chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mouth ulcers in various locations along the gum line.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient 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 02Apr2021 at 10:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 10:00, the patient experienced mouth ulcers in various locations along the gum line. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken for the reported events. The clinical outcome of the event mouth ulcers in various locations along the gum line was not resolved at the time of this report. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 23Apr2021 at 10:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This non-valid spontaneous report as received from a pharmacist refers to an unspecified patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 24-DEC-2018, the patient was vaccinated with expired dose of M-M-R II subcutaneously, lot # M042846, expiry date 21-OCT-2018 (dose was not provided) for prophylaxis. The sterile diluent used to reconstitute the vaccine was stored properly. Vaccine was stored in temperature of 47 to 77 Fahrenheit (also reported as 70 Fahrenheit) during one hour. Digital data logger was not involved. There were no previous excursions reported. No adverse effects were reported. This case is non-valid due to no patient identifiers.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 15-DEC-2014 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 30-DEC-2014 the patient was treated at a health center for the onset of severe vesicular rash accompanied by a weakened immune systems, which was diagnosed as severe herpes zoster. As a direct and proximate result of these malfunctions the patient suffered painful injuries and damages and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
headache; muscle ache; chills; joint pain; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 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 following information was reported: HEADACHE (non-serious), outcome "unknown"; MYALGIA (non-serious), outcome "unknown", described as "muscle ache"; CHILLS (non-serious), outcome "unknown"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; FATIGUE (non-serious), outcome "unknown".  Additional information: She got the shot yesterday and woke up with an excruciating headache, muscle aches, chills, fatigue, and joint pain. She wanted to know that how long would it take for side effects to go away and if these were common side effects or should she be concerned. she called regarding the Pfizer Covid vaccine 2023-2024 for adults.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Information has been received from a pharmacist concerning his 15 month old son with no prior medical history or allergies who on 10OCT2003 was vaccinated with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. Concomitant vaccination received on 10OCT2003 included varicella virus vaccine live and influenza virus vaccine. There was no other concomitant medication. On 18OCT2003 the patient developed a rash of small red dots on his back and stomach and a slight fever. The next day, the rash was on his head but the other area were starting to fade, he was afebrile and napping longer than usual. Medical attention was sought and he was treated with Tylenol as needed. Additional information was requested.
Initial misuse report received from a healthcare professional on 01 July 2013. A child patient (No other information was provided regarding the patient) had received ACTHIB component of PENTACEL vaccine which was reconstituted with sterile water and DTAP/IPB was not administered. No adverse event was reported. List of documents held by sender: none.
pt recvd vax & exp sore arm;31OCT94 could not lift rt arm up above waist w/o pain;could hardly walk because knees hurt;migraine h/a,stiffness in hands & knees;poss rheumatoid arthritis;RA factor +;stiffness,pain,swelling multiple joints
pt recvd vax 9FEB94 9AM & 1800 onset of cold sx eve of 9FEB but also c/o redness, heat, swelling @ inject site;
Woke up at 4:30 am with fever, chills, extreme body aches, headache and stomach ache. This continued for 48 hours. My temperature got as high as 100.1 with Tylenol. Symptoms were as strong as when I had Covid. On Monday I finally started to feel better. The entire time I was extremely weak and tired. On Tuesday I finally woke up and felt like myself again
NAUSEA; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. The batch numbers were not reported and have been requested. No concomitant medications were reported.  On 27-AUG-2021, the patient experienced nausea. The action taken with covid-19 vaccine was not applicable. The outcome of nausea was not reported. This report was non-serious. This case, from the same reporter is linked to 20210941047.
Less than 18 years of age received the vaccine.    No adverse effects noted.  Moderna COVID- 19 Vaccine EUA
Varicella admin to (R) arm. Pt stood up and walked short distance, then fainted. We safely guided her to floor, elevated legs, then revived with ammonia smelling salt. Pallor and thready pulse monitored until VSS. PMD & father notified. See VS below: 0850 = 84/50, 60.20(L), 0915 90/40, 60,30 (SH), 0840 = 110/60, 24 (lying) 0900 = 70/40 50 16(sit) 0930 90/45, 56,18 (stand). Father drove home at 0945.
This  5 years old patient came with his father on  the day of 06/25/2022 to receive his 1st dose of Pfizer pediatric vaccine, once registered the infant Pfizer vaccine was administered instead of the pediatric vaccine .
Body aches; She was feeling feverish; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PYREXIA (She was feeling feverish) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020.    On 26-Mar-2021 at 11:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PAIN (Body aches), PYREXIA (She was feeling feverish) and CHILLS (Chills). At the time of the report, PAIN (Body aches), PYREXIA (She was feeling feverish) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported.
One dose at age 12 and second dose at age 16 years; no adverse effect; This spontaneous report as received from a physician refers to a 16 year old adolescent patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.     On unknown dates, the patient was subsequently vaccinated with first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, anatomical location, Lot # and expiry date was not reported) at age 12 years and 16 years for prophylaxis (inappropriate schedule of product administration). The patient had no adverse event. There was no product quality compliant involved.
Patient stated she woke up next day with non-itchy rash on front of torso. Was gone in evening.
I am having an allergic reaction; My face and body are covered in welts; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced allergic reaction and welts. On an unknown date, the outcome of the allergic reaction and welts were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction and welts to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had allergic reaction and face and body were covered in welts. The reporter had to go to the hospital.
began with a fever, and slowly starting having nausea and diarrhea. we could not bring down fever with antibiotics
3/7 430 pm tiredness and foggy brain 3/8 5 am body aches, headache, dizziness 630 am pain in joints, muscles, back, nausea These symptoms lasted until 430 pm on 3/8
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 08-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Next morning after 2nd dose vaccination I had a headache, fever, chills, fatigue, covid arm and muscle aches. 4 days after the injection I had covid toes on my right foot on the pinky toe and top of foot turned purple. Still is purple as of the date of this writing. seeing Primary Care doctor today 4-13-21.
I felt sore and fatigue. One of my lymph node got swollen and sore. So, I went to the doctor. They did physical exam and knew right away that my lymph node was swollen.
Left and right thigh rash appear on both thighs around injection site five minutes after injections were given.  Patient referred to doctor.  Grandmother came with patient.  Telephone call to father notified of rash and ask to have MD check rash.
pt recv vax 26APR96 & 2MAY96 pt exp 8 pox on back; 1 on hip & 1 on chest;
25 hours after shot?Extreme  Fatigue,  chills, fever,  body aches, headache.  Symptoms subsided approximately 30 hours later
PAIN AT INJECTION SIGHT OVERALL FEELING OF FLU SORE NECK , BACK, ARMS
Intense nausea and stomach pain, chills - stomach cramps after send dose of pill oral typhoid as well, stopping treatment early now.
tested (+) 1/2/2022 via PCR at hospital. Unknown symptoms or course of illness.  Admitted 1/2/2022 and passed away 1/10/2022
Extreme fatigue, I am usually an early riser (around 4-5am), but since receiving my second vaccine injection I don?t feel like myself. I don?t want to get out of bed and would rather just be left alone, let me sleep. Will this eventually go away? It?s been 6 weeks already.
Narrative:  11/20/21 Per CCC Note, pt reports developing rash after pneumonia vaccine on 11/18/21; states the evening of 11/18/21, he had chills; on 11/19/21, he was sweating and then developed a generalized itchy, raised rash; pt reports using hydrocortisone with some improvement; methylprednisolone and diphenhydramine ordered
3-4 weeks after the 2nd dose experienced intermittent  atrial fibrillation for over 3 weeks, then developed hyper tension of 180/80-100. Currently on 2 BP meds, that is not controlling the pressure; hyper tension of 180/80-100. Currently on 2 BP meds, that is not controlling the pressure; This is a spontaneous report received from a contactable nurse (patient). A 63-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 01Mar2021 15:00 (Batch/Lot Number: EN6200) as 2ND DOSE, SINGLE for covid-19 immunisation. No pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered: Other. Medical history included Hypothyroid. No known drug allergies. Concomitant medication included thyroid (ARMOUR THYROID) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included BNT162B2 for COVID-19 Immunization [{product=COVID 19, brand=Pfizer, lot_number=EL9262, lot_unknown=False, administration_date=08FEB2021, administration_time=03:00 PM, vaccine_location=Right arm, dose_number=1}. Prior to vaccination, the patient was not diagnosed with COVID-19. Adverse_event was reported as 3-4 weeks after the 2nd dose experienced intermittent atrial fibrillation for over 3 weeks, then developed hyper tension of 180/80-100. Currently on 2 BP meds, that is not controlling the pressure. Adverse event start date: 29MAR2021, adverse event start time: 07:30 PM. Event treatment included telemetry monitor and 2 High BP Meds. Events resulted in: Doctor or other healthcare professional office/clinic visit. Event outcome was not recovered. The case was reported as Serious: No. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of  Atrial fibrillation,uncontrolled hypertension. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Severe vomiting for 7 hours, severe headache for 10 hours, stuffy nose for 7 hours, chills and body aches  for 12 hours.   Vomiting symptoms improved after taking ondansetron
Pt presented to the ED for groin pain; diagnosed with COVID approx 2 weeks prior to ED  (12/27/21), coughing led to right groin wound dishiscense (prior sx 11/30/21).  Continues to have sinus congestion from COVID as well as coughing.  Admitted for non-healing groin wound.  Discharged from the hospital 1/21/22 Moderna vaccine 04/20/21 & 05/18/21
aching to the bone; muscle fatigue; kidneys hurt; everything hurts, couldn't open car door; toes hurt; fever; Third dose caused chills; lymph node swelling; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (aching to the bone), MUSCLE FATIGUE (muscle fatigue), RENAL PAIN (kidneys hurt), PAIN (everything hurts, couldn't open car door) and PAIN IN EXTREMITY (toes hurt) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced BONE PAIN (aching to the bone), MUSCLE FATIGUE (muscle fatigue), RENAL PAIN (kidneys hurt), PAIN (everything hurts, couldn't open car door), PAIN IN EXTREMITY (toes hurt), PYREXIA (fever), CHILLS (Third dose caused chills) and LYMPHADENOPATHY (lymph node swelling). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency. At the time of the report, BONE PAIN (aching to the bone), MUSCLE FATIGUE (muscle fatigue), RENAL PAIN (kidneys hurt), PAIN (everything hurts, couldn't open car door), PAIN IN EXTREMITY (toes hurt), PYREXIA (fever), CHILLS (Third dose caused chills) and LYMPHADENOPATHY (lymph node swelling) outcome was unknown.            Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-300195, MOD-2021-300172 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up received and does not contains any new information.
5 days after shot, vision in left eye became blurry- went to primary eye doctors- sent to Surgeons- determined a blood clot in the back of the eye
(1) First vaccine - slight effects of Covid symptoms. (2) Second vaccine - Headache, slight fever (took tyenol) -Sat am - swollen tongue when I woke up.  Took benydril, swelling went down. tongue bled - (brush teeth, scrap tongue) -Sun - semi swollen tongue, rash lower abdomin. R am front area by under arm.
8 days post vaccine, my arm became slightly reddened, swollen, and slightly itchy. It is still.present on day 10.
Stabbing and shooting pain in arm starting at admin site and spreading down arm and into lats region. Severe enough to cause substantial discomfort and needed to take pain medication. Continued for over a week, progressively getting better but still bothersome.
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a six-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 12-Dec-2011, the patient inadvertently received expired FLUMIST. The product expired on 11-Dec-2011. There as no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Vaccine administered 3/4/15. Later on arm got red, swelled and ached. This continued for a few weeks. Pt iced arm and took it easy. Pt. came in and had noticeable swelling above 3 weeks later. Continued to ice. On May 20th pt still has some swelling.
held a clinic back in March and again in May 12. Patient came to both clinics and received J&J. Second clinic was not aware that he already received a dose
No adverse reaction. Patient was given the incorrect vaccine. Pfizer bivalent vaccine was requested but was given a Pfizer monovalent booster.
Received shot at 10:53pm; I did take all of my medications and supplements listed except for the Thyroid medicine  before going to before at midnight; very restless night of sleep. The pain in my arm woke me up. I never felt like I fell asleep. I woke up at 530am and took my Thyroid medicine and went back to bed until 6:30am. Felt fine until about 830am. I noticed I was starting to feel lightheaded and had this pressure on my head. I went back to bed and tried to fall asleep but really never did. I noticed that I would lose track of my train of thought often. Got up at 11am and  took a shower and still just didn't feel like I had any motivation to do anything, so rested again. I then noticed my face, ear lopes and cheeks felt a little numb. I would pinch them and I noticed they were numb. Also, there was still pressure on the back of my head and on the bridge of my nose. Still light headed. I layed in bed until about 3pm when I did notice the numbness going away and the pressure on the back of my head and on the bridge of my nose getting a little better. Also, no appetite.
Pfizer vaccine was administered outside of our facility - reported by patient- ? NO LOT NUMBER WERE SUPPLIED ---------------------------------------------------------------------------------------------------------------------- G47.33 OBSTRUCTIVE SLEEP APNEA 11/30/2021 HYPOXIA R09.02 HYPOXIA 11/30/2021 HYPOXIA G47.33 OBSTRUCTIVE SLEEP APNEA 11/30/2021 LEFT ANKLE FX ROUT SUBSEQ R09.02 HYPOXIA 11/30/2021 LEFT ANKLE FX ROUT SUBSEQ G47.33 OBSTRUCTIVE SLEEP APNEA 11/30/2021 LEFT BIMALLEOLAR FX DISPL ROUT SUBSEQ R09.02 HYPOXIA 11/30/2021 LEFT BIMALLEOLAR FX DISPL ROUT SUBSEQ G47.33 OBSTRUCTIVE SLEEP APNEA 11/30/2021 OPEN LEFT ANKLE DISLOCATION, INIT R09.02 HYPOXIA 11/30/2021 OPEN LEFT ANKLE DISLOCATION, INIT G47.33 OBSTRUCTIVE SLEEP APNEA 11/30/2021 HYPOXIA R09.02 HYPOXIA 11/30/2021 HYPOXIA
This is spontaneous report from a contactable physician (Pediatrician) via Pfizer sales representative. A patient of unspecified age ethnicity and gender received TRUMENBA at 0.5ml, single, HPV VACCINE at 1 DF, single for immunisation, MENACTRA from an at 1 DF, single, all via an unspecified route of administration on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced syncopal episode/fainted on an unspecified date with outcome of unknown. Course of events: the reporter stated that was having breakfast this morning with doctor. She made the comment about TRUMENBA that he/she administered TRUMENBA concomitantly with HPV and MENACTRA. The patient along with his mother proceeded out to the parking lot where the patient fainted. There was no injury and no hospitalization was necessary.
COPD with acute exacerbation - Chest x-ray did not show obvious pneumonia. Patient was given 1 dose of ceftriaxone and azithromycin for questionable right lung infiltrate. Procalcitonin was negative. There was no leukocytosis. Patient was started on IV Solu-Medrol and was admitted to the hospital. The next day, the patient felt much better. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.