chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Received the second one on day 34), PERIPHERAL SWELLING (Swelling of feet), ASTHENIA (Weakness), FEELING HOT (He had to wear heavy winter blankets, after that he got really hot) and BURNING SENSATION (he was still burning) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included LEVOTHYROXINE, NIFEDIPINE, METOPROLOL, ATORVASTATIN, HYDRALAZINE, OXYCODONE, ZOLPIDEM and FUROSEMIDE for an unknown indication. On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced OFF LABEL USE (Received the second one on day 34), PERIPHERAL SWELLING (Swelling of feet), ASTHENIA (Weakness), CHILLS (chills) and HEADACHE (Headache). On 04-Jul-2021, the patient experienced FEELING HOT (He had to wear heavy winter blankets, after that he got really hot), BURNING SENSATION (he was still burning) and CHILLS (Patient got chills, the chills lasted all day. He had to wear heavy winter blankets). On 17-Feb-2021, OFF LABEL USE (Received the second one on day 34) had resolved. At the time of the report, PERIPHERAL SWELLING (Swelling of feet), ASTHENIA (Weakness), FEELING HOT (He had to wear heavy winter blankets, after that he got really hot), BURNING SENSATION (he was still burning), CHILLS (chills), HEADACHE (Headache) and CHILLS (Patient got chills, the chills lasted all day. He had to wear heavy winter blankets) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Heart rate: 90-99 (Inconclusive) Heartbeat was up to 90-99 per minute. The patient was still experiencing adverse effects from the vaccine. It was reported that the effects happen four to five times a week. Treatment information was not provided. This case was linked to MOD-2021-023382 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Significant follow-up was received. Events added.; Sender's Comments:  MOD-2021-023382:Dose 1 case
a bottle of moderna was used for vaccination after it was supposed to be pulled from the fridge and discarded.  12 days "expired"  per manufacturer recommendations for storage and handling. manufacturer recommends re-vaccination for proven efficacy in opposite arm.  left 2 messages with patient for follow-up.
Severe swelling, redness, hardness, itching around injection site, about 3 inches in diameter.
fever; chills; pain (from head to toe) / soreness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had chickenpox as a child) and shingles (had as an adult and hospitalized because of it). Previously administered products included Covid-19 vaccine with an associated reaction of no adverse event (received on an unknown date) and flu vaccine with an associated reaction of no adverse event (received on an unknown date).   On 18th December 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced fever, chills and pain. On an unknown date, the outcome of the fever and chills were recovered/resolved and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the fever, chills and pain to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient received 1st dose at her local pharmacy. The patient experienced a fever, chills, pain from head to toe and soreness. The patient thought it was Covid-19. The adverse reactions lasted for about two and a half days, however, the soreness was still there (not severe but was bothersome). The reporter provided limited information and did not have the lot number and expiration date. The reporter did not give permission to follow-up with her health care professional.
10 minutes after receiving vaccine pt reports throat swelling and hoarse voice. Mouth assessed, no swelling noted to throat/lips/face. Pt's HR 74, BP 150/90. Ambulance called to scene and pt reporting improvement in symptoms upon ambulance arrival. Report provided to Paramedic, pt transported via ambulance to local hospital.
December 19th patient began complaining of a cough in the evening. Coughing got worse through out the following day and developed a sore throat. Called doctors office Tuesday morning and had a virtual visit. Determined to get tested for flu and COVID that same day. Father was tested later that afternoon and tested positive for COVID. Provider was called back and stated to assume since everyone in family was showing symptoms to assume they all have COVID. He is currently having his pulse OX levels monitored regularly and using his asthma medications as a preventative measure to avoid things getting worse.  Has a visit with pulmonologist on January 7th to rule out issues after COVID.
Coughing; diarrhea; nausea; vomiting; COVID-19 infection
Chills, very sore arm, fatigue.  Started during the night, continued the whole next day.
I was driving & felt faint. I became nauseous & vomited, vertigo & had to be taken to the ED.  Upon arrival my BP was really high. BP meds given, Nausea meds & Potassium IV administered.  CT head, EKG ordered. Admitted overnight for Hypertensive Emergency.
thrombosis in left ovary vein; blood in her legs was not circulating well; pain; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 30Mar2021 (Batch/Lot Number: EN6204) as 2nd dose, single for covid-19 immunisation. The first dose was received on 10Mar2021 (lot number: EN6204). Medical history included allergy to cherry. Patient was not pregnant. The patient's concomitant medications were not reported. No other vaccines were received within 4 weeks prior. The patient previously took cortisone and experienced allergy. On 05Apr2021, patient was admitted to hospital with thrombosis in left ovary vein. Moreover, blood in her legs was not circulating well, causing her so much pain. The event resulted in emergency care. Patient was given anticoagulants as treatment for 6 months. Patient was discharged on 08Apr2021. Patient had not been diagnosed with COVID prior to vaccination and had been tested post vaccination on an unspecified date with negative results. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Mother called and said that the she noticed redness, hot and swelling at child's right arm at DTaP and IPV injection site. She then brought the child to clinic and was referred to a MD and einephrine and prednisone, amoxicillin and zyrtec were given. Pt's symptoms resolved.
Developed cellulitis at the injection site spreading approx 5? down arm and spreading 3.5? across. Hard and reddened area.  Radiating heat to touch.   Not feeling well on 9th day after vaccine. No fever.
Light pink maculopapular rash starting face, palms and soles starting within 12 hours of vaccines. Low grade fever. Seen by physician. Tylenol PRN.
I had a reaction to the COVID, the booster shot of COVID 19; I had a reaction to the COVID, the booster shot of COVID 19; Fever; Body aches; Headache; This is a spontaneous report from a contactable consumer (patient) of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection,Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 3 (booster), single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the reporter stated that the patient had reaction to the COVID, the booster shot of COVID-19. The patient also had experienced fever, body aches, headache which lasted about 20 hours and then resolved. The outcome of the events was recovered at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within 6 hours of the vaccine, red spots that looked like pyoderma gangrenosum appeared on both feet and legs all the way up to lower thighs.  On August 21st, patient experienced muscle weakness in legs and arms.
vaccine given at 11:20am, reports of tingling and pressure on left side of neck starting around 11:35am.  VS taken: BP 170s/90s, HR 56, O2 Sat 100%, RR 12.  Oropharynx clear, no swelling to face, tongue, throat noted. Lungs clear.  Pt reported mild nausea and being nervous. Pt reported worsening of pressure and tingling feeling.  Epinephrine 0.3mg IM given at 11:50. EMS was activated at 11:50. Diphenhydramine 50mg IM given. at 11:52. VS: BP 150s/90s, HR 87, O2 Sat 100%, RR 16 Pt reported sensation in throat was improving, nausea improving.  Paramedics arrived at 12:04pm. All information was given to them. Pt was transferred to gurney by himself.
Patient complained of soreness and stiffness in left arm the day after vaccination. Two days after vaccination, she reported redness and swelling extending down to elbow and was referred to a walk-in clinic. Began using diclofenac 1% gel with little relief of symptoms. Reported to emergency department 8/15/18 due to continued pain.
inadvertently administered Adacel instead of Daptacel for 4th dose in DTaP series.; inadvertently administered Adacel instead of Daptacel for 4th dose in DTaP series.; Initial information received on 30-Dec-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old female patient who inadvertently administered DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] for 4th dose in DTAP series (wrong product administered and product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACT-HIB), [PNEUMOCOCCAL VACCINE] PNEUMONIA VACCINE.  It was a case of actual medication error due to wrong product administered and product administered to patient of inappropriate age as 15month old female was inadvertently administered Adacel instead of Daptacel for 4th dose in DTaP series.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Extreme and prolonged soreness in upper arm where vaccine was given. It was very sore for at least a couple of weeks and is still sore when pressed on after 8 months.
Information has been received from a certified medical assistant concerning a patient who was vaccinated with a dose of ZOSTAVAX. Subsequently, the patient experienced 2 bumps on head. At the time of reporting the patient had not recovered. The medical assistant questioned about the bumps being shingles. No product quality complaint was involved. Additional information has been requested.
He got the vaccine, mom received her shot and the pharmacist said they were done, and he told his mother that he was feeling a little dizzy and anxious and wanted to sit down.  They were going to the car and he got in first as he was going to drive, and mother got in the car, and he acted like his head was spinning, had a blank stare and started making weird sounds like he could not breath, started foaming at the mouth and then he passed out.  She called 9-1-1 and when they got there he was coming out of it.  They checked his VS and said that everything was OK, and felt that he did not need to go to the hospital but it was their call.  He didn't want to go either.  She drove him home and he slept OK, he had a bad headache and felt extremely tired and lied down.  He seemed to be OK the next day other than his arm being sore, but no other issues and he's been fine since.  The pharmacy did not have them wait before leaving to make sure they were OK, the pharmacist told her they were fine and they could go, but the incident occurred within 5 minutes of the vaccine.
No additional AEs; LPN calling for stability evaluation of vaccines with multiple TEs dating back to 03FEB2023. Caller reports that vaccines were administered. No additional AEs. no PQCs reported.; This spontaneous report was received from a nurse concerning to a 51-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 09-FEB-2023, the patient was vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml/once m (lot # U034712 has been verified to be a valid lot, expiration date 30-JUL-2023)  (strength  and anatomical location was not provided) for prophylaxis (Product storage error). There were multiple temperature excursions dating back to 03-FEB-2023. No additional adverse event was reported.  This is one of multiple reports received from the same reporter. ; Sender's Comments:  US-009507513-2302USA004298: US-009507513-2302USA004511: US-009507513-2302USA004369: US-009507513-2302USA004361:
This spontaneous report as received from a nurse refers to unspecified patients of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M039061, expiry date: 28-APR-2018) for prophylaxis, which was stored at a temperature of 35 degree Fahrenheit for a time frame of 24.91 hours. No adverse effects were reported. No previous temperature excursions were reported. No product quality complaint was involved. The call was because of a data logger. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA002354.
Child left exam room went to check out and fainted. Brought back to exam room, laid down on exam table, given H2O and TYLENOL. She said her head hurt. Dr. checked her over and said ok to go home. Mom called back 2 hours later with symptoms of a possible head injury. CT scan ordered 11/6/2017 and results came back negative. Dr. called mom and gave results of scan.
Patient fainted- unconscious for a few seconds, then became alert, but c/o tiredness, headache, nausea (no vomiting, didn't "feel right".  C/o feeling hot at first; later c/o feeling cold.  After laying in supine position she tried to sit up and c/o nausea and not feeling well.  She layed down again.  This happened 3 times.  Patient remained coherent.  Pulse strong and regular.  B/P 84/98, 90/50, and 100/60.  Transported to hospital by ambulance.
Immediate dizziness, vertigo,  and malaise fever on and off. 2 days then on day 3  broke out In rash all over trunk.  I still don?t feel right
Bell's Palsy (left sided facial droop, difficulty closing left eye lid). Outpatient treatment with oral corticosteroids, valacyclovir and topical Lacrilube (eye lubricant) prescribed by ED physician and referral to primary care for follow up.
pt recvd vax & devel local redness & swelling; pt lost all use of hand but it was noted that dependant reflexes were still present; No further details were provided;
Fainted, flushed colored skin, breathing limited, tachycardic.  EMS called and recommended a doctor visit for the day of. Was not transported to the hospital by EMS personnel.
My dad was in the hospital at this point, and around this time he went in for a uti and he contracted covid in the hospital. We all got tested and we came back negative. He had no idea he had covid, he only found out because of the tests done at the doctor. It is said that he contracted it in the hospital. It was stressful, and my mother got her booster a week before I did. I had sinus issues since that point. I felt fine after the booster for several hours but then it hit me that I was tired and I had chills and aches. That happened to me with the 2nd shot as well so I did not think anything of it. I was having a congested cough but it did get worse. The sinuses got worse. I did ignore them because my father was really sick and because of work I didn't have the time. My doctor did order me a chest x ray and I went in January. It was determined I had pneumonia. I was given an inhaler to take 4 times a day. I saw my doctor for a follow up and she extended the anti biotics, but I still have this crazy harsh cough. They had me on what was called Doxycycline 2 times a day. I have not tested positive at all for Covid. I constantly get tested for work and just because my mother is 80. About 3 to 4 weeks ago I ended up in the ER because I had shortness of breath and back pain. I was given a steroid but it resulted in nothing.
Shingles outbreak for the first time.; This is a spontaneous report from a contactable consumer. This 42-year-old male consumer (Patient) received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), via an unspecified route of administration on 18May2021 09:00 (Batch/Lot Number: EW0185) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported.  The patient experienced shingles outbreak for the first time on 27May2021. The patient received treatment of valtrex medication. Patient had no covid prior vaccination and did no covid tested post vaccination. The patient had no other vaccine in four weeks, had no allergies. The outcome of event was recovered.  Follow-up attempts are completed. No further information is expected.
My left lymph node near my collar bone is hard and tender to the touch. I also felt flu like symptoms for 48 hours after.
Information has been received from a nurse practitioner referring to a 7 year old female patient with enuresis and no known drug allergy. The patient had no illness at time of vaccination. Concomitant therapies included VARIVAX, diphtheria toxoid (+) tetanus toxoid, hepatitis a virus vaccine (unspecified) and poliovirus vaccine inactivated (unspecified). On 19-APR-2016 at 10:24, the patient was vaccinated with M-M-R II lot # reported as L042818 dose 2, subcutaneously in the left thigh. The vaccine was properly stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a nurse concerning her friend's approximately 19 year old son who on an unspecified date in approximately 1991 (18 years ago) was vaccinated with a dose of MMR II (HSA, lot#, route and site of administration not reported). Subsequently, the patient was autistic after vaccination. At the time of this report, the patient's outcome was unknown. Upon internal review, being autistic was considered to be an other important medical event. This is one of several reports from the same source. No further information is available.
This case was reported by a physician via call center representative and described the occurrence of testis discomfort in a 18-year-old male patient who received BEXSERO (batch number 169701A, expiry date January 2019). Co-suspect products included BEXSERO (batch number 169701A, expiry date 5th July 2017). On 5th July 2017, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 7th August 2017, the patient received the 2nd dose of BEXSERO (intramuscular) .5 ml. On 6th July 2017, 1 days after receiving BEXSERO and BEXSERO and not applicable after receiving BEXSERO, the patient experienced testis discomfort. On an unknown date, the patient experienced pain and testis discomfort. On an unknown date, the outcome of the testis discomfort and pain were recovered/resolved and the outcome of the testis discomfort was not recovered/not resolved. The reporter considered the testis discomfort to be possibly related to BEXSERO. It was unknown if the reporter considered the pain to be related to BEXSERO and BEXSERO. The reporter considered the testis discomfort to be possibly related to BEXSERO. Additional details were provided as follows: The patient reported testicular discomfort following both doses of BEXSERO. The patient did not report this after the second dose. Vague discomfort began approximately 24 hours after the first dose of BEXSERO and lasted about 7 days. The patient did not report this or seek treatment. After the second dose, the patient reported pain which might have begun prior to the second dose. The reporter stated that this was unclear whether pain started after 1st (less than a week) or 2nd (less than a month) doses of BEXSERO. Pain has persisted for 9 days and the patient was seen by his physician. The reporter stated that the patient did not had any medications and not received any other vaccines in the last month, from the date of reporting. The reporter would report the case of VAERS, but it was not done till the time of reporting.
This spontaneous report was received from a pharmacist concerning a 66 year old male patient. Patient had no pertinent medical history, drug reactions or allergies. No concomitant therapies were reported. On 07-JUL-2016, the patient was vaccinated with 0.65 ml dose of ZOSTAVAX 19400 PFU, subcutaneously, lot # M003487, expiration date: 21-APR-2017 (reported as Doctor recommended). Approximately on 23-SEP-2016 (reported as: two weeks ago), the patient experienced shingles (herpes zoster), located in the trunk and upper thigh area (unspecified if both thighs). He received treatment for the adverse event. At the time of the report the patient was recovering. The causal relationship between the event and ZOSTAVAX was unknown. There was no intervention to prevent serious criteria. Product quality complaint was not involved. Additional information has been requested.
12hrs - chills fatigue sweating, no fever 16hrs- migraine- that lasted 12 hours. Normal treatment that works for me( rizatroban) only slightly lessened. Advil Tylenol alternated for migraine and chills. Arm much less sore this time. I would say normal injection soreness.  But stayed in bed all day due to migraine, chills and fatigue. No way I could have worked. 36hrs- woke up feeling really foggy and some dizziness.  After drinking a few glasses of water feeling somewhat normal.  No fatigue today, arm feeling almost normal.
Unilateral (Right) Sensorineural Hearing Loss with hydrops of the cochlea
Two minutes after receiving the HPV vaccine, patient fainted. She was sitting on the Exam Table when she began to look weak. I was standing to her right, and leaned her onto me and then back on to the Exam table as she loss conciouisness. Patient was awake, alert and orientated with in 5 seconds after fainting.