chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a noncontactable other healthcare professional. A patient, of unspecified age and gender, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient's medical history not reported. The patient's concomitant medication(s) included Juvederm Volbella with Lidocaine (hyaluronic acid, lidocaine hydrochloride) taken as dermal filler injection. The patient was injected with 1mL in temples; 3mL in cheeks; 1mL Volift midface; 1 mL Volbella tear trough and 3mL Volux in chin. 2 months later patient also received 0.5mL non-Allergan dermal filler in lips and a small correction of 0.1mL in the left tear trough. Following month, patient received the COVID-19 vaccine. Next morning (unspecified date), patient woke up in the morning with edema on chin and lower eyelids. This record related to Juvederm Volbella with Lidocaine. The outcome of the events recovered on an unknown date. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
raised blood pressure/blood pressure has gone up some/elevated blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 85-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Jun2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 85 years for covid-19 immunisation. The patient's relevant medical history included: "had a fall" (unspecified if ongoing), notes: He is bent over, he had a fall; "permanently bent over" (ongoing), notes: He is permanently bent over and is walking around on a cane.; "walking around on a cane" (unspecified if ongoing), notes: He is permanently bent over and is walking around on a cane.; "bad hearing" (unspecified if ongoing), notes: He says I'm an older person and have bad hearing, and speak a little slower.; "speak a little slower" (unspecified if ongoing), notes: He says I'm an older person and have bad hearing, and speak a little slower.; "elevated blood pressure" (ongoing), notes: his medication hasn't changed for 15-20 years. Concomitant medication(s) included: ATENOLOL taken for blood pressure increased. The following information was reported: HYPERTENSION (non-serious) with onset Jun2023, outcome "unknown", described as "raised blood pressure/blood pressure has gone up some/elevated blood pressure". Relevant laboratory tests and procedures are available in the appropriate section. Clinical information: Patient received bivalent pfizer covid vaccine on 20Jun and since then he had experienced raised blood pressure after that. Patient was asking could that be a side effect and will it go back to normal? Patient stated he was on mild blood pressure medication for years. Reported it happened right after he got the shot. Later on 26Jun2023 patient reported he has had no problem with blood pressure until he got the shot, it had gone up some. His doctor said don't be worried yet. He would like to know, would it return soon to normal? He said he was an older person and have bad hearing, and spoke a little slower. He took Atenolol, he had elevated blood pressure, his medication hasn't changed for 15-20 years, until got Pfizer bivalent shot. He wanted to report it to Pfizer and find out if his blood pressure will fall back down. He was bent over, he had a fall, so he had no idea of height. Clarified this happened years ago before getting the vaccine, he was permanently bent over and was walking around on a cane. He had wonderful medical care so that was not a problem. He just wanted somebody to tell him that elevated blood pressure after having Pfizer bivalent shot is not unusual.  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.
Patient developed fever, hives ~ 24 hours after vaccines. Treated with Benadryl, improved. Approximately 1 week later, again developed fever increase 103 with swelling right thigh (urticaria).
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown gender and age. No relevant medical history of the patients was reported. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL (lot number, strength, dose, frequency and route of administration were not reported). There were no concomitant medications reported. No adverse effect was reported. It was unspecified if the patients had sought any medical attention. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
No adverse event; Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine). Concomitant medication details was not reported. The patient received 0.5ml of the dark blue cap vial vaccine that was intended for use in 6-11 years old age patient, instead of the new bivalent vaccine. Treatment details was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-657506 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657506:Master case (Crosslink case with same reporter)
Patient came in on 7/12/04 for 4th ADPT, 4th PRP-T, 1st MMR, and 1st VZV. Mother noted the swelling of injection site and upper outer thigh. Patient came in to have chicken pox 7/14/04 by doctor. Patient has given the prescription Benadryl 5ml prn.
I began having a sensation of fullness in both ears, like a feeling of water was in my ears. It progressed to a humming and vibrating noise in my right ear and a vibrating noise in my left ear. Noises amplify the sounds more, making it worse. I am not sure if I need to go see a Dr about this or if it will resolve on it's own.
Client presented to flu clinic for vaccination. Client stated she had never received a flu vaccination.  She stated she had never reacted to any former vaccines.  Denied any allergies to medications. Within 1-2 minutes of administering the vaccination, client felt dizzy, light-headed, short of breath, faint and her chest felt tight. PB 106/84; HR 78 R 22. "I feel like I will be having an asthma attack." She proceeded to use her inhaler. She is also insulin dependent diabetic. Glucose level was checked and was 200. She also stated she thought a headache was started. Rechecked her vitals again: BP 106/82; Resp 24, HR 80. It was recommended to client to let nurse call EMS but she refused. Reviewed paper document showing the difference between psychological fright and anaphylaxis in Policy Manual and she agreed that it was more than likely the psychological fright as the symptoms were slowly improving. Client chose to leave the clinic area but nurse recommended that she have co-worker take her to ER if her symptoms worsened and did not continue to improve. Nurse also recommended she have her flu shot next year at a physician's office.
Headache, nausea and vomiting, ear, eye and neck pain day after immunization., headache and neck pain persisted, pt was seen in ER on 2/27. Treated in ER with IV fluids, IV reglan, toradol and benadryl.
My upper arm started feeling odd ... numbness in my left upper arm. I liken the feeling to when I?m having dental work done and my mouth/lips are numb. Through the night I developed some aching in my left shoulder.  No treatment. Just an annoying feeling of not being able to feel my upper arm. It feels cold as well.
PT GOT FLU SHOT AT APPROXIMATELY 4:10PM AND SYMPTOMS STARTED AT 9PM SAME DAY. SYMPTOMS INCLUDE SEVERE SHAKING, EXTREME COLD FEELING, MUSCLE SPASMS LASTED 3 TO 4HRS (LITTLE OVER MIDNIGHT) THEN THE NEXT DAY 11/8/2018 MUSCLE WEAKNESS AND DELIRIOUS (WAS NOT AWARE OF DATE/TIME OR LOCATION) AND SEVERE MOOD BEHAVIOR CHANGE (LIKE YELLING AT FAMILY MEMBERS). PATIENT WAS FEELING HIMSELF AGAIN AFTER 48 HOURS OF VACCINATION 11/9/2018 4PM.
Patient had a rash on her chest and abdomen that was red and had raised bumps.  Mother noticed the rash around midday- noonish.  the rash was less severe at 6:00 pm, and hardly noticeable at 8 pm.
FLUARIX given L deltoid. The next day (9/29) achiness in deltoid at injection site. Achiness has gotten worse and is the whole arm with occasional sharp pain from injection site down arm to 5 digit L hand. Has not taken TYLENOL or ADVIL. Instructed to seek evaluation by her physician.
onset stridor & urticaria 15 mins p/DTP/OPV/HIB; responded to DPH & Adrenalin; stridor resolved & urticaria resolved; referred to ER;
Patient was anxious about vaccine . After receiving patient sat for about 10 minutes and tried to stand up. He took a few steps, then passed out. He was believed to have hit his head on the floor. Patient was conscious and then sat up. He was pale and exhibited a few seconds of convulsions/seizure activity that quickly resolved. Emergency personnel was contacted and they came and evaluated the patient. His stats were normal when they arivied and they observed him fer -15 minutes. He did not show any signs of head injury & declined further medical intervention (i.e. visit to the ER.) the patients mother took him home and was advised by paramedics to contact his PCP if he shows any signs of head injury as the day progressed.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 01-FEB-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M033214, expiration date: 13-JUL-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required data has been obtained. Sender's Comments: US-009507513-1611USA004113.
Intussusception noted 07/30/2008. Bloody stool, Air intussusception reduction successful, reporting because of association of rotavirus immunization and intussusception.  9/8/2008 MR received for DOS 7/30-31/2008 with D/C DX: S/P Reduction of Intussusception.  Pt presented with abdominal pain, vomiting x10-12 and bloody stool.  IS was noted on Barium Enema following a (+) US and reduced successfully. Admitted for observation o/n with no further problems.
I went in for ringing in my ear and was referred to an ear nose and throat doctor. I went to the ENT and all they did was look and tell me that nothing looked infected. I am still dealing with this at this time. I was not prescribed medication.
This case was reported by a nurse and described the occurrence of a swelling at the injection site in a 5 year old male pt who received Infanrix. On an unspecified date in 2004, the pt received the 5th dose of Infanrix (lot DTPA639B2). Concurrently the pt also received injections of MMRII and IPOL. At an unknown time after the administration of the 5th dose of Infanrix, the pt experienced swelling at the injection site which was "7 inches". The events resolved. The nurse considered the events to possibly be related to vaccination with Infanrix.
I just had diarrhea for a couple of days, my fingers were starting to tingle, this concerned me. I went to the emergency room to make sure that I was not having a stroke. The emergency room doctor did a physical touch test to ensure that I had not lost feeling in my hands, feet, arms, legs. I had a follow up visit with my endocrinologist who increased my calcium and calcitriol. This has help keep me from not having the tingle sensation.
8/30/21 at 9:30 started having numbness/tinlging to lower lips with swelling. Felt some throat tightness and chest pressure. Took benadryl and reduced. Woke up next morning and swelling present. Took another benadryl and improved with mild swelling remaining.
sinus infection; This is a spontaneous report received from a contactable consumer (patient's parent). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had an appointment today at 4PM for his second shot of the COVID-19 vaccine from Pfizer. The reporter wanted to reschedule, because the patient had a sinus infection and wouldn't be able to go. The outcome of sinus infection was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.
The day after I received the shot, my armed swelled.  The area around the shot became red and began to extend out.  My arm hurt to move. By late afternoon, I had body aches, and my head was pounding hard enough it made me nauseous.  The area around my shot remained swollen through today.  My headache has subsided - as have the body aches.  I followed the directions on the information given by the pharmacy and used ice packs, Tylenol, and lightweight clothing to help.  I did not phone my doctor.
Information has been received from a physician's nurse concerning a 13 year old female, who on 10-MAY-2008, received the first dose of GARDASIL (lot # 659180/17580), 0.5 ml, intramuscularly. Concomitant therapy included meningitis vaccine (manufacturer unspecified, lot # U2492AA). On 10-JUN-2008, the patient experienced joint pains, headache and decreased visual acuity. The patient returned for the second dose of GARDASIL (lot # 660393/0067X) on 21-JUL-2008. The patient was sent to an ophthalmologist, who diagnosed the decreased in visual acuity. The patient had a complete blood cell count (CBC) and x-ray test (results not provided). The patient would not be getting the third dose. It was not known if the adverse events had improved between the first and second dose of GARDASIL. At the time of the report, on 31-OCT-2008, the outcome of the patient was unknown. Additional information has been requested.
Received Two Doses of Heplisav-B, Not Immune; Initial report received on 26-May-2023.  A physician's assistant reported that a 24 year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient is not immune to hepatitis B after completing the series.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 21-Nov-2022, the patient received the first dose of HEPLISAV-B (Lot # 937230, expiration date 11-Sep-2023, and NDC # 43528-003-01) intramuscularly in the left deltoid. On 19-Dec-2022, the patient received the second dose of HEPLISAV-B (Lot # 937782, expiration date 23-Sep-2023, and NDC # 43528-003-01) intramuscularly in the right deltoid.  On 15-Feb-2023, 59 days after receiving the second dose and 87 days after having received the first dose of HEPLISAV-B, the patient was not immune to hepatitis B. A titer was drawn on 15-Feb-2023 and 21-Feb-2023 and both were low. No other adverse side effects reported. No pregnancy reported.  No additional information was reported.    Company Comment:  The company assessed the event as non-serious. The event was not immunologically confirmed for vaccine failure since the serological marker and titer results were not reported.; Sender's Comments: The company assessed the event as non-serious. The event was not immunologically confirmed for vaccine failure since the serological marker and titer results were not reported.
Face and eyes began to swell especially left side of face. Face became red and hot, sit of vac got swollen, sore, red. Called doctor who recommended Benadryl which helped a bit with the swelling. Next day face was swollen again to the point that pinching on upper lid of left eye. Doctor contacted who sent pt to ER. Was in ER all day on Benadryl and steroids. Discharged early evening with the following medications: Prednisone, hydraxon, cimetidine. 11/3/05 woke with swelling again and ER nurse asked her to come back again to ER to be treated spent all day there. Today doing much better, pt notes that can't work for 2 weeks due to the meds she is taking.
This spontaneous case report was received from caregiver (PVX2017-2909) on 13-Sep-2017. The report describes a 23-year-old adult female consumer who experienced fatigue, hot like fever, vomiting, anxiety and small rash on elbow following the intake of VAXCHORA for an unknown indication. It was reported that the consumer took VAXCHORA two days ago and developed adverse events an hour ago. The consumer vomited once, felt fatigued, and had a small rash on elbow. The consumer also felt hot like a fever, but the caregiver could not take her temperature. The caregiver stated the adverse events were not severe. The patient does not take any other medications but takes medications on an as needed basis. The action taken with VAXCHORA with respect to the events fatigue, hot like fever, vomiting, anxiety and small rash on elbow was not applicable. The clinical outcome of the events fatigue, hot like fever, vomiting, anxiety and small rash on elbow was unknown. Sender's Comments: Company's comments: In view of a temporal relationship between administration of VAXCHORA and the onset of the events, causality of the events with VAXCHORA was assessed as possible.
Arm was sore for 2 weeks then became stiff and unable to raise my arm.  I can now raise my arm but my muscle is still extremely painful
I made a prior report regarding the total body aches but now I have lost hearing in my right ear
Immediate pain at time of injection, pain no better a month later; pain in shoulder, especially at injection sight, when using arm. Also pain when laying on side of painful arm (left). I have intense pain when doing things like taking things on/off over my head, using arm to twist off jar lids, any kind of movement that uses the shoulder or puts pressure on the shoulder.
Vaccines don't work; Suspected COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Drug ineffective/ Vaccines don't work"; SUSPECTED COVID-19 (medically significant), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pfizer-BioNTech COVID-19 Vaccine EUA Instructions to report effects after receiving COVID-19 vaccine.  Symptoms of severe chills, muscle aches, fever, rapid heart rate, nausea, diarrhea  all lasting 48hrs with nausea continuing thereafter.  No treatment. Continued nausea, however otherwise recovered
About 12 hrs after the 2nd injection I got very severe joint pains accompanied by a fever of 100 degrees F. My legs became very weak, and I even fell, as I couldn't stand.  This episode lasted about 6 hours, but I also experienced weakness in my hands, which came and went for a full week. Both my PCP, and my rheumatologist, both said I had am inflammatory response (I do have significant arthritis). My PCP had me take an anti-inflammatory for a full week after this episode until this calmed down significantly.
newborn received Adacel instead of Hep B, no AE; newborn received Adacel, no AE; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a newborn patient (age and gender not reported) who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number not reported via unknown route in unknown administration site) instead of HEPATITIS B VACCINE on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration.  At the time of reporting, no adverse reactions were 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.
Lips and tongue were numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Lips and tongue were numb) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced HYPOAESTHESIA ORAL (Lips and tongue were numb). At the time of the report, HYPOAESTHESIA ORAL (Lips and tongue were numb) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
The Patient fainted in  front of the pharmacy after receiving the vaccines. We offered emergency assistant and observed    him and he recovered soon and was able to leave with his parents.