chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; New symptoms of weakness/lightheadedness/difficulty concentrating with positive rapid Covid test 6 days after completing Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient had no known allergies. There were no concomitant medications. The patient had not received any other vaccine within 2 weeks of vaccination. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 01Sep2022, outcome "unknown", described as "New symptoms of weakness/lightheadedness/difficulty concentrating with positive rapid Covid test 6 days after completing Paxlovid"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Sep2022) Positive, notes: Positive rapid COVID test 6 days after completing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient orally received Paxlovid as treatment for COVID 19 from 25Aug2022 to 30Aug2022. On 01Sep2022, new symptoms of weakness/lightheadedness/difficulty concentrating with positive rapid Covid test 6 days after completing Paxlovid. It was unknown if patient received treatment for new symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events  DISEASE RECURRENCE and DRUG INEFFECTIVE  and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
injection site sore; injection site red; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In October 2022, unknown after receiving Shingles vaccine, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were not recovered/not resolved.   The reporter considered the injection site pain and injection site erythema to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comment: The patient self-reported this case via (Shingrix ) interactive digital media. It was stated that injection site from the shingles vaccine was still red and sore after 4 days. Additional supportive information: The follow-up would not possible, as no contact, details were available.
A day of chills, body aches, and ibuprofen after the 3rd dose/have a little bit of chills; A day of chills, body aches, and ibuprofen after the 3rd dose; a little bit of muscle ache; arm soreness like he'd gotten a "hard punch in the shoulder."; side effects; he ofered up his arm for a third jab; This is a spontaneous report from a contactable healthcare professional, based on information received by Pfizer, for BNT162B2.  A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on Jan2021 as single dose for covid-19 immunization; first dose of covid-19 vaccine MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration from an unspecified date to an unspecified date, at SINGLE DOSE for an unspecified indication. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced a day of chills, body aches, and ibuprofen after the 3rd dose and have a little bit of chills, a little bit of muscle ache, arm soreness like he'd gotten a "hard punch in the shoulder", side effects, he ofered up his arm for a third jab. Therapeutic measures were taken as a result of a day of chills, body aches, and ibuprofen after the 3rd dose/have a little bit of chills, a day of chills, body aches, and ibuprofen after the 3rd dose, arm soreness like he'd gotten a "hard punch in the shoulder". The outcome of event was unknown.
Pt had swelling, heat over the injection, and large erythematous region over the injection site
patient of age range of 59 to 62 received Fluzone High-Dose, no AE; patient of age range of 59 to 62 received Fluzone High-Dose, no AE; Initial information was received on 03-Mar-2020 regarding an unsolicited valid non-serious case from a consumer.  This case is linked to cases 2020SA059559 and 2020SA059571 (same reporter).  This case involves a patient (age range of 59 to 62) (gender unknown) who received a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination in the last October to November.  Medical history, medical treatment, vaccination and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Skin blistering and bumps. Pustules and serous discharge. Rash on both arms, legs, back and chest.
Shaking, fever, watery eyes, sore arm, pain in arm, dizziness, sick, pain at site, sweating.
Got really really dizzy; Severe headache; Whole body was hurting; Severely dehydrated; Some gastro information (gastric inflammation); Severe cold chills and hot flashes when not running a fever; Severe cold chills and hot flashes when not running a fever; Ran a fever; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Sep2021 at 10:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included sertraline hydrochloride (ZOLOFT) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received hydrocodone bitartrate/ paracetamol (LORTAB) and experienced drug allergy. On 15Sep2021, the patient got really really dizzy, had severe headache, her whole body was hurting and she was dehydrated, severely dehydrated. The patient also had some gastro information (gastric inflammation). The patient experienced severe cold chills and hot flashes when not running a fever, and then she also ran a fever that she was still fighting. The patient did not have issues with cold chills while running a fever. The events resulted in emergency room/department or urgent care visit. Since the vaccination, the patient had been tested for COVID-19. On 16Sep2021, the patient underwent respiratory panel test via nasal swab and the test result was negative. Therapeutic measures were taken as a result of the events and the patient was prescribed with a muscle relaxer (unspecified). The clinical outcome of the events got really really dizzy, severe headache, whole body was hurting, severely dehydrated, some gastro information (gastric inflammation), severe cold chills and hot flashes when not running a fever and ran a fever was not recovered at the time of the report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Has small bruise on Right upper arm. There is an area the size of a large lemon that is red and warm to touch. Onset yesterday pm.
Swelling in injection sight; Swelling in injection sight and pain; Fever; Body aches; Tinnitus; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of: 27-years-old) as dose 1, single for COVID-19 immunization. The patient had no relevant medical history and no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in left arm on an 16Apr2021 as a dose 2, single for COVID-19 immunisation. On 03Apr2021, the patient experienced swelling in injection sight and pain which lasted for 4 days, fever and body aches for 3 days. Tinnitus is noticeably worse, 5 days after when reported and still present. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever and body aches that lasted for 3 days was resolved on 06Apr2021, while that of swelling in injection sight and pain that lasted for 4 days was resolved on 07Apr2021, tinnitus is noticeably worse was recovering.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a nurse via sales rep and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, chills, pain and fatigue. On an unknown date, the outcome of the fever, chills, pain and fatigue were recovered/resolved. It was unknown if the reporter considered the fever, chills, pain and fatigue to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced fever, chills, soreness and fatigue which lasted for 24 hours. The reporter agreed to be followed up.
Unusual sluggishness and tiredness, some aching, inability to function, take care of grandkids, and think, effectively. As of today, 20 some hours after the vaccine, the symptoms are lessening, but are clearly still present.
Small rash; This is a spontaneous case, reported by other non-health professional to agency (reference number: SEQ19-07176) and initially received on 02-Dec-2019, concerning an 8-year-old, female patient.  The patient had no medical history. The patient did not take any concomitant medications.  On 23-Nov-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number and expiration date: not reported] for influenza prophylaxis.  On 24-Nov-2019, one day after vaccination, the patient experienced a small rash. The patient did not receive any corrective treatment for the event.  On 25-Nov-2019, two days after vaccination, the patient recovered from the small rash.  The reporter assessed the event as non-serious and did not provide causality assessment to Flucelvax QIV.  This case is linked to the case 201907058 due to the same reporter.  Company Comment: The event is considered as related to Flucelvax QIV.; Sender's Comments: The event is considered as related to Flucelvax QIV.
Meningitis (entero) 1/98; mono 4/99; dx autoimmune thrombocytopenia 3/99; tx w/ pred w/ dec sx;
got sick from it the next full day; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick from it the next full day) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    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 ILLNESS (got sick from it the next full day). At the time of the report, ILLNESS (got sick from it the next full day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information provided.  No treatment information provided.  The patient stated that he was scheduled to have the 2nd shot tomorrow.
Headache, body aches, tingling from arm down to fingertips, decreased strength in hand, weakness.
Patient jerked his arm when needle went in, causing needle to come out of arm completely prior to dose being fully administered. We had to give him remainder of dose following this, (2 needlesticks for 1 dose of Pfizer).
10 to 15 minutes after receiving the vaccination.  The patient reported to a pharmacy technician they were feeling unwell.  As the patient went to sit down they fainted. Patient was unresponsive for roughly a minute exhibiting tensed arm and neck muscles. Muscles also contracted several times during the episode. Patients eyes were open during the episode but they could not be coaxed to speak signal or blink. Additional patient symptomology as follows: elevated pulse, constricted pupils, flushing/redness in the face & neck. For this reason, medical staff called 911. Patient became responsive and reported losing consciousness and having no recollection of majority of the event. Upon arrival EMT's took over patient care. Patient left with EMT's
-swelling down to elbow in left arm - hives -scratchy/irritated throat - vomiting
Patient felt shivering, fever, nausea, joint pain, lightheadedness, and fatigue about 7 hours after getting the vaccine. He also report sciatic pain shortly after receiving the vaccine that lasted until 11pm the same day. His symptoms are subsiding, but, more than 24 hours later he is still experiencing mild nausea, fatigue, aching, and some lightheadedness.
Fever of 102 degrees, muscle aches, fatigue, hoarseness, vomiting, confusion, disorientation.
My arm got immediately sore followed by hot flashes and being unable to control my body temperature, I have near lost all of my lung capacity, I get winded if I walk up the stairs too fast, barely able to breathe, heart racing
About 10 minutes after getting the vaccine I felt my neck starting to swell or get tight, it wasn't my throat it was on the outside (lymph nodes) I also got very lightheaded. I've had that same feeling swollen lymph nodes on both sides of my neck and being lightheaded ever since. Today (1/24) I started having waves of shortness of breath.
Child was given expired Hep B vaccine twice. First date was 6/23/04 and second time this occured was 8/4/04. Pt did not have any adverse reactions.
Since about a week after the first dose I have experienced daily nausea, stomach cramps most days. Whenever I do any abdominal workout I get stomach cramps and get my period the next day.
Patient was hospitalized for symptomatic COVID-19 on 06/24/2022. Patient received Janssen vaccine.   Pt admitted to the ED and states that he was in his usual state until about 3am this morning. He was at work when he coughed up what he describes as a copious amount of blood. Prior to this episode, he had not noted any coughing. He said this coughing spell was severe. He noted that he felt a pop in his chest with pain that lasted for approx 3s and then developed an "itching" sensation in his chest and an urge to cough where he expelled frank blood. He states that this lasted for almost half an hour. He estimates he coughed up approx 1 pint of blood.   Workup revealed that he is positive for COVID-19 infection.  He had some pulmonary distress with shortness of breath but he did not have significant hypoxia.  He was seen by Pulmonary and he did not require emergent intubation or bronchoscopy.  He had prompt improvement in his hemoptysis.  At the time of discharge, he continues to have cough productive of sputum but his sputum is white/yellow and not red.  He denies chest pain.  He denies worsening shortness of breath.  This morning, his O2 saturation was 94% on room air.  He is trying to quit smoking and estimates he smokes less than 10 cigarettes per day.  He also is working with his primary care provider for optimization of diabetes and hypertension.  He has a past medical history significant for coronary artery disease status post PCI.  He understands that he has COVID-19 infection and he should follow isolation/quarantine protocols and he should not return to work until his workplace protocol has been satisfied.  He generally feels well and he is interested in discharge.
Hot painful inflamed area. 70x55mm. Sent to hospital. Dx: cellulitis. Tx: Cephalexin.
Increase swelling and erythema approx 4 inch induration left deltoid. Warm and tender to touch. TX with Keflex 250mg TID x 10 Days.
CHILLS; SORENESS AT INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on MAR-2021, and was recovering from soreness at injection site. This report was non-serious.
Local Rxn to site of injection Sx onset 2 days after injection Redness and swelling.
Patient reported having having seizure 2 hours after having the moderna covid shot. He said he woke up and didn't know what was going on and went to the emergency room. That was all that was mentioned and it was several days later that he reported the incident.
Information has been received from a medical assistant referring to a 4 years old patient of unknown gender. Information regarding the patient's concomitant medications, medical history and drug reactions/allergies was not reported. On 12-SEP-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (lot# M015695 with expiration date 26-SEP-2017, therapy type rHA; dose and route were not reported) for prophylaxis. It was reported that the vaccine was improperly stored at -3.5 degrees Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received. Sender's Comments: US-009507513-1610USA011133: US-009507513-1610USA011245.
This spontaneous report was received from a physician, via a company representative, referring to a patient (encounter key # 171853) of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-AUG-2016, the patient was vaccinated with a dose of RECOMBIVAX HB, "10Pk 5 mcg/0.5 mL SDLLokCap Ped", lot # L016959, expiration date: 12-MAR-2016, (dose number and route of administration were unknown), which was improperly stored. On unspecified dates, RECOMBIVAX HB had three temperature excursions of 0.55 Celsius degrees (33 Fahrenheit) for 96 hours, 1.11 Celsius degrees (34 Fahrenheit) for 528 hours and -0.55 Celsius degrees (31 Fahrenheit) for 72 hours, respectively. The vaccine status was reported as in excursion and the type of excursion and storage criteria were reported as refrigerator (R). No adverse effects were reported and no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
This case was reported by nurse and described the occurrence of methicillin resistant staphylococcus aureus infection in a 12 year old female subject who was inadvertently vaccinated with the incorrect dose of hepatitis A vaccine inactivated (Havrix). for prophylaxis. On an unspecified date on October 2005 the subject received 1st dose of Havrix in the right deltoid muscle. The nurse reported that the subject inadvertently received the adult dose of Havrix, instead of the scheduled pediatric dose. The adult, 1 ml, dose of Havrix is recommended for immunizing individuals 19 years of age and older. Approximately three months after the 1st dose of Havrix, on an unspecified date in Feb 2006, the subject experienced methicillin resistant staphylococcus aureus infection on her chin and lower lip. The subject was seen at a physicians office and treated with antibiotics. The nurse reported that the subject was not hospitalized at the time of initial reporting, 2/13/2006. The nurse also stated that, the patients entire family is receiving prophylactic treatment with Bactroban nasal. The outcome of the methicillin resistant staphylococcus aureus infection was unknown at the time of reporting. The nurse considered the methicillin resistant staphylococcus aureus infection to not be related to vaccination with adult dose of Havrix. Comment: methicillin resistant staphylococcus aureus infection was assessed as medically serious by manufacturer (OMIC).
Initial unsolicited report received from physician on 19 Mar 2018. This case involves 74 years old female patient who was vaccinated with dose of INFLUENZA HIGH DOSE VACCINE (batch number, expiry date, route and site of administration were not reported) in right vastus on 08 Jan 2018. The patient's medical history and concomitant medication were not reported. On 12 Jan 2018 four days post vaccination patient reported that she had severe headache, burning, itching at the site, nausea no vomiting, teeth chattering and chills. Laboratory investigation and corrective treatment were not reported. Outcome of events was not reported. List of documents held by sender: none.
on 2/11/21 had a ocular miraine which lasted 30 minutes, drank coffee for caffine, took tylenol, still having minor headaches, do not know if attributed to taking the vaccine