chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse and described the occurrence of corneal abrasion in a 59-year-old female patient who received BOOSTRIX. On 12th October 2014, the patient received BOOSTRIX. On 12th October 2014, less than a day after receiving BOOSTRIX, the patient experienced corneal abrasion, burning in eye, eye pain, blurry vision in eye and inadvertent exposure to vaccine. The patient was treated with antibiotics nos, (Antibiotics (Drug Name Unknown)). On an unknown date, the outcome of the corneal abrasion, burning in eye, eye pain and blurry vision in eye were not recovered/not resolved and the outcome of the inadvertent exposure to vaccine was unknown. Additional information: Reporter was a nurse and was also the patient. Yesterday at 11 am at work she was drawing a BOOSTRIX vaccine and by mistake the BOOSTRIX vaccine splashed on her right eye. Reporter experienced right away and is still experiencing burning in her right eye, pain in her right eye, blurry vision in her right eye. Reporter immediately went to ER and was diagnosed with a corneal abrasion. She also said that she is currently seeing a floater for some reason. Patient is taking antibiotics.
3/16 vaccination  4/4 extreme HA, tired, High BP, dizzy.  4/6 went to the ER. Shot for headache. Tramadol for HA if got worse. I took Tylenol.  I saw PCM on Friday Meloxicam 7.5 1 per day.  Will go to 2 tablets per day if continues. Not consistent HA as of yet.  Scheduled echocardiogram on 4/29/2021  *Usual BP runs 115-120 range. Never had issue with BP. Knee replacement sx 12/1/2020 and no issues with BP then. Since vaccine my BP has been in the 150's. My BP has been consistently high since vaccine. Lowest has been 141 on 4/12/2021. I feel like I am out of breathe.
shingles; Information has been received from a lawyer referring to a patient of unknown age and gender. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 22-AUG-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) (date not reported), the patient suffered a bad case of shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event shingles was not recovered and causal relationship was assessed as related.   The lawyer considered the event shingles to be disability.
Husband noticed 2 inch in diameter lump right of injection site on R upper arm. Visible, possible knot in muscle. Does not hurt unless pushed on, then aches with sensation down to R hand, 4th and 5th fingers sometimes into elbow. Lump still on R arm as of today.  Went to different location for 2nd injection given by the Health Dept. A retired family physician and ED doctor were administering. They both looked at it and we all agreed we would have the 2nd injection administered in the opposite arm, L deltoid.  Seen PCP on 5/28/21, referred to dermatologist. Seen by dermatologist on 6/18/21. Ultrasound completed on 6/25/21. Have been taking Ibuprofen PRN. I realized I had never submitted this when I completed it and felt I should, as the lump is still there as of 4/5/23. If touched, it still creates a numbness to the 4th and 5th digits. I feel this is important to share and would appreciate knowing if this has occurred with others and what their outcomes were. I had spoke with our epidemiologist and neurologist regarding it.  The ultrasound showed a thick mass.
Headache (of head) Stiff muscles and weak muscles  Funny nose  Cough  Sweating  Cold sweats Being hot and then cold Hands and feet always cold I am tired all of the time  My vision will get blurry all of a sudden and then be fine  My right hand will shake randomly  Nauseous
headache and nausea approx. 2 hours after injection.  used ibuprofen.
Moderna Vaccine given on 09/02/2021. Expiration date was 08/31/2021
VOMITING; BLURRY VISION; DIZZINESS; NOT FEELING WELL; FEVER; HEADACHE/MIGRAINE; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid 19, and headache, and concurrent conditions included: non alcoholic, non smoker, and azithromycin allergy. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 1808982 expiry: 21-SEP-2021) dose was not reported, administered on 26-AUG-2021 14:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 26-AUG-2021, the patient experienced headache/migraine. On 27-AUG-2021, the patient experienced not feeling well. On 27-AUG-2021, the patient experienced fever. On 01-SEP-2021, the patient experienced blurry vision. On 01-SEP-2021, the patient experienced dizziness. On 09-SEP-2021, treatment medications included: sumatriptan. On 12-SEP-2021, the patient experienced vomiting. Additional treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine was not applicable. The patient recovered from blurry vision, dizziness, and vomiting on SEP-2021, not feeling well, and fever, and headache/migraine on 12-SEP-2021. This report was non-serious.
awakened 1NOV95 w/ 2 big toes & rt wrist in grid-lock w/the gout-lasted 5 days; no relationship to flu vax was MD opinion
At conclusion of H1N1 clinic it was discovered vaccine recommended for age 4 & older was given to 3 yr old.
This is a spontaneous report from a contactable unspecified Healthcare professional via a Pfizer sales representative. A 18-year-old female patient of unknown age and race/ethnicity received approximately a month before this report (unspecified date in 2018) a single dose of TRUMENBA, lot S58877, expiration date 28feb2019) for immunization. Medical history was not reported. Concomitant medication administered in the same date included hpv vaccine (manufacturer unknown) for immunization. Patient had a severe headache the evening of the vaccines given. Patient almost went to ER. Parent called the provider and she told her to take ADVIL. Patient did and the headache went away by morning. Headache lasted approximately 12 hours and resolved on an unspecified date in 2018.
Had a positive reaction/it cleared up her lungs and all her respiratory system; Helped with her asthma; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Had a positive reaction/it cleared up her lungs and all her respiratory system) and PRE-EXISTING CONDITION IMPROVED (Helped with her asthma) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A, 046A21A and 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Clotting disorder (Had blood clotting disorder called protein D deficiency and protein C). Concomitant products included ZAFIRLUKAST (ACCOLATE) for Asthma, RIVAROXABAN (XARELTO) and HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Had a positive reaction/it cleared up her lungs and all her respiratory system) and PRE-EXISTING CONDITION IMPROVED (Helped with her asthma). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Had a positive reaction/it cleared up her lungs and all her respiratory system) and PRE-EXISTING CONDITION IMPROVED (Helped with her asthma) outcome was unknown.            Treatment information was not provided.  Patient stated that she had good side effects from receiving Moderna COVID-19 vaccine although it did not work for long term but for 8 weeks previously. Her asthma was good and then it went back down.   This case was linked to MOD-2021-306177, MOD-2021-306179 (Patient Link).
chills, muscle aches especially upper back and shoulders, H/A, slight nausea, earache, activated peripheral neuropathy, hardly able to stand. Contacted her cardiologist by phone and he felt that this was a reaction to the flu shot but not unexpected
Pregnant; soreness around the injection site; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and VACCINATION SITE PAIN (soreness around the injection site) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 11-Jan-2021 and the estimated date of delivery was 25-Oct-2021. On 23-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and VACCINATION SITE PAIN (soreness around the injection site). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and VACCINATION SITE PAIN (soreness around the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported no medical history Patient reported no concomitant medications or treatment
This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown gender who would be 17 months old. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M023384 and expiration date on 20-JUL-2018 of lot # M033906 with expiration date on 06-JUN-2019 (dose and route of administration were not reported) for prophylaxis. The reporter could not provide details of which lot number the patient received. The doses of VARIVAX were exposed to a temperature excursion of 14.9 degrees Fahrenheit (°F) during a time frame of 11 hours, which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported. This is one of the several reports received from the same source.; Sender's Comments: US-009507513-1710USA008686: US-009507513-1710USA008693: US-009507513-1710USA001141: US-009507513-1710USA008689: US-009507513-1710USA008690: US-009507513-1710USA008691: US-009507513-1710USA008692: US-009507513-1710USA008685: US-009507513-1710USA008684: US-009507513-1710USA008687:
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's pertinent medical history included high blood pressure and high cholesterol. On 22-DEC-2008 the patient was vaccinated with ZOSTAVAX (strength not reported route subcutaneous. Concomitant therapies included LOVAZA and HYZAAR. The reporter stated that on an unknown date blood titer for Varicella Zoster Virus (VZV) antibodies was performed on the patient, and the level of antibodies was  low. The outcome of level of antibodies was low is unknown. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
after confirming patient name, DOB and vaccination (shingles dose #2 of 2) administered vaccine in left deltoid without incident. patient denied any serious adverse reactions after dose #1. instructed patient to remain in store for 15 minutes. patient sat in chair in pharmacy waiting room. as patient sat down, he expressed pain near his right knee, saying he could not bend it. Consulted with NP and she examined patient. She stated there appeared to be no injury and pain was from muscle tightness/tensing by the patient. Patient asked us to contact. we called them and they came to pharmacy and examined patient. they did not seem to find any serious issues with patient. they were able to assist patient up and to his vehicle. patient declined transportation to hospital.
had fever; chills; muscle aches; red blotchy area on her skin; itchy; painful/patchy rash; This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th November 2019, the patient received the 1st dose of Shingrix. On 6th November 2019, 1 days after receiving Shingrix, the patient experienced fever, chills and muscle pain. In November 2019, the patient experienced red blotches, itchy rash and painful rash. On 7th November 2019, the outcome of the fever, chills and muscle pain were recovered/resolved. On an unknown date, the outcome of the red blotches, itchy rash and painful rash were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, muscle pain, red blotches, itchy rash and painful rash to be related to Shingrix.  Additional details were reported as follows: The patient received dose and experienced had fever, chills and muscle aches next day. About 1 week after the dose she developed a red blotchy area on her skin that was painful and itchy. The area faded after about 4 days, but then reappeared on a different part of her body. She constantly had patches moving around to different parts of her body, always red, blotchy, painful and itchy, since. The patches seem to be getting higher up on her body as time goes on, and they appear on both sides of her body. None of the patches have developed blisters. The patient had seen her Health Care Professional about the patches. Emergency room visit was required. The reporter did not consent to follow up.
Recruit complaining of shortness of breath and chest pain. Breathing labored. Upper lung sounds diminished. Lower lung sounds absent. Skin hot. No itching/redness/hives present. Recruit given 0.3ml epinephrine at 0950 and 25mg Benadryl at 0952, both injections given IM.
Itching at site - then redness - hot to touch and chest discomfort. Elevated blood pressure. Pt. given 50mg oral BENADRYL and transported to hospital ER via ambulance.
Adacel and Fluzone Quadrivalent were administered after being exposed to 30 degree F, No Ae; Initial information was received on 11-Aug-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 22 years old female patient was administered with the  0.5 mL dose of vaccines INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and expiry date not reported) via unknown route in the left deltoid and dose of suspect  DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination after being exposed to 30 degree F on 09-Aug-2020 (product storage error).  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.  It was of actual medication error due to incorrect product storage.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
DEVELOPED BURNING MOUTH SYNDROME AROUND THE BOTTOM LIP AND INSIDE AND FEELS LIKE IT IS BURNING ALL THE TIME LIKE IT IS ON FIRE; This spontaneous report received from a consumer concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: breast cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced developed burning mouth syndrome around the bottom lip and inside and feels like it is burning all the time like it is on fire. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from developed burning mouth syndrome around the bottom lip and inside and feels like it is burning all the time like it is on fire. This report was non-serious.
Day 1: Arm hurt 6/10; Day 2-3: Pain 10/10 unable to move arm; Day 4-5: T-Rex arms only. Otherwise 10/10 pain in upper arm. Day 6-12: pain decreasing and regain mobility. Day 13-14: No improvement; Day 15-present increased pain.
pt recv vax 24APR96 & 26APR96 pt exp fatigue, malaise, & h/a;these sx resolved;8MAY96 pt was found to have elevated liver enzymes;ER or MD visit was required;liver enzymes remain elevated as of testing 17MAY96;
A report was received from a health care professional on 10/28/2003 concerning a 64 year old female vaccinee who experienced pruritis 2 days days after receiving Fluvirin on 10/01/03. On 10/03/03, the vaccinee experienced pruritis on both arms, back and chest 2 days after receiving Fluvirin. The vaccinee went to the nurse on 10/27/03 about itching since the pruritis had continued for 3 weeks. Antihistamines were prescribed for the vaccinee. At the time of reporting the vaccinee had not recovered and it was unknown whether the antihistamines have helped relieve the pruritis. The reporter has assessed the  relationship of the vaccine to the event was unrelated due to the nature of the event and since the vaccinee has been receiving the influenza vaccination every year for many years with no adverse events. Update 1, 12/05/2003: Follow up information received from a health care professional on 12/05/2003, which indicated that the vaccinee also experienced hives and urticaria 1 and a half days after receiving Fluvirin. The vaccinee was treated with hydroxyzine panoate and chlorhexidine gluconate. The vaccinee recovered from the urticaria and hives on 10/31/2003. It was not reported if the vaccinee had recovered from the pruritis. The reporter has assessed the relationship of the Fluvirin to urticaria and hives as possible. Update 2, 1/23/2004: A follow up letter was received from a health care professional indicating that the pruritis had resolved on 10/31/2003. No follow up pending, all information received.
A full  sixth dose  of 0.5 mL was in a 5 dose vial.  Full dose of 0.5 mL withdrawn and administered to patient.  - No Adverse events with patient.
Lumps developed under skin at injection site; Arm still shows redness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site lump in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site lump (Verbatim: Lumps developed under skin at injection site) and erythema of extremities (Verbatim: Arm still shows redness).The outcome of the injection site lump and erythema of extremities were not resolved.   It was unknown if the reporter considered the injection site lump and erythema of extremities to be related to Arexvy.     It was unknown if the company considered the injection site lump and erythema of extremities to be related to Arexvy.   Additional Information: GSK Receipt Date: 28-SEP-2023 This case was reported by a patient via interactive digital media. The reporter stated that arm still showed redness and lump developed under skin at the injection site.
UNSPECIFIED SIDE EFFECT; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number. No concomitant medications were reported.   On an unspecified date, the subject experienced unspecified side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified side effect was not reported. This report was non-serious.
On 4/5/05 in AM within 5 min of vaccines, pt was walking out and fainted. Mother shook pt and she opened eyes within 10 sec. No breathing problem. Then red papular rash began on both upper arms near injection sites. Benadryl given for 48 hrs. Pt nauseated and continued to have red upper arms.
This spontaneous report as received from a physician refers to a 21 year old female patient. On an unknown date the patient was vaccinated with a dose of RECOMBIVAX HB (dose, route and lot number not provided). The patient was revaccinated with one dose of RECOMBIVAX HB (dose, route and lot number not provided) adult dose, on an unspecified date. The physician reported that the patient was a non responder to RECOMBIVAX HB series. The patient sought unspecified medical attention. The patient had unspecified lab work that showed "less than 5". The outcome of non responder to RECOMBIVAX series was unknown. The causal relationship was not reported. This is one of several reports from the same source. Additional information has been requested.