chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tingling in my thumb and in my pinkie; It was kind of numbness; My left thumb kind of never really, the numbness is still a bit left; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 immunization. The following information was reported: PARAESTHESIA (non-serious), outcome "recovered", described as "Tingling in my thumb and in my pinkie"; HYPOAESTHESIA (non-serious), outcome "not recovered", described as "It was kind of numbness; My left thumb kind of never really, the numbness is still a bit left".  Additional information: Patient wanted to ask about their second vaccine, that they had it in early May and stated, when had the vaccine, patient got some tingling in the thumb and in pinkie, so then it kind of went away in few days. It was kind of numbness and patient was trying to stretch it out but the patient's left thumb kind of never really, the numbness was still a bit left and patient wanted to know if that was something, patient was hoping it was not permanently damaged, nerve damage. Patient wanted to know was that temporary or does that go away in a few months, it had been three months now. It was minor but it was still there, patient did not know what to do, exercises or patient had been trying to stretch it and stuff and so.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I contracted COVID-19 1/08/22 with symptoms of cough, sore throat, shortness of breathe, diarrhea, nausea/vomiting, chills, congestion, ears ringing, and I was ill for 5 to 7 days. I had a lingering symptom of ringing/heaviness in my ears.
Patient recounts that symptoms first began Nov 2nd when she had COVID and flu vaccines on the same day. The next day she was found to be positive for COVID after having a cough. She began taking Paxlovid on 11/5 and that same day she started having some symptoms of "wearing tight pants" from the level of her umbilicus down to her lower extremities. She was admitted 11/8-11/10 for these symptoms due to continued lower extremity numbness and weakness, and had extensive workup during that admission including MRI Brain, C/T/L spine which was unrevealing, as well as an LP which showed very minor protein elevation. Neurology was consulted for recommendations during this admission. Patient improved symptomatically without treatment and so was discharged home with plan for further outpatient neurology workup.    She represented on 11/13 due to continued symptoms and was again admitted for further workup and treatment 11/13-11/18. She received a repeat LP revealing for albuminocytologic dissociation with a protein of 57 and was treated for GBS. Neurology was consulted and recommended treatment with IVIG x5 days which the patient completed. The patient's symptoms improved during the hospitalization and she was evaluated by PT and discharged home with plan for further outpatient PT.    She attempted to take care of herself at home but recounts several falls over the weekend. She still has some weakness of her lower extremities and has to pull herself up off of the couch using her arms and lean on her walker to get around. She has never hit her head or lost consciousness from these falls and she has no prodromal symptoms when she has the falls. She has had several abrasions to her knees and various extremities from these falls but no swelling that she has noticed. She continues to endorse some numbness in her abdomen, lateral aspect of her LUE, and bilateral toes.    She denies recent infection, URI symptoms (cough, F/C, congestion, SOB). She denies N/V. She denies abdominal pain. She denies melena, BRBPR, hematemesis, hemoptysis. She endorses some decreased appetite. She endorses constipation. She denies any vaginal bleeding, states does not have periods after having IUD placed.
diarrhea; weight loss; migraine headache lasting for 3days; swollen left arm; bruises; Covid arm; chest and neck area were all swollen; sick in the stomach; rash; nausea; swollen lymph node; slept all day; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), WEIGHT DECREASED (weight loss), MIGRAINE (migraine headache lasting for 3days), PERIPHERAL SWELLING (swollen left arm) and CONTUSION (bruises) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (LARIN FE), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), VENLAFAXINE, LANSOPRAZOLE, TIZANIDINE HCL, BUSPIRONE, POTASSIUM, MAGNESIUM, ZINC, VITAMIN B NOS (B-COMPLEX [VITAMIN B NOS]), Butterbur, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and DUPILUMAB (DUPIXENT) for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced SOMNOLENCE (slept all day). On 26-Apr-2021, the patient experienced DIARRHOEA (diarrhea), WEIGHT DECREASED (weight loss), MIGRAINE (migraine headache lasting for 3days), PERIPHERAL SWELLING (swollen left arm), CONTUSION (bruises), VACCINATION COMPLICATION (Covid arm), SWELLING (chest and neck area were all swollen), ABDOMINAL DISCOMFORT (sick in the stomach), RASH (rash), NAUSEA (nausea) and LYMPHADENOPATHY (swollen lymph node). On 25-Apr-2021, SOMNOLENCE (slept all day) outcome was unknown. On 29-Apr-2021, WEIGHT DECREASED (weight loss) had resolved. At the time of the report, DIARRHOEA (diarrhea), MIGRAINE (migraine headache lasting for 3days), PERIPHERAL SWELLING (swollen left arm), CONTUSION (bruises), VACCINATION COMPLICATION (Covid arm), SWELLING (chest and neck area were all swollen), ABDOMINAL DISCOMFORT (sick in the stomach), RASH (rash), NAUSEA (nausea) and LYMPHADENOPATHY (swollen lymph node) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication includes Took Pepcid, Benadryl, Nauzene, and Ondansetron.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable   This case was linked to MOD-2021-106665 (Patient Link).
a hib dose from a pentacel carton was given to a patient with sterile water instead of the supplied diluent, no advese event; Initial information received on 06-Jan-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 5 month and 21 days old male patient who was vaccinated with a first dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number UJ084AAA and expiration date 24-Jul-2020) via an intramuscular route at an unknown administration site on 30-Dec-2019.  Medical history and concomitant medications were not reported.  It was an actual medication error case due to wrong solution used in drug reconstitution as Hib dose from a pentacel carton was given with sterile water instead of the supplied diluent.  No known symptoms were reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
W/in 24 hours after vaccines, I experienced heavy vomiting, diarrhea, lower body aches, hot flashes, cold chills.  Headache soreness in lower left calf muscle.  Loss of appetite.
I got the flu; Initial information was received on 12-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves 50-years-old patient (unknown gender) who got flu (influenza), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious got flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported that the patient was going to die after this.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
3/26/21 extreme fatigue, head ache, muscle aches, chills  On 3/27/21 horrible metal taste and extreme nausea began a long with a sore throat. 3/29/21 watery diarrhea began along with all the other symptoms diarrhea lasted thru 4/1/21. All other symptoms remained. Slight fever of 99.9 began on 4/2/21. Cheeks were very red and hot to touch. Decided to take my temp at the site of my cheeks the thermal scan revealed 101.9-102 temp. Fore head remained the same 99.9.  On 4/4/21 most symptoms gone little of the metallic taste remains.
The highest temperature reached 9.9 C and the total excursion lasted 30 minutes with no adverse event; Initial information received on 14-Jun-2022 regarding an unsolicited valid  non-serious case received from a pharmacist via call center.  This case involves a 2 years old female patient who experienced the highest temperature reached 9.9 c and the total excursion lasted 30 minutes with no adverse event while receiving vaccines PEDIARIX and IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (dtap) for immunization; pneumococcal vaccine conj (pneumococcal conjugate vaccine) for immunization; and hepatitis a vaccine (hepa [hepatitis a vaccine]) for Immunization.  On 09-Jun-2022, the patient received a  dose of suspect IPV (VERO) (batch lot T1E872M )(Expiry date:10-Oct-2022)(unknown dosage, strength)via intramuscular route in the left thigh and PEDIARIX not produced by Sanofi Pasteur (unknown batch lot number,dosage, strength, formulation via unknown route in unknown administration site.  On 09-Jun-2022 (latency :same day)the patient developed a non-serious event of the highest temperature reached 9.9 c and the total excursion lasted 30 minutes with no adverse event (product storage error) following the administration of IPV (VERO) and (unknown latency) following the administration of PEDIARIX.  Action taken with : not applicable.  At time of reporting, the outcome was Unknown for the event the highest temperature reached 9.9 c and the total excursion lasted 30 minutes with no adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01146537:
Flu shot (HD) caused fever 1-2 nights. Bruising on arm. Patient is on PLAVIX. Bruise about 5 inches x 8 inches on left arm. Pt. advised to use cold pack sporadically to minimize spread of bruise.
The  individual received her 2nd dose vaccine early, less than 21 days. - 6 days early. The nurse checked the date wrong.  Individual received 1st dose on 4/12/2021. Received her 2nd dose today, 4/27/2021.
pt recv vax 31MAR97 & 24JUN97 pt exp 25 to 30 lesions or vesicles which were everywhere x/child's face;pt was treated w/colloidal oatmeal & calamine;pt recovered;
pt recv vax 15NOV98 or 16NOV98 & 3 or 4 days later, devel fever & lethargy & became limp;w/in hours of fever onset, began vomiting;vomiting cont & pt began vomiting blood;taken to MD dx intussusception;pt hosp & underwent emergency surgery;
Tinnitus started evening of shot without recent noise exposure.  The high pitch sound in both ears has not gone away during 5 week period to date.
Patient did not experience adverse effect, this is a report of an error in administration of vaccine. Patient is under 18 years old received Moderna Vaccine. At the time of vaccination it was understood that in our state, anyone 16 and older could receive Moderna. Since it was pointed out by the DOH that it is not the case, our facility stopped vaccinating 16 to 18 year olds with Moderna.
Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 61 years old male patient who experienced received 0.5 ml vaccine FLUZONE HIGH DOSE lot UJ037AA via intramuscular route in right deltoid site on 12-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was reported that the patient had a poor health history and he normally gets the FLUZONE HIGH DOSE. It was a case of actual medication error due to inappropriate age at vaccine administration. It was not reported if the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Left arm soreness and weakness for the first two days. Nausea, vomiting, chills lasting from 2pm the day following the vaccine until the next morning
Redness noted around injection site approx. 1 hour after administration. Next morning a couple of red streaks noted & Cold compress applied. Resident on scheduled Benadryl. Today, redness extends to elbow. PRN Benadryl given.
really sick for 30 hours; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Jun-2021 and was forwarded to Moderna on 07-Jun-2021.     This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick for 30 hours) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.   On an unknown date, the patient experienced ILLNESS (really sick for 30 hours).   At the time of the report, ILLNESS (really sick for 30 hours) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.  Most recent FOLLOW-UP information incorporated above includes:  On 07-Jun-2021: Source Document(additional) added
strong lower back pain; slept the whole day; chills; headache; A spontaneous report was received from a consumer who was a 44-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, headache, slept the whole day and strong lower back pain.   The patient's medical history included COVID-19. No concomitant medications were reported.  On 04 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. The same night, the patient experienced chills and headache.    On 05 Jan 2021, the patient reported having slept whole day.   On 06 Jan 2021, the patient experienced strong lower back pain. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The events, chills, headache, slept the whole day, was considered resolved on 05 Jan 2021. The outcome for the event, strong lower back pain was unknown.  The reporter did not provide causality for the events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Initial information received on 12-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2018SA258705 (same reporter). This case involves a 11 years old male patient who received a dose of MENACTRA lot R011628, expiry date: 11-Dec-2020, in the left arm on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ADACEL for Immunisation; and GARDASIL for Immunisation. It was a case of actual medication error due to incorrect product storage and deteriorated drug administered. It was reported that some vaccines that arrived after 72 hours rather than 48 and that vaccines should not be used. It was not reported if the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by the sender: none.
Patient is experiencing redness out side of injection site (shoulder and lower arm). She mentioned she also had very bad muscle pain throughout the whole body on the date she received the  vaccination which is quite common. Pain is much better today but the swelling and redness made patient concerned.
an expired DAPTACEL was inadvertently given to a patient, with no adverse event; Initial information received on 16-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old patient of an unknown gender and reporter reported that the expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] was inadvertently given to a patient, with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-May-2023, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE for suspension for injection (strength: standard) (expiry date: 11-May-2023, lot C5883AA) via intramuscular route in the left deltoid for Immunization and on the same day expired daptacel was inadvertently given to a patient, with no adverse event (expired product administered).Information on the batch number was requested.  No lab data available.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
acute encephalopathy; seizures; This is a literature report.  A 69-year-old female patient received BNT162b2 (BNT162B2), 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: ENCEPHALOPATHY (hospitalization, medically significant), 5 days after the suspect product(s) administration, outcome "not recovered", described as "acute encephalopathy"; SEIZURE (hospitalization, medically significant), 5 days after the suspect product(s) administration, outcome "not recovered", described as "seizures". The patient underwent the following laboratory tests and procedures: Bacterial test: negative; CSF protein: 135 mg/dl; CSF test: revealed an elevated protein level (135 mg/dl); Fungal test: negative; HIV test: negative; autoimmune encephalitis panels: negative; negative; Magnetic resonance imaging head: showed gyriform-pattern diffusion restriction in t, notes: the right hemisphere and left frontoparietal region without features suggestive of an acute vascular event; showed similar findings to her previous scan with, notes: the addition of Wallerian degeneration in the right cerebral peduncle; Mycobacterium test: negative; SARS-CoV-2 antibody test: negative, notes: on post-immunization day 8; SARS-CoV-2 test: negative; Treponema test: negative; Vascular imaging: normal; Viral test: negative. Therapeutic measures were taken as a result of encephalopathy, seizure which includes empiric methylprednisolone and meningitis antibiotic/antiviral treatment  Clinical Course: Patient received her first dose of BNT162b2 five days prior, was found unresponsive. Within twenty-four hours of arrival, she developed focal seizures with secondary generalized, and remained in non-convulsive status epilepticus on longterm EEG monitoring until day 5 of admission despite three anti-seizure medications and a propofol drip. There was no significant improvement with treatment empiric methylprednisolone and meningitis antibiotic/antiviral treatment. She was discharged in a deeply comatose status on day 30 of hospital admission. Repeat MRI brain on day 14 showed similar findings to her previous scan with the addition of Wallerian degeneration in the right cerebral peduncle.  The lot number for BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided and temporal association, a causal relationship between BNT162B2 and the reported events encephalopathy, seizure cannot be excluded. 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.
Nausea, Vomiting, Diarrhea, Stomach Ache, Chest Pain