chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling of his eyes 2 months after booster; Swelling of face 2 months after booster; Swelling of neck 2 months after booster; Diagnosed with Hypereosinophilia syndrome 2 months after booster; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Swelling of his eyes 2 months after booster), SWELLING FACE (Swelling of face 2 months after booster), SWELLING (Swelling of neck 2 months after booster) and EOSINOPHILIA (Diagnosed with Hypereosinophilia syndrome 2 months after booster) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028K21A, 047B21A and 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy ((Nose Congestion), took OTC medications for allergies.).   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2022, the patient experienced EYE SWELLING (Swelling of his eyes 2 months after booster), SWELLING FACE (Swelling of face 2 months after booster), SWELLING (Swelling of neck 2 months after booster) and EOSINOPHILIA (Diagnosed with Hypereosinophilia syndrome 2 months after booster). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at a dose of 1 dosage form. At the time of the report, EYE SWELLING (Swelling of his eyes 2 months after booster), SWELLING FACE (Swelling of face 2 months after booster), SWELLING (Swelling of neck 2 months after booster) and EOSINOPHILIA (Diagnosed with Hypereosinophilia syndrome 2 months after booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   There was no concomitant medication reported.  Patient recently visited physician and they were in the process of diagnosing and finding treatment. Patient took Over the counter Claritin as treatment medication.   This case was linked to MOD-2022-572757 (Patient Link).
vaccination was expired beyond the 12 hour BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccination was expired beyond the 12 hour BUD) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2022 at 1:32 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccination was expired beyond the 12 hour BUD). On 05-Jan-2022, EXPIRED PRODUCT ADMINISTERED (vaccination was expired beyond the 12 hour BUD) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. The vial was initially stored in the refrigerator on 22-Dec-2021. The vial was first punctured on 04-Jan-2022 at 17:30 PM EST. The vial Refrigerated post puncture. Less than one hour  the vial was exposed to room temperature.
Red and Itching rash starting at the injection site and moving outward into the rest of the arm.  Slightly itchy.  The injection site is a little swollen and warmer than the rest of my arm.
Patients arm was red, swollen, and warm to touch at injection site and at least 3 inches below site. she stated it is a little itchy and has mild discomfort
My  adverse effect started the day after my shot was given at approx 3pm, i begin to experience extreme muscle/joint pain nausea loss of appetite and blood shot eyes.  I also had a mild  headache Around 7PM i felt very weak and could not keep my balance at times. i also began to experience blurry vision, By 9pm i was very weak and needed to lay down AT 10pm i felt like  a sharp pin go throw my left eye, sclera remained red, i then felt a electric type of shock go through my lower left leg where my leg had tingling and numbness. i continued with a more severe headache till appox 1 am. The third day i was tired but much improved. i did not seek out medical attention for the above side effects. i am only writing to you because people need to be aware of these possible side effects.
Severe pain upon receiving the vaccination in my left arm. Pain never went away and after 2 weeks I woke up in worse pain and I was unable to lift my arm. It felt like it was paralyzed.  I went to the Employee Health Department where I work and received the vaccination.  They referred me to a Health Clinic. After being seen at the Clinic, I was referred for 7 physical therapy treatments, I was able to slightly move my arm, but still had continuous pain.
Did not receive 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 02-DEC-2022 Reporter's comment: The pharmacist reported that the patient did not receive second dose of Shingrix within the recommended window post the first dose. The reporter did not have lot or expiry date of the first dose of Shingrix. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case had been linked to the case US2022181027, reported by the same reporter.; Sender's Comments:  US-GSK-US2022181027:Same reporter
BODY ACHES; MY ARM HURT THE REST OF THE DAY AND NIGHT; HEADACHE; FATIGUE; LOW FEVER (99-100); This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced body aches, my arm hurt the rest of the day and night, headache, fatigue, and low fever (99-100). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99-100. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, my arm hurt the rest of the day and night, headache, fatigue, and low fever (99-100). This report was non-serious.
Pfizer bivalent administered for second dose in series. Dose was well tolerated, no adverse events observed from patient.
Took Prevnar 23 vaccine. Within two days I had tremendous sinus clogging and sharp stomach pain. These symptoms correspond with my EGPA (diagnosed incidentally some time after have a myriad of life threatening and strange symptoms post taking Prevnar 13 in 2017). I've been on mepolizomab and have had virtually no symptoms for years until 2 days after taking the Prevnar 23 vaccine. I took 35 mg prednisone and within a day the symptoms abated. Prednisone is the medication my physicians prescribed for me in emergency situations with EGPA symptoms. Needless to say, the symptoms are so different from other things I've experienced and so unique that I know when the EGPA is acting up. I don't know if the link to the Prevnar vaccines is casual but this is not the second time. It's odd and scary.
This case was reported by a healthcare professional and described the occurrence of lymph node swelling in a 51-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline), HAVRIX. Concurrent medical conditions included penicillin allergy. Concurrent medications included FLOVENT and COMBIVENT. On 14 October 2010 at 10:27 the subject received 1st dose of ENGERIX B at 1.0 ml in the right deltoid. On 14 October 2010 the subject also received 1st dose of HAVRX (unknown). That same day, the subject developed lymph node swelling. Additional events reported include pain and tiredness. Lymph node swelling resolved on 17 October 2010. At the time of reporting the outcome of pain and tiredness was unknown. Attribution of the events to ENGERIX B was not provided.
This spontaneous report as received from a medical assistant, refers to an unknown number of patients of unknown demographics. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On unknown dates, for the past two years, the patients were vaccinated with improperly stored doses of PROQUAD (strength, dosing details, anatomical location, lot# and expiration date were unknown) for prophylaxis. The vaccine was reconstituted with Sterile Merck Diluent. The Medical assistant refused to provide any additional information including excursion details. No PQC was filed. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000103: US-009507513-1709USA000104.
Redness, itching, swelling, heat, pain 7 days post vaccine, redness not same as location of injection, cellulitis below vaccine injection site
prescription to have 4 doses of post exposure; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted product prescribing error in a patient who received Rabies NVS (RabAvert) for prophylaxis.   On an unknown date, the patient received RabAvert. On an unknown date, unknown after receiving RabAvert, the patient experienced intercepted product prescribing error. On an unknown date, the outcome of the intercepted product prescribing error was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Pharmacist reported the patient had a prescription to have 4 doses of post exposure treatment with RabAvert instead of 5, which led to intercepted product prescribing error. The Pharmacist said that he was going to make the doctors change the prescription to 5 doses. This case has been linked with case US2020AMR139748, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR139748:
Low grade temperature change 99-100.  Headache, facial symptoms such as sinuses burning,, felt like teeth were aching, neck pain, but most of all vertigo.  After a week, still dizzy, holding onto walls to walk.
Fever,  chills, sweating, didn't sleep well, about 20 hrs total
Pt. recieved vaccine drawn up greater than 12 hours. MD notified pt. of issue. No c/o adverse event. Pt. declined revaccination.
EXPIRED VACCINE  8/31/2019  WAS GIVEN BY ACCIDENT AT AROUND 2:45PM. PATIENT DID NOT REPORT ANY ADVERSE EVENT AT THIS MOMENT
10 minutes after receivng vaccines patient started to feel dizzy then said everything was going balck and she was going to pass out. Patient then passed out for about 30 seconds and then was coherent and talking normally.
unable to receive second dose, lack of availability; unable to receive second dose due to Covid pandemic; This case was reported by a consumer via call center representative and described the occurrence of product supply issue in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date, 0.5 ml,  intramuscularly about 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue and social problem. On an unknown date, the outcome of the product supply issue and social problem were unknown.  Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not applicable for this report. The patient received the first dose of Shingrix 2 years ago. he was unable to receive the second dose due to lack of availability , which led to product supply issue. And then later was not able to get the second dose due to the Covid pandemic, which led to social problem. The reporter did not consent to follow-up. This case was linked with US2021210625, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021210625:Same reporter
Shingles. Within 24 hours the right side of my mouth (tongue, gums, palate but not down the throat) was blistered. This resolved within about 4 days. Within 4 days my upper back, primarily the right side, had large single blisters. That resolved in another few days. Within a week my face, neck, and even scalp were covered in blisters and rashes - primarily on the right side and center. My hands were also blistered though not as severely. Because SHINGLES HAS NOT BEEN PUBLICIZED AS A POTENTIAL SIDE EFFECT (SHAME ON CDC), I had no clue what was going on. I used salt-water rinses for the mouth blisters, nothing on the back, and started with Benadryl and Caladryl for the rest. One April 21, the day my 2nd vaccine was due and it was clear something very wrong was going on, I went to an urgent care center and received a steroid shot, 7-day steroid pack, and topical steroid cream. The blisters and rash continued. I saw my general practitioner April 26. He said to continue the topical cream and wouldn't prescribe more steroids at that time. He also said I was past the time when the shingles anti-viral would be effective.  I STILL have blisters, though they are subsiding. NO ONE CAN TELL ME IF I SHOULD GET THE 2ND SHOT, WHEN I SHOULD GET IT, AND WHAT TO EXPECT. I hope to get it, but this is scary.
Couple of days after my booster shot my arm was sore then a week after the site of the shot you could ( can still see it ) see like a rectangle on my arm. Now it look like there's a bruise all along the site of the shot and the area is swollen. I have told my PCM about it over the phone and he told me that if it doesn't go away in a couple of months to report it to the CDC. So I am......
Out of  body feeling Small pupils with dizziness  Severe body aches Mild nausea  Feeling of being high Can?t focus
Itchy erythematous blanching hive-like swelling; non tender (R) deltoid 10x12 cm.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Dec2020 as dose 1, single (Lot number: EJ1685), in right arm, on 09Jan2021 as dose 2, single (Lot number: EJ1686), in right arm and on 27Sep2021 as dose 3 (booster), single (Lot number: EW0185) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "autoimmune gastritis" (unspecified if ongoing); "Known allergies: beer" (unspecified if ongoing). Concomitant medication(s) included: MODAFINIL; SERTRALINE; LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Oxygen saturation: (May2022) normal, notes: entire time; SARS-CoV-2 test: (04May2022) Positive; (12May2022) Positive; (16May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Adverse event: Consumer developed congestion on 03May2022, tested positive the morning of 04May2022 and began paxlovid the evening of 04May2022. Consumer took all doses as prescribed and had few symptoms of covid she noted an unpleasant taste in her mouth during the treatment. She finished paxlovid on the morning of 09May2022. She continued to improve and on the AM of 12May2022 retested herself to go back to work- her test was strongly positive. In the afternoon, she started to develop all of the symptoms of covid again: congestion, sore throat, cough, fatigue, muscle aches and had fever and chills overnight - the next day she was more ill than she had been the entire time and since then have slowly improved (today is May2016) -  now she still testing positive but only have a cough and congestion, some fatigue - none of this return of symptoms was subtle and it truly felt like she was starting all over with the infection; Her O2 sats were normal the entire time. Other medication in 2weeks product included Modafinil, Sertraline and Levothyroxine.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a causal relation between the events Drug ineffective, COVID-19 and the administration of the vaccine cannot be excluded.
redness; swelling; a 5 year old child who received an undiluted pfizer covid 19 vaccine; a 5 year old child who received an undiluted pfizer covid 19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 5-year-old patient received BNT162b2 (BNT162B2), on 12May2022 at 09:00 as dose 1, single (Batch/Lot number: unknown) at the age of 5 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: KINRIX intramuscular taken for immunisation, on 12May2022 as dose number unknown, single; PROQUAD subcutaneous, on 12May2022 as dose number unknown, single. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 12May2022, outcome "unknown" and all described as "a 5 year old child who received an undiluted pfizer covid 19 vaccine"; ERYTHEMA (non-serious), outcome "recovered", described as "redness"; SWELLING (non-serious), outcome "unknown". Therapeutic measures were not taken as a result of erythema.  Additional information: The caller was a pediatrician. He was requesting the possible side effects in a 05-year-old child who received an undiluted Pfizer COVID19 vaccine (orange cap). The patient provided information regarding the reported adverse event (s) with the use of the product. Pfizer/BioNTech Covid-19 Vaccine. Details: Dose: 1st anatomical site of injection: Left shoulder. Vaccination Facility Type: Doctor's office/Urgent care. Prior Vaccinations (within 4 weeks): Vaccine name: Proquand. Anatomical site of injection: L triceps. Date: 12May2022. Concomitant Drugs: None. Patient(s) Medical History (including any illness at time of vaccination): None. Family medical history relevant AE(S): None. Relevant Tests: None. Specific relevant test for thromboembolic events with thrombocytopenia: None. Patient mistakenly given undiluted dose of covid vaccine. continued patient's mother later that day to a test her. He contacted patient's family 10 days later to death on patient. mother reported that patient had redness & swelling not injection site. No treatment recommend by time of call.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (01Jun2022): This is a spontaneous follow-up report from a contactable Physician. This Physician reported in response to HCP letter sent which included updated information: new event (Redness, swelling) added. Event outcome and treatment receive added. Patient name, initial, age at vaccination added. Dosage Regimens (Route of Administration and Vaccine administration date, dose number, dose description). Vaccine Facility Information added.   The information on the batch/lot number for [BNT162B2], has been requested and will be submitted if and when received.
multiple unspecified patients were administered a dose of improperly stored PNEUMOVAX 23; No adverse symptoms were reported; This initial spontaneous report was received from a nurse referring to multiple patients of unknown age and gender. The patients' pertinent medical history, concomitant medication, concurrent condition and drug reactions/allergies were not provided.     On unknown dates, the patients were vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot# S013489, expiration date 06-MAR-2021; lot# S029916, expiration date 12-JUN-2021; dose, strength and route were not provided) for prophylaxis. The temperature excursions included below 2 degree Celsius (0 degree Celsius) for 80 hours and 49 minutes, below 0 degree Celsius (-0.6 degree Celsius) for 37 hours and 20 minutes (29 cycles). There was no previous temperature excursion. There was a data logger involved. No adverse symptoms were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:  manufacturercity: manufacturerstate: ; manufacturercountry:; devicelotnumber: S029916; expirationdate: 12-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Extreme pain in jaw. Lump tmj and in throat. Swollen glands on left side. Sharp pain when swallowing and ear ache.
Fever; Chills; his face was burning up; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiration date: 31May2021), via unspecified route of administration on left arm on 22Jan2021 at 08:15 AM at single dose for COVID-19 vaccination. The relevant medical history included three stents in his heart, allergy and medication for cholesterol (he just quit the medication, it was killing his legs). They have tried him on them 99 times but he cannot take statin drugs, they cripple him. Concomitant medications were reported as none. The patient previously took Claritin (doesn't know if he took this for food or medication allergies, he thought it was for sinus drainage most of it). The patient said he got his COVID shot and had a fever of 102 and he had chills with it too on 22Jan2021. He said he was wondering what he was supposed to do to get that fever down, which he clarified it was 102.4 degrees Fahrenheit. The fever started by the time he got back, it was a 2.5-3 hours drive, his wife checked his temperature about 5 minutes prior for the first time, because his face was burning up. He says that the NDC is not written on the vaccine card with the other handwritten information, it did say he went back 12Feb for the second one. He had not started any new medications or received any recent vaccinations. The patient underwent lab test included temperature elevation which showed 102.4 degrees Fahrenheiton on 22Jan2021. The outcome of the events was unknown.