chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; This is a spontaneous report received from contactable reporter(s) (Nurse and Consumer or other non HCP).  An 87-year-old female patient received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Amloidosis" (unspecified if ongoing), notes: Past Medical History: Amloidosis; "asthma" (unspecified if ongoing); "atrial fibrillation" (unspecified if ongoing); "disorder of lipoid metabolism" (unspecified if ongoing), notes: disorder of lipoid metabolism; "hypertension" (unspecified if ongoing); "mixed hyperlipidemia" (unspecified if ongoing); "macular degeneration" (unspecified if ongoing); "Allergies: Penicillin" (unspecified if ongoing), notes: Allergies: Penicillin. Concomitant medication(s) included: FERROUS GLUCONATE; KLOR-CON; VITAMIN B12 [VITAMIN B12 NOS]; VITAMIN D3; FUROSEMIDE; ELIQUIS; SINVASTATINA; VALSARTAN. Past drug history included: Spironolactone, reaction(s): "Allergies: Spironolactone", notes: Allergies: Penicillin, Spironolactone. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset May2022, outcome "not recovered".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approximately one hour after receiving the vaccine her arm was very sore by 8pm, 12 hours later, she was very fatigued and had an upset stomach. She slept from 8pm to 5am with a very sore arm, upset stomach, pounding headache and bad body aches. She continued to sleep the remainder of the day after the vaccine.
VERBALIZED "EVERYTHING IS GOING BLACK". HEAD SLUMPED FORWARD, BODY FELL FORWARD. PLACED IN SUPINE POSITION. ARMS AND LEGS STIFFENED THEN CROSSED. EYES CLOSED. NOT VERBALLY RESONSIVE FOR 10-12 SECONDS THEN RESPONDED AND ASKED "WHAT JUST HAPPENED".
This spontaneous report was received from a registered nurse and refers to a 2 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 13-JUN-2016, the patient was vaccinated with improperly stored VAQTA (lot # L048456, expiration date: 25-MAY-2017; dose and route of administration were not provided). On the same day, the patient was also vaccinated with M-M-R II, VARIVAX, PREVNAR, DAPTACEL and ACTHIB. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
patient had a small deltoid surface area and was given the subcutaneous injection in the posterior aspect of the upper arm, no AE.; Initial information received on 03-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 11 years old male patient was received IPV (VERO) [IPOL] vaccine lot P1A251M, expiry date: 02-May-2020, via subcutaneous route in the posterior upper right arm instead of deltoid surface area on 03-Sep-2019.  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 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) in the left deltoid for Immunisation; and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) in the right deltoid for Immunisation.  It was an actual medication error case due to Vaccine administered at inappropriate site .  No adverse event 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.
mom noticed red dots on body 29MAY98 AM started diarrhea 28MAY98;
Within 5 mins. of injection, developed hives and tachycardia, pain at site. Took ALLEGRA 180 mg and symptoms resolved in 20" except for approximately 24h generalized not feeling well and 2 wks. soreness at site.
POST GARDASIL#2, PT BECAME LIGHTHEADED WHEN WALKING OUT OF OFFICE. CAUGHT BY FATHER. NO SYNCOPE. SUPINE FOR 5 MINUTES, BLOOD PRESSURE AND PULSE WERE OK. PT RECOVERED WITHOUT INCIDENT. PT IS AVID ATHLETE.
passed away; This is a spontaneous report from a contactable consumer. A 51-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was stated that patient passed away one week after receiving the 1st Pfizer covid vaccine injection. He was young and healthy. The patient died on an unspecified date due to unknown cause of death. It was unknown if an autopsy was performed.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away
flu like symptoms; painful injection; This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms and injection site pain. On an unknown date, the outcome of the influenza-like symptoms and injection site pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms and injection site pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient experienced painful injection and flu like symptoms after receiving vaccine. The reporter consented to follow up
Pt broke out in hives within an hour of receiving vaccine. Red and very itchy. Was given oral BENADRAYL and SOKMEDROL. No difficulty breathing. Improved within 24 hours. Also c/o leg pain on the evening of the 23rd. Pt has had a headache since getting the vaccine 10/27/09 PCP medical records received service date 10/23/09. Assessment: Rash, pruritis, post H1N1 vaccine
This spontaneous report as received from a physician refers to a 16 year old female patient. No medical history or concurrent conditions were reported. Patient was not on any concomitant medication. On an unknown date, the patient was vaccinated with GARDASIL 9 (dosing details and lot number not known). On 13-AUG-2016, the patient had a severe headache, a burning sensation in both of her legs, was not able to sleep and had missed one day of school due to leg pain. Patient sought medical attention by calling the physician on the phone and received treatment for the events. The outcome of the events of headache, pain in extremity, insomnia and burning sensation was reported as not recovered, while outcome of activities of daily living impaired was not known. Causality assessment was not provided. Additional information has been requested.
This spontaneous report as received from a physician via a company representative refers to a 19 year old female patient. On an unknown date the patient was vaccinated with the second dose of GARDASIL (lot # not reported). The physician reported that the patient developed mononucleosis after receiving the second dose of GARDASIL (date unspecified). The date of the first shot in the series was unknown. It was unknown if the patient planned to continue with the GARDASIL series. Laboratory studies performed included unspecified lab test (diagnosis of mononucleosis). The patient came to doctor to seek medical attention and was given unspecified medication for treatment. The outcome of mononucleosis was reported as recovered/resolved. Additional information has been requested.
Within four hours of receiving the vaccine body started shaking slightly; Another couple hours go by and entire body was jerking,; Could not even walk; Teeth were chattering; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 21Apr2021 at 18:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included acid reflux when the patient was younger kid. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 31Mar2021 at 18:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 21Apr2021 at 22:00, within four hours of receiving the vaccine, the patient experienced body shaking slightly, another couple hours go by and the entire body was jerking and her teeth were chattering (all uncontrollably). The patient could not even walk due to how intensely the jerking/shaking was. This continued all through the night, and didn't stop until around 8:00 the following morning. Since the vaccination, the patient had not been tested for COVID-19. The events 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 events. The clinical outcome of events body started shaking slightly, the entire body was jerking, could not even walk and teeth were chattering were unknown at this time of this report.   No follow-up attempts are needed. No further information is expected.
Hives popped-up and went away all over her body. Itched badly. Antihistamines have helped.
Never was diagnosed for Herpes or had any symptoms. But a month after started getting severe symptoms; swelling on penis tip; sores on eye lids; This is a spontaneous report from a non-contactable consumer (reported for himself). A 39-year-old male patient received BNT162B2 (BNT162B2 Formulation: Solution for injection Batch/Lot number: Unknown Expiration Date: Unknown) via an unspecified route of administration on 28Apr2021 (at the age of 39-year-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. On 29Jun2021 Patient Never was diagnosed for Herpes or had any symptoms. But a month after started getting severe symptoms including swelling on penis tip, sores on eye lids. Have since been getting all symptoms and ashamed of himself. The only time he had sexual encounter was 12years ago never since. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown result. Outcome of all the events was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Pt reported on 2/4/10 that he had boils on his neck after vaccine administration
Patient reported that three days after receiving the vaccine, she developed swelling in left leg, ankle, hip, shoulder and hand. The symptoms stayed for a week and patient's leg was tingling, left hip aching, left shoulder pain, left hand feels like pins and needles, Achy all over and felt unwell.
pt had anxiety over getting the shot but felt forced by her employer since she is a nurse. pt had nause, shooting pain  and stiffness in neck, headache, sore arm.
Ringing in left ear and brain area (tinnitus) Received hearing test, MRI  and sinus exams Nothing found other than age related normal hearing loss
I began feeling sick with symptoms like fever, chills, nausea, vomiting, rash/spots.  Symptoms got worse over the next few days, and I ended up being admitted in the hospital for thrombocytopenia for 5 days.
Administered 1 ml instead of 0.5 ml; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Administered 1 ml instead of 0.5 ml) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 ml. On 26-Aug-2021, the patient experienced ACCIDENTAL OVERDOSE (Administered 1 ml instead of 0.5 ml). On 26-Aug-2021, ACCIDENTAL OVERDOSE (Administered 1 ml instead of 0.5 ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug was not reported.  Treatment medication was not reported.
Extreme Chills, Muscle Aches, Tiredness, Joint pain throughout the body. Rest and Motrin used. Length: 48hrs
left mandibular pain Narrative:  24 hours after 1st vaccination, felt severe left mandibular pain and fear that she will have dislocation of jaw. Fear of opening mouth., Pain grade 8/;10 now 4-/10 with use of Motrin 200mg 3x aday with Famotidine
Information has been received from a 29 year old female healthcare student who on 20-OCT-2006 was vaccinated with a 0.5 ml subcutaneous dose of MMR. Concomitant vaccine administered on the same day, but at a different site included RECOMBIVAX HB. "Two days post vaccination," on 24-OCT-2006, the patient developed a fever, muscle and joint pain, and injection site pain. The fever had since resolved, but the pain symptoms, while improving to some extent, have remained at the time of the report. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
pt recv vax;profound hypotonia;pt seemed to lose developmental milestones,dec vocalization,did not use rt arm as well;
A report was received from a health professional on 10/23/2002, concerning a female vaccinee of unknown age who inadvertently received frozen Fluvirin vaccine on 10/23/2002.  The vaccinee did not experience any adverse event. There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP-2002-00585, PJP-2002-00775. Update 1 12/23/2002 A report was received from a healthcare professional which indicated that the event resolved on an unspecified date.
Fatigue; Arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 15:00 (Lot number: EW0150) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: TRELEGY; SINGULAIR; FLONASE [FLUTICASONE PROPIONATE]; AMBIEN; ALBUTEROL [SALBUTAMOL]. The following information was reported: FATIGUE (non-serious) with onset Apr2021, outcome "not recovered", described as "Fatigue"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "not recovered", described as "Arm pain". Therapeutic measures were not taken as a result of fatigue, pain in extremity.  Additional Information: No known allergies. No other vaccine in four weeks. Unknown if she got Covid prior vaccination. Not Covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021497049 Same reporter/patient/vaccine, different dose/events
had a stroke; Bell's Palsy; he didnt feel well; This case was reported by a consumer via call center representative and described the occurrence of stroke in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced stroke (serious criteria hospitalization and GSK medically significant), bell's palsy (serious criteria hospitalization and GSK medically significant) and feeling unwell. On an unknown date, the outcome of the stroke, bell's palsy and feeling unwell were unknown.   It was unknown if the reporter considered the stroke, bell's palsy and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that after he got his second dose of shingrix he didnt feel well, went to the hospital, had a stroke and Bell's Palsy. The reporter did not consent to follow-up.
doctor had placed an order for a Daptacel, Daptacel was drawn up for a patient, according to the patient record the Daptacel was not needed, no AE.; Initial information received on 20-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a child patient (age and gender not reported) for whom a doctor placed an order for a DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5366AA, expiry 07-Feb-2020) on an unknown date.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of potential medication error due to product prescribing error. Caller stated that a doctor had placed an order for a Daptacel. Once the staff drew up the Daptacel, the mom showed the doctor the vaccine record for her child and the child wasn't due for a Daptacel.  It was unknown whether the vaccine was administered 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 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.
Solider was provided incorrect second dose.  Initial dose of vaccine was Moderna on 11/4/2021, but accidentally received Pfizer vaccine on 12/11/2021.    At time of completion of this form, solider is feeling well with no current symptoms.
Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Sore arm). The outcome of the pain in arm was resolved (duration 3 days).   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 23-MAR-2023 This case was reported by a patient via interactive digital media. The patient have to wait 3 months minimum between 1st dose and 2nd dose. The patient did her/his last summer and had no issues only a sore arm for 3 days. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.
LEFT ARM SWELLING TO THE POINT UNABLE TO RAISE ARM IN LATERAL MANNER. CALLED INTO WORK SICK CAUSE COULD NOT LIFT EITHER  1 YEAR OLD TWIN.  Also viral illness set in causing patient to miss 2 days of work.
Initial misuse report received from a healthcare professional on 01 August 2013. An 11-year-old patient was administered a dose of DAPTACEL. No other information was provided. Documents held by sender: none.
Employee c/o tingling, numbness and cold sensation in right arm, right side of neck and Right ear, shortly after receiving the Hepatitis B Vaccine. Also pain in Right hand, fingers and all of her right arm. Also had 50 cent size rash on injection site. Seen in ER and admitted to hospital. Diagnostic tests done and CVA was ruled out. Symptoms resolved except for some tingling and swelling in right hand and elbow. Released the following day and followed up 2 days later with Occupational Health physician.
Initial solicited report received on 22 October 2013 an investigator participating in the below mentioned trial. A 30-year-old male subject with no reported past medical history had received smallpox (vaccinia) vaccine, live (ACAM2000, lot number, route and site not reported) on 31 March 2011 and 16 days later was found to have on 16 April 2011 an elevated Troponin. The subject had a Troponin I level on 14 April 2011that was 0.64 ng/mL. Troponin was unable to be rechecked due to broken tube. The subject was asymptomatic. An ECG on 18 April 2011 was normal. The subject was seen by cardiology who performed and ECG and echocardiogram, they ruled out myopericarditis and the subject returned to fully duty. Troponin was redrawn on 18 April 2011 and rapid was within normal limits (WNL). Outcome was not recovered. According to the investigator, the event of elevated Troponin was considered an other important event and possibly related to vaccination. Relationship to investigational product according to company: associated. The serious adverse event did not lead to the termination of the subject from the study. List of documents held by sender: none. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Follow-up information was received from the investigator on 07 November 2013. Lot number and site of ACAM2000 was unknown, route was percutaneous. Final diagnosis and results of pending EKG was no cardiac pathology found. Date of outcome was unknown. Documents held by sender: None. Follow up information received on 07 April 2016: The subject's race was updated. The event elevated troponin was resolved on 18 April 2011. A questionnaire of smoking and drinking habits was received. Sender's Comments: Follow-up information received on 07 April 2016, does not change the previous medical assessment. A central lab troponin elevation in a male subject 16 days post-vaccination with ACAM2000. The patient had no symptoms. ECG was normal. This represents a case of potential myopericarditis per the Investigator and has subsequently been referred to the ACAM2000 Myopericarditis Adjudication Committee for assessment. Myopericarditis is a known event following vaccination with live vaccinia virus and is listed in the reference safety information. Follow-up information on 07 November 2013 did not alter prior assessment.
Pt reported full body neuropathy with burning and tingling of her skin on her entire body for 2 days.  c/o  skin hurting to touch, unable to sleep. Completely resolved spontaneously after 2 days.