chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 15 minutes of the patient getting the shot she developed tingling on her tongue, swelling of the tongue and throat, and started to develop hives. The patient was wheezing on assessment so a Epipen was injected. Swelling went down some but tingling persisted. She became dizzy and distraught, was given cold water and a towel with cold water on it for her neck. 911 was called and she was taken to the hospital.
Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 14 months old male patient who was vaccinated with a dose of QUADRACEL (batch number C5325BA) (expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to vaccine administered to patient of inappropriate age (the patient was vaccinated with QUADRACEL but do not have the required age (4-6)). No any information about adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Patient has been very dizzy and has had trouble with her equilibrium since the vaccine on 5/4/21. She also started to hallucinate on 5/9/21. She had not contacted her doctor at the time she reported this to our pharmacy but she said she would after she talked with us.
immed anaphylaxis, hypotonia, apnea, sz-all, torticollis, failure to thrive, demyelination, in wheelchair, totally disabled, no speech on 5 meds & an apnea monitor;  Nurse follow up on 08/19/04 states: "No new information."  Per annual report-cerebral palsy, apnea/Cheyne-Stokes respiration, hypotonia, wheelchair and home bound.  Non verbal, sedated completely due to intractable seizures.  G tube fed, on oxygen, 24 hr care 7 days per week.  Conversly-he is physically well.  Genetic testing reveals nothing-no disease found after 11 years at home with his family (two older brothers and mom and dad) who love him dearly.  PMSF in the vaccine did this!
Day 2 after the injection woke up with extreme dizziness to the point of falling out of bed, not being able to walk without holding to objects. One more incident that morning of falling. The rest of the day was very dizzy usually upon trying to get up, but a few times when just lying or sitting. Same thing the next day. By the third day the dizziness was only intermittent. Wednesday was very dizzy upon getting up in the morning, but it faded after that point. Thursday, dizziness and head spinning for about 15 seconds while laying in bed, but rest of the day until afternoon no dizziness. All throughout these days, including Day 1 after the shot, bad headache.
Patient administered vaccine after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Date the vial was initially stored in the refrigerator was unknown. Expiration date was reported as 09-Nov-2021. The vial did not undergone any temperature excursions. No treatment information were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received non-significant information and updated in the narrative.
Chills; fever; itchiness and periodic rashes that are the most annoying, even developed a rash on my eyelids, but most are on the hands and legs; itchiness and periodic rashes that are the most annoying, even developed a rash on my eyelids, but most are on the hands and legs; This is a spontaneous report from a contactable other healthcare professional. A 53 year old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 10Mar2021 14:30 (Batch/Lot number was not reported) as DOSE NUMBER, UNKNOWN, SINGLE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing Moderate/Severe Asthma, another lung condition, lung disorder from an unknown date and unknown if ongoing. Concomitant medication(s) included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for an unspecified indication, start and stop date were not reported. The patient experienced chills on 11Mar2021 with outcome of not recovered, fever on 11Mar2021 with outcome of not recovered, itchiness and periodic rashes that are the most annoying, even developed a rash on his eyelids, but most are on the hands and legs causing pruritus on 11Mar2021 with outcome of not recovered. Therapeutic measures were taken as a result of this with Hydrocortisone for itch and Children's Benadryl.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Around 6pm there was chills, feeling of fever. Around 8 pm: swelling of the lips, area above lip below nose, swelling under the tongue followed by slight nausea and chest tightness.
A nurse reported a pt received a vaccine on 4/6/2000 and subsequently developed a severe injection site reaction characterized by a hive-like area of swelling, redness and  induration which resembled cellulitis. Pt also developed swollen lymph nodes under the left arm. On 4/11 pt was treated with Prednisone. On 4/11/2000 pt developed shortness of breath, anxiety, malaise, general achiness,arm pain and fever.
NUMBNESS AND TINGLING IN ARM; IT STARTED IN HER LEFT PINKY AND RADIATED UP THE LEFT ARM. IT HURT FOR A FEW HOURS; BRAIN HURT; SHAKINESS; BODY PAIN; CHILLS; EXHAUSTION; SEIZURES; This spontaneous report received from a health care professional concerned a 19 year old  female. 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: Unknown) dose was not reported, 1 total, administered on 09-APR-2021 on left deltoid for prophylactic vaccination. The batch number was not reported and it has been requested.  No concomitant medications were reported.  On 09-APR-2021, the patient experienced seizures, confusion, pale appearance and nausea after forty five minutes patient was okay. The patient was drove back home and slept for 7 hours then experienced exhaustion. The next morning on 10-APR-2021, the patient's  brain hurt to work and experienced body pain, shakiness, chills. Ten days later on 19-APR-2021, the patient experienced numbness and tingling in left arm. It was started in left pinky finger and radiated up the left arm. It was hurt for a few hours (just 1 episode). health care professional has ordered tests but they had not been completed yet. The patient was seen by a pediatric neurologist on 22-APR-2021 for evaluation of seizures. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of seizures, exhaustion, chills, body pain, shakiness, brain hurt, numbness and tingling in arm, It started in her left pinky and radiated up the left arm, It hurt for a few hours was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210450038- JANSSEN COVID-19 VACCINE Ad26.COV2.S-Seizures. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 09-AUG-2012, the patient received improperly stored VARIVAX dose 2, from lot # 671861/1907AA, expiry date 05-DEC-2013 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
left arm sore; chills; body aches/ pain; Headache; low grade temp; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (left arm sore), CHILLS (chills), MYALGIA (body aches/ pain), HEADACHE (Headache) and PYREXIA (low grade temp) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (left arm sore), CHILLS (chills), MYALGIA (body aches/ pain), HEADACHE (Headache) and PYREXIA (low grade temp). At the time of the report, PAIN IN EXTREMITY (left arm sore), CHILLS (chills), MYALGIA (body aches/ pain), HEADACHE (Headache) and PYREXIA (low grade temp) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medication use was not provided by the reporter  Treatment no meds at this time patient reports he may take an ibuprofen.   Reporter did not allow further contact
itchy rash/hives on Left side of face & neck & abd. received Hep A (Right deltoid) & Tdap (Left deltoid) immunizations on Wednesday, 7/16/14 & on Saturday 7/19/14 am noticed rash with intense itching on face . states has been taking benadryl & using hydrocortisone cream to alleviate. On 7/24/14 patient seen again and rash/hives have now developed on Left thigh & buttock.  Referred to dermatologist and was seen on same day (7/24/14).  Was told by dermatologist that hives could possibly be due to one or both immunizations.  Was prescribed Hydrozyzine Hcl 25mg tab, Triamcinolone 0.1% cream & Cetirizine Hcl 10mg tab.
I had chest pains a few days after receiving the vaccine and  went to see my Doctor who referred to the ER to check to see if I had a blood clot.
Pain in right shoulder blade that radiated to chest and tingling in finger.  Went to ER around 4/17/21- d diner was done and was not elevated. Followed up with doctor a couple days later.  With same symptoms and more back pain. EKG Showed a slight inversion. Blood work including Troponin, liver, and platelet count all came back normal. Tried to work out but felt like I injured myself after only 10 sit-ups. This pain still exists. My anxiety grew like nothing I have ever experienced. Pain in my ankles, both feet began about a week later. Stress test done on May 4 with normal results. Followed up with doctor on May 5 for ankle pain and hip pain. Blood work tested Inflammation, Autoimmune, Rheumatoid, Thyroid all came back normal. Another d dimer came back elevated at. 65. Was prescribed buspirone for anxiety. Had a CT Scan and Venus Doppler- all came back clear. I still have pain in rib area where I feel like a pulled something. I am afraid to exercise, I still have pain in back and side. Will follow up with one more d dimer then hematologist if still elevated.
Patient is 14 years old, and the vaccine is not indicated for patients under the age of 18.  We have been checking in with the patient and the patient has not experienced any signs or symptoms of any adverse event.
11/30/21: Patient went to PCP with complaints of increasing SOB for weeks, nausea, syncopal events, increased edema and pain bilateral lower extremities. PCP diagnosed high suspicion for DVT/PE and recommended patient go to ER for evaluation. Patient refused. 12/1/21: Patient called EMS due to increased dyspnea and tachypnea, inability to ambulate without syncope. Arrived to ER with noted SOB at rest requiring 6L NC to sat 90%. RR 32-40, HR 110, +3 bilateral LE pitting edema, coarse rhonchi on auscultation throughout. Orthostatic hypotension in ER with BP 104/71 at rest then 75/49 upon standing with complaints of vision changes. During evaluation patient became suddenly unable to maintain oxygenation over 80%. despite increase in oxygen to 10L via HFNC.  Placed on BiPAP 10/5 FiO2 40% sat 98% with improved dyspnea.  CXR shows emphysema and diffuse pulmonary fibrosis.  NA 132, K5.5, eGFR 36 BUN/Creatine 34/2.5, AST 3214, ALT 1827, WBC 27.5, CRP 2.7, Lactic acid 8.7, d-dimer 856.  Admit with acute hypoxic respiratory failure and sepsis in the setting of COVID 19 PNA, new acute kidney injury with transaminitis, acute on chronic heart failure exacerbation, shocked liver.  Started on IV Lasix, rocephin, azythromycin, IV solumedrol, Lovenox, and home dulera, spiriva.  Remdesivir and baricitinib held due to AKI. 12/2/21:  CT negative for PE, dopplar negative for DVT.  RR 22-30, afebrile, HR 80, sat 93% on 6L via NC using BiPap at night 10/5 FiO2 40%.  BNP 2580 12/4/21:  ambulating in room on 4L NC sat 90%.  Sat 98% at rest.  RR 16-20, afebrile, SBP 90-110s.  No distress noted with speaking or ambulating.  BUN/Creating 42/1.2 eGFR >60, AST 332, ALT 1006. 12/5/21:  Patient to be discharged home on baseline home O2 of 4L.  Continue long steroid taper and have sleep study outpatient for new home CPAP at night.  WBC 14.7, BUN/Creating 22/0.9, ALT 711, AST 160.
Patient developed a rash on trunk and extremities, a maculopapular rash with some pearly papules, no pruritis, on day 1 after vaccine.
I am  very concerned that symptoms are related to the Pfizer's 1st vaccination, I noticed a dry cough that resolved on its own after 5 days. After 2nd vaccination, dry cough resumed and has not resolved since. Second dose 5/12/21. symptoms began 5/14/21 and have not resolved despite taking multiple medications. It has been more than 7 months but I have dry cough that occurs for every 4,5 minutes
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, and drug reactions/allergies  was reported. Concomitant therapies included the sterile diluent (STERILE DILUENT). On 10-APR-2017, the patient was inadvertently vaccinated with an expired VARIVAX single dose, subcutaneously for prophylaxis (lot # L008273 and expiration date was 11-MAR-2017). It was also reported that the vaccine had been improperly stored prior to the administration at a temperature of 40 °F for 6 hours. The vaccine did not have a previous temperature excursion and no data logger was involved. The sterile diluent, had been properly stored prior to the reconstitution of VARIVAX. No adverse effects were reported. Additional information is not expected because there was no consent to contact a physician.
The pt states that after the receipt of all three AVA vaccinations she experienced a "knot" at the injection site the day of the vaccination.  Additionally later in the day she experience "flu like symptoms" which included muscle aches, dizziness, lightheadedness and fatigue.  These symptoms resolved in 7 days without treatment.  The next day she noted an itchy rash (small red bumps) on her arms and chest.  This was treated with a cream (unknown) and the rash resolved in 2 days.  Symptoms:  Rash, pruritic, Nodule, subcutaneous, Dizziness, Muscle Pain, Fatigue, Malaise <60 days.
Day of vaccine - site soreness that lasted ~2 days; no other issues, no redness, discomfort resolved Day 10 - noticed in  middle of the night my left arm was sore at injection site; this morning it is bright red  (~3inch diameter) and slightly warm, tender; no fever or other symptoms
pt recv vax 13AUG97 745PM; 15AUg97 4AM both arms swollen, pt c/o pain on arms deltoids pink rash & raised red areas of back arm & chest & buttocks;coughing but no trouble breathing;
Prickling/Tingling; Right arm swollen up; Hard like a brick; Redness/Erythema; Feeling hot; Arm sore just where shot was; Hypersensitivity reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction), PARAESTHESIA (Prickling/Tingling), PERIPHERAL SWELLING (Right arm swollen up), INDURATION (Hard like a brick) and ERYTHEMA (Redness/Erythema) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypersensitivity reaction and Urticaria. Concurrent medical conditions included Hypertension (Condition improved now) since 18-Oct-2019, Diabetes mellitus (Condition good now) since 17-Dec-1985 and Drug allergy (Hives due to Codeine) since 1988. Concomitant products included INSULIN, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), METFORMIN HYDROCHLORIDE (METFORMIN ER), ATORVASTATIN, AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BENAZEPRIL) and LEVOFLOXACIN (LEVAQUIN) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). On an unknown date, the patient experienced PARAESTHESIA (Prickling/Tingling), PERIPHERAL SWELLING (Right arm swollen up), INDURATION (Hard like a brick), ERYTHEMA (Redness/Erythema), FEELING HOT (Feeling hot) and MYALGIA (Arm sore just where shot was). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Adverse event, at a dose of unknown and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) (oral) for Adverse event, at a dose of Unknown. At the time of the report, HYPERSENSITIVITY (Hypersensitivity reaction), PARAESTHESIA (Prickling/Tingling), PERIPHERAL SWELLING (Right arm swollen up), INDURATION (Hard like a brick), ERYTHEMA (Redness/Erythema), FEELING HOT (Feeling hot) and MYALGIA (Arm sore just where shot was) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included high blood pressure medicine.   This case was linked to MOD-2021-092451 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Added patient demographics, medical  history, new events and updated event outcome.
Severe headache, body aches, temp of 102.7, heart rate 120, blood oxygen level 89
Flublok was administered outside the 2 day window/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 17-Aug-2021 from a Nurse (Reference number- 00727907) and transmitted on 17-Aug-2021.  This case involves a patient (unknown age and gender) who was administered INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] outside the two- day window, with no adverse event (Inappropriate schedule of product administration).  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   On 16-Aug-2021, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot number and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to Inappropriate schedule of product administration (latency was on the same day).  It was reported that, "Flublok was received and administered to a patient outside the 2 day window. The nurse practitioner states that the Flublok was received yesterday from facility to the clinic and there was a message left with one of the nurses over the weekend that due to an error it was sent outside of the two day window. She states that when she received the shipment yesterday, she gave one to a patient which was "not good" and "very upsetting" to her that she did that. She said she didn't get the message until today that since it was sent outside of the two-day window that it needed to be quarantined and sent back. She states that nothing looked out of the ordinary. She states that she is confused as to what she needs to do with the patient. She wants to know if she is going to be receiving a return shipping label and if so will it be mailed or e-mailed to her".  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.  There will be no information on batch number for this case.
Patient was given a booster dose of Moderna vaccine 0n 07/15/2022. The last extended expiration date was noted to be 07/13/2022. Patient has not reported any adverse events since vaccine was administered.
red mark around the vaccine site and it itches; red mark around the vaccine site and it itches; This spontaneous case was reported by a consumer and describes the occurrence of   in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.            patient called in stating she received her 2nd vaccine 28Feb2021 and had a red mark around the vaccine site and it itches
Call to EE 12/22 regarding facial numbness/ tingling after vaccine. Notes she received vaccine 12/18. Was fine for first 15 minutes. Within 5-10 minutes of leaving, ee had facial numbness to right side of face and under bottom lip. Sx lasted about 3 hours and resolved 100%. No recurrence.