chrisvoncsefalvay/vaers-outcomes huggingface dataset:
immune complex mediated response due to vaccine; portal vein thrombosis; experienced a 30 pound weight loss (over the past two months); night sweats; intermittent fever of unknown origin; chills; This is a spontaneous report from a contactable health care profession and follow up report from a contactable consumer via Pfizer-sponsored program.  A 74-years-old male patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; ),  via an unspecified route of administration on 24Feb2021 (Batch/Lot Number: Not provided) as 2nd dose, single for covid-19 immunisation  .  Medical history included coronary artery,  chronic obstructive pulmonary disease,  chronic kidney disease, type II diabetes mellitus, hyperlipidaemia, hypertension. The patient's concomitant medications were not reported.  The patient experienced immune complex mediated response due to vaccine, portal vein thrombosis,  night sweats, intermittent fever, chills, experienced a 30 pound weight loss (over the past two months) on an unspecified date. The patient underwent lab tests and procedures which included ESR: 101 (elevated), CRP: 225 (elevated), White blood cell count elevated (18 today), Procalcitonin: 1.89 (elevated), Haptoglobin: 380, Quantitative IgG: 1,664 (elevated), Antinuclear Factor 1:320 ANA (at first came out negative then positive), Beta-2glycoprotein IgG: 33.4, Antiphospholipid panel: positive, Tumor marker CA 19-9: 46 (Mildly elevated) all on an unspecified date. Negative Lab results: Negative Cultures, Covid-19, RVP, TB, Hepatitis panel, dsDNA, EBV antigen, CMV, Lyme titers, quantitative IgA and IgM, beta 2 glyco IgA, venous duplex, white cell scan, nuclear scan of bone marrow, PNH panel all on an unspecified date. Reporter inquired Are there any reports on portal vein thrombosis after receiving both doses of the Pfizer Covid-19 vaccine? The clinical course was reported as follows Medical assistant stated that she has been treating a 74 year old male patient who received the first dose of the Pfizer Covid-19 vaccine on 02FEB2021 and the second dose on 24FEB2021 and after two weeks of receiving the second dose the patient  started experiencing night sweats (2-3 times a night), intermittent fever of unknown origin and chills, he experienced a 30 pound weight loss (over the past two months) and portal vein thrombosis, at this point the differential includes an immune complex mediated response due to vaccine. He has been admitted for two weeks (admitted on 20APR2021) and performed rheumatology, oncology, hematology panels and ruled out infectious causes. It was also reported They did a full work up but nothing came up except that PRIVACY has a portal vein thrombosis. They are wondering if it is related to the vaccine and if there are some reports regarding this side effects. First dose of the vaccine was given 02Feb or 03Feb (reporter is not sure). Second dose of the vaccine was given 24Feb2021. The clinical outcome of the events was unknown
Developed intermittent sharp chest pain 1-2 days after receiving the vaccine, worse when supine (c/w pericarditis); no fever or other symptoms.  Seen by his pediatrician & an EKG showed diffuse ST segment elevation; TnI was markedly elevated at 13,259ng/L (nl up to 57).  Was admitted to the PICU & begun on IV ketorolac.  By the time of admission he had no more chest pain.  Received two doses of IV ketorolac, then transitioned to po ibuprofen q.8h.
I was violently sick, had pain; Felt way above discomfort; Felt woozy, no appetite, bathroom every 15 minutes; Pain; Cold; Dizziness; Diarrhea; Had trouble sleeping; Chills; Felt nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I was violently sick, had pain), MALAISE (Felt way above discomfort), DECREASED APPETITE (Felt woozy, no appetite, bathroom every 15 minutes), PAIN (Pain) and NASOPHARYNGITIS (Cold) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 012M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDRALAZINE, DILTIAZEM, LEVOTHYROXINE SODIUM (SYNTHROID), DIGOXIN, SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]), TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), VITAMIN C [ASCORBIC ACID], COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), BIOTIN and APIXABAN (ELIQUIS) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (I was violently sick, had pain), MALAISE (Felt way above discomfort), DECREASED APPETITE (Felt woozy, no appetite, bathroom every 15 minutes), PAIN (Pain), NASOPHARYNGITIS (Cold), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), INSOMNIA (Had trouble sleeping), CHILLS (Chills), NAUSEA (Felt nausea) and VOMITING (Vomiting). At the time of the report, ILLNESS (I was violently sick, had pain), MALAISE (Felt way above discomfort), DECREASED APPETITE (Felt woozy, no appetite, bathroom every 15 minutes), PAIN (Pain), NASOPHARYNGITIS (Cold), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), INSOMNIA (Had trouble sleeping), CHILLS (Chills), NAUSEA (Felt nausea) and VOMITING (Vomiting) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 25-JAN-2019, the patient was vaccinated with an improperly VARIVAX (the dosage regimen information was not reported) lot # N035937 (expiration date: 18-DEC-2019) for prophylaxis, reconstituted with properly stored sterile diluent. No adverse effects were reported. The vaccines were exposed to a temperature of -8.16 and -10.96 Celsius degrees for a timeframe of 50 minutes and 13 hours respectively. It was found because of a digital data logger. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1901USA012336; US-009507513-1902USA005477.
deaf in left ear; Could not keep balance; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at age 57-year-old, via an unspecified route of administration, administered in arm left on 07Apr2021 16:30 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history was reported. There were no concomitant medication and no other vaccine received within 4 weeks. The patient could not keep balance and went deaf in left ear on 08Apr2021 12:00. The events resulted in doctor or other healthcare professional office/clinic visit. Unspecified treatment was given for the events. Patient recovered on an unspecified date. Patient was not diagnosed with COVID prior to vaccination and has been tested post vaccination on 13Apr2021 (nasal swab) with negative results.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of balance disorder and deaf in left ear due to temporal relationship.  Case will be re-assessed upon the additional information provided. 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.
Information has been received from a licensed practical nurse concerning a 4 year old female with no allergies or medical history who at one year of age, in approximately 2002, was vaccinated SC with a 0.5 ml dose of varicella virus vaccine live. There was no concomitant medication. Approximately, one year later, in 2003, the patient broke out with a mild case of varicella. Unspecified medical attention was sought and no treatment or prescription drug was required. No diagnostic laboratory tests were performed. Subsequently, the event abated and the patient recovered. It was noted that therapy with varicella virus vaccine live was "discontinued." A product quality complaint was not involved. Additional information has been requested. The licensed practical nurse also reported another patient who broke out in a rash after therapy with varicella virus vaccine live.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender who on 29-APR-2015 was vaccinated with a dose of MMR II, subcutaneous, lot # J003004 and expiration date on 14-MAR-2015. No temperature excursion was associated with MMR II. No adverse effect reported. Additional information has been requested.
On 5/2/2000, mom called and stated MD told her that pt had a reaction to MMR vaccine. She stated  that she had a fever, Friday night. Saturday a rash started all over her body. She was admitted to the hospital on 5/1/2000. Began jerking on 5/1/2000, that night. She was also told that the pt's lymph nodes were swollen, heart rate was elevated, platelets were low. The pt's skin was hot to touch but she had no fever.
Per mother, about 16 hrs. after vaccination, pt. woke up, w/stiffening and eyes rolled back, lasted for < 1 min. no cyanosis noted. Also, less appetite prior to episode. Per mother, pt. felt worsening but no fever documented.
I have had widespread soreness and pain over my entire body, I woke up at 3:30 AM and couldn't go back to sleep, I had light sensitivity, and a massive headache.
About 15 minutes after vaccine I felt dizzy and drunk lightheaded began getting a headache tried to leave in my car but went back  and they suggested to see my doctor which was actually closing so I went to urgent care instead
TEMPERATURE EXCURSION OCCURRED DUE TO THE PLACEMENT OF HAND WARMERS IN THE INSULATED BAG USED TO TRANSPORT VACCINE. ALL 81 PERSONS RECEIVING VACCINE IN LANES 5 AND 6 AT THE HEALTH DEPARTMENT ON 02/15/2021 BETWEEN 14:00 and 16:45 WERE NOTIFIED THEY  RECEIVED VACCINE THAT WAS OUTSIDE OF THE APPROPRIATE TEMPERATURE RANGE AND WERE RECOMMENDED TO BE REVACCINATED.
Site: Pain at Injection Site-Medium, Additional Details: Patient reports felt pain at time of injection and still experiencing pain/numbness
blurry vision, dizziness, h/a, pain & edema of lt arm;gen aching/malaise;fever, nausea;
High pitched screaming, loss of eye contact, loss of expression, loss of expressive and receptive language.
Booster; Fever; Tiredness; Chills; at the injection site still got a big lump and it still hurts; at the injection site still got a big lump and it still hurts; Feels swollen like the arm side; Headache; Pain; Muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 13Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Immunization series complete but unknown manufacturer, Dose 1), for Covid-19 Immunisation; Covid-19 vaccine (Immunization series complete but unknown manufacturer, Dose 2), for Covid-19 Immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 13Nov2021, outcome "unknown", described as "Booster"; SWELLING (non-serious) with onset Nov2021, outcome "unknown", described as "Feels swollen like the arm side"; HEADACHE (non-serious) with onset Nov2021, outcome "not recovered", described as "Headache"; PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "Pain"; MYALGIA (non-serious) with onset Nov2021, outcome "unknown", described as "Muscle pain"; PYREXIA (non-serious) with onset 13Nov2021, outcome "not recovered", described as "Fever"; FATIGUE (non-serious) with onset Nov2021, outcome "not recovered", described as "Tiredness"; CHILLS (non-serious) with onset Nov2021, outcome "unknown", described as "Chills"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE MASS (non-serious) all with onset Nov2021, outcome "not recovered" and all described as "at the injection site still got a big lump and it still hurts".  Additional information: Consumer stated, the patient had received the booster shot 2 days ago and the patient having a lot of side effects. Felt swollen like the arm side. The patient had been running a fever since Saturday, headache, pain, muscle pain. Consumer stated, "the patient having headache, tiredness, Patient have been running on fever for three days since the patient had the vaccine (further clarification unknown hence suspect captured as unspecified vaccine), the booster, the patient got the booster, muscle pain, chills, where the injection site, still got a big lump and it still hurts, too many side effects.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Per pt he has been lethargic for the last 3 weeks since getting the vaccine. Today was the first day he said that he was feeling ok.
expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 02-Jul-2021, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not report any adverse events or symptoms. Concomitant medication was not provided. Treatment information was not provided.
After administering the last injection, HPV Gardasil at 1:30 PM, client fainted, hands cool and dry to the touch, and 15 minutes later began developing fine tremors in upper & lower body extremities.  Given water, juice and crackers which client stated made him feel better, but fine tremors remained.
About 3 min after vaccines were admin. pt's eyes rolled back and pt became unconc. fell off exam table hit Rt. eye on handle of stand. Lasted about 1 min. Hurt leg.
Periorbital swelling (bilateral) Hives. Diphenydramine Hcl 25mg given in office; rx given for home administration. Assessed by physician.
This spontaneous report as received from a registered nurse refers to a multiple patients of unknown age and gender. No medical history or concurrent conditions were reported. On 11-DEC-2015, it was discovered that on unknown dates (reported as since that day), multiple unspecified patients were vaccinated with improperly stored doses of PROQUAD (doses and routes of administration were not provided, lot# L030586, expiration date: 10-FEB-2017). No adverse effects were reported. This is one of the reports from the same reporter. Additional information has been requested.
Swollen tonsils, sore throat, fever of 101 and higher throughout the night and next two days. Also, severe headache that prevent me from leaving the bed. I took Aleve and Tylenol alternating. Fever finally broke on 10/22/2009 around noon. However sore throat and swollen tonsils persist.
First dose was given on 01/11/2022. Patient returned to the pharmacy for his 2nd dose on 02/01/2022. Pharmacy staff discovered that it was early for his 2nd dose after it was administered. We contacted the patient to ask how he was feeling, patient stated no issues. We researched how to report the error & saw the guidance stating he will need to repeat his 2nd dose. We have called patient to schedule this but are waiting on a call back. No adverse reactions to report. 1 week ahead of schedule 2nd dose being reported only.
Pt had some 'frothing' or hypersalivation after last (2 mo) vaccines lasted 2-3 hrs and started 3h after shots.
pt stated had fever,diarrhea,nausea&passed out;the evening p/shot was given;unsure if rxn is from shot or from salad ate;daughter who ate same restaurant got nauseated also
Information has been received from a Registered Nurse concerning a 74 year old white female patient with a penicillin allergy who on Jul 12 2004 at 10:00 am was vaccinated into the right arm with a first dose of )PNEUMOVAX 23 (lot 647029/0460F). Within 48 hours, the patient developed a local reaction at the site of her injection. On Jul 14 2004, the patient was seen by her physician and was instructed to use ice on the involved area. On Jul 16 2004, the patient returned to the physicians office and the reaction appeared to be worse. The patient was to be treated with Omnicef. Follow up information from a registered nurse indicated that the patient developed swelling and redness of the right deltoid (approximate 2cm x 2cm area) on Jul 12 2004. There was no purulence or fluctuance and no neuro vascular compromise. There were no diagnostic studies on laboratory tests done. There was no illness at the time of vaccination. It was reported that the patient had recovered. It was also reported by the patients husband that the patient who has a history of diabetes was vaccinated with an adult dose of PNEUMOVAX 23 on Jul 07 2004 (reported by the nurse as Jul 12 2004). He reported that the day after she was vaccinated she developed swelling and redness. The husband noted that the patients experiences caused her significant disability or incapacity but she was recovering as of Dec 27 2004. There were no labs or diagnostic studies performed. Follow up information was received from the physician who stated that the patient was not disabled. The physician did report that the patient did have a long recovery and a lot of inflammation. She reported that although the patient had recovered, she did have occasional muscle pain in her arm which she could predict the weather with. Additional information is not expected.  Additional follow up information received from the patient's husband indicated that he believes that the specific lot (lot 647029/0460F) caused the reaction. The records of testing prior to release of this lot have been checked by Quality Assurance and found to satisfactory. The lot complies with the standards of the Center for Biological Evaluation and Research and was released. Additional information is not expected.
Fever, chills arm pain. OT for 3 weeks. Pain pills for 2 weeks.
no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 02-APR-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of the patient was 43.58 years.  Concomitant products were not provided.  On 31-Mar-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 6-Apr-2021, vial was moved to clinic on 15-Mar-2021. 18 vials were sent to clinic. Vaccine BUD date was 9-May-2021.  On 31-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 39, 12 AM: 43, 1PM: 44, 2 PM: 44, 3 PM: 46, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
HIVES--present X 2 weeks--Benadryl minimal effect, so Zyrtec given.  The hives started around vaccine site and spread to upper body, head --from there