chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hair started falling out; started to have memory problems; After the second dose the patient noticed that the burning in her right foot and leg continued; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (After the second dose the patient noticed that the burning in her right foot and leg continued), ALOPECIA (hair started falling out) and MEMORY IMPAIRMENT (started to have memory problems) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014FZ21A and 088D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced BURNING SENSATION (After the second dose the patient noticed that the burning in her right foot and leg continued) (seriousness criterion medically significant). In November 2021, the patient experienced MEMORY IMPAIRMENT (started to have memory problems) (seriousness criterion medically significant). In January 2022, the patient experienced ALOPECIA (hair started falling out) (seriousness criterion medically significant). At the time of the report, BURNING SENSATION (After the second dose the patient noticed that the burning in her right foot and leg continued) had not resolved and ALOPECIA (hair started falling out) and MEMORY IMPAIRMENT (started to have memory problems) outcome was unknown.            Concomitant medication was not reported.  The patient noticed that her hair was falling out starting a month. The patient noticed this about her hair in late January 2022. The patient stated she was kind of ol. The patient started to have memory problems in November 2021.  Treatment medication was not reported.   This case was linked to MOD-2022-494745 (Patient Link).; Sender's Comments: This spontaneous case concerns a 60-year-old female patient with no medical history reported, experienced the unexpected serious events Burning sensation, on same day, Memory impairment two months after and Alopecia four months after the second dose of mRNA-1273. It was reported that the patient developed, burning in her right foot and leg, memory problems and hair started falling off. The patient had burning sensation of foot after first dose which indicates a positive rechallenge. Elderly age of the patient and previous use of Gabapentin could be confounders for the events Memory impairment and Alopecia. At the time of reporting, the event Burning sensation had not resolved and outcome of Memory loss and Alopecia was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.
Body aches, pains, fever of 103 Fahrenheit, dizziness, falls.
Received Smallpox and Anthrax vaccinations on 6/9/06 following a negative urine pregnancy test. On 7/15/06 Serum Pregnancy test was done d/t last menstrual period on 5/17/06 and was positive. Pre-vaccination form was completed prior to vaccination and soldier did not indicate at that time any concerns regarding possibility of being pregnant.
This spontaneous report as received from a pharmacist regarding her son refers to a 14 year old male patient with current condition of mood disorder, drug reactions/allergies to penicillin-hives. Concomitant therapies included WELLBUTRIN, TENEX, and BUSPAR. On 17-JUN-2014 the patient was vaccinated with second dose GARDASIL lot # H020901 expiration date 05-JUL-2015, dose 0.5 ml, route, intramuscular. On 23-JUN-2014, the patient developed gross hematuria. The reporter also stated that the patient was evaluated at a local emergency room on 28-JUN-2014, which was confirmed through the urinalysis. Lab investigations included urinalysis (28-JUN-2014) hematuria. It was also reported no diagnosis was made and the patient was advised to increase fluid intake. The outcome of gross hematuria was reported as not recovered/not resolved. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Noticed petechiae on legs abdomen and chest.  Had severe bruising on legs. Platelet levels 3,000, I was at danger of spontaneous hemorrhage or death with fall/injury.  Started on 100 mg prednisone daily for 3 weeks. Consulted with clinic physician Platelet levels improved on prednisone.  Now weaning off prednisone and monitoring with weekly CBC.
flu; Initial information received on 21-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via social media.  This case involves a patient of unknown age and gender who developed flu after receiving Quadrivalent Influenza Vaccine (Influenza Vaccine (Quadrivalent)).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Quadrivalent Influenza Vaccine (dose, strength, formulation, lot number, route, administration site and expiry date: not reported) for influenza.  On an unknown date the patient developed flu (influenza) (unknown latency) following the administration of Quadrivalent Influenza Vaccine.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
10SEP93 had sz w/fever; 15SEP93 had a sz w/high fever; MD states fever D/T virus, pt also slept alot; Pt is taking Phenobarbitol still @ this time; probs with eyes going in, muscle spasms/tremors
During the 15 minute post-vaccination period patient reported a metallic taste in her mouth that started a few minutes after vaccination. She stated that other than that and some soreness at he injection site she was otherwise fine. She went on to state that she already noticed that the metallic taste was starting to dissipate, even after only a few minutes. I informed patient that arm soreness is normal and that a metallic taste is rarer, but still a potential side effect and to continue monitoring the situation and to contact us or her doctor if anything changes.
Rec'd vaccine 3/14/11 approximately 12:00pm - Sx noted approximately 24 hours later noted irreg. red, flat patches around area spread for approximately 24 hours after 1st appearance - gone at approximately 96 hours of inj. Touch sensitive - no itching (L) arm only.
VACCINE WAS RECEIVED BY CLINIC ON 9/15/2021 AND WAS NOT REFRIGERATED UNTIL APPROXIMATELY 9/20/21 PRIOR TO RECEIVING THE VACCINE ON 10/6/2021. (VACCINE SHIPMENT WAS NOT REFRIGERATED UPON DELIVERY - WAS AT ROOM TEMPERATURE FOR AT LEAST 5 DAYS, THEN PLACED IN THE REFRIGERATER AND THEN ADMINISTERED.
C/o rash inner forearms, upper arms, buttocks and torso 4 days post vaccine. C/o moderate itching relieved with Benadryl po. Raised red diffuse.
Itching of throat, swelling. History of anxiety. BP's - 182/123 (pulse 118), 164/102. Water given.
No reaction to first dose other than soreness in arm near injection site.  2nd dose reactions started about 12 hours after injection: sore/puffy around the eyes, fever, chills, headache, body aches, fatigue, swollen lymph nodes, redness around injection site (about 6 inch irregularly shaped area).
This spontaneous report as received from a registered nurse refers to a patient a current 14 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of M-M-R II (lot number not reported) at younger than 1 year of age. The nurse reported this dose was not considered valid due to the patient's age at the time of administration. On an unknown date, the patient was revaccinated with a second dose of M-M-R II (Lot number not reported). On 11-APR-2016, the patient was inadvertently vaccinated with a dose PROQUAD (Lot Number M029599, expiration !2-DEC-2017) instead of the intended third dose of M-M-R II . The nurse  was unable to clarify whether the error occurred due to product confusion between PROQUAD and M-M-R II. No additional dose of M-M-R II was administered on 11/4/2016. No adverse effect reported. Additional information has been requested.
5/1/2021 chills, headache, joint pain,body ache, tiredness was in bed all day . 5/2/2021  about 3:00 am rash, headache
Patient called 11/2/05 reporting itching rash occurring 1 day after receiving vaccines. Rash was located on back of neck. No other symptoms were reported. Rash resolved approximately 6 days later.
Redness, swelling, itching and tactile warmth at injection site of MMRV on right arm.  Treated with Keflex and mupriocin ointment.  Unable to contact patient to find out the current status.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 23Oct2023 to 28Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300357524 same reporter/patient, different drug/event;
Information regarding Prevnar (pneumococcal) 7-valent conjugate vaccine (diphtheria crm197 protein) unspecified was received from a healthcare professional regarding approximately 200 patients between the ages of 2 and 10 and some adults who experienced chronic sinusitis and rhinosinusitis.  The patients received a dose on an unspecified date.  Approximately 200 patients between the ages of 2 and 10 and some adults who experienced chronic sinusitis and rhinosinusitis (chronic sinusitis) with symptoms of runny nose, colored discharge and positive CT scan.  Additional cases will be created when identifying information is received.
Pt did not get the booster. Pt got the single valet instead of Bi valet.
This spontaneous report as received from a health professional refers to an 11 year old patient. On 19-MAY-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # J002319, expiration date 23-FEB-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
CLIENT RECEIVED VACCINE ON 5/18/2009 ON THE LEFT ARM ONE INCH BELOW THE TDAP. SHE EXPERIENCED FEVER OF 102, CHILLS, SENSITIVITY TO LIGT, HEADACHES, LOSS OF APPETITE, NAUSEA,NUMBNESS TO SITE AND LOSS OF FEELING IN ARM. TODAY THE SITE IS 3"X 3.5" RED,WARM, SLIGHTLY SWOLLEN AND VERY PAINFUL TO SLIGHT TOUCH. PULSE OF 88, TEMPERATURE OF 97 DEGREES. FINGERS TO LEFT HAND ARE PINK, WARM, CAPILLARY REFILL <3 SECONDS. ABLE TO MOVE FINGERS FREELY. ABLE TO LIFT LEFT ARM BUT C/O PAIN WHEN ARM IS LIFTED ABOVE SHOULDER LEVEL. REVIEWED THE SIDE EFFECTS LISTED IN THE PRODUCT FOLDER WITH CLIENT. INFORMED CLIENT NOT TO SCRATCH SITE AS SITE CAN BECOME INFECTED. INFORMED CLIENT IF SITE BECOMES MORE PAINFUL AND OOZES PUS AND HAS ODOR AND INCREASES IN SIZE AND HAS A THROBBING SENSATION  TO SEE PHYSICIAN. REVIEWED THE SIGNS AND SYMPTOMS OF INFECTION WITH CLIENT. INFORMED CLIENT IF FINGERS BECOME COOL AND FEEL NUMB TO SEE PHYSICIAN. ADMITS TO HAVING HEADACHE BECAUSE WISDOM TEETH ARE COMING OUT. INFORMED CLIENT TO CHECK ARM WITH BROTHER IN LAW WHO IS A NURSE IF HAVING MORE PROBLEMS OR SEE HER PHYSICIAN.
after receiving the second dose of gardasil the patient experienced fatigue which lasted one day, she also reports the right deltoid which received the gardasil vaccine became "hot".
pain at the injection site, fever over 102f, wheezing, difficulty of breathing, fast heart beat, high blood pressure, hives, weakness, dizziness, redness and swellen.
Excruciating Headaches, Light sensitivity, Pain in upper neck, nausea.
PATIENT DEVELOPED HIVES AND ITCHNESS AFTER FLUARIX.  PATIENT STATED THAT THE PATIENT RECEIVED OTHER FLU VACCINE BRANDS IN THE PAST WITHOUT REACTION (UNTIL LAST YEAR.) PATIENT IS RECOVERING AND GETTING WELL ON 10/18/2021. PATIENT WANTS TO MAKE SURE SHE WILL NOT GET THE SAME BRAND (FLUARIX) NEXT YEAR. POTENTIAL ALLERGIC REACTION WAS NOT SERIOUS, AND SHE DOES NOT PLAN TO MAKE ANY FURTHER ACTION IN FUTURE, AFTR  REPORTING TO THE PHARMACY ON 10/18/21).
CHIEF COMPLAINT:   Patient presents to ER with history of TIA. Pt was dizzy and lethargix lasting a approx. 3 min. EMS states all symptoms resolved before their arrival. denies SOB or SP. pt is A/O x 4. pt has full strength, no facial droop, arm drift. last known well: 0900   HISTORY OF PRESENT ILLNESS:     88-year-old female with a history of CKD stage III, atrial fibrillation, prior TIAs presenting for the evaluation of dizziness and near syncope.  Patient reports several episodes of dizziness and instability on her feet over the past day.  She states that she almost fainted while walking to the couch earlier this morning.  She denies chest pain, palpitations, shortness of breath.  She denies symptoms at rest.  Denies cough, fever, headache, neck stiffness.
PATIENT FELT WEAK IN THE EVENING,   COULD NOT GET OUT OF CHAIR.  DIZZINESS.  WENT TO ER AND WAS OBSERVED AND RELEASED
pt devel temp elevation, temp was not taken but mom states that pt felt warm; no other sx; mom began administering APAP; 10JUL93 t105.6 R; not responding to APAP; taken to ER; 13JUL93 devel rash over most of body;
Day 1 - 10 hours after- tightness in upper chest/throat and soreness in left arm. Day 2 - Woke up with my finger joints stiff, swollen and throbbing with pain (this subsided on day 4) Day 3 - No symptoms Day 4 - Woke up with rash (burning) on right side of my neck, and headache.
Patient inadvertently received a duplicate dose of Prevnar 20 on 4/7/23.  She had already received a dose of Prevnar 20 from her doctor's office on 1/24/23.
Guillain-Barre Syndrome.  11/18/09 ED, hospital records received, service dates 11/7/09 to 11/13/09. Assessment: Guillain-Barre suspected. Patient began to c/o tingling in upper/lower extremities 10-12 days prior to admission. Seen at two prior facilities where dx of viral illness was provided and patient discharged. Became weak, tired, slurred speech, walking unsteady, drooling. Pediatrician suspected Guillain-Barre and referred to ED. Body aches, Patient weak but not areflexic. Ataxic, deep tendon reflexes weak. Grip strength weak. Numbness.  11/19/09 DC summary received for service dates 11/7/09 to 11/13/09. Assessment: Cerebellitis. Admitted for sudden onset of tingling of upper and lower extremities, weakness, ataxia, and dysarthria. Deep tendon reflexes diminished, IVIG. Speech remained slurred, aspiration. NG tube placed. Discharged. Neurology and infectious disease consultations scheduled.   12/23/09  Clinic record received for DOS 11/16/09. DX: Acute sinusitis, Acute otitis media with effusion (R), Serous otitis media (L), sore throat -due to NG tube, Guillain-Barre syndrome.   Patient presents with c/o left earache, fever and sore throat. Patient tearful and tired-appearing. Muscles painful to palpation and patient using a walker. Has paresthesias of both hands and both feet. Feeling around lips and tongue improved. Patient prescribed amoxicillin and acetaminophen/codeine.  12/23/09 Clinic record and diagnostic test reports received for DOS 11/18/09-11/25/09  DX: Guillain-Barre syndrome, dysphasia. Muscle tenderness improved. Hypesthesia. Plan Swallow Study.
Pruritic swelling and induration 22cm x 22cm of right arm, post vax. This spread to back of the arm to about 4" with warmth, pain and hardness to touch. Pt was seen in ER and treated with Benadryl, Motrin, Tri-Levlen and ice pack. On 11/2/99, swelling became worse and spread to below the elbow, up to the shoulder and covering entire triceps area. Pt made a visit to the clinic on a sick-call. Then she was prescribed prednisone. No shortness of breath or tightness in chest reported.
This spontaneous report as received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were intramuscularly vaccinated with a "single dose" of improperly stored GARDASIL 9 lot # M031557, expiration date 07-APR-2019 (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 49 degrees Fahrenheit for 14 hours. The vaccines experienced previous temperature excursion of 47 degrees Fahrenheit for 24 hours and 32 degrees Fahrenheit for 15 hours. Data logger was not involved. No product quality complaint (PQC) was involved. Additional information is not expected, because there was no consent to contact the reporter.
pt in for routine well check & was given school boosters-2 days later parent called lt arm red & swollen-was advised to come in-pt came in w/mom-had about 4x5cm erythema & induration;
Within 2 minutes after the injection had a sharp pain go down (R) arm. My hand had a tremor, lost feeling in last 2 fingers of hand and sharp constricting pain to my medial and lateral wrist. Had a burning pins and needles feeling from upper arm down to wrist. Lost strength to (R) hand.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 17-OCT-2014 the patient was inadvertently vaccinated with a dose of (Merck) VARIVAX (lot # K001389, expiration date: 29-JAN-2016), 0.5 ml, subcutaneous instead of ZOSTAVAX (lot number, expiration date, dose, route were not reported). No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
suspected vaccination failure; whooping cough; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and whooping cough were unknown.   It was unknown if the reporter considered the vaccination failure and whooping cough to be related to DTPa vaccine.  Additional details were provided as follows: The age at vaccination was not applicable. The patient got DPT vaccination. The shot gave him whooping cough and he gave it to his mother and reporter. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for whooping cough and exact time to onset were unknown.
This initial report was received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 17-NOV-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot number L022795 with expiration date 05-NOV-2016 (dose, strength and route of administration were not reported). No adverse effects were reported. This is one of two reported from the same source (MARRS 1612USA000501). Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 61-year-old male patient who received SHINGRIX (batch number YE9YL, expiry date 6th February 2021) for prophylaxis. On 23rd July 2018, the patient received the 1st dose of SHINGRIX .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced general body pain (serious criteria disability), chills (serious criteria disability), fever (serious criteria disability), headache (serious criteria disability) and sleepiness. On an unknown date, the outcome of the general body pain, chills, fever, headache and sleepiness were unknown. It was unknown if the reporter considered the general body pain, chills, fever, headache and sleepiness to be related to SHINGRIX. Additional details were provided as follows: The reporting pharmacist reported this case for himself. The patient received SHINGRIX in the left deltoid. The patient experienced whole-body achiness, and worst headache he ever had. The patient thought it was disabling because he slept the whole day and missed work.
Heavy menstrual cycle came the day I got the Covid vaccine, despite not having period while on IUD for many months before this. Clotting in period, cramping.
woke up fr sound sleep-uncharacteristic cry & screaming; lasted 45 mins; inconsolable to hosp ER; afebriel pt calmed down while enroute to hosp; no further episodes; low fever 25JUN & 26JUN92; no local rxn @ inject site;
Pt recvd menactra + Hep A vaccine within 5 mins of receiving the vaccine the patient was getting ready to leave and passed out in our waiting room.  Patient was "out" no longer than 30 sec. and walked herself to waiting room.