chrisvoncsefalvay/vaers-outcomes huggingface dataset:
receives vaccines on delayed schedule, individually, not as combined products but like one a month with no adverse event; Initial information received on 01-Nov-2021 regarding an unsolicited valid non-serious case from consumer/ non health care professional via Health Authority (under reference: 00837153).  This case involved an unknown age male patient who experienced received vaccines on delayed schedule, individually, not as combined products but like one a month with no adverse event (inappropriate schedule of product administration) while receiving vaccines DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], IPV (VERO) [IPOL], HIB (PRP/T) VACCINE [ActHIB] and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect products DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], IPV (VERO) [IPOL], HIB (PRP/T) VACCINE [ActHIB] and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot number not reported via unknown route  On an unknown date, unknown latency after starting the suspect products, the patient developed a non-serious received vaccines on delayed schedule, individually, not as combined products but like one a month with no adverse event (inappropriate schedule of product administration).  No laboratory data reported.  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 was 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 was 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 had contributed to or is to be held liable for the occurrence of this medication error.  There would be no information on the batch number for this case.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient. A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 56 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 30Dec2020 as dose 1, single (Lot number: EK9231), in right arm, on 21Jan2021 as dose 2, single (Lot number: EL3249), in right arm, on 01Oct2021 as dose 3 (booster), single (Lot number: FD0809), in right arm and on 20May2022 as dose 4 (booster), single (Lot number: FM7553), in right arm for covid-19 immunisation. The patient's relevant medical history included: "gluten intolerance" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing); "migraine" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: SERTRALINE; MONTELUKAST; LORATADINE; METFORMIN; VITAMIN D [COLECALCIFEROL]; VITAMIN B COMPLEX; PROBIOTIC 10 [BIFIDOBACTERIUM BIFIDUM;BIFIDOBACTERIUM LACTIS;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS BREVIS;LACTOBACILLUS BULGARICUS;LACTOBACILLUS CASEI;LACTOBACILLUS PARACASEI;LACTOBACILLUS PLANTARUM;LACTOBACILLUS RHAMNOSUS;LACTOBACILLUS SALIVARIUS]; GUAIFENESIN; MUCINEX, start date: 22Nov2022, stop date: 04Dec2022; ACETAMINOPHEN, start date: 22Nov2022, stop date: 04Dec2022; IBUPROFEN, start date: 24Nov2022, stop date: 04Dec2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: 03Dec2022 relapse of Covid symptoms (HA, low grade fever, extreme fatigue, sore throat, cough and congestion) and positive antigen test 5 days after completing Paxlovid and 11 days after initial symptoms began 22Nov2022; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect products BNT162B2,BNT162b2 omi ba.4-5 (BNT162B2  cannot be fully excluded.
This case was reported by a nurse via call center representative and described the occurrence of injection site reaction in an unspecified number of patients who received Flu trivalent vaccine. On an unknown date, the patient received Flu trivalent vaccine at an unknown dose. On an unknown date, unknown after receiving Flu trivalent vaccine, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown. It was unknown if the reporter considered the injection site reaction to be related to Flu trivalent vaccine. Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that she was not sure, but there might had been an increased rate of localized injection site reactions at her facility with quadrivalent FLUARIX in patients compared to trivalent flu vaccines. The reporter stated that she was not sure of how many patients may had been affected. This case is linked with US2017GSK180863, as reported by same reporter for different suspect.
Became extremly light headed to the point of feeling like she was passing out.  Hard to breathe, hot, flushed
Morbilliform Rash;  Information has been received from a registered nurse concerning a 4 year old caucasian male patient with no known allergies and no past medical history who on 19 Jun 2000 was vaccinated SC in the right arm with a second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot # 634417/0260K).  Concomitan vaccinations on 19 June 2000 included a fifth dose IM in the left deltoid of diphtheria toxoid (+) pertussia vaccine (+) tetanus toxoid and a fourth dose SC in the left arm of poliovirus vaccine (IPOL).  On 23 Jun 2000 the patient's mother notified the physician's office that the patient had developed a measles-like rash.  follow up information from a registered nurse reported that the patient subsequently recovered.
pt recv vax 19NOV97 & 20NOV97 pt awoke w/swollen tongue & constrictive throat;to MD w/funny talk d/t swollen tongue & w/o resp distress;MD assessment was allergic rxn;pt to ER tx w/med;27NOV97 had second episode referred to MD dx allerg rxn
Hives/itching - Benadryl taken and is being taken every 4-6 hrs
Severe and debilitating multi-joint arthralgia.  Prior to this event, I did have some arthralgia, but nothing like the severity experienced starting 8/9.  Unable to roll over in bed, unable to bend knees, unable to lift arms using shoulders, unable to grasp and pull on socks, unable to lift coffee mug, unable to bend wrists, unable to turn head - without excessive pain or manual assistance.  Elbows, ankles, and thoracic spine and below not affected.  No apparent heat or swelling on any joint.  Muscle and tendon pain accompanied joint pain.  Duration approx. 2 weeks.  After this, pain began to improve slightly until Dr. appt.  Methylprednisolone dose pack resolved symptoms within 1 day.
Pt received vaccine on 4/20/21 at 1:00pm, observed 30 mins post injection with no adverse reaction noted. Pt collapsed at home early morning on 4/21 & transported to ED via ambulance where he later expired.
1/14/21- severe injection site muscle pain and feeling tired 1/15/21- very fatigued with low grade fever 1/16/21- fever to 100.4 with loss of taste and smell 1/17/21- no fever but still tired 1/18/21- taste and smell returned
12/1/21 pt had a positive COVID test and was admitted to hospital for COVID PNA; dc'd to home due to not requiring O2; 12/8/21 pt to ED via EMS again for worsening sx - increasing SOB, cough, weakness, diarrhea; O2 saturation 78% on RA; give O2, steroids, ABX, Remdesivir; pt's condition declined and he was placed on comfort measures and passed away in the hospital
16 year old received the first shot of the Moderna Covid vaccine; A spontaneous report was received from a pharmacist regarding a 16 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273)/Product administered to patient of inappropriate age.  No adverse event was reported after the administration of the vaccine.  The patient's medical history was not provided. No concomitant product use was reported.  On 25 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012M20A) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, it was reported that the patient who was 16 year old received the first shot.  Treatment information was not applicable.  Action taken with mRNA-1273 was unknown.  The outcome of the event, product administered to patient of inappropriate age, was resolved.; Reporter's Comments: This case concerns a 16-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 012M20A), reporting Product administered to patient of inappropriate age without any associated adverse events.
Estimate a couple weeks after vaccination (date unknown) started to have right pointer finger lose circulation some mornings.  By March 28 2021 became noticeable and bothering in some activities so seeked out Medical care. Blood flow would shut off to tip of right pointer finger at last joint and right pinky finger (whole finger) and would not recover until warm bath of hand given. Appointments made due to bothersome symptoms and preventing some activities and in an effort to determine cause. Treating by hydrating and staying warm and movement and avoid caffeine - still have symptoms on occasion. Undetermined cause - believed to be primary? Currently
Pain in left armpit radiating to side of breast. Swollen lymph node under left arm. Rash on left side near breast on 3rd day (10/12/2015).
There were no adverse reactions. Vaccine was administered 10 days before minimum interval was met. Patient had first dose of Hep B vaccine on 09.27.2021.
SAW DR . DR WAS NOT SURE IF IT WAS INFECTED SO HE PRESCRIBED A CREAM FOR THE ITCHING AND AN ANTIBIOTIC TO ONLY BE TAKEN IF IT GETS WORSE IN 2 MORE DAYS
The patient was vaccinated at another facility, but presented to our Emergency Department with reported fever of 101 at home and malaise and weakness.  Upon arrival, he was noted to be hypoxic at 91% on room air and tachycardic.  His evaluation ruled out PE, PNA, ACS, sepsis.  He was given oxygen therapy, nebulizer treatments and has been placed in observation.
Td vaccine given 11/4/02. Within 4 weeks, patient experienced pain in shoulder radiating to neck, down arms, sharp, stabbing pain and numbness. Patient states she cannot hold objects in her hand, lift heavy objects, difficulty with grooming, caring for children. Patient states she has difficulty driving, all ADL's. Patient went first to the Mobile Watch van where she received Vioxx and told to use Aleve. Patient status she went to the emergency room about a week later with pain in arms, shoulder and neck. Physician first suspected patient was having a heart attack. When that was ruled out, they prescribed Celebrex and referred patient to see her own physician. Patient was referred to a doctor of orthopedics. He prescribed Prednisone. Patient states Prednisone helped for a while. Patient is now seeing another doctor. He prescribed Bextra; patient states this has only given her minimal relief.  60-day follow up on 04/20/04: "Pt has not recovered from adverse event.  Nurse at health department called pt: "Arms not better.  Seen chiropractor.  No symptoms have gone away, on pain medication.  Pain is in shoulder through elbow into hand.  Sometimes can't move hand."5/19/04: Phone call to patient. Left message on voice mail. 5/19/04 PM. Phone call from patient. she is still feeling bad, on lots of pain medicine. No changes. Follow up report received 02/02/2005: Patient has not recovered from adverse event.  Patient continues to have mild arm and leg pain.  Takes Bextra for it.  Not thought to be vaccine related.  Symptoms did not start until 4 weeks past vaccination.
magnet sticking to their arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (magnet sticking to their arm) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (magnet sticking to their arm). At the time of the report, VACCINATION COMPLICATION (magnet sticking to their arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment medication were reported.   Reporter did not allow further contact
I have been having cramps in my stomach like; menstrual cramp or something; I have been having bloated in the stomach; I have been seeing a flashing blue and white light flashing, very bright; I am sitting here with flashes coming out my eye; From back of my head to the front of my right eye and it feels freaking today; I noticed the flicking of the light starting now after 8:00; Headache; 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 received bnt162b2 (BNT162B2), administration date 04Oct2021 (Lot number: 30155BA) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Lot 30135BA), for Covid-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "I have been having cramps in my stomach like"; DYSMENORRHOEA (non-serious), outcome "unknown", described as "menstrual cramp or something"; ABDOMINAL DISTENSION (non-serious), outcome "unknown", described as "I have been having bloated in the stomach"; PHOTOPSIA (non-serious), outcome "unknown", described as "I have been seeing a flashing blue and white light flashing, very bright; I am sitting here with flashes coming out my eye"; EYE DISORDER (non-serious), outcome "unknown", described as "From back of my head to the front of my right eye and it feels freaking today; I noticed the flicking of the light starting now after 8:00"; HEADACHE (non-serious), outcome "unknown", described as "Headache".  Additional information: The patient got the second shot on yesterday and she was having cramps in her stomach like and menstrual cramp or something and then having bloated in the stomach and seeing a flashing blue and white light flashing, very bright as she drive down the hallway she could see light up in the front of the car and backseat of the car (further not clarified). This ways of flashing light and then when she went into bed last night, she turned all the light off to walk upstairs and this light was so bright it kept coming from her right side of the eye like may be from back of the head to the front of the right eye and it feels freaking today. So she got the shot yesterday 1:00, maybe 01:30 and noticed the flicking of the light starting now after 8:00 and it's feels 6:00 now (not clarified). Patient had headache. Patient stated can somebody talk to her from medical representative or something because her Doctor had no idea what to tell.  No follow-up attempts are possible. No further information is expected.
Horrible genital herpes outbreak; This is a spontaneous report from a contactable nurse, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 27Jan2021(at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient previously received PCN for unknown indication on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 10Feb2021, the patient experienced horrible genital herpes outbreak. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken for the treatment of reported events which included valacyclovir (VALTREX) and pain medications(unspecified). The clinical outcome of the event horrible genital herpes outbreak was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a registered nurse concerning a patient who on an unknown date, was vaccinated with a dose of VARIVAX (Merck) (route and lot not reported). The nurse reported that on unspecified date the patient may had experienced a seizure after receiving VARIVAX (Merck). At the time of the report the outcome of the patient was unknown. Upon internal review, the patient may had experienced a seizure was considered to be an other important medical event. Additional information has been requested.
This spontaneous report as received from a nurse refers to an 11 months 3 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Moderna booster Experienced extreme fatigue, fever, tingling, chills, redness around injection site and down arm, patient states that she feels very weak. AE has been going on since 12/10/2021
Fever; Flu-like symptoms; Chills; Dizzy; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient). A 38-years-old female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever, flu-like symptoms, chills, dizzy on an unspecified date. Event took place after use of product. The outcome of the events was reported as unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
This spontaneous report was received from an office manager refers to an unspecified number of patients of unknown demographics. On an unknown date the patients were vaccinated with RECOMBIVAX HB (lot#, expiration date, dose and route were unknown) that underwent unsupported temperature excursions and no adverse effects reported. Follow up information was received from the office manager who reported that on 23-JUL-2013 one patient was vaccinated with RECOMBIVAX HB (lot# 1106AA, expiration date 05-APR-2014). This is one of the several reports from the same source. Additional information is not expected.
This spontaneous report was received from a pharmacist and refers to a 55-year-old female patient. The patient had no pertinent medical history. She had drug reactions/allergies to unspecified pain medicine and unspecified antibiotics. The patient was not pregnant. On 27-FEB-2017, the patient was vaccinated with ZOSTAVAX (lot # M033219, expiration date: 18-AUG-2017, vaccination) (dose and injection site were not provided) at the pharmacy. There was no concomitant medications. On 28-FEB-2017, the patient developed an unspecified rash (unspecified location on the body) and pain at the injection site (the site was unknown by the reporter). On 02-MAR-2017, the patient came to the pharmacy and the pharmacist described a red swollen area the size of a fist with a center the size of a kiwi, that was hard and darker. On an unspecified date, the patient took diphenhydramine hydrochloride (BENADRYL) for the rash. She has not consulted with her primary physician yet. Laboratory diagnostic studies were not performed. The outcome of the events was reported as not recovered, at the time of the report. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
3-20-22:  redness at injection site  and pain in a 1" diameter circle  and fever 100.1 degrees.  3-21-22:   fever gone and redness circle around injection site increasing  to about 2" diameter site along with an itch beginning .   3-22-22:  redness and swelling and more itching at injection site for about a 4" diameter circle.
Patient presented for virtual visit with complaints of persistent redness, swelling and mild pain at injection site.Concerned that the injection was given subq instead of IM, concerned about potential cellulitis. Pain, fever and swelling have decreased, not as red as prior, but patient outlined initial reaction site, and redness has slightly increased in size.
Information has been received from a health professional concerning a 5 year old white male with NKDA or medical Hx who on 01/15/2001 was vaccinated in his RL with a first dose of varicella virus vaccine live. On 02/17/2005 the pt developed only 30 lesions. Subsequently  on 02/24/05 the pt recovered.
Patient is 65 yo female with hx of MS.  Reports MS flares have occurred for her in the past when febrile.  She reported increased spasticity in her legs, and stiffness the day following the COVID vaccine.  It resolved on its own within one day.
Significant  pain and redness  all along upper arm; fatigue; upset stomach; headache
Rt thigh swollen, red, seen in ER diagnosed with cellulitis. However I believe more likely a reaction to MMRV given on 3/2.
Patient felt lightheaded and turned pale immediately after dose. He recovered within 10 minutes and was discharged after additional 20 min obs.