chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner concerning unspecified number of patients of unknown age and gender. Patients' medical history and concurrent conditions were not reported. Between 06-APR-2015 and 30-APR-2015, unspecified number of patients were vaccinated with a dose of improperly stored VARIVAX (Merck) (dose, lot# and route were not reported). No adverse effects were reported. Follow up information has been received from a receptionist during a phone call on 02-JUN-2015. The reporter could not supply patient identifiers, lot numbers or dates of vaccination. Follow up information was received on 15-JUN-2015 from a nurse practitioner. The reporter provided the names, dates and lot numbers with expiration dates of the patients who received VARIVAX (Merck) which was incorrectly stored. A total of 22 patients received the improperly stored vaccine between the dates of 06-APR-2015 and 30-APR-2015. On 09-APR-2015, a male patient of unknown age received VARIVAX (Merck) (lot number K018963, expiration date 15-OCT-2016). The vaccine was reported as improperly stored. No adverse event was reported. Follow up information was received on 16-JUN-2015 from a nurse practitioner. Multiple patients received the VARIVAX (Merck) vaccine which was exposed to higher than normal temperature. All vaccines were completed before the date required by the manufacturer. As of 16-JUN-2015, no vaccines were left from the event. Additional information has been requested.
Patient complained to her daughter since getting the Booster Shot on 8-23-21 of joint pain, neck pain and pain in her arm. When the daughter took the patient to a primary doctors visit on 10-8-21, the patient informed the primary doctor that she had been having pain in her arm and chest. During the office visit the Doctor, performed an ECG in the office. The Doctor was immediately concerned due to sinus rhythm (rapid) with right axis deviation. The Doctor instructed the daughter to take the patient to the Emergency Room.  At the Emergency room the patient was given another ECG. The diagnosis was Sinus Tachycardia, possible Left Atrial Enlargement, Rightward Axis, Incomplete Right Bundle Branch Block, Septal Infarct, Age Undetermined, Abnormal ECG when compared with ECG 7-22-21 Vent Rate has increased by 38 BPM, Incomplete Right Bundle Branch Block is Now Present, Septal Infract is Now Present. Patient has NEVER been diagnosed with COVID and ECG was abnormal AFTER the Booster Shot compared to a prior ECG. NT Pro NT Pro BNP High at 499.4 In addition, the family has noticed a significant increase in neurological issues starting after the Booster Shot and was seen by a Neurologist in 2022. Officially, diagnosed with Alzheimer?s Dementia in October 2022.
injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 25th September 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient.  The patient received Shingrix in left arm.  After receiving Shingrix, the patient had left arm injection site pain that resolved after about 3 days. The reporter consented to follow up. For tolerance of 2nd occurrence, refer case US2021AMR223285.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR223285:same reporter
pain like someone is jabbing my back; acute kidney pain; swollen right arm; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (pain like someone is jabbing my back), RENAL PAIN (acute kidney pain), PERIPHERAL SWELLING (swollen right arm) and PYREXIA (Feverish) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A and 013F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (pain like someone is jabbing my back), RENAL PAIN (acute kidney pain), PERIPHERAL SWELLING (swollen right arm) and PYREXIA (Feverish). At the time of the report, BACK PAIN (pain like someone is jabbing my back) had not resolved and RENAL PAIN (acute kidney pain), PERIPHERAL SWELLING (swollen right arm) and PYREXIA (Feverish) outcome was unknown.            No Concomitant medications were provided by the reporter. No Treatment information was reported.
PATIENT ARRIVED AT CLINIC AT 1:20 PM.  PT RECEIVED VACCINE AT 1:23 PM.  WHILE PATIENT WAS IN THE OBSERVATION AREA, HE WAS SPEAKING TO MY REGISTRATION SUPPORT ADVISING HE FELT DIZZY.  AS I WENT TO GRAB AN ICE PACK, HE FELL OUT OF HIS CHAIR AND ONTO THE FLOOR.  PT FELL ONTO THE FLOOR PRONE AT 1:26 PM.  PATIENT WAS UNCONSCIOUS AND UNRESPONSIVE FROM 1:26 PM 1:28 PM.  PARAMEDICS WERE CALLED AT 1:27 PM.  PATIENTS BP WAS 190/120 AT 1:28 PM.  PATIENT WAS PLACED IN TRENDELENBURG POSITION WITH HIS FEET PROPPED UP BY A CHAIR.  ICE PACK WAS PLACED ON PATIENTS FACE AT 1:28 PM.  PATIENT BECAUSE ALERT AT 1:28 PM BUT WAS NOT ORIENTED TO NAME, TIME OR PLACE.  AT 1:32 PM, PT WAS MORE ALERT AND ORIENTED TO NAME.  PARAMEDICS ARRIVED AT AND TOOK OVER ASSESSMENTS AT 1:47 PM.  PT HAD ANOTHER VASOVAGAL RESPONSE.  PARAMEDICS THEN TRANSPORTED PT TO HOSPITAL.
gastroparesis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A 34 year-old male patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The patient developed gastroparesis 10 days later his second vaccination. The gastroparesis has become more manageable over the past few months. The following information was reported: IMPAIRED GASTRIC EMPTYING (medically significant) with onset 2021, outcome "unknown", described as "gastroparesis". The lot number for bnt162b2 was not provided and will be requested during follow up.
Chest pains; Shortness of breath; Back pains; Arm pains; This is a spontaneous report received from a non-contactable consumer, the patient. A female patient of unspecified age received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 18Mar2021 at 16:15, as a single dose for COVID-19 immunisation. Medical history included penicillin allergy (PCN). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 20:00, the patient experienced chest pains, shortness of breath, back pains and arm pains. The adverse events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events and included treatment with ibuprofen (MANUFACTURER UNKNOWN) and PEPCID. The clinical outcome of the events chest pains, shortness of breath, back pains and arm pains were resolving at the time of this report.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
I went to the Pharmacy to get my 4th Covid Shot. I waited for 15 minutes.  I went home was a little tired but it subsided. Then 10 days later I started feeling bad. I had a stomach pain thought I was constipated.  The next day I was extremely fatigue went to bed and slept for 14 hrs. Woke up the next day continue with my stomach ache went to the bathroom several times and the last night that I went to the restroom I started having blood clots.  I continued with the stomach ache and went back to bed. I slept off and on between the night with cramping.  The next days got up early went to the restroom and continue passing blood clots at that point  I went to the hospital. I was hospitalized for 5 days and was diagnosed with Ischemic Colitis.   I am home but still not recovered completely.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: vasovagal reacion-Mild
Patient complained that her arm started hurting about 1 hour after receiving the vaccination.  It got worse over time and often runs down her arm into her hand and her whole arm is EXTREMELY  painful. She was very upset and wanted this reported, even though I mentioned that arm pain, joint pain was listed as a known side effect.  She was concerned that the pain increase, leveled off and then has never gone away.  It leveled off about 5 days after the shot, but has never gotten better.  She can not take NSAIDS and doesn't want to take any medications at all.
This case was reported by a consumer via sales rep and described the occurrence of groggy in a 66-year-old male patient who received SHINGRIX for prophylaxis. On 14th June 2018, the patient received SHINGRIX. On 15th June 2018, 1 days after receiving SHINGRIX, the patient experienced groggy. On 18th June 2018, the patient experienced common cold and sore throat. On 21st June 2018, the patient experienced cough, fever and mucus discharge. The patient was treated with levofloxacin and MUCINEX DM. On an unknown date, the outcome of the groggy, common cold and sore throat were unknown and the outcome of the cough and mucus discharge were recovering/resolving and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the groggy, common cold, sore throat, cough, fever and mucus discharge to be related to SHINGRIX. Additional details were provided as follows: On 14th June 2018, the patient received SHINGRIX about the noon time. 4 days after receiving SHINGRIX, the patient experienced cold symptoms and sore throat. 7 days after receiving SHINGRIX, the symptoms were worsened and the patient also experienced cough, cold symptom increase with discharge from coughing, groggy. The patient's body temperature was recorded as 99.4 to 99.9 degree F. On 22nd June 2018, the symptoms were worsened with uncontrollable coughing along with body temperature was up 100.4 degree F and on the same day, the patient called doctor to cure symptoms. On 23rd June 2018, the patient's body temperature was recessed and coughing reduced but still not normal.
Woke up with unpleasant taste in mouth/mucus.  Became aware that I could not smell coffee, etc.  This continued through day; the onset was sudden and while I have managed to get used to having no taste or smell ability to this day, it was rapid--from one day to the next--and as I say it continues to this day.  Notified primary care Dr. at time.  She stated she had never heard of this kind of condition but I contacted her again when I heard Corona 19 symptom.  She reminded me it was well before the Corona outbreak.  I have family living in country, and have traveled for last three years in country and country.
Patient received an expired dose of ActHIB that expired on 3/5/2023. There have been no adverse events until this point.
During injection into right deltoid, needle detached from syringe and greater than half the vaccine squirted out of syringe onto the floor and patient's arm.  Cleaned patient, monitored for reaction, and read through CDC site about  partial doses given. Discussed CDC recommendation of given vaccine again to patient in left deltoid. Patient agreeable and second attempt of first dose of vaccine given immediately. monitored for 15 minutes. No signs or symptoms of reaction.
sores on tongue; sores on tongue and inside mouth; lips feel numb; This spontaneous case was reported by a consumer and describes the occurrence of GLOSSODYNIA (sores on tongue), STOMATITIS (sores on tongue and inside mouth) and HYPOAESTHESIA ORAL (lips feel numb) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GLOSSODYNIA (sores on tongue), STOMATITIS (sores on tongue and inside mouth) and HYPOAESTHESIA ORAL (lips feel numb). At the time of the report, GLOSSODYNIA (sores on tongue), STOMATITIS (sores on tongue and inside mouth) and HYPOAESTHESIA ORAL (lips feel numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information were provided. No treatment information were provided.
Rash began one week after the vaccine was administered.  Left deltoid, same location that vaccine was given.  Related itching but no pain.  Examined approximately 18 hrs into the rash -- "mildly erythematous coalescing papule.  Total surface area 2 cm x 1.5 cm.  No significant warmth, non tender."  Not consistent with cellulitis.
About 1.5 hrs post vax, pt became shaky with trembling hands and complained of headache and nausea. Temp was 103.5. Pt remained febrile until 1 AM after being medicated with Tylenol. As of 5/30/01, pt had no problems.
really sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (really sick). At the time of the report, ILLNESS (really sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
5.5X2.5 inch area of induration, eurythmic and warm (R) deltoid.
12 hours after the vaccine  I felt shortness  of breath. Then I developed  a large lump on my collar bone area. I still can't breathe  right and get winded very easily.; 12 hours after the vaccine  I felt shortness  of breath. Then I developed  a large lump on my collar bone area. I still can't breathe  right and get winded very easily.; 12 hours after the vaccine  I felt shortness  of breath. Then I developed  a large lump on my collar bone area. I still can't breathe  right and get winded very easily.; This is a spontaneous report from contactable consumer (patient). A 49-years-old non-pregnant female patient received  bnt162b2 (BNT162B2, Solution for injection, Lot Number: ER8734, expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 31Mar2021 14:30 (at the age of 49-year-old) as Dose 2, Single for covid-19 immunization. The patients historical vaccine included first dose of BNT162B2 (lot number = EN6204) via an unspecified route of administration, administered in Arm Left on 10Mar2021 12:30 as Dose 1, Single for Covid-19 immunization. Medical history included Gastric sleeved and Known allergies: Penicillin. Concomitant medications included Oxycodone, Ambien, Trazadone, and Vitamins. It was reported that patient was not taken any other vaccine in four weeks. The patient had not covid prior to vaccination. On 01Apr2021 01:00, the patient experienced 12 hours after the vaccine I felt shortness of breath. then I developed a large lump on my collar bone area. I still can not breathe right and get winded very easily. The patient received Steriods and an inhaler, still being treated as therapy for the events. The patient underwent lab tests and procedures which included sars-cov-2 test which was negative   on 06May2021 on Nasal Swab. The patient was not recovered from the events.  No follow-up attempts were possible. No further information was expected.
started feeling  a little nauseous and dizzy about 5 hours after shot.  The next morning woke up feeling incredibly nauseous and dizzy.  Had to sit in my shower and then going  up stairs several times.  Later that day I began to have entire body aches making it feel like I'd been hit by a truck.  Around 10PM or so the symptoms seemed to start subsiding.  Still feeling out of it and easily drained this morning but doing much better.  I took Dramamine around 4PM that seemed to really help with my nauseous and dizzy symptoms and slept a lot.
Client vaccinated with Janssen COVID vaccine at 9:50 without incident.  Known severe allergies to banana.  15 minutes later when he was about to leave area he complained of his throat itching and was making loud, hoarse raspy breathing sound and rubbing his left hear. He was unable to speak a complete, clear sentence.  NP listened to his lungs.  Lungs clear and okayed administration of IM Benadryl which was given by charge nurse.  Within 2 -3 minutes felt fine, quit horsey noise and could talk again.  Left area and went back at 10:45 am.  1:45 pm - visited patient again who felt fine except for being tired and having a sore arm.
This case was reported by a consumer via call center representative and described the occurrence of rectal bleeding in a 45-year-old female patient who received FLUARIX QUADRIVALENT (batch number 2XR43, expiry date 30th June 2016). Concomitant products included Prenatal Vitamin. On 3rd March 2016, the patient received FLUARIX QUADRIVALENT (intramuscular). On 4th March 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain, sinus congestion, ringing in ears, sinus pain, productive cough, ear pain, feeling unwell and influenza. In March 2016, the patient experienced rectal bleeding (serious criteria GSK medically significant). On an unknown date, the patient experienced breastfeeding. In March 2016, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the rectal bleeding, sinus congestion, ringing in ears, sinus pain, productive cough and feeling unwell were not recovered/not resolved and the outcome of the ear pain, influenza and breastfeeding were unknown. The reporter considered the rectal bleeding, injection site pain, sinus congestion, ringing in ears, sinus pain, productive cough and ear pain to be related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the feeling unwell and influenza to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient was breastfeeding at the time of vaccination. The next day after vaccination, the patient experienced pain at the injection site (left arm), but also felt sick like she had the flu. The patient had severe sinus congestion and a heavy productive cough. Her ears hurt and ring. In March 2016, less than a month after vaccination, the patient experienced rectal bleeding, which she felt was due to the violent coughing she was experiencing. At the time of reporting, the patient was experiencing all of these respiratory symptoms.
CHILD WAS VACCINATED ON 11/10/09 WITH POLIO, HEP B, DTAP, AND PNEUMOCOCCAL.  PATIENT BECAME UNUSUALLY FUSSY AND OUT OF CHARACTER.  SHE PREFERRED TO CRAWL INSTEAD OF WALK.  DEVELOPED LOW GRADE FEVER, CRIED OFF AND ON ALL NIGHT AS WAS RESTLESS.  GRANDMOTHER CALLED POSION CONTROL HOTLINE BECAUSE DOCTOR'S OFFICE WAS CLOSED. PATIENT WORSENED THURS AND FRIDAY SO GRANDMOTHER TOOK HER TO PRIVATE DOCTOR.  DR. FELT THAT PNEUMOCOCCAL VACCINE WAS CAUSING PATIENT'S JOINT PAIN.  PATIENT HAS BEEN IN HIS CARE SINCE SHE WAS 5 MONTHS OLD.  PATIENT HAD IMMUNE SYSTEM ISSUES AT BIRTH WITH LOW PLATELET COUNT.  DOCTOR HELD OFF IMMUNIZATIONS UNTIL JUNE 2007 DUE TO LOW WEIGHT ISSUES.  DOCTOR FELT PATIENT SHOULD NOT HAVE 4 SHOTS SIMULTANEOUSLY AGAIN.
Lip swelling Narrative: Patient's spouse called to report patient developed lip swelling 4 days after receiving his 1st COVID vaccine (Pfizer) on 3/16. He was evaluated at ER and discharged home the same day. No information on ER visit at time of writing.
minor pain in the arm; little tired; bloating; diarrhea 3 times last night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (minor pain in the arm), FATIGUE (little tired), ABDOMINAL DISTENSION (bloating) and DIARRHOEA (diarrhea 3 times last night) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (minor pain in the arm), FATIGUE (little tired), ABDOMINAL DISTENSION (bloating) and DIARRHOEA (diarrhea 3 times last night). At the time of the report, PAIN IN EXTREMITY (minor pain in the arm), FATIGUE (little tired), ABDOMINAL DISTENSION (bloating) and DIARRHOEA (diarrhea 3 times last night) outcome was unknown. Not Provided          No relevant concomitant medication was reported.  Treatment details include, loperamide.   Reporter did not allow further contact
Pt developed edema and erythema around R eye and anterior lower neck. She was reported to be "acting hyper ten times her usual self" at dinner at home. Seen in clinic at 6:30pm that evening. Was calm and cooperative but had swelling as reported. Received Benadryl x 1. Was monitored x 30 mins with improvement of erythema and edema.
on date of injection @6pm itchy eyes,  cough, headache arm swelling.  Next am ( 12/30) tremulousness in am , did not sleep. 12/31 symptoms abated. Took neurontin and motrin for symptoms on 12/29 and 12/30/2020
48 hours after receiving the second dose of Pfizer vaccine, I developed terrible nausea, which still persists today. In addition, I developed lactose intolerance, which also persists. I saw my GI doctor, who suggested stopping all vitamins, which I did and there was no difference. I had an endoscopy which was normal. The nausea has gotten better but has not gone away. Still lactose tolerant, to the point of vomiting after ingestion of small amount of dairy.
20FEB93 started w/tingling, redness & blotching of neck; had fever but did not take temp; 21FEB93 numbness of lt arm & leg; 24FEB93 went to ER-was told had Bell's Palsy-was given B12 shot & sent home-pvt MD out of town; 1MAR93 poss GBS;
Mild increase in temperature between the evening of 01/24/2011 and 01/26/2011. Increased fever on 01/27/2011 @ 101F (identified on 7:00PM). Continuous fever of 101F-101.5 on 01/27/2011 - 01/28/2011. Fever increased 101.8 on 01/29/2011 at 7:00 AM. Fever further increased up to 103.8 F on 01/29/2011 while Tylenol was given every 5 hrs, and in the afternoon (and further) 6:00 PM Motrin was given (every 7 hrs) as per physician's recommendation. Fever remained at 103.3 up to 01/30/2011 (7:00 AM). Throughout the day Tylenol/Motrin were given as per recommendation of the physician and fever stayed at 102.2. By midnight 01/31/2011 temperature returned to normal.