chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported; patient was administered two live vaccines outside of the minimum interval; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The concomitant medications included sterile diluent. Information about the patient's pertinent medical history, concurrent conditions and previous drug reactions or allergies was not provided.   On 15-JUN-2017, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis (strength, route of administration, anatomical location, lot number and expiration date were unknown by the reporter).   On 06-JUL-2017, the patient was vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, route of administration, anatomical location, lot number and expiration date were unknown by the reporter).  It was reported that the patient was vaccinated with two live vaccines outside of the minimum interval (inappropriate schedule of product administration).  No adverse effects were reported.
Mother stated child was 11 years old. Nurse administered dose before confirming date-of-birth and realizing that it was the wrong Pfizer product.
No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to an 1-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-JUL-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #W026315, expiration date: 18-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Rebound of Covid after completion of Paxlovid. Return of symptoms and Positive test on 06Jul2022 (5 days after completion of Paxlovid); Rebound of Covid after completion of Paxlovid. Return of symptoms and Positive test on 06Jul2022 (5 days after completion of Paxlovid); This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Dec2020 as dose 1, single (Lot number: EK9321), in left arm, on 16Jan2021 as dose 2, single (Lot number: EL3246), in left arm and on 28Aug2021 as dose 3 (booster), single (Lot number: FC3182) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Lot number: 002M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Jackfruit allergy" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM, start date: 01Nov2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Rebound of Covid after completion of Paxlovid. Return of symptoms and Positive test on 06Jul2022 (5 days after completion of Paxlovid)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Result; (03Jul2022) Negative, notes: Negative test on 03Jul2022; (06Jul2022) Positive, notes: Return of symptoms and Positive test on 06Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.The adverse event resulted in none. Paxlovid Covid-19 treatment received from 27Jun2022 to 01Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and vaccination failure cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and vaccination failure  is : expected. The case will be reassessed further upon receipt of additional information.
Tachycardia; Rare skin condition called Bullous Pemphigoid; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia) and PEMPHIGOID (Rare skin condition called Bullous Pemphigoid) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (Tachycardia) (seriousness criterion medically significant) and PEMPHIGOID (Rare skin condition called Bullous Pemphigoid) (seriousness criterion medically significant). At the time of the report, TACHYCARDIA (Tachycardia) and PEMPHIGOID (Rare skin condition called Bullous Pemphigoid) outcome was unknown.            Concomitant product was not provided.  Caller stated that her grandfather who is 85 years old received the 2nd dose of the Moderna COVID 19 vaccine in APR2021. Months later he was diagnosed with tachycardia and his doctors are recommending pacemaker; he has also developed a rare skin condition called Bullous Pemphigoid. She stated that he has never had heart issues before. She declined to provide patient's information or medication information.  Treatment medication was not reported.  This case concerns an 85-year-old male patient with no relevant medical history, who experienced the unexpected events of Tachycardia and Pemphigoid. The event occurred an unknown date after receiving a dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns an 85-year-old male patient with no relevant medical history, who experienced the unexpected events of Tachycardia and Pemphigoid. The event occurred an unknown date after receiving a dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
body aches and weakness, especially in areas that I've had previous issues with (low back, ankle, and knee); body aches and weakness, especially in areas that I've had previous issues with (low back, ankle, and knee); body aches and weakness, especially in areas that I've had previous issues with (low back, ankle, and knee); body aches and weakness, especially in areas that I've had previous issues with (low back, ankle, and knee); hot and cold flashes; hot and cold flashes; light runny nose (light, yellowish/green); extreme fatigue; inability to concentrate; loss of appetite; soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), via an unspecified route of administration at the left arm on 21Jan2021 at 14:00 (02:00 PM) at single dose for COVID-19 immunization, administered at other facility (as reported). The patient was not pregnant. The patient had no medical history (reported as none). The patient had no COVID prior to vaccination. The patient has no known drug allergies. Concomitant medication included tocopherol (VITAMIN E), cetirizine hydrochloride (ZYRTEC), docosahexaenoic acid, eicosapentaenoic acid (OMEGA-3), and prenatal vitamins. The patient had no other vaccine in four weeks. On 23Jan2021 at 08:00 AM, the patient experienced body aches and weakness, especially in areas that she had previous issues with (low back, ankle, and knee), hot and cold flashes, light runny nose (light, yellowish/green), extreme fatigue, inability to concentrate, loss of appetite, and soreness at injection site. The patient has not been tested for COVID post vaccination. The patient did not receive treatment for the events. The outcome of the events was recovering.
This case was reported by a healthcare professional and described the occurrence of fever in a 2-month-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP, manufacturer unspecified) for prophylaxis. On an unspecified date the subject received 1st dose of DTaP (unknown). At an unspecified time after vaccination with DTaP, the subject experienced fever and irritability. Her fever was 103-103 degrees Fahrenheit. At the time of reporting the outcome of the events were unspecified. The subject only received diphtheria and tetanus for the next doses and did not receive any pertussis following these events. The reporter also stated that this reaction occurred when the subject was a patient at another office.
Injection site is red, swollen, warm to the touch, itchy and painful. Symptoms occurred after injection. Patient was counseled by doctor and pharmacist to take ibuprofen and BENADRYL.
Fever, Chills: 3days+; Viral like diarrhea: 14hrs 11/3/11; numbness and tingling and pain in the right hand and forearm: 3days+; headache contained in the upper left side of brain: lasting 3 days+; constant sneezing every morning since shot: lasting 2-3 hrs each morning; shortness of breath: 3 days+ not constant; fatigue 4+ days, with trouble sleeping, cannot rest normally; Odd chest pains: 1 day, sporadic.
PRURITIS Narrative: Patient treated with prednisone, diphenhydramine, and famotidine.
Numbness and tingling on the left side that increased over the course of 6 hours, followed by nerve and muscle pain mostly limited to the left side that continued until approximately 22 hours after the injection
This spontaneous report received from a consumer via a company representative 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced mild side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20221100231.
shortness of breath along with feeling of pressure in my chest after Flumist H1N1 virus.
Chills, fatigue, sleepyness, injection site swelling and pain in arm, headache;  all but the chills lssted the entire day. I had no reaction to previous doses
A couple of hours later arm hurt like if falling off body; pain at vaccination site. Put ice on it; did not take any medicine. Saturday felt sick on stomach, excruciating headache; spent in bed from 10-4pm. Started to gradually get better; it took 5-6 days.
After several days of fever, chills, and body ache, my smell and taste were been extremely affected by the vaccine and has lasted for the past four months. My taste and smell are distorted and strong scents and strong tasting food all smell and taste the same (like burnt hair. My ENT just prescribed prednisone and amoxicillin to try to treat possible underlying symptoms. A CT Scan and nasal spray are the next steps.
Developed itchy rash-like symptoms on torso, arms, hands, neck, and face, as well as upper back, and legs.  Nerve inflammation, also.
Temp 102. Sore throat. Cough. Sinus congestion. Bone aches. Complete exhaustion. Unable to swallow (1 day). Bed rest and liquids.
Vaccine given subcutaneously rather than intramuscularly. Patient reported 6 inch raised, red, warm, irritated area around vaccine site.
This is a spontaneous report from a contactable nurse. A 18-year-old female patient received TRUMENBA (Lot# N16808, Exp date Jul2017), via an unspecified route of administration, on 24May2017 at about 02:30 PM, at 0.5 ml single, for immunisation. The patient's medical history was not reported. Concomitant medication included NORETHIN, from 24Aug2016 and ongoing, for birth control. The patient experienced fever as high as 103.1, joint pain, muscle pain, redness of the ears and severe headache all in May2017 with outcome of not recovered. The reporter stated that pretty soon after vaccination the patient had fever and headache. The patient underwent lab tests and procedures which included body temperature: 103.1 in May2017, laboratory work (they were ordered on 25May2017). Therapeutic measures were taken as a result of fever as high as 103.1 and included treatment with TYLENOL about every 4 hours. The reporting nurse considered the event fever related to meningococcal group b rlp2086.
Palpitations; First Dose: Shortness of breath; Fever; Dose 1: body aches all over; Dose 1: Pressure in the chest; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: ER8733, Expiration date: 31Jul2021), via an unspecified route of administration, administered in Arm Left on 07Apr2021 (age at the vaccination 31-year-old) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. Medical history included narcolepsy from 2013 and ongoing. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) via unspecified route from unspecified date at 0.5 mg, once a day for narcolepsy. On 07Apr2021 patient got the first vaccine, she sat in the observation room for the 15 minutes and went home. When patient got home, patient called the location where she had gotten the vaccine. patient was having palpitations and shortness of breath. They told her to relax and that was one of the common side effects. However, patient did not see that listed on anything she was reading. Patient also had the fever and body aches all over and patient also felt like someone run her over, and pressure in chest. Patient did not visit emergency room and Physician office. Patient took Tylenol for the treatment of fever. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Two days after second shot I was hit and had onslaught of left side of head with sever migraine headaches, with intermittent pounding and spiking shot of even greater intensity of pain! It is non stop day and night preventing me from sleeping well and working  / do my job. I immediately went to see my PCP who gave my  tramdal but I could not handle it. Now I am on Prochlorperazine which is helping some with the pain, but migraine is still there. I had an MRI, and blood lab work! No growths seen in my head...but the symptoms I have are consistent with migraine which I never had until the second shot the of vaccine.  I need help! Nothing is making this away yet - I need this migraine headache to go away!
Not a true adverse event - given 3 months outside of age range.  Adacel was given and indicated for up to 64.  Patient just turned 65.
This spontaneous report was received from a medical assistance and refers to a 17-year-old patient. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 20-NOV-2017, the patient was vaccinated with VAQTA 1 ml, intramuscular (lot # and expiration date were not provided for prophylaxis. The patient was given incorrectly an adult dose of  VAQTA. No adverse effect was reported.
Red/blotchy patches across entire body (arms/legs/torso). Rash is neither raised, nor itchy. Patient hadn't treated in and did not present to pharmacy until 06/01/2016. Onset was significantly delayed (started approximately one month after administration of ZOSTAVAX). Patient/provider unable to determine the root cause of the reaction and patient presented back at pharmacy to inquire the possibility of it being from her immunization.
9/16 2021 Lump behind the ear. Pain Radiating throughout the head and neck .
I woke up in the morning with extreme swelling on the right side of my tongue. About a week after my vaccine. I didn't contact my DR, I initiated a telehealth appointment with my insurance and that DR told me to go to the emergency room so that is what I did. If I remember right, they gave me a steroid shot.
Gastrointestinal issues, migraines, fever and flu like symptoms, heart issues/palpitations, head fog, body aches, breathing issues, elevated inflammation and white blood cell count
got the shingle shot. I got shingles/ suspected Vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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 provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had shingles and when they were over, he/she got the Shingle shot and just last year he/she got shingles again. The patient stated he/she going to get the new shot they had out for Shingles and hopefully would never get Shingles again. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
pt recv vax;in sep93 lab eval revealed ALT 83;01jul94 lab revealed ALT 77 and AST 48; pt had no adverse exp;MD not overly concerned w/ lab results;f/u: MD noted that he had very limited information concerning the event;
Does not have the lot number. Is a daily smoker. When I got home an hour later my arm was sore so I put ice on it then I started getting nauseous and lightheaded. All day Wednesday nauseous and lightheaded. Yesterday (Thursday) I was feeling a little better and today I am feeling a little better still feeling the same symptoms just not as bad.
Sinus infection; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient self-reported). A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sinus infection and she was scheduled for her second dose of Pfizer vaccine on Tuesday, next week. The patient wanted to know if she would be able to take antibiotics for the infection or if it would have an effect the Pfizer vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Started with flu like symptoms, body aches and pain, nausea, low grade temp; condition persisted off and on; then in March noticed tender enlarged lymph node under left arm, along with vertigo, numbness left extremity, bloatiness and pressure RUQ, hypertension, blurred vision left eye; Started being seen by DR at that time; first visit showed that I also had low platelet count; started testing for everything from lymphoma to infectous diseases; continuing to be tested at this time but everything started after the Tdap vaccine administered; was placed on doxycycline for a week; also meds for hypertension; To this day condition remains the same along with increase muscle weakness.
Complaint of dizziness immediately after vaccination.  Waited a few minutes at the vaccination station and still complained of dizziness. Vital signs obtained x 2. She was given something to drink and rest. VSS. Escorted to waiting area by Nurse and patient's husband. Monitored for 30 minutes.  Client stated she felt better after drinking. Client able to walk unassisted and after 30 minute observation she was  discharged to home without further incident
Rash slightly purpuric, becoming urticarial. Persistent until fluids started 4/6/06. Information has been received from a mother, a physicain and medical records concerning a 17-week-old male with teething and a history of gastrenteritis and no allergies who on 17-MAR-2006 at 14:30 was vaccinated PO with the first dose of ROTAVIRUS vaccine live (lot # 653754/0139P). Suspect vaccinations administered on that same day at 14:30 included the second IM dose of DEPTACEL (lot #C239), the second IM dose of PREVNAR (lot # B08642), the second IM dose of HEPATITIS B (lot # 653524/1192R) and the second IM dose of IPOL (lot # Y0576). There was no illness at the time of vaccination. The mother reported that on 18-MAR-2006, her son developed a rash on his legs. The rash was characterized by red, nickel size blotches. The mother described the "hives" as light pink in the center, dark pink on the outside and all different sizes and shapes. The physician described the patient's rash as a fine pinhead purpuric rash which progressed to a urticarial rash. There was no itching or fever. On 21-MAR-2006 the patient was seen in the Emergency room, but was not admitted to the hospital. The patient was diagnosed with roseola at the ER. No laboratory/diagnostic tests were performed. On 22-MAR-2006 the patient was seen by the physician as his rash persisted. At the time, there was no blood in the stool. On 24-MAR-2006, the patient was seen again by the physician to re-check the rash on his hand. Since the time of onset, the rash had spread to the rest of the patient's body. It was noted that BENADRYL cleared the rash for the first few days, but wasnot effective after that. PREDNISONE was then prescribed to treat the patient's rash. On 26-MAR-2006, the patient was seen by another physician. At that time the patient had no feverm vomiting, diarrhea or difficulty breathing and appeared to be well hydrated. The patient was noted to have normal skin turgor, no lesions. He had a duffuse red pinpoint rash over his body with areas of hived and urticaria spread over the turso and extremities. The patient had more purple skin between lesions and thicker areas of hives, No petechia or purpura was noted at that time. The patient was encouraged to rest and consume fluids. On 11-APR-2006, the patient's purpuric red rash and urticaria resolved. Medical records also contained the following adverse event; runny nose (March 2006). This is a consolidation of two reports from the same patient. No further information is available. All available medical records will be provided upon request. It has been determined that WAES 0605USA00810 is a duplicate of WAES 0604USA00541. Therefore, WAES 0505USA00810 is being deleted from our files and the reports consolidated into WAES # 0604USA00541 for ROTAVIRUS vaccine live.