chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2:25PM 'FEELS LIGHTHEADED' PINK, W/D. NO SOB, NO ITCHING. BP 118/90, HR 98, R 16, 02 SAT 99%, BS 87MG/DL. 2:32PM 'FEELS BETTER'. PT DECLINES JUICE/CRACKERS. 2:40PM AMBULATORY TO EXIT- GAIT BRISK AND STEADY. A/O, PINK, W/D, RESP WITH EASE.
Patient experienced throat swelling and trouble breathing while at home. She went to walk in clinic and pulmonary function test.
Rash at injection site. Slightly itchy. Noticed rash 4/2/2021, but did not take medication (Benadryl) until 4/6/2021. Thought it would go away on its own. Still there as of today, 4/7/2021.
Redness and swelling at the injection site and several urticarial lesions on arms/face. Pt treated with oral benadryl and cool compresses with improvement.
Medical assistant diluting covid vaccines diluted the vaccine with sterile water instead of sodium chloride. She followed the rest of the steps of preparing the vaccine correctly other than what to dilute the vaccine with. It was not caught until a few month later that this MA had been diluting the covid vaccines with the incorrect diluent. Therefore many patients, including this patient, received the covid vaccine with the incorrect diluent. Pfizer, the manufacturer, was contact regarding this and no data is available if the incorrect diluent type is supported to be stable. Therefore this dose with the incorrect diluent should be considered invalid and should be repeated. Patient has not had any signs or symptoms since the incident. Patient appears to be well in health. Family is being notified of the incident and being advised to have the patient get the covid-19 bivalent booster as she is due for the booster and to revaccinate her from the incident.
Patient came in with elderly family member asking for COVID vaccine. Filled out the paperwork and spoke about potential side effects and the 15min wait. He stated an understanding.  Moderna Vaccine was administered to Left deltoid. Patient waited his 15mintues no reaction. After patient left and this RN was putting immunization it was discovered that he had already received his 3 doses series. Called patient to confirm. He stated he knew it was his 3 vaccine and he wanted a booster and did not tell this RN because he knew he would not be able to get it if he did. Explained the risks and that it is not studied or FDA approved and that adverse effects may not be known. Advised him to contact 911 or his PCP for adverse reactions.
COVID-19 symptoms starting 3/25/21, hospital admission 4/14/21 - 4/24/21 with hypoxia, multiple pulmonary emboli
Pt was sweating and turned pale after I administered TYPHIM. He was breathing heavily. He refused to go to ER.
This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age and ethnicity received the first dose of TRUMENBA (batch/lot and expiry date were not reported), via an unspecified route of administration on 02Aug2017 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient showed severe reaction to the shot that included severe Joint pain (9.5 out of 10), chills and nausea for several days after the shot. The outcome of the events was unknown. The patient was due for the second shot on 01Feb2018. The reported would like to know if the patient should get the shot and what was the likelihood of the patient showing the symptoms.
supraventricular tachycardia patient was given adenosine 6mg and 12mg then converted to normal sinus
Patient 65+ received both Prevnar 13 and PPSV23 previously but now has an immunocompromising condition; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  An elderly patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown,single (Batch/Lot number: unknown) for immunisation; pneumococcal polysaccharide vaccine, 23-valent (PNEUMOCOCCAL POLYSACCHARIDE VACCINE, 23-VALENT), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "Patient 65+ received both Prevnar 13 and PPSV23 previously but now has an immunocompromising condition".  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event immunodeficiency with the suspect product Prevenar -13 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
ACUTE NON ST ELEVATION MI CARDIOGENIC SHOCK 11/29/2022 &  12/21/2022 -- RECURRENCE OF SAME SYMPTOMS
4 weeks after given 2nd injection (March 8,2021) both ears "clogged up" at same time and extreme sinus pressure and hearing loss. Saw ear specialist (march 23,2021), hearing test confirmed hearing loss possibly due to a "virus', took steroid pills for 6 days ,2 steroid injections in right ear(4/13/21 and 4/23/21). "Slight improvement" in hearing loss. Recommended hearing aid if wanted. Both ears still clogged.  Saw another ear specialist-said possibly due to a "virus" and recommended getting hearing aid. Also taking a decongestant nose spray to relieve sinus and head pressure.  To this day, symptoms have remained the same
Red swollen hot injection site.  Dizziness, chills, tired, achey, headache.
Patient received her first vaccination at 9:48 this morning. Her 15 minute observation period was uneventful. She stayed for an additional 15 minutes with her fellow Sister .She remained asymptomatic for a  reaction and left at approximately 10:20.     Patient and her Sister returned to our facility at approximately 10:27 with the following symptoms:  lip numbness and right sided tongue numbness as described by the patient. She denied throat/lip swelling, shortness of breath, and respiratory compromise. Neuro check was negative.   At 10:40 she stated that she felt light headed, described as "a funny feeling in her head." Her neuro check was negative.  She was able to drink another 8 ounces of water and apple juice without difficulty.Her vital sign range remained unchanged:  BP 105/palp, P62 and sat (6%.   The decision was made with the patient, Charge Nurse and EMS to observe the patient for at least 30 minutes. During her observation period she was able to drink  24 ounces of water, 8 ounces of apple juice and consume 2 graham crackers. She showed no signs of compromise during that time. She continued to converse without difficulty.    Her vital signs per EMT were as follows: 10:27 upon arrival: BP 138/palp P60, O2Sat 98% 11:00 BP 103/palp, P 63, O2 Sat 97%  11:15 at discharge: BP 118/ palp, P 68, O2 Sat 97%   yAt the time of discharge her symptoms were resolved. Patient denied respiratory difficulty, none were noted, numbness of her lips and tongue and light headedness had resolved.  Emergency precautions were discussed and patient agreed to call 911 or be taken to the nearest ER if her symptoms recur. Her Sister agreed. Patient was also advised to notify her PCP with her reaction to her first COVID Vaccination. She was discharged in stable condition with her Sister.
Systemic: Fainting / Unresponsive-Mild, Additional Details: He was receiving two vaccine one for flu and other for bivalent covid pfizer vaccine. He got flu shot first and then when I administer the covid pfizer bivalent shot on other arm upon administration he fainted to the floor and was unresponsive for like 15 seconds
Syringe malfunctioned, causing some of the vaccine to end up on the skin, rather than in the patient
This spontaneous report was received from a pharmacist referring to unknown multiple patients of unknown age and gender. The patients' medical history, concurrent conditions, drug and allergy history were not reported. On an unknown date, the patients received improperly stored doses of PROQUAD lot # M022400 and lot # M022402 with expiration dates on 01-NOV-2017, for both, (dose and route were not provided) for prophylaxis. It was reported that the vaccines were reconstituted with sterile diluent (MRK INJ) (lot # and expiration date were not provided) which was not involved in a temperature excursion. On an unspecified day, the data logger registered that during 14 hours, 30 minutes the temperature under the vaccines were stored, was -14° Celsius (°C) to -10°C (-10,6°C), there was no prior temperature excursion and no adverse events were reported. This is one of the two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1706USA009576.
giant red lump at injection site. hot to the touch,  the circumference is about the size of the baseball. It was very red and very swollen. Entire arm is sore and very tender to touch. Itches.  Swelling has and redness has decreased slowly with each day since vaccine.
On the 7 days following Moderna shot, I started experiencing symptoms of ?COVID arm?. The site begin to itch and is now inflamed and red.
54 yo female with PMHx of cerebral palsy, spastic quadriplegia, traumatic brain injury, presence of PEG tube, admitted on 6/2/23 with acute hypoxemic respiratory failure 2/2 to COVID pneumonia, with ICU stay 6/3-6/7 for hypotension, transferred to medicine floor for on going care.      HPI on admission:    Per Dr.     Patient is a 54 Y  female with a history of spastic quadriplegic cerebral palsy, traumatic brain injury, presence of PEG tube presents to the emergency department from a nursing facility with onset of hypoxia.  History was obtained by ER provider as patient unable to provide history.  Patient was noted to be hypoxic with O2 sat in the low 80s on room air.  There is a COVID outbreak at her boarding care facility.   ER course: Basic labs, chest x-ray, cefepime x1, steroid x1, isolation, oxy mask. Temp of 100.4
Information has been received from a physician through the manf pregnancy registry concerning a 21 year old healthy female pt who on 24Mar04 was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccination on 24Mar04 included a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) and a dose of tetanus toxoid. The reporter stated the pt was vaccinated on 24Mar04 in another country and her LMP was 11Apr2004. The reporter noted the pregnancy was unremarkable so far. Unspecified medical attention was sought but treatment was not required. A product quality complaint was not involved. Follow up information was received from a woman in a physician's office who reported that she had checked with the physician, who confirmed that the female pt had a miscarriage at 14 weeks gestation, on approx 19Jul04. There was no other information provided regarding the pt's adverse experience. Additional information has been requested.
This spontaneous report as received from a pharmacist regarding to a 17 year old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 09-JUL-2016, patient was inadvertently administered with a 1 mL (adult dose) as the first dose of VAQTA (lot# M013653, expiry date: 26-MAY-2017) (route of administration: intramuscular). No adverse effects were reported. The outcome of the events was unknown. Additional information has been requested.
Tired; Aches all over the body; Neutropenia; A spontaneous report was received from a consumer (patient) concerning a 70-year-old, female patient was who received Moderna's COVID-19 Vaccine (mRNA-1273) and had neutropenia (neutropenia), tired (fatigue), aches all over the body (myalgia).  The patient's medical history included leukemia. No concomitant medications were reported.   On 01 Feb 2021, five days before the onset of events, the patient received their second of the two planned doses of mRNA-1273 (Batch number: 012M20A), intramuscularly for the prophylaxis of COVID-19 infection.  On 05 Feb 2021, the patient had a low count white cells (neutropenia). On 12 Feb 2021, she repeated the blood test and the white cells were perfect. On 02 Mar 2021, the patient was tired and had aches all over the body.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.   The event, neutropenia was considered recovered/resolved on 12 Mar 2021.  The outcome of the events, tired (fatigue) and aches all over the body (myalgia), was unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient was given 2nd dose covid vaccine but she wanted flu vaccine, she filled out covid registration form and was asked if this was her first dose and asked if she wanted Moderna or pfizer, she responded pfizer.  When administer Rph asked her again that this was her first pfizer and asked which arm. While waiting after dose administered she then said she had already gotten covid shot and was wanting flu shot.  We looked up records on database and she recieved a Janssen vaccine on 1/21/2022.
fever started within 2 hours of shot.  Next 2 days fevers and general lethargy.  Day 3 started OK but by 8 PM ran a 102.3 F temp.  Next day had issues breathing.  On advice of Teledoc went to ER about 93 hours after shot.  They did XRAYS and indicated it was a continued reaction to the vaccine.  I am now 168 hours since injection and am running 100.7F temp and generally not feeling well
Patient came in for a flu vaccine. The nurse administered a Tdap (Boostrix) vaccine inadvertently instead of a flu vaccine.
Extreme fatigue for 30 hours, followed by hives/rash down the arm below the injection site, still present 3 days later,
A report was received from a health care professional on 6 November 2003 concerning a 24 year old female vaccinee who experienced redness and warmth at the injection site 2 days after receiving Fluvirin on 3 November 2003. On 5 November 2003 the vaccinee experienced redness and warmth at the injection site. The vaccinee had not recovered at the time of this report. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with: PJP200301013.
I began having palpitations in the range of 115-160bpm, chest pain, and dizziness the day after I got my Covid shot. I had a two-week monitor placed in February 2022 that identified supraventricular tachycardia. The monitor recorded 1,698 runs of this rhythm during those two weeks, the shortest being a few seconds, and the longest being over two minutes. The highest heart rate it recorded was 220bpm.  Now, 11 months later, I am on metoprolol twice a day to help control the rate of my heartbeat.
Swelling arm; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling arm) and RASH (Rash) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling arm) and RASH (Rash). At the time of the report, PERIPHERAL SWELLING (Swelling arm) and RASH (Rash) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-398870, MOD-2021-398893 (Patient Link).
Headache, Fever, Tachycardia, rigor, lightheaded, back ache, BP 80/50, admitted to ER for observation from 11 am to 5 pm
Pfizer 12+ was accidentally administered to this 11yo who should have received Pfizer 5-11yo.
30 hours after receiving vaccination had the following symptoms: coughing, headache, rash, itching, nausea, fatigue   took two 25 mg of benadryl  and someting for nausea and all symptoms went away within about 1 hour
At 40 minutes post vaccination the patient experienced lightheadedness, nausea, and shaking.     at 60 minutes the patient experienced a slight lump in her throat which did not progress.   The patient was taken to the emergency room for observation.
shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number XC972, expiry date 29th August 2021) for prophylaxis.   On 15th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 17th July 2019, 63 days after receiving Shingrix, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported patient received 1st dose in the left arm and they called to remind of 2nd dose 2 months later and the patient noted she had shingles.  The patient was treated with Valtrex.
2 year old child with severe atopic dermatitis had exposure to father's smallpox vaccination which resulted in his development of eczema vaccinatum. Child has required critical care to include mechanical ventilation, anti-viral therapy, antibiotics and vaccinia immune globulin. 9/7/07 Received D/C summary which reveals patient experienced eczema vaccinatum over approx 70-80% of his body.  Admitted 3/3-4/19/2007.  Was in PICU until 4/7/07 on mechanical ventilation.  Parent had been vaccinated w/smallpox in mid January, had contact w/patient mid February prior to deployment.  Patient developed skin changes early March initially thought to be superinfected eczema.    Tx w/IV antibiotics for MRSA bacteremia.  ID, Allergy, Opthal, Cardio, Derm, Plastic Surg consult.  Received vaccinia immunoglobulin x 8 in March.  Tx w/experimental drug, ST-246 in March.  While in PICU, developed unstable BP, bilateral pleural effusions, fluid overload, severe hypoalbuminemia, ARDS, renal insufficiency, anemia, & abdominal compartment syndrome. Received multiple transfusions of PRBCs & FFP. PMH: severe eczema  FINAL DX: eczema vaccinatum requiring skin grafts
Allergic reaction to the Ethylenediaminetetraacetic acid (EDTA); This spontaneous report was received from a consumer who was the patient's mom concerning a male patient of unknown age. No information was provided regarding the patient's concurrent conditions, concomitant medications, pertinent medical history and drugs or allergies reactions.   On an unknown date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis  (strength, dose, frequency, anatomical site of injection, route of administration, lot number and expiration date were not reported).   On an unknown date (reporter as after receiving the varicella virus vaccine live (Oka/Merck) (VARIVAX)), the patient had an allergic reaction to the Ethylenediaminetetraacetic acid (EDTA) content (allergic reaction to excipient).   The outcome for the event was not reported.   The causality assessment between varicella virus vaccine live (Oka/Merck) (VARIVAX) and the event was not provided.
Information has been received from a physician concerning a 19 year old male who on 14-JUN-1993 was vaccinated with a first dose of MMR II.  On 01-JUL-1997, the patient was vaccinated with a second dose of MMR II (routes, sites and lot numbers were not reported).  On 29-NOV-2009, the patient experienced onset of mumps, and was diagnosed the same day with mumps.  The patient was afebrile and had left and right parotitis.  The parotitis count was 77.  The outcome for mumps was not reported.  Follow up information has been received and indicated that the 19 year old patient (also reported as 16 year old) experienced onset of mumps on 25-DEC-2009 and was diagnosed on 28-DEC-2009.  The patient had a temperature of 103 F degrees and had R parotitis.  It was also reported that the patient's first blood work was performed on 28-DEC-2009 and included: IgM: <1:10, IgG: 5.87 and serum amylase: 267.  The patient's outcome was not specified.  No further information is available.
period was about 5 days early; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 10:15 (Lot number: ER8733) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset Apr2021, outcome "unknown", described as "period was about 5 days early". Therapeutic measures were not taken as a result of menstruation irregular. Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are needed. No further information is expected.
Large area of redness at the injection site and warm  to the touch.; Large area of redness at the injection site and warm  to the touch.; This is a spontaneous report from a contactable other healthcare professional via a sales representative. A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration from an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had large area of redness at the injection site and warm to the touch on an unspecified date. No pain reported. Event took place after use of product. Outcome of the events was unknown.    No follow- up attempts are possible. No further information is expected.
Parent to clinic on 11/10/04 for episodic visit. Mother stated baby had run a fever for 3 days after getting vaccines on 9/28/04 (103 F). Did not seek treatment.