chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Knee operation; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4103863-00.  A 66 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single and intramuscular, administration date May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: KNEE OPERATION (medically significant) with onset Sep2021, outcome "recovering", described as "Knee operation". The action taken for adalimumab was unknown.  Clinical Course: In Sep2021, the patient experienced LEFT KNEE SURGERY. PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN) was also considered suspect. In Sep2021, the patient had left knee surgery and reason was unknown why she had the surgery. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In Apr2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer BioNTech. In May2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer BioNTech.  Causality for HUMIRA(ADALIMUMAB) -The reporter's causality for the event(s) of LEFT KNEE SURGERY was not provided. A regulatory authority opinion is that there is no reasonable possibility that the event of LEFT KNEE SURGERY is related to HUMIRA(ADALIMUMAB).   The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on underlying elderly age and Underlying history of Rheumatoid Arthritis a possible causal association between the event Knee operation was considered unrelated to the suspect BNT162B2 .
48 hours after injection developed micro-hemorrhages in her right eye.  Symptoms resolved and 12/29 recurrence of bleeding to right eye slightly worse than before.
Evening of April 30 after second vaccination, had a rapid continual heart beat along with shortness of breath and an excruciating headache.  The headache continued through 2 o'clock on May 1.  It resolved finally with some Tylenol. The rapid heart rate and shortness of breath continued with exertion along with some mild chest pain. This all continued for a couple of months until I began acupuncture treatments. I did not seek medical treatment.  I had a physical a few months ago and let my doctor know, Dr. He ran a cardiac enzyme blood test on me that came back within normal limits.  I am doing better now, but I occasionally do have a strange sensation in my chest after exertion at times since then.  Not sure if that could be the mitral valve regurgitation getting worse, but I had not had that sensation ever before my second vaccination.
Whole body, bright red, warm, itching-breaking out of hives, legs starting to swell-given Benadryl 25 mg po qd sent to hospital ER admit time 4:00-called office with complaints 5:45 (approx. vac time 4:30-4:45)
On 6-23-09 received Hep A and MCV-4 in L arm and HPV in R arm. Overnight pain and redness @ injection site. Increased pain and redness on 6-24-09.
Information has been received from a physician concerning a 22-week-old male who on 06-NOV-2007 was vaccinated with the first dose of Rotateq.  The patient was seen in the physician's office.  Additional information has been requested.
Woke up on June 11th morning with stiffness and mild swelling right knee, an hour later left knee stiff and swollen , as the day progressed wrists and  fingers stiffness, discomfort and swelling. this was worst on 6/11 and 6/12. called employee health and left a message to report event. Knees were fine by 6/15, continued mild stiffness and mild swelling fingers Rt hand >left. This has almost resolved very with some mild stiffness and discomfort IP joints , no swelling any longer.
08/11/2022 09:35:01 AM >Patient reports the following:  -yesterday (8/10/22) received  Monkeypox (JYNNEOS) 0.5 mL  -side effects noticed immediately after receiving injection  -c/o of the following: major swelling on posterior Left arm; hot to the touch; painfull; erythema; left pinky and ring fingers are numb since this AM -patient declines SOB and any other concerning s/s at this time -patient is not administering OTC pain medications, does not have thermometer at home to check today's temp -RN verbalized patient can apply cool compress, continue to monitor s/s, if worsening patient to be seen promptly, and educated upon most common side effects  Pictures attached to OV 8/10/22 for PCP to review and advise. 08/11/2022 04:44:15 PM > appreciate above and agree with your recommendations: cold compresses, Tylenol and/or NSAIDs. Please report to VAERS  and FU with pt tomorrow on symptoms. 08/12/2022 04:50:42 PM > patient reports the following is still occurring of Left upper extremity post 1st MonkeyPox vaccine:  -pain is 4/10  -edema below the left deltoid has decreased -erythema is still present; this has not increased -declines fever, chills at this time -still c/o numbness/tingling of left pinky and ring finger  plan: patient will continue to monitor s/s, TV with PCP on 8/19/22 to f/u on s/s.   RN submitted VERAS report
Head ace the next day could not work, had to go home. Felt like my head had a lot of pressure. Body was aching really bad and my legs were also in pain. Got home and just took a nap, but felt like if I was not all there. Head was hurting so I took Advil every 8hrs on Friday. Saturday was better and head pressure went down, but most of Saturday I was recovering
Vaccination site rash/red raised itchy tender rash; Cramps of upper extremities/muscle spasms in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Vaccination site rash/red raised itchy tender rash) and MUSCLE SPASMS (Cramps of upper extremities/muscle spasms in the arm) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa (Hidradenitis suppurativa symptoms).   On 19-Jun-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 80 milligram. On 03-Jul-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On 17-Jul-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. In December 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2021, the patient experienced VACCINATION SITE RASH (Vaccination site rash/red raised itchy tender rash) and MUSCLE SPASMS (Cramps of upper extremities/muscle spasms in the arm). At the time of the report, VACCINATION SITE RASH (Vaccination site rash/red raised itchy tender rash) had not resolved and MUSCLE SPASMS (Cramps of upper extremities/muscle spasms in the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
I got a rash of raised red bumps that were itchy on my right inner forearm, about 30. I first applied hydrocortisone anti-itch cream. Then, switched two neosporin. After five days, became pimple like and are smaller in size and starting to dry. This is the first day it has started to heal. no itching
Early November continual respiratory issues. 2017 pleural effusion. January 2018. Gastroparesis.  Feeding tube 3 moths. April 2018. Possible POTS or mast cell disease. Continued histamine reactions. On azythromyzin for stomachmotility and daily iv fluid and Iv benedryl.
Fever 101.2, shivering, headache, nausea, weak, total body aching.
developed a rash that looked like shingles; ache on the left side of my buttocks; Headache; Bodyaches; chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL PAIN (ache on the left side of my buttocks), RASH (developed a rash that looked like shingles), MYALGIA (Bodyaches), CHILLS (chills) and HEADACHE (Headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included MULTIVITAMIN [VITAMINS NOS] and VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]) for an unknown indication.    On 21-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced MYALGIA (Bodyaches) and CHILLS (chills). On 22-Jan-2021, the patient experienced HEADACHE (Headache). On 24-Jan-2021, the patient experienced MUSCULOSKELETAL PAIN (ache on the left side of my buttocks). On 29-Jan-2021, the patient experienced RASH (developed a rash that looked like shingles). At the time of the report, MUSCULOSKELETAL PAIN (ache on the left side of my buttocks), RASH (developed a rash that looked like shingles), MYALGIA (Bodyaches), CHILLS (chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was provided.
PATIENT WAS SUPPOSED TO GET THE PEDIATRIC DOSE WHICH WE DON'T CARRY AND ADULT DOSE WAS GIVEN. i MONITORED PATIENT AND SHE WAS OK.  MOTHER SAID PATIENT WAS OK ALSO. SHE WILL GET HER SECOND SHOT AT A STORE WITH THE PEDIATRIC VACCINE.  IT'S A COMPUTER GLITCH THAT ALLOWED HER TO BOOK AT OUR STORE.  I WILL FOLLOW UP WITH PATIENT.
Sxs 10 minutes post vax with nausea, lightheadedness, flushed.  Taken to ED from vax site. Given IVF, Zofran inj.
Pt came in 12/1/20 and stated since the vaccine her hands have been peeling
Presented to hospital with abdomen distention, and UTI. Pt treated with antibiotic. Pt discharged to HCF.
Pt rode the bus from one place to the school where her mother works. Mom thought she look well. Complained of a headache and stomach ache. Mom drove home and took pt's temp it was 102 degrees F. Took her to after hours care. Had a swollen throat and red ears. Was given a Z-pack and told it was a reaction to the live vaccine.
No known adverse effects; received dose of improperly stored Varivax and MMR II; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 05-AUG-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot number S015464 was verified to be valid, expiration date reported and established as 20-MAY-2020 (dose, route of administration and anatomical location were not provided) for prophylaxis. On the same day, the patient was also vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot number S013536 was verified to be valid, expiration date reported and established as 02-MAY-2020 (dose, route of administration and anatomical location were not provided) for prophylaxis.  The administered doses of vaccines experienced a temperature excursion of -14.3 Celsius degrees for 3 hours and 45 minutes. There was no previous temperature excursions. Digital Data Logger was involved.   The patient did not experience any additional adverse reactions.
Information has been received from a registered nurse concerning a 36 year old female who on 01/31/2001 was vaccinated with one dose of varicella virus vaccine live. On 05/21/2001, the pt learned that she was approximately 6 weeks pregnant. Follow-up information indicated that the pt was tested for varicella antibodies prior to vaccination with varicella virus vaccine live. The pt's prior pregnancies all resulted in full term births with no birth defects. The pt did not experience a local reaction at the vaccination site or varicella or herpes zoster symptoms post vaccination. On 12/27/2001 at 40 weeks gestation she gave birth to a male. His birth weight was 8 lb. 4 oz. He was born with an accessory digit attached to his left pinky. There were no complications during pregnancy, labor/delivery. An ultrasound was done during the pregnancy but the results were not reported. A maternal serum alpha fetal protein test on 07/19/2001 was negative x 3. There were no illnesses or infections during the pregnancy and not concurrent medical conditions or concomitant medications. Follow up information received from the pediatrician's office manager who reported that the infant's medical record notes that aside from the notation of the supernumerary digit, the baby appears to be healthy and normal. The ligation procedure took place in the hospital prior to the newborn's discharge and was not well documented in the pediatric record. A biopsy was done on the tissue from the left digit skin tag. The digit was described as small, pink, nodular tissue measuring 0.7cm overall. Microscopic examination of the tissue sections showed skin and subcutaneous tissue with cartilage and focal ossification. The diagnosis was Digit from left hand. Excision consistent with accessory digit. Follow up information received on 11/11/02 stated that the mother was a gravide 6 para 5 who following an 8 hour and 29 minute labor and artificial rupture of membranes with clear fluid, had a vaginal delivery of a boy with 8/9 Apgar's. The infant's birth weight was 8lbs 4ozs and length of 20 inches. On 12/27/01, the infant had a ligation and excision of a supernumerary digit on the left hand. At the same time, a Gomco circumcision was performed. Blood loss was estimated as minimal, and the infant was reported to be in good condition with no complications following the procedures. At 2 weeks of age, the infant weighed 8lbs 14ozs, was 21 inches in length, and had a head circumference of 38cm. This case is part of the pregnancy registry. Additional info has been requested.
Itching and swelling at vaccine site 1 day after, resolved 1 day later.
One diluent remained in box with no powder - 4 MENVEO immunizations given that day by 3 different nurses. Research did not provide which dose given incorrectly. All four clients notified to get revaccinated at no cost to client. Future use of meds with diluent will be banded to prevent future errors in their administration.
really sick; due to COVID, / she never received the second dose; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and TETANUS TOXOID (TETANUS VACCINE) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix. In 2019, the patient received TETANUS VACCINE. On an unknown date, less than a year after receiving Shingrix and TETANUS VACCINE and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms, sickness and social problem. On an unknown date, the outcome of the influenza-like symptoms and sickness were recovered/resolved and the outcome of the social problem was unknown.   It was unknown if the reporter considered the influenza-like symptoms and sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose of Shingrix. The patientreceived the Shingrix vaccine in 2019 and experienced a reaction that included flu like symptoms for 24 hours and they were bad, and she was really sick.   The next day she felt like a brand new person and her side effects resolved.   The patient received a tetanus shot on the same day, so she was not certain if her side effects were related to receiving both vaccines on one day. The patient was scheduled to receive the second dose in February 2020, however, due to COVID, and the side effects she experienced, she never received the second dose.   The reporter Consented to follow up.
Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: severe leg pain radiating from waist down her leg-Severe, Systemic: Flushed / Sweating-Mild
Client was given the Pediatric 5-11 age group dose. Patient was 12 years old at the time of the incident and should have gotten the Pfizer 12+ dose.
Pt in Immunizations section, received Anthrax vaccination to R arm and Smallpox vaccination to L arm.  Upon completion of smallpox vaccination pt began to turn pale and had a loss of consciousness x1-2 minutes.  Pt body seized and bilateral upper and lower extremities adducted inward w full body tension.  Pt awoke and took about 2 minutes to regain full orientation to person, place, time and event.  Pt BP's taken beginning at 0958 every 5 minutes as follows: 152/92, 125/79, 118/78, 119/79, 121/73.  Pt blood glucose taken at 1010 found to be 114.  Pt stated no medical issues, pt had surgery to L shoulder in Nov 2012, pt stated allergy to SULFA based medications.  Pt states extreme pain localized to L ankle at 8 out of 10 and spreading from posterior aspect of ankle to foot and upper posterior aspect of calf.  Pt stated last meal at 1830 yesterday, pt did not eat breakfast and did not participate in PT this am.  No other issues at persent, provider OIC saw PT and disposition in process.
Customer reports a child received 0.3 ml of PROQUAD vs the correct 0.5 ml of PROQUAD; Customer reports a child received 0.3 ml of PROQUAD vs the correct 0.5 ml of PROQUAD; This spontaneous report was received from a pharmacist concerning a patient of unspecified age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and historical drug were not provided.  On 24-SEP-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) recombinant human albumin (rHA) 0.3 milliliters (vaccine underdose/Incorrect dose administered) Lot number T013539 and expiration date 17-OCT-2021, for prophylaxis (route of administration, was not provided). The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT).
This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 79-year-old female patient who received SHINGRIX. The patient's past medical history included shingles (occurred in 1980s). Concurrent medical conditions included osteoarthritis, fusion lumbar spine and nerve pain (experienced after shingles, got flare of nerve pain in scapular nerve). Concomitant products included LIPITOR, PLAVIX, amlodipine, gabapentin, Lidocaine, Vitamin D3, CELEBRAX, NEXIUM, Estrogen Gel, Lisinopril, Mag Oxide, Metoprolol and tizanidine. In February 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In February 2018, immediately after receiving SHINGRIX, the patient experienced injection site swelling. In May 2018, the patient experienced nerve pain and condition aggravated. On 22nd May 2018, the patient experienced crying. On an unknown date, the outcome of the nerve pain, condition aggravated and crying were unknown and the outcome of the injection site swelling was recovered/resolved. The reporter considered the nerve pain and condition aggravated to be possibly related to SHINGRIX. The reporter considered the injection site swelling to be related to SHINGRIX. It was unknown if the reporter considered the crying to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left arm. The concomitant product include BIOMED cream. The patient experienced mild flare of the nerve pain which lasted about 2 weeks. Starting about 3 weeks before the reporting date, the patient had almost daily severe flares of nerve pain. The patient started crying because the patient was so bad. The swelling at injection site lasted about 3 days before resolving. The patient had not received the 2nd dose of SHINGRIX, till the time of reporting and was not sure if she should. This case has been linked to the case US2018092509, reported by same reported (wife's case).
Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Coronavirus test: (Positive) tested  positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
3rd dose give - no side effect - vaccine error One dose of Moderna vaccine given from a vial of Moderna vaccine expired on 10/13/2021 but kept in the refrigerator  Lot number 048c21A expired 10/13/2021 - Manufacture expiration date 11/09/2021 - removed from freezer on 09/13/2021 and kept in the refrigerator until 10/18/2021
I had a little soreness in the arm for a couple days. On 06/24/2022 I tested positive for COVID-19 with a home test. I had a telehealth visit with my doctor and she prescribed Paxlovid.  After taking all the Paxlovid two days later I had the symptoms again and tested positive again.
headaches, body aches, low grade fever (100), feeling flushed began 3/29. No neuro signs or symptoms. Over next couple days, body aches became worse and increased pain in left leg. No leg swelling. No bruising or petechiae. Mental fog, extreme fatigue. abdominal/pelvic pain developed 4/4/21
After about 10 min from administration, pt c/o dizziness, and headache with sharp pain to L side of head. GIven apple juice. Transferred to wheel chair. B/P: 162/105. Pulse ox 98, heart rate 93. . Transferred to bed in holding room. Remained dizzy with headache, B/P 155/93. Pulse ox 100%, heart rate 90. Complained of difficult to breathe laying flat. Elevated HOB to 30. Patient states feeling lik eshe could breathe better. Complains of nausea, but taking sips of water.. Pt has history of hypertension with self-reported baseline of 135/90's. Given water, allowed to rest. At 1421, BP 141/93 but remains dizzy, despite dark environment. At 1427. patient verbalizes still dizzy. Verbalizing stomach upset, nausea.  AT 1437, Pt Vomit. B/P 158/105. Report given to ER nurse. Pt transferred to ER at 1450.