chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hepatocellular pattern of liver injury; This is a literature report. A 25 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no liver disease history. Concomitant medication(s) included: IBUPROFEN. The following information was reported: LIVER INJURY (medically significant), outcome "recovering", described as "hepatocellular pattern of liver injury". The patient underwent the following laboratory tests and procedures: alanine aminotransferase: 635 IU/l; antinuclear antibody: 1:640; blood alkaline phosphatase: 465 IU/l; blood bilirubin: 2.8 mg/dl; international normalised ratio: 1.0; sars-cov-2 test: negative; smooth muscle antibody: 1:20; viral test: negative. Therapeutic measures were not taken as a result of liver injury. Timing of pattern presentation of injury was 24 days in relation to first dose of vaccine. The author acknowledged that this series of patients with hepatic injury following mRNA-based COVID-19 vaccination contains retrospective and observational data without adjudication. Thus, this report is not structured to evaluate potential causality. Drug induced liver injury is not readily implicated in this patient series, although it cannot be wholly excluded. The author also considered unlikely direct hepatotoxicity from SARS-CoV-2 mRNA vaccines, noting the strong safety profile for delivery of lipid nanoparticle mRNA vaccines to human tissues. Rather, vaccine-induced immune-mediated hepatitis is a known phenomenon, and other autoimmune events (e.g., AIH, ITP) have been reported following COVID-19 vaccination. It is plausible that a similar mechanism is occurring here, whereby the host immune response directed against the COVID-19 spike protein triggers an aberrant, autoimmune-like hepatic condition in predisposed individuals.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of liver injury. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202101834329 Same article/drug/event and different patient.
Information was received from a certified nurse assistance regarding an 11 year old female patient who was administered GARDASIL (lot # J008423) injection intramuscular 0.5ml in left deltoid on 21MAR2014. The GARDASIL was involved in a temperature excursion. No adverse event was reported. Please see additional information for other cases reported by same provider. Additional information is not expected.
chills; 100.7 F fever.; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (100.7 F fever.) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032Z20A) for COVID-19 vaccination.     No Medical History information was reported.  On 21-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced CHILLS (chills) and PYREXIA (100.7 F fever.). At the time of the report, CHILLS (chills) and PYREXIA (100.7 F fever.) outcome was unknown.      No relevant concomitant medications were reported.  No treatment.
A medical assistant called to determine the valiidity of the dose of PROQUAD given to 14 year old; No additional AE's; This spontaneous report was received from a certified medical assistant and refers to a 14-year-old patient of unknown gender. The patient's medical history, concomitant medications, concurrent conditions and drug reactions/ allergies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (product administered to patient of inappropriate age) (dose, lot number, expiration date, route of administration and injection site were not reported) for prophylaxis. The reporter called to determine the validity of this vaccination. No additional adverse events were reported.  This is one of 2 reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA005604:
Vaccinee rec'd Engerix-B series according to 0, 1, 6 months dosing schedule; Reporting employee hlth nurse indicated vaccinee had a negative titer p/the 3rd dose;
pt recv vax 4APR97 & 7APR97 PM sl itching noted;8APR97 PM itching entire body-hives all over-swelling eyes & face;took to ER was given IV med & inj for allerg rxn;mom unsure of names of med;also given breathing tx;mom reports pt recovered;
This spontaneous report was received from a medical assistant refers to unknown number of patients of unknown age and gender. On unknown date (between November 2013 and July 2013), the patients were vaccinated with ZOSTAVAX (dose, route and lot # were not reported) that had been improperly stored. No adverse effects reported. This is one of 6 reports received from the same reporter. Additional information has been requested.
Multiple cold sores on lips; Fungal infection in mouth; This is a spontaneous report from a contactable consumer, the parent. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO0171) via an unspecified route of administration in the right arm on 23Apr2021 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included Angelman syndrome with severe disability and COVID-19. Concomitant medications included phenobarbital (MANUFACTURER UNKNOWN) and clonazepam (MANUFACTURER UNKNOWN) from an unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL2613) via unspecified route of administration in the left arm on 02Apr2021 (at the age of 45-year-old) as single dose of COVID-19 immunisation. Prior to the vaccination, the patient was 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 four weeks prior to the COVID vaccine. On 26Apr2021, the patient experienced, multiple cold sores on lips and fungal infection in mouth. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received glucose azole (MANUFACTURER UNKNOWN) as a treatment for the events multiple cold sores on lips and fungal infection in mouth. The clinical outcome of the events cold sores on lips and fungal infection in mouth were resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
Second dose of pediatric pfizer was administered to patient. Afterwards, she stood and reported not feeling well. She was instructed to sit and proceeded to faint and slump off the chair to the floor. She reported feeling very tired and a "sizzling" sensation in her ears. Pharmacy provided her water, orange juice, and chips. After beginning to ingest the orange juice and chips, patient reported steady improvement. Patient and mother reported she had yet to eat anything that day and was feeling nervous about the vaccine. After several minutes resting, eating, and drinking, patient reported feeling great. She was then able to get up, walk around, and reported no further issue.
HEADACHE, FEVER, FATIGUE, LOCALIZED SWELLING AND REDNESS AND PAIN IN LEFT ARM 6 DAYS POST VACCINE
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a 0.5 ml dose of GARDASIL (lot number not reported).  It was reported that the patient experienced redness and swelling at the injection site when she received the vaccine.  It was unknown which dose in the series the patient received when she experienced the adverse event.  It was unknown if medical attention was sought.  The outcome of the patient was not reported.  Additional information has been requested.
Headaches and Fatigue increasing in first 6 months after, leading up to dizzy and fainting spells, low blood pressure, and Migraines. Still experiencing the Headaches, Migraines, Fatigue, Hypotension, and Dizziness.  6/22/09  MR received from PCP including neuro consults from 10/24/08-3/29/09 with Dx: headache (784.0), R/O aneurysm, non-ruptured cerebral (437.3), Pharyngitis (462), Concussion NOS (850.9), Syncope (780.2), Lumbar radiculopathy (724.4), Scoliosis, ideopathic (737.3) and low back pain syndrome (724.2). Pt initially presented with c/o H/A s/p fainting episode with LOC and vomiting on 10/4/08. Dx as Vasovagal in ER. Since that time c/o H/A with occ vomiting.  Using Benadryl to sleep. LMP 10/4/08. Neuro consults beginning  1/21/09 after 2nd episode 12/28/08. Pt felt sx coming on.  Felt shaky and sat down. Vomited after. Episodes have been assoc with heartracing/palpitations/flutter. Reports difficulty reading. Neuro exam WNL. Assessment:  Syncopal episodes w/o evidence of seizure.  Seen 3/23/09 with c/o sore throat, h/a, lightheadedness, fatigue. Exposure to strep throat. PE (+) for tender anterior cervical nodes, pharyngeal erythema.  Neuro f/u 3/23/09. Still reporting dizziness and daily h/a since initial event. Reports poor memory. To monitor BP at home. Heavy periods noted. MRI (+) for sinusitis.
patient received flu vaccine in the right arm first at which point she bled a little, after that she got the covid vaccine in the left arm. when she got that shot the patient fainted. the technician screamed for backup and the pharmacist and another technician went over to the room where the patient was limp, after a couple seconds the patient became alert again. the paramedics were called at which point they took her blood pressure which came back a bit low, they asked a couple questions and then left. after the paramedics left we discovered that the covid vaccine vial from which the patient was given her vaccine was first drawn 19 hours priors.
No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report was received from a medical assistant, concerning a 1-year-old male patient. His pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 15-APR-2022, the patient was vaccinated with improperly stored first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U025790, expiration date: 19-AUG-2023 (exact dose and anatomical location were not provided) administered subcutaneously for prophylaxis, after the vaccine underwent a temperature excursion of -14 degrees Celsius (C) up to -10 degrees C for 3 hours (h), 0 minutes (min) and 0 seconds (sec); -10 degrees C up to 8 degrees C for 1 h, 30 min, 0 sec on 23-MAR-2022 (Product storage error). No previous temperature excursion was reported. No additional adverse events were reported. The reporter verified viability of the vaccine on the Company hotline.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA008004: US-009507513-2205USA003614: US-009507513-2205USA007703: US-009507513-2205USA007704: US-009507513-2205USA007723: US-009507513-2205USA007809: US-009507513-2205USA007821: US-009507513-2205USA007847: US-009507513-2205USA007852: US-009507513-2205USA007860: US-009507513-2205USA007871: US-009507513-2205USA007957: US-009507513-2205USA007978: US-009507513-2205USA007982: US-009507513-2205USA008006: US-009507513-2205USA008008: US-009507513-2205USA008028: US-009507513-2205USA008051: US-009507513-2205USA008105: US-009507513-2205USA008189:
I started experiencing progressive elevation of blood pressure. I went to the doctor in January of 2023 and they diagnosed me with high blood pressure. I went for my annual checkup and they did an EKG, took my blood pressure, weight, and listened to my heart and lungs. Everything was normal except my blood pressure. My parents and siblings also have high blood pressure so I think this is just genetics. They did not give me any medications at that time. In February my blood pressure kept getting higher and higher so they gave me valsartan with hydrochlorothiazide and they increased my metoprolol. My blood pressure is controlled with the medication.
Extreme emotional meltdowns, self harm, suicidal thoughts. Later (May 2013) diagnosed as PANDAS, ADD (diagnosed May 2013) with some autistic features, Anxiety, OCD. Mercury toxicity (blood test; permeable gut resulting in multiple nutritional deficiencies. New teeth coming in had no enamel after perfect teeth up to this point. Documented, objective regression in fine motor and math.
On 11/05/2001 the patient experienced swelling, erythema and pain of the injection site. On 11/06/2001 the pain increased and the patient also had shortness of breath. The patient went to the ER and was diagnosed with an allergic reaction to influenza and cellulitis. Treatment for the cellulitis was initiated. The patient show improvement with Benadryl and NSAID's.
Pt admitted to MC for progressive lower extremity Weakness.  Diagnosed with Guillain-Barre syndrome. Respiratory status declined and required mechanical intubation.  5 day course of IVIG was given with improvement.  Patient discharged to rehab 11/10/2015.
Covid -19 Immunization given outside the 6 hour window after diluent added, vaccine stored in refrigerator.  Vaccine mixed at 09:30 Health Director notified immunization coordinator. Health Director notified RN dose acceptable within manufacture guidelines. Recommended to submit VAERS.
I had a low grade fever with chills. I had a blinding migraine all day that made me nauseous and fatigue.  I am  11 weeks pregnant and my estimated delivery date is 07/28/2021.
Hours after vaccination patient experienced drooling from left side of lips and started losing sensation on left side of face. Unable to close left eye.  Diagnosed with Bells palsy.   Treatment prednisone 60 MG for 10 days, valacyclovir 1000 mg for 7 days, Natural tears and erythromycin ointment for eye.
After the vaccination I had itchiness and cold chills and during the day and I was swollen in different parts of my body and hand got worst. I went to the doctor and had four doses of pentanone and it got better after the second day and lost weight because of it. I am getting swelling back and it doesn't go away and it's constant.
Fatigue extreme, bone pain, cannot stand up, Head ache, Chills, symptoms like Covid
Patient received 2nd dose of shingrix vaccine on 9/8/2020.  She came to the pharmacy today on 11/10/20 and told us that she has had an adverse event that she noticed within 7 days of receiving the vaccine.  She reports that she has had an internal itching on her right hip and waist that is unusual to her that has been continuing eve since it started.  She did not notice it before receiving the shot, but has now noticed it ever since.  She does not report any sort of external rash.
Fatigue, headache, muscle pain, and chills from 5:05-12am. With acetaminophen, symptoms lessened and woke up with no symptoms .
Patient is fully vaccinated.  COVID positive on 12/30/2021 at hospitalization. D dimer elevated (1,291).74-year-old female who presented to the hospital with shortness of breath and acute mental status changes.  Patient had a prolonged hospital stay with multiple complications and ICU admission.Patient presented with acute hypoxic respiratory failure in the setting of COVID-19 pneumonia as well as superimposed bacterial pneumonia.  She was intubated and transferred to the ICU.  Where she developed multiple complications, including a non-STEMI, and worsening renal failure which required hemodialysis.  She also developed severe sepsis in the setting of bacterial pneumonia, received IV antibiotics.  She also had acute blood loss anemia, in which she received multiple units of PRBCs transfused.  Patient became ventilator dependent and was unable to be weaned off of the ventilator. She is medically stable for discharge to an LTAC facility. Treatment:  Decadron, breo inhaler, albuterol. Completed remdesivir.
Abdominal cramping; Diarrhea; Headache; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal cramping), DIARRHEA (Diarrhea), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced ABDOMINAL PAIN (Abdominal cramping), DIARRHEA (Diarrhea), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, ABDOMINAL PAIN (Abdominal cramping), DIARRHEA (Diarrhea), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.            Patient had received J&J vaccine for the first dose.  No concomitant product was provided by the reporter. No treatment medication was provided.
Local reaction left upper arm with swelling, redness, induration (approx 10 x 10 cm), pain, sore throat, hoarseness, chest pain.
On 4/16/2021 I experienced pain in the lower left abdomen.  4/17 pain spread to all of left abdomen and left side of back.  By 4/19, pain was sharp burning pain from hips to ribs on both sides radiating into left leg.
This spontaneous report was received from an unspecified reporter via a company representatives and refers to a patient of unknown age and gender. No medical history, concurrent conditions or concomitant therapies were reported. On an unknown date, the patient was vaccinated with a second dose of GARDASIL or GARDASIL 9 intramuscular for prevention of HPV (lot #, dose and anatomical location were not reported). It was not confirmed if the patient received GARDASIL or GARDASIL 9. On an unknown date, the patient experienced severe involuntary muscle movements. The outcome of the event was unknown. The relatedness between the event and suspect vaccine was not reported. Additional information is not expected, as no contact details were provided.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unknown date, the patients were vaccinated with unspecified number of improperly stored MMR II, (dose and route not provided) (lot number # K024035, expiration date: 26-NOV-2016 or lot number # K022284, expired date 12-JUL-2016). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Immediately after vaccine had an increase in blood pressure, nausea, light headed. Afterwards continued to have bad headache.
Numerous tiny white bumps on both legs only that were somewhat itchy & disappeared completely after 4 days; no treatment given
c/o h/a, t103 have been giving APAP; temp goes down for 1-2 hrs then back up;
Student presented requesting booster shot.  She showed a vaccine card with only 2 doses, and she reported during prevaccination checklist that she had had 2 prior doses.  The vaccine was administered and well tolerated. When going to document this dose in clinic it was noted that she had initial vaccines Spring 2021 and a Booster in Oct. 2021. When asked about this, she admitted knowing she had already gotten a booster, but being told there was no documentation of this.  She needed evidence of a booster for job.  After consulting with her parent who is an MD she  decided to just come in and get another one without explaining the situation.
Patient girlfriend reported nausea, vomiting and intermittent stomach pain. Advised to try and get fluids and Tylenol and follow up with Doctor or call us back especially if symptoms persist past 24 hours
Expired Havrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 31st January 2023, the patient received Havrix. On 31st January 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 1-Feb-2023 Reporter's comment: The reporter did not had the patient's date of birth. The reporter consented to follow-up via email. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 03-JAN-2014, the patient was vaccinated at a community physicians clinic with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-MAR-2016 the patient was treated at physicians for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient came to ED via ambulance and was admitted to hospital for CVA, Covid pneumonia, and UTI.  Patient hypoxic and unresponsive.
After having the 3rd dose my scalp has starting itching severely and the area around my neck. Moderna
Pt was given ppsv 23 on 11/15/2019 and then given another one on 1/18/2022