chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4/17 Onset of tingling nerve pain in toes, fingers, back. Not resolved yet completely. 4/19 Elevated BP 4/21 Hypertension and some leg weakness 4/22 ER Visit - EKG and Blood test showed no emergency. No medications administered. Released with advice to follow-up with a neurologist. 4/23 - 4/26 Increased tingling pain and weakness 4/27 Virtual Neurologist appointment - unable to diagnose, allows scheduling of in-person visit 4/28 Neurologist prescribed Gabapentin 300mg per day for 3 days, 300mg/3000mg for the next 3 days, 300mg/300mg/300mg per day after 4/29 - 5/3 Weakness so bad that going up and down hills or stairs is risky and painful. Only slow movements are possible. 5/4 In-person visit with Neurologist. EMG and physical test confirm peripheral system impaired. Diagnoses Guillian-Barre Syndrome and facilitates same day hospital admittance. Hospital administers steroid IV, blood tests, Chest X-Ray, Covid Nasal test. 5/5 Lumbar test performed successfully. Results show high protein consistent with Guillian-Barre. Treatments began that night for a series of 5 nightly treatments. 5/6 Tingling increased. Take 300/300/600 of Gabapentin. Leg strength improved. 5/7 - 5/9 Small improvements in leg strength and tingling. Determined PT and OT are not required. 5/10 Discharged to continue Gabapentin at home. 5/13 Tingling decreased slightly. Took Gabapentin 300/300/300 5/17 Still some tingling
I got the shingles  approximately 5 days after the moderna booster. I was given Acyclovir, Lidocaine Ointment,  Hydrocodone/Aminophen Oral.
Patient received first dose of Moderna COVID-19 vaccine on 2/3/21.  Primary Care physician received call from coroner's office 2/8/21 asking for information contributing to cause of death.  Per Primary Care Physician notes, wife states she and patient took turns shoveling snow on 2/4/21.  On one trip back into the house she found him unresponsive on the floor and called 911.  Paramedics were unable to revive patient and he passed away (2/4/21).
covid rebound; covid rebound; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 08Nov2021 at 11:00 as dose 3 [booster], single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "lung infections/inflammation" (unspecified if ongoing), notes: Frequent (multiple times per year) lung infections/inflammation for ~2 decades. The patient's concomitant medications were not reported. Past drug history included: None, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccination (Primary immunization series complete, manufacturer unknown.), for Covid-19 immunization.  The following information was reported: COVID-19 (medically significant) with onset 15Apr2022, outcome "not recovered", DRUG INEFFECTIVE (medically significant) with onset 15Apr2022, outcome "unknown" and all described as "covid rebound". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (14Apr2022) Negative; (15Apr2022) positive, notes: strong positive antigen test. Therapeutic measures were taken as a result of covid-19.  Clinical course: covid rebound. The patient reported that on 14Apr2022 he had a negative antigen test. On 15Apr2022 he had a strong positive antigen test and became symptomatic with moderate nasal congestion, chest congestion, fatigue, and the beginning of fluid in lungs. Symptoms worsened rapidly over the course of the day. He started taking paxlovid that day and took the full course of medication. By the next day, symptoms stabilized and the following he was much improved. The only initial side effect was a strong bad/metallic taste. After finishing the full course, he still had a weak positive band by antigen test on Day 5. On day 7, he tested negative and again 2 days later he tested negative, with all symptoms resolved. On day 10, he returned to work. On day 12 (yesterday) he began to feel unwell again, with severe nasal congestion and mild chest congestion, GI symptoms, and fatigue. Last night, he took another antigen test and it was very strongly positive, higher even than the first time around. The patient received Anti-viral therapy for COVID 19. Treatment start date was on 15Apr2022 and treatment stop date on 19Apr2022.  This is a follow-up spontaneous report from a Product Quality Group providing investigation results: Updated information included: Product note 'Batch and lot tested and found within specifications' checked. This is a notification generated from the system. New/updated information pertaining to an AE was reported to PQC.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a physician, via a company representative, concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 30-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2016, 0.5 ml (route and anatomical location of administration were not reported). On unspecified dates, the PNEUMOVAX 23 had five temperature excursions of 0 Celsius Degrees (32 Fahrenheit) for 144 hours, 0.55 Celsius Degrees (33 Fahrenheit) for 128 hours, -1.11 Celsius Degrees (30 Fahrenheit) for 264 hours, -1.66 Celsius Degrees (29 Fahrenheit) for 256 hours, and -0.55 Celsius Degrees (31 Fahrenheit) for 344 hours, respectively. The vaccine status was reported as "in excursion" and the type of excursion and storage criteria were reported as "refrigerator (R)". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
INJECTION SITE PAIN; HEADACHE; TIREDNESS; SORE TO TOUCH; This spontaneous report received from a consumer concerned a 49 year old male. The patient's height, and weight were not reported. The patient's past medical history included stroke, and concurrent conditions included high blood pressure, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022) .5 ml, administered on 05-MAR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced injection site pain. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced tiredness. On 06-MAR-2021, the subject experienced sore to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain, headache, tiredness, and sore to touch. This report was non-serious.
Received Influenza vaccine either same day or day prior to first ever seizure.  Record of the type not available at this time.
Patient presented the next day with painful and cold left hand and forearm.  It began the night of the vaccine and continued ot worsen until she presented to the office on the afternoon of May 6, 2008.  She was referred to the emergency room for further evaluation of the vascular system.
Staring approx 10 Pm itching to back/ chest/ bottom of feet- when awoke at 3am seems to have disappeared  8am started fevers, tired, fevers lasted until aprox 8pm,  had no energy all Day
This case was reported by a nurse via call center representative and described the occurrence of regurgitation of medication in a 4-month-old female patient who received ROTARIX lyophilized formulation (batch number 23K4J, expiry date 14th October 2019) for prophylaxis. On 14th September 2018, the patient received the 2nd dose of ROTARIX lyophilized formulation (oral). On 14th September 2018, immediately after receiving ROTARIX lyophilized formulation, the patient experienced regurgitation of medication, vomiting and accidental underdose. On an unknown date, the outcome of the regurgitation of medication, vomiting and accidental underdose were unknown. It was unknown if the reporter considered the regurgitation of medication and vomiting to be related to ROTARIX lyophilized formulation. Additional details were provided as follows: The healthcare professional (HCP) reported that while administering the ROTARIX to the patient spit out some of the medication. The reporter stated that, they had to cancel the revaccination as the patient was spitting out the medication and vomiting. No side effects were reported.
Tiredness; Discomfort at jab site; This is a spontaneous report from a contactable other HCP received via a sales representative. A 16-years-old male patient received BNT162B2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tiredness and discomfort at jab site on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Began experiencing swelling, redness, and fever starting early afternoon on 10/25/17. Called local doctor's office on 10/26/17 at end of day, and because they did not have any appointments, she went to the ER. Symptoms include temp of 102.5, achy, extreme swelling, redness and itching at injection site. Patient was given IV fluids, IV antibiotic, and sent home on oral antibiotic of KEFLEX. Diagnosis was cellulitis.
Stomach cramps and diarrhea,  Came on suddenly and lasted around 12 hours (about 4 to 5 acute episodes during time period)
My son told me several days later that he had some chest pains described as shooting pains the day after vaccine dose #2
Days 1-2: fast heart rate, difficulty breathing, asthma attack requiring inhaler, muscle weakness.  Days 4+: rash at injection site - size of a dime
Approximately 11 days after vaccination had burning feeling all over body (Similar to reaction of taking sulfa antibiotic). This continued for 5 or 6 days.  I took Zyrtec and Benadryl for 5 days.  Symptom stopped on April 1, 2021.  On April 2, 2021 I was extremely dizzy, nauseous, severe headache, and heart palpitations.  This continued all day.  I contacted my physician and had an appointment.  She instructed me to go to urgent care she was afraid I was having a stroke.  I went to urgent care heart palpitations had stopped. My  BP 128/75, Pulse 83, Oxygen 97%.  They then performed a Rapid Covid test which came back inconclusive.
vials were stored in the refrigerator and thawed on same day of administration; Doses were administered after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date) and PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date) and PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient's weight was reported as 254. The patient had received booster one dose. No concomitant medications were reported. It was reported that the Vials was thawed on the same day of vaccine administration date. It was reported that vial did not undergo any temperature excursion. It was reported that patient had no known reaction in the office after receiving the dose. No treatment medications were reported.
Pt was given Moderna for 1st dose, Pfizer for second. No adverse reaction reported.
blood pressure reaching 212/147 normally 108/60; Fever; migraine headache; rapid heartbeat; nausea; not hungry; coughing; sore throat; swollen neck and lymph nodes; looks like strep in the back of my throat; loss of voice; pain in kidneys; confusion; loss of balance when standing; swollen neck and lymph nodes; This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old female patient (not pregnant) received the second dose of BNT162B2 via an unspecified route of administration on the left arm on 30Jul2021 at 19:00 at the age of 32-year-old as single dose for COVID-19 immunization. Medical history included Type 1 juvenile diabetes and morphine allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included insulin taken for type 1 juvenile diabetes. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 08Jul2021 at 05:00 PM at the age of 32-year-old as single dose for COVID-19 immunization. The patient previously taken morphine on an unspecified date and experienced known allergies. On 31Jul2021 at 07:00 am, the patient experienced fever, migraine headache, rapid heartbeat and blood pressure reaching 212/147 (normally 108/60), nausea, not hungry, coughing, sore throat, swollen neck and lymph nodes, looks like strep in the back of my throat, loss of voice, pain in kidneys, confusion and loss of balance when standing. No treatment was received. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sore arm for about 36 hours; On the 31st of December at 1:00 in pm. 100- 101.1 - fever and aches and chills for about 24 hours. I felt like I had a pressure/sinus headache. Got tested on Jan 2 - COVID negative; January 3 Urgent care - Doxycycline for 10 days. Took about two days on antibiotic and then I was fine.
Information has been received from a health professional concerning a patient with reactive airways disease and a history of rhinitis allergic and otitis media chronic who on 25-AUG-2004 was vaccinated with VARIVAX (Oka/Merck) SQ (Lot # 646363/0574N). On 05-NOV-2005 the patient experienced zoster on chest and abdomen. The patient was treated with OMNICEF 250 mg daily, ZOVIRAX 200 mg, and RONDEX DM. On 08-MAY-2008, the patient was vaccinated with the second dose of VARIVAX (Oka/Merck) (Lot # 656819/0172U). Concomitant therapy included TRIPEDIA (Lot # C2569AA). Additional information has been requested.
This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns an 82-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD TIV vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 25-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250802, expiry date, route of administration, anatomical location and dose: not reported]. At the time of this report, no adverse event was reported. This case 201805534 was crossed linked to original case 201804863 due to same reporter.
weight gain, peripheral edema, heart palpitations, fatigue, difficulty breathing, chest pain, cough, dizziness, elevated blood pressure, headache,
Day after vaccine, heart beating fast, chest hurt, back aches, headache, dizzy, difficulty breathing.   Lasted all day.  2nd day after shot- no symptoms.   Theses side effects aren?t told To you at the time of shot.  Should be a warning.
Started with what seemed to be a local reaction:  1. Local reaction, swollen arm, swollen lymph nodes, pain in injection point, armpit pain and swelling. My arm had gone numb from my shoulder to my fingers that morning. On the 26th (4 days following the flu shot) I went to my PCM provider complaining of pain in my armpit, breasts/chest, swollen lymph nodes.  This continued for a couple of weeks and subsided for a week. Week of 12/13, the pain returned and started resignating again in both arms, the chest, breasts, back of neck/back/shoulders. I feel stiffness in my neck, shoulders back, in the back of my skull. The pain in my breasts is aching and shooting pains.
My left arm was swollen, firm, red and sore for 2 weeks.  I had a large red mark on my arm at the injection site.  For 2 days, I could barely get out of bed.  Had fever, chills, headache, dizziness, and could barely stay awake.  It was like the worst case of flu.
Left arm red and swollen near injection site. Diagnosed with cellulitis and given Benadryl and Keflex 10 day course
Nausea Low grade fever Headache Weakness Malaise Received Shingrix injection around 1pm on 7/3/2019 Around 9pm began having a headache. Throughout the night, headache worsened and low grade fever / chills began. By morning, experienced weakness, nausea, body aches, etc Symptoms lasted approx 36-48 hr.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N002336 with expiry date 19-JUL-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
This spontaneous report was received from a licensed practical nurse concerning a 68 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-NOV-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 injection, lot number N024384, expiration date 18-MAY-2019 (strength, dose and route were not reported) for prophylaxis. On the same date, after vaccination, the patient had a red, swollen right arm near injection site and down the right arm. At the time of the report, the outcome of the event was unknown. The causality between the events and the PNEUMOVAX 23 was not reported. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1711USA013931.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 34 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Patient reported new onset redness, pain, and decreased range of motion in his right upper extremity after receiving Pneumococcal vaccine at 0801 on 1/24/2013. On 01/25/13, the medical team was notified and they started oral Clindamycin due to redness, edema and erythema in the RUE.
Chills Narrative:  Patient reported itching and dizziness as well as some chills after receiving the vaccine. Pt took two benadry capsules the next day all ae's were resolved.
This spontaneous report was received from a pharmacist and refers to a 25-year-old (discrepant information also reported as "23") male patient. Information about medical history, drug reactions, allergies or concomitant medications were not provided. On 26-JAN-2019, the patient was vaccinated with VARIVAX 0.5 mL, by intramuscular route, in the left arm, for prophylaxis, lot # R011809 and expiration date 23-APR-2020. The patient had not reported any other issues.
Case number PHEH2014US017320 is an initial spontaneous report received from a health care professional on 22 Aug 2014. This report refers to a 12 years old male patient. His medical history and concomitant medications were not reported. His vaccination status was reported as up to date. He was vaccinated with initial dose of MENVEO (batch number: not reported) at a dose of 0.5 ml intramuscularly in the right deltoid on 22 Jul 2014 at 10:36. It was reported that 18 to 24 hours after vaccination, on 22 Jul 2014, he experienced red and edematous area at the vaccination (site). It was reported that the patient was diagnosed with a vaccine reaction. The events outcome was reported as complete recovery on 26 Jul 2014. The seriousness and causality were not reported.
Information has been received from a female healthcare worker for GARDASIL, a Pregnancy Registry Product, reporting on herself, who in 2006, was vaccinated with GARDASIL (dose, route and lot number were not reported). The reporter stated that the patient had a normal Pap screening test, on an unspecified date, after receiving GARDASIL, but she was also reporting that the last Pap screening test she had was abnormal. The result indicated a precursor for cervical cancer. There was no treatment given, the Pap result will be rechecked at a later unspecified date. It was reported that the patient was pregnant. Her last menstrual period was in June, 2011 and she was due to deliver in 8 weeks, estimated delivery date was 19-MAR-2012. The patient sought medical attention, an office visit. Follow up information has been received from the healthcare worker who reported that "to her knowledge", the patient had given birth to a healthy baby. Additional information is not expected.
First, painful, hot arm; difficult to lift. Then by 9:00 PM, chills and fever. Next day fever peaked at 103.4 degrees with severe joint pain; fever subsided but did not return to normal until 2/6/14. Took Naproxen, applied ice and silver gel.
pt recv vax JUL95 & was found to be pregnant (LMP 20DEC95); estimated date of conception 2JAN96;Lab eval revealed that the pt was seronegative for varicella;No further details were provided
Information has been received from a physician concerning a 12 year old female patient who on 15-MAY-2009 was vaccinated with the first dose of GARDASIL and on 27-JUL-2009 was vaccinated with the second dose of GARDASIL (lot # not reported) and then ended up in the ER (name and location of hospital were unknown) on 02-AUG-2009 with lymphadenopathy. The patient discontinued the GARDASIL vaccine series and not reintroduced. The patient was not admitted to the hospital. At the time of reporting, the outcome of the patient was unknown. Additional information has been requested.