chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nurse reports a Physician Assistant administered a dose of Shingrix to a patient that was reconstituted with a sterile diluent instead of the supplied AS01B diluent; Inappropriate age at vacciner administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 31-year-old female patient who received Herpes zoster (Shingrix) (batch number 75JT4, expiry date 30-SEP-2025) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Nurse reports a Physician Assistant administered a dose of Shingrix to a patient that was reconstituted with a sterile diluent instead of the supplied AS01B diluent) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vacciner administration). The outcome of the wrong solution used in drug reconstitution and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 01-NOV-2023 The nurse reported a physician assistant administered a dose of Shingrix to a patient that was reconstituted with a sterile diluent instead of the supplied AS01B diluent. At the time of reporting, dose has not been repeated. The vaccine administration facility was the same as primary reporter. The Shingrix was reconstituted with wrong solution, which led to wrong solution used in drug reconstitution. A 31 year patient received Shingrix, which led to inappropriate age at vaccine administration. The reporter gave permission for follow-up.
stomach issue; This is a spontaneous report from a Pfizer sponsored program. A contactable other HCP and a contactable consumer (patient) reported that a 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation; palbociclib (IBRANCE), via an unspecified route of administration from 07Jun2021 to an unspecified date, at 125 mg for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced stomach issue on an unspecified date (reported as Tuesday). Patient thinks that it was related to the COVID shot she got that Sunday. The outcome was recovered after 1 day.  The action taken in response to the event for palbociclib was unknown.  No follow-up attempts are needed. No further information is expected.
three of their team members have Covid, and they all got it from different people/ high chance they are all vaccinated to some extent; three of their team members have Covid, and they all got it from different people/ high chance they are all vaccinated to some extent; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  An adult patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "exposure to COVID-19" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "three of their team members have Covid, and they all got it from different people/ high chance they are all vaccinated to some extent". Adverse event: Friend who works partly remote and partly at hospital says that three of their team members have Covid, and they all got it from different people. Though I do not know them personally, there is a high chance they are all vaccinated to some extent, though manufacturer and dosage is unknown.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.; Sender's Comments: Drug ineffective and Covid-19 are assessed as related to "COVID-19 Vaccine - Manufacturer Unknown". Limited information does not allow a medically meaningful assessment. Details regarding the vaccine dosing schedule and event onset date are not reported. The case will be re-evaluated upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-202200028596 same reporter/drug/AE, different patients;US-PFIZER INC-202200027172 same reporter/drug/AE, different patients;
1st on 05/2021, 2nd on 01/2022 but pharmacy has no record of it; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in May 2021).   In January 2022, the patient received the 2nd dose of Shingrix. In January 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 11-May-2022 Reporter's comments: The patient reported that, she received a late second dose of Shingrix. She asked if another dose was needed and would it be first dose of series again or should she wait for another year to make sure. The pharmacy told her that, they had no record of 2nd dose. Additional Supportive Information: The patients received 2nd dose 8 months apart, which led to lengthening of vaccination schedule.
Immediately after the shot, I experienced discomfort in my left arm. The discomfort continued to increase over time. It began to feel like a bruise from receiving a blow to my arm. Now, I feel pain that extends from the injection site up, down, and around my arm. Sometimes I feel a numbness or tingling. Symptoms have worsened rather than dissipating. I have never had this issue after other vaccines.
no adverse effect; administered a dose of VARIVAX today via intramuscular injection; This spontaneous report was received from a pharmacist (patient) of unknown age referring to herself. The patient's concurrent condition, medical history and concomitant therapy details were not reported.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), 1 dosage form, intramuscularly (lot# and expiry date were not reported) for prophylaxis (Incorrect route of product administration). No adverse events were reported. No product quality complaint was involved.
Approximately 5 minutes after receiving patient vomited x1, became pale, dizzy. She also was slightly hypotensive with BP 85/62, pulse 60-88 BPM. Patient was monitored for 30 minutes, rechecking vital signs every 5 minutes and monitored with a continuous pulse  ox. Oxygen saturation remained 98-99 % throughout, RR 18-20. 10:30 AM Patient's symptoms resolved and she reported feeling better. Patient left clinic with dad.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2022 at 1:06 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 25-Mar-2022 at 1:06 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021. Patient received booster dose on 25-Mar-2022 at 1:06 PM. No treatment medication was reported by reporter.   This case was linked to MOD-2022-542869.
Patient presented to emergency department on 10/22/2021 with bloody, loose stool. She reported having symptoms of cough and sinus drainage about a week before presentation. She was found to be COVID-19 positive during admission screening. Patient required no supportive care for management of COVID-19 symptoms during admission.
This case was reported by a physician (also the subject) and described the occurrence of rheumatoid arthritis in a 35-year-old female subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). Concurrent vaccination included hepatitis B vaccine recombinant ;manufacturer unspecified;unknown;unknown given on an unspecified date. In 2003 the subject received 3rd dose of Hepatitis B vaccine (intramuscular, unknown). Three weeks after vaccination with Hepatitis B vaccine, the subject experienced rheumatoid arthritis, hand pain and hand swelling and at an unknown time after vaccination with Hepatitis B vaccine and starting REMICADE, the subject experienced myositis and walking difficulty. Three weeks after the administration of the vaccine the subject developed pains and swelling in hands. Serologic testing was positive for rheumatoid arthritis (rheumatoid factor very high). At that time, the subject was started on PLAQUENIL and prednisone, then methotrexate and at the time of the report was currently on REMICADE. According to the subject, since starting REMICADE, she had now developed myositis "making walking very difficulty" (walking difficulty). The subject did not know which brand hepatitis B vaccine was administered. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
This spontaneous report was received from a nurse refers to a child patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VAQTA injection 25/0.5 (unspecified unit), 0.5 ml once intramuscularly (lot # M033611 and expiration date: 02-MAR-2018) for prophylaxis. No adverse effect reported. There was no product quality complaint (PQC) reported. No further information was obtained. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1803USA002039: US-009507513-1803USA002040.
Fever of 102 beginning hour 9 after first dose of vaccination and lasted for 18 hours.
Left deltoid and Left outer aspect of upper arm swollen, red, hot to touch, denies pain, DR notified and see client. Advise to apply ice or cold compress and take Motrin.
Patient had an injection site reaction (redness and swelling) as well as fever, muscle ache, and chills. She is currently taking ibuprofen to reduce inflammation from the reaction.
Temperature 104 degrees Fahrenheit, fussy, cries when moved- 04/01/2005 @ 3:30.
It looks like we had one syringe over here that is broken; This is a spontaneous report received from a contactable reporter (Pharmacist) from product quality group.  A female patient received pf-06928316 (ABRYSVO), as dose number unknown, single (Lot number: HF5016, Expiration Date: 28Feb2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "It looks like we had one syringe over here that is broken". Additional information: It was reported that they had one syringe that was broken, and they were hoping to get a replacement because it was a broken syringe. This never reached the patient because they saw that the tip was broken. They could not even twist a needle on to it because it's broken. It was 1 syringe, so 1 milliliter. It's just a defective syringe so that's the reason why they never got to give it to the patient. They had to use a different syringe for her. The sample of the product was available to be returned, if requested.  Investigation results included: Reportability Determination: After further review the Reportability Determination statement was not correct in the original assessment. This is Medical Device Related. Reportability Determination: This complaint for the tip was broken. We could not even twist a needle on to it because it's broken for ABRYSVO sfdpo 5x0.5ml gvl+syr is a reportable malfunction. If it were to recur, it could likely cause or contribute to death or serious injury. This event is NOT a reportable malfunction for rest of world (ROW) since the deficiency of the device was found prior to use on the patient and the deficiency would always be detected.   The reporter considered "it looks like we had one syringe over here that is broken" not related to pf-06928316. Causality for "it looks like we had one syringe over here that is broken" was determined associated to device constituent of pf-06928316 (malfunction).  Follow-up (12Sep2023): This is a spontaneous follow-up report received from the product quality group. Updated information includes: investigation results.; Sender's Comments: A possible contributory role of the device constituent cannot be excluded for the reported event based the information available
arm pain from the moment he received tie injection. Hands and fingers went numb. was told arthritis in shoulder. Went to Er on the 20th of july and a CT scan was done . Had stroke on the 21st . two blood clots were found
This spontaneous report as received from a pharmacist via a company representative refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 16-FEB-2018, the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date in February 2018, the patient developed a cough. The outcome of cough was unknown. The reporter considered cough to be related to PNEUMOVAX 23.
Information has been received from a physician concerning a female (demographics not provided) who on an unspecified date in January 2007, was vaccinated with Gardasil (lot # not provided). That same day the patient experienced dizziness after the vaccination. At the time of this report the patient had not recovered from the dizziness. Additional information has been requested.
She had the Johnson and Johnson and the Moderna booster; It wiped her out for a couple days, just tired; slept for about 18 hours; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (slept for about 18 hours), INTERCHANGE OF VACCINE PRODUCTS (She had the Johnson and Johnson and the Moderna booster) and FATIGUE (It wiped her out for a couple days, just tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Johnson & Johnson COVID19 Vaccine (LOT 1805025) on 24-Mar-2021. Past adverse reactions to the above products included No adverse reaction with Johnson & Johnson COVID19 Vaccine.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (She had the Johnson and Johnson and the Moderna booster). On an unknown date, the patient experienced HYPERSOMNIA (slept for about 18 hours) and FATIGUE (It wiped her out for a couple days, just tired). On 27-Oct-2021, INTERCHANGE OF VACCINE PRODUCTS (She had the Johnson and Johnson and the Moderna booster) had resolved. At the time of the report, HYPERSOMNIA (slept for about 18 hours) outcome was unknown and FATIGUE (It wiped her out for a couple days, just tired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Patient had the Johnson and Johnson and the moderna booster, and her doctor advised it was ok.  Treatment information was not provided.  Company comment: This is a case of interchange of vaccine products (received Johnson and Johnson Covid-19 vaccine) of this 74-year-old, female patient, with no disclosed medical history, who experienced the non-serious, unexpected events of hypersomnia and fatigue. The events occurred on unknown date after the dose of Moderna vaccine. The rechallenge is not applicable as patient only received one dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.; Sender's Comments: This is a case of interchange of vaccine products (received Johnson and Johnson Covid-19 vaccine) of this 74-year-old, female patient, with no disclosed medical history, who experienced the non-serious, unexpected events of hypersomnia and fatigue. The events occurred on unknown date after the dose of Moderna vaccine. The rechallenge is not applicable as patient only received one dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Dizziness, weakness, difficulty breathing, diaphoresis, nausea, angioedema of the face.
Rcvd BCG vaccine in another country 5/23/09.  Reports to Dr. 7/8/09 & finds 1.8 cm X 2.5 cm round bullous lesion right upper arm.  No erythema pus blood, & drainage noted.  Mother indicates pt w/o pain.  Mother covering lesion.  Returning to clinic monthly to recheck.
Ecchymosis of deltoid extending halfway down upper left arm.  Experienced dizziness the morning of 11/17/05 and bruising at site of injection which slowly progressed down left arm.
On 8-9-2010 client was given H1N1 0.1ml. intradermally instead of TB-PPD in the left inner forearm. 8-11-2010 - Injection site has 2 cm reddened area very slight. No c/o discomfort.
PT INITIALLY HAD ACUTE LIVER FAILURE 1 WEEK AFTER SECOND MODERNA VACCINE. THIS EVENTUALLY RESOLVED. PT NOW INPATIENT AT SHANDS BONE MARROW TRANSPLANT UNIT WITH SEVERE APLASTIC ANEMIA. HER HEMATOLOGIST NOTED IN HIS HISTORY AND PHYSICAL THAT THERE IS A SRONG POSSIBILITY THAT THIS IS VACCINE RELATED.
Get weak as well as other neurological symptoms and lack of mobility; Get weak as well as other neurological symptoms and lack of mobility; Get weak as well as other neurological symptoms and lack of mobility; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558).  A 70-year-old female patient received BNT162b2 (BNT162B2), 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: NEUROLOGICAL SYMPTOM (non-serious), ASTHENIA (non-serious), MOVEMENT DISORDER (non-serious), outcome "not recovered" and all described as "Get weak as well as other neurological symptoms and lack of mobility".  Additional information: The reporter was reporting about the possible side effects on his mother (the patient) that have continued for 1.5 years. The patient continues to get weak as well as other neurological symptoms and lack of mobility. The reporters brother in law has identical symptoms as his mother as well as 4 other people in the area. It was not just not the reporters mother but it was brought to his attention that his brother in law and 2 other friends have identical symptoms too. They are young and they forgot how to walk, literally. They report severe headaches all the time, they are just confused, can't keep thoughts in their heads.  The reporter does not know their names only their children. The reporter was doing a job and a customer told him about their mother. she had Alzheimer's prior and after she got the vaccine she got the identical symptoms. They thought it was due to the Alzheimer's and everyone has the same symptoms. The reporter does not know which vaccine they received it was just ironic they are having that too. A total of 4 patients that experienced identical symptoms which he had reported. The first patient is his mother (70 year-old female), the second is his brother-in-law (69 year-old male) and the 3rd and 4th are 2 female patients (both elderly, both over the age of 70, exact ages unknown). Reporter reported that he does not have any other patient information to provide on any of the patients.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : PFIZER INC-202201134938 Same reporter/drug, different patients/event;PFIZER INC-202201135619 Same reporter/drug, different patients/event; PFIZER INC-202201139437 Same reporter/drug/event, different patient;
The student received a flu vaccination walked back to chair in the waiting area and fainted in her chair.  Immediately arrousable with spirits of ammonia.  Able to ambulate.
Left upper arm got red, warm, swollen area 3 1/2" x 3 1/2"
5 inch patch of chicken pox like rash at sternum and also on lower back. Raised, sesame size itchy and slightly painful rash. Noticed it a day after vaccine as a "bumpy" area. Then it progressed. Now at day 5 it is starting to clear up.
Abdominal pain, joint pain, chills. Tylenol tabs every 4 hrs.
Immediate bulge/swelling and bleeding size of quarter followed by shortness of breath. Treated with EPIPEN.
She has "restless leg syndrome"(RLS). After taking the Pfizer-BioNTech COVID-19 Vaccine, Caller reported that there was no more RLS; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included restless legs syndrome. The patient's concomitant medications were not reported. Patient mentioned that she had "restless leg syndrome". After taking the Pfizer-BioNTech COVID-19 Vaccine, she reported that there was no more Restless leg syndrome.   No follow up attempts are possible; information about lot/batch number cannot be obtained.