chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hot to the touch right arm; swollen right arm; red right arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to the touch right arm), VACCINATION SITE SWELLING (swollen right arm), VACCINATION SITE ERYTHEMA (red right arm) and CHILLS (chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced VACCINATION SITE WARMTH (hot to the touch right arm), VACCINATION SITE SWELLING (swollen right arm), VACCINATION SITE ERYTHEMA (red right arm) and CHILLS (chills). At the time of the report, VACCINATION SITE WARMTH (hot to the touch right arm), VACCINATION SITE SWELLING (swollen right arm) and VACCINATION SITE ERYTHEMA (red right arm) outcome was unknown and CHILLS (chills) had resolved.            Concomitant product use was not provided by the reporter.  No treatment information was provided. Patient used cold compress on her right arm.
Patient developed welps 72hrs after vaccination w/ FLUMIST. Dr at Urgent Care believed it was due to FLUMIST. Treated with Prednisone 5mg/5ml 1 tsp. QID x 3 days. Spoke with mom today and patient is "perfectly fine".
This spontaneous report as received from a pharmacist refers to a 22 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-SEP-2016, the patient was vaccinated with the dose of PNEUMOVAX23 (lot # L035882, subcutaneously, in the abdomen; dose was not reported) for prophylaxis (reported as vaccination). In September 2016, the patient developed a 2 inch by 1 inch yellow/purple blister like reaction at injection site with redness extending into the surrounding tissue. The outcome of the adverse events was reported as not recovered at the time of this report. The relatedness between the adverse events and PNEUMOVAX23 was not provided. Additional information has been requested. This is a corrected report that events were corrected. Sender's Comments: MERCK 1609USA009304: Mfr number.
Approximately 2 minutes after administration of flu vaccine, patient had altered consciousness and tonic contraction of upper extremities concerning for seizure.  Lasted 10-30 seconds.  Resolved without treatment.  Returned to baseline quickly and is well now.
A 78yo male with PMH of Hyperlipidemia, Depression, Chronic PTSD, HTN, DM, HIV, ESRD and Hearing Loss. On March 3, 2022, attending physician reported the patient had a historical ADR of Covid -19 vaccine induced Urticaria classified as moderate.  with occurrence date of 03/24/2021. No other detailed information regarding the vaccine was provided and unknown whether the patient received any treatment for the reaction
Severe weakness, dizziness & lightheaded, dec appetite-sl cough; PE-pale, weak required assistance to walk; no focal neurologic signs-rest of complete PE-nl;
Rash - noted in the AM as dozens of discrete erythematous lesions, then spread/consolidated diffusely.  This evolved over the next days.  Lesions were stable and somewhat pruritic.  None vesicular. As of today (12/17), it is slowly resolving.
had shingles twice with the shot/ Suspected vaccination failure; had shingles twice with the shot; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 05-Jun-2022 Reporter's Comments: The case was reported by patient's child via interactive digital media. The patient had shingles twice with the shot. Additional Supportive Information:  This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Pt was given a Tdap in the emergency room on 6/28/2008 for right foot wound.
This is a spontaneous report from a contactable consumer reported for himself. This is the one of 4 reports from the same reporter. A 57-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection, Lot# and expiration date were not reported) via an unspecified route of administration, administered in Arm Left on 01Apr2021 as SINGLE DOSE for COVID-19 immunization. Concomitant medication included VITAMIN D. He did not take any other medications. The patient medical history was not reported. It was reported that, he received his first dose 01Apr2021, and had mild pain in left arm on the same day. It was nothing bad and improved. The outcome of event was reported as resolving. Follow-up attempts are possible. Further information is expected.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of oral ROTATEQ (lot # L029618 and expiration date 20-MAY-2017, lot # L035511 and expiration date 21-MAY-2017, orally; except doses were not provided). It was reported that the vaccines was exposed to temperature of 1.1 Celsius (C) degrees for 1 hour and 45 minutes and then for 1 hour and 17 minutes (cumulative 3 hours and 2 minutes at lowest 1.1 C) before administration to the patients. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Started the night of the second injection with chills. By 12:00am 1/22 the fever began. Fever up to 105.8 overnight. 1/22 fever stayed around 101 with fatigue. 1/23 fever was down to 99. By 1/24 symptoms had subsided.
sore shoulder for a day or two; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, sore shoulder for a day or two, ), for COVID-19 immunization, reaction(s): "sore shoulder for a day or two". The following information was reported: ARTHRALGIA (non-serious), outcome "recovered", described as "sore shoulder for a day or two".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200129597 same patient/vaccine/event, different dose;
blood pressure had increased after taking the first dose of the Pfizer COVID-19 vaccine / blood pressure has been high as 178/102; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 via an unspecified route of administration on 25Feb2021 (Batch/Lot number and expiration date were not reported) as single dose for covid-19 immunisation. The patient medical history included blood pressure dropped lower. Patient went to see a doctor who's not his regular doctor because his blood pressure (BP) dropped lower than it should. The doctor lowered his BP dose. Patient was currently taking a couple of medications which may have caused this fluctuation in his blood pressure. His blood pressure had increased after taking the first dose of BNT162B2 on 25Feb2021. His blood pressure had been high as 178/102. Normally his blood pressure came back to normal within a week but it was not coming down this time around. He would go see his regular doctor now. The outcome of event was not recovered.  Information on the lot/batch number has been requested.
Hot arm; Arm started itching; Really red arm; Swollen like a size of tennis ball around vaccine site; Felt like catching the flu; Had cold and needed extra cover to make me warm; Arm ached little more than 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm ached little more than 1st dose), INFLUENZA LIKE ILLNESS (Felt like catching the flu), FEELING COLD (Had cold and needed extra cover to make me warm), VACCINATION SITE WARMTH (Hot arm) and VACCINATION SITE PRURITUS (Arm started itching) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CARBIDOPA, LEVODOPA (CARBIDOPA-LEVODOPA-B), LEVOTHYROXINE and FAMOTIDINE for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm ached little more than 1st dose). On 15-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like catching the flu) and FEELING COLD (Had cold and needed extra cover to make me warm). On 16-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot arm), VACCINATION SITE PRURITUS (Arm started itching), VACCINATION SITE ERYTHEMA (Really red arm) and VACCINATION SITE SWELLING (Swollen like a size of tennis ball around vaccine site). At the time of the report, PAIN IN EXTREMITY (Arm ached little more than 1st dose), INFLUENZA LIKE ILLNESS (Felt like catching the flu), FEELING COLD (Had cold and needed extra cover to make me warm), VACCINATION SITE WARMTH (Hot arm), VACCINATION SITE PRURITUS (Arm started itching), VACCINATION SITE ERYTHEMA (Really red arm) and VACCINATION SITE SWELLING (Swollen like a size of tennis ball around vaccine site) outcome was unknown. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Mailing address was mentioned
expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Treatment medications was not provided. It has been reported that there  were no adverse event for patient.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow up received contains significant Information added in I narrative.
Patient describes a burning/tingling skin on arms, legs, feet starting about 4 hours after injection. Sensation spread to hands about 10 hours after injection. At 11 and a half hours after injection she believes the sensation is decreasing and a headache is developing. No rash, redness, swelling or other visible affects. She also has tenderness at injection site. Treatment has been rest.
Seen 4/9/09 with small induration and some redness. Advised to put cold compress + should resolve in a few day by doctor.
I started feeling bad on 1/3/22. I had a lot of coughing, sneezing, watery eyes, mild fever, fatigue, and sore throat. This lasted for about a week. I have ongoing headaches and fatigue. My husband tested positive for COVID-19 1/9/22.
Client reports approx 30-45 minutes after getting the shot was having trouble breathing & felt like having a heart attack. Went to ER by ambulance & was treasted with steroids & Nubain
Pt was negative for COVID on admission on 11/29.  He was re-tested on 12/8 and tested positive.  Pt was admitted for an NSTEMI.  He also had a cough and shortness of breath.
May 18, 2021 was woken up sweating profusely, heart beating fast and pounding, lightheaded, tightness in chest. Called 911 - HR was 116, BP 177/97 then 183/102.   I was taken to ER. Various tests were done. Blood test showed triponon elevated on second blood draw, 3rd test triponon decreased some.  ECHO was done. Heart ok. CT with contrast was done to rule out blood clots. That was normal. Cath was done and showed 30% blockage in L main. Nitroglyercin was given and helped relieve symptoms. Kept having high blood pressure & high heart rate issues for the next 2 weeks until put on higher dose of amlodopine and beta blocker
Chest pain/dizziness/throat swelling/weakness. 0.3 autoinjector EpiPen and 50mg IM Benadryl given while patient was observed for acute life-threatening changes. EMS came and took the patient in a distressed but stable condition to the nearest ER.
muscle fatigue; severe fatigue; Headache on and off; mild fatigue; mild headache; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (mild fatigue), HEADACHE (mild headache), MYALGIA (muscle pain), MUSCLE FATIGUE (muscle fatigue) and FATIGUE (severe fatigue) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced FATIGUE (mild fatigue), HEADACHE (mild headache) and MYALGIA (muscle pain). On 17-Jan-2021, the patient experienced MUSCLE FATIGUE (muscle fatigue), FATIGUE (severe fatigue) and HEADACHE (Headache on and off). At the time of the report, FATIGUE (mild fatigue), HEADACHE (mild headache), MYALGIA (muscle pain), MUSCLE FATIGUE (muscle fatigue), FATIGUE (severe fatigue) and HEADACHE (Headache on and off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.
Within 4-5 hours of shot, severe migraine type headache (+ nausea, photophobia, phonophobia) with associated SOB & tingling of face, arms & numbness of arms -> relieved by BENADRYL. HA continued for next 3-5 days.
Patient came back to clinic for 2nd shot. Said she was sick in bed for 3 days following her 1st injection. Said she had a stomach hurt, she was nausious and her arm hurt. She requested a different version of the vaccine made by a different manufacturer. Attempted to call following the second shot for f/u but unable to reach at this time.
my throat feels like someone is strangling me; Not a sore throat and no swollen lymph nodes. Just pressure or tight and hurts more when I bend, i.e., forward, backward; This is a spontaneous report from a contactable consumer. A 46-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 23Apr2021 11:30 (Batch/Lot Number: Ew0170) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included thyroid disorder, gastroesophageal reflux disease, seasonal allergy, hypersensitivity. Concomitant medication included minerals nos, quercetin, thioctic acid, vitamins nos (EMERGEN-C) taken for an unspecified indication, start and stop date were not reported; valacyclovir [valaciclovir] (VALACYCLOVIR [VALACICLOVIR]) taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; montelukast (MONTELUKAST) taken for an unspecified indication, start and stop date were not reported. The patient experienced that 3 days after vaccine in the late afternoon my throat feels like someone is strangling me. Not a sore throat and no swollen lymph nodes. Just pressure or tight and hurts more when I bend, forward, backward. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Began with stiff neck, progressed to sore shoulders front and back by Thurs. AM. Unable to sleep pain was so severe. Vertigo and severe pain 02/18- 2/19/2016. Stabbing pain migrated to right, then left sides. Stabbing pain on left side through 02/21/2016.
Patient called pharmacy describing a rash around his trunk and chest area with a little itching. Advised patient to take BENADRYL OTC to see if that resolved the reaction. Called patient later that evening and was told that it was not spreading but the rash was still there and he would contact his MD if it did not resolve by Monday morning.
Despite history of multiple vaccinations, patient presented to the Emergency Department on 7/22/23 testing positive for COVID.  She was brought in by family secondary to a fall in the bathroom, and stating that in their opinion the patient felt hot to the touch despite being in air conditioning.  She was admitted to the hospital the same day secondary to febrile illness, fall, and acute COVID infection.
FEVER OF 102 FOR 3 DAYS. SEVERE CHILLS AND NASUEA. SWELLING AND SORENESS OF ARM.
February 16th, 2022. The COVID 19 booster vaccine given to the patient looks to have been a 0.5 ml dose vs the regular 0.3ml dose for Pfizer. The pharmacist and Quality Manager (QM) was notified of the possible error immediately. The QM who is a nurse contacted the patient right after to notify them of this and gave recommendations for follow up care available should there be any adverse reaction along with the facilities contact information. The Patient seemed to appreciate and understand the information and reported no adverse outcome.
This spontaneous report as received from a nurse refers to a female patient of unknown age. On an unknown date the patient was vaccinated with second dose of GARDASIL intramuscular for prophylaxis (dosage information not provided). On an unknown date the patient experienced syncope. The patient sought medical attention by an emergency room visit on an unspecified date. The outcome of syncope is unknown. Additional information has been requested.
fever 102 R devel in afternoon p/inj;mom notified clinic next day 20MAR97 @ 9AM fever cont 103.2 R;
Showed a allergic reaction in the whole body, rash and blisters, it looks like varicella. The child is hospitalized every time is vaccinated and Benadryl is administered. At the 6 month vaccination the child developed the rash and also asthma.
Child rec 1st DTP shot OPV & HIBtiter vax on 18JAN91, child expired on 25JAN91 cause of death unknown at this point autopsy done - no results at this time 30JAN91
experience swelling; pain at the injection sites; This is a spontaneous report from a non-contactable physician. A patient of unspecified age and gender received BNT162B2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included lidocaine hcl  and hyaluronic acid, both for an unspecified indication. The patient was injected approx. 10 months prior with Juvederm VOLUMA with Lidocaine and Juvederm  VOLBELLA with Lidocaine and 11 months prior with Juvederm VOLUMA with Lidocaine and Juvederm  VOLITE. On an unspecified date, after the second dose, patient experienced swelling and pain at the injection sites. Patient was treated with Telfast and betacorten steroidal ointment. Symptoms resolved. The outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
have some stinging in my eye; having some slight itching and burning and some mild irritation; having some slight itching and burning and some mild irritation; having some slight itching and burning and some mild irritation; The vaccine squirted out from between where I attached the needle and the syringe; during administration of the vaccine to the patient, the vaccine squirted all over my face and got in my eyes and my mouth; Initial information received on 17-May-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 34 years old male patient (reporter) who experienced have some stinging in my eye, having some slight itching and burning and some mild irritation during administration of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (injection suspension) )to the patient. the vaccine squirt in her mouth and eye during administration.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 17-May-2019, the pharmacist was administering vaccine to the patient via unknown route and unknown administration site (lot number N1K811M exp date: 19-Oct-2019), and the vaccine squirted out from between where the needle and the syringe is attached. It squirted out while the needle was in the patient and while the pharmacist was pushing down on the plunger to administer the vaccine. The vaccine squirted all over the face and got in eyes and her mouth.   On an unknown date, the HCP had stinging in eye (eye pain) and having some slight itching and burning and some mild irritation (pruritus, skin irritation, skin burning sensation).   It is an actual medication error due to occupational exposure to product.  It is also a case of device issue due to syringe leak.  Lab test and corrective treatment not reported. HCP was advised to continue irrigating and washing the area and seek medical attention if necessary  Outcome of all the events was not reported.  Global PTC number was updated as: 100004481.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.  Follow-up information received on 20-May-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  Patient's gender was updated.  Follow-up information received on 20-May-2019 regarding an unsolicited valid non-serious case from a Quality department.  PTC number was updated and changes made in the field and narrative accordingly.  List of documents held by sender: none.
Swelling, redness, tenderness, warmth at and around injection site. Worst for 1 wk following injection. Got better but still dryness of peeling of skin noticed.