chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shortly after receiving the first dose of vaccination and before leaving the recovery area, patient had syncopal episode that was preceded by lightheadedness and visual darkness.  Patient reported history of syncope after blood draws. No injury incurred and patient immediately regained consciousness and went back to baseline. BP at the time was 101/86 mmHg then 86/45 mmHg. Patient was sent to the ER for evaluation with reports of nausea at that time.  Glucose finger stick and EKG were reported within normal limits. POC ultra sound showed fetal heart rate 143 and positive fetal movements.  Patient discharged from ER after observation.
04/15/04 5:30AM: Mother noted some redness, swelling and firmness at site of DTAP administration right deltoid.  Mother called health department, spoke with PNP, parent was advised to delineate observe and parent gave "Motrin".  This AM, swelling persists, redness and swelling excessed marks.  Child appearance and behavior normal throughout.  Family will apply cold compresses and observe, continuing Motrin.  Seen by FMP.
Got sick from the vaccine; In bed for two days; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (Got sick from the vaccine) and DECREASED ACTIVITY (In bed for two days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Family history included Immune disorder (NOS) since an unknown date.    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 ILLNESS (Got sick from the vaccine) and DECREASED ACTIVITY (In bed for two days). At the time of the report, ILLNESS (Got sick from the vaccine) outcome was unknown and DECREASED ACTIVITY (In bed for two days) 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 was reported. The patient stated that her family had immune issues and genetic issues. She further stated that, she and her brother got sick from the vaccine. She herself and her brother were in bed for two days. No treatment medication was reported.   This case was linked to MOD-2021-434459 (Patient Link).
Mother states that on the day after vaccination the area was red, hard, and warm. The infant had fever and was irritable.
ADMINISTRATION ERROR: Healthcare provided gave 5-11 dose, and patient just turned 12. healthcare professional wanted to report.
This spontaneous report was received from a 62-year-old female patient, who refers to herself. The patient concurrent conditions included penicillin allergy. The patient's historical conditions included shingles. There was no concomitant medications. On 24-FEB-2017, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (dose, strength, anatomical location, lot number and expiration date were not reported) for prophylaxis. On 25-FEB-2017, the patient experienced a red area about size of a quarter, itching blister, patches at the injection site. Due to this events, on an unknown date, the patient applied an unspecified cortisone cream. There was no lab diagnostic studies performed. The patient did not seek medical attention. The product quality complaint was not involved. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Developed yellow blisters at injection site next day after MMR. Crusted over and healed
Arm swelling, redness, red and warm to touch large portion of upper arm and shoulder.
Pain at the injection site. Fever, Fatigue, Flushing sensations, brain fog.
had shingles vaccine, I got shingles / suspected vaccination failure; shingles; Shingles was just awful.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID19 VACCINE) for prophylaxis.   The patient's past medical history included chickenpox (Had chickenpox when young).   On an unknown date, the patient received Shingles vaccine and the 2nd dose of COVID19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had chickenpox when young. The patient had Shingles vaccine about 5 years before reporting and 3rd day after 2nd COVID19 vaccine, patient got a severe case of shingles on the same side of my vaccine. Shingles was just awful. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Elevated temp 103 for 2 days. Symptom free until 08/07/2012, then headache, nausea, diarrhea. Mother reports patient raising eyebrows when he talks.
Erythema 3x4 cm, nodules and temp. 100.2 oral.
Arthralgia  INJECTION SITE SORENESS X 2DAYS  Narrative:  INJECTION SITE SORENESS & BODY ACHES X 2 DAYS
Twenty four hours after receiving vaccination the patient began to develop white bumps around the vaccination site--went to her Dr. The bumps began spreading to her shoulder and, at time of interview, have spread to her back and antierior thorax--Dr ordered an antihistamine and a 7 day steroid dose pack.
KINRIX given in right deltoid 11/27. 11/28, dad noticed right upper arm completely swollen, red, painful itching. Giving BENADRYL 7 ml and MOTRIN 7 ml w/ no improvement. No worsening or spreading of rash since yesterday. Low grade temps, loss of appetite since vaccine 11/27. No wheezing, no mouth/lip swelling.
Swelling, pain, immobility; resulted in frozen shoulder. Now needs physical therapy. Accumulated doctor's bills. Cannot afford. Went to regular doctor, orthopedic doctor and physical therapy. Very painful and difficult to anything with left arm.
Fever of 101F from around 10 AM to midnight; general exhaustion from 4 AM to noon the next day.
Patient is 51 and receiving a PCV13 at this age is only recommended if immunocompromised, chronic renal failure, nephritic syndrome or asplenia. Or cochlear implants of CSF leaks which none of that patient had.
Itching all over; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 02Apr2021 at 10:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic rhinitis, hypothyroidism, osteopenia and had known allergy to penicillins. The patient received codeine (MANUFACTURER UNKNOWN) on an unknown date, for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205) via an unspecified route of administration in the left arm on 12Mar2021 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. On 06Apr2021, the patient experienced itching all over. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken and included diphenhydramine hydrochloride (BENADRYL) and alprazolam (XANAX). The clinical outcome of the event itching all over was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
This case was reported by a physician and described the occurrence of fever in a 54-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 10 October 2010 at 11:00 the subject received a dose of FLUARIX (.5 ml, unknown route, right arm). On the evening of 12 October 2010, 2 days after vaccination with FLUARIX, the subject experienced fever (103.8 degrees Fahrenheit), myalgia and tremor. At the time of reporting the events were worse. The physician considered the events were probably related to vaccination with FLUARIX. Follow-up information received from the reporting physician on 26 October 2010: The physician reported the diagnosis as febrile adverse reaction. The physician considered the events were clinically significant (or requiring intervention) and indicated that medication (unspecified) was administered. At the time of reporting, the events were either improved or resolved on 19 October 2010; it was not specified which events were improved and which were resolved.
a blood clot was created which moved to my brain; stroke; It affected my eyesight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm, administration date 02Mar2021 (Lot number: EN6203) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Cancer" (unspecified if ongoing). There were no concomitant medications. Patient started, "No, that was given to them at that time." Prior vaccination (within 4 weeks, "No. Vaccination history included: Covid-19 vaccine (1st dose of covid vaccine, Manufacturer unknown, LOT#: patient stated, "For the first dose was EL, I do not know if it is a 4 or 9, 264), administration date: 09Feb2021, when the patient was 70 years old, for COVID-19 immunization. The following information was reported: CEREBRAL THROMBOSIS (medically significant) with onset 2021, outcome "unknown", described as "a blood clot was created which moved to my brain"; CEREBROVASCULAR ACCIDENT (medically significant) with onset 2021, outcome "unknown", described as "stroke"; VISUAL IMPAIRMENT (non-serious) with onset 2021, outcome "unknown", described as "It affected my eyesight". The patient underwent the following laboratory tests and procedures: investigation: unknown result, notes: Patient started, "I do them all the time. Yes, I think so. Within the last 4 weeks, I do not know about 2 weeks.". Concern: Patient stated, "I got my vaccine last year and after I got the second shot a blood clot was created which moved to my brain and I had a stroke and it was right after I got the second shot. I have been trying to report this twice and nobody could tell me where can I report this." When paraphrased the concern, patient stated, "I had a blood clot, it travelled to my brain and gave me a stroke. Plus, I keep getting things that I am supposed to get my booster and everything else but I am afraid to get it because of what happened before. I do not want to get it." When asked if do not want to get the booster shot: Patient stated, "Right, I might get the other shot."(further clarification unknown). Patient stated, "When we get the shot, why do not they give us any information to report any issues because I went to all my doctors because it affected my eyesight and I could not do much of anything and nobody seemed to know what to do." No follow-up attempts are possible. No further information is expected.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "Anxiety" (unspecified if ongoing); "seasonal and indoor allergies" (unspecified if ongoing); "PMDD" (unspecified if ongoing); "trigeminal neuralgia" (unspecified if ongoing); "Known allergies: Pineapple" (unspecified if ongoing), notes: Known allergies: Pineapple. 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 "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures including Paxlovid were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 to the reported events drug ineffective and COVID-19 cannot be ruled out.
PATIENT FELT HEAT AROUND INJECTION SITE THAT EVENING OF INJECTION, WENT TO EMERGENCY ROOM NEXT DAY WHERE THEY OUTLINED CELLULITIS AND IT WAS SHOWN TO WORSEN. PATIENT TREATED FOR CELLULITIS. UNKNOWN DURATION.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On 23-MAY-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # M004116, expiry 12-OCT-2017 (dose and route not reported). Temperature: 28 F. Time frame: one hour. No previous temperature excursions reported. Data logger was used. Additional information has been requested.
Splotchy rash in patches from neck to navel, large splotches on and around nipples.  This rash improves and then worsens and new irritations appear.  Skin becomes dry and irritated. Very itchy. I am prone to skin rashes and have a high tolerance for itchiness, but have been unable to stop scratching.
Mild erythematous and swelling, hot no cellulitis, Temperature 100 degrees Fahrenheit no lymphadenopathy, no streaking.
Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown). The patient was not pregnant at time of vaccination. The patient's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: amoxycillin, reaction(s): "Known allergies: amoxycillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. Therapeutic measures were taken as a result of covid-19.  The clinical course reported as COVID symptoms return, positive antigen test on day 13 after original infection - congestion, headache. The patient received other medications in two weeks. The patient received other medications in 2 weeks product was Macrobid, start date= 01May2022, stop date= 05May2022. The patient receive treatment with Brand=Paxlovid, start date/ stop date 04May2022. The patient known allergies Sulfa, amoxycillin.  No follow-up attempts are possible. No further information is expected.
Developed large inflamed area 10 in by 5 in. Put on Cipro 250 mg BID for 10 days.
Had a little bit of discomfort in her right arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Had a little bit of discomfort in her right arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 036B21A) for COVID-19 vaccination.     The patient's past medical history included Heart valve replacement (Mechanical heart valve.). Concomitant products included WARFARIN SODIUM for Heart valve replacement.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced LIMB DISCOMFORT (Had a little bit of discomfort in her right arm). At the time of the report, LIMB DISCOMFORT (Had a little bit of discomfort in her right arm) had resolved. Not Provided          Treatment details included band-aid's placement after the first dose.
4 by 2 inch bright red rash on left upper arm, warm to touch, burning/tingling pain to the touch, no itching. started to resolve after about 4 days
Case number PHEH2016US029317, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 65 years old female patient. Past medical history and concomitant medications were not reported. The nurse stated that first temperature excursion of FLUCELVAX Quadrivalent at 52F for 1 hour occurred on 18 Oct 2016. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: not reported) at a dose of 0.5 ml intramuscularly on 26 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34F and lasted 30 minutes each time. Third temperature excursion occurred on 02 Nov 2016, down to 32.2F three times over the course of 12 hours. Vaccine had been administered. It was unknown if vaccine was frozen. Nurse did not known which lot was given to which patient. No adverse event was reported following this administration error.
Terrible raw, sore throat. Sinus and nasal congestion and pressure, followed by about 2 days of migraine-like (pressure) headaches. Was out of work for almost two weeks. Was treated by ENT via Telehealth appt. with antibiotics.
pt rcvd vax; pt felt tired & arm heavy; pt seized involving a tonic, clonic reaction of both arms & legs & shorting respiration; pt unconscious for 10sec; pt groggy; sleepy; pale; radial pulse 50b/min; pt taken to ER & seen by MD;
Awoke with arm pain in AM and rash at injection site at 6PM, pt sought medical treatment at  ER Health Service, Attending Dr stated allergic reaction to vaccine, topical cream prescribed, symptoms have resolved some redness still at injection site
Extreme stomach/abdominal pain seven hours after moderna vaccination shot to left arm. Vomiting started seventh day after vaccination shot several times a day and she is on 22nd day after vaccination shot. She has not been able to keep any food down since march 19th at 4:00pm which was 7 hours after moderna vaccination shot. She has had her blood drawn twice for any possible deficiency, urine screening, I.V. cat scan and ultra sound done where none of which she has had done has anything came back abnormal. She's had 2 I.V. Bags put in due to dehydration and not being able to hold down any food or fluid. She has been prescribed zolfran and barely helps for any hour. No improvement & seems to slowly get worse.
Experienced fever, chills, drowsiness, vomiting, red rash on face and rest of body, body ache, lack of appetite, headache, and soreness of arm that received injection.
A report has been received from a Health Professional concerning a 5 year old, female subject, who had been receiving Nasal FLUMIST. FLUMIST QUADRIVALENT started on 23-Oct-2013. It was reported that patient received FLUMIST QUADRIVALENT twice which started on 05-Nov-2013. The outcome of the event of received FLUMIST QUADRIVALENT twice is unknown. The report was considered to be non-serious.
fever lasting 4 days with highest 104.7 on day 3 with associated severe weakness/lethargy, hypotension and tachycardia. Required hospitalization (currently in the hospital) - hypoxic requiring BiPAP and two pressers for hypotension - in the ICU.
Approximately 24 hrs after administration developed soreness and swelling at injection site with fever 101. 6/17 still with swelling. Fever resolved.
This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. On an unknown date the patient was vaccinated with PROQUAD (Merck) and a dose of VARIVAX (Merck) (dose, route and lot number were not provided) on the same day. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Case number PHEH2016US026076, is an initial spontaneous report received from a consumer on 07 Oct 2016. This report refers to a female patient of unknown age. Medical history and concomitant medications were not reported. The patient was vaccinated with influenza vaccine(unknown whether seasonal or pandemic, batch number: not reported) at an unknown dose on an unknown date. The patient received lidocaine (manufacturer unknown) for an unknown indication at an unknown dose on an unknown date. The patient also received Thimerosal (manufacturer unknown) for an unknown indication at an unknown dose on an unknown date. The consumer stated that, she had a reaction Thimerosal in the past with a Lidocaine and flu shot. The symptoms was cellulitis. The outcome of the event was unknown. The seriousness and causality of the events was not reported. The seriousness assessment of cellulitis was upgraded based on Novartis Important Medical Events list. The case was lost to follow up at initial.
Covid #1 given on 2/15/2021, #2 on 3/15/2021 and boosted on 10/31/2021.  Boosted was with 0.25 mL and not 0.5, which would have been more appropriate for an immunocompromised patient.   Booster dose given at Pharmacy.  Patient admitted to hospital on 12/30/2021 and expired on 1/6/2022 Tested positive for Covid-19 on admission
pt recv vax 6AUG96 & pt exp malaise, fever, h/a, & a sick/bad feeling;pt h/a persisted throughout the afternoon & evening;7AUG96 pt exp diarrhea;pt took APAP for sx;pt felt better on 8AUG96;
This medically confirmed spontaneous report (initial receipt: 07-Jun-2012) concerns a patient. The patient developed a severe allergic reaction to an influenza vaccine (manufacturer and brand name unspecified) two years ago which consisted of a severe rash, difficulty breathing and a high temperature. The event outcome was not reported.
At 7pm, i experienced chills, shivering, head fuzziness, muscle aches and right arm pain. At 9pm, experienced fever, headache and numbness in my finger tips. Took ibuprofen 600mg. Did not see any improvement for an hour. Went to bed at 12:30. Awoke at 3am with same  symptoms. Took ibuprofen 600mg at 6am.  Symptoms came back 1:30pm that day. Took another ibuprofen 600mg.  The rest of the evening was good except for a headache.
I started with a fever, really bad confusion and felt weak. I kept going to the doctor to regulate my blood pressure. I had to go to hospital by ambulance was told I was having a TIA; was hospitalized for 4 days. I was discharged with heart medications still feeling really weak was sleeping around 12 hrs a day. My face on left side, left leg was very weak and bad headaches. I had to go back to the hospital September 8-11 left side face, left leg was paralyzed was in ICU. The tests ran doesn't show any blockages and doctors think it started after I got my vaccine.
Moderna 5/12/21, 8/4/21. Positive on 8/27/22