chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FEVER; INJECTION SITE PAIN; This spontaneous report received from a consumer concerned a 67 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced injection site pain. Laboratory data included: Body temperature (NR: not provided) 100 F, 101.3 F. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.3 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and the outcome of injection site pain was not reported. This report was non-serious.
day p/vax pt exp swelling & tenderness, temp 99.4, mild redness of throat. treated w/child advil or tylenol.
This is a spontaneous report from a non-contactable consumer, the patient. A 54-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration in the right arm on 19Mar2021 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic lung disease and diabetes. The patient had a history of allergy to SEPTRA and CARDIOLITE. The concomitant medications included metformin (MANUFACTURER UNKNOWN), empagliflozin (JARDIANCE), losartan (MANUFACTURER UNKNOWN), acetylsalicylic acid (BABY ASPIRIN) and HCTC for unknown indication received within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200), via an unspecified route of administration in the right arm on 23Feb2021 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 23Mar2021, the patient experienced hard tender lump at injection site with size of a quarter which was still there after one week. swollen, hard, painful lymph node on the right ear, quite large, about 2 1/2 inches long. No therapeutic measures were taken for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the vaccination site lump and painful lymphadenopathy was not resolved at the time of report. No follow-up attempts are needed. No further information is expected.
Child was vaccinated 10/03/00 around 14:00. Mother called clinic and stated that the child has a fever of 100.9F (R) and that she has a fine white rash on her face and back. States PMD has not returned her call. On 10/6/00, per call to mother; child is doing fine. Took child to pediatrician, who stated rash due to dry skin and treated with ointment.
Follow up with PCP 2 days after Pneumococcal 23 given L deltoid. Pt complains of redness, swelling and pain in upper arm. Pt stated no fever/chills. Pt has applied ice to area and taken BENADRYL. Provider prescribed Dicloxacillin 500 mg and advised pt if swelling doesn't improve over weekend to go to Urgent Care over weekend.
Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Systemic: Weakness-Mild, Additional Details: PT fainted for 1 second and regaine consciousness right away. he declined 911/paramedics and asked for water and something to fan himself with. pts bp taken was 92/68 , pusle 69. pt stated his level of uncomfortability was 10 (worse) to 2,4, then 1. dad/sis came pick him up after monitoring him for 30 mins
Pediatric dose of Pfizer was given to the patient for her first dose. Based on age, patient should have received an adult dose of Pfizer.
Patient had this vaccine administered on 1/26/22 after its "use-by date" of 1/1/22. 1/1/22 is the 31 days of refrigeration. Expiration date is February 2022. No adverse reactions reported. Per manufacturer, administration not recommended past 31 days + an additional 14 days of temperature excursion. Per manufacturer, patient will need revaccination. No minimum time interval for this revaccination.
Pt. fainted directly after receiving vaccine. Pt. also developed rash on R arm.
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. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, oral herpes and pain. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)) and prednisone. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown and the outcome of the oral herpes was recovering/resolving. It was unknown if the reporter considered the vaccination failure, shingles, oral herpes and pain to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had received both Shingles vaccine. At the time of reporting, the patient was recovering from 4th outbreak. The patient reported that this time he/she got oral shingles, which was very rare and very painful. The patient was fortunately familiar with the pain, so he/she went right away to urgent care. The patient reported that antiviral and Prednisone were working. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as no contact details were provided.
A very vivid nightmare woke me up at 3:30 am - 13 hrs after I had received the first dose of the vaccine. I stood up and got lightheaded. I started sweating,  felt very nauseous and vomited.  I had a fever. Spent the rest of the night with very bad chills. Next day had a headache and fever.
Pt had arm to turn red, become warm, tender in 4 x 4 cm area 5-6h after injxn-then rash around reaction ->hips. 2 shots on shoulders-lesions are resolving now 2 days after.
My daughter started to vomit and complained headache in the afternoon of the second day after the injection, and did not sleep for 10 days in a row. She became more and more grumpy, cried, and finally developed to not eating or drinking. This condition episodes ?last for about 10 days ?monthly  that have continued to the present.
I got Covid-19 within a week after my second dose of the vaccine. I had a slight cough and some flu-like symptoms and my fever was 101 degrees. I was sweating a lot two days later and I lost my sense of smell that evening. I lost my sense of smell for two days. My taste was affected a little. I got rapid tested the next day and I was positive for Covid-19. Overall, it was very few symptoms and they lasted about one week. I got Covid-19 again two months after my Booster in late January of 2022. I had a sore throat at first. I tested positive in a home test kit on the third day. I had a slight fever and a cough and sore throat. My symptoms lasted for about one week but I really didn't feel bad. I did not lose my sense of taste or smell. I tested positive on home tests for six days. The test line got fainter and fainter and then went away.
PATIENT STATES WAS IN MVA ON 04/02/2018 AND SEEN AT ER DEPT AT LOCAL HOSPITAL. PATIENT STATED SHE RECEIVED A TDAP VACCINE TO RIGHT ARM AROUND 6:00 PM THAT DAY. THE NEXT MORNING (04/03/2018) UPON AWAKENING NOTICED BRIGHT REDNESS TO ARM, PAIN WHEN TOUCHING SITE AND WARM TO TOUCH. PATIENT STATES NOTICED "BALL" UNDER ARM IN ARMPIT AREA THAT DAY AS WELL. PATIENT STATED REDNESS AND PAIN HAVE IMPROVED SINCE THEN.
Within 1-2 hrs of receiving vaccine, pt. c/0 itching (generalized/all over) and fingers and feet. Given Benadryl 50mg IM at 1005 and Epinephrine 0.3 ml SQ at 1015 - per doctor. Advised to repeat 50mg Benadryl PO per doctor in afternoon.
This spontaneous report was received from a physician assistant refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On 28-JAN-2016, the unspecified patient was inadvertently vaccinated with fourth dose of GARDASIL (dose and route of administration not provided). No concomitant therapy was reported. The reporter could not confirm the administration dates for the first, second and third dose administrations of GARDASIL. No adverse effect was reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
Woke up that morning very weak, body aches all over, extremely exhausted, fever and very foggy. These symptoms lasted for 5 days when they started to change. My chest started hurting and it became difficult to breathe. I became short of breath and coughing along with still being exhausted and weak. Fever subsided on day 7. Within 7 days I lost 5 pounds as well. The exhaustion passed finally on May 31st, but my breathing and coughing were still bad to the point I was coughing up blood. As of June 5th the coughing up blood stopped, the coughing has gotten to be less, but the shortness of breath and heavy chest it still there. I was an avid runner with no breathing problems. I have not run since May 17th. I started walking again on June 4th but still having shortness of breath. I did contact my doctor's office several times throughout this event. At first they said it was from the shot and it would only last a couple days. On Friday May 21st they said if I wasn't better to call them on Monday and they did lab work. Monday May 24th I called them and saw them. They said yes it was from the shot and they gave me an inhaler. That was it. On Thursday May 27th I called them again-explained I could not stop sleeping, I was still not feeling well and I thought they should report this. The doctors office called me back and said my doctor said this has gone on too long to be the shot and they were going to prescribe me a prescription-Zpak. I started the prescription that night. I have not called my doctor back and told them I am still not right and still having breathing problems because they clearly have not taken any of this serious and gave me a prescription without even knowing what is wrong with me. I am sure I should have gone to the hospital during week one because I was so ILL, but at this point I am just hoping this will pass soon.
Itching all over body 3 minutes after administration.  Difficulty swallowing, thick feeling in throat.
I received the vaccine Saturday afternoon. During the 15 minute waiting period I was warm but not feverish. No further adverse affects noticed for the remainder of the day. Sunday my left arm was sore at the injection site but no other issues. Sunday night/Monday morning I woke up at 1:30am and had diarrhea. I returned to bed and tossed and turned for another hour. I woke up at 2:30am and vomited. I had a restless night sleep for the remainder of the night. Monday I couldn?t get out of bed and suffered from chills. Tuesday I was tired but relatively fine. Wednesday I felt pretty much normal. Thursday was fine.
Infection in vagina area; yeast infection; HSN1; This is a spontaneous report from a contactable consumer (patient). A female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0178), via an unspecified route of administration in arm left on an unspecified date as a dose 1, single and the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0181), via an unspecified route of administration in arm left on an unspecified date as a dose 2, single for COVID-19 immunisation. The patient's medical history included diabetes. The patient had allergies to strawberries, pineapple, tomatoes, nuts. The patient's concomitant medications within 2 weeks of vaccination included levocetirizine dihydrochloride (XYZAL), ergocalciferol (VIT D), biotin, probiotic, dulaglutide (TRULICITY), metformin hydrochloride (METFOR). It was reported that, the patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as yes. On 07Jun2021, the patient experienced infection in vagina area, yeast infection, HSN1. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not had prolonged hospitalization. Treatment medications included ceohalexin, fluconazole and metformin. On 15Jun2021, the patient underwent lab tests and procedures which included nasal swab, resulted as negative. The outcome of the events was resolving.  Information about lot/batch number was provided. Additional information has been requested.
Started aching immediately. As the day progressed site became swollen, red and painful. Eventually the redness went away after 1 1/2 yrs. There is still a lump which is still very painful. I am unable to sleep on my right side.
pt recv vax 13AUG96 & 4SEP96 pt devel red, pox-like lesions on the neck which spread to the back area accompanied by a fever;tx w/APAP;approx 20 chicken pox w low-grade fever;
patient had redness and swelling the following day after the shot.  She went to urgent care and they said she had cellulitis.
OFF LABEL USE; This spontaneous report received from a patient via a company representative concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included covid-19 vaccine for prophylactic vaccination.  On an unspecified date, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label use was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Suspect breakthrough case  Ascorbic acid, Zinc, Tylenol  Inpatient
Dizziness, Headache, Fever, chills / night sweats Narrative:
headache, fever, chills, body aches, nausea, lightheadedness, chest pain
Pt came into the pharmacy and showed us the redness on his deltoid. He was at the doctor's office and the dr stated he has a staph infection and they drew a border around the redness.
Got DTaP on 04/30/2003:  Swelling, redness, noted at Left upper lateral thigh since 05/01/2003.
Pt rec'd vaccine through work .  Called clinic (PCP) to report tenderness at inj. site eve of injection.  By Wed am, progressed to severe upper arm and shoulder pain.  C/O, waking her from sleep 7/10 pain and unable to make a fist.  48 hours later symptoms unchanged and persisting.  She is using ibuprofen  and ice to tx.   Pt believes vaccine was given too high in deltoid, reports close to shoulder joint.  Also notes shaking, chills and GI upset wed am, resolved after 15 min and hasn't recurred.   Pt wanted to report sx.  Advised, would complete VAERS on her behalf and update her PCP.
First five minutes seemed normal but suddenly passed out and hit my face on the floor.  paramedics were called and my blood pressure dropped and pulse was as low as 32 bpm.  I had a lot of sweat everywhere as well.  I was feeling tired as well.  I thought I was getting better then passed out again.  For about 10 seconds I couldn't get enough air and thought I was going to die.  I finally returned to normal after an hour.
Right arm is red; Right arm is itchy; Right arm has a rash; Caller report mild pain, states the arm isn't any more worse then a sore muscle.; While sleeping right arm became sore again; While sleeping right arm swollen again; Right arm was sore; Right arm kind swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm was sore), PERIPHERAL SWELLING (Right arm kind swollen), PAIN IN EXTREMITY (While sleeping right arm became sore again), PERIPHERAL SWELLING (While sleeping right arm swollen again) and ERYTHEMA (Right arm is red) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information reported.  Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL AND HYDROCHLOROTHIAZIDE) for an unknown indication.    On 16-Mar-2021 at 6:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Right arm was sore) and PERIPHERAL SWELLING (Right arm kind swollen). On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (While sleeping right arm became sore again) and PERIPHERAL SWELLING (While sleeping right arm swollen again). On 26-Mar-2021, the patient experienced ERYTHEMA (Right arm is red), PRURITUS (Right arm is itchy), VACCINATION SITE RASH (Right arm has a rash) and MYALGIA (Caller report mild pain, states the arm isn't any more worse then a sore muscle.). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) at an unspecified dose and frequency. On 18-Mar-2021, PAIN IN EXTREMITY (Right arm was sore) and PERIPHERAL SWELLING (Right arm kind swollen) had resolved. At the time of the report, PAIN IN EXTREMITY (While sleeping right arm became sore again), PERIPHERAL SWELLING (While sleeping right arm swollen again), ERYTHEMA (Right arm is red), PRURITUS (Right arm is itchy), VACCINATION SITE RASH (Right arm has a rash) and MYALGIA (Caller report mild pain, states the arm isn't any more worse then a sore muscle.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter states states taking Claritin to help relieve side effects.
Recieved menactra on june 24 2009. She had seizure during the night bit tongue severely. Went to doctor next day, said to watch her. She had another seizure on September 1, 2009 during class at college. Was sent to emergency room.They are tonic clonic seizures. No family history of seizures and she was fine up until menactra vaccine.She has seen neurologist who has now put her on seizure medicine.
Pt received FLULAVAL 2009/2010 formula. No reaction or adverse reaction noted (vaccine for ages 19 and over).
expired polio vaccine that was given, of the 10 patients we gave this lot, 6 had this expiration date charted as 7/20/15, others had an expiration of 3/28/15 with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via Medical Information (Reference number-00788547) and transmitted to Sanofi on 24-Sep-2021.  This case involves six patients of unknown demographics to whom an expired IPV (VERO) [IPOL] was given, of the 10 patients that were given this lot, 6 had this expiration date charted as 7/20/15, others had an expiration of 3/28/15 (expired product administered).  Medical history, past medical treatment(s), vaccination(s) and family history of the patients were not provided.  Concomitant medications were not reported.  On an unknown date, six patients received a dose of suspect IPV (VERO) (lot number: J1406; expiry date: 20-Jul-2015) via unknown route in unknown administration site for prophylactic vaccination.  It was the case of actual medication error due to expired vaccine used (latency: same day).  It was reported "I have a random question. We received a call from a school nurse about and expired polio vaccine that was given here. Our records show it expired 7/20/15. Can you verify when the lot # J1406 of IPV expired? Of the 10 patients we gave this lot # to, 6 had this expiration date charted. Others had an expiration of 3/28/15."  No adverse events were reported at the time of this report.  The outcome of the event was reported as unknown.  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 the guidelines. 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.
Swelling at injection site however swelling has moved and is currently way below the injection and is now in the upper arm a little above elbow.   I have taken. Tylenol and applied heat to the area
Headache after 30 minutes Joint pain after 5 minutes Nausea after 30 minutes  Hand/arm numbness after 3 hours Chills after 4 hours Injection site pain after a day
Patient is 3 years old and was given a Kinrix, I didn't recheck his age and wrote down and he needed a Kinrix and another MA gave it.
This spontaneous report was received from a pharmacist concerning a 39 year old female patient. Medical history and concurrent conditions were not reported. On 29-SEP-2014, the patient was vaccinated with a dose of M-M-R II (dose number, lot number and expiration date were not reported), 0.5 ml, subcutaneous. Co-suspect and concomitant therapies were not reported. The pharmacist reported that the patient received expired M-M-R II vaccine (Exp. August, 2014, lot unspecified) on 29-SEP-2014. No adverse effects reported. Additional information has been requested.
PATIENT FAINTED ABOUT 10-15 MINUTES AFTER VACCINE ADMINISTRATION.
CLIENT PRESENTED 30 MINUTES AFTER MODERNA IMMUNIZATION WITH HIVES ON CHEST.  NO HIVES ON FACE ,TRUNK, OR ABD. C/O OF TONGUE SWELLING.  NO RESPIRATORY DISTRESS OR SOB.  BENADRYL 50MG IM GIVEN IN THE R DELTOID @9:03. VS REMAINED STABLE THROUGHOUT 9:03 HR 68, SAO2 98% , RR 16, BP 98/70.  CLIENT MONITORED AND EMERGENCY SERVICES CALLED @9:10am.  WHEN EMS ARRIVED CLIENT WAS FEELING BETTER AND REFUSED TO GO TO ER FOR MONITORING AGAINST MEDICAL ADVICE.  SHE WAS MONITORED WITH NO FURTHER PROGRESSION OF SYMPTOMS AND RASH IMPROVED.  THE CLIENT WAS DISCHARGED TO HER SUPERVISOR AT WORK AND GIVEN ORAL BENDARYL 50MG WITH INSTRUCTIONS TO CALL 911 AND TAKE BENADRYL AS DIRECTED IF SYMPTONS DO NOT IMPROVE OR WORSEN.  HUSBAND TO DRIVE CLIENT HOME.