chrisvoncsefalvay/vaers-outcomes huggingface dataset:
while patient was waiting the 15 minutes post vaccine in the waiting area she reported feeling tingling in her tongue. she described the feeling as if  "brushing her tongue with a very sharp toothpaste". told the patient that we will keep her for an additional 15 minutes to make sure it doesn't get worse or if it gets better.  After 30 minutes the patient reported no change. Gave the patient 10ml (25mg) of liquid benadryl ( 12.5mg/5ml sus)  which she said she will not take just yet but wait a little longer. took patients blood pressure which was high 160/100 (patient has history of BP) told the patient to wait inside the counseling room where I can keep a direct eye on but will check her BP again in 15 mins.  after 15 mins the patients blood pressure was 140/85. she stated that her tongue was feeling a little better but the sensation wasn't completely gone. she said that she feels comfortable leaving and that she will take the benadryl if she felt worse.  Tried calling the patient at 6:30pm but patient didn't answer.
REPORTS TINGLING SENSATION TO TONGUE (SIMILAR TO PREVIOUS REACTION WHEN GIVEN FIRST DOSE)
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: pcn" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
19OCT98 red blotches, itching back then to legs, arms & face;also diarrhea ;
My son started showing significant personality changes two days after the vaccine was given. He became extremely irritable and we were unable to calm him. He then started getting sick with one cold or stomach bug after the other. Seemingly ever sickness he was exposed to he caught. These symptoms lasted for months. He then began drinking large amounts of water throughout the day and even waking at night to ask for a drink multiple times. He also started to lose weight. Four months and ten days after his vaccination he was diagnosed with Type One Diabetes (9/29/15). We have no family history of this disease.
fluid around heart; hard time breathing; Chest pain; unable to perform as well; lack of cognitive focus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 20-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (dose number: 1), for COVID-19 immunization. The following information was reported: PLEURAL EFFUSION (disability), outcome "unknown", described as "fluid around heart"; DYSPNOEA (disability), outcome "unknown", described as "hard time breathing"; CHEST PAIN (disability), outcome "unknown"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (disability), outcome "unknown", described as "unable to perform as well"; COGNITIVE DISORDER (disability), outcome "unknown", described as "lack of cognitive focus". The events "fluid around heart", "hard time breathing", "chest pain", "unable to perform as well" and "lack of cognitive focus" required physician office visit. Therapeutic measures were taken as a result of pleural effusion, dyspnoea, chest pain, loss of personal independence in daily activities, cognitive disorder. Clinical course: Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
administered ActHIB 13 days after expiry with no reported adverse event; Initial information was received on 23-Aug-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 2 months old male patient who was administered HIB (PRP/T) vaccine [ACT-HIB] 13 days after expiry with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (YEAST), pertussis vaccine acellular 3-component, polio vaccine inact 3V (VERO), tetanus vaccine toxoid (PEDIARIX), pneumococcal vaccine conj 7V (CRM197) (PREVNAR) and rotavirus vaccine live reassort oral 5V (ROTATEQ) for Prophylactic vaccination.  On 23-Aug-2023, the patient received a 0.5 ml dose (dose 1) (once) of suspect HIB (PRP/T) vaccine (Powder and solvent for solution for injection) (lot:UJ739AB, expiry date: 10-Aug-2023, strength: standard) via intramuscular route in the right thigh for Immunisation and was administered acthib 13 days after expiry with no reported adverse event (expired product administered) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
No additional adverse event filled; The customer reported that after he administered the MMR II, he retracted the needle, and 2-3 drops of M-M-R II "went into the air"; This spontaneous report was received from a physician, who was also the patient's husband and refers to a 37-year-old non-pregnant female patient. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 21-APR-2022, the patient was vaccinated with a dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. The reporter stated that after the administration, he retracted the needle and 2-3 drops of the vaccine "went into the air" (incorrect dose administered). There was a treatment given for the event. The reporter was was very worried about the possible exposure of the live virus in the air, especially because they had an infant in the home and the possible lack of effect for the patient since her titers were "undetectable" (the reporter did not specify which titers he was referring to). The reporter was also unable to confirm if the patient had ever received measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) or any other unspecified vaccine in the past. There was no additional adverse event reported.  This is one of 2 reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA007608:
Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program Pfizer First Connect. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the twelfth of 20 reports.  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of suspect BNT162B2 cannot be completely excluded for reported events.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
CDC is looking into Pfizer being the catalyst for my stroke; I had the droop on right side of my face; my right arm was going numb; This is a spontaneous report from a Non-contactable consumer (patient) via Pfizer sales representative. This consumer (patient) reported that an unknown age and gender patient received 2nd dose of BNT162B2 at single dose for Covid-19 Immunisation. Medical history was diabetic neuropathy. Concomitant drugs were not reported. Historical Vaccine was 1st dose of BNT162B2 for Covid-19 Immunisation. The CDC is looking into Pfizer being the catalyst for my stroke (Life-threatening). It pretty much exacerbated my current diabetic neuropathy problem. Which as why covid is dangerous for diabetic people. So when I got 2nd dose. I started to notice something was wrong the following Friday. My right arm was going numb and I could not understand what I was writing on the computer and it felt like my right hand and my left hand were switching as I typed. Which Is a clear indicator that something was affecting my brain (several strokes happened in the coronata radiata that is on the left side of our brain and it affected my speech and my right side of my body). And then ability to speak was next to go and my reading comprehension. And of course I had the droop on right side of my face that happened on Saturday. Good thing I'm left handed or my writing would have been affected. I should have went to the ER on that Friday. But I ended up thinking I could sleep it Off. I didn't go to the ER until that Sunday. Cause I kept thinking I can sleep it off. Once you notice the sign don't be like me. Go to the ER quickly. They can give you something to reverse it if you catch it on time. It was too late for me if I had gone on Friday they would have saved me. But still I am getting better. So I'm not regretting my decision to take the vaccine. I know if had gotten the more severe variant of the virus I would died. So this complication is nothing. As long as I'm getting better and people can understand me and I will be alight. Something was wrong the following Friday. I wish to return to work once my right hand is up to speed. I'm on leave. They want me back too. I feel like matter at my job. They appreciate me. I don't get paid because it's been less than a year. Outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Full body rash - went to Urgent care - received steroid shot and prescription for oral steroids 20mg twice per day and hydroxyzine 10mg as needed.. Rash got better by Sunday afternoon and Monday, returned worse Tuesday and then started to get better Wednesday evening moving forward.  It is gone completely now.
Hives and flu like symptoms.  When walking straight feels like she's going to the left. Had a sudden awareness of her heart. Left eye blurriness.
Information has been received from a pharmacist, concerning an unknown number of unspecified patients of unknown age and gender. There was no information about the patients' medical history or concurrent conditions. Concomitant therapies included sterile diluent (DILUENT MR). On an unknown date in 2017, on or after 23-JUN-2017, the patients were vaccinated with improperly stored doses of VARIVAX, lot number M025865 with expiration date 24-MAY-2018 (dosage schedule, anatomical location and route of administration were not provided) for prophylaxis, and the administered doses were exposed to a temperature higher than 6 F (Fahrenheit degrees) but lower than 17 F (Fahrenheit degrees) for 1 hour (digital data logger) with a previous temperature excursion higher than 6 F (Fahrenheit degrees) but lower than 14 F (Fahrenheit degrees) for 45 minutes. No adverse effects were reported.; Sender's Comments: US-009507513-1708USA010732:
10/24/19 Patient reported to Occupational Health, " I woke up around 2 am 10/10/2019 with severe vertigo and nausea. I have never had vertigo. I reported to my PCP. It is now 2 weeks later and i am better, but still have vertigo with certain position changes and head movements."
approx 3 days p/ vax pt devel fever & convulsion & seen in ER, discharged;later in day devel fever & convulsion & admitted to hosp. Annual follow-up dated 2/21/01 states the pt had otitis media at the time of the febrile seizure. The pt has another febrile seizure on 9/8/99 secondary to strep throat.
1 of 5 pts who exp an inject site react w/in 24 hrs p/vax; react was the size of a quarter, hard, raised & warm to touch; Afebrile; No tx initiated;
Patient with 1 dose of J&J vaccine admitted for COVID infection 2/4/22
Information has been received from a registered nurse (R.N.) concerning her son who was vaccinated with one dose of Rotateq.  There was no concomitant medication.  She reported that after vaccination her son experienced two episodes of rotavirus.  The date of the first episode was unknown and the second episode occurred in August 2007.  Her son experienced very watery diarrhea, up to 20 times per day; a bad diaper rash; and a "specific smell that is indicative of rotavirus infection".  Her son's physician diagnosed rotavirus over the phone based on the symptoms.  There was no diagnosis with a stool sample.  He was treated with PEDIALYTE during the second episode to keep him hydrated and he recovered within 9 days.  The nurse could not remember what was done during the first episode but her son recovered within 10 days.  Additional information has been requested.
Information has been received from a physician concerning a 27 month old male who on 06-MAY-2005 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot # 648478/0634P). On 13-APR-2006 the patient developed mumps. The patient was diagnosed with mumps on 18-APR-2006. The diagnosis was made clinically and with lab values. The child progressed from unilateral to bilateral involvement. It was later reported that the laboratory results received for the patient, IgM level less than 10, showed that the patient did not have mumps. It was noted that the patients IGG was 1.6. The patient had not yet recovered at the time of reporting. There was no product quality complaint involved. Follow-up information indicated that the patient did not have mumps. Additional information is not expected.
The patient received two Influenza vaccines in 2021 upon review of the registry. The patient received the Flulaval Quad PF on 10/20/21 by another provider. On 11/17/21 our pharmacy administered a 2nd Flulaval Quad PF. No adverse reaction noted at time of VAERS report.
Follow up information received from a physician, provided the lot number and date of administration of the child's fourth dose of Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a Epidemiologist regarding a 35 month old male patient who received a fourth dose of Prevnar on 7/19/2003, In 3/15/2005, the patient developed pneumococcal pneumonia and on 3/21/2005, developed pneumococcal bacteremia. Reported as none. Indication for Prevnar was immunization. Product was administered on 7/19/2003. Dose regimen was 1 dose. Concomitant medications were not reported. On 7/19/2003, the patient received a fourth dose of Prevenar. On 3/15/2005, the child developed pneumonia. On 3/21/2005, he was hospitalized. A blood culture was performed which positive for streptococcus pneumonia, serotype not included (pneumococcal bacteraemia) (drug ineffective). A pleural fluid culture was performed, which also revealed streptococcus pneumoniae, serotype not included (pneumonia pneumococcal) (drug ineffective). Susceptibility cultures were not reported. As of 3/28/2005, the patients recovery status is unknown. Blood culture (results positive for streptococcus pneumonia, no serotype was included in report) and Culture (results Pleural fluid was examined. Reported as positive for streptococcus pneumonia, serotype not included. Were done in 3/2005. No additional information was available at the time of this report.
Patient experienced flu like symptoms for 2-3 days. Patient also had a red elevated, hot, sore rash that started the day of and grew larger over 1 week. After 1 week, the rash then dissapaited on its own.
Information has been received from a physician assistant concerning a female who was vaccinated with GARDASIL vaccine (yeast) unsure how many doses and had a positive HPV result from a PAP smear test post vaccination. The physician assistant stated the patient became sexually active at this time frame. The patient sought medical attention. No further information is available.
C/o lightheaded with tunnel vision (compared to distorted vision experienced with ocular migraine headaches experienced). Bp 156/90, pulse and resp WNL. Observed X30 min. until symptoms subsided. F/u call 30 minutes later patient states "I'm fine" - Patient notes felt nausea, muscle aches, HA with prior two doses of RABAVERT administered at hospital.
Shingrix: 2nd dose longer than recommended intervals; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 1 year ago).   On an unknown date, the patients received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patients experienced drug dose administration interval too long (Verbatim: Shingrix: 2nd dose longer than recommended intervals). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 21-Jun-2023 The physician reported that several patients, she did not had the count or details probably around 5 to 8 patients they come in for the 2nd dose of Shingrix after 1 year and she gave the 2nd dose. No other information was available. The reporter consented to follow-up. The patients received the 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Fever for 24-hrs, localized tenderness at site of injection, discomfort in the cervical and thoracic regions.
Fever for several days.  Cough starting shortly there after and lasting over a month - still coughing.
3 hours after 2nd Pfizer dose my body was profusely sweating. I developed a terrible headache and pressure in my head, along with mild fever, body aches, nausea, hot flushes, brain fog, dizziness and temperature deregulation.  After 4 days in bed, the fever subsided and the symptoms got a little better. However, the headaches, brain fog, dizziness, nausea, hot flushes and extreme fatigue persisted. I thought these symptoms would go away in a day or so, but they have persisted for over 2 months now. I have been to the doctor multiple times, she ordered pcr tests to rule out covid and multiple blood tests. Doctor thinks I have a form of long covid syndrome, but triggered by the spike protein rather than the virus itself. The most debilitating thing has been the extreme fatigue and brain pressure and brain fog / cognitive slowness. It has prevented me from working and made my life a living hell.  I would have to lie down and be in bed after something so simple as going to the grocery store. In the last week symptoms have improved a little, but still the headaches, head pressure, light headedness and fatigue remain as of today June 28th 2021.
Initial report received from a pharmacist on 06 November 2013. A female patient (age unknown), whose medical history and concomitant medication was not reported, received dose of FLUZONE ID route unknown, batch number: UT4726AA, expiry date 23 April 2014, (dose and exact site of administration not reported) on an unspecified date. On 06 November 2013, the patient had developed silver dollar size redness and swelling at the injection site. Patient experienced pain for 4 days at the injection site. Lab investigation and corrective treatment were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none. This case is linked to 2013SA117345, 2014SA012989 and 2014SA012994.
rash all over chest, neck and back that is not not solid rash but splotchy; itching; This is a spontaneous report from a contactable consumer (patient). A 68-year-female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Mar2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient got the second dose of the Pfizer covid 19 vaccine on Friday (19Mar2021) and had some itching yesterday (21Mar2021) but she did not pay attention to it. Today (22Mar2021), she noticed after a shower that she had rash all over chest, neck and back that was not solid rash but splotchy. She thought that it could be because of the vaccine since she did not recall getting something else. She was 68 years old. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
11/05/2017: 1:00 AM, Awaken in a complete body sweat, temp of 102, unable to breathe (panting), 3 large multicolored patches on right arm, abdominal pain. 11/05/2017: 1:30 AM, Transported to Emergency Room, via ambulance, temp 101 - 102. Treated at emergency room, temp 99.4. Released 11/05/17 at 9:30 AM.
Tonic clonic movements for approximately 60 seconds. Given fluids placed in Trendelenburg position. Somewhat disoriented for approximately 5 minutes while recovering.
Initial report was received from a consumer on 06 September 2012. A female patient (age not reported) had received an injection of ADACEL, Sanofi Pasteur Ltd. lot number C4210 (Sanofi Pasteur Inc. lot number U4395AA) and an injection of MENACTRA, lot number U3906AB and within 24 hours of receiving the immunizations the patient was hospitalized with flu like symptoms, fever of 103 degrees (39.4 degrees Celsius), vomiting, aches and dehydration. No additional information was provided. The patient's outcome was not reported. Documents held by sender: None.