chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Lot number: P220395-0021L), in left arm, on 14Jan2021 as dose 2, single (Lot number: P220395-0021L), in left arm, on 27Oct2021 as dose 3 (booster), single (Lot number: P220395-0090L), in left arm and on 14Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "menopause" (unspecified if ongoing); "mild arthritis in fingers and toes" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 31Dec2009; SANDOZ-ESTRADIOL, start date: 31Dec2009; CARLSON VITAMIN D3, start date: 31Dec2019; CALCIUM, start date: 31Dec2019; LYSINE, start date: 31Dec2019. Past drug history included: Known allergies: lactose, reaction(s): "Known allergies: Lactose", notes: Known allergies: Lactose. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the information in the case narrative, a causal relationship between reported events and suspect BNT162B2 is possible.
Fever 102.2, chills, body aches, dizziness, nausea. Lasted for 15 hours. Went away on it?s own.
Fever; Nausea; Slight headache; Chills; Sore arm; Extremely painful lymph node under left arm; Muscle ache/muscle pain; Joint ache/joint pain; dose number=3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 64-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Dec2021 at 15:00 (Batch/Lot number: 33130BA) at the age of 64 Year(s) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Drug intolerance" (unspecified if ongoing), notes: known allergies: Intolerant of opioids. The patient did not receive concomitant medications. Past drug history included: Aspirin, reaction(s): "Drug intolerance", notes: known allergies: Intolerant of aspirin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EN6206; Administration time: 10:00 Administration Location: Left Arm), administration date: 18Mar2021, when the patient was 63 year(s) old, for COVID-19 immunisation, reaction(s): "No adverse event" and Bnt162b2 (DOSE 2, SINGLE; Lot Number: ER8734; Administration time: 10:00 Administration Location: Left Arm), administration date: 08Apr2021, when the patient was 63 year(s) old, for COVID-19 immunisation, reaction(s): "No adverse event". The following information was reported: IMMUNISATION (non-serious) with onset 28Dec2021 at 15:00, outcome "unknown", described as "dose number=3"; PYREXIA (non-serious) with onset 29Dec2021 at 06:00, outcome "recovered" (29Dec2021), described as "Fever"; NAUSEA (non-serious) with onset 29Dec2021 at 06:00, outcome "recovered" (29Dec2021), described as "Nausea"; HEADACHE (non-serious) with onset 29Dec2021 at 06:00, outcome "recovered" (29Dec2021), described as "Slight headache"; CHILLS (non-serious) with onset 29Dec2021 at 06:00, outcome "recovered" (29Dec2021), described as "Chills"; PAIN IN EXTREMITY (non-serious) with onset 29Dec2021 at 06:00, outcome "recovered" (29Dec2021), described as "Sore arm"; LYMPH NODE PAIN (non-serious) with onset 29Dec2021 at 06:00, outcome "recovering", described as "Extremely painful lymph node under left arm"; MYALGIA (non-serious) with onset 29Dec2021 at 06:00, outcome "recovering", described as "Muscle ache/muscle pain"; ARTHRALGIA (non-serious) with onset 29Dec2021 at 06:00, outcome "recovering", described as "Joint ache/joint pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, nausea, headache, chills, pain in extremity, lymph node pain, myalgia and arthralgia.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
5/15/2021: Pain around the injection site. Chills, muscle pain, and fever over 101 degree . Taken acetaminophen twice.   5/16/2021: Urinary tract infection. Healthcare provider prescribed nitrofurantoin for 5 days.
tender lymph node underarm; swollen lymph node underarm; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 34 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPH NODE PAIN (non-serious), outcome "unknown", described as "tender lymph node underarm"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph node underarm".  Additional Information: Description of Event: 34yr, female, experienced swollen/tender lymph node underarm. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
14 days of intercranial pressure, dull headache, intermittent nausea, constant light sensitivity. Constant mild brain fog.
APRIL 2ND NUMBNESS IN TONGUE, FOLLOWED BY NUMBNESS IN LIP AND PART OF CHEEK, FOLLOWED BY NUMBNESS IN RIGHT HAND. TRIP TO EMERGENCY ROOM . A BLOOD TEST AND MRI WAS GIVEN AND A STROKE WAS CONFIRMED. I WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION IN EARLY MORNING OF APRIL 3RD. ECHO CARDIOGRAM WAS ADMINISTERED ON APRIL 3. I WAS DISMISSED FROM THE HOSPITAL ON APRIL 3. ON APRIL 5 I PICKED UP A HEART MONITOR TO WEAR FOR ONE MONTH. I HAVE A SCHEDULED APPOINTMENT WITH MY PRIMARY CARE DOCTOR ON FRIDAY, APRIL 16.
Patient received (COVID-19) Ag [Presence] in Respiratory specimen by (COVID-19) Ag [Presence] in Respiratory specimen by Rapid immunoassay test on 7/8/2021 and came back positive. Case investigation interview with patient has not been performed at the time of this note.
Case number PHEH2014US025083, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 19-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN, (batch number: 145701) intramuscularly at a dose of 0.5 ml on 23 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration (incorrect storage of drug).
A week after the vaccine I developed a rash. It started on the lower inner left thigh and spread to the inside of my calf, then it spread to the same area on my right leg. It also showed up on both of my forearms. The rash is patchy and red, and it is itchy and scaly. Bumps also developed after a couple of days. It?s almost a week later, and I still have the rash.
Information has been received from a licensed practical nurse (L.P.N.) concerning a 24-month-old female with a history of wheezing in 2006 and no allergies, who on 26-OCT-2006 was vaccinated subcutaneously in the left arm with a 0.5 milliliter dose of ProQuad (Oka/Merck upgrade process) (lot# 655624/1090F). Concomitant vaccination included ActHIB and Prevnar. On 25-Oct-2007, the patient was seen in the office and diagnosed with shingles. She had a rash on her back, chest and under her left arm that developed "4 days ago", on 21-Oct-2007. There were no laboratory or diagnostic tests performed. The patient's shingles persisted. It was noted that the physician was not interested in the VZV identification program. No product quality complaint was involved. Follow-up information received indicates that the patient was vaccinated at 9:20 AM with a first dose of MMR (Oka/Merck upgrade process). Concomitant vaccination at 9:20 AM included a fourth intramuscular dose in the right arm of Prevnar (lot# B08682A). It was reported that the patient had bilateral otitis media at the time of vaccination. On 21-Oct-2007, the patient developed a vesicular rash on the left back, chest and upper arm. The outcome was not reported. Additional information has been requested.  Follow-up information received indicated that the patient was recovered (date unspecified). Additional information has been requested.
In December 1999 the patient experienced varicella with a high fever. Additional patients had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested.
Delayed reaction 8th day post injection of large red, itchy lesion at original injection site.  Plus onset of fatigue.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. In July 2014 the patients were vaccinated with VARIVAX (Merck) (dose, route of administration and lot # were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
blurred vision and sweats within 5 minutes of injection. +throat tightness. stomach cramping started several hours later.
Petechial rash developed on bilateral lower extremities. Nonpuritic. Coalesced into purpural lesions on the bilateral posterior knees. Rash resolved within one week.
The patient was given the vaccine about 1258PM, she started to report some SOB about 5 minutes later.  I, became aware at about 1:15 there was some concern.  I spoke with patient she was having some trouble answering questions and appeared in moderate distress.  She reported to me having some SOB after her first dose.  Dr. had been contacted already.  At 1:19PM the patient appeared to have trouble catching her breath and reported SOB was worse than with first dose.  At this point I decided to administer 0.3mg of epinephrine as a precaution due to significant SOB.  Dr. came on the scene shortly after, the patient was monitored a bit longer, HR increased then decreased with oxygen.  The decision was made to contact EMS.
Some burning, discomfort in the injection site within the first 15 minutes, which dissipated after about an hour later.  Some itching/irritation in the back of the throat, about 30 minutes after injection, that turned into a inflamed/sore tonsil on the right side around 8:00pm in the evening.  Waking this morning the day after, around 7:00am, the soreness and irritation in the throat is on both sides, but has dissipated after a few hours, and drinking dome water. My arm has increased soreness the next day, described as a dull ache at rest, and painful with movement. I also have a residual headache that has not dissipated since waking up, but is barely noticeable, and will treat most of these side effects with Ibuprofen.
side effects were minor; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects were minor) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Crohn's disease (auto immune ptoblems) and Inflammation (inflamation in her eyes and head). Concurrent medical conditions included Immune disorder (NOS) (krones and inflamation in her eyes and head).   On 01-Mar-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 VACCINATION COMPLICATION (side effects were minor). At the time of the report, VACCINATION COMPLICATION (side effects were minor) outcome was unknown.            No concomitant medications reported. Treatment information not reported.   This case was linked to MOD-2021-315273 (Patient Link).
59 year old woman, complicated health history including Rheumatoid Arthritis, hEDS, Hemiplegic Migraines, Atypical Myasthenia Gravis, current ANA 1:1280. Received Prevnar20 vaccine 2pm 3/11/2022, pharmacy. No reaction other than 3-4/10 injection site pain *until* approximately 26 hours after recieving vaccine. At the time extremely painful 7-8/10 RA flare began. Joint swelling, pain. lack of movement in hands, wrists, fingers,elbows, shoulders. base of skill, cervical joints,hips, knees, ankles, feet, and toes. I had the same RA flare up to the Moderna Covid-19 vaccine lasting 3 weeks, both doses. I did *not* have this reaction to since dose J&J Covid-19 vaccine March 2021, or Pfizer Covid-19 vaccine August and September 2021, and 3rd dose January 2022 Nor did I have this reaction to 2021 Flu vaccine recieved in October. I am not taking any medications for RA. Tramadol 50mg 1x every 4 hours, and Methocarbomal 500mg 1x every 4 hours does not dent the pain.
Pt recv vax on 9/10/97; on 9/19/97 pt exp sxs of Bell's Palsy; tx=Zovirax
Starting 11/27/21, patient noted left sided facial droop and facial weakness - diagnosed with Bells Palsy 12/1/21
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and MULTIVITAMIN & MINERAL for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications also included Emer-GN-cee.   This case was linked to INC.-MOD-2021-078089 (E2B Linked Report).; Sender's Comments: INC.-MOD-2021-078089:
patient was underage at the time of vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient was underage at the time of vaccination) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient was underage at the time of vaccination). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient was underage at the time of vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
This spontaneous report as receive from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 03-FEB-2015, the patient was vaccinated with GARDASIL (lot number: K007264 with unspecified expiration date) (dose, frequency and route unspecified) that had underwent temperature excursion (incorrect product storage). Concomitant medications were not reported. No adverse effects (no adverse event) were reported. The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Information has been received from a health care professional concerning 8 pts in one pre-school classroom who were vaccinated with varicella virus vaccine. Subsequently the pts developed breakthrough chickenpox following exposure to a child with wild type. The children had lesions in the oral and genital areas. Subsequently laboratory evaluation revealed negative seroconversion following vaccination. It was noted that the reporter suspected either a problem with the lot number or problems with storage and handling. No further details were provided.
Engerix-b expired, was administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 19-year-old female patient who received HBV (Engerix B) (batch number J7H4D, expiry date 23rd March 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   In July 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. In July 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 25-Jul-2022 Reporter's comment: The health care professional reported that Engerix-B was expired on 23rd March 2022 and was administered over the weekend between 23rd July 2022 and 24th July 2022.  No reactions were reported. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up via email.  Additional supportive information: The patient received an expired dose of Engerix-B, which led to expired vaccine used.
Parents noted excessive bruising after dermoid cyst removal 2-14-2014. CBC performed 2/18 showed platelet count 11K. Referred to Hematology and treated with IVIG for ITP.
Patient began to feel lightheaded/dizzy and experienced tingling at the injection site and in mouth.
This spontaneous report as received from a pharmacist refers to a 68 year old female patient. The patient did not have any pertinent medical history and drug reactions or allergies. She was not using any concomitant medications. On 02-NOV-2016, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration were not reported, lot # M033335, expiry date 11-OCT-2017. On an unknown date in November 2016 (also reported as at an unspecified time after receiving the vaccine), the patient noticed that the injection site was red an swollen. The redness and swelling went down. Then, on an unknown date in November 2016 (also reported as a few days ago), the injection site was pink but there was a lump under the skin where the injection was. No treatment was given for the events and no lab diagnostics studies were performed. The patient sought medical attention by coming to the pharmacy. The outcome of injection site lump was reported as not recovered. The outcome of injection site redness and swelling was recovering. The relatedness between events and ZOSTAVAX was not reported. The reporting pharmacist asked for a lot check to see in any other patients had experienced the same adverse reaction. Additional information has been requested.
fever; chils; Initial information regarding an unsolicited valid non-serious social media case was received from a patient on 03-Dec-2020.  This case involves a patient with unknown demographics who got a fever (Pyrexia) and chills when received INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concurrent condition, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the last two years (unknown latency), the patient had the stronger flu shot because of age. Shortly after, both times, the patient got a fever (Pyrexia) and chills that lasted for about 24 hours following the administration of INFLUENZA VACCINE.   Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events were unknown.  There will be no information available on the batch number for this case.
Rapid Heart rate; Shortness of breath; weak memory (inability to recall something); pain at the injection site; dizziness; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non pregnant female patient reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route of administration, administered in left arm on 23Jun2021 at 01:00 AM (age at vaccination was 27 years) as dose 1, single for COVID-19 immunisation. Vaccination facility was school or student health clinic. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were not reported. No known allergies reported. The patient did not receive other vaccine in four weeks and did not receive other medications in two weeks. On 24Jun2021, the patient experienced rapid heart rate, pain at the injection site, dizziness, shortness of breath and weak memory (inability to recall something). The patient did not receive treatment for adverse events. No covid prior vaccination and not tested covid post vaccination. Outcome of the events was recovered/resolved with sequel.  Information about lot/batch number has been requested.
Large red spot, raised area, Lt upper arm where varicella was administered. Dr checked area on 3/31/09.
Rash, petechial rash to lower extremities and neck. Resembling HSP rash in mild form.