chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient only received about 75 percent of the injection; Injecting the Moderna bivalent booster the needle leaked out; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (The patient only received about 75 percent of the injection), DEVICE CONNECTION ISSUE (Injecting the Moderna bivalent booster the needle leaked out) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (The patient only received about 75 percent of the injection), DEVICE CONNECTION ISSUE (Injecting the Moderna bivalent booster the needle leaked out) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (The patient only received about 75 percent of the injection), DEVICE CONNECTION ISSUE (Injecting the Moderna bivalent booster the needle leaked out) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for UNDERDOSE (The patient only received about 75 percent of the injection) and DEVICE CONNECTION ISSUE (Injecting the Moderna bivalent booster the needle leaked out).    The concomitant and treatment medication was not reported.  When injecting the Moderna bivalent booster the needle leaked out and the patient only received about 75 percent of the injection.
Patient reported history of fainting with previous vaccinations. Patient received 1st dose of Pfizer vaccination and was screened a couple of minutes after administration and patient said he felt fine. Patient stood up and walked to the waiting chair where the patient fell and hit his head causing bleeding  and patient appeared to shake but came out and was responsive immediately.  Provided first aid, gave patient paper towel, to wipe off blood and provided ice pack  and bandages and suggested immediate medical care. The patient looked pale and was sweating after fainting.  Offered to call 911 but patient declined and Store management assisted and filed report.
father received the first dose of Pfizer COVID 19 vaccine on 04Mar, he tested positive for coronavirus on 15Mar.; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's son) reported that a 67-year-old male patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration, administered in the arm on 04Mar2021 (Lot Number: EN6206) as single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient could have possibly gotten the shingles vaccine (prior vaccination within 4 weeks). The reporter stated that his father received the first dose of Pfizer COVID 19 vaccine on 04Mar2021. PCR COVID test done on 15Mar2021 and he tested positive for coronavirus. The reporter is asking if his father could get the 2nd dose of the vaccine if he contracted coronavirus after the 1st dose. The outcome of the event was unknown.
On 05.23.21 client  received her second dose of the Pfizer Covid-19 Vaccine (LOT # EW0185 EXP. 08/2021). Client approached EMT and stated that they felt "nausea." Lead nurse and Co-Lead nurse  also responded. Client was a 17-year-old non-binary individual alert and tracking with their eyes. Client had a chief complaint of nausea. Client stated that they noticed their nausea a few minutes after beginning their observation. This was the clients second dose of the Pfizer vaccine. Client denied any medical history and stated they only take melatonin at bedtime. Assessment revealed no swelling, hives, discoloration, shortness of breath or other signs of anaphylaxis. Client was complaining of nausea that came on abruptly after their vaccination. Client stated they had breakfast this morning but not very much water. Client also stated they felt nervous after their vaccination. Airway, breathing and circulation are intact. Client's initial vitals at 0915 were: 92/64 blood pressure, 68 heartrate, respirations 14, O2 100% on room air, alert and oriented to person, place, date and event. Temperature 97.8*f. Client consented to an additional 30-minute observation and was asked to lie down for at least 15 minutes. Client was provided with water and was reassessed every five minutes until their complaint was resolved. After lying down for 15 minutes, the client stated that their nausea had resolved. Client sat up in an observation chair for the last 15 minutes and stated that their nausea was all gone at the completion of their observation. Clients remaining vitals were 0920 - 110/74, 84, 100%, resp. 14. 0925 - 110/74, 84, 100%, resp 14, 0925- 110/74, 84, 100%, 0930 - 110/74, 88, 100% resp. 14, 0940- 120/78, 88, 100%, resp. 16, 0945 - 118/78, 80, 100% resp 14. Client was provided with relevant vaccine information and instructed to seek emergency care if a severe reaction happened later. RN and EMT worked together to educate client about possible symptoms they could experience. Client acknowledged what they were told and departed facility at 0947 with their mother in positive disposition with steady gait.
Fever; chills; body aches (severe); fatigue; This is a spontaneous report from a contactable nurse (patient). A 38-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EL3246, Expiry date: not reported) via an intramuscular route of administration in arm left on 15Jan2021 (age at vaccination 38-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included hypertension during pregnancy only 2011 and 2012 and non-smoker from an unknown date and unknown if ongoing. Concomitant medications included multi vitamin d3, zinc, bupropion and fluoxetine taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EK5730, Expiry date: Mar2021), dose 1 via an intramuscular route of administration, administered in arm left on 26Dec2020 as DOSE 1, SINGLE for COVID-19 immunisation. It was reported that the patient had no pre-existing diseases worsened during the SARS-CoV2 infection. The patient had no display clinical signs at rest indicative of severe systemic illness. The patient had not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. There were not any of the events above considered serious due to being life-threatening or due to persistent or significant disability/incapacity or any other reason. On an unspecified date, the patient experienced fever, chills, body aches (severe) and fatigue. The events did not require hospitalization. Adverse events did not require to visit intensive care unit/ emergency room/ physician office. The event required the initiation of new medication or other treatment or procedure included OTC supplements, ASA 50mg, vit c, vitd3, zinc, famotidine, melatonin, vit b complex, elderberry, multi vitamin and quercetin. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 04Jan2021 (Nasal swab NAA/PCR). The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018130 same patient/drug, different dose
Received flu vaccine on 10/24/05. One week later developed numbness related to cranial nerve 9. Symptoms lasted for 10-12 weeks. Examined by a neurologist and expects a full recovery (OMIC)
I experienced a breakthrough case of COVID-19 on 10/12/2022. I received my fifth dose of Moderna Bivalent on 09/09/2022. I started to experience symptoms on 10/11/2022. I experienced a mild sore throat and increased congestion. I tested the next morning and the result was positive. I had a tele-visit with my physician. He prescribed a reduced dose of PAXLOVID, but we decided that I wouldn't take it right away because my symptoms were so mild. I deteriorated over the next few days and started taking PAXLOVID on 10/15/2022 and my last dose will be today 10/19/2022. I feel that PAXLOVID helped me start to feel better. As of today, I'm still not back to normal. I have a cough and my energy level is not where it normally is, but I'm about 90 percent better.
tested positive for Covid-19 after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid-19 after the 1st dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for Covid-19 after the 1st dose). At the time of the report, COVID-19 (tested positive for Covid-19 after the 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.   Reporter did not allow further contact
2:58pm c/o feeling lightheaded and drowsy.  Skin warm but diaphoretic.  BP 79/44, HR 57, R 18, O2Sat 98% @ scene. 3:20pm Paramedics remain on scene, BP 90/50, transported to EMS truck, BS taken 92. not diaphoretic at this time. 3:25pm BP standing 128/71, sitting 116/73. 3:26pm Skin w/d, states feeling better.  BP 116/76.
unable to complete her second vaccine with in the 28 day interval; unable to complete her second vaccine with in the 28 day interval; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (unable to complete her second vaccine with in the 28 day interval) and PRODUCT AVAILABILITY ISSUE (unable to complete her second vaccine with in the 28 day interval) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (unable to complete her second vaccine with in the 28 day interval) and PRODUCT AVAILABILITY ISSUE (unable to complete her second vaccine with in the 28 day interval). On 29-Apr-2021, PRODUCT ADMINISTRATION INTERRUPTED (unable to complete her second vaccine with in the 28 day interval) and PRODUCT AVAILABILITY ISSUE (unable to complete her second vaccine with in the 28 day interval) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment medications was not given.
Shot was administered around 12:30pm. Pt complained of severe pain at 3:30pm. She went to Dr at 4:00 but they could not see her. 4:15 she went to ER. ER nurse gave IV injection of Dilaudid and nausea med. ER took X ray of shoulder. Was given another inj of Dilaudid. Sent home with RX for prednisone, pain, muscle relaxants.
This spontaneous report was received from a registered nurse referring to a 16 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 11-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Itchy hived rash over thighs; Itchy hived rash over thighs; Heat-like rash on shins; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the right arm on 24Aug2021 at 15:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The medical history included allergies to sulfa, adhesives and onions. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included various over the counter (OTC) vitamins for unknown indications from unknown dates and unknown if ongoing. On 29Aug2021, the patient experienced itchy hived rash over thighs and heat like rash on shins. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events itchy hived rash over thighs and heat like rash on shins was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of general body pain in a patient who received RABAVERT. On an unknown date, the patient received RABAVERT at an unknown dose. On an unknown date, 4 days after receiving RABAVERT, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was unknown. It was unknown if the reporter considered the general body pain to be related to RABAVERT. Additional details were reported as follows: The age at vaccination was not reported. The patient reported that they experienced general body ache after receiving a dose of RABAVERT. The patient refused to provide all other details.
legs in pain; headache; chills; fever of about 100°F; she's still been feeling very tired; This is a spontaneous report from a contactable consumer. A 78-year-old female patient reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number and Expiration date was unknown) via an unspecified route of administration on 03Feb2021 at 09:00 AM as 2nd dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine of the patient included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date was unknown) via an unspecified route of administration on 13Jan2021 as 1st dose, single for COVID-19 immunization with no adverse events and stated that everything was fine. On the next day 04Feb202, Everything was fine until around 3 AM the next day and when she woke up from her sound sleep she had experienced pain in her legs, head ache, chills, and a fever of about 100 degree farenheit. She mentioned that she took Tylenol for her fever and currently some of the side effects already went away but she was still been feeling very tired. Patient wanted to know if it was also common to experience these side effects after the 2nd dose and for how long these side effects would last and if she needed to consult a doctor or should she just wait it out. The patient underwent lab tests and procedures which included body temperature 100 degree Fahrenheit on 04Feb2021. The outcome of the event very tired was not recovered and outcome for rest of events was unknown.  Information on the lot/ batch number has been requested.  Follow-up attempts were completed. No further information was expected.
Presented 7/24/21 to the hospital with recurrent seizure and declining mental status after persistent headache for the several previous days. On imaging found to have extensive dural venous sinus thrombosis with hemorrhage. Treated with anticoagulation, anti-seizure medications, invasive mechanical ventilation, and transferred to alternate hospital for consideration of endovascular treatment.
Pfizer vaccine temperature excursion. The vaccine was placed in the freezer for 3 weeks then removed and placed in the fridge for a week. After that the vaccine was administered,
Raised, red, warm, allergic reaction at the site of administration (5 x 4.5 cm) within 24 hours.
booster; Pneumonia; cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for covid-19 immunization, reaction(s): "Sick"; Bnt162b2 (Dose: 2), for covid-19 immunization, reaction(s): "Sick". The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; PNEUMONIA (medically significant), outcome "recovered", described as "Pneumonia"; COUGH (non-serious), outcome "recovered", described as "cough". She said as well that before getting the booster shot she was sick and she had a cough now when she had her booster shot she had her Pneumonia together she claims that she got well. She wants to see if Pfizer can have a correlation between the Booster shots and Pneumonia shots/vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
she cut her hand; Sore arm; This is a spontaneous report received from a contactable consumer reporting for herself.     A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  The patient medical history  and concomitant medications were not reported.  The patient  cut her hand  and had sore arm  on an unspecified date with outcome of unknown.  The event cut her hand was considered an Important Medical Event.  The patient  got stitches, a tetanus vaccine and was prescribed cephalexin as a result of the event.  The patient is wondering if she can take the 2nd dose as scheduled.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
therapy non-respoder; Inappropriate preparation of medication; intercepted medication error; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Concurrent medical conditions included immunodeficiency.   On an unknown date, the patient received Hepatitis B vaccine at an unknown dose and Engerix B at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine and not applicable after receiving Engerix B, the patient experienced therapy non-responder, inappropriate preparation of medication and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the therapy non-responder, inappropriate preparation of medication and circumstance or information capable of leading to medication error were unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter did not have patient's gender or age.  The patient was previously vaccinated with Hepatitis B series (unknown manufacturer of series). The patient was immunocompromised and was not responding to Hepatitis B series.  The reporter inquired about combining two doses of Engerix-B into one syringe, which led to circumstance or information capable of leading to medication error and would have led to inappropriate preparation of medication if administered. The reporter refused to provide any patient information and address of hospital.
Severe back and leg pain. Chills, migraine headache and low-grade temp.
received 2nd injection into his thigh muscle; having "little side effects"; hang-over that lasted one day; thigh area "a little tender"; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (received 2nd injection into his thigh muscle), VACCINATION SITE REACTION (having "little side effects"), FEELING ABNORMAL (hang-over that lasted one day) and VACCINATION SITE PAIN (thigh area "a little tender") in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Rotator cuff repair (Have left rotator cuff surgery in his upper left arm and there is remaining subcutaneous fluid there).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (received 2nd injection into his thigh muscle), VACCINATION SITE REACTION (having "little side effects"), FEELING ABNORMAL (hang-over that lasted one day) and VACCINATION SITE PAIN (thigh area "a little tender"). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (received 2nd injection into his thigh muscle) had resolved and VACCINATION SITE REACTION (having "little side effects"), FEELING ABNORMAL (hang-over that lasted one day) and VACCINATION SITE PAIN (thigh area "a little tender") outcome was unknown.            Concomitant  medications were not reported. Treatment medications were not reported.
Itching on my stomach area from above my navel to below my breast, stretching from one side of my body to the other.  This area became red and itchy all over. The redness/itchiness was gone when I awaken the next day.
Received  first dose Moderna COVID vaccine on 12/28/2020; on that same day 12/28 he noticed a dry cough; on 1/1/2021 he reported fever, chills, body aches, Headache, sinus congestion.  On 1/1/2021 he tested positive for COVID-19, he reported being with a family member on Christmas who had COVID symptoms.  On 1/11/2021 he required hospitalization for COVID-19 pneumonia
Post having the vaccination experienced symptoms of tachycardia and shortness of breath over to a period of 2 to 3 weeks.  Engaged in exam with cardiology who then put on a external  monitor recorder.  Recorder showed episodes of tachycardia as well.  Post vaccination approximately 6 weeks ended up with a atrial fibrillation rhythm.  Approximately 3 months post received a external echocardiogram which showed normal heart function.  Currently symptoms have resolved back to baseline
WOKE UP WITH FEVER AND LARGE RED WELTS ON LEFT THIGH AND SPREADING TO BUTTOCKS AND RIGHT THIGH.
2:00 pm - Tdap (L) deltoid; 2:15pm - itching bilateral hands/feet, "feeling funny"; 2:30 - BENADRYL 50mg PO; 2:45 - full trunk urticaria, bilateral upper extremity; 3:15pm - 125mg SOLU-MEDROL IM; 3:45 - Slight improvement (PO Prednisone 40mg qd x 5 days sent).
Patient states symptoms resemble chicken pox he had as a young adult, but 'worse' and 'open and oozing'.  Patient complains of systemic effects, such as fatigue.  Redness and pain 2 to 3 inches around injection site in arm.