chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was reported the patient had body temperature regulation problems since; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001471 (Novavax).  A female patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation. The following information was reported: BODY TEMPERATURE ABNORMAL (non-serious), outcome "unknown", described as "It was reported the patient had body temperature regulation problems since".
Patient describes having numbness from his upper arm to his fingers. The numbness occasionally will subside with sharp burning, tingling sensations. Patient made appointment with primary care provider. Primary care provider gave patient a new prescription for gabapentin. Primary care provider is monitoring.
t105 had sz; transported by ambulance to hosp ER; not admitted; APAP given;
Injection site itchiness to start, then irritated/pain. Now swelling and lumps around injecting site and approximately 1inch radius.
On the 17th through the 19th, I experienced a very scant and dull headache, with cold-sweats, aching muscles, and chills. The mild dull headache has come and gone in intensity, but has not gone away for any duration longer than 12 hours u[ to this day and time 4/27/2021 at 9:45 AM.
Dizziness. Patient sat down briefly, felt better, returned home. Follow up call two hours later pt reported feeling fine.
nurse said it was a double dose; Sick; nauseous; headache; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On 1st October 2020, less than 2 months after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced sickness, nausea and headache. On an unknown date, the patient experienced overdose. On an unknown date, the outcome of the sickness, nausea and headache were recovered/resolved and the outcome of the overdose was unknown.   It was unknown if the reporter considered the sickness, nausea and headache to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were reported as follows: The age at vaccination was not reported. The patient got the vaccine few days ago and was sick, nauseous and had headache one day before day of reporting. The patient was fine on the day of reporting. The patient stated that the nurse said that it was a double dose because of the particular strain of the virus this time which led to overdose.
bronchitis/inflammation in my bronchial tubes; brain fog; exhaustion; joint aches; general malaise; worsening depression & mental health; worsening depression & mental health; 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 received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "1st in Nov2020 before the vaccines", start date: Nov2020 (unspecified if ongoing); "being u thyroid since 2004", start date: 2004 (unspecified if ongoing); "Celiac disease" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization; Bnt162b2 (Dose 3), for COVID-19 Immunization. The following information was reported: BRONCHITIS (non-serious), outcome "unknown", described as "bronchitis/inflammation in my bronchial tubes"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "brain fog"; FATIGUE (non-serious), outcome "unknown", described as "exhaustion"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint aches"; MALAISE (non-serious), outcome "unknown", described as "general malaise"; DEPRESSION (non-serious), MENTAL DISORDER (non-serious), outcome "unknown" and all described as "worsening depression & mental health".  Additional info: "I have had an acute COVID infection twice, both times contracted from work, as I work in healthcare as support staff, 1st in Nov2020 before the vaccines, the 2nd time after receiving both COVID Pfizer vaccines and 2 boosters; in Nov2022. The first time I had pneumonia in my left lung and the 2nd time I had bronchitis and inflammation in my bronchial tubes. I'm still experiencing brain fog, exhaustion, joint aches and general malaise; as well as worsening depression & mental health both times. The 2nd infection occurred while working in a cancer clinic as a Medical Assistant, where I still work. The 1st infection, I was working as a personal care aide at an assisted living home. I'm 47, a single mother of 3, have a somewhat weakened immune system from being u thyroid since 2004 & having Celiac disease as well as high blood pressure. My blood type is A+. Both infections I believe occurred due to other coworkers improperly wearing masks or not wearing them at all at work. I even lost time from work that I was not paid for-both times, the I practice safe hand hygiene, wear a mask at my job and stayed home and isolated from my own kids and to protect the patients I help care for."  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200125601 same reporter/patient  drug, different dose/event;
pt recv vax 24SEP97 & 7 days post vax pt devel rash x 1wk;8 days post vax pt was irritable, tired, had a dec appetite & temp of 102;pt also devel one papule on face;exp viral infect;
c/o cold sx 8JAN93; mom states t101-103ax PM 7JAN93; did not eat or drink normally from time of vax until mom took to hosp 11JAN93; lt leg red & swollen day of vax; pt still has cough;
I thought I had bites on my ankle, over a few days it went up both legs but worse at the ankles, swollen, purple and itchy.
NAUSEA VOMITING DIARRHEA FATIGUE STOMACH PAIN BACK PAIN
pt in office on 10/25/2023 and received 4 vaccines; by evening on day of office visit MOC noticed right leg with warm raised rash to skin at injection site with approximate size of mini orange (cutie); pt did not have any pain or itch at that time; by next morning sx's were still the same; by Thursday evening (10/26/2023) MOC noticed same sx's to leg leg/thigh with approximate size of a quarter; this morning (Friday 10/27/2023) sx's of rash were lighter in presentation and the rash to right leg appeared to have spread
Syncope - Pharmacist supported patient as she went to the floor and rised her legs. Patient soon regained consciousness and it was confirmed that there was no difficulty breathing. The pharmacy proceeded to call 911 as a precaution.
This spontaneous report was received from a Licensed Practical Nurse, referring to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 06-JAN-2016, the patient was vaccinated with an expired PNEUMOVAX23 (lot # K007262, expiration date 25-NOV-2015). No concomitant medication was reported. No adverse effect has been reported. The reporter stated that no product quality complaint was involved. Additional information has been requested.
Intense chills/coldness/ inability to warm up ? temp outside is 46 degrees. Wearing three layers and four blankets and unable to get warm. This has never happened to me before. NO rigors or shaking chills ? just extremely cold.
Approximately 6-7 weeks after vaccination the patient developed lower extremity weakness with numbness tingling and burning pain in his lower extremities. He also developed some numbness and tingling at the tips of his fingers. He complains of decreased sensation in the perineal and genital area as well. He presented to Hospital on 10/1 after having symptoms for 3 months.
Warm to touch; Side of the arm swollen; left side of the arm swollen,itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE SWELLING (Side of the arm swollen) and VACCINATION SITE PRURITUS (left side of the arm swollen,itchy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE SWELLING (Side of the arm swollen) and VACCINATION SITE PRURITUS (left side of the arm swollen,itchy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE SWELLING (Side of the arm swollen) and VACCINATION SITE PRURITUS (left side of the arm swollen,itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported.
Bexsero instead of Menveo; error was made because the medical assistant thought that Bexsero and Menveo were indicated to prevent the same type of meningococcal disease; This case was reported by a nurse via sales rep and described the occurrence of wrong vaccine administered in a 11-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd November 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd November 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and product administration error. On an unknown date, the outcome of the wrong vaccine administered and product administration error were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: A newly hired medical assistant inadvertently received Bexsero instead of the prescribed vaccine Menveo, which led to wrong vaccine administered. Patient had not yet been notified at the time of report.  The error was made because the medical assistant thought that Bexsero and Menveo were indicated to prevent the same type of meningococcal disease, which led to product administration error. This case was linked with US2021220233, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021220233:Same reporter
Cold symptoms; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold symptoms), PYREXIA (Fever) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history is provided by reporter.     On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold symptoms), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, NASOPHARYNGITIS (Cold symptoms), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative.         The concomitant medications were not reported.  The treatment information was not provided.   Reporter did not allow further contact
Complained of rash on arm; lesion on right arm with secondary impetigo which started 7 days after shots given.
2/6/02 within 2 hrs, L arm had swelling, pain, redness and warmth to area, size of swelling 3x3" approx, - mom gave Advil and ice compress to arm.
12/13/2022 sore throat; dizziness; fatigue; diarrhea; hot flashes; tested positive for covid for 12 days.
Patient called the Vaccination Information Line in regards to HPV vaccine she received starting on 11MAY2016. Patient reported beginning on UUU, described as, since receiving this vaccine, she has experienced, "so many" frequent urinary tract infections and is currently experiencing one at this time. Patient reported she has seen doctors, been to urgent care, and saw a urologist. The current UTI started "5 days ago", she was seen for the UTI, and is being treated with a medication. Event remained ongoing. No additional information was provided.
Approximately 5-6 cm x 3 cm area of erythema and slight swelling on left upper outer arm, no significant warmth, very minimal tenderness to palpation, no fluctuance, no urticaria. Seen later for worsening at an after hours clinic and 9 x 5.5 cm erythematous wheal on left deltoid, needle mark visible within wheal. Pt had full ROM of left arm.
A non-serious spontaneous report of "29 patients received expired FLUMIST" was received from a physician concerning a 40-year-old female. The patients' medical history included no history of asthma. Concomitant medications were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications). There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error. Additional information was received on 31-Mar-2009 that included the results of a lot investigation: Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.
Patient stated itching approximately 27 hours after vaccine.  Returned to have edema and flushing approximately 5" in diameter from IM site.  Patient denies any pain or discharge.
This spontaneous report as received from a physician refers to a couple of patients. On unknown dates the patients might be vaccinated with PNEUMOVAX23 (also reported as unspecified vaccine) (dose, indication, and route not reported). The physician stated since approximately 1998 (10-15 years ago), he had a couple of patients who might have had allergic reactions to an unspecified vaccine, whether their reaction was caused by a vaccine was unknown and what the reaction was, if present at all, was unclear to the physician. Also, if vaccine was cause of reaction, it was not clear if it was a MERCK product. Adverse effects, if any, were not able to be identified. The physician asked for studies pertaining to PNEUMOVAX23 and allergic reactions and also asked if yeast was an ingredient. No PQC. The outcome of allergic reaction is unknown. Additional information has been requested.
Had Covid vaccine yesterday and developed body aches headaches and Nauseous symptoms and is unable to work today.
Seen in ER for cat bite, given Td in Left deltoid, still complaining of left arm pain from inj on 10/6/05 with tingling in hand and arm.
Received shot on 2/27 2/28 & 2/29 fever , chills, joint aches, headaches, took Tylenol for fever 2/30 rash started at injection site. I took Benadryl  but rash spread and got worse  3/4 went Emergency center for worsening rash, sever itching, and unable to sleep. I was given a Benadryl  25mg injection and a steroid shot. I was to continue taking Benadryl and set up an appointment with my PCP.
according to mom who called office @ 1415 on 30NOV92 that pt had not stopped crying since had vax; some high pitched crying episodes; cont until afternoon or early PM; OK p/that period; instructed to give APAP & cool cloth to DTP site;
Patient came in to pharmacy with concearns of a adverse reaction. Patients left arm is in pain and has developed a rash.  Patient was advised to take Benadryl and Advil to help with reaction and pain.
patient only wants to sleep; in pain/in agony; every muscle hurts/everything hurts; patient was very tired; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (patient only wants to sleep), PAIN (in pain/in agony), MYALGIA (every muscle hurts/everything hurts) and FATIGUE (patient was very tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037832b, 006b21a and 003a21a) for COVID-19 vaccination.     It was reported as patient  never had COVID positive test or diagnosis,no history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination and patient received none of the other vaccines given within one month prior to Moderna COVID-19 Vaccine.  Concurrent medical conditions included Pollen allergy (Patient is allergic to pollen dust).   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (patient only wants to sleep), PAIN (in pain/in agony), MYALGIA (every muscle hurts/everything hurts) and FATIGUE (patient was very tired). At the time of the report, SOMNOLENCE (patient only wants to sleep), PAIN (in pain/in agony), MYALGIA (every muscle hurts/everything hurts) and FATIGUE (patient was very tired) had not resolved.            Patient height reported as 5 Foot 9 It was reported as patient was concern about her heart as it is muscle and it was also reported that no AE cause patient to seek medical care so far,patient never experienced a similar event in the past and symptoms was not really improved. No concomitant information was reported was by the reporter. Treatment includes: pain medication which has its own side effects and could stand it only for a few days.   This case was linked to MOD-2022-581273 (Patient Link).
I had no reaction 1st week. Then, 8 days later, injection site was lightly itchy with a 2" diameter  lumpy under the skin.   The next 5 days; Lumps disappeared as the skin became Bright red, hot, & slightly itchy.  This Bright red, hot area  grew down to nearly my elbow over the next 5 days. Approx. day 13 after the shot, itchiness stopped and red disappeared.
This spontaneous report as received from a healthcare worker, via a company representative, refers to a patient 2 of 2 female patients (age not provided). A healthcare worker told the company representative that there was an article from a press out today (08-NOV-2013). The article reported that 2 patients who are sisters claimed that GARDASIL caused ovarian failure. Dosing information, route of administration and lot number GARDASIL were not provided. The outcome of ovarian failure was not provided. This case is linked to case 1311USA003734 (patient 1 of 2 female patients). Additional information has been requested.
nausea, vomiting, diarrhea, headache, labile uncontrolled hypertension, shortness of breath
Swelling on right side of body.  Multiple headaches. Nerve tingling. Cold feet Also got reactions form the Booster shot (IM, LA, Moderna) Swelling with booster, pain from shoulder down on the left side.
ACUTE NON ST ELEVATION MI DEMAND ISCHEMIA 8/16/2022 -- RECURRENCE OF SAME SYMPTOMS
broke out into full body hives after receiving quadracel; Initial information received on 18-May-2022 regarding an unsolicited valid non-serious case received from a physician via call center.  This case involves a 5-year-old female patient who broke out into full body hives after receiving vaccine Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine (dose, route, strength, formulation, frequency, batch lot number and expiry date: unknown) in unknown administration site for immunization. Information on batch lot number is requested.  On an unknown date the patient developed a non-serious event broke out into full body hives after receiving quadracel (urticaria) (unknown latency) following the administration of diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine.  it was reported that the HCP (health care professional) said this has been reported previously and they had received form to complete. Unable to locate previous report.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (urticaria).  At time of reporting, the outcome was Unknown for the event urticaria.
Received vaccine at 12:00 received a call from RPH at 1:30 pm nurse reported on the way home blacked out, low BP. heart rate and diaphoretic upon arriving at hospital. Treated for anaphylactic reaction. 2nd observation at hospital, nurse reports he is ok. Will be hospitalizes overnight for observation. Also rash on stomach
Resident received booster dose, had received 1st booster on 5/6/22 while hospitalized.  No reaction noted at the time of administration by health care team, continued monitoring by nursing staff for the next 24 hours.  No issues noted at the time of this report