chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TESTED + FOR COVID ON 7-15-22  AT hospital.   DECEASED 10-1-22     TO ER   8/30/22 WITH MULTIPLE FALLS AND ADMITTED WITH HYPOKALEMIA AND ACUTE HEPATITIC ENCEPHALOPATHY .   Had chronic debility and parkinsons,  cirrhosis and was having dysphagia presenting trouble taking meds.  Hospice was consulted and pt was made DNR /DNI.  He became hypoxic and had lethargy with high ammonia levels.  decided to give him comfort measures only and transferred to hospice center.
ACUTE RESPIRATORY FAILURE 10/21/2022 LUNG CANCER, LEFT UPPER LOBE  ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/3/2022 LUNG CANCER, LEFT UPPER LOBE  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 10/21/2022 LUNG CANCER, LEFT UPPER LOBE  HYPOXIA 10/3/2022 LUNG CANCER, LEFT UPPER LOBE  ACUTE RESPIRATORY FAILURE 10/21/2022 DERMATITIS  ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/3/2022 DERMATITIS  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 10/21/2022 DERMATITIS  HYPOXIA 10/3/2022 DERMATITIS  ACUTE RESPIRATORY FAILURE 10/21/2022 AUTOIMMUNE HEPATITIS  ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/3/2022 AUTOIMMUNE HEPATITIS  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 10/21/2022 AUTOIMMUNE HEPATITIS  HYPOXIA 10/3/2022 AUTOIMMUNE HEPATITIS  ACUTE RESPIRATORY FAILURE 10/21/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE  ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/3/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 10/21/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE  HYPOXIA 10/3/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE  ACUTE RESPIRATORY FAILURE 10/21/2022 SEPTIC SHOCK  ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/3/2022 SEPTIC SHOCK  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 10/21/2022 SEPTIC SHOCK  HYPOXIA 10/3/2022 SEPTIC SHOCK
severe blurred vision; shortness of breath; shaking; stiffness in his jaws; patient who fainted; This is a spontaneous report from a contactable pharmacist. A 22-year-old male patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date (received at the age of 22-years-old) as SINGLE DOSE for COVID-19 immunisation. Medical history SVT (supraventricular tachycardia) (diagnosed with SVT by his cardiologist, however it was never confirmed), palpitation, and had fainted in two different situations in the past. Concomitant medications were not reported. The patient fainted after the first dose of COVID-19 vaccine as soon as he stood up. He was unconscious for about 5 seconds. He was experiencing severe blurred vision, shortness of breath, shaking and stiffness in his jaws. He was 22 years old, 170 pounds, and 6 feet tall. He has history of palpitation. In the past he was diagnosed with SVT by his cardiologist, however it was never confirmed. In addition, he had fainted in two different situations in the past. Based on what the patient says, his health issues and why he faints was never fully understood by medical doctors. Outcome of the events was unknown.   Information about Lot/batch number is requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on event syncope cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 26Jan2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first vaccine on the 26Jan2021. She had the COVID-19 test on the 31Jan2021 and received the results on 01Feb2021 and tested positive. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Feb2021. The patient was scheduled for the 2nd dose on 16Feb2021. The outcome of the event was unknown. Information about Batch/Lot number has been requested.
Case number PHEH2013US009465, is an initial spontaneous report received from a nurse on 24 APR 2013, and with a follow up received on 16 MAY 2013. This report refers to a 19-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch  number: M11042) at a dose of 0.5 ml, intramuscularly into left arm, on 24 APR 2013 at 9:20 AM. Nurse reported that the patient received MENVEO injection which had experienced multiple temperature excursions down to 1.9 C, but not frozen (dates of temperature excursions: 14 APR 2013; 21 APR 2013 and 23 APR 2013). No adverse was reported following this medication error (incorrect storage of drug).   Follow up report received on 16 MAY 2013. Updated dose and site of vaccination.
5 minutes post administration complaint of lightheadedness.   15 minutes post administration bilateral hand tingling, hot flushed and sweaty.   Oral Benadryl 25mg given.   5 minutes, resolution of sweaty/hot flushing.  15 minutes post Benadryl resolution of all symptoms. Monitored for 60 minutes, full resolution
Around 9pm on 06/29/2018 patient started with a cough and runny nose. On Saturday 06/30/2018 the immunization area was very big, very red, warm to touch and hard. I drew a circle around it to make sure it didn't spread and kept a close eye on it while using ibuprofen and TYLENOL alternating doses for pain and swelling. I called the doctors office Monday and they got her in and checked her out, said to keep a close eye on it and if it spread or got worse bring her back. We are at a month later and she still has a hard pea sized bump in immunization spot and you can still see the area that was all swollen and red. Talked to Drs. office this morning 07/26/2018 around 11am and they said to keep an eye on it and they were going to talk to Dr. to see if he wants to see her.
redness at injection site; itchiness at injection site; Loss of appetite; Hoarseness; Hives right arm above injection site; low grade fever; Tiredness; Queasy/ Nausea; Diarrhea; Muscle weakness; Headache; could not keep eyes open; swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received Flu Seasonal QIV(Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   The patient's past medical history included transient ischemic attack (in 2009), tachycardia, bradycardia and hypertension (bedrest due to HTN,). Previously administered products included Steroid shot (steroid shot in right knee August 2021). Concurrent medical conditions included intervertebral disc protrusion (bulging disks) and overweight.   On 24th September 2021, the patient received Influenza vaccine Quadrivalent 2021-2022 season (intramuscular). In September 2021, several hours after receiving Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced injection site erythema, injection site itching and injection site swelling. On 25th September 2021, the patient experienced appetite lost, hoarseness, hives, low grade fever, tiredness, nausea, diarrhea, muscle weakness, headache and eyelid function disorder. In September 2021, the outcome of the injection site erythema, injection site itching, appetite lost, hoarseness, hives, low grade fever, tiredness, nausea, diarrhea, muscle weakness, headache and eyelid function disorder were recovered/resolved. On an unknown date, the outcome of the injection site swelling was unknown.   It was unknown if the reporter considered the injection site erythema, injection site itching, injection site swelling, appetite lost, hoarseness, hives, low grade fever, tiredness, nausea, diarrhea, muscle weakness, headache and eyelid function disorder to be related to Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were reported as follows: This case was reported by the patient for herself. The patient stated that she received Flu shot (did not know which one) and had the following reactions like redness, swelling and itchiness at injection site hours after vaccine given in right arm. The patient also stated that, the next day itching got worse and she had a low grade fever, tiredness, queasy/nausea, diarrhea, muscle weakness, headache, could not keep her eyes open, hoarseness and loss of appetite. The patient also had hives at right arm above the injection site. The patient stated she had recovered since then. The reporter consented to follow-up. Note: There is discrepancy reported for the time to onset of event hoarsness and loss of appetite. In the structured field it is reported as 2 days however, in the narrative it is reported as occurred on the next day of vaccination. The TTO for these events captured as per narrative.
17 Y male came for flu vaccination received flu vaccine on his left deltoid. 5 minutes later, patient complained of dizziness to mother and started passing out. Assisted patient to the ground by mother and nurse. Observed patient with eyes rolled to the back and with confusion. Patient recovered in 45 sec. Patient assisted to chair. Patient given juice and came around. 10 minutes later patient had complaints of dizziness and blurry vision. Pale in appearance. Called ambulance and patient transferred to hospital. Per ED Notes Precipitating or alleviating factors: had some vagal sx before(Last year when he had rhinosinusitis),  , Associated signs and symptoms: vagal sx. Symptoms were positive for diaphoresis, syncope
Complete right arm started tingling from my fingertips to my shoulder and today it?s still doing the same pain associated with fingers and thumb, While driving or when my hand is extended above my shoulder deep pain tingling numbness feeling is unbearable!
24NOV mom reported arm sore w/red rash all around area of inj;when seen 24NOV area 3 1/2" x 4" redness;swelling w/fluctuation;rx warm wet compresses & PCN
red hives-lower back size of baseball 3/4 inches in diameter under arms, belly; 28APR94 hives disappeared-applied DPH ointment;
Per pt, red, swollen hard lump x 3-4 days. Hot to touch.
Vaccines administered Tues 9-26-06 mother stated didn't notice reaction on left leg until pm of 9/28/06 but stated child had complain leg hurting. Mother stated large, red, swollen hot area approximately 3" by 5" on left leg.  Made trip to emergency room.  Treated with BENADRL and cream. Child's weight 84#.
laid up; light headedness; coughing; joint in her feet hurt; joints in her knees hurt; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (laid up), DIZZINESS (light headedness), COUGH (coughing), ARTHRALGIA (joints in her knees hurt) and PAIN IN EXTREMITY (joint in her feet hurt) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 Vaccination.     The patient's past medical history included No adverse event (medical information not provided).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced ILLNESS (laid up), DIZZINESS (light headedness), COUGH (coughing), ARTHRALGIA (joints in her knees hurt) and PAIN IN EXTREMITY (joint in her feet hurt). At the time of the report, ILLNESS (laid up), DIZZINESS (light headedness), COUGH (coughing), ARTHRALGIA (joints in her knees hurt) and PAIN IN EXTREMITY (joint in her feet hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medication not provided  Treatment information not provided
I began to have hives that covered my face, neck, and arms. My upper and lower airways began to constrict and I experienced difficulty breathing and shortness of breath.  I took oral antihistamines over the course of one day and that resolved the hives. My airway compromise lasted over the course of a week. I went to urgent care and was given an albuterol aerosol treatment and I was given immediate relief of the tightness in my chest an lungs. The Nurse Practitioner also sent me home with oral prednisone and an inhaler and my upper airway symptoms began to subside over the course of a week.
devel localized pain, rash day p/vax;was seen by MD 2NOV98;tx was ice packs;
there is a risk of being exposed for Covid; General malaise; muscle aches and pain; This is a spontaneous report from two contactable consumers A 65-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date not reported), intramuscular in the right deltoid on 18Dec2020 07:15 at a single dose to prevent covid. Medical history included hypertension, stage 3 renal failure and his creatinine level was elevated ( and now it was under control since he was not taking nsaids and changed his medications around; he cannot take nsaids; and his creatinine was 1.6 and now it was 1.27 (dates unspecified)). Concomitant medication included unspecified medication for hypertension. Patient had no prior vaccinations (within 4 weeks) aside from first dose of covid vaccine. He got the local flu shot a few months ago as it was required by his employer. He received the mmr v vaccine about 4.5 years ago and he had a terrible reaction for a week: he had muscle aches, pain and joint pain and everything hurts and it eventually went away. He does not have the exact name, lot, ndc, or expiration date to provide. It is on record at his employer. On day 4, 22Dec2020, after the first dose of the vaccine he had generalized malaise, muscle aches and pain, it was painful to put a pair of socks on and it went away within 24 hours. He sees covid patients everyday at the hospital. He does echocardiography and he is close to the patients for 20 minutes and there is a risk of being exposed for Covid. He clarified he is a registered diagnostic licensed medical sonographer, not a hcp. The outcome of the events general malaise and muscle aches and pain was recovered on 23Dec2020.   Information on the Lot/Batch number has been requested
Case number PHEH2013US026705 is an initial spontaneous report received from a pharmacist on 31 Dec 2013. This report refers to a 30-years-old female patient. She had a history of latex allergy. She was vaccinated with FLUVIRIN (batch number: 13424P, expiry date: 30 Apr 2014) on 31 Dec 2013. No adverse event was reported following the maladministration.
Shortly after receiving the covid vaccination, Patient began to feel lightheaded.  He was placed on cot and bp was low 96/50.  Encouraged to drink fluids.  Mentioned that frequently he becomes faint with other vaccinations as well.  After 25 minutes, he was able to stand without dizziness and left on own.  Encouraged to call if further sxs develop.  Had 2 bottles of water and snacks to bring blood pressure up.  last bp reading was 128/70.
Received his second dose vaccination on 1/25/21.  Was not due until 2/11.  Patient has no adverse sign and symptoms and reports feeling fine at this time.
Fevers, chills, body aches experienced at 0200 on 1/12. Vaccine was received at 1100 on 1/11.
Increased blanching, redness, swelling and itching to right deltoid, 15-45 seconds, thereafter. States localized to general arm under axilla. Treatment: Benadryl, ice and watched pt X 2 hours. Follow-up appt. next day.
Severe maculo papular rash on the body; itchy; pinkish with wheel formation. Will clear after taking Claritin 10 mg initially but will reappear. Now Taking Allegra 180 mg in am and Claritin 24 Hr. in PM daily for at least one week. Rash disappears only to reappear a few hours later and then goes away again.
3 inch diameter erythema, tenderness on upper left thigh, also hot to the touch-onset was approximately 36 hours after vaccinations were given and lasted 3-4 days.
Information has been received from a licensed practical nurse concerning a 16 week old male who on 08-NOV-2011 received his first dose of ROTATEQ (Lot# not reported). No adverse effect reported. Follow up information has been received from a licensed practical nurse concerning a male who on 08-NOV-2011 at 1:20 p.m. received his first dose of ROTATEQ (Lot# 669821/1034AA). Concomitant vaccination included the second dose of PENTACEL (Lot# C3834AA) which was vaccinated IM in the left upper thigh on 08-NOV-2011 at 12:30 p.m. and the second dose of PREVNAR 13 (Lot# 916617) which was vaccinated IM in the right upper thigh on 08-NOV-2011 at 12:30 p.m. There was no adverse event. No further information is available.
15 year old patient received dose of the Pfizer vaccine. The patient and her mother verbally reported her age as 16, however upon charting the vaccine and verifying the actual DOB (after the vaccine was administered) it was realized she was in fact 15 years old.
Total body and joints  pain. On a scale of 1 to 10, most of the time 6 to 8. And also very weak with no stamina.  Lasted until 12 /25/2020. Felt horrible like I also had a fever. Although I never did run a temp.
Fatigue, increasing redness and inflammation at the injection site, itchiness (rash) at injection site, soreness around left clavicle
per pt says her left armhas been extremelt sore.  cannot lift up very far. went to hospital 4 times . last md decided that pt has bursitis in left shoulder due to vaccine flu shot
shingles; Information has been received from a lawyer regarding a case in litigation and refers to a currently 79-year-old patient (pt) of unknown gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided.  On or about 13-APR-2009, pt was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported).   Subsequently, on an unknown date, pt had shingles (herpes zoster) and received treatment for this injury.  At reporting time, the outcome of herpes zoster was unknown and this event was considered to be related to zoster vaccine live (ZOSTAVAX).
Administration Error: 3 year old female patient receives the first dose of pediatric vaccine from the orange cap presentation authorized for patients aged 5-11 years.
Patient had no adverse events, patient stated she had the Moderna vaccine as her first COVID-19 vaccination but the patient actually had the Pfizer vaccine as her first dose of COVID-19 vaccine and was inadvertently given the Moderna vaccine as second dose.  Again the patient has not reported any adverse events, was first given Pfizer vaccine and then the Moderna vaccine as second dose.
Temperature of 102; Extreme tremors in extremities; Could not get up; Headache; Vision has been blurry; Numbness/tingling in hands and arms; Numbness/tingling in hands and arms/ Occasionaltingling in legs and feet; Can't sleep; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW0161) via an unspecified route of administration in the right arm on 10May2021 at 10:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: ER8732) via an unspecified route of administration in the left arm on 19Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 10May2021 at 22:30, exactly 12 hours after second injection, the patient's temperature was of 102 (unit unspecified) that lasted for 4 days and extreme tremors in extremities to the point she could not get up for 8 hours. It was reported that headache accompanied these. Ever since, the patient's vision was blurry and had numbness/tingling in hands and arms that was always there, sometimes bad enough that she could not sleep and occasional tingling in legs and feet. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 24Aug2021, the patient underwent binax now nasal swab COVID test and the result was negative. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event temperature of 102 was recovered on 14May2021. The clinical outcome of the events extreme tremors in extremities, could not get up, headache, vision has been blurry, numbness/tingling in hands and arms, numbness/tingling in hands and arms/ occasional tingling in legs and feet and can't sleep was not recovered at the time of this report.
Swelling, pain, and redness to vaccine site.  Started PM of 6-3-08.  KEFLEX and BENADRYL.
Information has been received from a medical assistant concerning multiple unspecified patients (ages and gender were not indicated). The pertinent medical history of patient and their concurrent conditions were not provided. It was reported that on an unknown date multiple unspecified patients were administered improperly stored doses of M-M-R II lot # L039613, expiration date 08-OCT-2017 (concentration, dosage and therapy route were not provided). There were no concomitant therapies reported. No adverse effects were reported. The vaccine was exposed to 88 F for 735 hours and 15 minutes. There was no data logger or previous exposures. No product quality complaint (PQC) was involved. This is one of five reports from the same source (MARRS # 1608USA009575, 1608USA010370, 1608USA010371, 1608USA010372). Additional information has been requested.
pt recvd vax on 25nov92 at 11:30am;asleep 12:10pm & put in crib;found unconscious & not breathing around 2pm;to hosp & pronounced dead at 2:30pm;
I am having allergic reaction/I was allergic to it; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received first dose of 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. On an unspecified date, the patient experienced allergic reaction/ allergic to it so my primary care provider suggested that I call you guys, to let you guys know as that patient having allergic reaction and what should be the second if I take the second, what should I do for the second dose. The outcome of the events was unknown.  No Follow-up attempts are needed. information about lot/batch number cannot be obtained.