chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pericarditis after admit and negative ECHO, and CTA; Chest discomfort; initially thought it was heart burn lasted over 15 overs decided to visit ER.; Had elevated troponins was diagnosed with Pericarditis after admit and negative ECHO, and CTA; This is a spontaneous report from a contactable nurse (patient) reported that a 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on the left arm on 14Jan2021 15:30 at a single dose for COVID-19 immunization. Medical history included high cholesterol from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received influenza vaccine (FLU) on 10Dec2020 for immunization; and received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) on 24Dec2020 15:30 for Covid-19 immunization. On 16Jan2021 15:30, the patient experienced chest discomfort, initially thought it was heart burn lasted over 15 "overs" decided to visit ER. The patient had elevated troponins, and was diagnosed with Pericarditis after admit and negative ECHO, and CTA. As treatment, patient received IV Toradol. The reported events resulted hospitalization for 1 day. The patient underwent lab tests and procedures which included angiogram (CTA): negative, echocardiogram (ECHO): negative, troponin: elevated; all on 16Jan2021. The outcome of the events was recovering.; Sender's Comments: Based on the vaccine's safety profile, the event pericarditis and the associated symptoms are more likely intercurrent condition, unrelated to suspect vaccine BNT162B2 administration.  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.
CHILD'S DATE OF BIRTH WRITTEN AS 8/1/2009 ON CONSENT. CHILD IDENTIFIED IN IMMTRAC2 #151061872 WITH DATE OF BIRTH OF 8/1/2010. CHILD WAS 11 AT TIME OF BOOSTER AND PREVIOUS SERIES AS WELL. NOT ELIGIBLE FOR ADULT  BOOSTER DOSE.
pt recv vax 13JAN97 & awoke w/t101.8 by auricular temp, later 102.4 R;fussy & shivering, tremulous;refused to walk, body still;walking w/limp;t102.5 dx viral synd;
About 2 weeks after the vaccination, 08/30/2021, I wake up with a headache everyday. But not every day is severe  when I wake up. As the day goes on, it wears down, its not that bad, it's mild. The headache is there all day. I have learned to live with it, because I don't want to take medicine,  the medicine does not help.  I have not recovered from the adverse event. I still continue to have headaches. I have had headaches prior to taking the Pfizer Dose 2, but they have gotten worse. The headaches are more constant now.
3yr old male given the Flumist on 10/06/08.  Nine days later he presented to my office with orbital cellulitis.  Pt.seen in ER 10/16/08 CAT scan showed preseptal orbital cellulitis. In addition he had pan sinusitis. Pt. had no resp. symptoms prodrome. Rx. with Vancomycin followed by Augmentin given. Pt. doing well now.
Pt received his first dose of Pfizer COVID vaccine on 4/10/21 and started having myalgias and cough on 4/14.  He was tested for COVID on 4/16 and received the positive result on 4/19. He then developed fever, loss of taste, nausea, and shortness of breath which prompted him to present to urgent care, and they told him to go to ED on 4/22/21. Patient was found to be hypoxic and was admitted to the hospital for COVID treatment.
Other patients having similar side effects such as fast heart beat; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Other patients having similar side effects such as fast heart beat) in a female patient of an unknown age 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) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Other patients having similar side effects such as fast heart beat). At the time of the report, PALPITATIONS (Other patients having similar side effects such as fast heart beat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant product reported by reporter. No treatment medication reported by reporter.
Severe soreness in spinal area of back, severe chest pains when lying down and shortness of breath. Lasted for about 10 day after shot. Visited my Doctor on 7/22/21,symptoms in back had faded. Was still having chest pains and shortness of breath when laying at night to go to sleep. Stopped having chest pain  & shortness of breath around 7/26/21.
fever; Chills; Felt unwell; This is a spontaneous report from a contactable other healthcare professional.   A 63-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1, via an unspecified route of administration, administered (at the age of 63 years old) in the right arm on 17Feb2021 11:00 (Lot Number: Unknown) as a SINGLE DOSE for covid-19 immunisation.  Medical history included covid from Apr2020 to an unknown date.  The patient had no known allergies.   The patient's concomitant medications included multivitamins. The patient did not receive any other vaccine within 4 weeks prior to the vaccine.  On 18Feb2021 10:30, the patient experienced chills, felt unwell and fever of 99.3. Therapeutic measures were taken as a result of fever which included the patient took acetaminophen (TYLENOL), went to bed and rested. The patient underwent lab tests and procedures which included temperature: 99.3. on 18Feb2021. The patient did not receive treatment for chills and felt unwell. Outcome of the events chills, felt unwell and fever of 99.3 was recovered in Feb2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
I am a breastfeeding mother of a 3 month old. One day after my second Pfizer vaccine I began to have symptoms of mastitis in my left breast. By Sunday I had full blown mastitis, running a fever of 102.5. I received antibiotics from my primary care and the infection began to resolve after a few days.
I got the booster at the local pharmacy,  it was Moderna..   about a week later I noticed my heart fluttering. I  noticed it when I am in bed at night I can feel my heart. I never felt this before and assume it might be from the shot. Will it go away.? I do not have a problem breathing..
Approximately 25 minutes after immunizations, child was walking with mother in Pharmacy and collapsed into merchandise and slid to floor.  Mother said she was limp & unresponsive for about 1 minute.  EMS was called. EMS took vital signs. Mother said EMS told her the vital signs were normal so mom refused transport.  Child has 2 superficial abrasions on her chin approximately 2cm X 1cm each. No bruising noted.  Mom denied other injuries.
presented to office with a 2 day history of blurred vision of his right eye.  He has been diagnosed with an acute Central Retinal Vein Occlusion of his right eye. (H34.8112).  No treatment at this time.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "no" (unspecified if ongoing), notes: known allergies: no, other medical history: no. Concomitant medication(s) included: PROBIOTICS. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Anti-viral treatment with Paxlovid started on 26Nov2022 till 30Nov2022 (Lot#2692134).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
102 degree fever, neck stiffness, leg stiffness, headache, dizzy, abdominal pain, hyperventilation. Mother gave pt. Tylenol at time of event. Mom call our office in the morning and gave ibuprofen and brought pt in to see doctor. Pt had received TDap and Varicella in the past with no problems.
fever; COVID-19; cough that did not go away for over a week; feeling tired; arm swelled a little bit; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), COUGH (cough that did not go away for over a week), FATIGUE (feeling tired), VACCINATION SITE SWELLING (arm swelled a little bit) and PYREXIA (fever) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No medical history was reported.     On 28-Feb-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced COUGH (cough that did not go away for over a week), FATIGUE (feeling tired) and VACCINATION SITE SWELLING (arm swelled a little bit). On 10-Mar-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19), COUGH (cough that did not go away for over a week), FATIGUE (feeling tired), VACCINATION SITE SWELLING (arm swelled a little bit) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     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.   Concomitant medication was not reported. Treatment medication included unspecified Cough medicine for Cough
Intense headache began within 2 days from vaccine. States headache was better when lying down and much more severe upright. Lasted several weeks. Went to doctor. Had MRI scan with negative results.
Swimmers ear; Vertigo; brain fog; Shortness of breath trouble breathing; coughing; panic attacks; Anxiety; This a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number: CUS 295) dose 1 via an unspecified route of administration, administered in left arm on 12Oct2021 at 12:00 hours as DOSE 1, SINGLE (at the age of 46-years-old) for COVID-19 immunization. The patient's medical history included bipolar disorder, hypertension, and cholesterol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications within 2 weeks of vaccination included Lamotrigine (LAMICTAL); Atorvastatin calcium (LIPITOR); and Amlodipine besilate (NORVASC). The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 14Oct2021, the patient experienced swimmers' ear, vertigo, brain fog, shortness of breath trouble breathing, Anxiety, panic attacks, and coughing. The events were resulted in doctor/other health care professional office/clinic visit. Therapeutic measures were taken as a result of the events. Treatment received included ear drops and ibuprofen. The clinical outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.
About a week after receiving the omicon covid booster (3 prior covid vaccines were moderna) I began to notice irritability, anxiety, and trouble sleeping. I then noticed depression symptoms. I doubled my dose of mirtazapine to 15 mg and increased my exercise which is usually enough to prevent a flare up. The symptoms got worse with depression severe enough to make it difficult to function, severe insomnia, anxiety and panic attacks (I have not had panic attacks in the past even with bad flare ups). My doctor gave me trazodone to add to the increased dose of mirtazapine, the depression symptoms are beginning to ease.
1OCT97 pt taken to hosp ER w/large local rxn 8cm x 11cm;questionable cellulitis;MD put on ATB;
Patients states she woke up the next morning with unusually stiff arm. Upper arm was swollen and very badly bruised. Patient reported reaction to pharmacy on 9/30/14. Arm is no longer swollen but bruise approximately 2x2 inches still very apparent.
On the morning after receiving the shot, the patient called and reported a red, raised welt in the area the shot was given. Patient advised to watch for spread of welt or fever. On the second day after receiving the shot, the welt had spread to 2 inches below injection site and about 3 inches above and not quite halfway around the arm and she developed a fever of 99.8 degrees F. Shot was given subcutaneously rather than intramuscularly as indicated.
Clots are being made and destroyed at a faster rate; Couldn't walk; Severe pain; This spontaneous case was reported by a nurse and describes the occurrence of COAGULOPATHY (Clots are being made and destroyed at a faster rate), GAIT INABILITY (Couldn't walk) and PAIN (Severe pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 042L20A) for COVID-19 vaccination.    Co-suspect product included non-company product ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    Concurrent medical conditions included Blood pressure high (1.5 years ago) and Coronary artery disease (1.5 years ago). Concomitant products included METOPROLOL for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. and ATORVASTATIN CALCIUM (LIPITOR) (unknown route) Stopped the Lipitor for one month and restarted. In October 2021, the patient experienced GAIT INABILITY (Couldn't walk) and PAIN (Severe pain). On an unknown date, the patient experienced COAGULOPATHY (Clots are being made and destroyed at a faster rate). The patient was treated with CEFIXIME (FLEXERIL [CEFIXIME]) at a dose of 1 dosage form. At the time of the report, COAGULOPATHY (Clots are being made and destroyed at a faster rate) outcome was unknown and GAIT INABILITY (Couldn't walk) and PAIN (Severe pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Fibrin D dimer: 1.31 (High) D-Dimer lab value was elevated. Hematologist stated there may be a connection to the elevated D-Dimer lab value and the Moderna vaccine.. In October 2021, Laboratory test: used to identify dvt's used to identify a clotting Disorder (DVT's).. In October 2021, Ultrasound scan: to rule out blood clots To rule out blood clots.. In November 2021, Fibrin D dimer: 1.06 (High) 1.06.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered COAGULOPATHY (Clots are being made and destroyed at a faster rate) to be related. No further causality assessments were provided for GAIT INABILITY (Couldn't walk) and PAIN (Severe pain).    This case was linked to MOD-2022-568930 (Patient Link).
Administration of vaccine past published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  The first dose details were not asked. The vaccine was thawed on the day of administration and administration was spread out throughout the end of March to the beginning of April.  The vial was initially stored in the refrigerator on 01Apr2022/thawed on the day of use. 19 patients were administered on 29 Mar 2022, 30 Mar 2022, 31 Mar 2022, 01 Apr 2022 and 04 Apr 2022. The vial did not undergo any temperature excursions.  No treatment information was provided.
11NOV98 noticed sl swelling & redness to lt elbow;12NOV98 large amount of swelling to entire elbow, red, painful when pressure applied;warm to touch;dx cellulitis cause unk;elbow & arm sl swollen;
Patient received Pfizer COVID-19 vaccine on 5/28/21 from Nurse. Felt fine right after the vaccine. He did tell the nurse that he is afraid of needles. While waiting the 15 minute observation period, patient came to the pick up window and stated " I do not feel well". He then squatted down and felt backwards onto his back. He was non responsive for around 30 seconds then regained consciousness. I proceeded to call ED and ran out to assist the patient. By the time I went out there, he regained consciousness. I instructed him to elevate his legs while lying down. Two fire department members assisted us while we waited for emergency services. Person declined to go to the hospital but emergency services advised him todo so since his blood pressure was low. Patient was taken by ambulance to the hospital
Patient received 1st dose of moderna vaccine on 3/31/21. Patient went to the ED on 4/18/21 complaining of 2 weeks of worsening shortness of breath, fatigue, weakness, and new onset chest heaviness which ultimately was a pulmonary embolism (PE). Patient did not have any prior health/risk factors to PE. Patient did test positive for COVID-19 on 4/18
Pt presents to Urgent Care with left arm edematous, taut, red and hot to touch. Pt states that is site of vaccine. No fever. Pt was treated by Urgent Care MD.
Intense shoulder pain and stiffness.  Alternating chills and hot spells.  Intense all over body ache.  Sharp headache left temple.  Symptoms peaked 12-24 hrs after shot.  All symptoms gone by 48 hrs, except shoulder pain/stiffness which is now tolerable without pain medication.
mom reported pt had tremors & elevated temp; whimpering lasting approx 24 hrs p/vax given; tremors persisted for about 1 wk off & on; inject site was very red hot-swollen;
Red, swollen arm below the injection site. Occipital and frontal headache. Right jaw pain
Symptoms included: Upset stomach, nausea, diarrhea, stomach cramping, arm muscle pain (from shoulder to elbow), weakness, fatigue.
Sore throat, cough, fullness in sinuses and ears.  (no fever)   The symptoms began 25 days after receiving the 2nd booster(4th shot).  I was confirmed positive for Covid on day 6 of symptoms.  I was started on Vit C, Vit D3, Zinc, BASA and Augmentin for 10 days.
Pt received Spike Moderna 23-24 formula 4 weeks early. Patient did not have any reaction to vaccine administer early, patient was fine after 15 post vaccination observation.
Patient received a DTaP vaccine on May 2, 2008 and within a week of getting the DTaP vaccine, the patient exhibited multiple signs of an adverse reaction including fever, diarrhea, vomiting, collapse, weakness, lethargic, crying bout for several weeks, generally exhibited unusual behavior, and loss of appetite, He is just now starting to act like himself again.
I was hospitalized on 6/2/2021 due to viral Meningoencephalitis.  Althought this was 6 weeks after 2nd shot, was told I should still report it since it was caused by a virus that the hospital was unable to determine after negative tests for other viruses.  Had high fever, which led to loss of consciousness and possible seizure.  Experienced hallucinations and loss of self-awareness (forgot who I was).  Taken to hospital, entered into ICU for 5 days.  Spinal tap revealed viral infection.  Throat culture revealed strep throat.  Given antibiotics and IV fluids for several days.  Restored self-awareness and fever disappeared after a few days.  Intense headaches persisted for days.   Was discharged from hospital on June 7, 2021 after 7 days.  Experienced possible repeat seizure 5 days later in public, loss of sensation in legs, slurred speech.  Was re-administered into different hospital on June 13, 2021.  Spent ~5 days in that hospital, received EEG which showed brain damage on right temporal lobe.  Received another spinal tap which showed infection was improving.  Discharged on June 16, 2021.
This spontaneous report was received from a pharmacist and refers to a 71 year old female patient. No medical history, current conditions and concomitant therapies were reported. On 30-MAY-2015, the patient experienced warmth, swelling and redness at the injection site. The outcome of the event was unknown. The patient sought medical attention, she visited the pharmacy. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
At 10:10am Patient felt "fuzzy headed" while in observation. Vital signs assessed BP 160/90,  Heart rate 91, O2 sat 99%.  Patient reports that the palm of his left hand looks a little red. Benadryl 25mg administered IM right deltoid at 10:10am.  Vital signs assessed 10:12am BP 160/91, Heart Rate 63, O2 sat 99%.  Vital signs assessed 10:18 BP 161/90, heart rate 66, O2 sat 98%, Vitals signs assessed 10:25 BP 157/93, Heart rate 66, O2 sat 97%, Vitals assessed 10:30am  BP 158/86, Heart rate 59, O2 sat 98.  Patient had no itching, no rash, no acute distress and did not faint. Patient left clinic with wife at 10:45 in no acute distress.
This initial spontaneous case, was received from pharmacist on 13-Nov-2017, concerning a 55-year-old, adult female patient. The patient's medical history and concomitant medications were not reported. On 13-Nov-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 178302A and expiry date: Apr-2018) under the age of 65-year-old (explicitly coded as: inappropriate age at vaccine administration. It was reported that, the patient had not experienced any adverse event after the administration of the vaccine. The reporter assessed the case as non-serious. Follow up received on 04-Dec-2017: The reporter confirmed that, the patient had not experienced any adverse event after the administration of the vaccine. The narrative was amended accordingly.
Noticed redness/swelling/warmth at site starting two-three days after injection. Denies fevers, chills. Ibuprofen relieves pain around site. Area by shot improving per pt-less red, less warm, less painful.  Cellulitis treated with cephalexin