chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Subsequent to receiving one dose of varicella virus vaccine live approximately 120 pts experienced chickenpox. Upon follow-up there were only 39 cases of chickenpox, and 90% of these were vaccinated with varicella virus vaccine live.
HUSBAND REPORTS PT'S SX FOLLOWING DAY AS MUSCLE ACHES, HEADACHE, SORE ARM, HARD TIME SLEEPING NIGHT BEFORE - DID SAY SX IMPROVING - REC F/U W/DR IF SX DON'T IMPROVE - SX LISTED ADES FOR SHINGRIX, FLU SHOT DAY PRIOR - PT WAS COUNSELED ON THESE ADES PRIOR TO RECEIVING VACCINES - HAVE NOT HEARD FROM PT SINCE INITIAL REPORT.
swollen glands left side only; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number ej1686 and expiry date unknown, via unspecified route of administration at the left arm on 11Jan2021 12:00 PM at single dose for Covid-19 immunization in a hospital. Medical history was none. The patient's concomitant medications were not reported. The patient has no other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021 12:00 PM, the patient experienced swollen glands left side only. The patient has not been tested for COVID-19 since vaccination. The patient did not received treatment due to the events. The outcome of the event was recovering. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.  No follow-up attempts are possible. No further information is expected.
Pt reported rapid heart rate and injection site symptoms (swollen, red, hot to touch). Taking OTC BENADRYL and advised pt 4/1/13 to contact MD.
Two days after taking the 1st vaccination, I developed a cough. As the days have passed, the cough got worse and has leveled off to a lingering productive cough with a dull ache on the left side of my back. I have suffered from pneumonia several times in my life and this feels similar to the early stages, however, I have no other symptoms and have nor felt as though I had an elevated temperature.   I work as a technical support rep and have to talk on the phone eight hours a day and I have found it difficult over the last three days to talk for extended periods of time. I get mild shortness of breath and as the day progresses, the coughing gets worse and I am awakened several times during the night coughing.
Pt received Janssen Booster.  Pt previously received Pfizer Covid Vaccine x1 and Janssen Covid Vaccine x1  30mins post vaccination pt was observed to be dizzy by observation RN.  Pt had a near syncopal event.   Pt escorted by w/c to triage area and assess by provider.  Pt denies SOB, chest pain.  Provider recommended to call 911 for further evaluation at the ER @11:30. Vitals: 160/101, 83, 18, 100% A&O x4, dizzy upon standing -- > 155/94, 83, 18. Pt d/c  to ER via EMS w/ family member  In ED: Pt reports that he noticed he was  feeling "weird" and generally unwell Described as pre-syncope States similar s/s w/receipt of prev covid vax. However, endorses mild CP w/onset of s/s States s/s ongoing but gradually improving. NO further information available.  Pt appears to have been discharged from ED without intervention.
Injection site sore, resolved, then 7 days after vaccination swollen, large red, raised in area of injection.
Pityriasis rosea, diagnosed 4/7/2021; This is a spontaneous report from a contactable pharmacist, the patient. A 52-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration on 03Mar2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine and high cholesterol. Concomitant medications included sumatriptan (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and magnesium supplements (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications. Prior to 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 an unknown date in Mar2021, the patient experienced pityriasis rosea, which was diagnosed 04Jul2021.The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of pityriasis rosea and included treatment with topical antihistamine and steroid cream. The clinical outcome of the event pityriasis rosea was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Mid back pain difficult to take a deep breath or stand up straight. Pain started about 5 PM day of shot. Lt. side greater than Rt. side.
4INCH X 2 INCH LARGE lump in left deltoid region. onset of inflammation was two days after receiving vaccine. area  is hot to the touch itchy and sharp pains shooting from site of inflammation to my small and ring finger.  pain and swelling under my left arm pit. ibuprofen Benadryl and cortisone cream tried with no relief.  Injection site is continuing to get larger and more inflamed every day.  NP thinks it may be turning to cellulitis.  Antibiotics being contemplated as treatment if swelling and heat do not resolve.  Sharp shooting  pains in hips lasting about 3-5 seconds, pain is so bad it causes me to scream out loud when it happens. this happens about 3-5 times daily since the second day of injection this to is not resolving.
Around 3 am on 1/18/2021  I woke up with a very sore lymph node on my lower head left side. Within a few hours lympnodes in my neck, behind my ear and on my  collar bone were all swollen and painful.  On Wednesday  01/20/2021  I developed hives on my scalp, in my left ear, and on and around all swollen lymph nodes.  I left work on 1/20, still couldn't go to work 1/21 on 1/22 I saw Dr. Who have me a shot of Kenalog and some triamcinolone  cream for hives. I tried to work, but only lasted 4 hrs and went home. It is now one week since vaccine number two and on top of still raw spreading hives, and swollen glands , I now have a sharp pain constantly shooting through my left temple which is relentless.  I am miserable.
Patient had redness and inflammation on his right deltoid that measured 80 mm. He had TDAP and Menveo administered in this arm.
Lethargic, cough, fever grew to 102 degrees by mid day Friday 11/13, accompanied by chills, bronchial cough, difficulty breathing, and ataxia.  Fever broke by Friday night.  Doctor prescribed antibiotic, steroid, and ventalin inhaler.  Patient also took Robitussin and Tylenol.
Herpes Zoster; This initial spontaneous report has been received from a lawyer regarding a case in litigation referring to a 58-year-old female patient. No information was provided regarding concomitant medications, concurrent conditions or medical history.     On 20-OCT-2014, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) vaccine for the long-term prevention of shingles and zoster-related conditions (dose, route, and lot number not provided).         On an unknown date, the patient experienced herpes zoster and was treated by a doctor. The outcome of the event was unknown. Causality assessment was related.
shortness of breath, increased sputum production, covid infection, increased oxygen requirement Narrative:  COVID infection following completion of COVID vaccine series 12/30 COVID vaccine dose #1 01/21 COVID vaccine dose #2 01/29 Cataract surgery 02/28 admitted to non-agency hosp for COPD exacerbation, COVID positive; c/o SOB, fever, increased sputum production x 2 days, given solu-medrol, remdesivir, azithromycin, rocephin 03/01 back to baseline oxygen use and breathing improved 03/03 had runs of asymptomatic NSVT, started on amiodarone 03/25 reports increased mucous production yellow in color 04/02 reports increased SOB and increased home oxygen use 04/05 admitted through ED with lower abdominal pain and feeling bloated, lack of energy, worsening leg edema, SOB, DOE, and diaphoresis since covid diagnosis, still testing covid positive
Syncopal episode 11/28/12, 2 days after immunizations - recovered & none since.
ExpiredTwinrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 77-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 13th January 2023, unknown after receiving Twinrix and Twinrix 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 Information: GSK receipt date :13 JAN 2023 Reporters comment: The pharmacist reported that dose of Twinrix that expired on 1st January 2023 was administered to a patient. The vaccine administration facility is the same as primary reporter. Reporter consented to follow up. Additional supportive information: As patient received the expired Twinrix vaccine which led to expired vaccine used.
some right arm and leg twitching; a small red patch by the injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (some right arm and leg twitching), VACCINATION SITE ERYTHEMA (a small red patch by the injection site) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (some right arm and leg twitching), VACCINATION SITE ERYTHEMA (a small red patch by the injection site) and HEADACHE (headache). At the time of the report, MUSCLE TWITCHING (some right arm and leg twitching), VACCINATION SITE ERYTHEMA (a small red patch by the injection site) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
12/8/10 patient received vaccines, arm was tender and low grade temp (per mother report) 12/9/10 pts mother called and spoke with nurse: swollen, warm to touch at site, low grade temp. Will manage with ice to area, control with TYLENOL/ADVIL. 12/10/10 saw MD, given abx for 10d for cellulitis.
Within minutes, my arm that received the shot developed multiple red raised bumps. I notified the pharmacist. She told to stay there. I started having tightness in my chest and wheezing. I felt dizzy. I took two puffs of xopenex but it only helped for a few minutes. The wheezing got worse, the redness moved to my chest and neck. The pharmacist called 911 and gave me an Epi-pen shot. Paramedics arrived and gave oxygen, checked O2 sat, and said the Epi-pen seemed to be working. They suggested some Benadryl. I jumped in my car and went to the ER. By the time I got there, my chest was even tighter and the wheezing worse. The Er Dr. gave me a steroid shot, Pepcid, and a 20 minute breathing treatment. He put me on 60 miiligrams of prednisone, 20 milligrams of Famotidine, and 50 milligrams of Benadryl. My chest stills feel a little tight. I am under Dr's. care for the allergic reaction to this shot. The Er Doctor told me not to take this stupid H1N1 shot again. I took the regular flu shot four or five weeks ago with no problem.
About 10 minutes after injection, got dizzy/clammy. It took about 5-10 minutes after that with EMTs to wait until my blood pressure normalized, and then I was fine.  Walked off site.  Slowly throughout the day had an increasingly bad headache, which peaked about 10 hours after the injection. Around that same time, bad fatigue started, and then slight chills. The headache at this point was extremely severe for about 10-12 hours. After that (so 20-22 hours after initial injection) the fatigue and chills subsided, but came back occasionally. The headache was less severe at that point, but in total did not go away until an additional 15 hours had passed.   My estimate is that took about 36-40 hours to feel 100% normal again.
Inadvertently administer diluent vial without reconstitution; Inadvertently administer diluent vial without reconstitution; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) (batch number C9Z43, expiry date 08-JUL-2024) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Inadvertently administer diluent vial without reconstitution) and inappropriate dose of vaccine administered (Verbatim: Inadvertently administer diluent vial without reconstitution). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 28-APR-2023 The pharmacist inadvertently administered diluent vial without reconstitution. Even though the pharmacist had administered hundreds, if not thousands of Shingrix doses, he/she administered one where it was only the adjuvant/diluent prior to reconstituting the vaccine. The reporter contacted the patient when the error was discovered and she since came in to have it readministered.  Now the reporter was short 1 vial of diluent, so he/she had asked for credit for 1 dose of vaccine since he/she had been told that it was not possible for only a single vial of diluent to be sent to her/him. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Covid vaccine monitoring documentation. 90 yof patient presented to ED 3/4/21 at 1233 unresponsive via EMS due to cardiac arrest. BP documented 82/43 at 1233, pulse 49. Prior to arrival, patient had been in bathroom and had syncopal event. Patient lived with family.  EMS began CPR and administered doses of Epi. Documentation also stated patient?s family member said patient received their 2nd covid vaccine 5 days prior and has not been okay since. After arrival to ED, patient was intubated, cardiac ultrasound showed no cardiac activity and no pericardial fluid.  Patient received sodium bicarbonate and calcium chloride.  Patient expired in the ED department at 03/04/2021 12:51.  Per Death Summary Form clinical diagnosis cardiopulmonary arrest, clinical impression of cause of death or terminal events leading to death, possible myocardial infarction.   Pfizer    EL9265 on 1/30/21, Pfizer    EL9266 on 2/20/21.
induration @ inj site; pt reports initial lump approx size of fifty cents piece; observed 13SEP95 to be approx size of twenty five cents piece;pt reports site w/some tenderness remaining
MODERN 0.5 ML FOR IM LOT 038B21A EPX:09/25/2021 No known adverse events.
Ptosis of the left eyelid started on 3/19. Seen by specialist on 3/20 at Hospital. MRI showed inflammation of the left eye socket. No treatment at this time until second vaccine has been administered and two weeks have passed.
Rash, flesh colored papules to shoulder with surrounding hyperpigmentation also with flesh colored papules to chest.
Info has been received from a DDS concerning a female who was vax'd w/Hep B vax recombinant. The PT received the 1st dose of Hep B vax recombinant w/out any prob's. The PT received the 2nd dose (date UNK) and w/in 24 hrs she developed a rash on the one leg. The PT was treated w/diphenhydramine hydrochloride (Benadryl) and the rash "was gone the next day". Unspecified medical attention was sought. Add'l info has been requested.
Date of Admission: 10/16/2022   Date of Discharge: 10/16/2022   Admission Diagnosis: No admission diagnoses are documented for this encounter.   Hospital Principal Problem (Discharge Diagnoses): COPD exacerbation COVID 19
Developed shingles in right side of face after receiving vaccination. First symptom (headache, localized to right side of head) appeared 9/28, two days after vaccination. Shingles rash appeared on right side of face on 10/1, 5 days after vaccination.  Pregnant with twins - 34 weeks 6 days pregnant on date of vaccination. 40w due date 11/1. C-section scheduled for 10/19. Gestational diabetes in pregnancy, diet-controlled. No other complications.
Cold-like symptoms -- sneezing, light headache, drowsiness Progressively worsening symptoms from onset.
24 hours after vaccine developed a red rash and swelling. Started to go away on day 6. On day 7 the rash got worse and spread over my arm. Took Benadryl and Claritin with good results. Rash seemed to go away. On day 12 rash came back and spread over a bigger portion of my Left arm and I have had to start taking Benadryl and Claritin again. Rash is itchy and site is swollen but responds well to Benadryl. But now a bigger portion of my arm is affected
Multiple skin lesions varying in size from 4mm to 10 mm Lesions first arose as pinkish red circles or ovals, and would darken over a period of a few days, often erupting and leaving a shallow oval crater. Lesions eventually healed and disappeared, leaving very little vestige of discoloration.  Lesions became as many as about 40 in my right armpit, and places as varied as left arm, left calf, right thigh, right eyelid, left nose bridge, left nostril (internal), right armpit, and right temple.  Finished around 07/31/2021
Extreme epigastric pain; hives; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Extreme epigastric pain) and URTICARIA (hives) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Extreme epigastric pain) and URTICARIA (hives). At the time of the report, ABDOMINAL PAIN UPPER (Extreme epigastric pain) and URTICARIA (hives) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Information has been received on 05-JAN-2018 regarding a case in litigation from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 04-MAR-2013, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-FEB-2016, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as sever herpes zoster or shingles with complications. The patient was prescribed valacyclovir, acyclovir and tramadol for management of her painful symptoms. 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. Additional information has been requested.
Very itchy; Pinkish red spot; Red patch at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Very itchy), RASH MACULAR (Pinkish red spot) and VACCINATION SITE ERYTHEMA (Red patch at the injection site) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to sulfa), Drug allergy (allergic to Bactrim) and Allergy to venom.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PRURITUS (Very itchy), RASH MACULAR (Pinkish red spot) and VACCINATION SITE ERYTHEMA (Red patch at the injection site). At the time of the report, PRURITUS (Very itchy), RASH MACULAR (Pinkish red spot) and VACCINATION SITE ERYTHEMA (Red patch at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jan2022 as dose 1, single (Lot number: EL3246), in left arm, on 04Feb2021 as dose 2, single (Lot number: El9265), in left arm, on 07Oct2021 as dose 3 (booster), single (Lot number: Fd8448), in left arm and on 04Apr2022 as dose 4 (booster), single (Lot number: Fk9894) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sjogrens Syndrome" (unspecified if ongoing); "Lichen sclerosus" (unspecified if ongoing); "depression" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE; METHOTREXATE, start date: 06Feb2022, stop date: 26Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 which included paxlovid.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Headache-Mild, Additional Details: patient reported swelling in eyelids and the whole area around the eye that started wednesday 6/23; 2 days after pfizer 1st shot, pt. went to an urgent care that prescribed the patients triamcinolone 0.025% cream to apply to affected area. pt reported swelling reduction after treatment but on friday that the right eye started to swell up as well but not as bad as the left. no vision changes has been reported, Pt is to follow up with an eye doctor next week.
I started to experience gradual hearing loss in my right ear. I can hear if someone is facing me, but if they are next to me on the right talking to me, or if there is a large crowd I wont hear them. I had a physical scheduled for 05/23/2022 so when I went to the appointment I told my doctor about the hearing loss. She checked to see if my ear was clogged and it was not. She referred me to a hearing specialist and I have an appointment in 08/25/2022.
Starting within a day of receiving the vaccine, I developed fatigue. It seems to be progressively worsening since receiving this dose. I went to urgent care on 06/09/2022 and they basically told me to get more rest, drink fluids and follow up with my PCP. The fatigue is so bad that I am struggling to get up out of bed and I can sit in a chair and just fall asleep. I have never had fatigue before in my life.