chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the PCP did an antigen test and that was positive 29Mar2022; the PCP did an antigen test and that was positive 29Mar2022; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality.  A 39 year-old male patient received bnt162b2 (BNT162B2), administration date 30Nov2021 (Lot number: FF2589) at the age of 38 years as dose 3 (booster), single, administration date 24Feb2021 (Lot number: EL3247) as dose 2, single and administration date 03Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Mar2022, outcome "unknown" and all described as "the PCP did an antigen test and that was positive 29Mar2022". The event "the pcp did an antigen test and that was positive 29mar2022" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Mar2022) negative, notes: Unknown; (29Mar2022) positive. It was unknown if therapeutic measures were taken as a result of covid-19.  Clinical Information: It was reported that the patient was Sick on 28Mar fever cough ST runny nose "classic cold" tested with at home ag all neg but the PCP did an antigen test and that was positive 29Mar2022. Prior to vaccination, the patient was not diagnosed with COVID-19  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available and known safety profile of suspect product the casual association between the reported events vaccination failure and covid-19 and suspected vaccine BNT162B2 cannot be completely excluded.
This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the left arm on 02Feb2021 01:00 at single dose for COVID-19 immunization.  Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a workplace clinic. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included benazepril, atorvastatin calcium (LIPITOR), and ubidecarenone (COQ 10). On 02Feb2021 01:15, after 5 minutes getting the vaccine on her left arm, it started to get numb and her back and left leg. She had a headache and nausea. The nurse at the clinic took her to a room to rest and applied ice pack on her left arm. She stayed in the room for 2 hours. At night, her heart rate was rapid and she could not sleep. Next day, she had muscles sore and headache. Therapeutic measure was taken as a result of  numbness in the left arm,. No treatment was received for the other events. Clinical outcome of the events was recovered with sequelae.  Information on the lot/batch number has been requested.
This case was reported by a healthcare professional and described the occurrence of wrong route of administration in an adult subject of unspecified gender who was vaccinated with Engerix B for prophylaxis. The subject was not a patient of the reporter. The reporter was informed of this by another healthcare professional. On an unspecified date the subject inadvertently received an unspecified dose of Engerix B (intravenous). The subject experienced wrong route of administration as the dose was given intravenously and the correct route is intramuscular. The healthcare professional considered the event was clinically significant (or requiring intervention). At the time of reporting the outcome of the event was unspecified.
PATIENT RECEIVED ADULT DOSE PFIZER BIVALENT VACCINE INSTEAD OF FLU SHOT
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. Beginning on 28-MAY-2018, the patients were vaccinated with improperly stored doses of VAQTA lot # N026997 (expiration date: 10-NOV-2018, additional dosage information was not reported) for prophylaxis. No adverse effects were reported. The vaccines were exposed to a temperature of 9-25 Celsius degrees for a timeframe of 1 hour and to a temperature below to 0 Celsius degrees for 19 hours. There was no previous excursion. No digital data logger was involved.
Severe menstrual bleeding that lasted for several weeks after the first dose. Second dose was not as severe but triggered another bleeding session; Severe menstrual bleeding that lasted for several weeks after the first dose. Second dose was not as severe but triggered another bleeding session; This is a spontaneous report from a non-contactable consumer (patient). A 47-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 (at the age of 47 years old) via an unspecified route of administration, administered in left arm on an unspecified date (Batch/Lot number was not reported) as single for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient previously received 1st dose of bnt162b2 on 17Jun2021 in the left arm for COVID-19 immunisation and experienced severe menstrual bleeding that lasted for several weeks and fixed anemia. On 21Jun2021, the patient had severe menstrual bleeding that lasted for several weeks after the first dose. Second dose was not as severe but triggered another bleeding session on an unspecified date. Her cycle is extremely regular otherwise. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment were iron and progesterone.  No follow up attempts are possible; information about lot/batch number cannot be requested. No further information is expected.
Pt had shingles vaccine on 8-9-17 in the R upper arm. That night pt noted redness and swelling, itchiness at injection site. On September 12 pt noted raised bumpy erythematous lesion, +itching R calf on 9/12/17. This past Saturday 9/30 pt noted blister on R upper arm.  Around the same time she also noticed itchiness in R medial back.
Presents to office with a 3.5 cm x 3 cm indurated light red, blanching area to right upper thigh. Day 11 post vaccine, last day of Amox, she developed a full body blanching maculopapular rash.
A non-serious spontaneous report of "we gave expired H1N1 to several patients" was received from a registered nurse/health professional concerning a 14-year-old male out of 17 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. The original expiration date was 12-Feb-2010, that had been changed to 15-Jan-2010. On 20-Jan-2010, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered recovered.
I do have pain in the bottom of my arm like in my armpit area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 11Feb2022 (Lot number: FK9896) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose 1, single), for COVID-19 immunization; Moderna covid-19 vaccine (Dose 2, single), for COVID-19 immunization. The following information was reported: AXILLARY PAIN (non-serious), outcome "unknown", described as "I do have pain in the bottom of my arm like in my armpit area".  Additional information: Consumer stated, I got my Booster of Pfizer but I don't know how, I am getting because my actual 2 Covid Vaccines being Moderna. Would that give me any side effects because I do have pain in the bottom of my arm like in my armpit area.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a pharmacist and refers to a 54-year-old female patient with unspecified concomitant medications and unspecified pertinent medical history. The patient's concurrent conditions included food-related allergy. On 29-DEC-2017, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously, lot number N028099 with expiration date 06-JAN-2019 (dose not reported), as vaccine. The ZOSTAVAX was reconstituted with sterile diluent (MERCK), subcutaneously, (dose, frequency, lot number and expiration date were not reported) for prophylaxis. On 30-DEC-2017, the patient returned to the pharmacy with site reaction which was red and warmth to touch. Then, on an unspecified date in December 2017, the patient went to an urgent care and was informed that she had infection due to ZOSTAVAX which was administered too close (about an inch) to a scar; the urgent care prescribed the patient KEFLEX as treatment which was administered. At the time of the report, the patient did not recover from the vaccination site infection. The reporter considered vaccination site infection to be related to ZOSTAVAX.
Breakthrough COVID. First vaccine 3/13/21. Patient is a 60 yo M with history of hypertension. Pt admitted to ED. Pt reports testing positive for COVID19 on 1/17/22 but symptos progrssively worsened. Pt admits to productive cough, headache, and SOB at rest but denies fever, chills, nausea, vomiting, chest pain, diarrhea, abdominal pain, dizziness, body aches or any other symptoms. ED workup included bloodwork that showed hypokalemia and CT Angio Chest revealed "bilat. lower lobe predominant groundglass and airspace infiltrates most in keeping with atypical infection, possibly viral pneumonia."
When I awoke this am the fingers on my lf upper ext were numb and tingling.  This has not gone away.  Called the Associate Health Nurse and she took report and contacted supervisor.
no adverse event; patient was administered an improperly stored dose of ROTATEQ; This spontaneous report was received from a medical assistant referring to a patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 18-MAR-2020, the patient was administered an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter, oral for prophylaxis (lot # 1660112, expiration date 18-OCT-2020). The vaccine was incorrectly stored for 15 minutes above 47 Fahrenheit degrees (F)(52.1 F) and had a previous temperature excursion above 47 Fahrenheit degrees (F)(55 F) for 21 minutes. The error was identified due to a data logger. No additional AE information provided (no adverse event).
When I went for a mammogram , over one month after my 2nd shot, they found a cyst in my left breast.  They did a needle biopsy and it was just fluid. Around the middle of August I developed a lump on the bottom of my left foot.  I went to a podiatrist on 9/28/21.  He said that I had a fibrous mass in my foot. I am also developing a bump on my right middle finger on the  left side of my first joint.  Right now the bump is slight, but I am going to watch it. Are these cysts, masses due to the Pfizer shots?  Is this something you are tracking?
102 degree F temperature starting 9/8/16 at night to 9-10-16. patient also stated feeling shaky that night.
Arm soreness at injection site, then fatigue, chills, and body aches during day after shot received. On third day, small red raised bumps all over back and arms and chest and neck, that are itchy.
PATIENT WAS IN POST-VACCINE WAITING PERIOD IN A CHAIR NEAR PHARMACY TWO TO THREE MINUTES POST VACCINE AND HAD A SYNCOPAL EPISODE. PATIENT SLOWLY FELL OUT OF CHAIR ONTO THE FLOOR. PHARMACIST WAS NEAR AND WAS ABLE TO HOLD ONTO HIM AND LOWER HIM TO THE FLOOR ALONG WITH HIS MOTHER. WHILE 911 WAS CALLED PHARMACIST CHECKED BLOOD PRESSURE AND LOWERED HIM TO A YOGA MAT. BP WAS 95/63 WITH PULSE 49. PATIENT SWEATING PROFUSELY BUT DID REGAIN CONSCIOUSNESS QUICKLY. PATIENT WAS REMOVED FROM PHARMACY VIA PARAMEDICS ON A STRETCHER. VACCINE ADMINISTERED AT 6:16PM, EMS ARRIVED AT 6:27PM. PATIENT'S MOTHER RETURNED TO PHARMACY AROUND 6:45PM AND STATED THAT HE WAS RELEASED FROM AMBULANCE AND WAS GOING HOME WITH HER.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 27Sep2021 as dose 3 (booster), single (Lot number: ER8737) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (ongoing). Concomitant medication(s) included: TOPROL XL taken for blood pressure abnormal (ongoing); LIPITOR (ongoing); SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE. Vaccination history included: pfizer vaccine (Lot no: EN5318, Dose : 1), administration date: 24Jan2021, when the patient was 67-year-old, for COVID-19 Immunization, reaction(s): "both knees began to ache and turn stiff", "both knees began to ache and turn stiff", "can hardly stand up", "his knees became puffy, pink, swollen, and warm"; pfizer vaccine (Lot no: EN5318, Dose : 2), administration date: 22Feb2021, when the patient was 67-year-old, for COVID-19 Immunization, reaction(s): "both knees began to ache and turn stiff", "both knees began to ache and turn stiff", "can hardly stand up", "his knees became puffy, pink, swollen, and warm"; Flu shot (He gets a Flu shot every year.), for Immunization. The following information was reported: ARTHRALGIA (non-serious), JOINT STIFFNESS (non-serious) all with onset 2021, outcome "not recovered" and all described as "Both knees began to ache and turn stiff"; DYSSTASIA (non-serious) with onset 2021, outcome "not recovered", described as "Can hardly stand up"; JOINT SWELLING (non-serious) with onset 2021, outcome "not recovered", described as "His knees became puffy, pink, swollen, and warm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, joint stiffness.  Additional information:He gets a Flu shot every year. He did get his Flu shot in late Sep2022 and had a reaction to it. It was elevated heart rate and rapid breathing; it was the stronger dose. NDC/lot/expiration: Unknown He considers himself fairly healthy. It didn't seem like osteoarthritis. He did have a meniscus trim in Jan2022. His Knees were in great shape with no arthritis or roughness then. There was a little reduction from spacing from inside to outside, but minimal. From Jan2022 and Jan2023, the space was now gone. They tested him for Rheumatoid arthritis factor it was negative. He has been on the same medications for a long time. Prior Vaccinations (within 4 weeks): none, If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None. He gets a Flu shot every year.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s): PFIZER INC-202300053948 Same patient/vaccine/event, different dose;
Severe generalized muscle pain and weakness, general bone pain, general organ pain, short of breath, itching, severe chills alternating with fever, chest pain, facial nerve numbness, blurry vision, sore throat, nausea, diarrhea.  Treatment was a Medrol Dose pack for 6 days. Outcome was severe symptoms decreased after 4 hours of taking first dose (6 tabs) of prednisone.  As the prednisone dose decreases each day there is increased muscle pain and shortness of breath/lung tightness with activity, and severe fatigue
Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Myalgia) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Lisinoprill and Statin for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Myalgia). At the time of the report, MYALGIA (Myalgia) outcome was unknown.        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.   This case was linked to MOD-2021-259911 (Patient Link).
Woke up on Wednesday 7/28/2021 with bilateral redness at eyelids. Noticed the right eye was more swollen than the left eye. Started taking OTC benadryl. States today 07/29/2021 that the redness has gone away and but there is swelling under the right eye. Pt states she was vaccinated in the right arm. No other problems to report.
Within 30 hours of receiving the SECOND dose of the Pfizer Vaccine, I began experiencing dull and sharp chest pains, shortness of breath, fatigue, and I lost the ability to stay out of bed for very long. I felt like if I walked or stood for any amount of time, my heart would give out, and I could barely even sit up in bed or in a comfortable chair. My entire range of abilities changed overnight. I am an extreme health nut, active 31 year old woman with no pre-existing medical conditions.
Patient bleeding was more than usual; Needle of the syrine inadvertently came out of arm and drip; A report was received from a pharmacist concerning a 34-year-old patient who was participating in mRNA-1273 Emergency Use Program and experienced the events, product administration error and bleeding more than usual.  The patients' medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 on 23 Dec 2020. On 23 Dec 2020, at the same time as the events, the patient received their first of two planned doses of mRNA-1273 (lot 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 23 Dec 2020, when the patient was receiving the vaccine, the needle of the syringe inadvertently came out of the patient's arm and two drips of the dose dripped out of the syringe. The needle was replaced and the remaining dose in the syringe was administered to the patient at a close site of the original injection site on left arm. The patient bleeding was more than usual and is under post vaccination protocol. Treatment for the events was not provided.  The outcome of the events, product administration error and bleeding more than usual, was not reported.   Action taken with mRNA-1273 in response to the events was not provided.  The reporter assessment of causality of events, product administration error, bleeding more than usual, was not provided.; Reporter's Comments: This case concerns a 34-year-old, patient who experienced the unlisted events of injection site bleeding and product administration error. The events of injection site bleeding and product administration error occurred on the same day after the first dose of Moderna COVID-19 Vaccine administration. The reporter causality assessment for the events was not provided. Due to the temporal association between onset of injection site bleeding and the administration of the vaccine, a causal relationship cannot be excluded. Additional information regarding the reason for the bleeding, patient's medical history and concomitant medication details are required for further assessment. However, the needle of the syringe slipping out of the arm is more of a human error. The event of product administration error was unlikely related to Moderna COVID-19 Vaccine.
Bell's palsy developed 3 days after injection. Patient reported to ED on 8/22/2020 and was given Bell's palsy diagnosis.
weird feeling in my chest; Chest pain; This is a spontaneous report from a contactable consumer. This 51-year-old consumer reported that.  A 51-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: ER8737), dose 1 via an unspecified route of administration, administered in Arm Left on 10Apr2021 (Age at time of vaccination 51-years-old) as DOSE 1, SINGLE for covid-19 immunization. Medical history included type 1 diabetes mellitus, hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included insulin aspart (NOVOLOG) taken for type 1 diabetes mellitus, atorvastatin (ATORVASTATIN), calcium (CALCIUM), biotin (BIOTIN), iron (IRON), cetirizine hydrochloride (ZYRTEC) taken for hypersensitivity, ascorbic acid, biotin, folic acid, iodine, pantothenic acid, pyridoxine hydrochloride, retinol, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc (CENTRUM MULTIGUMMIES), colecalciferol (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported. Consumer stated due vaccination date for the second shot On 01May2021. On 10Apr2021 The patient experienced weird feeling in my chest, chest pain. Events were consider as non serious. The outcome of events were unknown.  No follow up attempts are possible. no further information is expected.
low fever, much discomfort, pt laid in bed & cried & moaned, 3-4 days p/vax rash travelled over pt body & lasted @ least 1 wk;w/in 6 wk of vax pt was observed as losing prev gained language & social skills;dx autistic;
The next day patient got fever/chills, red circle around injection site. Patient came into the pharmacy to report incident on 3/08/2019. She said she didn't see a doctor, but the fever/chills went away. The redness didn't look as bad as the first day.
Bright red patch appeared on the injection arm - about 2-3 inches across and 1.5-2 inches high.  Was itchy, slightly warm and slightly puffy the first day, so we applied cortizone cream.  It got slightly larger over the next day or so and then has slowly faded...though has not gone away completely.  Even today it is still slightly pink.  It didn't itch after the first day.
Inadvertently administered 30mcg adult dose to 11-year-old patient instead of pediatric 10mcg dose. No symptoms or adverse reactions experienced as of yet.
Narrative:  Patient had a PCP visit on 04/02/2021. Found to have unintentional weight loss and agreed to having a CT of chest/abdomen/pelvis with contrast. On 4/02/2021 he received the Janssen COVID-19 vaccine. Patient's CT was scheduled for 04/24/2021, where it was found he had an incidental finding of a pulmonary embolism. He was started on apixaban at that time.
had not been feeling well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (had not been feeling well) 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 MALAISE (had not been feeling well). At the time of the report, MALAISE (had not been feeling well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: unknown (Negative) the test have indicated antibodies.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medication was provided. No treatment  was provided. Patient took the Moderna vaccine in February(unknown dose). The patient's Doctor ordered a Covid test, reporter asked if ' Should the test have indicated antibodies"
Severe chills and stabbing pain in joints for 3 hours beginning around 4:15 am on 3/14/2021. Insomnia from 3/14-3/17/2021.