chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Knee swelling/knees swelled significantly; Patients hands were swollen to the point that he was unable to dress unassisted; Diminished mobility; Patient had such extreme symptions and pain; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Knee swelling/knees swelled significantly), PERIPHERAL SWELLING (Patients hands were swollen to the point that he was unable to dress unassisted), MOBILITY DECREASED (Diminished mobility) and PAIN (Patient had such extreme symptions and pain) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Adult onset Still's disease (After Moderna patient experienced significant swelling and pain that patient never experienced before) since August 2000.   On 19-Feb-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021 at 1:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced JOINT SWELLING (Knee swelling/knees swelled significantly), PERIPHERAL SWELLING (Patients hands were swollen to the point that he was unable to dress unassisted), MOBILITY DECREASED (Diminished mobility) and PAIN (Patient had such extreme symptions and pain). The patient was treated with PREDNISONE ongoing from June 2021 for Swelling and Pain, at a dose of 60-mg-5mg and CANAKINUMAB (ILARIS) from 28-Sep-2021 to 14-Jan-2022 for Autoimmune disorder, at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (Knee swelling/knees swelled significantly), PERIPHERAL SWELLING (Patients hands were swollen to the point that he was unable to dress unassisted), MOBILITY DECREASED (Diminished mobility) and PAIN (Patient had such extreme symptions and pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, C-reactive protein: 189 C-Reactive Protein- 189. In 2021, Red blood cell sedimentation rate: 80 SED rate was 80. In 2021, White blood cell count: 17.2 WBC -17.2.         No concomitant medications were reported.  Patient was unable to make a twisting movement such as to remove a water bottle lid and patient had to hold their coffee cup with 2 hands. Patient started Ilaris injections on 28-Sep-2021 and had a positive response from this medication.   This case was linked to MOD-2022-452278, MOD-2022-510055 (Patient Link).
Vaccine was reconstituted on the previous day and beyond the recommended 12 hour mark.  Phone call made to Pfizer who supplied studies supporting vaccine continues to be stable up to 24 hours after reconstituting.  Child was vaccinated just shy of the 24 hour mark.  Child did not have any adverse effects, this was an administration error.
This spontaneous report was received from a registered nurse and refers to a 4 year old male patient. The patient had scabies (acarodermatitis) at the time of vaccination but he did not have any pre-existing physician-diagnosed allergy, birth defects or medical conditions. Concomitant medications included permethrin. On 21-SEP-2018, the patient was vaccinated with the first dose of M-M-R II lot # R011802, expiration date: 21-OCT-2019, subcutaneously (SC) in the left thigh (LT); and the third dose of diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (MRC-5), tetanus toxoid, lot # C5325BA (expiration date not provided), intramuscularly (IM) in the right thigh (RT). All the vaccines were administered for prophylaxis and purchased with public funds. The administered doses of the vaccines experienced a freezer temperature excursion (not specified) as recorded from a digital data logger which ocurred at the time of storage in clinical practice. None adverse effects were reported. Also, the patient received an unspecified treatment for the experience. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA002756: US-009507513-1901USA002765: US-009507513-1901USA002758: US-009507513-1901USA002759: US-009507513-1901USA002760: US-009507513-1901USA002761: US-009507513-1901USA002762: US-009507513-1901USA002763: US-009507513-1901USA002764: US-009507513-1901USA002755: US-009507513-1901USA002754: US-009507513-1809USA010598: US-009507513-1901USA002757:
Patient received her first dose of Pfizer vaccine on 1.8.2021. When receiving the vaccine, the patient reports that her left cheek went numb. Patient reports the feeling came back the next day. Patient reports extreme soreness, to the point of not being able to use her arm. She also reports "excruciating" pain on her entire right side of the body that radiated into her knees and hips. Patient was seen by her PCP on 1.11.21. Patient was prescribed a steroid at the time. On 1/14, the patient returned back to work and describes her pain as tolerable now.
Pt experienced vasovagal syncope right after vaccine. Administered vaccine, initially patient felt fine and stated that he "didn't even feel it." Roughly 30 seconds later, after applying bandage, pt stated that "I'm actually starting to feel queasy." Immunizer looked up and pt had passed out in chair, head rolled back, eyes fluttered, and began having jerking movements. Immunizer designated team member to call 911, at that point pt regained consciousness (symptoms lasted roughly 10-15 seconds). No injuries were sustained, he was slightly nauseous. Pt laid down for a few minutes, drank orange juice. Pt was monitored for 15-20 minutes afterward, paramedics arrived and took vitals. Paramedics cleared pt to leave, pt felt back to normal and was comfortable leaving the store. Provided contact details for any further questions/concerns.
18 hours after woke up to chills, sweats, & low grade fever.  Severe neck pain backside/headache, tired. Slept most of day.  42 hours after woke up in a massive pile of sweat.  Soaked bed.  Still tired.
COVID arm reaction; Bullseye rash; m circular rash that does not bother he; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID arm reaction), RASH (Bullseye rash) and RASH (m circular rash that does not bother he) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID arm reaction), RASH (Bullseye rash) and RASH (m circular rash that does not bother he). At the time of the report, COVID-19 (COVID arm reaction), RASH (Bullseye rash) and RASH (m circular rash that does not bother he) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.
hives; developed hives and red blotches around the vaccinated area; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) and VACCINATION SITE RASH (developed hives and red blotches around the vaccinated area) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives) and VACCINATION SITE RASH (developed hives and red blotches around the vaccinated area). At the time of the report, URTICARIA (hives) and VACCINATION SITE RASH (developed hives and red blotches around the vaccinated area) outcome was unknown.            Treatment information not provided. List of concomitant medication were not given.
Office Visit   10/18/2021  Family Medicine Cough  Dx Cough  Reason for Visit  Chief Complaint   Exposure to COVID-19 virus X'S 3 WEEKS was seen at UC      ASSESSMENT and PLAN: Patient was seen today for cough.  Patient presents with ? Cough    1. Cough/exposure COVID 19. Concern that she has now started to have a fever. Will check chest xray and COVID test. If evidence of bacterial infection, will start zpak likely. I recommend a trial of pred taper and monitoring symptoms. Symptomatic treatment with albuterol PRN and codeine cough syrup PRN at bed time. Should stay well hydrated. Let us know if symptoms are worsening or not improving.    The patient was advised to follow up at the next regularly scheduled visit or sooner PRN.    Note reviewed- UC   The patient was advised to follow up at the next regularly scheduled visit or sooner PRN.   SUBJECTIVE: Had a cough in her chest and was getting better but now has a fever of 101. This happened over the weekend. Has been using inhaler. Has been using medication which helped. Using OTC mucinex. Initially started 3 weeks ago and then went to UC one week ago. Was started on steroids and cough medication which was not helpful. Cough at night is keeping her up and having some discomfort from coughing. Was on a 10 day pred taper.    Denies nausea, vomiting Denies sick contacts Has been vaccinated against COVID Denies diarrhea Denies runny nose, congestion    10/19/21 10:07 AM Note COVID 19 test POSITIVE    Patient was notified of positive test results from test completed on 10/18/2021 Signs and symptoms: 1. When did your symptoms start? 10/16/2021 2. What symptoms have you experienced? Fever, cough, SOB, laryngitis     Close contact questions: 1.   # in household: 3 2.   Have you been in close contact with anyone two days before symptoms including going to work while you were sick? yes
ENGERIX B #2 administered at 11 am on 2/9/09 at noon cheeks became red and flushed then pale, severe headache.. Premedicated at 7am with TYLENOL x 5 x2. Left work at 1:30pm that evening had hives on arms, front legs and chest. Headache continued on and off till 2/12/09. On 2/9/09 in evening at temperature 101 degree F.
Hives all over her leg; Rash all over her leg; Arm became very red around the injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Arm became very red around the injection site), HEADACHE (Headache), URTICARIA (Hives all over her leg) and RASH (Rash all over her leg) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and PITAVASTATIN CALCIUM (LIVALO) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 18-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm became very red around the injection site) and HEADACHE (Headache). On 21-Jan-2021, the patient experienced URTICARIA (Hives all over her leg) and RASH (Rash all over her leg). At the time of the report, VACCINATION SITE ERYTHEMA (Arm became very red around the injection site), HEADACHE (Headache), URTICARIA (Hives all over her leg) and RASH (Rash all over her leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Patient received first moderna vaccine and was sitting in the waiting area for her after shot evaluation. After about 5-7 minutes patient came up to the counter and stated that she felt her throat was closing.  Pharmacist went out and had patient sit in shot booth. He called 911, administered oral benadryl and asked patient how she felt. She stated she still felt that her throat was closing so pharmacist administered epi-pen. Pharmacist stayed with patient until EMS arrived. At no time did patient lose consciousness or show any outward signs of allergic reaction
Pt recvd 1st dose of Hep B vax 29NOV91 & devel pruritus of the hands & feet & a rash on the area of the mid-forearm; No further details were provided;
Indurated, red, hot, swollen 6x4cm to injection site on left thigh.
9-24-09 got flu shot.  9-25-09 rash on left torso.  9-26-09 rash on Rt torso.  Then nothing till 10-7-09.  Severe hives on upper thighs in AM.  About 4 PM hives started on torso, one was the size of a dinner plate and raised about 1/2 ".  Went to ER, and they gave me ATARAX 50 mg.  PREDNISONE 20 mg and PEPCID 20 mg.  Followed up with my doc.
head cold, fever of 100, achy, cough, chest tightness referred to MD to r/o illness
Redness and pain at the injection site, muscle aches, fever of 99.2 to 102.0, fatigue.
New positive home antigen test; New positive home antigen test; 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 68-year-old male patient received BNT162b2 (BNT162B2), on 29Oct2021 as dose 3 (booster), single (Lot number: FH8020), in right arm and on 02May2022 as dose 4 (booster) , single (Lot number: FK9893) at the age of 67 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SERTRALINE; LAMOTRIGINE; ATORVASTATIN; BUPROPION; L-METHYLFOLATE. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "New positive home antigen test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: New positive home antigen test. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Investigation of conclusion: Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE lot FH8020 and FK9893 were investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FH8020, fill lot FG3521, and the bulk formulated drug product lot FH0137. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. RA concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  additional information: Known allergies: No, Other medication in 2weeks: Yes.
At injection site I had an area, about the size of a quarter, that raised up (like a hive). It was red, warm to the touch, and itched occasionally. Within another 24 hours the size spead to about 2? wide. Still red, warm to the touch. Took about 6 days to be totally gone.  Arm never hurt or was sore from the shot - seemed to be a local area reaction.
ARM SORENESS; HIGH HEART RATE WHILE RUNNING; NUMBNESS IN LEFT LEG; CHEST PAIN; POSSIBLE WEAKNESS; This spontaneous report received from a patient. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, the subject experienced possible weakness. On MAR-2021, the subject experienced high heart rate while running. On MAR-2021, the subject experienced numbness in left leg. On MAR-2021, the subject experienced chest pain. Laboratory data included: Heart rate (NR: not provided) 192 high speed while running. On 06-MAR-2021, the subject experienced arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm soreness, high heart rate while running, numbness in left leg, chest pain and possible weakness was not reported. This report was non-serious.
This spontaneous report was received from a Medical Assistant and refers to an unknown number of unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not provided. On an unknown dates the patients were vaccinated with improperly stored GARDASIL 9, lot number M018810, Expiration date 28-MAY-2018, (frequency, route and anatomical location were not reported). No adverse effects were reported in any patient. No digital data logger was involved. No product quality complain was involved. No other suspect or concomitant therapies were reported. This is one of several reports from the same reporter. Additional information has been requested.
Right axilla lymphadenopathy and pain, still present but overall improving. Confirmed via ultrasound
Information has been received from the relative of a patient concerning the patient was vaccinated with 2 doses of GARDASIL.  The patient experienced rash and blisters in vaginal area after first and second doses of GARDASIL.  Unspecified medical attention was sought.  No outcomes were reported.  No further information is available.
This case was reported by a nurse via sales rep and described the occurrence of shingles in a 76-year-old female patient who received SHINGRIX for prophylaxis. In February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, 2 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with VALTREX. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient did not have a history of immunosuppressive treatments or disease states. The age at vaccination was not reported but the patient could be 75 or 76 years old. The nurse reported that the patient experienced shingles 2 days after receiving SHINGRIX. The physician provided the patient with VALTREX on 19th February 2019. The reporter did not agree to follow up from GlaxoSmithKline.
This spontaneous report as received from medical assistant refers to a patient of unknown age (gender not reported). The patient was vaccinated intramuscularly with the first, the second and the third dose of GARDASIL on 26-NOV-2011 on 01-MAR-2012 and on 07-MAY-2012, respectively (doses and lot numbers not reported). No other co-suspects were reported. No concomitant medications were reported. No known adverse effects. Additional information is not expected.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 06-MAR-2013 at 11:20 am, the patient was vaccinated with RECOMBIVAX HB (lot # H018689 and expiration date 07-NOV-2014) (dose, therapy route and anatomical location unspecified). The physician reported that on an unknown date, RECOMBIVAX HB was exposed to multiple low temperature excursions. The excursion time at -1 was 51.50 hours (also reported as 17 hours -1, then 131 normal 2 admin). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Apr2021 as dose 1, single (Lot number: EW0172), in left arm, on 14May2021 as dose 2, single (Lot number: EW0183), in right arm and on 12Jan2022 as dose 3 (booster), single (Lot number: 33030BD) at the age of 30 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "adhd" (unspecified if ongoing); "asthma" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "iron deficiency anemia" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE, start date: 03Aug2016, stop date: 07Jul2022; BUPROPION, start date: 05Jan2022; IRON [FERROUS CITRATE], start date: 01Jan2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19.
86-year-old female presenting with severe dizziness.  She states she was in her usual state of health yesterday, went to bed at 9 PM last night, when she woke up this morning she was so severely dizzy she was not able to walk and was vomiting multiple times.  She states that feels like she is spinning and unsteady.  She denies any focal numbness or weakness.  No speech changes.  No headache.  No prior history of vertigo however she did have some dizziness in the very distant past which was attributed to a mass in her brain which was surgically removed, she has not had any problems with dizziness since then.  Almost 1 month ago she was diagnosed with nonobstructing bilateral renal calculi but completely denies any urinary symptoms, abdominal pain or flank pain today.  Has any fever.
Immediate swelling and soreness at injection site. After 3 hours soreness spread to elbow and neck. I was tired and muscle hurt, and a little dizzy for the next few days. Third day after injection, had an adverse event, severe dizziness and disorientation. Almost lost consciousness several times, but did not.  Mental thought process was affected. Had sensation of not receiving enough oxygen. Severe diarrhea and sick to my stomach, sinus congestion. Episode lasted several hours, next 24 hours was dizzy, weak, and soreness of arm. Had another slight episode of dizziness, sinus congestion, tiredness, and chills on day 11 after the vaccine.
PT. RECEIVED SMALLPOX VACCINE IN LEFT ARM 3/26/03. EARLY MORNING OF 3/27, DEVELOPED CHEST PAIN AND WAS SEEN IN ER HOS. WITH ABNORMAL CARDIAC ENZYMES AND ECG.  HE WAS TRAN. TO ANOTHER HOS. AT 09:00 3/27.  EMERGENT CARDIAC CATH WAS NEG. HOWEVER, HIS REPEAT CARDIAC ENZYMES WERE AGAIN POSITIVE.  HE CONT. TO HAVE CHEST DISCOMFORT FOR REMAINDER OF HIS STAY.  THE CARDIOLOGIST FELT HIS CP WAS DUE TO CORONARY VASPOSPAMS. HIS ONLY RISK FACTOR FOR CAD WAS TOBACCO USE (1 PACK/DAY).
About 2-3 minutes after getting my first dose of the Pfizer Covid vaccine, I was directed to the front desk to make my next appointment. While standing, I went unconscious, fell backward and hit my head. I then seized on the floor. We aren?t sure if the seizure was from hitting my head or if I seized and then fell. I currently have a concussion and wound on my head from the fall.