chrisvoncsefalvay/vaers-outcomes huggingface dataset:
For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022; Expired doses administered beyond the BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered beyond the BUD) and PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022) in a 91-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered beyond the BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered beyond the BUD) and PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient took 2nd booster of Moderna and took total 4 doses. Lot number 083J21A was refrigerated on 7-Feb-2022. Vial did not undergo any temperature excursion. No treatment information was reported .
on evening of 21OCT93 noted redness @ inject site & sore arm; upon awakening 22OCT93 found red raised itchy rash over body-worse in creases;
I felt like I was getting a bug. Since I was expected to travel on March 06. It felt like a flu or cold was coming on but then it got worse. Continuous runny, sinus, sneezing and a cough. I didn't notice losing any taste. I had little headaches with a slight fever around 98. My normal body temperature is 94. I had 3 or 4 days of off and on diarrhea. A doctor prescribed Paxlovid and I started taking it on March 04, 2023. I messed up my dosage once, so I took the last capsule late. I also took Vitamin D and Vitamin C. Along with 70 MG of Zinc. I took some Quercetin and Melatonin at night. I still have brain fog and I am still tired sometimes. I feel like it hards to do work. I also still have a bit of a cough, but I was also a smoker.
This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain and general malaise. On an unknown date, the outcome of the injection site erythema, injection site pain and general malaise were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site pain and general malaise to be related to SHINGRIX. Additional details were provided as follows: This case was received via webform email. The age at vaccination was not reported. But, it could be 65 or 66 years old. The healthcare professional stated that, the patient did not report any abnormal side effects, but only injection site redness, soreness and general malaise for a duration of 2 days post-injection. No further information was provided.
Arm sore and swollen at site of shot and difficulty sleeping for a night or 2, followed by lingering muscle weakness that persists, and occasional tingling down inside of arm. Cannot lift weight that I could lift prior to the shot.
my vision went wavy, got a wave to it and it turned out that I had a macular hole; my vision went wavy, got a wave to it and it turned out that I had a macular hole; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Feb2021 (Lot number: EN6202) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: RAPAFLO; CLONAZEPAM; ADDERALL. The following information was reported: MACULAR HOLE (medically significant), VISUAL IMPAIRMENT (non-serious) all with onset 2021, outcome "not recovered" and all described as "my vision went wavy, got a wave to it and it turned out that I had a macular hole".  Clinical Course: Consumer further stated, I had a, within a week of the first one my vision went wavy, got a wave to it and it turned out that I had a macular hole, I was going to say I didn't go to the eye doctor until after the second shot when It got worse but that's when they discovered that I had a Macular hole. Prior vaccination before 4 weeks: Consumer stated No. Consumer stated, I do not know the name of that but I also have another eye issue but I do not know the name of it in the other eye also from the shot and did not know the name of it. It's when retinol gel pull out' and get stuck and the happened after the second shot, The first and the second shot also then when I got the third shot it got much worse.  Follow-Up (15Feb2022): Follow-up attempts are completed. No further information is expected.
New pt presented on 01/04/05 at our office with fever and morbilliform rash over entire body and hands and palms of hands; around neck beginning of petechiae.
Large red hot firm bump at injection site.  Fever and chills and lethargy and headache 2 days
On 05/15/02 began complaining with headache, chills, nausea, hyperventilation. Seen in ER pm of 05/15/02. States X-rays, blood tests, urinalysis neg.
Arm soreness within hours of vaccine Extreme fatigue, headache, body aches, feverish/chills, nausea, other cold symptoms, running nose/congestion in later that evening. Lasted for the entire next day and improving mid day 48hrs  after vaccine. Fatigue, body aches/chills with no fever was persistent
A very sore arm/ He couldn't lift it up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A very sore arm/ He couldn't lift it up) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (A very sore arm/ He couldn't lift it up). At the time of the report, PAIN IN EXTREMITY (A very sore arm/ He couldn't lift it up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Superficial blood clot in right foot. Symptoms: pain in arch of right foot, red blotch and tender area on top of right food after about 2 days after 2nd shot.  Area of pain gradually expanded and traveled up the right leg with some swelling and tender areas.
Got Shingles shot and still have small break outs of shingles/Suspected vaccination failure; small break outs shingles; Stress; 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.   The patient's past medical history included shingles (had been ten years since had the shingles) and injury to facial nerve (had a permanent nerve damage in face).   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: Got Shingles shot and still have small break outs of shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: small break outs shingles) and stress (Verbatim: Stress). The outcome of the vaccination failure was unknown and the outcome of the shingles and stress were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and stress to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and stress to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2023  This case was reported by a patient via interactive digital media. The patient had gotten a shingles shot and still had a small breakouts of shingles when under a lot of stress. The patient further stated that it was not fun. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
swollen lymph nodes in neck by jaw. left side (same side as shot); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 15:00 (Lot number: EN6206) at the age of 62 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TERBINAFINE; OMEPRAZOLE. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 08Mar2021 14:00, outcome "not recovered", described as "swollen lymph nodes in neck by jaw. left side (same side as shot)". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: The patient had no known allergies. The patient did not received other vaccine in four weeks. Patient received no treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID. Post vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
About 45 min after vaccine, on our way home, I began feeling very lightheaded and passed out. Husband took me to the ER as I wasn't coming around and stayed out of it for maybe an hour, but I can't be certain. Vitals were took, everything came back fine. They listed it as unknown. When we got home I looked up eating before getting the vaccine and read one should eat beforehand. I hadn't eaten in 15 hours.
Mother reported left arm hot to touch, red and swollen. Saw MD this a.m. and he ordered cold pack, antibiotics and Tylenol (3/7/03) stated left arm (inject site) was 1.5 times the size of right arm.
Approx 3 days after pt had PREVNAR administered she noted a large rash on R deltoid, red in color, hot to touch. Dr dictated this area was pruritic erythematous patch approx. 6cm x 4cm. Treated with doxycycline 100mg Take 1 tab by mouth twice daily for 5 days. Heart and lungs normal per physical assessment.
outbreaks of herpes zoster; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On an unspecified date, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and zoster-related conditions.  On an unspecified date, subsequent to the patient vaccination, the patient presented multiple outbreaks of herpes zoster. As a direct and proximate result, the patient had been treated by a medical provided. Additionally, the symptoms had been resulted in physical limitation not presented prior vaccination. The patient sustained severe and permanent injuries; the patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's conditions.  As a direct and proximate result, the patient suffered severe and permanent physical injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.   The reporter considered the event multiple outbreaks of herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
On the 15th I noticed a big red welt at my arm. Not at injection site. I had a couple on my back and one on my other arm. Monday morning, I had one on my foot that was really itchy. I figured it was a booster reaction. I contacted Primary Care and the provider prescribed topical steroid and Benadryl.  The 23rd my head was very itchy. I thought my family had lice so you treated everyone for lice Sunday evening  01/23/2022 I contacted my Dermatologist. I saw a PA and I cannot remember the name but I was prescribed Zyrtec OTC twice a day for 2 weeks and then once a week for remaining 6 weeks for 2 months total. She also prescribed prednisone if it has not got better.  The itching did get better but I am still covered in hives from head to toe.
Suspected Vaccination Failure; The vaccine gave my grandma shingles.; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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:28-Feb-2023. Reporter's Comment: This case was reported by a consumer via interactive digital media. The reporter was patient's relative. Reporter stated vaccine gave his/her grandma shingles. 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. Follow-up would not possible as no contact details were available.
got the shot ended up with Shingles /suspected vaccination failure; Shingles; pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's son or daughter. The age at vaccination was not reported. The reporter stated that, his or her mother got the shot and ended up with the king of shingles as her physician diagnosed with so much pain for a very long time. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
This spontaneous report was received from a register nurse and refers to multiple unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L004754 with expiration date 10-NOV-2016 and lot #M010212 with expiration date 21-JAN-2019 (dosage and route of administration were not reported), which were exposed to temperature excursion (temperature was 51.6 degrees F, time frame:1 hour and 45 minutes) because of data logger. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one the several reports from the same reporter.
No adverse effects were reported; HCP called to report a TE with PNEUMOVAX 23 PFS. The outcome was "not supported" for the excursion of 72 hours 0 minutes 0 seconds at 46.7F (47F).  The excursion was discovered upon looking at the data logs.  Data logger recorded a 46.7F temp on Marc; This spontaneous report was received from a consumer and refers to a 70-year-old patient of unspecified gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-MAR-2023, the patient was vaccinated with an improper stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) at a dose of 0.5 ml, lot #W027449, (expiration date: 25-SEP-2024), administered for prophylaxis (strength, and route of administration were not provided) following a temperature excursion of 46.7F (47F) for 72 hours 0 minutes 0 seconds discovered upon looking at the data logs (product storage error). Data logger did not record again until logging a 43F temperature on 06-MAR-2023, worst case scenario of 46.7F was used for the full 72 hours of the weekend per health care professional direction. No additional adverse event was reported (no adverse event).  This is one from several cases from the same reporter. ; Sender's Comments:  US-009507513-2304USA002650: US-009507513-2304USA002696: US-009507513-2304USA002667: US-009507513-2304USA002675: US-009507513-2304USA002694: US-009507513-2304USA002696: US-009507513-2304USA002759: US-009507513-2304USA002776: US-009507513-2304USA002932: US-009507513-2304USA002667:
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional 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  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine  was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
trouble breathing; Brain Fog; feeling really  tired; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (trouble breathing), FEELING ABNORMAL (Brain Fog) and FATIGUE (feeling really  tired) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product MACITENTAN tablet for Pulmonary hypertension.    The patient's past medical history included COVID-19 in November 2020 and Hospitalization (hospitalized after being diagnosed with COVID.) from 01-Nov-2020 to 05-Nov-2020. Concurrent medical conditions included Primary pulmonary hypertension and Clinical trial participant. Concomitant products included SILDENAFIL CITRATE for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started MACITENTAN (Oral) 10 mg once a day. On an unknown date, MACITENTAN (Oral) dosage was changed to at an unspecified dose. In April 2021, the patient experienced DYSPNOEA (trouble breathing), FEELING ABNORMAL (Brain Fog) and FATIGUE (feeling really  tired). At the time of the report, DYSPNOEA (trouble breathing), FEELING ABNORMAL (Brain Fog) and FATIGUE (feeling really  tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2020, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-162997 (Patient Link).
Pt recv vax on 11/13/98; on 11/14/98 pt exp right facial palsy w/ inability to close right eye, right side mouth droop
Information has been received from an office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On an unknown date in April 2012 the patient was vaccinated with the first dose of GARDASIL (dose, route, lot # and expiration date were unknown). It was reported that the second dose of GARDASIL (dose, route, lot # and expiration date were unknown) was given in November 2012 and the third dose (dose, route, lot # and expiration date unknown) was given on 20-AUG-2014. No adverse effects were reported. Additional information has been requested.
11-4-10 Patient notified Health Dept that she had had (R) arm weakness & pain since approx 24-48 hrs. after vaccination. Evaluation by PCP, incl. shoulder xray. Denies fever, erythema or local reaction. States that (R) arm function is improving - feels it is going to resolve.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid 19 vaccine (Dose:1, Manufactured: Unknown), for Covid 19 immunization; Covid-19 vaccine (Dose:2, Manufactured: Unknown), for COVID-19 immunisation. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever of 101F approximately 20 hours". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a physician refers to a 20 year old female patient with no pertinent medical history or drug reactions/allergies. On 23-JAN-1994, 21-FEB-1994, and 27-JUL-1994, the patient was respectively vaccinated with the first, the second and the third dose of RECOMBIVAX HB, (dose, route, lot # and expiration date not reported). There was no concomitant medication. On 21-JUL-2014, the result of "hepatitis B titer" was "less than 5 (units not provided)". As a treatment for the "low titer", on that same date, the patient may had been administered an expired dose (fourth dose) of RECOMBIVAX HB, (possibly from lot # 1572AA and expiration date 26-MAY-2014). At the time of the report, the outcome of the events was unknown. Additional information has been requested.