chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a 73 year old male with Hepatitis C, hypertension, asthma, osteoarthritis, hyperglycaemia, hematospermia, no known allergies and a history of chickenpox who on 01 Nov 2006 was vaccinated SC in left arm with a 0.65ml dose of varicella zoster virus vaccine live (lot 652925/0621F). Concomitant therapy included lisinopril (ZESTRIL), Felodipine, and sildenafil citrate (VIAGRA) as needed. Subsequently on 01 Nov 2006 the patient experienced a sore arm and joints, which lasted for three days. The patient also developed a fever and chills and also had discomfort. Fever was reported as 101.8 F (the duration of this temperature was unknown). There was no anaphylaxis, no edema and no rash. The patient's fever and chills lasted for 5 days, broke on the morning of 06 Nov 2006 and the patient recovered. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. This is in follow-up report(s) previously submitted on 12/14/2006:  3/23/2007.  Information has been received from a health professional concerning a 73 year old male with Hepatitis C, hypertension, asthma, osteoarthritis, hyperglycaemia, hematospermia, no known allergies and a history of chickenpox who on 01-NOV-2006 at 10:11 was vaccinated SC in left arm with a 0.65 ml first dose of ZOSTAVAX (Merck) (lot # 652925/0621F).  Concomitant therapy included ZESTRIL, Felodipine (MSD) and VIAGRA as needed.  Subsequently on 01-NOV-2006 the patient experienced a sore arm and joints, which lasted for three days.  The patient also developed a fever and chills and also had discomfort.  Fever was reported as 101.8 F (the duration of this temperature was unknown).  There was no analphylaxis, no edema and no rash.  The patient's fever and chills lasted for 5 days, broke on the morning of 06-NOV-2006 and the patient recovered.  Unspecified medical attention was sought.  There was no product quality complaint involved.  Additional information from the physician indicated that the patient is a retired orthopedist who reported three days of fever and joint pain after injection.  The patient was not seen and subsequently recovered.  The patient has a history of interferon treatment for hepatitis C many years ago, no treatment within the past three years.  The patient was not immunocompromised.  No laboratory tests were performed.  Follow up information received from a physician reported that on an unspecified date the patient had some type of blood serum poisoning after he received the vaccine.  No further information was provided.  No further information is expected.
Approximately 10 mins post vaccine administration, patient began to feel that her throat was tight, similar to when she has had reactions to shrimp in the past. Patient's lungs were clear, sat >97%, speaking in clear sentences. Given 50mg IM benadryl and 60mg PO prednisone with some relief of symptoms. Several minutes later, patient felt that symptoms were returning. At this point patient was given .3mL IM epi with some relief of symptoms. Patient maintained airway throughout entire encounter and sat remained above 97. EMS was called, report was given to EMs along with her visit documentation.
After shot arm was very weak and stayed that way for months. In late Aug turned to a frozen shoulder. Was tested for nerve damage, but confirmed no nerve damage. Frozen shoulder.
Patient immediately regressed, it was like the lights had turned out.  He lost words, babbling, laughing, smiling, eye contact.  He started clapping with fists instead of open hands.  He stopped trying new foods or touching new toys and now suffers from sensory processing issues, global developmental delay, as well as atypical Autism.  Patient was on track developmentally before this vaccine.
Recognizable change in menstrual cycle, ongoing spotting  now 8-days after period and I never spot. I have not done anything different otherwise and the only major change was me making the decision to get the vaccination thinking more than enough people have been test dummies and I should be in the clear. Of course, now, I see that this is an adverse side effect that is mostly being ignored or written up as an anomaly due to reporting sample size. It is an obvious side effect regardless of type of vaccination being taken and it should not be being ignored. You cannot protect the public by providing misleading information in hopes of pushing an agenda as it creates a feeling of distrust.
Patient experienced an episode of SVT and then sinus tachycardia for approximately 6 hours after injection
and got shingles/suspected vaccination failure; and got shingles; He said it was the worst pain affliction he ever had in his life.; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: and got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: and got shingles) and pain (Verbatim: He said it was the worst pain affliction he ever had in his life.). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 01-AUG-2023 This case was reported by patient via interactive digital media. The reporter states that he/she heard that a lot of people who got the covid vaccine and boosters are more prone to get shingles.  The reporter states that the vaccine weak your innate immune system, and then the dormant shingles virus manifests.  He/she heard that shingles cases are on the rise because of this, he/she know someone who got vaccinated to retain his job, and got shingles. He said it was the worst pain affliction he ever had in his life. Follow up was not possible, as no contact details were available.
Very swollen eyes 5-7 minutes after leaving the clinic. Diphenhydramine given, observed x 1 hour without furhter complication.
Then on 19Aug2021 diagnosed with acute kidney failure determined to be caused by terminal multiple myeloma; Then on 19Aug2021 diagnosed with acute kidney failure determined to be caused by terminal multiple myeloma; prev dose administration date=18Jun2021, prev dose dose number=2/prev dose administration date=19Apr2021, dose 1; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 18Jun2021 as dose 2, single (Lot number: EW0187) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: High cholesterol at that time only, minor other unrelated health concerns; "known allergies: New stings" (unspecified if ongoing), notes: known allergies: New stings; "COVID" (unspecified if ongoing), notes: COVID prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Ew0169, Stroke of unknown origin on 02May2021 that caused Permanent disability.), administration date: 19Apr2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "Stroke of unknown origin", "COVID-19". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 18Jun2021, outcome "unknown", described as "prev dose administration date=18Jun2021, prev dose dose number=2/prev dose administration date=19Apr2021, dose 1"; ACUTE KIDNEY INJURY (hospitalization, disability, medically significant, life threatening) with onset 19Aug2021, outcome "not recovered", PLASMA CELL MYELOMA (hospitalization, disability, medically significant, life threatening), outcome "not recovered" and all described as "Then on 19Aug2021 diagnosed with acute kidney failure determined to be caused by terminal multiple myeloma". The patient was hospitalized for acute kidney injury, plasma cell myeloma (hospitalization duration: 30 day(s)). The event "then on 19aug2021 diagnosed with acute kidney failure determined to be caused by terminal multiple myeloma" required emergency room visit. Therapeutic measures were taken as a result of acute kidney injury, plasma cell myeloma.  Clinical course: It was reported that the report was about COVID vaccine. Dose received More than 3.The patient had no other vaccine in four weeks.In Doctor's office/urgent care facility the most recent COVID-19 vaccine was administered. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient received treatment for AE. AE treatment: Stroke rehab. Patient had COVID tested post vaccination. COVID test type post vaccination was Nasal Swab.
P/receiving a dose of Td, pt c/o fever, h/a, & generalized achiness the next day; 2 days p/inject, had a large red swollen area on arm;
Muscle and joint pain, fatigue, feeling of being cold without shivering, headache.  Tyleonol, 1000mg, prophylactic, x3
Rapid heart rate 138bpm- 3:20 am. Stayed elevated all night Uncontrollable shacking- 12:30 am. Lasted 10-15 mins
Arm hurts; Pinkish and in one area the look like dots and the other are they are is bigger; Raised bumps; Rash on my stomach also on my lower back/rib section; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm hurts), SKIN DISCOLOURATION (Pinkish and in one area the look like dots and the other are they are is bigger), MASS (Raised bumps) and RASH (Rash on my stomach also on my lower back/rib section) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced PAIN IN EXTREMITY (Arm hurts), SKIN DISCOLOURATION (Pinkish and in one area the look like dots and the other are they are is bigger), MASS (Raised bumps) and RASH (Rash on my stomach also on my lower back/rib section). At the time of the report, PAIN IN EXTREMITY (Arm hurts), SKIN DISCOLOURATION (Pinkish and in one area the look like dots and the other are they are is bigger), MASS (Raised bumps) and RASH (Rash on my stomach also on my lower back/rib section) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment details were reported.
Patients mother stated child became febrile.  Child was taken to emergency room and had a febrile seizure.  Outcome child is doing well and is home at this time.
10/2/15 at 8:15 AM employee presents to office with a 65 mm size erythemic area to flu injection site. States slight itching and soreness.
Patient waited 15 minutes after vaccine.  Patient left building and started to c/o chills and 'felt like she was going to pass out' in vehicle.  Patient complained of headache and 'labored breathing'.  Brought back into building and placed on 0 2 via N/C.  Ambulance called for transport to local ED.  Epi given by EMS.  Pulse ox 97 %. History of allergy to Bee  Stings.  PMH -diabetes. Patient provided Benadryl in ED, blood sugar elevated.  held in ED for ~ approximately 4 hours and released to home.
For first shot on 2/5 R arm, developed a red rash type thing on my arm. As time went on (weeks) the redness grew bigger and looked like a welt. Arm was very sore, hot to the touch, and swollen for nearly 3 weeks following the injection.  Second shot on 3/5 R arm, also developed a small red rash but was smaller and went away within a week. Within 24 hours of getting the vaccine, a high fever developed, fatigue, weakness, nausea, pain throughout my body, and migraines.
Pt reports she couldn't hear or see and ears were ringing.  Pt put head in arms. Pt states she slept for a minute. Mom states that she was responsive.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients. No information regarding their pertinent medical history, concomitant medications, drug reactions, or allergies was provided. From 08-SEP-201 to 12-OCT-2016, the patients were vaccinated with improperly stored doses of PEDVAXHIB injection (dose, route of administration, lot# and expiration date were not provided). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 15 degrees Celsius for 3 hours and 40 minutes. There was no previous temperature excursion. Digital Data Logger was involved. This is one of several reports received from the same reporter. Follow up information was received from the medical assistant on 27-DEC-2016. She was going to fax the patients' identifiers, dates of vaccination, lot# and expiration dates. Additional information has been requested. Sender's Comments: US-009507513-1612USA014131: US-009507513-1612USA014132: US-009507513-1610USA008206.
THROMBOSIS; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced thrombosis. Treatment medications (dates unspecified) included: apixaban for thrombosis.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of thrombosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210516823-Covid-19 vaccine ad26.cov2.s -Thrombosis. This event is considered unassessable. The event 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.
Pt noted swelling, pain, reddness @ inject site within 24 hours of receiving vaccine.  Applied heat and cold, cortisone cream and took allegra, swelling and pain on the underside of arm increased over the next 24 hrs. See comments.
It started off with me becoming really irritable over the smallest things.  I started getting cold chills even though it was 70F.  I had a nightmare that felt like an eternity. My dreams get warped when I'm sick.  I woke up and I had a headache that was centered around several spots in my head. I couldn't get comfortable no matter what I did.  It's impossible to lay down on the side you get the shot on. It hurt like... 7x more than the first one when they're administering it.  The scariest symptoms though, for me, was that I couldn't catch my breath. You know when you take a hot shower and you can't really breathe 100% because of the steam? That's how I felt all day after the 2nd dose. Also, I couldn't tell if I was full or not when I ate. The only way I could tell was stomach pains.   That's all that's happening/has happened to me. I do feel better alot better though two days after having the 2nd dose.
Narrative:  Patient received Moderna Covid #1 on 2/13/21 and #2 on 3/13/21. On 4/3/21, he was seen in our ER for a skin lesion that had been present x 2 months on his left lower chest. He was given a tetanus shot and referred to dermatology. On 4/7/21, he was taken to a facility after he was found unresponsive and pulseless by his wife. He was down for an unknown amount of time. He was admitted to the ICU and intubated. He was seen by cardiology and neurology and suspected cause of event was hypoxic/hypercapnic respiratory failure. He also had a CT of the chest while there and was found to have a lung mass, noted history of COPD. He was given Solumedrol, Duonebs, fentanyl, Propofol and cefepime/vancomycin (for pneumonia/COPD exacerbation). He remained there until his date of death of 4/10/21. No autopsy reports available. Time from 2nd vaccine to date of death was 28 days.
First:  headache for 6 days. Body aches and low grade temp intermittently. Itching on day 8? Second:  chills and low grade temps x  10 days. Joint pain x 10 days. Itching on day 13. Intermittent headaches and brain fog x 10 days.
Red swollen area on upper left arm with pain and soreness.  Also tingling and intermittent sharp pains.  Swollen area appears the same after 36 hours and does not appear to be easing off.
BAD CHEST PAIN , UPPER CHEST LEFT SIDE , FEELS LIKE I GOT HIT IN CHEST , LIKE A BIG BRUISE TYPE PAIN WHEN I TOUCH IT . TODAY IS JUNE 11 2021 AND STILL HAVE PAIN .
lethargic; hot and cold; very sore throat; brain fog; sore chest; struggling to breath; This is a spontaneous report from a contactable consumer (patient) via . This non-pregnant 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0151) via an unspecified route of administration in the left arm on 09Apr2021 at 19:30 (at 45-years-old) as a single dose for COVID-19 immunisation. Medical history included common variable immunodeficiency (CVID), mast cell activation syndrome (MCAS), mitral valve, allergy to wheat, allergy to dairy, and allergy to capsicum, all from unknown dates and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19. Concomitant medications included estradiol, loratadine (ALLERCLEAR), olive leaf, pre-biotics, and post-biotics, all from unknown dates for unknown indications. The patient previously received immunoglobulin from an unknown date for an unknown indication and experienced allergy; and previously received the first dose of BNT162B2 (lot number ER2613) in the left arm on 16Mar2021 at 14:15 (at 45-years-old) for COVID-19 immunisation. The patient reported that on 10Apr2021 at 21:30 she was struggling to breath. Her husband put her on their home nebulizer with budesonide two times and that was not helping so he administered epinephrine (EPIPEN) then followed up with 2 diphenhydramine hydrochloride (BENADRYL) and things began calming down. Today (as of 11Apr2021) the patient was lethargic, hot and cold, had very sore throat, brain fog, and sore chest. She reported that if they didn't have their own nebulizer, they would have had to call an ambulance and gone to the hospital, further reporting this was a pretty serious reaction. She stated she had Mast Cell Activation Syndrome (MCAS) and Common Variable Immune Disease (CVID) and she had not received immunoglobulins for 1.5 years so far. The events did not require hospitalization. The clinical outcomes of the events were reported as recovering. It was also reported that since vaccination the patient had not been tested for COVID-19.
I was running fever 99.7-102.00. I have lots of body aches.
Pt. had dizziness and nausea after vaccination. Had pallor and diaphoresis. Vital stable. CNS exam. WNL. Referred to ER for eval.
Fatigue, sore throat, congestion in nose and lungs, cough, headache, muscle aches, nausea.
Vaccinated on 7/16/15, reactoin appeared on 7/20/15. Slightly raised erythemic area on left deltoid, AMOX 100 mm x 84 mm. Mild discomfort  warm tou touch.
pt recv one .5 cc dose; 2 days p/ exp fever. abdominal pain, vomiting; sx resolve in 2 days
This spontaneous report as received from a consumer refers to her son, a male patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, lot, expiry date unknown). On an unknown date, after vaccination (reported as and then), the patient was diagnosed with unspecified autoimmune disease. The outcome of unspecified autoimmune disease was unknown. Additional information has been requested.
Information has been received from a nurse concerning a 12 month old female who on 27-FEB-2007 was vaccinated subcutaneously (SC) with ProQuad. The nurse reported that the consumer's mother contacted the doctors office stating that her daughter had developed "a red rash and red spots all over body." The patient sought unspecified medical attention. No labs were reported. The patient's outcome was not reported. There was no product quality complaint involved. Additional information has been requested.
Sat 5pm eyeballs began to hurt.  The entire eyeball was painfully sore.  At night I woke up with tongue that felt thick or swollen.  Then the next am woke up with aches, headache, chills, hot (suspected fever but did not get up and check) tiredness.  Spit up yellow fluid (thought it might be from GERD) and laided around all day.  Did not eat as stomach felt nauseated.   At 3 pm I ate half a sandwich and at 4 ate half a banana and drank some water and 1/4 of cup of sweet tea.  By 6pm I was really sick to my stomach got up and threw up sandwich and banana.  I thought I saw some blood but was not sure.  I continued to throw up and it became all blood (bright red) mixed with water.  This occured twice and then I called doctors office and the dr on call advised me to go to ER since urgent cares were closed.  I went to ER about 8:30pm with continued headache, nausea, lightheadedness.  I tried to tell ER dr that I was there mainly for throwing up blood.  I sat in waiting room.  ER dr saw me at 3am and gave me Zofran for nausea as i thought I was going to be sick and gave me EKG, Blood panel and Blood Pressure readings.  Told me I was mildly dehydrated. My BP was higher than I think I have ever seen it.
possible delayed allergic reaction; hives / over his right arm (not the injection site); This case was reported by a physician via call center representative and described the occurrence of allergic reaction in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 4977T, expiry date 5th September 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th April 2021, the patient received the 3rd dose of Pediarix and Pediarix Pre-Filled Syringe Device. In April 2021, less than a day after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced allergic reaction and hives. On an unknown date, the outcome of the allergic reaction and hives were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction and hives to be related to Pediarix and Pediarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter mentioned that, the patient that may have had an adverse reaction to Pediarix and would like further advice. The patient received Pediarix yesterday afternoon from the reporting date and on 16th April 2021, in morning (on the day of reporting) patient's mother sent a picture showing hives that have developed over his right arm (not the injection site). The reporter wondered if this was a possible delayed allergic reaction. The reporter consented to follow-up.