chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received the first dosage of Moderna on Feb 3rd by injection on my right arm.  On Feb 8th I started experiencing rash/hives around my neck, chest, arms, stomach,  along with swelling  around my neck.  The swelling on my neck was oozing.  The  itching was unbearable.    However I was advised to get the second shot on March  3 rd.  However after the second vaccine my condition got worse.  I went to the ER and i was admitted into the hospital and spend a day in the hospital.  The treatment give did not help.  I was prescribed Benadryl and it did not help.  I continued to itch all over my body and it's unbearable.  I went to my primary care doctor for relief and i was sent to the emergency room once again.  I was prescribed Benadryl for the itching.  I have been taking Benadryl for over a month. The swellings on my neck they are scared to operate.  My life has been turned upside down after getting this Moderna vaccine.  It cause me to take time off from my job.  I am itching over and over.  I am in pain. My body is full of rash, the welling on my neck hurt.  I am uncomfortable.
I received my second Pfizer booster for COVID-19 on 4/10/2022. I also received a Fluzone Quadrivalent injection at the same time. Within a week of getting that shot, I got an inflammation at the base of my left thumb, where the hand meets the wrist. I was unable to use my thumb, as it was so painful, so I got a brace for my thumb to immobilize it. I also had pain in my neck, and it extended from my neck to the base of my spine and along my left shoulder to the shoulder joint. Also, I had pain and stiffness in the right shoulder joint, and it made it very painful to move my arm. On 6/8/2022 and 7/27/2022, I spoke to my PCP about my symptoms. I had a previous injury to my right shoulder from 50 years ago, and it never healed properly, and the inflammation I developed after the vaccinations aggravated this. My PCP suggested that I see an orthopedic surgeon to discuss possibilities for surgery. The orthopedic surgeon recommended that I undergo a right shoulder replacement to alleviate the difficulties that I had from my 50-year-old injury.  I spoke with my PCP and my physical therapist, and they agreed that the inflammation that happened soon after I received my second booster was most likely caused by the injections, especially since I received two different ones at the same time. I decided to hold off on getting the shoulder replacement that was recommended by the orthopedic surgeon to see if the inflammation would resolve itself, which it did gradually over the course of several months. Since it resolved itself, I decided not to have the surgery. When I got my third booster in late September, I waited about a week until I got my flu shot. I experienced symptoms that were similar to the ones previously described, but much milder and much shorter in duration.
Hives all around site of injection going towards trunk. Fever of 103.9, very fussy and flushed red everywhere.
10 minutes after receiving vaccine in left upper arm she developed right arm pain, right leg tingling, lightheadedness, and bilateral hand swelling. Patient to ED, when arrived symptoms improved, reporting very mild lightheadedness and feeling very anxious. Pt observed of over 1 hour with vital signs stable and discharged to home.
loss of sight; passed out; Vertigo; sweats; sore injection site; rapid heart rate; loss of memory; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 06Aug2021 12:00 (Lot Number: FC3180) as single dose (at the age of 56-years-old) for COVID-19 immunization. The patient's medical history was not reported. The patient was not diagnosed with COVID prior vaccination. The patient had no known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced loss of sight, passed out, vertigo, sweats, sore injection site, rapid heart rate, and loss of memory; all on 06Aug2021 13:00. The events resulted in Emergency room/department or urgent care. No treatment received for the events. The outcome of the events was not recovered. The events loss of sight and passed out were considered as serious (medically significant).  Facility where the most recent COVID-19 vaccine was administered was in the Pharmacy or Drug Store. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Within 45 minutes, had an overwhelming metallic taste in mouth.  Lost ability to taste food for 36 hours.  Also had a fuzzy feeling in ears.    Next day had fatigue, headache, aches, shortness of breath.  Subsided within 48 hours.
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; lovastatin (LOVASTATIN), (Batch/Lot number: unknown) at 40 mg 1x/day (40 mg, 1x/day, (at bedtime)). The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17May2022, outcome "unknown" and all described as "Tested positive for COVID"; EXPOSURE TO SARS-COV-2 (non-serious) with onset 2022, outcome "unknown", described as "He tested positive for COVID on 17May2022 after being exposed to someone who had COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17May2022) Positive. The action taken for lovastatin was unknown. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a registered nurse, via a company representative, referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of M-M-R II for prophylaxis, intramuscular route instead of the recommended subcutaneous route (dose, strength, frequency, lot/batch number and expiration date were not reported). No adverse events were reported.  Additional information has been requested.
Received HPV #3 on 7/15/09. This vaccine expired on 6/29/09. Parents contacted. Pt will receive an additional HPV vaccine in 4 months to insure efficiency.
fatigue; uncomfortable; This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in an unspecified number of adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue and discomfort. On an unknown date, the outcome of the fatigue and discomfort were unknown.   It was unknown if the reporter considered the fatigue and discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient's age was not reported but age group was captured as adult as per vaccine indication. The patients experienced crummy fatigue and felt uncomfortable.  The reporter was unable to quantify or provide details regarding these patients. The reporter consented to follow up.  This case has been linked to US2019104149, reported by the same reporter. No other details were obtained.
Vertigo four days after vaccine, with no other symptoms until the vertigo started; The vertigo can be described as dizziness and nausea when moving head, which resulted in vomiting; The vertigo can be described as dizziness and nausea when moving head, which resulted in vomiting; The vertigo can be described as dizziness and nausea when moving head, which resulted in vomiting; This is a spontaneous report from a non-contactable consumer, the patient. A 13-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the left arm on 24May2021 at 13:00 (at the age of 13-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Concomitant medications were not reported. The patient previously taken drug name was reported as no.  On 28May2021 at 09:00, the patient experienced vertigo four days after vaccine, with no other symptoms until the vertigo started, the vertigo can be described as dizziness and nausea when moving head, which resulted in vomiting. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of vertigo, dizziness, nausea and vomiting and included treatment with PHENERGAN and BENADRYL from an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events vertigo four days after vaccine, with no other symptoms until the vertigo started, the vertigo can be described as dizziness and nausea when moving head, which resulted in vomiting was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Upon second medical examination of the case during internal review, a significant correction was performed on 31 Dec 2018 to change suspect product from FLUBLOK QIV (529) to suspect FLUBLOK TRIVALENT (528). Initial solicited report received on 01 April 2016 from an investigator participating in a study. This case involves a 86-years-old female subject who had Influenza and pneuminia during the study participation. The subject's medical history was not reported. The subject concomitant therapy was not reported. On 29 September 2015, same day after receiving a intramuscular dose of FLUBLOK TIV vaccine in arm on 29 September 2015 (batch number 550653F), the patient developed Influenza and pneuminia. The event was considered as life-threatening. It was reported that the subject had influenza and pneumonia. The lab data was not reported. Corrective treatment was not reported. The outcome of the events was reported as unknown. Relationship to investigational product according to reporter: related. Relationship to investigational product according to company: reportable. List of documents held by sender: none. Addendum 31 Dec 2018. Upon second medical examination of the case during internal review, a significant correction was performed on 31 Dec 2018 to change suspect product from FLUBLOK QIV (529) to suspect FLUBLOK TRIVALENT (528).; Sender's Comments: The same day of receiving TIV patient had influenza and pneumonia hence temporal relation not plausible. Based on limited data available role of vaccine can not be assessed.
Information has been received from an office manager of a physician's office concerning a 68 year old male with no relevant medical history reported who on 18-AUG-2006 was vaccinated with a dose of Pneumovax 23 (lot 650644/0004P). Concomitant therapy included vitamins (unspecified). Within 24 hours of vaccination, the patient developed redness, swelling, and pain at injection site. The patient sought unspecified medical attention. Subsequently, the patient recovered. Additional information has been requested.
pt was walking around & talking in lobby 10 mins p/vax; pt came back for another bandaid; mom took off bandaid pt rt arm had blood & passed out; taken to lab; ammonia inhalant waved under nose & eyes opened; stayed in clinic approx 15 mins;
pt recvd 1 & 2 doses of vax;2-3 wks p/ recving 2nd dose,exp elevated liver func tests,flu-like sxs;orthostatic hypotension,fever,enlarged & tender liver,cachexia,anorexia,& dec sodium;
fever & local rxn of pimples on arm;8DEC94 f/u fever 101 evening of inoculation;gone next morning;
p/vax pt devel a varicella like rash, under 50 lesions;
Heart races. Noticed it as soon as I received the injection.; This is a spontaneous report from a contactable consumer(patient). A 64-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 25Jan2021 09:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included High blood pressure. Concomitant medication(s) included amlodipine besylate (AMLODIPINE BESYLATE) taken for an unspecified indication, start and stop date were not reported; rosuvastatin (ROSUVASTATIN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no known allergies. Allergies to medications, food, or other products was none. On 25Jan2021 09:30 AM, the patient experienced Heart races. Noticed it as soon as he received the injection. Did not seem to be all the time but periodically he would notice. The patient just wanting to confirm how long this side effect would last and should he take the second dose. The event was assessed as non serious. No treatment received for the adverse event. Outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Information has been received on 03-JAN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age and her husband. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient developed tremors and memory issues. Thereafter, the patient was diagnosed with encephalitis, which resulted in the patient being in a coma for two weeks. As a direct and proximate result of these malfunctions, 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 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. Upon internal review, encephalitis and coma were considered to be medically significant. Encephalitis, persistent strain of herpes zoster, coma, tremors, and memory issues were considered to be disabling. Additional information has been requested.
p/vax an immunofluorescence titer revealed a lack of seroconversion;pt sought unspecified medical attention;
Headache & Myalgia Narrative: Initial dose of vaccine received 1/12/21. On 1/14/21 onset of severe headache and significant body aches. Missed work x 1 day. Has history of positive COVID test on 11/16/20.
Pt received 2nd dose vaccine, waited her 15 minutes and upon leaving was witnessed by PD to have slumped on the floor, without trauma and began to seize. EMS called to scene and medical OIC called. Upon arrival, 911 called, SpO2 placed. VSS and respirations adequate. Negative for emesis. After 2 seizures, the patient regained consciousness and was able to communicate that her husband was outside, his name was in a blue vehicle. She confirmed she had a history of seizures. Her husband informed us she has a history of these seizures and brain CA. EMS arrived and took control of patient and transported to hospital.
Heart attack; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history was provided.  The patient's past medical history included Bypass surgery. Concomitant products included VITAMINS NOS for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization and medically significant). The patient was treated with Surgery (Quadruple bypass) for Myocardial infarction. At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications includes blood pressure medication, diabetes medication and medicine to stop rapid heart beat.  Patient had open heart surgery and quadruple bypass as a treatment.  Patient was unsure if it was vaccine related.  Company comment: This is a spontaneous case concerns a 68-year-old male patient, without any reported medical history who experienced the unexpected, serious (medically significant, hospitalization) adverse event of special interest Myocardial infarction. The event occurred 8 days after receiving the first dose of mRNA1273. The patient suffered from heart attack post vaccination and was treated via open heart surgery and quadruple bypass. Further details regarding the clinical course, diagnostic test done and complete treatment protocols on the patient were not provided. It was also reported that the patient was taking medications for blood pressure, diabetes and treatments to stop rapid heart beat, these concurrent conditions along with the elderly age of the patient may be considered as risk factors for myocardial infarction. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-608597 (Patient Link).; Sender's Comments: This is a spontaneous case concerns a 68-year-old male patient, without any reported medical history who experienced the unexpected, serious (medically significant, hospitalization) adverse event of special interest Myocardial infarction. The event occurred 8 days after receiving the first dose of mRNA1273. The patient suffered from heart attack post vaccination and was treated via open heart surgery and quadruple bypass. Further details regarding the clinical course, diagnostic test done and complete treatment protocols on the patient were not provided. It was also reported that the patient was taking medications for blood pressure, diabetes and treatments to stop rapid heart beat, these concurrent conditions along with the elderly age of the patient may be considered as risk factors for myocardial infarction. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Tinnitus-onset 4 days after vaccine. Static sound, constant, has had only 2 brief pauses in tinnitus since onset. Tinnitus left ear only. No pain.  Saw ENT-normal Saw Audiology-normal
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. On or about 03-JUL-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 09-JUL-2015, the patient was treated for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The outcome of the events is unknown. 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. Additional information has been requested.
Chills, severe shakes, teeth shattering shakes for over an hour.  Fever, head and neck hurt, felt nauseous. The next day, still running fever, felt like I had been run over by a truck.  Head, neck and back ached.  Wanted to stay in bed and sleep.
hives on neck and one hive on face with dry mouth. Redness and swelling around site of injection
His vaccine sites on his thighs were indurated, itching, and erythematous.; His vaccine sites on his thighs were indurated, itching, and erythematous.; His vaccine sites on his thighs were indurated, itching, and erythematous.; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2260423-1. The original narrative from the sender is the following:  Patient received vaccines listed above on 26-APR-2022.  He presented to the clinic 02-MAY-2022.  His vaccine sites on his thighs are indurated , itching, and erythematous.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported event "His vaccine sites on his thighs are indurated , itching, and erythematous."  No further information is expected.
Patient states that arm was immediately sore and was still bleeding 9 hours later; He also states that the imz was given high on arm.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Pertinent medical history and concomitant medications were not reported. On 26-JUN-2015, the patient was vaccinated with improperly stored VAQTA (lot # reported as 1004743 with expiration date 01-JUN-2017, dose and route not reported). No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
I developed a 103 degrees fever for 2 days and cellulitis at the injection site.  I also still have a lump in my arm.
While injection Decavac IM Needle was loose and approx 1/4 solution dripped down arm. I called immunization hotline who stated it would be ok to administer another dose to opposite arm.
Low grade fever, nausea and migraine. Fever and migraine lasted one day. Nausea lasted for two days.
Information has been received from a health professional, with no medical history and no allergies, who was vaccinated intradermally with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine.  There was no concomitant medication.  On 01/25/2005 the patient had a local injection site reaction with swelling, redness, pain and warmth to the touch.  The patient was treated with ibuprofen and ice.  It was reported that the patient showed slight improvement after taking medication.  There were no laboratory or diagnostic tests performed.  No product quality complaint was involved.  Additional information has been requested.