chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache, Myalgia, 24 HOURS AFTER INJECTION REPORTED HEADACHE, FAIGUE, AND BODY ACHES LASTING ABOUT 24 HOURS. REPORTED INJECTION SITE SORENESS X 6 DAYS Narrative:  Other Relevant History:
PATIENT WAS  9 WEEKS OLD AT TIME OF VISIT AND QUADRACEL WAS GIVEN. WE DID NOT  REALIZE AS VACCINE COUNT MATCHED IN DEC. IT WAS REALIZED TODAY WHEN MOM CALLED TO SCHEDULE SHOTS ONLY VACCINE AND REINTERATED THAT SHE ONLY DOES 1 VACCINE AT A TIME.
pt had rash on lt side of face inject site, abdo  & neck and back, appearance of hives like rash; walked to ER;
Significant pain in arm at site of injection of TDAP vaccine to the extent that certain movement of arm is prohibited.  Pain continues over 4 weeks later with no reduction.
soreness in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 35 year-old female patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose 1, single and administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "soreness in the arm".  Additional information: Caller was a father reporting that her 35 year old daughter received the booster shot of Pfizer bioNtech covid vaccine 10 months after the primary series. She didn't show much side effects after the first and second dose only some soreness in the arm. But after getting the booster on Friday her arm has been very numb she feels very numb in the fingers and hands were tingling. It has already been 6 days and this feeling doesn't go away.  Follow-up attempts are completed; The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Minutes after receiving injection: blood pressure up to 165/105, pins and needles down arms, legs, and throughout body, feeling of throat tightening and closing, difficulty swallowing, constriction in nasal, face, and head, headache, pain in face, eyes, and nose, feeling of loss of motor function in legs and arms-not walking as usual. Long term for 5 days after injection: sinus constriction, eye pain, headache, face, nose, sinus, eye, and head pressure--like something was going to pop, high blood pressue
Small petechiae/purpura like (not professionally diagnosed) lesions on upper thigh below buttocks. The small purple/red dots are clustered together in an area roughly 2" by 2" in the same spot on each leg.
Passed out the morning after the vaccine which resulted in a broken ankle. I have never passed out before
soreness in arm and a little achy; slight headache; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a 77-year-old male patient (husband). A 77-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3247; Expiration Date: 31May2021), dose 1 via an unspecified route of administration, administered in arm left on 23Jan2021 (at the age of 77 years), as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. Medical history included 10-year lung cancer survivor, in remission/cancer (the patient had many complications from that, he was not released from the hospital in Nov2019; After surgery he had been just a mess, just sits on couch. But taking ADVIL does help) from an unknown date and unknown if ongoing, open heart surgery in Jul2019 (prior to the lockdown) to an unknown date, high blood pressure from an unknown date and unknown if ongoing, diabetes from an unknown date and unknown if ongoing, shingles from an unknown date and unknown if ongoing (all before the vaccination). Concomitant medications included ibuprofen (ADVIL) and oxycodone hydrochloride, paracetamol (PERCOCET); taken both for pain from chemo (takes ADVIL daily/due to his condition, because he suffered from pain from chemo, his "PCP tells him he can take up to 6 ADVIL a day when needed and up to 4 PERCOCET a day as needed"), start and stop date were not reported. Reportedly, the patient had minimal side effect post the first injection with the PFIZER-BIONTECH COVID-19 VACCINE. Reporter stated her husband attempted to limit his PERCOCET intake to one a day while using the ADVIL to compensate (tried to not take PERCOCET because he tried not to take narcotics and relies heavily on ADVIL per doctor) and it was mentioned that he can take ADVIL. She mentioned her mother who received the MODERNA COVID-19 vaccine was told "not to take TYLENOL and ADVIL before and after vaccination". She said her husband was due for his second dose of the Pfizer-BioNTech vaccine unspecified date (tomorrow). The patient had minimal side effects from 1st dose, had soreness in arm and a little achy; and had slight headache on unspecified date. Reporter expressed her concern on a potential interaction between the vaccine and the pain medication and asked if her husband could take ADVIL and asked if he stops the pain medication tomorrow, "will it reduce the potential lowered response to the vaccine". Reporter explained that she was unable to reach primary health care provider (PCP) and needed an answer as to whether her husband should stop or continue his medication and asked was it worst for her husband to stop his pain medication today and tomorrow and be in pain". Reported serious was none. The clinical outcome of the events was unknown at the time of report. Follow-up attempts are completed. No further information is expected.
Received Moderna vaccines on 1/12/21, 2/9/21, 10/27/21; COVID positive on 4/23/22 by PCR; admitted to hospital on 4/23/22 due to delirium, bilateral airspace opacities in lower lobes.  Acute encephalopathy likely due to COVID. Underlying dementia.
A 76-YEAR-OLD FEMALE PATIENT REFERS ITCHING IN THE PUNCTURE AREA, SYMPTOM THAT REFERS IMPROVEMENT WHEN REMOVING ADHESIVE BANDAGE.
pt describes rash as like carpet burn on both arms & legs-ears & checks bright red in color; phone call to family MD & advised to take DPH & came to hosp if poss reaction inc or worsens; recovering only rash around inject site;
Crohn's related issue; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4196913-00 (Agency).  A 43 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 27Oct2021 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single and intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CROHN'S DISEASE (medically significant) with onset 2021, outcome "unknown", described as "Crohn's related issue". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial  Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of CROHNS RELATED ISSUES was not provided.  Causality for PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN) The reporter's causality for the event(s) of CROHNS RELATED ISSUES was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As per available information , the causal association between the event Crohns disease and the suspect drug BNT162B2 cannot be excluded.   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.
8/10 whole lower abdominal pain, constant. The whole day abdomnal pain ranged from 4-8/10 and constant until the 3rd day in the morning. Chills, temp of 103F.  Muscle/joints pain. Fatigue. Headache. Treated with Motrin for fever as needed. Absence from school, unable to do routine activities of the day. Seen by MD on the 3rd day because of continued fever, this time on the 3rd day abdominal pain subsided. Urine test done,positive for UTI.
The patient came to the pharmacy at 2:21 pm for Covid vaccination. He was accompanied by mother father and 3 other siblings.  The patient  and other 3 siblings received Covid vaccination. ( 3  received Pfizer regular and 1 received Pfizer pediatric). The  patient received Pfizer 1st dose Lot #fk9896 at 2:28 pm. After vaccination patient and his sibling were asked to wait for observation period of 15 minutes. After about 10 minutes of getting vaccination patient fell on the floor with eyes open. He was standing on foot before falling. the pharmacist approached patient immediately after the patient fell. The patient seemed confused . When he became alert and came back to his senses he told he did not know what happened to him. He did not feel  anything before falling.  His mother told that he has not eaten anything since morning. He was empty stomach before vaccination.  Mother also complained the patient keep forgetting what happened to him and mother had to explain many times about the incident to the patient. His other 3 sibling were fine. Didn't experience anything.  He was kept under observation for 45 minutes after incident. He was fully alert and aware before leaving the pharmacy. Mother was asked to follow up the primary care physician.
Pt recv vax on 10/2/98; on same day pt exp achiness in arms to neck, hot &cold flashes, dizzy, laryngitis, myalgia, head congested.
Extension of period, extreme fatigue, brain fog, lack of appetite. Dizzy and naseous. Headache. Injection arm under arm pain. Increased heart rate.
No adverse effect; temperature excursion; This spontaneous report was received from a healthcare professional referring to a 6-month-old male patient. The patient's historical vaccine included hepatitis B vaccine. The patient's concomitant vaccines included pneumococcal vaccine conj 7V (CRM197) (PREVENAR) and diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3V (MRC 5), tetanus vaccine toxoid (PENTACEL). The patient's medical history, concurrent conditions, and past drug reactions or allergies were not reported.   On 12-JUN-2023, the patient was vaccinated with rotavirus vaccine live, pentavalent (ROTATEQ) oral liquid (lot#: 1968385, expiration date: 22-MAY-2024; strength and dose were not reported) orally for prophylaxis. The vaccine administered experienced temperature excursion (product storage error). The alarm had some sensory issue, and the vaccine was monitored with back up logger. No adverse effects (no adverse event).
Systemic: Anaphylaxis-Severe, Systemic: Nausea-Medium, Systemic: Fainting-Medium
Patient did not have any adverse outcomes.  Received 2 doses of Moderna.  Moderna authorized at the time for 18 years of age and older.
Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Age of the patient was reported as 27 year 8 months.   No concomitant drug information was provided.  The patient had received Moderna Covid-19 vaccine that were given beyond the 30 day use by date after the thaw process. No patient had any adverse reactions and no reports of any reactions after administration of the vaccine was noted.   No treatment drug information was received.   This case was linked to MOD-2022-542869 (Patient Link).
Employee reports after second dose onset on chills, and soreness to injection site. sxs resolved on own.  Employee reports having both Pfizer vaccines 1st dose 12/23/20, 2nd dose 1/12/21. Employee became symptomatic and tested Covid positive 3/25/21. BWH Infection contact tracing team has identified the employee as contracting Covid by a Community Contact.  Employee quarantining at this time.
Patient received Pfizer COVID-19 vaccine on 5/14/21 and 6/4/21 at pharmacy. On 6/16/21, patient was admitted to Medical Center for seizure. Patient was found to have new left focal status epilepticus, right frontoparietal intraparenchymal hemorrhage and superior sagittal sinus thrombus. Patient underwent mechanical thrombectomy on 6/17/21 with partial recanalization. Patient is still admitted in the hospital as of 6/23/21.
Tinnitus. Constant  high pitched ringing in my ears. Came on gradually and as best I can recall it started about a month/four weeks after my first shot
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Urinated on himself
Vitamin B12 deficiency; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 11Apr2021 as dose 2, single (Lot number: EW0153) at the age of 49 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "choroidal melanoma", start date: Oct2012 (ongoing), notes: Pertinent details: plaque therapy (radioactive) left eye; "Dad allergic to penicillin." (unspecified if ongoing), notes: Dad allergic to penicillin. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1st, Date: 21Mar2021, Time: ?, Anatomical Site of injection: Right arm, Route of administration: Intramuscular, Batch/Lot Number: ER2613), administration date: 21Mar2021, when the patient was 49-year-old, for Covid-19 immunization. The following information was reported: VITAMIN B12 DEFICIENCY (non-serious) with onset 16Apr2022, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient took dose 3 on 30Dec2021 on right arm intramuscular (Batch/Lot Number: Moderna 069F21A .25 mcg).
Patient became nauseated and lightheaded after receiving vaccination (2nd dose). We took Pt to lie down. Pt vomited once. Pt was evaluated - vaccinator. BP 120-60. Pt states this happens when he receives a shot or has blood drawn. Pt felt better after resting and was able to drive himself home. EMS was not called.
Localized redness and itching past normal.  Advised to take BENADRYL and if not cleared see primary care doctor.  Was getting better at the time.
Right arm has red, raised area, warm to touch and painful. Symptoms first appeared on 8/24/2000.
Days after first dose I developed a dark, red spot on my leg.  Biopsy revealed Granuloma Annulare.  This progressed aggressively, covering large areas of my legs, arms and trunk.  It is the generalized type.  It itches and burns.  It continues to spread.  It has caused extreme anxiety and worry.
Patient received Pfizer COVID vaccine on 2/15/21 (lot # EN6200), 3/8/21 (lot # EN6199), and 10/7/21 (lot # FF2587) in the per vaccine card.  On 2/26/22, patient admitted with acute hypoxemic respiratory failure and COVID-19 pneumonia (positive result confirmed upon admission). Patient is immunocompromised with multiple myeloma status post stem cell transplant. As of today (3/3/22), patient is still admitted in our med/surg unit.
Oral swelling, hot flashes.  Patient did not seek medical attention during event, states she self medicated with diphenhydramine within an hour of vaccination.  Symptoms completely resolved by next morning.  Patient endorsed symptoms during screening for second dose of vaccine 21-days later.
It started three weeks later, I had tinnitus in the ear. I had that before but then after the vaccine it got worse. So, I had an appt with an audiologist and he nothing that they can do about it. I was told to always have sounds going on to not notice the ringing in my ears. They tested my hearing and I was told that I have really good hearing for my age.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received Shingrix for prophylaxis. In June 2018, the patient received the 1st dose of Shingrix. In June 2018, 2 hrs after receiving Shingrix, the patient experienced injection site pain, injected limb mobility decreased and pain in arm. The patient was treated with oxycodone. On an unknown date, the outcome of the injection site pain and pain in arm were recovered/resolved and the outcome of the injected limb mobility decreased was unknown. It was unknown if the reporter considered the injection site pain, injected limb mobility decreased and pain in arm to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient reported injection site pain, arm pain, and could not raise his arm. The patient went to an emergency department and was prescribed oxycodone. After 1 month, the events resolved. The patient had denied permission to contact their physician. The reporter was the wife of the patient and she had to end the call.
Right Leg tingling; Strange Feeling; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162B2 via an unspecified route of administration on 20Jan2021 10:00 AM at a single dose as COVID vaccine. There were no medical history and no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). The patient had no known allergies. The patient experienced right leg tingling and strange feeling on unspecified dates. Treatment was not received for the events. He had no COVID prior to vaccination. He did not have COVID tested post vaccination. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
COVID-19; Felt terrible; This is a spontaneous report received from Pfizer Sponsored Program. A non-contactable consumer (patient herself) reported that an unspecified aged female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient stated that she received her first dose of Pfizer COVID-19 vaccine and has felt terrible since and explained she was exposed to COVID-19 virus also and she had antibodies tested against the COVID-19 virus, but she tested negative twice for the COVID-19 virus. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2016, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving zoster vaccine live for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
shaking, rash & abd pain that started approx 1015 1JUL95; pt DPH;
Swelling, redness and induration of right thigh, cellulitis noted. Treated with KEFLEX and BENADRYL.
Moderna COVID-19 Vaccine EUA - recurring sharp pain in left side of abdomen. have taken Tylenol and Pepcid to treat the pain. similar reaction after first dose on 3/20.
PERSISTENT HEADACHES IN THE BACK OF THE HEAD, ON TOP OF THE NECK AND BEHIND THE EARS; PAIN AT THE SITE OF INJECTION FOR 2 DAYS; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 24A21A, expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the subject experienced pain at the site of injection for 2 days. On JUN-2021, the subject experienced persistent headaches in the back of the head, on top of the neck and behind the ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at the site of injection for 2 days on 30-MAY-2021, and had not recovered from persistent headaches in the back of the head, on top of the neck and behind the ears. This report was non-serious.
Information has been received from a registered nurse from a pediatrician's office, concerning a 43 year old patient's mother who on 24-MAY-2010 was vaccinated with a dose of VARIVAX (Merck) (lot#: not reported). It was reported that in approximately June 2010, "now" the patient had chickenpox. At the time of the report, the patient had not recovered. Additional information has been received from an office staff member who reported that the patient listed in the adverse event was an adult and not a patient of the office. No further information is available.
pt recv vax & devel a local rxn;no further details available as of the date of this report;this is one of two patients from this site who exp the above rxn p/receiving the same lot#;