chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had a  Lifeline screening ( they did an EKG and a Carotid and Blood tests on me) after  the vaccine- I got a odd reading on a c-reactive protein - inflammation and infection in the body - Can get those records from them. Started taking my blood pressure and I noticed thing weren't right with my heart. I went to my doctor   his office clinic  they are moving their office, though next month) with a federally funded program for the testosterone  replacement therapy- he had give me testosterone replacement therapy which I have since stopped with recommendation by the cardiologist - it makes my blood very thick ) and he told me I had A-Fib - gave me samples of Xarelto and he said to come back on Monday and confirmed the A-Fib. doctor cardiologist and he confirmed A-Fib and recommended a procedure - to reset the heart with the paddles - I haven't done that yet. Since then,  I have had chronic fatigue, heart palpitations, difficulty breathing; I think it's related to my heart. I am taking naps every day. I wake up and I'm just wasted. I go run errands and then I'm exhausted. Chronic fatigue. I will be seeing my  brand new primary care doctor on Thursday and I want to talk to Doctor provided me with a whole bunch of diagnoses for all of it. They are saying on the diagnoses paperwork that I could have "blood cancer." But it could come from TRT treatment. Dental at first and then went to Affordable Dental - Periodontal work done - there was an infection there and they gave me antibiotic mouthwash. I will be going back in three months. I have not recovered from A-Fib - have to get Cardio Version test and I have chronic fatigue - it comes and goes. The blood cancer - I haven't had a chance to talk to anyone about it yet and no one has been in touch with me about it.  I went to Hospital ER the other day - mostly to get a more accurate diagnosis - I do have chemical disorder history in past. I had mental confusion - it was chemical - it was just like what I had in 2000. But hospital misdiagnosed it.
3 days after receiving his first dose, patient had 102 fever and contracted COVID Pneumonia and is now hospitalized in the ICU
Erythema and edema at administration site extending up anterior thigh to groin and down to foot of both lower extremities.  No fever.  Patient crying and fussy.
I was awakened by intense jerking of my arms and legs, and possibly my torso.  I couldn't control these.  I also had felt very cold but it was to decide if I was cold or not because the jerking was so intense it blocked out other sensations.  I also had to get up and urinate a large amount which was unusual as I had urinated just before going to bed about 1-2 hours before this started.  The jerking lasted about 30 minutes.  After another hour I had to get up again to urinate a large amount.
This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a male patient who received SHINGRIX for prophylaxis. On 12th February 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site itching and pruritus. On an unknown date, the outcome of the injection site itching and pruritus were unknown. It was unknown if the reporter considered the injection site itching and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe itching in arm where the vaccine was given as well as across the top of back and also in scalp. The patient did not associate these effects with the vaccine. This is 1 of 2 cases, reported by the same reporter for same patient.
The vaccine was given in my son's right arm. Everything was fine after the shot was given. It was later that night into the next day, his arm around the injection site swelled up a lot to his shoulder. It became red and hot to touch. Lasted about 4 days. Gave BENADRYL to treat it.
Called 6 weeks post vax - arm still hurts intermittently, lifting things or arm behind back causes pain. Saw Orthopedist and was dxed with rotator cuff injury. Prescribed Vioxx and exercise. 04/20 was advised to file VAERS report.
felt awful; Headache; dizzy feeling; hard to focus my eyes; nauseous; my head is spinning; Jittery; felt too sick to drink; This case was reported by a consumer via call center representative and described the occurrence of feels awful in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose, refer case US2019GSK087398.). Concomitant products included mepolizumab (Nucala), prednisone and methotrexate.   On 4th May 2019, the patient received the 2nd dose of Shingrix. On 5th May 2019, 1 days after receiving Shingrix and an unknown time after starting Nucala, the patient experienced feels awful, headache, dizziness, difficulty focusing eyes, nausea and head spinning. In May 2019, the patient experienced jitteriness and feeling unwell. On an unknown date, the outcome of the feels awful, headache, dizziness, difficulty focusing eyes, nausea, head spinning, jitteriness and feeling unwell were unknown.   It was unknown if the reporter considered the feels awful, headache, dizziness, difficulty focusing eyes, nausea, head spinning, jitteriness and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient receiving monthy Nucala injection. The age at vaccination was not reported. The patient had Shingrix vaccine this past Saturday before the date of reporting. On next morning, the patient felt awful headaches, dizzy feeling, hard to focus my eyes, nauseous, it feels like my head was spinning. The patient was very jittery inside as if I am over caffeinated, which the patient felt too sick to drink it.  The patient started a new job this week and this had made it extremely difficult.
CAPILLARY LEAKAGE; SWELLING OF FACE; SWELLING OF EYES; This spontaneous report received from a consumer concerned a 92 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included cardiovascular disease, and polyethylene glycol, polysorbate allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 09:46 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, colecalciferol, diltiazem, losartan, metformin, and risedronate sodium. On 09-APR-2021 18:01, the subject experienced capillary leakage. On 09-APR-2021 18:01, the subject experienced swelling of face. On 09-APR-2021 18:01, the subject experienced swelling of eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swelling of face, capillary leakage and swelling of eyes was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Case number PHEH2013US020750 is an initial spontaneous report from a health care professional received on 02 OCT 2013, with a follow-up received on 18 NOV 2013. This report refers to a 03-year-old female child.  No medical history and concurrent conditions were reported. No concomitant medications were reported. The reporter stated that this 03 year old child inadvertently administered FLUVIRIN 2013/2014 (batch number: 13401P) at a dose of 0.5 ml intramuscularly into left thigh on 27 SEP 2013 at 12:00. No adverse reaction was experienced by the patient after this medication error.  Follow-up was received on 18 NOV 2013: Patient demographics, vaccination dose, vaccination site and time and information that no adverse reaction was experienced were updated.
HX OF SYNCOPE WITH BLOOD DRAW, FEELING FAINT, HYDRATE, , RESOLVED, REFUSED TRANSPORT
No reaction; Per caller the patient was administered an expired dose of VARIVAX yesterday 21JUN2022; This spontaneous report was received from pharmacist concerning a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 21-JUN-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) with expiration date: 13-JUN-2022, administered as prophylaxis (dose, lot #, and route of administration and anatomical location were not provided). There were no temperature excursions for the vaccine.  Follow-up information has been received from a nurse practitioner on 08-AUG-2022. It was reported that the patient was a 24-year-old female patient. The information regarding the suspect therapy was updated:  On an unknown date, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, lot #, expiration date, route of administration and anatomical location were not provided).  On 22-JUN-2022, she received the expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T020651, has been verified to be a valid lot number for varicella virus vaccine live (oka/merck), expiration date: 16-JUN-2022 (expired product administered) for prophylaxis, which was administered for a healthcare professional. The patient did not have a response nor reaction to the vaccination and the event was not treated (no adverse event). No illness, allergies at time of vaccination were reported.  It was reported that the medication error occurred at the storage in clinical practice, dispensing, preparation for administration and administration. The vaccine was obtained from their own pharmacy just before reconstitution/administration. It was reported that the experience did not reappear after reintroduction (conflicting information). The outcome for expired product administered was reported as recovered/resolved. The action taken was reported as "monitoring", but assessed as not applicable.  This case was previously considered non-valid, but upon receipt of follow-up it was determined to be valid.
A nurse reported that a 29-year-old male did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series. The pt's medical history, concurrent conditions and concurrent medications were unknown. The pt received injections of Engerix-B on 03/25/2002 (lot ENG5257A4), 05/20/2002 (lot ENG5257A4) and 11/26/2002 (lot ENG5291A4). 42 days after his 3rd injection of Engerix-B, on 01/07/2003, an unspecified titer was "less than 2". Comment: The reporter indicated that 4 additional subjects did not achieve protective antibody titers following immunization with Engerix-B. Please see reports A0398883A, A0400568A, A0400569A and A0400570A.
After 15 minutes of observation and no adverse reactions, patient went to the restroom, and went shopping.  30 minutes after administration, patient was extremely fatigued, unresponsive, unable to be aroused.  Called 911. Blood pressure was 60/Error or blood pressure machine was not working properly. Began to gasp and vomit.  Epinephrine was administered at that time. 45 minutes after administration, EMS arrived. Patient was discharged from hospital around 3pm and her diagnosis was syncope.
Post vax, pt said she didn't feel well. Color pale and arms rigid. Immediately, pt was transferred from chair to floor in lying position by 2 nurses. Eyes receded and arms stiff for about 5 seconds. Color returned and arms relaxed. Pt responsive. BP 130/62 and pulse 80 and regular. At 11:00 AM, she sat in upright position and complained of a headache. She denied any further medical treatment but asked that we call her husband for transport home. Left at 12:00, noon. Site of MMR was reddened. All other sites showed no signs of any reaction.
A  report has been received from a Pharmacist concerning a 10 year old, female subject, who had been receiving FLUMIST. FLUMIST started on 11-Nov-2013. The patient received only a half dose FLUMIST in one nostril which started on 11-Nov-2013. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious by the reporter.
local reaction redness, tender to touch & edema 3.5-4" in circumference @ deltoid site;
vomiting; right gland felt sore and swollen; right gland felt sore and swollen; diarrhea; nausea; unable to eat or drink; already exhausted and went to sleep; This is a spontaneous report from two contactable healthcare professionals (one of which is the patient herself). A 40-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EK5730), intramuscular at left shoulder muscle (Deltoid Left) on 19Dec2020 14:30 at a single dose for COVID-19 immunisation. There were no medical history and no concomitant medications. The patient has no prior vaccinations (within 4 weeks prior to the first administration of Covid-19 vaccine). The patient reported that within 10 mins of vaccination, her right gland felt sore and swollen, lasted 24 hours and went away. She was already exhausted, and she fell asleep when she went home in Dec2020. She couldn't hold down any food or water for about 24 hours, and this started about 10 minutes after getting the vaccine on 19Dec2020. She has had violent vomiting within 10 minutes of receiving the vaccine on 19Dec2020, and she also had diarrhea really bad on 19Dec2020. She was unable to eat or drink from diarrhea and from nausea also. She was only able to eat on Monday (21Dec2020); she ate 2 granola bars and was able to hold down water. Today on 22Dec2020, she went to the bathroom and it was just water. She has talked to HCP. She would get the second vaccine on the 9th and wanted to know what she should expect. She is asking if she will have these symptoms again or will they worsen, because she has 2 kids to take care of. The adverse events did not require visit to Emergency Room. She reported to have a negative COVID-19 virus test (COVID-19 MC 2000 slide and rapid COVID-19 swab) on unspecified date. The outcome of the events "unable to eat or drink" and diarrhea was not recovered; for the events vomiting and nausea was recovering; while for the other events was unknown.
Chest pain; Shortness of breath; he didn't want to lay down to go to sleep; After he got the second vaccine, it got really bad.; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL9246) via an unspecified route of administration in left arm/shoulder on 26Mar2021 between 09:00-09:30 (age at vaccination 42years) as dose 1, single and second dose on BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0153) via an unspecified route of administration in left arm/shoulder on 23Apr2021 between 09:00-09:30 (age at vaccination 42years) as dose 2, single for COVID-19 immunization. Medical history was not reported. Family history includes heart issue (mother had a bypass and brother had to have a bypass two years ago. The patient's concomitant medications were not reported. Patient had not received any other vaccinations within 4 weeks prior to the first administration date of the suspect vaccine. Patient don't have AE prior vaccination. Patient had had 4-5 weeks between his two vaccines. On unspecified date in 2021 patient experienced chest pain and shortness of breath a week or two after the first shot, but it was really mild. Patient was stubborn and ignored it. Patient got second dose and it got really bad. Evening of second vaccine when patient really worried and he didn't want to lay down to go to sleep. Patient landed in ER with chest pain and shortness of breath. Patient kept quite for a long time. In ER they did scan of his heart and couldn't find anything wrong. Right after that, patient heard reports of inflammation of the heart muscle related to the COVID-19 Vaccine. Patient didn't know if this was his condition or if the local healthcare providers weren't aware to look for that. The reporter felt symptoms and the COVID-19 Vaccines are directly related. Patient was discharged from ER and was not admitted to hospital. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included Blood cholesterol: good and heart scan: couldn't find anything wrong in 2021. The outcome of the events was recovered on unspecified date (A week after he left the ER, he recovered completely).  Follow-Up (01Nov2021): Follow-up attempts are completed. No further information is expected.
IN THE FIRST 15 MINS THE PT EXPERIENCED DIZZINESS, SENSED HER NERVES AT BACK OF NECK TINGLY, AND LIPS WERE QUIVERING. PT STAYED SEATED FOR ANOTHER 15 MINS AND SAYS SYMPTOMS HAS LESSENED AND STATED SHE WAS OK TO LEAVE.
generalized weakness 3/17/22, tested positive for covid on 3/19/22
Full body rash. Started at site of injection site woke up next morning with a completely full body red, itchy, bumpy rash. Went to dermatologist and they said it was from vaccine they prescribed me an external cream to take.
Reported by phone call area left arm 2-3 inches long several like tennis ball knot.  Offered appointment mother declined.
After the vaccine, the patient was experiencing numbness in her lips, tingling in the upper body, SOB, tightness in chest, and hot flashes.
This spontaneous report as received from a registered nurse who is an immunization official refers to unspecified patients of an unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date in 2017, the patients were vaccinated with improperly stored doses of PROQUAD (dose, frequency, route, lot # and expiration date were not provided) for prophylaxis. The vaccines were improperly stored in January 2017 with a temperature excursion of - 14 °C to - 10 °C for a time frame of 16 hours. There was no data logger involved. There were no previous temperature excursions. No product quality complaint was involved. This is one of two reported received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA011950.
Flublok vaccine was administered to a 13 years old patient/ No adverse event; Initial information regarding this valid unsolicited non-serious case from Medical Information (Reference number- 00303684) was received from pharmacist and transmitted to Sanofi on 06-Oct-2020.  This case involved a 13 years old female patient received a standard dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number- QFAA2015, expiration date- 30-Jun-2021) (Product administered to patient of inappropriate age) via intramuscular route in the left arm for prophylactic vaccination on 29-Sep-2020.  The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant drug was not reported.  It was a case of actual medication error due to inappropriate age at vaccine administration. (Latency: Same day).  At the time of reporting it was not reported that the patient had experienced any adverse event.  Reporter wanted to know that if the patient should revaccinated or not.  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.
Tender to touch at injection site 5 hours after shot was given, At 24 hours front of upper arm hot, hard and painful. used Ice for 3 day along with ibuprofen 800mg every 4 to 5 hours for 3 days. Redness to back of arm on day 4, still painful and swollen. Day 5 painful to touch injection site. Redness and lump about 3 Inches long and went to the armpit. Patient has pictures.
This spontaneous report was received from a healthcare worker refers to multiple unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (therapy type: Digital data logger; lot # K026531, expiry date: 15-APR-2017; lot # L044917, expiry date: 05-OCT-2018). Healthcare worker stated that the vaccine underwent a temperature excursion at 49.5 degree Fahrenheit for 186 hours. There were no previous temperature excursions. Healthcare worker confirmed that the vaccine was administered on unspecified dates before their expiration date. No adverse effects were reported. This is one of the six reports received from the same reporter. Additional information has been requested.
Feeling bad; Drug dose administration interval too long; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (first dose received in August 2020).   On 31-MAR-2023, the patient received the 2nd dose of Shingles vaccine. On 31-MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced drug dose administration interval too long (Verbatim: Drug dose administration interval too long). On an unknown date, the patient experienced feeling bad (Verbatim: Feeling bad). The outcome of the feeling bad was not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.     It was unknown if the company considered the feeling bad to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-APR-2023 This case was reported by a patient via interactive digital media. The reporter was the patient. The patient had first dose of the vaccine in August 2020 and felt bad. The patient had second dose on last Friday. The reporter asked if another dose was required or it was ok with those two doses. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
6SEP90, 1 day p/1st Hepatitis B inject experienced urticaria (hives w/itching) & diffused erythematous rash. P/1st dose, took advil & tylenol. 9OCT90, one day p/2nd Engerix-B inject, urticaria more intense & lasted longer. 23OCT sxs persist
Information has been received from a physician concerning her family member, a 14 year old female with a family history of cardiac problems who on an unspecified date was vaccinated with the second 0.5ml dose of GARDASIL (lot#, route and site of administration not reported). It was reported that about a month after each dose of GARDASIL the patient experienced chest pain and tightness, left arm pain, shortness of breath and dizziness. When she had the same experience after the second dose, the patient went to the emergency room and was diagnosed with dysautonomia. The patient was told that it was due to GARDASIL and was referred to a pediatric cardiologist. Unspecified laboratory diagnostics studies were performed. On an unspecified date the patient had recovered. No further information is available.