pfizer vaccine, #1. Pt reported that she has a history of "fainting" when receiving injections and blood draws. Pt was placed on the exam table, consent signed and EAU given. Her husband was also present. Pt was given the injection and tolerated well. 2 minutes post injection she became pale and vasovagal response occurred. She was safe on the exam table and awoke within seconds. She did have some mild hand tremor as she was waking. She drank some gatorade and was talking and coherent after event. About 3 minutes later after reporting that she felt embarassed she had a similar event that lasted seconds and she awoke with mild hand tremor. Pt remained safe on the exam table the entire time. She waited for 30 minutes past this, reported she felt good and walked out the clinic on her own accompanied by her husband.
Information regarding PREVNAR was received from a consumer regarding a 2 month old female patient who experienced eczema and severe hives. The patient received a dose on an unspecified date and a dose on an unspecified date. The patient experienced eczema and severe hives. Outcome was unknown. No additional information was available at the time of this report.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 12-SEP-2016, the patient received his first dose of VAQTA (strength, lot number and expiration date were not reported) and received the second dose of VAQTA (strength, lot number and expiration date were not reported), on 13-OCT-2016 (also reported as about a month after the first dose). No adverse effects were reported and no product quality complaint was involved. Additional information is not expected as the pharmacist did not consent for a follow up.
Stated the next day she began experiencing abdominal cramps, kidney cramps, and a flaccid bladder which caused her to lose urinary continence. Pt states it felt like UTI symptoms but suddenly resolved 4 days later. Lasted aprox. 4-5 days
I started getting tired, running a fever. My fever was up to 102.9. I was admitted to the hospital on August 30. I passed out twice and had extreme diarrhea. I was admitted to the hospital and stayed until maybe the 3rd or 4th of September. When I was at the hospital they tested me for COVID 19 and it was positive. Having this also affected my kidneys and they had to call a kidney specialist. I have not been able to work a full day since then.   MY blood pressure was 82/55 so they took me off all of medication while I was in the hospital.
heart was a little weird but then it went away; heart beating really fast; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 34-years-old male patient received bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration, administered in Arm Right on 17Mar2021 (at the age of 34-year-old)  (Lot Number: EN6208) as 1ST DOSE, SINGLE DOSE for covid-19 immunization. Medical history included heart problems (a month ago). He was eating really bad junk food/eating a lot of junk food. He was also smoking a lot of marijuana prior, but he stopped that like a month ago because he started getting a lot of heart problems a month ago which was almost like a month after the vaccine or a few weeks after. The patient concomitant medications were not reported. Regarding family Medical History Relevant to AE, consumer stated, No, but he was eating really bad junk food for like two years so that could also not make it any better. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that, the first shot which was on 17Mar2021 and his heart was a little weird but then it went away and also reported that, it was not the too serious it was just heart beating really fast and then yeah on 17Mar2021. Also reported that, there was a possibility or reports of people having issues with their heart after receiving the vaccine or not. Reporter would like to know if the vaccine could cause heart issues. The patient underwent lab tests and procedures which included blood test, electrocardiogram, and magnetic resonance imaging results unknown on unknown dates (but they were saying they were waiting for the MRI he got a do MRI). The clinical outcome of the event heart was a little weird but then it went away was recovered on an unspecified date and heart beating really fast was unknown.
Syncope, difficulty focusing- Evaluated by EMS-Transported to Emergency room/department or urgent care.
Experience fever and chills at about the 8 hours after injection.  Throughout the night develop fatigue and achiness in entire body.  Temperature reached 101.5 before subsiding.
Starting about 12 hours after shot, began feeling shortness of breath along with headache, body aches, sore throat. The shortness of breath left me exhausted and 36 hours later my chest is tight from having to breathe heavily for so long
I broke out in itchy hives even though I have no known allergies. The hives started on my legs but within a day have expanded to cover almost all of my body.
Experiencing vertigo. Severe dizziness upon laying down and throughout the night as I turn. Also experiencing headaches, nausea and vomiting likely as a result of the vertigo. Will be visiting physician has a result of these symptoms.
Information has been received from a registered nurse referring to a 2 year old patient. Information regarding concomitant medication, medical history and drug reactions/allergies were not reported. On 26-JUL-2016, the patient was vaccinated with the second dose in the series of VAQTA 25/0.5 (united not provided) (lot # M002268 with expiration date 20-SEP-2017, route unknown). It was reported that the patient moved while the vaccine was injected and the patient received unknown amount of VAQTA (accidental under dose). It was unspecified when the first dose of VAQTA (lot #, expiration date and route were unspecified) was administered. No adverse effects were noted. Additional information has been requested.
p/vax pt adm to hosp w/poss dx of cellulitis vs deep tissue abscess involving lt leg;lab testing revealed an elevated WBC count 27.5;  Annual follow-up received on 11/27/00 states the pt has recovered.
Flu shot given 10/21/2004: seen in office 10/22/04 with fever, headache and left hip pain.
Arm pain; This non-serious case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Arm pain).  The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt date: 29-AUG-2023 The reporter stated that she had grade 3 arm pain after dose of Shingrix, so much so that she did not complete 2nd dose. The reporter consented to follow up.
This spontaneous report was received from a medical assistant and refers to a 18 month old female patient. The patient has no relevant medical history, past drug history, concomitant medications or drug allergies. On 14-Jan-2015, the patient received a (Oka/Merck) VARIVAX (0.5 ml, subcutaneously, lot # KI005176, expiry date: 10-APR-2016) for her 18 month well baby appointment. It was reported that received vaccine had undergone a temperature excursion. The excursion that occurred was at 23 degrees Fahrenheit for up to 2.5 weeks. The patient's relevant laboratory data was unknown. The patient present status at the time of the report was not unknown. This is one of several report from the same reporter. Additional information has been requested.
TONGUE SWELLING; THROAT SWELLING; HEADACHE; FEVER; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, non-smoker, and seasonal allergy, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. 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 03-APR-2021 in left deltoid for prophylactic vaccination. The batch number is not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On 03-APR-2021, the subject experienced flu like symptoms. On 03-APR-2021, the subject experienced throat swelling. On 03-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced fever. On 04-APR-2021, the subject experienced tongue swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, headache, and fever, and was recovering from tongue swelling, and throat swelling. This report was non-serious.
This spontaneous report as received from a nurse refers to a group of patients of unspecified number and demographics. On unknown dates,those patients received doses of improperly stored vaccines: VAQTA (lot#M036459, expiration date 18-JAN-2018; lot#M027879, expiration date 24-JAN-2018; dose and route of administration were not provided). It was reported that the vaccines were improperly stored for one hour, in the temperature of 33 degrees Fahrenheit. It was reported there was no previous temperature excursion and it was not a case of a "data logger". No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA006077: US-009507513-1702USA006078: US-009507513-1702USA005322:
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with 2 doses of improperly stored (Oka/Merck) VARIVAX (L013067, expiration date 14-APR-2017; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
No additional AE information provided.; VARIVAX was administered to a patient on 12-DEC-2022 after a supported temperature excursion that took place on 01-DEC-2022.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 01-DEC-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number W018825 with expiration date 14-JUN-2024 (dose, route and anatomical location were not reported) which was exposed to temperature excursion (/product storage error) for prophylaxis. The varicella virus vaccine live (oka/merck)(VARIVAX) was exposed to temperature of 19.4 degrees Fahrenheit for 50 minutes. There was no previous temperature excursion. No additional adverse events were reported.; Sender's Comments:  US-009507513-2301USA001031:
ROTATEQ was administered on 7/12/11. Pt. went to ER on 7/19/11 with bilious emesis - had surgery for suspicion per mother and had ileocolic intussusception.
I am a physician with many years of experience, former medical school professor, and widely published biological scientist. I have never had an adverse reaction to any drug or vaccine before SHINGRIX and am in good health. My adverse effects from this vaccine were extremely severe! Two days after receiving it I developed severe flu-like symptoms including bronchitis with wheezing. Within the next few days I developed a viral encephalitis that seriously impaired by ability to think (especially creatively), to move quickly, or to carry out most of my normal functions. I felt like I had aged about 25 years in a few days. This lasted for about two weeks and was deeply frightening. Another side effect was an almost complete loss of sexual function. These symptoms were treated with valacyclovir at full therapeutic doses for several weeks, and gradually decreased. I am not sure that even now 2 months later I have been restored to full health. I have discussed my symptoms with several other people, including other physicians, who have received this vaccine and some of them reported similar hard-to-describe but clear cut impairments of mental function. I BELIEVE THIS VACCINE IS DANGEROUS AND IT SHOULD BE REMOVED FROM THE MARKET UNTIL A DETAILED REASSESSMENT OF ITS ADVERSE EFFECTS IS COMPLETED. I have no economic or other hidden interest in making the above statement, but I am convinced on the basis of about 50 years of experience in medicine and medical research that this live modified virus is a threat to public health and that its advantages, if any, over the prior shingles vaccine in shingles prevention are more than outweighed by its obvious frequent and in some cases VERY severe adverse reactions. I hope you will pay careful attention to this communication.
09/28/21 1915 hrs. Immediately after i jection began to feel odd but no apparent breathing issues, stayed at clinic 30 min. 60 min after injection, site was very itchy, starting to swell and warm. Itchyess spread and at 2- 2.5 hr mark after injection whole body extreme itchy, even scalp, eyelids and areas inbetween fingers/toes. Best described like a burning heat rash when rubbed against anything. Small rash developed under restrictive clothing like bra straps and waist band. Headache developed (started tylenol) as well as mild nausousness, little sleep due to extreme itchyness and pricklyness all over. Focused on drinking water. 09/29/21- called off work, took benedryl for some relief from body itchyness. Tylenol for relentless headache, nausous so did not eat, slept off and on all day, fever developed, 99.8, chills, body aches like hit by bus. Injection site swollen, warm, itchy and red. 9/30/21-Still fever, tylenol, itchy remains, diahreah developed, headache remains but moderate, called off work. Arm pit area on injection side beginning to feel swollen like a baseball and extemely sore like hit with baseball bat. Injection site swollen, sore, itchy 10/1/21- No fever, itchyness remains but not as intense. Mild nausous, diahrea still, arm pit area remains extremely sore, reported for work, mild headache remains. Injection site, sore, swollen, itchy. Reports also made by vsafe app. Made appointment with PCP. Symptoms remained for another 4-5 days but in decreasing intensity. Was able to see PCP on Oct. 11.  I have also experienced a lot of daily fatigue.
Just a little red/ it is redness; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received second dose of BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 03Sep2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient previously received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation and experienced just the lot of itchiness and a rash on my body. The patient medical history and concomitant medications were not reported. The patient experienced just a little red/ it is redness on an unspecified date in 2021. The patient stated that, I took the last dosage, the last shot of the vaccine this morning. The only question was, was there any side effect, if I was to drink one Beer or two Beers in the evening. I am just a little, well I am just a little red but, I had came out of shower so I think it was just because of that but it was redness, there was swallowing in the face, (I know these were some of side effects, General statement hence event was not made). The patient was just curious just about the alcohol beverages. The outcome of the event was not recovered at the time of this report.   Follow-up attempts completed. Batch/lot number not available for [vaccine/BNT162B2]. No further information expected.
On 09/21/2022, around mid-day, I started feeling mildly nauseous and fatigued. It continued and increased until 09/25/2022. At that point, I was also having confusion and some disorientation. I was also feeling weaker and was not eating very much. I went to the emergency room on 09/25/2022 where I was given intravenous fluids and was diagnosed with an acute urinary tract infection and hypokalemia. I was released that day with a prescription for an antibiotic and a Potassium supplement. While I was there, they treated me with an I.V. of Potassium and anti-nausea medication. I have never had a urinary tract infection before, so this was an abnormal situation for me.
Localized reaction 11 x 9 cm warm, erythema indurated will treat with BENADRYL.
20MAY 5:00 t100 fever, both legs swollen, APAP given; 8:00-t1103.4 fever, legs swollen, fevish, phoned MD liquids, APAP & cool bath were instructed; 21MAY 1230AM-cool bath, APAP & clear liquids; 430AM cool bath, APAP & clear liquids;
Flushed face with an itchy rash going from face, down my neck and chest. Lips were not swollen, but were tingling. No wheezing or difficulty breathing or shortness of breath, so I stayed the weekend with friends/coworkers who are also healthcare workers so that they could monitor symptoms and I took a Zyrtec and 600mg of Ibuprofen.
Administered vaccine to patient in left arm, placed bandage on arm. Patient questioned what side effects she should watch for as it was the second dose. As I was discussing possible signs of anaphylactic reaction, patient passed out (slumped to the left side)- this was approximately 3 minutes after administering vaccine  Patient did not respond verbal stimuli. I called for pharmacy technician to help and when the technician came into consultation room, patient began to shake.  This lasted about 30 seconds. Patient had no recollection of the events when she came to. She stated that she felt nauseous before I administered vaccine.  Denied symptoms of anaphylaxis like trouble breathing. Was sweaty and shaky. We called 911 to come, they checked her blood pressure and her glucose levels and they were within normal range. Patient refused transport to hospital.
Low grade fever, chills, body aches, headache, shot site pain - lasted 12 hours