chrisvoncsefalvay/vaers-outcomes huggingface dataset:
UTIs; vaginal burning; felt crummy; low grade fever (99-100.3F); nausea; back pain; This case was reported by a physician via call center representative and described the occurrence of urinary tract infection in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th November 2020, the patient received the 1st dose of Shingrix. On 25th November 2020, less than a day after receiving Shingrix, the patient experienced fever, nausea, back pain and feeling unwell. On 22nd December 2020, the patient experienced urinary tract infection and vaginal burning sensation. The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)) and estrogens conjugated (Premarin Cream). On an unknown date, the outcome of the urinary tract infection, nausea, back pain and vaginal burning sensation were recovered/resolved and the outcome of the fever was not recovered/not resolved and the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the urinary tract infection, fever, nausea, back pain, vaginal burning sensation and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and felt crummy. The patient experienced low grade fever 99 to 100.3F, nausea and back pain. The reporter stated that, the patient had some UTIs (urinary tract infection) and had some back pain and vaginal burning. The patient was placed on antibiotics and Premarin cream.  The UTIs resolved sometime and was feeling much better and continues to had a low grade fever.  The reporter did not know when nausea resolved. The reporter consented to follow up. Lot and expiration date were not available.
Information has been received from a physician concerning a female who was vaccinated with varicella virus vaccine live. Fourteen days, post vax, the pt experienced transverse myelitis. The transverse myelitis was considered to be an "Other Medical Event". Additional information has been requested.
Red streak around the arm; Arm  sore at the injection site; Redness about 2 inches wide; Lymphnodes underneath her armpit down to her breast; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red streak around the arm), INJECTION SITE PAIN (Arm  sore at the injection site), VACCINATION SITE ERYTHEMA (Redness about 2 inches wide) and LYMPHADENOPATHY (Lymphnodes underneath her armpit down to her breast) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 05-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced ERYTHEMA (Red streak around the arm), INJECTION SITE PAIN (Arm  sore at the injection site), VACCINATION SITE ERYTHEMA (Redness about 2 inches wide) and LYMPHADENOPATHY (Lymphnodes underneath her armpit down to her breast). At the time of the report, ERYTHEMA (Red streak around the arm), INJECTION SITE PAIN (Arm  sore at the injection site), VACCINATION SITE ERYTHEMA (Redness about 2 inches wide) and LYMPHADENOPATHY (Lymphnodes underneath her armpit down to her breast) had resolved.            Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: TCR : AE outcome added
Began with itching on head and chest and turned into body wide hives a little over a week after vaccination. Needing urgent care visit with starting zyrtec twice a day, steroid cream, and oral steroid. Rash improved over course of 10 day oral steroid but once the oral steroid was completed within 48 hours the rash/hives came back on neck, head, arms, and chest. Dermatologist seen for follow-up visit for acne and was given diagnosis of hives and the doctor thought likely from the COVID booster. Steroid injection given and Allegra added. Still taking zyrtec twice a day and Allegra once a day with occasional itchiness.
started feeling bad on Wednesday June 22.  sore through, cough, runny nose, soreness, headaches.  Ran a home health test Thursday morning and it was negative.  Thursday picked up the remaining symptom, fever, chills and diarrhea.   Went to urgent care on Friday and tested positive.   I did not work Thursday or Friday. June 23  24.  Started to feel better but by Tuesday of the next week (June 28) was feeling worse and coughing up a lot of mucus.  Setup a zoom appointment and got prescribed antibiotic for the sinus infection.
evening that got imm nausea, vomiting, fever, all over muslcu pain. couldnt move arm for 1week after imm, then muscle pain whole arm, gradually moving to injection site.
Arm sore on Sat/Sun of with massive bruise and Monday just bruising soreness gone. Pt will follow-up with MD on Tuesday.
PATIENT COMPLAINED FEELING WARM, FLUSHING FACE PALPITATIONS AND DIZZY IMMEDIATELY AFTER RECEIVING VACCINATION.
I woke up on 3/24/2021 with swollen/puffy and tingling lips, numb face, tingling in the hands and feet.  I called the advice nurse and zyrtec was recommened. Later that day, doctor suggested I take zyrtec and tylenol. 5 months later, I am still experiencing face numb on occasion and tingling in the hands, feet, and lips.
The patient complained about soreness in the arm after vaccine was supposedly given too low in the arm. Patient is still having soreness 70 days post vaccination. They have tried tylenol, benedryl and steroids.
Site of shot aches.   So tired 11/26 slept most of day and had nausea.  Approximately 48 hours after shot, developed an itchy spot on leg and thought it was a bug  bite.  However, woke up 11/28 to find chest, breasts, upper arms, belly, butt, upper legs covered with red, itchy spots.  Went to ER - Dr. had never seen it before, but said it had to be an allergic reaction to the Shindrix as it happened within the 48 hours time period.  Prescribed Prednisone 50 mg, Famotidine 20 mg and OTC Benadryl.
CMA received order for PROQUAD, vaccine mixed and administered intramuscular instead of subcutaneous route. Error was not noted till documenting the vaccination when it was noted that the order read subcutaneous and there was no drop down option for intramuscular in the EMR.
The Moderna Bivalent vaccine was administered by accident instead of the Pfizer Bivalent for the patient's third vaccine. No treatment was needed. Pt does not need a to repeat a dose.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional) from medical information team. The reporter is the patient. A 62 year-old male patient received bnt162b2 (BNT162B2), administration date 22Dec2021 (Lot number: FJ8762) at the age of 62 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN CALCIUM 80 mg, one in the evening taken for transient ischaemic attack; ASPIRIN 81, 81 mg once a day taken for blood disorder. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 immunization, reaction(s): "Hardness in the arm, stiff arm that was fine". The following information was reported: COVID-19 (medically significant), outcome "unknown", described as "tested positive for Covid-19 (OMICRON)"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "drug ineffective"; RASH (non-serious) with onset 24Dec2021, outcome "recovered", described as "rash on my arm and between my legs"; OROPHARYNGEAL PAIN (non-serious) with onset 24Dec2021, outcome "unknown", described as "sore throat"; COUGH (non-serious) with onset 31Dec2021, outcome "unknown", described as "Coughing and coughing up phlegm"; ILLNESS (non-serious), outcome "unknown", described as "sick"; VACCINATION SITE WARMTH (non-serious), outcome "unknown", described as "hot 'casing' on where I got my shot"; SEASONAL ALLERGY (non-serious), outcome "unknown", described as "pollen reaction". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: OMICRON. Therapeutic measure Benadryl was taken as a result of rash. Follow-up (10Jan2022): This is a spontaneous follow up report from a contactable consumer. Updated information: Patient information: Additional information: Concomitant drugs added(Atorvastatin Calcium and Aspirin), lot number added, event onset for sore throat added, new events (sick, Vaccination site warmth) added. No follow-up attempts are needed. No further information is expected.
This case was reported by a nurse and described the occurrence of hives in an infant female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. On an unknown date the subject was vaccinated with Pediarix. The subject was also vaccinated with 7-valent pneumococcal conjugate vaccine (Prevnar) and Haemophilus influenzae type b conjugate vaccine (HibTITER). Two days after vaccination with Pediarix, the subject experienced hives. The outcome and causality of the events was unknown.
EngerixB intravenous instead of intramuscular; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 82-year-old female patient who received HBV (Engerix B) (batch number F73DG, expiry date 3rd July 2023) for prophylaxis.   On 4th May 2022, the patient received Engerix B (intravenous). On 4th May 2022, unknown after receiving Engerix B, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 04-MAY-2022 Reporter's Comment: Registered nurse reported that on the day of reporting (today) another nurse accidentally gave Engerix B to a patient intravenous instead of intramuscular.  Health care provider wanted to knew if there was any information related to adverse event due to this situation or any information available regarding patient safety The reporter consented to follow up. Additional Supportive Information: The patient received Engerix B intravenous instead of intramuscular. which led to intramuscular formulation administered by other route.
Approximately 7 days after receiving vaccine he developed very high fevers >103 which lasted for 8 days. He also had a febrile seizure on 2/23/07 which caused a visit to local ER full workup. Over the course of the 8 days of febrile illness he saw his doctor twice developed thrombocytopenia, weight less of >10% of his body weight and is still trying to recover. No more vaccines/poisons for him.
It was "reported that after his flu shot on 10/5, he began to experience soreness and pain to left flank and kidney area. No fever, no hematuria, no treatment given." From additional correspondence received on 11/22/99, addition pt information was provided.
severe high pitched crying spell, febrile 102 R, quad red & swollen;ER 850PM CBC done;crying x 1hr-non stop;rt thigh sl red & swollen, very large bumps in triangle;irritable, t101
tinnitus and dizziness developed about 4 weeks later.  I tried Prednisone and Sudafed to reduce head congestion but to no avail.  I tried ibuprofen before bed and i woke up the next morning with no signs of tinnitus.
Initial and follow up information has been received from a nurse concerning a 43 year old female with history of fever with previously vaccinations with yellow fever and tetanus, no known medication allergies, no known illness at the time of vaccination, who on 15-AUG-2008 was vaccinated at a travel clinic with a first dose of VARIVAX (Oka/Merck); lot # 658587/1520U; 0.5 mL subcutaneously. On 15-AUG-2008, concomitant vaccination included a dose of TYPHIM VI (Lot no. B0347) and a dose of yellow fever virus vaccine (Lot no UF426AA). About 7 days after vaccination, on approximately 22-AUG-2008, the patient complained of varicella type rash on her foot and scalp as well as a low grade fever. There were no lab diagnostic studies performed. On an unknown date the patient had recovered. The nurse reported that the patient was not seen by a physician, but she consulted by phone. On an unknown day, the second dose of VARIVAX vaccine (Oka/Merck) was given to the patient with no post symptoms. No further information is available.
This spontaneous report was received from a registered nurse and refers to a 23 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N012132 with expiry date: 17-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
Arm swelling; nauseated; chills; muscle pain, dizziness. This progressed to difficult and painful breathing and severe coughing; vomiting, spiking fevers; increased severity of chills; severe headaches; dx of pneumonia.
Participant states that she had a sore arm, did not feel normal with very low energy. She also had a fever. She did not go to the doctor.
After receiving vaccine, patient said she was itchy all over.  I advised her to sit down and consider taking Benadryl.  She then said she was having trouble breathing and her throat and lips were swelling.  She did take Benadryl, but her symptoms were getting worse, so I administered an Epi-pen, and we called 911.  Within minutes she seemed better, but was still complaining that it felt like a lump was in her throat.  I stayed with her until the ambulance arrived.  They evaluated her and she left with them.
Breakthrough case admission after four vaccines Pfizer 2/26/21 Lot# En6201;  Pfizer 3/19/21 Lot# EN6198;   Pfizer 11/19/21 Lot# FF2593;  Moderna 6/17/22 Lot# 037A22B
On 02/08/2021 I started experiencing menstrual  brown spotting which increased in volume to bright red blood and cramping on 02/11/2021. I am on hormonal birth control and my period should not start until approximately 02/20/2021. Breakthrough bleeding has never occurred while I have been on nuvaring (for 14 years).
Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from Consumer/Non-HCP (office staff). This case involves a 55 years old female patient who experienced 4 inch diameter welt on her left arm surrounding the injection site. redness, swelling, fluid under the skin, hot to the touch and pain, while she received vaccine FLUZONE QUADRIVALENT. The patient's past vaccination(s) included FLU with every year. The patient's past medical history, medical treatment(s), concomitant medication and family history were not provided. On 05-Oct-2018, the patient received a 0.5 ml standard dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ035AA expiry date 30-Jun-2018 via unknown route in the left deltoid. On 08-Oct-2018, patient developed a non-serious 4 inch diameter welt on her left arm surrounding the injection site. redness, swelling, fluid under the skin, hot to the touch and pain (urticaria) 3 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On 08-Oct-2018, patient developed a non-serious 4 inch diameter welt on her left arm surrounding the injection site. redness, swelling, fluid under the skin, hot to the touch and pain (inflammation) 3 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On 08-Oct-2018, patient developed a non-serious 4 inch diameter welt on her left arm surrounding the injection site. redness, swelling, fluid under the skin, hot to the touch and pain (vaccination site reaction) 3 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Lab data was not reported. Final diagnosis was 4 inch diameter welt on her left arm surrounding the injection site. redness, swelling, fluid under the skin, hot to the touch and pain. It was not reported if the patient received a corrective treatment. The event of injection site swelling was ongoing at the time of reporting and outcome of other event was not reported. Documents held by sender: none
consumer reported that durin 1990 flu season pt exp a fever for approx 1 wk postimmunization; no other sx were present; pt recovered; prior to this episode pt has been receiving flu vax every yr for the past 30 yrs w/no adverse events;
Not feeling well; Tingling in her hands and feet; Fatigue; Nausea; Chills; Confusion; Brain fogginess; Cold hands; Very anxious about having; A spontaneous report was received from a nurse concerning a 56-year-old female patient who experienced confusion [confusion], brain fogginess [foggy feeling in head], not feeling well [malaise], cold hands, are intermittent or waxing and waning, and mostly noticed when going to bed [cold hands], very anxious about having received the vaccine [anxiety], tingling in her hands and feet [tingling feet/hands], fatigue [fatigue], nausea [nausea] and chills [chills].  The patient's medical history was not provided. Concomitant medication use was not provided by the reporter.   On 29-Dec-2020, approximately one day prior to the onset of symptoms, the patient received one of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly in an unknown injection site for prophylaxis of COVID-19 infection.   Since 30-Dec-2020 she has been experiencing fatigue, confusion, brain fogginess, "not feeling well," nausea, chills, and tingling in her hands and feet. The tingling in her hands and feet are accompanied by cold hands, are intermittent and mostly noticed when the patient is going to bed. The caller believes the recipient is also very anxious about having received the vaccine and experiences these symptoms most noticeably before bed due the anxiety. Fatigue has improved somewhat but her other symptoms continue to occur every night. She received negative covid-19 test results on 01-Jan-2021.   Treatment for the events was unknown.    Action taken with mRNA-1273 in response to the events was not applicable.   The event, fatigue, was resolving. The outcomes of the remaining events were not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
12 days after moderna booster I began to have itchy underarms then palms of hands, then hands, then chest and stomach, then feet. Now my entire body is itchy without a rash aside from when I scratch and get welts that last about an hour. I took one Benadryl so far and believe alcohol is one of the triggers of  the itching.
18JUN96 p/vax t100-101 ear APAP given;19JUN96 t106 ear APAP given during PM-tepid bath;t102 ear;crying, screaming occurred w/inc temp;seen by MD-ears clear, fever/pain given med;macular type rash;21JUN dec oral intake, dec wet diapers
This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally (lot # M040269 with expiration date at 28-APR-2018 and lot # M033338 with expiration date at 15-APR-2018; dose was not reported), for prophylaxis. The administered doses of vaccine experienced multiple temperature excursions. From16-MAR-2017 to 31-MAR-2017, the doses of ROTATEQ with lot numbers: M040269 and M033338 were exposed to a temperature in the range between 47 degrees Fahrenheit (F) to 77 degrees Fahrenheit (F) for 1 hour and 52 minutes in total. On 21-MAR-2017, took place the longest (35 min) excursion with temperature of 49 degrees Fahrenheit (F). Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected since all scheduled correspondence was received.; Sender's Comments: US-009507513-1705USA015599: US-009507513-1705USA015600: US-009507513-1705USA015601: US-009507513-1705USA015602: US-009507513-1705USA015598: US-009507513-1705USA000770:
This spontaneous report as received from a medical assistant refers to a 8 week old male patient. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 21-OCT-2016 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # M016238 and expiration date: 07-DEC-2017), (dosing regimen and frequency unknown) orally for prophylaxis (product storage error). On 04-APR-2017 the patient was vaccinated with second dose of ROTATEQ (lot # M016238 and expiration date: 07-DEC-2017), (dosing regimen and frequency unknown) orally for prophylaxis. The ROTATEQ vaccines were stored between 44 Fahrenheit degrees (F) and 77 F for 45 minutes. There was no previous temperature excursion. There was no previous temperature excursion. The medical assistant also stated that a data logger was involved on 23-OCT-2017 that prompted her to call the company. This is one of the many reports from the same source. Sender's Comments: US-009507513-1710USA012197; US-009507513-1805USA007925; US-009507513-1805USA007927; US-009507513-1805USA007928; US-009507513-1805USA007929.
Chills  Headaches  Body aches  Fatigue Slight fever   Using Tylenol and  ibuprofen for treatment   Vaccine received on  2/14 effects still happening on night of 2/15 (Second dose)
headache; Diarrhea; dizziness/severe dizziness; weakness/very weak; muscles and joints are aching and painful; muscles and joints are aching and painful; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no: EL1284, expiry date not reported), via an unspecified route of administration on 13Jan2021 at a single dose on left arm for Covid-19 immunization. Medical history included pre-diabetes 3-4 years ago. The patient's concomitant medications were not reported.  Certified Nursing Assistant said that she has been experience some side effects from the Pfizer-BioNTech Covid-19 Vaccine which she took two days ago, 13Jan2021. She said she was having side effects include headache on an unspecified date. Furthermore, she experienced diarrhea, dizziness/severe dizziness, weakness/very weak and muscles and joints are aching and painful on 14Jan2021. The outcome of all events was not recovered except for headache that was unknown. She wanted to know what she should take and what she should do about these symptoms.
Symptoms of a fever (full body ache, sensitive skin, headache) started around 5:30pm on 4/9. (No temp taken.) 600mg of Ibuprofen was taken around 8:30, by 10:30 fever symptoms were reduced and only a strong headache remained. 4/10 3:30am-- woke up in extreme pain associated with a fever (actual temp 99.6 F). 600mg of Ibuprofen was taken at that time. 7:30am--600mg of Ibuprofen was taken 1:30pm--fever symptoms started to return, 600mg of Ibuprofen was taken. 8:30pm--fever symptoms were returning but not at strong. 600mg of Ibuprofen was taken  4/11--no more fever symptoms, general arm soreness at site of injection. 400mg of Ibuprofen taken at 8am