chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa drugs" (unspecified if ongoing); "hypertrophic cardiomyopathy" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "reflux" (unspecified if ongoing); "hearing loss" (unspecified if ongoing); "eczema" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Never tested negative, but test line did get very faint; Positive, notes: Relapsed on Day 14 with slightly different symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Never tested negative, but test line did get very faint. Relapsed on Day 14 with slightly different symptoms. Patient received other medication within 2 weeks. Patient received Paxlovid from 08Jun2022 to12Jun2022 for treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Progressively worse symptoms since shot administered.  Severe migraines and blurred vision in Left eye beginning in October.  On February 10th, patient had deep vein thrombosis of the left arm.  Has progressively gotten worse over time with joint pain, muscle pain, fatigue, high fevers daily, lower jaw pain, chest pain, racing heart, hair loss, abnormal menstrual cycle, weight loss, appetite loss and continues will all mentioned symptoms today.
mom c/o knot in child lower rt leg (thigh);advised mom to use cool compresses three to four times a day;
I received a call this morning about what the patient thinks may be a ?possible? Pfizer bivalent reaction.  Patient received Pfizer bivalent on 11/4/22 around 245pm.  Patient reports that she started having pain and redness in her thumb joint of her hand. Patient had went to her PCP at this time to be evaluated for gout.  The patient does not have gout and had taken allopurinol as a preventive before her lab test came back with no change, as well as taking cephalexin thinking maybe it was a infection in the cuticle?that was before it started moving from one digit to another one.  The redness/soreness in her thumb went away and came back in her pinky finger. The digits are reddened in the middle part of her digits.  The soreness/redness comes and goes and reappears in different digits.  The latest was her ring finger middle digit with redness and soreness. She states she has increased her water intake and is monitoring closely.
Painful lump on top of shoulder above injection site. No treatment.A month later, no pain. Small lump remains. Was told by an orthopedic surgeon that it was the result of the shot.She called it a local soft tissue reaction.
Seizure-fever 106.7 followed by biazarre behavior-seizure activity. Rx Pediaprofen. 60 day follow up on 10/27/03: "Vaccine recipient did not recover from the adverse event.  Has chronic encelapathy, hypothalamic dysfuction, asthma, heart palpatations, headaches, ADHD, inability to concentrate severe obesity and much more.  She is on disability due to the severity of her health."
3-4 days after vaccine dose reported, patient developed a primary oral herpes outbreak to the right side of his mouth.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. On 30-JUN-2014, the patients were inadvertently vaccinated with improperly stored doses of GARDASIL (lot # not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
12 hrs. after vaccine, severe headache, nausea, vomiting. Severe Headache lasted 24 hr. Low grade headache 2 to 3 additional days. Nausea lasted 36 hrs. Vomiting, dry heaves 12 hrs. Exhaustion 36 hrs.  Additional tiredness, malaise, another 3 days.
lump at injection site; hot at injection site; Redness at injection site (3-4in diameter); Joint pain everywhere; soreness in left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump at injection site), VACCINATION SITE WARMTH (hot at injection site), PAIN IN EXTREMITY (soreness in left arm), VACCINATION SITE ERYTHEMA (Redness at injection site (3-4in diameter)) and ARTHRALGIA (Joint pain everywhere) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 030L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D NOS and METHOTREXATE for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness in left arm) and ARTHRALGIA (Joint pain everywhere). On 02-Feb-2021, the patient experienced VACCINATION SITE MASS (lump at injection site), VACCINATION SITE WARMTH (hot at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site (3-4in diameter)). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 05-Feb-2021, VACCINATION SITE MASS (lump at injection site), VACCINATION SITE WARMTH (hot at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site (3-4in diameter)) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness in left arm) and ARTHRALGIA (Joint pain everywhere) had not resolved.
She came down with a high fever in the evening of 01/05/2014. Her fever stayed upwards of 102 plus until Weds, January 8th. At this point her fever finally broke but she has remained pale and fatigued since then. She has been trying to resume normal activities but is lethargic.
Information has been received from a Nurse Practitioner (N.P.) concerning a 69 year old female with no Drug reactions/allergies and no pertinent medical history who on 21-SEP-2010 was vaccinated with PNEUMOVAX 23 (Lot#665924/0930Z; Exp: 17-JUL-2011). On 22-SEP-2010 the patient developed cellulitis. It improved after treatment with prednisone. The patient called office to seek medical attention. Cellulitis was considered to be an other important medical event and life-threatening by the reporter. A priority lot check investigation has been finalized. All in-process quality checks for the lot number in question (lot # 665924/0903Z) were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the and was released. Follow-up information has been received from a physician concerning the patient (female, weight reported as 151 without unit specified). The patient received PNEUMOVAX 23 in her left deltoid on 21-SEP-2010. On 22-SEP-2010 the patient developed right arm erythema, edema, and "pain outside of typical site reaction". The patient recovered from the events on 25-SEP-2010. The physician considered the events as other important medical events. No further information is available.
Patient received vaccine 10/27/23 by MA in left deltoid area became red, bruised and bumps on left deltoid. Patient has tried triamciolone cream and hydrocortisone cream to area and has not helped. Patient is diabetic. On 11/14/23 patient came into office  and area still had bumps on left deltoid saw arnp at this time. Silvadene cream given to patient to apply to area per arnp. Informed if got worse to call clinic and voiced understanding.
patient was inadvertently administered the Arexvy Adjuvant component only without the Lyophilized component; patient was inadvertently administered the Arexvy Adjuvant component only without the Lyophilized component; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: patient was inadvertently administered the Arexvy Adjuvant component only without the Lyophilized component) and inappropriate dose of vaccine administered (Verbatim: patient was inadvertently administered the Arexvy Adjuvant component only without the Lyophilized component).The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-OCT-2023 The reporter inquired what to do and asked if the patient should be revaccinated. The reporter reported that a patient was inadvertently administered the Arexvy Adjuvant component only without the Lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter was unable to provide any vaccine or patient details. The reporter did not consent to follow-up.
She started with chills next day after receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (She started with chills next day after receiving 2nd dose) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Sinus disorder and Diabetes.   On 02-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced CHILLS (She started with chills next day after receiving 2nd dose). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, CHILLS (She started with chills next day after receiving 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included BP medicine, Sinus medicine, Diabetes medicine.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable      Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up information was received on 30 Jun 2021 wherein event outcome of the event Chills was updated from unknown to resolved
Rashes on the left arm (receiving arm), starting from inside area of the elbow, second day spread to lower and upper areas of the same arm.  In addition, rashes were seen on shoulder and other areas. Pain in the injection site and near by areas
Pfizer COVID-19 vaccine reconstituted with sterile water instead of normal saline. Patient given a dose of diluted suspension. Error caught. No adverse effects noted. Vaccine remade with normal saline and patient given dose of correctly reconstituted suspension.
Fever up to 102. Chills; Chills; Muscle aches; Joint pain; Mssive headache; Nausea; Weakness; Injection site soreness; This is a spontaneous report from a contactable consumer (Patient). A 42-years-old non-pregnant female patient received second dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EN6201), via an unspecified route of administration, administered in Arm Left on 19Feb2021 12:30 (at the age of 42-years-old) as dose 2, single for COVID-19 immunization. Medical history included allergies to sulpha drug from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included sertraline, diltiazem taken for an unspecified indication, start and stop date were not reported and colecalciferol (D3) for supplementation therapy, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: EL9264) in left arm on Jan2021 at 10:30 (at the age of 42 years old) for covid-19 immunisation. No other medical history was reported. On 19Feb2021 at 23:00 the patient experienced fever up to 102. Chills, muscle aches joint pain, massive headache, nausea, weakness, and injection site soreness. On 19Feb2021 the patient underwent lab tests and procedures which included body temperature as 102. The patient did not receive any treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Expired Twinrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 68-year-old female patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 27th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 27-Jan-2023 Reporter's comment: The pharmacist stated a dose of Twinrix was dispensed to an assisted living facility where it was administered to a patient on the day of reporting.  The reporter was unsure which dose number in the series this was for the patient.   At the time of reporting, dose has not been repeated. The reporter gave permission for the follow-up. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Big round red rash, very hot and very painful. Large hard tissue underneath. Extremely itchy.  Woke up with it, has been getting steadily worse throughout the day, pain has begun to creep up to neck, and down forearm. Rash size has been contained for last several hours, but pain level increasing. Have not taken medication, so as not to dull any worsening in case seeking urgent care makes sense.  Have researched online and understand this is a rare side effect and should clear up, and no known cause. Adding to the database so you have my history in case you can find a link in cases / cause for it. It hurts and is pretty debilitating!   On receiving initial shot, did not feel anything - not like getting a normal flu shot, where you do feel it and it is sore. If I had not watched her do it, I would question whether she gave me the shot. Started feeling tired and a little under the weather that evening. Woke up the next day with regular flu shot ache in arm, and did not feel like I was at 100% - felt the way people describe feeling after the 2nd shot. Felt better the following day, arm ache never quite went away but never felt more than just a flu shot ache so thought nothing of it until this morning - woke up and knew it was completely different.
Missed menstrual cycle multiple consecutive months, high prolactin levels, MRI done which revealed an abnormal spot on her brain near the pituitary gland
Patient with injection site tenderness, fatigue, arthralgias, neck stiffness, muscle cramping.  Supportive care.
Patient was given Moderna bivalent booster past the beyond use date of 11/11/2022. Vaccine was administered on 11/14/2022. No signs or symptoms of adverse reactions
Excruciating pain when I make sudden moves in my arm of injection. Very very painful. I have to stop what i am doing just to get through the pain.
inconsolable crying off and on for 16 hours post-vaccination-resolved without sequelae
Received Anthrax #1 6/23/03. Developed pruritic rash from shoulder to hand of vaccinated arm within 10 hours of vaccination.  No treatment sought.  Received Anthrax #2 8/7/03.  Was pretreated with oral Benadryl and oral steroid.  Developed same reaction within 24 hours of vaccination.  No treatment sought.
Extreme pain in the left armpit area where lymph nodes are located; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 30Mar2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation and also the patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Apr2021 at 13:45 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received ibuprofen (MANUFACTURER UNKNOWN) and experienced drug allergy. On an unknown date in 2021, the patient experienced extreme pain in the left armpit area where lymph nodes are located. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event extreme pain in the left armpit area where lymph nodes are located was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The Second shot the next day my lymph nodes swole up as big a baseballs under my arms, hot flashes, uncontrollable shakes on lefts side. But now I am shaking on both sides, short of breath, and headache
Pt reviewed VIS form and said she was ok to have MMR vaccine. Patient on Humera (a biological immunosuppressant), last dose 7/31/2019. Patient provided MMR immunization through Employee Health on 8/1/2019. The patient had a reaction to the vaccine with rash, fever, sore throat, headache and shortness of breath. Patient was seen at Urgent Care later on 8/1/2019 as well as the ED on 8/2/2019 and 8/5/2019. Twice she was diagnosed with potential vaccine mediated measles.
~4 hours after receiving the vaccination, my arm was in extreme pain. It was far worse than anything I had experienced from previous vaccines  with known side effects of ?sore arm/punch in the arm discomfort?  That intensity lasted 2 days before it became milder form of sore arm.   The day before the rash appeared (08FEB2021) was 6 days post injection. I was experiencing pain and discomfort in my forearm that gradually followed to the injection site. Shortly after the discomfort feelings reached my injection site I experienced intense itching. The following morning, I woke up to a large rash with a mass forming underneath with heat coming off of the area. The redness of the rash got deeper in color as did the size and the mass underneath and presence of heat. This lasted for  lasted for 5 days and then by the 5th day the rash began to fade slowly and was gone by day 9  of it appearing (18FEB2021)
was administered an expired dose ofVARIV AX; no adverse effect; This spontaneous report was received from a medical assistant and refers to a 6 year old patient of unknown gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.      On 19-AUG-2019, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis, lot # N021719 and expiration date 10-AUG-2019 (dose, strength, route of administration and frequency were not reported).  The patient experienced no adverse effects.
This spontaneous report as received form a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 14-JUN-2016, the patient was vaccinated with an improperly store dose of (Oka-Merck) PROQUAD lot # M001152 (exact dose, expiration date, therapy type and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was only 15 years old and vaccine is only approved for 16 years and up at this time.
Vaccine given through outside source - Patient reported J96.00 ACUTE RESPIRATORY FAILURE 8/28/2021 ACOUSTIC NEUROMA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 7/6/2021 ACOUSTIC NEUROMA
Pins and Needles; This is a spontaneous report from a contactable consumer, the patient. A 48-years-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration in the left arm on 25Mar2021 (at the age of 48 years), as a single dose for COVID-19 immunisation. Medical history included Multiple Sclerosis, hypertension, Hypothyroid. The patient was allergic to Macrobid. Medications received within two weeks of vaccination include Synthroid (MANUFACTURER UNKNOWN), Sertraline (MANUFACTURER UNKNOWN), Copaxone (MANUFACTURER UNKNOWN), Simvastatin (MANUFACTURER UNKNOWN) since an unknown date for unknown indications. The patient not received 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 had not been tested for COVID-19. On 25Mar2021, 12 hours after the first dose, the patient experienced pins and needles sensation in random various spots all over the body. The patient had not received any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event pins and needles sensation was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a physician refers to a 30 years patient. On an unknown date, the physician had prescribed GARDASIL (dose, route, and lot# unknown) to the 30 year old patient and no adverse effects reported. No other co-suspects were reported. No concomitant medications were reported. It was unknown if the patient had sought medical attention. The outcome and action taken were unknown. The reporter did not provide assessment of the relationship of the adverse event to the suspect therapy. Additional information has been requested.
Pt received Shingrix #2 on 11/8/19 @ 4:00 pm on 11/09/19 pt started running a fever of 101.9 degrees Pt also developed a red, tender, itchy, spotchy rash on her upper left forearm Fever diminished on 11/10/19 Rash still visible on 11/12/19