chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via a company representative and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. The reporter read in an article online that, on unspecified dates, an unspecified number of patients were vaccinated with GARDASIL (lot number, expiry date, dose, route and anatomical site of injection were not reported). Concomitant therapies were not provided. The article reported that an unspecified number of patients developed premature ovarian failure an unspecified time after receiving GARDASIL. Additionally, the article mentioned that an unspecified number of patients passed away on unknown dates, on an unspecified time after receiving GARDASIL. It was unspecified if the patients that passed away were the same patients that developed premature ovarian failure. It was unknown if an autopsy was performed. At the time of reporting, the outcome of premature ovarian failure was unknown. The reporter did not provide a causality assessment between the reported events and the GARDASIL. The cause of death was not mentioned. Additional information is not expected, as the reporting physician did not allow further contact for follow-up.
I have had ringing/tinnitus in my left ear since 2/13/21.
Patient (myself) now has recuring Bell's Palsy, Partial (L-side) facial paralysis, lasting approx 2-3 weeks per episode, with episode recurring approx. ever 6 months
became pale, lethargic, shallow breathing; thin high pitched faint cry w/in 2 hr;
no additional AE; HBP called to report a TE with PROQUAD from 8/19/2022.  Administered to this patient on 11/22/2022.; This spontaneous report was received from an other reporter referring to 1-year-old patient of gender. Information about the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On 22-NOV-2022, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) injection (0.5 mL, lot #U039621 was not valid, expiration date was not established but it was reported as 09-JUN-2023, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Product storage error).  On 19-AUG-2022, the measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) had a temperature excursion. No additional adverse event (AE) or product quality complaint (PQC) were reported (No adverse event).  This is one of several reports from the same reporter.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates in 2017, the patients were possibly vaccinated with improperly stored doses of ROTATEQ liquid orally, lot # M040270 with expiration date 29-APR-2018 and lot # M038744 with expiration date 26-APR-2018 (dose was not reported). ROTATEQ was stored between 32 and 35 degrees Fahrenheit for 11 hours and 5 minutes, and between 47 and 77 degrees Fahrenheit for 40 minutes. There was previous temperature excursion. The digital data logger was involved in recording the excursion. There was no product quality complaint involved in this case. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015613: US-009507513-1705USA015614: US-009507513-1705USA015615: US-009507513-1705USA015617: US-009507513-1705USA007801:
At least 6 to 12 weeks before my adverse event, I found myself tired enough by 6 PM that I had to take a short nap. This was a change for me as I'm quite energetic and a night person. I spoke with my PCP about my tiredness. But I had had blood work done in March which was not remarkable in any way. So I ignored the fatigue. I often get headaches when tired and I did have those on and off during that period. Around June 3, I had a headache and very intermittent chills . And I noticed that my heart rate on my Apple watch was at least 15 points higher than normal.  By June 4th it was 30 points higher. So I went to an urgent care near me where they did an EKG which was normal. They also did a rapid Covid test which.
Patient telephone on 12/21/2011 to report chill & fever. She was scheduled an appointment. She was examined and had no redness/swelling noted at appt. Patient reports to clinic again 12/22/2011. Patient with induration of 8-10 cm/no erythema/tenderness/afebrile at visit.
The day after the PREVNAR 13 injection, patient had swelling the size of an orange and it felt very hot at the injection site. Symptoms persisted for 2 days and swelling went down.
The patient could not find his card and said he was due for his 2nd dose of Moderna vaccine. The Moderna vaccine was administered then he found his card and we discovered he was a week early for his 2nd dose. He received his first dose of Moderna vaccine lot number 027A21A on March 9th and his 2nd dose of Moderna vaccine lot number 017B21A on March 30th. This was not in the 4 day grace period.
horrible itching; it is so bad that it effects my daily life.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "not recovered", described as "horrible itching"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "not recovered", described as "it is so bad that it effects my daily life.". The events "horrible itching" and "it is so bad that it effects my daily life." were evaluated at the physician office visit.  Additional Information: Subject: Patient Assistance, Customer Verbatim: Hello, I have had horrible itching without a rash since my covid vaccine. I have seen doctor after doctor and nothing. it is so bad that it effects my daily life. Wondering who to contact with Pfizer to find out if there have been any other reports of this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (04Mar2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE STROKE DUE TO OCCLUSION OF RIGHT MIDDLE CEREBRAL ARTERY
0.5 mL given IM in left deltoid at approximately 8:30 am. There was a large localized reaction on the LA-erythema, swelling, and tenderness. Subjective fever, afebrile today. Nausea, malaise, HA, arthralgia, severe left shoulder pain, decreased ROM. Circle drawn around spot, told to return if extends. Told to ice and use BENADRYL prn.
7/16 mother called and stated child received shots on yesterday and now has a swollen face on right side.  Denies fever this time.  Had fever last night  instructed to apply warm compresses to face.  If swelling gets worse go to ER and see MD.  Denies any other symptoms. 2:45 called and spoke with grandmaother, instructed her to bring child to health department so nurse can examine face.
NOT an adverse event, just strong reaction. Fatigue/Body aches started 1-2 hours after vaccination. Fever started 6 hours after injection and rose to 103.4 F (at height). Stayed above 102 F for about 8 hours. Accompanied by chills, nausea, headache, and night sweats. Following day (14 hours after injection), fever subsided and side effects consisted only of body aches, soreness, and fatigue
This spontaneous report has been received from a nurse referring to a patient of unknown age or gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 01-MAY-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX23 (strength, dose, route and anatomical location were not reported) lot # M036728 and expiration date on 20-MAY-2018, for prophylaxis; which experienced a temperature excursion at 29.7 Fahrenheit degrees for 10 hours 52 minutes. No previous temperature excursions were reported. Data logger was involved. No adverse effect reported and no further information was provided. A product quality complaint was not involved. Additional information has been requested.
The patient has a history of diffuse large B-cell lymphoma on chemotherapy. She was seen in the ED on 4/26 with one week of cough along with weakness, fatigue, and diarrhea. In the ED, she was diagnosed with pneumonia and ultimately admitted. A COVID-19 test resulted positive on 4/27 and she was diagnosed with COVID-19 pneumonia. She was treated with remdesivir and steroids. She additionally received a course of antibiotics to cover superimposed bacterial infection. On 5/7, she was intubated due to progressive hypoxia and work of breathing. Ultimately, compassionate extubation was done on 5/13 and the patient passed away shortly afterwards. Of note, she had received the COVID-19 primary vaccine series and two boosters.
Nausea, vomiting, body aches, episodic low-grade fevers, frequent chills, mild dyspnea on exertion, and sensation of being slightly short of breath, pain in legs, intermittent blurry vision, feeling jumpy.
No issues the day of the vaccine. Woke up the next morning with what I believe is called ?COVID arm? I had a large red rash around the injection site. The red circle is raised and tender to touch and very warm.  Additionally I noticed several tiny speckled bruises on my body. Some on my chest and some under my arm. I also have a swollen tender left eye lid. My eye could be vaccine related or not, I just noticed it the morning after I got the shot.
fever, hives, treated with otc pain medicine, hydrocortisone, cold compress and Benadryl. could also possibly be related to flu shot that was given in same arm
After the 1st dose of the Pfizer COVID vaccine she had wrist pain; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, 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: ARTHRALGIA (non-serious), outcome "recovered", described as "After the 1st dose of the Pfizer COVID vaccine she had wrist pain". Therapeutic measures were not taken as a result of arthralgia.  Additional information: It was reported that, After the 1st dose of the Pfizer COVID vaccine she had wrist pain, but it resolved on it's own.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Initial case was received on 02 August 2010 from a healthcare professional. This was a cluster of three patients (two of them unidentified) who were reported to have reactions following an injection of ADACEL with the same lot number (sanofi pasteur Inc. U3083CA, sanofi pasteur Ltd. C3313). The two unidentified patients had localized reaction of swelling, redness and pain at the injection site. The serious adverse event of the identified patient is captured in this case (2010-04142). A 50 year old male patient received on 29 July 2010, a left deltoid injection of ADACEL (lot number sanofi pasteur Inc. U3083CA, sanofi pasteur Ltd. C3313). On an unspecified date following the vaccination the patient experienced severe swelling of the entire arm, redness to forearm and pain. On 02 August 2010 his hand became swollen. The treatment included prednisone and an antibiotic (NOS). It was unknown if the patient had any concurrent illnesses, pre-existing medical conditions, use of other medications, or if he had received any other vaccinations within 4 weeks of 29 July 2010. At the time of this report it was unknown if the patient had recovered. Documents held by sender: None.
Incorrect dosage given. She was given booster shot dosing at 0.25mL when patient was supposed to get second shot dose (0.5mL).
PATIENT REPORTS LIGHTHEADEDNESS, DIAPHORESIS AFTER NEEDLE WAS WITHDRAWN. PATIENT WAS GIVEN A SNACK AND APPLE JUICE
Fainted after leaving exam room, hit head on floor in waiting room, rested approx 1/2 hr in office. Evaluated by MD prior to leaving had snack here in office. No breakfast most likely due to vaso vagal episode.
Symptomatic of COVID infection despite vaccination; no test to confirm; Symptomatic of COVID infection despite vaccination; no test to confirm; This is a spontaneous report from a contactable consumer or other non health care professional. A male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if the patient tested COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On an unspecified date in Jul2021, the patient was symptomatic of covid infection despite vaccination; no test to confirm. Patient did not receive treatment for the events. The outcome the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In or about 2013, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 2013, the patient was treated for the onset of a severe vesicular rash accompanied, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Runny nose, burning bloodshot eyes that teared up for hours, diarrhea, exhaustion, irritable lasted until next morning. Eyes were better in A. M.  Other symptoms 50% better.
On 2/14/01, pt had a febrile seizure and another on 2/15/01.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 05-JAN-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 132 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Right hand swelling with no numbness or tingling.  Looked in no acute distress.  Observed for 30 minutes and discharged home in a stable condition.
Pain in the arm; Swelling in her lymph nodes; This is a spontaneous report from a Pfizer-sponsored program. A contactable physician (patient's colleague) reported that a female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in arm, on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 for COVID-19 immunization (in arm). On an unspecified date, the patient received the second dose of the COVID-19 vaccine in the same arm as the first dose and was experiencing pain in the arm and swelling in her lymph nodes (after the second dose administration). The physician would like to know if there is any information on whether or not the second dose should be given in the opposite arm of the first dose. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Patient received lower dose (Pfizer 5 to 11) for second dose instead of 12+ dose.
This spontaneous report as received from a nurse practitioner refers to her 22 years old daughter who was not pregnant with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated intramuscularly with first and second doses of 0.5 ml GARDASIL (Lot number reported as H013831, expiration date 06-MAR-2015) in June 2012 and on 07-NOV-2012 respectively. There was no concomitant medication. The patient experienced "red blotches radiating from the injection site to the wrist" within one half hour after administration of the second dose of GARDASIL on 07-NOV-2012. The arm felt "heavy and painful" and the patient also experienced nausea. The patient called unspecified physician's office for medical attention. No laboratory studies performed. The symptoms resolved in 5 hours without requiring treatment. Additional information has been requested.
got shingles after she got the shot/ Suspected Vaccination Failure; shingles; This case was reported by a consumer via 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's son or daughter. The age at vaccination was not reported. The reporter stated that, his or her mother got shingles after she got the shot. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
pt had recurrent vomiting x3 p/vax-needed revaluated by MD same day;
Pt recvd 3 doses of Engerix-B & was a marginal non-responder; booster dose of Engerix-B given 8APR92;
Patient called to report that she had a quarter size red bump on her arm a day after receiving the vaccine which has resolved. 3 days after receiving the vaccine she started having "itching all over at night" which she states feels like "wearing wool all over." She has taken Tylenol PM with some relief and is going to use Benedryl instead tonight.
TINGLING IN ARM; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced tingling in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tingling in arm was not reported. This report was non-serious.
2 days after vaccine patient was complaining of extreme fatigue for 9 days still unresolved.
Information has been received from a licensed practical nurse concerning a 72 year old female long term smoker with severe chronic obstructive pulmonary disease, chronic sinusitis, and a penicillin allergy who on 7/15/03 at 10am was vaccinated SC in the left arm with a second dose of pneumococcal 23 poysaccharide vaccine. There was no illness at the time of vaccination. Concomitant therapy included alendronate sodium (70mg daily, started in February 2003), Combivnet (2 puffs QID), Prilosec (20mg daily) and Evista (60mg daily). The pt was vaccinated with a first dose of pneumococcal 23 polysaccharide vaccine on 1/22/98. On 7/15/03 the pt developed warmth, swelling, and redness between her shoulder and elbow. Unspecified medical attention was sought. The pt was started on a medrol dose pack. A product quality complaint was not involved. Follow-up info was received from a licensed practical nurse which indicated that on 7/15/03 at 11am, the pt developed left upper arm swelling which began about seven hours after injection. The event began as itching and then swelling. On 7/16/03 the entire upper arm and elbow was swollen. The left elbow site was positive for erythema, tenderness and pitting edema. The pt was treated with ice and a Medrol dose pack (4mg). The pt recovered two to three days later. No diagnostic or laboratory tests were performed. The reporter indicated that the pt was admitted to the hospital on 8/26/03 under her pulmonary physician with an admitting diagnosis of obstructive chronic bronchitis with acute exacerbation, acute respiratory failure and pneumonia. It was noted that it was a right middle lobe pneumonia with infiltrates. Her final diagnoses were pneumonia, chronic obstructive pulmonary disease, chronic sinusitis and positive tobacco use. The pt subsequently recovered and was discharged from the hospital on 9/4/03. No laboratory data regarding the hospitalization was available. Information was received on 9/19/03 which pertained to events that occurred approximately one month after vaccination with pneumococcal 23 polysaccharide vaccine. This info contained the following adverse experiences: pneumonia (8/26/03), chronic obstructive pulmonary disease (8/26/03), and chronic sinusitis (8/26/03). Additional info has been requested.  Follow up on 10/20/2003: "Follow up information was received from the office of the pulmonary physician which indicated that the pneumococcal 23v polysaccharide vaccine was not given at their office.  No further information is expected."
9 X 8 cm area of erythema to (L) deltoid, no fever, no tenderness.
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients. On an unknown date, the unspecified number of patients were vaccinated with VARIVAX. On an unknown date, the patients may have received improperly stored of VARIVAX. No adverse event was reported. Additional information is not expected.