chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Increased heart rate; Facial swelling; some swelling in my neck right underneath my chin; Shortness of breath and difficulty in breathing when my heart rate spikes; Numbness down my right arm; This is a spontaneous report from a contactable consumer. This 36-years old female consumer (patient) reported for herself.  A 36-year-old female patient received second dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EW0180, Expiration date: unknown), via unspecified route, administered in right arm on 29Jul2021 (at the age of 36-year-old) as dose 2, single for COVID-19 immunization. The patient medical history includes Coeliac disease from an unspecified date to unknown ongoing and concomitant medications includes loratadine, pseudoephedrine sulphate (CLARITIN-D) for an unknown indication, cyanocobalamin (B-12) for unknown indication, cholecalciferol, menaquinone-7, Phyto menadione, retinol palmitate, tocopherol, tocotrienols nos (VITAMIN D COMPLEX) for unknown indication. No vaccine was taken within four weeks prior to vaccinations. On 29Jul2021, immediately after the vaccination, the patient experienced increased heart rate that went down on its own within 15-to-20-minute, patient noticed that her heart rate was experiencing spikes even when she was sitting completely still. Her heart rate was increased to 110, 120 and 125. she wears a heart monitor, a watch that monitors her heart rate. Patient also experienced facial swelling and some swelling in the neck right underneath her chin, which was noticeable externally. Patient also started to experience some shortness of breath and difficulty in breathing when her heart rate spikes. patient also experienced numbness down the right arm, the same arm that she got the shot, not at the injection site its down the higher length of her arm. The patient lab data includes heart rate readings on unspecified dates which showed 110, 120, and 125. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Pt. states swelling of the throat approximately 15 mins. after receiving TWINRIX & MMR vaccines.
felt a soreness in my left breast arm pit 1/26/2021 and woke up 1/27/2021 with a soreness and itching sensation in left arm at location of vaccine. Upon inspection I had 2 red nickel sized  areas on my left arm at vaccine site. There was a lump under the skin that was sore.  The redness and lump spread through the day. The lump is shaped approx like an egg after 12 hours (not the thicknesss of an egg). I feel a strange sensation like I do with allergies and had  a slight headache off and on though the day.
Pfizer vaccines on 4/13/21 and 5/11/21, patient admitted for 3 days to the Hospital for COVID symptoms.
Moderna given to 12 year old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna given to 12 year old) in a 12-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna given to 12 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna given to 12 year old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter.  Treatment information was not reported.  The patient has monitored for a week and no adverse reaction was reported by child or parent.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: contain Non significant information.
Patient given Pfizer vaccine in error 3 months after 3rd dose. Patient did not have any reaction after waiting in the pharmacy area for 30 minutes. Patient directed to report back to pharmacy if experiencing any adverse effects.
pt devel small hive appeared size of nickel at inject site; pt given benadryl was gone shortly afterwards;
Covid 19 + 08/28/2021 with onset 08/27/2021
This spontaneous report was received from a medical assistant regarding a 9 week old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 18-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L029618, expiry date 20-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degrees F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
booster shot; my left arm aint never stopped hurting since I took the booster shot; I haven''t been sleeping since I received the Pfizer shot; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 10:00 (Lot number: FF2588) at the age of 47 years as dose 3 (booster) , single for covid-19 immunisation. Relevant medical history included: "Vitamin deficiency" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "weakened immune system" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3 taken for hypovitaminosis, start date: 22Jul2021 (ongoing); LISINOPRIL HCTZ taken for hypertension, start date: 28Oct2019 (ongoing); ATORVASTATIN taken for blood cholesterol increased, start date: 04May2020 (ongoing). Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6205, Location of injection: Arm Left, Vaccine Administration Time: 02:45 PM), administration date: 01Apr2021, when the patient was 47 years old, for COVID-19 Immunization, reaction(s): "I haven''t been sleeping since I received the Pfizer shot"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6198, Location of injection: Arm Left, Vaccine Administration Time: 11:30 AM), administration date: 11Mar2021, when the patient was 46 years old, for COVID-19 Immunization, reaction(s): "I haven''t been sleeping since I received the Pfizer shot". The following information was reported: IMMUNISATION (non-serious) with onset 04Oct2021, outcome "unknown", described as "booster shot"; INSOMNIA (non-serious) with onset 01Apr2021 22:00, outcome "not recovered", described as "I haven''t been sleeping since I received the Pfizer shot"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "not recovered", described as "my left arm aint never stopped hurting since I took the booster shot". The event "i haven''t been sleeping since i received the pfizer shot" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of insomnia, pain in extremity.  Additional information: The patient had no other vaccine within four weeks and no other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any allergies.   Follow-up attempts are completed. No further information is expected.
Information has been received from a healthcare worker for GARDASIL, a Pregnancy Registry product, concerning a 22 year old female with allergy to mushrooms and a history of irregular menses who on 01-AUG-2011 was vaccinated intramuscularly with 0.5 ml of the first dose of GARDASIL (lot number: 0626AA, expired date 23-JUN-2013). The patient had no known drug allergies. On 01-NOV-2011, the patient was vaccinated intramuscularly with 0.5 ml of the second of GARDASIL (lot number: 1140AA, expired date: 25-APR-2014), and the patient has been pregnant, pregnancy test was positive. The LMP was reported as 25-SEP-2011, estimated delivery date was on 01-JUL-2012. At the time of the reporting, the outcome of the pregnancy was unknown. The patient sought medical attention by office visit. Follow-up information was received from a nurse who stated that the patient was no longer a patient at the office. The patient's last appointment was on 17-NOV-2011, and was transferred to other healthcare center. On 25-FEB-2014, a phone call was placed to the new healthcare center, a nurse stated that she had no record of the patient. Additional information is not expected.
Patient was signed up via Covid clinic at our pharmacy. His date of birth was listed he signed  in with this birthdate. He was a very big young man. Birthday error not realized until after vaccine administration. He is 17. This is administrative error.  There were language issues at time of sign up. We had interpreters present but birthday year was missed. The volunteers reach out to local community to help vaccinate.  His parents got vaccinated as well.  Confusion for age as Pfizer is ok but not moderna. Reporting this error. Not sure how to proceed going forward and what else we can do. Thank you
Tdap vaccine while pregnant, due date Jan 25th 2019. Developed SVT, heart rate of 200 several hours after the vaccine. Went to ER, where I got medication to bring my heart rate back to normal. No history of anything like this before.
This is a spontaneous report from a non-contactable pharmacist.  A patient of unspecified age and gender received a single dose of PREVNAR 13 on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported.  The vaccine was probably administered to the patient subcutaneously since an unknown date the patient experienced a significant swelling. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.  On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not reported. It was unknown if the reporter considered the pain in arm to be related to Flu vaccine. Additional details were reported as follows: The age at vaccination was not reported. The every year the patient gets the flu vaccine and she gets a sore arm. This case was linked with case US2018180124, reported by same reporter and having same patient.
This is a Male, age 4 Years old, who presents for cold symptoms. Fevers, cough, swelling in both legs and pain in legs with walking ( as of Sunday Nov 11). By Tuesday Nov 13, PT had improved with occasional cough.
Patient became light headed, dizzy and weak outside office - very pale and clammy skin. While being brought into physician office, patient became limp and fainted. Received and was talking to staff within 45 secs of fainting episode.
At the time of received the vaccine, patient was starting get tingling finger, tongue, shaky, and high heart rate, but normal breathing.  When the paramedic arrived her Heart rate 120 and came down to 100 after 20 minutes.  Blood pressure 200/140 came down to 180/100, Normal EKG.  They took her to the hospital and was discharge the same day.  She was giving Benadryl in the hospital due to allergy to the preservative.  They advised to get J & J next time.
A week after I first notice was red spots from my thigh down to my feet, they were not hives but they were red spots. In august they started to fade away but now gone completely, my high blood pressure is high, and I have never had this issue before. It has always been at a normal range and this time was really high.
Redness 2 x 2 in left deltoid area, no other rashes, redness was demarcated.
Shingles; other zoster-related conditions; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medications.   On or about 11-SEP-2012, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for the long-term prevention of shingles and zoster related-conditions.   On an unknown date, the patient was treated by a physician for shingles and other zoster-related conditions (ill-defined disorder).  The outcome of the shingles and other zoster-related conditions (ill-defined disorder) was unknown and the casuality assessment between the aforementioned events and the vaccination with a dose of zoster vaccine live (ZOSTAVAX) was reported as related.  Follow-up information received from pharmacy records on 24-FEB-2022 indicated that the patient was vaccinated on 11-SEP-2012 with a dose of zoster vaccine live (ZOSTAVAX) at a pharmacy. Later, on 02-OCT-2012, the patient was also vaccinated with a dose of influenza vaccine inact sag 3v(FLUVIRIN) multidose vial, 0.5 ml (lot number, dosage and route of administration not provided).
immune problem; extremely tired; This is a spontaneous report from a contactable consumer (Patient). A 81-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation:Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single and via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller was an 81-year-old consumer who has already gotten her first 2 doses of the Pfizer BioNTech COVID-19 vaccine, and she would like to get a booster. She has an immune problem and was a little compromised. She was scheduled for surgery, which has been postponed several times due to the pandemic, but she wanted that dose prior to that. She was 6 months out from her primary doses. She was asking when she can get that. She had very little trouble with her first two doses, aside from being extremely tired. She was asked what she should expect with the third. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
After the first inoculation I had some transient pains in my head, and a few hive like welts, some tiredness.  Then I had the second inoculation.  The morning of 3/11/21 I woke up sweating with a fever and this very strange feeling was rolling through my body, from my head, down to my toes, then back up to my head and on and on.  I took my temperature and it was 100.5 F. Also, I had begun breaking out in a few hive-like red welts on my legs, arms, stomach, back,  maybe 8 to 10, hard to tell,  but strange looking, unusual,  and uncomfortable.  Then around that Wednesday, the 16th, my urine was brownish and smelled smoky.  I had not taken any supplements in days. The next day it was beige, smoky, then the next day bright yellow.  The next day it went back to normal. More welts.   EXTREME exhaustion.  Then  on  the 18th I developed chills and more itching and welts. One on my face.  One or two on my scalp.  More around my waist, arms, neck, and legs.  I am still having intermittent chills and hives/welts, and EXTREME  tiredness.  I have a cold sore in my mouth or throat, I can't tell exactly where.
I woke up with severe stomach pain less than 24 hours after vaccination, went to hospital where they diagnosed me with appendicitis, within 8 hours I was in surgery to remove my appendix.
Father stated pt was taken to ER for t103, sl redness around inject site, neg hardening of site & no treatment was required; Pt was not brought into clinic p/ER visit;
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. Approximately in 2016 (reported as last week), the patient was vaccinated with PNEUMOVAX 23, 1 shot subcutaneously. Approximately in 2016, the patient experienced injection site reaction, swelling, redness, and a lot of pain around the area in her arm. The reporter did not mention any treatment for the events. The patient sought medical attention which included a visit to doctor's office. The outcome of injection site reaction, swelling, redness, and a lot of pain around the area in her arm was reported as recovering/resolving. The reporter did not provided the causality between the events and PNEUMOVAX 23. There were no product quality complaints (PQC) involved. Additional information has been requested.
Pt recvd 1st dose of Engerix-B for Hepatitis B & 5 to 7 days later exp severe pruritus all over body; Seen in ER 3 times & had 1 MD visit; tx meds;
Grandmother called back 9/29/2015 stating patient complained of vomiting, diarrhea, dizziness, fever and fatigue the evening of 9/28/15 and all day 9/29/15. Symptoms resolved by 9/30/15.
I felt fatigued the morning after until about 2 PM. My arm was also sore but that is standard with any shot.
LOSS OF APPETITE; DIARRHEA; HEADACHE; DIZZY; BODY ACHE; NAUSEA; TIRED; URINARY TRACT INFECTION; This spontaneous report received from a patient concerned an 84 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included atrial fibrillation, hypothyroidism, high cholesterol, and allergy to codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced urinary tract infection. On 18-APR-2021, the subject experienced body ache. On 18-APR-2021, the subject experienced tired. On 18-APR-2021, the subject experienced nausea. On 25-APR-2021, the subject experienced dizzy. On 26-APR-2021, the subject experienced diarrhea. On 26-APR-2021, the subject experienced headache. On an unspecified date, the subject experienced loss of appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, headache, tired, and diarrhea, and the outcome of body ache, dizzy, loss of appetite and urinary tract infection was not reported. This report was non-serious.
Information has been received from a registered nurse concerning a male who in 1961, was vaccinated with MMR II (lot number, route and site of administration not reported). It was reported that the patient was vaccinated as a child and at the time of reporting the patient had low titers. Additional information has been requested.
Pt recvd 1st & 2nd dose of Engerix-B vax; P/1st dose c/o dry, itchy eyes which resolved; p/2nd dose pt sys sees brown, hazy spots in front of eyes;
Patient started experiencing side effects around 3-4pm. Arm pain was severe to the point she felt she was unable to move her arm without severe pain. During the night she experienced chills/sweats and fatigue, when she took her temperature it was 103F. Denies redness, rash, or bump  at the site. Reports arm tenderness. Took Tylenol for the fever. Symptoms completely resolved by  Sunday 11/1.
pt recv vax 10MAR99 seen 24MAR99 w/red, raised rash all over body;no fever;did take amoxicillin x 8 days for OM has recently added eggs to diet, has changed detergents;seen by MD thinks rash is from MMR;
Left side of my face became swollen; Itched all over my face and my body was itchy; Incredibly nauseous; This is a spontaneous report from a contactable other healthcare professional. A 57-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 30Mar2021 at 10:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included sjogren's, fibromyalgia, crohn's, osteoarthritis (OA), degenerative disc disease (DDD), hypothyroidism. The patient had known allergies to medications, food or other products. Concomitant medications included oxycodone (MANUFACTURER UNKNOWN), hydroxychloroquine phosphate (PLAQUENIL), febuxostat (ULORIC), baclofen (MANUFACTURER UNKNOWN), potassium chloride (Kcl) (MANUFACTURER UNKNOWN), pregabalin (GABAP); all from an unknown date for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the arm left on 09Mar2021 at 10:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021, 3 days after second vaccination, the patient experienced the left side of her face became swollen, itched all over face and body was itchy and was incredibly nauseous. The first two days the patient slept. all day both days. The patient had other meds that patient took that would not fit on section. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of itchy, swollen face and nausea were unknown.    No follow-up attempts are needed. No further information is expected.
This case was reported by a nurse and described the occurrence of an injection site reaction in a 5 year old female patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  The patient's past medical history included Eczema.  On 03/15/2004, the patient received the 5th dose of Infanrix (DTPA630B2) in her left thigh.  Approximately 2 days after administration of Infanrix, on 03/17/2004, the patient experienced an injection site reaction characterized as swelling, pruritus, warmth, and hardening.  The nurse described the injection site as 6 to 7cm in diameter.  The patient was treated with diphenhydramine hydrochloride, paracetamol, and ice.  The outcome of the events is unknown.  The nurse considered the injections site reaction to possibly be related to vaccination with Infanrix.  Report received via Merck and Co, Inc.
p/vax pt c/o vomiting, diarrhea, h/a & abd cramping;also having sl tightness in throat;dizzy spells x 1wk;+lump, swelling, redness on inj area;lump larger than quarter;tender by touch;general tricep area, numbness, tingling on hands;
At roughly 4:00pm on 01/31/2021, I started having severe pain in my left deltoid which subsided a bit within about 2 hours.  By around 6:00pm on 01/31/2021, I started experiencing fatigued, what felt like a tension headache,  and cold to the point of shivering. I also started experiencing aching all over my body. At around 8:00pm, my body temperature was at 100.2 degrees Fahrenheit (sublingual measurement). By 10:00pm, my body temperature was 101.3 degrees Fahrenheit. I alternated between feeling really cold to feeling hot to the point of sweating through my sheets throughout the night.  I took an initial dose of acetaminophen 1000mg PO at  around 6pm, and continued taking an additional acetaminophen 500 mg PO every 2-3 hours until 4 am. In total, I took 3500mg of acetaminophen.   By 1pm on 02/01/2021, my flu-like symptoms had resolved. I continued to have a low level headache and a sore left arm until 02/02/2021.