chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Trouble sleeping; Hives; Swollen ankle; Vaccination site pain; Break out on the whole body/ broke over the arm; Lesions over the arm; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Trouble sleeping), URTICARIA (Hives), JOINT SWELLING (Swollen ankle), SKIN LESION (Lesions over the arm) and VACCINATION SITE PAIN (Vaccination site pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 049B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack (Three years before had a heart attack.). Previously administered products included for an unreported indication: SHINGRIX. Concurrent medical conditions included Blood pressure management. Concomitant products included AMMONIUM CHLORIDE, CAFFEINE (WATER [AMMONIUM CHLORIDE;CAFFEINE]) and POTASSIUM for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SKIN LESION (Lesions over the arm). On an unknown date, the patient experienced INSOMNIA (Trouble sleeping), URTICARIA (Hives), JOINT SWELLING (Swollen ankle), VACCINATION SITE PAIN (Vaccination site pain) and RASH (Break out on the whole body/ broke over the arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE for Itching, at an unspecified dose and frequency. At the time of the report, INSOMNIA (Trouble sleeping), URTICARIA (Hives), JOINT SWELLING (Swollen ankle), SKIN LESION (Lesions over the arm), VACCINATION SITE PAIN (Vaccination site pain) and RASH (Break out on the whole body/ broke over the arm) outcome was unknown.            The concomitant medications also include blood pressure medications and heart medications.  Treatment also include putting iced bottle and steroids.   This case was linked to MOD-2021-122479 (Patient Link).
Loss of taste; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Loss of taste). At the time of the report, AGEUSIA (Loss of taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
COVID + for 10 days prior to event;  HPI: Fever, weakness; medications: cozar 50mg qd; phenobarbital  64.8mg bid; phenytoin  100mg q 12 h;  hx of htn, cva, dementia, seizure disorder; viral pneuminitis suspected superimposed upon chronic disease; Dx: hypoxia, pneumonia due to COVID-19, hypertension, hyponatremia
The vaccine was expired and given past the 30-day recommendations. No s/s of any adverse event at this time
DTaP, HiB given 4/26/2013. High fever 4/27/13. Febrile seizure early AM 4/28/13. Diagnosed bilateral otitis, Pneumonia.
?fever, red swollen site;nausea onset about 7AUG (delayed) tx w/ice & ASA
This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. the patients' pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # L027076, expiration date: 25-MAY-2017 (strength and dose were not reported) for prophylaxis (incorrect product storage). No adverse effects were reported. The temperature was between >8C - <25C, for a time frame of 5 hours, 30 minutes.  There were no previous temperature excursions. The call was  because of a data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004386: US-009507513-1701USA004701: US-009507513-1701USA004702: US-009507513-1701USA004704.
Initial unsolicited report received from a consumer on 14 October 2015. This case involves a male patient (age not reported) who was vaccinated with a dose of FLUZONE (lot number, route and site of administration, dose in series were not reported) on 13 October 2015 at 13:00 hours. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were not reported. Patient denies of any illness at the time of vaccination. On 13 October 2015, few hours after vaccination, the patient experienced twitching in the evening. Then woke up with severe headache "this am". The patient's Laboratory data was not reported. The patient's corrective treatment was not reported. The outcome of the event was unknown. List of documents held by sender: none.
Tuesday 3/16/21: Woke up with headache and had excruciating pain in both knees and bottoms of both feet. Extreme difficulty in getting out of bed due to the pain. Feet felt like I was walking on nails. My left hand, finger joints and thumb were badly swollen and painful. Pain and swelling persisted in knees, left hand, finger and thumb joints, but bottoms of feet improved. Sunday 3/21/21: Woke up and right wrist, fingers and thumb on right hand extremely swollen and painful. Could not use right hand for two days until the swelling and pain decreased. Headache every morning when I woke until Wednesday 3/24/21.
Report A0372018A describes Lyme disease in a 32 year old female who received Lyme disease vaccine recombinant OspA. This report was received from the vaccinee and has not been verified by a physician or other health care professional. Medical history and concurrent conditions were not specified. Concurrent medications included Synthroid and "Cetemil." The vaccinee reported that she received the third injection of LYMErix was administered in March 2000. In March 2000, post-immunization, the vaccinee experienced fatigue and stiffening in joints and muscles. "Prior to January 2002 but after March 2000," the vaccinee experienced swollen glands. In January 2002, she began to experience headaches, sore throats, and nausea. The vaccinee was seen by a physician. She stated that an unspecified test for Lyme disease was positive on 6/4/02. The physician reportedly made a diagnosis of Lyme disease and prescribed doxycycline. As of 6/18/02, the stiff muscles and joints and fatigue were worse. The swollen glands, nausea, headaches, and sore throats persisted.
Narrative: 63 YO F with PMHx of toxic multinodular goiter, dysphagia, hypothyroidism, iron deficiency anemia, Thalassemia, chest pain, and arthralgia presented to ED after receiving first dose of COVID-19 vaccine. Patient states that ~ 1 hour after getting vaccine, she noticed feeling of chest discomfort and tightness. EMS was called and patient was given 4 baby aspirins and taken to local ED. There she had cardiac workup of chest pain which was negative and discharge home. Patient followed-up with PCP 4 days after incident. At the appt, patient denied chest pain but reported continued fatigue and inability to focus.
Information has been received from a mother concerning her approx 25 month old daughter, who was born with severe reflux disease, who in March 2005, was vaccinated with a dose of varicella virus vaccine live. It was noted that in late March or early April 2006 the pt had undergone fundoplication surgery to correct her constant reflux which had caused esophageal ulcerations. A tube was inserted in order to feed her. The pt was being fed both through the tube and orally, The pt had the feeding tubes replaced on occasion at the hospital. On 7/18/06 the pt was seen in a pediatricians office with a rash on her upper arm. The pediatrician was treating the rash with antibiotics to see if it would clear. The rash did not get any better and was spreading on 7/23/06. The pt was admitted to the hospital with a diagnosis of methicillin resistant staphylococcal aureus and was given IV antibiotics. On 7/24/06, the pts mother was told that her daughter also had a case of shingles, which they said was brought on by the pts vaccination with varicella virus vaccine live. They told her that the virus laid dormant in the pts system and came out as shingles. At the time of the report the pt was still hospitalized. Follow up information from the pts mother indicated that the pt was treated with acyclovir Zovirax for her shingles. The pt was released from the hospital on 7/25/06 and was recovering from methicillin resistant staphylococcal aureus and shingles. At the time of the report, the pt still had remnants of the rash, but was still taking antibiotics. Additional information is not expected.
This case was reported by a nurse via sales rep and described the occurrence of hives in a infant male patient who received FLULAVAL QUADRIVALENT for prophylaxis. Co-suspect products included PEDIARIX for prophylaxis, PEDVAXHIB for prophylaxis, PREVNAR for prophylaxis and ROTATEQ for prophylaxis. On an unknown date, the patient received the 1st dose of FLULAVAL QUADRIVALENT, the 3rd dose of PEDIARIX, PEDVAXHIB at an unknown dose, PREVNAR at an unknown dose and ROTATEQ at an unknown dose. On an unknown date, 6 days after receiving FLULAVAL QUADRIVALENT, PEDIARIX and PEDVAXHIB, the patient experienced hives. The patient was treated with steroids NOS. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to FLULAVAL QUADRIVALENT and PEDIARIX. Additional details were provided as follows: The age at vaccination was not reported. The Healthcare professional (HCP) said that an patient received 6 month vaccines including PEDIARIX, PEDVAX HIB, ROATEQ and FLULAVAL QUADRIVALENT. A 6 days later patient experienced large hives to the face. The HCP planned to give steroid for the hives. It was unknown if the health care professional consider the event(s) to be life threatening. The patient did not admit to the hospital overnight or prolong an existing hospitalization. The event did not result in a congenital anomaly or birth defect. The patient did not patient die. It was unknown if the reporter considered the hives to be related to ROTATEQ and PREVNAR. No problem at second or fourth month visit receiving vaccines.
p/vax pt was taken to MD & sent pt to hosp where pt was adm & given IV; pt ran high fever that broke later in that night
Pt. reported she started experiencing symptoms approximately four hours after receiving the vaccination. Symptoms included wheezing, eyes - burning, itching, redness and swelling, swelling of the throat, fever, and headache. Stated she took Advil and went to bed. Called the Health Department and made the report the next day.
Headache stuffy nose Narrative:  Patient stated he received his Covid vaccination on Monday 1/4/2021. States he has stuffy nose and headache. States he missed work today 1/7/2021.
On 09/17/2022 I was feeling tired and thought it was due to an overactive weekend. The next day I woke up feeling much worse and slept most of the day. I felt like I was running a fever off and on. The worst symptoms were fatigue, off/on fever. 09/22/2022 I began having trouble breathing. Made appointment with PCP. On Monday symptoms were still worsening and I was instructed to go to urgent care. Urgent care ordered x-rays which were negative. I was put on prednisone for 5 days and nebulizer which both made my symptoms. Fatigue persisted another week and then I felt better.
Hoarseness, not moving legs: took to clinic appointment 4pm and saw PA. No treatment ordered except to continue with Tylenol q 4 hours 12:30 AM 11/13/2004  102 degree fever, hoarse, not moving legs, swollen left thigh, took to ER, doctor contacted. No treatment ordered, but continued with Tylenol. 11/13/04 5p, up walking, no fever,hoarse, drinking, no discomfort noted.
An unknown number of improperly stored vaccines were administered; No adverse effect reported; This spontaneous report was received from a nurse an unknown number of patients of unknown age or gender. There was no information about the patients' medical history, drug reactions, allergies, concurrent conditions or concomitant medications to be reported.  It was reported that on unknown dates, the patient received improperly stored vaccines of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PEDVAXHIB), lot numbers: R000877 (expiration date: 24-SEP-2020) and R001086 (expiration date: 25-SEP-2020); Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot number: N025894 (expiration date: 19-SEP-2019) and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot numbers: R013288 (expiration date: 01-DEC-2019), R007152 (expiration date: 25-OCT-2019) and R002517 (expiration date: 19-SEP-2019) (strength, doses and routed not reported) all administered for prophylaxis (product storage error).  The vaccines were stored above 9 degrees Celsius (°C) for a timeframe of 39 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported.  This case is considered non-valid due to the lack of patient identifiers.
Little bit of soreness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Little bit of soreness) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced MYALGIA (Little bit of soreness). At the time of the report, MYALGIA (Little bit of soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Red, swollen, warm to touch, itchy at injection site. Employee was seen by pcp and treated with prednisone.
Lympnode under left arm is swollen.; Some pain; This is a spontaneous report from a contactable consumer. This 72-year-old male consumer reported that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9264) via an unspecified route of administration on 08Feb2021 (at 72-year-old) on left arm as dose 2, single for COVID-19 immunization. The medical history of the patient included penicillin allergy and hypertension. It was mentioned that patient did not receive any other vaccine in four weeks, did not have covid prior vaccination and was not tested for covid post vaccination. The concomitant medications included indapamide, amlodipine and finasteride all taken at unknown dose, start date and stop date unknown) taken for unknown indication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL 3747) via an unspecified route of administration on 17Jan2021 at 01:30 PM (at 72-year-old) on left arm as dose 1, single for COVID-19 immunization. On 11Feb2021 at 06:00 Am the patient noticed swelling and exposed vein and experienced lymphadenopathy and pain. No treatment was received, and patient had not recovered.  Follow-up attempts were completed. No further information was expected.
: Pt received both doses of the pfizer covid vaccine; 23Feb2021 and 22Mar2021 (lot EN6207) and diagnosed with covid on 21May2021; Diagnosed with covid on 21May2021; This is a spontaneous report from a contactable other healthcare profession (HCP). A 64-year-old male patient at the age of 64 years old received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 23Feb2021 (Lot Number: EN6200) as 1st dose, single, dose 2 via an unspecified route of administration on 22Mar2021 (Lot number: EN6207) as 2nd dose, single for covid-19 immunisation.  Medical history included diabetes mellitus (DM), hypertension (HTN), Granulomatosis, rhinitis allergic. Concomitant medications within 2 weeks of vaccination included amlodipine; lisinopril; fexofenadine; metformin; spironolactone; rituximab. The patient previously took allopurinol and experienced drug hypersensitivity (Known allergie-Allopurinol). Patient received both doses of the Pfizer covid vaccine; 23Feb2021 and 22Mar2021 (lot EN6207) and diagnosed with covid on 21May2021. the adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient been undergoing lab tests and procedures which included Rapid PCR: positive on 21May2021 (Nasal Swab). No treatment received for the events. Outcome of the events was unknown. It was reported as non-Seriousness. Seriousness criteria of Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect were all no.   Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, there is reasonable possibility that the reported events Vaccination failure and COVID-19 are related to BNT162B2.
a bit of a sore throat; very achy; upset stomach; low-grade fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (a bit of a sore throat), PAIN (very achy), ABDOMINAL DISCOMFORT (upset stomach) and PYREXIA (low-grade fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for an unknown indication.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced OROPHARYNGEAL PAIN (a bit of a sore throat), PAIN (very achy), ABDOMINAL DISCOMFORT (upset stomach) and PYREXIA (low-grade fever). At the time of the report, OROPHARYNGEAL PAIN (a bit of a sore throat), PAIN (very achy), ABDOMINAL DISCOMFORT (upset stomach) and PYREXIA (low-grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Nov-2021, Body temperature: low (Low) fever.         No treatment details were reported.  She was not a fever person; she did not get fever when she gets the flu.
Erythema, swelling one day of injections on both arms lasting at least 5 days. Mom neglected to tell us this has happened with previous injections.
jerking movements of arms and legs lasting less than 1 min; Patient developed febrile seizure at 12 midnight on 2/7/23.; Dad reports tactile fever/ He continues to have fever at this time; SARS-COV-2 test negative; Respiratory syncytial virus test negative; Influenza virus test negative; This case was retrieved during monitoring on 12-APR-2023. The original narrative from the sender is as follows:  Patient developed febrile seizure at 12 midnight on 2/7/23. Dad reports tactile fever at that time and jerking movements of arms and legs lasting less than 1 min. He was evaluated in the Emergency Dept and no focal source of infection was identified. Dx home with dx of febrile seizure. He continues to have fever at this time.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "dyskinesia, febrile convulsion and pyrexia". Due to the nature of the event the causal relationship between Vaxelis and the events, "Influenza virus test negative, Respiratory syncytial virus test negative and SARS-COV-2 test negative" is not applicable.  No further information is expected.  Duplicate follow-up information was received by the partner from the Reporting System monitoring on 18-APR-2023 and forwarded on 24-APR-2023.   No further information is expected as product was not administered.
Patient says that she started her period on 05/03/2021 and has continued to have a heavy period. She came in to report on 05/15/2021 and her period was still on going.
Fever 100.4, Severe deep cough (Identified as Wheezing on 2/22/16).
lt deltoid area devel cellulitis about 1-2 day p/inject, centered around inject site 20 x 15 cm;
19Jan98 Pt recv 1 dose varicella vax. Concomitant therapy - Tylenol. Pt devel red,raised,itchy rash. "no pocks". One hr of vax. By 20Jan98 rash persisted & Pt afebrile. Pt tx w/ benadryl.
Narrative:  64 year old male with PMH of adenocarcinoma of the lungs, multiple lung nodules, HTN, stenosis of liver, BPH, GERD received second dose of COVID-19 vaccine (Moderna) on 4/8/21. On 4/16/21 he called the hospital with complaint of new upper back pain, cough with yellow mucus. He stated that he initially had a fever the day of the vaccine, but was afebrile that morning. Later the same day he reported to the ER with generalized weakness, cough and pain with breathing. Denied nausea/vomiting. BP: 123/75, HR: 62, RR: 16, Pulse Ox: 99, Temp: 98.1F. Notable labs included Eosinophils 5.5% (up from 3.3% in February) Basophils 1.3% (up from 0.7% in February). ED treatment plan noted that ketorolac injection improved symptoms, however no other documentation to show ketorolac was actually administered, so unclear if this was given. Discharged home same day. Follow up messaging with PC later that month and clinic visit 5/7/21 appears the symptoms resolved.
April 29th. Adverse event-Bells Palsy. Treated for 6 days with steroid(Prednisone) and Valprex. Symptoms- distorted mouth, slurring of words, left eye won't close unless right eye is closed. Left side of face doesn't respond to stimulus.
Child developed a knot 6-7in in diameter in the left thigh 24 hours after vaccination with DTAP.  Diagnosis: Cellulitis by ER staff. She is being treated with Cencef, Tylenol and Keflex.
patient received vaccine on Jan 23, 2021. developed weakness on Jan 25, 2021. Sent to ED on Jan 27, 2021 with hypoxia requiring 6 L O2, low Bp, declining mental status. Per family request transitioned to hospice and passed away on Jan 30, 2021
Patient seen and diagnosed with Varicella  without complications on 3/15/2019. Symptoms included rash, on face , torso, arms, for 1 day.
larger than nl areas of redness & swelling;this is one of three patients from this site who exp the above rxn;
Information has been received from a physician concerning a newborn male patient who's mother was vaccinated on an unspecified date with a first dose of GARDASIL. 09-SEP-2008 the patient's mother was vaccinated with a second dose of GARDASIL. On 21-MAY-2009, the patient experienced fetal tachycardia during labor and delivery. The patient's outcome was unknown. The mother's experience has been captured in WAES # 0810USA04882. Additional information has been requested.
I began to get a sore throat and then runny nose. I then had a cough that was almost uncontrollable for about two weeks. I consulted with a doctor on the boat I was on February 12, 2023. I was prescribed a Z-Pack. The cough persisted another 10 days or so. As of today I feel just fine. I tested negative for COVID-19 two different times, February 10th and 15th.