chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cardiac dysrhythmia development (Symptomatic PAC/PVCs); Cardiac dysrhythmia development (Symptomatic PAC/PVCs); Cardiac dysrhythmia development (Symptomatic PAC/PVCs); This is a spontaneous report from a contactable other HCP (healthcare professional/patient). A 20-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection) via an unspecified route of administration on 06Jan2021 at 12:00 (at the age of 20-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included known allergy to tree nuts from an unspecified date and unspecified if ongoing. Other medical history was reported as no. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications ("other medications in two weeks") were reported as no. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jan2021 the patient experienced cardiac dysrhythmia development (Symptomatic PAC/PVCs). The event resulted in an Emergency Room visit and required treatment with a Holter monitor, echocardiogram and cardiologist. The clinical outcome of the event cardiac dysrhythmia development (Symptomatic PAC/PVCs) was recovering/resolving. Since the vaccination, the patient tested positive for COVID-19 via a nasal swab on 13Apr2021 (captured in AER: 2021456226).   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and known product profile, the causal relationship  between the reported cardiac dysrhythmia development (Symptomatic PAC/PVCs) and the use of BNT162B2 cannot be fully excluded. The case will be assessed further upon receipt of additional information.  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 Committees and Investigators, as appropriate.
allergic reaction/I had broke out after my second shot, 'its a rash'/it's been spread over my body, its there and it itch real bad; allergic reaction/I had broke out after my second shot, 'its a rash'/it's been spread over my body, its there and it itch real bad; allergic reaction/I had broke out after my second shot, 'its a rash'/it's been spread over my body, its there and it itch real bad; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received second dose of BNT162B2 (FIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, NDC number, UPC number and Expiry Date were unknown), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (FIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. Patient reported that patient experienced, allergic reaction; Had broke out after second shot, it's been spread over body, it itch real bad; Spreading over body, had a rash and it's spread on body on an unspecified date. Patient stated that, was trying to see what have to do to get the rash out of my body, from the shot?". Also stated that what need to do after shot would give me cream or something." Patient added, that is going to the ER. Seriousness of the events was not reported. The outcome of the events was unknown.  Information about Lot/Batch number has been requested.
Rapid heart rate, headache, swelling of throat over period of 5 hours - Took Tylenol & Benedryl.  Resolved over a period of 3 hours after taking meds
The second time she contracted COVID-19 was in 2022, after she had already received vaccination; The second time she contracted COVID-19 was in 2022, after she had already received vaccination; she had fever at work; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 04Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 02May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in 2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "contracted COVID-19", start date: 2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Aug2022, outcome "not recovered" and all described as "The second time she contracted COVID-19 was in 2022, after she had already received vaccination"; PYREXIA (non-serious) with onset 16Aug2022, outcome "unknown", described as "she had fever at work". The patient underwent the following laboratory tests and procedures: Pulmonary function test: (unspecified date) //2022; SARS-CoV-2 test: (19Aug2022) positive, notes: PCR test; (16Aug2022) positive. Additional information:This second time the patient contracted COVID-19 was in 2022. She went to a private doctor to have her lungs checked, she stated that she could breathe, but her voice was hoarser and she had more phlegm. On Tuesday afternoon 16Aug2022 she began to feel unwell, she had fever at work, when she got home around 7:00 she did a rapid-test which came back positive for COVID-19; on Friday 19Aug2022 she made an appointment and there they did the other  test (PCR),  she got the results on Sunday night which also confirmed she was positive (COVID). She requested information about Paxlovid, for emergency use, she wants to know if it is indicated for her and how to take it (she has not started taking Paxlovid yet).    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Really achy and sore in left arm; A headache; I have some achiness in my right leg; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 08Apr2021 at 12:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included my right leg that I broke last year and I have a metal rod and screws in it. The patient had no known allergies to medications, food or other products. The patient did not receive any concomitant medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 09Apr2021 at 09:00 the patient experienced really achy and sore in left arm, a headache, patient had some achiness in right leg that broke last year and had a metal rod and screws in it. Therapeutic measures were taken as a result of reported events which included treatment with ibuprofen (MANUFACTURER UNKNOWN) and heating pad and it was helping. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the events really achy and sore in left arm, a headache and achiness in my right leg were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt experienced erythema & edema @ the injection site in his rt thigh /w a T. of 102 /p receiving DT.  Pt was also iritable & cried for 2.5 hrs.
Information had been received on 02-MAR-2017 from a nurse who reported that two male patients (age unknown) were inadvertently administered expired doses of MMR II (lot# L004658, expiration 11-FEB-2017). The patient was administered a dose on 15-FEB-2017 and the other patient (see MARRS# 1703USA001814) was administered a dose on 24-FEB-2017. No adverse effect reported for either patient. No further information was provided. This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA001814:
Left are at the injection site was itchy 1 week after injection.  Upon a closer look the area around the site injection is slightly red and tender.  At the time of completing this form on 2/25/21 it is now 10 or 11 days after the injection on 2/15/21.
Child with history of mild cerebral atrophy, thin corpus callosum given vaccines 4 days prior to patient having 2 short seizures. Less than 30-45 seconds duration. No cyanosis. Tonic/clonic in nature. Admitted to hospital. Doing well.
This spontaneous report received from a patient concerned a 34-year-old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 19-SEP-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced sweating, felt hot, feverish, and headache. On 11-APR-2021, the patient experienced woke up in the middle of the night, face puffy and inflamed, right arm inflammation, she tripped on the stairs/almost fell, pinched nerve, could not feel right leg, leg and arm on right side felt heavy, and face numbness right cheek. On 14-APR-2021, Laboratory data included: CT scan (NR: not provided) Not reported, and MRI (NR: not provided) Not reported. On an unspecified date, the patient experienced nerve issue, scary, and stressful. The action taken with covid-19 vaccine was not applicable. The patient was recovering from feverish, felt hot, headache, sweating, could not feel right leg, leg and arm on right side felt heavy, face numbness right cheek, face puffy and inflamed, right arm inflammation, she tripped on the stairs/almost fell, pinched nerve, and woke up in the middle of the night, and the outcome of stressful, scary and nerve issue was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Fever chills myalgia. She was unable to function for 24 hours. Localized induration and redness at the injection site of 9cm. This was the second booster shot. The first shot provoked a much milder reaction. We have a picture of reaction, if desired.
Mod. to severe nausea (no vomiting), headache, vertigo on 2nd day (First day of shot, nothing).  3rd day nausea much worse also just general bad feeling (I think the expression is "sick as a dog"?  Also injection site red, swollen, very painful.  4th day (today) all symptoms gone except arm, still red and painful.  Never been this sick before, not even with the worst flu!
This spontaneous report was received from an office manager, concerning a multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug allergies or concomitant therapies were not reported. On unknown dates in 2017 (reported as "on or after 09-MAR-2017"), patients were vaccinated with improperly stored doses of GARDASIL 9 injection (strength, dose, anatomical location and route were not reported) lot number: M031557, expiration date: 07-APR-2019, for prophylaxis. According to the reporter, GARDASIL 9 doses were exposed to the following temperature excursions: 1 hour and 30 minutes at 31 degrees Fahrenheit (F) or below (30.2F); and 24 hours and 10 minutes between 32F to 35F. No previous temperature excursions were reported. No adverse effects were reported. A digital data logger was involved. This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA012729:
SORE ARM WITH ALL THREE COVID VACCINES; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (SORE ARM WITH ALL THREE COVID VACCINES) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product VENETOCLAX (VENCLEXTA) for Chronic lymphocytic leukaemia.    Previously administered products included for Drug use for unknown indication: PENICILIN, SIMVASTATIN and LIVALO. Past adverse reactions to the above products included Allergy with LIVALO, PENICILIN and SIMVASTATIN. Concurrent medical conditions included Chronic lymphocytic leukaemia. Concomitant products included ACETAMINOPHEN, ATORVASTATIN, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ), OMEPRAZOLE, ALLOPURINOL, TRAMADOL and VITAMINS NOS (MULTIVITAMINUM) for an unknown indication.   On 06-Aug-2021, the patient started VENETOCLAX (VENCLEXTA) (Oral) 100 milligram. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (SORE ARM WITH ALL THREE COVID VACCINES). At the time of the report, PAIN IN EXTREMITY (SORE ARM WITH ALL THREE COVID VACCINES) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporters causality for VENCLEXTA of the event of SORE ARM WITH ALL THREE COVID VACCINES was not provided.  No treatment medication were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-622062 (Patient Link).
Second dose greater than 6 months./Second dose not yet given.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 13th August 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. Pharmacist reported that 2nd dose of Shingrix greater than 6 months and 2nd dose not yet given till the time of reporting which led to incomplete course of vaccination. The reporter did not consent to follow-up. The case had been linked with US2019129052 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019129052:Same reporter
did not received the full dose/50% of the vaccine remain in the syringe; problem with the fitting of the needle; This case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 2KD4D, expiry date 8th May 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th June 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 30th June 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced accidental underdose and needle issue. On an unknown date, the outcome of the accidental underdose and needle issue were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the pediatric patient did not receive the full dose of Pediarix, due to problem with the fitting of the needle to the pre filled syringe, when administering the dose, 50 percent of the vaccine remained in the syringe, which led to accidental underdose. The reporter consented to follow up. This case has been linked to US2021172418, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021172418:Same reporter
4 doses of the Moderna vaccine given to 4 patients 34 days after vial was first refrigerated; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT STORAGE ERROR (4 doses of the Moderna vaccine given to 4 patients 34 days after vial was first refrigerated) in a patient of an unknown age and gender 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 01-Jun-2021, the patient experienced PRODUCT STORAGE ERROR (4 doses of the Moderna vaccine given to 4 patients 34 days after vial was first refrigerated). At the time of the report, PRODUCT STORAGE ERROR (4 doses of the Moderna vaccine given to 4 patients 34 days after vial was first refrigerated) had resolved. Not Provided      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.   Patient had some issues with filling out AE forms No treatment medications were provided by the reporter No concomitant products were reported by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow-up information received on 02-JUN-2021 contains non-significant information.
I noticed that my menstrual cycle after the first dose (9/8/21) was abnormal. It only lasted 2 days and was extremely light, whereas it normally lasts 7 days. After my second dose (10/13/21) I did not have a menstrual cycle in October or November. My cycle was absent both months, when it has been regular.
Overall I am a very healthy guy, rarely get sick, and when I do quickly recover. I got a cold just about 2 months after receiving my COVID vaccine. After about a week of having the cold I developed bronchitis (confirmed via chest X-ray). I highly suspect that the COVID vaccine may be causing my immune system to overact to my cold causing this bronchitis. Again I have never had bronchitis in my life and I have always been healthy. Although impossible to prove this link, CDC please take this report seriously as my wife also has bronchitis right now and research what this is doing to our immune systems. Thank you.
Headache; Fever; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever) and FATIGUE (Tiredness) in a 46-year-old male patient 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 26-Mar-2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever) and FATIGUE (Tiredness). At the time of the report, HEADACHE (Headache), PYREXIA (Fever) and FATIGUE (Tiredness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided  No treatment medications provided
05/16/2021: (1) occasional mild itching at and around injection site, (2) substantial soreness of injection are to touch and upon movement, (3) chills, (4) full body aches 05/17/2021 (1) occasional mild itching at and around injection site, (2) approximately 3 inch by 4 inch area of redness of skin around injection site and red skin area hot to the touch
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL9264), in right arm, on 18Feb2021 as dose 2, single (Lot number: EL9266), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 17Apr2022 as dose 4 (booster), single (Lot number: FK9893), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known Allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa and Lipitor. There were no concomitant medications. Past drug history included: Known allergies: lipitor, reaction(s): "Known allergies: lipitor". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (unspecified date) Negative, notes: Tested positive 5 days after competing Paxlovid and negative test; (29Jun2022) Positive, notes: Tested positive 5 days after competing Paxlovid and negative test. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Raised red rash and hives on all extremities and stomach and lower back. Not itchy but looked terrible. After worsening for 24 hours I called my primary physician & she started me on oral steroids. Rash gone after 10 days.
Fever; Injection site pain; Heart rate up; Body aches; Headache/Head face pounding; Chills; Tired; This is a spontaneous report from a contactable other HCP (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EK5730) intramuscularly at left arm on 30Dec2020 at 12:15 PM at a single dose (dose number: 1) for COVID-19 immunization. Medical history included environmental allergies only. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced fever, head face pounding, heart rate up, body aches, headache, chills, tired, injection site pain; on 30Dec2020 at 06:00 PM. The events were non-serious. No treatment received for events. The outcome of events was not recovered. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Hives starting on day 2 in the evening and every subsequent evening - now on 4th evening.  Am taking 2 Benadryl nightly.  cortisone cream, and cold compress.
Super weak. Strange vibration running through my body, a fight or flight syndrome causing me to shake. Extreme tiredness, fevers that came and left through out the week - 50episodes, Goose bumps, chills, mental fog, and sore arm. All of these symptoms lasted one week.
Patient received first dose of vaccine 3 weeks prior with no issues. She returned today 24 hours after 2nd dose and had a swollen, red, warm area at the site of injection that measured about 2 inches by 2 inches. She said she wasn't experiencing any other systemic symptoms.