chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At approximately 24 hr post-vaccination, patient developed a severe headache, nausea, and diarrhea. These symptoms continued for approximately 5 hours before she fell asleep at about 10pm, at which point the symptoms began to improve. Patient also had extreme soreness at and near the injection site for approximately 48 hr post-vaccination.
THICKNESS OF AN ARTERY IN BRAIN; PROBLEM WITH MEMORY/COULD NOT REMEMBER PRAYERS; FEELING FOGGINESS/LIKE FOGGY BRAIN/DON'T FEEL RIGHT/SOMEDAYS FEEL LIKE GOING IN BED AND SOMEDAYS DON'T FEEL LIKE/WAKE UP AT NIGHT FEELING LIKE WAS IN A COMA; FELT DIZZINESS; VERY TIRED; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: blood clot in left leg (3 to 4 years ago), and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient did not get covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 and expiry: 25-MAY-2022) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. Age at time of vaccination 68 years old. No concomitant medications were reported. On 2021, the patient experienced problem with memory/could not remember prayers, feeling fogginess/like foggy brain/don't feel right/somedays feel like going in bed and somedays don't feel like/wake up at night feeling like was in a coma, felt dizziness, and very tired. On an unspecified date, the patient experienced thickness of an artery in brain. Laboratory data (dates unspecified) included: CAT scan (NR: not provided) thickness of an artery in brain. Treatment medications (dates unspecified) included: apixaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling fogginess/like foggy brain/don't feel right/somedays feel like going in bed and somedays don't feel like/wake up at night feeling like was in a coma, felt dizziness, very tired, and problem with memory/could not remember prayers, and the outcome of thickness of an artery in brain was not reported. This report was non-serious. Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
patient called 6 days after the shot complaining her arm was still very sore and swollen in certain parts.
Parent called stating she noted Pt's Right Arm with redness at both injection sites along with pain a day after receiving vaccines. Parent stated she applied cool compresses as instructed by this Nurse for relief of discomfort. Parent stated the redness has improved on today when she called in. Stated pain is also improving. Pt no longer complaining as often like day  before. Parent also stated she notes some bruising at one injection site only which has improved since day after injection. Parent stated Pt is not disoriented or confused and is otherwise normal.   Advised Parent to continue to apply cool compress and to also administer a pain reliever to help with discomfort and seek medical assistance if Pt worsens or if she feels Pt needs to be examined. Pt verbalized understanding stating she will monitor and administer pain reliever and cool compress.
Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 65 years old male patient who had vaccine that started out as intramuscular but the patient pulled away and the rest may have been injected subcutaneously, while he received vaccine FLUZONE HD. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient did not receive any other injections or concomitant medications. On 27-Sep-2018, the patient received a  0.5 ml once dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ023AB, expiry date- 25-Apr-2019 via subcutaneous route in the right arm. It was a case of actual medication error due to inappropriate route of vaccination. It was unknown whether adverse events occurred. 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.
patient developed a 102 degree fever, nausea, and oxygen dropped.  The event lasted about 24 hours then resolved
Picked up cold last week; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Picked up cold last week) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Picked up cold last week). At the time of the report, NASOPHARYNGITIS (Picked up cold last week) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Sore throat, coughing, fever, mucus, blocked nasal passages on both sides, loss of appetite, general weakness.
This case was reported by a consumer via call center representative and described the occurrence of chills in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (had a serious case of shingles last summer). Previously administered products included SHINGRIX (1st dose received on an unknown date). On 10th February 2019, the patient received the 2nd dose of SHINGRIX. On 11th February 2019, 1 days after receiving SHINGRIX, the patient experienced chills and body temperature increased. The patient was treated with benadryl (nos) (Benadryl) and paracetamol (Tylenol). On an unknown date, the outcome of the chills and body temperature increased were unknown. It was unknown if the reporter considered the chills and body temperature increased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported.After vaccination, the patient was fine during the day, but awoke with chills. They continued to grow worse during the morning. The patient's husband reported that when they got a reading of 103.4 F for patient's body temperature, he grew very concerned. Benadryl and Tylenol had helped them through the day but the patient was clearly having trouble. The patient's breathing was not affected, but it was a reaction to the shot.
left side of mouth and 3 fingers of left hand went numb.  no drooping of face
arm is very red and hot to the touch below injection site. pt reports it has been getting better since time of injection
patient received annual flu vaccine at time of visit in clinic 10/10/22, she has had them in the past with no side effects. patients time of death 10/20/2022, presumed from MI. unclear if association with vaccination.
Pt received COVID19 Vaccine (Moderna) at 9am 1/8/2021.  -Pt completed 15 min observation and then returned to work.  -Pt came back at 12:30 with the following symptoms: stomach pain, nausea, shivering, feeling very cold, headache, "sleepiness" of his left arm (same arm as the shot), itchy throat, cough, and feeling very thirsty.  -Pt reports his headache as very painful, b/l, and feeling as if his head was very "hot." Pt has no hx of headaches.  -Nausea in and out, never vomited.  -Denied dizziness, change in vision, shortness of breath, difficulty breathing, chest pain, difficulty swallowing, rash, lightheadedness.  -Pt did not eat anything all morning.  -Took vitals, blood glucose (see vitals section). High BP and pulse. Sugar: 169 -Pt given Benadryl 25mg IM (on opposite side of vaccine).  -Pt took 500mg Tylenol and then a few hours later 500mg more Tylenol (on own accord). -Pt observed 12:30-4:30. Slept off and on. Felt a lot better at 4:30. Pt discharged.  -Pt was also seen and evaluated by MD.   -Of note, pt does not have any allergies that he is aware of.  -Has "pre HTN and pre diabetes." -Hx of heart disease - father CABG, in mid 40s.   -Pt was observed for 4 hours.  -BP  went down after pt calmed down a little bit and was given Benadryl and Tylenol.  -Pulse was also very high, but then decreased throughout observation (see VITALS section). -Pt feeling fine at 4:30 and discharged.
Report 2001011532 described throat constriction in a vaccinee of unspecified gender and age who received hep B vaccine (Engerix-B). The vaccinee's allergies, medical history, and concomitant medications were not specified. On an unspecified date, the vaccinee received the first dose of Engerix-B. Subsequently, the vaccinee experienced throat constriction, vomiting, and swollen eyes. As of 05/08/2001, the adverse events resolved.
Pt received Moderna vaccines previously.  This is her first Pfizer. She complained that she became fatigued, sore arm, swollen. She felt dizzy.
Pt received rabies vaccine 5/14/03 - began itching on arms on 5/17/03 without visible rash. Arm itching subsided by 5/19/03 when began itching on palms and anterior surface of feet for 1-2 hours. This also subsided. Tx Benadryl 25 mg PO x 1.
3/16/05 right arm swelling, no fever, increased swelling 3/17/05, redness, no pain, itch, hot per mom 3/18/05. Right arm swelling from shoulder to wrist, able to move all fingers, erythema and slight warmth, no tenderness. Good cap refill 2+ radial pulse in right. Tx with Keflex 250mg/5ml susp. 5ml PO q 6hr x 10 days.
Severe numbness of the rear tongue, post nasal drip, dry eye, noticable lack of facial symmetry.
A non-serious spontaneous report of expired dose of FLUMIST given was received from a health professional concerning a seven-year-old female patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 09-Jan-2011. The patient received the expired FLUMIST on 18-Jan-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 05-Apr-2011 which confirmed that the patient did not experience any adverse events following administration of expired FLUMIST. This information was incorporated into the narrative.
Approx. 5 min post administration recipient complained of not feeling well. On exam  patient was bradycardic, diaphoretic, pale and altered. Patient appearance worsened, and level of responsiveness continued to decrease. Patient was hot and indicated difficulty breathing, and nodded in confirmation when asked if her throat felt tight. Patient given 0.3mg epinephrine IM via autoinjector in the right thigh. Patient condition improved rapidly and regained awareness. Patient transported to ER for ekg and monioting, discharged without incident.
At 45 mins post immunizations, the pt noticed runny nose, watery eyes, coughing and feeling that throat was closing and difficulty taking full breaths. Exam revealed wheezing and rales. Given Epinephrine and nebulizer treatments.
Pt received Shingrix immunization on 9/3/19.  On the morning of 9/4/19, she states that she began to have redness on the arm of the immunization.  She stated that her arm was warm on 9/4/19.  She states the warm feeling was better on 9/5/19 but it was still present.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not provided. On unspecified dates during the time period of 06-DEC-2016 to 13-DEC2016, the patients were vaccinated with improperly stored VARIVAX (lot # M028553, expiration date: 07-JUN-2018; lot # M030138, expiration date: 15-JUN-2018; lot # M014908, expiration date: 25-MAR-2018; lot # M034586, expiration date: 27-JUL-2018; dose and route were unknown) for prophylaxis. The detail of the storage was a temperature excursion of 22.5 Fahrenheit for 2 hours 36 minutes for the freezer vaccine VARIVAX. No adverse effect was reported.  This is one of several reports received from the same reporter. Additional information is not expected as follow up with the reporter is not permitted.; Sender's Comments: US-009507513-1701USA001925: US-009507513-1701USA001926: US-009507513-1701USA001927:
overall body chills that stayed with her for several hours.; Right arm injection site was sore.; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (overall body chills that stayed with her for several hours.) and VACCINATION SITE PAIN (Right arm injection site was sore.) in a 71-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 013M20A, 012M20A and 939906) for an unknown indication.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced CHILLS (overall body chills that stayed with her for several hours.) and VACCINATION SITE PAIN (Right arm injection site was sore.). At the time of the report, CHILLS (overall body chills that stayed with her for several hours.) had resolved and VACCINATION SITE PAIN (Right arm injection site was sore.) outcome was unknown.            Concomitant and treatment medication was not reported. The patient reports no adverse events or side effects after the Moderna COVID-19 booster dose.   This case was linked to MOD-2022-507429 (Patient Link).
Status post vaccine- hyperventilation, shaking. patient c/o trouble breathing had some patchy redness to neck which resulted in epinephrine being administered IM per Dr.  Epinephrine administered at 1831. BP 138/82 HR 78. PT was transferred to the local ER for further evaluation and was released at the ER.
1st dose in 2020, late for 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter did not have the patient's initials, date of birth, and specific vaccination information available at the time of reporting. The reporter consented to follow up.
Dose was not drawn up in syringe and nothing was administered though patient received the IM injection.
Pt recvd 3 doses of Hep B vax on 14MAR89, 14APR89, 14SEP89 & on 13AUG89 lab eval revealed a pos anti-HBs; repeat tests on 3APR91 showed a neg anti-HBs;
Swelling and red macular rash on (R) thigh noticed 2 days after immunizations.
patient called the pharmacy (2/18/21) stating that on 2/16/21 he lost  muscle control of both legs and was unable to walk. As of 2/18/21 he had not contacted his doctor and full muscle control had not returned.
Patient reported symptoms below started 10/06/2020.  Weak sense of smell, loss of taste, decrease in energy, appetite and ability to sleep. patient developed diarrhea  10/15/2020.   As of today, 10/19/2020 patient is starting to have sense of taste and smell return but complains of persistent lack of energy.
Ct. received shingles vaccine on 11/21/08. Outbreak of shingles on 12/1/08. MD visit on 12/5/08 and was informed by MD to call to report to manufacturer.
headache; joint pain; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Strength: unknown, Batch/Lot Number: EP7534), dose 2 in the left arm on 21MAR2021 ( 16:00) as Dose 2 SINGLE for covid-19 immunization (Age at vaccination was 63-year-old). The patient medical included Rheumatoid arthritis from Oct2016 and she was allergic to penicillin. The patient previously received (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Strength: unknown, Batch/Lot Number: unknown) as Dose 1 single, for covid 19 immunization. The patient took ibuprofen 800 mg for the joint pain. Concomitant medications were not reported. The patient had not received any prior vaccination within 4 weeks and the adverse event was not following prior vaccination. On 22Mar2021 the patient had joint pain and on 23Mar2021 the patient had bad headache. She had no reaction after receiving the first Covid 19 vaccine. 24 hours after the second Covid 19 vaccine she had a reaction. Her joints started to ache, and she had a really bad headache. She could not find any place that will tell her if she could take the ibuprofen. She called the pharmacy where she received the vaccine and her rheumatologist who told her she would have to go through the health gateway, and it could take several hours before she had an answer. She wanted to know if she took Ibuprofen or does she need to take Motrin or Tylenol. She did sign up with the health check for receiving the vaccine. The outcome of the events were not recovered.  No follow up attempts are possible. No further information is expected.
On 3/22/2023, I had sore throat, head and chest congestion, headache, fever, and muscle aches. I later developed a cough. I tested positive on a home antigen test and was prescribed PAXLOVID, which I began taking on the evening of 3/23/2023. My last time taking the PAXLOVID was the morning of 3/27/2023. I felt well at that point, but I started to feel sick again on 3/28/2023. I had the same symptoms as before, plus a cough. On about 4/2/2023 or 4/3/2023, I noticed that I had an elevated heartrate by observing my pulse oximeter. If I just stood still, my heartrate was 100 or 105. If I talked while sitting, my heartrate went up to 107-108. If I walked slowly, it was 115-125. On 4/4/2023, I felt very dizzy while showering, but I did not pass out. I called my PCP, and she instructed me to go to the ER to be checked for pneumonia. At the ER, I underwent a chest X-ray. It was determined I was developing pneumonia, and they prescribed me a seven-day dose of doxycycline hyclate (100mg). I took it for six days. From 4/7/2023-4/9/2023, my husband had norovirus. I developed symptoms of it on 4/10/2023. I had nausea and vomiting. This is the reason why I was unable to take the antibiotic for the seventh day. I still have an elevated heartrate. I saw my PCP earlier today, and she referred me to a cardiologist, whom I am scheduled to see tomorrow. I took a home antigen test on around 4/7/2023 and got a negative result. Since first developing COVID-19 symptoms, I have had fatigue, which was the predominant symptom and still lingers.
First shot: 3/30/21. After 8 days, a rash started spreading from injection site towards the lower part of the right arm. Itchiness and pain in rash area. Rash disappeared gradually after 4 days.  Second shot: 4/27/21. After 18 hours, a rash appeared 3 inches below injection site, continuing growing and spreading throughout the left arm. Rash also appeared across chest, upper back, and other arm. Rash was itchy, hot, and painful. It has gradually fainted over the past few weeks and is now very faint. Some itching remains (5/17/21).
Swelling to lips and tongue hive like rash to bilateral cheeks. reaction around 3:30 pm 5ml benadryl admin in office. EMS called and Patient transported to nearest ER.
I had the vaccine in my left arm, then a week later, I was nauseous and was real sick for one day, then when I woke up in the morning, my left hand was numb.  I called my doctor and left a message for the nurse to call me back, but when she did, she told me not to worry about it and just to keep an eye on it.  Long story short, my two fingers and on side on my palm is been numb for a while now.  At night, my two fingers that are numb starts thrubbing.  I am not sure how long this is suppose to go on, but so far, the last time I went into see my doctor, they prescribed some gel that I have been rubbing on my two fingers.  I was told to stop wearing my wrist watch, and I have done that, so far, my two I am not sure how much longer this is going to go on.  So far, the people at hospital didn't really know what to do for me.  I am not sure what they wrote in my chat, but I have never had any issues with my fingers, hands, legs, and I have taking care of myself throughout this entire Covid crisis.  I wear my mask, I wash my hands, and continue to practice social distance.  As for work, I've been working from home since October of last year, so I have taken the necessary precautions and I was fine until my first vaccine shot.  Now I am still waiting for someone who really knows what's going on with this vaccine to be able to help me.
Patient was seen on 4/11/2022 for a well child visit, MMRV and Hep A were ordered by the Doctor and given by the MA.  While documenting the vaccine in system the MA realized that the patient had already been given these vaccines on 1/31/22.  This was reported to the Doctor and Supervisor.  The parent was notified and to date there have been no issues so far.