chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Myocarditis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient received bnt162b2 (BNT162B2), on 15Jun2022 as dose 2, single (Lot number: FM0173) at the age of 50 years for COVID-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: she has had it for years. There were no concomitant medications. Vaccination history included: bnt162b2 (First Dose: 25May2022 Lot: FJ4989), administration date: 25May2022, when the patient was 50-year-old, for COVID-19 Immunization. The following information was reported: MYOCARDITIS (hospitalization) with onset Oct2022, outcome "not recovered". The patient was hospitalized for myocarditis (start date: Oct2022, discharge date: Oct2022). The patient underwent the following laboratory tests and procedures: Computerised tomogram: Unknown results; Unknown results. Therapeutic measures were taken as a result of myocarditis. Additional information: The reporter stated she developed, after she took the vaccine, myocarditis and was hospitalized. She got the vaccine in Jun2022, and shortly after that, she started having pains in her chest so then she thought she will watch it because sometimes maybe it is just pleuritic chest pain but then it kept going on and on and when she was walking outside, she would get short of breath with anything physical and she would be out of breath. She stated she couldn't understand how that would happen. One time she came to work, and it got harder to physically do stuff and then in Oct2022 she decided she was going to the ER (emergency room). She stated one Friday it got so bad, she said she was going to the hospital, so she went to the ER, and she got admitted and diagnosed with Myocarditis. She was hospitalized for 8 days. She also stated it hasn't resolved; it is ongoing. She was going about her business and going to work and coming home. She doesn't have a lot of activities and shopping and partying and all that stuff, she just goes to work and comes home. This year, in May2023, she ended up back in the hospital because of the same problems all over again. She went to the ER and it was the same thing again and she was admitted for 6 days in May2023. Even now she was having the same problems. It is persistent, she was just watching it. She is at work and at this point she has used up so much of her sick time, if she doesn't work, she won't get paid, she had to be watching it to see how long she can bear this. Treatment plan for the patient included hospitalization. They gave her a CAT scan and CT scan with dye, antibiotics, anti-Inflammatory in her IV (intravenous) line, pills, and they gave her medication in her IV. The reporter stated that the tests that they did at the hospital were done to come up with her diagnosis.
began dropping things/cannot hold on to things; sitting on bed 'Indian style', and suddenly fell over in bed; sleeping a lot; Headache everyday,massive headache as very severe from brain stem to forehead; left upper arm got sore and lasted for 12 hours.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Apr-2021 and was forwarded to Moderna on 28-Apr-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GRIP STRENGTH DECREASED (began dropping things/cannot hold on to things), FALL (sitting on bed 'Indian style', and suddenly fell over in bed), HYPERSOMNIA (sleeping a lot), VACCINATION SITE PAIN (left upper arm got sore and lasted for 12 hours.) and HEADACHE (Headache everyday,massive headache as very severe from brain stem to forehead) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018821A and 045821A) for COVID-19 vaccination.     The patient's past medical history included Headache. Concomitant products included IBUPROFEN (MOTRIN MIGRAINE PAIN) for Headache, CEFIXIME (FLEXERIL [CEFIXIME]) for Tendonitis, CLONAZEPAM (CLONOPIN), CHOLESTEROL, CLOPIDOGREL BISULFATE (PLAVIX), TRIGLYCERIDES and CEFIXIME (FLEXERIL [CEFIXIME]) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced VACCINATION SITE PAIN (left upper arm got sore and lasted for 12 hours.). On 23-Apr-2021, the patient experienced HEADACHE (Headache everyday,massive headache as very severe from brain stem to forehead). On an unknown date, the patient experienced GRIP STRENGTH DECREASED (began dropping things/cannot hold on to things), FALL (sitting on bed 'Indian style', and suddenly fell over in bed) and HYPERSOMNIA (sleeping a lot). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Headache and Pain, at a dose of 1 dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL N) for Headache and Pain, at a dose of 1 dosage form and CLONAZEPAM (CLONOPIN) ongoing since an unknown date at a dose of 1 dosage form. On 23-Apr-2021, VACCINATION SITE PAIN (left upper arm got sore and lasted for 12 hours.) outcome was unknown. At the time of the report, GRIP STRENGTH DECREASED (began dropping things/cannot hold on to things), FALL (sitting on bed 'Indian style', and suddenly fell over in bed), HYPERSOMNIA (sleeping a lot) and HEADACHE (Headache everyday,massive headache as very severe from brain stem to forehead) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included Motrin, Butalb-acetamin-Caff  and Benadryl for headache pain and Flexaril and clonopin for unknown indication.   This case was linked to MOD-2021-095432 (Patient Link).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jan2022 as dose 3 (booster), single (Lot number: FJ8762) at the age of 60 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "Vit D Deficiency" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN oral. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Anti-viral details for COVID 19 Treatment included PAXLOVID (lot number: unknown), administrated orally, treatment start date was on 30Jul2022 and treatment stop date was on 30Jul2022.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out.
Pt received 0.5 mL of this vaccination for her booster dose instead of the 1.0 mL dose indicated for this reason. No other noted adverse issues; pt will need to get a full booster dose per CDC recommendations by MD
Patient received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 19-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB0588, expiry date 31st March 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th April 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 19th April 2022, unknown after receiving Bexsero and Bexsero 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: 19-Apr-2022 Reporter's comments: The nurse reported that the patient received an expired dose of Bexsero. The consent to follow up was given. Additional Supportive Information: The patient received expired dose of Bexsero, which led to expired vaccine used.
Pt. received DTAP and varicella L arm-developed redness and swelling, warmth of entire arm (shoulder->elbow) 2 days later.
consumer on chemotherapy (every 3 wks) recvd pnu-imune; exp a red, swollen arm 24 hrs p/vax; induration was size of 50 cent piece;
The patient developed profuse vomiting after being vaccinated with M-M-R II and a DTAP; Her daughter was allergic to the sterile diluent; This spontaneous report was received from a Registered Nurse referring to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 29-OCT-2003, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)(strength, route, dose, frequency, anatomical location, indication, lot # and expiration date were unknown) and diphtheria toxoid, pertussis acellular vaccine (unspecified) tetanus toxoid(manufacturer unknown)(strength, route, dose, frequency, anatomical location, indication, lot # and expiration date were unknown) that were reconstituded with sterile diluent(manufacturer unknown) due to be vaccinated.      After the vaccination, the patient developed profuse vomiting. Additionally, the the patient's mother (name unspecified) stated her daughter was allergic to the sterile diluent (manufacturer unknown by)(drug hypersensitivity).   At the time or the report, the outcome of vomiting was reported as resolved, and the outcome of drug hypersensitivity was unknown. The reporter did not mention the causality assessment between the events and therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), diphtheria toxoid, pertussis acellular vaccine (unspecified) tetanus toxoid(manufacturer unknown) and  the sterile diluent(manufacturer unknown).
This is a spontaneous report from a contactable consumer (patient's parent/reported for son). A 30-year-old male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot#, NDC/UPC number, expiry date: unknown/not reported), at the age of 30, via an unspecified route of administration, on Sep 3, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Reporter's son had rashes all over his body (on an unspecified date in Sep 2021). The reporter did not know how to go about that so they want to know what Pfizer wants to do to the rashes. The event outcome: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Information has been received from an employees in a MD office concerning a 9 year old white female who on 10/28/1999 was vaccinated SQ with her first dose of varicella virus vaccine live. On 01/24/05 the pt developed a stuffy nose and a HA. The pt also developed 10-25 lesions on her face, torso, and arms. As of 01/28/05 the pt recovered. Additional information has been requested.
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a adult female patient who received FLUARIX TETRA. On 16th September 2016, the patient received FLUARIX TETRA. In September 2016, less than a day after receiving FLUARIX TETRA, the patient experienced cold. On 16th September 2016, the patient experienced injection site pain, hyper sensation skin and wrong injection technique. On an unknown date, the outcome of the injection site pain and hyper sensation skin were recovered/resolved and the outcome of the cold was not recovered/not resolved and the outcome of the wrong injection technique was unknown. The reporter considered the injection site pain and hyper sensation skin to be related to FLUARIX TETRA. The reporter considered the cold to be unrelated to FLUARIX TETRA. Additional details were provided as follows: The patient experienced pain, specifically burning, at and around the injection site and also reported skin sensitivity around injection site, went up the back of her neck. The symptoms lasted for few days and diminished. At the time of reporting the patient was also experiencing cold which appeared around the same time as the FLUARIX injection. The nurse administering vaccine swabbed injection site with alcohol prior to injection. Nurse did not wait full 15 seconds before injecting, but reporter continued to fee like these reactions were due to the FLUARIX. Specific event onset dates were unknown. The reporter had lot number if required further. This case is one of the three cases reported by the same reporter.
1. Frequently migraines 2. Joint pain especially on elbows, knees and heels.
Throbbing Left arm pain at the injection site that spread upward to the neck and downward to the elbow.  Followed by numbness and tingling to the left hand. Associated nausea and joint pain.
Patient fell forward post vaccine and wasn't responsive. Hands were tremulous. Taken to ED.
Information has been received from a licensed practical nurse concerning a 53 year old female housewife with diabetes mellitus and allergies to sulfa and penicillin who on Oct 28 2004 was vaccinated intramuscularly with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P). On approximately Oct 28 2004, the patient developed pain and soreness in her shoulder post vaccination. The patient sought unspecified medical attention. Additional information has been received from the physician. About 4 days ago in the office the patient was given boosters. Her last pneumococcal 23v polysaccharide vaccine was reported to have been 1999. The patient was cautioned about a possible local reaction, which she also experienced with her first vaccination with pneumococcal 23v polysaccharide vaccine. She presented with a complaint of continued severe shoulder pain. She was unable to sleep in bed because of the pain and had to sleep in a recliner and really had difficulty moving her arm around and has to help her right arm with with left arm. She reported today the pain was slightly better than previously, but still present to very uncomfortable degree. Her blood pressure was 150/90. pulse 84 and respirations 18. There were no obvious external abnormalities. Palpitation over the deltoid was tender in the injection was applied. She had not tried icing the shoulder. She had tried some heat, which was only effective for as long as it was applied. The patient was place on Naprosyn 500 mg BID for the discomfort. No additional information is expected.
Redness and warm to touch with quarter size knot 2 weeks past injection at injection site. Was given PO antibiotics and steroids.
Received vaccines at approximately 4pm on 2/28/11. 1st reported issue when arrived at Dep of Health bldg 3/2/11 at 1030 am with c/o itchy skin that first started 3/1/11 at 5pm and by 8pm - welts appeared all over body. 3/2/11 at 1030 - Mom indicated much better hardly noticeable and less itchy. Was not seen by MD and no fever indicated. Pt does not have any known allergies.
This spontaneous report as received from a pharmacist refers to an older than 26 years old male patient. On an unspecified date in 2014, the patient was vaccinated with the first dose of GARDASIL (dose, frequency and lot number not provide) when he was older than 26 years of age. No adverse events were reported. Additional information has been requested.
No symptoms. Patient allegedly reieved a dose of Moderna Covid-19  a day after receiving a dose of Pfizer Covid-19.  We have not been able to contact the patient.  She will not return our calls.
pt devel a 10cm x 7cm area of induration erythema @ inj site-confluent & round;tx w/ATB
Client given Moderna Vaccine, Primary dose, at a drive though clinic. It was discovered Friday am that we had given a Moderna Vaccine to someone under the age of 18.  Our team discussed the issue and then contacted our Health officer,  the Dept of Health , the client, her parent, the Paramedic who provided the vaccination, and completed the VAERS report. The client c/o a sore arm, which was an expected side effect of the shot. They had no other complaints. We also developed a new protocol when making appointments, checking into clinic and screening the patients to avoid a repeat of error
Information has been received from a medical assistant concerning a 12 month old male, with no allergies, who on 12-Dec-2006 was vaccinated with a dose of ROTATEQ (human-bovine) (Lot # 654247/0600F). Concomitant vaccine included a dose of influenza virus vaccine (unspecified). On 12-Dec-2006 the patient experienced vomiting after returning home from the physician's office. The patient was brought back to the office and found to have an ear infection. The patient was prescribed ROCEPHIN. It was reported that the patient was not hospitalized. No product quality complaint was involved. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of ear buzzing in a 61-year-old female patient who SHINGRIX (batch number PK9BY, expiry date 19th March 2021) for prophylaxis. On 28th September 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 28th September 2018, less than a day after receiving SHINGRIX, the patient experienced ear buzzing, migraine, fever and chills. On 29th September 2018, the patient experienced night sweat. On an unknown date, the outcome of the ear buzzing and night sweat were not recovered/not resolved and the outcome of the migraine was recovering/resolving and the outcome of the fever and chills were recovered/resolved. It was unknown if the reporter considered the ear buzzing, night sweat, migraine, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccination and started to had side effects that evening. She woke up the next morning with night sweats which continued. The chills and fever resolved within 1 to 2 days. The patient had a light migraine which was improving at the time of reporting. She had buzzing in her right ear and possibly her left ear but the right side was so prominent she was not sure. The pharmacist was transferred to MI (medical information) for additional information. The pharmacist stated to send letter from Regulatory Authority to her and she would provide for the patient should she want to follow up on it.
Chills began about 9 hours after vaccine. No fever noted. Slept a long time. Very weak the next day. Recovered by Sunday Nov. 3rd, two days later.
one week before the admission (07-29-2021), he reported being fatigued, poor appetite, fever, nausea and vomiting and abdominal pain. During admission he was found to be in cardiogenic shock, with evidence of poor cardiac function (EF 25%), that required Milrinone and Epinephrine drip and Solumedrol. he was also started on ASA because of evidence of a dilated RCA. He improved after several days and was transitioned to oral medications (Lisinopril, Prednisone and ASA and was discharged home one week after being admitted with normal cardiac function. Dx: Dilated cardiomyopathy (cardiogenic shock) secondary to Atypical Kawasaki vs MIS-C
Left lateral thigh 4 x 8cm area with mild erythema, mild increase temp at site, 3cm area.
Patient reported experiencing intense itching at the site and the surrounding area. When patient came in on 7/22/2016 morning, the site of injection appeared to be red and tender, including 2 inches surrounding the injection site. Instructed patient to take Benadryl for itching. Patient will call primary doctor for evaluation.
Last night my arm starting hurting a bit; During the night I couldn't sleep and I was up every hour; 'm bipolar and I get this wave of depression over me; I'm feeling very weak and tired; My injection site is a little pink but it's not red red; I'm feeling very weak and tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Last night my arm starting hurting a bit), INSOMNIA (During the night I couldn't sleep and I was up every hour), DEPRESSION ('m bipolar and I get this wave of depression over me), ASTHENIA (I'm feeling very weak and tired) and VACCINATION SITE DISCOLOURATION (My injection site is a little pink but it's not red red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bipolar disorder.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY, INSOMNIA, DEPRESSION, ASTHENIA, VACCINATION SITE DISCOLOURATION and FATIGUE. At the time of the report, PAIN IN EXTREMITY had resolved, INSOMNIA, DEPRESSION, ASTHENIA, and FATIGUE had not resolved and VACCINATION SITE DISCOLOURATION outcome was unknown. Not Provided.          Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-223823.   Most recent FOLLOW-UP information incorporated above included on 16-Jun-2021: Event outcome updated. On 14-Jul-2021: Follow up received on 14-07-2021 contain no new information.
Information has been received from an office manager concerning a 17 years old male patient who on 29-JUN-2010 was vaccinated with a fourth dose of RECOMBIVAX HB (lot number not available). The office manager reported that after the patient was vaccinated with the three doses of RECOMBIVAX HB, all blood work (Hepatitis B surface antibody) came back negative (less than 5), "not immune", requiring a fourth dose of RECOMBIVAX HB. The patient did not develop hepatitis B. No other adverse events were reported. At the time of the report the patient had not had follow up laboratories. The patient's outcome was unknown. It was unspecified if the patient sought medical attention. Follow up information received via medical records indicated that the patient was a non smoker male (height 78, weight 178), who on 29-JUN-2010 was vaccinated with a fourth dose of RECOMBIVAX HB (manufacturer unknown) (lot # AHBVB7989AACA). On 14-JUL-1992 the patient received a first dose of hepatitis B virus vaccine (unspecified) (manufacturer unknown); on 09-SEP-1992 the patient received a second dose of hepatitis B virus vaccine (unspecified) (manufacturer unknown) and on 10-MAR-1993 the patient received a third dose of hepatitis B virus vaccine (unspecified) (manufacturer unknown). On 22-JUN-2010 the patient had an anti-HBs titer (less than 5) it was reported that the patient did not developed immunity to hepatitis B virus. On the same date the patient had a varicella zoster virus IGG AB (2.44, the presence of IgG VZV antibody was consistent with immunity). On 17-AUG-2010 the patient had another anti-HBs titer (> 1000; patient had immunity to hepatitis B virus). This is one of several reports received from the same source. No further information is available.