chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever for one day; Severe headache; New rash resembling insect bites on shins, thighs, forearms starting 3-4 days after second shot; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 67-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP6955), via an unspecified route of administration, administered in arm right on 19Mar2021 (at the age of 67-year-old) as a single dose for COVID-19 immunization. Medical history included asthma, sleep apnoea, arthritis, rosacea, transient ischaemic attack, rubber sensitivity and COPD overlap syndrome, seasonal and environmental allergies and Known allergies with Tetracycline, Latex. The patient's concomitant medications were not reported.  Historical vaccines included first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198), via an unspecified route of administration, administered in Arm Right on 26Feb2021 at 15:00 as a single dose for COVID-19 immunisation and on 03Mar2021 at 07:00 patient experienced rash resembling insect bites on shins and forearms starting 4-5 days after first shot. Patient did not receive any other vaccine in four weeks. On an unknown date in Mar2021, 3-4 days after second shot patient experienced new rash resembling insect bites on shins, thighs, forearms. It is not completely gone yet after three weeks. Severe headache and fever for one day, five days after second shot (24Mar2021). Patient did not receive any treatment for the events. The clinical events outcome was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Pt received Comvax and Prevnar on 4/8/01. On 4/10/01, mother noticed dusky appearance but no details on O2 sats. On 4/11/01, baby on 1/8 L O2, desaturated to 65%. Recovered, O2 increased to 1/4 L, baby desaturated to 75%. Recovered.
suspected COVID-19 with symptoms; suspected COVID-19 with symptoms; congestion; running nose; This is a spontaneous report from a contactable consumer reporting for his/her mother.  A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 19Jan2021 (when 70 years old) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever, congestion, running nose, chills, cough, covid 19 symptoms on 02Feb2021 with outcome of unknown. The reporter wanted to know what kind of the covid test should she get done and if the patient could take the second dose on 08Feb2021 or should she wait.  Information on the lot/batch number has been requested.
Significant bruising starting 2 inches underneath the vaccination site & ending right above the elbow.
Soreness surrounding & below injection site day 1 through present.  Itching below injection site day 5 & 6. Redness/rash below injection site day 6 through present.  Developed lump in left arm, below injection site, approx 2 x 4 inches wide. Headache & intermittent low grade temperature (100.4) from day 2 through present.
Patient reported extensive soreness and swelling throughout his upper right arm.  Above his right elbow he had a large bump.  His entire upper arm was warm to the touch.  He was advised to see a doctor ASAP.  Doctor at urgent care advised that it was an adverse reaction to the PNEUMOVAX.  He was advised to ice the area and keep it wrapped.  After follow-up with patient, he was reported full recovery.
No adverse event; Vaccine administered after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after BUD) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine administered after BUD).    Concomitant medication was not provided. Vaccine was received at vaccination centre on date 07-Jun-2022 and before use date was reported as 07-Jul-2022. Treatment information was not reported.
Got cold and cough on Dec 4, 2009. Home 3 days. Still getting better cough same.
Patient was incorrectly given an incomplete dose (0.3ml) of Janssen shot instead of her 2nd Pfizer shot. Pt not reporting adverse effects at this time.
leg was reddened around (warm) site & leg was really swollen twice size & fluid filled; cried continuously 5 hrs; went to ER; seen by MD
immediately after second shot: soreness, sinus inflammation, headache 3 months later, might be related: dizziness, headaches, nausea
3rd day. broke out in rash all over body. 4th day mostly still in right arm where I received shot.  2-3 inch circle 2 inches below shot with extreme itch, pain and heat.
Lips swelled 24 hours after receiving first dose. No history of dermal fillers. Lip swelling was very itchy and lasted 5 hours. Also difficulty breathing began around that time and progressively got worse until 8/11/2021, when I decided to go to the ER. They could not give me an explanation of why I was having difficulty breathing. I am still having chest discomfort as I am writing this.
Pt. states that after receiving the 1st dose of Moderna 08/31/2021, started experiencing symptoms 2hrs after of Tinnitus in the right ear (unknown whether both) Primary visit *10/12/2021 recommendation for Specialist visit.
This was a Moderna booster 6 months after my Jansen vaccine.  I had a similar, not quite as bad reaction, to the Jansen.   Reaction to the Moderna booster:  Significant headaches, chills, muscle aches for four hours followed by an additional 18 hours of deep fatigue.  All AEs fully resolved
This spontaneous case was reported by a consumer and describes the occurrence of RASH (rashes across lower back, underside of left leg, on thigh, came back on back,rashes are on left side of body) and VACCINATION SITE RASH (Rashes appear on left side which is same side vaccine was injection into left arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 016M20A and 013LZ0A) for COVID-19 vaccination.     The patient's past medical history included Hives (Hives as a kid & whenever rashes pop up, it can happen on same area he sits.). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LEVOTHYROXINE SODIUM (SYNTHROID) and ZOLPIDEM for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (rashes across lower back, underside of left leg, on thigh, came back on back,rashes are on left side of body) and VACCINATION SITE RASH (Rashes appear on left side which is same side vaccine was injection into left arm). At the time of the report, RASH (rashes across lower back, underside of left leg, on thigh, came back on back,rashes are on left side of body) and VACCINATION SITE RASH (Rashes appear on left side which is same side vaccine was injection into left arm) outcome was unknown.            Treatment medication includes: Heating pads, Steroids, Topical creams It was reported that the patient visited his dermatologist who stated that Rash was related to medications.
URI since 6/21, Fever 6/23, psosible coxsackie virus, used ibuprofen. Checkup 7/8, well child, recv'd MMR, no analgesics given. Rash started night of 7/11, by 7/12 hives and indurated lesions with surrounding erythema, hot and swollen joints: knee, ankle, thumbs, save BENADRYL and Prednisolone. Much better 3 hr later, continued course of prednisolone.
I haven't been feeling good.; My shoulder, on the arm I got the vaccine, hurts; I get up in the mornings my legs ache.; I have stiffness in my joints when I get up every morning.; I have a headache and my neck is stiff.; I have a headache and my neck is stiff.; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced haven't been feeling good on an unspecified date, shoulder hurts on the arm where she got the vaccine, legs ache on an unspecified date with outcome of unknown, stiffness in joints to get up every morning on an unspecified date with outcome of unknown, have a headache and neck is stiff. The outcome of the events was unknown. Therapeutic measures were taken as a result of events. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
patient received vaccine on 3/1 on 3/8 the injection site became very swollen and hot to the touch and patient reported itching and pain. the area remained swollen when she reported on 3/10. when i checked in with her on 3/11 she said the swelling had gone down but it was still itchy.
Breakthrough case admission after 2 vaccines Pfizer 12/14/21 Lot# FF2593;  1/4/22 Pfizer Lot# FF2593
Information has been received from a 24 year old female with no pertinent medical history and no known allergies who on 31-DEC-2007 was vaccinated with the first dose of Gardasil 0.5 mL IM.  Concomitant therapy included a tetanus shot in the opposite arm.  On 31-DEC-2007 the patient felt nauseous and had a pain in her arm.  On 01-JAN-2008, the patient felt like she had the flu and had muscle spasms in the arm she got the injection in.  Unspecified medical attention was sought.  As of 04-JAN-2008, the patient's arm was "kind of tingly and numb" and she reported she was recovering.  Additional information has been requested. 04/07/2008 Information has been received from a 24 year old female (117 lbs.. 53 in.) with chronic perennial allergic rhinitis who on 31-DEC-2007 was vaccinated with the first dose of GARDASIL (Lot #659055/1522U) 0.5 mL IM. Concomitant therapy included a tetanus shot in the opposite arm. On 31-DEC-2007 the patient felt nauseous and had a pain in her arm. On 01-JAN-2008, the patient felt like she had the flu and had muscle spasms in the arm she got the injection in. Unspecified medical attention was sought. As of 04-JAN-2008, the patient's arm was "kind of tingly and numb" and she reported she was recovering. Follow-up information received from the physician reported that the patient reported arm pain, nausea, chills and sweats on 02-JAN-2008. The patient's outcome was not reported. No further information is expected.
Redness with induration to (L) thigh where immunization admin. on 3-6-12.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 5 (booster), single (Lot number: 6J2526) at the age of 69 years, in left arm 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive; (2022) Negative. Therapeutic measures were taken as a result of drug ineffective, COVID-19 with Paxlovid from 12Dec2022 to 17Dec2022.
The injection was quite painful when the needle went in the right arm muscle near the shoulder. The next day the range of motion in the right shoulder joint became slightly limited due to pain. These symptoms persisted for 8 months, at which time, in early-March, the pain became severe all of a sudden, and resulted in no range of motion in the right shoulder joint due to pain and stiffness. At which time, I sought medical treatment.
8/8/2018 Patient fainted after applying TRUMENBA. Explaining to patient all the symptoms (gave her the VIS form) to look for after receiving shot, the brother had a question so I turned around for not even 3 seconds and patient stood up and fell face first (got a bump to her left side of forehead). She then stood up and looked very confused, sleepy, felt like vomiting, and she said she had bit her tongue. Blood pressure was checked and was 67/34-5 minutes later she started focusing and was answering our questions. Ambulance arrived at 1:15, patient refused to go in the ambulance, brother will take her to hospital. Patient left clinic at 1:25.
Slumped backward in chair, jerky movements of arms (left, then right, not at same time). Eyes rolled back. non-arousable for approximately 15-20 seconds; then gradually woke up; aware of surroundings. Denied dizziness or feeling faint prior to vaccination. Reported some issues with recent blood draw but not with past vaccinations. Kept in clinic for 25 minutes past event. given water & juice.
Pt exp an immediate inject site rxn following DTP vax; redness @ site of inject was 5 inch in diameter;
Advised mother of the administered dose one of Pediarix and administered 2nd dose of Hep-B instead of just Pediarix.  Unauthorized age group: Patient received 10 mcg/0.5ml Hep-B in left leg.  Vaccine administered by employee.  The director of nursing spoke with the patients mother on 11/4/2022 @ 5:40p. The mother denies the patient has/had any adverse event(s) from the vaccine.   The mother states:"he is his normal self. So far so good."  Explained to the mother to report any problems, PCP and to take patient to the emergercy room with any adverse affects.   Answered all questions and gave mother Directors contact information.
Treatment with Bactrim DS for 7 days, beginning today.  Patient developed rash after inoculation which resolved the following day; then reappeared one week later developed the same itchy, warm rash spreading down her left arm.
Rather intense chills and headache. Chills and headache started 13 hours after 2nd vaccination dose. The symptoms lasted for 12 hours.
On 02/14/22 the patient received his second dose of Pfizer vaccine with a purple cap 0.3ml instead of the adolescent dose.
Arm went totally heavy.  Can?t move it. Can?t sleep on it. Hand numb. Very painful
Information has been received from a registered nurse concerning a 9 year old female patient wit no past medical history who on 03MAY1996 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 03MAR2004, the patient presented with a mild case of chickenpox with lesions scattered over her upper body. Diphenhydramine hydrochloride was ordered to control pruritus. A product quality complaint was not involved. Additional information has been requested.
High fever, uncontrollable shaking, severe pain in left arm and major swelling, redness traveling down left arm to hand. Severe pain in fingers on left hand and shoulder. In bed for three days and going to doctor tomorrow 11/10/13.
Flu had to go to ER for treatment. Got ill 3 days after receiving shot, I am still sick.
This patient had a fever of 102 - 103, arm was swollen and sore. The sickness lasted 2 days.
Information has been received from a consumer concerning her 24 year old daughter with sulfonamide allergy and no relevant medical history who on 03-JUL-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). There was no concomitant medication. On 13-JUL-2008 the patient experienced stomach cramps, back pain, extreme fatigue, pain upon urination, headaches and irregular menstrual cycles. Unspecified medical attention was sought. The patient's events persisted. Additional information has been requested.
Lymph node swelling with tenderness in left underarm and breast (right-side remained normal), fatigue.
ON THE EVENING OF 3/30/2021 SHE DEVELOPED  LETHARGY,BACK PAIN , HEADACHE, FEVER , CHILLS, ACUTE RIGHT ARM PAIN AND LUMP ON SITE OF VACCINATION, WEAKNESS AND NAUSEA.
Rash (red) approximately 2 1/2 inches in diameter on (L) shoulder.
thinks she has covid/experiencing covid symptoms; may have fever; couldn't taste mint; couldn't smell Vicks; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (thinks she has covid/experiencing covid symptoms), AGEUSIA (couldn't taste mint), ANOSMIA (couldn't smell Vicks) and PYREXIA (may have fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer (On her right side), Sinus disorder NOS (sinus drainage), Cough, Allergy (The patient had bad allergies) and Runny nose.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced AGEUSIA (couldn't taste mint) and ANOSMIA (couldn't smell Vicks). On an unknown date, the patient experienced COVID-19 (thinks she has covid/experiencing covid symptoms) and PYREXIA (may have fever). At the time of the report, COVID-19 (thinks she has covid/experiencing covid symptoms), AGEUSIA (couldn't taste mint), ANOSMIA (couldn't smell Vicks) and PYREXIA (may have fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.   The patient did not get tested for Covid-19
Information has been received from a consumer on 07/30/02 concerning his daughter with acid reflux and no known allerigies, who "recently" (date not specified) was vaccinated with a dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) (lot # not given). The father reported that concomitant therapy that same day included "two shots" of Haemophilus b conjugate vaccine (HIBTITER). Other concomitant therapy included an  unnamed medication for acid reflux. Subsequently, the patient developed a slight fever. No medical attention was sought. Additional information has been requested.
Itching, slight rash, and facial flushing approximately 4 hours after influenza vaccine received.  She took po Benadryl which provided some relief of itching.
Daily headaches. Brain fog that prevents coherent thoughts and conversation. Occasional migraine. Constant fatigue. Increased sleep but constantly feeling lack of rest. Decrease in appetite in both physical hunger and the appeal of eating.
Spontaneous termination of pregnancy- uncertain of exact time & date.  Found out 12/07/2009 that the pregnancy terminated shortly after the visit on 11/09/2009, at which time the fetus appeared healthy and had a healthy heartbeat.
Developed erythema both arms and lesions similar to pox on anterior neck and trunk. Fever x 1 day resolved with TYLENOL. 3.5 cm annular erythema at inj site both arms random "pox" spots anterior mid neck x 1 multiple spots posterior trunk mostly on (L) trunk - crosses midline.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. 8 months ago, in March 2014, the patient was vaccinated with the 1st dose of PNEUMOVAX 23 (injection, lot#, expiry date, dose and route were not provided). On 04-NOV-2014 the patient was inadvertently vaccinated with a 2nd dose of PNEUMVOX 23 (injection, lot#, expiry date, dose and route were not provided). No adverse effect was reported. Additional information has been requested.
Moderna Covid-19 vaccine was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022; vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022) in a 58-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (LANTUS allergy), Drug allergy (PENICILLIN V POTASSIUM allergy) and Type 2 diabetes mellitus. Concomitant products included TERCONAZOLE, BETAMETHASONE, CLOTRIMAZOLE (CLOTRIMAZOLE AND BETAMETHASONE), SALBUTAMOL (VENTOLIN [SALBUTAMOL]), LORATADINE, ALBUTEROL SULFATE, MELOXICAM, LANSOPRAZOL, ASPIRIN [ACETYLSALICYLIC ACID], SIMVASTATIN and LISINOPRIL for an unknown indication.    On 13-Apr-2022 at 4:01 PM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022 at 4:01 PM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Other concomitant medications included BD Pen and NovoFine.  The vial was initially stored in refrigerator on 25-Feb-2022. The vial did not undergo temperature excursion. it was reported that the patient was vaccinated post 30 day use period (expiration date 25-Mar-2022). The patient did not experience any side effects.  No treatment details were reported.
all tested positive for Covid last week.; all tested positive for Covid last week.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent.  An 8-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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 01Jun2022, outcome "unknown" and all described as "all tested positive for Covid last week.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.