chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inappropriate schedule of vaccine administered; no adverse events were reported; This spontaneous report was received from a pharmacist, concerning an elderly patient of unknown age. The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications were unknown by the reporter  On an unknown date, the patient was vaccinated before he was 65-years-old with a series of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) and pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported), both for prophylaxis.   It was also reported that on unknown date, the patient was vaccinated with another series of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) and pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13)  at age 66-year-old (inappropriate schedule of product administration) and then, he was vaccinated once again when he was in early 70s with another series of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) and pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) No adverse events were reported.
This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. The patient was vaccinated with first dose of GARDASIL (lot # unspecified) "two years ago" on JULY 2010 and received her second dose on 09-JUL-2012. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Pt reports covid vaccinated. No other information concerning vaccine. Admitted to inpatient facility with positive covid diagnosis
Date and time adverse event started:  04/11 8-9p.m. (bad headache, flu like symptoms, nausea, chills, lethargy) Adverse events experienced and are they still occurring now:   aches and pain subsided , still experiencing dizziness when getting up and working, lightheaded when standing for long periods of time  Recommendation: please call your doctor for a check up, I would also recommend you to get tested for COVID just to make sure you don't potentially have it
Throat felt "fuzzy" and slightly swollen approximately 10 minutes post vaccination, seen in ED, given benadryl, IV, famotidine, ondansetron, metylprednisolone and discharged to home
Pt. states that after receiving the 1st dose of Moderna 09/11/2021, started experiencing symptoms that evening of joint pain (knee, shoulders, hips). 10/2021 progressive joint pain throughout of the body and injection site pain. 02/2022 Primary visit/communications with recommendations of no following vaccinations.
Tdap-adm 4/16/07-then second dose 8/20/07
Information has been received from a registered nurse concerning a 5 year old female patient who on 08/18/1999 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  In February 2004, the patient developed a mild case of breakout chickenpox.  Unspecified medical attention was sought, but treatment was not required.  Subsequently, the patient fully recovered.  A product quality complaint was not involved.  The patient also mentioned another patient who developed chickenpox post vaccination with varicella virus vaccine live (Oka/Merck).  Additional information is not expected.
pt recv vax; T 102R for 24 hr; lethargic heavy sleep approx 16-20 hr; screaming for 30-60 mins; very heavy labored breathing;
Within 6 hours I started to feel weak, had muscle spasm, left leg cramps, headaches  Went to the Emergency Room about 12 days later due to having continue to have severe headaches and my leg would not stop cramping. There was an immediate suspicion that I may have blood clotting even being on Eliquis or bleeding in my brain. A brain cat scan and other tests were performed. I was discharged from the hospital the same day.  I am past a monthly the Janssen vaccine now and still have left leg cramps and headaches. My body feels weak and is restless.
Patient was administered 0.25mL of Moderna COVID-19 Vaccine, Bivalent, instead of 0.5mL; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered 0.25mL of Moderna COVID-19 Vaccine, Bivalent, instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered 0.25mL of Moderna COVID-19 Vaccine, Bivalent, instead of 0.5mL) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered 0.25mL of Moderna COVID-19 Vaccine, Bivalent, instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered 0.25mL of Moderna COVID-19 Vaccine, Bivalent, instead of 0.5mL).    No concomitant medications were reported.  No treatment medications were reported.
At the end of the next day after getting the vaccine, patient reported that she had blisters in her mouth and a rash over the trunk and arms of her body. Patient went to the ER and was given an injection of Kenalog. That did not fully treat all the symptoms, so she went to her family doctor and received prednisone 10mg (9/27/19), triamcinolone 0.1% cream (9/27/19), and azithromycin 250mg dose pack (9/19/19).
Pt left and returned with complaints of SOB and coughing. Pt received benadryl 25mg IM, also requested no Epi. No other symptoms presented. Symptoms resolved at 1220, went home with husband driving.
2 days after injection my right jaw muscles were very stiff and sore, very difficult to open jaw fully.  Onset of symptom was sudden.  It is now 25 days since injection and the issue remains, but significantly reduced. I've never had any symptom like that before.
she received Fluzone HD QIV for the past five years, despite being under the age of 65 with no reported adverse event; Initial information received on 24-Oct-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves Adult female patient who received influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] for the past five years, despite being under the age of 65 with no reported adverse event.  The patient's past medical history included Lung transplant. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of 0.7 mL of suspect influenza quadrival A-B high dose HV vaccine (strength, formulation, expiry date, lot number not reported) via unknown route in unknown administration site for immunization. Information on the batch number was not available.  On an unknown date the patient received influenza quadrival A-B high dose HV vaccine for the past five years, despite being under the age of 65 with no reported adverse event (off label use) (latency- same day).  Reportedly, The pharmacist stated that an under 65-year-old female patient presented to his pharmacy and requested a flu shot with Fluzone HD QIV. The patient stated that she has received Fluzone HD QIV yearly for the past five years from her doctor's office. The reason she gave for this off-label use is that her doctor says she needs the high-dose vaccine in order to best protect her as a double-lung transplant recipient. The pharmacist informed the patient that his pharmacy is unable to give Fluzone HD QIV in an off-label manner. He referred her back to her physician.
feeling ill; Positive 2 days later; Positive 2 days later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group, Program ID.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 3 (booster), single (Lot number: GH9694) at the age of 61 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Lyme disease" (unspecified if ongoing); "stones" (unspecified if ongoing); "immunocompromised" (unspecified if ongoing), notes: her husband is immunocompromised (Intent: history). Concomitant medication(s) included: METFORMIN; METOPROLOL; GLIPIZIDE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Sep2022, outcome "unknown" and all described as "Positive 2 days later"; MALAISE (non-serious), outcome "unknown", described as "feeling ill". The patient underwent the following laboratory tests and procedures: Antinuclear antibody: (unspecified date) antibodies were raised; Lab work: (unspecified date) all great, notes: He had Liver function, Metabolic panel, CVP stuff like that. His antibodies were raised for his ANA that was the only thing and his liver enzymes were raised but they are all great (As the results of Lab test was not available over the call hence, tab left unchecked); Liver function test: (unspecified date) raised but they are all great; Metabolic function test: (unspecified date) all great; SARS-CoV-2 test: (12Sep2022) Positive, notes: He received the vaccine on 10Sep then he tested positive on 12Sep. Therapeutic measures were taken as a result of drug ineffective, covid-19.For Covid patient took Paxlovid.  Product Quality Group provided investigational results on 26Oct2022 for BNT162b2, BNT162b2 omi ba.4-5 included Conclusion of Previously Completed Investigation: The complaint for "PFIZER BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9694. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Company (Name) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The company process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.
Systemic: Allergic: Itch (specify: facial area, extremities)-Mild, Additional Details: at 5:15pm pt was coughing and complained of itchy throat, gave 25mg Benadryl and monitored pt ofr another 20 minutes, bp1:146/101 hr:55 at 5:23pm, bp2: 151/106 hr:53 at 5:30pm. pt left at 5:35pm advised pt to monitor for symptoms of allergic reaction and seek medical help if increased in swelling or and airway issues. advised pt to take another 25mg Benadryl in 4 hrs
Patient received influenza Afluria and Pneumovax-23. Patient received both injections and showed no abnormal signs. While patient was checking out at pharmacy (approximately 5 minutes after being vaccinated) she developed syncope and fell. Patient was caught before falling and placed on bench for 15-20 minutes. Attempted to check blood pressure via automatic cuff but was unable to acquire accurate reading. Provided patient with cold pack/paper towels and instructed her to remain seated for 15 to 20 minutes. She then went to an urgent care for follow up from physician.
Information has been received from the Merck Pregnancy registry from a nurse concerning a 22 year old female who on 12-JUN-2007 was vaccinated IM with a 0.5 ml first dose of GARDASIL. When the patient received her first vaccination she was not pregnant. On 14-AUG-2007 the patient received the second dose of of GARDASIL (Lot # 658222/0927U). There was no concomitant medication. Subsequently, the patient was pregnant at the time of the vaccination. On 29-AUG-2007 the patient came into the physician office and had a positive pregnancy test. The patient last menstrual period was 21-JUL-2007 and the estimated date of delivery was 26-APR-2008. On 11-APR-2008, the patient gave birth to a healthy female. It was reported that during labor/delivery, the mother developed increased blood pressure. Additional information is not expected.
The office manager in a physician's office reported that unknown number of patients received improperly stored vaccines.; No additional AEs were reported; This spontaneous report has been received from an office manager concerning an unknown number of patients of unknown age and gender. The patients' concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On an unknown date, the patients were vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # u037810, has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent, expiration date reported and upon internal validation established as 28-MAR-2023) (dose, anatomical location and route of administration were not reported) for prophylaxis. The vaccine was stored at a temperature of Fahrenheit (F) during 6 hours and 59 minutes (Product storage error). The vaccine did not suffer previous temperature excursions.  No adverse event was reported.
This spontaneous report was received from a licensed vocational nurse refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 13-JUL-2015, the patient was vaccinated with a dose of an improperly stored PROQUAD (Merck), lot number L007230, expiration date 03-SEP-2016, (dose and route were not reported). No adverse effects reported. This is one of several reports from the same source. Lot number L007230 has been verified to be a valid lot number for PROQUAD (Merck). Additional information has been requested.
Pt had a febrile seizure on 8/5/01 and was treated at the hospital with Tylenol suppository. Detected otitis media and treated with amoxicillin. Temperature was 103.5F. Seizure lasted 3-4 minutes.
Extreme exhaustion lasting over a week and continuing, mental confusion,  fever, muscle aches extreme headaches still ongoing,
Red eye that started on May 10 and on May 15 went to my primary doctor then several eye doctors and then to a specialist. I have lost half of my eyesight on my right eye I had surgery still can't see.
Headache, Arthralgia & Nausea Vomiting Narrative: Received 2nd dose at 1000 on 1/26/21 and by 1500 had developed nausea and arm soreness. The next morning 1/27/21 had a headache, nausea and aching joints. Symptoms resolved in 24-36 hours. Missed work x 1 day. No known prior covid infection
Starting In May 2021, I had a very strange red inflammation in my eyes that I went to the doctor 2 times for.  It was nothing like red allergy eyes at all and not pink eye.  Then End of June 2021, I ended up going to the ER because I had excruciating back pain that radiated around my sides to stomach.  I was given a CAT scan and some pain meds and sent home told to rest.  I was fine for about a week and then it started back up on July 9th and eventually got worse causing serious issues with walking, sleeping and sitting.  It took. me almost a month to get to a spinal surgeon to get an MRI to find out that I had Myeomalacia or Spinal Stenosis, with Cysts that were compromising my spine.  I had not had any falls over the last year that could have caused this and it literally came out of nowhere
extreme weakness; headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (extreme weakness) and HEADACHE (headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced ASTHENIA (extreme weakness) and HEADACHE (headache). At the time of the report, ASTHENIA (extreme weakness) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.
Vaccine administered after beeing in the fridge for 40 days; vaccine administered after beeing in the fridge for 40 days; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after beeing in the fridge for 40 days) and EXPIRED PRODUCT ADMINISTERED (vaccine administered after beeing in the fridge for 40 days) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after beeing in the fridge for 40 days) and EXPIRED PRODUCT ADMINISTERED (vaccine administered after beeing in the fridge for 40 days). On 31-Aug-2021, PRODUCT STORAGE ERROR (Vaccine administered after beeing in the fridge for 40 days) and EXPIRED PRODUCT ADMINISTERED (vaccine administered after beeing in the fridge for 40 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were provided  The nurse stated that the patient was administered 3 dose being immunocompromised.; Sender's Comments: This report refers to a case of "Product storage error" and "Expired product administered" for mRNA-1273, lot # 040C21A with no associated AEs. The causality will be considered "Not Applicable "for these events.
This spontaneous report as received from a Certified medical Assistant refers to a multiple unspecified patients of unknown ages and genders. The patient's medical history and concurrent conditions were not reported. On an unknown date between 01-JUL-2016 and 14-JUL-2016 the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot number, expiration date, dose, route and frequency were not provided). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
It was reported that a 70 year old male pt received a Fluzone vaccination on 11/25/02. About 10 days later, the pt developed pain in his hip, which was described as being like sciatic nerve pain. At the time of this report, the symptoms are unresolved. Further info is expected.
Note: I am not sure if this is related to the vaccine or not.  From 5/4 to 5/24 I had a fever of unknown origin. My symptoms were persistent, low-grade fever, headache, extreme fatigue, weakness, foggy, poor focus. After 5/24 the fever lifted. My energy levels slowly returned, but fatigue did persist for a while after that date.
This spontaneous report as received from a nurse practitioner refers to a 65 year old male patient. On 09-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). On 09-OCT-2015, the patient received another dose of ZOSTAVAX (dose, route and lot # not reported). In October 2015, the patient experienced a rash on his face and both sides of his arm. On 23-OCT-2015, the patient was seen by a physician and he was diagnosed with chicken pox. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
PAIN AND NUMBNESS TO LEFT SHOULDER, NECK AREA WITH NUMBNESS TO LEFT ARM AND RADIATING TO LEFT SIDE OF FACE. THE NEXT MORNING LEFT LEG AND ARM NUMBNESS WITH BURNING PAIN AND WEAKNESS TO BOTH LEFT ARM AND LEFT LEG.  NUMBNESS AND WEAKNESS PERSISTING AND ON 10/15/2015 RIGHT ARM AND RIGHT LEG WITH NUMBNESS AND WEAKNESS.
pt devel pain in lt upper arm @ inj site;pt also devel a varicella rash w/pustules on back & head;rash devel on trunk & arms, malaise & h/a;this occurred 11 days post vax;
No adverse effect; patient received a dose or PROQUAD instead of MMR Il; adult patient received a dose or PROQUAD instead of MMR Il; This spontaneous report was received from a registered nurse referring to an adult patient of unknown age and gender. Information about patient's concurrent condition, medical history, drug allergy/reaction was not reported.   On 25-NOV-2019, an adult patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) therapy type: rHA, lot # R026720, expiration date: 17-MAR-2020 (strength, dose number, route, anatomical location was not reported) for prophylaxis instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (wrong product administered and product administered to patient of inappropriate age). Other suspect therapy included sterile diluent (strength, dose, route, lot/batch #, expiration date was not reported). It was also reported that the patient received a dose of varicella virus vaccine live (oka/merck)(VARIVAX) on the same visit (concomitant therapy). No adverse events were reported. No product quality complaint was involved.
pt reported noted indentation on the deltoid area where vax given;noted had pain in area p/second shot 1DEC97;
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, 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 SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had shingles. His primary care provider administered SHINGRIX before his symptoms had gone away. Naturally the SHINGRIX reactivated his shingles, and with a vengeance. On 08th March 2019 (on next day of reporting), the patient entering the 13th week with shingles. The patient wanted to know whether the vaccination he received was good because it was administered at the wrong time, or should he get the first vaccination over again once his shingles are totally gone. The patient requested to answer by email, so that he could print it out to present to his primary care provider. The agency did not seem to have a lot of knowledge about SHINGRIX. This case was considered as suspected vaccination failure as vaccine schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
Elevated heart rate (tachycardia) most of the day. Heart rate while reclined and resting was approximately 105-110 bpm for a few hours. This was accompanied by mild fever (100.4-100.7) and patient took Acetaminophen at approximately 7:45pm. Fever and Tachycardia improved over the course of the next 3-4 hours. With a temperature of 99.6 and heart rate while resting approximately 95 bpm last measures before sleep. Heart rate still slightly elevated the next day with mid-80s bpm while resting. No chest pains or shortness of breath throughout. Heart rate was measured nearly constantly via a Fitbit smart watch.