chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A physician reported the occurrence of bilateral knee swelling in a 17 year old male who was vaccinated with Lyme disease vaccine recombinant OsaP (Lymerix) for prophylaxis.  The subject's medical history, concurrent conditions and concurrent medications were unknown.  In early 2002, the subject received two injections of Lymerix.  In approximately May 2002, the subject experienced a "transient" episode of knee swelling, which resolved.  "Recently", on an unspecified date, the subject presented to the physician with swelling of the other knee.  Synovial fluid was aspirated; it showed "lots of positive IgG bands".  As of 03/03/03, the event persisted.
Severe itching on arms, back, head (not the face); This is a spontaneous report received from a contactable consumer, the patient. A 72-year-old non- pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; batch no: En6199 Dose number: 1) via unspecified route of administration in the right arm on 09Mar2021 09:00hours as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccination. The patients concomitant medication included 70/30 insulin, lisinopril (MANUFACTURER UNKNOWN), low-dose asprin (MANUFACTURER UNKNOWN), flonase (MANUFACTURER UNKNOWN) taken for unknown indication from an unknown date. Medical history included diabetes, bronchitis/COPD, arthritis. The patient had allergies to penicillin, morphine, fentadoyl, iodine/shellfish. On 09Mar2021 at 11:00 hours, the patient experienced severe itching on arms, back, head (not the face). Therapeutic measures were taken for the events with Certazine (Zyrtec). The clinical outcome of the event severe itching on arms, back, head (not the face) were reported as recovered on an unknown date at the time of this report.  No follow-up attempts possible. No further information expected.
01/24/2021 - vertigo++ , bedrest all day 01/25/2021 -vertigo+, bedrest all day 02/01/2021- continued dizziness, headaches. tinnitus, right earache Urgent Care visit, COVID rapid test - negative, dx - viral infection unspecified 02/02/2021 - Family physician visit. Prescribed Meclizine 02/15/2021 - continued dizziness, headaches, tinnitus, right earache. Urgent Care visit. DX - otitis media RX - Augmentin 2x per day for 10 days 02/18/2021 - continued dizziness, headaches, tinnitus, right earache. SARS-COV-2 RNA, QL, RT PCR test - NEGATIVE 03/01/2021 - continued dizziness, headaches, tinnitus, right earache. Family physician visit. RX - Allegra. MRI/MRA with/without contrast ordered 03/10/2021 - continued dizziness, headaches, tinnitus, right earache. MRI/MRA with/without contrast performed.  03/17/2021 - continued dizziness, headaches, tinnitus, right earache. Visit with ENT specialist. Hearing and balance tests normal. VNG test ordered. 04/06/2021 - continued dizziness, headaches, tinnitus, right earache. VNG test performed - Normal results 04/13/2021 - continued dizziness, headaches, tinnitus, right earache. Visit with family physician. ESR test ordered. 04/19/2021 - ESR test performed. Results normal
fatigue; swelling at the injection site; injection site soreness; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE PAIN (injection site soreness) and VACCINATION SITE ERYTHEMA (Injection site redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced FATIGUE (fatigue), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE PAIN (injection site soreness) and VACCINATION SITE ERYTHEMA (Injection site redness). On 26-Jan-2021, FATIGUE (fatigue), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE PAIN (injection site soreness) and VACCINATION SITE ERYTHEMA (Injection site redness) had resolved. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Rash on stomach, leg, arm. Very short feeling in throat. Have esophagus issues so do not know if that was from that. Do not think so. Rash has come and gone over few days.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 04-SEP-2015, the patient was vaccinated with an improperly stored PNEUMOVAX 23 10 PK, lot # L002310, expiration date 08-JUL-2016, at a dose of 0.5 ml, (route and anatomical location of administration were unspecified). The vaccine underwent a total temperature excursion, of 240 hours. The lowest recorded temperature was 27 Fahrenheit degrees (-2.777777778 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
102 Fever, chills, headache, vomiting, sore arm, fatigue with 2nd and 3rd dose. Onset 10-12 hours after shot. Lasting 24-36 hours after onset.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, Poor sleep, Chills Narrative: Developed arthralgias/myalgias day of 2nd dose (1/29/21), which lasted x 2 days. On 1/31/21 developed headache which lasted several days. Noted nausea/vomiting on 2/2/21. Fever and chills through 2/3/21. Missed work x 3 days. No prior known COVID infection.
BODY ACHE FELT MOSTLY ON KNEES, PELVIS AND HIPS; NAUSEA; INJECTION SITE PAIN; FEELING VERY TIRED; This spontaneous report received from a patient concerned a female. The patient's height, and weight were not reported. The patient's past medical history included anxiety, and concurrent conditions included bactrim allergy, alcohol use, and non-smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage.  The patient was previously treated with lorazepam for anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21A or batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced body ache felt mostly on knees, pelvis and hips. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced injection site pain. On 10-APR-2021, the subject experienced feeling very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and feeling very tired on APR-2021, and was recovering from body ache felt mostly on knees, pelvis and hips, and injection site pain. This report was non-serious.
TUESDAY NIGHT, NIGHT OF INJECTION, ANXIOUSNESS. NEXT DAY  IRRATIBILTIY, HIGH GLUCOSE READING IN AM , SORE SWOLLEN ARM (INJECTION SITE). LATE AFTERNOON DAY 2, SEVERE PAIN HANDS AND FEET, ESPECIALLY TOES AND FINGERS, VERY TIRED, AND INCREASE IN APPETITE AND JOINT PAIN. DAY 3 ALL DAY 2 EXCEPT GLUCOSE  AM WAS BACK TO NORMAL, BUT ARM MORE SORE , SWOLLEN AND RED AND NOW HOT TO TOUCH. THESE SYMPTOMS  CONTINUED UNTIL THE FOLLOWING SUNDAY. THE ARM CONTINUED TO BE SORE, RED AND SWOLLEN.  TODAY, 2/23/2021, IS 3 WEEKS SINCE I WAS VACCNATED. MY ARM IS STILL SORE BUT I HAVE A LARGE SPOT ON MY UPPER ARM, INJECTION SITE, WHICH IS STILL SWOLLEN, RED AND HOT TO TOUCH BUT ALSO VERY ITCHY. CAN I HAVE SHOT #2?
Patient was admitted to hospital with confusion and hallucinations 3 days after receiving her 2nd dose of Moderna COVID-19 vaccine. Patient had been hospitalized at a different facility after receiving her first dose.
maternal exposure during pregnancy with no adverse event; Initial information received on 09-Sep-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 30 years old female patient who was exposed to vaccine QUADRIVAL A-B VACCINE [FLUZONE QIV] in context of maternal exposure during pregnancy with no adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported maternal exposure during pregnancy with no adverse event occurred at 22 weeks of pregnancy and the patient was exposed to QUADRIVAL A-B VACCINE at 22 weeks of pregnancy, during second pregnancy trimester for QUADRIVAL A-B VACCINE.  The date of last menstrual period was reported as 08-Apr-2022. The estimated due date is 22-Jan-2023. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. The patient previous pregnancy was not reported.    On 08-Sep-2022, the patient received a dose 1 of suspect QUADRIVAL A-B VACCINE suspension for injection at an unknown dose (lot UT7682KA, expiry date: not reported) via intramuscular route in unknown administration site for immunisation.  On 08-Sep-2022 the patient had maternal exposure during pregnancy with no adverse event (exposure during pregnancy) same day latency following the administration of QUADRIVAL A-B VACCINE.  Relevant prenatal testing after exposure was not reported.  Action taken: Not applicable.  Outcome: Unknown for the event maternal exposure during pregnancy with no adverse event. Additionally, at time of reporting, the pregnancy is still ongoing.
Had nap after shots, then intractible vomiting until Benadryl given. No perfusion, angioedema or respiratory/wheezing problems.
COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient not had any drug allergy.  The patient's past medical history included Factor V Leiden mutation.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 23-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Negative. On 27-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported.  It was reported that the COVID antigen test was negative by day 5 and symptoms resolved. Symptoms recurred 5 days later on 27-May-2022, increasing in severity, and strong positive antigen test recorded 3 days later.  No Treatment medication reported.  Company comment: This spontaneous case concerns a 40-year-old female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 19-May to 23-May. Symptoms resolved after 5 days of treatment with Paxlovid, and patient tested negative for COVID 19. Symptoms recurred 5 days later with increased severity. Patient again tested positive 3 days later. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 40-year-old female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 19-May to 23-May. Symptoms resolved after 5 days of treatment with Paxlovid, and patient tested negative for COVID 19. Symptoms recurred 5 days later with increased severity. Patient again tested positive 3 days later. The benefit-risk relationship of mRNA-1273 is not affected by this report.
PATIENT HAD A 2 INCH DIAMETER HARD NODULE AT THE INJECTION SITE ON 10/16/10. ON 10/19/10 PATIENT SAYS SWELLING HAS GONE DOWN.
Patient stated after receiving the vaccine she got really sick. Patient stated she had a fever of ~103 degrees F and had a terrible migraine for several days. She stated she was almost hospitalized due to her severe reaction.
She got her vaccine at 10:00 AM, and she had probably about 9:00 PM she was really cold, and had shivers.  Her teeth were chattering.  This lasted about 1 1/2 - 2 hours.  By the time she went to bed last night she was fine.  She was cold during the night and then woke up this morning and is fine.
Shot given at work. I usually have mild tendinitis around my right hip, but the day after the shot, it turned into full-blown crippling pain. Made it impossible to sleep in bed and difficult to drive. The side of my hip was not swollen, but extremely tender and tight. (shot was administered in arm) I have been limping for a week now, and am seeing an Orthopedic doctor tomorrow.
Continued pain at injection site as well as numbness and a cold sensation that runs from point of injection to fingertips, as well as arthritic like pain in left wrist and joints of each finger.
Two hours after receiving vaccine, I experienced sudden onset extremely painful throat, swollen gooey uvula, followed by hives on face, neck, chest, and underarms, moderately swollen lips and eye areas. I took Benadryl 1/2 hour after onset, eventually resolving hives and face swelling. 25 hours later, I'm still experiencing the painful throat/swollen uvula issue. Appetite is fine, though swallowing is painful. Injection sight became painful 18-20 hours after vaccination.
Woke up at 3am with bad chills and headache. Took temperature and it was 100.0 degrees F. Drank water and took 500mg of Tylenol and eventually went back to sleep around 5:30am. Continued to drink water when I woke up again around 8am. Took 1g of Tylenol around 9am. Continued to experience symptoms, including sore injection site, throughout the day although the Tylenol mildly helped alleviate symptoms. Experienced mild headache the following morning (2/10) but it went away after a couple of hours. No chills or fever on 2/10 but continued to have sore injection site through 2/11.
Per receptionist:  He had his booster shot on Friday and he feels achy and has a cough. He would like to speak to a nurse about the side effects he is having.  COVID+ results on 12/7/21; Monoclonal antibody infusion given on 12/10.  Per Provider: 79yr old male here with complaints of cough and congestion since two days ago, Sunday. Has been achy. Booster on Friday.  Took Tylenol 3 days ago for achey shoulder, and yesterday afternoon, nothing for cough
At 1:15AM on July 15, I woke up with high blood pressure with a high heart rate. My doctor told me I had Atrial fibrillation.
Patient was given her 1st dose of the Moderna vaccine from a vial that had been taken out the day before and was past the 12 hour expiration mark. The expired vial has been separated from the new vial prior to being administered to the patient. Patient was immediately informed of this as soon as it was discovered that the wrong vial had been used. Patient stayed in the waiting room for 20 minutes and no adverse reaction occured. We have contacted the manufacturer for further information regarding the stability of the vaccine
fever, aches, chills about 7-8 hours after the shot. Lasted about 10 hours, and then a weakened level for another 12
Patient was given 720 units of HAVRIX (pediatric dose) and had to be given an additional shot of 720 units (same day) to give correct dose.
compromised with severe respiratory problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The reporter stated that he is calling on behalf of his son who took the Pfizer primary series and one booster shot. The caller said that his son was disabled, and he is compromised with severe respiratory problems. The caller is asking where his son can get the new variant vaccine. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt states  felt vision get dark and hard to hear and slumped over in chair slowly going down to floor.  Partner said she hit her head at temple on left side .  Pt taken to triage to be assessed by MDs and EMTs. Pt reports she has not eaten or had anything to drink today.  Provided PO hydration.  Pt DC home at 1300 in stable condition and has recovered.
a few hours after getting vaccinated, I got a HUGE migraine headache, nausea and later a rash on my face. I couldn't lay down, had to keep my head elevated. It last almost two day. I felt brain fog for 4-5 days.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 02-JUN-2017, the patient was vaccinated with PROQUAD lot # reported as  M019232 and expiration date 17-OCT-2017 for prophylaxis. There was no adverse effect reported. Administered dose of VARIVAX experienced the temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 10 minutes. There was previous temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 10 minutes. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA000408: US-009507513-1707USA000412: US-009507513-1707USA000410: US-009507513-1707USA000411: US-009507513-1707USA000407: US-009507513-1706USA004091.
Pt recv vax on 7/22/97; on 7/23/97 pt exp head cold; as of 7/25/97 pt imp.
Covid arm as described by Dermatology. Red welt, firm, itchy, hot, growing in size (currently size of a baseball) at injection site.
This spontaneous report as received from a public health nurse and refers to a currently 3 month old male patient. There was no information about patient's concurrent conditions, medical history or concomitant medications. Two instances of a temperature excursion took place. The first excursion occurred on an unspecified date in March 2018. Following which, it was reported that approval was provided from the manufacturer for the effected vaccinations to be administered. On 08-MAY-2018, the patient, at an approximated age of 2 months, was vaccinated with improperly stored ROTATEQ orally, lot # N012757 with expiration date of 27-JAN-2019 for prophylaxis. Dosing details were not reported. The first temperature excursion occurred in a range at or above 32 Fahrenheit (°F) degrees to 35°F for 19 hours and 30 minutes. The second excursion occurred on 15-MAY-2018; the details of which were not reported. Following the second temperature excursion, no doses of the ROTATEQ were administered. No adverse effects were reported. A previous temperature excursion was reported to have occurred on an unknown date in a range at or above 32°F to 35°F for 4 hours. A digital data logger was involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1806USA004704: US-009507513-1803USA011860.
Swollen arm (L) with a red rash from injection site to elbow. Prednisone 5 ml QD x 7 days, cephalexin 250/5 3 ml Q8 hrs x 10 days. Prescription loratadine 3 ml QD x 14 days.
This is 1 of a cluster of 2 patients who experienced similar adverse events following vaccination with YF VAX. The event of the second patient was captured in case number 2010-06901. Initial report received from a health care professional on 09 December 2010. A 22-year-old female patient received on 03 December 2010 a left arm subcutaneous injection of YF VAX, lot number UF798AA, a right deltoid intramuscular injection of TYPHIM VI, lot number D1087, and a left deltoid intramuscular injection of Hepatitis A vaccine, GSK lot number AHAVB406AA. The patient had a history of exercise induced asthma and acne. She was allergic to doxycycline, tetracycline and KEFLEX. The patient denied any illness at the time of vaccination. On 04 December 2010, the patient developed swollen lymph nodes and slight swelling of the left side of the lip. The patient took BENADRYL and it had resolved. Now she discovered redness, soreness and itching at the site which has not resolved. The outcome was reported as not resolved. Follow-up information was received 03 January 2011 from a health care professional. TYPHIM VI lot number was confirmed to have been D1087 with expiration date of 13 November 2011. Redness, soreness and itching occurred at the YF site of injection; the left posterior upper arm. The patient had not been seen by a physician and no further treatment was required. The patient had not received any other vaccines within four weeks of the vaccines reported. On 23 December 2010, the nurse called and left a message to check on the patient's status with no reply. No additional information was available at the time of the report. Follow-up information was received 23 February 2011 from a health care professional. According to the reporter, the patient stated that by 11 December 2010, "everything cleared up and fine". Outcome was recovered. Documents held by sender: None.
Patient's symptoms started 05/28. Patient tested positive 05/30 at the primary care physician's office. Patient went to the hospital 06/04 and received monoclonal antibody therapy.
pt. c/o feeling little tightness on her throat.  She is able to swallow.  seems anxious resolving.    Hx - anxiety
One week after second shot, pt developed rashes and bruising and started with no bleeding that wasn't healing. Was told to see the health nurse and was then referred to the ED. Was in hospital for 3 days.  Hospital MR received which revealed a previously healthy and well 28 yr old man who developed loss of taste and nose bleeds following HepB vax (#2) on 3/14/2006. One week later he noted petechial hemorrhages developing and bruising covering his body, beginning on the chest and spreading to the extremities. Emergency room visit revealed a platelet count of 4,000.  He was admitted and started on high dose oral prednisone. Platelet count rose to 16,000 the following day. The patient was discharged in stable condition.  Discharge Diagnosis: 1)Idiopathic thrombocytopenia purpura 2) Renal insufficiency. Records received from hematologist revealing a diagnosis of ITP. Significant drops in platelet count were attributed to stopping prednisone, or missing prednisone doses.  Splenectomy recommended.
1/4/22 admitted to hosp for generalized weakness, body aches, sore throat, SOB, Cough, N/V/D x 2 days; poor oral intake; found to be positive for COVID; currently being worked up for heart transplant list; AKI secondary to hypovolemia/hypotension; suffered cardiac arrest; intubated; revived; pt self extubated and made himself a DNI; pt passed away in the hospital