chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had the expected side effects for about two days after the vaccine. A week later I started to have pain and tightness in my jaw. I waited about a week and the pain seemed to be spreading into my face. I started to have a headache after that and consulted my doctor. The headache and pressure in my sinuses and cheeks has been persisting for eight weeks. It happens intermittently and some days it seems to come on later in the day. The tightness in my jaw has gone away and it is a nagging headache now. When I run it seems to be a slight tightness in my sinuses. I have been using some Allergy medication and they only hep a little.
Information has been received from a Registered Nurse concerning a 28 year old female with "a lot of medical history" (unspecified) and no drug allergies who on 17-Oct-2005 was vaccinated IM in left arm with a dose of pneumococcal 23v polysaccharide vaccine (lot #651318/1006P). On approximately 19-Oct-2005 the patient was hospitalized with a staph infection. She was treated with an IV antibiotic and was recovering at the time of the report. The reporter considered staph infection to be disabling and to be another important medical event (OMIC). Additional information has been requested.
Itchy rash all over body. The Doctor said that it is psoriasis, which I didn?t have prior to the vaccine.
Information has been received from a physician concerning a 12 year old female patient with no known drug allergies or pertinent medical history who on 17-JUN-2009 was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (Lot number not provided). On 17-AUG-2009 the patient was vaccinated intramuscularly with the second 0.5 mL dose of GARDASIL (Lot number not provided). There was no concomitant medication. In approximately July 2009, the patient experienced amenorrhea. Her last menstrual period was in June 2009. In early August 2009, the patient was diagnosed with mononucleosis, but has recovered completely. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. At the time of the report, the patient's amenorrhea persisted. Additional information has been requested.
Client states she felt light-headed and tired the day of vaccine administration.  The day after, she feels very tired, denies light-headedness, states that she felt just kind of sick.  Client also states she is currently on prednisone 20 mg (5 day treatment).
Information has been received from a physician concerning a 23 year old female patient with no pertinent medical history who on 02-AUG-2010 was vaccinated with a first dose of GARDASIL (Lot # 666121/1778Y). There was no concomitant medication. On 04-AUG-2010 the patient experienced an acne-like rash from the middle of her chest, on her forehead and on her back after receiving her first dose of GARDASIL. The patient did visit an unspecified dermatologist and the results of that visit were unknown. When the patient returned for her second dose of GARDASIL the physician declined to administer it due to the previously stated adverse event. At the time of the report, the patient's acne like rash on her chest, forehead and back persisted. Follow up information was received from the registered nurse who stated that the patient with not known drug allergies was vaccinated intramuscularly into the right deltoid with the first dose of GARASIL (lot # 666121/1778Y) The registered nurse reported that a patient reported there that on 21-AUG-2010 she broke out with a rash on her chest, arm and face. The second dose was not given. At the time of the report, the outcome of the patient was unknown. There were not laboratories performed. No further information is available.
Erythema, slight induration at site of injection.  Sore at site of injection.
malaise, body aches progressing to fulminant kidney failure as of today.  being dialyzed now.
About 24 hours after shot: Nauseous, body ache, head ache About 42 hours after shot: head ache, stomach ache No treatment course taken
A 15 y/o male had a syncopal episode 5 minutes after receiving his Fluarix vaccine. The patient slipped out of his chair while sitting with his family mebers in the post vaccine observation area. Pt had mild abrasions to the left side of his face. The patient had full recall of the event. Paramedics on sight evaluated and treated the patient. No signs of allergic reaction noted from the vaccine. The patients Mother signed a form refusing transport to the hospital by ambulance.
After administer5ing the injection and removing the needle there was a splatter of blood that came out with the needle that seemed considerable. upon calling the CDC I was instructed to repeat the dose ASAP so the patient is coming back Tuesday for another dose
This spontaneous report was received from a medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of RECOMBIVAX HB (lot#, expiration date and route not reported). The vaccine was exposed to an unsupported temperature excursion (48.9 Fahrenheit (F) for 10 days). No adverse effect reported. No further information is available. This is one of the several reports from the same source. Additional information has been requested.
pt recvd vax & 2 hrs later devel facial swelling; eyes nearly swollen shut; resolved w/3-4 hrs; no resp sx, no rashes; not witnessed-occurred @ home;
TINGLING AND PRICKING SENSATION ON LOWER AND UPPER EXTREMETIES. ANXIETY.
Mother brought her son to get his second dose of Pfizer vaccine and it was discovered that he was only 11 years old.  She wanted me to give him the 2nd dose, but I told her that he needed to be 12 years old and we would need to wait until 6/30/21 before administering the 2nd dose due to his age. Mom filled out son's date of birth wrong and age: 12 on the administration form that was filled out on 6/2/21.  No adverse events occurred after 1st dose was administered and mother wanted to get son a second dose as quickly as possible.  This form required that I fill in a date and time of adverse event but no adverse event was reported.
Severe chills shaking for over 2.5., severe headache fever spiked at 104.2,.   Next two days  had mild fever 100.1 and tired, aching muscles
Body aches, nausea, joint pain, and muscle spasm. Local area swelling. Benadryl.
child received ActHIB subcutaneously/no AE; Upon internal review on 04-DEC-2018, a significant amendment was performed on 23-May-2019 to update the case from non-case to valid case as per local reference document.  Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves patient (possibly 1 year, gender unknown) who received vaccine HIB (PRP/T) VACCINE [Act-HIB] lot number not reported via subcutaneous route in the arm NOS on 30-Nov-2018.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant:Possibly live vaccines.  It was a case of actual medication error due to inappropriate route of vaccination.  No adverse event was reported.   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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  Information on the batch number was requested.  Addendum: significant correction was performed on 23-May-2019 to update the case from non-case to valid case as per local reference document.  Documents held by sender: none.
infection; Initial information received on 22-Oct-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional.  This case involves Adult male patient who had infection after receiving INFLUENZA VACCINE.  The patient's medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious infection (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available.  No laboratory data reported.  It was reported "Anybody get sick I got a infection several days on antibiotics no shot for me this year."  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information on the batch number for this case.
Information has been received from a physician concerning a male patient who on an unspecified date was vaccinated with a 0.65 ml dose of Zostavax. Subsequently the patient experienced an outbreak of shingles. Unspecified medical attention was sought. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
FEVER, DRY COUGH, CONGESTION, DIARRHEA - OUTPATIENT PROGRESS NOTE  09/13/21 ASSESSMENT AND PLAN  Diagnoses and all orders for this visit:  Pneumonia due to COVID-19 virus   Patient was hypoxemic to 8 7% on 2 L of oxygen on my exam today.  He was also in mild respiratory distress due to hypoxia and tachypnea.  991 was called in for urgent transfer of the patient to the hospital.   SUBJECTIVE   Patient is a 70 y.o. male who presented with his wife for evaluation of cough, shortness of breath, nausea, vomiting and positive Covid test results.  Patient has been having the symptoms for past few days.  Initially he had over-the-counter Covid test which was negative, he tried taking over-the-counter medication and repeated his Covid test which came back positive.  He called our office to get the Covid test on 9/10 recently been positive.  Patient reports he has intermittent severe cough and sometimes noted difficulty in swallowing food.  Denies any chest pain or shortness of breath but does report getting short of breath when he coughs.  Denies headache, abdominal pain or swelling in the legs.  Patient also noticed loose bowel movement this morning. Patient had both doses of COVID vaccine in March. He didn't take his regular medication in last few days due to feeling sick.    ED to Hosp-Admission Discharged  9/13/2021 - 9/14/2021 (22 hours) Hospital - Acute respiratory failure with hypoxia  DETAILS OF HOSPITAL STAY   Presenting Problem/History of Present Illness/Reason for Admission Hypoxemia  Acute respiratory failure with hypoxia  COVID-19 virus infection      Hospital Course Patient is an 70 y.o. male with past medical history of hypertension, hyperlipidemia, hypothyroidism presented to the emergency room with 1 week history of cough, generalized fatigue and shortness of breath.  Patient was noted to be hypoxic at 87% at room air at PCPs office and sent over here.     Initially patient was on 2 L of oxygen via nasal cannula.  Patient was diagnosed with COVID-19 last Thursday but having symptoms for at least 10 days.  After initiation of remdesivir and steroid we were able to wean patient off oxygen and today patient saturating 94 to 95% at room air and was able to ambulate without any symptoms.  Though his cough is still persisting.  Blood culture did not grow any organism.  Patient is stable from our standpoint to be discharged home on p.o. steroid for another 10 days.  I recommend patient to come back to hospital if worsening symptoms including fever
arm red, slightly warm to touch. 2"x3" inch area (right deltoid area.) No fever.
injection site pain; SWELLING; redness; general aches and pains; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in an unspecified number of an adolescent patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site pain, swelling, erythema and general body pain. On an unknown date, the outcome of the injection site pain, swelling, erythema and general body pain were unknown.   It was unknown if the reporter considered the injection site pain, swelling, erythema and general body pain to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. The reporter felt they were getting more patients reporting adverse events with Bexsero. Some were from call backs after receiving Bexsero. But also, they were calling patients back for a 2nd dose and patients were asking if they would get the same adverse event with 2nd dose. Complaints were pain at the injection site, swelling, redness, general aches and pains. The reporter wondered if they got a bad batch of vaccine. The reporter did not consent to follow up. This case is 1 of the 13 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR210157:same reporter US-GLAXOSMITHKLINE-US2020AMR210158:same reporter US-GLAXOSMITHKLINE-US2020AMR210162:same reporter US-GLAXOSMITHKLINE-US2020AMR210160:same reporter US-GLAXOSMITHKLINE-US2020AMR210163:same reporter US-GLAXOSMITHKLINE-US2020AMR210164: US-GLAXOSMITHKLINE-US2020AMR210159:same reporter US-GLAXOSMITHKLINE-US2020AMR210161:same reporter US-GLAXOSMITHKLINE-US2020AMR210165:same reporter US-GLAXOSMITHKLINE-US2020AMR210166:same reporter US-GLAXOSMITHKLINE-US2020AMR210156:same reporter US-GLAXOSMITHKLINE-US2020208660:same reporter
inadvertently gave a two-year-old the Quadracel vaccine with no reported adverse event; Initial information was received on 05-Apr-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old male patient to whom nurse inadvertently gave DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Prophylactic vaccination.  On 30-Mar-2023, the patient received 0.5ml of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE, suspension for injection (lot C6002BAand expiry 18-May-2024) (strength,: unknown) via intramuscular route in the left thigh prophylactic vaccination (immunization).  On 30-MAR-2023 the patient developed a non-serious inadvertently gave a two-year-old the quadracel vaccine with no reported adverse event (product administered to patient of inappropriate age) (latency same day)  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE (QUADRACEL) was not applicable.  At time of reporting, the outcome was Unknown for the event inadvertently gave a two-year-old the quadracel vaccine with no reported adverse event.  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.
Information has been received from a nurse practitioner concerning a 16 year old female patient with an irregular heart rate, menstrual issues and migraines who was vaccinated intramuscularly with the third 0.5 mL dose of GARDASIL.  Concomitant therapy included hormonal contraceptives (unspecified).  Subsequently, It was reported that the patient experienced a seizure after her third dose of GARDASIL.  The patient sought unspecified medical attention.  Diagnostic studies performed included neurological testing and a sleep study but no results were reported.  At the time of this report, the patient had not recovered.  No product quality complaint was involved.  Upon internal review, seizure is considered to be an other important medical event.  Additional information has been requested.
Patient received PNEUMOVAX IM in Left deltoid at PCP on 8/9/16 at 1100. Pt reported that the evening after the PNEUMOVAX was administered, her chronic (since 2009) right shoulder pain worsened. Patient tried ice packs, tramadol with no relief. Patient presented to emergency department on 8/10/16, where physician reported physical exam: Right shoulder - no swelling/redness/warmth, but tender to palpation generalized even on simple touch. Her PCP had written for NORCO 7.5 mg and pt wanted to go with that and continue heat/ice packs TID prn. Physician informed pt. that pain may be related to shoulder surgery in 2009 (rotator cuff repair, arthritis in AC joint, decompression). Discharged home in stable condition. On follow up call on 8/11, pt. reported pain is less sharp, is taking tramadol, hydrocodone and muscle relaxers, doing ice packs. Symptoms: and Right shoulder pain. Treatment: Tramadol 50 mg TID, Acetaminophen/hydrocodone 7.5mg/325mg mg TID, Tizanidine 4 mg TID.
Patient is fully vaccinate.  ED visit 12/24/2021.  Patient test + for COVID 12/24/2021. Chief complaint; SOB.  38-year-old female who presents to the ED complaining of cough, shortness of breath, chest pain, body aches, subjective fever, diarrhea for the last 2 days. She was exposed to someone with COVID-19 at work. Her chest pain is across her anterior chest and feels like a tightness worse with taking a deep breath. Vital signs reviewed and found to be within acceptable limits. SpO2 99%  She was given IV fluids, Tylenol, Robaxin, Robitussin-AC.Given the patient's history of lupus she was given a referral for monoclonal antibody therapy.The patient was discharged and told to return to the ED immediately with new or worsening symptoms.
Breakthrough - Pt Deceased, cant confirm Vaxx   1st dose - pfizer - 3/10/2021 - EN6207 2nd Dose - p[fizer - 3/31/2021 - EP7533 3rd dose - pfizer - 11/22/2021
I have had allergic reaction to wear my lips and face hands and feet; break out in hives; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 17Sep2021 14:00 (Batch/Lot number: unknown) at the age of 35 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications (also reported as Other medications in two weeks: None). The following information was reported: DRUG HYPERSENSITIVITY (medically significant, disability) with onset 17Sep2021, outcome "not recovered", described as "I have had allergic reaction to wear my lips and face hands and feet"; URTICARIA (medically significant, disability) with onset 17Sep2021, outcome "not recovered", described as "break out in hives". The events "i have had allergic reaction to wear my lips and face hands and feet" and "break out in hives" were evaluated at the physician office visit. Therapeutic measures were taken as a result of hypersensitivity, urticaria which is Steroid shot an EpiPen was given to the patient and Benadryl.  Additional information: The patient had no covid prior vaccination and not covid tested post vaccination. No other vaccine in four weeks. It was added that the events last anywhere from an hour to two hours and they reoccur throughout the whole day. The events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
fever; feels sick; arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), ILLNESS (feels sick) and PAIN IN EXTREMITY (arm hurts) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PYREXIA (fever), ILLNESS (feels sick) and PAIN IN EXTREMITY (arm hurts). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever), ILLNESS (feels sick) and PAIN IN EXTREMITY (arm hurts) outcome was unknown.            No concomitant medications were provided by the reporter.
coughing, choking, limp, diaphoretic, was breathing shallow & slow approx 10mins recvd 02 by mask;no fever-poss bronchospasm h/o bronchiolitis
Initial report received from a healthcare professional (pharmacist) on 29 August 2012. A male patient with medical history of diabetes and elevated cholesterol and no reported concomitant medications received intradermal FLUZONE (batch number: UT4463BA) in the deltoid on 27 August 2012. On 27 August 2012, after vaccination the patient experienced large red, rash, itching area around injection site on arm and lump at injection site. At the time of this report, the events had not resolved. Documents held by sender: none.
Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 PAIN IN EXTREMITY (Arm pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient had pain in the arm and is bothering her for about 3 months no.  No concomitant medication was reported  No treatment medication was reported