chrisvoncsefalvay/vaers-outcomes huggingface dataset:
High white blood count; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 19Feb2021 at 07:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously had naproxen sodium (ALEVE) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Feb2021, 3 days after the vaccination, the patient had a high white blood count. On the same day, the patient underwent a blood test and the result was a high white blood count. Therapeutic measures were not taken as a result of the event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and the emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event high white blood count was unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
The immunization was given on 7/21/22, but the vaccine was expired on 6/30/22. The pharmacy manager contacted to the manufacture (GSK), the manufacture said "  The patient has not report any adverse reaction.  Bexsero remains within the  approved specifications for up to 30 days following the expiration date of the vaccine if stored  under appropriate temperature and storage conditions as described in the Prescribing  Information." The patient has not reported any adverse reaction.
This spontaneous report as received from a Doctor of Pharmacy refers to a patient of unknown age and gender. The patient was vaccinated with dose 1 PNUEMOVAX 23 4-5 years ago, in approximately 2007 (route, dose unknown). The pharmacist mentioned that a nurse unfamiliar with PNEUMOVAX 23 multidose vial, on 06-DEC-2012, gave a patient the entire vial (5 doses) of the multidoses PNEUMOVAX 23 (route unknown). No other co-suspects were reported. No concomitant medications were reported. The patient was not experiencing any known symptom. Additional information has been requested.
Mom phoned clinic on 2/2/01 with complaint of fever. No provider available. Advised to give Motrin for fever and monitor. Mother denies redness or swelling. Advised to seek ER if no improvement. On 2/6/01, presents in clinic with complaint of still having fever. Reports the site of injection swelled up 2 times normal size. No swelling at this time. No fever.
LA posterior redness 3x4 1/2 in elevated in duration 1 1/2in initial 0 dc 0 Adenopathy.
Takotsubo Cardiomyopathy, Acute Pulmonary Edema, Hospital Admission, Diuresis.
This spontaneous report was received from a physician regarding an unspecified number of patients of unknown ages and gender. The patients medical history, drug reactions or allergies were not provided. Between 09-OCT-2015 and 16-OCT-2015, an unspecified number of patients received unspecified doses of PEDVAXHIB immunization series (dose and route were not provided, Lot number L009649 and expiration date 29-NOV-2017). Concomitant medications were not provided. There was no adverse effects reported. This is one of three reports from the same source (MARRS #1510USA008696 and 1510USA013292). Additional information has been requested.
Starting 03/01/2022 at 2:30PM I had an unexplained fainting spell. On route in the ambulance, I was in tachycardia which precipitated 48 hours of hospitalization and numerous tests. Chemistrys, xrays and other tests all came back negative except for the stress echo which indicated a trace mitrovalve regurgitation, and a slightly high white blood cell count. To this day, they still have not figured out what caused it. They are treating me with B12 in hopes that may account for the elevated WBC. I will be re-evaluated on 04/14.
I was administered the first Moderna Covid Shot (Lot #010M20A) on 2-11-2021 and the second shot (Lot#026A21A) on 3-11-2021. I felt no reaction from either shot except for mild arm soreness where the vaccine was given. This soreness disappeared within a day or two.  About a week after receiving my second shot of Moderna, I started having mild chest pains. I did not relate these pains to a Covid shot. On the evening of March 31, 2021, I was feeling tired and told my wife I would take a bath and go to bed, which I did. I couldn't get comfortable in bed as my chest was hurting, so I got up and sat to watch TV for a while. While sitting up, the chest pain went away. I went back to bed, and the chest pain intensified anI went back to bed, and the chest pain intensified and was radiating down my left arm. I got up and told my wife I thought I was having a heart attack. She immediately drove me to the hospital, where I was admitted to the Emergency Room and given a battery of tests. At 5:00 AM, I was admitted to the hospital overnight for more testing. On April 1, the diagnosis was pericarditis. The hospital doctor prescribed Colchicine which I took daily. On April 25 I sent a message to my Dr., my Cardiologist: I wanted to update you on the status of my symptoms. I have been taking an antibiotic ( Doxycycline Hyclate 100 MG) for the past three weeks. Today I ran out of the prescription. It doesn't seem to matter as I have continuously hacked up sputum all day for the past three weeks. The anti biotic doesn't seem to be doing any good. Also my pericarditis used to be causing me pain only when I lay on my back in bed. For the past week, it is causing me pain in my chest and shoulder when I stand or sit. It is not severe pain, but it is there. It appears to be getting worse. I have run out of my Ibuprofen prescription and have been taking Advil (three 200 MG pills). I had an appointment with Dr. (Rheumatologist) on 4/27 and she seemed to believe that my heart issue was associated with my upper chest condition. I have an appointment with Dr. (Pulmonary) on May 4. Medication doesn't seem to be helping. Any suggestions?  I just want to confirm with you that you are taking the Colchicine daily as well? Thank you, RN.  Yes, I am taking the Colchicine daily, but as I indicated, my chest pain seems to be getting worse, not better. My chest pain is there even if I am not lying down. It is not severe, but it is there when I breathe.  On May 4, 2021, I visited Dr., a Pulmonologist, for coughing up yellow sputum. He prescribed a PredniSONE taper and scheduled a complete pulmonary function test in late June.  On July 8, I visited Dr., and he stopped the prescription for Colchicine as he believed the pericarditis was resolved. Also, on July 8, I saw Dr., Pulmonologist, and he believed my upper chest infection had been resolved, but scheduled a full pulmonory test on my lungs which was done on July 28. It showed my lungs were clear and breathing normally. "This test showed no obstructive or restrictive ventilatory defect. Overall, lung volumes are normal. Diffusion capacity is also normal."
Numbness - 45 minutes after shot. "Hangover" type headache - by 24 hours. Left sided pain, extreme fatigue, left sided cervical lymphadenopathy (left = immunization side) during next 48 hours.
Pt recvd vax & 20 mins later pt suffered a crdiac arrest & died; MD feels this event was unrelated to flu shield;
Seen 2/8/10 with new onset motor / vocal tics. Mother states started 1 week after 2nd dose H1N1 injection.
8-10 hours of chills, body aches, and severe malaise.  treated with tylenol.
Breakthrough COVID infection in fully vaccinated patient. Positive date 07/30/2021.
Heart palpitations  Dizziness  Nausea  Headache Fever Numbness in my fingers in toes  Fatigue  Burning in my eyes, blurred vision Sharp, burning pains throughout my body Pain in the middle of my back, in my knees, in all my joints
I feel tired all the time; Running a fever all day long; This is a spontaneous report from a contactable Consumer or other non-health professional (Patient). A female patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EN6198) via an unspecified route of administration on 16Mar2021 as dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Patient stated that I received the shot on yesterday and I feel tired all the time. Yesterday, I received the shot, and, on this day, I seemed to be running a fever all day long. She was wondering whether running a fever was normal. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
An MA reported that a 70 year old male received a dose of Pnu-Imune 23 vaccine in 6/01. He subsequently, developed an injection site reaction. He was seen in the ER and prescribed antibiotics for cellulitis. He recovered. This is 1 of 3 pts from this facility who experienced this event following receipt of Pnu-Imune 23, lot 468147. (See HQ 2484325JUN2001 and HQ 3428718JUL2001).
Information has been received from a medical assistant concerning another medical assistant who on 30-DEC-2010, was administering the second dose of GARDASIL (Lot # not reported) to a patient, when some of the dose splashed in her eyes. She washed her eye for 10 minutes and experienced some eye pain during washing. Her pain had since resolved. Additional information has been requested.
Vaginal itching and brown discharge three days after  swine vaccine injection.  Systems still persist as of 04/07/21.
No sign or symptom immediately but had a major stroke within 20 hours, post vax, with atrial fibrillation. Is in Rehab.
Patient received his first dose of Pfizer Covid 19 on 9/7/21. The next day he started experiencing nausea and fatigue. He contacted the pharmacy after speaking to his primary care doctor. After 2 weeks of experiencing nausea, fatigue, lightheadedness, and chills with no fever, he went to urgent care. At that time, he was told try to get more rest. After 3 weeks with no changes, he saw his primary care doctor. He has also complained of the back of his neck feeling stiff and shoulders feeling weak. His primary care physician has prescribed steroids at this time. She recommended he notify us so we could report.
Nausea two hours after injection. Four hours after injection in the upper left arm, the left shoulder join became inflamed. There was throbbing, and pain intensified with any attempt to lift the arm higher than thirty degrees from the neutral hanging position. Pain was sufficiently intense as to require a heating pad in order to sleep. Pain diminished slightly and mobility improved slightly the next day. By that day's afternoon the arm could be raised almost horizontal. By the end of the third day, the second day after the injection, most mobility had been restored. The shoulder was back to normal in just less than a week.
This spontaneous report from a pharmacy Intern concerning to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose, route, lot# and the expiration date were not reported) for prophylaxis. There was no concomitant medication provided. There was no Product Quality Complaint (PQC) involved nor adverse effects reported. The temperature and the time of the excursion were unknown by the reporter and also it was unknown if a data logger was involved. Additional information has been requested.
1 dose of Moderna Covid-19 vaccine (Monovalent) was given after the temperature excursion.; No adverse event; 1 dose of Moderna Covid-19 vaccine (Monovalent) was given after the temperature excursion.; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 vaccine (Monovalent) was given after the temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (1 dose of Moderna Covid-19 vaccine (Monovalent) was given after the temperature excursion.) and  (No adverse event) in a 2-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 vaccine (Monovalent) was given after the temperature excursion.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (1 dose of Moderna Covid-19 vaccine (Monovalent) was given after the temperature excursion.) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 vaccine (Monovalent) was given after the temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (1 dose of Moderna Covid-19 vaccine (Monovalent) was given after the temperature excursion.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 vaccine (Monovalent) was given after the temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (1 dose of Moderna Covid-19 vaccine (Monovalent) was given after the temperature excursion.).    No concomitant product reported by reporter. Two temperature excursions were occurred with Moderna COVID-19 vaccine (Monovalent) in the freezer. Storage condition at the time of excursion was frozen.  Vials were returned to freezer. No changes were observed upon visual inspection of the vials. No treatment medication reported by reporter.
09May90 pt vax;  devel coughing & wheezing.   BP 100/70, repiration 24, pulse 140.  Tx w/ unspec. drug.  EXp no problems after 1st vax at 1 yr of age.
Swelling, redness at site of injection,  mild myalgias and low grade  temperature elevation
This spontaneous report was received from a medical assistance referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX lot numbers: L034368, expiration date 08-SEP-2017; M033904, expiration date 20-JUN-2018 and M035142, expiration date 30-AUG-2018 (dose and route of administration were not provided) for prophylaxis. There was no adverse effect reported. Administered doses of VARIVAX were exposed to a temperature excursion of 29°F for 6 hours and 48°F for 3 hours. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA005585: US-009507513-1702USA010876.
This is a spontaneous report from a contactable consumer, the patient's mother. A 3-month-old male patient received a dose of PREVNAR13 intramuscularly in the thigh and the first dose of ACT-HIB intramuscularly at 14:00 on 09JAN2012. The patient had no relevant medical history or relevant concomitant medications. Vaccines taken within the last four weeks were none. On 09JAN2012, the patient had decreased sleep. Relevant lab data was none. The event did not require an emergency room or doctor visit, At the time of the report, the patient had not recovered from the event.
pt recv vax 2APR97 & it was reported that sam day pt devel lymph node swelling;
Received 2nd dose of Bexsero early; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 23-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO).   On 25-JUL-2023, the patient received the 2nd dose of Bexsero. On 25-JUL-2023, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: Received 2nd dose of Bexsero early).  The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-AUG-2023 The patient received 2nd dose of Bexsero, early than the recommended interval, which led to shortening of vaccination schedule. The reporter did not consent to follow up.
fever 101.3 Urticaria covering neck, chest, abdomen, arms, legs
1st dose 18Dec2019, 2nd dose 12Aug2020; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18th December 2019).   On 12th August 2020, the patient received the 2nd dose of Shingrix. On 12th August 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 08-JUL-2022 Reporter's Comments: The pharmacist reported that the patient received second dose on 12th August 2020. No reactions reported. The reporter did not consent to follow up. Additional Supportive Information: The patient received the second dose later than the recommended interval, which led to lengthening of vaccination schedule.
Varivax vaccine given on 7/22/08 in left arm. Since came in on 7/24/08 with 5.5 x 8 cm swollen warm, induration. no vesicles. No assessment revealed. Motrin as recommendation. Benadryl, topical cool compresses, monitor size.
I woke up on Jan 23, 2022. My hand was very tight and stiff and tingling. I could hardly open my fingers up. The next day I got up and went to urgent care. The doctor said he believes someone hit a nerve when giving the vaccine. He prescribed medication to take for 7 days and if it didn't get any better, he gave me information for a neurologist. Another week passed since then, I couldn't afford for the neurologist that week and had to quit my job because of COVID. I want to get help but I didn't need the bills. It wasn't getting any better so I went to the hospital and it was really bad at night time. I went to the hospital on Friday and they gave me pain medication and a pain patch. So my arm is still the same and it gets so bad at night time with pins and needles. They did do 3 x-rays on my hand they said they didn't see anything. Nothing noticeable, after 10 days to get another x-ray. Told me to go to an orthopedic surgeon. Feeling has not changed in 2 weeks going on 3. Very numb, now taking a regular Tylenol or aspirin to help me sleep with my hand because it's painful. Driving is also painful sometimes. Showering is hard to do because the hand almost seems as if it doesn't have feeling. Sometimes I pick up something and drop it. It's hard to use and painful at night time. Hard to describe, numbing feeling that gets painful between the fingers and gets worse at night. Worse as the day goes on. Hard to do daily chores. Hard to function with one hand.
Five minutes after vaccination, he felt "dizziness, weakness of lower extremities", tingling in bilateral legs and feet.  No problem walking. Gave water/juice. Stable, released from vaccination site.
Pt w/hx of COPD/current smoker presented to ED w/2 week episode of dizziness, syncopy, poor appetite, chills, N/V/D with no SOB or fevers. Pt stated that she may have had COVID infxn months ago prior to receiving Moderna vaccines on 2/25 & 3/25. CXR impression consistent w/known COVID-19 infection upon workup and subsequent positive COVID test (5/8).  Admitted on 5/5 for additional management of acute hypoxic respiratory failure d/t bilat PNA.  Pt received dexamethasone, convalescent plasma, and tocizumab and is still in hospital requiring 9L of O2.
Narrative:  covid booster and influenza vaccine administered 10/27/21, patient with baseline dementia and was screening prior to administration of vaccine and was in usual state of health. Fevers presented w/in 24 hours and resolved. Patient continued with fatigue, muscle pain and decreased appetite with difficulties eating (pocketing food) which was new. Confusion increased and developed hand tremors. Five days after vaccine patient had little urine output, was hollering in pain, gritting teeth when touched by caregiver. As patient with dementia at 88 years old, treatment plan did not include returning for further hospitalization. Patient became more sedated and began sleeping almost all day, developed further mouth breathing. Hospice services were ordered, however patient passed prior to starting on 11/3/21. Caregiver denied any other changes to patients routine/medications prior to administration of vaccines.
Got vaccines, shingles every two months / suspected Vaccination failure; shingles every two months in same spot; This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, 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 Shingrix.     Additional Information: GSK Receipt Date: 10-FEB-2023 Reporter's comment: The patient was in her late 50s. The nurse had stated that, after the patient had received Shingrix vaccines, she had been getting shingles every two months in the same spot. The reporter had consented to follow-up. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
He got his vaccine, he waited the 15 minute time period and then he had a headache that started to develop.  The headache feels like a head cold, felt like his head was swelling up on the inside.  He did not have any other symptoms until the next day when he would get sleepy spells, one minute fine, next minute tired.  This went on for a couple of days.  After the 1st day he started accumulating hearing loss in his left ear, little at first and then progressed to where he could not hear.  It then transferred over to the right ear, and then that ear corrected, but the left ear he still cannot hear out of it.  He also had a very sore throat, tonsils, and having difficulty breathing at times.  He has not been able to get into his PCP but the phone # has been disconnected.   The sleepy spells went away, headache went away, but the ear is still bothering him and has not let up at all.
Heart racing and edema caused by  application of compounded hormone cream post-vaccine and never had any side effects previous to covid vaccination. Had been on HRT since 8/2020.
Patient called the pharmacy the morning of 3/30/15 to report event to pharmacist. Onset time unknown; patient reported AE as the inability to lift his arm and classified it as severe.  The patient had spoken to a nurse and had tried to be seen by his PCP whose office is closed until early April.