chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bad rash all over body; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Apr2021 at 08:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Allergies to medications, food, or other products was reported as Not Applicable. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included hydrocodone (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN), tamsulosin (MANUFACTURER UNKNOWN) and metoprolol (MANUFACTURER UNKNOWN), all from unknown dates for unknown indications and unknown if ongoing. The patient previously 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 26Mar2021 at 08:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 09:30, the patient experienced bad rash all over body. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of bad rash all over body. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event bad rash all over body was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Initial report was received from a health care professional on 22 October 2010. A 37 year-old female patient, had received on 19 October 2010 a subcutaneous injection of ADACEL (lot number and site of administration not reported) and a Influenza vaccine (manufacturer, lot number, route and site of administration not reported). On 20 October the patient experienced a two inch by two inch area of redness, warmth and swelling. She also complained of itching and pain. The patient's past medical history, concomitant medications and treatments provided were not reported. No further information was available at the time of the report. The patient's outcome was not recovered. The reporter for this case is the same as for 2010-06136. Documents held by sender: none.
Joint inflammation and pain through the entire body.  Pain, throbbing and spasming of old surgery sites and old injuries.  Burning in knuckles with arthurites.
On the first night at around 11pm started to experience left sided chest/muscle pain. The next day 4/30, I noticed my veins in my hands were bulging and others around noticed as well.  Both hands affected, very uncomfortable and this continued until the 3rd or 4th day and then slowly over the next couple weeks were lessening, still experiencing the swollen veins as of today 5/18/21.   On Day 2 I also started experiencing left upper leg pain as well as the chest pain.  All left sided, even though my shot was in my right arm.
Visited ER as I thought I was having an allergic reaction. Treated with Pepcid, prescribed prednisone and streeted. Visited personal allergy physician 4/9/21. per MD Allergist/Immunologist DXd = systemic immunological vasculitis. Most probably a delayed hyper immune response to my vaccine. Legs, arms and sides covered in innumerable petechial eruptions beginning 6 days post vaccination and 3 days post vaccination side effects (chills, headache nausea) subsided. Eruptions spread consistently for 36 hours and are constant not intermittent. They are hot, painful to the touch, and do not blanch. I?m on 60mgs of prednisone for 5 days (the highest dose given outside a hospital) and then 40 for 5 days and then 20 for 4 days. If I get any mouth nose or eye or interior genital irritation I have to go to the hospital and be admitted for higher dose steroids and constant monitoring. Dr advised  this  will take weeks to resolve and the eruptions will likely fade slowly and possibly peel.
Approximately 10 days after vaccination, fever went to 103 degrees; following this febrile rxn, she started stuttering and lost some of her language skills,  approximately 60% vocabulary.  This lasted about a week and she slowly began to talk again, but with a stutter.  Her stuttering has improved gradually.  Now she stutters about 1-2 times/day.  She forgets her words 1-2 times a week.  per mom, language skills have improved about 80-90%.  In the past, she has had fever up to 102 degrees at approximately 4-5 months of age, but there was no developmental regression then.
Patient is 6 y.o. female with developmental delay, epilepsy (on ketogenic diet and multiple AEDs), neurogenic bladder with suprapubic catheter in place who is admitted to the PICU due to presumed septic shock and altered mental status.    Patient developed URI symptoms on day prior to presentation with subsequent development of fever and emesis today. Mother was concerned for subclinical seizures given that patient was not as active as she normally is, so administered rescue dose of ativan. Due to persistent fever and lethargy, was brought to ED for evaluation.    In the ED she was febrile and tachycardic. Labs obtained and significant for film array positive for human metapneumovirus. Procal elevated to 0.54 and UA with large LE and 46 WBCs, although this is baseline compared to previous urinalyses. Blood pressure trended down over the course of the ED stay, requiring 3 NS boluses without significant improvement. Admitted to the PICU for further monitoring.    Evaluated upon arrival to PICU. Responds appropriately to stimuli, then falls back asleep. Pupils reactive. Extremities warm and well perfused, cap refill 2-3 seconds. Abdomen soft; suprapubic catheter in place; Contractures of extremities present.     Requires admission to the PICU due to hemodynamic instability from presumed shock and possible subclinical seizure activity.    Plan as follows:    Neuro:   - NCC consulted  - Will place EEG  - Ativan bridge while NPO     CV:  - MAP goal > 55   RS: - 2L NC     FEN/GI:  - ketogenic diet  - NS IVFs  - NPO  - monitor glucoses    ID:  - blood and urine cultures pending  - Ceftazidime  Patient is a 6 y.o. 4 m.o. female with complex PMHx including of recurrent epileptic spasms and perinatal interventricular hemorrhage (requring ketogenic diet and multiple antiepileptic medications), intrauterine drug exposure, global developmental delay, G-tube dependence, and suprapubic catheter with recurrent urinary tract infection who presents today with increased lethargy, fever, vomiting x1 day. Per mother, pt was irritable at school, not tolerating feeds, felt warm. Tmax PTA 101, given tylenol/motrin and rescue ativan with single episode emesis shortly thereafter. Pt has been tired and lethargic all day, normally interactive at baseline. Recent increase in Banzel a few weeks ago. Mother denies diarrhea, rash, sick contacts. Pt had covid 5-6 weeks prior, no monoclonal antibody therapy.   In the ED, pt's blood pressure remained low with systolic pressures in the 70s despite 40cc/kg bolus. Film array positive for metaneumovirus; CBC, CXR unremarkable. Procalcitonin 0.54. Neurology consulted, recommending continuous EEG. Admitted to PICU for further management given continued soft blood pressures.   Admitted from: ED   History was provided by the parent and mother.
dizziness; Nausea; weakness; exhaustion; headache; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 43-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Sep2021 14:30 (Lot number: FC3180) at the age of 43 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST; VITAMIN B; VITAMIN C [ASCORBIC ACID]; VITAMIN D; VITAMIN E; ZINC; MAGNESIUM. The following information was reported: DIZZINESS (non-serious) with onset 02Sep2021 23:00, outcome "recovered" (2021), described as "dizziness"; NAUSEA (non-serious) with onset 02Sep2021 23:00, outcome "recovered" (2021), described as "Nausea"; ASTHENIA (non-serious) with onset 02Sep2021 23:00, outcome "recovered" (2021), described as "weakness"; FATIGUE (non-serious) with onset 02Sep2021 23:00, outcome "recovered" (2021), described as "exhaustion"; HEADACHE (non-serious) with onset 02Sep2021 23:00, outcome "recovered" (2021), described as "headache"; PAIN (non-serious) with onset 02Sep2021 23:00, outcome "recovered" (2021), described as "body aches". Therapeutic measures were not taken as a result of dizziness, nausea, asthenia, fatigue, headache, pain.  Additional Information: The patient had no known allergies. Other medical history included asthma. She did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Other medications the patient received within 2 weeks of vaccination: Montelukast, vitamin B, C, D, E, zinc, magnesium. No treatment received for adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Patient developed pruritic maculopapular eruption first on legs then back and torso 7 hours after receipt of Fluzone vaccine.  Diagnosed by dermatologist as erythema multiforme, treated with high-dose prednisone over 2 weeks, with good response and no recurrence.
Pt received VARICELLA vaccine in R arm on 1-4-12 and mother called on 1-5-12 to report site is swollen, red, and painful to touch. PC to pt's mother 1-1-12 & mother reports pain & edema to Rt upper arm resolved.
Patient fainted about 5-10 minutes post injection. I'm unaware of her symptoms leading up to the syncope.
Patient received a booster dose of Modera COVID-19 vaccine on December 13, 2021. He did not disclose on his consent form that he had received monoclonal antibodies. After confirming with the provider, he did receive monoclonal antibodies on October 28th. 90 days had not lapsed since his monoclonal antibody infusion at time of vaccination.
3 days prior to receiving his covid 19 vaccine, the pt had a sedated bronchoscopy at hospital. At the time, no lung tissue samples were taken due to no symptoms of rejection. Within a few days to a week of receiving his covid 19 vaccine, he started experiencing shortness of breath, returned to the transplant doctor at hospital and was diagnosed with rejection.   The timeline suggest to me that this could have been induced by the vaccine. I requested that  the transplant coordinator make the report, but she said the rejection had nothing to do with the vaccine.   Hospital is currently doing a study concerning rejection post covid vaccine in transplant patients.   I want the accurate information reported
I was sick the following day--fever, chills, headache, and site soreness. Day three, same symptoms but better. Day four, fever and chills are gone, but injection site is bruised, swollen, red, and very warm. There is tingling and numbness in the hand of the arm where the injection was administered. I am a teacher & my school nurse said I should report the reaction.
I got the shot about 1:15 pm on the 26th. It started swelling which i noticed the night i got the shot and was taking off the band-aid on Friday the 26th around 10pm. The band-aid was tight against my arm and the skin was stretching around it. When i woke on the 27th it was red, about 2.5 inches around, firm, sore to the touch, and itchy. Today is the 30th, it is still a little red and itchy but most of the swelling is down.
pt recv vax NOV95 & 12APR96 titers revealed that the pt failed to seroconvert;
16 days p/vax woke up unable to walk-better; then 20 days p/unable to walk again; took to hosp seen by peds orthopedic specialist; r/o hairline fx; decided was capsilitis-inflamation o joint due to MMR; did bone scan & blood tests;
Swollen lymph node on the left side above the collar bone. Nausea. Pain in clavicle and neck.
Patient developed Henoch-Schoenlein Purpura (HSP) on 1/27/22, beginning with myalgia/arthralgias 16 days after receiving his first COVID-19 vaccine. Family denies any recent/previous viral illnesses prior to onset HSP. Pt had appx 5-6 'waves' of HSP (typical course) with no sig renal involvement. Hospitalized overnight once for emesis/dehydration, experienced typical petechiae/purpura, arthralgias, abd pains but otherwise well.
Extreme swelling and redness.  Tender to the touch and slightly warm.  Patient was seen by MD and was diagnosed with local allergic reaction. Patient self-treated with Benadryl and hydrocortisone cream.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Additional Details: Patient felt lightheaded and dizzy after vaccination, nausea and wanted to vomit, slight shaking of arms. She had a light breakfast and was offered orange juice which she drank and felt better after observing her she was going to get a meal after she left pharmacy and was feeling better after observing her for about 30 minutes
Headache (lasting 6 days and counting), fever (101.8), extreme chills, night sweats, muscle ache, fatigue,  pain injection site
First dose: Fatigue- days 2,3; Status Epilepticus day 8 (other triggers suggested as cause). Second doe: 24 hours of EXTREME PAIN in areas of previous chronic pain requiring extra doses of pain medication and equivalent to pain levels experienced immediately after major orthopedic surgery.
had a sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 01-Aug-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient got both the doses and just had a sore arm. Additional supportive information: The follow-up would not possible, as no contact, details were available.; Sender's Comments:  US-GSK-US2022AMR119493:case deletion
Patient is < 12 years old and recieved the Pfizer COVID vaccine.  No adverse events occured while he was waiting his 15 minutes. Discrepancy was noticed after patient left when the orders were being entered into the system
Very slow heart beat; A spontaneous report was received from an 85 year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a very slow heartbeat.   The patient's medical history was not provided.   Concomitant medications were not reported.  On 25-FEB-2021, prior to the onset of the event, the patient received his first of two planned doses of mRNA-1273 (lot number: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On an unspecified date after receiving the mRNA-1273 vaccine, the patient developed a very slow heartbeat. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded.
Patient had a syncope episode followed by a period of decreased breathing and a seizure. Patient was given 0.3 mL EpiPen in right anterior thigh and 2-dose Albuterol 90mg. 911 dispatched. Patient declined transport. Instead, transported by personal vehicle with wife. Was seen at the hospital.
patient received vaccine 5 days past the expiration date/no AE; Initial information was received on 24-Jun-2021 regarding an unsolicited valid non-serious case received from a other health professional via Agency (reference number: 00655566).  This case involves a patient of unknown age and unknown gender who was vaccinated with DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] 5 days past the expiration date (batch number C5638AA and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination (Expired product administered).  The patient's medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  The patient had no adverse events and did well with the vaccine. Where could find the most recent information about whether it should be re-administered since the vaccine was expired? It had been stored properly and no other issues with the administration.  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.
Observation Nurse ,RN, at 12:05 pm patient came to observation area, got her 1st dose of covid vaccine at 12:00 pm,At 12:05 pm  patient reported tingling in her right hand, advised her to move her fingers and hand, as per patient her tingling subsided after finger movements.She was stable but at 12:18 pm patient complained numbness in her legs and wanted to stand.Nurse instructed patient to open her car door and sit on the side, patient complained dizziness.At 12:23pm nurse administer Oxygen at 15 ltrs. Patients oxygen sat was 99% after Oxygen administration.At 12:34 pm patient said she is feeling much better, patient did stand close to the car door.Took off her oxygen at 12:38 pm.At 12:42 pm patient insisted to leave observation area, instructed her in self monitoring and to report in worsening s/sx to MD and ER.Patient reported understanding and was able to move all her extremities without any tingling and numbness.Patient drove home by herself.
Moderna Covid-19 Vaccine as their 1st dose & Pfizer as their 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Moderna Covid-19 Vaccine as their 1st dose & Pfizer as their 2nd dose) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jun-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 13-Jun-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Moderna Covid-19 Vaccine as their 1st dose & Pfizer as their 2nd dose). On 13-Jun-2021, INTERCHANGE OF VACCINE PRODUCTS (Moderna Covid-19 Vaccine as their 1st dose & Pfizer as their 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
10Jul90 pt vax;  20Jul90 devel tooth abscess.  Tx w/ Bactrim-DS.
The patient received the vaccination at 1212pm and did not complain or show any signs of distress. He then waited in the room as his wife received her vaccinated approximately 3 minutes later. The patient sat upright in the chair and did not display any signs of a reaction. He talked and joked while his wife received her vaccination and while I filled out their vaccination cards. He exited the exam room walking and talking with his wife around 1219. He and his wife walked about 10 feet from the clinic when the wife called out for help. The patient was found extremely diaphoretic, confused, weak and very anxious. He then stated that he could not see and that everything was black. EMS was called and it was discovered his heart rate was elevated at 200 and his blood pressure was low at 100/90. The wife did state that he has a fear of needles but stated that he would normally pass out at the sight of the need, not minutes after the administration. The patient was taken from the clinic via EMS services.
It is believed that the patient was given a 0.3 ml dose of vaccine that was not reconstituted on Friday Oct 1, 2021. On Saturday Oct 2, patient complaint of fever off and on up to 102.1, nausea, vomiting, weakness, decreased appetite.
Complaint of dizziness. Denies shortness of breath, chest pain, difficulty breathing and pain. No blurred vision. Patient did not eat or take prescribed medications prior to vaccination. Patient alert and oriented x3. Vitals: BP 120/78, T 97.9, P 89, R 18, O2 95%.  Vitals prior to discharge BP 122/80, T 97.4, P 91, R 20, O2 95%. Patient discharged from clinic.
work on Scleroderma; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Scleroderma" (ongoing), notes: I say reversed my chronic condition which presumably is Scleroderma. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization.  The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "work on Scleroderma". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated that since started getting COVID vaccine shots, it improved. The patient said reversed chronic condition which presumably was Scleroderma. Other part of the patient protocol was Neem. Getting a booster every few weeks together with caps/oil seem remarkably appear to actually work on Scleroderma, which was a nasty incurable condition. The patient wanted to share this in case you want to explore new applications for your mRNA products. In terms of bloodwork I have antibodies.   Follow-up attempts are completed. No further information is expected.