chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness at injection site for a few days immediately following shot, slight achiness within the first 24 hours. 7 days after injection, a red rash (3 inches by 2 inches) appeared at injection site. I treated with Benadryl cream as needed to reduce irritation, and it faded over the course of four days.
Prolongation of hospitalization.  Pt s/p cervical-thoracic spinal decompression-fusion. For placement in acute rehab facility, pt was tested for COVID. Positive result impacted ability to place patient. No COVID drugs prescribed due to clinical stability. Intermediate dosing of enoxaparin initiated due to elevated d-dimer. Pt discharged to rehab facility following 14 days isolation.
Vomiting within the same night of the shot and continuing for 2 days after, fussiness ever since the shot was administered, fever started on the 2nd day after the shot was administered, no appetite, etc.
Fever (101 degrees F for ~6 hours)  Tachycardia (greater than 120 beats per minute for ~6 hours)  Confusion and Headache for ~6 hours
Difficulty speaking and swallowing starting March 9 with worsening after the second vaccine.  Muscle pain in his legs and difficulty walking.
Redness, itchy, firmness, inferior to area of injection - TDAP. Negative cellulitis/ negative abscess.
This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On 28-MAR-2017, the patient was vaccinated with an unspecified expired dose of ROTATEQ orally for prophylaxis (lot # L013197 with an expiration date of 26-JAN-2017). Other suspect and concomitant medications were not provided. No known adverse effects were reported. Additional information has been requested.
loss of taste and smell on Sunday July 25. Covid test taken at pharmacy and rapid test and PCR at Dr on Monday &/26/2021. All tests negative. Taste and smell returned on 9/14.2021 Reporting number EKB 61716 64407
Initial unsolicited report received from a nurse on 21 March 2016. This case involves a 25 years male patient who was vaccinated with a dose of ADACEL (batch number U5298AA, expiration date, site of administration was not reported), intramuscularly on 01 February 2016. The patient's medical history and concomitant medications were not reported. On 02 February 2016, one day following the vaccination, the patient had broke out in a rash and it was stated as generalized rash noted over the patient's arms, chest, back, and hips. Lab data and corrective treatments were not reported. The outcome of event was not reported. Follow up information received from nurse 03 May 2016. It was reported that patient received 0.5 ml dose of ADACEL "Tdap" (expiration date 27 March 2018) intramuscularly in right deltoid on 1 February 2016. The patient had a medical history of eczema, smoker (0.25 packs per day for 4 years) quit from 01 November 2015, had alcohol use of 1.2 oz/week and no known allergy. Patient family history included, mother had lung cancer (non-small cell, non-smoker, age of onset 50) and maternal grandmother had diabetes mellitus (obesity), heart disease and hypertension. On an unspecified date, following vaccination patient developed Streptococcal pharyngitis, sore throat, stomach ache and allergy "Tdap listed as allergy". Laboratory data included POC rapid strep test which was positive, temperature (36.9 degree Celsius) and Saturation of Peripheral Oxygen (SpO2) was 98 %. Other Laboratory data included blood pressure (128/70 mmHg), pulse 87, eyes (Pupils Equal, Round, Reactive to Light, extraocular muscle), sexually transmitted infection (STI) screening was negative, ENT (MMM, oropharynx with bilaterally tonsillar erythema without edema or exudates), Neck (full range of motion, no thyromegaly, no palpable lymph nodes), Chest (clear to auscultation bilaterally, no wheezes), heart (regular rate and rhythms, no murmurs) and dermatology test included fine moderately erythematous popular rash over erythematous patches, worst over the flexor surfaces of the elbows and lower back, upper buttocks with associated excoriations, also involves upper back, abdomen and lateral hips and no sand paper texture. STI screening was negative and O positive blood type. The patient received corrective treatment with CLARITIN, BENADRYL (25-50 mg) every 6 hours for itching and rash, hydrocortisone(1%) cream up to three times daily over itchiest area, VEETIDS 1 tablet (500 mg total two times a day for 10 days) and for conservative management for symptoms gargling and ibuprofen. Outcome of events was not reported. List of documents held by sender: none.
VIOLENT chills started approximately 13 hours after this 2nd dose.  I was shaking so badly I couldn't get out of  bed for 30 minutes. Unable to trust myself to walk down the stairs to where my thermometer was.  Unknown if a fever accompanied / preceded / followed the chills. (They were so violent I can only say they were like a prolonged seizure, that I  was awake)  After approximately 30 minutes or so I was able to get up and drink about 8 oz. of water, and that seemed to calm them chills to a tolerable level.  Took an additional day off of work due to being so terribly tired and exhausted.
Patient called a few hours after receiving her pneumo vaccine stating she was having a reaction to the shot. She stated she had a large red swollen area around the site of injection of her left arm and it was itching. She stated she had take 600mg of Ibuprofen.  I recommended she take some benadryl as well and to continue both if needed.  She also received the flu shot in her right arm but had no issues with that arm.
pt has had the Flu Shot in the past when pregnant with no reported adverse event; Initial information received on 12-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age female patient who was exposed to vaccine Influenza Quadrival A-B Vaccine [FLUZONE QIV] in the past when pregnant with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported pt has had the Flu Shot in the past when pregnant with no reported adverse event occurred at unknown gestation period.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had previous pregnancy/ies.   On an unknown date, the patient received a dose of suspect Influenza Quadrival A-B Vaccine suspension for injection (lot UT8069JA, expiry date: Jun-2024 with unknown strength and dose) via unknown route in unknown administration site as prophylactic vaccination in the past when pregnant with no reported adverse event (exposure during pregnancy) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event. Additionally, at time of reporting, the outcome of the pregnancy is unknown.
I passed out in my bathroom the morning after the vaccine shot around 5:30am. I called the doctors and they said that was unrelated to the vaccine, but I had intense dizziness and tinnitis before I passed out. I was incredibly fatigued all day long for the rest of the day and had a migraine - both to be expected. However, I am 3 weeks post-vaccine (April 3) and have been having intense muscle cramping and fatigue in my legs during exercise. I wake up with muscle soreness that goes away throughout the day and then comes back during exercise.
feel sick; Initial information received on 12-Dec-2022 regarding an unsolicited valid social media non-serious case from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who feel sick while receiving vaccine influenza vaccine.  The patient's past medical treatment(s), vaccination(s), concomitant medication and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for Flu.  On an unknown date the patient developed a non-serious feel sick (illness) (unknown latency) following the administration of influenza vaccine.  It was reported, "I've had that "vaccination" exactly once, in my 62 years of mostly healthy life. It made me feel sick for two days! I've never gotten it since, and have been just fine!"  It is unknown if there were lab data/results available.    Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Recovered / Resolved on an unknown date for the event feel sick.
Admitted to Hospital Emergency Center complaining of itching in her chest arm and legs, feeling cold and severe shaky., chest tightness, shortness of breath sweeping in the face lips tongue and throat wheezing
rash on the side; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on the side) in a male 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 RASH (rash on the side). At the time of the report, RASH (rash on the side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
patient had the Pfizer COVID-19 Vaccine/patient was diagnosed with COVID on Friday; patient had the Pfizer COVID-19 Vaccine/patient was diagnosed with COVID on Friday; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 64-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Apr2022, outcome "unknown" and all described as "patient had the Pfizer COVID-19 Vaccine/patient was diagnosed with COVID on Friday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Apr2022) Positive, notes: the patient was diagnosed with COVID on Friday last week. Therapeutic measures were taken as a result of covid-19 included with Paxlovid . Clinical course: Nurse Practitioner reported about a 64y/o female patient taking PAXLOVID. The patient was diagnosed with COVID on Friday last week. Patient's symptoms started on Monday and patient was given PAXLOVID. Reporter wanted to know if the patient needs to be retested and for further guidelines. Reporter stated that she had called CDC and was told to call Pfizer. Reporter thinks the patient had the Pfizer COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective and COVID-19 cannot be excluded.
No adverse event occurred, but patient was given expired vaccine per BUD. The BUD was 11.26 @ 900, but the patient received the vaccine on 11.26 @ 11:57am. Pfizer was contacted and their BUD extended stability data shows vaccine good for 32 days and no excursions occurred, so vaccine ok.
Pain and swelling and redness in vaccine area and fatigue (commonly reported side effects) but the unusual reaction that experienced after abut 4 or 5 days after having received the vaccine were red, distinct eruptions that resembled pustules and about a day later there were spike-like, pointy protrusions that resembled thin thorns(rough to the touch) that emerged from middle of the red bumps. in the mid area of the inner arm (both above and below the elbow joint,  I pulled some of those "spikes" but not all and decided to take a picture.
ACHILLES HEEL IS FEELING SORE; LIMPING; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol user, non smoker, hay fever allergy, and allergic to Dilantin, and other pre-existing medical conditions included does not abuse drug or illicit drug use. The patient was previously treated with phenytoin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and  expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced Achilles heel is feeling sore. On 12-APR-2021, the subject experienced limping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from Achilles heel is feeling sore, and limping. This report was non-serious.
On 02/17/1999 varivax was administered. On 02/28/2002 varicella rash developed.
Dose 4 reaction, after 3 days in the middle of the night I woke up with bad vertigo and was really dizzy and I couldn't stand up which caused me to be very nauseous and that lasted for about 6-7 hours, and it went away. I called my doctor and she said that was more likely a common thing that happened with the Covid vaccine and told me if it got worse to call and it didn't get worse, and I did get better. COVID-19 symptoms started on 09/28/2022 evening, tested positive on the 29th. Symptoms included bad cold-symptoms, low grade fever but didn't reach 100, I had a headache, and sinus drainage and didn't have a sore throat. Those were the symptoms I started out with before PAXLOVID. I started taking PAXLOVID the same day of diagnosis on 09/29/2022 so I'm not sure if symptoms were because of Covid or the PAXLOVID. I felt very tired with the taste I've ever experienced, and it was so bad it made me nauseous, and I still have the sinus congestion. The symptoms of sinus cold didn't get worse and nausea symptoms might be because of medication and doctor said it was common and told me to keep taking it and took it 4-5 days. The only thing I was left with was a decreased sense of smell.
Case number PHEH2013US026174 is an initial spontaneous report received from a health care professional on 17 DEC 2013. This report refers to a 22 month old female infant. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1310201, expiry date: 31 MAY 2013) intramuscularly at a dose of 0.5 ml on 13 DEC 2013. No adverse event was reported following this administration error.
Initially, SOB, fever, chills, muscle aches, fatigue, headache. Patient still experiencing shortness of breathe but states that "shortness of breathe has eased up a lot."   Date and time of vaccination: (list both if they received both shots): 1/6/21, 1340, 2/1/21, 1840 Brand and lot of vaccine: 1st vaccine:Moderna 011-20A 2nd vaccine: Moderna 028-20A
Chills, left ventricle tightened, severe headache, heart palpitations.
After first shot I was very tired and sore for four weeks.  I had to nap often and take ibuprofen.  I postponed second shot.  I was very tired and sore for several weeks after second shot.  I had aches in all my joints.  I had to nap often.  I had to cancel activities. I had to take ibuprofen.   I needed help around the house.  I was waiting for symptoms to resolve before filing a report.  I am better but I still have intermittent body aches in my joints.    I still have some residual fatigue.  I am still hoping to make a full recovery.  I don't know if that will happen.
5ml syringes that had been provided by Health Authority were used to draw up diluent for mixing the 5-11 year old Pfizer COVID-19 vaccine vial on 12/16/21.  Diluent drawn up and injected into the vaccine vial was 1.6ml rather than 1.3ml.  Diluent was measured on the 5ml syringes incorrectly:  Counting each mark as 0.1 rather than 0.2ml.  This resulted in the vial being mixed with 0.3ml extra diluent.  Vial had a bonus dose (so 11 doses total).  Patient was given a vaccine dose at 90% of the correct concentration.  Error has been reported to Pfizer.  Family was contacted  by phone to be alerted of the error and offered a re-dose if they would like this.  No adverse effects to patient have been reported.
Caller has had three other shots with Moderna with no serious reactions other than soreness at the sight; Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) and INJECTION SITE PAIN (Caller has had three other shots with Moderna with no serious reactions other than soreness at the sight) in a 77-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 vaccination.     The patient's past medical history included Stroke (medications for his stroke - Amlodipine, Clopidogrel 75, Atorvastatin). Previously administered products included for Drug use for unknown indication: Caller got the flu shot 4 weeks before. Past adverse reactions to the above products included No adverse reaction with Caller got the flu shot 4 weeks before.   On an unknown date, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 13-Aug-2022, the patient experienced COVID-19 (Covid-19). On an unknown date, the patient experienced INJECTION SITE PAIN (Caller has had three other shots with Moderna with no serious reactions other than soreness at the sight). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19) and INJECTION SITE PAIN (Caller has had three other shots with Moderna with no serious reactions other than soreness at the sight) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   This case was linked to MOD-2023-749767 (Patient Link).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 64-year-old male patient received BNT162b2 (BNT162B2), on 01Aug2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "htn" (unspecified if ongoing); "depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that the lot was not available/ provided to reporter at the time of report completion. Patient has received other medication guaifenesin in 2 weeks and patient had no known drug allergy. Patient received anti-viral as COVID 19 treatment from 08Jan2023 via oral route.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely
Headache; pains in knee and muscle above knee; pains in knee and muscle above knee; Fever; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EN5318 expiration date: 31Jan2021, via an unspecified route of administration on 31Jan2021 12:20 at a single dose in the right arm for COVID-19 immunization. The patient had no family medical history and no concomitant medications. The patient had her first dose yesterday (31Jan2021), and she had some reactions to it last night 31Jan2021, had fever, headache and pains in knee and muscle above knee. She knows some of the side effect was normal. She was wondering more so, when is it ok to take a pain reliever for it, like aspirin or Ibuprofen. She went online and it said not to take anything, so she did not. She imagined her fever went away sometime during the night, she took it (unspecified) twice last night. This morning when she woke up, she had the headache, and it's gone now. Her pain in the knee started 4 hours after the injection, it was still sore but much better. The events did not require a visit to the emergency room. The patient had no prior vaccinations within four weeks. The outcome of the event fever was recovered on 31Jan2021, headache recovered on 01Feb2021 and for events pains in knee and muscle above knee was recovering.  Information on the lot/batch number has been requested.
I had slight uncomfortable in left arm day of vaccine and the day following. On 01/20/2021 I developed a 4" red swollen very itchy circle around vaccine area on left arm this lasted until 01/22/2021.     on 01/23/2021 the swelling went away but arm still itchy and red
12:20p flu shot given, 12:30p N/V hoarseness feeling flush - constantly clearing her throat, states that "feels like a lump in my throat" - reported these symptoms to nurse at 12: 40pm, 1:45 Respirations WNL BP 157/91, P 65 - EMS called and arrived at 12:54. Patient refused to go to ER. Agreed to go to ER if symptoms worsen.
Bell's palsy; This is a spontaneous report from a contactable consumer (wife) reporting for patient (Reporters Husband). A 49-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Left arm, upper arm on 20Aug2021 (Batch/Lot Number: FC3181, at the age of 49-year-old) as single dose for COVID-19 immunisation. The patient's relevant medical history and concurrent conditions included high blood pressure from an unknown date. Concomitant medication included lisinopril taken for blood pressure high, start and stop date were not reported. There was investigation assessment, prior vaccinations were none. Reporter stated that they received their vaccine on Friday, last Friday and her husband. Well, they took him to the doctor the previous day, on 26Aug2021, he got Bell's palsy, so she had called the pharmacy, they told her to report it to Pfizer too. Treatment for AE included reporter stated that they put him on steroid pack Prednisone. The patient underwent lab tests and procedures which included blood work (blood test): result unknown on Thursday, 26Aug2021 at the doctor's office. The Reporter asked, how did they know if he was supposed to get the second shot and asked whether she supposed to wait for the side effect to clear up. Reporter also asked what she do there. Reporter seriousness for Bell's palsy was unspecified. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.