chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient noticed that her right eyelid would not open and the right side of her face was numb.  This was at 0300 on 9/11/21.  She also noted that her right side of her face was dropping and she could not smile.  She immediately presented to the ER at 0345 on 9/11/21.  She was diagnosed with Bell's Palsy.  She had progression of her facial drop after she presented to the ER.  She was given Steroids in the ER and underwent a CT of her head (which was negative for pathology).
That night 4/27/2021, I woke up at midnight and I was achy all over and my shoulder was the worst, I had the chills and I was sweating, I was nauseated and I had a terrible headache lasting 12 hours. I felt awful. Felt like I had the flu. I had a fever was relatively high 102 if I remember correctly. I never recovered from fatigue. I can't do any standard duties. I took Tylenol that night and all the next day. May 24, 2021 to the doctor was my 2nd. I was losing hair. Soft tissue swelling from that palm to almost to elbow.
Rash over the lower part of both legs, near ankle; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash over the lower part of both legs, near ankle) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 RASH (rash over the lower part of both legs, near ankle). At the time of the report, RASH (rash over the lower part of both legs, near ankle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: TCR received on 7-JUL-2021, added second dose without any event, updated event outcome for first dose.
Pain in legs moving upward throughout body within two days also affected hand movement. Leg paralysis leading to hospitalization. From then on headaches body spasms, burning sensation in extremities. Extreme Pain, confusion, nausea, diarrhea, unconfirmed diagnosis of GBS treated with pain medication and intravenous immunoglobulin.
An unidentified patient received her fisrt dose of Gardasil 9 at age 12 years and her second dose at age 16 years; No adverse effects reported; This spontaneous report as received from a nurse prescriber and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dosage schedule, route of administration, anatomical site, lot number and expiration date were not reported).   It was reported that the patient received her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) when she was 12 years old and the second dose at the age of 16 (Inappropriate schedule of vaccine administered). Both administrations were performed by a different healthcare provider. No adverse effects were reported.
01/29/22 presents to ED for "Syncope". PMHx of "prostate ca w/ metastatic disease, PE, CKD"
SEVERE SOFTBALL-SIZED BRUISING AND SWELLING OF LEFT SHOULDER WITH ACCOMPANYING PAIN. SEVERAL FIBROUS SUB-DERMAL MASSES BENEATH BRUISED AREA. SHOULDER SWOLLEN TO A PERIMETER THAT IS NEARLY 2" LARGER THAN RIGHT SHOULDER. I HAVE PHOTOGRAPHS BUT CANNOT ATTACH THEM TO THIS FORM.
No adverse event; Patient received a regular Moderna instead of the bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received a regular Moderna instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Patient received a regular Moderna instead of the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received a regular Moderna instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received a regular Moderna instead of the bivalent booster).    No concomitant medication information was provided.  Pharmacist wants information to see when the patient can get the bivalent booster (lot number 052B22A).  No treatment medication was provided.
Pharmacy did not dispense or administer this Moderna COVID vaccine and therefore have no specific information on it. Patient reported taking vaccine in March 2021. Then shortly thereafter, she woke up covered in red, itchy, scaly patches on her skin. She was diagnosed with psoriasis vulgaris. By May 2021, patient had developed severe, debilitating psoriatic arthritis. At that time, she was "bedridden" and could only get up to go to bathroom using a walker. She described very severe pain. Pt was placed onTremfya in October 2021, and at this time, August, 2022, her skin is completely clear of psoriasis and her psoriatic arthritis is still pain level 4/10, but she is able to ambulate unassisted, goes to the gym 3 days a week for cardio and weight machine workouts.
After injection, patient passed out after walking away from pharmacy, associate alerted pharmacy, pharmacist attended to patient, patient was given water and was seated for 10+minutes.
p/vax pt devel cold; tiredness; fever; aching in joints & muscles which pt likened to a sensation of drilling into her hips; inj site arm was also sore; symptoms resolved; but achiness persisted
Have hives on forearms, top of right leg, couple on stomach and couple on left leg at the top. May have some in hair.  Dizzy feeling.
Fever rose to 104.9 degrees and seizure occured. Seized the entire duration of the ambulance, approximately 30 minutes. Stopped breathing on the way to the hospital, was intubated, put on life support and flown to hospital where he then had another seizure. Was stabilized and given phenobarbitol, which he has to take for 6 months.
Patient reports experiencing generalized joint pain with severe joint pain in the knees a few days after receiving immunizations. Pt. reports that the joint pain resolved within a few days of onset without treatment. Patient currently reports no joint pain and reports no other adverse symptoms.
BONE PAIN; JOINT PAIN; PAIN RADIATING TO THE FRONT AND INTO THE MUSCLES AT SITE OF INJECTION; BURNING SENSATION; STABBING FEELING 6 ON 10 PAIN SCALE; MILD ITCHING LIKE A BUG CRAWLING UNDER THE SKIN; MUSCLE TIGHTNESS OR TENSION; SHOULDER DISCOMFORT; TOP OF SHOULDER PAIN; This spontaneous report received from a patient concerned a 76 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included electrocardiogram t wave inversion, and concurrent conditions included alcohol consumer, and other pre-existing medical conditions included drug abuse. The patient experienced drug allergy when treated with levothyroxine sodium. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 23-JUN-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced shoulder discomfort. On MAY-2021, the subject experienced top of shoulder pain. On 20-MAY-2021, the subject experienced muscle tightness or tension. On 26-MAY-2021, the subject experienced burning sensation. On 26-MAY-2021, the subject experienced stabbing feeling 6 on 10 pain scale. On 26-MAY-2021, the subject experienced mild itching like a bug crawling under the skin. On 27-MAY-2021, the subject experienced bone pain. On 27-MAY-2021, the subject experienced joint pain. On 27-MAY-2021, the subject experienced pain radiating to the front and into the muscles at site of injection. On 02-JUN-2021, Laboratory data included: Blood pressure (NR: not provided) normal, Body temperature (NR: not provided) 96.6, Heart rate (NR: not provided) 72 bpm, and Weight (NR: not provided) 180. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle tightness or tension, burning sensation, stabbing feeling 6 on 10 pain scale, mild itching like a bug crawling under the skin, top of shoulder pain, shoulder discomfort, joint pain, bone pain and pain radiating to the front and into the muscles at site of injection was not reported. This report was non-serious.
On 04/25/2002, the pt had a seizure for 40 minutes requiring intubation and intensive care. Temperature elevation to 101-102 deg. F. range. The follow up received on 12/3/02 states, "mom states child developed a rash while in the PICU and was told it was roseola."
1st dose 18Sep2021, 2nd not yet; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18 September 2021).   On an unknown date, the patient did not receive 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 Information: GSK receipt date: 15-Feb-2023 Reporter's comment:  The case was reported by the physician. The physician reported that the patient received 1st dose on 18th September 2021 and has not received a second dose. Additional supportive information: Till the time of reporting the patient did not received the 2nd dose of vaccine which led to incomplete course of vaccination. Reporter did not consent to follow up.
Symptom onset was 7-13-2021. Symptoms included fever, cough, shortness of breath, congestion, diarrhea, headache, fatigue, myalgia, ear infection, UTI. Patient was hospitalized from 7-28-21 through 8-15-2021. She passed away on 8-15-2021.
Symptoms began approximately 8 hours after the injection. Injection site pain, fever, chills, vertigo, headache, joint pain, muscle aches. Now 43 hours post injection & still very sick feeling.
About 2.5 weeks after receiving the booster shot while (unknowingly) simultaneously having COVID, I has about 2 days of stuffy sinuses and experiencing intermittent severe pain when swallowing, ear, jaw and tongue hurting on right side, with a swollen gland. On 12/3  this pain became constant, I went to see an ENT doctor on 12/6 who diagnosed with sialadenitis (infected salivary gland) on my right side. I was treated with a course of metylPREDNISolone 4 mg tablets (started 12/7, finished 12/12) and Clindamycin HC 300 mg capsule, of which I took 12 of 21 doses before discontinuing per my ENT doctor's instruction because of GI upset (started evening of 12/6, last dose mid-day 12/10).  The symptoms of my sialadenitis (severe pain when swallowing, ear, jaw and tongue hurting on right side, swollen gland) are completely gone.
Pt developed a small orange size rash in left arm, lasting approximately 24 hours. Warm to the touch, hard, spotty and raised slightly. Hardness slightly present the one day post onset, however redness, warmth gone. No treatment was given.
Patient received Moderna COVID vaccine on 4/19/21 (lot # 043B21A), 5/17/21 (lot # 041C21A), and Pfizer COVID vaccine on 12/10/21 (lot # FF2589). On 1/25/22, patient admitted to our inpatient facility (med/surg unit) with acute hypoxic respiratory failure, COVID19 pneumonia,  severe pulmonary hypertension, chronic right heart failure, uncontrolled HTN, and methamphetamine abuse (urine toxicity test positive). As of today (1/27/22), patient is still admitted in the med/surg unit.
Reddened, tender, and warm area developed 12-16 hours after receiving the flu shot.
Moderna vaccine to a 17 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine to a 17 year old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 045B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine to a 17 year old). On 19-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine to a 17 year old) had resolved.        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 concomitant medication was reported No treatment medication was reported   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received on 11-May-2021, Added Patient Demographics, Suspect drug information.
Developed a cellulitis in injection arm requiring treatment at an Urgent Care Center with subsequent 10 day course of oral antibiotics.; This is a spontaneous report from a contactable nurse (patient). A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8737), via an unspecified route of administration, administered in arm left on 13Apr2021 at 14:45 (at the age of 59-years-old) as 2nd dose, single for COVID-19 immunisation. Medical history included Sjogren's syndrome, arthritis and sleep apnoea syndrome from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Batch/Lot Number: EP7534), administered in left arm on 23Mar2021 at 05:00 pm (at the age of 59-years-old) for COVID-19 immunisation. On 16Apr2021, the patient developed a cellulitis in injection arm requiring treatment at an Urgent Care Center with subsequent 10-day course of oral antibiotics. Adverse event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the event. The outcome of the event was recovered on an unspecified date.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event of Cellulitis and suspect drug BNT162B2 cannot be excluded. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
3 hrs after vaccine: starting itching at injection site. Next AM redness spread and itching continued. 2nd day redness spread farther and muscle soreness - muscle soreness is very uncomfortable.
6 Doses administered beyond the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 Doses administered beyond the expiration date) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 2000. Concomitant products included LOSARTAN from 2000 to an unknown date for an unknown indication.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 Doses administered beyond the expiration date). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (6 Doses administered beyond the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medications were reported.  Patient received the booster dose on 08-Nov-2021.  Patient stated from the three people she heard from there was no adverse event.   This case was linked to MOD-2021-381182, MOD-2021-381177 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Non-significant follow up. Information captured in I narative On 12-Nov-2021: follow-up received on 12-Nov-2021 includes information concomitant drug.
Shortness of breath and high resting heart rate (120s) staring 12/4/21. Went to ER 12/7/21 - admitted to hospital (24hr ICU stay) with DVT/PE. DVT - right popliteal. Multiple PEs in all five lobes. Given  tPA.
bruise on my abdomen; widespread chronic itching and some hives; widespread chronic itching and some hives; developed a mass in the same location; eczema; Morphea; This is a spontaneous report from a contactable nurse (patient). A 41 years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown), via an unspecified route of administration in arm right on 15Jan2021 (at the age of 41 years-old) as dose 2, single for COVID-19 immunization at hospital. The patient's medical history included HTN and Hyperlipidaemia since an unknown date. Patient had no known allergies. Concomitant medications were not reported. Historical vaccine included the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration in right arm on an 22dec2020(Batch/Lot number unknown) (at the age of 41 years-old) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 20Jan2021 12:00 AM, 2-3 days after his second vaccine the patient developed a bruise on his abdomen. He also started to develop widespread chronic itching and some hives. The bruise went away and he developed a mass in the same location. The itching was getting worse followed by eczema. After an ultrasound showed no mass. He went to see a dermatologists about the itching and eczema and asked about the mass which had now turned to a white patch. They biopsied the mass and was diagnosed with Morphea and eczema. Which he had no predispositions to any auto-immune disorder or had ever had eczema. It was concluded that he may be having a systemic reaction to the vaccine. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. On 20Jan2021, the patient underwent lab tests and procedures which included Biopsy: diagnosed with Morphea, ultrasound: no mass. The patient received multiple treatments for adverse event. The outcome of events was recovering.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.  Information regarding lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
squirted all over the patient, no AE; Leaking at the base of the needle hub to the tip of the syringe, could not turn the needle any further on the syringe, no AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age female patient who received a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot UT6686NA expiry date 30-Jun-2020 via unknown route in unknown administration site.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of exposure via skin contact and syringe issue.   It was stated the needle was on the syringe tight because when reporter checked it after she attempted the injection and it had squirted all over the patient. She checked the needle and could not turn the needle any further on the syringe. The patient stated she did not feel any of the injection go into her arm.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Adult patient received a pediatric dose of Covid19 Pfizer booster shot into L deltoid. No symptoms, signs, from patient. Patient was notified and is agreeable to coming back in 21 days to get his 3rd adult booster of Pfizer.  Infection control was contacted. Patient did not receive the full 30 micrograms of and only received 10 micrograms of the Pfizer booster.  No adverse affects occured.