chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 84-year-old patient received BNT162b2 (BNT162B2), on 28Oct2021 as dose 3 (booster), single (Lot number: 320308D) for covid-19 immunisation. The patient's relevant medical history included: "canker sores in my mouth and on my tongue " (unspecified if ongoing), notes: I have had canker sores in my mouth and on my tongue on a constant basis. This began as young as 4 years old. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, Lot: EL1283), administration date: 01Feb2021, for COVID-19 immunization, reaction(s): "a potential solution to the treatment of Canker Sores"; BNT162b2 (Dose: 2, Lot: EN6210), administration date: 22Feb2021, for COVID-19 immunization, reaction(s): "a potential solution to the treatment of Canker Sores". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "a potential solution to the treatment of Canker Sores". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Almost all my life I have had Canker Sores in my mouth and on my tongue on a constant basis. This began as young as 4 years old. Through my childhood I was examined and treated by several Dentist. There were times the Dentist told me and my Parents that I had as many as 21 Canker Sores with some of them as large as a Dime. They could never eliminate them. Through my adult life this continued and caused me extreme discomfort. I always have had at least 4 to 5 Canker Sores in my mouth. I was born and raised in (withheld) and over the years have lived in (addresses withheld). Since the Vaccinations I have only had 3 Canker Sores and all 3 occurred where I bit my cheek or tongue while eating. I thought you might be interested in this as a potential solution to the treatment of Canker Sores. Follow-up attempts are completed. No further information is expected.
Took the shots and still got shingles/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Took the shots and still got shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The patient was treated with aloe vera. The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-MAR-2023 This case was reported by a patient friend via interactive digital media. The reporter reported that his or her friend received Shingles vaccine and still experienced shingles. The patient received aloe vera gel as a treatment which was helping 100 percentage. The reporter also experienced shingles on front and back oh his or her leg and it was for about 3 weeks the front side shingles are healed but back side shingles had not. The reporter stated that if you experienced shingles did not scratch it, it leaves horrible scarring. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Shortness of breath, chest pain and dizzyness when exercising. Went to Hospital ER on March 25th.  "Acute Lesion" 90% occlusion of LAD Coronary artery. Lesion in LAD Coronary artery requiring placement of Stent (3.0 x 16 mm Synergy) placed in mid LAD.
10MAY95 fever 102; fine red rash-face, arms, neck; swollen eyelids;
Vaccinator noticed that needle seemed to retract into syringe during injection and clear liquid noted on skin, so dose of injected vaccine not known.  0.3 cc administered in opposite arm.
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-JAN-2015, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided), for its intended purpose the prevention of shingles. As a direct result of ZOSTAVAX, on 18-NOV-2015 the patient experienced a shingles outbreak in addition to chronic pain, rash, and lesions to various parts of his body. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX the patient sustained severe and permanent personal injuries. As a direct and proximate consequence, the patient has sustained serious personal injuries and related losses, including but not limited to, mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, medical and related expenses, and other losses and damages. Shingles outbreak and chronic pain were considered disabling. Additional information has been requested.
Patient reports that she was sleeping and was awoken with a very intense sharp pain in the left arm. She is unable to lift or flex the arm and there is slight swelling around the deltoid muscle. No redness has been noted.
EXTRA DOSE ADMINISTERED; NO ADVERSE EVENT; This case was retrieved during the ICSR monitoring on Vaccine Adverse Event Reporting System (VAERS) on 11-Apr-2022 with the following reference number: 2028440-1. The original narrative from the sender is:  No adverse reaction, gave two doses of Hep B at time of vaccine.
Extreme fussiness, inconsolability, and brief vomiting. Onset 5 hours after dose of vaccine. Treated with FEVERALL.
Pt described a raised, reddened large circular area that appeared a few hours after both shots were administered.  She stated that the redness was above and below where the injection site was but did not seem to affect the immediate injection site.  She said the arm became firm to the touch and very sore.  She had a nurse friend observe it who recommended ice, advil and benadryl.  She took all and the redness became increasingly better over the course of the next few days.  As of today it is nearly resolved (3 days later) although still slightly red.  Patient did have Hodkins Lymphoma over 15 years ago and per the patient she has had 2 previous Pneumovax vaccines in her liftetime.  She thinks the first was in 2005 and is unsure when her last one was.  I cannot find any record in the State immunization registry of any previous pneumonia vaccines.
Breakthrough Covid-19 infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 19Nov2021 (Lot number: FD0809) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: No. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Route of Administration: Intramuscular), administration date: 10Apr2021, when the patient was 27 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Route of Administration: Intramuscular), administration date: 20Mar2021, when the patient was 27 years old, for Covid-19 immunization. The following information was reported: immunization, vaccination failure, pain, fatigue, headache, cough, nasal congestion and rhinorrhea all not recovered with onset 19Dec2021. Therapeutic measures were taken as a result of immunisation, covid-19, vaccination failure, pain, fatigue, headache, cough, nasal congestion, rhinorrhoea.   Additional information: Patient was treated with Dayquil every 4 hours. Patient was not Covid prior vaccination.  Investigational results of RA: The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EP6955, fill lot EP6954, and the formulated drug product lot EP6953. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Patient is presenting a cellulitis in the left arm. The arm is red, hot and  has a type of encapsulation (hard part). The same day she received the vaccine presented fever and pain in the arm. She used acetaminophen and started tacking Augmentin 875 mg every 12 hours.
Patient with history of COVID-19 vaccination admitted to hospital with COVID-19 detected test. Per provider discharge note, "Hospital Course: Patient was admitted for toxic metabolic encephalopathy suspected secondary to polypharmacy and acute hypoxic respiratory insufficiency secondary to COVID Infection. He also presented with bradycardia, for which beta blocker was placed on hold. He complained of urinary retention, likely secondary to anticholinergic syndrome, possibly secondary to patient's home atarax. Patient was weaned off oxygen. His mental status returned to baseline. He was medically optimized and stable for discharge home with appropriate follow up. "
Patient appeared to be fainting, eyes rolled partially upwards, both hands were trembling for less than 10 seconds, and slumped in the chair. Wife noted dilated pupils and suggested it was a seizure(?); patient has had episodes of "syncope" before in the 1980s. Patient was guided to lie down on the ground and lift his legs up on the chair. He appeared fully conscious and aware of himself and surroundings-- no difficulty breathing or swallowing.
After waiting , the patient left and while walking out, he felt weak and his legs have out on him and he fell.  He reported that he had a history of his legs giving out on him so he wasn?t sure if it had anything to do with the vaccine.
Woke up at 8 am with soreness of his leg where the vaccine was given but was able to eat breakfast. He began becoming lethargic and sleepy at 10 am. By 11 am, he was pale, cold and couldn't stand on his own. At around 12 pm, he vomited his breakfast and continued vomiting. From 12pm - 6pm, he was unable to hold down any food or liquids and was lethargic and drowsy. He was given sips of apple juice during this time but continued vomiting it. He was then given lollipops to suck on. Around 6pm, he stopped vomiting and was less lethargic and drowsy.
Information has been received from a registered nurse concerning a 70 year old female patient who on 10/02/01 was vaccinated with one dose of pneumococcal vaccine 23 polyvalent (lot # 637094/0945K). The patient called the physician's office 2-3 days post-vaccination because her arm was sore. It was noted that her whole arm hurt. The patient was instructed to use ibuprofen. The patient called the physician's office because the arm pain continued. It was recommended that she use ice packs and ibuprofen. It was also reported that the patient developed an unduly injection site reaction described as very severe redness, swelling and hard lumps around the injection site. It was noted that this reaction persisted for several weeks. It was also reported that the lumps took several weeks to resolve. The patient never needed to go into the office for a visit and has since recovered. The nurse and a physician reported feeling strongly that the vial was contaminated. There were no cracks in the vial, the flip off cap was intact upon first use and the liquid remaining in the vial was clear. The office reported only using these three doses from this 5 dose vial. The reporter noted that they sent a sample for testing. The patient sought unspecified medical attention. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. it was also reported that two other patients were vaccinated with one dose of pneumococcal vaccine 23 polyvalent from the same lot (lot # 637094/0945K) and experienced similar events (WAES01104576 and WAES01113399). No further information is available.
Pt states she noticed nickel size knot at inj site around 6 days post inj. Has not D'd in site-tender to touch.
Fever chills Narrative:  employee states: first vaccine: 12/22/2020 at 10am he only  experienced slight pain at the injection site (left shoulder) for about 48-72 hours second vaccine: approx. 13 hours after injection he began to experience chills and a slight fever. The next morning still felt a slight fever. took 600mg of Motrin  about an hour later felt fine. Interestingly did not experience any pain at the  injection site with the second injection, even though administered in the same  location
1/15/21: Via fax, client stated on 01/14/2021 @ 12:30 PM she noticed tingling/burning with red raised rash at injection site and surrounding area.  Client stated her skin feels tight and is hot to touch.  Per client she put a cold compress on the area which seemed to help ease the burning sensation.  01/19/21 @4:41 spoke with client who stated the redness has spread and is warm to touch to entire left upper arm.  Client agreed to seek medical attention for left upper arm. RN
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; 190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown 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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    Concomitant products were not provided. Unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment medication were not reported. This case was for the 118th patient out of 190 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER CASE
Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. In 2015 the patient was inoculated with ZOSTAVAX vaccine at a pharmacy for routine adult health maintenance and the prevention of shingles.  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2015 the patient was treated at a hospital onset of a vesicular outbreak, which was diagnosed as herpes zoster or shingles As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
Mild Sore Arm after first primary dose/ Little More Sore Arm than Flu Shot after first primary shot; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Mild Sore Arm after first primary dose/ Little More Sore Arm than Flu Shot after first primary shot) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2020, the patient experienced PAIN IN EXTREMITY (Mild Sore Arm after first primary dose/ Little More Sore Arm than Flu Shot after first primary shot). At the time of the report, PAIN IN EXTREMITY (Mild Sore Arm after first primary dose/ Little More Sore Arm than Flu Shot after first primary shot) 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.   The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-655011 (E2B Linked Report). This case was linked to MOD-2022-654972, MOD-2022-654973 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-655011:other patient case
Injection site reaction  (swollen lymph node, tender/painful arm).  Received a toradol injection for the pain from her prescriber.
Patient stated she got a rash. She did seek medical attention and the thought was chicken pox. She is following up with other Drs. to get more information and for treatment.
Sore arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A, 025C21A and 037A21B) for COVID-19 vaccination. No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced VACCINATION SITE PAIN (Sore arm.). On 17-Nov-2021, VACCINATION SITE PAIN (Sore arm.) had resolved.            Concomitant medications include birth control pills. Treatment details were not reported.
Headache, CoughWheeze, NauseaVomiting, Fatigue, chills
Pain behind right ear and into the jawline (24 hours after), numb tongue on right side (36 hours after), facial paralysis of the right side of face (48 hours after), bruise-like feeling on right side of face (1 week after). Diagnosed with Bell?s Palsy 48 hours after.
flu-ish; feverish; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-ish) and PYREXIA (feverish) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. In February 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-ish) and PYREXIA (feverish). At the time of the report, INFLUENZA LIKE ILLNESS (flu-ish) and PYREXIA (feverish) outcome was unknown.            No concomitant medication and treatment information was provided.  Action taken with  mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) was not applicable.
Experience cough; chills; low grade temp; body aches; joint pain; This is a spontaneous report from a contactable Nurse, the patient. A 66-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265), via an unspecified route of administration, administered on left arm on 24Feb2021 (at the age of 66-years-old) at single dose for covid-19 immunization at Hospital. Medical history included hypertension, arthritis. The patient had no allergies. 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 in two weeks included amlodipine besilate (NORVASC); aspirin [acetylsalicylic acid]; calcium; vitamin d3. The patient had no other vaccine within four weeks. On 03Mar2021, the patient experienced cough, chills, low grade temp, body aches and joint pain. Therapeutic measures were taken and treatment included with tylenol 2 - 500mg tabs every 6 hrs. The relevant lab tests included body temperature, result: low grade temp on an unspecified date. The Outcome of the event was resolving.  No follow-up attempts are possible. No further information is expected.
Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was provided.  Concurrent medical conditions included Immunocompromised. Concomitant products included GOLIMUMAB (SIMPONI) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was using a biological medication at the time when she was getting the third dose of vaccination. Treatment information was not provided.   This case was linked to MOD-2021-303370, MOD-2021-301320 (Patient Link).