chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching and rash under the central line dressing; very tired (fatigue); pain; temperature of 104(pyrexia); flu like symptoms (influenza like illness); This is a spontaneous report from a non-contactable consumer (patient) via a pharmacy. A 42-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 31Mar2021 (Lot Number: 2101713; Expiration Date: 31Mar2022) as single dose for covid-19 immunisation, treprostinil sodium (REMODULIN, injection, strength 1.0 mg/ml), current dose was reported as 0.0355 ug/kg, continuous, taken for primary pulmonary arterial hypertension from 09Apr2020 and ongoing.  Medical history included pulmonary arterial hypertension and adhesive tape allergy. Concomitant medications included sildenafil citrate (SILDENAFIL CITRATE) taken for an unspecified indication, start and stop date were not reported; macitentan (OPSUMIT) taken for an unspecified indication, start and stop date were not reported. On 31Mar2021, the patient experienced the events of pain (pain), flu like symptoms (influenza like illness) and temperature of 104(pyrexia). On an unreported date, patient experienced the event of itching and rash under the central line dressing (dermatitis contact). On 31Mar2021, 6 months 28 days (as reported), after initiating IV (intravenous) Remodulin, the patient had received her second COVID Vaccine the previously day (of the reporting date) and was experiencing pain, flu-like symptoms, and temperature of 104. She has been informed to take tylenol and to stay hydrated. The patient was going to call her doctor if fever does not come down after taking Tylenol. Moreover, patient also complained of itching and rash under the central line dressing. Also, she had used different dressings but itching continued. On an unreported date, the patient experienced the event of very tired (fatigue). Action taken with IV Remodulin was unknown for the events of pain, influenza like illness, pyrexia and dermatitis contact and fatigue. Action taken with Covid-19 vaccine was not applicable for the events. At the time of report, the outcome of pain, influenza like illness and pyrexia, and fatigue was unknown. At the time of report, the outcome of dermatitis contact was not resolved. The reporter did not provide causality for the events of pain, influenza like illness, pyrexia and dermatitis contact and fatigue.   No follow-up attempts are needed. No further information is expected.
Fever, chills, bone and joint aches, painful arm from injection site, debilitating headache.  I took 2 Advil every 6 hours over a 24 hour time period.  After sleeping for over 30 hours, I was able to eat and return to work. I missed a full day of work.
BP has been quite high and hard to control; Stress; This is a spontaneous report from contactable consumer (patient). A non-pregnant 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP6955), via an unspecified route of administration in right arm, on 05Mar2021 at 01:30 PM (13:30) (at the age of 62 years), as dose 1, single, for COVID-19 immunization. The patient's medical history included ongoing high blood pressure (BP) and supraventricular tachycardia (SVT) under control with medicine; allergies to almonds; and multivitamin. The patient's concomitant medications included metoprolol tartrate for high blood pressure and SVT; and an unspecified multivitamin. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The most recent COVID-19 vaccine was administered in a pharmacy or drug store. The patient had high BP and SVT in the past which was under control with only metoprolol tartrate. On 10Mar2021 at 07:00 AM (after the vaccine), the patient's BP has been quite high and hard to control. The patient had now added lisinopril and actually tried an anxiety pill because of the stress of the high BP (10Mar2021 at 07:00 AM). The patient was also wearing an HR event monitor now (since an unspecified date in 2021). Treatment to the events included more BP medicine and anxiety pill. The adverse events resulted in doctor or other healthcare professional office or clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.  Follow-up attempts are completed. No further information is expected.
Pt developed hives and a rash near site of injection--rash has spread to a larger part of arm--patient used ice for swelling and Benadryl for itching
In 1998 the patient was vaccinated with one does of rubella virus vaccine. Subsequently, the patient developed rheumatoid arthritis, which she claims was caused by the vaccination. The patient sought unspecified medical attention. At the time of the report, 09/05/2000, the patient still suffers from the rheumatoid arthritis. No further details were provided.
12DEC95 pt recvd vax & that evening noted some pain & swelling in lt deltoid area, chills; seen @ 2PM 13DEC on urgent basis w/fluid pocket;purulent fluid lt deltoid pocket I&D 14DEC95 ICU w/sepsis as of 17DEC95;
Immun recvd 7JAN92 early AM 8JAN92 noticed redness & swelling & warmth "fever" in rt arm; pt recvd APAP; later dec in discomfort but splotchy area;
devel fever of 102 evening of inj;pt afeb next day but devel fever 104 that evening;pt was seen in office 17OCT96;afeb @ that time & PE was nl;
12/24 @ 2200: generalized abdominal pain, abdominal pressure, nausea, vomiting 12/25 @ 0500: presented to ED. Elevated WBC. CT (+) appendicitis. 12/25 @ 1100: appendectomy
Low grade fever aches pains met with primary care had extreme joint pain blood work up done sed rate at 81 and crp at 1.9 then referred to RA specialist not RA did more blood work sed rate up to 94 crp 2.7 put on prednisone.
Swollen lymphnodes- arm pit and neck(three days).; Headaches; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Dec2021 08:45 (Lot number: FL3197) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "spinal stenosis" (unspecified if ongoing); "Degenerative disk dz" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing), notes: Known allergies: Latex, steroids. Concomitant medication(s) included: SINGULAIR. Past drug history included: Steroids, reaction(s): "Known allergies: steroids", notes: Known allergies: Latex, steroids. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 31Dec2021 12:00, outcome "not recovered", described as "Swollen lymphnodes- arm pit and neck(three days)."; HEADACHE (non-serious) with onset 31Dec2021 12:00, outcome "not recovered", described as "Headaches"; FATIGUE (non-serious) with onset 31Dec2021 12:00, outcome "not recovered", described as "fatigue". Therapeutic measures were not taken as a result of lymphadenopathy, headache, fatigue.  Additional information: The patient did not take any other vaccine in four weeks prior COVID -19 vaccine. The patient was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Elevated heart rate up to the 160bpm at approximately 22 hours post vaccine with lightheadedness, headache and nausea. Contacted PCP who directed to urgent care. Upon arrival to urgent care, temp 100.5, hr 150. Covid and flu tests completed and negative. EKG showing only sinus tachycardia. Sent home. Over the course of the next 12 hours, continued to have tachycardia, lightheadedness, and nausea. Around 1pm developed severe body aches and temp increased to 101. By 2pm temp was 102. Other symptoms remained, severe headache, had to stop working for the day. 4pm temp 102.2, took Tylenol, 6pm 100.8 took ibuprofen and fell asleep. Woke next morning with all but tachycardia resolved. Tachycardia still present (120-130) at time of writing. Slight local reaction to injection site and extremely sore arm present throughout . Previously had 2 Pfizer and Moderna booster. COVID twice, most recent January 30, 2023.
pt recv vax & 15min post vax exp a typical sz which lasted 15min;pt was tired afterwards & recovered;
shingles; product supply issue; This case was reported by a physician via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and product supply issue. On an unknown date, the outcome of the shingles and product supply issue were unknown.   The reporter considered the shingles to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's 2nd dose of Shingrix was delayed past the six month mark because of Shingrix lack of availability.  The patient then developed shingles before getting the 2nd dose of Shingrix. The reporter was in office and did not have time to provide further details about patient, product or incident.  The reporter agreed to receive a follow up letter.   The reporter did not think the shingles was related to Shingrix.
Approximately 9 days post vax pt experienced transient joint pain and stiffness in the hands, feet, ankles and knees.  Pt was treated with naproxen.
COVID-19. I received my 2nd booster shot on 04/02/2022 and my COVID-19 started on 06/30/2022 at 09:00AM in the morning fatigue, scratchy throat, congestions and cough. The next day I had fever 104. I started sweating at night. On 07/01/2022 I had all the symptoms plus fever. I called my PCP and he said me to gargle with salt, and prescribed me Z-PAK for 5 days. I am recovering now and very close to completely getting better. I wear hearing aide but after COVID I feel like my right ear has been inflamed. I can't hear the way I did a week ago.
ANAPHYLACTOID RESPONSE WITH SWELLING OF EYES AND LIPS, TIGHTNESS IN CHEST. TOOK 40 MG OF PREDNISONE. FOLLOWING DAY 20 MG PREDNISONE AND RECOVERED.
No additional adverse events; administered products after they were involved in a temperature excursion.; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-NOV-2022 (also reported as today), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #W018836, expiration date: 14-JUN-2024, administered as prophylaxis (strength, and route of administration were not provided), after it was involved in a temperature excursion at 7.5 Fahrenheit degrees for 6 hours and 58 minutes (Improper storage of product in use). No previous temperature excursions or additional adverse events were reported.   This is one of two reports received from the same reporter.
Patient experiences pain from head to shoulder, arm to hand, wrist & thumb, Feels tightness & weak, Flu like symptoms patient was treated with methylprednisolone, From doctor - pain seems to relief by taking two Advil
This spontaneous report was received from a registered nurse and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 27-JUL-2021, the patient was vaccinated with a dose of improperly stored M-M-R II, 0.5 milliliter (route of administration, lot # and expiration date were not reported) for prophylaxis. No further adverse event reported. On an unknown date, the temperature excursion was 59 degrees Fahrenheit, for a time frame of 15 minutes. There was no previous temperature excursion. The digital data logger was involved.
Left side face numb, droopy; Huge cluster of cold sores left side face. Mouth and eye; Lips cherry red; Huge cluster of cold sores left side face. Mouth and eye; Left side face numb, droopy; Loss appetite; Kidney pain; mild body aches; tired and not wanting to do anything; simply not feeling well,; This is a spontaneous report from a contactable other hcp (patient). A 40-year-old female non-pregnant patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at age of 40 years old as single dose for covid-19 immunization. Medical history included Asthma, allergies, Herpes Virus and Penicillin allergies. Concomitant medications included montelukast sodium (SINGULAIR); fluticasone propionate, salmeterol (WIXELA INHUB); salbutamol sulfate (PROVENTIL HFA); cetirizine hydrochloride (ZYRTEC ALLERGY); budesonide (RHINOCORT ALLERGY). No other vaccines received within 4 weeks prior to the COVID vaccine. No covid prior vaccination. Covid tested not done post vaccination. The patient previously took Amoxicillin and experienced allergies, first dose of bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) (Lot number: EW0185) on 08May2021 10:13 AM at Right arm as single dose for covid-19 immunization. Adverse events occurred after 1st dose from 09May2021 07:00 AM included mild body aches, no arm pain, tired and not wanting to do anything after few days, simply not feeling well, loss appetite and kidney pain. Acyclovir was received as treatment and not recovered. After 2nd dose, lips were cherry red next day. By end of day, huge cluster of cold sores left side face, mouth and eye. Left side face was numb, droopy. The patient still had no will do anything but didn't feel sick. Loss appetite and kidney pain progressed from time 1st dose to 2nd.  The outcome of the events was unknown.   Information on lot number/batch number was requested.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the event so facial droopy, huge cluster of cold sores left side face, mouth and eye cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : 2021530924 same patient/reporter/drug, different AE/dose
I developed a condition a autoimmune disorder to the sun which is a ongoing chronic condition. When I'm exposed to sun my neck and chest break out.
Urinary tract infection; Frequent urination; amber to brown urine; Everything I put into my mouth tasted bitter for a day; This is a spontaneous report from a non-contactable consumer (patient). A 66-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration in left arm on 16Feb2021 at 12:15 as single dose for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines in four weeks of vaccination. The patient had no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration on an unspecified date as single dose for COVID-19 Immunization. The patient was not diagnosed with COVID prior vaccination. The patient has not been tested for COVID post vaccination. On an unspecified date, the patient felt like she had UTI, frequent urination, amber to brown urine and everything she put into her mouth tasted bitter for a day. She stated that she had a shot on Sunday and everything still tastes bitter till Tuesday. The patient did not received treatment for the events. The outcome of events was not recovered.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information was expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021225127 same reporter/drug with different patient, similar AE
About 60 hours later around 11PM I started having shakes and chills, diarrhea, precative fever, muscle/joint pain all over (pre-hip replacement) and vomiting. I didn?t take any medication I just laid down under a number of blankets to keep warm. The next day it was all over with.
Within a few hours after immunization administration: Chills, "sun burn" feeling over skin, polyarthralgias, fever 104, abdominal pain. Called triage line and was advised to report to local ER.  Patient did not go to ER. States he took TYLENOL, fever came down in an hour, and felt better by morning. Denies injection site problems.
her mind is getting bad too; This is a spontaneous report from a contactable consumer (Patient) from Pfizer sponsored program. A 88-years-old female patient received first dose of bnt162b2(PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EW0158), via an unspecified route of administration, administered in Arm Left on 07Jul2021(at the age of 88-years-old) as a single dose for COVID-19 immunisation.  Medical history included spinal operation from Mar2021 to an unknown date Verbatim: Back surgery , Blood pressure from an unknown date and unknown if ongoing , cholesterol from an unknown date and unknown if ongoing , arthritis from an unknown date and unknown if ongoing , irritable bowel syndrome from an unknown date and unknown if ongoing , fibromyalgia from an unknown date and unknown if ongoing , Low Thyroid from an unknown date and unknown if ongoing , abdominal discomfort from an unknown date and unknown if ongoing , anaemia from an unknown date and unknown if ongoing. Concomitant medication(s) included fluoxetine taken for fibromyalgia from 2015 and ongoing; dicycloverine hydrochloride (BENTYL) taken for irritable bowel syndrome from an unspecified start date and ongoing; omeprazole taken for abdominal discomfort from an unspecified start date and ongoing; prednisone taken for arthritis from an unspecified start date and ongoing(Does not seem to be helping.); levothyroxine taken for hypothyroidism from an unspecified start date and ongoing; simvastatin taken for blood cholesterol from an unspecified start date and ongoing; trazodone taken for sleep disorder from an unspecified start date and ongoing; colecalciferol (VITAMIN D3) taken for an unspecified indication from an unspecified start date and ongoing; calcium taken for an unspecified indication, start and stop date were not reported; lisinopril taken for hypertension from an unspecified start date and ongoing, Multivitamin taken for unspecified indication from an unspecified start date and ongoing. On an unspecified date, the patient mind is getting bad too. It was reported that she can no longer remember the date of the first dose of the Pfizer Covid 19 vaccine shot. Her second dose is scheduled tomorrow 28Jul2021, and she might miss it due to a family gathering. Was advised by the transferring agent to contact the vaccine facility to reschedule the second dose. Clarified with the caller that she was trying to schedule her second dose. Pfizer Covid 19 vaccine: Just had the first dose 3 weeks ago, thinks it was 2Jul2021. It will be 3 weeks tomorrow. After looking at the covid vaccine card caller confirms that the date of the first dose is 07Jul2021. When trying to recall indication for Fluoxetine caller says her mind is getting bad too. Had blood drawn for anemia. She is real low on iron. It was a month or so ago. Caller again advised to contact facility and local or state health department to schedule the vaccine. Caller stating, she could not find a phone number but may try to drive over there, to the clinic. The patient underwent lab tests and procedures which included blood iron with result low on an unknown date 2021.The outcome of the event was unknown.
no additional AEs; it was reported multiple temperature excursion 16-NOV-2022 and 09-DEC-2022 and were administered PEDVAXHIB, ROTATEQ and VAQTA; This spontaneous report was received from a medical assistant and refers to an unspecified group of patients of unknown age and gender. Their medical history, concurrent conditions and concomitant therapies were not reported.  On 16-NOV-2022 and 09-DEC-2022, the patients were vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot number: U029144 and expiration date: 31-MAR-2024; with Hepatitis A Vaccine, Inactivated (VAQTA) lot number: W015191 and expiration date: 27-OCT-2023; and with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number: U038854 and expiration date: 20-APR-2023. The vaccines were administered only once for prophylaxis, but dosage regimens, route of administrations and anatomical locations were not reported.  It was reported that the vaccines were administered after multiple temperature excursions (product storage error). Temperature was above 47 Fahrenheit (F) degree (50.0 F) for 0 hours 12 minutes and 0 seconds on 16-NOV-2022 and above 47 F (47.6F) for 0 hours 15 minutes and 0 seconds. Time frame was total 27 minutes. Additionally, no previous temperature excursion was reported. No other adverse event was reported (no adverse event).  Follow-up information was received from the medical assistant on 28-DEC-2022. This report refers to a 6 month old patient who was vaccinated on 05-DEC-2022 with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number: U038854 and expiration date: 20-APR-2023, orally (PO). The primary thermometer displayed out of range temperature for less than 15 minutes. The back-up thermometer did not display max. that was out of range. Log was ran and the temperatures were within range. The primary thermometer was re-calibrated.  Patients' identifiers were missing in the previous report but have now been provided.
Information has been received from a physician concerning a 65 year old male consumer with CELEBREX allergy who 6 weeks ago on approximately 29-JAN-2008 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included lovastatin (manufacturer unknown). The physician reported 3-4 weeks post vaccination approximately 26-FEB-2008 the patient developed erythema multiform after receiving zoster vaccine live (Oka/Merck). The physician stated he is sure it is erythema multiform because of the "characteristic target rash." The patient reported mild itching. Medical attention was sought in the office, there were no lab studies performed. The patient was treated with topical creams with no success. The patient was recently switched from LIPITOR to lovastatin (manufacturer unknown) shortly before the rash appeared. He was switched back to LIPITOR 2 weeks ago but the rash has not resolved. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.