chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Present to ED on 9/13/21 with pain in right calf and back of leg x 4 days 9/13/21: No current chest pain or shortness of breath.  Normal vital signs 97% O2 sat.  She was found to have DVT acute from Doppler ultrasound from triage.  She has no history of blood clots in the past.  No chest pain or shortness of breath. - complains of minimal swelling (but states has been swollen since surgery on ankle fracture 5/21/21) - discharged on 9/13/21 on apixaban
Reported to me by RN.  Fax would not go through so I am entering electronically - Pt initially entered POD with parents who signed his consent form.  His DOB was brought to RN attention.   She instructed registration that Moderna vaccine was approved only for 18 years old and up and he could not be vaccinated.  Without her knowledge, he returned to the clinic later that day and received his vaccine.  He returned 3/5/21 for his second dose and was stopped at registration.  This is when the RN was notified that he was, indeed, vaccinated despite her instructions to the contrary.
23DEC97 vomiting;light mental confusion;24DEC97 sz;25DEC97 sz, lesion on brain & lungs, brain, swelling, fever;24JUL98-5AUG98 mental confusion tx w/ATB, steroids, sz medication, antifungal, mannitol, IVIG;
Hives and itchy on entire body; skin is red and inflamed but not swollen; skin is red and inflamed but not swollen; itchy on entire body; This is a spontaneous report from a contactable consumer. A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9269), dose 2 via an unspecified route of administration, administered in Arm Left on 13Feb2021 06:00 as 2ND DOSE, SINGLE for covid-19 immunisation. Patient was not pregnant at time of vaccination. Medical history included former diagnosis of hashimoto's, penicillin and all varieties of antibiotics in this category, penicillin and all varieties of antibiotics and allergic to dairy and whey, ginger from an unknown date and unknown if ongoing. Concomitant medications included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) and sertraline hydrochloride (SERTRALINE HYDROCHLORIDE) both taken for an unspecified indication, start and stop date were not reported. The patient previously received 1st dose on 17Jan2021 for covid-19 immunisation. On 16Feb2021, the patient experienced hives and itchy on entire body and skin is red and inflamed but not swollen. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested positive for covid. No treatment received for events. Outcome for the events was unknown.  Follow-up attempts are completed. No further information is expected.
Both legs very stiff and painful especially at joints causing me to walk with limp.  Approximately 30 minutes later I could not move my legs or walk at intervals.  After sitting for couple of minutes severe spasms starting in both my legs, the right greater than the left.  Sitting caused the pain and spasms to increase.  The spasms would stop for a minute when I stand up.  Once I start walking the pain and spasms would start again.  I am a nurse.  I could not sit, walk or work without pain so I had to leave work. I went to Clinic to report the incident and be seen by a physician.  They told me I had to wait 1 1/2 hrs to be seen but I could not stand to sit, so I left.  I visited Dr. office.  I stayed in bed all day and self medicated my self with Mobic, Vicodin, Robaxin, Airborne Flu meds.  I attempted to return back to work the next day but realized driving caused the spasms to return so I left the parking lot and went home.  I took the same meds along with Benadryl tablets all day which seemed to lessen the pain the next day.  Today, I am still having the leg and joint pain but not as bad.
I got the Pfizer vaccine and no reactions but I still got covid; I got the Pfizer vaccine and no reactions but I still got covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team). The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "I got the Pfizer vaccine and no reactions but I still got covid". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Therapeutic measures included Paxlovid. It was reported that patient was on Plaxovid and was very tired. She was in bed a lot of course with covid. She had that horrible taste. She felt good for a couple days then 3 days after sheI got off it she had debilitating fatigue all of a sudden.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
vaccine administered from a vial punctured more than 18 hours ago; A spontaneous report was received from a pharmacist, concerning a 26-year-old male patient, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine administered from a vial punctured more than 18 hours ago/expired product administered.             The patient's medical history and concomitant history wa not reported                      On 11 Mar 2021,  the patient received their first of two planned doses of mRNA-1273 (Lot number: 027A21A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 11 Mar 2021, the patient received a dose the Moderna COVID-19 vaccine that had been previous punctured more than 18 hours prior to his vaccination.  The Action taken with the first dose of mRNA-1273 in response to the event was unknown.  The  outcome of the event, vaccine administered from a vial punctured more than 18 hours ago/expired product administered, was considered resolved on 11 Mar 2021.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 with no associated AEs.
Immediate swelling and redness. By 8pm there was a 2.5 in radius of bright red, swollen skin with a center that is dark purple. Treated with ASA 325 mg at 8pm and again at 7am. 24 hours post injection redness remains in 2 inch radius with localized swelling, warmth and discomfort.
I received the vaccine at 13:00 on 4/6/21.   By 22:00, I was feeling pretty tired.   When I woke up at 08:00 on 4/7/21, I was so tired, I couldn't get out of bed.  I was also running a fever of 101.9.  I slept all day and had no appetite.  By the evening, my temp had risen to 102.9, so I took a Tylenol and went to bed.  By the morning of 4/8/21, my fever had dropped to around 100.  I was still tired but not as bad as the day before.  By the evening of 4/8/21, the fever was gone.  The only other side effect I experienced was soreness at the injection site.
Pneumonia and progressive respiratory distress and bronchospasm with subsequent myocardial depression requiring intubation X2 days and IV pressors (dopamine and dobutamine).
monitor vs 70 MIN, feels hot, NO HX OF PREVIOUS REACTIONS REPORTED, left at 1620
Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown age patient who was vaccinated with TYPHIM VI (Lot number: N1K811M) route and site of administration was unknown. It was reported that as nurse was giving the TYPHIM VI vaccine to patient the fluid shot out sideways, before reaching the Luer-Lok adaptor. Fluid was all over the patient during administration while needle was in patient skin (syringe leakage and exposure via skin contact). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any adverse event. Id: 100002708 Batch no: N1K811M, Expiry date: 19-Oct-2019 Sample status: Requested and Awaited. List of documents held by sender: None.
The pt came into office on 05/02/2002 with multiple chicken pox over body. Began to break out on 04/30/2002.
COVID Positive test/Late August 2022; I have noticed that I have been having a problem with ringing in my ear/Tinnitus is constant; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (I have noticed that I have been having a problem with ringing in my ear/Tinnitus is constant) and COVID-19 (COVID Positive test/Late August 2022) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 002B21A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol high, Blood pressure high and Ulcerative colitis. Concomitant products included LISINOPRIL for Blood cholesterol abnormal, ATORVASTATIN for Blood pressure high, BALSALAZIDE for Ulcerative colitis.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 19-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In June 2022, the patient experienced TINNITUS (I have noticed that I have been having a problem with ringing in my ear/Tinnitus is constant). In August 2022, the patient experienced COVID-19 (COVID Positive test/Late August 2022). At the time of the report, TINNITUS (I have noticed that I have been having a problem with ringing in my ear/Tinnitus is constant) had not resolved and COVID-19 (COVID Positive test/Late August 2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, SARS-CoV-2 test: Positive.         No other vaccines were received by the patient within 1 month prior to Moderna COVID-19 vaccine.   Reported that patient had problem with ringing in ear. HCP said it was probably a sign of hearing loss. It was reported that patient seek medical care and went to ENT. Patient did not experience a similar event in the past.   No treatment medication was provided.
Pt vaccinated with Meruvax II developed redness at the inject site, fever, headache, malaise, painful & swollen joints.
Fever began the evening of immunizations. Baby was seen and examined the following day since he had URI sxs preceding immunizations. There was no evidence OM. He continued to be extremely fussy & irritable & febrile. Seen again 10/17 - no bacterial infection, no meds. Baby did develop facial eczematous rash on 10/15 - resolved with tx for eczema & BENADRYL. Took 2 weeks before happy baby again. MARKED BEHAVIORAL DIFFERENCE.
itching; swollen arm; warm at the site; a little bit of pain; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), PAIN (a little bit of pain), PERIPHERAL SWELLING (swollen arm) and VACCINATION SITE WARMTH (warm at the site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN (a little bit of pain). On 21-Mar-2021, the patient experienced PRURITUS (itching), PERIPHERAL SWELLING (swollen arm) and VACCINATION SITE WARMTH (warm at the site). At the time of the report, PRURITUS (itching), PAIN (a little bit of pain), PERIPHERAL SWELLING (swollen arm) and VACCINATION SITE WARMTH (warm at the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information provided No Concomitant medications were provided
Swelling, redness and soreness at injection site. Vomited about 9:30am.  Diarrhea onset at 5:00 pm.  Diarrhea contined off and on until Morning of Dec 28.  Vomited again at 1:00 pm on Dec 27.
Information was received from a pediatrician via a company representative concerning a female patient of unknown age, who on an unknown date was vaccinated with either GARDASIL 4 or GARDASIL 9 (dosage, lot number, and route of administration not provided. The pediatrician reported that an ex-patient was unable to walk (onset not provided) after receiving GARDASIL 4 or GARDASIL 9 (exact one unknown). The pediatrician reported that she learned of this adverse reaction from the news media in September 2015. The outcome of unable to walk is unknown. No further information provided. Additional information is not expected.
When needle came out there was a squirt so maybe didn't get the full dose; A spontaneous report was received from a consumer concerning a 74 year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced when needle came out there was a squirt so maybe didn't get the full dose (Product administration error, Incomplete dose administered).     The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.       On 14-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011L20A) on 14-JAN-2021.    On 11-FEB-2021, approximately prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 030L20A) intramuscularly in the for prophylaxis of COVID-19 infection.    On 11-FEB-2021, during administration of the second dose, when the needle came out there was a squirt so he thought maybe he didn't get the full dose.   Treatment information was not provided/unknown.    The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of the event was recovered on 11 Feb 2021.; Reporter's Comments: This is a case of 74-year-old male patient who was administered second dose of mRNA-1273 vaccine and experienced  needle came out there was a squirt so maybe didn't get the full dose (Product administration error, Incomplete dose administered) Lot #: 030L20A. There was no associated adverse event reported for the events of Product administration error, Incomplete dose administered.
This literature marketed information has been received from a published literature article and refers to a 4-year-old boy with known gelatin, beef, pork allergy. The patient developed on an unspecified date in approximately 2012, vomiting, itching, flushing, difficulty breathing within 5 min of vaccination with M-M-R II (dose, route, vaccination site, lot# and expiration date were not provided) and VARIVAX (dose, route, vaccination site, lot# and expiration date were not provided), for prophylaxis. Concomitant vaccines, administered on the same date, included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) and haemophilus influenza B (manufacturer unknown). The patient was diagnosed as anaphylaxis by treating physician. The patient was treated with antihistamines and 2 doses of intramuscular epinephrine. At the time of reporting, the outcome of the anaphylactic reaction was not reported. The author considered the event as a reaction associated to M-M-R II and VARIVAX. Upon internal review, anaphylactic reaction was determined to be medically significant. This is one of several reports from the same reporter (Case # US-009507513-1809USA011156, US-009507513-1809USA012060, US-009507513-1809USA012067, US-009507513-1809USA012064, US-009507513-1809USA012065, US-009507513-1809USA012066, US-009507513-1809USA012062).; Sender's Comments: US-009507513-1809USA011156:
Rash spraying over all my right arm, extremely itching.  Applying over the counter Cortisone.
Headaches; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 09Apr2021 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included possible gastroesophageal reflux disease (GERD) from an unknown date. It was unknown whether the patient had any known allergies. 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 COVID vaccine. The patient did not receive any concomitant medications. Since 16Jun2021, the patient was having headaches for about a month. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headaches was not recovered at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Following day patient experienced lethargy and had sore arm; following that arm is red, hot and itchy at injection site; redness getting larger every day.
Pt complained of a 3 inch hard area that was warm to the touch and achiness at injection site.
1 of 4 pts who exp an inject site rxn & fever following vax; pt was seen in office; tx included APAP & cold coompresses;
my arm is sore; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (my arm is sore) and HEADACHE (headache) 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 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced PAIN IN EXTREMITY (my arm is sore) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (my arm is sore) and HEADACHE (headache) 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.   No concomitant medication reported
Dr. office called and stated client reports feeling "nodule" in left armpit since shortly after administration of yellow fever vaccine.
Swollen lymph nodes in right under arm (armpit), back of neck right side, front of neck under chin right side. Duration lasted for 8-10 days.
DOSE ADMINISTERD AFTER 30 DAYS STORAGE BETWEEN 2-8 DEGREE C
White blood cell count decreased; Staphylococcus lugdunensis infection; Leg pain; Redness; Pain in face; This spontaneous case was reported by a consumer and describes the occurrence of STAPHYLOCOCCAL INFECTION (Staphylococcus lugdunensis infection) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arthritis. Concurrent medical conditions included Type 2 diabetes mellitus.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced FACIAL PAIN (Pain in face). On 10-May-2021, the patient experienced STAPHYLOCOCCAL INFECTION (Staphylococcus lugdunensis infection) (seriousness criterion medically significant), PAIN IN EXTREMITY (Leg pain) and ERYTHEMA (Redness). In June 2021, the patient experienced WHITE BLOOD CELL COUNT DECREASED (White blood cell count decreased). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; CODEINE at a dose of 1 dosage form; CLINDAMYCIN at a dose of 1 dosage form; DOXYCYCLINE at a dose of 1 dosage form and DAPSONE at a dose of 1 dosage form. On 17-Apr-2021, FACIAL PAIN (Pain in face) outcome was unknown. At the time of the report, STAPHYLOCOCCAL INFECTION (Staphylococcus lugdunensis infection), PAIN IN EXTREMITY (Leg pain), ERYTHEMA (Redness) and WHITE BLOOD CELL COUNT DECREASED (White blood cell count decreased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: low (Low) Low White Blood Count.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient on 1985 post partum & post Rubella vaccine and  had a similar skin lesion but patient not sure if was the same infection. Patient medication was taken probiotic.  Action taken with mRNA-1273 in response to the events was not applicable.  Company comment: 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; Sender'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
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reaction/allergies. On an unknown date, the patient was vaccinated with PROQUAD (rHA) via intramuscular, for prophylaxis, lot # R001543 and expiration date 15-JUL-2019 (dose was not reported). The vaccine was diluted with sterile diluent, lot # N031941 and expiration date 03-AUG-2020. The outcome of the event incorrect route of product administration was not reported.
Patient received FLUARIX at the pharmacy on 9/12/17. She "stopped by" on 9/14/17 since she was in the store to show me her arm which had a softball sized, unraised red area that was a little warm to the touch. She stated she was not concerned, but she has had flu shots in the past and never any problems. I asked her if it seemed to be getting worse at this point and she stated it did not. I told her it seemed very localized and did not seem to be anything to cause great alarm at this time, to try applying a cold compress and if it seems to get worse instead of better, to give her PCP a call. She states no allergies. I plan to give her a follow-up call tomorrow.
Extreme tiredness, very red and itchy eyes, shortness of breath. Lasted about 16 hours