chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This medically confirmed spontaneous report (initial receipt 30 Mar-2016) concerns a male patient of at least adult age (possibly elderly). The patient has a medical history of Guillain-Barre Syndrome (GBS). In Nov-2011, the patient received Afluria (influenza virus vaccine polyvalent; batch no: not reported; dose: 0.5 ml) via the intramuscular route for indication not reported. Five days after Afluria administration, the patient received a flu vaccine (influenza virus vaccine; brand and batch number unspecified). On an unknown date following the second flu vaccination, the patient's GBS symptoms worsened and were aggravated. The GBS became chronic inflammatory demyelinating polyneuropathy (CIDP) about two months later. The patient insists that the flu symptoms worsened and aggravated the pre-existing GBS.  The worsening of symptoms includes falling down, fogginess and loss of balance. The patient is being treated with intravenous immunoglobulin (IVIG) once daily every seven weeks. The outcome was not reported. Reporter's Comments: The reporter stated that worsening of symptoms include falling down, fogginess and loss of balance. Sender's Comments: Company comment: Seriousness: Serious. Medically significant. Listedness: Unlisted. Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the Afluria Product Information, CIDP is unlisted.  All other events are also unlisted except GBS (symptoms worsened) and flu symptoms are listed. Causality: Unassessable. Time to onset was not specified. It is likely patient had CIDP at the outset diagnosed as GBS due to the similarity of presentation and as CIDP has recurrences with partial or complete recovery. Flu symptoms are likely due to influenza like illness that can follow vaccination but information such as (time to onset and laboratory diagnosis) is lacking to confirm potential lack of effect. Similarly it is not known if patient received a further dose of seasonal Influenza vaccine or pandemic (H1N1) vaccination within the same week and the effect of this on the reported events. Influenza vaccination is generally not advised in person with known history of GBS.  Overall there is insufficient information to attribute causality to Afluria.
Nausea after receiving vaccine; This is a spontaneous report from a non-contactable consumer or Non-healthcare Professional reporting for a patient. A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced nausea after receiving vaccine. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness to neck, face very pale with red blotches, tightening of throat, complained of feeling like throat closing off, dizziness, flushing and burning of ears, roaring in ears, felt like she might pass out, increased heart rate, weak.
-Right arm pain -General Malaise -Pt. thinks this vaccine gave the reaction since it was done in error (not needed)
EVERY JOINT IN MY BODY ACHED.  COULD HARDLY MOVE.  CONTACTED  DR.  HE SAID I COULD TAKE 200 MG OF IBUPROFIN PER DAY & KEEP IN CONTACT WITH HIM.  FIRST DAY I TOOK 200 TWICE A DAY;SLEPT MOST OF DAY & 2 DAYS AFTER.  WASN'T HUNGRY, DRANK ALOT.  4TH DAY IT FELT LIKE I HAD A METAL HELMET ON; HEAVYNESS IN MY EYES, TEMPLES ETC.  CONTACTED DR. AGAIN HE SAID CONTINUE AS PRESCRIBED.  THIS LASTED 8 DAYS.  NO ENERGY = EXHAUSTED THRU HOLIDAY.  ON 12-24-2020 HAD SEVERE VERTIGO, WENT TO URGENT CARE; STILL STRUGGLING  WITH THIS. DOING PT  THERAPY.  HAVE MECLIZINE 25 MG FOR DIZZYNESS  &  ONDSETRONAN FOR  NAUSEA.  QUESTION WHETHER THE SHINGLES SHOT IS RESPONSIBLE FOR THE DECEMBER/VERTIGO??  SCARED TO TAKE 2ND SHINGLES SHOT.  DR.  SAID I COULD TAKE IT WITHIN THE 60 MO PERIOD WHICH WOULD BE MID-MAY.   WILL TAKE COVID VACCINE IN MARCH IF I'M BETTER.....
Secretary of the Immunization Program discovered that Tdap was given instead of Td by the Lot No.  When client was notified, she said she had no adverse reactions to the Tdap instead of the Td.
pneumovax given 12/29/2008 in upper right arm, small bruise and swelling day of adminstration.  Pharmacy and physician contacted and determined to be local reaction.  12/30/2008 (today) right arm swollen, red, and hot from wrist to mid upper arm (starting next to injection site).  Physician aware.
Raised itchy, rash first noticed in the right pectoral region extending from the sub clavicular area to the upper medial shoulder.; Raised itchy, rash first noticed in the right pectoral region extending from the sub clavicular area to the upper medial shoulder.; Rash was characterized by several (1-3) erythematous, macular lesions with progression to flat dark flesh colored scars over the next week or so.; Rash was characterized by several (1-3) erythematous, macular lesions with progression to flat dark flesh colored scars over the next week or so.; This is a spontaneous report from a contactable healthcare professional, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the arm right on 20Apr2021 at 14:00 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the arm right on 30Mar2021 at 14:00 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 at 06:00, the patient developed raised itchy rash which was first noticed in the right pectoral region extending from the sub clavicular area to the upper medial shoulder. Rash developed within 12 hours from injection, at a distance from the injection site (Deltoid). Rash was characterized by several (1-3) erythematous, macular lesions with progression to flat dark flesh colored "scars" over the next week or so. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events raised rash, itchy rash, rash erythematous and macular scar were recovered with sequelae on an unknown date in May2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
"Got vaccine 8 am 12/29, started symptoms on 5 pm yesterday high grade fever and chills"
I started off being uncomfortable at night then I put a heating pad on it; when I woke up I was having discomfort breathing by noon I couldn't take any deep breath I could bend down or really move because it was cutting down my breathing; I couldn't take any deep breath because I had a sharp pain I went to emergency room my blood pressure was so high 204/97.
worst case of shingles and she took the vaccine/suspected vaccination failure; worst case of shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's relative. The age at vaccination was not reported. The reporter's mother in law had the worst case of shingles and the patient took the vaccine. The reporter said that she/he would not be taking shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Pt recv vax on 2/10/99; within 20 min post vax pt exp flu-like sx of fever, cough, rhinorrhea, pruritus
This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # M041394, expiration date: 23-MAY-2018. No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion 34.3 degrees Fahrenheit for 30 minutes. Data logger was involved. There were no previous excursions reported.
No adverse event; HCP calling to report expired dose of PNEUMOVAX 23 was administered post expiry. Per memo product was supported post expiry. Permission to contact HCP was granted. No additional information provided. No AE/PQC reported.; This spontaneous report was received from Pharmacist and refers to a patient of an unspecified age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, (lot number W015900 has been confirmed to be valid for polyvalent (23-valent) (PNEUMOVAX23) expiration date reported as 20-OCT-2023) (strength, route of administration, and indication were not provided).  The reported calling to report that the expired dose of PNEUMOVAX 23 was administered post expiry (Expired vaccine used) and no additional information was provided.
Patient stated the day after she received the vaccine that she had violent shivering that occurred for about 30 minutes. She has since stated that she is ok now and has spoken to her md regarding this event.
At injection site a hard, red with white swollen area appeared 7 days later.  It is now day 11 and still throbbing.  It is feverish, local only.  When I apply a cold pack the red swelling goes away, but comes back when ice removed.  I have pictures I could send via text if helpful. Wanting to know if I should seek help or will it go away on own.  Also, concerned for 2nd dosage because reported side effects are worse.  How should I proceed?
Patient presents to the ED with shortness of breath and admitted for further covid evaluation and treated with remdesivir.
Patient with history of COPD. She was brought into the ED on 7/3 by EMS for weakness and a fall. She additionally reported a cough. She was hypoxic per the paramedics and was placed on supplemental O2.  COVID-19 PCR test was done in the ED which was positive. Patient admitted from 7/3-7/12, discharge diagnoses included septic shock secondary to E. coli bacteremia and acute hypoxic respiratory failure secondary to COVID infection, among others. This meets criteria for vaccine breakthrough case review.
Began experiancing tingling and soreness on back and waist on one side of torso. 2 days later broke out into shingle sores and blisters. Sores were on opposite side from where shingle vaccine was administered. Dr. prescribed Valtrex to be taken for 10 days.
COVID-19 Vccine   stomach aches, low fever, headaches, general malaise for 3 days.  Currently, I am still having stomach aches all day/night.
This study case was received from the investigator on 16 August 2012. A male subject with medical history of smoking experienced on 10 August 2012 one brief episode of mild non-exertional chest pain 1 day after he had received on 09 August 2012 the following vaccines: ACAM2000 (lot number, route and site of administration not reported), and an injection of TYPHOID VACCINE (lot number, route and site of administration not reported), and an injection of Anthrax vaccine (lot number, route and site of administration not reported). On 16 August 2012, the subject was evaluated for follow-up of smallpox vaccination and reported that on 10 August 2012 while he was sitting smoking a cigarette he experienced one brief episode of mild chest pain. The subject did not take any medications to treat the SAE, and did not seek medical attention. Laboratory test revealed a negative "rapid" test, and an EKG revealed no signs of ischemia. Troponin results were to follow. The subject marked "no hurt" on Wong Baker scale. The subject was referred to his PCM (Primary Care Manager). The investigator reported that the chest pain was unlikely to be cardiac. It was noted the subject had a history of left ankle pain that began on 14 November 2011 (reported as 2012) and was being treated with Naproxen 1 tab 4 times a day that was started on 15 August 2012. This represents a case of potential myopericarditis per the Investigator and has subsequently been referred to the Adjudication Committee for assessment. Documents held by sender: none.
Red hot rash over the bicep muscle. Rash did not include injection site appeared 24 hours after immunization bicep muscle was the left arm.
Swelling of right arm, tightness in chest, Couldn't hardly breathe, every bone in body ached, fever off and on for three days. Treatment by MD, put ice on arm and take Tylenol.
left Bicep red, swollen, inflamed, warm to Touch. Pt went to see MD. Pt given augmentin 875 mg and Mobic 15 mg by MD.
A report has been received from a Health Professional concerning an 11 year old, subject of unknown gender, Height: 57.5 Inches, Weight: 80.0 Pounds, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal), 0.2 Millilitres, Once/Single administration. FLUMIST Quadrivalent (Intranasal) started on 05-Jan-2016. The patient received an expired FLUMIST Quadrivalent on 04-Jan-2016. No adverse event was reported. The outcome of the event of given an expired FLUMIST Quadrivalent is unknown. The report was considered to be non-serious by the company physician. Summary of follow-up information received by Medimmune on 01-Feb-2016 from a health professional: event term changed from caller reported giving FLUMIST Quadrivalent with an expiration date of 30-DEC-2015 today 5-JAN-2016 to given an expired FLUMIST Quadrivalent. Narrative updated. Corrected report: new report added, manufacturer added, action taken changed from none to not applicable.
Redness/swelling/warm by touch hurt. Pt has experienced symptoms for a week.
underarm feeling like swelling; underarm feeling like Hurt; Tingle; have little fever; swollen at injection, the place that they put the injection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization; Bnt162b2 (2nd dose), for Covid-19 immunization. The following information was reported: SWELLING (non-serious), outcome "unknown", described as "underarm feeling like swelling"; AXILLARY PAIN (non-serious), outcome "unknown", described as "underarm feeling like Hurt"; PARAESTHESIA (non-serious), outcome "unknown", described as "Tingle"; PYREXIA (non-serious), outcome "unknown", described as "have little fever"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "swollen at injection, the place that they put the injection". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
VOMITING; CHILLS; HEADACHE; NAUSEA; ACHY; This spontaneous report received from a patient concerned a female of unspecified age. 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, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 16-MAR-2021, the subject experienced achy. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced headache. On 16-MAR-2021, the subject experienced nausea. On 18-MAR-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 17-MAR-2021, and had not recovered from headache, nausea, vomiting, and achy. This report was non-serious.
Swelling, hives that merge together, hard skin, wrapped around entire upper arm where shot was given.  Lasted about 3-4 hours.
received the HAVRIX that expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received HAV (Havrix) (batch number 3HR79, expiry date 16th September 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device injection syringe for prophylaxis.   On 24th September 2021, the patient received Havrix and hepatitis A vaccine pre-filled syringe device. On 24th September 2021, unknown after receiving Havrix and hepatitis A vaccine pre-filled syringe device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   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 health care professional stated that, the patient received expired dose of Havrix, which led to expired vaccine used. No reactions reported. The reporter did not consent to follow up.
Around 4OCT2022 I was a little spacey and in my home I hit my head on a pipe although I did not loose consciousness I was diagnosed with a concussion. I just followed the protocol of rest for a week or two and I was fine but I kind of have had these spacey issues since I am reporting this event, I have fallen down a few times although not reported but a bleeding knee but nothing to go to hospital over.
INCREASED HEART RATE; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, dose number in series was 1, 1 total administered on 08-JUL-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. Since the past weekend (19-DEC-2021) patient had been lethargic. It was reported that symptoms did not really hit till Monday (20-DEC-2021). Patient had increased heart rate, dry cough, really bad headache which has gotten better, a little bit of a runny nose. Patient tested at home with the BinaxNow rapid test and it came out positive (suspected covid-19 infection and suspected clinical vaccination failure). Patient tested with the same kit yesterday (21-Dec-2021) and it was negative. The doctor prescribed some medication. Dose number in series was 1. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, increased heart rate, and suspected clinical vaccination failure. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000208377.; Sender's Comments: V0:20211251194-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Next morning, 09/17/2021, woke up with all over joint pain that caused difficulty in moving, tinnitus worsening, and additional difficulty in hearing. I had to turn up my hearing aid volume in order to hear clearly and understand conversation. The joint pain started easing by the 2nd day, 09/18/2021, and was completely gone by the 3rd day, 09/20/2021. Tinnitus and increase hearing trouble has not changed.
she had a positive covid 19 test done; she had a positive covid 19 test done; This is a spontaneous report from a contactable consumer (patient herself) via Pfizer Sponsored Program.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot number and Expiration date: UNKNOWN), via an unspecified route of administration on 13Mar2021 at SINGLE DOSE for COVID-19 immunisation.The patient medical history and concomitant medications were  not reported.   On 29Mar2021, patient had a positive COVID-19 test done. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 29Mar2021.The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Received flu shot high on left deltoid.  Felt intense pain immediately.  Pain in left shoulder since then which radiates into left elbow and hand at times. Also occasional numbness in elbow and pinky and ring finger of left arm.  Decreased range of motion, sometimes needing help with getting dressed.  Unable to lift arm above level of shoulder without pain.
Approximately 13 days after vaccination, the patient developed headache, fever, chills, myalgias, arthralgias, and neck stiffness. There was no chest pain or shortness of breath. He required hospitalization 6/6/21-6/7/21. He was found to have elevated cardiac enzymes (Troponin). Viral myocarditis vs vaccine associated myocarditis were considered in the differential diagnosis.
itchy left hand, itchy left ankle and itchy left neck; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy left hand, itchy left ankle and itchy left neck) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 immunisation.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced PRURITUS (itchy left hand, itchy left ankle and itchy left neck). At the time of the report, PRURITUS (itchy left hand, itchy left ankle and itchy left neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant medication was provided. The patient went to visit his doctor and was prescribed a medication (unspecified).