chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 12-DEC-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # N016089, expiration date 22-NOV-2019 (also reported as 22-NOV-2018), therapy type RHA for prophylaxis. No adverse effects were reported. The PROQUAD underwent a temperature excursion of -14 to -10 degrees Celsius for 96 minutes. There was no previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA002684: US-009507513-1801USA002686: US-009507513-1801USA002315:
Client came in for 2nd COVID vaccine of Moderna. Client had a medical consult in the previous week and was told to come back at a later time. Client medical consult resulted in an approval for 2nd COVID vaccine of Moderna. Client received 2nd COVID vaccine of Moderna (Lot# 026C21A, expiration 07/11/21) at 1319. Client completed 20 minutes in the observation waiting area when reported to EMT, EMT, and EMT about itchiness on the left clavicle area and right forearm at 1338. PHN and PHN responded to this event at 1339. At 1339, vital signs are blood pressure 132/82, heart rate 113, oxygen saturation 99%. Client reports no medical history, no medication, and no known allergies. PHN assessed left clavicle and right forearm. Skin is warm to touch and is red. Client is scratching arm and left clavicle. PHN offered Client Benadryl 50mg by mouth and explained that the client will become tired and fatigued if taken. Client denied Benadryl 50mg by mouth. Client reason for denying Benadryl is because client is taking the bus home. Client  denies shortness of breath, lightheaded, chest pain, dizziness, and vomiting. Client was offered water and gold fish snacks. Client accepted water and denied the snacks. Client continues to scratch and almost breaks skin PHN offers Benadryl to client, and Client denies. PHN offered to call emergency services for further evaluation and client accepted. At 1350, emergency services was called and arrived at 1353. At 1353, vital signs are blood pressure 132/88, heart rate 107, oxygen saturation 97%. Emergency services evaluated Client and offered their services. Client denied services and left against medical advise from emergency services at 1359. Emergency services left facility at 1400. PHN gave Client education about common adverse effects of COVID vaccine and ED precautions. In addition, Client was given Scripps urgent care information. Client reports no new symptoms, but continues to feel itchy in the right forearm. PHN and PHN advised Client to follow up with primary care provider. At 1425, vital signs are blood pressure 138/86, heart rate 103, oxygen saturation 98%. Client reports itchiness has spread to left forearm, left clavicle, and both knees. PHN offered Benadryl and emergency services again for further evaluation, and Client denied. At 1427, Client stood up with no complaints and left facility with a steady gait.
Off-Label use; Interchange of vaccine products; Booster; a 40 year old female patient who got a booster dose of Comirnaty 30 days ago, and is now positive for Covid; a 40 year old female patient who got a booster dose of Comirnaty 30 days ago, and is now positive for Covid; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A 40-year-old female patient received BNT162b2 (COMIRNATY), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Jan2022 as dose 1, single (Batch/Lot number: unknown), on 15Feb2022 as dose 2, single (Batch/Lot number: unknown) and on 03Jun2022 as dose 3 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Aug2022, outcome "not recovered" and all described as "a 40 year old female patient who got a booster dose of Comirnaty 30 days ago, and is now positive for Covid"; OFF LABEL USE (medically significant), outcome "not recovered", described as "Off-Label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "not recovered"; IMMUNISATION (medically significant), outcome "not recovered", described as "Booster". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Aug2022) Positive, notes: She tested positive for Covid today. Clinical course: The reporter stated that patient who got a booster dose of Comirnaty 30 days ago, and now positive for Covid. They were wondering if she can take Paxlovid that close to the booster dose. The reporter was originally asking about the interval from getting the booster dose and taking Paxlovid, was asking if it is ok to take or too soon.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product cannot be fully excluded.
Fever 102.6, sleepy, lethargic, not responding to Tylenol. On Augmentin. Inspected ear/throat.
3 days, post vax, pt had knot on left leg and developed a circumferential redness, measuring 2 1/2" X 2 1/4". Treat with Motrin and Benadryl or Zyrtec.
Insomnia, Stomach craps, head ache, fog brain, achy body, weird taste in my mouth following injection
Erroneously gave patient a Pfizer-Covid 19 dose that exceeded the recommended 6 hour time frame of being in a syringe once the source vial was diluted. Patient experienced no symptoms after receiving dose.
congestion; headache; running nose; This is a spontaneous report from a contactable Nurse reporting for herself. A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1686) via an unspecified route of administration on left arm, on 06Jan2021, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were reported as none. On 10Jan2021, the patient experienced congestion, running nose and headache. The headache comes and goes. Outcome of the events congestion and headache was recovering at the time of the report while it was unknown for running nose.
Intense headache, large swollen lymph node in left arm, smaller swollen lymph node in right arm
Initial unsolicited report received consumer via other company on 23-Jan-2017. Manufacture control number: 16K-163-18015522-00. This case involves a 54-year-old male patient who was vaccinated with a dose of QUADRACEL and received 40 milligram dose of HUMIRA (form: solution for injection in prefilled pen) subcutaneously (Batch number, expiry date and site of administration was not reported) on an unspecified date in 2016. Patient's medical history included, in summer 2010 patient had cellulitis. In 2015 patient had double hernia for which he had laparoscopic surgery. Discovered bowel was twisted but it untwisted itself in summer of 2015. In summer of 2015 patient had cellulitis in legs and volvulus of bowel. On an unspecified date in 2015, double hernia, cellulitis in legs and bowel was twisted and cellulitis was resolved. Concomitant medication was not reported. On an unspecified date in 2016, following vaccination patient got infection in both feet which went septic and hospitalized in late November 2016 and cellulitis septic it was healing on right foot other foot might have to have a small part of the left foot cut off; it was a size of a half dollar, it was a callus with infection and lost nearly 100 pounds with this down to 199 pounds and lost most of muscle tone in calfs and arms. Patient was diagnosed as cellulitis. On 13 Dec 2016 patient would see his dermatologist. Lab test includes Glycohemoglobin, results not reported. On an unspecified date, patient received antibiotics intravenously, Betamethasone Dipropionate and clotrimazole as a corrective treatment. Patient was recovering from foot callus, infection in feet, cellulitis, sepsis and muscle tone in calfs and arms and outcome of other event was unknown. Case was reported as serious by reporter. List of documents held by sender: none. Sender's Comments: A 54 years old male had history of Double hernia, cellulitis in leg, and bowel was twisted, who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE and experienced Hyperkeratosis, Infection in both feet/cellulitis, Sepsis, Weight decreased and Hypotonia. Hypotonia is listed with DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE however Hyperkeratosis, Infection in both feet/cellulitis, Sepsis, Weight decreased are not listed with DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE. Time to onset is unknown. Details regarding relevant medical history, concurrent condition, concomitant medication, vaccination history and its tolerance are needed to complete assessment of the case.
Patient claimed the pharmacist gave the injection on her left arm very close to her shoulder joint. Patient believes pharmacist had hit a ligament, since patient experienced an intense pain in her left should for two weeks, causing sleepless nights and a lot of unnecessary suffering.
My eye seemed blurry. A black film over the eyes and I had a foggy vision.
Fever, peaking around 102F, for around 24-36 hours (tapering off over final 12 hours or so). Headache, body aches, chills, sweating.
Patient got an ocular migraine almost immediately after the injection.  Her mother had to come pick her from work up due to vision being distorted.
Itchy Rash on both legs covered from ankles to waist, patches on arms, back, stomach and chest.  Extreme exhaustion lightheaded and could not stand, high fever, chills and extreme headache.
Pain at injection site, nausea, increased thirst, joint pain, muscle pain, fever, headache. Ibuprofen and fluids.
She has an abscess on her finger; This is a spontaneous report from a contactable consumer reported (for wife). A female patient of a 61 (unit: unknown) age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 01Mar2021 as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. Patient received unspecified concomitant therapy. She had the first dose of Pfizer COVID vaccine on 01Mar2021. She has an abscess on her finger on an unspecified date in 2021. NP gave her antibiotic-cephalexin 500mg. She wanted to confirm that taking the antibiotic would it affect the efficacy of the vaccine. She stated that abscess has nothing to do with the vaccine. The patient receive treatment for the event with antibiotic-cephalexin 500mg. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Soreness at vaccination site, redness at site, stomach upset, muscle soreness, weakness - still having on 2nd day after vaccine.
Pt admit 1/27/22 w/ acute on chronic CHF (COVID negative at that time); on 1/30/22 pt had positive COVID test, with increased O2 needs; Pt received 2 doses of Moderna (no booster) 4/13/21 & 5/12/21)
Six hours after receiving the vaccine, I developed severe full body tremors and facial twitching including eyes, rapid and irregular heartbeat, high blood pressure, fatigue, headache, weakness in my legs due to shaking from tremors. I called the HCF and they said only go to hospital if I swell up. It should all go away. I contacted my doctor the next day as everything continued. He said to give it a couple of days to pass. When I went to my doctors office two days later and he saw my condition he said I needed to see a neurologist for possible Parkinson?s disease or Lyme disease. The two neurologists I saw said they were both seeing many patients with this reaction to the vaccine.  I had an MRI of the brain to rule out Parkinsons disease. I was put on 60 mgs of Propanolol to help control the tremors but it didn?t completely work so dose was raised to 120 mgs. I saw the cardiologist who did an echo stress test on 08/16/2021 as the symptoms persisted, both tremors and heart. On May 11 2021 I wore a 30 day heart monitor which diagnosed an arrythmia. My blood pressure continues to be high. I had a nuclear medicine myocardial stress test on 09/08/2021 which was normal. I am currently on 40 mgs of propranolol to control the tremors. I have tremors nearly every day. I contacted Moderna on 03/03/2021. My case numbers are MOD21-043326 and subsequently contacted them with case numbers MOD21-121787, MOD21-121807. They have never called me back. I have been told by 3 doctors not to get another covid vaccine.
Dizzy, lightheaded, fever, shakes, soreness in injection sights and aches in my lower body
Case number PHEH2012US024671 is an initial spontaneous report received from a nurse on 10 Dec 2012: This case refers to an 11-years-old male patient. He was vaccinated with MENVEO (batch number: M12009 and expiry date: Feb 2014), at dose of 0.5 ml intramuscularly on 27 Nov 2012. The MENVEO had experienced multiple temperature excursions. On 15 Nov 2012, the temperature reading of 34 F for unknown time, on 19 Nov 2012 and 26 Nov 2012, the temperature reading of 32 F for unknown time and reporter stated that, at 09:00am the temperature reading was 36 F respectively. Reporter stated that, she does not know if the vaccine was frozen at any time. No adverse reaction reported following this administration error (incorrect storage of drug).
Localized reaction 2.5 in in diameter with some swelling at injection site day after shot was given patient advised to take BENADRYL and use cold compress. Contact office if any symptoms worsen or more develop.
This case was reported by a healthcare professional and described the occurrence of injection site soreness in an adult male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2008, about one week prior to this report, the subject received a dose of FLULAVAL at 0.5 ml in the left arm. One day following vaccination with FLULAVAL, the subject experienced injection site soreness. The subject was instructed to put cold packs on the affected area. The event resolved. The reporter felt that the event was probably related to treatment with FLULAVAL.
Diagnosed Frozen shoulder, right arm initially with surgery in April and extensive PT, advanced to left shoulder in May of 2021, maintain chronic pain and unknown future of left shoulder at this time. No problems with or symptoms to either shoulder prior to vaccine
broke out in hives; patient had a reaction to it after receiving the vaccine a few years ago; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (dose, route of administration, lot number and expiration date were not reported) for prophylaxis.         On an unknown date, the patient broke out in hives (urticaria) and had a reaction (vaccination complication).      The outcome of urticaria and vaccination complication was unknown. The causal relationship between the vaccine and urticaria was not reported, while the causality with vaccine complication was related.
Pt received 3rd dose of HPV vaccine. Pt fainted and had tonic/clonic seizures for about 5-10 seconds, and then she recovered.
Severe itching all over the body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Severe itching all over the body) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PRURITUS (Severe itching all over the body). At the time of the report, PRURITUS (Severe itching all over the body) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included diphenhydramine.
Pfizer BioNTech COVID-19 Vaccine EUA  Received vaccine 11/3 at 2:30 pm. On 11/4, around 1;30 am, I woke up out of my sleep due to severe chills, fever,  aches, and a headache. Little improvement of fever with both Tylenol and Motrin. T-max was 103.6 on 11/4 at 2:00 pm.  As of 11/5 (4:00 pm, time of writing this note), fever improving and chills stopped at 11:00 am. Still feeling achey/tired and lightheaded at times.   Had to miss work today at the hospital due to fevers.
Lump at the injection site the size of a plum and pain in the area.  Slowly subsided, but took 1 week to no longer have a visible lump or pain and soreness.
No adverse event; Received Bivalent booster from a vial with Red Cap instead of blue cap; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received Bivalent booster from a vial with Red Cap instead of blue cap) and NO ADVERSE EVENT (No adverse event) in a 54-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Sep-2022, 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 15-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received Bivalent booster from a vial with Red Cap instead of blue cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received Bivalent booster from a vial with Red Cap instead of blue cap) and NO ADVERSE EVENT (No adverse event) outcome was unknown. No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Sep-2022: Significant Live Follow up received contains patient age and lot number updated.
Nausea, dizziness, throbbing headache. Bedridden the whole day following the vaccination.
Patient brought to the ED by EMS on 11/14 for urinary symptoms (urinary incontinence, frequency, urgency) and flu-like symptoms (chills, subjective fever, sore throat, rhinorrhea, cough, and shortness of breath). Patient's family also notes patient has been more confused. He required 4L O2 and is on RA at baseline. He was tested for COVID-19 by PCR and was positive. Ultimately patient was admitted 11/14/22 - 11/17/22 for UTI, acute hypoxic respiratory failure, COVID-19, among other problems. He initially required supplemental O2, however was able to be weaned off. Patient has received the COVID primary vaccine series and one booster.
got the vacinne, got shingles really bad/suspected vaccination failure; got shingles really bad; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 1-Mar-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the vaccine and got shingles really bad. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This spontaneous report as received from a nurse practitioner, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 21-JAN-2015, unspecified number of patients were vaccinated with improperly stored PNEUMOVAX 23 injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse experience had been reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Blurry vision. Unable to stand. Extreme sweating. Able to have similar blood pressure standing and sitting by ~ 12:30. Felt off the day and a half.
1 week after shots had hives. Took Benadryl and Prednisone. Starts with small bumps, get larger than blister some 30 X 40 mm. In various stages on body. Diagnosed as: Linear IgG Bulbous Disease since January has been taking: Hydroxyzine 50 mg Dapson 50 mg daily  Doxycycline 100 mg twice a day, Naspan 500 mg twice a day, Ranitidine 150 mg daily, Prednisone. 7/7/06 Received medical records from primary dermatologist which reveal patient experienced linear IgA dermatitis (confirmed by multiple biopsies) beginning 1 week after her 1st Hep B vax & continues to have frequent flares/recurrences w/occasional infections from scalp, face incl eyes & mouth, trunk, arms, buttocks, legs & occasionally eyes.  Continues on Prednisone w/intermittent flare ups.  7/13/06 Received medical records from dermatology clinic which reveal patient see 3/05 & concurred with dx of linear IgA dermatitis.  Meds adjusted & some changed.
Gave vaccine to 17 year old; A spontaneous report was received from a nurse concerning a 17-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and resulting in the event, gave vaccine to a 17-year-old/inappropriate age of dose of administration.  The patient's medical history was not provided. Concomitant medications were not reported.  On 05 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013M20A) for prophylaxis of COVID-19 infection.  On 05 Feb 2021, the patient received the vaccine resulting in the event of inappropriate age of dose of administration.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, gave vaccine to a 17-year-old, was considered resolved on 05 Feb 2021.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # 013M20A with no associated AEs.