chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have had zero herpes outbreaks.; had one breakthrough covid infection; had one breakthrough covid infection; This is a spontaneous report received from a contactable reporter(s) (Physician), Program ID: (Unknown). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 30Dec2020 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "flair-ups with herpes I oral infections" (unspecified if ongoing), notes: several times a year and have been able to control out breaks with medications.; "flair-ups with herpes I oral infections" (unspecified if ongoing), notes: several times a year and have been able to control out breaks with medications. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "had one breakthrough covid infection"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I have had zero herpes outbreaks.".  Additional information: Since 1997, patient had had issues with frequent flair-ups with herpes / had oral infections several times a year and had been able to control out breaks with medications. On 30Dec2020, patient received the first moderna injection and ever since then, received every booster. Patient only had one breakthrough covid infection that was mild in Apr of 2022. However, patient had had zero herpes outbreaks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the narrative information provided and the known drug safety profile, the reported events Drug ineffective and Suspected COVID-19 are considered as related to BNT162b2 (BNT162B2).
Day of vaccine - violent vomiting; Day 3 - Forearms began to itch, rash appeared during evening.  I applied Hydrocortisone; Day 4 to present -rash has spread over arms, down my legs, and lower back region.  Today - I applied Hydrocortisone and took a Benadryl pill.  This rash itches!!
Fever 104, body aches, congestion, could not get out of bed   Lasted 3 days
itching head to toe eyes roof of mouth; itching head to toe eyes roof of mouth; itching head to toe eyes roof of mouth; This is a spontaneous report from a contactable consumer. This 68-years-old consumer (patient) reported that he/she received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot ER8731) single dose at right arm on 12Apr2021 for COVID-19 immunization. Medical history included obesity, obesity hypertension, penicillin allergy. Historical vaccine included 1st dose of BNT162B2 (lot EN6207, Right arm) on 15Mar2021 for COVID-19 immunization (24 hrs after injection developed generalized itching). Concomitant drugs were not provided. 2 1/2 hours after shot, itching started again on 12Apr2021. The patient has been taking diphenhydramine hydrochloride (BENADRYL) every 6 hours. The patient had itching head to toe, eyes, roof of mouth. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Patient accidentally received the children's dose of the Pfizer vaccine.  No adverse event was observed after monitoring.  Patient was notified of error and made aware. He was also information to contact healthcare provider in the event of an adverse reaction.
Constant headache located front/top of the head; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Jan2023 as dose 3 (booster), single (Lot number: GJ6742) at the age of 28 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Migraines", start date: 2010 (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: prior to vaccination. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (dose 1, single; lot number: FJ9943; site: left arm), administration date: 29Mar2022, when the patient was 27-year-old, for COVID-19 immunization; BNT162b2 (dose 2, single; lot number: FJ9943; site: left arm), administration date: 26Apr2022, when the patient was 27-year-old, for COVID-19 immunization. The following information was reported: HEADACHE (medically significant) with onset 20Jan2023, outcome "not recovered", described as "Constant headache located front/top of the head". The event "constant headache located front/top of the head" required physician office visit. Therapeutic measures were taken as a result of headache. Clinical course: Constant headache located front/top of the head. No relief even with OTC medications and prescribed medications (3 different medications). Went to the doctor 4 times with the same complaint. Headaches started the day after 3rd dose of the Pfizer COVID shot. The patient has not tested for COVID post-vaccination. She has no known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the temporal relation, the association between the event headache and the suspect product cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Patient called stating after receiving her vaccination from another pharmacist on May 9 her arm had begun hurting. She described that the pain had kept getting worse and worse and described a 75% reduction in range of motion in the arm. Patient states arm still hurts. Stated she had begun to do ibuprofen around the clock and a lidocaine role on.
Fever; Swelling; Hot area; Pain; Redness; Itching; Chills; Muscle aches; Flu Like Symptoms; This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 12th August 2019, 1 days after receiving Shingrix, the patient experienced fever, chills, muscle pain, influenza-like symptoms, injection site swelling, injection site warmth, injection site pain and injection site erythema. In August 2019, the patient experienced injection site itching. On an unknown date, the outcome of the fever, chills, muscle pain, influenza-like symptoms, injection site swelling and injection site pain were recovered/resolved and the outcome of the injection site warmth, injection site erythema and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, muscle pain, influenza-like symptoms, injection site swelling, injection site warmth, injection site pain, injection site erythema and injection site itching to be related to Shingrix.  Additional details were reported as follows: The patient reported that the day after vaccination she woke up with fever, chills, muscle ache and flu like symptoms. She had a low grade fever that lasted for 2 days. The chills, muscle ache and flu like symptoms lasted for about a day and a half.  The patient also experienced redness, swelling, pain and hot area on the injection site covering an area of one and half inches by 3 inches.  It was not painful or swollen anymore. The area was still red and now the patient was experiencing itching. The reporter consented to follow up.
Approximately 15 minutes after administering the first dose of the Moderna vaccine, patient started to feel fatigued and was sweating profusely. Checked patient's temperature and it was decreasing. Patient appeared to be disoriented and was going to pass out. Patient was seated the entire time and did not move. Ambulance came and checked patient's vitals and took him to the hospital.
Suspect COVID breakthrough case Presented with vomiting and diagnosed with diabetic ketoacidosis with subsequent COVID finding
She states that she is experiencing body aches; This is a spontaneous report from a contactable Other Health Professional (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number was not reported, via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is a 55-year-old female patient assistant who received the COVID-19 vaccine yesterday, on 05Jan2021. She stated that she was experiencing body aches with outcome of unknown in Jan2021. She would like to know if taking TYLENOL is permitted after receiving the vaccine.  Information about lot/batch number has been requested.
Bloody Nose.  Unable to stop for over an hour.  Continues to this date of 10/21/2009 several times per day.
LEFT WRIST HAS A BONY KNOT (LOOKS LIKE MOSQUITO BITE BUT BONE); NERVE PAIN; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's past medical history included car accident, and concurrent conditions included plate in right upper arm and left lower arm. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 13-JUN-2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced left wrist has a bony knot (looks like mosquito bite but bone). On 12-APR-2021, the subject experienced nerve pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left wrist has a bony knot (looks like mosquito bite but bone), and the outcome of nerve pain was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
7 days after second dose I began to get what seems to be hives. 9 days after multiple large red itchy swellings on both cheeks, on butt, on non-shot upper arm
Woke up at 8:00 with a headache and face ache. Coughed a few times and discovered it was very painful to my rib cage. Had slight fever all day and now it's 4:00 p.m. I still have headache and slight fever. Slept a few hours today. Very sore neck muscles. Might have sinus pressure and eyes very sensitive to light.
Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with first dose of Gardasil (yeast) (lot # not reported) injection. Subsequently, the patient experienced nausea and diarrhea. Medical attention was sought. On an unspecified date, the patient recovered from nausea and diarrhea. No further information was available at the time of reporting. Additional information has been requested.
Patient came in today complaining of terrible pain in her arm since the day of vaccination. She cannot raise her arm to brush her hair and even moving the arm is causing pain. Pain is not really responding to OTC pain meds (Aleve, Advil, Tylenol). I saw where the vaccine was placed on her arm and it was less than 2 finger spaces from the shoulder joint. Patient was aware herself that it was given too high on the arm.
left arm lymph node got swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (left arm lymph node got swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced LYMPHADENOPATHY (left arm lymph node got swollen). At the time of the report, LYMPHADENOPATHY (left arm lymph node got swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications and treatment information  were not provided.
This was a medication error.  The patient had requested Janssen for his first dose.  The nurse mistakenly administered a booster dose of Moderna (1/2 dose or .025 mL).  The mistake was noted immediately, and the patient was informed of the mistake.  After an MD consult, the nurse administered an additional 1/2 dose of Moderna to equal a full dose for dose #1 of Moderna.  The patient was advised to get a 2nd dose of Moderna in 28 days.  No known adverse event or outcome, other than patient had to get 2 shots.
I got the shot on Tuesday. My arm was a little sore but then it got really sore.  By Wednesday,  my arm by the injection site was swollen, red, and really hot. As Wednesday went on, I got really nauseous.  I ended up throwing up starting at around 5:30 pm until 12 midnight off and on. I woke up Thursday with a rash looking thing across my chest and the right side of my neck.  My arm was still sore,  hot and red and now itching.  It had not gone down any.   I felt like crap so I went to the er thinking it might have been an allergic reaction about 10:45 am.  The dr at the er put me on iv fluids,  benadryl and nausea medicine.  The redness and swelling went down a tiny bit while at the er. From Thursday to today, the swelling and redness is almost gone.  It does itch still and still nauseous.
PT STATED SHE NEEDED HER FIRST DOSE OF THE COVID VACCINE AND SHE WANTED PFIZER. AFTER THE SHOT WAS GIVEN, THE INSURANCE REJECTED THE CLAIM STATING SHE HAS GOTTEN HER FIRST DOSE OF MODERNA AT A PHARMACY ON 7/29/21. WE CALLED THAT PHARMACY AND CONFIRMED SHE HAS GOTTEN IT.
Received COVID-19 Vaccine on 03/08/2021. About 7:00 am the next morning began having N/V x4 past 12 hrs, diarrhea x 6, headache and blood in urine. Chronic illness  of stage 4 kidney disease with bilateral nephrostomy and acute bloody discharge, ulcerative colitis with colostomy and acute high output, CAD with 7 cardiac stents and 2 CABG.   A&Ox4, Malaise, tachycardia and hypotension, afebrile.  Patient reports chronic abdominal pain unchanged today.  Denies back pain, chest pain, cough, or SHOB. Afebrile. Patient has new diagnosis of UTI. IV fluids administered, IV Zofran, Meropenem, and po Hydrocodone/APAP.  Transferred due to creatinine of 4.3, bloody urine, and UTI. T: 98.1 HR 91, R-14 BP 106/71, O2 sat 97%
I82.433 ACUTE DVT OF BILAT POPLITEAL VEINS 8/13/2022 LEFT FEMORAL NECK UNSPECIFIED TYPE FX, INIT J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 8/13/2022 LEFT FEMORAL NECK UNSPECIFIED TYPE FX, INIT I82.433 ACUTE DVT OF BILAT POPLITEAL VEINS 8/13/2022 LEFT HIP ARTHROPLASTY DISLOCATION, INIT J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 8/13/2022 LEFT HIP ARTHROPLASTY DISLOCATION, INIT
Narrative: Patient received the Moderna COVID vaccine on the following dates at this facility: 3-9-21, 4-6-21, and 1-11-22. Patient then was admitted to the hospital for COVID pneumonia on 2/25/22.
This case was reported by a pharmacist and described the occurrence of drug dose administration interval too long in a 51-year-old female patient who received TWINRIX. Co-suspect products included TWINRIX. Previously administered products included TWINRIX (dose 1). On 25th September 2014, the patient received the 2nd dose of TWINRIX 1 ml. On 10th December 2014, the patient received the 3rd dose of TWINRIX. On an unknown date, an unknown time after receiving TWINRIX and TWINRIX, the patient experienced drug dose administration interval too long and drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too long and drug dose administration interval too short were unknown. Additional information received: TWINRIX was administered on 5/2013 and then on Sept 25, 2014 and then on 12/10/2014. The dose 2 was delayed and dose 3 was given too early. No specific reason for this.
Developed intermittent whole-body rash with extreme itching. Initial rash started out on upper back and arms. Subsequent events expanded the rash to include chest & abdomen and sometimes thighs. Sometimes hot flashes precede outbreak of the rash. After experiencing 3 - 4 outbreaks of the rash, I went to see my dermatologist. Initial treatment by my dermatologist included an IM injection in the buttocks of  Kenalog in mid-June. A follow-up visit as a result of an additional outbreak was also treated in office with an additional IM injection in the buttocks of  Kenalog. I don't remember the doses; the second was less than the first.  Ongoing treatment includes Triamcinolone Acetonide 0.1% cream applied to the rash
I started having the symptoms in the afternoon. I was really fatigued and throwing up multiple times (nothing left in my stomach); had chest pain. My boyfriend rushed me to the hospital. While I was at the hospital (about 3:00 am) I threw up again at the hospital. They monitored me and put an IV on me. When I was able to hold down water and stop throwing up they let me go home - which was about 7. Prescribed Zofran and Pepsin.  And they put me on a clear liquid diet for a day.  They told me to Zofran, Pepsin and Benadryl before the second dose and told me to eat a meal before getting the second dose and I had no symptoms at all with second dose.
Information has been received from a registered nurse (R.N.) concerning a 12-month-old male who on 14-AUG-2007 was vaccinated with the left leg with a first dose of MMR II (lot# 654984/1169F). Suspect vaccination included a first dose in the right left of VARIVAX (Oka/Merck) (lot# reported as "07160"). Concomitant vaccinations included a fourth dose in the left leg of PREVNAR (lot# B26510A) and a first dose of in the right leg of HAVRIX (lot# AHAVB13BA). On approximately 14-AUG-2007, the patient experienced fevers that lasted until 20-Aug-2007. It is reported that he did well from the fevers. The fevers abated for 4 days and then recurred on 24-Aug-2007. TYLENOL was given at home. On 25-Aug-2007, he had an episode of full body rigidity, cyanosis, and rhythmic shaking of all his limbs for 2-3 minutes and was brought to the emergency room by ambulance. On arrival to the emergency room, he had a temperature of 106 and was started on ceftriaxone sodium. Blood and urine cultures were taken. He was observed overnight tolerated a regular diet and did well with no further episodes of seizure activity. A second dose of ceftriaxone sodium IV was administered on 26-Aug-2007. He recovered on 26-Aug-2007 and was discharged from the hospital in good condition. The reporter felt that fevers was related to therapy with MMR II. Febrile seizures are considered to be an other important medical event. Additional information has been requested.
mRNA vaccine induced myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (mRNA vaccine induced myocarditis) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   The patient's past medical history included COVID-19 (Patient had been diagnosed with confirmed COVID-19 infection seven months prior to presentation.). Concurrent medical conditions included Asthma.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDITIS (mRNA vaccine induced myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (mRNA vaccine induced myocarditis) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Investigation: abnormal (abnormal) Elevated cardiac and infammatory markers, but further workup was negative for signifcant coronary artery disease.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (mRNA vaccine induced myocarditis) to be related.    The disease course was mild. Treatment was conservative and  he experienced resolution of most of the reported symptoms. Follow up was reassuring.   The diagnosis was made based on the constellation of clinical fndings, exclusion of other causes of myocarditis and the temporal relationship to C-19 vaccine administration. Notably, the case occurred in patient with confrmed previous COVID-19 infection.  Company comment: This is a literature case concerning a 30-year-old male patient with medical history of COVID-19 infection seven months prior to presentation and asthma, who experienced the expected serious AESI of Myocarditis 24 hours after the second dose of mRNA-1273 vaccine. The outcome was reported as recovering. Medical history remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-460665 (Patient Link).; Sender's Comments: This is a literature case concerning a 30-year-old male patient with medical history of COVID-19 infection seven months prior to presentation and asthma, who experienced the expected serious AESI of Myocarditis 24 hours after the second dose of mRNA-1273 vaccine. The outcome was reported as recovering. Medical history remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
On 11/16, child woke up with fever-102 degrees. Fever off and on x 3 days. On 11/19-developed rash; red; flat rash on trunk, red, hairline, sl on arms/legs, buttocks. Rash lasted 6 days. Given Benadryl, Tylenol, Motrin.
Pt received the 2nd dose of COVID_19 Moderna vaccine on 2/26/21 and got a stroke on 3/1/21. Pt's girlfriend mentioned that the doctor believed that stroke was from a plaque in the carotid artery
Hives the evening of imm. cleared w/BENADRYL. Hives came back 5/16/13.
RN intended to administer Meningococcal Conjugate; Administered Meningococcal B in error.
This case was reported by a consumer via call center representative and described the occurrence of tic in a female patient who received RABAVERT. Concomitant products included RABAVERT. On an unknown date, the patient received the 2nd dose of RABAVERT. On an unknown date, 1 day 14 hrs after receiving RABAVERT, the patient experienced tic. On an unknown date, the outcome of the tic was unknown. It was unknown if the reporter considered the tic to be related to RABAVERT. Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that he daughter experienced full body tics about 38 hours after receiving the 2nd dose of a post-exposure rabies series. The physician described the reaction as myoclonic tics, but the patient did not have myoclonic seizures. The series was discontinued after the 2nd dose. The patient had denied permission to contact their physician. The reporter did not want to went through the whole form. When she had a change to gather more information she would complete the VAERS form.