chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received expired vaccine; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 73-year-old female patient who received HAV (Havrix) (batch number J95H7, expiry date 22nd May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th June 2022, the patient received the 1st dose of Havrix and Havrix Pre-Filled Syringe Device. On 8th June 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-June-2022 Reporter's comment: The patient received an expired Havrix vaccine. This was patient´s first dose. The reporter consented to follow up. The Vaccine Administration Facility was same as Primary Reporter. Additional Supportive Information: The patient received expired havrix which led to expired vaccine used.
decision making (didn't choose correct route out of parking lot). When home felt brain over load to determine what pain medication to buy. Forgot what I was working on at my golf lesson 9am that morning. Had written it down but forgot that too. Memory of events came back later on that night, about 3-4 hours after the shot. Received shot in left arm get tingling feeling in left hand. Happens 1-3 times a day (always when waking up in the morning) and goes away once i shake my arm.
arm only hurt a little; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (arm only hurt a little) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 017B21A)) for COVID-19 vaccination.     No medical history was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (arm only hurt a little). At the time of the report, PAIN IN EXTREMITY (arm only hurt a little) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use included cholesterol medication Treatment information not provided.  Action taken with mRNA-1273 was not applicable
On November 11 I started feeling fatigue and on the 12th I started having a sore throat. On November 13 I had lots of congestion I tested for COVID-19 and was negative. On November 14 I stayed in the bed and didn't do much. On November 15 I lost all sense of smell and taste but still had congestion and fatigue. My husband prescribed PAXLOVID, he is a doctor. I was isolated until November 21 and was able to go back to work. By the 28th of November I was back to my normal self.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown demographics. No information regarding the patient's medical history, concomitant medications and concurrent conditions was provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL injection (dose, route of administration, lot number and expiration date were not reported). Subsequently, on an unknown date, the patient received a dose of GARDASIL 9 injection (dose, route of administration, lot number and expiration date were not reported). No adverse events were reported. Additional information has been requested.
Immediate pulse / swoosh in right ear, severe tinnitus , and tachycardia episodes.
Numbness, burning, tingling like when your body part falls asleep.  Most often at night and is in both hands bilaterally, but primarily in my fingertips.  Especially, my r. thumb.  This is painful and happens every night where I wake up and have to sit up or stand to drain the blood back to my extremity to decrease the burning sensation and even then I'm now finding it doesn't always help.  I have noticed this is happening during the day to my right hand more often and I'm dropping objects picked up with my r. hand.  I have an appt to visit my doctor regarding this because it has become so bothersome and is new onset since vaccination.
Delayed skin reaction; Below the injection site which was hot to the touch; Red rash on her arm below the injection site; Below the injection site which was swollen; Below the injection site which was itching; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (Delayed skin reaction), VACCINATION SITE WARMTH (Below the injection site which was hot to the touch), VACCINATION SITE RASH (Red rash on her arm below the injection site), VACCINATION SITE SWELLING (Below the injection site which was swollen) and VACCINATION SITE PRURITUS (Below the injection site which was itching) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN REACTION (Delayed skin reaction), VACCINATION SITE WARMTH (Below the injection site which was hot to the touch), VACCINATION SITE RASH (Red rash on her arm below the injection site), VACCINATION SITE SWELLING (Below the injection site which was swollen) and VACCINATION SITE PRURITUS (Below the injection site which was itching). At the time of the report, SKIN REACTION (Delayed skin reaction), VACCINATION SITE WARMTH (Below the injection site which was hot to the touch), VACCINATION SITE RASH (Red rash on her arm below the injection site), VACCINATION SITE SWELLING (Below the injection site which was swollen) and VACCINATION SITE PRURITUS (Below the injection site which was itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Delayed skin reaction and Vaccination site warmth added as new event. Lower level term updated for all existing events.
Approximately 2 weeks post vaccine, I started getting bumps that itched. I thought at first, it was ring worms from cats. Then I noticed at my bra site. I notice it started to spread. I had a patch on the right side underneath my bra and it spread down my back, and on the right side of my stomach. They were painful and weeping. It was a couple of weeks after the vaccine, I went to the doctor. When I noticed it was spreading is when I went to the doctor. The doctor diagnosed it as shingles. The doctor prescribed a pill I had to take, but I have no idea what it is called. It took a close to a month for it to completely dry up and go away. I am still scared from the them.
This spontaneous report as received from a other health professional refers to unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with ROTATEQ lot # M043562 expiration date of 03-JUN-2018 for prophylaxis. On an unknown date, the vaccine was incorrectly storage at a temperature of 11.8 °C. There was no previous temperature excursion. Data logger was involved. No adverse event was reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA000453: US-009507513-1708USA001110:
This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 17th September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced blister, tingling of extremity, wakefulness and pruritus. On 17th September 2018, the patient experienced erythema of extremities, injection site burning and extensive swelling of vaccinated limb. SHINGRIX was discontinued. On an unknown date, the outcome of the erythema of extremities, injection site burning, extensive swelling of vaccinated limb, blister, tingling of extremity, wakefulness and pruritus were unknown. It was unknown if the reporter considered the erythema of extremities, injection site burning, extensive swelling of vaccinated limb, blister, tingling of extremity, wakefulness and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right arm. The patient reported that vaccine burnt as it was being administered. At the afternoon, less than a day after receiving the SHINGRIX, the patient noted that the injection site was becoming red and swollen. The redness and swelling increased until it extended almost fully around her right arm. She went to her physician's office and was evaluated by the physician assistant. She went back to and saw her physician a couple of days later and was told that she should not get the second dose. Her physician filled out a report at the time she was seen related to her symptoms. She described that red blisters began to appear on the area from her knuckles to her fingertips within a few days after receiving the vaccine. She went to her physician again (the fourth visit), approximately a week after being told by her not to get the second dose of the product, to have the blisters evaluated. She was given a cream but the cream made the blisters worse. She had more blisters on her fingers. She did not have very many on her pinky finger but her ring, middle and index fingers are covered with blisters on the top. The ring finger has one blister underneath that was itchy. The tips of her fingers tingle almost continuously. This tingling has caused her to wake up several times during the night. She reported that we can still see a faint pink outline of where the redness and swelling at the injection site occurred. Emergency room visit was required. The reporter gave permission for her physician to be contacted. The reporter was unable to obtain additional information. Counseled reporter to contact the manufacturer of the cream to report her experience.
parent noticed significant redness and slight swelling at injection site; parent noticed significant redness and slight swelling at injection site; Child received Fluzone subcutaneous injection in upper arm.; Initial information received on 25-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer (patient's mom).  This case involves a 4 years old patient for whom parent noticed significant redness and slight swelling at injection site (Injection site erythema and injection site swelling) and child received fluzone subcutaneous injection in upper arm. (incorrect route of product administration), while child received vaccine INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE].  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 USP TRIVAL A-B SUBVIRION VACCINE lot number not reported via subcutaneous route  in the upper arm, for prophylactic vaccination.  On an unknown date (unknown latency), Patient's mom reported that Child received Fluzone subcutaneous injection (incorrect route of product administration) in upper arm. 24 hours later, parent noticed significant redness and slight swelling at injection site (Injection site erythema  and injection site swelling), a circle of about 3 inches in diameter. Red area took up child's entire biceps. Child had no other symptoms and no discomfort at injection site. Redness resolved within 72 hours without any over the counter (OTC) interventions.   No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event was not applicable for incorrect route of product administration and as unknown for injection site swelling at the time of reporting.  There will be no information available on the batch number for this case.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
This spontaneous report as received from a healthcare worker (also reported as medical assistant) refers to unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # K012874 and expiry date of 09-JUN-2016 or lot # K014190 and expiry date of 24-OCT-2016 or lot # J007946 and expiry date of 24-MAR-2016 or lot # K006682 and expiry date of 17-DEC-2015 (unknown route, strength and dose). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Injection site pain Muscle pain (difficult to lift left arm) Feeling unwell Fatigue  Body aches
Initial information received on 20-Dec-2018 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case involves a female patient of unknown age (reported as over 40 years old) who experienced unspecified mononeuropathy of right upper limb and pain and swelling at the injection site, while she received vaccine FLUZONE QUADRIVALENT]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. Reported as no other vaccines. On 05-Nov-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in the right deltoid. On an unknown date, the patient developed a non-serious unspecified mononeuropathy of right upper limb (mononeuropathy) and pain and swelling at the injection site (injection site inflammation) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported that on an unknown date 2weeks post injection visited urgent care and on 05-Dec-2018 to an orthopedic who prescribed her a prednisone pack. Orthopedic notes: had limited abduction 90 degrees forward post injection. Limited rotation, rotator cuff is in intact. Deltoid atrophy, intact radial and ulnar pulses. Right shoulder pain, secondary axillary nerve irritation. Recommended gentle exercises to be done at home. Will hold off on physical therapy. Diagnosis is unspecified mononeuropathy of right upper limb. (Other relevant tests included No lab data.) Final diagnosis was pain and swelling at the injection site and unspecified mononeuropathy of right upper limb. The patient was treated with PREDNISONE (PREDNISONE). Reported as it helped her pain about 50% but once treatment was done the pain returned as it was before. The patient outcome is reported as Unknown for still experiencing pain and swelling at the injection site and as Unknown for diagnosis is unspecified mononeuropathy of right upper limb. List of documents held by sender: none.
Hives that night on arms, back, head; sugar was high. Hives still there 1/2/19. Blood sugar improved.
Get the vaccine it's a little soreness at the injection site for a couple days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: Get the vaccine it's a little soreness at the injection site for a couple days). The patient was treated with paracetamol (Tylenol). The outcome of the injection site pain was resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 02-AUG-2023 This case was reported by patient via interactive digital media. The patient reported that he/she got the vaccine it was a little soreness at the injection site for a couple days, take Tylenol. It was a lot better than dealing with the full-blown shingles pain.
Ordered Hiberix / Patient that will be having  pancreatic surgery; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a adult female patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. The reporter called and wants to double check if Hiberix was ok to use in adults because she ordered Hiberix for a female patient that would be having pancreatic surgery. She noticed this past time, when she got the prescription, the age indication on the box. The Hiberix not yet administered to patient, which led to intercepted drug prescribing error. No additional details provided. The reporter did not consent to follow up.
NODULE/GRANULOMA MEASURING 1CM ON HER RIGHT SIDE OF PIRIFORM FOSSA; VIRAL ILLNESS; This spontaneous report received from a physician concerned a 38 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no allergies or medical history, had no fillers or toxins in the past, and does routinely use other products or medications. the patient was not ill in the month prior to treatment. the patient has not had any dental procedures in the last 6-12 months. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Non-company suspect drugs included: hyaluronic acid ( batch number: 18481 expiry: 31-AUG-2022, form of admin, route of admin, and were not reported) .2 ml, frequency was not reported, from 12-APR-2021, .2 ml, frequency was not reported, from 12-APR-2021, and .6 ml, frequency was not reported, from 12-APR-2021 for an unspecified indication. No concomitant medications were reported. On 18-JUN-2021, the subject experienced viral illness. On 02-JUL-2021, the subject experienced nodule/granuloma measuring 1cm on her right side of piriform fossa. Treatment medications (dates unspecified) included: vorhyaluronidase alfa. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with hyaluronic acid was not reported. The patient had not recovered from nodule/granuloma measuring 1cm on her right side of piriform fossa, and the outcome of viral illness was not reported. This report was non-serious.
Rash on torso started on 12-18-20 and got worse on 12-19-20.
No additional AE reported; A consumer received the first dose of GARDASIL-9 about 3 years ago. She has not received her second dose at this time; This spontaneous report has been received from a registered nurse (inconsistent information, also reported as a consumer) referring to a female patient of unspecified age. The patient's pertinent medical history, concomitant medications, previous drug reactions, and allergies were not reported.   Approximately in 2018 (reported as "about three years ago"), the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (formulation, administered dose, vaccination scheme frequency, route of administration, anatomical location of vaccination, lot number, and expiration date were not reported).         Up to 1-year period on an unspecified date in 2019 and by reporting time, the patient had not received her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration).  No additional adverse events (AE) were reported.
After injection patient c/o burning at site & became unconscious with facial grimacing and arms and legs becoming stiff lasting 60-90 secs then became/awoke with c/o headache and ringing of ears x 30 min. Rest x 1 hr & then discharged.
Swelling of right arm and hand. Infection at injection site. Lymph nodes swelling in right arm restricted blood flow to right arm.  Arm was cold and blue. Arm/hand was unusable for many weeks.  And still has not been restored to original state.  Multiple antibiotics, 3 rounds of steroids, multiple Ultra Sounds,  veinograph, blood work, occupational therapy, and compression wrap. Some treatments are still ongoing.
blew his nose and it was full of blood; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (reporter's husband). A 70-year old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection, Lot Number: unknown), via an unspecified route of administration on 13Apr2021 11:10(at the age of 70-years) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The reporter stated that she and her husband, just had their first Pfizer covid vaccine at 11:10 this morning and at about 2:45 on 13Apr2021, her husband was eating and he blew his nose and it was full of blood. After a couple of blows, it stopped. Case assessed as non-serious by reporter. Could this be related to the vaccine. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a 13-year-old male who in 1996 was vaccinated with a 0.5 ml dose of Varivax. Recently, the patient experienced a break through case; he had 50 to 250 lesions on the trunk and the rest of body. Unspecified medical attention was sought. No additional information to report. There was no product quality complaint involved. Additional information has been requested.