chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initially experienced nausea & tingling in lower extremities. BP141/93,P73.  Sat another 15minutes: LE's still not feeling right.  Accompanied to ambulate outside for fresh air.  Stated felt better afterwards but remained quiet & not feeling WNL as had felt before receiving the vaccine.  Stated was "feeling fine now" @11:50am, & was ambulating  & conversing WNL. Agreed w/plan discussed w/both site leaders to be transported by supervisor back to work@testing site where medical staff were present in event she had any further symptoms. Accompanied to ride.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On an unknown date the patients were vaccinated with unspecified doses of improperly stored PROQUAD (Merck) (lot # L027634 with expiration date 21-JAN-2017; dose, dose number and route were not reported). No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
The injection site on left arm was swollen and red; all of left arm became red, bumpy and itchy (hives); patient had to take 75 mg of Benadryl three times in order to get relief.
Facial, anterior chest rash with itching, redness, tx with Benadryl with mild relief.  Improved 10% from yesterday and less itching.
pt recvd vax;t of 104.5 in er; spinal tap showed 4 red cells & 10 white cells;put on rocephin x 72 hrs during hosp;upon discharge was prescribed amoxicillin for 10 days; Urine antigens pos for haemophilius;wbc=19,000;
pt devel seizures 4 days p/vax; later found to have herpes meningitis; brother had cold sores
First was an episode of disconnect between a word I had in my mind and trying to speak that word. I could talk but I couldn't get the word I wanted to use even if I knew what it was. It went away. I did see a doctor and had an MRI. I was told if this happened again to go to the ER. The second episode on 07/22 at 8:30AM my husband called the ambulance and they went through the entire stroke protocol. I was told to start taking a regular aspirin everyday.
Pt mom called 3 hours post inj stating she had to carry child to ER for trouble breathing.
Information has been received from a registered nurse referring to an unspecified number of patients of unkonwn age and gender. On an unknown dates these patients were vaccinated with doses of improperly stored GARDASIL (dose, frequency, route and lot# were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
This spontaneous report was received from a pharmacist concerning a non pregnant female patient of currently 57 years old. Pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were unknown by the reporter. On an unspecified date in March 2018, the patient was vaccinated with VARIVAX injection, for prophylaxis (strength, dose, dosage schedule, route, anatomical location, lot # and expiry date were not provided); also, on the same month, the patient started therapy prednisone (manufacturer unknown) tablet, orally, for an unspecified reason (strength, dose, frequency, lot # and expiry date were not reported). Subsequently, on an unspecified date in 2018, the patient was diagnosed with an unspecified dermatological disease. Also a biopsy was performed, however no details were known. Therefore, she had been treated with unspecified high doses of methotrexate until the time of reporting. The pharmacist stated that it was not known exactly why the patient needed VARIVAX but it was believed to be proof of vaccination. It was unknown by the reporter if the patient sought medical attention. At the reporting time, the patient had not recovered from the event. The action taken with prednisone (manufacturer unknown) and the reporter's causality assessment between prednisone (manufacturer unknown) and VARIVAX with skin disorder were not reported. Upon internal review, unspecified dermatological disease treated with methotrexate was considered to be medically significant.
Experienced a migraine starting about 2 hours after the vaccine /severe migraines daily lasting 3-12 hours each.; This is a spontaneous report from a contactable consumer (Patient). A 25-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer COVID-19 Vaccine, Solution for injection, Lot Number: FP7534), via an unspecified route of administration, administered in left arm on 29Mar2021 at 10:00 (at the age of 25-years-old) as single dose for COVID-19 immunisation. Medical history included Hashimoto's thyroiditis, PCOS, Asthma, Bipolar 2, ASD, ADHD, MDD, GAD. Patient had no known allergies. Patient was not diagnosed with Covid prior vaccination. The patient did not receive any other vaccine four weeks prior vaccination. Concomitant medications included propranolol (PROPRANOLOL), venlafaxine hydrochloride (EFFEXOR).On 29Mar2021 at 12:00 (within 2-hours after vaccination), patient experienced a migraine/severe migraines daily lasting 3-12 hours each. Patient have been getting them almost every single day since the first dose on 29Mar2021. It has now been just over 2 months. They commonly start in the morning then go away and come back later in the day, but they've also started later in the day on quite a few occasions. Patient tried Motrin, Tylenol, Excedrin Migraine, Midol, and Ubrelvy and they do not help much if at all. The only thing that helped significantly is medical Marijuana with CBD. Patient visited 2 different doctors multiple times and no other cause has been found. The patient underwent lab tests and procedures which included extensive blood work and CT, however, nothing has been found to explain the migraines from the investigations on an unspecified date. It was reported that patient had not received any specific treatment for event. Patient was not diagnosed with Covid prior vaccination and not tested for Covid post vaccination. The outcome of the events was unknown.   No follow up attempts possible. No further information is expected.
Lipschutz ulcers doxycycline 100 mg twice a day and 2 ointments that you can use up to 3 times a day: triamcinolone and mupirocin and follow up with dermatology and Oxycodone 5mg immediate release tablets
mom reports pt in crib not breathing 530PM;pt recv vax same day 145PM;f/u 2 days later mom reported no further sx of any kind;
Allergic to the vaccine; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient's wife). A 76-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (unknown manufacturer), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation.  The patient's medical history was not reported. Concomitant medications were none. The patient was allergic to the vaccine on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Pfizer is a Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report if another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.
a little sore left arm in the site of injection, not that bad; left arm a bit red in the site of injection; site of injection very hot to the touch; could be due to an infection; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (a little sore left arm in the site of injection, not that bad), VACCINATION SITE ERYTHEMA (left arm a bit red in the site of injection), VACCINATION SITE WARMTH (site of injection very hot to the touch) and VACCINATION SITE INFECTION (could be due to an infection) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054A22A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Penicillin allergy, Blood pressure high, High cholesterol and Acid reflux (esophageal). Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Acid reflux (esophageal), VALSARTAN for Blood pressure high, SIMVASTATIN for High cholesterol.   On 28-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-May-2022, the patient experienced VACCINATION SITE PAIN (a little sore left arm in the site of injection, not that bad), VACCINATION SITE ERYTHEMA (left arm a bit red in the site of injection), VACCINATION SITE WARMTH (site of injection very hot to the touch) and VACCINATION SITE INFECTION (could be due to an infection). At the time of the report, VACCINATION SITE PAIN (a little sore left arm in the site of injection, not that bad), VACCINATION SITE ERYTHEMA (left arm a bit red in the site of injection), VACCINATION SITE WARMTH (site of injection very hot to the touch) and VACCINATION SITE INFECTION (could be due to an infection) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: positive (Positive) very mild case.         No treatment was reported   This case was linked to MOD-2022-581141.
Patient complains of pain in arm where vaccine was given. Followed up with MD on 8-30-18 per patient. "He told me that it may be an abscess under the skin in the muscle". "They gave me antibiotic shot and some to take at home". States that she will follow up with MD on 9-3-18 if area has not improved. Patient denies any visual signs of abscess or drainage.
expired ACTHIB was administered in which the diluent only was expired with no reported adverse event; Initial information received on 25-Apr-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 1 years old male patient who was administered expired HIB (PRP/T) vaccine [ACT-HIB] in which the diluent only was expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis A vaccine inact (Havrix) for Immunisation; and measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar ra 27/3), varicella zoster vaccine live (oka/merck) (Proquad) for Immunisation.  On 17-Apr-2023, the patient received an unknown dose of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (batch: UJ739ABA; expiry date: 07-Apr-2023) via intramuscular route in the left vastus lateralis for Immunization in which the diluent only was expired with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired acthib was administered in which the diluent only was expired with no reported adverse 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.
booster (pfizer) 21Aug2021; booster (pfizer) 21Aug2021; symptoms of arthritis flare on and off since coronavirus booster (pfizer) 21Aug2021; This is a spontaneous report from a contactable other HCP. A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number was not reported), via an unspecified route of administration on 21Aug2021 (at the age of 54-year-old), as dose 3 (BOOSTER), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced symptoms of arthritis flare on and off since coronavirus booster (pfizer) 21Aug2021 on an unspecified date in 2021. Patient received booster (pfizer) on 21aug2021 as off label use. The clinical outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Left leg increasing redness, swelling and warmth over 4 days. Omnicef x 10 days
Narrative:  Pt died after COVID vaccine dose #1 01/24 pt fell at home and was brought to ED, BP 200/100, bilateral legs/feet swollen, discharged on lasix and potassium x 5 days 02/15 COVID vaccine dose #1 02/17 pt seen by PCP, 'feeling very weak and not walking well, had several falls at home' 02/19 pt with fever 101.4 and diarrhea, chills, admitted to hospital, weakness and shortness of breath; CC: dyspnea/congestive heart failure and bilateral lower extremity edema CT of chest no pulmonary embolism, stable sternal dehiscence, moderate atherosclerotic calcifications, bilateral renal cysts. High troponins clinical impression moderate persistent asthma with acute exacerbation no status asthmaticus. 02/22 discharged from hospital: acute respiratory failure due to COPD, recurrent fall with deconditioning, chronic kidney disease stage III, sternal dehiscence, hyperglycemia; given rx for Combivent and Symbicort, 5 days of doxycycline and Mucinex 02/25 continued sob, on steroids 03/10 pt admitted to hospital, on ventilator due to pseudomonas infection 03/27 weaned from ventilator, sent to telemetry floor, suffered CVA, transferred to stroke facility, intubated and placed in ICU 04/03 pt passed away Vaccine not likely contributor to patient's death. Patient was hospitalized before and after vaccine with unstable medical condition. Never diagnosed with COVID. No ADR immediately after vaccine. Multiple contributors to death including advanced age and comorbidities.
Received PROQUAD 6/4/13. Called office 6/8/13. Patient c/o blister rash around injection site. Some have scabbed. Dr discussed with mom. Told not unusual watch.
patient had a partial seizure and hard time breathing approximately 20 minutes after receiving Moderna vaccine booster (2nd booster shot). We called 911 and took care of the patient until paramedics arrived. patient was still having seizures when paramedics took him away. I am not sure if he forgot to take his anti-epileptic drug for today or if partial seizures were caused by 2nd Moderna vaccine. His mom/grandma did mention to tech who was taking care of the patient at the time of the seizure that she neglected to mention or write on the patient consent form that he has a history of seizures. She just wanted him to receive his 2nd dose.
Positive COVID-19 test on 29Jul2021; Positive COVID-19 test on 29Jul2021; This is a spontaneous report from a contactable consumer or other non hcp.A 43-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Batch/Lot Number: EL3247) via intramuscular route of administration, administered in Arm Left (Age at time of vaccination: 43 years old) on 19Jan2021 as DOSE 1, SINGLE, dose 2 via intramuscular route of administration, administered in Arm Left on 08Feb2021 (Batch/Lot Number: EL3247) as DOSE 2,SINGLE for covid-19 immunisation at clinic. Medical history included migraine. There were no concomitant medications. The patient previously took sesame oil and experienced drug hypersensitivity. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19.The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. The patient experienced positive covid-19 test on 29Jul2021. The patient did not received treatment. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 29Jul2021.The outcome of the events were recovering on unspecified date.  Follow-up attempts are completed. No further information is expected.
Fever then thirty scabbed varicella lesions diffusely distributed over body  = atypical varicella
Fever, body aches, Sweats, dizzy, muslce pain, vomit.
Redness, Pain, itching and tingling and slight swelling in the arm below the injection site, along with some other mild symptoms shortly after injection.
According to pt mother, approx. 2 hours after vaccination pt began to have redness at site of injection as well as a fever. Mother states pt had a fever up to 102 at home. Highest temp in the ER was 100.2. Redness on R arm at time of ER eval extended from R shoulder to R elbow. Pt denied pain and itching.
Diarrhea. A second episode occurred at 08:00 PM 9/14/2012.
Extreme dizziness,  severe swelling at inj site, upset stomach, redness, itching
Sore throat and upper respiratory congestion which has worsened to include fever and extreme lethargy over the last five days. I have missed work and spent most of the week in bed.
Patient reported pain in left shoulder and neck about 12 hours after administration. Patient has contacted doctor and reported receiving one steroid shot and will be seen again.
Redness and swelling at injection site radiating to axilla. Heat in tissue involved. Augmentin PO given for 10 days.
Myalgais, paresthesias, facial weakness; atypical Guillian Barre syndrome
c/o coughing spasms, throat tightness, wheezing and blurred vision within 3 hours after vaccine, blurred vision and sore throat continued and eyes started matting.  Patient sent to MD, recieved corticosteroid shot and rx for antihistamines/eye gtts.  Continues to feel "kind of tired" today.
2 days after vaccine started with fevers that lasted for 2-3 days, 2 days after fevers stopped patient developed flat red rash on back and trunk.
Pt vaccinated with DTP experienced Grade 4 apnea/bradycardia spell approx 23 hrs after immunication with significant cyanosis treated w/vigorous stimulation & increase in oxygen.
Pt recvd vax & 1 hrs later was feverish; 3 hrs later exp fever, petechiae & was lethargic; hospitalized for 1 noc; treated @ hosp w/DPh & Solu-Medrol;
Severe chest  pain waking me up from sleep on 10/7/2021 at 3 am. Pain was behind the sternum area/ felt like "gas pain" in esophagus - almost like excessive gas but unable to burp. It did hurt swallowing liquids and solid. resolved spontaneously after 24v hours. Severe generalized itchy rash on 10/8/2021:  the rash involved my back, Lips/face, legs and arms. I do have chronic urticaria usually well controlled by antihistamines but this rash was very acute and way more severe - something that I have NEVER encountered before. I went directly to the ED for that and received steroid therapy.
Hospitalization for primarily bilateral lower extremity weakness and also COVID-19 symptoms on dates 11/11/22- 11/16/22. Treated with dexamethasone, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Itchy hives which turned red,; Local reaction was 20cm longer in size; Headache; Tired and slept the whole day; slept the whole day; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept the whole day), URTICARIA (Itchy hives which turned red,), URTICARIA (Local reaction was 20cm longer in size), HEADACHE (Headache) and FATIGUE (Tired and slept the whole day) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced SOMNOLENCE (slept the whole day), HEADACHE (Headache) and FATIGUE (Tired and slept the whole day). On 20-Apr-2021, the patient experienced URTICARIA (Itchy hives which turned red,) and URTICARIA (Local reaction was 20cm longer in size). On 16-Apr-2021, SOMNOLENCE (slept the whole day), HEADACHE (Headache) and FATIGUE (Tired and slept the whole day) had resolved. On 27-Apr-2021, URTICARIA (Itchy hives which turned red,) outcome was unknown and URTICARIA (Local reaction was 20cm longer in size) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Took Levocetirizine and applied topical hydrocortisone
Jan 11th around 2100 the site injection became really itchy. Jan 12th at 0630 site injection was red, warm and very itchy. Got hydrocortisone to put over injection site to stop the itchiness. Jan 13th at 0730 the red area on arm was much larger, size of palm, swollen, warm and itchy.
Patient received vaccine with no complications... then about 15 minutes later, he began to develop dizziness, high blood pressure, sweating
fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and CHILLS (chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). At the time of the report, PYREXIA (fever) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-079277, US-MODERNATX, INC.-MOD-2021-079444 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079277:Sister's case US-MODERNATX, INC.-MOD-2021-079444:First Dose
Patient reported shortness of breath and dizziness following first dose of Pfizer vaccine.  Patient was answering pharmacist's questions regarding symptoms of the reaction and other health status questions when she reported an increase of tightening in throat, difficulty speaking and breathing  that resulted in the use of  0.3mg epinephrine pen IM injection to right thigh at 12:45 pm. by pharmacist.  EMS was called to the pharmacy as a precaution immediately following the administration of epinephrine.  The epinephrine did quickly resolved the symptoms of airway restriction and patient was able to breath full and speak afterwards.  Patient was advised that reaction may return as epinephrine wore off and agreed to let EMS take her to hospital at  1:08 pm.
patient called pharmacy 05/21 stated  after recieved the shot,on next day her under arm and shoulder swelling,cause discomfort so she took advil then 3 days ago which 05/18 her neck swelling while her arm and shoulder feel a bit relief. she only use ice pack and take advil
26JAN93 when pt awoke mom noticed the face of the pt appeared red & blistered then hives appears & would recede & reappear for 2 days; no fever sl lethargy; was given APAP;
Lump on the roof of mouth. Lump appeared about 2.5 days after initial vaccine.  Lump is small, maybe 1/8 inch in diameter.  Lump is smooth.  So far lump hasn't become larger or smaller.  It isn't painful.  I have never had a lump on the roof of my mouth before.