chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a consumer (reported as 'consumer's daughter') and refers to a 14 year old female patient (currently 21 years old). Patient's concurrent condition included 'pollyosis' (Poliosis). The patient had allergies to unspecified seizure medication. In 2008 the patient was vaccinated with GARDASIL (3 injections). The reporter stated that she had a perfectly healthy 'young girl' before the patient had taken the GARDASIL vaccine. After the vaccine was taken, the patient began experiencing seizures. The patient also suffered brain damage. The patient sought medical attention-she had been in and out of hospitals, was in 2 comas and she suffered through seizures that were over 20 minutes long. The patient also developed an immune disease called 'estinbarr' (immune system disorder). The patient was treated with VIMPAT, 'Popnaf (also reported as Topnax)', 'Nortthintron' and NEURONTIN (these drugs were also reported as concomitant medications). The patient had not recovered from the events. Causality assessment was not provided. The reporter considered all the events to be serious due to hospitalization. Upon internal review, seizure and coma was considered to be medically significant. Additional information has been requested.
R09.02 HYPOXIA 6/6/2022 ADENOCARCINOMA LUNG, UNSPECIFIED SITE
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 73-year-old male patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). The patient's past medical history included shingles. On 24th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 25th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site rash and injection site warmth. On an unknown date, the outcome of the injection site rash was recovering/resolving and the outcome of the injection site warmth was unknown. The reporter considered the injection site rash and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: At 14:35, the patient received SHINGRIX in left deltoid. The patient experienced a rash just below the injection site and the rash seemed to spread down the arm. Also the rash was warm to the touch.
Information has been received from a health professional concerning a few females who were vaccinated with 0.5 ml Gardasil IM.  Subsequently, they experienced momentary discomfort during Gardasil administration.  The nurse was unable to confirm the actual number of patients or identification of the patients.  No further adverse reactions were reported.  No lab testing was performed.  Additional information has been requested.
Side effects from vaccine 9/27/2021 Our family had covid back in March 2021. Demonstrated antibodies. Felt pressure to give vaccine to family.  9/27/2021 - Afternoon - pain in arm.  4 pm - arm started hurting more  515 pm - feeling tired  615 pm - bad taste in mouth 8 pm - exhaustion  9pm - body aches  - from feet to legs and back  10 pm - went to bed - very restless sleep until 12 30 am - waking and feeling pain and aches - Jabbing pains throughout body Bad taste in mouth 9/28/2021  1 am - aches in lower back  Can?t sleep  Arm hurts - don?t want to even move it.  Miserable.  Pains in legs  continuing  Chest feeling gross  Itchy head Cracking joints 426 am - kept waking up. Hurting and aching badly. Feels like Covid is coming back. How awful.  Lower back pain.  Terrible taste in mouth  Sinuses tight and painful. Burning.  Arm is throbbing.  Lips cracked and burning.  Even my toes hurt.  Shooting pains through lower back.  Hot pain in leg.  Pains in neck, shoulders, back of head Still awake 535 am  Took more Advil 630 am Up again 632 am broke into hot sweat.  10 am woke up Overly Crusty eyes  Lower back pain  Can?t see to type on my phone.  Chest tight and hurts. Cough.  Skin hurts. Prickly to the touch.  1140 pm - feel like crying. The aches hurt. Lowe back and hips. Shooting pains in my legs.  Waves of Hot and cold.  Itchy head - hair hurts to scratch it.  1215 pm fever 99.9 even though taking Advil  Talked to doctor - took Advil again and aspirin 145 pm - achy  2 pm - Shoulders - headache  Sweaty chest - cold feet  304 pm  eyes burning and tearing 424 pm bad lower back pain 630 took 3 Advil for pain Dinner Broke into hot sweat  812 pm - another wave of more severe lower back pain  Taking aspirin  Sinus pressure 930 continual sweat outbreaks 1030 3 Advil bedtime  Lower back hurts bad -  9/29/2021  Woke up 130 am foggy back hurt Woke up 630 with kids - took Advil  Slept til 1030  Exhausted still! Back starting to hurt.  1220 pm Arm still hurts  Still fatigued. Still missing work.
Shoulder pain, loss of strength, and movement, shot was given on 11-2-2016, symptoms on 11-3-2016. Severe pain-treatment-home therapy, anti-inflammatory and pain pills.
expired pentacel was administered with no reported adverse event; Initial information was received on 23-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old female patient to whom expired diphtheria/tetanus/5 hybrid AC pertussis/ipv(vero)/HIB(PRP/T) vaccine [Pentacel (VERO)] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Oct-2023, the patient received a 0.5ml, once dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/ipv(vero)/HIB(PRP/T) vaccine Suspension for injection (lot UJ799AA, expiry date: 02-Oct-2023, strength: standard) via intramuscular route in the left thigh for Immunization and expired pentacel was administered with no reported adverse event (expired product administered) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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 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.
02/11/22 presents to ED for "Leg Pain". PMHx of "hypertension, CKD, A. fib"
Rash developed rash all over body after receiving the Smallpox vaccination.  Pt dx with Vaccina. Pt treated with Keflex 500mg and Zyrtec 10 mg and instructed to return to clinic if condition persists or worsens.
pt to ED with c/o worsening SOB and cough; states respiratory sx started in past week, was diagnosed positive for COVID on 9/14/21 and received monoclonal antibodies a few days later; in ED diagnosed with hypoxemic respiratory failure, A Fib with RVR; treated with steroids for COVID; O2 requirements increased requiring Vapotherm then BiPAP; pt placed on TPN; comfort care measures requested and pt died in the hospital
Client walked out of the health dept and fell (passed out), and got up and passed out again hitting his head and face on the concrete. He came to very shortly and then said he had passed out once before after vaccines. Taken by ambulance to ER where he got stitches in his chin and was diagnosed with low blood sugar.
Pt told vaccinator vasovagal reaction prior with flu vaccine.  Rec'd vaccine lying down due to past vasovagal episode after flu vaccine 5yrs ago. Within 30 seconds pt complained of dizziness, feeling flushed, warm, became pale and diaphoretic. Elevated legs above heart, provided.  ice pack to back of neck.  VS taken BP 164/90,  hr 82 reg strong, resps 14 reg,  non-labored,  Sp02 98% RA.   Provided reassurance.  Approx 15 minutes after vaccine given pt stated I feel better, sat her up on cot then moved to recovery area seating.  provided water for hydration. Pallor and diaphoresis subsided. Ok'd to exit after 30 min  encouraged to sign onto V-safe website.  RN
Patient stated nausea, vomiting, extreme fatigue, chills/hot flashes, loss of appetite When he did try to eat he vomited. No fever. Symptoms lasted 3 weeks
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 15Apr2021 as dose 2, single (Lot number: ER8731), in left arm, on 11Oct2021 as dose 3 (booster), single (Lot number: FF2987), in left arm and on 30Aug2022 at 14:00 as dose 4 (booster), single (Lot number: FPT135) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). There were no concomitant medications. The patient was not received other medication in 2 weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 30Nov2022 to 05Dec2022
Sore arm started 1 day after injection, worsened for 2 days, then dissipated after e days.   Mild Redness, itching, and mild swelling at site started on 7th day after injection (03/11) and persists as of today (3/14).  Mild fatigue, brief mild periods of chest tightness, and generally feeling unwell began on 3/10 and persisted through 3/12 PM.
Patient was given an extra HPV9. Patient was supposed to receive a Menactra but instead received an HPV9. He had already completed the HPV series. Pt had no s/s of adverse rxn.
p/vax pt upper arm started aching & swelling which then proceeded down the arm into the hand;the arm was warm to touch;it stayed swollen all day;
Caller continues to say that the vaccine is giving him Covid-19; Caller continues to say that the vaccine is giving him Covid-19; This is a spontaneous report from a non-contactable consumer (patient).   A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an un-specified date, the patient continued to say that the vaccine was giving him covid-19. The case was assessed as non-serious. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. Outcome of events was unknown.   No follow-up attempts were possible; information about lot/batch number could not be obtained.
10 minutes after injection patient reported feeling dizzy/lightheaded, a sensation like her ears needed to pop, fingers tingling, abdominal pain and nausea. She denied any problems breathing or feeling of swollen tongue/lips/throat. Rph checked on her, gave her some water and offered to call EMS. Pt wanted to wait 10-15 mins and reassess. Rph checked back in on patient in waiting room and she was feeling better. Pt sat in waiting room for about 30 additional minutes then stated she felt much better before she left. She stated the nausea and lightheadedness had subsided. She did still have the ear pressure and some tingling in fingers but felt considerably better. Her husband was with her and she felt comfortable going home. Rph called her about 1.5 hours later and she stated her symptoms continued to improve and she was feeling much better.
intern checked patient in for vaccine and did not realize it was 3 weeks since last dose not the 4 weeks it should be. nurse did not catch early vaccine AND VACCINE WAS ADMINISTERED
No adverse event; they gave the wrong concentration of the vaccine to children age group 6 months to 5 years; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (they gave the wrong concentration of the vaccine to children age group 6 months to 5 years) and NO ADVERSE EVENT (No adverse event) in a 4-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 201L22A) for COVID-19 prophylaxis.     It was reported that the patient's caregiver did not report any relevant medical history, conditions, allergy, concomitant diseases or risk factor (including any previous COVID-19 diagnosis).  Previously administered products included for Product used for unknown indication: HEPATITIS A VACCINE, FLU [INFLUENZA VACCINE], MEASLES, MUMPS AND RUBELLA VACCINE, VACCINE /PERTUSSIS/TETANUS/DIPHTHERIA/, HIB VACCINE and PNEUMOCOCCAL VACCINE CONJ 15V (CRM197). Past adverse reactions to the above products included No adverse event with FLU [INFLUENZA VACCINE], HEPATITIS A VACCINE, HIB VACCINE, MEASLES, MUMPS AND RUBELLA VACCINE, PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) and VACCINE /PERTUSSIS/TETANUS/DIPHTHERIA/.    On 01-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .2 milliliter. On 01-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (they gave the wrong concentration of the vaccine to children age group 6 months to 5 years). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (they gave the wrong concentration of the vaccine to children age group 6 months to 5 years) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (they gave the wrong concentration of the vaccine to children age group 6 months to 5 years).    Concomitant drugs were not reported. It was reported that patient received vaccine from a dark pink with yellow box a dosage of 0.2 ml instead of blue cap with gray border since they have not received the vaccine before.  Treatment medications were not provided.  This case was reported for patient 1.   This case was linked to US-MODERNATX, INC.-MOD-2023-728517 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728517:patient 2
Conjunctivitis, eye twitching, muscle twitching face arms legs entire body, neck pain; numb feeling from head down, occipital pain, pain down legs, problems sleeping, severe back pain, shoulder pain, stomach pain, tingling legs & arms;
March 5th Ultrasound revealed Severe DVT in left leg.  Emergency room March 5th prescribed Eliquis 10mg twice daily.  May 24, 2021   blood work showed elevated Ddimer. Dr requested another Ultrasound, May 27, 2021 Severe DVT not responding to blood thinners.  May 30, 2021 Dr.  switched to Xerelto 20mg.  June 3, 2021 Dr.  determined that patient has developed Chronic DVT and will continue to follow up with Blood work and Blood thinners.  Next appointment is June 11, 2021.
Nausea; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received the 2nd dose of Shingrix. In March 2019, 1 day after receiving Shingrix, the patient experienced nausea. On an unknown date, the outcome of the nausea was recovered/resolved.   It was unknown if the reporter considered the nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine in right arm. The patient received the second dose of the Shingrix vaccine 6 months ago. The patient experienced nausea the day after receiving the vaccine that lasted for one day. The reporter was unable to provide additional information. The reporter consented to follow up. This was 2 of 4 linked cases reported by the same reporter.
Soreness and pain from the site of the injection all the way to the wrist. Symptoms last for more than 1 week now and only subside when taking acetaminophen.  Patient was instructed to contact Primary Care Physician for follow-up.
Went to pediatric ER for abdominal pain and bloody diarrhea on 08/19/2018.
Mild headache; This is a spontaneous report from a contactable consumer (patient) through a Pfizer sales representative.   A 32-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech covid-19 vaccine) on an unspecified date, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced mild headache within 45 minutes of first Covid vaccine. Clinical outcome of the event was unknown at time of this report.   Information on the Lot/Batch number has been requested.
Pain in elbow and bruising at injection site. Later rash - took Benadryl; rash subsided but itchy. 10/19 raised, red area with a blotchy rash. 10/20 neck and shoulder pain. Saw her physician. Reported reaction 01/29/14 to Employee Health.
have a high fever, chills, congestion and a horrible headache. sweats and achy
48 hrs p/vax pt had generalized tonic-clonic sz lasting 15min; no fever; subsequently has had many focal seizures, now controlled; No previous hx of seizures, no family hx;
Pt presented to ER with complaints of SOB and high fevers. Evaluation noting high fever and hypoxia on RA improving with supplemental oxygen 2-3L. Lab work up noting creatinine of 5.8. CXR with patchy bilateral airspace disease. Subsequently admitted with consults to ID and nephrology. IVF ordered with improvement.  Discharge diagnosis was COVID 19 pneumonia positive test on 10/3/21; s/p rocephin/doxy, ID following  Acute hypoxic respiratory failure second to above; requiring supplemental oxygen 3LPM; on decadron
On morniing of 1/30/11 patient presented with confusion, unilateral weakness  - diagnosed and admitted with CVA - embolism of R middle cerebral artery per CT scan.  Noted to be in atrial fibrillation during admission.  Discharged to rehab center on 2/3/21.
Swollen, red, hot to the touch.  Itchy and red patch to upper arm. Treatment provided was Bactrim 800 mg every 12 hours for 10 days and triamcinolone acetonide topical to affected area 2 times per day.
My heart is pounding every morning. You can see it pounding outside my body. I need to get up in the middle of the night and walk around, breathe deep and sip water. Laying down exacerbates it.
Swelling, redness and itching spread down the arm (spanned the space between the deltoid and elbow, them spread across the back to the other arm.  Patient's lips were tingling and she was coughing
Pulmonary embolism occurred at the end of August, 30 days after second dose of Moderna. While walking started to have difficulty with breathing. Went to the doctor who diagnosed a clot and was put on blood thinners 2x/day for 6 months. The doctor said is he had waited a week to get his appointment, he would  have died from the clot.
PATIENT WAS GIVEN JANSEEN COVID 19 VACCINE ON 08/14/21 @ 10:20AM AND PATIENT WAS WAITING IN WAITING AREA AND START COMPLAINING ABOUT DIZZINESS , SWEATING  AND NAUSEATED. CALLED EMERGENCY SERVICES AND EMS TEAM CAME IN FEW MINUTES AND MONITORED HER . EMS ASKED IF PATIENT WANTS TO GO TO HOSPITAL BUT PATIENT REFUSED AND  MENTIONED SHE IS FEELING BETTER AND SHE IS FINE. PATIENT WAS ALSO ADVISED TO REPORT IN VAERS AND PROVIDED THE FACT SHEET ABOUT THE VACCINE.
Rashes all over body; Swollen lips; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Mar2021 at 12:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient apparently had unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. On 14Apr2021 at 07:00, the patient experienced rashes all over body and swollen lips. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of events and included treatment with diphenhydramine hydrochloride (BENADRYL) and cetrizine hydrochloride (ZERTEC). The clinical outcome of the events rashes all over body and swollen lips were not recovered at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Apr2021 at 12:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain) and DYSPNOEA (difficulty of breathing/his difficulty of breathing got worse). On 02-Feb-2021, the patient experienced FATIGUE (fatigue). On an unknown date, the patient experienced NAUSEA (nauseous). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain), DYSPNOEA (difficulty of breathing/his difficulty of breathing got worse) and FATIGUE (fatigue) outcome was unknown and NAUSEA (nauseous) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Oxygen saturation: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
PATIENT CONTRACTED COVID DESPITE BEING FULLY VACCINATED AT TIME OF EXPOSURE/POSITIVE PCR TEST
11/21/07 local reaction left deltoid, heat, red, swollen dollar size coin at injection site. 11/22/07 local reaction - swollen, hot and red area 7 inches in length, very tender/pain. 11/22 systemic reaction, myalgia, malaise, fever, joint pain and headache.
My immune system has been weakened. I have had illness symptoms since November, congestion, cough, runny nose, headaches. Before the two doses of the vaccine, I was quite healthy for more than a year. Before that, colds and viruses would usually last a few weeks and then slowly resolve to full health. This is no longer happening as I have had symptoms on and off for the past five months and have not felt full health since last October. Further, I have had some new food intolerances that cause gastrointestinal trouble. It seems to be an intolerance to milk and cheese. Previously I used to eat a bowl of cereal with milk daily, and now I need to stay away from milk and cheese products.