chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a 46 years old non-pregnant, female nurse who refers, via company representative, to herself. The patient was vaccinated with a dose of (Merck) VARIVAX (dose, route and lot# not reported) when she was child (date and age not specified). On an unknown date the patient experienced shingles 2 times and chicken pox 13 times. The outcome of shingles 2 times and chicken pox 13 times was reported as recovered/resolved 9recovery dates were not reported). It was also reported that the patient sought unspecified medical attention. Additional information has been requested. This is one of several reports from the same source.
she tested positive for covid today; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (she tested positive for covid today) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Oct-2022, the patient experienced COVID-19 (she tested positive for covid today). At the time of the report, COVID-19 (she tested positive for covid today) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Oct-2022, SARS-CoV-2 test: (Positive) tested positive for covid today.         No concomitant medication information was provided.  Patient asked "Did she get a breakthrough infection? Did she catch a variant that the booster did not cover.  No treatment medication was provided.   Reporter did not allow further contact
10 minutes after vaccine administration patient developed a large area of swelling and redness around the injection site. Pt also experienced itching. Pt was treated with 50 mg Benadryl and ice packs. Pt was observed for 30 minutes and then released.
Pt recv vax on 5/5/98; on 5/15/98 pt exp urticaria rash
On September 10th, 2021, I woke up with a rash which I initially assumed were bug bites,  After getting treated with two different pathways, Permethrin Cream and Ivermectin, it continued to persist.  I made an emergency appointment with my Dermatologist, brought pictures and returned a second day to show them what it looked like, they proceeded with a biopsy, Hydroxyzine and a topical steroid.  It was determined that I had hives.  The treatments failed and after 30 days I took myself to a hospital seeing they just continually got worse, more and more swollen and itchy on all parts of my body.  There was no rhyme or reason and would come and go but always staying longer and more prominent each time they arrived.  The hospital took my blood pressure, gave me a PCR covid test, did blood work, gave me an EKG and did a chest X-Ray.  Everything came back negative and they told me I had no underlying issues/infections for the hives.  They provided an inhaler and the steroid pack Prednisone.  I am 2 days out from finishing the steroids and it seems to have subsided at the present moment.  I also wanted to make sure I could get my Phizer covid booster shot safely.  I went to get my Phizer (33025BD) covid booster on 12/27/21 (Acme 2855).  The hives came back even stronger than ever once I reacted to the Pfizer booster 48 hours after the shot.  I did some research on the J&J vaccine and there have been over 400 cases of something similar to my situation.  The pictures I found on-line were consistent with my pictures.
Nauseous, chills, swearing, dizziness, weakness, pain and throbbing at injection site.
Sore Arm - 2 days Severe Headache - 2 days Malaise, achy - 1 day
patient said she experienced a raised hard welt and it has been getting progressively larger and warm to the touch
Red area at site of vaccine shot on upper left arm with some minor heat nine days later. Soreness for 3 days after vaccine had passed. Currently no soreness just a local sensation of heat.
received  one 2 months ago in September and got one on 10NOV2020; soreness at the injection site; Initial information regarding an unsolicited valid non-serious case received via a pharmacist on 13-Nov-2020.  This case involves an unknown age male patient who experienced soreness at the injection site (injection site pain) and received one 2 months ago in september and got one on 10nov2020 (extra dose administered), while treated with influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.   On an unknown date in September 2020, the patient received a dose of suspect influenza quadrival a-b high dose hv vaccine (lot number: UJ540AA, expiry date: 30-Jun-2021) at an unknown dose, frequency via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in 2020, (unknown latency) after starting the suspect vaccine therapy the patient had soreness at the injection site (injection site pain).  On 10-Nov-2020, approximately two months after starting the suspect vaccine therapy patient got another dose (extra dose administered).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event injection site pain was unknown.  Disclaimer: 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.
Besides many aches and pains that occurred later that evening and the next two days, I wanted to inform the CDC about a lump in my arm pit of the injected arm.  It felt as though it may have been approximately an inch in diameter upon self-examination.  The painful lump remained for three days; was diminished in size on the third day; and was gone on the 4th day.
Pt received vaccine 3/30/00 and subsequently developed an injection site reaction characterized by redness and warmth.
kidney dysfunction; blockage of the kidney; creatinine was high; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration in Apr2021 (Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization and felt dizzy. On 01May2021, the patient experienced kidney dysfunction and blockage of the kidney. On the same date, when his bloodwork was checked by the doctor, his creatinine was high. The patient has not gone through this before and thought it must be a side effect of the COVID-19 Vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Temporary loss of taste followed by decreased hearing in the left ear. There were in addition to joint pains, pain the rt arm, body aches.
Cold w/cough; not able to eat or drink secondary to vomiting; temp 104.8F; not urinating; had area of redness @ inject site the size of quarter.
Pt. received 4th dose of Hepatitis B pt. received 1st dose 10/26/2000 2nd dose 11/30/2000 3rd dose 7/25/2001 4th 8/29/12 no adverse event (just 4th dose).
On 1/28 at ~1330 employee woke up from nap with chest pains. No previous history of chest pain or any other significant health issues. No medication was taken at time of vaccination or prior to appointment. Was advised to seek care. Went to urgent care and diagnosed with costochondritis. Given Toradol shot and chest pain began relieve within 30 min. 1/29 reports no chest pain, but still has weakness and persistent headache.
Initial report was received from a health care professional on 05 January 2011. A 49 year-old female patient with a past medical history of thyroid cancer and hypothyroid had received an intramuscular injection of ADACEL (lot number, site of administration not reported) in December 2010 (exact date not reported) and approximately 10 days later, reported she could not move her shoulder, had "a lot of pain" at the site and experienced injection site tenderness, slight swelling and redness. The patient was evaluated by a physician. Treatments were not reported. Concomitant medications included LEVOXYL (spelled LEVOXIL). No further information was available at the time of report. The patient's outcome was reported as not recovered. Documents held by sender: none.
DTaP and Hib given 06/01/05. About 4 hours later very fussy with red flushed legs all the way down to ankles. Fussiness resolved with Tylenol overnight. This a.m. acting normal but extensive petechire on both legs from waist down.
Pt recvd Hep B vax in approx 1984 & on 25MAR92 recvd 4th dose of vax & exp local tenderness @ the inject site which persisted for several days; 28MAR92 pt devel severe shoulder pain & neck pain;
Got sore throat and upper respiratory infection the day after vaccination, he ended up with bronchitis treated with amoxicillin and steroids in hospital, then diagnosed with serum syndrome. Still in hospital as of 10/2/14.
arm swollen, red, hard, temp, dizzy, nauseated, diarrhea;saw nurse @ health center;also saw pvt MD
Stated that symptoms began with a cough around 6/12, and symptoms gradually got worse since then. Pt was tested first on 6/22 from their family doctor, and then was admitted to medical center on 6/24. Pt was diagnosed with bilateral pneumonia and is in the ICU currently because he is on oxygen (not mechanical ventilation). Pt has high blood pressure and history with kidney stones.
This spontaneous report as received from a medical assistant refers to 4 years old patient of unknown gender. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. The patient received VARIVAX dose 0.5 ml, intramuscularly, lot J006358 expiry 23-MAY-2015, between 12-APR-2014 and 24-APR-2014. There was a site visit from local health department on an unspecified date. No adverse effects was reported. This is one of several reports from the same source. Additional information has been requested.
Discharge Attending of Record: MD Primary Care Provider: MD  Documenting Provider: PA-C Admission Date and Time:  10/31/2022  8:29 PM Discharge Date and Time: 11/03/2022 1:09 PM Positive Covid Date: 11/1/2022  Admission Diagnosis:   1. Dyspnea Discharge Diagnosis:   1. Dyspnea with history of severe pulmonary emphysema and hypoxia 2. COVID-19 infection with no evidence for COVID pneumonia   The patient is an 83-year-old male with history of severe emphysema, moderate chronic obstructive pulmonary disease with exacerbations who presented to the emergency department with increasing dyspnea.  He did have a workup in the emergency department of a chest x-ray that did show chronic changes of pulmonary emphysema along with persistent opacity along the lateral aspect to the left upper lung which could represent scar less likely pneumonia.  Emergency department did place the patient into the observation unit for further workup of the cause of his dyspnea.  His it did see that the patient was having a chronic obstructive pulmonary disease exacerbation he was given steroids along with duo nebulized treatments.  We also did order a Lexiscan Myoview cardiac stress test to ensure that his dyspnea was not a cardiac equivalent.  Patient had stable troponins with no life-threatening arrhythmias on telemetry.  Lexiscan Myoview did not show any signs of ischemia.  Secondary to patient's history of severe emphysema pulmonology was consulted who did recommend a film array.  His COVID-19 was negative initially been on film array it was positive.  Pulmonology did feel that steroids and DuoNebs were appropriate.  Patient was overall feeling improved.  He was desatting his oxygen on ambulation so pulmonary rehab was consulted and they did set him up for home oxygen.  Repeat chest x-ray does not show any evidence of infiltrate.  At this time pulmonology feels comfortable discharging home with a long week of steroids which was written.  He does have his inhalers at home and will have home oxygen.  He will follow-up with his pulmonologist in the next couple of weeks as he does have an appointment.  No antibiotics are recommended by pulmonology at this time.  He feels improved upon discharge.  He will come back with any progressive symptoms or concerns but is sent home feeling overall improved.  He did see physical therapy and occupational therapy while here who did not recommend any additional modalities.
Exposed to Covid 12Jun, experienced symptoms starting 15Jun. Tested positive 17Jun.; Exposed to Covid 12Jun, experienced symptoms starting 15Jun. Tested positive 17Jun.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 30Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 31Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "birth control" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 15Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 15Jun2022, outcome "recovering" and all described as "Exposed to Covid 12Jun, experienced symptoms starting 15Jun. Tested positive 17Jun.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jun2022) Positive, notes: Tested positive 17Jun. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks product reported synthroid, birth control. Exposed to Covid 12Jun, experienced symptoms starting 15Jun. Tested positive 17Jun. Started Paxlovid 17Jun in the evening. Took the 5 day dose. Felt better then had a sore throat come back 27Jun-29Jun.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
transplant patient was given 0.25mL booster instead of 3rd 0.5mL dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (transplant patient was given 0.25mL booster instead of 3rd 0.5mL dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (transplant patient was given 0.25mL booster instead of 3rd 0.5mL dose). At the time of the report, ACCIDENTAL UNDERDOSE (transplant patient was given 0.25mL booster instead of 3rd 0.5mL dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
EXPERIENCED NUMBING AT THE BASE OF THE TONGUE THE EVENING OF 2/13/21.  EXPERIENCED TINGLING AT THE NAPE OF THE HEAD 2/14/21.  PT WAS NOT ABLE TO CLOSE LEFT EYE COMPLETELY THE MORNING OF 2/15/21.
DIED; This spontaneous report received from consumer social media via a company representative concerned a 20 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died from unknown cause of death and it was unknown if an autopsy was performed. The action taken with covid-19 vaccine was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210902775.; Sender's Comments: V0:20210902754-covid-19 vaccine  Died. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Pt came in today (8/27/15) around 11 AM with redness and swelling on (L) arm where varicella vaccine was given. Pt noted it swelled up day after inj. (8/26/15) and that it continued to swell even more. Walked pt in w/ FNP-C. Pt given Z-PAK 250 mg cap QD #6.
The pt developed left hip pain 24 hours later and 11x6cm rash at injection site.
er states pt exp allergic rxn with lips swollen, urticaria rash, inject site pain, primary diagnosis: angioedema/urticaria
Pain in left arm on first day; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non- pregnant female patient received first dose of BNT162B2(PFIZER- BIONTECH COVID-19 mRNA Vaccine; Lot number: EN6208), via an unspecified route of administration in the left arm on 16Mar2021 at 11:45 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy to Codeine. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not tested for COVID-19. On 16Mar2021 at 18:00, the patient experienced pain in left arm. The patient made sure to drink a lot of water and workout but her arm was still really sore. No therapeutic measures were taken for the reported event. The clinical outcome of the event vaccination site pain was not recovered/ not resolved.    No follow-up attempts are needed. No further information is expected.
Right facial Bell's palsy onset 8/9/2018 with complete paralysis on 8/12/2018. As of 8/17/2018 exam she has right facial weakness with no forehead muscle activation, limited eyelid closure, and inability to smile. She needs to drink from a straw. She also had pain. She did go to an ER on 8/11 and was prescribed prednisone and Valtrex. Steroids have been completed and last dose of Valtrex is on 8/17/2018.
Around 2pm on 11/10/21 an elderly woman and her husband came for their vaccinations. The woman had some difficulty with sitting and standing, so I administered her vaccinations first so she could stay seated while I administered to her husband. While her husband was getting his shirt ready, I noticed the female patient was staring off into space, so I checked on her and she was not as responsive as she had been before and directly after receiving her vaccinations. She then started to report abdominal pain/cramping which is when I got the attention of in the pharmacy to be on stand-by to call a Department 50 if needed. Within a few seconds, the patient said her back started hurting and I had call a Department 50. The patient's face then became very flush and red and she continued to have stomach and back discomfort. I had one of the team grab a more comfortable chair to transfer the patient to with the hopes of relieving the stomach and back discomfort. The patient's back pain very quickly reduced when transferred to the more comfortable chair, and the stomach discomfort also reduced and went away within a few minutes. We offered water and juice and the patient did not want anything. I verified the patient had eaten breakfast and lunch before coming in. The facial flushing went away as her stomach and back pain went away as well. After the patient said they were back to full baseline, I administered both vaccinations to her husband. When the female patient and her husband were ready to leave, store leadership offered to have an ambulance come by to check on the female patient, the female patient declined this offer. I strongly suggested the female patient use a wheelchair for the rest of their time in the store, but the patient also refused that suggestion. I had the patient stand and stay still to ensure she was steady and less likely to fall. The patient displayed no signs that she was any less stable on her feet than she was when she initially presented to us for her vaccinations. I observed the patient and her husband as they walked away down the and there were no signs of increased fall risk any more so than when they initially presented.
Tachycardia/ possible supra ventricular tachycardia/heart rate 209; Temp 99.9 (orally); Mild local discomfort at injection site; General fatigue; This is a spontaneous report from a contactable physician reported for himself. A 74-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 18Jan2021 13:15 at single dose for COVID-19 immunisation. There was no medical history. No allergies to medications, food, or other products. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Morning following the injection noted mild local discomfort at injection site on 19Jan2021, no other signs or symptoms. General fatigue later that day. Awakened 11:30 pm (19Jan2021) with temp 99.9 (orally). Noted tachycardia. Did limited ECG with Kardia: heart rate 209, possible supra ventricular tachycardia. Otherwise asymptomatic. Slept until 5am on 20Jan2021. Awoke asymptomatic. Afebrile, sinus rhythm, pulse 102. At 5pm 20Jan2021, afebrile, sinus rhythm, pulse 92, asymptomatic. On 21 and 22 January, asymptomatic. Sinus rhythm, pulse <100.  Limited ECG 9 am on 22Jan2021 showed RSR, rate 87. Note that the patient has had NO previous history of cardiac problems, take no medications or supplements, all ECG's previously normal. No treatment received for the adverse event. Events outcome was recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported event "Tachycardia/ possible supra ventricular tachycardia/heart rate 209" cannot be completely excluded based on temporal association. This case will be re-assessed when additional information becomes available.   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 identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Wed. I got the shot at 11:00 am - at 6:30 PM I got a pain in my shoulder. On Sat night 7:00 PM my muscle froze into a hard knot. The pain in my shoulder and arm remained. I used Aspirin for pain and a heating pad 3 times a day. Today is next Sat., the pain is slight.