chrisvoncsefalvay/vaers-outcomes huggingface dataset:
denied new detergents, lotions; new food: handful of zing crackers ranch evening of 19AUG; fine til bath 830PM 8-10 during which devel hives & fever 102; to ER stat areas became flat, red, size of 1/2 dollar;
Fever; Chills; Headache; Body aches; Shaking; Nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Sep2022 at 15:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 25 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; (BOOSTER) MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 11Sep2022 at 22:00, outcome "recovered" (13Sep2022), described as "Body aches"; CHILLS (non-serious) with onset 11Sep2022 at 22:00, outcome "recovered" (13Sep2022); PYREXIA (non-serious) with onset 11Sep2022 at 22:00, outcome "recovered" (13Sep2022), described as "Fever"; HEADACHE (non-serious) with onset 11Sep2022 at 22:00, outcome "recovered" (13Sep2022); NAUSEA (non-serious) with onset 11Sep2022 at 22:00, outcome "recovered" (12Sep2022 at 13:00); TREMOR (non-serious) with onset 11Sep2022 at 22:00, outcome "recovered" (13Sep2022), described as "Shaking". Therapeutic measures were not taken as a result of pyrexia, chills, headache, pain, tremor, nausea.  Adverse event: All symptoms began 7 hours after the shot. Nausea subsided by 1 pm the following day, all other symptoms lasted until two days later. Patient did not receive any treatment. Patient  did not get covid prior vaccination and was not tested post vaccination. Patient did not receive any vaccine in four weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
An 11 year old patient was administered a Pfizer COVID-19 on 8/30/21 at pharmacy. No adverse effects were reported. No treatments were provided. Parent was advised that the second dose could be given when the patient turns 12 or the vaccine is approved for younger ages.
Fever 100.5. Chills, fatigue, vomiting. Very much flu-like. Lasted about 24 hrs. Took Motrin then Tylenol. Rested and hydrated. I had the same reaction with the first shot, but this time,  the symptoms came on faster and ended faster.
Patient received SHINGRIX in error instead of HAVRIX. Patient complain about fever and throwing up. She took TYLENOL and she is feeling better.
Development of maculopapular blanching rash centrifugally distributed, confluent lesions on face trunk, extremities palms and soles.
SEVERE level 10 abdominal PAIN. totally bedridden except for crawling to bathroom. completely incapacitated and unable to do any normal daily activities for 3 days now. Completely disabled. I am hoping this goes away
Client given 0.5mL instead of booster dose 0.25mL on 11/19/2021. On 11/24/2021, patient had tactile fever and body aches, which lasted 2 days starting on the evening of 11/19/2021. Followed up with patient on 11/16/2021 and 12/1/2021 all symptoms resolved. No reports of new symptoms.
pt exhibited a body rash,no fever,but was very irritable;sx most of the noc;27FEB96;spoke w/pt's dad this AM-rash still present but pt not was irritable
Complete and Sudden loss of hearing in right ear 4 months after the 2nd dose of Moderna vaccine. Now undergoing steriod treatment for possible viral issues and ENT Specialist say this has been seen in a few cases. No return of any hearing only tinitius and vertigo that is driving me crazy
Extreme red swollen knot, itching that could not be tolerated, encompassing whole upper arm. Things done to allieve: ice pack, cortizone cream (which burned so had to be cleaned off). Started when patient woke up in the morning, got progressively worse as the days wore on. Lasted approximately a week.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2014, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient. In February 2017, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of his injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Hospitalized (9.16.21);  COVID-19 positive (9.14.21);  fully vaccinated  Discharge Provider: MD Primary Care Provider: MD Admission Date: 9/16/2021 Discharge Date: Sep 21, 2021 PRESENTING PROBLEM: Acute respiratory failure with hypoxia (HCC) [J96.01] Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 67 year old male with a past medical history of HTN, HLD who presented with worsening shortness of breath x 2 weeks, found to be positive for COVID-19 (9/15). He has been vaccinated against COVID 19 (Pfizer x 2).  CTA thorax negative for PE, but showing extensive bilateral airspace disease consistent with Covid pneumonia. Blood cultures, Legionella antigen, Strep pneumonia antigen negative. Sputum cultures with normal respiratory flora. Patient was not a candidate for monoclonal antibody or Remdesivir. He did complete a 5 day course of antibiotics for CAP coverage.  Ten day dose of dexamethasone was also initiated and he was placed on HFNC and weaned steadily each day as tolerated. Patient worked with pulmonary rehabilitation and prone positioning during his hospitalization. He was able to wean to 3L nasal cannula 9/20 and to room air 9/21. Patient had also been experiencing diarrhea prior to admission. This symptom was improved during hospital stay without need for medication. Sodium of 129 on admission, likely due to hypovolemia. This improved with improved appetite. However, on last day of hospitalization it dropped back to 131. His primary care provider was notified and a follow up CBC within 1 week recommended to ensure that his sodium remains stable.    Of note, Patient agreed to participate in two trials during his hospitalization. For this reason he was provided Cyclosporine as part of the trial. He was provided with the information of the trial coordinator for any further follow up questions he may have and he is aware that he may opt out at any time. Pulmonary therapy met with patient 9/21 to evaluate and prepare him with his home oxygenation needs. Having completed his testing without any oxygen requirements, he will be returning home on room air.  He is provided with pulse oximeter and instructed to follow up with PCP if he sees his saturation below 91%. Upon evaluation, his vitals were stable and he was oxygenating well on room air. He is instructed to restart his statin upon return home and finish out his course of dexamethasone with 4 more tablets provided.  He had no further questions or concerns at discharge and felt comfortable returning home in stable condition to his family.   Discharge Disposition:  home health care   Active Issues Requiring Follow-up:  Low Sodium - follow up outpatient and further discussion with PCP Low Oxygenation - continue to monitor this with your pulse oximetry and follow up if dropping below 91%
evening of vax nose & feet became red & itchy then vomitted once-then no further sx;states felt fine;
Extreme arm pain, Red swollen hot, Terrible pain, Felt tired and sluggish for 2 days.
Nausea; Headache; Painful bump on the left side of her neck.; This is a spontaneous report from a contactable consumer (patient). A 45-years-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date in May2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that she had a dose of the vaccine last Wednesday, and the first two days she did not feel anything, abnormal. Reported that on Friday, Saturday, Sunday and today, she was feeling nauseas and has a headache, not sure if it is from the vaccine. On an unspecified date in May2021, the patient experienced nausea, headache, painful bump on the left side of her neck. The outcomes of events were unknown.  Information on the lot/batch number has been requested.
This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a male patient who received SHINGRIX (batch number 4492P, expiry date unknown). Concurrent medical conditions included hypertension. Concomitant products included Lisinopril. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 12 hrs after receiving SHINGRIX, the patient experienced injection site swelling, injection  site pain, malaise and influenza-like symptoms. On an unknown date, the outcome of the injection site swelling, injection site pain, malaise and influenza-like symptoms were recovered/resolved. The reporter considered the injection site swelling, injection site pain, malaise and influenza-like symptoms to be almost certainly related to SHINGRIX. Additional details were provided as follows: This case was reported by a medical assistant. The patient received SHINGRIX in the left arm. The reporter did not have batch number expiration date. The symptoms resolved after 3 to 4 days. No medical intervention was taken. The reporting medical assistant stated that patient's physician was almost certain that symptoms were caused by SHINGRIX.
This spontaneous report as received from a Registered Nurse refers to a 10 month old female patient. Pertinent medical history, concomitant medication, drug reactions and allergies were not provided. On an unknown date, the patient was vaccinated with a first dose of VARIVAX (dose, route of administration, lot number and expiration date were not reported). No adverse symptoms were reported. Additional information has been requested.
A non-serious spontaneous report of administration of expired product was received from a registered nurses concerning a 24-month-old female who received FLUMIST.  The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009.  Neither the patient's medical history nor concomitant medications were reported.  The patient is one of a pair of siblings who received the FLUMIST on 31-Dec-2008, which expired on 30-Dec-2008.  All the expired FLUMIST vaccines were part of the 309 units with same lot # delivered to the pediatric clinic on 21-Oct-2008.  All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccine.  The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on the day that expired FLUMIST were given to the 16 patients.  There was no adverse event associated with the medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse event.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. The Patient was not receiving regular care through the health system. Patient was a 90 yo, has PMH significant for hypertension, T2DM, Sleep Apnea, Hyperlipidemia, H/O DVT and PE. No documentation in chart for Cause of Death.
Mother called health dept on 3/12/04 reporting a reaction her child had after immunizations. Child's records revealed she received a MMR and varicella on 2/27/04. Several attempts to contact mother. She returned call on 3/17/04 and relates the following: Child developed a rash on day 2 after immunizations. Rash started on legs and spread to back and became more generalized. Rash described as small, red rash. On day 7 child developed a fever of 104.5. She called child's Dr and was told child was having a reaction to "shots." She treated child thru weekend with Motrin and Tylenol. Child's fever gradually subsided and child was fully improved by Monday so she didn't take child to Dr for medical care. Dr told mother we shouldn't have given the child the MMR and varicella at the same time because they are both live viruses.
little sore; Depression; weaker; weird physical problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "little sore"; DEPRESSION (non-serious) with onset 2021, outcome "unknown", described as "Depression"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "weaker"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "weird physical problems". Therapeutic measures were taken as a result of depression.  Additional information: Caller apologizes as she states she did not explain this correctly to the transferring agent. The caller wants it known the depression is nothing from the vaccine, they don't feel this has anything to do with the vaccine though it is confirmed this occurred after getting both shot. This started within the last few weeks. There are other things going on with him and they are not worried that this has anything to do with the vaccine. It was noted, with the depression issues he was having and the medication he was on, he was waiting to get the booster. She wants to get the booster shot but wants to make sure she cant give him anything that she may experience after getting the shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arm and legs have [had some pain and] experienced weakness; Arm and legs have had some pain; Arm and legs have [had some pain and experienced weakness] stiffness; Arm and legs have [had some pain and experienced weakness, stiffness] had some twitching like symptoms; This is a spontaneous case initially received from other non-health professional (consumer) on 20-Dec-2018, concerning a 44-year-old adult male patient.  Patient did not have any relevant medical history and was not taking any concomitant medications at the time of vaccination.  On 02-Nov-2018, the patient was administered Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived, dose: 0.5 ml, anatomical location: upper arm, batch number: 252665, expiration date: 30-Jun-2019 and route of administration: not reported) for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine  On 14-Nov-2018 (reported as 10-12 days after vaccination), patient experienced some reactions which included pain in arm and legs, weakness, stiffness and had some twitching like symptoms. Patient went to several doctors but took no medicines or any treatment measures till the time of reporting.  The outcome of the events was not recovered (ongoing).  The reporter assessed this case as non-serious.  Non-significant follow-up reported by reporter on 15-Feb-2019: The Med Info Number: SEQ19-00245 was added in the additional information tab. It was reported that attempt to contact the reporter was made on 14-Jan-2019 and the reporter had not reached back out to the date. Hence, this case was considered as lost to follow-up. No changes were made in the narrative.; Reporter's Comments: A 44-year-old, male patient experienced pain, weakness, stiffness in extremities (arm and legs) and twitching 12 days after administration of Flucelvax Quadrivalent. The company assessed the causality of the events as related to the suspect vaccine due to plausible temporal relationship between the events and the suspect vaccine.
Received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine). On 16-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
I received the shot in the evening. After about 18 hours I noticed that I was having headache, tiredness, and muscle aches/soreness. But I also had joint pains and muscle tension, especially in my shoulders and upper back. I took ibuprofen but it didn't help. I got home from work about 3pm and accidentally fell asleep for almost 3 hours, from pain and exhaustion.
DON'T HAVE FEELING IN 2 FINGERS OF SAME ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced don't have feeling in 2 fingers of same arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from don't have feeling in 2 fingers of same arm. This report was non-serious.
MILD generalized vaccinia 11 days after vaccination (primary vaccination-3 jabs).   Developed rash on chest, upper back, shoulders.  Pruritis raised macules/early papules.  Sweats at night x1.  No fevers or chills.   Major reaction w/o excess induration.   Pt describes notable adenopathy day 5-7 in both axillary regions, but this resolved at time of presentation.
Redness, discomfort, heat start day of vaccination, report to pharmacy 3 days later. Pt had not removed band-aid yet. Third day, pt seen in ER dx cellulitis received antibiotic rx.
had it and I had all the shots/suspected vaccination failure; had it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had it and I had all the shots/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had it). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 19-Mar-2023 The case was received from the patient via interactive digital media. The patient had all the shots and had them. The patient stated that they said there was a 10 percent chance of that happening. The patient stated it was a pain. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Note: Very difficult to read product name and/ Manufacture Lot number secondary poor handwriting so there may be an error there.  Healthy pregnancy this far. Was fourth pregnancy for patient with no history of prior miscarriage. No bleeding etc.  prior to event or following event.  Fetus was found to have no heart beat at well visit on 4/1. Ultrasound records reported fetus stopped growing appropriately at time of first vaccination. Estimated Due Date was 10/4.