chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt reports that his arm began to swell around the site of the injection and then more into that same arm.  He reports that he developed a fever.  Pt reports that he later developed chills.  Pt does not have a thermometer and cannot tell us the degree of his reported fever.  He states that over the course of the day the swelling in his arm did go down.
After eating a burger and fries  about 1 PM, I became nauseated and had a headache at about 8 PM. I laid down hoping it was just fatigue, but soon began to vomit. I vomited several times over the course of the next few hours. I slept most of the next day. I left work early on Wednesday, still feeling weak, tired, and with a new symptom of chest pain when taking a deep breath. Given my age, family history, and Covid infection in March 2020, I considered that it was possible my symptoms were of a heart attack, not food poisoning as I first thought. So, out of an abundance of caution, I went to the ER to get checked out. Tests all came back normal for heart activity, esophageal integrity, and absence of blood clots. Today (Friday, May 6) I once again feel fine and believe my symptoms were indeed food poisoning. I heard that a friend of my son ate at the same restaurant and was vomiting the same day. This was all unrelated to my Covid vaccine, but here is the data you wanted!
Injection site swelling, red, warm, and itching lasting more than 3 days.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with third dose of GARDASIL (route of administration and dose were not reported). On an unknown date the patient received third dose of GARDASIL to early; one month after the second dose. No adverse effect reported. Additional information is not expected. Reporter did not wish to be contacted.
This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine; batch/lot# EN6208), at the age of 59, via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient had no medical history and there were no concomitant medications. The patient stated that she took the COVID-19 vaccine on Monday. She had been sick since that Monday until the day of report. The patient stated the symptoms they go and come back and same again. On Monday, patient's arm was sore (that was expected). On Tuesday morning she woke up with a cough. On Wednesday, she had fever, and had been shivering. The patient had fever and a cough. On Thursday, the cough stopped, and she had diarrhea. On Friday, patient had a headache and lost her taste. She lost taste since that Friday until the day of report. The patient was coughing and shivering no matter what she took. Nothing really helped. The patient took Tylenol. It helped for a while, then after that she went back to the same point again. The patient stated the cough was back where it was before. The patient could not even go to work, she felt so weak. She had muscle aches all over her body; her bone all over. She was wondering if she had to go for the second dose. The patient underwent lab tests and procedures, which included COVID test: result unknown on Mar 7, 2021. The outcome of cough, shivering, lost taste: not recovered; and outcome of other events: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Patient states she has been having some dull muscle pain in her arm since she was given the vaccine- no sharp shooting pain or nerve pain reported. She also states that she has a torn rotator cuff in the shoulder of the same arm but does not believe that the pain could be related to this. She has been using warm compresses on the area.
Patient reports Rash morning after vaccine was recieved, patient seeked medical attention two days after 5/28/2021 due to rash  and itching through out the body, more particularly on his legs, hands and feet.  Reports rash is intermittent.   Patient denied any medication use, changes in products or history any allergies.
After being full vaccination with Moderna this patient tested positive for COVID-19 on 8/5/2021.
Shingles.......given Valtrex.......still having some fatigue......diagnosed on  02/09
Patient was administered a dose of the monovalent COVID-19 vaccines after they were no longer authorized. Patients' parents were notified and they did state she had some cold symptoms. She came into our clinic 05/17/2023 and was given ibuprofen 100 mg/5 mL oral suspension for her acute upper respiratory infection.
Patient was 15 years old when administered a covid vaccine. Not for use in less than 16.
Reported 12/12/13 at 10 AM. Received TC from Dr. office. Dr. reported that this pt developed hematoma 4-5 days after vaccines were given to pt. Pt is on aspirin po QD. Also, Dr. reported that pt developed nausea, anorexia and weight loss 6-7 day after shots. LFTs were done - WNL, as per Dr. Pt. completely recovered.
Patient was given Pediatric Pfizer vaccine on 10/8/2022 with short-dated expiration (9/30/2022), notified by manufacturer 10/12/22. After administration, stability data provided stability through 10/19/22. Patient notification not required. No adverse event occurred. Reporting was required by Office
2 1/2" area of redness and swelling on L deltoid, shoulder pain, hard to move arm. Tx ibuprofen and heat.
19 year old client was given an adult dose of Hep B Vaccine. Unlike the other immunizations Hep B changes from adolescent to adult dosing at age 20. He B vaccine administration reviewed on CDC immunization web site.
MODERNA COVID 19 VACCINR EUA 102 FEVER  headache chills and sweats
1415- Patient in observation, recovering from 2nd vaccination. Complained of feeling dizzy.  Very anxious prior to receiving vaccination, needed the support of several nurses to keep her calm, per NP. NP evaluating patient. EMS here.  EKG leads attached.  BP initial 170/118; HR 49-52. Sat on RA 98%.  Monitor shows sinus bradycardia, ? > pr interval, inverted T waves.  O2 3 L np applied at 1428.  No change in HR . BP 168/98.  EMS wishes to transport patient to hospital.  Patient has refused.  Patient signed AMA form, and completed Observation time without incident. Police Department Sargeant to speak w patient, advising her she should notify a family member and not drive, etc. Patient appeared lucid to Officer.  He had no reason to detain her. Patient exited clinic using her walker @ 1450.
LIGHTHEADEDNESS; CHILLS; FEVER 8 HOURS AFTER VACCINATION; This spontaneous report received from a patient concerned a female of unspecified age. 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 MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced lightheadedness. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever 8 hours after vaccination. Laboratory data included: Body temperature (NR: not provided) 100 + (unit not provided). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever 8 hours after vaccination on MAR-2021, and the outcome of chills and lightheadedness was not reported. This report was non-serious.
Pt recv vax on unknown day; post vax pt exp vax site rx of redness & warmth
Canker sores in mouth and tongue, painful; canker sores in mouth that were painful also; red spots on Uvula and throat; This case was reported by a consumer via call center representative and described the occurrence of canker sores oral in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   The patient's past medical history included canker sore (getting often prior to menopause). Concurrent medical conditions included sore throat.   On an unknown date, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2021-2022 season. On an unknown date, 24 hrs after receiving Shingrix and Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced canker sores oral, oral pain and petechia. On an unknown date, the outcome of the canker sores oral, oral pain and petechia were not recovered/not resolved.   It was unknown if the reporter considered the canker sores oral, oral pain and petechia to be related to Shingrix and Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were reported as follows: The patient self-reported this case. The patient gets sore throats more often and she takes allergy pills thinking that it may be some type of drainage issue.   The patient used to get canker sores often prior to menopause. The patient received her first dose of Shingrix about 3 months ago of reporting date, it was given in right arm.   The patient also received the Flu vaccine at the same time but it was administered in the left arm.   Within 24 hours the patient developed small canker sores in her mouth that were painful but only lasted a couple of days and then went away.   Since then, the patient got red spots on her Uvula and down her throat as well as small canker sores on her tongue, that also lasts a couple of days then goes away.   The patient stated that these events come back on a regular basis.    The reporter consented to follow up. GSK note- Time to onset for cancker sore was provided as 24 hours in structured field, however the narrative it is mentioned as within 24 hours. Time to onset captured as per structured field
This spontaneous report was received from an office manager and refers to a 19 year old male patient. The patient's concurrent condition included developmental delay, scoliosis, microcephaly, hydrocephaly and allergy to BACTRIM. The patient did not have any concomitant medications. On 19-MAR-2015, the patient was vaccinated with the first dose of GARDASIL 9 (expiration date: 19-FEB-2017, exact dose and anatomical location were not reported, intramuscular). The reporter reported GARDASIL 9 with lot # K006960 which was not valid for GARDASIL 9. However, Lot # K006960 is valid for GARDASIL. On 24-AUG-2016, the patient was vaccinated with the second dose of GARDASIL 9 (lot # reported as M017983, expiration date 30-MAY-2018, exact dose and anatomical location were not reported, intramuscular). A few minutes after the patient was administered the second dose of GARDASIL 9, he became dizzy, pale and lightheaded. The patient was immediately laid down and monitored for several minutes. Once he recovered on the same day, he left the facility and had been fine since. There were no laboratory tests performed. The relatedness between pallor, dizziness, lightheadedness and GARDASIL 9 was not reported. Additional information has been requested.
Low Fever Tuesday that turned into a High Fever at Night (102), only giving him both Tylenol and Motrin together brought the temp down; Wednesday just a fever around 100 to 101; Thursday low fever with a rash developing on neck and face; Friday no fever but rash
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 66-year-old female patient who received SHINGRIX (batch number 79N59, expiry date 30th January 2020). On 9th March 2018 03:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th March 2018 03:30, immediately after receiving SHINGRIX, the patient experienced injection site swelling (serious criteria other: as per reporter), injection site bruising (serious criteria other: as per reporter), injection site pain (serious criteria other: as per reporter) and injection site erythema (serious criteria other: as per reporter). The patient was treated with Ice Pack (NOS). On an unknown date, the outcome of the injection site swelling, injection site bruising, injection site pain and injection site erythema were recovering/resolving. The reporter considered the injection site swelling, injection site bruising, injection site pain and injection site erythema to be almost certainly related to SHINGRIX. Additional details were reported as follows: This case was reported by a pharmacist for herself. The patient received SHINGRIX on left arm. The events were immediately treated with the intervention of an ice pack.
Received Covid vaccine and tested positive for Covid 10 days after; Received Covid vaccine and tested positive for Covid 10 days after; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient received COVID vaccine and tested positive for COVID, 10 days after on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
I have experienced low-level numbness/tingling in my left hand; primarily in my thumb and index finger. Range of motion has been normal. No pain either. Strangely it began 1 week after my first injection. It was intermittent in the time after that and before the 2nd injection. On the day of the second injection I experienced renewed symptoms in the same hand immediately after receiving my 2nd dose. I spoke with the attending physician at the time and was told that she had heard about some instances of numbness but it would probably fade with time. Unfortunately I am now over 2 weeks since the second dose was administered and my symptoms have been nearly constant and do not appear to be waning.
Breakthrough COVID infection; Breakthrough COVID infection; This is a spontaneous report from a contactable Nurse. This Nurse reported in response to HCP letter. A 29-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EH9899 and expiry date: unknown), dose 2 via intramuscular, administered in Deltoid Left on 07Jan2021 as 2nd DOSE, SINGLE for Covid-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced breakthrough Covid-19 infection on 17Feb2021. The patient underwent lab tests and procedures which included an asymptomatic COVID test (COVID 19 PCR-done of state) prior to visiting elderly family on 17Feb2021 which was positive. The patient was then re-tested using SARS-CoV-2 on 22Feb2021 and 23Feb2021, both of which were negative. The patient was not hospitalized and not admitted to an Intensive Care Unit. The patient did not display clinical signs at rest indicative of severe systemic illness. The patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. The patient did not experience respiratory symptoms like Dyspnea, Tachypnea, Hypoxemia, COVID-pneumonia, Respiratory failure, Acute Respiratory Distress Syndrome (ARDS) and cardiovascular symptoms like Heart failure ,Cardiogenic shock, Acute myocardial infarction, Arrhythmia , Myocarditis and Gastrointestinal/Hepatic   symptoms like Vomiting, Diarrhea ,Abdominal pain, Jaundice, Acute liver failure and vascular symptoms like Deep vein thrombosis, Pulmonary embolism, Limb ischemia, Vasculitis and  any other thromboembolic events) and renal symptoms like acute kidney injury, Renal failure and Neurological  symptoms like Altered consciousness, Convulsions/seizures, Encephalopathy, Meningitis, cerebrovascular accident and Hematological symptoms like thrombocytopenia, Disseminated intravascular coagulation and dermatological  symptoms like Chillblains, Erythema multiforme and other symptoms like multisystem inflammatory syndrome. The patient did not receive any additional therapies for COVID-19.  On an unknown date in Feb2021 the outcome of the events was recovered.  Follow up attempts are needed. Further information has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 or comirnaty to the reported event vaccination failure and covid-19 cannot be ruled out.
Patient received Covid Vaccine (Moderna)  at  at 13:44. At 14:00, patient states "I'm having trouble swallowing." Dr  assessed the patient, orders given to call EMS. EMS called at 1400. Patient is spanish-speaking, and Dr. speaking spanish, no interpreter needed. Patient is AxO3, able to speak in full sentences, ambulatory, and able to take sips of water and swallow own secretions. Vitals taken, BP 145/97, HR 99, SpO2 100%, RR 20.  and  EMS arrived at 1405 . Patient's husband called from parking lot to patient's side, and informed of plan of care. Endorsed care to  EMS by Dr. . Patient sent to emergency department via ambulance at 14:15.
the Flublok Quadrivalent was accidentally administered to a 13 year old/No AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA295399 same reporter.  This case involves a 13 years old patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot number not reported via unknown route in unknown administration site 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 actual medication error due to Inappropriate age at vaccine administration.  At the time of report no adverse event was 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 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.  Information on the batch number was requested.
Mucousy stool started 3 days after his vaccines.  Stomach pains, diarrhea (green/liquid/mucousy) lasted for a little over a week.
FLUZONE QIV NP was administered to a patient under 6 months old instead of VAXELIS with no reported adverse event; FLUZONE QIV NP was administered to a patient under 6 months old instead of VAXELIS with no reported adverse event; FLUZONE QIV NP was administered to a patient under 6 months old instead of VAXELIS with no reported adverse event; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-APR-2023 with the following VAERS Primary ID 2573888-1. The original narrative from the sender is the following:  FLUZONE QIV NP was administered to a patient under 6 months old instead of VAXELIS with no reported adverse event; FLUZONE QIV NP was administered to a patient under 6 months old instead of VAXELIS with no reported adverse event; Initial information received on 27-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 3 months old male patient to whom INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV was administered to a patient under 6 months old instead of vaxelis with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination. On 27-JAN-2023 the patient developed a non-serious event of fluzone qiv np (strength, formulation was unknown,dose:0.5ml, batch number: UT7689LA and expiry date:30-Jun-2023 via intramuscular route in Left thigh for prophylactic vaccination) was administered to a patient under 6 months old instead of vaxelis with no reported adverse event (product administered to patient of inappropriate age, wrong product administered) (Latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE and VAXELIS. Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), HIB VACCINE CONJ (MENIGOCOCCAL PROTEIN), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (VAXELIS) was not applicable. Outcome: 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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "FLUZONE QIV NP was administered to a patient under 6 months old instead of VAXELIS with no reported adverse event".  No further information is expected.
Arm hurt tremendously (sore); Bad vertigo; Excruciating pain / Hurtful; Needle felt different; Trouble moving the arm; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt tremendously (sore)), VERTIGO (Bad vertigo), PAIN (Excruciating pain / Hurtful), DEVICE CONNECTION ISSUE (Needle felt different) and MOBILITY DECREASED (Trouble moving the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Muscle damage (Muscle damage on shoulder 10 years ago). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurt tremendously (sore)), VERTIGO (Bad vertigo), PAIN (Excruciating pain / Hurtful), DEVICE CONNECTION ISSUE (Needle felt different), MOBILITY DECREASED (Trouble moving the arm) and HEADACHE (Headaches). At the time of the report, PAIN IN EXTREMITY (Arm hurt tremendously (sore)), VERTIGO (Bad vertigo), PAIN (Excruciating pain / Hurtful), DEVICE CONNECTION ISSUE (Needle felt different), MOBILITY DECREASED (Trouble moving the arm) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that she received 1st shot on beginning of April,2021. Concomitant medication also included Blood pressure medications but was unable to provide the name of the blood pressure medication. Treatment included 1 pill for vertigo which was a common generic medication.
Headache, Myalgia, Diarrhea, NauseaVomiting, CHILLS Narrative:
Headache, NauseaVomiting, Chills, fever, Body ache, Muscle pain Narrative: