chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lingering painful headaches; lethargy; exhaustion; discoloration at the injection site where the bandaid was.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Mar2023 at 12:00 as dose 5 (booster), single (Lot number: GJ6742) at the age of 35 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: WELLBUTRIN; ATORVASTATIN; FLUOXETINE. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN, lot number and expiration date not provided.), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN, lot number and expiration date not provided.), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN, lot number and expiration date not provided.), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN, lot number and expiration date not provided.), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 08Mar2023 at 16:00, outcome "not recovered", described as "Lingering painful headaches"; VACCINATION SITE DISCOLOURATION (non-serious) with onset 08Mar2023 at 16:00, outcome "not recovered", described as "discoloration at the injection site where the bandaid was."; FATIGUE (non-serious) with onset 08Mar2023 at 16:00, outcome "not recovered", described as "exhaustion"; LETHARGY (non-serious) with onset 08Mar2023 at 16:00, outcome "not recovered". Therapeutic measures were not taken as a result of headache, lethargy, fatigue, vaccination site discolouration.  Additional Information: It was reported that no  allergies and no other vaccination was taken in four weeks. There was no COVID prior vaccination and COVID was not tested post vaccination.
Rapid weight gain, fatigue, hair growth on face and midsection, stretch marks on abdomen, elevated cortisol levels, MRI revealed pituitary adenoma.  Two transphenodial surgeries and radiation followed.  Diagnosed Cushings Disease.
Discharge Provider: DO Primary Care Provider: DO Admission Date: 3/31/2023 Discharge Date: Apr 1, 2023  PRESENTING PROBLEM: Dizziness [R42] Ataxia [R27.0] ESRD (end stage renal disease) on dialysis [N18.6, Z99.2] Anemia, unspecified type [D64.9] COVID-19 virus infection [U07.1] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 62 y.o. male with past medical history significant for ESRD on hemodialysis, combined heart failure, coronary artery disease, seizure, type 2 diabetes, GI bleed, paroxysmal AFib, who present to emergency department with a complaint of positive COVID19. Patient stated he developed worsening generalized weakness and dizziness when he gets up.  Symptoms started Monday and he was tested positive for COVID-19.   Upon arrival at emergency department patient's vitals blood pressure 159/51, pulse 61, temperature 97.9°, respirations 20, O2 sat 100% on room air. Labs shows BMP sodium 136, potassium 4.6, chloride 94, glucose 230, bicarb 20 anion gap 22, BUN 60 creatinine 10.3.  Complete blood count hemoglobin 7.6, white count 5.4, platelet 148. CT angiogram head and neck showed No large vessel occlusions throughout the intracranial arteries. There is a 2 mm saccular aneurysm extending posteriorly along the origin of the right ACA. And Scattered atherosclerotic changes.    Patient received medications from the emergency department including meclizine, normal saline 1 L, scopolamine transderm, Zofran, Antivert. Given his persistent dizziness, ESRD on hemodialysis as well as positive COVID, patient is admitted for further management.   Regarding the saccular aneurysm, an outpatient referral to neurosurgery was sent. MRI head was negative for any acute processes.   He improved significantly with his weakness and dizziness.  He was able to be discharged home on 04/01/2023 with plans to follow-up with dialysis on Tuesday until his COVID isolation as finished at Clinic.  That is where he previously was doing his dialysis prior to admission.
I exp the red rash on Sunday itchy around the injections site. I woke up Monday morning the rash area was warm to touch, felt discomfort, slightly swollen and itchy. I contacted my PCP about my symptoms was informed to take Dose 2 my immune system reacting. I wonder if the size of needle matters depending on the size of the person.
Swelling, warm, tender, itchy @ site L upper arm. Parents took child to ER told that it was cellulitis. Parents came to HD to have checked. DR eval and determined to be redness.
This spontaneous report was received from a medical assistant refers to multiple unspecified patients. The patients concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored VAQTA (Lot#K012457 and Expiry date 04-JUN-2017; Lot#L018499 and Expiry date:25-FEB-2017;Lot#L002717 and Expiry date: 02-JUN-2017). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
passed away; chest pain; trouble breathing; This is a spontaneous report from a contactable physician and from  three non-contactable consumers from a Pfizer-sponsored program. A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as SINGLE DOSE for covid-19 immunisation.  The patient had just taken the COVID-19 vaccine and he was hospitalized due to the effects. The patient was rushed to hospital with chest pains and was experiencing trouble breathing. The patient was in the ICU fighting the effects of the vaccine. The patient passed away four hours late on an unspecified date. The outcome of chest pains and trouble breathing was unknown. Cause of death was unknown. It was unknown if an autopsy was performed.  Information on the lot/Batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events death, chest pain and dyspnea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: passed away
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 17-SEP-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 ten 0.5ml single-dose vial (SDV) (lot # K019561, expiration date 20-APR-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 24, 47 and R; 112, 49 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Positional Vertigo beginning on Day 1 ov Vaccination and persisting at least 30 days after vaccine; This is a spontaneous report from a contactable physician. A 67-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 11Feb2021 at 10:00(at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had received unspecified concomitant medications  On 11Feb2021, the patient experienced positional vertigo beginning on day 1 of vaccination and persisting at least 30 days after vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event positional vertigo beginning on day 1 of vaccination and persisting at least 30 days after vaccine was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Injection site was raised about 3 inches in diameter; Red (injection site); Hot to touch (injection site); A spontaneous report was received from an other HCP concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  vaccination site swelling, vaccination site erythema, Vaccine administered at inappropriate site and vaccination site warmth.  The patient's medical history was not provided. No relevant concomitant medications were reported.     On an unknown date, the patient received their first of two planned doses of mRNA-1273 (lot :unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced the Injection site erythema (redness) and Injection site warmth (hot to touch), Vaccine administered at inappropriate site (Received the vaccine 2 or 3 inches below of where it should have been given: Was given halfway) and Vaccination site swelling (injection site was raised about 3 inches in diameter).  No Laboratory details was provided.   Treatment included as Tylenol, Advil and Ice.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event was unknwon.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  The causality for the event of vaccine administered at inappropriate site is assessed as not applicable.
Server headaches and head pressure. Sudden hearing loss in right ear and ringing in both ears for over four weeks. My doctor has put  me on steroids. Ringing in my ears has not stopped
Shingles; rash getting worse; Only diluent administered; Only Shingrix diluent portion; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th April 2022, the patient received the 1st dose of Shingrix. On 25th April 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.     Additional Information: GSK receipt date: 3-Aug-2022 Reporter's comment: The pharmacist called to report that the immunocompetent patient developed shingles after received only Shingrix diluent portion. The rash was getting worse as the patient stated. The reporter consented to follow-up by email. Additional supportive information: The patient received only Shingrix diluent portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
L arm swollen, red and hot from elbow to shoulder. Received DTaP 7/17/02. Onset edema 7/18/02. Seen at family practice 7/19/02. Treated with Amoxicillin and Motrin. 7/22-mother says edema decreased.
I started having body aches and a light headache and fatigue. My wife was feeling really sick 24 hour prior to myself. I was out of town and waited until we got back home then tested and was positive. I do believe I also had a slight fever. After testing positive for COVID-19 along with my wife we contacted my son that is a HCP and he prescribed PAXLOVID. The medicine did work and the only symptom I had left was the fatigue that lasted for a week or more. In early November I was part of an experimental vaccine.
Client c/o numbness and tingling of lips 25 minutes after receiving Pfizer vaccine.  Client seen and assessed by EMjS.  V.S. are B/P 143/79, HR 79, O2 96.  Client voiced that sensation had stopped after 5 minutes and was cleared to go home by EMS.
Sore arm; Could not tolerate the smell of food; Lost my sense of taste; Could not keep my eyes open; Fatigue; Nagging headache; Weak; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (Sore arm), PAROSMIA (Could not tolerate the smell of food) and AGEUSIA (Lost my sense of taste) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weak), PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (Sore arm), PAROSMIA (Could not tolerate the smell of food), AGEUSIA (Lost my sense of taste), ASTHENOPIA (Could not keep my eyes open), FATIGUE (Fatigue) and HEADACHE (Nagging headache). At the time of the report, ASTHENIA (Weak), PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (Sore arm), PAROSMIA (Could not tolerate the smell of food), AGEUSIA (Lost my sense of taste), ASTHENOPIA (Could not keep my eyes open), FATIGUE (Fatigue) and HEADACHE (Nagging headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-123338 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-123338:Wife's case
soreness on arm; chills; feeling tired; joint pain; arm hurting; A spontaneous report was received from a consumer concerning a 68 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced myalgia, chills, fatigue, arthralgia and limb discomfort.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient was diagnosed with COVID-19 in June 2020. On 20 JAN 2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 21 JAN 2021, The patient said that his arm was hurting, had soreness on arm, had chills, (no chills since that noon) was feeling tired, had slight joint pain.  No laboratory details were provided.  Patient took Tylenol one in the morning and the other in the evening to relieve the symptoms.   Action taken with mRNA-1273 in response to the events was not reported.   On 21 JAN 2021, the outcome of the event Chills was resolved. At the time of this report, the outcome of the events like myalgia, fatigue, arthralgia and limb discomfort was unknown.
(4/19) Began experiencing discomfort in right side (bottom of rib cage) when getting in/out of bed; no other symptoms. (4/30) Rapid fever onset with chills from 98.6 to 102.7 within four (4) hours; increased pain in right side; .  Seen at urgent care: blood pressure normal; elevated heart rate (130); sub-normal SpO2; urinalysis negative; chest x-ray negative; COVID test negative.  Referred to ER. (4/30) ER: increased pain; no coughing or symptoms beyond extreme chills/fever; two additional COVID tests negative; extremely high white cell count (25K), CT showed small pneumonia on right side.  Treated with multiple antibiotics and released. (5/1-5/7) Continued elevated (99-100F) fever; occassional lethargy; no coughing or other symptoms. (5/8) Temperature normal; occassional lethargy; no coughing; increased pain on right side at night. ( through 7/10) increasing pain on right side; present constantly but worse at night; radiates front to back on right side below rib cage; no other symptoms. (5/12,6/23,7/1) Follow-up visits with PCP; additional chest x-ray negative; CT scheduled for 7/14.
RAsh on neck. Not itchy, not painful. Developed day after both vaccines given.  He has had this rash before, but cant remember when and is doing fine.  Will take some Benadryl until it resolves.
My heart was having sharp pains, I thought I was having a heart attack. It lasted for about 1-2 hours.  The pain was mild.  It continued  slightly for days after.  Like it would have very mild sharp pains.
Chronic arm/shoulder pain on left arm that started on day of injection at about 8:00pm. Chronic arm pain lasted about 10 days. After 10 days pain subdued and now tolerable. But however, there's still pain and not able to move arm freely about. There was no fever for first vaccine given, just body aches and arm/shoulder pain.
9 years old patient received Flublok Quadrivalent/no AE; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case was linked to cases 2019SA304486 and 2019SA304462 (same reporter).  This case involves a 9 years old male patient who received vaccine  INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] ].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient did not have any concomitant therapy.   On 12-Oct-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via intramuscular route in the left deltoid.  It was of actual medication error case due to Inappropriate age at vaccine administration.  It was unknown whether adverse event was experienced ornot.  Information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
RECURRING POUNDING HEADACHE - TOOK 800 MG. IBUPROFEN FOR THREE DAYS - HEADACHE WENT AWAY ON THIRD DAY. EXTREME BODY/JOINT PAIN - TOOK 800 MG. IBUPROFEN FOR THREE DAYS AND BEDREST- STARTED FEELING BETTER ON DAY THREE. CHILLS AND FEVER - FEVER DIMINISHED AFTER DAY TWO - CHILLS DIMINISHED BY DAY THREE. DIARREAH - TOOK IMODIUM FOR ONE DAY - DIARREAH RESOLVED AFTER FIRST DAY. UNPLEASANT ODIR OR SMELL IN MY NOSE - NO TREATMENT -STILL HAVE IT THREE DAYS AFTER RECEIVING VACCINE.
Within 4 hours of injection acquired sore arm causing other muscles to stiffen and cause headache.  Then it continued into pain at injection site that felt like being stabbed by a knife upon moving the afflicted arm. Cold air causes skin to feel like it's on fire and stomach irritation issues by the morning after the injection.
markedly swollen and erythematous Rt arm (shoulder to elbow) within 24 hrs of receiving vaccine. No fever, vomited x 1.
Large hives sporadically over entire body, started with one large hive on left wrist. Is now behind knees, thighs, back,  arms, stomach
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 20-SEP-2017, the patient may had received an improperly stored dose of VARIVAX lot # M045205 and expiration date on 11-NOV-2018 (dose and route of administration were not reported) for prophylaxis. The doses of VARIVAX were exposed to a temperature excursion of -14 degrees Celsius (°C) to -10°C during a time frame of 3 hours and 42 minutes, which was detected by the data logger. There was no prior temperature excursion and neither adverse events nor product quality complaints were reported.
Vaccine brand unknown=Moderna; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8733), in right arm, on 21Apr2021 as dose 2, single (Lot number: ERR0169), in left arm and on 11Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 49 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Oct2022 at 19:00 as dose 4 (booster), single (Lot number: 060F22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Oct2022 at 19:00, outcome "unknown", described as "Vaccine brand unknown=Moderna". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures, Paxlovid from 28Nov022 to 29Nov2022, were taken as a result of vaccination failure, covid-19.
This case was reported by a consumer and described the occurrence of erythema multiforme in an 8 year old female patient who received hepatitis B vaccine.  The reporter is the mother of the patient.  A physician or other health care professional has not verified this report.    On an unspecified date in 1998, the patient received the first dose of hepatitis B vaccines.  Approximately one day after the administration of hepatitis B vaccine, on an unspecified date in 1998, the patient experienced erythema multiforme, joint swelling "two to three times normal size", and joint pain.  The patient was seen at a phyisician;s office and was treated with prednisone and antihistamines.  The erythema multifirme (presumably, the skin lesions) and joint swelling resolved in "eight to nine days".  The joint pain was ongoing at the time of initial reporting in AUG 2004.  The immunization series with hepatitis B vaccine was discontinued.    Comment: Erythema multiforme was assessed as medically serious by GSK.
Child received FLUMIST at school on 10/14/2011. On 10/19/2011 he developed rash with itching on face and trunk. Mom took him to ER; see by Dr. Prescribed BENADRYL Liq. - some relieve. 10/21/11 - Entire body covered in rash. Took to PCP.
Patient tested positive for COVID on 01/06/2021. Patient received out patient monoclonal antibody treatment on 01/10/2021. Patient received out patient IV fluid bolus (NS 1 liter) on 01/13/2021.