chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Child became pale with cold extreminites. Semi conscious, (not verbal) BP checked and not able to get one. HR 105. BP rechecked and unable to get one called EMS. They arrived at 10:25. At 10:28 BP 84/60. Child able to verbailize feeling better. 10:40 child able to stand and was released with parent.
The patient was given a vaccination and told to stay in the area for 15 to 20 minutes to be sure there were no adverse reactions.  The patient experienced syncope about 5 minutes following the vaccination.  The patient fell and suffered a cut on the nose, bleeding, and possible broken nose.  The patient was placed on a bench to lie down and given a cold compress and water to drink.  The patient had already phoned his mother by that time and she  showed up a few minutes later.  The patient had not reported any adverse effects prior to my initial contact with him after the vaccination when he asked for something to stop the bleeding from his nose.
Headache, Myalgia, Fever, Chills, fatigue Narrative: Had to leave work early due to symptoms, next day also
pt recvd vax;devel transient URI 4 hrs p/ vax;fever of 105 per mom;to er;advil & apap given;T dec to 99;no further problems;pt's brother was seen in clinic at the same time;
Right arm swollen and has a rash all over started yesterday.  Treated with Benadryl.  This morning rash is gone but still swollen.
About 12 hours after injection, experienced significant muscle and bodyaches, and headache.  Then during the course of the night experienced significant night sweats with pillow case very wet on both sides.  Fatigue set in about 8 hours after injection.  Significant arm pain at injection site.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On unspecified dates, the unknown number of patients were inadvertently administered PROQUAD, that had been improperly stored (strength, dose, dose schedule, route, anatomical location, lot number and expiration date were unspecified). NO concomitant therapies were reported. No adverse effects reported. Follow up information received on 19-AUG-2014. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received from a registered nurse refers to an unknown number of patients of unknown demographics. On unspecified dates after 12-AUG-2014, those patients were administered doses of PROQUAD and VARIVAX injections (dose, frequency, route of administration, lot# and therapy date unspecified for both), that were improperly stored on 14-AUG-2014 and 15-AUG-2014. No concomitant medications were reported. This is one of several reports from the same source. Additional information has been requested.
Significant drop in blood pressure, couldn't walk more than 1/2 block, shortness of breath.  This happened about 5 weeks after the 2nd dose of the vaccine.  Had blood work, showed very low blood counts to the point of maybe needing a transfusion.   Had GI work up today, no bleeding.   Could this be an autoimmune reaction to the vaccine.  His blood counts were fine prior to the vaccine.
GIVEN A BOOSTER DOSE from a vial that had been puncture ~27 hours earlier & therefore was beyond use date. Had been refrigerated at monitored temperature for whole period. CDC & MD & supervisor informed. Pt contacted & informed of advice that should be repeated but hesitant to do so because experienced the same flu-like symptoms he had with previous dose in series. Will consider more & let us know if anything changes. All related processes reviewed with all involved personnel
Patient experienced vasovagal syncope about 5 minutes after receiving the vaccination.  She was very nervous about the needle before getting the immunization but was acting normal and coherent directly following the shot.  Her friend then received his shot, whom was also very nervous. They were both encouraged to stay in our waiting area and as they were collecting their belonings she lost her balance and fell.  I left the pharmacy to help her up.  She said she was fine and got up and started to walk and then fell again, losing conciousness for a few seconds cutting her lip on her teeth.  Myself and her friend helped her to a chair and I gave her a gauze pad for her lip.  She refused an ambulence and said she felt okay, just a little light headed.  They stayed for about 30 minutes and decided to go to an urgent care to get checked out just in case.
This spontaneous report as received from a licensed practical nurse refers to unspecified number of patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. On unknown dates, unknown number of patients have been administered GARDASIL (lot number, dose, frequency and route unspecified) which was improperly stored. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. Product quality issues was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown dates, the patients received improperly stored RECOMBIVAX HB (dose, route, lot numbers and expiration dates were not provided). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Patient was given a COVID-19 vaccine on 07MAR21 at 0930.  She complained of numbness of her tongue and lips.  She was given Benadryl 25 mg po by one of our registered nurses.  She was monitored for an additional 30 minutes.
first dose- sore left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 (Lot number: ER8734) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (ongoing); "Anxiety" (ongoing); "Blood Pressure" (ongoing), notes: she used to take blood pressure medication; "Vitamin D Low" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol increased (ongoing); ESCITALOPRAM taken for anxiety (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 02Apr2021, outcome "recovered" (2021), described as "first dose- sore left arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity.  Additional information: Concomitant Products Atorvastatin: (Start: Unknown Stop: Ongoing, expiration date of May2022, lot 100017564, Dosage text : 80mg tablet with water once a day after supper). Escitalopram: (Start: Unknown Stop: Ongoing) her doctor increased it, patient was on 40mg. Later stated that she does not know if he increased it or not, Dosage text:  one 20mg by mouth once daily around noon. Patient used to take blood pressure medication but was doing okay and does not have medication name. Caller stated that she wanted to report that when she got her first shot of Pfizer that on the third day her arm was sore and she took Aleve. Stated that it was okay. Stated that her arm was still hurting but not as much as it was.  No follow-up attempts are possible. No further information is expected.
he started having "really bad" abdominal cramping and pain; these symptoms made him "so tired"; This is a spontaneous report from a contactable (patient). A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 06Apr2021 (at 70-years age) as single dose for covid-19 immunisatio and patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which included polymyositis but states that came back negative. After receiving second dose patient started having really bad abdominal cramping and pain. Patient reported that these symptoms made him so tired that he had to leave work one day and his side effects are better now that his doctor took him off of work. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
A few hours after receiving immunizations the child began complaining of swelling of lips and tongue. Also swelling of chest and difficulty breathing.
fever of 101, achy, tired, dizzy, lightheaded. Took two naps and slept 10 hours that night. Felt a bit better the next day.
Mom requested BP be taken due to being elevated at another office earlier today. Taken at 445pm it was 109/80. Patient sat for 10-15 minutes with mom. When I went back to check on her she was very dizzy and could not keep her eyes open. Got a provider, laid her down and rechecked her BP it was 139/90. Staff grabbed some water and sprite and some sugary snacks okayed by mom to try and give to the patient. Patient sipped some of the water and sprite but felt like she was going to get sick. Monitored for 1 hour with some sips of water here and there. Dr. and NP came in to monitor the patient as well. Vitals taken- oxygen stayed stable, heart rate was elevated and came down after a bit. Patient complaining of abdominal pain, feeling hot, nauseous, and dizzy with sitting up. BP taken again at 559pm 133/89. Staff called ambulance to take the patient to hospital as instructed by Dr. since no improvement for an hour.
allergic reactions; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reactions) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced HYPERSENSITIVITY (allergic reactions). At the time of the report, HYPERSENSITIVITY (allergic reactions) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Medium, Additional Details: pt passed out after reporting not feeling well, 911 had been called, pt taken to hospital and released today, severe muscle twitching possible seizure like
Approximately 2 hours after received flu shot client starting sneezing and coughing.  Eye lids began to swell and had difficulty breathing.
Covid-19 Vaccine Pfizer EUA- Patient received vaccine and waited recommended 15 minutes. As she was leaving she stopped and felt tired. Tired enough to have to sit down. Patient caretaker did say these "tired spells" happen frequently after she walks longer than normal distances.  Patient representative was not aware of what medications patient took. With permission from the caretakers, we took patient blood pressure  and received 2 higher than normal readings 15 min apart. We recommended care taker to contact healthcare provider and make them aware of the higher BP readings.   Patient and caretaker we comfortable to leave store.
it did not work with no reported adverse event; Initial information received on 06-Jan-2023 regarding an unsolicited valid Social Media serious case received via consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who stated that it did not work with no reported adverse event while receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, batch lot number, expiry date: unknown) not reported via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient had an event of it did not work with no reported adverse event (vaccination failure) (unknown latency) following the administration of influenza vaccine.   Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown.  Seriousness Criteria: This event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 11-Jan-2022: This case involves an unknown age and unknown gender patient who stated that it did not work with no reported adverse event while receiving influenza vaccine. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Patient came in to receive vaccinations for school. Patient received Hepatitis A, Varicella, Tdap, and Meningococcal. After patient received vaccinations had patient stay in chair. I finished up information in ECW, patient fainted I placed cold pack behind patient's neck, elevated feet, and fanned patient. Called out patient's name she responded and stated " I think I have to throw up." I placed trash can beside patient, patient did not throw up. I pulled out an orange juice for patient to drink she started feeling better. While leaving clinic room walked behind patient. Patient left with no signs or symptoms of distress.
Hives as well as an itchy and painful rash within 1 hour of injection.
Suspected vaccination failure; Had shingles; Worst pain ever on my back; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Had shingles) and back pain (Verbatim: Worst pain ever on my back). The outcome of the vaccination failure was unknown and the outcome of the shingles and back pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and back pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and back pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 25-MAR-2023 This case was reported by a patient via interactive digital media. The patient got the shot and had shingles worst pain ever on her/his back. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This spontaneous report as received from a nurse refers to a 16 years old female patient. The patient was intramuscularly vaccinated with the first dose GARDASIL (lot # 673256/0629AE, exp 16-DEC-204) on 27-JUL-2012. On 27-JUL-2012, the patient had her first dose GARDASIL and fainted for about 15 seconds. No treatment was given for the event. The outcome of patient was reported as recovering/resolving. The patient did not seek medical attention. Additional information is not expected.
No ADVERSE EVENT -  reporting nursing staff was not aware she had to use liquid conjugate component with the Men A  Lyophilized conjugate component  sh e used sterile injection diluent , spoke with mother informed her per CDC recommendation repeat vaccine . I Marked box with sharpie to mix together gray cap and orange cap together , also putting a rubber band around both vials that need to be reconstituted .
Severe uncontrollable chills,  could not get warm. fever of 101.8.  Almost went to the E.R. Symptoms lasted about 5 hours,  from 6PM - 11PM
The next day after vaccine, I started bleeding not related to mensuration. I have been bleeding in between every period since. It is very heavy and I also have sharp pains in my pelvic area. I am going  to the OBGYN and she is going to do blood work, ultrasound, and physical exam which I am going to Thursday.
Vaccine given to patient younger then 18 years old and pharmacist missed the age piece.  Received prescription from patients prescriber for the second dose.  Patient is fine after completing the series.
This spontaneous report as received from a female consumer refers to her 19-year-old son with no pertinent medical history. On 17-JUN-2010, the patient was vaccinated with the first dose of GARDASIL under the skin in the arm (dose and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The reporter stated that the patient had only received 1 out of 3 doses of GARDASIL to date. Additional information has been requested.
Soreness in arm after 1st dose; Couldn't sleep after 1st dose; Fatigue after 1st dose; Muscle aches in legs after 1st dose; Exhaustion after 1st dose; This spontaneous case was reported by a health care professional and describes the occurrence of AXILLARY PAIN (Soreness in arm after 1st dose), INSOMNIA (Couldn't sleep after 1st dose), FATIGUE (Fatigue after 1st dose), MYALGIA (Muscle aches in legs after 1st dose) and FATIGUE (Exhaustion after 1st dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022m20a and 046a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AXILLARY PAIN (Soreness in arm after 1st dose), INSOMNIA (Couldn't sleep after 1st dose), FATIGUE (Fatigue after 1st dose), MYALGIA (Muscle aches in legs after 1st dose) and FATIGUE (Exhaustion after 1st dose). At the time of the report, AXILLARY PAIN (Soreness in arm after 1st dose), INSOMNIA (Couldn't sleep after 1st dose), FATIGUE (Fatigue after 1st dose), MYALGIA (Muscle aches in legs after 1st dose) and FATIGUE (Exhaustion after 1st dose) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable No concomitant medication were reported No treatment medication were reported.
PERIPHERAL NEUROPATHY 4/10/2023 ACQUIRED LONG QT SYNDROME
This retrospective pregnancy case was reported in a literature article and described the occurrence of spontaneous abortion in a female subject who received Flu seasonal TIV Dresden. On an unknown date, less than a year after receiving Flu seasonal TIV Dresden, the subject developed spontaneous abortion. Serious criteria included GSK medically significant. Additional event(s) included vaccine exposure before pregnancy. The outcome of spontaneous abortion was unknown. The outcome(s) of the additional event(s) included vaccine exposure before pregnancy (unknown). The pregnancy ended in a spontaneous abortion at less than 22 weeks gestation with no apparent congenital anomaly present. The investigator considered that there was a reasonable possibility that the spontaneous abortion may have been caused by Flu seasonal TIV Dresden. Additional information was provided. This retrospective pregnancy case was reported in a literature article and described the occurrence of spontaneous abortion in a pregnant female of unspecified age who vaccinated with unspecified seasonal influenza vaccine (manufacturer unknown) before pregnancy. The patient was a part of study to evaluate the fetal risk and relative safety of the seasonal influenza vaccine overall and secondarily season by season from 2010-2014 using data from the Vaccines and Medications in Pregnancy Surveillance System (VAMPSS), a research program developed specifically to evaluate medications and vaccines used by pregnant women. The patient's last menstrual period was on an unknown date. Estimated date of delivery was on an unknown date. No information on patient's medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date between 2010 and 2011, the patient received unspecified seasonal influenza vaccine (administration route and site unspecified; dosage unknown; batch number not provided) between LMP-DOC (in this study, LMP-DOC is defined as exposure between 1st day of last menstrual period and estimated date of conception. Vaccine year started from August 1st of each year). On an unspecified date, an unknown period after vaccination exposure, the patient had spontaneous abortion (in this study, spontaneous abortion was defined as spontaneous pregnancy loss at less than 20 gestational weeks). Treatment was unknown. The authors did not comment on the relationship between spontaneous abortion and unspecified seasonal influenza vaccine. The authors concluded that "Combining the 2010-2014 influenza seasons, we found a moderately elevated RR for major birth defects overall, but no evidence of a specific pattern; 95% CIs included 1, and this finding could be due to chance. In the combined seasons, we found no meaningful evidence of an increased risk for spontaneous abortion or preterm delivery following exposure to the seasonal influenza vaccine." This is 1 of the 5 valid cases from the same literature article.
Patient experienced dizziness, clammy, nausea, tingling in hands & feet 8-10 minutes after vaccination. Onsite EMS was called vitals were taken BP 102/70 100% O2 room air HR 80. No previous reactions to vaccines in the past. Last flu vaccine 8 years ago. Symptoms subsided. Patient stated she was a little anxious prior to receiving the vaccine.
Information has been received from a physician concerning a female patient who was vaccinated with the complete series of GARDASIL (lot not reported) when the vaccine was fairly new on the market and recently was found to had an abnormal PAP. The patient had HPV. At the time of reporting, 10-DEC-2008, the outcome of the patient was unknown. Additional information was unknown.
Symptom onset (no description of symptoms) 12/17/21; fever of 103F 12/21/21. Patient endorsed lower left quadrant abdominal pain, no nausea/vomiting.
Reaction to Tdap, muscle aches, headaches, fatigue.  Worst was injection site allergic reaction to pertussus vaccine.  Arm was very red, swollen, very hot and had an large red area covering approximately 3-4 inches.  Called facility and was told to take ibuprofen, to take benadryl and use warm wet compresses.  I was told to watch for redness spreading and any lumps under the arm.  I took acetamenaphine, benadryl and used compresses and slept a lot for a few days.  Symptoms are diminishing but still present.
Asymmetry on the face with the Rt side of the mouth more droopy; cannot close right eye well.