chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine.; This is a spontaneous report from a contactable nurse. This nurse reported the same event for 20 patients (15 residents and 5 staff members). This is the fourth of 20 reports.  A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient has tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if the patient should receive the second dose.   Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 03Jan2021, and tested positive for the virus (COVID-19) in Jan2021.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like COVID infection date needed for a full meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
Itchiness and hives on lower body and lower extremities, starting 1 week after vaccines and lasting less than 24 hours.
3 weeks later he developed Tinnitus/Tinnitus was reported as worsened; cannot sleep; headache; anxiety; This is a spontaneous report from a contactable consumer. A 24-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: ER8729, patient was 24 years old at the time of vaccination), via an unspecified route of administration in Arm Left on 17Apr2021 at 13:00(Patient age at time of vaccination: 24 years) as a single dose for covid-19 immunisation at pharmacy. The patient's medical history and concomitant medications were not reported. There was no Family Medical History Relevant to AEs. There was no Prior Vaccinations (within 4 weeks) and no associated AEs following prior vaccinations. The reporter stated that patient gets a flu shot every year and is ok. The patient experienced tinnitus 3 weeks later. Upon follow up (11-may-2021), it was reported that on 06May2021, the patient experienced slight side effect in his ear like Tinnitus, Cannot sleep (ongoing), ongoing Headache, ongoing Anxiety and seriousness for Tinnitus was reported as worsened, whereas reporter seriousness for all other events was unspecified. The patient tinnitus did not stop for 5 continuous days and sounds like tinnitus all the way. The patient visited the ENT on 10May2021 and the patient's ear was clear and there was no other physical damage whatsoever to the patient's ear and he did not have any problems in his ear before vaccinating with the Covid-19 vaccine. The reporter reported that the patient's tinnitus seems like it's louder and sound is very low and that the patient cannot do low sounds. The patient anxiety and headache are from the tinnitus. The reporter unable to provide NDC number or expiry date of the Covid-19 vaccine as it was not included on the patient's vaccination paperwork. The event Tinnitus resulted in Physician Office visit. The outcome of reported events was not recovered.  Follow-Up (11May2021): Upon follow up, new information included:  Time of vaccine administration details, Anatomical site location details, lot details, Reported seriousness of the event Tinnitus details.  No follow-up attempts are needed. No further information is expected.
Pain to the left stomach area when using the restroom; Extremely nauseous; This is a spontaneous report from a non-contactable consumer, the patient. A 14-year-old female patient 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 15May2021 at 10:45 (at the age of 14-years-old), as a single dose for COVID-19 immunisation. The patient did not have any other medical history. The patient had no known allergies. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16May2021 at 18:45, the patient experienced extremely nauseous and pain to the left stomach area when using the restroom. It was unknown whether any therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events extremely nauseous and pain to the left stomach area when using the restroom were resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
No additional AE. No PQC. No further information available; GARDASIL 9 in 2016 when Patient was 12 years old was administered the 2nd GARDASIL 9 dose on 04/13/2021; This spontaneous report was received from a Nurse, referring to a 16 year old female patient. Information regrading the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided.   In 2016, when the patient was 12 year old, she was vaccinated with the 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) with lot # L024993 and expiration date on 17-OCT-2017 (route of administration was not provided) for prophylaxis.  Subsequently, on 13-APR-2021, the patient was vaccinated with the 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (route of administration, lot # and expiration date were not provided) also for prophylaxis.  No additional adverse events were reported.
COVID+ 10/13/22  -Vaccination status - pfizer x3   DATE OF ADMISSION:  10/13/2022 DATE OF DISCHARGE:    HOSPITAL COURSE The patient is a very pleasant 67-year-old female with past medical history as listed above including multiple myeloma, who presented to hospital as a transfer from outlying facility secondary to shortness of breath and worsening dyspnea on exertion.  Initial laboratory studies and imaging can be found per review.  The patient was hypoxic with O2 saturation of 87% on room air in the ED.  She was COVID positive.  Blood cultures were obtained and were negative.  Lactate was normal.  BNP 1674 and normal troponins.  CTA of the chest was negative for PE but showed bilateral lower lobe pneumonia with multifocal bilateral lower lobe mucous plugging.  She was transferred to hospital under the Oncology Service and started on remdesivir.  She was placed on dexamethasone for hypoxia.  She was started on antibiotics for superimposed bacterial pneumonia.  Pulmonology was consulted.  MRSA was negative.  Broad-spectrum antibiotics were initially recommended.  Streptococcus and Legionella were negative.  MRSA screen was negative.  Infectious Disease was consulted, who agreed with remdesivir and okay to stop at discharge.  They also agree with dexamethasone.  Recommended continuing or finish a 5-day course of ceftriaxone, azithromycin or stop at discharge.  The patient was hypotensive in the ED with a blood pressure of 74/57.  This improved with fluid bolus.  Her atenolol was held, then resumed with stable blood pressures.  She had transaminitis that is improving.  We will continue to hold her Lipitor.  Overall, she did well during the course of the hospital stay.  Her oxygen was weaned off and she was felt medically stable for discharge on 10/17/2022 in stable condition.  MEDICATIONS AT DISCHARGE Atenolol 50 mg per PEG daily, Wellbutrin XL 300 mg daily, Mucinex 600 mg b.i.d., levofloxacin 750 mg for 2 days, levothyroxine 88 mcg daily, Osmolite tube feeds as before, albuterol 2 puffs q.6 hours p.r.n., BMX solution 10 mL every 3 hours p.r.n., Zyrtec 10 mg daily p.r.n., Pepcid 20 mg b.i.d. p.r.n., DuoNeb 3 mL nebulizer every 6 hours p.r.n., Trelegy Ellipta 1 inhalation daily.
severe ear problem/cannot hear; This is a spontaneous report from a contactable consumer (patient's sister). A female patient of unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) at dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had a severe ear problem. Further clarified that the patient was not in pain but cannot hear. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
No additional AE/PQC. No symptoms/adverse events reported; an adult dose of VAQTA was inadvertently given to a 17 year old patient.; Adult and pediatric doses look very similar.; This spontaneous report has been received from a registered nurse, referring to a 17 years old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.   On 09-AUG-2023, the patient was vaccinated with the first dose of an adult dose (1 dosage form) inadvertently of hepatitis a vaccine, inactivated (VAQTA) 50/1.0 U/ml (expiration date: 10-JUL-2024) intramuscularly for prophylaxis (incorrect dose administered). It was reported that adult pediatric doses looked very similar (product dose confusion). No symptoms/adverse events were reported.  Lot # w02855A was evaluated and changed to the valid Lot # W028554 valid for hepatitis a vaccine, inactivated (VAQTA) (formulation prefilled syringe).
Severe pain in arms and especially joints. Could not raise arms above head w/o exceptional discomfort. Some cramping in hands. Nausea, lightheadedness and inability to sleep. Lethargy continued all the next day. Head was "fuzzy" to point could not drive. Slept most of 10/08/2011 and symptoms gradually dissipated. Morning of 10/09/2011 some soreness and discomfort persists but most function has returned.
lt arm erythema 9cm x 4cm extending downward from puncture site;warm to touch, sl swelling;no streaking or drainage noted;
painful to move arm; soreness in his left arm at sight at injection; feeling as if he has been hit by a train; Tiredness; Headache; feeling achy; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 1st November 2019, 1 days after receiving Shingrix, the patient experienced injected limb mobility decreased, injection site pain, feeling abnormal, tiredness, headache and pain. On an unknown date, the outcome of the injected limb mobility decreased and feeling abnormal were unknown and the outcome of the injection site pain, tiredness, headache and pain were not recovered/not resolved.   It was unknown if the reporter considered the injected limb mobility decreased, injection site pain, feeling abnormal, tiredness, headache and pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and feeling as if he has been hit by a train and tiredness, headache, feeling achy, and soreness in his left arm at sight at injection and painful to move arm.  The reporter did not consent to follow up. The reporter was fine with receiving acknowledgment letter from GlaxoSmithKline.
24 hrs. later; Rash all over body, 1/2 c, in diameter, hot to the touch, red color. After, several hours, rash decreased in size and intensity OTC medications were given
feels light headed and dizziness; disorientated; does not have appetite.; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feels light headed and dizziness), DISORIENTATION (disorientated), DECREASED APPETITE (does not have appetite.) and NAUSEA (nausea) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced DIZZINESS (feels light headed and dizziness), DISORIENTATION (disorientated), DECREASED APPETITE (does not have appetite.) and NAUSEA (nausea). At the time of the report, DIZZINESS (feels light headed and dizziness), DISORIENTATION (disorientated), DECREASED APPETITE (does not have appetite.) and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included Dramamine.
received a 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 9ZJ25, expiry date 30th January 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   In December 2021, the patient received the 3rd dose of Shingrix. In December 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was unknown. The patient did not informed the pharmacist that two previous doses were administered. The patient received 3rd dose of Shingrix, which led to extra dose administered. The reporter did not consent to follow up. This case was linked with case US2022019042, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022019042:Same reporter
Right arm pain/weakness, radiating into the neck.  No bruising or swelling noted by patient.
Fever of 103, severe chills, body aches, joint pain, weakness, cough, headache, sore throat
Pt. said he got shingles 1 month after receiving vaccine 9/22/09. Pt states that not all vaccine given. Some ran down arm & was not vaccinated properly leading to his outbreak.
Breakthrough varicella. 40 lesion on skin 6/3/05. Fever 6/2/05.
Pulmonary Embolism. I saw her in clinic 6 days after her second dose. She had started feeling increasingly short of breath starting day 1 post 2nd dose. Vitals were stable, CXR and labs done. D-dimer 2020, sent to ER, CTA done and dx made. Started on outpatient Eliquis  and was DC'd from ER hemodynamically stable.
motion sickness; flue like symptoms; clear drainage coming from her nose; sore throat; body ache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of MOTION SICKNESS (motion sickness), INFLUENZA LIKE ILLNESS (flue like symptoms), RHINORRHOEA (clear drainage coming from her nose), OROPHARYNGEAL PAIN (sore throat) and MYALGIA (body ache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced MOTION SICKNESS (motion sickness), INFLUENZA LIKE ILLNESS (flue like symptoms), RHINORRHOEA (clear drainage coming from her nose), OROPHARYNGEAL PAIN (sore throat), MYALGIA (body ache) and NAUSEA (nausea). On 08-May-2021, OROPHARYNGEAL PAIN (sore throat) had resolved. At the time of the report, MOTION SICKNESS (motion sickness), INFLUENZA LIKE ILLNESS (flue like symptoms), RHINORRHOEA (clear drainage coming from her nose), MYALGIA (body ache) and NAUSEA (nausea) outcome was unknown.      No concomitant and treatment details were provided.
Bell's palsy L side of face impacting eye and partial of mouth; not resolved at this time
Redness at the site went up to my neck into the left side of the face, under my left eye and temple.; Tingling in this patterned area; Difficulty breathing; Vision impaired with black/white specks; Vision impaired with black/white specks; Server chills; Muscle aches; Inflammation in joints; Emotional.; Redness at the site went up to my neck into the left side of the face, under my left eye and temple.; Lack of clarity; This is a spontaneous report from a contactable other hcp. A 42-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (at the age of 42-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced redness at the site went up to my neck into the left side of the face, under my left eye and temple, tingling in this patterned area, difficulty breathing, vision impaired with black/white specks, server chills, muscle aches, inflammation in joints, emotional and Lack of clarity. Facility where the most recent COVID-19 vaccine was administered was withheld. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received no other medications within 2 weeks of vaccination. Outcome of the events were unknown.  Information about batch/lot number has been requested
Child became very fussy near bedtime at 8:00 PM and then began screaming uncontrollably for 2 hours.  He had no other symptoms or outward signs of illness at the time.  In the morning at approx 8:00 AM he had a fever of 102, rosy cheeks and still very fussy. Called nurse in AM and instructed me that fever wasn't high enough to worry and crying was just because shots hurt.
The patient apparently woke up in the morning and told his wife that he was tired and went back to bed and did not wake up.
Patient reported aching from waist up/pain/discomfort. Arrival home, several hours later, patient got a headache, couldn't sleep, and eventually in the AM hours about 14 hours after the IMZ,  had the diarrhea. Patient took IBU. Next day patient was extremely fatigued. 48 hours later patient reports feeling a lot better, but still is tired. She was able to go to work as well.
side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (side effects) in a  patient of an unknown age and gender 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) at an unspecified dose. On an unknown date, the patient experienced ADVERSE REACTION (side effects). At the time of the report, ADVERSE REACTION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Bilateral arm aches lasting from date of first vaccination (12/23/2020) to present 1/13/2021). Red, raised bumpy rash along right arm, and across chest on both sides lasting from the day after the vaccination to today's date. Itchy, non-open skin. Feels dry/scaly.
hives mostly upper body , improved after Benadryl, steroids and Pepcid no tongue swelling or edema
I became ill one week after my vaccination. I started out with a scratchy throat and coughing (April19th to April 15th) . By the next day, I was week and couldn't get out of bed. It felt as if I had the flu. I lost my appetite as well for a brief period.
arm was swelling, and developed a bump of 3 inches x 2.5 inches that was red and hot; arm  was itching; arm was swelling, and developed a bump of 3 inches x 2.5 inches that was red and hot; arm was swelling, and developed a bump of 3 inches x 2.5 inches that was red and hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm was swelling, and developed a bump of 3 inches x 2.5 inches that was red and hot), VACCINATION SITE PRURITUS (arm  was itching), VACCINATION SITE SWELLING (arm was swelling, and developed a bump of 3 inches x 2.5 inches that was red and hot) and VACCINATION SITE ERYTHEMA (arm was swelling, and developed a bump of 3 inches x 2.5 inches that was red and hot) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Vitamin D deficiency and High cholesterol. Concomitant products included HYDROCHLOROTHIAZIDE, VALSARTAN (DIOVAN HCT) for Blood pressure high, MONASCUS PURPUREUS, UBIDECARENONE (CHOLEAST) for Hypercholesterolaemia, COLECALCIFEROL (VIT D3) for Vitamin D3 deficiency.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE WARMTH (arm was swelling, and developed a bump of 3 inches x 2.5 inches that was red and hot), VACCINATION SITE PRURITUS (arm  was itching), VACCINATION SITE SWELLING (arm was swelling, and developed a bump of 3 inches x 2.5 inches that was red and hot) and VACCINATION SITE ERYTHEMA (arm was swelling, and developed a bump of 3 inches x 2.5 inches that was red and hot). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of 625 milligram and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. On 28-Jan-2021, VACCINATION SITE WARMTH (arm was swelling, and developed a bump of 3 inches x 2.5 inches that was red and hot), VACCINATION SITE PRURITUS (arm  was itching), VACCINATION SITE SWELLING (arm was swelling, and developed a bump of 3 inches x 2.5 inches that was red and hot) and VACCINATION SITE ERYTHEMA (arm was swelling, and developed a bump of 3 inches x 2.5 inches that was red and hot) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       This case was linked to MOD-2021-252963 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: Follow up received on 11JUL2021, included reporter's contact details, updated patient's demographics, medical history, 2nd dose was given 12FEB2021 Lot@039K20A and action taken with the drug was updated to no change, concomitant medications, treatment medication (Acetaminophen), events stop date and outcome was updated as recovered.