chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Undiluted Pfizer vaccine was given to one of the member of family of 3. Patient is doing fine.
02/09/2021 my upper left arm was slightly itchy with a red circle in same area, approximately 3" in diameter 02/10/2021 my upper left arm had a slightly red circle same size 02/11/2021 very faint red circle 02/12/2021 arm shows no signs of red rash.
Information has been received from a physician concerning a 14 year old female who in September 2007, was injected with her third dose of GARDASIL (lot number and site not reported). The patient completed all three doses of GARDASIL last year. The patient now has been experiencing seizures. There is no further information was provided. Upon internal review seizures were considered an other important event. Unspecified medical attention was sought. Additional information has been requested.  12/02/08  Reviewed ER medical records of 08/12/2008. FINAL DX: juvenile myoclonic epilepsy Records reveal patient experienced 2-3 min of generalized tonic-clonic seizure activity & bit her tongue.  Neuro consult done.  Tx w/antiseizure meds & d/c to home for neuro f/u as outpatient.
Itchy rash on ears, jawline, arms, legs, feet, vulva area, below breast, in mouth and torso. Was provided oral steroids by healthcare professional,  used calamine lotion as well.
During the night of 4/24 I experienced cold chills and sweats.  Stayed under 4 blankets all night and woke up with sweats 4 times during the night.  In the morning of 4/25 woke up with migraine and still had cold chills.  Took Ibuprofen in AM and afternoon of 4/25.  Took naps and had minor cold chills all day 4/25.  Took nyquil and ibuprofen night of 4/25 and woke up on 4/26 with all symptoms gone.
She got her vaccine, was perfectly fine when she got it, but a couple of hours later when she got home at 5:00 she started vomiting out of no where.  She just started and then started with diarrhea.  She had to get up with having to use the toilet last night, and she was feeling really rotten, and today she just does not feel good at all.  She does not know if this was connected with the vaccine or what, she has never connected the vaccines in the past with any AE.    Today she is having symptoms of feeling terrible.  She had to cancel 2 medical appointments today.  She is not running any fever, she has not had diarrhea since she got up at 12:00.  She did have some toast and a pot of tea, and she took her regular medicines when she got up and was able to hold that down.    She did not call her doctor, did call the pharmacy and spoke with Dr. who told her to call us and gave her our phone # and suggested that she call and report her reaction.
soreness on arm with redness on injection side that still present a week after injection and start with pimple  on 1/13/21, and small abscess with purulent discharge
LEG PAIN; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of leg pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20210925773.
A report has been received from a Health Professional concerning, subject of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. The patient received expired FLUMIST QUADRIVALENT that were two days expired. Patient have reported no adverse effects. The patient experienced sixteen patients received expired FLUMIST QUADRIVALENT which started on 15-Jan-2014. The outcome of the event of sixteen patients received expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.
Baseball-size red lump at the injection site; Tennis-ball-size red lump at the injection site/Baseball-size red lump at the injection site; A spontaneous report was received from a type concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tennis-ball-size red lump at the injection site, baseball-size red lump at the injection site.  The patient's medical history was not provided. Concomitant medications reported were Prozac, Estradiol, Furosemide, Omeprazole, Somatostatin, vitamins for drug use for unknown indication.  On 23 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 033M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 24 Feb 2021, the patient experienced the event(s) tennis-ball-size red lump at the injection site . On 3 Mar 2021, the patient experienced the event(s) baseball-size red lump at the injection site.  Treatment details included Antibiotics.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event,  tennis-ball-size red lump at the injection site was considered resolved on 26 Feb 2021. The outcome of event, baseball-size red lump at the injection site,  was unknown.
Fast heart rate, heart rate kept fluctuating went to 120 then 112 then 90 and 80, it went high for like at least half an hour, I kept feeling that palpitation; Sweaty; Tired; Body pain and ache; This is a spontaneous report from a contactable Consumer (patient). The 39-years-old female patient received bnt162b2 (BNT162B2), unknown on unknown date in Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. Consumer stated, "I am calling because I got the COVID Vaccine yesterday morning and then after I got the vaccine I had a fast heart rate and then my heart rate kept fluctuating, it went to 120 then 112 then 90 and 80 and it kept, it went high for like at least half an hour not more and then I kept feeling that palpitation and then today I am still feeling sweaty, tired, body pain and ache. So, I want to see what should I do regarding that? Is that considered like a severe allergic reaction and I need to do something about it or what should I do? So, I contact my employee health and they told me I need to contact you guys." The outcome of the event Palpitation was unknown and was not recovered for the rest events.  Information on the lot/batch number has been requested
A Pharmacist was supposed to give Fluarix, however accidentally grabbed and administered Fluzone High Dose Quadrivalent with no adverse event; patient was administered with 0.7 ml of suspect drug with no adverse event; A Pharmacist was supposed to give Fluarix, however accidentally grabbed and administered Fluzone High Dose Quadrivalent with no adverse event; Initial information received on 15-Nov-2020 regarding an unsolicited valid non-serious case received from an other health professional (pharmacy manager) via call center.  This case is linked to cases 2020SA323787, 2020SA323795, 2020SA323899, 2020SA323872, 2020SA324116 and 2020SA323597 (same reporter).  This case involves a 38 year old female patent for whom it was reported that a pharmacist was supposed to give INFLUENZA VACCINE INACT SPLIT 3V [FLUARIX], however accidentally grabbed and administered influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose Quadrivalent] (wrong product administered, inappropriate age at vaccine administration) on 13-Nov-2020 (batch number: UJ552AA and expiration date: 20-Jun-2021) at a dose of 0.7 ml via intramuscular route in the left arm for prophylactic vaccination (overdose).  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to the event wrong vaccine administered, inappropriate age at vaccine administration and overdose (latency: same days).  At the time of reporting, no adverse event was reported.  No laboratory data was reported.  Disclaimer: 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.
low grade fever; muscle aches; vomiting all night; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Jun2022 at 10:15 as dose 4 (booster), single (Lot number: Fp7135) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ms" (unspecified if ongoing); "chronic kidney disease" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "hasimotos thyroid" (unspecified if ongoing); "known allergies: Erythromycin" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; LOSARTIN; LEVOTHYROXINE; B12 [CYANOCOBALAMIN]; D3; PRILOSEC [OMEPRAZOLE], 83 (as reported). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: En6202, Location of administration: Right arm), administration date: 28Feb2021, when the patient was 67-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot number: En6204, Location of administration: Right arm), administration date: 21Mar2021, when the patient was 67-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE , Lot number: 30130aa, Location of administration: Right arm), administration date: 04Oct2021, when the patient was 68-year-old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 11Jun2022 at 12:00, outcome "recovered" (Jun2022); PYREXIA (non-serious) with onset 11Jun2022 at 12:00, outcome "recovered" (Jun2022), described as "low grade fever"; MYALGIA (non-serious) with onset 11Jun2022 at 12:00, outcome "recovered" (Jun2022), described as "muscle aches"; VOMITING (non-serious) with onset 11Jun2022 at 12:00, outcome "recovered" (Jun2022), described as "vomiting all night". Therapeutic measures were not taken as a result of pyrexia, myalgia, vomiting, fatigue.  Additional information: The facility type vaccine was Pharmacy or Drug Store. The patient had not received any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed as COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Patient was sitting in waiting area and became very diaphoretic and dizzy.  Patient collapsed to the floor witnessed by family member and nurse.  Within 5-10 seconds patient jumped off floor confused but alert.  Left eyebrow had 3cm  cut with blood coming from his eyebrow.  A small abrasion  to the left lateral nose was noted. Patient was assisted to the chair and was alert and oriented x3. EMS was notified and came out to evaluate patient. Vitals were as followed b/p 100/64, HR 51, O2 98%. Cold compress was placed on patients neck. Pressure placed on laceration. Minimum bleeding noted to area. Patient refused to be taken by EMS to the hospital and stated that he would be taken by his accompanied family member. Vitals upon leaving were B\P 115/65,  HR 79, O2 99% and alert and oriented x3.
Patient did well the vaccine, then during the observation period almost 15 minutes patient stated, she felt like she was have a panic attack. Felt like her heart was racing and felt like she wanted to cry, Took vital signs and gave her a beverage and pudding. She called her mother. She felt better after she spoke with her mother. Took another set of vitals and pt. stated, "I feel better and the staff handed patient off to her mother. Time it took was maybe 25 minutes after receiving the vaccine.
August 15th - Right shoulder pain - Went to Urgent care and then I ended up at the hospital. ER - Hospital. September 10th is the day I went. They eventually diagnosed me with cancer. Still waiting to hear back as to what specific kind of cancer. I was in the hospital over 4 weeks. I just got out of the hospital yesterday. They have tried everything for my pain. They gave me chemotherapy infusion - have had two of them. I will have a series of them coming up. I am still having the pain a little bit.
Drooping of left eyelid and mild pupil dialation. Mild swelling on left cheek around orbit and below.
patient fainted; become dizzy; his vitals dropped as well; mild fevers; loss of appetite; lethargic; This spontaneous report was received from a physician and refers to a approximately 16-years-old male patient. The patient's drug reactions or allergies, medical history and concomitant medications were not reported.     On an unknown date in December 2018, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot#, expiration date, dose and route of administration were not reported) as prophylaxis. He had mild fevers, loss of appetite and was lethargic for the following 4 days. On an unknown date, he recovered from that events.  On 26-FEB-2019 at 15:10, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot#, expiration date and dose were not reported) administered in the left arm as prophylaxis. On that day, he become dizzy and fainted. He was monitored for about 20 minutes afterward because his vitals dropped as well. At the reporting time, he was doing better and on an unknown date in 2019, he recovered from the events. However, reporter was worried about the patient's 3rd dose and whether he should have it because the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) "dose not bode well" with him.  The relatedness between all events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Upon internal review, the syncope was determined to be medically significant.
Pain in the right arm also gut rot bloating I'm feeling like I'm nauseous and that I'm having episodes like I'm feeling like I might die due to the causes of the vaccine before I felt fine until my last injection where I felt the same type of events.
She developed shingle after she got a shingle shot. She didn't treat anything. It was a bump on her back.
pt recv vax 21OCT97 or 28OCT97 & approx 1hr p/vax became nauseous, felt like was going to pass out & started to wheeze;high fevers, burning in head, abn thinking;
Febrile reaction, day after immunizations were given. Gave Tylenol to treat fever.
Swelling, redness, heat, and slight injection site tenderness starting 8 days after injection given.  No other symptoms otherwise to date.
(R) arm swollen, all the way down to hand, pain upper arm. Examined by Health Dept physician. Local reaction only.
hives, little bump on the upper breast and arm; hives, little bump on the upper breast and arm; hives, little bump on the upper breast and arm; little itchiness; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives, little bump on the upper breast and arm), BREAST MASS (hives, little bump on the upper breast and arm), PERIPHERAL SWELLING (hives, little bump on the upper breast and arm) and PRURITUS (little itchiness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy, Pollen allergy and Dust allergy. Concomitant products included ATENOLOL for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced URTICARIA (hives, little bump on the upper breast and arm), BREAST MASS (hives, little bump on the upper breast and arm), PERIPHERAL SWELLING (hives, little bump on the upper breast and arm) and PRURITUS (little itchiness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 09-Mar-2021 at a dose of 1 dosage form. At the time of the report, URTICARIA (hives, little bump on the upper breast and arm), BREAST MASS (hives, little bump on the upper breast and arm), PERIPHERAL SWELLING (hives, little bump on the upper breast and arm) and PRURITUS (little itchiness) outcome was unknown.            Other concomitant drug include Allergy meds.
Local reaction to DTAP vaccine - swelling / knotting at injection site, fever at site, hurts to straighten leg or to touch it - Ice, TYLENOL PRN, BENADRYL for itching.
legs sometimes doesn't work right; Back hurts got lot worse after vaccine; Pain making nervous; Right leg was swelling; Had to lay on left side and cannot lay on right side; Having temperature; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (legs sometimes doesn't work right), BACK PAIN (Back hurts got lot worse after vaccine), TENSION (Pain making nervous), PERIPHERAL SWELLING (Right leg was swelling) and SLEEP DISORDER (Had to lay on left side and cannot lay on right side) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not provided) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Back ache (Patient stated her back hurts which she had all her life and got lot worse after vaccine.).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (legs sometimes doesn't work right), BACK PAIN (Back hurts got lot worse after vaccine), TENSION (Pain making nervous), PERIPHERAL SWELLING (Right leg was swelling), SLEEP DISORDER (Had to lay on left side and cannot lay on right side) and PYREXIA (Having temperature). At the time of the report, LIMB DISCOMFORT (legs sometimes doesn't work right), BACK PAIN (Back hurts got lot worse after vaccine), TENSION (Pain making nervous), PERIPHERAL SWELLING (Right leg was swelling) and SLEEP DISORDER (Had to lay on left side and cannot lay on right side) outcome was unknown and PYREXIA (Having temperature) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: unknown lot of problem with blood pressure..         The action taken with mRNA-1273 in response to the events was not applicable.  No concomitant medications were reported.  No treatment medications were reported.  Patient reported that she received both the doses of moderna covid-19 vaccine and doesn't remember the dates on which she received the vaccine.  Patient stated that she was having dimple in her right butt, this occurred 4 or 5 days after receiving the shot and she never seen that before. Patient said that her back hurts which she had that all her life and got lot worse after vaccine. She had to lay on left side and cannot lay on right side, was still having temperature as of 17Jun2021, lot of problem with blood pressure. she also stated that pain she had was making her nervous.
She had soreness the day after the shot.  A day or two later, she developed swelling and a rash going from site of administration to inside of the arm.  She denied being outside for having a bug bite.  There is redness about 5 inches around the injection site, and it is swollen with some blistering.  She did not have hives, but the rash itched and was sore to the touch.  She was counselled to hydrate and use cold compresses to reduce the swelling.  She was told to report to us on 4/29/19 if it had not improved.
02/08 Arm sore from injection and stiffening up - Kept moving it and took Ibuprofen- a week 02/08 Afternoon - Fatigue and body aches - Fatigue lasted a couple days - slept 02/09 Headache, fever, and body aches - Ibuprofen and bathes 02/10 Rash at injection site size of quarter and hard, arm sore and warm - Ibuprofen 02/11 Rash, pain, and itchy has grown in size 4"x3"  02/12 Rash, pain, and itchy still present - Contacted Teladoc to discuss reactions; advised to circle rash to see if rash spreads and follow up if rash spreads and to contact (company that administered vaccine) 02/13 Rash, pain, and itchy not spreading - took some Benadryl - did not do follow up since it had not spread. Rash, pain, and itchiness have subsided to a degree. Site still has a lump where rash was and is itchy at times still.  I have also experienced numbness in the arm which comes and goes.
24 hours after second Pfizer vaccination, began to experience eye pain and swelling in the right eye / conjunctivitis;  which escalated dramatically on 4/14/2021.  on 4/15/2021 eye pain continued to escalate and began experiencing severe light sensitivity.  Saw opthalmologist on 04/15/2021 and began taking steroid drops to reduce eye inflammation.  Pain reduced, but experiencing fuzzy vision on 04/17/2021 and 04/18/21.  Unsure yet of resolution.    24 hours after second Pfizer vaccination experienced fever of 101.2 before reducing with tylenol (lasted from about 5pm to 9pm on 04/13/2021).  Extremely tired with brain fog throughout the week (and still experiencing as of 04/19/2021)
Pain and swelling in right deltoid.  Itching and red.  Mother applied ice and gave Benadryl.  Symptoms subsided by 04/25/07.
(R) upper arm cellulitis. Rx Abx (Keflex) 250mg tid x 10 days.
Patient complained of chest pain, dizziness, and weakness on 11/04/2003 after receiving flu vaccine on 11/03/2003.
No further AE/PQC reported; Pneumovax23 being administered 4 days after expiration; This spontaneous report has been received from a physician referring to an unspecified patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On 06-AUG-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) with expiration date of 02-AUG-2020 (strength, indication, dose, route, frequency, anatomical location, and lot # were not provided) for prophylaxis.  This is a non-valid case due to the lack of patient's identifiers.
Reported arm very swollen, red and hot to touch. Also reported headache and stomach pain. Advised him to go to urgent card or emergent dept.
After Receiving Shot Left Arm. I Can't Lift My arm . It's Been 2 Days
Heart - Irregular strong missed heartbeat, V-Tach heartbeat, saw doctor, PA, and Cardiologist on 11Jun2021. Doctor said just monitor.
Rash developed in red spots on chest area noticed signs on body on 12-30-2013 until now. January 2014 notice of pain in my wrist area both wrist and elbow area. Went to the doctor on or about January 3, 2014 put on cream and methylprednisolone. Rash developed on stomach area and arm started 2-1-2014. Rash is continue over body. Due to see my doctor and continue on cream prescribed.
About 4 min after vx pt dizzy & fainted for a moment. Within a few minutes of laying down, dizziness resolved. This patient tends to faint at sight of blood.
pt was found blue, not breathing in crib;pt was rushed to ER where resuscitation performed to no avail
Pt recv vax on 4/23/99; shortly post vax pt exp disoriented, sore vax site, chills, weak, muscle joint pain, fever