chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vomiting; Body aches; Fever; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 21Mar2021 at 13:15 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history included thyroid cancer and breast cancer. The patient had unspecified allergies to medications, food, or other products. The concomitant medication included levothyroxine (SYNTHROID) and pantoprazole (MANUFACTURER UNKNOWN) from unknown indication since unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21Mar2021, the patient experienced vomiting, body aches and fever. The patient did not receive any treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events vomiting, body aches and fever was unknown at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Parent of patient wrote the birth year as 2009, instead of 2010, so patient received an adult-size dose of the COVID019 vaccine.
Guillain-Barre Syndrome; This is a spontaneous report from a non-contactable physician. A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, male 64 admitted at (Institution name) on 30Jan2021 with Guillain-Barre Syndrome after receiving Pfizer COVID vaccine. Event took place after use of product. It was shared on 30Jan2021 with physician by a doctor in town. They were in the doctors lounge this morning discussing the case. This was all of the information physician have. The event was considered as serious (hospitalization) by the physician. The 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.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of Guillain-Barre Syndrome due to temporal relationship.  This case will be reassessed once additional 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 RAs, Ethics Committees, and Investigators, as appropriate.
Patient complained of severe pain in left arm. Patient describes as sore to touch, not an ache. Started approximately two days status post injection. Site of pain is below injection site. Pain worse yesterday and improving today. No redness or swelling.
Chills, muscle soreness, head ache, nausea. All side effects took about 12 hours to set in. The worst of the intensity peaked 12 more hours later, and then the next half day they slowly went away.
stomach pain; Diarrhea; she became very Dizzy; Muscle aches; Nausea; Fever 104 F; This spontaneous case was reported by a nurse and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain), DIARRHOEA (Diarrhea), DIZZINESS (she became very Dizzy), MYALGIA (Muscle aches) and NAUSEA (Nausea) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903 and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021 at 4:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain), DIARRHOEA (Diarrhea), DIZZINESS (she became very Dizzy), MYALGIA (Muscle aches), NAUSEA (Nausea) and PYREXIA (Fever 104 F). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain), DIARRHOEA (Diarrhea), DIZZINESS (she became very Dizzy), MYALGIA (Muscle aches), NAUSEA (Nausea) and PYREXIA (Fever 104 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Nov-2021, Body temperature: 104 (High) Fever 104 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-052696 (Patient Link).
p/vax one inj site cont bleeding for approx 5min even w/direct pressure;upon questioning mother it was discovered was born @ a birthing center & that vit K was not given d/t not having it;
2 to 3 days of hip discomfort; unable to sit for any length of time, or lay on side for any length of time; This is a spontaneous report from a contactable nurse (reporting for herself).  A non-pregnant 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK4176), via an unspecified route of administration, on 08Jan2021 11:00 at a single dose for COVID-19 immunization.  The patients medical history was not reported.  Concomitant medication included venlafaxine hydrochloride (EFFEXOR), calcium (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), curcuma longa root (TURMERIC CURCUMIN), calcium pantothenate, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (B COM) , polycarbophil calcium (FIBER).  The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EH9899), on 18Dec2020 at 11:00 AM in the left arm for COVID-19 immunization. The patient has no known drug allergies. The patient experienced, 2 to 3 days of hip discomfort; unable to sit for any length of time, or lay on side for any length of time on 09Jan2021 07:30.  No treatment was received for the event.  The outcome of the event was recovered in Jan2021.
Crying, rash chest, forehead, vomiting and diarrhea x 2 weeks. Not crying. Patient is a twin. "Not my child".
Volunteer staff at COVID-19 vaccination site, provided the Moderna vaccine to a patient sixteen days prior to the due date. Patient did not experience any adverse events as a result of the early administration of the vaccine.
Vaccine dripping out on arm; Vaccine dripping out on arm; A spontaneous report was received from a consumer concerning an 80-years-old, male patient who experienced vaccine dripping out on arm.    The patient's medical history included chronic obstructive pulmonary disease (COPD) and diabetes. Concomitant product use was not provided by the reporter.   On 17 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 [Lot number 0bIL20A] intramuscularly for prophylaxis of COVID-19 infection.    On 17 Feb 2021, the patient experienced vaccine dripping out and going down his arm. Treatment information was not provided.    The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The event vaccine dripping out on arm was considered recovered/resolved on 17 Feb 2021.; Reporter's Comments: This report refers to a case of vaccine underdose and exposure via skin for mRNA-1273 [Lot number 0bIL20A] with no associated AEs.
4 hours after vaccine, dizziness, fatigue & nausea. Extreme fatigue for 24 hours with BAD headache, & body aches/weakness, fever & chills. As bad as when I had COVID-19 (Positive PCR test early Dec 2020). Symptoms from vaccine went away completely after 48 hours.  **Still have long term effects from COVID-19 such as low oxygen saturation, (averages low 90?s),  shortness of breath, mental confusion, extreme fatigue, headaches, body aches, inner leg pain at top of leg, &  NO smell/taste. Consider myself relatively healthy before COVID-19.  Push myself to try to do as did before COVID-19. Always social distance & wear mask. Would NOT hesitate to get vaccine again! Benefits outweigh the side effects.  Expected short term symptoms since had  COVID-19.
Within 12 hours of injection severe pain in shoulder. Unable to move arm or put weight on it. Paper stated that it may happen. Still 3 weeks later arm does not have full motion and severe pain at joint. Injection given to high on deltoid possible in bursa.
Pt experienced episode of vasovagal syncope about 10 minutes after receiving vaccine.  She had initially laid down for about 5 minutes before sitting up and walking to the waiting room, where she continued to feel dizzy.  She arose to let the front desk staff that she needed to lie down about and proceeded to faint - she started going forward, hit right side of forehead on door jam and was caught by admin who helped her lay down backwards on her back.  She regained consciousness within seconds, and attempted to stand, got dizzy again as she was walking into my exam room, and fainted for a second time in my arms.  I carried her to exam table, where she came to again. BP was initially low, but returned to low normal within the next 20 mins.  She developed very minor headache in the next 15 mins, but felt back to normal with no dizziness, no vision changes, no neuro deficits.  Physical exam unremarkable by the time she left - no redness, contusion, bump or broken skin on forehead or scalp,.  She was discharged back to work after resting for 30 mins with clear aftercare instructions.
any and all of its sequelae; Shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 78 year old male patient. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On 17-JUL-2015, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not reported) as prophylaxis.  As a result of his receipt of zoster vaccine live (ZOSTAVAX), in August 2015 the patient was caused to suffer shingles including any and all of it's sequelae.  As a result of his receipt of zoster vaccine live (ZOSTAVAX), Plaintiff, has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages.  Defendants failed to exercise ordinary care in the designing, researching, manufacturing, marketing, supplying, promoting, packaging, sale, testing, quality assurance, quality control, and/or distribution of zoster vaccine live (ZOSTAVAX),  into interstate commerce in that Defendants knew or should have known that using zoster vaccine live (ZOSTAVAX), created a high risk of unreasonable, dangerous side effects, including Shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications.   The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Target like rash/lesions on hands, palms, abdomen.  Some transient oral lesions/ulcers noted 1 week later. Hyperpigmented macular lesions on neck 1-2 weeks after onset of initial rash.  Lesions persist despite treatment with hydrocortisone ointment.
pt recv vax 10DEC96 & same day pt exp varicella-like rash on buttocks, inj site, & abd which resoled w/in 24hr;
Achiness all over her body / More pain allover her body with the 2nd dose compared to the 1st dose; pain in my left foot, pain in fingers; Sore throat every morning; Fatigue; Both knees ache really bad; Aching, soreness in right foot; Sore arm of injection; extreme fatigue; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achiness all over her body / More pain allover her body with the 2nd dose compared to the 1st dose), PAIN IN EXTREMITY (pain in my left foot, pain in fingers), OROPHARYNGEAL PAIN (Sore throat every morning), FATIGUE (extreme fatigue) and MYALGIA (Myalgia) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902 and 048C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee injury (Patient injured her right knee 15 years ago.). Concurrent medical conditions included Food allergy.   On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Aug-2021 at 7:00 AM, the patient experienced FATIGUE (extreme fatigue) and MYALGIA (Myalgia). On an unknown date, the patient experienced PAIN (Achiness all over her body / More pain allover her body with the 2nd dose compared to the 1st dose), PAIN IN EXTREMITY (pain in my left foot, pain in fingers), OROPHARYNGEAL PAIN (Sore throat every morning), FATIGUE (Fatigue), ARTHRALGIA (Both knees ache really bad), MYALGIA (Aching, soreness in right foot) and VACCINATION SITE PAIN (Sore arm of injection). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of UNK dosage form. At the time of the report, PAIN (Achiness all over her body / More pain allover her body with the 2nd dose compared to the 1st dose), PAIN IN EXTREMITY (pain in my left foot, pain in fingers), OROPHARYNGEAL PAIN (Sore throat every morning), FATIGUE (Fatigue), ARTHRALGIA (Both knees ache really bad), MYALGIA (Aching, soreness in right foot) and VACCINATION SITE PAIN (Sore arm of injection) outcome was unknown and FATIGUE (extreme fatigue) and MYALGIA (Myalgia) had not resolved.            No relevant concomitant medications were reported.   This case was linked to MOD-2021-304918 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Follow-up document received on 09-Sep-2021, events and facility information were reported - significant
Pt called triage line on 08/28/22 at 1956, c/o left arm swelling, redness and pain x 2 days.  She did not seek care at urgent care or ER. She states the erythema is about 8 inches in length and does seem to be  progressing to a larger skin area. There are also some red areas below the arm that are not even near the injection  per her report.  Had her take her temperature while on the phone and it was 98.4 F.  She states there is continued pain to the site as well to the point she is not  able to lay on that side. States skin is hot to touch per her report also. Advised she seek care at urgent care or ED.
COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Dec2020 as dose 1, single (Lot number: EL1284), in left arm, on 21Jan2021 as dose 2, single (Lot number: EK9231), in left arm, on 04Sep2021 as dose 3 (booster), single (Lot number: FC3182), in left arm and on 24Jan2022 as dose 4 (booster), single (Lot number: 33036BD) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: high blood pressure; "Type 2 Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN [METFORMIN HYDROCHLORIDE], start date: Mar2017; LISINOPRIL, start date: Mar2008. Past drug history included: Amoxicillin, reaction(s): "Known allergies: amoxicillin", notes: Known allergies: amoxicillin; Iodine for Known allergies: Iodine, notes: Known allergies: Iodine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative, notes: I have a positive COVID test after six days with negative results; (May2022) Positive, notes: I have a positive COVID test after six days with negative results. Therapeutic measures were taken as a result of vaccination failure, covid-19.Product:COVID 19 Treatment, Brand: Paxlovid, Treatment start date:20May2022,Treatment stop date:24May2022.
never ran a temp, nausea and vomiting starting 430am to noon Christmas eve, diarrhea until 3pm, 2nd of January I felt like I had a head cold, I went to the Dr on the 3rd or 4th, he was going to give me a shot but I had an IUI,  diagnosed with thrush on the 12 of Jan,  niastantin 4x daily was prescribed.  I was pregnant during one of the covid injections but then I lost the pregnancy.  I was 4 weeks 3 days when I lost the fetus.
Right upper chest pain at end of inspiration and when lying flat - 5/10/2021-5/10/2021. Left calf pain and swelling 5/15/2021 to present.  DVT diagnosed 6/1/2021.
Pt received influenza vaccine on 9/29/2010 in the left upper arm. Pt returned to pharmacy on 10/24/10 complaining he hadn't been able to move his left arm since he received the vaccine and that it is very sore. He said there was no visible marking only muscle soreness. He also said he contacted his Dr & was told to return to pharmacy.
IMMEDIATE STABBING PAINS IN MY HEART; SUBSEQUENT COVID SYMPTOMS, SEVERE: PRODUCTIVE COUGH, PRODUCTIVE SINUS DISCHARGE (MASSIVE FOR WEEKS); ACHES; HEADACHE; DIZINESS; EXTREME FATIGUE; EXHAUSTION; COLLAPSING. THIS IS MY BOOSTER.
no history of heart issues prior to vaccine, as of today Aorta Valve Replacement done April 29, 2021
Information has been received from a physician concerning a female who was vaccinated with Hepatitis B vaccine. Subsequently, the patient experienced pain at the injection site for 2.5 months and numbness at the injection site for 3 days after the injection. Additional information has been requested.
This spontaneous report as received from a Medical Assistant refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ oral, Lot # K004795 expiration date 11-FEB-2016 and Lot # reported as J012670, expiration date 15-APR-2015 (dose and route were not reported). No adverse effects reported. No product quality complaint (PQC) was reported. This is one of several report received from the same source. Additional information has been requested.
Spontaneous crying/extreme sensitivity to sad triggers (despite not feeling sad nor depressed), very vivid dreams, flashes in my head that feel like "cranial hot flashes", for 12 hours, felt like I had Covid again
fever that was "100.4F or a little higher"; This non-serious spontaneous Safety Report, with reference numbers 02239599/02239593, was received by partner on 02-SEP-2022 and forwarded to Agency on 05-SEP-2022 from a Nurse.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "fever".  Further information is expected.
Patient complained of headache, lightheadedness and anxiety.  Observation awake, alert and anxious. No wheezing.  Initial blood pressure was 190/100 pulse 92 .  Lungs clear.  After 5 minutes of observation symptoms unchanged. 170/90 pulse 90 . Extra systoles on pulse palpation.  Administered 12.5 mgs Benadryl p.o.. No change in symptoms, no further improvement in blood pressure and pulse. Patient remained anxious, lives alone, transported patient to emergency room.
p/vax pt exp arm redness at inj site; later pain at inj site; swelling;
Arm was swollen and very painful. By 12;00 PM began to run fever. Chills, headache arm hurt more. At 5:00 Pm Dr sent out an antibiotic and had us circle the area. He told us to go to emergency if the redness went out of the circle.
No adverse effect reported; 6 month old received first dose of ROTATEQ yesterday; This spontaneous report has been received from a physician referring to a 6 months old patient. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.               On 29-OCT-2019 (reported as yesterday), the patient was vaccinated the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #: S004399, expiration date: 06-NOV-2020) orally for prophylaxis (product administered to patient of inappropriate age). No adverse effect reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1910USA017641:same reporter
Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female 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 24Feb2021 at 09:45 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received unspecified medications within two weeks prior to the vaccination.  On 24Feb2021 at 22:00, the patient experienced sore arm. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm was recovered on an unknown date in Feb2021.   No follow-up attempts are required; information about lot number cannot be obtained. No further information is expected.
The pt developed a fever the night of vaccination. He developed cough and decreased energy the next day. Then he wouldn't be breast fed and still had a continued fever. He was diagnosed with right sided pneumonia.
Had received shots on 06/27/02. At 2am 06/29/02, developed sore throat, difficulty to breath, hoarse voice and wheezing. Taken to ED and prescribed prelone syrup for 5 days.
Pt. received BOOSTRIX and GARDASIL in RD. When pt. left exam room to schedule appt. for next inj. she felt lightheaded and dizzy. Became very pale and fell to the floor with support from Mom returned pt. to exam room. BP checked, 100/72. Pt. stayed in exam room for approx 30 min longer with no further episodes of dizziness.
Presented to ED with swelling to right leg. Had ultrasound and has a DVT. Normal cardiopulmonary exam with LCTAB and HRRR. No swelling to R calf. R calf is warm to touch, red, and TTP. Patient is well appearing, non-toxic and in no acute distress. Patient's US of the RLE that revealed a R calf DVT involving mid calf posterior tibial vein from her Dr.'s office. BMP was unremarkable. Prescribed the Patient Xarelto and she received her first dose in the ED today. Follow-up with PCP in the next 2-3 days. Return to the ED for new or worsening symptoms.