chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Experienced significant worsening of symptoms from vestibular disorder, including vertigo; Ear pressure and discomfort, noise; Visual intolerance; Nausea; This is a spontaneous report from a contactable pharmacist, the patient. A female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 01Apr2021 at 10:30 as a single dose for COVID-19 immunisation. Medical history included vestibular disorder, sinusitis and tinnitus. The patient had unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 06Apr2021, the patient experienced significant worsening of symptoms from vestibular disorder, including vertigo, ear pressure and discomfort, noise and visual intolerance and nausea. The symptoms continued for past 3 weeks from this report and were only seem to be lessening at reporting time. The patient was not sure if should take the second dose. The events resulted in doctor or other healthcare professional office/clinic. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vestibular disorder, including vertigo, ear pressure noise and discomfort, visual intolerance and nausea was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Presented with shingles about two weeks after dose. Not sure if it?s related but thought I?d send it off just in case it was.
I am not able to schedule the 2nd dose appointment.  None of the days are available next week or after.
pt is 63 and should have gotten fluzone quad.  I gave her the fluzone hd by mistake . when I called her at 1:45 pm today to let her know, she said she had vomiting and diarrhea and was on the floor.
fever for two days; This is a spontaneous report from a non-contactable consumer or other non hcp, patient.    A 32-years-old male patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 22May2021 as dose 2, single for covid-19 immunisation.  The patient medical history was not reported. The historical vaccine includes bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 01May2021 as dose 1, single for covid-19 immunisation. Concomitant medication(s) included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. No COVID prior vaccination. It was unknown if COVID tested post vaccination. On 23May2021, the patient had a fever for two days since the second dose of the vaccine. The patient took Tylenol and had since recovered from the fever. The outcome of event was recovered on an unspecified date in 2021.    Follow-up attempts completed. No further information expected
Client returned to clinic ~ 30min after vaccinations with red, swollen eyelids; shallow breathing. 911 called, ambulance arrived. (No body rash noted) father states IV Benadryl, steroids in ER; Breathing treatment.
"itchy warm slight raised rash radiating out from the site of the injection about 4inches by 2 inches in size towards my elbow." used antihistamine and cortisone
The morning of May 3 I woke up with a sever sore throat and a fever of 101.3 and normally I would just treat a sore throat and I would normally just write it off as sinus or allergies. The fever indicated something else so we tested and I tested positive but my husband was negative. I then called my doctor I  sent them a positive test picture and they talked about infusion or medication. I really didn't want to be in the infusion center around other COVID Positive people. They prescribed me Paxlovid they gave me 2 pills instead of 3 because of the Gilbert syndrome. I isolated in the lower part of my house and cleaned everything upstairs to keep my spouse from getting ill. I kept record of my fever for 3 days and I don't have a fever now. I then came up with a productive cough. At first it seemed like it would be triggered and now I just have a cough with some mucus. Today was the first day I had a negative test and I'm now having just sinus issues because I have been working outside for the past few days. I have not taken my Atorvastatin per the pharmacist they didn't want the two medications to be taken around the same time. Not for at least three days after taking the Paxlovid.
Still has a bruise; A little blood came out during the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (A little blood came out during the injection) and VACCINATION SITE BRUISING (Still has a bruise) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (A little blood came out during the injection). On 12-Mar-2021, the patient experienced VACCINATION SITE BRUISING (Still has a bruise). At the time of the report, VACCINATION SITE HAEMORRHAGE (A little blood came out during the injection) outcome was unknown and VACCINATION SITE BRUISING (Still has a bruise) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age.  No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2015, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On an unknown date in 2017, the patient was treated in hospital for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Three days post vaccine, I noticed tenderness on my left breast near the nipple. Within the next week, it had become more painful and I could feel a mass in that same area.  Below, I've outlined everything that has happened since. I'm currently awaiting another surgical procedure which will remove a significant portion of my left breast including the nipple.
Large local hematoma with significant pain for a week, fever with one brief febrile seizure lasting less than 3 minutes.
Pt with 2" x 4 1/2" bruise around injection site down arm. Yellow in color with dark purple at bottom states feeling better. Encouraged to call LMD. No ASA that am.
Pt. presented to clinic Monday 8/30/10 at 0800 with erythema around injection site (est. 60-70mm) and small blisters noted directly over site of injection. Onset 24 hours after inj.: fever, chills, body aches, malaise. Spoke with pt. via telephone 8/31/10. States injection site has improved.
Information has been received from a physician concerning an 18 year old female who on 18-MAY-2007 was vaccinated IM in her left arm with Vaqta. Concomitant therapy included Gardasil and Boostrix. On 19-MAY-2007 the patient experienced severe lower right abdominal pain. he patient sought medical attention at the hospital and had a CT Scan performed. It was reported the CT Scan was normal and the patient was not admitted to the hospital. Subsequently, the patient recovered from severe lower right abdominal pain. Additional information has been requested.
Flu like symptoms last two days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced influenza-like symptoms (Verbatim: Flu like symptoms last two days). The outcome of the influenza-like symptoms was resolved (duration 2 days).   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine.     It was unknown if the company considered the influenza-like symptoms to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 16-MAR-2023 This case was reported by a patient via interactive digital media. The patient just got the booster, and flu like systems last two days. The follow-up could not be possible as no contact details were available.
1st dose on 09Aug2022, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 6-month-old patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   Previously administered products included Rotarix (received 1st dose on 9th August 2022).   On an unknown date, the patient did not  receive the 2nd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16 DEC 2022 Reporter's comment: The pharmacist reported that the patient, had not given a second dose and now the patient was over 24 weeks of age.  Reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Rotarix which led to incomplete course of vaccination.
confused; arm being sore; tired/bushed; lethargic; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (confused), LETHARGY (lethargic), PAIN IN EXTREMITY (arm being sore) and FATIGUE (tired/bushed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021 at 1:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced LETHARGY (lethargic). On an unknown date, the patient experienced CONFUSIONAL STATE (confused), PAIN IN EXTREMITY (arm being sore) and FATIGUE (tired/bushed). At the time of the report, CONFUSIONAL STATE (confused), LETHARGY (lethargic), PAIN IN EXTREMITY (arm being sore) and FATIGUE (tired/bushed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were reported.
Sudden onset of severe paresthesias 6 hours after injection, lasting 6 hours. So painful that he could not sit or drive, difficult to move. Had not had paresthesias since 2012, when he had a prolonged episode lasting several months.
pt to ED 1/19/21 with c/o worsening SOB and abdominal pain; was recently in the hospital and contracted COVID, positive test on1/13/22, was treated with remdesivir, dexamethasone, ABX; pt still for COVID on 1/19/22; rectal bleeding; O2 supplementation; COVID pneumonia; pt's condition worsened; more hypoxic; transitioned to comfort care and passed away in the hospital
Received dose from expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 054C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperglycemia since 29-Sep-2019 and Pure hypercholesterolemia since 26-Aug-2008. Concomitant products included HYDROCHLOROTHIAZIDE from 17-Sep-2019 to an unknown date for an unknown indication.   On 17-May-2021 at 1:38 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021 at 9:26 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial). On 24-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
aches; congestion; sneezing; stuffy nose; soreness of arm; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (aches), NASAL CONGESTION (congestion), SNEEZING (sneezing), NASAL CONGESTION (stuffy nose) and PAIN IN EXTREMITY (soreness of arm) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced PAIN (aches), NASAL CONGESTION (congestion), SNEEZING (sneezing), NASAL CONGESTION (stuffy nose), PAIN IN EXTREMITY (soreness of arm) and CHILLS (chills). On 08-May-2021, CHILLS (chills) outcome was unknown. On 15-May-2021, PAIN (aches), NASAL CONGESTION (congestion), SNEEZING (sneezing) and NASAL CONGESTION (stuffy nose) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness of arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.  PCP said symptoms might be from the people hangs out with. Mother believes the chills are from the vaccine.
This spontaneous report as received from a healthcare worker refers to patient of unknown age and gender. On 06-AUG-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot # K011562, expiration date 08-APR-2017) (strength, dose and route were not provided). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Pt recvd a series of 3 Engerix-B vax on 8OCT90, 20NOV90, 16MAY91 & was a poss non-responder; also had glaucoma treated w/eye drops daily;
He was sitting and eating at the dinner table and he had a 30 sec to 1 minute episode of shaking, and stiff arms. No choking on food. He said a brief " hi" when he came out of it and then he was sleepy. This has never happened again, and he does not have a history of this. Grandmother had seizures with the pertussis immunization when she was little. He did get immunizations 1/28/2010 prior to this.
Administered vaccine w/o diluent.  Informed parent to monitor closely and call with concerns.
Rash began on posterior L neck 5/19/21. Gradually progressed to L arm then Left breast Left stomach left thigh. Then began on right after 5-6 days. Raised papular and macular erythematous areas. Pruritic. Started Prednisone taper and triamcinolone cream today .
Infant was found supine in crib, having emesis around mouth, pale color and very listless upon attempt to arouse. Parents brought infant immediately to pediatrician and was evaluated immediately upon arrival. 10 minutes from home, color pale, not cyanotic, lethargic and mildly tachypneic. 9-1-1 called and face mask oxygen given.  1/8/08 Received vax record which confirms dose & lot #s as reported./ss 1/18/08 Reviewed hospital medical records which reveal patient experienced vomiting & pallor followed by unresonsive episode.    Admitted 12/20-12/22/2007. No further episodes while hospitalized.  D/C to home on apnea monitor. FINAL DX: ALTE.
Symptoms noted on 8/11/2021 at site of injection on Right thigh. Right Lateral thigh with oval Red area, waRm to  touch, nontender, no pus, no induRation - ARea is  7cmX6cm
started getting arm pain in the injection site 03/28/2021,  arm pain,fever, chills, nausea, exhaustion 03/29/2021,
Lost taste and smell 2 days post vaccine along with a positive cover test 3 days post vaccine
pain in the injection site; experienced difficulty when sleeping at night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: Vaccination site pain (non-serious), outcome "unknown", described as "pain in the injection site"; INSOMNIA (non-serious), outcome "unknown", described as "experienced difficulty when sleeping at night".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
booster; Ocassional rheumatoid arthritis flare up; Weak; Chills; This is a solicited report based on information received by Pfizer from a company. MFR Control No.: 21K-163-4147000-00. A contactable 52-year-old male consumer (patient) reporter for himself that:  Solicited report by a consumer of an adult male with events of non-serious occasional rheumatoid arthritis flair up, weak after Pfizer booster and chills after Pfizer booster with Humira (adalimumab). There was no reported medical history. No known allergies. No Concomitant Drugs Taken. No Relevant Medical History. On unknown dates, the patient experienced occasional rheumatoid arthritis flair up, weak after Pfizer booster and chills after Pfizer booster. On unknown dates, weak after Pfizer booster and chills after Pfizer booster resolved. Pfizer BioNTech covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. He received COVID-19 Vaccine manufactured by Pfizer/BioNTech. The patient was treated with Tylenol paracetamol.  The reporter's causality for the events of occasional rheumatoid arthritis flair up, weak after Pfizer booster and chills after Pfizer booster with Humira (adalimumab) was no reasonable possibility.  The reporter's causality for the events of occasional rheumatoid arthritis flair up, weak after Pfizer booster and chills after Pfizer booster with Pfizer-BioNTech Covid-19 Vaccine was not reported.  The reporter's assessment of the causal relationship of the events with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are needed; information about lot/batch no. can not be obtained. No further information is expected.; Sender's Comments: Based on the information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be established. 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.
No adverse event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medications details were reported.  Patient received vaccine at Pharmacy.  Beyond use date of the vaccine was 17-Feb-2022.  No treatment medications details were reported.  NDC number was reported as 80777-273-10.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow-up received wherein patient and vaccination details added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:master case
Fever spiking to 105 degrees F, sustained at 104 degree F for approximately 11 hours, accompanied by severe nausea. Treated with max dose of TYLENOL.
About 8 and 1/2 minutes I started not feeling well. I got up told the observer I was going to go lie down and did not make it. I passed out, I was probably out for 2 minutes. At that point the observer was with me for about 20-30 minutes. I had hit my head and my jaw was sore from falling on my face. I went home. I went to my PCP with in a week or so to document the bruising. I'm actually going to get an MRI in the coming month. About mid June after my 2nd vaccine, I started having a weird sensation in my left temporal lobe. For the first several weeks I just thought it was from the fall and then it persisted. I'm going to have an MRI next Monday to rule out any issues.
pt recvd vax 1APR93 & 5APR93 revealed a neg titer; no further details are available as the pt was lost to f/u;
Onset of symptoms on 11/6/23 at approximately 2200: not wanting to nurse, irritable, not making wet diapers in over 4 hours, one bloody stool, appeared to be in pain. Advised to go to the ER.  Went to ER.  Diagnosed with Intussusception and transferred to another hospital.  IV hydration and non-surgical reduction attempted with barium enema, but unsuccessful.   Surgical reduction with removal of right lower colon and part of the small intestines.
Patient presented to emergency department on 8/23/2021 with abdominal pain and rectal bleeding. She had tested positive for COVID-19 on 8/12/2021 at an outpatient facility following a trip. At that time she had fever, coughing, headache and body aches. She did not report any of these symptoms during admission and was not treated for COVID-19 during admission. She was discharged on 8/27/2021.