chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain all over the body; coughing; sore throat; fever; soreness on site; Headaches; This is a spontaneous report from a contactable healthcare professional, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 26Mar2021 at 16:30 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, arthritis and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did receive regular medicines within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021 at 05:00, the patient experienced headaches, fever, pain all over the body, soreness on site, coughing and sore throat. The patient was in bed for four days. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events headaches, fever, pain all over the body, soreness on site, coughing and sore throat was resolved on an unknown date in 2021. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 16Apr2021 (at the age of 62-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
I had the Shingrix vaccine on September 20th.  The morning of September 23rd, I woke up and went to the restroom.  As I was sitting on the toilet both feet started to tingle and the tingling sensation went up both legs to my knees.  I have never had this happen to me before.  I was alone and it scared me as I was thinking - what if the tingling keeps moving upward?  I unlocked the front door and kept my cell phone next to me just in case I needed to call EMS.  The tingling and strange numbness continued for the morning.  By the afternoon my legs just felt kind of weak and numb.  My legs felt weird the rest of the weekend.  Needless to say, I will not be taking the 2nd dose of the Shingrix vaccine.  I notified my Dr. and she agrees.
Daughter has a large round oval on her arm where it was injected and it is raised; It is probably about 2 inches long by 1 inch wide; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Daughter has a large round oval on her arm where it was injected and it is raised; It is probably about 2 inches long by 1 inch wide".  Additional Information: The reporter mentioned that they (her, her husband and her daughter) got the Covid shot (Clarified as Pfizer COVID-19 Vaccine), the other day at the Pharmacy. Reporter's daughter (patient) has a large round oval on her arm where it was injected and it was raised. It was probably about 2 inches long by 1 inch wide. She asked if it was something to worry about. None of them has ever had this before. Reporter further clarified that it was the Pfizer, it was Covid-19 Vaccine. Reporter mentioned that safety report can be filed but she was more concerned if this was something dangerous that they need to take the patient to the emergency room. That's what she wanted to know. She also said that there was nobody else that they can talk to. She called the pharmacy local and they do not know anything about this shot either. Reporter was suggested to contact nearest Health care professional and also suggested to contact Pfizer Medical Information on Monday morning for the concern.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Severe Immune-Mediated Liver Injury Following COVID-19 Vaccination Necessitating Liver Transplantation in a Patient with Cirrhosis; This is a literature report for the following literature source(s):   A 65-year-old male patient received BNT162b2, as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "epilepsy" (unspecified if ongoing); "coronary artery disease" (unspecified if ongoing); "excessive alcohol use" (unspecified if ongoing), notes: 30+ years. The patient's concomitant medications were not reported. Past drug history included: Levetiracetam for epilepsy; Metoprolol for coronary artery disease; Ramipril; Aspirin; Omeprazole. The following information was reported: IMMUNE-MEDIATED HEPATIC DISORDER (medically significant, life threatening), 10 days after the suspect product(s) administration, outcome "unknown", described as "Severe Immune-Mediated Liver Injury Following COVID-19 Vaccination Necessitating Liver Transplantation in a Patient with Cirrhosis". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 1613; Antimitochondrial antibody: Positive; Antinuclear antibody: Positive; Aspartate aminotransferase: 1786; Blood alkaline phosphatase: 182; Blood creatine: 0.7; 2.6; Blood immunoglobulin G: 1310; Computerized tomogram abdomen: heterogeneous liver with steatosis and mild, notes: nodularity, splenomegaly, ascites, patent vasculature, and no biliary dilation. Liver biopsy: marked portal and lobular inflammation with interface hepatitis and lymphoplasmacytic infiltrates, confluent necrosis with hemorrhage, balloon degeneration, cholestasis and reticulin collapse; Cytomegalovirus test: Negative; Enzyme level test: normal; Epstein-Barr virus test: Negative; Hepatitis A virus test: Negative; Hepatitis B virus test: Negative; Hepatitis C virus test: Negative; HIV test: Negative; International normalised ratio: 2.1; Skin test: 9; Smooth muscle antibody: Positive.  Clinical Information: Reporter reported that Patient was presented with jaundice and ascites on day 10 after first C19V and did not have known liver disease and had normal liver enzymes prior, No family history of autoimmune diseases. Sender's Comments: Based on the information provided, and a temporal association, a causal association between reported event immune mediated hepatic disorder and suspect BNT162B2 cannot be excluded. This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
AFTER RECIEVING THE FOURTH COVID SHOT (MODERNA 0.25ML, 2ND BOOSTER, 4TH SHOT) WHICH WAS ON THE LEFT ARM-- APPROXIMATELY 1 INCH FROM ACROMION PROCESS, INTO INTRAMUSCULAR DELTOID MUSCLE, THE PATIENT IMMEDIATELY DEVELOPED A INJECTION NODULE AND THE INJECTION SITE STARTED BLEEDING. IT APPEARS THAT THE INJECTION NODULE CONTAINS THE INJECTED COVID MODERNA VACCINE. THE PATIENT REPORTS THAT SHE WAS LIGHT HEADED AND REQUIRED ORANGE JUICE. AFTER SITTING AND WAITING FOR APPROX 20 MINUTES FOR OBSERVATION, THE PATIENT LEFT AND STATED THAT SHE FELT BETTER. PATIENT DID REPORT THAT SHE IS NOT ON ANY BLOOD THINNERS AND/OR NSAIDS. THE PATIENT ALSO STATED THAT SHE HAS MILD ANXIETY TO SHOTS AND DID EAT BREAKFAST THIS MORNING BEFORE  THE SHOT APPOINTMENT. THE PATIENT WAS COUNSELLED THAT THE INJECTION NODULE WILL DISSIPATE THOUGHOUT THE DAY AND THAT SOME PATIENTS MIGHT HAVE BLEEDING THAT IS MORE THAT A DROP OF BLOOD. PATIENT CALLED BACK LATER THAT DAY AT APPROXIMATELY 3PM AND STATED THAT SHE WAS FEELING BETTER AND THAT HER ARM HURTS. SHE CONFIRMS THAT THIS IS PROBABLY DUE TO THE EFFECTS OF THE MODERNA SHOT AS SHE FELT THIS IN THE PAST. PATIENT ALSO REPORTS THAT SHE IS EXTREMELY ANXIOUS AND CONCERNED THAT THIS MIGHT HAVE BEEN A ADVERSE SIDE EFFECT FROM THE MODERNA SHOT. SHE ALSO IS CONCERNED THAT SHE MIGHT HAVE THE SAME REACTION TO SUBSEQUENT BOOSTER DOSES OF MODERNA IN THE FUTURE.
expired Daptacel was accidentally administered to a patient (with no adverse event); Initial information received on 31-Jul-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old female patient and expired Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] was accidentally administered to patient (with no adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine Conj 7v (Crm197) (Prevnar) for Prophylactic vaccination.  On an unknown date, the patient received 0.5 ml of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (strength unknown) (lot number: C5893AA, Expiry date: 21-Jun-2023) via intramuscular route in the left thigh for immunization.  On an unknown date, expired Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine was accidentally administered to patient (with no adverse event) (expired product administered) (latency: same day).  It was reported, Caller reported that an expired DAPTACEL was accidentally administered to a patient and wants to know if they need to re-dose.  Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Swollen left armpit after the 1st shot, but it wasn't too noticeable. The second dose did create a bigger lump under the same armpit.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration on 22Jul2021 at 12:00 (at the age of 41-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration on 12Aug2021 at 13:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. It was unknown if the patient had any allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included amoxicillin (MANUFACTURER UNKNOWN) and multivitamins (MANUFACTURER UNKNOWN), both taken for an unspecified indication from an unknown date and unknown if ongoing. On an unknown date in 2021, after the first shot, the patient experienced swollen left armpit but it was not too noticeable. After the second dose, on 13Aug2021 at 20:00, the patient had a bigger lump under the same armpit. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 15Jul2021, the patient underwent SARS-COV-2 test (polymerase chain reaction (PCR)) through blood test and the result was negative. The clinical outcome of the event after the first shot, swollen left armpit but it was not too noticeable and the second dose it did create a bigger lump under the same armpit was not resolved at the time of this report.
This man developed fever (102 degrees, body aches, headache, joint pain, muscle pain, and a grapefruit size swelling in axilla area.  His physician prescribed antibiotics and told him it was a reaction to the vaccine.
7/3/21-c/o general malaise. and sore throat T 99.9.  7/3/21- covid antigen tested and negative 7/5/21- unresponsive episode, sent out to ER,  resident admitted to hospital went to ICU. CT scan showed L side subdural hematoma acute on chronic hypoxia 7/10/21- arrived back to facility.
Pt's mom noticed a small, raised, red "welt" around injection site on left leg one day after shots were given. Pt. had no fever, and no pain. Pt. was diagnosed with cellulitis and prescribed KEFLEX for treatment.
Dr. called the mother of patient and explained that the child should not have any adverse effects.  MOther was no upset.
COVID-19; COVID-19; OFF LABEL USE; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EN6199), in left arm and on 29Mar2021 as dose 2, single (Lot number: ER2613), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Oct2021 as dose 3 (booster), single (Lot number: 017F21A), in left arm and on 05Apr2022 as dose 4 (booster), single (Lot number: 022L21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OFF LABEL USE (medically significant) with onset 05Apr2022, outcome "unknown"; IMMUNISATION (medically significant) with onset 05Apr2022, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28May2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) negative, notes: tested positive after being negative; (28May2022) Positive, notes: tested positive after being negative. Therapeutic measures were taken as a result of vaccination failure, covid-19, off label use, immunisation.  Clinical course information: The patient was not taking any other medications within 2 weeks and the patient had return of congestion and tested positive after being negative. The patient had no known allergies.
No adverse events during 15 minute observation period at clinic. Driving home my throat began to swell and became itchy. I pulled into gas station, purchased Benadryl and administered one tablet. I rested and after 15 minutes the swelling did not progress. I then drove home and contacted my GP. She advised me to monitor symptoms and advised to receive 2nd dose in a hospital setting due to concerns about adverse event.
flulike symptoms for a week, sore arm for several days, fatigue, irregular heart beat and severe burning in chest when taking a walk.
My arm started to hurt suddenly. It swelled up to the size of a tennis ball. It was not discolored. I iced t and it got hot to the touch. It showed a little bruising. The condition resolved within 4 days,  The pain was not too bad.
I was having symptoms after first vaccine 11/22/21, SOB, Fatigue, Flu like symptoms, alleviated themselves within a week.  Had 2nd dose 12/20/21 and same symptoms and the SOB progressed, the fatigue persisted, Leg swelling bilaterally, dizzy, etc.  Went to ER on 1/16/22 and my heart was only functioning at 15-20%, my BUN was over 2000, I was in complete kidney failure, swelled up with almost 35 lbs worth of fluid.  They gave my IV Lasix for a week to get fluids off.  Had 4 liters of Oxygen at time of admission.  I almost had a Life vest put on as a way to save me from Sudden Cardiac Death.
Arm from shoulder to elbow was red and swelled up double the size of her arm.  Ran a fever of 101.  I called and was told this was normal.  Day after vaccine my daughter would not respond to me after consistently calling her name in the car for about 30 seconds.  I almost stopped the vehicle but she finally responded.  She was having a staring spell which she has never had before.
Two weeks after the shot, the patient has become very sick. She is feeling dizzy, very weak, and can't eat. She also has a rash on certain areas of her body (knees and groin area).
The report was first received from practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 04-DEC-2017, the patient was vaccinated with ROTATEQ (strength were unknown, lot# M042169 and expiration date 22-JUN-2018) 1 dose form orally for prophylaxis (product storage error). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017 was 47 degree Celsius for max 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001958.
only on right side of face- numbness and swelling in the lower part.  this happened on 3 separate occasion. 1 day after/ 1 week after/ then maybe 10 or 11 days post vaccine.  she feels like it is getting ready to start again today
This spontaneous report  has been received from a male consumer of unknown age reporting on himself with history of shingles. None drug reactions/allergies. On approximately 14-OCT-2013 reproted as 2 weeks ago, the patient was vaccinated with ZOSTAVAX refrigerated vial 19400 PUF, (dose, lot # and route not reported). None concomitant medication. In October 2013, the patient has developed a burning sensation in his back and little white blisters. The patient did not receive any treatment at the time of the report and did not seek medical attention. The action taken for ZOSTAVAX was not applicable. Additional information has been requested.
left jugular left vein thrombosis; This is a spontaneous report from a contactable consumer physician (reporting for herself). This 35- year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EN6208), via an unspecified route of administration, on 12Apr2021 as a single dose for COVID-19 vaccination. No relevant medical history and concomitant medications was reported. States: no past medical history of blood clots, not on birth control pills and had two children with no issues. She received her first dose of the Pfizer BioNTech Covid 19 vaccine on 12Apr2021, she developed symptoms 5 days later, and then went to the ER and was diagnosed with a left jugular left vein thrombosis on 19Apr2021. Patient was released on Xarelto starter pack and then will be on Xarelto 20mg.  The clinical outcome of the events was unknown.  Information about the Lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Jugular vein thrombosis cannot be excluded.  The case will be reassessed if additional information becomes available.  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.
Pain commenced in left arm Sunday evening about 7:00 P.M. . Thinking it may be a precursor to a heart attack visited Hospital. Following extensive tests to eliminate a heart problem it was determined the pain  may be due to the Covid injection as no other untoward experience had taken place in that arm.  Sunday night the pain was so intense the nursing staff administered  morphine twice to achieve relief. Pain continued Monday and Tuesday, but is somewhat subdued by Tylenol. . Upon palpation of the left arm at singular site invokes extreme pain. The entire arm aches and feels "heavy."
Flu shot administered 9-11-15 patient developed bruise in deltoid area and arm. Patient on warfarin.
pt recvd vax 22SEP95 & pt to ER 24SEP95 w/redness, swelling @ inj site; to OHC 25SEP95 w/redness, swelling, approx 2inch area SQ, mass, painful; cont on Keflex given in ER;
Headache, Chills, Injection site pain, Slight fever.  Lasted one day.  Tylenol resolved.
While giving the patient his first vaccination, the needle was not properly secured to the syringe and the two parts separated while giving the vaccine. He got at least part of the dose, but we discussed giving him a second shot so he could receive the full dose. The patient seemed fine so I went to draw up the next dose, and as I was doing that, he started to get a little pale and said he was not feeling well. I gave him some water and sat with him while he was in a chair. He then began to fall forward and was unconscious. I caught him before he hit the ground, laid him down on his side, and he woke up fairly quickly after. We did not administer the rest of the dose and the patient waited around the pharmacy for 30 minutes, but he stated he felt much better with no concerns fairly quickly after the reaction.
This spontaneous report was received from a registered nurse refers to a 4 months old patient of unknown gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were unspecified. The reporter stated that, on 26-APR-2016, the patient was inadvertently vaccinated with a dose of VARIVAX (dose, strength, vaccination site, route unspecified). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information is not expected since these was no consent to contact the reporter.
fatigue; soreness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and VACCINATION SITE PAIN (soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) and CLONAZEPAM for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced FATIGUE (fatigue) and VACCINATION SITE PAIN (soreness). At the time of the report, FATIGUE (fatigue) and VACCINATION SITE PAIN (soreness) outcome was unknown.      Treatment details were not provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
admitted with lower back pain x 2 weeks. recent biopsy consistent with myeloma. Pt became hypoxemic and letharrgic during admit with increasing O2 requirements. COVID +; pneumonia; rec'd dexamethasone, laxix administered.  transferred to hospice.
Itching at the site of injection, shoulder, arm, down to the left hand. Treat with OTC anti-itching cr. She stated that anti-itching cream help.
On 4022/01 phone call from a school nurse. Child complained of redness and soreness at injection site, left deltoid, temperature of 99 (oral). Shot given Friday, 04/20/01, soreness started 04/21/01, mother applied cool compresses. Encouraged mom to take the child to PMD. On 04/25/01, PMD diagnosed infection at the injection site from the child scratching. RX: Neosporin and warm compresses. Site much improved as per mother, no fever.