chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client started becoming very fussy/cranky in afternoon & it became more severe during evening & night. Morning of 4/7/10 clients upper right arm inflamed with indurated area "size of silver dollar" per mother at site of lower IM injection. By 4/8/10 inflammation & fussiness resolved. Given MOTRIN x 3 4/6/10.
02/07/22 presents to ED for "Groin pain". PMHx of "CAD, CABG, paroxysmal atrial fibrillation not on anticoagulation, hyperlipidemia, hypertension, DVT, CHF, prostate cancer, Crohn's disease collocated by fistula with abscess, history of colostomy takedown and hernia repair of parastomal hernia in January 2021"
BRAIN FOG; DIZZY; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for  this case. No concomitant medications were reported. On APR-2021, the subject experienced brain fog. On APR-2021, the subject experienced dizzy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from brain fog, and dizzy. This report was non-serious.
Left arm from shoulder red and swollen on 10/26/08 per mother. Redness and swelling decreased on 10/27/08 to about the size of an orange.
Tingling and numbness in arm. History of cervical and thoracic spine fusion. She was feeling the spasms prior to receiving the flu shot and still feels the same spasms.
sore injection site arm; felt fatigued for a day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (felt fatigued for a day) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (felt fatigued for a day). At the time of the report, VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (felt fatigued for a day) outcome was unknown.            No concomitant medications was reported.  No treatment drug details was reported.   This case was linked to MOD-2021-367699 (Patient Link).
I experienced the known, Headache, body/joint pain, injection site pain....what followed was severe abdominal pain followed by frequent diarrhea & high levels of gas.  This started approx 10 hours after my second injection(on Wed 4/14/21)and lasted until midday 4 days (Sunday 4/18/21).  I did not run a temperature.  After waiting for it to go away (48 hours),  I called COVID-19 line and they said to go to BRAT diet.  I did that & added Pedialyte to replenish electrolytes & help with the extreme fatigue(over and above my usual MS fatigue).  I also treated the extreme gas with gas-x chewable tablets.  The diarrhea was like prepping for a colonoscopy, nothing stayed in my system & the stools were very loose & yellow in color.
The patient had requested a Moderna booster dose for his Moderna series. After registration, the vaccinator mistakenly administered a Pfizer booster dose instead of the requested Moderna dose. The patient was made aware of the situation and he left after his 15 minute wait time. The booster is available to mix with other brands, so no adverse events occurred.  The proper dose given was recorded for his PrepMod record.
Chicken pox dx 12/1/00. Rash lasted 8 days and resolved without complications.
sudden onset 5 days post inject; fever to 104 oral, joint pain, h/a, chills;
She tested positive for COVID 1/10/22. She was subsequently hospitalized 1/11/22.
left sided chest pain and shortness of breath approximately 1 month started after the vaccine, worse at time of presentation having shortness o f breath on exertion
Patient had flushing/sweating and dizziness, BP 112/71, HR91, RR16. No documentation of outcome
She complaint about itchiness on the arms and body so I gave her the liquid Benadryl  50 mg .  She feels her throat and tongue is numb so I asked patient if she wants to go to the ER but  she said she does not  need to go  ER.  She feels little dizzy and blurred vision due to possible side effect from Benadryl.
Only diluent was used; Only diluent was administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number amxa762a, expiry date October 2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional Information: GSK Receipt Date: 31-JAN-2023 Reporter's Comments: HCP was the reporter.  The reporter mentioned that only the Menveo diluent (MenCYW-135) was administered to a patient. Minimal information available. The reporter consented to follow up. Additional Supportive Information: The patient received only nly the Menveo diluent was administered to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Redness, swelling, and warmth over the right deltoid area. States there is tenderness to the site as well.
Frequent headaches since receiving the vaccine 11 days ago with tingling in fingers on left hand; Frequent headaches since receiving the vaccine 11 days ago with tingling in fingers on left hand; This is a spontaneous report from a contactable 68-year-old male consumer reported for himself that who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Arm Right on 28Jan2021 17:30 (Batch/Lot number was not reported) as, SINGLE for covid-19 immunization. The patient's medical history included allergic to penicillin, erythromycin and lactose intolerant from an unknown date and unknown if ongoing. Concomitant medications included simvastatin, lisinopril and primidone; all used for unknown indication start and stop date was not provided. On 29Jan2021 at 07:00 AM, the patient experienced frequent headaches with tingling in fingers on left hand. Patient was not received any treatment. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. The outcome of both events was not recovered.  Follow-up attempts are completed. No further information is expected.
Itching at the injection site; Reaction of a rash; Redness at the injection site; Swollen injection site; Tender to the touch injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE RASH (Reaction of a rash), VACCINATION SITE SWELLING (Swollen injection site), VACCINATION SITE PAIN (Tender to the touch injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (to sulfur) and Penicillin allergy. Concomitant products included LISINOPRIL, LEVOTHYROXINE, RIVAROXABAN (XARELTO), METOPROLOL TARTRATE, VITAMIN D3 and CALCIUM for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swollen injection site) and VACCINATION SITE PAIN (Tender to the touch injection site). On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE RASH (Reaction of a rash) and VACCINATION SITE ERYTHEMA (Redness at the injection site). The patient was treated with LORATADINE (oral) ongoing since an unknown date for Itching, at a dose of 1 dosage form every 24 hours. At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site) had resolved and VACCINATION SITE RASH (Reaction of a rash), VACCINATION SITE SWELLING (Swollen injection site), VACCINATION SITE PAIN (Tender to the touch injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
FLUMIST given 3-11-16 exp 3-9-16. Medimmune case # IL257901.
I noticed when I took my shower that my private part was swollen. I called my dr and he told me it?s probably a reaction and to fill this form out.
Paralyzed with GBS. On ventilator for two months. In hospital for six months. Residual numbness and balance problems. Uses walker Medical record states fever, apnea, ptosis, dysphagia, injury accident, pain.
Began with fatigue, next day developed myalgia, arthralgia, fatigue, fever, chills and malaise.  Following day after diffuse sweating mainly fatigue and weakness.  Also developed moderate tender axillary lymphadenopathy.  Except for adenopathy symptoms mostly resolved in a little over 48 hours.  Injection site moderately sore.  Had Covid back in November 2020.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 23-SEP-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1 injection, lot # S022584, expiration date: 31-OCT-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Patient describes since recieving flu shot on 12/11/07 she has been experiencing discomfort in her upper arm making it painful to move arm in certain directions.  She doesn't believe this is a normal reaction because she has had flu shots in the past with no difficulty.  She spoke to a pharmacist at a local pharmacy, not ours who stated that the needle may have punctured a vein or nerve.
Lost sense of taste 3 hours after vaccine and it hasn't returned as of today> 4/30/21; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 27Apr2021 at 13:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Apr2021 at 16:45, 3 hours after vaccine, the patient lost sense of taste and it had not returned as of the present day, on 30Apr2021. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lost sense of taste was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
She is now having floaters in her right vision of her right eye.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021417155 (Pfizer).  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14Apr2021 04:45 (Lot number: EW0153) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer,, lot number=ER8730,, administration date=24Mar2021,, administration time=04:45 PM,, vaccine_ ocation=Right arm,, dose number=1.), for Covid-19 Immunization. The following information was reported: VITREOUS FLOATERS (non-serious) with onset 15Apr2021 10:30, outcome "unknown", described as "She is now having floaters in her right vision of her right eye.".  Clinical course: The vaccine was given in the right arm, and today her right eye was affected. The patient had multiple floaters, and some with a tail. The patient had an appointment today at 14:00 to see her optometrist. The patient never had this many floater in her eye before, especially with the tails. The patient reported that she did not saw a side effect about vision after the vaccine.  Additional information: The patient did not receive other vaccine within four weeks prior to COVID vaccine. Other medications in two weeks: Centrum silver multi vitamin. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit. It was unknown whether the patient received treatment for adverse event or not. The patient did not had COVID-19 prior to vaccination. The patient was not tested for COVID post vaccination. The patient did not had known allergies.  No follow-up attempts are possible. No further information is expected.
PATIENT RECEIVED VACCINE THAT IS APPROVED FOR 16 YEARS OLD AND OLDER WHEN PATIENT WAS ONLY 15 YEARS OLD.
Exactly 2 weeks after my second shot: sore throat, congestion, loss of taste/smell for a few hours.
lasting non-productive cough-has not changed since symptoms started in the evening of 11/25/21, exposure-wife positive for covid,
Erythema with minimal swelling at injection site of varicella vaccine (left arm given subcutaneously) no tenderness or warmth on palpation no induration improved with 25 mg of BENADRYL given orally (No systemic symptoms).
NAUSEA; FATIGUE; MUSCLE SORENESS ALL OVER BACK; LOW ENERGY; This spontaneous report received from a patient concerned a 45 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced muscle soreness all over back. On 11-APR-2021, the subject experienced low energy. On 13-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle soreness all over back on 12-APR-2021, and had not recovered from fatigue, low energy, and nausea. This report was non-serious.
General fatigue x 72 hours, nausea without vomiting x 48 hours, diarrhea x 48 hours, body aches x 48 hours, lightheadedness/dizziness x 72 hours, fever > 100F x 24 hours, conservative treatment at home - returned to baseline at 4 dats post vaccine.
Break out on face and neck small bumps and scars and left arm. Patient had pneumonia. 3 meds given but do not go away antibiotic 1 day Oct 16 204 FLUVIRIN Multidose and VAX 23 Sept 17 2014.
Swelling of throat and tongue, anaphylaxis, hives, redness, swelling
expired doses of fluzone high dose quadrivalent were administered with no reported adverse event; Initial information received on 11-Oct-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age and unknown gender patient to whom expired doses of Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] were administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, formulation, dose, route: unknown) (lot number: UJ742AC and expiry date: 30-Jun-2022) in unknown administration site for Immunization, reportedly expired doses were administered with no reported adverse event (expired product administered) (unknown latency).  Action taken was not applicable.  At time of reporting, the outcome was Unknown.  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.
Per patient "The site is half way between my elbow & shoulder. It was swollen and red quickly after the injection and I had a headache. Now it's almost 2 weeks post injection and the site remains very red (in fact seems to be enlarging) and is painful like someone punched me plus it feels hot and itches".
With first dose of covid Pfizer got rash on arms and rash on chest. Rash on chest was at its worse ten days after second vaccine. Second covid vaccine was done 3/20/21 Pfizer lot # GR8727
ARM BECAME VERY SORE AT INJECTION SITE STARTING A FEW HOURS AFTER INJECTION. THE FOLLOWING MORNING, PATIENT AWOKE WITH CHILLS, BODY ACHES, AND OTHER FLU-LIKE SYMPTOMS AS WELL AS TINNITIUS. AS THE DAY PROGRESSED, PATIENT FELT TINGLING ACROSS BACK, TOOTH SENSITIVITY, AND A LARGE RED AREA SURROUNDING THE INJECTION SITE. ALL ADVERSE EVENTS DISSIPATED AFTER 24 HOURS EXCEPT THE RED PATCH WHICH HAS PERSISTED TO TIME OF REPORTING 3 DAYS POST-INJECTION.
This is a spontaneous report from a contactable consumer or other non hcp. A 41-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 at 15:30 (at the age of 41-years-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported.Patient had no known allergies. The patient's concomitant medications were not reported. The patient received no other vaccine in four weeks and no other medications in two weeks. Historical vaccine included bnt162b2 via an unspecified route of administration, administered in Arm Left on 03Feb2021 at 14:15 (at the age of 41-years-old) as dose 1, single for covid-19 immunisation. On 25Feb2021 at 01:00, the patient experienced nausea, insomnia, loss of appetite, chills/shivering, low grade fever, dizzy, swollen lymph node near breast on side of shot and exhausted. No treatment was given for the events. Patient was not covid prior vaccination. Patient did not test for covid post vaccination. Outcome of the events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Muscle pain I got about 3 days after my second dose still persist three months later; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain I got about 3 days after my second dose still persist three months later) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Muscle pain I got about 3 days after my second dose still persist three months later). At the time of the report, MYALGIA (Muscle pain I got about 3 days after my second dose still persist three months later) outcome was unknown.            No Concomitant Medications details were provided. No Treatment Medications details were provided.   Reporter did not allow further contact
About 1 hour after Nausea, vomiting.  Days later a large local reaction.  Then inability to move left arm.  Progressive decline in her autonomic nervous system and now she is in a wheel chair.
Within 24 hrs I started having weakness in my legs, that was wed. P.m., thurs., fri.,sat.,sun., had extreme weakness in legs and severe shortness of breath. Saw dr on that Mon., he did an EKG I was in total v-tack, he called for ambulance , , taken to hospital.  Released on wed nite, echo car diagram showed no heart problem, I have also had a heart mri which results were perfect. In other words this booster sent me to the hospital in a dire condition. I was put on heart meds to be taken till heart MRI whicH made my hair fall out in clumps
Rash over the entire body; Severe Chills; Body ache; Vomitting; Nausea; Frequent urination; Fatigue; Headache; This is a spontaneous report from a contactable consumer, the patient. A 69-years-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6199) via an unspecified route of administration in the right arm on 04Mar2021 at 15:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included COVID-19 (Lot number: el 9267) (MANUFACTURER UNKNOWN) unspecified route of administration in the right arm on 11Feb2021 for an unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 15Mar2021, the patient had experienced fatigue, headache. On 16Mar2021 the patient had experienced severe chills, fatigue, headache, body aches, vomiting, nausea, frequent urination. On 17Mar2021, the patient had experienced rash over entire body, fatigue, headache, body aches. The patient did not receive any treatment for the events. The clinical outcome of fatigue, headache, severe chills, fatigue, rash over entire body, body aches, vomiting, nausea and frequent urination were not resolved. No follow-up attempts are needed. No further information is expected.