chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lack of drug effect; This is a solicited report Facilitated Collect based on the information received by Pfizer (MFR Control No. # 21K-163-3870248-00). A contactable 46-year-old female consumer (patient) reported for herself that. A 46-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscular on an unspecified date (age at vaccination 46-years) (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation; adalimumab (HUMIRA, Suspension for injection in pre-filled pen) , subcutaneous from an unspecified date (Batch/Lot Number: 1138527) to an unspecified date, at unspecified dose for Psoriatic arthritis.  The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced lack of drug effect (drug ineffective) (medically significant). On an unknown date, the patient experienced Humira did not work. COVID-19 vaccine was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the event for adalimumab was unknown. Outcome of the event was not recovered.  The reporter's assessment of the causal relationship of the event with the suspect product was not reported at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event Drug ineffective and suspect drug BNT162B2 cannot be excluded.
I was given TDAP on Friday, July 30. During the night following the tetanus shot, I developed very severe pain in my neck, shoulder and down my arm. I was unable to participate in regular daily activities and could not sleep as a result of the pain. I was also experiencing numbness in 2 fingers.  I returned to my doctors office on Monday after an excruciating weekend. I was prescribed steroids and muscle relaxers. The muscle relaxers were not effective and later in the week after a follow-up call with my doctor, I was prescribed gabapentin.  The following week, still in severe pain and continuing to experience arm weakness, I went to clinic. The doctor at clinic diagnosed me with Brachial Neuritis / Parsonnage Turner Syndrome. He prescribed a stronger and longer course of steroids and tripled the gabapentin dosage and increased frequency from 1x daily to 2x daily.  I was referred to a neurologist who confirmed the diagnosis. I also had an MRI and electrodiagnostic evaluation to confirm. During the electrodiagnostic evaluation, muscle atrophy was noted.  After 3 months I still have residual weakness in my arm although the pain has subsided and is being managed with gabapentin.
bad swollen lymph node under right arm pit  injection swelling low fever really bad chills headache  injection pain tired cough cold low fever pain
Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Additional Details: PATIENT REPORTED SMALL RED DOTS ON HER EXTREMITIES (ARMS AND LEGS) ON DAY 2, BY DAY 3 SHE WAS HAVING THEM ON HER CORE (FRONT AND BACK). BY THE 4TH DAY SHE REPORTED THEY STARTED TO BREAK OUT ON HER FACE AND IN HER EAR. SHE REPORTED SOME OF THEM RUPTURED WITH A LITTLE PUSS. WHEN SHE CAME TO THE PHARMACY, IT LOOKED LIKE SEVERE ROSACEA OR ACNE
Moderna COVID-19 Vaccine EUA 5-7pm started with muscle aches, by 9pm had headache, chills, increased muscle aches, at 10:30 all symptoms worsening , took Tylenol at 10:30 and fever of 101.5 at 11pm after taking Tylenol at 10:30,   Shaking chills, teeth chattering, slept with 4 blankets, body hurt from head to toes, nausea through the night , severe headache.    Fever of 100 continued through the night in to the next day, continued taking tylenol and alternating with ibuprofen,   nausea subsided enough by 6 PM on Sunday to have a small bowl of soup.   Started to feel improvement by Sunday night, one episode of chills while sleeping Sunday night and by Monday I was mostly normal.   Just tired and alittle achiness
3 days after vaccine was administered a 3 1/2" hot red circle popped out - it was extremely painful. I saw my doctor who said it was a bacterial infection - not caused by the serum - but from improper handling.
Left eye itching, sweating, headache, progressing to eye swelling.  Left sclera injection.  Returned to clinic 12:20 pm.  Exam showed marked swelling around left eye. Left scleral injection, injection Right TM.  Given 0.3cc 1:1000 epi with clearing of swelling and itching.  Sent home with Benadryl P.O.
Pt. states that his skin is hurting like crazy. He states that he feels like his body is on fire. It is affecting his back, stomach, and legs. Per pt. he has no rash. Per pt. the pain is not at the site of the injections. Pt. states that he had a fever, nausea and vomiting, 3 or 4 days ago. Does not have these symptoms at the time of report, just the all over pain.
Gradual loss of eyesight from 08/21/2019 to 09/02/2019      Total loss of eyesight on 09/03/2019     Many tests and doctors Hospitalization for 5 days with 1000 units of IV steroids      Continued steroids for weeks     Gradual improvement over 6 months-not 100%    Some permanent damage to Optic nerve
pt recvd vax & devel urticaria; tx w/ hydroxyzine, iv solu medrol, & hydrocortisone topical ointment;
Pt. reports she feels fatigue and has had an intermittent non-productive cough for the past 10 days
Itchy red hives and rash all over body and face. Painful joints. Swelling so bad it is Painful to walk on feet and use hands.
PATIENT DEVELOPED SEVERE JOINT PAIN A COUPLE OF DAYS AFTER VACCINE WAS ADMINISTERED.  PATIENT EVENTUALLY WAS ADMITTED TO HOSPITAL WITH NO PLATELETS.  WAS IN HOSPITAL UNTIL PLATELETS RESTORED. MD AND HEMATOLOGIST BELIEVE THAT FLU SHOT STARTED THE CASCADE OF EVENTS.  03/21/2008  MR received for DOS 12/16-23/2007 with D/C DX:  Severe Thrombocytopenia, presumed ITP. Pt presented to local ER with c/o several day hx of bleeding mouth sores and melena. Platelet count noted to be 0 (zero) and pt transfered to current facilty for eval and tx. PE (+) for purpuric raised rash on arms, submucosal bleeding and black pigmented rash noted in mouth, on tongue and lips.  Pt txd with Solumedrol, IVIG and platelet transfusions. D/C to home on prednisone
Bad muscle and body aches feeling feverish-took ibuprofen and acetaminophen to alleviate some of the discomfort no reaction at injection no site.
Flu vaccine given on 10/13/2006, torticollis developed on 10/18/2006, seen by me on 10/18/2006 symptoms, and signs subsided in 36-48 hours.
Fever, lack of appetite, fatigue, headache, joint pain, dizziness, sensitivity to light.
COVID-19; COVID-19; Back pain; FACILITATED COLLECT  This is a solicited report received from contactable reporter (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier: 21K-163-4152682-00 (AbbVie). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular, administration date 10Apr2021 (Batch/Lot number: unknown) at the age of 44 years as dose 1, single and via intramuscular, administration date 22Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for psoriatic arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2021, outcome "not recovered" and all described as "COVID-19"; BACK PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Back pain". Clinical source as follows: In 2021, the patient experienced BACK PAIN and COVID.  PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the events of BACK PAIN with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event of COVID-19 was not provided. Causality for bnt162b2: The reporter's causality for the events of BACK PAIN and COVID-19 with bnt162b2 both were possible. The action taken for adalimumab was unknown. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is no reasonable possibility of causal association between the events drug ineffective, covid-19 and back pain (non-serious) and BNT162B2.  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Syncopal episode lasting a few seconds.  She was sitting in her moms lap so she didn't fall to the floor.  Once she came to, she placed her head between her legs for a few minutes.  She was given water to drink and a cool compress for her head.  She also felt as if she was going to vomit.  She was monitored for about 20 minutes before leaving the office.
Shortly after vaccine he developed a rash most consistent with shingles, and experienced persistent ipsilateral arm weakness since the vaccine.
Patient had hives on the right side of face, especially right eye, starting around 4pm on 9/15.  He took a tablet of Claritin and 2 tablets of Advil.  The rash subsided next morning.
received the vaccination yesterday! I am currently dealing with me not being able to get warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (received the vaccination yesterday! I am currently dealing with me not being able to get warm) 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 information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (received the vaccination yesterday! I am currently dealing with me not being able to get warm). At the time of the report, VACCINATION COMPLICATION (received the vaccination yesterday! I am currently dealing with me not being able to get warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.   Reporter did not allow further contact
On 10/05/2001, Pt received MMR #2. On 10/06/2001 pt went to OHER. Left arm swollen, red and warm from shoulder to elbow. Child put on antibiotic, ER doctor ask pt mom to call us. Mom was called 10/10/2001. better. Arm decreased in size.
Received vaccine 10/24/2013 and about a week later developed pain in arm with "moving elbow away from body." Reported to employee health 11/12/13 after about 2 weeks of discomfort. Continues discomfort today (12/4/13).
PATIENT CAME IN 8/1/20 AND REPORTED THAT AFTER GETTING THIS VACCINE ON 1/18/20 HE DEVELOPED A MILD RASH, ESPECIALLY ON HIS HANDS. I ENCOURAGED HIM TO GET EXPLICIT PERMISSION / RECOMMENDATION FROM HIS DOCTOR BEFORE GETTING SECOND SHINGRIX. HE AGREED THAT WAS A GOOD IDEA.
extreme pain in left arm for 3 days  then started sore throat on monday the 11 swelling continued untill wed morning the 13 I could hardy swallow and went to  doctor got a steroid tha reduced the swelling in my throar and am still taking medication for 5 days  Dexamethasone
PT RECEIVED SEASONAL FLUMIST IN OUR OFFICE ON 10-03-2009 AND RECEIVED THE H1N1 VACCINE AT THEIR SCHOOL TODAY 10/21/2009. NO SYMPTOMS AS YET
Patient walked into pharmacy and requested Johnson & Johnson Covid-19 shot.  He stated on the consent form that he did not receive any other Covid-19 shots, and that he did not have health insurance.   However, during the data entry of this vaccine, his insurance showed that  received Pfizer Covid vaccine on 4/16 /2021 and 5/7/2021.  Thus, he have received third Covid-19 shot, Johnson & Johnson Covid-19.
Itchy hives developed near my lower part body near leg and but tuck 24-32 hours after vaccine. I woke up 4 AM due to itch, and took zyrtec for the hives. Hives went away in the morning when I woke up; Itchy hives developed near my lower part body near leg and but tuck 24-32 hours after vaccine. I woke up 4 AM due to itch, and took zyrtec for the hives. Hives went away in the morning when I woke up; started to notice tinnitus or ringing in my ear as well.; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Right on 06Aug2021 11:45 AM (at the age of 41-years-old) as dose 1, single for covid-19 immunization at Doctor's office/urgent care. Medical history included known allergies to pollen, dust mite, tumble weeds, cat, dog all from an unknown date to unknown if ongoing and No spleen and only one kidney due to an accident, single functional kidney. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]), tocopherol (VITAMIN E [TOCOPHEROL]), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), ubidecarenone (COQ10 [UBIDECARENONE]), turmeric [curcuma longa rhizome] (TURMERIC [CURCUMA LONGA RHIZOME]) all were taken for an unspecified indication, start and stop date were not reported. Patient did not receive other vaccines within four weeks of vaccination. Patient had no covid prior vaccination and has been tested for covid post vaccination. On 08Aug2021, at 02:00Am patient developed Itchy hives near his lower part body near leg and but tuck 24-32 hours after vaccine. He woke up 4 AM due to itch and took zyrtec for the hives. Hives went away in the morning when he woke up. And also started to notice tinnitus or ringing in his ear as well, it was developed a day after vaccine, and he still have it so patient reporting the side effects. Not sure if tinnitus going to go away. That was the two side effects that are obvious to him so far. The patient underwent lab tests and procedures which included sars-cov-2 Nasal Swab test results negative for Covid-19 on an unknown date in Jun2021. Patient did not receive any treatment for the events itchy and Tinnitus and took Zyrtec for Hives. Outcome of the event hives was recovered on an unknown date in Aug2021 and not recovered for Itchy and Tinnitus.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
Localized redness, itching, 8 cm in size - presumed allergic reaction.
left deltoid swollen at area of vaccination area hard reddened and hot itchy. No fever not painful per mother. Child received DTaP & IPV area was painful the day IZ given only.
"Splitting headache, frontal and occipital" not relieved by otc medications lasting from 11/12 pm until 11/15 pm.  Orbital pain "globes hurt" from 11/12 pm until 11/18 pm not relieved by otc pain meds.  No loss of vision or other visual symptoms. OTC meds included Tylenol and ibuprofen.  Symptoms resolved spontaneously without sequela.  Exam by this physician performed on 11/19 revealed no abnormalities.
Swollen underarm/armpit lymph nodes (left armpit)  on the side of injection for about a week.  Tender to touch.  Nothing major, just wanted to let you guys.  I wasn't concerned at all.
tenderness, redness, swelling warm inc daily 8AUG-15AUG; MD put pt on ATB on 15AUG; area affected lateral upper arm approx 6" x 3 1/2" area; responded well to ATB
Patient fainted, called 911, took approximately 3 minutes to open eyes, she told me all she saw was white space around her responders checked blood pressure and oxygen levels, patient did not want to go to hospital, responders checked that she was not dizzy and she walked well and she went home.
Booster dose given after 2 months instead of 5 months. It was caught immediately after given. No symptoms reported at this time.
Three or so hours after taking the pill I begin to cry uncontrollably. I remain emotional and defensive throughout the two days between pills.
She had fever and muscle aches for 2 days and she had headache and stomach upset for 5 days after vaccine given
I have breakthrough COVID; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (I have breakthrough COVID) 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.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DRUG INEFFECTIVE (I have breakthrough COVID). At the time of the report, DRUG INEFFECTIVE (I have breakthrough COVID) outcome was unknown.            No concomitant medication information was provided.  No treatment medication were provided.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild
On (L) arm swelling, redness, itching and thickening at the site of the injection hours after receiving vaccines. Treated with ibuprofen 2tsp/10ml, ice for swelling.
Lost her sense of taste; This is a spontaneous report from a contactable consumer via medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the COVID shot on 21Jan2021 and on 22Jan2021 she noticed that she lost her sense of taste starting a few hours ago. She has no other symptoms aside from that. She said she feels fine. She asked if it is normal to lose the sense of taste after receiving the COVID-19 vaccine. The outcome of the event was unknown.   Information on the Lot/Batch number has been requested.
From initial information received on 4/20/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 49 year old female patient received a dose of TD ADS ADULT, lot number U1018AA, administered IM in the deltoid. The following day, the patient experienced body aches as well as redness, swelling and soreness at the site of injection. Reportedly, the symptoms lasted one week and the patient recovered from these events. The reporter of this case is the same reporter of case 200401652. No further information is anticipated, this case is considered closed.
immed p/vax had soreness rt arm c/o recent soreness in back occasional lightheaded sensation;late w/menstral cycle was due 15MAY ha snot had period yet denies pregnancy;
4-5 min episode of stiffening, unresponsiveness, no clonic movements, eyes open, with post-ictal period, in presence of fever (100.8) after TYLENOL.
At 900PM patient was crying and fever was 102.1. Child started shaking all over and some foaming at the corner of mouth that was less than a minute patient followed up in our office on 10/4/2013 seen Dr. and was referred to a neurologist.
Pt mom reported t103, pt tolerating fluids; mom states pt had been sick the last couple of days a/the shot & did not think it was necessary to tell the nurse a/shot given;
Right arm - Erythema, Induration, Warmth, Swelling. Left arm - Redness. Advised use of cold packs, acetaminophen, and ibuprofen as needed for discomfort until resolution.
patient jerked arm away during administration of Arexvy dose and didn't get the full dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: patient jerked arm away during administration of Arexvy dose and didn't get the full dose).The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 09-OCT-2023 The reporter called to inquire that how to proceed with patient receiving a partial dose. The reporter reported a patient jerked arm away during administration of Arexvy dose and did not get the full dose, which led to incomplete dose administered. The reporter unable to provide any vaccine or patient details.  The reporter did not consent to follow-up.
This case was reported by a physician via sales rep and described the occurrence of fever in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose, refer case US2018GSK135832). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and pain. The patient was treated with ALEVE. On an unknown date, the outcome of the fever and pain were unknown. It was unknown if the reporter considered the fever and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's body temperature was 100.9 and was aching. The patient felt better within hours. Lab Comments: On an unknown date, body temperature was 100.9.
Patient was sick after testing for covid. Within a month he was hospitalized for 5 days. They pumped him full of crap at the hospital that in turn caused him to be released worse off. He got 2 vaccines and had not been the same since this. He was constantly sick, short of breath, exhausted, and flu like continuously. Pt died June 10th, 2022 almost exactly 6 months from the 2nd vaccine. He died of myocardial infarction. he Never had health issues. granted he was 58 but he had a physical before testing that he passed with flying colors. I believe the hospital GAVE him covid with their test. Then talked him into getting the vaccine. I NEVER got covid. I never tested for it and I believe he was given COVID from the test to push this worthless killer vaccine!
A FEW ACHES AND PAINS; LOW GRADE FEVER; This spontaneous report received from a patient via an unspecified company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination.The batch number was not reported. The unspecified Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced a few aches and pains, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever, and the outcome of a few aches and pains was not reported. This report was non-serious.