chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to the COVID-19 Vaccination Clinic on 10/27/2021 for her first COVID-19 vaccine. She received the adult-formulation of Pfizer with the lot number EWO185-H. However, a routine audit revealed that her age at the time of vaccination was 11.97 years old, rendering this dose inappropriate for her age as she should have been 12 years old in order to receive it. The physician was contacted regarding the occurrence and reported that he had no medical concerns regarding this vaccination and that revaccination would not be required.   During the investigation to determine whether the occurrence had been a documentation or a vaccine administration error, the client?s guardians were able to be contacted via email. Once the investigation was completed and it was determined that the client had received an adult-formulation Pfizer dose 11 days early, this writer attempted to contact the client?s guardians on 5/7/2022 by calling, leaving a voicemail, and sending another email to the thread to which the client?s guardians had previously responded. This writer also called and left a voicemail again on 5/15/2022 and sent another, separate email to the client?s guardians on 5/20/2022. They have not yet responded as of the time of this report.  All staff at the COVID-19 vaccination clinic had been educated on a new procedure designed to reduce such errors: vaccination staff ask clients to confirm their name and DOB and then respond by speaking the client?s age aloud and verbally confirming which vaccine the client is receiving. They will also verbally confirm the vaccine type aloud when they choose the vaccine type from the drop-down menu in order to reduce the risk of documentation errors.
pt recv vax 8JUL96 & 11JUL96 to MD c/o 1cm lump in wall of rt cheek, cough, nasal congestion & runny nose;PE revealed bilat ceruminosis, mild bilat cervical lymphadenopathy;dx sialolithiasis, ceruminosis & lower resp infect;
Fever 2 hrs pediatric immunizations. INER = 100.1 deg F. Home = 100.6 deg F.
Pt received 2 vaccinations in right arm greater than 1 inch apart due to her request on 11/30, pt contacted the pharmacy on 12/2/17 to inquire if there could be a interaction with her Meloxicam that she has been taking for her chronic knee issues. Pt stated that she has had to rely on her cane more since the vaccination and has experienced " Charlie Horse" discomfort in her right hip/muscle after taking 2-3 steps. Advised the pt to follow up with Dr if the issue continues.
mild lip swelling and itchy 30 minutes post vaccine.  Took benedryl and pepcid at home.  Develop throat tightness next day.  Took dose of prednisone and epi pen for fear of developing anaphylaxsis.  Reported to ED for evaluation.  Got IV and another epi pen in ED
Shot given in left shoulder.  Within 1-3 days after developed pain in shoulder joint and then day 3-5 pain in left elbow tendon. Tendonitis set in.  After about 5 days Neuropathy in feet became more intense, even with use of Voltaren gel for pain.  Both conditions currently are not improving. I have taken time of from working out and doing less activity that did not improve any of the symptoms.  Nasal & Chest congestion started after a full week and still persist.  I have taken a COVID test to see if that had re-occurred (had COVID in Nov 2020), with negative results.
24 hours after vaccines, bilateral thighs were swollen all the way around without redness, resolved after 12 hours, (L) thigh was red but (R) was not, 3 days later baby became tired x 12 hours, (L) leg redness resolved but 1.5 cm lump remains
pt recvd vax 15DEC94 & w/in 4-5 hrs p/vax began developing hives which eventually covered entire body;given several doses of antihistamines over a 12hr period;hives resolved;
Woke up with stiff neck. As day progressed pain moved down back. On 10/15/2012 by midday, intense pain developed in left hip. Pain intensified by evening and moved into upper thigh. Extremely painful for 10-12 hours. Could not sleep with pain. On 10/16/2012 pain remained but lessened. Some pain radiated into knee, calf and foot arch area. Pain remained for several more days but lessened in intensity.
This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 55, via an unspecified route of administration, in the left arm, on Apr 8, 2021, at 08:45, single dose, for COVID-19 immunisation. No medical history or allergies reported. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included metoprolol, for an unknown indication from an unknown date and unknown if ongoing. On Apr 8, 2021, patient experienced fever onset at 12 hours. On Apr 10, 2021 (after 48 hours), patient experienced loose bowels/diarrhea. On Apr 15, 2021, at 16:30, patient experienced headache fairly consistent for 3 days. Since the vaccination, patient has not tested for COVID-19. No therapeutic measures taken as a result of the reported events. The patient recovered from the fever on an unknown date in Apr 2021. The headache and loose bowels/diarrhea: not recovered (at the time of this report). No follow-up attempts required. Information about lot/batch number cannot be obtained. No further information expected.
Patient received first dose of Covid Vaccine on 5/27/2021, and this was Pfizer. 2nd dose administered on 1/8/2021 was given  as Moderna, in the form of two .25mL injections to left deltoid.   Mother later reported patient experienced fatigue during the period 1/10/2021 to 1/13/2021, with one episode of vomiting on 1/10/2021.  Patient was tested for Covid with a rapid test, which was negative on 1/11/2021.  Plan is to order pcr covid test, and follow up with primary care provider.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown ages and genders. None of their pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with M-M-R II (which had lot numbers as K024825 and L028274 with expiration dates of 02-DEC-2016 and 28-JUL-2017, respectively; however, the dosage numbers, doses, anatomical locations and routes of administration were unknown). The vaccine experienced a temperature excursion of 10.3 degrees C for a time frame of 15 minutes. In addition to this, there was a previous temperature excursion of 11 degrees C for a time frame of 1 hour. The former excursion was called out due to a data logger and the temperature, at the time of reporting, was back in range. Despite being vaccinated with such an improperly stored vaccine, no adverse effects were reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Facial numbness was first noticed in the morning on 12/17/2021 with about 40% loss of movement, and continued to increase over the next 3 days.  On 12/20/2021, patient went into urgent care to confirm Bell?s Palsy and received prescription for PredniSONE
Pfizer Dose 1 4/15/21 (EW0153) Pfizer Dose 2 5/7/21 (ER8736) COVID Positive 1/27/22  2/2/22: Patient is a pleasant 92-year-old female with past medical history of arthritis, hypercholesterolemia, hypertension, hypothyroidism comes in with chief complaint of weakness malaise.  Patient reports she tested positive for COVID-19 on the 27th of January, antibody infusion "few days back", since that time has been having increasing malaise, fatigue decreased p.o. intake.  She is brought into the emergency department today for further evaluation. Mildly elevated lactic acid, CK 315, blood gases mild alkalosis no hypoxemia, CBC without acute derangement PT without acute derangement.  Chest x-ray was obtained per ED provider sign-out concerns for mild infiltrate official read is pending.  Patient still too weak to ambulate request was made to admit to medical service for further evaluation and possible therapy evaluation.  Bedside patient is sitting comfortably in bed denies lightheadedness, dizziness, chills, does endorse subjective fevers decreased appetite, weakness lower extremities, malaise a known sick contact, no swelling of extremities no chest pain or palpitations.  At rest does not endorse any significant shortness of breath.  She denies tobacco, alcohol, marijuana/recreational drug use.  Otherwise has taken off her medications as prescribed.  It has received COVID vaccination at least 2 doses.  No recent travel outside the area the, lives with son.  Family history otherwise reviewed and noncontributory to presenting finding  2/4/22: Patient is a 92-year-old female who presented to the emergency room with some increasing generalized malaise, fatigue and weakness along with decreased oral intake.  Patient was found to have a mildly elevated lactic acid level, CK level along with a chest x-ray that showed mild bilateral infiltrates.  Patient was found to be COVID positive and was started on appropriate treatment for this. Patient did not require oxygen while admitted to the hospital and was also started on IV antibiotics due to underlying community-acquired pneumonia.  Patient continued to improve and on the morning of 02/04/2022 was feeling well enough to be considered for discharge.  Therapy did see and evaluate the patient who felt the patient would benefit from a skilled referral.  A skilled facility was located who did accept the patient.  I did discuss and review the patient's imaging studies, vital signs, laboratory studies, current medications and plan of care as well as our plan to discharge her to a skilled facility. Patient is in agreement with this approach.  Patient's questions were answered to the best of my abilities.
Member was feeling lightheaded following 4 mile run prior to vaccine. Member has a syncopal episode 30 min after vaccine. Member was able to walk to aid station and was given full neuro exam without any defects. Vital signs were all normal. Member was monitored at aid station for 40 min and had no residual symptoms. Member continued to hydrate at lightheadedness went away. Member was given 24 hrs light duty and instructed to follow up in 24 hrs. Member was also evaluated at 2:00 and had no complaints. This was members 3rd series of Rabies and he has never had adverse reaction before.
pt had discoloration in the face, tingling and upper extremity stiffness, extreme nausea and cold sweats. no signs or symptoms of anaphylaxis. no fever recorded. ED was called and pt was examined by emt.
Severe prutirus of entire body [including eyes, inner ear canals and vagina/rectum]; syncope; all-over skin redness; large pruritic gives on face, neck and jaw; numbness and tingling in extremities; pruritus more pronounced over all pulse points
This case involves a patient with unknown gender 6 month old who is currently breast feeding - with no reported adverse event while receiving vaccine YELLOW FEVER VACCINE [YF-VAX]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 29-Dec-2021, the patient received a dose of suspect YELLOW FEVER VACCINE - US lot number, expiry date and formulation was not reported via transmammary route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious event "6 month old who is currently breast feeding - with no reported adverse event" (maternal exposure during breast feeding) (unknown latency) following the administration of YELLOW FEVER VACCINE. It was reported, "Nursing mother received YF vaccine on Dec 29, 2021". Action taken with YELLOW FEVER VACCINE (YF-VAX) was not applicable. It was not reported if the patient received a corrective treatment for the event (6 month old who is currently breast feeding - with no reported adverse event). At time of reporting, the outcome was Unknown for the event 6 month old who is currently breast feeding - with no reported adverse event.
Chest and ribs painful; Diarrhea; Fever; Pain in muscles; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest and ribs painful), DIARRHOEA (Diarrhea), PYREXIA (Fever) and MYALGIA (Pain in muscles) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest and ribs painful), DIARRHOEA (Diarrhea), PYREXIA (Fever) and MYALGIA (Pain in muscles). The patient was treated with ASA at a dose of UNK dosage form. At the time of the report, CHEST PAIN (Chest and ribs painful), DIARRHOEA (Diarrhea), PYREXIA (Fever) and MYALGIA (Pain in muscles) was resolving.            Action taken with mRNA-1273 in response to the event was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Document contains no new information (NNI).
Rt upper arm with redness, swelling. IV cefazolin 1 gm. Cephalexin 500mg x 10 days. DX= cellulitis on Sept 22, 2018.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 8:40 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 42.76.  Concomitant products were not provided.  On 31-Mar-2021, Excursion time was 08 AM, temperature was 32, total doses given for the day was 199, Condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 31-Mar-2021. 4 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976.
Body aches Bladder discomfort with colored urine Urgent need to urinate every 20 minutes or so Swollen armpit at vaccinated arm Lower back pain
PT RECIEVED FLU SHOT ON 9/22/2011. SHE C/O ARM HURTING IMMEDIATELY AND SWELLING WITHIN ONE HOUR OF RECIEVING FLU VACCINE. PT TOOK ADVIL FOR PAIN, BUT DID NOT USE COLD COMPRESS AS ADVISED.
Admit Date: 8/15/2022 10:52 PM  Discharge Date:  8/19/2022    Admitting Physician:   Discharge Physician: M.D.     Discharge Diagnosis:  Principal Problem:    Acute respiratory failure with hypoxemia  Active Problems:    Pneumonia due to COVID-19 virus    Stage 3b chronic kidney disease    Atrial fibrillation    Acquired hypothyroidism    HTN (hypertension)    Mixed hyperlipidemia    Diabetes mellitus type 2, diet-controlled           HPI: "Patiemt is a 82 y.o. female with a history below admitted for Acute respiratory failure with hypoxemia. Pt came in with complaints of sob, worsening over past week, dry cough. Worse with exertion. No other associated symptoms. In er, found to be hypoxic and require new O2. Discussed with er and will admit".     Hospital Course:  The patient was admitted to the hospital and was evaluated and treated per below.         * Acute respiratory failure with hypoxemia  Description of the Problem/Progression: New. cxr with bilateral pna. Covid +. Procal low. Hx of interstitial lung disease. No previous O2 use.   Plan:   ?Pneumonia due to Covid 19 virus with acute respiratory failure with hypoxia. Improving on current treatment. Continue Remdesivir D4/5 and IV Decadron. Nebs and inhalers as ordered. Continue to follow up daily inflammatory markers and d-dimer. Patient was weaned off to room air today. Continue nebs and inhalers. Encourage incentive spirometry use and pronating. Continue supportive/symptomatic treatment and supplements as ordered per COVID protocol. Follow up daily lab. Pulmonary following and advised receiving antibiotics due to low pro-calcitonin and negative cultures so far. Antibiotics discontinued accordingly. Pulmonary clear to discharge to follow up on outpatient basis.   ?Atrial fibrillation. Controlled. Continue appropriate home medications including oral anticoagulation. Monitor on telemetry.   ?CKD 3b. Hold Cozaar due to increased serum Cr. Decrease Lasix to 40 mg PO ONCE DAILY. Monitor renal function with daily lab. Resume low dose Cozaar on discharge.    ?Diabetes mellitus type 2. Continue with same home regimen/equivalent. Monitor blood sugar and cover with insulin sliding scale. Diabetic diet and A1c ordered.   ?Hypertension. Poor Control. Added Norvasc, adjusted dose up to 10 mg PO QD. Follow up daily labs.    ?Hyperlipidemia. Continue statin therapy. Lipid profile ordered.   ?Hypothyroidism. Continue Synthroid. TSH and free T4 ordered.            Physical Exam on the Date of Discharge:  Stable and improved.         Consults:    IP CONSULT TO PULMONOLOGY  IP CONSULT TO SOCIAL WORK     Significant Diagnostic Studies:     labs, microbiology, radiology, and cardiac graphics: per chart.        Disposition:  home     Discharge Condition:  good
Aggressive fever for 5 days (104.3), high pitch screaming and vomiting once a day.
Reddened area right arm approx 20 x 6 cm. Referred to PCP for F/U.
Shortness of breath, rapid heart rate, Dizziness, Flush, Dry mouth, some minor swelling of the throat, within 15 minutes of receiving the injection. Symptoms lasted 3 or more hours. Drank plenty of fluids and took Benadryl.
Acute Pancreatitis Onset of nausea abd pain, previous biliary pancreatitis 1998.
8/28/07 - Fever 103, fussy, (L) leg painful (3 hrs after Imm. reaction started). 1/31/08 - Fever103 about 3-4 hrs after Pediarix and Imm, fussy x 3 1/2 days. Pt having black stools - bright red skin x 2 days after imm.
Difficulty breathing, throat swelling. EPIPEN, DEPO MEDROL, oxygen.
Initial case was received on 13 September 2010 from a healthcare professional. A 6 month old patient received on 09 September 2010, the following vaccines: a right thigh intramuscular injection of H1N1 (lot number UP069AA); a right thigh intramuscular injection of PENTACEL (lot number C3656AA); a left thigh injection of PCV13 (lot number E63006, manufacturer Pfizer); a left thigh injection of Hep B (lot number AHBVB842AA, manufacturer not reported) and an oral dose of Rotavirus (lot number 06872, manufacturer not reported). On 10 September 2010 at 1:09 AM, the patient was taken to the emergency room (ER) experiencing vomiting and diarrhea, "that occurred through the night". The patient was treated (unspecified treatment) and released from the ER. The patient had a runny nose and cough at the time of the vaccinations. She had no pre-existing medical conditions, no concomitant medications and had not experienced any adverse events following prior vaccinations. The patient recovered from the events of vomiting and diarrhea (date not reported). Documents held by sender: None.
pass 34 days he has been having headaches daily; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (pass 34 days he has been having headaches daily) in a male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (pass 34 days he has been having headaches daily). At the time of the report, HEADACHE (pass 34 days he has been having headaches daily) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  Treatment information was not reported.
This spontaneous report as received from a health care worker refers to currently 4 year old child patient of unknown gender. No information about medical history, concurrent conditions was reported for the patient. On 23-APR-2015 the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (dose in series unspecified) lot# K010440, expiration date 22-JUL-2016, 0.5 ml, once subcutaneously for routine vaccination. No adverse effects reported. The outcome of events reported was unknown. No product quality complaint was involved. This case is linked to the case 1506USA007776 via same reporter link. Additional information has been requested.
5 min after administration, nausea, disorientation, stomach cramps, blood pressure drop,  partial loss of hearing and sight, cold swat, on the verge of loosing consciousness.   Reaction lasted for approximately 20 min, no medical help was administered.  After 30 min, the symptoms subdued, 2 hours later were gone.
INFECTIONS ON THE RIGHT SIDE WHERE THE SHOT WAS GIVEN; VACCINATION SITE SWELLING; VACCINATION SITE PAIN; This spontaneous report received from a consumer via a company representative concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the patient experienced infections on the right side where the shot was given, vaccination site swelling, and vaccination site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the infections on the right side where the shot was given, vaccination site swelling and vaccination site pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20220421592.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
PATIENT FELT LIGHT HEADED AND FELT LIKE SHE WAS GOING TO PASS OUT. SHE REQUESTED TO SIT ON THE FLOOR. UPON MOVING TO THE FLOOR, SHE TOLD HER HUSBAND SHE WAS GOING TO PASS OUT. HER EYES CLOSED SO 911 WAS CALLED IMMEDIATELY. SHE OPENED HER EYES SHORTLY AFTER AND WAS TOLD HELP WAS ON THE WAY. EMS CAME, ASKED HER SOME QUESTIONS, TOOK HER BLOOD PRESSURE AND BLOOD GLUCOSE. EMS WALKED HER OUT OF THE STORE.