chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable nurse. This nurse reported similar events for 15 patients. This is the 14th of 15 reports.  A patient of an unspecified age, gender and race/ethnicity received PREVNAR 13 (lot number N4385, expiry date 31Oct2017) via an unspecified route of administration, on an unspecified date, at single dose, for immunization.  The patient medical history and concomitant medications were not reported. The patient received the vaccine after temperature excursion and experienced severe reaction on arm on an unspecified date, with unknown outcome.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017060849 Same reporter, product, event, different patient.
Sore arm; stomach pains; diarrhea; This is a spontaneous report from a contactable consumer (patient herself). A 75-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number EM9809), via an unspecified route of administration, administered in Arm Left on 23Feb2021 11:15 (at the age of 75 years old ) as dose 2, single , Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for Covid -19 immunization. Medical history included atrial fibrillation. There were no concomitant medications. The patient did not have any known allergies. The patient did not receive any other vaccine in last 4 weeks. The patient did not have COVID prior to vaccination. The was not tested for COVID after the vaccination. The patient was not pregnant at the time of vaccination. On unspecified date the patient experienced sore arm, stomach pains, diarrhea. The patient did not receive any treatment for the adverse events. The outcome of the events was recovering.   Follow-up attempts completed. No further information expected.
Tunnel vision, vomiting, chills, cold sweats, and very close to fainting. These effects occurred at 3AM the morning after the second dose was administered.  Nausea, lack of appetite, arm soreness and fatigue continued through the day. Fatigue continued the day after but the effects seem to be wearing off.
FATHER REPORTS CHILD DEVELOPED MIDABDOMINAL PAIN, DIARRHEA, AND VOMITED ONCE STARTING 1/23/09.  IT BECAME INCREASINGLY WORSE AND SHE BECAME PALE ON 1/25/09.  PARENTS TOOK HER TO THE EMERGENCY ROOM AND SHE WAS GIVEN IV FLUIDS, BLOOD TESTS, AND URINE TESTS.  ALL TESTS WERE NORMAL. FATHER IS CONCERNED AS HE BELIEVES IT IS RELATED TO THE GARDISIL VACCINE. 2/23/09 Received ER medical records of 2/1/2009. FINAL DX: gastroenteritis Records reveal patient experienced nausea, vomiting, diarrhea, abdominal pain, fever, oral intake reduced, urinary frequency, dysuria, eye drainage, SOB, increased heart rate, weakness x 3 days.  Patient had similar experience after initial HPV vaccine.  Tx w/antinausea meds & IVF.  Improved & d/c to home.  2/26/09 Received PCP medical records of 8/30/07-12/8/08. FINAL DX: epigastric pain, likely gastritis Records reveal patient experienced abdominal pain intermittently x several months when seen 12/3, 12/7 & 12/8/2008.  Tx w/meds.
The pt experienced a swollen, tender right deltoid within 4 hours of the vax. This was followed by an episode of vomiting starting at 4 hours and into the next morning for 3 times. The pt experienced a watery diarrhea and nasal congestion. All symptoms were mild.
I had a positive test for Covid on 6/28/2022; very mild; took Paxlovid; negative test on day 6.
Patient diagnosed with COVID-19 on 3/2/2021 and patient hospitalized on 3/5/2021.  The patient completed the 2 dose Pfizer Covid19 vaccine series on 2/3/2021
Patient received 2 dose series in 2020. Patient came in for a flu shot. Patient was accidentally administered a Shingrix shot. This is the 3rd Shingrix patient has received and was unnecessary.
Unwitnessed seizure-like activity. Father reports that after vaccines were administered and pt was sitting in the car about to leave she c/o "feeling nauseous". Father reports that immediately her eyes opened widely and she seemed as if she was not there. Father says that one leg was extended and stiff and her arms were pulled into her chest with stiffness and jerking. Father was touching pts face and asking if she was okay but was "unresponsive". Child's lips were pale and white. Father estimates this episode lasted 5-7 seconds. Afterwards pt did not seem to know what had happened. Patient reports that she remembers saying she was feeling nauseous and then "blacked out". Pt was brought back into the clinic withing 5 minutes of episode and was very pale appearing. Pt was laid down on exam table. VS re-taken and pt was offered juice. All VS stable and pt reported that she felt okay. Father asked if an ambulance needed to be called and I told him that this was most likely a vasovagal syncopal episode but that a EEG would be ordered to evaluate for seizures. Father would like to take child to ER to have more testing done.
Patient describes sharp pain in shoulder with rotation of arm and limitation in range of motion of arm and shoulder due to pain.
After receiving the vaccine, I had a fever. The fever didn't go away after 3 days. The fever was high.  I was shaking and my fever went up to 103.5 degrees. On Sunday I couldn't even move. I didn't have a cough. I just had a fever, headache, body ache, chills, and nausea. On the first day I couldn't hardly walk. It was in the middle of the day, and I was shaking. My fever was so high, so I took 1000mg of Tylenol. My fever went down to 99 degrees then after a couple hours it went back up. I went to the urgent care on Friday night on 12/10/2021. They prescribed me Ibuprofen 800mg and Zofran 4mg. On 12/13/2021 I went to the ER. I was diagnosed with a UTI. I was prescribed an antibiotic for it which was cephalexin 500mg.
The evening of the flu shot, noticed raised lesions that resemble hives, vesicle fluid filled, itched-broke out on arms, chest- injection site- no lesions noted- no fever noted - lesion scarred in two days.
This case was reported by a consumer and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 1st June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st June 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and injection site erythema. On an unknown date, the outcome of the pain in arm and injection site erythema were recovered/resolved. It was unknown if the reporter considered the pain in arm and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The reporter reported that, her arm was extremely painful after the injection. It was painful enough to wake her up if she rolled on it when sleeping. The patient also had some redness at the injection site. The pain finally resolved after about 1 week. Caller stated that, her pharmacist called and spoke with GlaxoSmithKline about her reaction, however, no duplicate case could be found.
pt recvd 3 doses of Engerix-B vax & never seroconverted; also had elevated enzymes SGOT; no other info is available;
redness near injection site; swelling near injection site; itchy sensation near the injection site; A regulatory authority report was received from a non-health care professional concerning 66-year-old, female patient who received Moderna's COVID-19 Vaccine (m-RNA-1273) and experienced redness, swelling, itchy sensation at injection site.   The patient medical history was not reported. Concomitant medication was not reported. Laboratory data were not provided.  On 13-Jan-2021, prior to the onset events, the patient received their first dose of mRNA-1273 [lot/batch: 026L20A] intramuscular in left upper arm for prophylaxis of Covid-19 infection.  On 19-Jan-2021 The patient experienced redness, swelling, itchy sensation near injection site. The patient reported that these symptoms have seemed to lessen on 22-JAN-2021. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the experienced events redness, swelling, itchy sensation near injection site was unknown.
This infant received his 1st dose of Prevnar on 01/18/01. He contracted pneumococcal meningitis (serotype 9V) on 03/11/01. He had a seizure on 03/15/01. The infant had RSV bronchiolitis and was admitted for this on 02/26/01.
infection; big lump in the injection site; feels like it is on fire to the touch; Feels like cyst/ It is silky, moveable, squishy and does not feel like it is connected; Very red; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (infection), VACCINATION SITE MASS (big lump in the injection site), VACCINATION SITE WARMTH (feels like it is on fire to the touch), VACCINATION SITE CYST (Feels like cyst/ It is silky, moveable, squishy and does not feel like it is connected) and VACCINATION SITE ERYTHEMA (Very red) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFECTION (infection), VACCINATION SITE MASS (big lump in the injection site), VACCINATION SITE WARMTH (feels like it is on fire to the touch), VACCINATION SITE CYST (Feels like cyst/ It is silky, moveable, squishy and does not feel like it is connected), VACCINATION SITE ERYTHEMA (Very red) and VACCINATION SITE SWELLING (Swollen). At the time of the report, INFECTION (infection), VACCINATION SITE MASS (big lump in the injection site), VACCINATION SITE WARMTH (feels like it is on fire to the touch), VACCINATION SITE CYST (Feels like cyst/ It is silky, moveable, squishy and does not feel like it is connected), VACCINATION SITE ERYTHEMA (Very red) and VACCINATION SITE SWELLING (Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient does not take any concomitant medications in her daily life. Patient did not take medications to treat her symptoms.
Patient developed severe herpes zoster (shingles) of the right back, flank and chest in T6 and T7 distribution. Treatment was started on 5/16/12 with generic VALTREX 1 gram tid x 7 days. Reported as vaccine failure.
tested positive greater than 14 days post 2nd vaccine  Narrative: tested positive greater than 14 days post vaccine.
Received a booster dose /before the six month mark; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 19-month-old male patient who received HAV (Havrix) (batch number 7HJ74, expiry date unknown) for prophylaxis.   Previously administered products included Havrix (received 1st dose on 2nd March 2021).   On 17th August 2021, the patient received the 2nd dose of Havrix. On 17th August 2021, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details provided were as follows: Health care professional called to report that the patient had received a booster dose of the Havrix vaccine before the six month mark which led to shortening of vaccination schedule. The reporter consented to follow-up by mail.
99-100 fever (12:30-3:00 AM) Inconsolable crying (12:30/1:23/3:00 AM)
PROBABLE STOMACH FLU; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced probable stomach flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of probable stomach flu was not reported. This report was non-serious.
This spontaneous case reported by a consumer, describes the occurrence of malaise (feeling sick), hyperhidrosis (sweating), feeling abnormal (feeling yucky), nausea (nauseated) and chills in a  patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Nov 4, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced malaise (feeling sick), hyperhidrosis (sweating), feeling abnormal (feeling yucky), nausea (nauseated), chills and headache. At the time of the report, malaise (feeling sick), hyperhidrosis (sweating), feeling abnormal (feeling yucky), nausea (nauseated), chills and headache outcome: unknown. No concomitant medications or treatment information provided.
Superficial and deep vein thrombosis was diagnosed on  27th of January.  Symptoms had been going on for around 2 weeks.
Pt said red bumps all over her body. Sunburn feeling. Swollen legs. Blurry vision.
Cancer; WBC was down to 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 11:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "testicular cancer" (unspecified if ongoing), notes: Treated for Cancer in 17Dec2020. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/lot number: EN6203, Time: at 13:00, Anatomical location: Left arm, Route of administration: Intramuscular), administration date: 25Feb2021, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE, Batch/Lot number: EP7534, Time : at 11:30 Anatomical location: Right arm and Route of administration: Intramuscular), administration date: 18Mar2021, for COVID-19 immunisation; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Batch/Lot number: FF2590; At time : 14:00, ), administration date: 26Oct2021, for COVID-19 immunisation. The following information was reported: NEOPLASM MALIGNANT (medically significant) with onset 08Dec2022, outcome "not recovered", described as "Cancer"; WHITE BLOOD CELL COUNT DECREASED (medically significant) with onset 08Dec2022, outcome "unknown", described as "WBC was down to 4". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jan2023) Positive; (2023) Positive, notes: COVID symptoms returned 21Jan2023 and tested positive again; White blood cell count: (08Dec2022) 4, notes: WBC was down to 4. Therapeutic measures were taken as a result of neoplasm malignant. Clinical course: Vaccination Facility Type: Doctors Office/Urgent Care. Concomitant Medications: one a day multivitamin, route: daily. WBC was low due to cancer.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300031485 same patient, different vaccine dose/different event;US-PFIZER INC-202300031252 same patient, different product/event;
patient administered Pfizer 30mcg/0.3ml as her booster dose and not the appropriate 10mcg/0.2ml dose for her age group.
Affected the central nervous system first. Enlarged heart and esophagus. Sleep apnea. I thought I was having heart attacks. Onset of GERD and peptic ulcer disease w/high blood pressure and racing heart. Treatment: EKG, esophagus and stomach scoped. Given medications VALIUM and blood pressure meds. ZANTAC. I am disabled. I was never as sick as I have been since the non FDA approved Anthrax shots. How could government allow us to take non FDA approved medications? Shame on them.
Extreme dizziness when bending  head or laying down, turning over. OK to walk but trouble with excercise and sleep.
Developed nodule at the site of injection, then developed centrifugal erythema around the site 5 days later.
Flu-like symptoms ; fever, chills, injection site pain and redness. 8 hours after administration of vaccines.
Abnormally fussy 11/4 but had been giving ibuprofen per dr. 11 AM 11/5 felt warm. Checked temp 102.4. Runny nose, coughing, crying. Hard to get temp below 100. 11/7, temp better but still coughing and breathing through his mouth.
pt recv vax FEB98 & MAR98 pt broke out in a rash described as mild;
The patient was admitted to the hospital with episodes of weakness, paresthesia, brain fog of unclear etiology, who had unremarkable MRI of the brain, MRI of the C-spine, MRI of the thoracic spine, EMG, EEG, and various laboratory studies. The patient has been followed closely by a HCF for neurologic disorder who suspects a component of functional/psychomotor component in the patient's presentation, but would benefit from an outpatient ambulatory EEG that can be facilitated through outpatient Neurology followup.  The patient does have antibodies for myasthenia gravis that are still pending at time of this dictation, but suspicion is low. The patient continues to have improvement in functional status, who was seen by PT, OT who recommends no outpatient therapy this time secondary to improvement. Case discussed with the patient's sister, advocate and recommend follow up with Neurology and get a tertiary opinion at another HCF.
Information has been received from a registered nurse concerning a male over 60 years old who on 16, Mar 2007 was vaccinated in the forearm with a 0.65 ml dose if zoster vaccine live (Oka/Merck). Subsequently, the patient developed a rash. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
chills,shivering; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (chills,shivering) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 013A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), METHOTREXATE, LISINOPRIL, FOLIC ACID and CHROMIC CHLORIDE, CINNAMOMUM SPP., GYMNEMA SYLVESTRE, THIOCTIC ACID (DIABETES) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 11-Mar-2021, the patient experienced CHILLS (chills,shivering) (seriousness criterion hospitalization). At the time of the report, CHILLS (chills,shivering) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Deceased (9.26.21);  Hospitalized due to COVID-19 (9.2.21);  COVID-19 positive (8.31.21);  Fully vaccinated   Admission Date: 9/2/2021 Died 9/26/21 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypoxia [R09.02] Pneumonia due to COVID-19 virus [U07.1, J12.82] Acute hypoxemic respiratory failure (HCC) [J96.01] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 65 y.o. female with a PMHx of COPD not on home oxygen, HTN, Hypothyroid, RA on immunomodulator therapy who was admitted for AHRF secondary to Covid pneumonia. Completed 4 days of dexamethasone, 3 days of remdesivir so far. Bcx, other infectious work-up have been negative. Going intermittently between HFNC and BiPAP, stays relatively comfortable without additional work of breathing. She has been responding well to once/day diuresis. Multiple conversations at that time were held with the patient, who has elected to be DNR/DNI - okay with vasopressor medications if needed. After transfer out of the ICU she completed dexamethasone, remdesivir, diuresis as needed- she developed an AkI that resolved. She was able to alternate between HFNC and BiPAP but developed hypoxia despite continuous BiPAP at 100%. She was readmitted to the ICU on 9/11 and was unsure of her code status to be DNR or FULL. Overnight she remained on continuous BiPAP with O2 sats in the high 80s. A CTA to rule out PE was unable to be performed given her respiratory status, U/S showed no signsof DVT. On 9/12 Patient had increased work of breathing and anxiety, especially with repositioning and requested to be FULL CODE and was electively intubated for hypoxic respiratory failure 2/2 COVID-19 PNA.    Following intubation, the patient did develop worsening urine output and AKI.  She ultimately was started on CRRT for volume overload.  With volume overload, her O2 requirement did improve somewhat, but she still had significant ventilatory needs due to her COVID-19 pneumonia.  Patient also had persistent tachycardia during her hospital stay.  Her serotonergic medications were held to rule out serotonin syndrome, repeat cultures were obtained without any growth, and extremity ultrasounds were performed which did show equivocal left coronal DVT.  Patient was started on heparin drip for this possible DVT.   Due to the persistent high ventilatory needs, goals of care were discussed with the family.  It was agreed that tracheostomy tube placement was not in line with the patient's goals of care, and due to her persistent refractory hypoxemia requiring high ventilatory needs, plan was made to transition patient to comfort care on Monday, 09/27/2021. On Sunday 9/26 patient had acute worsening in clinical status with decreasing oxygen levels. Based on patient's families wishes for the patient to be with her husband upon passing the patient was made comfort care and passed away at 1108 AM. Date of Death: 9/26/21 Time of Death: 11:08 AM Preliminary Cause of Death: COVID-19
Pt. c/o tingling in right arm approx. 15 minutes after receiving vaccine.  Denies shortness of breath or lightheadedness.  BP 106/66,  97%O2  P-60,  repeat 98%O2, P-62.  Pt. advised slow deep breaths, drink H2O2, massage hand and arm.  Pt. reports normal sensation after 20 minutes.  Pt advised home, rest, ice on vaccination site PRN, tylenol or ibuprofen prn, call 911 if shortness of breath, swollen lips & tongue & eyes, or tightening in throat develop.  Pt & her father verbalize understanding.
27JUl pt had sz like sx following bath; stiff, eyes rolled back lasting a few seconds followed by limpness, pale & was taken to ER, very sleepy next couple days; Following day had fine rash;
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 22-JUL-2016, the patient was vaccinated with improperly stored VARIVAX lot # L011082, expiration date reported as 01-APR-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose vaccine experienced the temperature excursion of 7 degrees Fahrenheit for 5 hours 48 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reported. Additional information has been requested.