chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The night prior to syncopal event, was told by spouse that I was "burning up"  I did not feel warm.  The next day, prodromal lightheadedness while standing during singing resulted in a fall to floor.  In retrospect, I hit head as now experiencing point tenderness posteriorly.  After regaining awareness was able to resume usual activity.
Swelling at left arm injection site that has increased in size and pain since day 2. Body aches, dizziness since day 3. Fever since day 4.
expired ACT-HIB was accidentally given to a 1-year-old female patient/ no AE; Initial information was received on 30-Jun-2021 regarding an unsolicited valid non-serious case received from a Other health care professional via Agency (Reference number- 00663874) and transmitted to Sanofi on 30-Jun-2021.  This case involves a one-year-old female who was mistakenly vaccinated with expired dose of 0.5 mL of (total) HIB (PRP/T) VACCINE [ACT-HIB] (lot number UJ329AB and expiry date 06-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination on 30-Jun-2021 (expired vaccine used).]  Diluent batch number U6789AA and expiry date 21-Oct-2021.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for prophylactic vaccination, PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of reporting, patient had no adverse event.  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.
30 y/o female pt complaining of dry mouth & difficulty swallowing. Pt CAO x 4, Vitals stable. Visual inspection of oropharynx was normal. Pt recovered w/o treatment.
Information has been received from a registered pharmacist concerning an adult patient (age and gender unknown) who was "recently vaccinated intramuscularly with a 0.5 mL dose of Pneumovax 23. Subsequently the patient developed injection site redness, swelling and local heat. The patient sought unspecified medical attention. At the time of this report, the patient was recovering. Additional information has been requested.
Initial report was received from a health care professional on 18 October 2010. An unidentified female patient with no reported past medical history, had received FLUZONE HIGH-DOSE No Preservative 2010-2011 (lot number, date, route and site of administration not reported) and an unspecified amount of time later, experienced "trouble breathing". The patient was evaluated in the emergency room (ER). No further information was available at the time of the report. The patient's outcome was not reported. The reporter for this case is the same as for 2010-06069. Documents held by sender: none.
Swollen lymph nodes; This is a spontaneous report from a contactable Consumer or other non-health professional (reported for daughter). A female patient of unknown age (Age:18; unit: Unknown) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number and expiration date: not reported) via an unknown route of administration on an unknown date in 2021 (reported as a week ago) as single dose for COVID-19 immunization. Patient received first dose of BNT162B2 (solution for injection, Batch/Lot number and expiration date: not reported) via an unknown route of administration on an unknown date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, the caller was calling regarding the covid vaccine. The caller's daughter was 18, the whole family got vaccinated, when the caller's daughter got the first shot her armpit lymph nodes were swollen and then it went away on an unknown date. Now the caller's daughter noticed that, underneath her jaw her lymph nodes were swollen. The caller made an appointment to go to the doctor a little bit later. The caller wants to know this could be a side effect even though she took the second vaccine a week ago. The first time the lymph nodes were inflamed under the caller's daughter's arms, but the caller's daughter just noticed this swelling under her neck/jaw area, so the reporter was unsure how long it has been like this. The outcome of the event was unknown.   No follow-up attempts were possible; information about lot/batch number cannot be obtained.
Diagnosed with Central Retinal Vein Occlusion by Ophthalmologist in right eye.  Vision became blurry and over time got to the point that pt could not see.  Doctor made the diagnosis and gave patient steroid injection in affected eye.  Sight is beginning to return to normal.
The day after the vaccination, I woke up with atypically cold and discolored red violet hands to wrists, lasting about six days. Irregular heart rhythm and breathing especially during sleep. Intense headaches for roughly 8 days, high blood pressure. Roughly days 4,5,6, being the worst for the headaches, blood pressure and rhythm.  Also, day 8 and 9 after the vaccination, sudden red spot on left arm, site of injection appeared, being itchy. Diminished day 10.   Day five and six  I was very concerned with out of synch breathing, headaches and high blood pressure.  Hands still flashes of being cold, and less severe headaches.
Pounding heart with noticeable skipped beats, similar to prior occasional PVC's induced by caffeine, but much more noticeable and constant.  Occasionally would become more rapid, and cause me to cough.  Started about 2 hours after second moderna vaccination and lasted for about 3 months in the constant phase...then became more intermittent until just occasional almost a year later.
Shoulder, chest, underarm and left breast pain on my left side.; Shoulder, chest, underarm and left breast pain on my left side.; Shoulder, chest, underarm and left breast pain on my left side.; Shoulder, chest, underarm and left breast pain on my left side.; This is a spontaneous report from a contactable consumer(patient). A 59-year-old non pregnant female patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EWO151), via an unspecified route of administration on 19Apr2021 at 10:30 ( at the age of 59 year old) into left arm as a single dose for COVID-19 immunization. Medical history included high blood pressure, cancerous cyst removed, covid-19, Cholesterol. The concomitant medications included blood pressure and cholesterol medication. The patient did not receive any other vaccine in four weeks. Prior to the vaccination, the patient was diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. The patient did not have any allergies. On 20Apr2021 at 08:30 AM, the patient experienced Shoulder, chest, underarm and left breast pain on my left side. The patient was performed EKG and scheduled stress test for heart precaution. The adverse event did result Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering.
Cellulitis left thigh - seen at ER Tx: Ibuprofen - Benadryl Rechecked 02/16/06 at clinic - sx improving
Colitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 44 years 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: COLITIS (non-serious), outcome "unknown", described as "Colitis".  Additional information: Report not related to a study or programme. Pfizer COVID-19 vaccine manufacturer was unspecified. Reason for no lot number: of Pfizer COVID-19 vaccine: Caller unwilling to complete the report. Expiry Date of Pfizer COVID-19 vaccine not Provided. Investigation Assessment not Provided. Consumer says he would like to know if colitis could be a symptom from Pfizer vaccination, clarified to Pfizer COVID-19 vaccine. He says he looked it up and it said it was an inflammation of intestines, and he wants to know if it could be related in any way to the vaccine. Caller declines to complete a report at this time, and says that he got the vaccine at the (place withheld) and they said it was Pfizer.  Address: Caller declines to provide. Caller says he is kind of in a panic, and wants to know the medical stuff, he went to the hospital and read and googled it and it said something about it with the vaccine. No further details provided about going to a hospital. No further details captured, reported, or documented at this time.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
When she left for travel overseas on 8/2/04, caught a cold, which progressed over the next few days and weeks to high fever, weakness, leg cramps. Fatigue was so severe that she "felt like I was going to die." Also had some non-bloody diarrhea on the trip and altitude sickness. Extreme fatigue, leg cramps, difficulty walking lasted about 2 months or more. Treated with Zoloft and conditions improved.
no adverse event; Improperly stored dose of PROQUAD administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 14-DEC-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # U019286, expiration date 15-DEC-2022 (therapy type rHA), 0.5 milliliter, subcutaneously, for prophylaxis.     The vaccine was stored at a temperature of 6.8 fahrenheit degrees during 8 hours and 5 minutes. There were no previous temperature excursions. No adverse events were reported.
Nausea and vomiting for 1 day.  Prescription provided today for Zofran (4mg) 2 tablets by mouth 2 times a day as needed up to 4 doses
Got second dose of vaccine 6/2.  Same day had chills, myalgia, fatigue and soreness at injection site.  6/3 developed substernal chest pain and dyspnea.  Admitted to hospital for suspected myocarditis given elevated troponin and mildly elevated inflammatory markers 6/4.   No treatments given.  Symptoms resolved and troponins improved prior to discharge 6/8.  He remains well today 6/14.
S/S of Bell's Palsy, Left side of face weak and numb, hard to close Lt. eye.  Lt. 7th nerve palsy. Treated with steroids.
she had her first Shingrix vaccination 3-4 years ago; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st Shingrix vaccination 3 to 4 years ago).   On an unknown date, the patient did not receive Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: she had her first Shingrix vaccination 3-4 years ago).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 22-SEP-2023 Consumer was the reporter stated she had her 1st Shingrix vaccination 3 to 4 years ago no further information was known, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Severe thrombocytopenia (life-threatening); This is a spontaneous report from a contactable pharmacist. A 24-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FD8448), via an unspecified route of administration at the age of 24-year-old administered in arm left on 04Sep2021 at single dose for covid-19 immunisation. Medical history included obesity. The patient's concomitant medications were not reported. There was no other vaccine in four weeks. The patient previously received first dose of BNT162B2(COMIRNATY, Batch/Lot number: FD8448) at the age of 24-year-old on 14Aug2021 at left arm for COVID-19 immunisation. The patient experienced severe thrombocytopenia on 12Sep2021. Adverse event resulted in Emergency room/department or urgent care, hospitalization and life threatening. The patient was hospitalized for event for 16 days. The patient underwent lab tests COVID-19 Rapid Abbott IDNow: negative on 22Oct2021. Adverse event was treatment included a lot of medications and products. The outcome of event was recovering.; Sender's Comments: Based on the temporal relationship the role of the vaccine BNT162B2 in contributing to the reported event severe thrombocytopenia 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 RAs, Ethics Committees, and Investigators, as appropriate.
Male neglected to inform staff that he had received first dose of pfizer covid vaccine in between his first and second dose of moderna  covid vaccines.
Information has been received from a nurse concerning a female who on 21-SEP-2009 was vaccinated SC with 0.5 ml dose of ZOSTAVAX (Merck) (lot # 664634/0742Y). On 07-JAN-2011 the patient experienced a vesicular rash on her right leg that appeared to be herpes zoster. The outcome of vesicular rash on her right leg was unknown. The patient was given TYLENOL and FAMVIR (also reported as MAVIR). The patient sought unspecified medical attention. No  further information is available.
Pt recv vax on 9/9/98; 3 hrs later pt exp hives & swollen lips.  Family directed to call E.R. for tx.
This case was reported by a physician via call center representative and described the occurrence of ophthalmic herpes zoster in a 75-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), herpes zoster and herpes simplex type I reactivation. The patient was treated with VALTREX. On an unknown date, the outcome of the ophthalmic herpes zoster, herpes zoster and herpes simplex type I reactivation were recovering/resolving. It was unknown if the reporter considered the ophthalmic herpes zoster, herpes zoster and herpes simplex type I reactivation to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported but, it could be 74 or 75 years. The patient developed severe reaction to vaccine with ophthalmic and facial distribution of herpes zoster and reactivation at the same time of herpes simplex virus (HSV) I. The patient was treated with VALTREX full dose for 10 days and it took almost 4 weeks for her to get better. The reporter wanted to know, if the patient could be given 2nd dose of vaccine and if the patient should be pre-medicated or should be treated during when the symptoms were back.
Pinkish rash appeared near injection site and has been getting larger,moving upwards toward the shoulder,  since first noticed.  It does not itch and is not painful. There is a bit of puffiness.
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient warned pharmacist he passes out often after vaccines or blood draws. Within 1 minute after vaccine, patient started to sweat and lean forward off of bench he was sitting on. Pharmacist helped patient sit back at first but then decided to lay the patient down on the patient after it was clear patient was about to faint. Patient fainted for about 10-20 seconds then abruptly opened eyes and quickly acknowledged that he had fainting and sat up. Patient was given water and left in 40 minutes
The patient reported that she has known vaso-vagal syncope with shots or blood draws so she was given the shot in the medical tent by nursing staff in supine position. She tolerated well. She was observed x 15 minutes and felt well, however, when she stood up to leave she reported feeling light-headed again. EMS evaluated her and found BP 70/50 and HR in 30s-40s.  BS 111. RR 16. The patient was put back into supine position and reported feeling well after a few minutes. She was able to sit up and drink water and orange juice, however, she continued to have episodes of bradycardia and hypotension. EKGs were performed laying, sitting, and standing. NSR with HR in 60's while laying down but bradycardia with HR 30s-40s when sitting or standing and patient reported feeling light-headed in those positions. She initially refused transfer to the ED for further evaluation but after counseling she did agree and was transferred via ambulance in stable condition.
sick; This case was reported by a consumer via media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received a dose 10 years ago and was fine).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received the current Shingles vaccine and was sick as a dog. The patient thought that he/she would rather suffer the disease. The follow-up could not be possible as no contact details were available.
injection site redness; Injection site swelling; injection site pain; joint aches; fatigue; body aches; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site pain, joint pain, fatigue and general body pain. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site pain were recovered/resolved and the outcome of the joint pain, fatigue and general body pain were recovering/resolving.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain, joint pain, fatigue and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Five months before the time of reporting, the patient received the Shingrix vaccine via intramuscular route. One day following the vaccination, the patient developed injection site redness, pain, and swelling accompanied by body aches, joint aches and feeling fatigued. On an unknown date the injection site redness, pain, and swelling resolved. However the body aches, joint aches, and feeling fatigue was reported as ongoing, but improving. The reporter did not consent to follow up.
The patient was given the Pediatric Pfizer dose as her booster for ages 5-11.  The patient turned 12 on 3/23/22.
Arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Arm was sore at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.    The patient's past medical history included No adverse event. Concurrent medical conditions included No adverse event.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced INJECTION SITE PAIN (Arm was sore at the injection site). At the time of the report, INJECTION SITE PAIN (Arm was sore at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 12-SEP-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In approximately 2013 [reported as "shortly after" receiving the ZOSTAVAX], the patient suffered vision issues including but not limited to blurry vision, floaters and black swirls in his vision. The patient was diagnosed with posterior vitreous detachment of the left eye and partial retinal detachment of the right eye. He was additionally diagnosed with blepharitis in both eyes. As a direct and proximate result of the ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of his condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including, but not limited to, the following: patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical expenses and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, posterior vitreous detachment of the left eye and partial retinal detachment of the right eye were determined to be medically significant. Posterior vitreous detachment of the left eye, partial retinal detachment of the right eye, and blepharitis in both eyes were considered to be disabling.  Additional information has been requested.
starting 12 hrs after vaccination and lasting ~24 hrs: chills, joint ache, headache, weakness, loss of appetite --- all symptoms gone as of morning of  2/28 --- NOTE: I tested positive for covid 12/14/2020, moderate symptoms lasted about a week (similar to above), no med facility visit, subsequently tested negative about a week later.
A 2 x 2 1/4 area of erythema and warmth a site of vaccination, no induration. Given a prescription for cephalexin 500mg twice day for 7 days.