chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received form a physician via company representative refers to a patient (no demographics were provided) of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot # and expiry date unknown) (also reported as) vaccine. No concomitant medication was reported. On an unknown date (also reported as six months after vaccination), the patient developed shingles.No further event information was provided. There was no product quality complaint. Outcome of the reported event was unknown. Causality of the reported event was unknown for ZOSTAVAX. This case related to 1404USA014474 (Same Reporter Link). Additional information has been requested.
Case number PHEH2012US011315 is an initial spontaneous report received from a nurse on 01 Jun 2012 and a follow up received from a healthcare professional on 19 Jun 2012: This case refers to a patient of 35-year-old male. He was previously vaccinated with MENVEO which was tolerated well. On 05 Feb 2012 he was vaccinated only with Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: unknown), intramuscularly, without reconstituting with Men A component. It was reported that, later she was received the correct dose of MENVEO. No adverse event was reported following this administration error. Follow up information received from a healthcare professional on 19 Jun 2012: updated patient demographics, vaccination history, and confirmed that no adverse event happened following vaccination.
Received PCV13 on 4/11 9:30 AM. S/S include swelling of right shoulder and at least 1-2 teaspoons of yellow pus/drainage from injection site. No reports of difficulty breathing.
About 2 minutes after administering the vaccine to the patient, the patients fiance notice that the patient began to roll his eyes and slump over. Upon accessing the patient I notice that the patient was unresponsive to my calls, at which point I motion for my technician to call for emergency; then I proceeded to try to move the patient from the chair to the floor with the aid of his fiance. The patient became responsive a second before we go him to the floor and he seemed responsive and was breathing pretty well. The patient was unresponsive for about 35 second at which point his eyes were rolled backwards, his head was sweating profusely as well as his muscles seemed to become very rigid. Thankfully within 5 minutes emergency personal was at the scene and they took his blood pressure and heart rate with both values being on the lower end. The patient objected to going to the hospital, at which point they offered to roll him outside for him to get fresh air and observes him before leaving with his fiance
Approximately 10 minutes after this patient had  a vaccine given, she had 30-60 second seizure. No history of seizure disorder. The patient had not eaten in a while also.
Patient presents to the ED after falling. He complained for bilateral shoulder and rib pain. He was admitted with rhabdomyolysis and AKI. He was discharge to a skilled nursing facility 8 days later.
About a month after the vaccine, I started getting sores inside of my mouth. An my gums have started bleeding and teeth started hurting.  Now I have to go to the dentist to see what's wrong. Than my eyes starting  hurting and now I have blocked tear ducts. Went to the eye Dr. 4 times and I have had six blocked tear ducks. I have to go see a Retina doctor. I have to sit in the dark and put my steroids eye drops in. I haven't been able to go to work. The doctor said I might need to go see an  Auto immune disease doctor.
Became irritable, 2-3 days, post vax. On 5th day, had fever of 102-103 and inconsolable, crying and loss of appetite for 3 days. Seen on 5th day by MD and taken to ER on 6th day.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: tingling in fingers
I have been experimenting an intermittent burning sensation by my left lateral bicep; this feeling occurs  at rest and on exertion.  I noticed it three weeks after I had the first Moderna Vaccine.
Urinary Tract Infection (UTI); A Little Injection Site Swelling; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (Urinary Tract Infection (UTI)) and INJECTION SITE SWELLING (A Little Injection Site Swelling) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Dec-2020, the patient experienced INJECTION SITE SWELLING (A Little Injection Site Swelling). On 11-Jan-2021, the patient experienced URINARY TRACT INFECTION (Urinary Tract Infection (UTI)). On 25-Dec-2020, INJECTION SITE SWELLING (A Little Injection Site Swelling) had resolved. At the time of the report, URINARY TRACT INFECTION (Urinary Tract Infection (UTI)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
direct admit, transferred to the emergency department for hypoxia.  Confused at baseline, worsening since COVID pneumonia.
Generalized red rash starting on the right fore arm (Immunized on right arm) and then the rash spread to whole body with in 24 hrs.  Benadryl did not provide any benefit. Started on steroids.
Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a non-health professional (Pharmacy manager). This case involves 12 months old patient (gender not reported) who was vaccinated with a 0.5 ml expired dose of ACT-HIB (Batch number: UI807AAA, expiration date: 01 Oct 2018) via intramuscular route in left thigh on 30-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13 for Immunisation. It was an actual medication error due to expired vaccine used. It was unknown if patient had adverse event. 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. List of documents held by sender: none.
A report has been received from a Health Professional concerning a patient, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST started on an unknown date. The patient was accidentally given expired FLUMIST. The outcome of the event of accidentally gave expired FLUMIST is unknown. The report was considered to be non-serious.
Client fainted, was given water after the episode passed. No injuries seen. Client was sitting at the time of the fainting episode and was held in sitting position until regained consciousness.
On Friday, 4/2/21, a client (49 yr old male) arrived to the 30 minute Vaccine Recovery lot after COVID 19 Moderna Lot# 020B21A administration at 11:40am. Patient had reported history of rash after taking both Cipro and Penicillin. At 11:55 am while pt was being assessed by vaccine recovery lot, pt reported sudden onset of involuntary movements and mild shortness of breath. The EMT called for the Vaccine Recovery Lot Medical Lead. Began assessing patient at 11:57 am, noting the pt was having involuntary movements of the upper and lower extremities every few seconds. 12:00 pm BP 152/98, pulse 65. Patient was alert and oriented with normal skin color.  Pt reported feeling anxious and "maybe it is all in my head". Pt reported the blood pressure on scene was " higher than my normal at 120s/80s. Pt denied any history of recent illness or other vaccines. Pt stated, " I should have known something would happen, I had a premonition about this". Repeat vital signs at 12:32 pm BP 152/98 and pulse 65. Pt continued to have episodes of the involuntary upper and lower extremities lasting approx 3-5 minutes per episode. NP explained to pt that she could not allow him to drive with these movements and pt agreed to evaluation with EMS and transport to local ER for further evaluation. NP instructed to call for EMS. Call was made at 12:48pm and EMS/Fire arrived onsite shortly after. While awaiting Fire Department and EMS, pt reported to NP, "I have a history of Aspergers Syndrome". Also NP spoke with pt's spouse who also agreed pt should be evaluated at local ER. He was transported to the local hospital.
Patient developed tingling on tongue and mouth; normal vital signs; given diphenhydramine 25 mg IM; no progression of symptoms.  The next day she had malaise and fever but no other allergic symptoms.
Patient received vaccine after the expiry time allowed in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the expiry time allowed in the fridge) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No medical history were reported. .    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the expiry time allowed in the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the expiry time allowed in the fridge) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Pharmacist is unaware if patient is taking other medications. HCP is unaware patient received vaccine after the expiry time allow in the fridge. Safety consent to follow up with the pharmacist received. No concomitants medication were provided. No treatment medication were provided. No lab data has been provided by the reporter.
booster; felt tired for a few days; creatinine levels jumped another 20%/goes up 20% higher than baseline; sluggish; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162B2 (COMIRNATY), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Chronic Kidney Disease" (ongoing), notes: he has kidney issues. The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (Dose: 1, felt tired for a few days), for COVID-19 immunisation, reaction(s): "tired"; Comirnaty (Dose: 2, felt tired for a few days), for COVID-19 immunisation, reaction(s): "tired"; Comirnaty (Dose: 2, to 20% and then got better/ 2nd shot to have raised his creatinine numbers 25% and he recovered from that), for COVID-19 immunisation, reaction(s): "creatinine went up". The following information was reported: IMMUNISATION (non-serious) with onset Oct2021, outcome "unknown", described as "booster"; FATIGUE (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "felt tired for a few days"; BLOOD CREATININE INCREASED (non-serious) with onset Oct2021, outcome "not recovered", described as "creatinine levels jumped another 20%/goes up 20% higher than baseline"; SLUGGISHNESS (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "sluggish". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Clinical Course: Patient was advised by his provider to take the Pfizer COVID vaccine and he has since had dose 1, 2 and 3. Patient stated after receiving the document he "dealt with a few days, felt tired for a few days." Patient also reported that his creatinine level jumped 20-25% and took 4,5,6 weeks to go back to normal. He stated when he was reading and took the booster dose 1 week ago and now again noticed that his creatinine levels jumped another 20%. He stated that the levels came back to what it was and then jumped again during his dosing of the vaccines. He feels as though this time he will come back down as well but did not know if Pfizer had any recommendations. Patient stated that he felt okay now but for a week he was "sluggish." He was wondering why his kidney creatinine levels did that with the 2nd shot and then came back down after 6 weeks. With the 3rd booster dose he again stated it says it "goes up 20% higher than baseline" and was not sure if this was a listed side effect. After the "2nd shot" the creatinine went up to 20% and then got better, now happened 2 times where it went up. The patient did not feel any problems, he felt fine. Four days of sluggishness when he took the shot now he's fine. Patient had an elevated number when he took his blood test today. The events were reported as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This non-serious listed case involves one of a cluster of two, (identical twins) out of two vaccinees who had received DAPTACEL, lot number C4050AA. Information regarding the other patient is captured in non-serious case number 2012-05755. Documents held by sender: None. Follow up information received on 28 June 2012: It was reported that the patient had no known drug allergy and had apnea of prematurity. The weight of the patient at the time of report was reported as 4 pounds and 14. ounces. The time of vaccination of dose one of DAPTACEL was reported as 3: 19 pm. The patient had received subcutaneous dose of IPV (lot number: H1305, on right thigh on 18 May 2012 and intramuscular dose of PREVANR 13 vaccine (Mfr Wyeth) (lot number: F88044, on left thigh on 25 May 2012. the patient's concomitant medication included caffeine citrate.
11:52 am 150/100, 78-95%, immediately after injection started to feel nauseous and then wheezy.  No difficulty breathing. 12:00 pm 147/100 advised to wait. 12:11 pm Stated feel better, nausea subsiding.  Advised to sagely pull over and call 911 if symptoms return
little itchy bumps around the site of the shot; injection site pain; injection site itching; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site rash, injection site pain and injection site itching. On an unknown date, the outcome of the injection site rash and injection site itching were unknown and the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site rash, injection site pain and injection site itching to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrex shot about 6-7 months ago, and its hurt terribly bad and a still aches like the patient had a hot poker in it. That shot felt like the old penicillin shots that the patient had as a kid.  The patient also had little itchy bumps around the site of the shot. The patient received 2nd shot on right arm had no problems. The patient just caught the end of a radio show where the announcer was talking about the pain he had with his Shingrix shot, the patient wish that he could talk to him.  The patient would take the series again but I would take a NSAID before the shot.  The patient asked are those normal reactions. This case is linked with US2019GSK080239, by same reporter
arm was just sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old patient received bnt162b2 (BNT162B2), administered in arm right (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "arm was just sore".  Additional information: The first arm of the patient was just sore until second shot on 21jun2021 with in 2 weeks later the patient arm would experience hike an electric shot and still soreness was unable to move arm, the patient left arm was semi-paralyzed for about 10-20 seconds a couple times while driving still experiencing same symptoms presently.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
received 2nd dose too early; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose too early) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose too early). On 07-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose too early) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment information was not reported.  The patient who received 2nd dose of Moderna COVID-19 vaccine too early on 07 April2021. The scheduled date of 2nd dose was 14 April2021. The patient handed his vaccination card to pharmacist card after getting 2nd dose, that was when pharmacist noticed he was due to get 2nd dose on 14April2021. The pharmacist did not know the date when 1st dose was administered. The pharmacist said patient got 2nd dose 8 days earlier.  This report refers to a case of Inappropriate schedule of product administration, for mRNA-1273, lot # 007B21A,  with no associated AEs.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration, for mRNA-1273, lot # 007B21A,  with no associated AEs.
Patient loss consciousness immediately after receiving the vaccine. EMS arrived immediately and the patient regained consciousness. The mother believes that the loss of consciousness may be due to the patient's medications and not the vaccine. Patient stated she felt tired and refused EMS treatment. No further issues.
swollen lymph nodes in right neck/clavicle area, right armpit, left liver/abdomen
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 4 (booster), single (Lot number: gj3277) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: el8982), in left arm, on 12Feb2021 as dose 2, single (Lot number: en6204), in left arm and on 04Oct2021 as dose 3 (booster), single (Lot number: ew0191), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had Paxlovid Treatment from 25Jun2023 to 29Jun2023; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300244276 Same patient, different drug, different event;
This is a spontaneous report from a contactable Physician via Pfizer sales representative, reporting for 4 patients. For one of the patients 2 cases were reported regarding to different doses: this is the 2nd report regarding the events occurred with the 2nd dose received. An 18-year-old male patient of unspecified ethnicity received TRUMENBA via an unspecified route, at single dose on 07Jan2016, on 10Mar2016 and on 20Jul2016 for immunisation. No medical history or concomitant medications were reported. The patient previously received the 1st dose and experienced redness and swelling on 07Jan2016. The patient experienced chills, headache and shaking on 10Mar2016. The outcome of the events was unknown. The patient experienced no events with the vaccination received on 20Jul2016. Follow-up (09OCT2016): Follow-up attempts are completed. No further information is expected.
The patient was 17 at the time of receiving a dose of the Janssen COVID-19 vaccine. He did not experience any adverse event and left after observation.
Patient was given Moderna NDC Number 80777-273-99, Lot number 052B33A , Expiration Date: 02/23/2023. This Moderna vaccine was given after the expiration date of 02/232023 on 3/13/2023. At this point patient has not reported any adverse effects. Department of Health is aware of this issue. I have called the Moderna Contact information desk, Spoke with safety dept, case # given, transferred to excursion department, pending  answer in 2-5 days.
Patient was given Adult formulation of Pfizer COVID-19 vaccine instead of the Pediatric formulation.
Developed a rash on her leg within 40mins of vaccination. 2 days after vaccination, patient has developed muscle spasms in her back as well as chest tightness.
OBSTRUCTIVE SLEEP APNEA 3/17/2023 RENAL MASS
12 year old girl 8/27/19 rcvd 1st Guardasil injection. 8/28 woke to 100 degree temp, severe tiredness.
Presented to the hospital with encephalopathy and AMS. Tested positive for covid. Pt treated with antibiotics and oxygen. Meds adjusted to manage chronic issues. Pt discharged to a SNF.
Patient appears to have myocarditis/ viral pneumonia, hypoxia on 6/3/21 positive Sars-CoV-2 on viral panel in ED today.
Intense joint pain from approximately 2-3 weeks after injection up to current time. Swelling of knees and toe joints. Swelling and aching of hips fingers and elbows. Hospitalized for pain and blacking out from 8/15/21-8/17/21. Have been put on Prednisone a couple of times for treatment.
Day after flu shot - major swelling to (R) arm (R) breast. (R) armpit with lymph nodes, major pain, (R) shoulder swelling and pain.
Pruritis followed by swelling and pain resulting in limited ROM. Conservative management with heat/cold packs and NSAIDS PRN.