chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccines were given on 4/30/2007.  Yesterday 05/06/2007, in the morning Mother noticed small slightly raised rash on upper abdominal area.  Throughout the day she noted it getting worse and by this morning he had the rash all over his trunk, legs, arms and head. She said she wouldn't have given the vaccines he received a week ago any thought, but there was a distinct redness and lump aroud the injection site of his right leg.  Prior to this rash, he did not seem to have any problems following the vaccinations.  Mom took him to an Immediate Care Facility. this morning where the Dr. told her it was an allergic reation but to what is still in question. He advised her to give Benadryl and report the reaction to our facility, although it is doubtful that this episode was due to the vaccination received on the 30th of April.
It was reported that an 18 month old patient (3 of 3) received a Trihibit and an IPOL vacicnation on 5/10/01. Reportedly sometime after the vaccination (date not specified) the patient developed a large local reaction. From mailed correspondence received on 7/19/01, additional patient, vaccine, vaccine administrator and responsible physician information was provided. From telephone contact on 8/7/01 it was reported that the patient developed a red, swollen, hard, warm area at the injection site in the deltoid, 10-20 mm in diameter. This reaction resolved. This case is closed.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Dec2021 as dose 3 (booster), single (Lot number: FG8757) at the age of 45 years, in left arm for Covid-19 immunization; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunization. The patient's relevant medical history included: "Ehlers Danlos Syndrome" (unspecified if ongoing); "narcolepsy" (unspecified if ongoing); "lower motor neuron symptoms" (unspecified if ongoing), notes: lower motor neuron symptoms (without a diagnosis yet). The patient's concomitant medications were not reported. Past drug history included: Known allergies: salicylates, reaction(s): "Known allergies: salicylates", notes: Known allergies: salicylates. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) faint positive line, notes: Still faint positive line on test this morning. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Therapeutic measures for COVID 19 included Paxlovid (Treatment start date: 08May2022, Treatment stop date: 12May2022, Lot number: FX4465). The patient took 5-day course after bad COVID illness. Had 2 shots plus booster, plus prolonged exposure in Nov21. Last dose of Paxlovid was last night and still faint positive line on test this morning. Follow-Up (17May2022): Follow-up attempts are completed. No further information is expected.
Left side stroke-like symptoms. I was walking and 20 minutes in I started having left leg weakness. This then turned into full left side numb/foggy feeling. I was with my son (and I'm a nurse) so I asked him to test for signs of a stroke. I could smile evenly but it didn't feel like it. I had strength in both hands and could lift my arms. I was able to communicate what to look for to my son without slurred speech. But I was not stable on my left foot and felt as if I was listing to the left side. My left side was foggy. I moved my arm but flet it in slow motion. When I got home, I sat down and stretched. The symptoms went away and I was able to continue the day without episode. The episode lasted 20-30 minutes as I was walking home still. In hind sight, I did have a similar eposide after the first dose (Moderna lot 037K20A on 1/29/20) while exercising at home but sat down and thought it was due to a hard workout. That time it was just a weak left leg that was giving out on me and lasted 5 minutes because I stopped the workout.
I was given a vaccine that  expired  06/30/2022.  I am so anxious now. This was administered at an outreach clinic to vulnerable, minoritzed populations. The person who gave me the  vaccine was a student at a Nursing facility. . I also witnessed her face the cap back on the needle. The level of supervision and attention to detail is stand guard and harmful. I just discovered it when I looked at the vaccine card.
pt recv vax 3JUN98 & 6JUN98 pt exp a rash @ inj site;
This spontaneous report as received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not provided. On an unknown date, the patients were administered improperly stored doses of GARDASIL 9 injection, for prophylaxis. (Strength, dose number, lot number and expiration date were not provided). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA011668: US-009507513-1612USA013214.
Rash developed around injection site.  Hot to touch, raised.  Rapidly developed (with in one hour of injection).
Pt developed swelling around injection site, had 10 x 10cm area of erythema, induration, tenderness.
PFIZER PEDIATRIC COVID-19 VACCINE WAS GIVEN ON 10/07/2022. THE COVID VACCINE GIVEN WAS  FOUND TO HAVE EXPIRED ON 09/30/2022 PT'S GRANDMOTHER NOTIFIED OF ERROR ON 10/18/22. SHE REPORTED NO S/E FROM VACCINE. INFORMATION GIVEN FOR VAERS AND FOLLOW-UP VACCINE INFORMATION.
5 MINUTES AFTER RECIEVEING VACCINE, PATIENT STATED THAT HER THROAT WAS ITCHY AND SCRATCHY.  911 WAS CALLED, PARAMEDICS EVALUATED PATIENT AND SHE CHOSE NOT TO GO WITH AND WENT HOME WITH DAUGHTER.
A 71 year old male patient received 2 intravesical instillations of Tice BCG.  Within the first 48 hours after, the second instillation, he had developed "flu-like symptoms", including a fever, initially 100 degrees F, which progressed to 103 degrees F and persisted up to 103 degrees through 02/16/2003. He also experienced chills, achiness and a sore throat.  Prior to receiving the BCG, he had already been experiencing a cough, which continued intermittently after the BCG, and for which the patient reported he had taken Penicillin for approximately 2-3 days, but discontinued before receiving any BCG.
Around 02/22/2023, I got up in the middle of the night and I had a fluttering, uncomfortable feeling in my chest. When I checked my pulse rate, it was 137 and I hadn't done anything to make it go up that high. I went to the doctor the next day. Because I have a family history of heart issues, he wanted me to go to the cardiologist. I've had a plethora of tests, but as far as I know, all of the results came back normally. I will follow up, but it hasn't happened before and hasn't happened since.
3" x 3" in. diameter w/deeper red bullae 1.5" x 1.5" rash radiating outward from initial rash. Warm to touch.
Nausea within 30 mins, low fever within 2 hours. Chills and sever body aches throughout the first 24 hours, high fever around 104 lasted another 20 hours, dizziness and weakness lasted 5 days
Pt with history of immune suppression due to rheumatoid arthritis and allergy to latex, was given a Moderna Covid-19 vaccination and approximately 2 minutes later developed redness and increased warmth in the right arm where she received the injection and developed nausea and felt like she needed to take a puff from her albuterol inhaler. She was immediately directed to the urgent care for treatment.
First dose was administered on 01-Apr-21 and second dose was administered on 20-May-21; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 01-Apr-21 and second dose was administered on 20-May-21) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE RHEUMATOID ARTHRITIS).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 01-Apr-21 and second dose was administered on 20-May-21) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 01-Apr-21 and second dose was administered on 20-May-21) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication were reported.  It was reported that the primary reporter did not have the lot number information, because the packaging was discarded.  No treatment medication were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-623369 (Patient Link).
woke up at 2 am (March 3) with racing heart, headache and bad dreams.....awoke again at 7 am with heart racing and headache.  Flu like symptoms started at 11 am and lasted throughout the entire day
I had extreme stomach pains that were worse than childbirth. I went to the doctor to find out what was going on with my stomach, they did not run any test aside from a urinalysis. It did show that I had not been eating as I could not hold anything down. I was given four different medications to help relax my stomach and one for nausea. I took them for a couple of days, then I was able to start eating and hold it down.
Diffuse Alveolar Hemorrhage; This is a literature report.   A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIFFUSE ALVEOLAR DAMAGE (medically significant), outcome "unknown", described as "Diffuse Alveolar Hemorrhage".  ; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and Diffuse alveolar damage cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Began to feel dizzy or lightheaded; Spacey and weak; Spacey and weak; Tired; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8731) via an unspecified route of administration in the left arm on 23Apr2021 at 10:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa antibiotics. Concomitant medications included pravastatin (MANUFACTURER UNKNOWN) and melatonin (MANUFACTURER UNKNOWN); both taken for unknown indications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received moxifloxacin hydrochloride (AVELOX) taken for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 23Apr2021 at 16:00, approximately 5.5 hours after receiving the vaccine, the patient began to feel dizzy or lightheaded, or spacey and weak. This lasted for 5-10 minutes, then the patient was tired for the rest of the evening. Although it was not major, the patient thought it was best to report. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events began to feel dizzy or lightheaded and spacey and weak were recovered on 23Apr2021 while the event tired was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Pt recv vax on 11/16/98; on same day pt exp red/ hot/ itchy/ hives at vax site; tx=Benadryl
dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that, there was a confusion between the expiration date printed in the carton the expiration date when the QR code was scanned.   The vial was initially refrigerated on 22-Sep-2021, the vial did not undergo any temperature excursion and patient did not experience any adverse events.  No treatment medications were reported.
Flu-like symptoms; Swelling; Malaise; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms, swelling and malaise. On an unknown date, the outcome of the influenza-like symptoms, swelling and malaise were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, swelling and malaise to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not applicable for this report. The number of patient's have reported having general flu-like symptoms, malaise, swelling, after receiving a dose of Shingrix. The symptoms had resolved. The reporter did not consent to followup. No specific patient or vaccine details available.
Patient experienced severe abdominal cramping plus severe diarrhea over several days. Still occurring but relieved by OTC products.
This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. On 14-NOV-2018, the patient was inadvertently vaccinated with an expired dose of VAQTA 25/0.5 (unit unspecified) (lot # N020689 and expiry date: 22-OCT-2018) via intramuscular route for prophylaxis. No adverse effect was reported. There was no product quality complaint (PQC) reported. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1812USA011184.
Got shingles and was vaccinated/ suspected vaccination failure; Got shingles twice; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shingles and was vaccinated/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got shingles twice). 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: 21-MAR-2023 This case was reported by consumer via interactive digital media. The reporter reported that it happened to her/his mom, and her physician was a dick and told her that it was probably something else because physician really could not believed she got shingles twice, especially when she was vaccinated. 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. Follow up was not possible, as no contact details were available.
Patient received a vaccine that experienced a temperature excursion. Vaccine was kept in the refrigerator for more than 30 days. No reaction.
sick; flu; cough; Initial information was received on 23-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves patient (unknown demographic) who had sick (illness), flu (influenza) and cough, while patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination(s) 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 and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness), flu (influenza) and cough (unknown latency) after the administration of INFLUENZA VACCINE.  Laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting the outcome of events were unknown for all events.  There will be no information available on the batch number for this case.
No additional AE; Expired PROQUAD U022983 / 07/22/2023 was administered 07/27/2023; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-JUL-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot number was reported as U022983 but upon internal validation it was not valid, expiration date: 22-JUL-2023, administered for prophylaxis (dose, strength and route of administration were not provided) (Expired product administered). Patient denies signs/symptoms of adverse effects. No additional adverse event (AE) (No adverse event).
pt recv vax & devel an inj site rxn characterized by redness & swelling, which spread from shoulder down to the elbow & chest wall;pt also c/o chills, fever, & aches;pt recovered;
Heat and swelling at injection site 12 hours post vaccine continuing until at least 23 hours post vaccine when reported   Pain and weakness in right hand 13 hours post vaccine continuing until at least 23 hours post vaccine when reported    Heart racing and trouble breathing 16 hours post vaccine intermittent symptoms coming and going continuing until at least 23 hours post vaccine when reported   Nausea 17 hours post vaccine intermittent symptoms coming and going continuing until at least 23 hours post vaccine when reported   Swollen and painful lymph node in right armpit 21  hours post vaccine continuing until at least 23 hours post vaccine when reported   Pain in right breast 21  hours post vaccine continuing until at least 23 hours post vaccine when reported
severe tendon/ligament issue in his knee; severe tendon/ligament issue in his knee; patient is over 25 years old; This non-serious case was reported by a physician via sales rep and described the occurrence of tendon disorder in a adult male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, 3 weeks after receiving Bexsero, the patient experienced tendon disorder (Verbatim: severe tendon/ligament issue in his knee), ligament disorder (Verbatim: severe tendon/ligament issue in his knee) and inappropriate age at vaccine administration (Verbatim: patient is over 25 years old). The outcome of the tendon disorder, ligament disorder and inappropriate age at vaccine administration were unknown.   The reporter considered the tendon disorder and ligament disorder to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     The company considered the tendon disorder and ligament disorder to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2023AMR084621   Additional Information: GSK Receipt Date: 13-JUN-2023 The patient self-reported this case. The patient was over 25 years old. The patient received the Bexsero in preparation for a trip. Three weeks after the administration of first dose of Bexsero he experienced a severe tendon/ligament issue in his knee because he runs every day. Initially, the patient attributed it to being older (age and DOB unknown). The patient believed it was related to Bexsero. The reporter consented to follow up. No further information was reported. For tolerance of 2nd dose refer case US2023AMR084621, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR084621:Same patient, different dose
Patient began having hot flashes roughly 1 1/2 weeks after receiving her first COVID vaccine. They are frequent (almost hourly) and last approximately 15 minutes at a time. The doctor isn't 100% sure if it's vaccine related, but all of her blood work is normal.