chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SWEATING; CHILLS; FEVER; HEADACHE; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 61 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: 1805025, and expiry: unknown) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced sweating. On 18-MAR-2021, the subject experienced chills. On 18-MAR-2021, the subject experienced fever. On 18-MAR-2021, the subject experienced headache. On 18-MAR-2021, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, chills, and fever on MAR-2021, and had not recovered from headache, and soreness at injection site. This report was non-serious.
Information has been received from a physician concerning a 11 year old patient who on 10/19/1995 was vaccinated with a dose of varicella virus vaccine live (lot 610248/0446B). On 5/16/2005 the patient developed a rash. On 05/18/2005 the physician diagnosed the patient with breakthrough chickenpox with less than 50 lesions. The patient was afebrile. There were no complications. It was reported that the patient had no prior history of chickenpox. The patients chickenpox was confirmed by a direct fluorescent antibody test. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
On Day 3 evening, one hive appeared, with redness/swelling just below injection site. On Day 4 evening, multiple hives (around 20) appeared, then merged into one larger mound (around 1.5" x 2").  Previously, on Day 1 evening, soreness of arm and fever started. Fever reached 103.4 degrees. Fever lasted 2 days but lower grade - 101 degrees or so. Day 2 saw bad headache and armpit pain. Day 5 seems to have recovered from hives, but will continue to watch.
Severe headache over right eye/temple.  Sudden and most painful headache ever- in my 64 years.  Used ice to no avail,  and then took three . Advil tablets.  After about two hours, it was under control.
Patient became light headed and broke out in a cold sweat. He was assisted from a seated position to lying down due to excessive dizziness. He remained laying down for approximately 10 minutes, and was conscious the entire time. He then sat up for a few minutes and then moved back to the chair for an additional 10 minutes. At that point, he felt well enough to get up and walk around. He phoned his father to come pick him up because he didn?t want to drive.
SMALL RED BUMPS ON RIGHT ARM, RIGHT HAND, LEFT ARM, AND FACE.
Antiphospholipid Syndrom and Thrombosis of the liver, causing blood clots in various places in my body. Two month hospital stay on blood thinners. Am now taking Eliquis, a blood thinner.
Fingers numb, turned  and became numb. Occurred on both hands at different times. Raynauds.
We had a 38 y/o female in the office this morning who received her booster dose of Pfizer. Pt has e[episodes where she goes into muscle spasms but they don?t typically last as long as they are this morning. Pt states that she is being seen by her PCP and is being evaluated for a Cervical Disconnect syndrome. She received the vaccine and within about 15 seconds she went into a spasm that started in her and moved into the neck and continued.  She would have the spasm ease up and then it would go back to it pulling her head back. This lasted about 20-30 minutes. 911 was called and they took her to the ER. Pts vitals were normal. She continued to talk and breath during the spasm. Dr. did come in and evaluate her and advised her to go to the ER.
Started menstruations within 2 weeks of receiving shot. Due to IUD birth control have not had a menstruation in over 12 years.
persistent headache for 2 weeks,headache worse when standing up and headache better when puts head down; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of HEADACHE (persistent headache for 2 weeks,headache worse when standing up and headache better when puts head down) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (persistent headache for 2 weeks,headache worse when standing up and headache better when puts head down). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of UNK dosage form. At the time of the report, HEADACHE (persistent headache for 2 weeks,headache worse when standing up and headache better when puts head down) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
No adverse effects reported; an unknown patient was administered the 3rd dose of ROTATEQ in the series after the recommended 8 months on 05/28/2019; an unknown patient was administered the 3rd dose of ROTATEQ in the series after the recommended 8 months on 05/28/2019; This spontaneous report was received from a medical assistant via a company representative concerning to an infant patient of 8 months old of an unknown race and gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On 28-MAY-2019, after the recommended 8 months, the patient received the third dose of the Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) series (inappropriate schedule of vaccine administered, and product administered to patient of inappropriate age), orally for prophylaxis (strength, lot number and expiration date were not reported).  No adverse effects were reported.
Mild injection site pain on first day. Continued through day three. At midnight on the start of day three, I noticed that I had hives on the torso and shoulder and chest in a striped pattern that matches the typical pattern for shingles on the torso. I also had had a mosquito bite for about six days, and at that same time, my mosquito bite on the same arm as the injection became very swollen. At present there is probably about 2 ounces of fluid trapped below the skin surface, which is raised and pink. The injection site remains raised in pink with a circular inflamed area about 1 1/2 inches wide.
22SEP93 t103 fever for 48 hrs APAP used w/no drop in temp; pt very irritable for 48 hrs;
No adverse event; doses were administered prior to temperature excursion/ stated there may have been additional previous temperature excursions for these products; This spontaneous report was received from other health professional and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 25-NOV-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #U033047, expiration date: 21-OCT-2023 (strength, dose, dosage regimen, anatomical location, and route of administration were not provided) as prophylaxis. It was informed that the vaccine underwent three previous temperature excursion. No adverse event was reported.  This is one of several cases reported by the same reporter.
Patient is a 67 y.o. female patient ofl, DO with history of arthritis, CKD, GERD, essential HN, HLD, hypothyroidism, COPD, and OSA  presented to General Hospital with SOB and  worsening breathing.   Acute hypoxic respiratory failure d/t Sepsis was present on admission s/t COVID-19 pneumonia NSTEMI, suspected type 2 due to demand Suspected acute PE with elevated D-dimer -ruled out on VQ scan P/w 10 day history of cough, nasal congestion, and sore throat. Pt fully vaccinated with 1 booster shot Afebrile on arrival, HR 84, RR 18, BP 120/73, satting >92% on 2L by NC (no home O2 needs) CBC unremarkable. BMP with AKI as below CXR: Slight area of inflammation or small infiltrate in the lateral aspect in the right midlung field Cont supplemental O2 to maintain goal SpO2 >90%, wean off to room air as tolerated Decadron 6mg daily for 10 days CRP 16.9, Pro-Cal 0.07 Albuterol, robitussin-DM, tylenol PRN; encourage IS use Contact precautions PT/OT/SW VQ scan negative for PE.  Lovenox changed to prophylactic dose Home O2 evaluation prior to discharge.  Case management consulted for discharge needs   Acute kidney injury Initial Cr 2.09 (baseline ~1).  Likely pre-renal given poor PO intake secondary to above  Improved with IVF   Essential HTN HLD Normotensive on admission Continue home amlodipine and statin Hold hyzaar pending improvement of kidney function    Hypothyroidism Continue home synthroid    GERD Continue home protonix PRN tums   Chronic arthritic pain Continue home tramadol and gabapentin   Obesity  OSA Body mass index is 37.12 kg/m². Discussed dietary and lifestyle modifications Continue home CPAP   Nicotine dependence Current 1 PPD smoker Discussed and encouraged smoking cessation, >3min total time spent Nicotine replacement ordered
No adverse reactions, this form was filled out to report a vaccination error on behalf of the individual  filling out this report. An extra dose of Hep B was given on todays date.
59-year-old female presented complaining of shortness of breath. Patient stated that she was recently in the hospital for urinary tract infection. She stated that the day prior to arrival she began having worsening shortness of breath and sputum production. She admitted to fever and chills. She normally wears 4 L nasal cannula at home and today was requiring 6LNC. Pt smokes 4 ppd and has not been wearing her oxygen per husband.
One day post vaccination, the patient reported "massive headache" x 1 week, and continuous burning in the eyes and "mental fog". He doesn't feel like being social.
Headache, Myalgia, NauseaVomiting, Fatigue Limping Narrative:
This case meets criteria for vaccine breakthrough review.  SxS 10 days PTA SOB, cough, poor po intake, v/d
10/13/2010  2:30PM Received Influenza Vaccine 7:00pm Hands trembling/ shaking, cold sensation feet  10/14/2010 12:00 AM Nausea/vomiting  4:00 am Not feeling well/drained/weakness 6:45am Observed by co-worker "passed Out" for approx 1-2 mins Nursing staff called observed Patient pale watery eyes, awake and responding Blood sugar 112, SPO2 99%, BP 106/59 P 73 R 18 6:55 Am c/o being hot/cold Declined to have EMS called. Husband was called Per her request and she went home. Information obtained on 10/15/2010 from patient: 10/14/2010 8:00AM Slept until 9:30 AM 11:15 AM Appointment with own personal physician EKG, Blood work was done and Dr. determined episode was reaction to Influenza Vaccine. 12:00pm return to own home and slept through night until approx 8:00am 10/15/10 Spoke with patient this AM feeling better.
the patient returned to may office on 10/25/08 with multiple whelts on the body, especially the lower extremities with significant induration around the site of the needle mark for the pediarix.
Low grade fever; Stomach ache; Depressed; Fatigue; Insomnia; This is a spontaneous report received from a contactable consumer. This consumer reported for a 12-year-old female patient. A 12-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 1 intramuscular, administered in Arm Left on 01Jun2021 15:30 (at the age of 58-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient had no other vaccine within four weeks and no other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Jun2021 15:30, the patient experienced low grade fever, stomach ache, depressed, fatigue, insomnia. The patient received treatment with tylenol. No hospitalization prolonged. Outcome of the event was recovering, at the time of this report. Information about batch/lot number has been requested. Follow-up attempts completed. No further information expected.
Painful injection site for 3 days.  Can't sleep.  Going to doctor today.  Dr. told her that shot probably hit a tendon or ligament and gave her some pain pills to use at night.  Still sore 10/6/07.
Per mom; noticed redness, swelling and 99F temperature on 8/30/01 at 08:00. Tylenol was given at that time. On 8/31/01, redness/swelling was gone but there was a "knot" palpable. No loss of appetite; breast feeding. One "looser" than normal stool noted by mom during the episode.
A report has been received from a Health Professional concerning a patient, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT (INTRANASAL). FLUMIST QUADRIVALENT (INTRANASAL) started on 30-Dec-2013. It was reported that forty two patients were administered with expired FLUMIST QUADRIVALENT on 30-Dec-2013. The outcome of the event of GAVE EXPIRED FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Patient reports consistent pain for almost 2 months since vaccination. Pain in top of muscle sometimes radiates from shoulder to elbow, and worsens with movement. It is only relieved with TENs unit and rest. Patient has not sought treatment, but she is going to consult her son who is a neurologist.
Chest pain beginning on April 9th described as pleuritic-type pain.  Left shoulder pain on April 14 with pain worsening over next two days preventing patient from sleeping well.  The patient is a doctor and self-noted that he heard friction rub and went to ER on April 16.  There he had normal chest X-ray and changes from his usual baseline ECG, namely ST segment elevation.  Transferred to Hospital and spent 24 hour under observation of a cardiologist beginning the evening of the 16th. Other physicians could not hear friction rub.  A stress cardiogram was normal with no pericaridal fluid being noted. Cardiac enzymes were normal as were CBC and sedimentation rate.  At hospital he received an injection of Toradol and then started Indocin for one week.  Shoulder pain improved markedly after injection of Toradol.  He had no unusual symptoms during the three weeks after the vaccination.
Headache, body aches, temperature between 99.4 - 100.8, chills, fatigue.
Worsening of psoriasis, asthma attacks at nights, memory problems, speech impairment, rheumatoid arthritis, pernicious anemia, tired, tired, tired, stomach area pain.
Lt arm swollen and warm, non tender 2 day after 1st 1 2 S. No Tx other than symptomatic.
Rashes all over body for over a period of 8 months, lost of breath in different occasions.
Initial information received from another manufacturer (service request number 1-7327089847) on 03 June 2013. The information was originally provided to the other manufacturer from a healthcare professional (pharmacist). A 58-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of Tdap vaccine (unknown manufacturer) (batch number, dose number, route and anatomical site of administration were not reported) on an unspecified date. It was reported that, the patient had experienced a bad reaction to vaccine within the last 6 months. The pharmacist reported the patient had a fever over 103 degrees Fahrenheit, body aches lasted for 3 days and a local reaction of size of an orange at vaccination site. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome of events was not reported. Follow-up information received from a healthcare professional on 12 July 2013: The patient had recovered from the events on an unspecified date. Documents held by sender: none.
Pt was very anxious about shot. After tech administered pt reported chest tightness and " a kinda scratchy throat."  Said didn't really feel like throat was closing, nor any difficulty breathing.  Mom got her something to drink.  After 30 min nothing worsened and pt said felt little better.  Mom said hadn't eaten anything all day. I was said would get food and f/u with dr.  Advised pt to take Benadryl when she got home where she would be monitored by another adult.
Anaphylaxis (SOB, throat closing, wheezing, tachycardia, change in mentation over 10 minutes) Given Epi-Pen and Benadryl, Transported via EMT to ER
This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint Pain) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057G20A) for COVID-19 vaccination. No Medical History information was reported. On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced ARTHRALGIA (Joint Pain). At the time of the report, ARTHRALGIA (Joint Pain) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant product was reported. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Contains non-significant information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt left arm at site of vaccine administration red swollen and warm to touch, pt instructed to seek medical attention, pt seen at ER and treated with antibiotic for cellulitis.
patient is claiming it was given subconsciously because she has no reaction to it; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (patient is claiming it was given subconsciously because she has no reaction to it) in a female patient of an unknown age 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 INCORRECT ROUTE OF PRODUCT ADMINISTRATION (patient is claiming it was given subconsciously because she has no reaction to it). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (patient is claiming it was given subconsciously because she has no reaction to it) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.   Reporter did not allow further contact
Localized erythema and induration, initially at right thigh which progressed to > 4.5cm diameter with associated warmth. Gradually resolved with warm compresses and Tylenol for comfort.
Information has been received from a physician concerning a 14 year old female who on approximately 02-JUN-2008 was vaccinated in her right deltoid with GARDASIL vaccine (yeast) (lot #, and dose not reported). Concomitant therapy included meningococcal AVYW conj vaccine (dip toxoid) (MENACTRA). The physician reported that the patient experienced excessive pain that radiated to her armpit. That night the patient was sweating, had nausea, and was vomiting. The physician noted that the patient also had a fever of 102 and shooting pain that went across her abdomen. The physician also stated that when the patient came back in the office for a check up she still had a lot of pain at the injection site. Medical attention was sought by the patient. No further information was provided. Additional information has been requested.
Leg cramps, eyes swelled, arm (site of inject) red & swelled, elevated temp w/chills & fever; family talked w/MD & were advised to go to hosp ER; pt chose not to go;
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 08Apr2021 as dose 2, single (Lot number: EP7533), in left arm, on 26Oct2021 as dose 3 (booster), single (Lot number: FC3181), in left arm and on 12Apr2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "recovered" (Sep2022) and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Sep2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient received vaccine and other medications in 2 weeks. Patient had COVID 19 Treatment with Paxlovid (Lot number :1910754A) for which treatment started was on 02Sep2022 and stopped on 06Sep2022. The patient had received other medications with in 2 weeks which included Lozarton started on 01Aug2022 and stopped on 10Sep2022. Tested negative 1 day after the fifth/final day of taking Paxlovid. Most symptoms were gone. The third day after finishing the Paxlovid had runny nose and mild cough - became stuffy nose overnight and the next day, which is now. The patient had no known allergies. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Device Date : 10Sep2022.
After injection she got dizzy and had a very brief 2 second syncope possibly vaso-vagal. Treatment Dr. monitored patient room for 15 minutes and patient laid down and drank water.
1.  Loss of equilibrium/ balance/ dizziness - starting  May 18. after three days it started to subside and was medium and light loss of equilibrium until My 31, when major loss of equilibrium reappeared  2. Left eye inflamed and partially closed ; painful when closed eyelid; gradually got better and almost all better as of repor
Post vax, mom put child to sleep and when she went to check on him she found him face down in the crib
Patient was given pneumonia vaccine on 2nd shift. Patient complained of pain in deltoid. Swelling was noted. No redness or heat.
Entire body covered in a red rash; This is a spontaneous report from a contactable consumer (patient). A 63-year-old (non pregnant) female consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9266 and expiration date was not reported), dose 2 via an unspecified route of administration, in left arm on 23Feb2021 12.30 as single dose for COVID-19 immunization. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9265 and expiration date was not reported), via an unspecified route of administration, in left arm on 02Feb2021 16.45 as single dose for COVID-19 immunization. Medical history included Type 2 diabetic (recent A1C is 6.1) and soap sensitive. The concomitant medications included Januvia, Jardiance, Glipizide and Rouvest. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination and the patient was not tested positive for COVID-19, since the vaccination. On 25Feb2021 at 21:00, the patient had entire body covered in a red rash. The outcome of the event was reported as not recovered.