chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no additional adverse event; VARIVAX and MMRII administered after a TE; This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender. The patient's medical history, concomitant medications, concurrent conditions, previous drug reactions and allergies were not provided.  On 25-JUL-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number U030161 which has been verified to be valid, expiration date reported and validated as 28-SEP-2023) and measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) injection (lot number U028163 which has been verified to be valid, expiration date reported and validated as 09-SEP-2023); both administered as prophylaxis (doses, routes of administration and anatomical sites of injection were not reported). The administered dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) was stored at a temperature of - 10 degrees Celsius (C) up to 8 C, during an unspecified time frame; and 3.4 C, during a time frame of 10 hours. The administered dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) was stored at a temperature of 23.8 C, during a time frame of 9 hours and 45 minutes (product storage error). There was no previous temperature excursion. No additional adverse events were reported in the patient.
A report has been received from a literature source concerning an Adult, subject of unknown gender, who had been receiving FLUMIST (intranasal). FLUMIST started on an unknown date. The patient experienced nausea and chills. The outcome of the event of nausea and chills is unknown. The report was considered to be non-serious.
Initial COVID-19 infection prior to COVID-19 treatment; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Penicillin allergy.    On 02-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 21-May-2022 to 25-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-May-2022, SARS-CoV-2 test: positive (Positive) rebound infection indicated by symptom return and home antigen testing.         No concomitant medication was reported.  It was reported that patient had not taking any other medications within 2 weeks of starting COVID-19 treatment. Hospitalization prolonged reported as no  Treatment received reported as no.  Company Comment:  This is a spontaneous case concerning a 76-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, described as initial COVID-19 infection prior to COVID-19 treatment, which occurred approximately one month after receiving a dose of mRNA-1273 as the fourth dose of COVID-19 vaccine (no information disclosed on previous COVID-19 vaccinations). Patient took a five-day-course of COVID-19 treatment for the initial COVID-19 infection. However, six days after the completion of COVID-19 treatment, patient reported returned of symptoms and rebound infection, which was supported by a positive COVID-19 antigen test. Outcome of the event for the initial COVID-19 infection had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 76-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, described as initial COVID-19 infection prior to COVID-19 treatment, which occurred approximately one month after receiving a dose of mRNA-1273 as the fourth dose of COVID-19 vaccine (no information disclosed on previous COVID-19 vaccinations). Patient took a five-day-course of COVID-19 treatment for the initial COVID-19 infection. However, six days after the completion of COVID-19 treatment, patient reported returned of symptoms and rebound infection, which was supported by a positive COVID-19 antigen test. Outcome of the event for the initial COVID-19 infection had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient came in to get her booster dose. She reported experiencing a local rash with her first dose.  She self treated with Benadryl and did not report to her doctor. She had no adverse reactions with the second dose and currently doing fine with her booster dose.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history or drug reactions/allergies were not provided. On 12-DEC-2016 the patient was vaccinated with an expired dose of VARIVAX (lot # K018964, expiration date 15-OCT-2016; dose and route unknown) for prophylaxis. The healthcare worker reported this dose of VARIVAX was always properly stored. No adverse effects were reported. Additional information has been requested.
Already described above.  Basically soreness of arm and shoulder which increased throughout evening and made sleep very uncomfortable.  Continued for a couple of days.
This case was reported by a physician to a sales representative and described the occurrence of decreased white cell count in a patient who was vaccinated with Pediarix for prophylaxis.  On an unspecified date on or before 19 October 2005, patient received a dose of Pediarix.  At an unspecified time after vaccination with Pediarix, on an unspecified date on or before 19 October 2005, the subject experienced " a white count of 25 and a prolonged fever."  The outcome of the events was not reported.
10/21/21 reported lymph node swelling in neck and right armpit. Stated very sore. 11/10/21 - Per Dr note: Continued pain and swelling since vaccination of right armpit. Steroids prescribed which caused increased blood sugar issues. He noted "softball size lymphadenopathy" that resulted in pain and reduced use of right arm. Continues to be treated by her PCP with next appt on 11/17/21.
Starting 05/22/2022, I developed severe head and face pain. I went to see my doctor the next day and they didn't know what it was. 2 days later, I was still having the pain and I broke out in a rash. So, they diagnosed me with Shingles. They put me on Valacyclovir and Gabapentin, which didn't seem to help at first. They had to increase the Gabapentin dose to help decrease the pain. Hopefully the higher dose will help with  the pain and, I still have the rash and pain, to this day.
FEVER OF 100 FOR 24 HOURS BODY ACHES AND DISCOMFORT.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP) from product quality group. The reporter is the patient.  An 82-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2022 at 09:00 as dose 4 (booster), single (Lot number: FL3209) at the age of 81 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Tested positive (after negative antigen test) 7 days after stopped treatment with Paxlovid. Symptoms included runny nose, fatigue, and cough.  Follow-up attempts are completed. No further information is expected.
pt earlier in day ahdt100;this was obtained by a skin temp probe @ forehead;p/vax approx 130PM next time temp check was 8PM taken by skin probe 100;then sz & temp noted 1030 taken to ER;
Headache, Myalgia, Fever, NauseaVomiting fatigue and injection site pain Narrative:
Spiking high Temp. Fluid in heart, lungs, and pelvis, weak limbs, gall bladder attacks had to be on meds. Amox TR-K CLV 875-125 MG Tab.
a family came in together for flu shots, but the children received ADACEL instead with no AE; Initial information was received on 21-Oct-2021 regarding an unsolicited valid non-serious case received via an other health care professional via a physician via phone (under agency Inquiry Number: 00822801).  This case is linked to cluster case US-SA-2021SA353235.  This case involves a 24 months old female patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of INFLUENZA VACCINE with no reported adverse event (wrong product administered).  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   On 21-Oct-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U7055BA and expiry date: 30-Jun-2023) via unknown route in the right thigh for prophylactic vaccination.  It was a case of an actual medication error due to wrong vaccine administered (Latency: same day).  It was reported "Caller states that a family came in together for flu shots, but the children received ADACEL instead of the flu shot. Caller would like to know if there is any safety issue and how will this affect their dosing schedule."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt was given incorrect dosing. was supposed to get 0.3ml and was given 0.5ml
This spontaneous report has been received from a pharmacist referring two patients of unknown age and gender. Information regarding pertinent medical history, drug reactions and concurrent conditions was not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX, injection, lot # L032397, expiration date 26-NOV-2016 (route of administration, dose, and frequency were not provided). Concomitant therapies were not reported. The administered doses experience a temperature excursion of 47 F for 3 hours. No previous excursions were reported. The temperature excursion was detected by a data logger. No adverse symptoms were reported. Product quality complaint was not involved. Additional information has been requested.
Developed rash at vaccine administration site (L thigh) which spread to face and other thigh. PE vesicles on face, papules on thigh surrounding site.
Initially patient claims entire body was sore and swollen on 10/1/21. Then on 10/2/21 only under his arm/chest was still sore and swollen.
Site reaction- left deltoid used for injection site, 7 days later the site became red, swollen, itchy, and warm to touch.  Lymph nodes in left axilla became mildly painful (pain rate 3/10).  Redness and swelling progressed to cover entire lateral aspect of my left upper arm within 24 hours of symptom onset.  I had a doctor look at it and she prescribed me Doxycycline x 5 days in case it was cellulitis.  Symptoms gradually subsided within 4 days.
The day after receiving the first vaccine, I felt lightheaded and foggy. About one week after the vaccine, I woke up in the middle of the night with severely itchy hands and feet. This has continued every night for the past 16 days. I also have sore red/purple bumps on my fingers and toes. I began taking Allegra  which has helped, but middle of the night itching, particularly on the bottoms of my big toes, continues. I have no gotten any additional bumps, but the ones that remain are extremely sore (almost like blisters).
Patient was given an undiluted dose of Pfizer Covid vaccine, 0.3mL.  Patient did not have a reaction post vaccine.
After the booster shot on 12/27/21 I had swollen lymph nodes under my left armpit.  (note the lot number on the 3rd shot was difficult to read as it was handwritten) Within a couple of weeks (Mid January 2022), tightness and soreness in lower back started.  I started to see a chiropractor but nothing helped with the tightness.   Beginning Mid February 2022, I began experiencing joint pain in my hips which eventually moved to my knees.  Severe pain as I have trouble walking and getting out of bed.  The soreness has  kept me from exercising which I actively participate at least 3 times a week.   I have never experienced anything like this so I began to wonder if I was getting arthritis.
On the 11th at 5 am I started to develop a fever of 103 and my left arm was painful enough to wake me up in the middle of night. I had swelling in my arm all the way up to my collar bone and I noticed a swollen lymph node. I also had splotchy rash with a little bit of itching. when my fever got to 103.3 my doctor advised me to take Tylenol and about an hour it went down to 101.4, and then as the Tylenol would wear off my fever would spike again, On Feb 12at 3 am my fever was 100.9. When my fever would break after I would take Tylenol I would sweat so much I had to change my clothes. By Friday the 12th  my fever had broken completely . I had a tele-med appointment over the phone with my nurse.
arthritic response to lyme vax which has persisted since 2nd inj;mild rxn 2/26/99 2nd dose 3/26/99 severe did not recv 3rd dose of vax;
experienced nausea; extreme fatigue; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient in her 40's received bnt162b2 (BNT162B2), administration date 18Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), when the patient was in their 40's, for COVID-19 immunization; Bnt162b2 (2nd dose), when the patient was in their 40's, for COVID-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 19Oct2021 03:00, outcome "not recovered", described as "experienced nausea"; FATIGUE (non-serious) with onset 19Oct2021 03:00, outcome "not recovered", described as "extreme fatigue".  Follow-up (24Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Petechiae on right ankle/lower calf. Approximately 10 spots in a cluster. Cluster is roughly 7 cm x 4 cm. No other symptoms. No treatment.
The day I got the second dose of the vaccine I was itchy all over. I started to get little dots on my shoulders. It traveled all around my torso and spread as hives. It was unusual that my father had the same symptoms, and he had the same medical conditions as I have. The hives were extremely itchy, and they were in big patches. I tried Benadryl, Calamine Lotion, Cortisone cream and oatmeal baths and nothing helped. About two weeks later I consulted my doctor and they prescribed Prednisone and an antihistamine. After a few days the hives cleared up and they did not return. I had not had any reaction to the first dose.
PAIN UNDER RIBS; FINGERS NUMB ON LEFT HAND; BLOOD PRESSURE 177/79; PAIN UNDER ARM; LEFT ARM HURTING; PAIN FROM SHOULDER TO ELBOW; HEADACHE; This spontaneous report received from a patient concerned an 82 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. Concomitant medications included losartan. On MAY-2021, Laboratory data included: Blood pressure (NR: not provided) 177/79 mmHg. On 07-MAY-2021, the subject experienced headache. On 10-MAY-2021, the subject experienced pain under ribs. On 10-MAY-2021, the subject experienced fingers numb on left hand. On 10-MAY-2021, the subject experienced blood pressure 177/79. On 10-MAY-2021, the subject experienced pain under arm. On 10-MAY-2021, the subject experienced left arm hurting. On 10-MAY-2021, the subject experienced pain from shoulder to elbow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, left arm hurting, pain under ribs, pain from shoulder to elbow, fingers numb on left hand, blood pressure 177/79, and pain under arm. This report was non-serious.
12 hours after injection:  felt cold water through body, extreme aches and difficulty walking due to pain in limbs.  R arm swelled, hot and itchy and stayed from 3/13-3/17.  The area was about 4 fingers wide and in height.  Unable to put any pressure on the area.  Light headed and dizzy 3/13 9 AM.  Needed a cold rag on forehead to avoid passing out. Dissipated after 30 minutes. Spent the day in bed. Extreme night sweats and fatigue 3/13, 3/15. Woke every hour soaking wet.  3/15 less night sweats, only 1 was bad.  Tried sleeping on R arm 3/14 & 3/15. Woke up with difficulty breathing through the nose and mouth. Nose was so dry it hurt.  This was better by 3/16.   Almost felt like an inhaler was needed, but eventually after 20-30 minutes the mouth breathing had calmed down.     Finally it's 3/17 and my arm feels only slightly sore and very localized.  It is not warm nor is it red.    Treatments for itchy arm - Allegra each day (didn't help).  Hydrocortizone cream ( helped a bit), Sarna lotion (helped a bit) Treatments for pain in arm - tylenol/hydrocodone  - didn't help so gave up.
tooth pain/ache; aches; pain at injection; fever-like chills; exhaustion; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration in left arm on 02Apr2021 (at the age of 24-year-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown), via an unspecified route of administration on an unknown date at single dose for COVID-19 immunisation. On an unknown date in Apr2021, the patient experienced tooth pain/ache, aches, pain at injection, fever-like chills, exhaustion. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events was recovered in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Her back, neck and shoulders have this rash/inner part of her arm has also this rash; Crusty feeling; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Her back, neck and shoulders have this rash/inner part of her arm has also this rash) and FEELING ABNORMAL (Crusty feeling) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced RASH (Her back, neck and shoulders have this rash/inner part of her arm has also this rash) and FEELING ABNORMAL (Crusty feeling). At the time of the report, RASH (Her back, neck and shoulders have this rash/inner part of her arm has also this rash) and FEELING ABNORMAL (Crusty feeling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
No additional AE; accidently administered an expired dose of MMR II to a patient; This spontaneous report was received from a registered nurse and refers to a 61-year-old patient of an unknown gender. The patient's medical history was not reported. The patient's concurrent conditions included non hodgkin's lymphoma in remission. Concomitant therapies were not reported. On 16-MAR-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) once (lot #T007234, expiration date: 27-FEB-2022) (formulation, dose and route of administration were not reported) for prophylaxis. The vaccine had no prior temperature excursions. No adverse events were reported.
Pt states approx 10 min after injection started with a headache and dizziness. Pt ate something around 0900. Patient was given a granola bar and water. at 1405 BP 171/90, HR 83, SP02 98%, RR 16. Pt states heart is "fluttery", pulse regular. 1416 pt states headache is better. pt denies chest pain or SOB. After sitting up from laying position pt states she was dizzier, repeated BP at 1427, no improvement. Gave pt juice b/c she felt shaky and thinks it's because she hasn't eaten. Had pt rest for 10-20 mins more and then obtained orthostatic vitals, no concern for orthostatic HTN, pt states she no longer has headache or is dizzy. Per pt's visitor her color had returned to normal, pt still feels a little shaky. Pt rested another 5 mins, repeated vitals and pts BP was elevated. Discussed with pt and visitor that due to her hx of HTN and her already being on BP meds, pt should be seen in ER and EMS called. Explained that she should have an EKG done b/c of flutters and HTN along with headache. Educated pt on importance of being seen in ED. Gave pt and visitor time to discuss suggestion, when returning pt states, "Talked to niece who is EMT and said I should be fine if I just went home, rested, ate, and checked BP and took another BP pill (1/2) like suggested with doc before getting ahold of physician. All they'll do in ED is continue to check BP". Advised pt that ED would do more than that. Pt refused EMS and wished to go home. Pt visitor stated that they would watch patient and if anything changed take to ED. Patient left clinic in wheelchair and assisted to vehicle. Pt denies any symptoms that she initially presented with but states she just feeling weak.