chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient is an 86-year-old male with past medical history significant for BPH with urinary retention, history of complete heart block status post permanent pacemaker, chronic kidney disease stage III, aortic stenosis status post TAVR, coronary artery disease, type 2 diabetes mellitus, atrial fibrillation, hypertension, hypothyroidism and Barrett's esophagus who presented to the emergency department today due to acute onset speech difficulty and left leg weakness.  Today at approximatly 12 noon, patient began to have stuttering and speech difficulty while he was ambulating to the restroom.  His wife was concerned that patient was having a stroke.  They called his son and he was brought into the emergency department for evaluation.  He was brought into the emergency department in a wheelchair.  Within a 15-minute time course, patient's speaking difficulty resolved.  Over the course of next few hours, his leg weakness also resolved. He underwent imaging with a CT Head and CTA head and neck and did not have any CVA demonstrated on imaging. He was admitted to med surg for further work pu and neurology consultation.
This spontaneous report as received from a pharmacist refers to a 71 year old female patient. The patient had drug allergy to Morphine and no pertinent medical history. On 10-DEC-2014 the patient was vaccinated with one dose of ZOSTAVAX (lot # K012785, expiration date: 28-NOV-2015, 0.65 ml) subcutaneously. Concomitant therapies included potassium chloride (manufacturer unknown) and DAYPRO. On 11-DEC-2014, the patient presented with red, warm, swollen, painful rash on her bilateral cheeks that the pharmacist described the presentation as "resembling Rosacea in appearance". There was no treatment given for the adverse event. No lab diagnostics studies performed. The patient saw the pharmacist for medical attention. The outcome of the adverse event was reported as not recovered. The causal relationship between the adverse event and ZOSTAVAX was not provided. Additional information has been requested.
The information for this report is extracted from the ED and inpatient medical record. 60 y.o. M with a prior hx CVA x 2 but no previous seizure history had not been feeling well and went to his PCP on 6/1 (exact time unknown), during that visit he received a B12 shot and a shot for shingles, later on at 20:15 the patient had a witnessed seizure, was taken to ED where he had 2 more witnessed seizures. In ED he was treated with Ativan, loaded with IV Keppra then put on oral Keppra 500mg po bid. He was admitted to hospital, EEG and MRI negative except for finding of old CVA, neuro consult, no further seizures and patient discharged 6/3. Per MD, the seizures are new onset and probably secondary to old CVA. Case manager noted vaccine administration earlier on same day of seizure onset and reported to pharmacy, pharmacy is making this VAERS report based on the information in the patient medical record.
Fever, 101.7, chills, muscle aches Tylenol Fatigue only after 48 hours
12/28/22 presents to ED for "coronavirus concern". PMHx of "A-fib (On apixaban), CHF s/p ICD placement, COPD (On 3: NC at home), HTN, OSA, and DM2"
thigh stiffness; mild fever; body aches; pain at the injected arm; stiffness of the of the legs, with a lot of pain; muscle spasms in her thighs; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL STIFFNESS (thigh stiffness), PYREXIA (mild fever), MYALGIA (body aches), VACCINATION SITE PAIN (pain at the injected arm) and PAIN IN EXTREMITY (stiffness of the of the legs, with a lot of pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced MYALGIA (body aches), VACCINATION SITE PAIN (pain at the injected arm) and MUSCLE SPASMS (muscle spasms in her thighs). 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (stiffness of the of the legs, with a lot of pain). On 26-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (thigh stiffness) and PYREXIA (mild fever). The patient was treated with IBUPROFEN for Prophylaxis, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (thigh stiffness), PYREXIA (mild fever), MYALGIA (body aches), VACCINATION SITE PAIN (pain at the injected arm), PAIN IN EXTREMITY (stiffness of the of the legs, with a lot of pain) and MUSCLE SPASMS (muscle spasms in her thighs) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included Ibuprofen 200 No Concomitant medications were provided    Reporter did not allow further contact
This spontaneous report as received from a nurse refers to a patient of unknown age and unknown gender. On 15-SEP-2014 the patient was inadvertently vaccinated with a dose of PROQUAD, injection, subcutaneous, (dose was not reported, lot # was reported as "K009890", expired date was reported as "11-JAN-2016"), which was improperly stored. Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
EXTREME BODY STIFFNESS; BODY PAIN THROUGHOUT; FORGETFULNESS; FUZZY THINKING; SLEPT 12 OUT OF 17 HOURS.; This is a spontaneous report from a contactable consumer. A 69-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 06Apr2021 at 16:00 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient did not receive any medication within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 16Mar2021 at 15:15 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Apr2021 at 22:00 the patient experienced sleepy (slept 12 out of 17 hours), extreme body stiffness (stiffness), body pain throughout (general body pain), forgetfulness(forgetfulness) and fuzzy thinking (abnormal thinking). No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events experienced sleepy (slept 12 out of 17 hours),extreme body stiffness (stiffness), body pain throughout (general body pain), forgetfulness(forgetful) and fuzzy thinking (abnormal thinking) were resolving at the time of the report.  No follow-up attempts are needed. No further information is expected.
Information has been received from a 36 year old male consumer with no past medical history who on 07/31/2001 at 9am was vaccinated with a first dose of varicella vaccine in the left arm. There was no illness at the time of vaccination. It was reported that on 08/13/2001 the pt had a "break through case" of chicken pox. There were only a few lesions. The pt was tested and he had shown to seroconvert and the physician did not recommend a booster dose. Follow-up info reported that the pt had a mild case of chicken pox, 20-25 pox marks on the torso, head, back, legs and the marks disappeared after three to four days. It was reported that the pt recovered on 08/17/2001. There was  no blistering or fever. It was also noted that the pt did not experience an adverse event following previous vaccinations. The pt sought unspecified medical attention. No further info is expected.
Received 4 doses (all Pfizer COVID 19 Vaccine)Tested Positive 25Aug2023 no symptoms; Received 4 doses (all Pfizer COVID 19 Vaccine)Tested Positive 25Aug2023 no symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation; 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 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Aug2023, outcome "recovered" (Aug2023) and all described as "Received 4 doses (all Pfizer COVID 19 Vaccine)Tested Positive 25Aug2023 no symptoms". Clinical course: no symptoms. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Aug2023) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162b2, BNT162b2 omi ba.4-5 in this patient cannot be completely excluded.
After my first shot on March 10, I had minor soreness around the injection site and fatigue the day following the injection.  After my second shot on April 6, I had minor soreness around the injection site, fatigue which lasted two days and low grade fever which I treated with one 400mg dose of ibuprofen.  I also developed a persistent high pitch "ringing" in my head/ears.  I believe it's what is know as tinnitus.  The volume on a range of 1(low) to 10(high) is 2/3 to 5/6.  For the first four weeks after my second shot, the ringing was constant and daily.  I noticed beginning week 5 that there would be days where it would completely stop or be barely noticeable.  The quiet periods ranged from a couple of hours to almost an entire day.  The quiet periods are generally begin in the mornings when I first get up. Otherwise they don't appear to follow a pattern.  I also noticed, if I consume alcohol it lessens or eliminates the ringing.
Events: chills, slight headache, body aches, fatigue Treatment:  Ibuprofen, antacid tablets, rest Outcome:  sweated out, body aches subsided  Was a 21 hour challenge.
chills; fever; weakness; body malaise; pain on the injection site; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional (patient reported for himself). A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6206), second dose via an unspecified route of administration on 10Mar2021 (at the age of 65-year-old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine given to patient previously was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9266), first dose via an unspecified route of administration on 16Feb2021 as dose 1, single for COVID-19 immunisation. On an unspecified date, the patient experienced, fever, weakness, body malaise, pain on the injection site. It was reported that had 2nd dose on 10Mar2021. Patient was feeling ok. 20 hits after the injection, patient developed chills and fever. Also, experienced weakness, body malaise and pain on the injection site. Took Tylenol and the usual Flu measures and by the second day and was good as new. feels like superman. Therapeutic measures were taken as a result of chills (chills), fever (pyrexia), weakness (asthenia), body malaise (malaise), pain on the injection site (vaccination site pain). The outcome of the event was reported as resolved on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Patient presented to a primary care office for a PNEUMOVAX-23 vaccination. A few minutes after administration, he developed redness and itching of both arms. Physician ordered the administration of SOLU-MEDROL 125 mg IM and BENADRYL 25 mg IM injection. The redness and itching resolved shortly after and he was able to leave the clinic with his wife.
Immediate c/o numbness/tingling @ injection site & down arm & fingers, nausea, lightheaded, became diaphoretic, passed out momentarily came to immediately & talkative. Rx Head between knees, fan to cool, H2O. Called 911 as continued to be shaky. Transport/Amb to hospital. OK in @ 1 hr reported.
Felt fine after receiving the shot in the morning. Went to bed around 10 and woke up about 1 am with a severe headache and felt nauseous. Got up and vomited several times. Headache became worse and eventually all my joints, even my jaw felt like they were on fire with pain. Slept all the next day since headache and nausea would not go away.  I walked the next day but felt weak, most likely from not eating. Still not much of an appetite the second day. Third day, today, feeling much better and able to eat more. Headache is gone and no joint pain.
can't touch the circle, skin was hard; it was warm to touch; it started to swell and this morning it was swollen around the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 22Apr2021 (Lot number: EW0191) at the age of 65 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot number: EW0150), administration date: 01Apr2021, when the patient was 65 years old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 22Apr2021, outcome "not recovered", described as "it started to swell and this morning it was swollen around the arm"; VACCINATION SITE INDURATION (non-serious) with onset 23Apr2021, outcome "not recovered", described as "can't touch the circle, skin was hard"; VACCINATION SITE WARMTH (non-serious) with onset 23Apr2021, outcome "not recovered", described as "it was warm to touch". Clinical course: Patient had her second vaccine on 22Apr2021 (reported as yesterday) and on 22Apr2021 (reported as last night), it started to swell and this morning it was swollen around the arm, can't touch the circle, skin was hard, and it was warm to touch. Events were persisting. It was reported that the patient took 500 mg, 2 Tylenol "yesterday", right after he got home. Patient was querying if this was normal and if it would be okay.  No follow-up attempts are possible. No further information is expected.
Headache; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 02Apr2021 at 13:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and had no concomitant medications. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 14:30, the patient experienced headache. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event headache was recovering at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Discharge Provider: MD Primary Care Provider at Discharge: DO    Admission Date: 10/20/2022 Discharge Date: 10/22/2022  Condition on discharge: Improved  Patient is a 94 y.o. male with medical history significant for coronary artery disease status post PTCA of RCA (2000) with occlusion of RCA '06, ICM status post dual-chamber ICD placement '06, hypertension, dyslipidemia, type 2 diabetes mellitus not insulin dependent, CKD stage IIIB.  Presents to ER for fatigue, weakness, worsening cough, COVID-19 infection. States he was at baseline health until about 4-5 days ago, developed dry cough and fatigue that has been worsening since then.  Did a home COVID-19 test which was positive.  May have been exposed to family members at a gathering about a week ago. Notes he received his 2nd COVID-19 booster on 10/04 with no immediate side effects.  Additionally, has been having intermittent sharp lower chest pain vs upper abdominal pain, unable to state where pain is coming from, does feel different from his normal anginal pain and is not associated with exertion, comes and goes at any time.  Most recently had the pain Thursday afternoon for several minutes before spontaneously resolving.  Also notes worsening lower extremity edema from baseline as well as some pain behind his right knee which he attributes to a prior knee replacement.  Says his wife of 74 years passed away last year and he currently lives with his daughter.  Mostly independent with ADLs however he is becoming more limited recently due to loss of his eyesight.                 In ER, mildly tachypneic, did briefly desaturate to 88% on room air while ambulating, however never placed on supplemental oxygen. EKG sinus rhythm with first-degree AV block, LBBB which is known, no acute ischemic changes when compared to EKG image from 09/02/2022.  Initial troponin 95-- >120 ---- > 185 -- > 285.  Blood glucose 222.  Labs otherwise stable.  Repeat COVID-19 PCR positive.  CXR with no acute process.  Given ASA 325mg in ER.  He was admitted for observation. Cardiology consulted, and were not concerned with mild chronic troponin elevation, also with CKD III. Chest pain resolved, no further testing recommended. Continue home meds.  Due to COVID-19 and risk for DVT/PE he had negative Doppler US of legs and NM perfusion only study. He never required O2, so was not give Decadron.Continue Mucinex, albuterol inhaler p.r.n.                     DM Type II, well controlled with last Hgb. A1c 6.3 in September, continue home meds. Seen by PT/OT and recommended to discharge home with assist, with home health, PT (resume home health PT)
The patient came into the pharmacy on 4/9/20 complaining of right arm pain that radiates to her shoulder and neck. She said it sarted on the day she received her Shingrix vaccine on 3/3/20, and the pain has not gone away since.
Swollen, raised, hard, red circle around arm. Warm to the touch and painful.
Information has been received from a health professional concerning an 87 year old white male with allergies to Bactrim, sulfa, tetanus, "mairodentin" and "ERYC" and a history of positive Mantoux test who on 8/21/01 was vaccinated IM in the right deltoid, with a 1st dose of pneumococcal vaccine 23 polyvalent (lot 637095/0946K). There were no illnesses at the time of vaccination. On 8/21/01, the pt developed reddened arm, swollen to elbow with burning sensation. The pt complained of a fever on the evening of 8/21/01. He was treated with Augmentin 500mg and subsequently recovered. No further information is available.
Inadvertently given pediatric dosage 5-11 vaccine instead of our adult Moderna booster dose. No actual adverse reaction thus far
It was the new yearly Covid 23-24-m SVD Comirnaty 12+ shot Went into Atrial fibrillation was in two different  hospitals
pt devel a band of severe redness @ the inj site & pain @ the inj site;rxn began 7-9 days p/vax given;pt devel cellulitis @ the site 5 days p/vax;
Information has been received from a physician concerning a 12 month old female patient who on approximately 20MAR2003 was vaccinated with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation). About one week later, on approximately 27MAR2003, the patient developed a rash characterized by hundreds of red, discrete papules which are "measles like." It was reported that the patient did not require any hospitalization or treatment and was "improved.' Unspecified medical attention was sought. Additional information has been requested.
Patient received 1st dose 2 years ago, 2nd dose has not been administered.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix series 2 years ago in 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-MAY-2022 Reporter's comment: The pharmacist reported that patient received first dose of Shingrix series two years ago and dose was given at a different facility, so pharmacist did not have the date of administration, lot number, or expiration date information. Till the time of reporting, second dose of Shingrix has not been administered. The reporter declined to provide email address. The reporter consented to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
fluid in her arm; deep, deep redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE OEDEMA (fluid in her arm) and VACCINATION SITE ERYTHEMA (deep, deep redness) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE OEDEMA (fluid in her arm) and VACCINATION SITE ERYTHEMA (deep, deep redness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Redness, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Oedema, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE OEDEMA (fluid in her arm) and VACCINATION SITE ERYTHEMA (deep, deep redness) outcome was unknown.            No concomitant medication reported.