chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow up information has been received from the Merck Pregnancy Registry for GARDASIL via a physician concerning a "healthy" 18 year old white female smoker with a history of some problems with her menses who on 29-JUN-2007 was vaccinated intramuscularly into the left arm with a 0.5 ml first dose of GARDASIL. On 05-NOV-2007, the patient was vaccinated with a second dose of GARDASIL. On 05-NOV-2007, the patient was vaccinated with a second dose of GARDASIL (Lot #655620/0170U). Concomitant therapy included SEASONALE. Subsequently, the patient called the doctor's office and stated her home pregnancy test was positive. On 14-NOV-2007, she was seen in the doctor's office and a urine test confirmed pregnancy. A Quantitative blood test for pregnancy was also performed, but the results were not available yet. The patient's last menstrual period was on 04-OCT-2007, estimated date of conception was 18-OCT-2007 and the estimated date of delivery was 10-Jul-2008. On an unspecified date, the patient developed seasonal allergies and was treated with montelukast (MSD). On 22-FEB-2008 and 19-MAY-2008 the patient had routine ultrasound tests with "good" results. It was reported the patient delivered a normal, 18 1/4 inch, 6 lb. 7 oz. female at 38 weeks, 5 days with a had circumference of 12 3/4 inches (Apgar score not reported). Additional information has been requested.
pt recvd flu vax-pt was 1 of 15 who devel influenza & was hospitalized;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 73 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "microadenoma on pituitary" (unspecified if ongoing); "claudication in legs" (unspecified if ongoing); "pre diabetes" (unspecified if ongoing); "raynauds" (unspecified if ongoing); "dry eye" (unspecified if ongoing). Concomitant medication(s) included: BROMOCRIPTINE; METHOTREXATE; LISINOPRIL; SOLIFENACIN SUCCINATE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No allergies.  Anti viral details: Product: COVID 19 Treatment,Treatment start date: 28May2022,Treatment stop date: 01Jun2022,Indication: Treatment of COVID-19  Follow-up attempts are completed. No further information is expected.
Right after receiving the shot, patient complained of pain at the injection site, and feeling a little dizzy. Patient was advised to remain seated, and was given a cup of water. Approximately 2 minutes after that, patient fainted for about 30 seconds. Patient regained consciousness. We called 911, and the EMT came and checked on patient (blood pressure was 120/50, blood sugar was normal, EKG was normal). Patient said she feels fine and did not want to go to the hospital. Clinical RPh and PDM was contacted. Incident report was filed. Primary care MD was notified.
sharp pain in left chest when breathing in and moving pressure in right chest low energy in whole body feeling of being overwhelmed shortness of breath pain under ribs and stomach that comes and goes hearing sounds in ear when swallowing
Following vaccination, I had a headache for few days along with some  pain on injection arm. The headache continued and soon some fatigue and tiredness accompanied it for 7-10 days following vaccination.  Then ten days after, I had an increase in symtpoms that included heightened fatigue, loss of appetite, feeling "cold"/ "hot" (no fever), and abdominal pain with nausea and some diarrhea.    Two weeks after vaccination, I had an increased of fatigue and not feeling well, accompained by a fever of (101.5 F) and chills, sore throat, and lethargy.  My symptoms of fever, chills, sore throat, body aches, congestion, and fatigue remained over the next few days and soon included chest pain and some increase work of breath.  With two negative Covid tests through work, it was recommended I go to see a physician, who instead sent me to Immediate Care.  There I had an EKG which showed sinus bradycardia and they sent me to ER due to my symptoms of chest pain and shortness of breath.   At the ER, multiple tests were run to negative results.  ER Physician suspects that some of my struggles could be related to Covid vaccine but that I also may have caught an non-Covid virus on top of it which led to acute bronchitis.
I had nasal sniffles then the next day I felt lightheaded and felt like I had a low grade fever. I tested positive at for COVID-19 at home. I had a little dry cough and sore throat. When I took my temperature it was a little elevated but I did not have fever. I talked to my doctor and they prescribed me PAXLOVID with prednisone. My symptoms were gone by August 15th. I was still testing positive even though I did not have any symptoms so my PCP prescribed me another round of PAXLOVID and I tested negative for COVID-19 on that same day.
Left deltoid reaction 53 centimeters wide by 85 centimeters in length, increase itchy.
severe fatigue , & body aches, for 3 days;  nausea & headache for 2 days,   injection site pain  starting on injection day- slowly resolving. slight swelling and knot under the skin
Patient presented with swelling at injection site 10 minutes after injection. Site was slightly firm to the touch - ice applied. Pt instructed to take TYLENOL/MOTRIN and BENADRYL as needed.
Soon after her 2 month shots, she developed watery diarrhea and keratosis pilaris on her skin.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old male patient received BNT162b2 (BNT162B2), on 19Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in left arm 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: "Depression" (unspecified if ongoing), notes: Other medical history- Depression. Concomitant medication(s) included: LEXAPRO; TRUVADA. Past drug history included: Nsaids, reaction(s): "Drug Allergy", notes: Known allergies - NSAIDs. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 2022, outcome "not recovered", DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of suspected covid-19, drug ineffective.  Additional information: Report about covid treatment reported as Yes. If vaccine received and Other medication in 2weeks reported as Yes. Known allergies reported as NSAIDs. Other medical history reported Depression.  Follow-up attempts are completed. No further information is expected.
Patient came to receive his 2nd dose of the Moderna COVID-19 vaccine. He initially said that he did not have his vaccination card with him, but self reported that his first dose was on 2-8-2021. Provider had told the patient that he would be due for his second dose in three weeks, which prompted the patient to come in. After giving the vaccine, patient mentioned that he actually did have his card on him, and the date of his first vaccine was identified as actually being 2-18-2021. Patient did not have any immediate reactions and is doing fine to our best knowledge.
Approximately 6:55 Friday March 12th I went from feeling perfectly fine to having to lay down I felt so sick.  I took my temperature and it had dropped to 97.6 within a matter of minutes.  And then my temperature continued to drop and drop and drop until it reached 96.1.  I've never in my life had a temperature that low.  I have not had problems with temperature fluctuation like this since I started on thyroid medication.  My normal temperature ranges in the 98s.
varicella - information has been received from a registered nurse concerning a 2 year old male patient with allergies to azathloprine (Zithromax) who on 13 apr 1999 was vaccinated with one dose of varicella virus vaccine live (lot 628524/1657h)  Concomitant therapy included polymyxin B sulfate (+) trimethoprim (Polytrim).  The patient was exposed to his brother (waes 00050383)  who developed varicella on 18 Apr 2000.  It was noted that the patient subsequently broke out with chickenpox.  The patient was febrile and had greated than 25 pruritic lesions.  unspecified medical attention was sought.  Additional information has been requested.
Hives starting next AM with some pruritis bilateraly to thighs X4 days.
Treatment of COVID-19/ diagnosed with covid; Treatment of COVID-19/ diagnosed with covid; Moderna Dose Number 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 12:15 as dose 4 (booster), single (Lot number: GJ5342) at the age of 46 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 02Feb2021 at 12:30 as dose 1, single (Lot number: EL13002), in left arm and on 23Feb2021 at 12:30 as dose 2, single (Lot number: EL9263), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Oct2021 at 12:15 as dose 3 (booster), single (Lot number: D24C21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "ulcerative colitis" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergy.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Oct2021 at 12:15, outcome "unknown", described as "Moderna Dose Number 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Sep2023, outcome "unknown" and all described as "Treatment of COVID-19/ diagnosed with covid". Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid from 02Sep2023 to 07Sep2023.
DIFFICULTY SLEEPING; NIGHT TIME AWAKENINGS; SORENESS IN LEFT ARM; NAUSEA; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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, start therapy date were not reported 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 difficulty sleeping, night time awakenings, soreness in left arm, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the difficulty sleeping, soreness in left arm, nausea and night time awakenings was not reported. This report was non-serious.
After the 2nd and 3rd doses I missed my menstrual cycle for one month and then had prolonged excessive bleeding the month after that. I am still on about day 28 of bleeding after the 3rd shot.
Patient received Pediarix doses 2 and 3 late; Patient received Pediarix doses 2 and 3 late; Patient received 1st Infanrix dose on 20-oct-21; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 5-month-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd December 2021, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 14th March 2022, the patient received the 3rd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 20th October 2021, the patient received the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 20th October 2021, not applicable after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device and unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On 22nd December 2021, the patient experienced drug dose administration interval too long. On 14th March 2022, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long, drug dose administration interval too long and wrong vaccine administered were 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: 16-MAY-2022 Reporters comment: The patient received 2nd and 3rd dose of Pediarix late. Healthcare professional also stated that, the patient received 1 dose of Infanrix too early.  The reporter consented to follow up. Additional supportive information: The patient received 2nd and 3rd dose of Pediarix, later than the recommended schedule, which led to lengthening of vaccination schedule and 1 dose of Infanrix, which led to wrong vaccine administered.
Patient reports red, inflamed area around injection site with small bumps.  She also reports small, red blisters on her lip.
About 4 days after my vaccine, 07/04/2021, my mouth just hurt, really bad at 1st. I was  unable to eat solid food for like a week and a half. Then I developed a sore throat  and it was really swollen and red, but like spots that were swollen. I still have the sore throat as of today, 07/13/2021,  my throat is still swollen and the spots kind a  red and white. Dr. believes it was ulcer that were a side effect of the vaccine. She told me to wait it out and take Tylenol. No,  I have not recovered because I still have swelling, redness and white spot, It's just less painful, as of last week.
C/O HEART RACING; SHAKING EPISODE X  3 ;  AFTER THIRD EPISODE AGREED TO GO TO ER;  AMBULANCE TRANSPORTED TO HOSPITAL..   SPOKE WITH CASE @0803 ON 3/26/2021;  STATES THEY DID NOT KEEP HER.  OBSERVED HER IN ER FOR A WHILE THEN DISCHARGED HER.  NO FURTHER PROBLEMS.  FINE TODAY
Vertigo/ Caller states that her sister (81-year-old female) also experienced "similar symptoms" as she had after receiving the Pfizer Covid19 vaccine; Vertigo which has affected her balance and vision/Off balance; Vertigo which has affected her balance and vision; Throwing up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 81-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: VERTIGO (non-serious), outcome "unknown", described as "Vertigo/ Caller states that her sister (81-year-old female) also experienced "similar symptoms" as she had after receiving the Pfizer Covid19 vaccine"; BALANCE DISORDER (non-serious), outcome "unknown", described as "Vertigo which has affected her balance and vision/Off balance"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "Vertigo which has affected her balance and vision"; VOMITING (non-serious), outcome "unknown", described as "Throwing up".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vaccine was administered after the 30 day BUD of December 1, 2022.
Wednesday, the morning after the shot:   101.7 fever and  in bed all day; chills/cold; can "feel my skin;" stomach and diet off; bowels off; chest and upper back pressure; deliberate taking of a deep breath; tinny taste in my mouth; slightly headache; low energy;    Thursday, the second day after the shot:  99.7 temp; stomach and diet off; chest and upper back pressure; deliberate taking of a deep breath; tinny taste in my mouth; thirsty  Friday, day three:  stomach and die off; chest and upper back pressure; deliberate taking of a deep breath; tinny taste in my mouth; thirsty  Saturday, day four:  chest and upper back pressure; deliberate taking of a deep breath; tinny taste in my mouth  Sunday, day five:  chest and upper back pressure; deliberate taking of a deep breath  Monday, day six:  chest and upper back pressure; deliberate taking of a deep breath  Tuesday, day seven:   chest and upper back pressure; deliberate taking of a deep breath  Wednesday, day eight:  chest and upper back pressure; deliberate taking of a deep breath
Woke up in the middle of the night to use the restroom after feeling dizzy had a syncopal episode woke up on the floor with a large hematoma over right eye
PATIENT RECEIVED SHOT ON 9/8/17, DEVELOPED NUMBNESS, TINGLING, LOSS OF SENSATION IN LEFT SIDE OF FACE ON 9/9/17. SYMPTOMS HAVE PERSISTED TILL NOW WHEN HE REPORTS TO ME 9/11/17. PATIENT REPORTS NO PAIN AND NO WORSENING OF SYMPTOMS SINCE 9/9/17. PATIENT FEELS LIKE HE CANNOT BE EXPRESSIVE WITH FACIAL EXPRESSIONS. IS STILL ABLE TO FEEL TOUCH OF FINGERS WHEN TOUCHING HIS FACE.
Redness, warmth, swelling & induration at the Kinrix injection site (right thigh).  Area of erythema 9 cm x 7 cm.
Caller stated he had covid and had a horrible 5 days in the hospital and was scared; Sick a little bit, recovering fine; Drug ineffective; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0153, Expiration date: 31Jul2021), via an unspecified route of administration on 09Apr2021at single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6205, Expiration date: 30Jun2021), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient stated him and his wife had received both their vaccines. He stated his second one was this past friday. Patient was very happy they were able to receive the Pfizer vaccine. Patient stated he was a little bit sick, recovering, fine. Everything is so far so good. The patient further stated he had covid and had a horrible 5 days in the hospital and was scared. Patient declined a Safety report. The patient stated he did not have an email and declined to provide his address. The patient did not state further information for the report. Patient wanted to know if the expiry date on his covid 19 vaccination card meant he had to go get another vaccine after the expiration. The patient stated he would like to be transferred to regulatory authority to make sure of these expiration dates. The outcome of the events was resolving.
Pt developed pruritic hives to her back. She has taken Benadryl and applied topical cortisone.
Injection site was itching all morning and later turned into hot red rash, sore to the touch, about 3? in diameter.
Patient was informed that they were receiving a Pfizer vaccine. This was their second dose and the pharmacy asked the patient for the vaccine card. The patient did not have the vaccine care at the time and would bring it by afterwards to have the card filled out. The Pfizer vaccine was given. The patient brought the vaccine card later that night and the pharmacy noticed the patient's first dose was with the Moderna vaccine. Patient was informed that the second dose should have remained the same as the first dose and the patient explained that they were unaware that they needed to complete the second dose with Moderna.
Was really tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17Mar2021 08:00 (Lot number: ER8727) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lung carcinoma cell type unspecified stage IV" (ongoing), notes: Verbatim: Lung cancer stage IV; "Recently broken collar bone", start date: Feb2021 (unspecified if ongoing), notes: Verbatim: Recently broken collar bone; "Heart attack", start date: Oct2020 (unspecified if ongoing), notes: Verbatim: Heart attack. The patient's concomitant medications were not reported. Vaccination history included: Flu shot (AE(s) following prior vaccinations: One time, yes, caller had severe allergic reaction to got flu shot and something else can't remember. Very severe reactions to these, years ago.), for immunization, reaction(s): "Severe allergic reaction". The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "recovering", described as "Was really tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller is a consumer reporting she received both doses of the Pfizer Covid Vaccine. Received first dose and then like three weeks later received second dose and then got Covid and ended up in the hospital. Caller remembers her first night in the hospital hearing on the local news that the second dose for caller was given at the facility and the dosage wasn't right where caller received second dose. Caller heard on the news a nurse messed up on the dosage from like 0810 to 0840 in the morning and that happened to be the time when the caller received her second dose Pfizer Covid Vaccine. Caller was curious if she was one of those people. Caller was diagnosed with Covid the same day the caller received the second dose Pfizer Covid Vaccine, 07Apr2021. Caller reports she was really tired. This began the end of March. Caller was still tired but it was getting better. Caller states it had improved.  No follow-up attempts are possible. No further information is expected.