chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling really bad...she has been out of it all day; she has been sleeping most of the day; she is forgetting things; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Blood pressure. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), administration date: Dec2021, for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feeling really bad...she has been out of it all day"; SOMNOLENCE (non-serious), outcome "unknown", described as "she has been sleeping most of the day"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "she is forgetting things". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of feeling abnormal, somnolence, memory impairment.  Additional information: Reporter stated that patient takes blood pressure medicine. The past two weeks patient did go to the doctor and they did blood work but reporter was not sure if it was last 2 week.  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-202201236368 same reporter, product, and event, different patient;
2 month shots (HepB, Rotavirus, Pneumococcal, Polio, Hib, DTaP) were given on 1/15/2009. On the morning of 1/17/2009 (approximately 9:30 AM), I notice swelling in patient's left hand and left foot. Upon contacting the doctor's office, the nurse stated that she had not heard of this type of reaction before. She spoke with the doctor on duty and called me back, stating that the doctor instructed her to tell me to use cool compresses for the swelling. The compresses did not work and by 6:30 that evening, patient's right hand and right foot also began to swell. After contacting the after-hours line and not getting a call back, I took her to the ED. Triage indicated there was not a fever at the time that we arrived. Upon being taken into the treatment room, the doctor indicated that she does not believe that the swelling was caused by the immunization and that patient has a fever and that she believes the swelling may be a sign of infection. They started IV antibiotics, did a straight catherization, took a chest x-ray, and also took blood for a blood culture. All findings were negative. Patient was hospitalized from 1/17/2009 - 1/19/2009. It was indicated that patient was given one dose of Benadryl on 1/18/2009 at 5 AM. On the evening of 1/18/2009, a rash appeared on patient's right torso and in her diaper area. Shortly after, the rash disappeared. The rash appeared again that evening on patient's left torso and in her diaper area. The doctor stated that she does not believe that the antibiotics caused the rash nor does she believe that the immunizations caused the rash or the swelling. On the afternoon of 1/19/2008, an allergist from the hospital stopped by. She stated that she does not believe that the immunizations caused the swelling because the swelling occurred 2 days after the shots were given. By this time, most of the swelling was gone. There was still swelling in patient's right hand (possibly due to the IV in her right arm) and very slight swelling in her right foot. The IV was removed from her arm and we were discharged shortly thereafter. No diagnosis was ever given. Patient continues to have rashes to appear and disapper, now on her entire torso, diaper area, and sometimes on her legs. Prior to the immunizations and course of antibiotics, she had never had any swelling or rashes. 2/2/09-records received for DOS 1/17-1/19/09-DC DX: swelling of hand/feet. Presented with left food and hand swelling progressing to right foot and hand. Increased fussiness, mild cough. Impression Angioedema,allergic reaction to vaccine.
24 hours after vaccine, Urine had blood & blood clots for 12 hours.  Urine has been clear since midnight today (16 hours so far).
Adjacent to injection site, Raised rash or welt, hot to the touch, not painful, not itchy
Heart Inflammation Chest Inflammation Chest Pain All Lasted for about 8 weeks Became worse when exercising
This spontaneous report was received from a medical assistant regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored GARDASIL 9, 0.5 ml, intramuscular. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pemphigus; This is a spontaneous report from a contactable pharmacist. A 94-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced pemphigus on an unspecified date with outcome of unknown.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Shot received approx 4 pm. Same day@ 9 pm rash started on face and neck. Took Benadryl. At 5:30 am next morning while standing - fainted. Rash returned early evening and took another Benadryl.
I had a CT scan on 6/18. In may, I had reactive arthritis. My joints were stiff and painful. I was unable to dress or even feed myself. I was put on methotrexate. I am not getting more pain from that. I am back to normal mobility. I am now experiencing throbbing temple when I stand up from laying or sitting down. I am seeing a doctor today to rule out temporal arthritis, I have never experienced them before. One doctor thought I had polymyalgia rheumatica  which affects the optic nerve in the eye which can lead to blindness. Since receiving the shot, I had diverticulitis, colitis and now I have fatty liver. I have never been this sick before. I also did not have any of these prior to the shot.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 14-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Lot # K007822, expiration date 15-AUG-2015) dose, route and anatomical location were not provided. There was no concomitant medication provided. On an unknown date, the PNEUMOVAX had a temperature excursion for 1704 hours, the highest recorded temperature was 59.9 F (15.5 Celsius). The vaccine status was reported as "in excursion", and was storage in a Refrigerator (R). There was no product quality complaint involved and no adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Fatigue; Fever; Nausea; Headache; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache) and VACCINATION SITE PAIN (Injection site pain) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced FATIGUE (Fatigue), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache) and VACCINATION SITE PAIN (Injection site pain). At the time of the report, FATIGUE (Fatigue), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache) and VACCINATION SITE PAIN (Injection site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Body temperature: 102.4 (High) 102.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided; 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.
Provider on duty refused to give second dose due to previous allergic reaction from the 1st dose; Swelling in my face; Redness in my face; Itching in his face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Swelling in my face), ERYTHEMA (Redness in my face) and PRURITUS (Itching in his face) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced SWELLING FACE (Swelling in my face) (seriousness criterion medically significant), ERYTHEMA (Redness in my face) (seriousness criterion medically significant) and PRURITUS (Itching in his face) (seriousness criterion medically significant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Provider on duty refused to give second dose due to previous allergic reaction from the 1st dose). The patient was treated with PREDNISONE at a dose of 1 dosage form. On 03-Apr-2021, SWELLING FACE (Swelling in my face), ERYTHEMA (Redness in my face) and PRURITUS (Itching in his face) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Provider on duty refused to give second dose due to previous allergic reaction from the 1st dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  Treatment information was prescribed antiallergic medicine and Prednisone but the patient took only prednisone.  The patient was supposed to get the 2nd dose on 01May2021 but the healthcare provider on duty refused to give the shot as he had previous allergic reaction to the 1st dose.  Action taken was no change.  Company Comment: This case concerns a 63-year-old male with serious unexpected events of swelling face, erythema and pruritus. Event latency within 5 minutes after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 63-year-old male with serious unexpected events of swelling face, erythema and pruritus. Event latency within 5 minutes after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report as received from a physician refers to a 12 month old female patient. The physician stated the patient had already received 2 doses of PREVNAR. On 12-MAY-2015, the patient was vaccinated with a dose of M-M-R II (dose, route and expiration date were not reported). Other suspect therapies included VAQTA lot# K019560 (dose, route and expiration date were not reported) and PREVNAR (dose, route, lot number and expiration date were not reported). There was no concomitant medication provided. On the same date after receiving the vaccines (during the same visit), the patient experienced a severe allergic reaction (hypersensitivity). The physician also reported that two hours after receiving these vaccines, the patient experienced an onset of lethargy, "seemed to be gagging" (retching), became pale (pallor) and limp (gait disturbance). The patient's parents took the child to an emergency department at an unspecified hospital, where the patient received BENADRYL and oxygen supplementation. The outcome of lethargy, gait disturbance, pallor, retching and hypersensitivity was reported as recovered on that same day (on 12-MAY-2015) and went home.  Relatedness between the therapy with the suspect therapies and the events was not reported. Additional information has been requested. Lot number L004012 is an invalid lot number for M-M-R II.
DIZZY; HEADACHE; DRY EYES; FEELS LAZY; SLEEPY; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included anemic, and hysterectomy, and concurrent conditions included stones in gallbladder, high cholesterol, borderline diabetic, overweight, alcohol user, and non-smoker, and other pre-existing medical conditions included no known drug allergies. The patient experienced stomach upset when treated with paracetamol for pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced dry eyes. On 12-APR-2021, the subject experienced feels lazy. On 12-APR-2021, the subject experienced sleepy. On 13-APR-2021, the subject experienced dizzy. On 13-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dry eyes, feels lazy, sleepy, headache, and dizzy. This report was non-serious.
Fever; Chills; This is a spontaneous report from a Pfizer sponsor programme Pfizer COVAX Support. A Contactable consumer (patient's husband) reported for female patient (wife). A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient previously received first dose of BNT162B2 on an unspecified date vas single dose for COVID-19 immunisation. The patient experienced fever and chills on an unspecified date. The reporter asked if after two months like they would like to ask if that was still related to the Covid 19 vaccine. The outcome of the events was reported as unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Error or mistake of using bivalent as a second dose.  Patient received  one pfizer monvalent 1st dose on August 9th 2022 and bivalent vaccine was accidentally used for second dose. Called CDC to check and was confirmed that bivalent can be used as second dose and pt will get another bivalent booster in two months.
Within 24 hours post vax the pt developed respiratory congestion.  Pt has history of numerous allergies including food coloring and corn syrup.
Redness and heat at vaccine sites. Silver dollars sized area of redness per mom @ VARIVAX site. Slight redness, hot and sore -  smaller area to R IM injection site, as well (MENACTRA). Hot packs advised and TYLENOL or MOTRIN.
COVID-19 PNEUMONIA; DEPENDENCE ON VENTILATOR; NOT ABLE TO WALK; COULD NOT WORK; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pollen allergy, alcohol user (not often), and non-smoker, and he had no chronic medical history. He did not have any drug abuse/illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: unknown) dose was not reported, 1 total, administered on 09-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. After vaccination on 10-APR-2021 (Saturday), he was feeling bad and 11-APR-2021 (Sunday) and 8 days later went to the hospital. He did a polymerase chain reaction (PCR) covid-19 test at the hospital on 16-April-2021 and result was positive. He went back home but on 28-APR-2021, because his oxygen levels dropped and had trouble breathing. He was ventilated for 18 days. He was hospitalized for Covid-19 pneumonia (pneumonia, feeling bad and lost 45 pounds) for 36 days. He was discharged from hospital on 03-JUN-2021. On an unspecified date, he was not able to walk. He had home therapy and nursing therapy to be able to walk again and he lost 45 pounds. Since unspecified date, he could not work for 3 months.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 pneumonia on 03-JUN-2021, and dependence on ventilator, and could not work, and had not recovered from not able to walk. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This report was associated with product quality complaint: 90000182426. The suspected product quality complaint has been confirmed to be not voided. The patient received the vaccine on 09-APR-2021 and had a positive Covid-19 test on 16-APR-2021 with 7 days elapsed between vaccination and test. There was not sufficient time elapsed for the patient to achieve immunity; therefore this report was not considered a lack of effect for Janssen COVID-19 vaccine.; Sender's Comments: V0: 20210622074-covid-19 vaccine ad26.cov2. s-Covid 19 Pneumonia, Dependence on Ventilator. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient noticed extreme warmth and redness on the evening of his injection. Swelling started the-next day and continued x 4 days. Also experienced nausea and headache x 1 1/2 days.
15 min period of being limp and unresponsive.  No breathing difficulties, no jerking, no fever.
The day of the vaccine was in the mall and several hundred people attended. When I got to the lady who administered my shot, she was rude. She stabbed the needle into my shoulder. I said "wow that was vicious" and she said "it didn't hurt did it". It DID hurt and still does. The second vaccine was at pharmacy and was a gentle process. I applied ice on my arm that night and several days after. I have shooting pains down my arm into my fingers, I have pain at the injection site to this day, I have limited mobility in the left arm, I can not reach above my shoulder. The pain feels like needles sticking in my shoulder. I can not do simple house work like sweeping and hanging clothes nor can I pick up my kids. I scheduled an appointment  in June with my PCP Dr. for July 6 @ 11:15. He wants to do an MRI but wanted me to try steroids', I took 10 mg per day for 7 days with no change in pain. He has scheduled me an MRI for July. 26 @ 11:00. This has been a life altering experience. Please help.
PAIN IN INJECTION ARM; TIREDNESS; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to bees, allergic to trees, and contrast allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: not reported) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced tiredness. On 05-MAR-2021, the subject experienced pain in injection arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in injection arm on 05-MAR-2021, and tiredness on 09-MAR-2021. This report was non-serious.
Developed large itchy red patch at site of injection 3 days after shot.  Using Benadryl cream
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE PERICARDITIS, UNSPECIFIED ACUTE PULMONARY EMBOLISM  10/11/2022 -- RECURRENCE OF SAME SYMPTOMS
upper left arm pain/Injection site pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th June 2019, the patient received the 1st dose of Shingrix. On 8th June 2019, 1 days after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The batch number and expiry date of Shingrix was not reported. The patient reported that, after vaccination with Shingrix, he had been experiencing intermittent pain while laying down at night in his upper left arm where he got the shot, and the pain was 3 on the pain scale of 1-10. The patient reported that, his arm was sore on the first day, 4 on pain scale of 1-10 and on second day the pain had decreased to 2. The patint stated that, he would not be getting 2nd dose of Shingrix. The patient did not consent to follow up.
Sore arm from 11 Jan improved until 18 Jan when it became sore again. Developed a rash 18 Jan that has slowly spread from site of injection (left arm). Rash is warm to the touch and itchy. Have experienced elevated temperatures at night but unsure if this is due to a reaction of the shot.
Sore and scratchy throat; low-grade fever; pronounced soreness in arm at shot site.
Left arm completely numb, weak, not able to make a fist. Headache about left eye. Left side numb, weak, poor balance walking. Left side facial drooping. 11/19/2021 approximately 6pm went to Urgent care to be evaluated, sent via ambulance straight to Emergency Room.
Chills/fever at bedtime followed by swelling around injection site and under left arm pit with muscle soreness and soft tissue lump under left arm pit from Monday night 11/30 thru Thurs 12/02 soreness still present with lump. Treatment: 2x daily rubbing w alcohol with epsom salt solution and massage 3x daily Reported to health department nurse today by phone 12/02/2021. She stated it may be related to immune system lymph nodes swelling but should improve in next few days.
He received his 6th Tdap vaccine in one arm (unsure which name/brand). He also received his 1st meningococcal conjugate vaccine in the opposite arm (unsure which name/brand).  Moments after injections he became rigid, body shook, eyes rolled around and he lost consciousness.  He regained consciousness quickly but was weak and sweaty for about 20 minutes afterward.
Case tested positive for COVID 19 on 8/18/2021. Asymptomatic