chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 58 y.o. female with history obesity, gastric bypass surgery, obesity hypoventilation syndrome with chronic tracheostomy, a multiple healing wounds, chronic iron deficiency anemia, neurogenic bladder with chronic indwelling Foley catheter, and PICC line associated DVT on Eliquis.  The patient presents from her rehab facility due to positive COVID test.  The patient states she has been feeling in normal health.  They started testing residents on her floor after staff members tested positive for COVID-19.  She had several negative COVID tests earlier this week.  When she woke up this morning she noticed decreased sense of taste and smell so she received another COVID test which was positive today.  Patient denies fevers, chills, chest pain, shortness of breath, worsening cough, myalgias, or other new concern.  She does have a chronic intermittently productive cough due to tracheostomy, which patient states is at baseline.  The patient was sent to the hospital to verify positive COVID test.   In the ER, patient vitals remained stable, afebrile, tachycardic heart rate 90-100, normotensive, with O2 sat 97% on room air.  Lab work was unremarkable with normal renal function, no leukocytosis, stable hemoglobin 8.6.  COVID test was positive.  Patient's facility declined to accept the patient back due to risk to other residents.  At this time, patient does not meet admission criteria was placed in observation until appropriate discharge disposition could be arranged.  Patient was transferred to Hospital and placed in observation with Internal Medicine.
UPPER ARM WAS SWOLLEN, PAINFUL, RED, AND WARM. PATIENT WENT TO HOSPITAL AND TREATED FOR CELLULITIS.
This spontaneous report was received from a medical assistant referring to a 11 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with lot # N002720 and expiration date 12-MAY-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Follow up information was received on 18-SEP-2017 from the medical assistant, concerning GARDASIL 9 with lot # N002720. On 11-MAY-2017 at 12:24, the time in the range 32°Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009214 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009214 is being deleted from our files and the case is consolidated into case # 1711USA003933 with the correct Aware Date 18-SEP-2017. Sender's Comments: US-009507513-1708USA011654.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on 17th December 2018, refer case US2018228726) and ZOSTAVAX (Received on an unknown date). On 17th March 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm and influenza like illness. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm and influenza like illness were unknown. It was unknown if the reporter considered the pain in arm and influenza like illness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX yesterday at noon. The patient received SHINGRIX and had a sore arm. The patient stated that it worse than anything and she has felt like she has the flu for a day or so. Her call disconnected abruptly. This case linked with US2018228726, reported by same reporter for the same patient.
SWOLLEN LYMPH NODE IN R ARMPIT (MODERATE, ONGOING) FEVER (MILD, REDUCED WITH TYLENOL) HEADACHE (MODERATE, ONGOING) STOMACH UPSET (MILD, INTERMITTENT)
Mother reported T 101 deg evening after shot, chills, headache, "heart racing", and "everything hurt".
This information has been received from a nurse concerning a 71 year old male patient. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On 31-MAR-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 with lot number L024132 and expiration date on 21-JAN-2017 (dose, dose number, route of administration and anatomical location were not provided), administered for prophylaxis. The reporter stated that the vaccine was stored properly. No product quality complained was involved. No adverse effect was reported. Additional information is not expected as there was no consent to contact the reporter.
Swollen lymph node on the left side that the vaccine was administered; Inflamed; swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node on the left side that the vaccine was administered), VACCINATION SITE INFLAMMATION (Inflamed) and VACCINATION SITE SWELLING (swelling at the injection site) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph node on the left side that the vaccine was administered), VACCINATION SITE INFLAMMATION (Inflamed) and VACCINATION SITE SWELLING (swelling at the injection site). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form and LORATADINE (CLARITIN [LORATADINE]) at a dose of UNK dosage form. At the time of the report, LYMPHADENOPATHY (Swollen lymph node on the left side that the vaccine was administered) and VACCINATION SITE SWELLING (swelling at the injection site) outcome was unknown and VACCINATION SITE INFLAMMATION (Inflamed) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  According to the patient, the swelling at the injection site was still about the same, but had gone down a bit, at the time of reporting.
At 3:30 pm, my nose started running with runny mucus . At 4:30 pm, I developed a severe headache above my eyes. At the same time, my eyes started hurting (like sandpaper in them), and I found big chunks of white heavy mucus coming out of both eyes ending up at the inner corners. I removed the mucus with a wet qtip. Minutes later, and now hours later the white mucus persists after I keep removing it.  Very low grade fever, about 1 degree higher than my normal. 5 hours later, I still have my headache and my runny nose in spite of taking 3 extra strength Tylenol and Claritin. My eyes hurt and the mucus is slightly green now. I also have a racing heartbeat. No muscle aches or pains. Visual problems due to the sandy feel of my eyes and the constant mucus coming out.
1/26/16 - fever, wheezing, labored breathing starting 5 hours after vaccines. Frequent breathing concerns and hospital admits since initial reaction.
Patient received the second dose more than 36 days after the first dose.; Vaccine administered after temperature excursion; Vaccine administered after temperature excursion; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Apr-2021 and was forwarded to Moderna on 03-Apr-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose more than 36 days after the first dose.) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). On 06-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose more than 36 days after the first dose.). On 02-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose more than 36 days after the first dose.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not reported. Treatment information was not reported. The action taken with mRNA-1273 with the event was considered as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up information received contains No new information. On 06-Aug-2021: Follow up information received contains significant information. Added Second dose details. Added Events. Medical error case.
This case was reported by a healthcare professional and described the occurrence of angioedema in a 70-year-old female subject who was vaccinated with Twinrix, GlaxoSmithKline for prophylaxis. Concurrent medical conditions included hypertension. Concurrent vaccination included Salmonella typhi Vi capsular polysaccharide vaccine (oral) given on 17 April 2007; Twinrix 1st dose; GlaxoSmithKline given on 14 March 2007 in the right arm; live attenuated oral poliomyelitis vaccine (Sanofi) given on 14 March 2007; unspecified vaccine (Sanofi) given on 14 March 2007; yellow fever vaccine (Sanofi) given on 14 March 2007. Concurrent medications included Diovan and Risedronic acid (Actonel). On 17 April 2007 the subject received 2nd dose of Twinrix at 1.0 ml. In July 2007, after the 2nd vaccination with Twinrix, the subject experienced angioedema, swelling of cheek and lip swelling. The subject had three separate incidence of these events and was seen by two other physicians that related the event to her Diovan. Diovan was discontinued on 28 July 2007 and she was treated with Benadryl each time and the events resolved. The subject reported that two of the events occurred. At the time of reporting the events were resolved.
Abdominal pain, light headedness, headache started on 01/01/2021. All other symptoms resolved but persistent,  significant headache has not resolved yet.
Rash around injection site. Appeared after I scratched my arm in that area. I felt a sharp pain and then approximately 30 min after scratching I noticed a circular (ring) rash around the injection site. The rash did not itch or hurt.
I woke up in the middle of the night on 02/06/2021 with restless leg syndrome, back pain and arm pain. Also, I had general malaise. I spent most of the day with body aches and fatigue. The symptoms improved the next day. I started noticing lumps in my armpit area when showering and I made an appointment with my gynecologist for March/April. The gynecologist did not address it much as he attributed it to the vaccine because other women had reported it and were told to hold off on mammograms for that reason. I dismissed it as well but continued having intermittent sensitivity, swelling and pain. I received the Moderna booster on 10/28/2021. So, when I went into my PCP for an annual checkup in November, they decided to have me go for imaging. I had a 3D imaging and mammogram on the right breast on 12/14/2021. Immediately following, I was told I had nothing wrong. I received a letter of the results indicating a benign area of tissue in the right breast and to return in 9 months for a checkup. To this day, I still get intermittent tenderness in that area but nothing like before. Occasionally, I get a pain in that area but its fleeting and random.
Presented to doctor's office on 10/2/23 with complaints of increased redness , swelling, and warmth at injection site. Reports that symptoms have been worsening but no fever or chills. At the time of presentation on 10/2, redness and swelling was moving all the way down to patient's elbow. Patient started on cefuroxime and reported symptoms began improving on 10/3.
came into the pharmacy on morning of 11/23/2021 inquiring about flu and covid shots. Since appointments are required at this site, they made appointments online and stopped back that afternoon during a rush time. I saw them waiting and remembered our conversation earlier about covid vaccines. Therefore, I pushed paperwork forward for booster shots  after verifying eligibility and gave them to our nurse. After vaccinations, they were asked for their covid cards and it was then determined their appointments were made for flu shots. I immediately told them about the error and asked if they were experiencing any issues. I updated their covid cards to reflect booster doses given and will follow-up with them. They declined flu shots at that time because they wanted to space shots out. After they left, I contacted their doctor to alert them of the error.
This spontaneous report was received from a Medical Assistant, referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 10-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L042265; expiration date: 26-OCT-2017, (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. The vaccine underwent a temperature excursion (10F) for a time frame of 3 hours and 16 minutes. No previous temperature excursions were reported. This is one of several reports from the same reporter. Additional information has been requested.
itching and hives to arms, legs and abdomen. gave Benadryl  25mg initially, then 1 hr later another  25mg . next morning gave an additional 25mg. No swelling, no SOB. improved by afternoon 2nd day
Immediate raised area at the injection site.  This raised lump went down within the next 30 minutes.
Pain in left arm after injection of BEXSERO. Rash on left arm 2 days after vaccine given.
late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in April 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: late 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 7-Jul-2023 A pharmacist did not had the exact date of the 1st dose and the patient's date of birth was not asked. The reporter consented to follow-up via postal mail. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
jetlag comes 100; not been sleeping; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (not been sleeping) and CIRCADIAN RHYTHM SLEEP DISORDER (jetlag comes 100) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced INSOMNIA (not been sleeping). On an unknown date, the patient experienced CIRCADIAN RHYTHM SLEEP DISORDER (jetlag comes 100). At the time of the report, INSOMNIA (not been sleeping) and CIRCADIAN RHYTHM SLEEP DISORDER (jetlag comes 100) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
This spontaneous report was received from a patient's mother and refers to a 22 year old female non-pregnant patient. It was reported that the patient had no pertinent medical history and drug reactions or allergies. Concomitant therapies included unspecified birth control pills. On 22-FEB-2007, the patient was vaccinated with the first dose of GARDASIL (lot # reported as 0263U, expiration date August 2007) 0.5 ml, intramuscularly. On 13-MAR-2008, the patient was vaccinated with the second dose of GARDASIL (lot # reported as 1757U, expiration date 13-MAR-2008) 0.5 ml, intramuscularly. On 27-JUN-2008, the patient was vaccinated with the third dose of GARDASIL (lot # reported as 0070X, expiration date October 2010) 0.5 ml, intramuscularly. The reporter stated that the vaccines were given to the patient outside of the recommended schedule. In September 2014 and approximately July 2015 (reported as about 6 months ago), the patient's Papanicolaou (PAP) tests came back abnormal. On 22-JAN-2016, the patient received test results saying that the patient had tested positive showing for an unspecified high risk strain of human papilloma virus (HPV). It was unspecified if the patient's last two PAP test results were related with the patient's current HPV infection. It was reported that the patient did not seek any medical attention and no treatment was given for the events. The outcome of the events was unknown. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
vertigo pre covid/every time I have gotten the vaccine I finally feel clear headed and not having a serious case of vertigo as I previously had; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I suffer from vertigo pre covid and it got worse during early 2020", start date: 2020 (unspecified if ongoing); "Vertigo" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Meclizine, reaction(s): "no impact anymore it feels like", notes: Meclizine 25mg. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization, reaction(s): "Vertigo pre covid/every time I have gotten the vaccine I finally feel clear headed and not having a serious case of vertigo as I previously had"; Bnt162b2 (Dose: 2), for Covid-19 immunization, reaction(s): "Vertigo pre covid/every time I have gotten the vaccine I finally feel clear headed and not having a serious case of vertigo as I previously had"; Bnt162b2, bnt162b2 omi ba.4-5 (Dose: 3), for COVID-19 immunization, reaction(s): "Vertigo pre covid/every time I have gotten the vaccine I finally feel clear headed and not having a serious case of vertigo as I previously had". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "vertigo pre covid/every time I have gotten the vaccine I finally feel clear headed and not having a serious case of vertigo as I previously had".  Additional information: Patient has a general question about the Pfizer vaccine and impact of curing vertigo. Again curing it not causing it, if there's any links to case studies or general information about it. Patient suffer from vertigo pre COVID and it got worse during early 2020. patient noticed every time patient have gotten the vaccine patient finally feel clear headed and not having a serious case of vertigo as patient previously had. Meclizine 25mg has had no impact anymore it feels like, patient had 5 shots already of.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.