chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever 101; fatigue; nausea; migraine; This is a spontaneous report from a contactable Nurse(patient). A 32-years-old female patient received BNT162B2(Lot number: EK9231) , intramuscular on 06Jan2021 08:15 at 32 years old at Arm Right at single dose for COVID-19 immunization.  Medical history included migraine, Allergies to Latex.  Concomitant medications included asa, ascorbic acid (VIT C), cetirizine hydrochloride (ZYRTEC) and ascorbic acid, chromium, copper, folic acid, inositol, magnesium, manganese, nicotinamide, pantothenic acid, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (Multi Vit). The patient experienced fever 101, fatigue, nausea, migraine on 06Jan2021 19:00.  There was no treatment received for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on 06Jan2021. The outcome of events was recovering.
Allergic reaction; This case was reported by a other health professional and described the occurrence of allergic reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th January 2021, the patient received Shingrix. In January 2021, less than 3 weeks after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had received Shingrix vaccine and seemed to have had an allergic reaction. The reporter had questioned as how long should the reaction last and could the patient get a COVID vaccine.
Acute onset LE weakness 11/15/09. Extended to involve upper extremities over next 24 hours. (presumed Gullain-Barre).  11/19/09 Physical Medicine, Neurology, Infectious Diseases consultation records received service dates 11/16/09 to 11/17/09. Assessment: Atypical Guillain-Barre Syndrome. Two weeks ago patient had febrile flu-like illness, with chills, cough, and congestion, lasting 6 days. Subsequently she received an H1N1 vaccine and later began to complain of malaise, decreased energy, with generalized aches in neck and legs. Stumbling. Unable to walk or get out of bed without assistance. Weakness in legs and arms, decreased reflexes. Tenderness deltoids and paraspinal muscles lower back.   11/24/09 Hospital discharge summary received. Service dates 11/16/09 to 11/23/09. Assessment: AMAN varient of Guillain-Barre syndrome. Patient presents with weakness mostly in her hip flexors with moderate weakness in upper extremities. Pain - back, neck, legs. Facial hemiplegia. Anxiety. IVIG.
Varivax administered after temperature excursion; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 27-APR-2022, the patient received inappropriately stored (product storage error) live (oka/merck) (VARIVAX) with lot number U026207 and expiration date 24-AUG-2023 or with lot number U029496 and expiration date 21-SEP-2023 (route of administration and anatomical location were not reported).  The temperature excursion was at a temperature of -9 degree Celsius for a timeframe of 1 hour and 45 minutes, without previous excursions. No PQC (product quality complaint) was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA006728: US-009507513-2205USA006727: US-009507513-2205USA006726: US-009507513-2205USA006725: US-009507513-2205USA006729: US-009507513-2205USA006724:
Drug ineffective; Covid symptoms returned; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A 35-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown (booster), 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: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered", described as "Covid symptoms returned". Clinical course: Reporter Contact Information: (city name withheld). Patient not wanted to report name. Seemed better then had Moderna booster and Covid symptoms returned. No better.  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 suspected LOE.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   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.,Linked Report(s) : US-PFIZER INC-PV202300048756 Same patient/product, different dose/events;
patient came in for a monovalent, but an expired dose was given. It expired on 27Nov2022.; No adverse event; patient came in for a monovalent, but an expired dose was given. It expired on 27Nov2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (patient came in for a monovalent, but an expired dose was given. It expired on 27Nov2022.), EXPIRED PRODUCT ADMINISTERED (patient came in for a monovalent, but an expired dose was given. It expired on 27Nov2022. ) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Dec-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient came in for a monovalent, but an expired dose was given. It expired on 27Nov2022. ). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient came in for a monovalent, but an expired dose was given. It expired on 27Nov2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (patient came in for a monovalent, but an expired dose was given. It expired on 27Nov2022.), EXPIRED PRODUCT ADMINISTERED (patient came in for a monovalent, but an expired dose was given. It expired on 27Nov2022. ) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (patient came in for a monovalent, but an expired dose was given. It expired on 27Nov2022.) and EXPIRED PRODUCT ADMINISTERED (patient came in for a monovalent, but an expired dose was given. It expired on 27Nov2022. ).    No relevant concomitant medications were reported. It was reported that the administrator mistake was that they looked at the expiration date of a bivalent vaccine instead. Date the vial was initially stored in the refrigerator was on 15 Dec 2022. The vial haven't undergone any temperature excursions. No treatment medication reported.
Patient admitted to Hospital on 2/5/2022 in the setting of 6 days of fever (Tm 104F), mucocutaneous changes (strawberry tongue, limbic sparing conjunctivitis, lip changes) and GI symptoms (abd pain x 2 days). Labs showed ALC 660, CRP 111, ESR 33. Admitted with MIS-C and treated with IVIG 2g/kg x1 and steroid taper with aspirin daily. Improved by discharged on 2/8/22.
On 5-20-11 mother noted unusual bruising and petechiae. Child seen 5-23-11, labs completed. Dx with Idiopathic thrombocytopenic purpura.
Narrative: The patient received three doses of Moderna COVID 19 Vaccine in Apr,May,Sep 2021. The patient tested positive for COVID 19 on 1 Feb 2022. The patient presented to the ED after a fall. The patient was admitted with acute kidney injury, rhabdomyolysis, elevated troponin, and covid 19. The patient was treated with fluids and electrolytes. The patient was discharged on 14 Feb 22 in stable condition. Reported per EUA.
Information has been received from an RN concerning a 72 year old white female pt with hypertension, diabetes, and a hx of irritable bowel syndrome, obesity and previous vaccination with dose of pneumococcal 23v polysaccharide vaccine in 1996, who on 24NOV2004 was vaccinated IM in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine.  Other therapy administered on 24NOV2003 included a dose of influenza virus vaccine. Concomitant therapy included Lipitor, Xanax, Bentyl, Anafranil and Avandia. The registered nurse reported that the pt developed a local site reaction described as redness, swelling, pain and splotchiness on the arm. It was noted the pain at the site radiated to her neck. The reporter noted that on 25NOV2003 the symptoms were getting worse and were being treated with Benadryl and "soma". Unspecified medical attention was sought. There was no product quality complaint reported. Additional information received from the RN reported the pt recovered. Additional information is not expected. The registered nurse also mentioned that three other pts experienced similar site reactions: redness, swelling, pain and splotchiness following vaccination with dose of pneumococcal 23v polysaccharide vaccine.
Starting in June of 2021 I started nonstop heavy menstrual bleeding. A uterine ablation was attempted in August 2021. It was unsuccessful. A hysterectomy was then performed October 4th 2021.
Our technician administered the first dose of Pfizer to the patient and shortly afterwards the patient stood up and placed back against wall and I was told that the patient began to fall limp and fainted and hit his head on the door. Patient father was with him and we provided him some juice and the patient was asked how they were feeling and him and the father hung around until the patient felt okay and then they left.
Severe body aches all over, painful to move, bad chills resulting in wearing gives, heavy socks and many blankets while lying in bed.
On 12/6/22, patient received 1 dose of Trumenba and 1 dose of Bexsero, but he should have only received one or the other. There have been no known adverse reactions.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 14Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 30Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LOSARTAN; LEXAPRO. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid rebound. Symptoms and positive home test a few days after recovery. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Treatment included Paxlovid, Treatment start date was 12Jul2022, Treatment stop date was 17Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Violent shivering/shaking; Felt cold; Headache; a bit of nausea; had trouble sleeping; Shaking; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose of the vaccine with no reactions).   On 10th January 2021 11:00, the patient received the 2nd dose of Shingrix (intramuscular). On 10th January 2021 23:00, 12 hrs after receiving Shingrix, the patient experienced shivering, feeling cold, headache, nausea, difficulty sleeping and tremor. On an unknown date, the outcome of the shivering, feeling cold, headache, nausea, difficulty sleeping and tremor were recovered/resolved.   It was unknown if the reporter considered the shivering, feeling cold, headache, nausea, difficulty sleeping and tremor to be related to Shingrix.  Additional details were reported as follows: The patient  experienced shivering/shaking, felt cold, headache, a bit of nausea for 2-3 hours. The patient also stated that he had trouble sleeping last night. The patient received the vaccine at 11am yesterday morning in the upper left arm. The symptoms occurred 12 hours later at 11pm last night. .The reporter consented to follow up. No further information was available. Patient did give permission to follow-up with their HCP, and provided the following contact information.
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2 NOS), in Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2023) Negative; (21Apr2023) Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid for COVID-19 Treatment from 12Apr2023 to 16Apr2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300166772 same reporter/patient, different drug/AE;
Information has been received from a Certified Medical Assistant referring to multiple unspecified patients. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. On unspecified dates, the patients were administered VAQTA (L022259, Expiration Date 06-APR-2017; dose, frequency and route unspecified). The Hepatitis A Vaccine, VAQTA had been exposed to temperature of 1 degree centigrade, coldest temperature. The total cumulative time was unspecified. The reporter was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Two to 3 weeks after my Covid shot my Red Blood Count started to go down  from 13.6  to 5.5  6 months later. I was in the Hospital for 2 weeks.
Pt c/o redness, warmth on right upper arm on 8/14/12. Along with pain, but no fever noted. Pt was seen at Dr office on 8/15/12 & dx with reaction vs early infection and placed on KEFLEX 500mg one tab q 12 hr for 10 days.
Initial information received on 09-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a two-months old patient who received a dose of PENTACEL (Lot number: C5542AA, expiry date: 08-Sep-2019), which was inappropriately reconstituted, intramuscularly in thigh NOS on 08-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that nurse gave PENTACEL as two injections. HIB portion given with sterile Patient. It was not reported if the patient experienced any adverse event or not. 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 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. Documents held by sender: none.
Weakness Dizziness Swelling of the left arm Intense pain all over my body Headache
Information has been received from a physician assistant concerning a female who was vaccinated with a dose of Gardasil.  Subsequently the patient fainted.  The patient recovered before leaving the office.  Additional information has been requested.
Tonic/clonic seizure as described by mom lasting several seconds. No fever and no history of fever.
Information has been received from a certified nurses aid concerning a 19 year old female who on 22-MAR-2007 was vaccinated with the first dose of GARDASIL. Concomitant medication was reported as none. On 22-MAR-2007, the patient experienced burning feeling at the injection site, the patient passed out and had a seizure for about 10 minutes. An ambulance was called and the patient was rushed to the emergency room. The outcome and causality of the events were not reported. Burning feeling at the injection site, passed out and seizure were considered to be other important medical events. Additional information has been requested.
Ipol was administered to patient on 04Oct2021 but the product had an expiration date of 03Oct2021 with no reported adverse event; Initial information received on 05-Oct-2021 regarding an unsolicited valid non-serious case from nurse, physician and consumer/ non healthcare professional. This case involves a 8 years old male patient who received POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) on 04-Oct-2021 but the product had an expiration date of 03-Oct-2021 (expired product administered).  No other vaccines were administered to the patient.  The medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  On 04-Oct-2021, the patient received a 0.5 mL fifth dose of suspect IPOL (Total, lot R1F97 and expiration date: 03-Oct-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (same day latency).  It was reported "Caller requests information on administering expired product."  At time of reporting, no adverse event reported.  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.
the patient had no side effects associated with the vaccination/ No additional AE information provided; received her second dose of VAQTA one week early; This spontaneous report was received from a bachelor of science in nursing and refers to a female patient of unknown age. There was no information regarding her medical history, concurrent conditions nor concomitant therapies provided.  On 09-DEC-2020, the patient was vaccinated with the first dose of hepatitis A vaccine, inactivated (VAQTA) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 24-MAY-2021 (reported as today), one week too early, she received the second dose of the vaccine (0.5 mL, lot # T035720, expiration date 15-APR-2022; route of administration and anatomical location were not provided) (inappropriate schedule of vaccine administered). The reporter stated that the patient had no side effects associated with the vaccination and no adverse event (AE) information was provided. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035720; expirationdate: 15-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability