chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller took 2 doses of the Pfizer COVID-19 vaccine. No problems with the vaccine, no side effects from the vaccine, just the terrible side effects from the Paxlovid.; Caller took 2 doses of the Pfizer COVID-19 vaccine. No problems with the vaccine, no side effects from the vaccine, just the terrible side effects from the Paxlovid.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "thyroid cancer" (unspecified if ongoing), notes: Caller is a cancer patient, and takes Synthroid because caller doesn't take have a thyroid. Caller also takes caprelsa which is a chemo medication for caller's thyroid cancer. Concomitant medication(s) included: SYNTHROID; CAPRELSA taken for thyroid cancer. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Caller took 2 doses of the Pfizer COVID-19 vaccine. No problems with the vaccine, no side effects from the vaccine, just the terrible side effects from the Paxlovid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Patient was calling about Paxlovid, patient's doctor prescribed the medication for the patient and she took the medication for 1 and a half day only, so patient only took 9 pills total of the medication. Patient had a side effect which was horrendous, patient's stomach was burning, felt like an upset stomach. Patient went to take a bowel movement and the feces burned so much as the feces was coming out of the patient and at the end of the bowel movement there was a little bit of blood in the feces. Felt like acid coming out when patient was taking a bowel movement so patient stopped taking the medication. Patient stated this was good for Pfizer to know about, the pharmacists, because maybe the medicine was not for every patient. Patient was a cancer patient and takes Synthroid because patient doesn't have a thyroid. Patient also takes Caprelsa which was a chemo medication for patient's thyroid cancer. Patient was taking Paxlovid and stated that caller took 2 doses of the Pfizer COVID-19 vaccine. Unable to confirm the indication for why caller was taking Paxlovid because caller declined to continue completing the report.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a RN concerning a pt who on 24Apr98 was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt developed chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No additional information is available.
Three days after vaccination patient developed itching then rash.  Rash was unusually scattered and erythematous papular.  No blisters or pustules.  Areas of buttocks, legs, back.
Lethargy; I can barely get through a day without feeling like I am going to fall asleep at some point; Low energy levels; This is a spontaneous report from a contactable other hcp. A 47-year-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in left arm on 04Mar2021 10:00 (Batch/Lot Number: EN6203) as Dose 1, single (at the age of 50 year) for covid-19 immunisation, dose 2 intramuscular, administered in Arm Left on 25Mar2021 03:00 (Batch/Lot Number: EL3248) as Dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient did not have covid prior vaccination, was not tested for covid post vaccination and no other vaccine in four weeks. The patient experienced lethargy, he can barely get through a day without feeling like he was going to fall asleep at some point, low energy levels (asthenia) on Mar2021. The patient did not received treatment for the events. Outcome of the events was not recovered.
Injection was received late afternoon Wednesday.  Fever, chills, headache, total body aches/pain, stomach upset, dizziness.  I spent Thursday lying on the sofa unable to eat (no appetite) or do anything else (couldn't walk my dog).  I texted my neighbor about 6:00 pm (Thursday) for help when it looked like the symptoms were not getting better, as I live alone and do not normally take pain medications so had nothing to treat the pain.  He brought me Ibuprofen.  I drank water but had no appetite for food.  (lost 3 pounds).  By Friday I was able to eat a little and leave my post on the sofa.  Today is Wednesday, a week after the injection, and my appetite is still very poor and I cannot raise my left arm above my head because the area of the armpit is quite tight and sore.
PT had an acute intracranial hemorrhage 4/15/23 following recent international travel, incidentally was also found to be COVID + on PCR. She was also noted to have  Mildly Dilated aortic root and ascending aorta on echo performed 4/16/2023
2nd Booster given on 2/25/2021 By 3/19/21  Urgent Care : Swollen Lump Nodes, Swollen Thyroid, Sore Throat, Swollen Gums in mouth Diagnosis: Thyroiditis
Sore arm muscle at injection site, still, 19 days later.  It's limiting the motion of my left arm.
Suspect COVID breakthrough case Admitted for decubitus ulcer with incidental covid finding (asymptomatic)
Received vaccine along with first Anthrax shot around 02/25/2003. Was very sick for about 6-8 weeks afterwards. Missed several days of work. Massive headaches, fever, constant 24/7 draining of sinuses into throat, several heart palpitations, constant cough. Had all of these symptoms through all of March and most of April before it cleared up.
Breakthrough hospitalization of vaccinated COVID19 patient.  Pt was DNR with a history of major neurocognitive disorder.  Pt had acute non-ST elevation myocardial infection. Family made patient comfort care and she passed away on 10/19.
Patient report severe body ache and severe pain at the injection site. Patient was unable to lie down without feeling pain resulting in insomnia for 2 days,  fever of 100F. He had had shingle before and what he experienced with the vaccine is the exact symptoms of shingle minus the lesions. He felt like the vaccine might had trigger his body to have shingle like symptoms. He was in so much pain that he wanted to go to the emergency room but he did not end up going there. On the third day after the vaccine was administered, patient is feeling a little bit better, no longer having fever but still having residual pain.
9JUL97 pt recv vax & few hr later crying, irritable would eat, would quiet down, motrin helped;cont until 13JUL97;taken to ER transferred to hosp in PM;dx viral meningitis per hosp;t104 11JUL97;
Swollen lymph node under the arm pit injected arm (baseball Size); This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node under the arm pit injected arm (baseball Size)) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included THYROID (ARMOUR THYROID) for Hypothyroidism.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph node under the arm pit injected arm (baseball Size)). At the time of the report, LYMPHADENOPATHY (Swollen lymph node under the arm pit injected arm (baseball Size)) outcome was unknown.            No treatment medications were reported.
Patient received an expired pfizer bivalent dose (Beyond used date: 12/27/2022; administered on 01/02/2023). Spoke to patient's mother and she said patient feels Injection site reactions, tired, and overall malaise.
Prior to arrival, the patient received her first COVID vaccine at the clinic, after which she suddenly felt dizzy, described as lightheadedness, and felt warm. She was noted to be hypotensive with SBP at 67. She subsequently drank water with some improvement. No syncope, severe headache, numbness, tingling sensations, or focal weakness. Mother was concerned and brought the child to the ED for further evaluation. Currently the patient feels better. No similar symptoms in the past. The patient denies any chest pain or pressure, shortness of breath, or abdominal pain. No recent fever or cough.She is otherwise healthy and has a normal cardiopulmonary exam and reassuring EKG.  The description of her symptoms and the environment which happened is very consistent with vasovagal syncope and she does not have any stigmata, and acute neurologic or cardiac emergency.  I believe she is safe and stable for discharge home and she was discharged with return precautions and follow-up instructions.
Client into County Dept of Public Health today. Reports raised red papules (pimples), that began as "red blothces" on interior, posterior torso, spreading to arms and legs. Very pruritic; papules had no discharge. Denies dyspnea, heart  (can't read) rash. Saw a few different doctors. Lesions began resolving 10/28/05.
Tachycardia, rapid heart rate, burning sensation in chest, elevated bilirubin, elevated blood pressure
Janssen vaccine is indicated for 18yrs and up- patient is 16yrs old.  No adverse effects reported
Severe chills lasting 4 hours, fever (100-101.8) lasting 10 hours
5/8 Sought neurologists treatment for persistent "nerve pain" rotating from back of head across right mastoid region extending to top of head. MRI done to check on known Cervical Rupt. Discs. (No change) (Never relayed information to Dr. of "pimples" on scalp in lower hair line at back of head). Pain has diminished but not disappeared.
Double dose of HIB administered. One dose of HIB, and an additional dose in Pentacel.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. It was also reported that the patient also received Paxlovid from 14May2022 to 19May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 2:10 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 32.04.  Concomitant products were not provided.  On 17-FEB-2021, Excursion time was 08 AM, temperature was 20, 09 AM, temperature was 22, total doses given for the day was 62, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 11-FEB-2021, vial was moved to clinic on 17-FEB-2021. 5 vials were sent to clinic. Vaccine BUD date was 13-MAR-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
COVID-19; COVID-19; Rheumatoid arthritis flare up in hands; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4365181-00 (Agency).  A 66-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Lot number: 1154506), oral for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19"; RHEUMATOID ARTHRITIS (medically significant), outcome "recovered", described as "Rheumatoid arthritis flare up in hands". The action taken for upadacitinib was unknown. Clinical course: The patient stated she was having pains In her hands. It was unknown If patient was enrolled in a COVID-19 Vaccine Trial.  Causality for Rinvoq (Upadacitinib): The reporter's causality for the events of Covid-19 and Rheumatoid Arthritis Flare up in Hands with Rinvoq (Upadacitinib) was no reasonable possibility.  Causality for Pfizer-BioNTech Covid-19 Vaccine (Tozinameran): The reporter's causality for the events of Covid-19 and Rheumatoid Arthritis Flare up in Hands with was possible.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Nausea and vomiting starting on day 2 after getting shot. On day 3 patient had a severe migraine headache requiring a trip to the Emergency Room with continued headache and nausea lasting aproximately 4 days.
COVID EXACERBATION, HEADACHE, INCREASED THIRST, CHANGE IN TASTE, DRY COUGH, INCREASING SHORTNESS OF BREATH, DIARRHEA, FEVER
Non-responsive, anorexic 4PM w/shallow breathing unresponsive body covered w/rash 7PM glassy eyed & floppy; Taken to ER adm in shock w/sepsis; recd APAP was intubated; lost all her toes, fingers & thumb on rt hand; One joint off 2 fingers;
Fainted, nausea, could not open eyes, could not move legs, hallucination (thought she was on the phone with husband). Follow up with patient's husband-she is doing OK.
about 1 hour after shot, I got very cold and chilled, then that night or following day, I felt like I had a cold and sore throat and congested. Each day it got a tiny bit worse, I was soo sick but lethargic and unwell. It got a tiny bit worse the next day but I am hoarse and my throat feels annoyed and I don't feel like me. Even though all this happened I would go through with it again. The injection site hurt the next day and it went away.
Congestive Heart Failure; Information has been received regarding a case in litigation from a lawyer and refers to a 66-year-old male patient (conflicting information as it was also reported that the pt was born on a different date as reported). No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2018, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route, anatomical location, lot # and expiration date was not provided) as prophylaxis at a pharmacy. As a result of his receipt of zoster vaccine live (ZOSTAVAX), in 2018, the pt was caused to suffer pain as a result of his Congestive Heart Failure, including any and all of its sequelae. As a result of his receipt of zoster vaccine live (ZOSTAVAX), the pt, has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. The outcome of Congestive Heart Failure was considered not recovered. The event was considered to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, Congestive Heart Failure was determined to be medically significant.
Pt. has a history of MS.  Staff member of Hospital claiming that symptoms of MS were possibly exacerbated by getting the H1N1 shot. Approx 2mths. after getting shot pt. claims she started to become more and more fatigued, eventually leading into a full excerbation of MS symptoms, fatigue, weakness, pain etc., causing her to be out of work for several months begining in January of 2010. First day back was June 1, 2010. Pt. not sure if the H1N1 shot started this but has a strong feeling it was.
Pt exp migraine w/in 6 hrs of receiving Engerix-B; a day later devel very swollen lymph glands under rt arm & rt neck w/less swelling on lt neck;
Large, round, red and swollen area to injection site. Area of injection site extremely sore to touch and pain with moving arm, lasting 2-3 days. Approximately 9 hours after vaccine, started with body aches, chills, headache, fever up to 103.9 F, joint pain, extreme fatigue lasting over 5-6 days. I am still having fatigue and body aches 7 days after vaccine.
Swollen wrist first with pain then right followed by constant pain in both thumbs and hands falling asleep, tingling, on going body stiffness
Fever to muscle aches, to not able to walk and severe localized pain through out both legs. Hospital ED visit.
Client reported adverse effects from 1st dose Moderna on 04/1/2021 including hot sensation onset immediately after receiving vaccine, intermittent nausea onset immediately after receiving vaccine, body aches and cramping onset immediately after receiving vaccine lasting for several days, and numbness on the L side of body onset immediately after receiving vaccine lasting for 1 month. Baseline vitals were taken by co-lead RN with 116/50 BP in L arm sitting down, HR 40, 02 100%. Medical consult was sent to vaccine operation leads. Received approval to proceed with 2nd dose Moderna and advise client to wait 30 minutes for observation. Client recieved 2nd dose Moderna (lot #011F21A) in R arm at approximately 0230. Client did not report any adverse effects. Client left the vaccine site AMA after 15 minutes of observation with her mom. Client left site at approximately 0245 with a steady and symmetrical gait.
Patient had her routine dialysis and was administered PPV23.  Went home, felt weak.  Husband found her slouched over.  911 called.  Patient sent to ICU.  Placed on comfort cares and passed away.
I received my shot around 8:30 in the morning and started feeling side effects around 10 pm. I felt a little bit fatigued and my left arm was extremely sore to the point where I could barely move it. The next day, it was still sore but I was able to move it much more. I had muscle aches through my entire body. It is now 2 days after the day I got the vaccine and my arm is still sore and hurt when I extend my arm.
Initial unsolicited report received from pharmacist on 06 February 2015. A 45-year-old patient (gender was not reported), whose medical history and concomitant medication were not reported, had received a dose of MENACTRA (Batch number, expiry date was not reported) via intramuscular in deltoid left on 04 February 2015. On 06 February 2015, 2 days after vaccination, the patient had experienced arm feels heavy and lump at injection site and no redness at site. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. The laboratory investigation and corrective treatment was not reported. At the time of this report, the outcome of the event was not resolved. List of documents held by sender: none. Follow-up report received from a physician on 01 May 2015. Gender of patient was reported as male and the patient did not have any known drug allergy. Documents held by sender: none. Follow-up misuse information received from physician on 14 May 2015. The patient had not received any vaccine within four weeks prior to vaccination. The patient's pre-existing physician diagnosed allergies, birth defects and medical conditions, illness at the time of vaccination, relevant diagnostic test or laboratory data, other medication and adverse event following prior vaccination were reported as none. Number of previous doses was reported as more than three years ago. The patient was vaccinated at pharmacy and vaccine was purchased with private funds. Physician further reported that patient apparently had a local reaction at the site of injection which according to the patient was related to the technique rather than the vaccine itself. Patient claimed, the pharmacist injected the vaccine which was too deep, hit the bone. Patient noticed that the needle was bent. It was a wrong injection technique as the patient was injected the vaccine too deep that hit the bone. At the time of this report, patient had recovered from the events on an unspecified date. List of documents held by sender: none.
Treatment sought in the Emergency Department after seizure activity during the PM hours after receiving the flu shot; Evalauted by neurologist and he states that the vaccine lowered the seizure threshold.
Slight aches especially in lower back and legs but only lasted for a few hours the day after my vaccine
Difficulty breathing, sharp pains in chest area, dizziness, tightness & pain in legs and back.
About 30 seconds to a minute after vaccine admin pt started sweating/chills/ I had her sit & relax then she started to develop ringing in the ears/vision loss & turned a grey color. Lasted about 10 mins she then started to slowly recover & was fine 20 mins later.