chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Abscess on bottom; Sore spot on bottom; This spontaneous case was reported by a consumer and describes the occurrence of ABSCESS (Abscess on bottom) and PAIN (Sore spot on bottom) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20a) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced ABSCESS (Abscess on bottom) and PAIN (Sore spot on bottom). At the time of the report, ABSCESS (Abscess on bottom) and PAIN (Sore spot on bottom) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. on 07-APR-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
A few minutes after receiving immunizations child began to fall. Mother and RN caught child and assisted her to sit down. After a few minutes we assisted to walk her to a place to lie down. While getting onto cot, child vomited. VS taken -> all normal. After about 20 min, child and mom left clinic.
10 minutes of so after injection, patient reported that he felt itchy all over his left arm and spine,  His eye felt weird, and he was dry heaving. I gave him a chair to sit in since he looked unsteady, had him sit on the chair, gave him 10 mL of children's Benadryl (dye free).  He threw up in a trash can and sat for 10 more minutes, and felt fine and left the pharmacy.
This case was reported by a consumer via call center representative and described the occurrence of drowsiness in a 4-month-old female patient who received KINRIX. On an unknown date, the patient received KINRIX. On an unknown date, less than a year after receiving KINRIX, the patient experienced drowsiness, appetite absent, wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the drowsiness, appetite absent, wrong vaccine administered and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the drowsiness and appetite absent to be related to KINRIX. Additional details were provided as follows: The reporter stated that at his daughter's (patient) four month check-up she inadvertently received  the KINRIX vaccine instead of the PEDIARIX vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration. The patient was administered 2 other shots and an oral intake vaccine as well on the same day. After receiving KINRIX the patient experienced drowsiness and lack of appetite. The batch number and expiry date were unknown. This case was not associated with product complaint. No additional details were provided. The reporter did not want to answer additional details on the adverse event report. The patient had denied the permission to contact their physician.
tingling in arms; Extreme fatigue; sleeping 18 or more hrs a day.; Loss of appetite; chills; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2022 at 15:45 as dose 1, single (Lot number: FK9893) at the age of 69 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 18Apr2022 at 13:00, outcome "not recovered", described as "Extreme fatigue"; DECREASED APPETITE (non-serious) with onset 18Apr2022 at 13:00, outcome "not recovered", described as "Loss of appetite"; CHILLS (non-serious) with onset 18Apr2022 at 13:00, outcome "not recovered"; SLEEP DISORDER (non-serious) with onset 18Apr2022 at 13:00, outcome "not recovered", described as "sleeping 18 or more hrs a day."; PARAESTHESIA (non-serious) with onset 18Apr2022 at 13:00, outcome "not recovered", described as "tingling in arms". The events "tingling in arms", "extreme fatigue", "sleeping 18 or more hrs a day.", "loss of appetite" and "chills" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of paraesthesia, fatigue, sleep disorder, decreased appetite, chills.  Additional information: Seriousness criteria-Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect: No. No other medications in two weeks. No other vaccine in four weeks. Extreme fatigue for over 3 months, sleeping 18 or more hours a day. Loss of appetite, chills, tingling in arms. AE resulted in: [Doctor or other healthcare professional office/clinic visit]. No treatment for AE. No COVID prior to vaccination.  No follow-up attempts possible. No further information expected.
Information has been received from a physician via company representative referring to numerous unspecified patients of unknown age and gender, reported in an unspecified article published in a scientific (unspecified publication date). The patients medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. On an unknown date, the patients were vaccinated with GARDASIL for prophylaxis (route  of administration, lot #, expiration date, dose and anatomical location were not provided) and with MENVEO (route  of administration, lot #, expiration date, dose and anatomical location were not provided) for prophylaxis. Following this, on an unknown date, after receiving both vaccines the patients experienced Bell's palsy which upon internal review, was determined to be medically significant. At the time of reporting, the physician stated that according with the article most of the patients recovered fine without the need of medication. Additionally, the reporter did no provided causal relationship between the Bell's palsy and therapy with suspect therapies. There was no product quality complaint involved. Additional information is not expected as there was no consent to contact reporter.
Pt reported pain at injection site 1 day following administration of the flu shot. The pain has persisted for 2 weeks pain with movement and raising his left arm.
This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age ethnicity and gender received PREVNAR 13 (LOT# and Expiration date not provided) (reported as Prevnar 23, pending clarification), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient had a flu shot and the PREVENAR 23 yesterday and the patient's arm was swollen, elbow clear up to shoulder, had fever and chills. The patient need to know if it was not a normal. The fact that the patient had never had a problem before. The outcome of the events was unknown.
pt became very sleepy, parents had difficulty arousing her and waking her up. This lasted for several hours. Mom called MD. through the answering service.
patient reported arm pain in a week and now reporting of loss of movement on upper (vaccinated arm) @injection site
Pain so bad he could barely walk on his left leg; Barely walk; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain so bad he could barely walk on his left leg) and GAIT DISTURBANCE (Barely walk) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical history reported.).    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain so bad he could barely walk on his left leg) and GAIT DISTURBANCE (Barely walk). At the time of the report, PAIN IN EXTREMITY (Pain so bad he could barely walk on his left leg) and GAIT DISTURBANCE (Barely walk) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Muscle soreness, fatigue, low fever, nausea, diarrhea, chemical smelling stools.
body tremors; joint issues with my hands, neck, face, knees and shoulder's; insomnia; don't feel well overall; distress; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 23-year-old patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TREMOR (non-serious), outcome "unknown", described as "body tremors"; ARTHROPATHY (non-serious), outcome "unknown", described as "joint issues with my hands, neck, face, knees and shoulder's"; INSOMNIA (non-serious), outcome "unknown"; MALAISE (non-serious), outcome "unknown", described as "don't feel well overall"; EMOTIONAL DISTRESS (non-serious), outcome "unknown", described as "distress". Additional information: The patient reported that "I started having health issues. I was a healthy 23 year old graduating from college. I received the shot in Apr about a month before graduation. Within two weeks I began to experience body tremors all over. These persisted for the better part of 9 months and then I began having joint issues with my hands, neck, face, knees and shoulder's. I have insomnia and don't feel well overall. It has caused great distress to me".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient reports being delirious the day after receiving the immunizations. She had a fever, was driving like she was drunk, pulled into her neighbors driveway instead of own, and tore apart her house looking for a "piece for her internet." This included removing the dishwasher from the wall. These symptoms lasted less than 24 hours. However, she reports her right arm is still having pain with movement.
Horrible breathing issues; Emphysema; Lack of drug effect; Tested positive/exacerbated by COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive/exacerbated by COVID), DYSPNOEA (Horrible breathing issues), EMPHYSEMA (Emphysema) and DRUG INEFFECTIVE (Lack of drug effect) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced COVID-19 (Tested positive/exacerbated by COVID) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced DYSPNOEA (Horrible breathing issues) and EMPHYSEMA (Emphysema). At the time of the report, COVID-19 (Tested positive/exacerbated by COVID), DYSPNOEA (Horrible breathing issues), EMPHYSEMA (Emphysema) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment drugs were reported.  Pulmonologist suggested that she get her booster shot. Patient wants to know if she can take the shot. Was there any harm in getting the booster after having COVID, and was there a time to wait before getting the booster.  Company Comment:  This is a spontaneous case of drug innefective,  concerning a 61-year-old, female patient with unknonw medical history, who experienced the unexpected non-serious, AESI event of COVID-19. At the momento of the report, the outcome is unknown. The event occurred 7 months after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Follow-up received:  follow-up-reporter, patient demographics, dose details, event has been added.; Sender's Comments: This is a spontaneous case of drug innefective,  concerning a 61-year-old, female patient with unknonw medical history, who experienced the unexpected non-serious, AESI event of COVID-19. At the momento of the report, the outcome is unknown. The event occurred 7 months after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was unknown), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 14Mar2021 (evening), patient had shingles and took first dose of medicine (treatment). On 15Mar2021, patient was scheduled to get second shot and patient was in line to get it. Patient wanted to know if it is okay to get this shot. Outcome of event was unknown. No follow-up attempts are possible; information about lot or batch number cannot be obtained.
Arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm is sore) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced MYALGIA (Arm is sore). At the time of the report, MYALGIA (Arm is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure medication,cholesterol medication,urinary control medication and blood thinners (Unspecified).
Information has been received from a licensed practical nurse (LPN) concerning a female who on 24-SEP-2007 was vaccinated by injection with the second dose of Gardasil.  The nurse reported that "after the patient received the second dose, the patient had experienced burning and muscle tightness.  The burning and muscle tightness lasted for about five minutes and then it went away.  There was no redness or swelling.  The nurse said that they used a different arm from the first injection of Gardasil".  The nurse also reported this same experienced happened to other patients after their second dose.  (WAES # 0710USA00703).  Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available.  Additional information has been requested. This is in follow-up to report (s) previouisly submitted on 10/12/2007. In follow-up the LPN reported that the patient was 18 years or older. Additional information has been requested.
Woke up the day after getting the Tdap and her left deltoid was red, swollen, a hard knot was present. Later that day dry looking blisters appeared. She came back to the office on 1/25/10 and an area of induration and erythema 11x10 cm was noted by her PCP. The RN called and there is light improvement in the arm today.
shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On an unknown date in 2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider for shingles. As a direct and proximate result of pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered/not resolved. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
ON MARCH 30,21, WHILE CLIMBING STEPS, HAD TO START PULLING MYSELF UP, AS LEGS FELT WEAK. THIS INCREASED AND ON APRIL 2ND, WHILE GETTING UP AFTER SITTING, COULD NOT STAND, AS MY LEGS GAVE WAY UNDER ME. I WOULD FEEL LIGHT HEADED, BUT NOT DIZZY.MY LEGS ACHED AND I NEEDED SUPPORT TO GET TO BED. THIS CONTINUED ON AND OFF TILL APTIL 15TH. WENT TO URGENT CARE ON 11TH AS WAS VERY CONCEREND I WOULD NOT BE ABLE TO WALK. CAT SCAN AND LABS NORMAL. FELL WHILE GETTING OFF THE EXAM TABLE. ON 14TH WENT TO NEUROLOGIST. TESTS WERE ALL NORMAL. THE WEAKNESS WAS LESS IF I RESTED AND PUT LESS STRAIN ON THE EYES. THESE SUBSIDED 17 DAYS. SOME WEAKNESS WHEN CLIMBING STEPS.
About 40 minutes after vaccination the patient complained of L sided chest pain radiating to axilla/ No other symptoms including sob. EKG normal.  BP 129/89 P 71 RR 18 O2 97%
This spontaneous report was received from an unspecified reporter via company representative refers to a 78 year old female patient. The patient's concurrent conditions included diabetes. The patient's medical history was not reported. The patient's concomitant therapies included JANUVIA and LYRICA. It was unknown if the patient had any drug reactions/allergies. On an unknown date in 2013 (also reported as, at an unspecified time five years ago), the patient was vaccinated with ZOSTAVAX, (dose, units, frequency, lot number, expiration date not reported) as an injection. On 12-FEB-2018, the patient developed shingles on her left arm (herpes zoster). The patient was given treatment for the event. It was unknown if any lab diagnostics/studies were performed. The patient sought medical attention for the event. The patient was not given any intervention. The event did not lead to significant disability or incapacity, neither resulted in hospitalization. No further information was provided. The outcome of herpes zoster was not recovered. The reporter did not provide the causality of herpes zoster with ZOSTAVAX. No product quality complaint (PQC) was involved.
Patient experienced worsening of diabetic neuropathy symptoms after receiving the vaccine. The patient reached out to the pharmacy 11/12/18 because the stinging sensation had spread to her trunk. On 11/1418 the patient was given a rx for NORCO 5/325 mg to help with these sensations and the husband reported the patient was feeling somewhat better.
Muscle pain, headache, shivering, fever, nausea, weakness, loss of appetite, dizziness
This spontaneous report was received from a nurse refers to one-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 12-SEP-2017, the patient was vaccinated with improperly stored VAQTA, lot # N008823, expiry date: 26-MAY-2018, and M-M-R II, lot# M045392, expiry date: 17-NOV-2018;  dosing details not provided, both for prophylaxis. The lot# of M-M-R II was reconstituted with properly stored sterile diluent. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
1st dose May2022, no 2nd dose yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on May 2022 by intramuscular route in an unknown arm).   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: 1st dose May2022, no 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 05-MAY-2023 The patient was self-reported this case. The patient reported that he received first dose of Shingrix vaccine about 1 year ago. The patient stated that he will contact healthcare professional for second dose of Shingrix vaccine. The reporter did not consent to follow up. Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination.
Patient presents with c/o lightheadedness, dizziness, diaphoretic following 1st dose of Pfizer vaccine. Patient being evaluated by EMS. Vitals assessed. 0 SOB. Patient in Trendelenburg position. Refused IV. refused transport to ER. Continuous monitoring until vitals  WNL.
19APR93 pt c/o numbness lt arm & dec in handwriting (is lt handed); drags lt leg; onset 7 days p/receiving MMR) that 1st day, pt felt dizzy & lt arm & leg felt numb; all tendon reflexes ++ rt arm & leg & +++ lt arm & leg; Babinski neg bilat
Participant emailed 08/02/2021 and stated:  day after PCV13 vaccination "started experiencing skin itchiness and fatigue.  Itchiness persisted and progressed to my trunk and extremities, patchy intermittent migrating red blotchy rash, and extreme sensitivity to contact of my skin with clothing (red, inflamed streaks and exaggerated redness to scratching).  By the end of the week I began having itchiness of the palms of my hands and soles of my feet, and that progressed to pain yesterday (08/02/21) (difficulty holding a broom).  Went to Urgent Care 08/02/2021 and "received a steroid injection, methylpred 4 mg taper pack and instructions to take both H1 and H2 blocker antihistamines.  States was better last evening and 90% today. (08/03/2021)