chrisvoncsefalvay/vaers-outcomes huggingface dataset:
25 hours after getting the second vaccine, severe chills, high fever, nausea, vomiting,  full body aching,headache
On 5/6/96, the pt developed a "moderate case of chicken pox." 10 to 14 days post onset, the pt recovered. Additional information has been requested.
Overnight after shot developed aches and significant chills; Overnight after shot developed aches and significant chills; May have had other flu-like symptoms; This is a spontaneous report from a contactable consumer, the parent. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included birth control to help with cystic acne, celiac disease and known allergies to some fruit/nut allergy (mild). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified birth control medication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 07Apr2021 at 23:30, overnight after shot, the patient developed aches and significant chills and other flu like symptoms. The patient tried long hot showers, baths, blankets and by 05:30 took an Advil and continued to take Advil as per label at times day after shot. The patient reported that by second day after shot, seemed like symptoms had mostly cleared. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with ibuprofen (ADVIL), hot showers and blanket. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events aches, chills and flu like symptoms were resolved on an unknown date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case, initially received from other health professional on 12-Oct-2018, concerns a 21-month-old, infant male patient. The patient had no historical condition. The patient did not receive any concomitant medication. On 12-Oct-2018, the infant patient was administered FLUCELVAX QIVc (dose: 0.5 ml, batch number: 252656, expiry date: 31-May-2019, route of administration and anatomical location: not reported). No adverse event was reported. The reporter assessed the case as non-serious. The reporter did not provide consent to follow-up. Hence, this case is considered as lost to follow-up.
thyroiditis subacute; C-reactive protein increased; Pyrexia; Blood thyroid stimulating hormone; SARS-CoV-2 test negative; Ultrasound scan abnormal; the patient experienced SAT already after the first dose and that symptoms recurred with the second; This is a spontaneous report from a contactable consumer or other non hcp. This case is for patient 8. A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 as first dose for Covid-19 immunization and experienced Subacute Thyroiditis. On an unspecified date, the patient experienced thyroiditis subacute, c-reactive protein increased, pyrexia, blood thyroid stimulating hormone, sars-cov-2 test negative, ultrasound scan abnormal. The patient underwent lab tests and procedures which included c-reactive protein: increased, sars-cov-2 test: negative, tri-iodothyronine: normal, ultrasound scan: abnormal, white blood cell count: normal. The time to onset of event was 1 month. None of the event caused hospitalization or any other seriousness criteria. It was reported that the SAT onset was after the second dose, it was mentioned that the patient experienced SAT already after the first dose and that symptoms recurred with the second (positive rechallenge). Time to onset (TTO) in this case was reported as one day after vaccination with the second dose. The patient seemed to have an underlying thyroid disorder. It was reported that the symptoms of SAT resolved when she stopped her thyroid medication. Since it was not specified what kind of medication the patient was taking, it is not possible to conclude whether it was underlying hyper or hypothyroidism. SAT is not labelled as a potential adverse reaction in the three included vaccines Summaries of Product Characteristics (SmPCs). Outcome of the events were recovered.  Follow-up (26Jul2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a patient included clinical information.  Follow-up (26Jul2021): This follow up report contains no new safety information.  Follow-up (27Jul2021): This follow up report contains no new safety information.  No follow-up attempts are possible; information about Lot/Batch number could not be obtained.
WITHIN 2 HRS AFTER IMMUN., INFANT BEGAN SCREAMING AND CRYING WHICH PERSISTED THRU THE NIGHT; HAD SWELLING AND PURPURA IN BOTH LEGS-WAIST TO TOE.ADVISED HOSP BUT WAS REFUSED. NEXT DAY IN OFFICE 100.4 TEMP,IRRITABILITY,SLIGHT BRUISING ON LEGS
Patient's wife states that patient developed Guillain-Barré syndrome shortly following administration of MRNA COVID 19 vaccine in March 2020. She states that since this incident the patient has required the use of a walker device.
After I got the vaccine for the remainder of the day I had a racing heartbeat that went on for the next two days. For the next two months I had erratic heartbeats and just did not feel right. I used my smart watch to take ECG readings that showed A-FIB readings. My pulse was not regular for what is my normal, not even when I exercise.
Throwing up every fifteen to thirty minutes. Not projectile. Lasted a few hours. I think it has finally stopped. Also had a runny nose (did not previously have before the immunizations).
I am a cardiology nurse and have a previous history as a dermatology/Mohs surgical nurse. Day 3 after the vaccine my first of 2 vaccines received on 12/28/2019,  I have a reaction from my chin line up to my forhead. Please note that I had botox and fillers in this area in August of 2020.  The worst of the reaction was directly where I had the fillers and botox. The area became hot, red, itchy, and swollen. I also experienced my throat feeling tight.  I did visit my PCP office (where I had the vaccine administered but at the time they nor I were aware of the reaction to fillers). The next day I became aware of the rare reaction to fillers/Botox. Then on day 5 after the first injection, an area on my upper left chest that has a tattoo and I am currently in the process of having removed with multiple laser treatments (The last treatment was in the fall of 2020) became hot, red swollen and itchy.  Both reactions were separate and lasted approximately 2 days before resolving.   Then 24 days after that same first injection I had an additional reaction on my face. This time my chin rapidly became hot, tight and very painful, red, swollen, and very itchy as well as it started weeping fluid.  I also had the feeling of my throat closing. This was more severe than either of the other reactions and came on very quickly. I did visit the ED and was given IV Benedryl, decadron, Pepcid, and zosyn.  This helped the reaction to clear quickly.   Of note, I had my second vaccine on 1/25/2021 and to date, I have not had another reaction.
Mon-Tues 9:00pm-6:00am - paralyzed on back in full body pain, literally unable to move AT ALL Tues-Wed 6:00am-5:00am (next day) - able only to roll onto side; unable to get up except 2-3 times to bathroom; almost passed out one time; unable to keep down even sips of water; dry heaves; 100.8 fever; chills/fever; severe headache Wed-Sat - severe exhaustion; out of bed only occasionally and very briefly; able to keep down a little broth and then chicken soup; periodic chills, headache, nausea Sun-Mon - a little more improvement in all areas Tues - much better!  At some point, I developed Livedo reticularis in left calf. Went to urgent care on March 19. EKG normal. No DVT. Possibly caused by spasm. Saw physician today March 23.  Cause undetermined.
5cm urticarial rash on inj site 5 days p/vax;cellulitis dx, bandaid left on a long time-days;
pt recvd vax;24 hrs later c/o swelling redness & bumps at inject site on lt arm; c/o aching in arms & legs & feeling very sick; 48 hrs later aching & sick feeling gone, arm remained red, sore , bumpy
Received shot around 7 am by 6 pm  chills aches  fever  fatigue  throbbing headache. Took 400 mg of ibuprophen drank water slept. 2/6 woke thought felt better went to bathroom throbbing headache started  chills body aches  and with activity shortness of breath . In bed all day took 800 mg of ibuprophen  every 6 hours drank water slept . Injection site tender no redness or swelling. Till Sunday 2/7 .  On 2/7 slight headache no body aches or chills felt better but arm rash started slight tenderness to arm but increase swelling redness warmth.  Monday 2/8 redness expanding on arm with increase swelling slight tenderness and warmth no body aches chills or headache. Tuesday 2/9  redness /swelling decreasing  to arm  no warmth. Intermittent headache took ibuprofen x1. As far as fever goes  it fluctuated  from like grade to 102.3  2/5 to 2/6.
Administration error: prevnar 20 given instead of prevnar 13. Prevnar 20  lot: FJ2605
I developed a red swelling at injection site and an itchy rash on both arms, neck, face, scalp, torso and thighs. I was prescribed oral steroid 6 day pack and also took Benedryl and Claritin.  I still have the remnants of the rash and it is still a little itchy on February 22, 2021.
This spontaneous report as received from a physician via a company representative refers to a 3-year-old male patient with Wiedemann-Steiner syndrome (captured as short stature, developmental delay, muscle hypotonia, facial dysmorphism and hairy elbow syndrome). No other information regarding his pertinent medical history, drug reactions or allergies and concomitant medications was reported. On 12-MAR-2019, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (lot # R025297 has been verified to be a valid lot number, expiration date 08-JUN-2020) (exact dose, route of administration and injection site were not provided) as immunization for the prevention of pneumococcal disease. On 13-MAR-2019, he began to experience coughing and sneezing. The patient did not seek medical treatment for the events. On 14-MAR-2019, the patient died. The cause of death was unknown. It was unknown what medical intervention was sought or performed on 14-MAR-2019 or if an autopsy was performed. The outcome of the coughing and sneezing was unknown. The relatedness between the events and the suspect vaccine was not provided.
Headache & nausea after a few hours.  Around 20 hours after the shot, body aches, low grade fever, chills.  Around 26 hours after shot, increased heart rate (115-120 bpm while resting) along with cold sweat, headache & body aches.  All side effects resolved within 30 hours from shot.
"Bee sting" sensation soon after injection; redness and swelling at injection site within 24 hours; felt feverish, increased hoarseness, sneezing and cold symptoms, headache 24 hours. Patient stated resolved after 48 hours. Redness/Swelling in left arm resolved after 72 hours. Patient reported chest tightness beginning 4th night. Patient instructed to follow-up with 1 hour with MD for evaluation of chest tightness. Pt reported initial 3 times at 48 hours. Instructed to use warm compress an follow up next day. Patient also instructed to use Tylenol as needed per over the counter and to use dipherhydramine 12.5mg-25mg and seek care of symptoms worsen. 1/24/02-Pt reported still feeling "croupy"--stated she got treatment advice from 1 time MD and pharmacist.
On 7/16/03 at 10 AM, 2 days after receiving Twinrix, she woke with pain in her left arm (site of injection) that radiated to her neck and back. The pain then progressed down her left arm and leg. Approx. 6PM she c/o air hunger and SOB. No swelling of face or tongue. At 8:33 PM she was seen at ER. She was treated with Vistaril, DepaMedrol, Ativan and Darvocet for an "allergic reaction with secondary pain, hyperventilation." Discharged at 9:53 PM.
BODY PAIN AND ACHES; PAIN IN THE ARM; FEELING ILL; HEADACHE; FEELING TIRED; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol use, and smoker, and other pre-existing medical conditions included: Patient had no known drug allergies. Patient had no health conditions. Patient had taken some vitamins for treatment. 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 24-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 24-SEP-2021, the patient experienced body pain and aches. On 24-SEP-2021, the patient experienced pain in the arm. On 24-SEP-2021, the patient experienced feeling ill. On 24-SEP-2021, the patient experienced headache. On 24-SEP-2021, the patient experienced feeling tired. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain in the arm, body pain and aches, headache, feeling tired, and feeling ill. This report was non-serious.
Sudden jump in heart followed by pounding, rapid heart rate which lasted about 2-3 minutes.  Somewhat light feeling throughout body.
Pulmonary Embolus; Sudden Cardiac Arrest; Myocarditis; Pericarditis; This is a spontaneous report from a contactable consumer (patient herself). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the right arm on 27Apr2021 at 09:45 at the age of 45 years old (Batch/Lot Number: EN6206, Expiration date: unknown) as dose 2, single for COVID-19 immunization. The vaccination facility type was the physician/doctor's office/urgent care. The patient was not pregnant at the time of vaccination. Relevant medical history included anxiety and migraines, both from an unknown date and unknown if ongoing. The patient had no known allergies. The patient had no COVID-19 prior vaccination. The patient had no other vaccine in four weeks. Concomitant medications in two weeks included fluoxetine; minocycline; nortriptyline; and "Spironolac" (as reported); all taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in the right arm on 30Mar2021 at 09:00 AM at the age of 45 years old (Batch/Lot number: EN6202, Expiration date: unknown), as dose 1, single for COVID-19 immunization. On 31May2021 at 08:00, the patient experienced pulmonary embolus, sudden cardiac arrest, myocarditis, and pericarditis. The adverse events (AEs) resulted in both doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. This report was considered serious, as the events resulted in hospitalization and disability and were also considered life threatening. The patient was hospitalized for pulmonary embolus, sudden cardiac arrest, myocarditis, and pericarditis on an unspecified date for 6 days. The patient underwent lab test and procedure, which included COVID-19 test via nasal swab: negative on 26May2021. Therapeutic measures were taken as a result of pulmonary embolus, sudden cardiac arrest, myocarditis, and pericarditis, which included resuscitation, blood thinners, colchicine, and implantable cardioverter defibrillator (ICD). The patient had recovered with sequelae from all the events on an unspecified date in 2021.
2ND VACCINE GIVEN TOO EARLY- 15 DAYS BETWEEN 1ST DOSE AND 2ND DOSE.  NO EFFECTS NOTED WITH THE PATIENT.
9JUL91 pt recvd vax & was reported screaming constantly since recvd immun this morning x/1 hr nap; t100.3 R threw up, bit of redness & swelling around the inject sight & tenderness for about 7 days p/immun;
Painful neck glands, stiff joints, pain in right side of head with movement, numbness in right side of head and face
Very high fever, screaming, lethargic, pale, sleeping constantly, not eating, confused.
Within several hours of receiving the vaccine patient got a extremely sore arm with pain in the neck and back. Pain so severe in right arm. Patient is unable to move his arm.
OFF LABEL USE; DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a physician concerned a 12 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 08-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-JUN-2021, the subject experienced off label use. On 08-JUN-2021, the subject experienced drug administered to subject of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and drug administered to patient of inappropriate age was not reported. This report was non-serious.
After receiving the 2nd vaccine, I  had my menstrual cycle again for the month of October and have not stopped bleeding with daily headaches, fatigue, joint pain and leg pain.
evening of 4OCT93 pt ran fever of 101-102 & was fussy; stated resp problems noisy seemed to have a hard time catching breath but not severe; would not take formula-just juices; MD called
Red spots pop up all over his arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red spots pop up all over his arms) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced RASH MACULAR (Red spots pop up all over his arms). At the time of the report, RASH MACULAR (Red spots pop up all over his arms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Rt arm from deltoid to just below elbow was red, swollen, very warm to touch on lateral half of arm. Also had pain and itching X today. Slight redness and itching, yesterday with slight pain and itching on day of vaccine. Had previous reactions with DTP vaccines at age of 2 mo, 4 mo, 6 mo and 18 mo.
This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (had bouts of tinnitus after his Moderna Covid-19 vaccines / developed tinnitus over the past several months) and VACCINATION SITE PAIN (had pain in his injection site left arm) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE PAIN (had pain in his injection site left arm). On an unknown date, the patient experienced TINNITUS (had bouts of tinnitus after his Moderna Covid-19 vaccines / developed tinnitus over the past several months). At the time of the report, TINNITUS (had bouts of tinnitus after his Moderna Covid-19 vaccines / developed tinnitus over the past several months) and VACCINATION SITE PAIN (had pain in his injection site left arm) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant product use was not provided by the reporter. No treatment information was provided. This case was linked to MOD-2022-569012, MOD-2022-569013 (Patient Link).
Pain in left bicep and tricep. Redness, swelling, and warmness, in area.
Information has been received from a health professional concerning a 5 year old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 26-APR-2007, the patient was diagnosed with chickenpox. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. This is one of several from same source. Further information has been requested.
Within a few minutes client turned pale, stiffened body, arched back, arms curled to chest, eyes rolled back, head jerked back and forth. Lowered client to floor elevated and elevated legs. No injury.
Tested positive after the first dose; Tested positive after the first dose; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A male patient of an unspecified age received 1st dose of BNT162B2 (Pfizer/BioNTech COVID-19 Vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive after the first dose on an unspecified date. The patient underwent lab tests and procedures which included Covid test: positive on an unspecified date. The outcome of event was unknown.  Information about batch/lot number requested.
Severe flu-like symptoms began 6 hours after the shot and lasted for 2 days with fatigue and weakness continuing for another 2 days, 2 days after the shot (1/13) developed costochondritis which a PA believed could be tied to vaccine, this lasted for 9 days
I got vaccinated and got shingles/suspected vaccination failure; shingles. Had to go to urgent care. Was not happy; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In September 2020, the patient received Shingles vaccine. In April 2021, between 6 and 8 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got vaccinated with Shingles vaccine and got shingles.  The physician said they could not see the patient, the patient had to go to urgent care, so the patient was not happy. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.