chrisvoncsefalvay/vaers-outcomes huggingface dataset:
excessive urination; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (excessive urination) in a patient of an unknown age and 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POLLAKIURIA (excessive urination). At the time of the report, POLLAKIURIA (excessive urination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Pt c/o dizziness.  V/S were obtained.  While obtaining vitals pt c/o difficulty breathing.  Epi 0.3 was administered to R thigh @ 1330.  Pt then c/o nausea and still was dizzy.  P-102 pt then stated she was still having trouble breathing.  Epi 0.3 was administered @ 1335.  EMT was called @ 1335.  EMT was called @ 1331.  Pt was transferred into w/c and moved to front of building where rescue obtained V/S BP-160/90 P-89, R-22.  Rescue transferred pt to ED @ 1345.
Significant pain, erythema and induration in area (anterior and medial) around left deltoid. Significant streaking of tissue with well demarcated erythema, but no axillary node involvement. Fevers with temperature of 101 F. Symptoms began at 12 hours post administration and were still present on days. Treated with Ibuprofen (600 mg, QID) and antibiotics for possible cellulitis (Cefpodudine 400, BID x 7 OMS)
As soon as vaccine given by the nurse I had a strong smell of aluminum in my nose (masked) and my face, chest, hands, and underarms felt very flushed. My heart rate jumped to 150 then dropped into 80s-110s, accompanied by a sense of panic, dizziness, and blurry vision. My chest, underarms, and forehead burned exceptionally bad like on fire, alternating between hot fire and cold fire.  My pulse rate stabilized within a half hour.  I had a meeting with the doctor before leaving. I was told to go home, take Benadryl, relax, and to go to the ER if I had throat issues.   I returned to feeling very sick on my short five to ten minutes ride home. At home the burning intensified, the dizziness  increased, my pulse rate was spiking to the 140s then dropping to 70s-80s. My throat started to hurt. I took Benadryl and swallowing was hard and painful. That combined with the other symptoms I decided to go to the ER.  In triage I had a very hard time sitting still for an EKG because my nerves were jumping so bad, especially in my legs. As I understand my oxygen rate was okay and my pulse was fast. I was told the Benadryl probably had kicked in to help.   I had about a two to three hour wait at the ER before I was taken back. As long as I stayed very still I felt mostly okay except being very hot. If I tried to walk such as a short distance to the restroom I has very dizzy and had bad balance.   At one point in the waiting, having been sitting still, I thought I was okay to go home. But as soon as I got outside I was very dizzy and had to sit down on the ground. The ER intake staff came and got me with a wheelchair.   One I was taken to a room in the ER I was feeling better than I did two-three hours before, but was still yo-yoing with dizziness, burning pain in my chest and back. It still felt like my heart was racing some.  The doctor prescribed a steroid allergy medicine to treat allergies. After about one hour I started feeling a lot better. The burning sensation went away and I was able to walk without being dizzy. I still felt sick and my chest felt like it was very severely bruised.   After about five hours in the ER I started getting very anxious, overhearing the covid and trauma patients. I was treated for that then discharged.  Once home by about 9:00 pm I felt very achy and bruised in some places, but overall better. At about midnight the chest pain and burning returned and I had a small headache. I took more Benadryl.   It is now after 2:30 am and my chest is still cold and burning and the nerves in my legs are very jumpy. I have low to moderate pain in my muscles and joints, especially jaw, wrists, and hips.
Redness at injection site and large big circle that is firm. Injection site is sore and raised slightly. My fourth Covid shot and this has never happened before. Began this morning and received the shot/vaccine yesterday at 5:00 PM
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EW6202), in left arm, on 01Apr2021 as dose 2, single (Lot number: FR5130), in left arm, on 28Oct2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 13Apr2022 at 14:30 as dose 4 (booster), single (Lot number: FK9896) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Scleroderma" (unspecified if ongoing). Concomitant medication(s) included: NIFEDIPINE; SYNTHROID; ESTRADIOL; PROGESTERONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.  Day 10 after taking drug, felt better, tested negative. Then cold symptoms started Day 12, tested strong positive again Day 13 & Day 15; congestion, phlegm, cough; fever Day 16; finally tested negative again Day 19: Rebound lasting full week. Probably contagious again during rebound. People taking Paxlovid should quarantine 14 full days and test again before ending isolation. Also, had extreme fatigue, constipation and muscle soreness/weakness while taking drug; not sure if side effect or caused by virus. Rebound completely different symptoms - more like bad cold.  No follow-up attempts are possible. No further information is expected.
I did not have an adverse reaction to the vaccine. I have had a problem with an enlarged prostate for 2 years. On 01/20/2023, I had the rezum procedure.  I had a follow up appointment today and I was advised it will take time for the swelling to go down.
Adverse reaction started around 5pm.  the patient had been cutting firewood.  he had swelling all the way down his arm into his forearm and rash started later within 24 hours of vaccination
pt was given MMR vax & exp some couging about 10 mins later; about 30 mins c/o itching pt observed hives on forehead; returned to clinic DPH given;
delayed local reaction after vaccination; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) from a contactable physician. A patient of unspecified age and gender received bnt162b2 (Pfizer BioNTech COVID vaccine, reported as COVID Vaccine), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced delayed local reaction after vaccination on an unspecified date. Patient was supposed to get the next dose in a few days and reporter was unsure. The outcome of event was unknown.   Information on the lot/batch number has been requested.
Delayed start all over body urticaria. Body rash is ongoing and weve just realized that same rash appeared last year not long after 2nd dose of Covid 19 Moderna and resolved on it's own after at least a month. Rash was and is frequently all over itchy and painful.
Numbness, tingling and weakness in hands. Significant hair loss. Eyes swollen shut. Hives. Stomach upset including acute vomiting. Chronic fatigue.
A non-serious report was received from a consumer of fever, bodyaches, sneezing and coughing involving a 33-year-old female. No medical history or concomitant medication was reported for this patient. The patient was administered FluMist on 29 Nov 2007. On 30 Nov 2007, the patient began to experience body-aches. The following day, the patient developed a fever of 103, experienced sneezing, coughing, nasal congestion and continued to have body aches with pain in her neck. The patient indicated that her symptoms felt like a "strong flu", however she was not taking medications. Outcome for the reported adverse events was not provided. Action taken with FluMist was not indicated. The reporter did not provide a statement of causality for the adverse events. The reporting source of this is spontaneous, thus the sponsor's comment is not applicable.
Information has been received from a nurse practitioner concerning a 19 year old female who on 09-APR-2007 the patient experienced a tickly feeling in her throat for 24 hours after receiving the vaccine. She needed to clear her throat constantly. There was no soreness noted to the injection site. It was reported that the patient sought unspecified medical attention. Subsequently, the patient recovered tickly feeling in her throat. This is one of two reports that was received from the same source for a sibling. No further details were provided. Additional information has been requested.
Information has been received from a consumer who thinks she transmitted shingles to her sister on an unspecified date.  On 31-JAN-2011 the reporter was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported) (WAES# 1102USA02514).  On 10-FEB-2011 the reporter's sister broke out in shingles on her forehead and face; she had been throwing up and had bad headaches and was hospitalized.  At the time of the report the patient's outcome was unknown.  This is one of two reports received from the same source.  Additional information has been requested.
Pt said she woke up next morning with diarrhea, hands swelling, trouble swallowing and breathing. Went to ER. MD diagnosed allergic reaction to FLUVIRIN. Pt took BENADRYL and said she was feeling better. Call was 24 hours after shot.
About 2 inches from the injection site I have a red patch of skin. It is not raised like a typical rash. There is no swelling or bruising. It is roughly 1 inch in diameter. It is tender to the touch, very hot compared to surrounding normal skin, and is itchy. I first noticed it at approximately 8:30pm on April 28, 2021. It has not gotten larger since it was first noticed. It has gotten itchier and more uncomfortable throughout the day of April 29, 2021.
Information has been received from a doctor of pharmacy concerning a 65 year old female patient with Hydrocodone Bitartrate and VICODIN and LEVAQUIN allergy. On 22-AUG-2012, the patient was vaccinated subcutaneously with a dose of 0.65 ml of ZOSTAVAX (lot #: 0071AE; Exp date: 03-APR-2013). On approximately 24-AUG-2012 "approximately 2 days later", the patient developed an injection site rash. The patient sought medical attention 29-AUG-2012 by contacting the pharmacist to examine her rash. No treatment was given for the event. Pharmacist reported that the rash extended from the injection site proximally 4 inches and was 1 inch wide. The patient told the pharmacist that "the rash was improving, and that she was keeping it covered to avoid transmitting the zoster virus (VZV) to susceptible contacts". There were no laboratory diagnostic test performed. At the time of the report, the patient's outcome for injection site rash and VZV were reported as recovering/resolving. Additional information has been requested.
On the day of the vaccination, we mistakenly gave Pentacel vaccine instead of an ActHib and he was also administered a Pediarix.
Boostrix was exposed to 55-64 F for 2 weeks it was administered to more than one patient.; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) (batch number H4Y3G, expiry date 12th March 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.    This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 27-Apr-2022 Reporter's comment: The case was created for unspecified number of patients. Registered nurse stated that Boostrix was exposed to 55 to 64 Fahrenheit for 2 weeks. No prior excursions.  The dates of administration were 18th April 2022, 19th April 2022 and 21st April 2022. No patient demographics available at this time. Consented to follow up via email. Additional Supportive Information: The registered nurse stated that Boostrix was exposed to 55 to 64 Fahrenheit for 2 weeks and administered to more than one patient, which led to incorrect storage of drug. This was 1 of 7 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070813:Same Reporter US-GLAXOSMITHKLINE-US2022AMR071808:Same Reporter US-GLAXOSMITHKLINE-US2022AMR071809:Same Reporter US-GLAXOSMITHKLINE-US2022AMR071810:Same Reporter US-GLAXOSMITHKLINE-US2022AMR071811:Same Reporter US-GLAXOSMITHKLINE-US2022AMR071812:Same Reporter
patient received an expired dose of ACT-HIB, no AE; Initial information regarding an unsolicited valid non-serious case was received from the other healthcare professional via Medical Information (Reference number- 00585968) and transmitted to Sanofi on 03-May-2021.  This case involves a 15 month old female patient who was administered a 0.5 ml expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (lot number:UJ120AAB; expiry date: 22-Jan-2021; Strength: standard) via intramuscular route in left thigh site for prophylactic vaccination on 06-Apr-2021(expired product administered).  Medical history, medical treatment(s), past vaccination(s) and family history were not provided.  The patient's concomitant vaccinations included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) in left thigh for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  The reporter wanted to know what to do.  At the time of report, no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
The second time, the second vaccination I had a delay in my menstrual cycle for over 49 days; cramping from many weeks until I started my menstrual cycle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: MENSTRUATION DELAYED (non-serious), outcome "unknown", described as "The second time, the second vaccination I had a delay in my menstrual cycle for over 49 days"; PREMENSTRUAL PAIN (non-serious), outcome "unknown", described as "cramping from many weeks until I started my menstrual cycle". The event "the second time, the second vaccination i had a delay in my menstrual cycle for over 49 days" required physician office visit. Therapeutic measures were not taken as a result of menstruation delayed.  Additional information: Patient said last to the second shot and she had similar consequences with this like she had similar cramping from many weeks until she started menstrual cycle. And again it was, it took 49 days.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201341646 Same patient, vaccine, different dose and event;
Less than 23 hours after receiving the shots, my granddaughter had a raised red and very itchy rash going across her entire chest. The following day, the rash appeared across her entire back and since then, it has popped up at different location on her entire body including her buttocks, neck, arm, face, etc. The rashes are extremely itchy when they appear and then they disappear and reappear in a different location on her body.
Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age female patient who experienced vomit, while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in Nov 2017, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via intramuscular route in the thigh nos. On an unknown date in Nov 2017, the patient developed a non-serious vomit, (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was reported that, the patient covered in vomit from head to toe. (Other relevant tests included no lab data.) Final diagnosis was vomit. It was not reported if the patient received a corrective treatment. The patient outcome is reported as unknown for vomit.
Information has been received from a registered nurse (R.N.) concerning a healthy, 12-month-old female with no known allergies, who on 31-MAY-2007 was vaccinated with a subcutaneous 0.5 milliliter first dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (lot# 655847/1386F).  There was no concomitant medication.  On 11-Jun-2007 the patient developed a measles like fine rash over her entire body, a low fever and swollen lymph nodes in her neck.  The child was treated with over the counter TYLENOL.  A throat culture on 12-Jun-2007, was negative for streptococcus.  It is reported that the patient is recovering.  No product quality complaint was involved.  Follow up information received on 30-Jul-2007 states that the patient is a female who on 04-Jun-2007, 4 days post vaccination developed swollen nodes, red throat and a fever.  On 11-Jun-2007 the patient developed a macular rash consistent with measles.  The outcome is unknown.  No more information is expected.
CHEST POUNDING, HEART RATE SPIKING TO 206 WHILE RESTING ON 3 SEPARATE OCCASIONS, BLOOD PRESSURE AT 160, LIGHT HEADED, EXHAUSTION. DIAGNOSES WAS ATRIAL FIBRILLATION.  TREATMENT WAS INJECTIONS TO LOWER HEART RATE AND BLOOD THINNER. PRESCRIBED PRADAXA 150MG X2/DAY AND DILTIAZEM 180MG X2/DAY.
itchy; Big hives at the injection site; red; swollen; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PRURITUS (itchy), INJECTION SITE URTICARIA (Big hives at the injection site), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 008B21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Behcet's disease, Ankylosing spondylitis, Addison's disease and Gastroesophageal reflux disease. Concomitant products included PREDNISONE, SARILUMAB (KEVZARA), METHOTREXATE, OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC), NORTRIPTYLINE and PARACETAMOL (TYLENOL) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (itchy), INJECTION SITE URTICARIA (Big hives at the injection site), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itchy), INJECTION SITE URTICARIA (Big hives at the injection site), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked toMOD-2021-090191,MOD-2021-090148 (E2B Linked Report).; Sender's Comments:  MOD-2021-090191:Same reporter MOD-2021-090148:Same reporter
Per parents got immunization 6/24/08 -> started rash 6/25/08/ No associated symptoms. (+) urticarial lesion face/trunk no mucosal involvement.
swelling; Pain in the arm; axillary pain; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), PAIN IN EXTREMITY (Pain in the arm), AXILLARY PAIN (axillary pain) and MYALGIA (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced SWELLING (swelling), PAIN IN EXTREMITY (Pain in the arm), AXILLARY PAIN (axillary pain) and MYALGIA (sore arm). At the time of the report, SWELLING (swelling), PAIN IN EXTREMITY (Pain in the arm), AXILLARY PAIN (axillary pain) and MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
Initial information was received on 12 June 2014 from a health care professional. Two unidentified patients, ages, dates of birth, and genders were not reported, were vaccinated intramuscularly on an unspecified date in June 2014 with ADACEL, Batch number C4519AA. The sites of administration were not reported. On an unspecified date in June 2014, the patients experienced redness, tenderness and swelling at the injection site. Both were seen by a physician and were diagnosed with cellulitis. Concomitant medications were not reported. The patients did not have any illness at the time of vaccination. Their medical histories were not reported. Laboratory tests and treatments were not provided. The patients' outcomes are not recovered. Documents held by sender: None.
Vaccination nurse gave dose of moderna before realizing patient was scheduled to receive 2nd dose of Pfizer. Dr, Epidemiologist at facility,  notified of mistake. Dr.  advised that patient does not need anything additional; patient is fully vaccinated after receiving Moderna dose post Phizer 1st dose due to vaccine's mechanism of action.  Patient educated and aware. 2nd vaccine nurse checked in with patient at 3pm. Patient had no adverse reaction at that time.
migraine, fatigue, weakness, nightmares, sore arm, skin hurt, red rash around injection site.
My son soon after getting the covid vaccine started loosing weight looking ill unhealthy has no preexisting illnesses.  Started drinking nonstop and urinating way too often even wet the bed at 14 that?s very unusual and unusual for him?  then on Monday the 22nd he started getting lethargic, vomiting,  weak, dehydrated.. rushed him to hospital. He had a blood sugar of 800 and was diagnosed with type 1 diabetes.