chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a adult female patient who received Hepatitis B vaccine. Co-suspect products included ENGERIX B. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. In December 2016, the patient received ENGERIX B. In July 2017, unknown after receiving Hepatitis B vaccine and less than a year after receiving ENGERIX B, the patient experienced therapy non-responder. On an unknown date, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder and therapy non-responder were unknown. It was unknown if the reporter considered the therapy non-responder and therapy non-responder to be related to Hepatitis B vaccine. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B. Additional details were provided as follows: This case was reported by a nurse, who herself was the patient. The age at vaccination was not reported, but it could be 41 years or 42 years. The patient received a full series of an unknown brand of hepatitis B vaccine in 1991 and had negative titers drawn in 1995. Thus, leading to be a therapy non-responder. In December 2016, one dose of ENGERIX-B was given as a booster dose to the patient. In July 2017, two weeks before the reporting date, negative titers were drawn. Thus, again leading the patient to be a therapy non-responder.
After injection, patient became diaphoretic and pale. Patient reclined his car seat and was closing his eyes but remained fully responsive to verbal stimuli. Ice pack applied to forehead and base of neck. B/P 128/84,pulse 70 BPM and SPO2 99%. Patient was observed additional 15 minutes. Patient reported feeling much better and returned to baseline prior to his departure with driver.
Red, blotchy face 20-30 min. after vaccines given. Hives all over body. Ears red, swollen, itchy. Lung sounds clear. 12.5 ml BENADRYL by mouth given around 10:30 am. Good response by 11:00 am. Rash completely resolved 3 pm.
Information had been received regarding a case for PNEUMOVAX 23 (MARRS# 1309USA014552). A female reported, "Following these events we have come to realize that serious reactions and pulmonary infection are more common than the vaccine information implies. Several people that I have met have had similar reactions." This is one of several reports from the same source. No further information is anticipated.
Skin burned after laying in the sun; Eyes burned after laying in the sun; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (Skin burned after laying in the sun) and EYE IRRITATION (Eyes burned after laying in the sun) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced SKIN BURNING SENSATION (Skin burned after laying in the sun) and EYE IRRITATION (Eyes burned after laying in the sun). At the time of the report, SKIN BURNING SENSATION (Skin burned after laying in the sun) and EYE IRRITATION (Eyes burned after laying in the sun) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication details were reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up information was received on 17-JUN-2021 contains no new information.
03/28/2023, I had a checkup with my doctor, and I found out that I continued to have high blood pressure, and I didn't think of this before. I noticed after my first dose, Janssen, and after my second dose, Moderna, that my blood pressure was gradually going up. On 03/28/2023, my blood pressure was 174/83. I did not have high blood pressure prior to my vaccines. I am now being treated with valsartan 40 mg. I have my blood pressure under control with my medication and they may take me off my medication.
Pt stated her arm was red, swollen, and got fever. Went to ER for tx. was given antibiotic.
Started itching her, so she scratched it, which made it worse, but that now is flat and red, but like the size of a small orange, is not raised, but is really red; Started itching her, so she scratched it, which made it worse, but that now is flat and red, but like the size of a small orange, is not raised, but is really red; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH PRURITIC (non-serious), RASH ERYTHEMATOUS (non-serious), outcome "unknown" and all described as "Started itching her, so she scratched it, which made it worse, but that now is flat and red, but like the size of a small orange, is not raised, but is really red".  Additional information: It was reported that the patient has a reaction to Prevnar 20. The side effects are those that have been reported and is listed, however, the caller asked for the onset and duration of the side effects reported from Prevnar 20. Reporter mentioned that the patient was doing okay for a couple of days but then it started itching her, so she scratched it, which made it worse, but that now is flat and red, but like the size of a small orange, was not raised, but was really red.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
4wo term infant with VZV PCR confirmed rash that began on DOL24. Mother varicella IgG neg so given VAR postnatally on infant's DOL2 while in room with infant. Mother developed 1 itchy papule at vaccine site (RUE). No known rash or varicella contacts. Fussy and tactile fever at home. Admitted with fussiness and known varicella, started on acyclovir - currently on day 3.
Onset April 24, 2022: Constant, boring, daily frontal HA, 5-6/10 intensity, constant, unrelieved by Tylenol or ASA, seems no worse with activity, minimal relief with rest. Associated fatigue and bilateral leg weakness, increased right > left hand tremor. As of May 5, 2022 all symptoms resolved except headache which continues at 1-3/10 intensity, improves with ASA.
Shoulder throbbing; Chest throbbing; Shaking; Dizzy in the head; Could not sleep; A spontaneous report was received from a consumer concerning a 57-year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced shoulder throbbing, chest throbbing, shaking, dizzy in the head and could not sleep.  The patient's medical history, as provided by the reporter, included chronic obstructive pulmonary disease (COPD), asthma, blood pressure and bronchitis. Concomitant medications reported included unspecified blood pressure medication.   On 05 Jan 2021 at 11:00, approximately 11 hours and 30 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 via unknown route for prophylaxis of COVID-19 infection.  On 05 Jan 2021 at 22:30, the patient began to experience shoulder and chest throbbing, shaking, dizziness, and insomnia.   No treatment was received in response to the events.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, shoulder throbbing, chest throbbing, shaking, dizzy in the head and could not sleep was unknown.; Reporter's Comments: Based on the information provided, a strong temporal association between the reported events and administration of mRNA-1273 vaccine, and excluding any other etiology, a causal association cannot be excluded.  Arthralgia is consistent with the mRNA-1273  safety profile.
48 hours after injection, site turned red, warm to touch, and slight tenderness, signs treated with warm compresses
Serious Constipation; shingles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONSTIPATION (Serious Constipation) and HERPES ZOSTER (shingles) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03CM20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced CONSTIPATION (Serious Constipation) and HERPES ZOSTER (shingles). At the time of the report, CONSTIPATION (Serious Constipation) and HERPES ZOSTER (shingles) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter
Information has been received from a physician concerning her 8-week-old son who on 16-AUG-2007 was vaccinated with the first dose of Rotateq. Concomitant vaccinations administered on that same day included a dose of Prevnar, Pediarix and a dose of Hib (manufacturer unknown). The physician reported that on 16-AUG-2007, her son developed a slight fever which she treated with acetaminophen (TYLENOL). On 18-AUG-2007, at 1900, the patient started crying and passed three stools with blood in them (not fresh) which looked coagulated with some mucous. The boy was taken to the Emergency Room (ER) where an ultrasound was negative for intussusception. No tests were done on the stool and no other laboratory tests were performed. At the time of this report, the outcome was unknown. Upon internal review three stools with blood was determined to be an other important medical event. Additional information has been requested.
Pt received #1 dose H1N1 at flu clinic-school location during school hours (mother had signed consent). Mother returned to clinic after school hrs, thinking child had not received vaccine. #2 mist given same day. Pt had no adverse reaction.
Daughter received the 3rd Gardasil shot at the age go 16, within 30 seconds eyes went back, and started convulsing. Blood pressure dropped. My daughter said as soon as she felt it go in, she knew something was feeling off.
Was eating dinner (seasoned smoked chicken, broccoli, cauliflower, fries) and soon after, felt my lips starting to swell. I had seasonal allergies occurring that day, so I kept eating a bit longer. My tongue then started tingling. I took a dose of Children's Benadryl (all I had for Benadryl at the time). I then waited about 10 minutes before I felt my throat starting to close. We headed straight to emergency room (5 mins away). By the time I got there, I started to have a little trouble taking breaths. When I got into the trauma room moments later, I became nauseous and dry heaving.  They gave me an epinephrine shot, Benadryl, Pepto, and Prednisone.   They watched me for a few hours before release. Upon discharge, they provided me a prescription for epi-pens, famotidine, prednisone, and fexofenadine (5-day prescriptions).
Initial report received on 19 September 2011 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in a 14 month old female subject (initials not collected) was identified by the investigator based on review of data from the system's electronic database. The subject's vaccine history included 3 doses of PENTACEL; lot number C3667AA received on 30 August 2010, lot number C3747AB received on 15 November 2010, and lot number C3740AA received on 21 December 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 24 August 2011, approximately eight months after the last dose. On 26 August 2011, the subject developed a paroxysmal cough with a whoop and posttussive vomiting. The subject also experienced sleep disturbance. Laboratory testing included positive PCR and positive culture on 31 August 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 31 August 2011 for five days. The subject was not hospitalized. At the time of final contact on 15 September 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 22 days. Outcome was not recovered. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Severe headache and fever of 38.5° average, controlled with acetaminophen Loss of appetite and frequent nausea Unusual muscle and joint pains, in muscles that I have not exercised but the pain is similar to exercised muscles, last two days and disappear,  I had on my thighs, calves, tendons, both hands, both feet, lower back. Right now I have my left forearm, right hip, middle back, wrists, ankles, waist. Very intense pain in the spleen when breathing. It lasted three days, and Canker sores disappeared on the hard palate. It may be a consequence of repeated fever Rash on the lip (manifestation of herpes), I guess it is due to the low defenses, It had not happened to me in the last 10 years IMPORTANT; There is no pain in the liver, kidneys, stomach, pancreas, lungs or heart. There is no pulmonary congestion or flu symptoms.
really bad rash on her right arm (dominant); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (really bad rash on her right arm (dominant)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE RASH (really bad rash on her right arm (dominant)). At the time of the report, VACCINATION SITE RASH (really bad rash on her right arm (dominant)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Cortizone cream twice daily for 4 days.   Reporter did not allow further contact
Varicella Information has been received from a physician and a school nurse concerning an 5 year old female who on 02-OCT-2001 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy that day included a dose of measles virus vaccine live (Ender-Edmonston) (+) mumps virus vaccine live (Jeryl-Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). A school nurse reported to the physician that between 24-MAR-2005 and 09-MAY-2005 the child developed a mild case of break through varicella with less than 50 lesion. Unspecified medical attention was sought. The outcome was recovered. A product quality complain was not involved. No additional information is expected.
15 minutes after injection, felt hot ears, itching throughout body and scalp.  No SOB.  Took 50 mg diphenhydramine 40 min post vaccine.  Symptoms subsided over next 4 hours.
Flu type symptoms. Chills, sever muscle aches and weakness Started 8hrs after injection and lasted for 18 hrs
Expired vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 9ey93, expiry date 15-APR-2023) for prophylaxis.   On 17-APR-2023, the patient received Shingrix. On 17-APR-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Expired vaccine administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 21-APR-2023 The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up via email. The patient received a Shingrix which was already expired, which led to expired vaccine used. This case had been linked with US2023059003 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023059003:Same report/Other patient
47-year old male c/o frontal headache since Friday, 4/9/2021. Received his Johnson & Johnson vaccine on Thursday, 4/8/2021. Still having his headache now. 9/10 pressure-like on the frontal head - constant States, "I never had this kind of headache before". 6/10 burning epigastric pain.  Also has bodyaches.  Has mild dizziness.  Denies any photosensitivity, fever, flu-like sx, nausea/vomiting, chest pain, dyspnea, numbness, tingly sensation, slurred speech,  back pain, rectal bleeding.
Headaches; 37-38oC fever; Dizziness; pain in the arm where the vaccine was administrated (left); This is a spontaneous report from a non-contactable other health care professional (patient herself). A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection and Lot Number: ER8733) via an unspecified route of administration, administered in Arm Left on 30Mar2021 at 16:00 as 1st dose, single for COVID-19 immunization. Medical history included depression, ulcerative gastritis and shrimps Shrimps Allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline and lansoprazole within 2 weeks of vaccination. COVID-19 vaccine was administered in hospital. On 01Apr2021 at 12:00 the patient experienced headaches, 37-38 degree c fever, dizziness and pain in the arm where the vaccine was administrated. Headaches, 37-38oC fever and Dizziness lasted for one day and more than 48hrs of pain in the arm where the vaccine was administrated (left). Paracetamol was given as treatment. The events were not serious as none of the events were meeting the seriousness criteria. Since the vaccination, the patient has not been tested for COVID-19. Upon follow up 06Apr2021, translation spontaneous report was received about the anatomical location and the outcome of the events. The patient underwent lab tests and procedures which included body temperature: 37-38 centigrade on an unspecified date. Treatment received was update das yes for all the events. Outcome of the events was recovering.   On 14May2021, follow-up attempts completed. No further information expected.
12/25 within 24 hrs itch all over & mild rash & SOB - seen in ER - Rx Benadryl & steroids - not filled and symptoms recurred. 12/26 - presented to ER with mild stridor pruritus angioedema and SOB - admitted - IV Solumedrol IV. DC'd 12/27/06
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: lung problems (was born early). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection. This report was non-serious.
Pt awoke at 2:30 am with hives on back, buttocks and legs. Palms of hands and hives were itchy.  Eyes were swollen.  Pt administered 2 BENADRYL quick dissolve strips.  itching resolved in 10-15 minutes.  Within 1 hr remainder of symptoms resolved and pt returned to sleep.
This spontaneous report as received from a physician, via a company representative refers to a 62 year old female patient. On 03-APR-2013, the patient was vaccinated with a single dose of ZOSTAVAX, subcutaneous (lot number and expiry date not provided). On an unknown date in 2013, the patient experienced a rash and was diagnosed with chickenpox after receiving the ZOSTAVAX. The outcome of diagnosed the adverse event was reported as recovering/resolving. The patient sought medical attention by seeing a doctor. Additional information has been requested.
TREMBLING; HEADACHE; LOWER BACK PAIN; ACHING ALL OVER; CHILLS; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug or non drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) .5 ml, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced lower back pain. On 13-MAR-2021, the subject experienced aching all over. On 13-MAR-2021, the subject experienced chills. On an unspecified date, the subject experienced trembling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and trembling, was recovering from aching all over, and had not recovered from headache, and lower back pain. This report was non-serious.
Tickling couch beginning 48hr hour vaccine, loss of voice beginning 52hr post vaccine, 101 fever beginning 72hr post vaccine, tested positive for covid 96hr post vaccine.
I received a Moderna COVID-19 booster on 4/19/2022. Sometime in June or July 2022, I had sudden high-pitched, beeping noises that would occur in both ears (not always in both ears at the same time). For about a week or so, the noise was intermittent. After that, it was constant and in both ears. Ever since then, I have constant tinnitus in both ears. Nowadays, the noise is usually a high-pitched, staticky sound, but occasionally there is more of a high-pitched beep. I saw an audiologist on 12/15/2022, and she told me that I had had some mid-ranged hearing loss and that I definitely had tinnitus. The mid-ranged hearing loss does not interfere with my ability to function, but the high-pitched tinnitus did interfere some with my ability to hear during the hearing test she administered. The results of the test indicated that I had a hearing loss at about 3000 Hz and 40dB. Although the tinnitus may have interfered with my ability to hear during the test, it has not affected me socially, as I can still hear properly when other people speak. This includes the high-pitched voices of women, plus I can still hear high-pitched bird calls.
pt unable to walk 24 hours after vaccine, attempted to stand and could not bear weight, after, 36 hours after vaccine was administerd pt able to walk
Chills, fever, body aches, nausea, diarrhea, dizziness, feels like I have the flu
I woke up 37 hours after first dose of vaccine with dizziness, which became dizziness.  I began vomiting within a couple hours.  Around noontime I vomited twice more.  I got worse, could not walk around.  I felt extremely sick but felt better when I lay down in bed.  I was not able to go to work, had to cancel the substitute teaching assignment I had taken.  I did sleep some. No doctor called me back except my daughter texted with me.  She is an intern, said she wished she could be with me.  My neighbor brought some Pedialyte.  This morning, the next day, I am still weak and nauseous, but it is less.  At the end of the day yesterday, I did eat a little rice with carrots.  And I just ate a little plain oatmeal with raisins and salt.  I am praying the 2nd dose will not be worse, as my daughter warned, because I can't remember when I was so sick and incapacitated.  Maybe a long time ago.