chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have had a headache with sinus pressure and pressure on the back of my head; I have had a headache with sinus pressure and pressure on the back of my head; I have had a headache with sinus pressure and pressure on the back of my head; EXTREME DIZZINESS AND BLURRED VISION; EXTREME DIZZINESS AND BLURRED VISION; It is accompanied by sweating and feeling faint; It is accompanied by sweating and feeling faint; It is making it hard to concentrate; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Oct2021 07:30 (Formulation: solution for injection, Lot number: EW0191) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known Allergies: Pineapples" (unspecified if ongoing). There were no concomitant medications. The following information was reported: HEADACHE (non-serious), PARANASAL SINUS DISCOMFORT (non-serious), HEAD DISCOMFORT (non-serious) all with onset 04Oct2021 09:00, outcome "not recovered" and all described as "I have had a headache with sinus pressure and pressure on the back of my head"; DIZZINESS (non-serious), VISION BLURRED (non-serious) all with onset 04Oct2021 09:00, outcome "not recovered" and all described as "EXTREME DIZZINESS AND BLURRED VISION"; HYPERHIDROSIS (non-serious), DIZZINESS (non-serious) all with onset 04Oct2021 09:00, outcome "not recovered" and all described as "It is accompanied by sweating and feeling faint"; DISTURBANCE IN ATTENTION (non-serious) with onset 04Oct2021 09:00, outcome "not recovered", described as "It is making it hard to concentrate". Therapeutic measures were not taken as a result of headache, paranasal sinus discomfort, head discomfort, dizziness, vision blurred, hyperhidrosis, dizziness, disturbance in attention.  Additional information: The patient received the vaccine in a hospital. The patient did not have any other vaccine in four weeks or had any other medication in two weeks. She had a headache with sinus pressure and pressure on the back of head with EXTREME DIZZINESS AND BLURRED VISION. It was accompanied by sweating and feeling faint. It was making hard to concentrate on whatever task she was trying to complete at the time. The patient did not have covid prior to vaccination nor was tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In January 2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 01-JUL-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as a herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Information has been received from a physician concerning a female between 11 and 18 years old (exact age unspecified) who, on an unspecified date, was vaccinated intramuscularly with a 0.5 mL dose of Gardasil. Subsequently, on and unspecified date, the patient felt dizzy and fainted. It was noted that the patient received at least one other vaccine on the same date as when Gardasil was administered. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. The patient recovered on the same day as when the injection was given. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow up information has been received from a physician concerning a 15 year old female student with no drug allergies and no medical history who, on 26-MAR-2007 at approximately 14:30 was vaccinated intramuscularly in the left deltoid with a 0.5 mL first dose of GARDASIL (Lot# 655165/1425F). Subsequently, the patient felt very dirry (it was previously reported that the patient had fainted) which was not noted by staff but witnessed by the patient's mom. The patient noted that she sat on the exam table for a while and felt better. It was noted that the patient received at least one other vaccine on the same date was when GARDASIL was administered. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed and there were no illnesses at the time of vaccination. The patient recovered on 26-MAR-2007. On 11-JUL-2007 the patient was vaccinated with a second dose of GARDASIL. The patient layed on the exam table for five minutes and no adverse effects were reported after the second dose. No product quality complaint was involved. This is on of several reports received from the same source. Additional information is not expected.
Having had no history of this issue, I started to hear bell sounds in my ear while yawning. I searched for it online and looks like the medical term for it is Tinnitus, Also, There was one occasion that I started to hear my blood flow in my ear for a couple of minutes. The bell while yawning hasn't gone away after about 2 weeks. Luckily I don't hear the sound when I am not yawning which is a blessing.
Pt recvd 3 doses of Engerix-B & was determined to be a non-responder on 15JAN92;
Initial consumer report received on 28 Dec 2009: This nursing patient was vaccinated with Influenza vaccine (batch no 1008133P) on 12 Nov 2009. One hour after receiving the vaccine, she experienced a tingling in her hands and feet and dizziness. She has also experienced bouts of difficulty breathing, difficulty sleeping, muscle weakness ("like her nervous system is not working right"), upset stomach, and a change in bowel habits. She has been to the emergency room twice regarding this. She states that her mother and her husband received the same vaccine lot without incident.
Congestion, headache, body aches, and fever symptoms the day after vaccination.  Lasting the entire day.
2cm erythematous warm tender area with induration on left arm (site of varicella vaccine).
103 fever for 24 hours; chills; very tired; no energy; nausea; achy muscles; it felt like the flu; a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (103 fever for 24 hours), CHILLS (chills), FATIGUE (very tired), ASTHENIA (no energy) and NAUSEA (nausea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (a sore arm). On 18-Feb-2021, the patient experienced PYREXIA (103 fever for 24 hours), CHILLS (chills), FATIGUE (very tired), ASTHENIA (no energy), NAUSEA (nausea), PAIN (achy muscles) and INFLUENZA (it felt like the flu). On 19-Feb-2021, PYREXIA (103 fever for 24 hours) had resolved. On 22-Feb-2021, FATIGUE (very tired), ASTHENIA (no energy), NAUSEA (nausea) and PAIN (achy muscles) had resolved. At the time of the report, CHILLS (chills), PAIN IN EXTREMITY (a sore arm) and INFLUENZA (it felt like the flu) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 103 (High) she had a 103 fever for 24 hours..
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On 20-JAN-2016 the patient was administered with a dose of improperly stored oral, ROTATEQ (lot# L008996 and expiration date 01-DEC-2016, dose, dose# and route not reported). No adverse effects reported. Additional information is not expected since there was no consent for follow up contact.
Moderna COVID-19 Vaccine EUA: patient with existing vision loss hospitalized for worsening vision loss. Determined to be a result of breast cancer metastases.  Received radiation treatment and steroids and discharged to home medically stable.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported.    On unspecified dates, the patients were each vaccinated with a dose of improperly stored of ROTATEQ (lot #, expiration date and dose were not provided) orally for prophylaxis, which were exposed to 28.8 Fahrenheit (F) for 8 hours 43 minutes. There was no previous temperature excursion. No adverse effects were reported. The data logger issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA000631: US-009507513-1612USA009007:
Reddish small flat papules, warm 1 cm node in axilla swelling large and inclusive of medial side of arm.
Onset this a.m. father called to report RA red and swollen. Advised cool cloth for 1st 24 hours and post 24 hours warm cloth. TYLENOL PRN. Assessed as a local reaction. If worsens or no better in 3-4 days seek medical attn.
Nausea, vomiting, SVT. Rx'ed with Digoxin and Cardiazem. Medical records states bradycardia. msv
blurring vision 3 wks p/flu shot;segmental loss of vision which caused localized loss of vision in lt eye as revealed by field of vision exam;
Broke out into a severe rash on both hand within 7 days from first vaccine. Rash and itching lasted for 4 months. I now have numbness in left arm, unrelieved with medical treatment. Eye twitching in right eye since vaccine and skin is still itching. I take a Benadryl almost every night just to sleep. I now have restless leg and jerking movements in my arms.
has it now and got his last shot a month ago/suspected vaccination failure; has it now and got his last shot a month ago; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included cancer (unfortunately had cancer 2 years ago). Previously administered products included Chemotherapy (chemotherapy was one of the top 4 things that could bring shingles out).   In FEB-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: has it now and got his last shot a month ago/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: has it now and got his last shot a month ago). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2023 This case was reported by the patient's wife via interactive digital media. The reporter reported that the patient had shingles now and got his last shingles shot a month ago. This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible, as no contact details were available.
H1N1 Vaccinations were done in the High School. Patient reported to the school Nurses office c/o sore throat and cough. Had just eaten lunch. No signs of local reaction at injection site. Then stated felt nauseous. B/P 102/64 P 64/min, Pulse Ox- 99%, resp.-20/min MD consulted. Mother notified. Sending child to ER via ambulance. Mother arrives- mother feels this is result of acid reflux and asthma. 11/2/2009 mother reported to school nurse that patient vomited in ER afternoon of 10/30/2009, and felt better. No further symptoms.
I clicked on the text to do my VSAFE check in and one of the questions was have you contracted COVID and I clicked YES and then a few days later you guys called, so here I am. My 2nd booster was given on APRIL 15th and on MAY 18th  I woke up with massive nasal and chest congestion, very lethargic, couldn't and didn't want to get out of bed, extreme fatigue, massive headache, scratchy throat (yet it didn't hurt to swallow), flemmy cough on and off through the day. On MAY 19th took an at home test and came back positive. On MAY 20th I called our area CLINIC and spoke to nurse who was able to get a prescription for PAXLOVID through pharmacy which I started that evening and am currently on course to complete by WED MAY 25th when I'll see if it worked or if I rebound. Backing up a bit....my entire family is fully vaxxed and boosted, my adult kids are all at home. After Mothers Day my 20 year old daughter went back to her apartment (on May 10th) for college, she told me she spent the next 4 days on her bathroom floor with similar symptoms but she had a fever over 100 ( my temp stayed around 98). She took TWO at home tests while there and both came back negative while she was still experiencing symptoms. She returned back home here on May 14th Saturday, still sick (again she tested negative twice). Long story short, on Wednesday May 18th, My 28 year old son and my 24 (soon to be 25 the next day) daughter and I all woke up with the same symptoms of stuffy congested nose and chest, cough etc. My son coughed so hard he almost vomited and then hepassed out on the floor.  Later that day my son and daughter do an at home test and they come back positive.  I test May 19th Im postive too. My husband tests negative and has no symptoms.
Mind fog; Head ache; Body ache; night sweating; inability to concentrate; sense of balance; loss of appetite; general feeling of exhaustion; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6198), administered in the left arm, on 08Mar2021 at 13:15 (at the age of 69-years-old) at dose 1, single for COVID-19 immunisation. Medical history included COVID prior vaccination; Kienbock's disease; chronic lymphocytic leukemia; rheumatoid arthritis. No COVID tested post vaccination. The patient had not known allergies. No other vaccine received in four weeks. Concomitant medications included allopurinol, pravastatin, fluoxetine, meloxicam; reported as other medications in two weeks. The patient experienced headache, body ache, night sweating, inability to concentrate, sense of balance, mind fog, loss of appetite and general feeling of exhaustion on 09Mar2021 at 01:00. No treatment administered for the events. The patient was recovering from the events.
Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent; No adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event) in an adult patient of an unknown gender 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live Significant Follow-up appended: Patient details (Age group) was added.
Had the vaccine, got shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 11-MAY-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had shingle vaccine and still got the shingles. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up could not be possible as no contact details were available.
Got dizzy; My heart started pounding; Very tired; Very, very sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 6th May 2022, the patient received the 1st dose of Shingles vaccine. On 6th May 2022, less than a day after receiving Shingles vaccine, the patient experienced pain in arm. On 7th May 2022, the patient experienced dizziness, heart pounding and fatigue. On 8th May 2022, the outcome of the pain in arm, dizziness, heart pounding and fatigue were recovered/resolved.   It was unknown if the reporter considered the pain in arm, dizziness, heart pounding and fatigue to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-May-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient got first shot on Friday and had very, very sore arm.  The next day, the patient was cleaning off some porch furniture and got dizzy, and heart started pounding, was very tired. On Sunday, was all good. The patient stated, it was better than getting Shingles for sure. Additional supportive information: Follow-up would not possible as no contact details were available.
Severe vomiting; nausea; bodyaches; fever; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 17 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "Severe vomiting"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; PAIN (non-serious), outcome "unknown", described as "bodyaches"; PYREXIA (non-serious), outcome "unknown", described as "fever".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient got vaccination on 11/23/21. Reported to pharmacist that she has had shoulder pain and trouble with moving her should (limited range of motion) since that time. Has seen MD and been prescribed medications and is still experiencing issues with pain and limited range of motion.
My arm broke out in red rash and hives. Over the next couple days it spread all the way to my ankles.
After vaccine I had extreme fever chills, I was freezing cold and could not get warm. I felt extremely sick. I ended up with the glands under my left arm severe swollen all the way to my breast. My fever was a bit over 100 and was barely able to get out of bed. This lasted about 4 days. I had these reactions to vaccines 2 and 3 the same but no where near as intense. My husband had the vaccine at the same time and he too had a fever and was extremely tired, but he was no where near what I was. On July 9th I woke up with symptoms of COVID and went to urgent care where I was tested positive. My current symptoms are extreme sore throat, pain in sinuses, a bit of fever, and cough. I went to urgent care again and they gave me a chest X ray to check my airway. It was fine. They gave me antibiotic in fear I was getting a severe sinus infection.
Immediately after vaccine pt reported feeling lightheaded/nauseated. She waited 5-10 min; began feeling better and left. She fainted before leaving store. After fainting she admitted she had fainted after a previous flu shot several years previous. RPh follow up w/pt on 5-1-17 and she is fine.
Patient came to ED with chest pain and nausea and vomiting.  Patient admitted with Covid pneumonia.
The Patient and his brother came to get vaccinations for COVID and FLU.  His brother is 12 yo and the patient is 10 yo. I feel that I may have inadvertently given the adult COVID-19 ( Comirnaty).  I am not completely sure about this.  I found myself trying to process his vaccination form for the adult COVID-19 shot; However, the vaccination form states only FLU vaccine for the patient.  I'm unaware of any adverse events occurring to the patient at this time.
12/1/2019 9:50 am nausea. Continued until 12/2/2019 noon 11/30/2019 6:30 pm pain in the injection site. Ended 12/6/2019 in evening
DIZZY; WEAKNESS; MUSCLE ACHE; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included abstains from alcohol, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any drug abuse/illicit drug use. 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 16-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included paracetamol. On 17-MAR-2021, the subject experienced dizzy. On 17-MAR-2021, the subject experienced weakness. On 17-MAR-2021, the subject experienced muscle ache. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, weakness, muscle ache, headache, and fever on 20-MAR-2021. This report was non-serious.