chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health care worker concerning a 52 year old female patient with asthma, latex allergy, IVP dye allergy and "kitten triggers her allergies", who on 08-APR-2011 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot# 667913/1021Z, expiration date 27-FEB-2012) intramuscularly into her left deltoid.  Concomitant therapy included PROAIR.  On 08-APR-2011, minutes post vaccination the patient experienced achiness and pain in left arm that increased in intensity later on in the evening.  It was reported that the pain was in the upper left arm and then the patient developed pain in her anterior chest.  The patient called the doctor office the next morning on 09-APR-2011 at 7:30 AM, and the service suggested she go to the emergency room, which she did.  The patient had been seen at emergency room where several tests were performed: chest X-ray normal, CBC with white blood count at 11.3 and Troponin test normal.  The patient's pain level, on scale of 1 to 10 with one being the lowest, was 8 for her arm and 5 for her chest.  The patient was treated with TORADOL and MOTRIN 600 mg every 6 to 8 hours and was released without hospitalized.  The patient called her doctor's office on 22-APR-2011 to let them know now she was no more symptoms.  All events were considered to be other important medical events by the reporter.  Additional information has been requested.  The patient had been seen at hospital ER where several tests were performed.
day 1-7 arm wasn't sore it freakin HURT and there was heat and pink color... day 2-7 i had diaheara, nausea/vomiting, chronic headache that my migraine meds wouldn't quite get rid of...biggest concern was it triggered my tachycardia and bp...I had to take alot of extra heart meds during that week due to how hard my heart pounded and worked
24 hours after shot - high fever for about 10 hours; Six days after shot - rash on neck, shoulders and lower back.  Significant itching.  Went to doctor and was given Triamcinolone .1% cream.
L/H upper back of arm had a softball-sized purple ring with raised (round) red/pink center within 48 hours of vaccination. These symptoms lasted approx. 48 hours, when purple ring subsided and red/pink area remained. Area itched through the duration.
Patient received second vaccine dose and felt well without significant symptoms in the days following.  Then, on 2/19 she developed epistaxis, brusining, and petechiae.   She had labs drawn by a local provider and platelet count was 7.   (baseline, even on chemotherapy for her AML is in the normal range).   Therefore, she reported to a local health center and a recheck of the platelet count was <3k.     WBC and Hb were within normal range.   No circulating blasts or other evidence of AML.  No recent infections or other exposures.   That center reached out for transfer to our hospital as we initially diagnosed and treated her AML.  I advised dexamethasone 40mg and transfer (they also transfused 5u platelets prior to her departure)  Upon arrival at our center about 12hrs later, platelet count was 210 and on 2 rechecks it has remained in the normal range while continuing dexamethasone 40mg daily.   Bleeding symptoms ceased and she was discharged in stable condition.  She plans to return back to home after discharge with repeat lab testing later this week after stopping steroids.   Chemotherapy to be held at least one extra week to ensure stability.
Imz given at 1:45PM. Arm became sore with 3:45PM. As night progressed arm became sore. 7/19/05 AM diff to raise arm and noticed arm red. 7/20/05 arm as red but not beyond boundaries, sore to touch, able to lift. Slightly warm.
Onset of fever more than 100F, generalized varicella rash with 5-10 lesions, neck stiffness, chills and sweats began 14 days after injection.
On 12/15/99, the pt experienced redness, pain, and swelling at the injection site that measured 5 1/4" x 2 1/2". The pt was given Diprolene. The pt recovered on 12/19/99.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "DMEK corneal transplant" (unspecified if ongoing), notes: resulting from a diagnosis of Fuchs Dystrophy; "Fuchs Dystrophy" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: 03Apr2017. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative; negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient tested negative on days 6 and 7 from the date he started 5 day course on Paxlovid. During the time he used Paxlovid, he was symptom-free from COVID except for an afternoon on the 3rd day when he felt fatigued. Today is day 13 from the date of symptom onset and the only symptom the patient currently has is a cough and some mild upper respiratory congestion.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, there is a reasonable possibility of a causal  association between the reported adverse events drug ineffective, Covid-19 and the suspect  product BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5).
presented to ED with progressive generalized weakness, dyspnea and anorexia over several weeks; +Covid-19 pneumonia and acute hypoxemic resp failure; treated with dexamethasone and remdesivir along with oxygen support and empiric abx (ceftriaxone+azithromycin). Abx were discontinued after 5 days. His condition improved with treatment but deteriorated after he completed 10-day course of dexamethasone. Hospitalization was complicated by acute metabolic encephalopathy and acute on chronic HFrEF. Respiratory failure with hypoxia and encephalopathy progressed quickly during the last 3 days of hospitalization which required sedation and BiPAP therapy. Family decided to transition to comfort care only on day 15. BiPAP was discontinued for comfort. Pt died on day 16.
Information has been received from a healthcare professional concerning a male with rosacea who on 1998 was vaccinated IM with a dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown). concomitant therapy included tetracycline hydrochloride. In September 1998, the patient experienced polyneuropathy.
Progress Notes (Physician Assistant) Cosigned by MD at 3/23/2021 1:26 PM Expand All VACCINE CLINIC. Patient: Subjective Patient a 62 yr. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience itching on the left side of her abdomen. She denied rash, hives, difficulty breathing, difficulty swallowing and wheezing. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality, rapid progression of symptoms, respiratory distress and skin changes. ALLERGY REVIEW OF SYSTEMS: Patient complains of itching of skin. Patient denies chills, fever, facial swelling, cough, chest tightness, shortness of breath, wheezing, dizziness and headaches. Previous Reactions: Denies. Objective Vitals: 03/22/21 1421, 03/22/21 1426, BP:(!) 185/105, 132/84, Pulse:78, 70, SpO2: 99%, 99%, Physical Exam Constitutional: Appearance: Normal appearance.  HENT: Head: Normocephalic and atraumatic. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema. Comments: No swelling or lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Assessment/Plan, Treatment included: Had patient take her at home dose of Clonazepam 0.5mg and Metoprolol 50mg. She usually takes these at 5pm. Her BP improved with home medications. She denied itching on discharge, discussed taking antihistamine at home if needed for itching if it returns. First BP was taken with a cuff that was too small. BP greatly improved with larger cuff use. Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Vaccine-Related Anxiety (include misc. mental health) and Systemic reaction (hypoglycemia, hypotension, generalized rash), PA-C Electronically Signed. 3/22/2021 2:46 PM. Health Clinic.
MODERNA COVID VACCINE #3 GIVEN 11/3/21, LOT #006D21A; 2/16/22 pt had a positive COVID test; EMS brought pt to ED 2/19/22 with increase in weakness, SOB, decreased appetite; O2 saturation 50-60% on RA; COVID pneumonia; O2 supplementation; admitted to ICU; given Remdesivir, Baricitinib, Vitamins, Steroids, DNR; transitioned to comfort care and pt expired in the hospital
Joint pain/In pain; Doesn't feel well; Hands and feet swollen; Alopecia/lost just about all of her hair/bald; Rash/have a rash on my face all of the time; she can't work; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "not recovered", described as "Joint pain/In pain"; MALAISE (non-serious), outcome "unknown", described as "Doesn't feel well"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Hands and feet swollen"; ALOPECIA (non-serious), outcome "unknown", described as "Alopecia/lost just about all of her hair/bald"; RASH (non-serious), outcome "not recovered", described as "Rash/have a rash on my face all of the time"; IMPAIRED WORK ABILITY (non-serious), outcome "not recovered", described as "she can't work".  Additional information: Patient had the first a second dose and doesn't feel well. Reported joint pain, hands and feet swollen, alopecia and rash. Querying if there is anything Pfizer could suggest for her symptoms. She said she had lost just about all of her hair and was about to shave her head. This had become a nightmare and she can't work because she was in pain, bald, and had a rash on her face all the time. She said she went from a thriving, spry person to a not leaving the house person. She doesn't want this to happen to anyone else. She was a healthy, exercising, vegan, organic person and now she doesn't leave her house. She connected the dots because she had read the side effect information already. She doesn't know how this can keep happening. She doesn't want to spend another 30 years like this. This was awful. Caller stated the side effects were not published until a court order forced them to be published and that Pfizer wanted to keep them secret for 75 years.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300079948 Same patient/vaccine, different dose and event;
Arm pain; arm pain as intermittent only when the arm was moved in an upward motion; Redness; This case was reported by a physician via call center representative and described the occurrence of erythema in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced erythema, pain in arm and pain upon movement. On an unknown date, the outcome of the erythema was recovered/resolved and the outcome of the pain in arm was not recovered/not resolved and the outcome of the pain upon movement was unknown.   It was unknown if the reporter considered the erythema, pain in arm and pain upon movement to be related to Shingrix.  Additional details were reported as follows: The physician reported the patient had experienced redness and arm pain with abduction. HCP describes arm pain as intermittent only when the arm was moved in an upward motion. HCP describes redness as erythema lasting only four or five days after receipt of dose one of Shingrix.  HCP could not provide lot number or expiration date for the dose administered.  No additional details provided. The reporter consented to follow up.
Information has been received from a registered pharmacist concerning a patient who on an unknown date was vaccinated with a dose of PNEUMOVAX (unspecified). Concomitant therapy included influenza virus vaccine (unspecified). Subsequently, the patient developed an injection site reaction that was described as the PNEUMOVAX site swelling up to the size of a baseball. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. This is one of three reports from the same source. Additional information has been requested.
muscle pain; Elevated Antistreptolysin O (ASO); This non-serious case was reported by a consumer via sales rep and described the occurrence of muscle pain in a elderly male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Additional patient notes included No symptoms of strep throat.   On an unknown date, the patient received RSV vaccine. On an unknown date, less than a week after receiving RSV vaccine, the patient experienced muscle pain (Verbatim: muscle pain) and antistreptolysin o increased (Verbatim: Elevated Antistreptolysin O (ASO)).  The outcome of the muscle pain was not reported and the outcome of the antistreptolysin o increased was unknown.   It was unknown if the reporter considered the muscle pain and antistreptolysin o increased to be related to RSV vaccine.     It was unknown if the company considered the muscle pain and antistreptolysin o increased to be related to RSV vaccine.   Additional Information: GSK Receipt date: 25-SEP-2023 Reporter was uncertain of patient's exact age, but thought he was in 70 to 79 year age range. The reporter reported that the older adult patient went for well check one week after RSV vaccine (brand not reported) and reported muscle pain, elevated or high ASO level. No symptoms of strep throat. Reporter reported that physician ordered bloodwork for patient. Reporter worked at GSK and asked about her friend's results. The follow-up could not be possible as the as no contact details were available.
Diagnosed with Bells Palsy after first dose of vaccine; A spontaneous report was received from a physician concerning, a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and diagnosed with Bell's Palsy after first dose of vaccine.  The patient's medical history and concomitant medication was not provided.  On an unknown date, approximately 3 weeks prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 22 Jan 2021, approximately 3 weeks after receiving mRNA-1273, patient was diagnosed with Bell's palsy by an emergency room physician. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.    The outcome of the event, diagnosed with Bell's palsy, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Patient c/o itching all over and hives and redness a near the vaccination site (left deltoid) started 30 minutes after vaccine. patient given Solumedrol 125 mg IM left ventrogluteal.
Itchy, bumpy hives on right shin appeared next morning. I woke at 6:30 am with them present and itchy. They were colorless when I found them when I woke and proceeded to redden as the morning progressed. At 9:53 am they are tolerably itchy, red and blotchy.
Patient was given PENTACEL as well as ACT-HIB on the same day/ no AE; Initial information was received on 30-Jul-2021 regarding an unsolicited valid non-serious case received from a Nurse via Global Medical Information (GMI) (Reference number- 00704764) and transmitted to Sanofi on 30-Jul-2021.  This case involves a two-month-old male patient reported that patient was given HIB (PRP/T) VACCINE [ACT-HIB] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] on the same day (extra dose administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination, PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for prophylactic vaccination, HEPATITIS B VACCINE (HEP [HEPATITIS B VACCINE]) for prophylactic vaccination and INFLUENZA VACCINE INACT SPLIT 3V (FLUZONE HIGH DOSE) for prophylactic vaccination.  On 30-Jul-2021, the patient received 0.5 ml (total) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot UJ415AAA and expiry date 12-May-2022] via intramuscular route in unknown administration site for prophylactic vaccination and a dose of suspect HIB (PRP/T) VACCINE [lot UJ426AAA and expiry date 28-May-2022] via unknown route in unknown administration site for prophylactic vaccination.  It was reported that, "Nurse stated 2 month old child was given PENTACEL as well as ACT-HIB today. Caller is requesting to know if child will be ok and what to do".  It was a case of actual medication error due to extra dose administered (latency was on same day).  At the time of reporting, patient had no adverse event.  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.
pt recv vax & w/in a few hr of vax pt exp a gen varicella-like rash on the stomach, back, lower legs, face, & ankles;pt was seen @ clinic or ER;pt was treated for URI;MD felt rash was not assoc w/vax;
patient received an ActHIB vaccine that was mixed with sterile water and not the diluent that came with the product (0.4 percent sodium chloride), no AE; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional.  This case involves a patient (with unknown demographics) who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] lot number not reported via unknown route in unknown administration site on an unknown date, which was mixed with sterile water and not the diluent that came with the product (0.4 % sodium chloride).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to wrong solution used in drug reconstitution.  At the time of reporting, no adverse reactions were reported.  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.  Information on the batch number was requested.
Fever, chills, sweating, nausea, headache, pain at injection site, fatigue. Symptoms started a few hours after the injection and have continued for at least 24 hours. I still have symptoms at the time I'm filling this out.
My body hurt . Also i have fever and my head hurts. When I got it the first I stated feeling bad when I got home. But Saturday I started feeling horrible. I have fever and my body feel tired . I feel good somedays and then it comes back
Sore throat; Diarrhea; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 at 17:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis, HSCT autologous stem cell transplant (hematopoietic stem cell transplant) and known allergies to cantaloupe melon. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 24Apr2021 at 04:30, 2 days after vaccine, the patient experienced diahrrea, vomiting and sore throat for 3 days. The events resulted in emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were not taken as a result of reported events. The clinical outcome of the events sore throat, diarrhea and vomiting was recovered on 26Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
3 hrs post vax, pt R arm (pneumo vac site) began to hurt, well & turn red. Last 2 fingers on R hand were numb. Pt felt "hot & cold" but didn't ck temp. Symptoms persisted for 5 days. Advised not to have additional pneumonia vaccines.
This is my second report:  My left back jaw is very resistant and painful with a popping sensation when opening and closing my mouth and while chewing food since Friday, October 1, 2021.
Admit for COVID Pneumonia. Fully vaccinated "four months ago". Treated w/ IV abx, remdesivir, steroids, O2, lovenox, lasix, tocilizumab and plasma. Intubated 7/28. Also w/ acute cystitis. Patient remains on full mechanical ventilated support in prone positioning. Still admitted at time of review 7/29.