chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from medical records concerning a 3 weeks old male with a history of serotonin syndrome (SSRI) and jaundice neonatal who on 21-NOV-2008 was vaccinated with a first dose of hepatitis B virus vaccine(manufacturer unknown). On approximately 08-DEC-2008 the patient was taken to the clinic by parents for evaluation because of a 12-24 hour history of slight cough and runny nose. They reported that he had been a little fussy, but feeding. The physician's physical exam showed that the lung was clear to auscultation without rales, rhonchi, or wheeze. Respiratory rate was 40-50 and unlabored. Impression was a 3-week newborn with an upper respiratory infection. Recommendation was bulb syringe for removing secretions and to follow up if symptoms did not improve in 3-5 days or if fever developed. On 02-JAN-2009, the baby was brought in by the mother to see the physician with primary complaints about a bad cough, rattling in his chest that started 3-4 days prior. He might have had a slight fever initially but none for the past 3-4 days. She reported that his appetite might have been a little decreased. The physicians' examination showed clear tympanic membranes, nares slightly congested, oropharynx with good moist mucus membranes, lungs clear to auscultation without rales, rhonchi or wheeze. Respiratory rate was 40-50 and unlabored. Impression was upper respiratory infection and cough in a 6-week old infant. Recommendation was that parent was to continue to monitor him and could use TYLENOL for comfort. Also discussed use of a humidifier or a vicks vaporizer and to follow up if no improvement in 1-2 weeks. On 15-JAN-2009, the baby was vaccinated with a first dose of ROTATEQ PO, PEDIARIX in left thigh, PREVNAR IM in right thigh and ACTHIB IM in right thigh. On 11-FEB-2009 the baby was brought to clinic by father who said the baby had red cheeks, crying and had a temperature of 100 axillary. Physical exam was normal. Impression was acute fever, and rule out strep infection. A rapid Streptococcus group A test was done and was negative. Plan was to continue checks, TYLENOL BID, observe behavior and call for temp>101, dry diaper for 6 hrs, vomiting or respiratory distress. On 17-APR-2009 the patient was brought in for a clinic visit with complaints of cold. He was pulling his right ear and had no fever. He was congested for 4 days. On examination his ears and tympanic membranes were abnormal. The abnormal findings were that his tympanic membranes was dull and bulging. The physicians' impression was right otitis media. The plan was to put the baby on AMOXIL 125/5 and to use humidifier. Additional information is not expected. Medical records will be provided upon request.
My hand is still itching; The itching started yesterday but it got worse; I had an allergic reaction; I had it broken all over my face, all over my arms and my legs; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FH8020), dose 1 via an unspecified route of administration, administered in left arm on 11Nov2021 (at age of 58-year-old) as dose 1, single for covid-19 immunization. Medical history included thyroid cancer and blood pressure from an unspecified date and unknown if was ongoing. Concomitant medications included levothyroxine (LEVOTHYROXINE) for an unspecified indication and amlodipine besilate (NORVASC) taken for blood pressure measurement start and stop dates are not reported for both. The patient did not receive any prior vaccinations within 4 weeks. The patient said, my hand is still itching, the itching started yesterday but it got worse on 12Nov2021, I had an allergic reaction; I had it broken all over my face, all over my arms and my legs (all medically significant) on Nov2021. The patient stated, "Yeah, I got my COVID shot Thursday, my Pfizer COVID shot, first shot Thursday at work and just today, I had been to emergency room. I had an allergic reaction. I had it broken all over my face, all over my arms and my legs and in the emergency room they gave me Benadryl and stuff and 'not clear'. My hand is still itching. That's why I called because I had an allergic reaction when I took the shot." Patient stated, "Yes I took my first. I will take my second 02Dec." Treatment for side effects (Other than Benadryl) was none. Patient stated, " Benadryl; No, they gave me in the emergency room. I don't know how many doses they gave me. They gave it my arm. They gave me an IV, so I don't know how many." For reassurance, patient stated, "No, that's it." Reporter seriousness for the events was unspecified. The outcome of events my hand is still itching, the itching started yesterday but it got worse not recovered, I had an allergic reaction; I had it broken all over my face, all over my arms and my legs was unknown.  Follow-up attempts are completed. No further information is expected.
Patient had syncope at work with periorbital swelling and closure of airway with swelling of the mouth.  patient was given subq epi pen, solumedrol, and bendryl via EMS prior to ER arrival. 21:45pm on 05/06/2021
This spontaneous report as received from a registered nurse refers to a 56 year old female who on 23-OCT-2012 at 6:22 pm, was vaccinated intramuscularly in the deltoid with the dose of PEDVAXHIB (lot # H012570, dose and expiration date not reported). The patient received PEDVAXHIB in error when she was suppose to get an unspecified Hepatitis B Vaccine. The patient was vaccinated intramuscularly in the deltoid with a dose of RECOMBIVAX HB (lot number H014132, expiration date: 08-FEB-2015, dose not reported) on 15-NOV-2012 at 1:36 pm. There was no adverse event. This is one of several reports received from the same source (other patients are captured under MARRS # 1211USA004476, 1302USA004704 and 1302USA004703). Additional information is not expected.
Site: Pain at Injection Site-Mild, Additional Details: pt has pain at injection site to this date, but husband says pt still has range of motion.  has fu with md this tuesday. saw md x1 (date unknown)
No reflux since receiving Moderna vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-May-2021 and was forwarded to Moderna on 14-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (No reflux since receiving Moderna vaccine) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 004M2dA) for COVID-19 vaccination.     The patient's past medical history included Acid reflux (esophageal) (30 years old Chronic Acid Reflux Condition.), Heart disease, unspecified and Peripheral arterial disease. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) and ALUMINIUM HYDROXIDE, MAGNESIUM CARBONATE, SODIUM ALGINATE (GAVISCON [ALUMINIUM HYDROXIDE;MAGNESIUM CARBONATE;SODIUM ALGINATE]) for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (No reflux since receiving Moderna vaccine). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (No reflux since receiving Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up information was received : updated reporter name. On 22-Jun-2021: Significant follow up:: Details updated were: patient race, Height and weight, Relevant History, Vaccine dose 2 info with time of administration. No new event was reported.
Chills all night, later developed headache. Next day still had headache, and had generalized body aches and fatigue.
Patient was playing basketball within a couple of hours of the shot. He was hit in the arm, in the exact spot that the shot was administered, during the game and the arm swelled up drasticly. In addition, he had to use his inhaler for a coincident breathing difficulty.  His swelling was quite a bit less, later in the evening.  He was fully recovered the next morning.  He wanted it said that he had a bit more bleeding than normal from the shot location, right after the needle was withdrawn. It stopped after a few minutes.
A Pfizer pediatric dose (orange cap) was administered without the diluent on 1/31/2022. The pharmacist on duty followed up with the patient's mother the next day and the mother said that he is doing okay. The only side effect that the patient experienced was a sore arm at the injection site.
Sharply declining vision in right eye, diagnosed ( )     cataract requiring surgery                                                                                                                       4, June 18
Left leg hives from top to bottom of leg, right leg hives from thigh to knee. Patient went to urgent care.  Started on 3 day course of prednisone.
After receiving his Pfizer booster dose, the patient reported shortness of breath and chest pain. We called EMS. EMTs came and examined the patient. They determined the patient is fine and asked if he still wants to go to hospital. The patient declined and stayed at the vaccination site another ~30 minutes. We made sure the patient is fine and able to drive before letting him go. We also educated his son on when he has to call EMS.
Body aches; Neck pain; Painful head; Fever/  lowest 99.9, highest 101.4; extremely cold extremities; lethargic; This is a spontaneous report from contactable consumer, the patient. A 63 years old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration on left arm on 24Mar2021 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included Hypertension, hypothyroid, obesity and collagenous colitis. Concomitant medication included famotidine (MANUFACTURER UNKNOWN), torsemide (MANUFACTURER UNKNOWN), valsartan (MANUFACTURER UNKNOWN), methylcellulose (CITRUCEL), vitamins nos, minerals nos (CENTRUM) for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an unspecified route of administration on left arm on 03Mar2021 at 13:45 (at the age of 63 years old) as a single dose for COVID-19 immunisation, also received MACROBID and was allergic to it. Prior to the vaccination, the patient was not 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-19 vaccine. On 25Mar2021 at 09:00, patient experienced body aches including neck and head more painful to hold up head, fever at (lowest 99.9 range and highest 101.4 range), extremely cold extremities in hands and feet this lasted for 36 hours. lethargic lasted for 3 days and total of 5 days. The lab data on 25Mar2021 included body temperature and ranges between lowest 99.9 and highest 101.4. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures and treatments were not taken for the adverse events. The clinical outcome for the events cold extremities recovered on 26Mar2021 at 21:00, while the event of lethargy was recovered on 27Mar2021, while the events body aches, neck pain, head pain, fever, cold extremities in hands and feet was recovered on 30Mar2021.   No follow-up attempts are needed. No further information is expected.
Symptoms lasted approximately 36 hours. Felt extremely sleepy/tired 15 minutes after injection. A few hours later I developed a headache and minor body ache. The next morning, the body aches were worse and I had chills & a fever of 101.6.
suspected vaccination failure; My Mom had shingles; Shot was mildly painful; Covered with oozing rashes / couldn't even wear a light shirt; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and rash. On an unknown date, the outcome of the vaccination failure, shingles, pain and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and rash to be related to Shingles vaccine.  Additional details provided were as follows: Age at vaccination was not reported. The reporter was the patient's daughter/son. The patient received the Shingles shot which was midly painful and experienced Shingles.The patient was covered with oozing rashes front and back and could not even wear a light shirt but put a towel in the elastic waistband of her slacks. The reporter visited the patient daily to make sure that she had at least one or two meals. Follow-up was not possible as no contact details available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Initial misuse report received from a healthcare professional on 19 November 2013 and the case was received on 21 March 2014. A 10-month-old patient (gender was not reported) had received a dose of 0.5 ml FLUZONE (batch number, route and site of administration was not reported) on an unspecified date. No adverse event was reported. List of documents held by sender: none.
COVID 19; COVID 19; This is a spontaneous report from a contactable consumer. The reporter is the patient. A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6198), in right arm, on 31Mar2021 as dose 2, single (Lot number: ER2613), in right arm and on 31Dec2021 as dose 3 (booster), single at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "IBS"; "constipation". There were no concomitant medications (No other medication in 2weeks). Past drug history included: gabapentin, reaction: "known allergies: gabapentin". The following information was reported: vaccination failure (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Aug2022) Positive; (unspecified date) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 including PAXLOVID from 20Aug2022 to 24Aug2022. Patient also had rebound infection. Patient was tested positive on 28Aug2022 using a BinaxNow home test.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient fainted due to possible fear of needles, patient got dizzy and fainted.  Patient was talked to and tapped and woke up, EMS came later and checked vitals and all was good.
Underarm and lower neck are swollen and painful on the side shot was administered; running fever and chills for 24 hours so far, general joint aches
8 days post vaccination dose 1, injection site redness 2" in diameter with swelling, tenderness, and warmth and axillary lymph pain.
Red, warm swelling around injection site (R thigh). Rash spreading up to hip and down to knee.
Pt received Hep-A and Prevnar at 11:30 AM. Went home and had lunch at 12:15 PM. /// /// /// which she had before w/o reaction. About 12:30 PM, mother noted "red blotches" all over. Pt returned to office at 14:00 PM and found to have multiple hives and (wheal /// reaction), on face, abdomen, buttock and legs. No swelling. No wheals. Otherwise, well.
Approximately 20-25 min after vaccination, after leaving 15 min observation time, daughter started complaining of a ball in her throat and "closing sensation"
This spontaneous report was received from a Medical assistant referring to multiple unknown patients of unknown age and gender. Patient's concurrent conditions and medical history were not reported. On an unspecific date the patients were vaccinated with improperly stored ROTATEQ (lot # L037924, expiry date 22-JUN-2017) concentration, dose and route of administration were not reported. It was reported that the temperature excursion was for 46 minutes at 1.7 degrees C, according to the data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Started itching around day 7 post vaccination and rash appeared in the axilla area of both arms and also on my chest on day 9 post vaccination.
Sick a few days later intense pain in stomach, after testing found a clot in deep vein, never had any clots.
Severe acute myalgia to RUE. 10/10 pain. Went to local ER.
Systemic burning sensations throughout all parts of body externally like in spine, back and extremities and in internal organs like the stomach and lower abdomen. My burning started in my head/ scalp, which is now numb! My neurologist suspects small fiber polyneuropathy. Skin changes and discoloration. Loss of body hair in extremities. Muscle twitching. Numbness and tingling in different areas of body. Over 15 pounds of unintentional weight loss. Cessation of menstrual cycles (I have always been very regular!) Increased tinnitus. Increased anxiety, panic, insomnia and PTSD due to symptoms. None of symptoms have resolved and I am currently 13 weeks post dose 2 of Covid 19 vaccine. I am terrified for my health!
Pt reporting standard minor reaction around the shoulder the day following the vaccination. That evening the skin on her hands began feeling like it was burned while washing her hands. No new chemical/brand exposure in the house.  There isn't pain in general, but when she flexes her hands the skin feels burned.
Client received IZs at 5 pm began developing itchy spots on face in the morning. Approximately 8-10 spots were clearly visible around her eyes.
diagnosed with covid 1/14/2022, vaccinated 02/03/2021 and 03/03/2021. nasal congestion, fever chills as symptoms
her liver enzymes, specifically her ALT and AST, were elevated 3 times higher than normal; her liver enzymes, specifically her ALT and AST, were elevated 3 times higher than normal; feeling tired; having pain/feeling like it was coming from the inside out; This is a spontaneous report received from a non-contactable reporter (consumer) from Medical Information Team, Program ID. The reporter is the patient.  A 61-year-old female patient received BNT162B2 OMI XBB.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in arm for COVID-19 immunization; influenza vaccine (FLU [INFLUENZA VACCINE]), as dose number unknown, single (Batch/Lot number: unknown), in arm for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALANINE AMINOTRANSFERASE INCREASED (medically significant), ASPARTATE AMINOTRANSFERASE INCREASED (medically significant), outcome "unknown" and all described as "her liver enzymes, specifically her ALT and AST, were elevated 3 times higher than normal"; FATIGUE (non-serious), outcome "unknown", described as "feeling tired"; PAIN (non-serious), outcome "unknown", described as "having pain/feeling like it was coming from the inside out".  Clinical course: The reporter considered events as non-serious. The patient was calling in for the side effect of the COVID-19 shot. She got her flu shot and COVID-19 shot at the same time on two different arms. "Was that possible that it was from the shot?" The reporter reported being administered COMIRNATY in one arm and the flu vaccine in the other arm on the same day/visit. Afterwards, the caller experienced feeling tired and having pain. The pain was further described as "feeling like it was coming from the inside out". The patient had lab work done 2 to 3 days after the COMIRNATY and flu vaccinations and her liver enzymes, specifically her ALT and AST, were elevated 3 times higher than normal. When probed to clarify the name of the other vaccine other than the COMIRNATY vaccine: Transferring agent stated, "She only got a total of two vaccines. The first, she got COMIRNATY in one arm and then in the other arm she got flu vaccine. I don't know the brand of the flu vaccine. So, she got the COMIRNATY and the flu vaccine at the same time, but they were in different arms. Yes, same day, that's correct".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Part of the dose was administered intramuscularly and part of the dose was administered subcutaneously with no reported adverse event; Initial information received on 30-Oct-2023 regarding an unsolicited valid non-serious case received from a Pharmacist.  This case involves an unknown age and unknown gender patient where part of the dose of vaccine influenza quadrival a-b vaccine [Fluzone QIV] was administered intramuscularly and part of the dose was administered subcutaneously with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza quadrival a-b vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation (incorrect route of product administration). There will be no information available on the batch number for this case.  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the 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 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.
Immunizations on Sept 28, 2007.  Rash started on Oct. 9. Erythematous rash spots on entire trunk including diaper area. Has had a runny nose for a couple of days.
Difficulty swallowing, palpitations, dry mouth. Patient left and returned to parking lot and was assessed by the EMS-cleared
Shakiness, pressure in chest, unfocused vision about 10 minutes after receiving vaccine.
New onset vertigo about 4 weeks after booster dose of Covid vaccine.  Cause of vertigo still under investigation but BPPV, vestibular migraine, intracranial abnormality ruled out. No prior history of vertigo in this patient.
Sweating, loss of color in skin, nausea, light-headedness, dizziness.