chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shoulder pain; could not turn his neck for about 3 weeks; Fingers are really bad; fingers bent down at night and he had to pull them and straighten them up; Could not walk because his toes and fingers hurt; All his blood work for the rheumatoid markers were elevated; Severe neck pain; it aggravated his Rheumatoid Arthritis; sweats; low grade fever; A spontaneous  report was received from a consumer concerning a- 53 Years old, Male patient who experienced aggravated Rheumatoid Arthritis.   The patient's medical history included that he has had Rheumatoid Arthritis for a couple of years Products known to have been used by the patient, within two weeks prior to the event, included Prednisone and Leflunomide   On 15 Jan 202, the patient received their first of two planned doses of mRNA-1273 (Batch number: [0126ZOA])  On 12 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: [013L20A]) for prophylaxis of COVID-19 infection.   On 12 FEB 2021, the patient experienced low grade fever and sweats. On an unknown date, the patient experienced flare up of his Rheumatoid Arthritis with shoulder pain, severe neck pain and was unable to turn his neck for about 3 weeks, fingers were really bad, bent down at night and he had to pull to straighten them up and was not walk because his toes and fingers were hurting. Blood work for the rheumatoid markers were elevated. Treatment included prednisone and leflunomide.  Action taken with the drug in response to the event(s) is not applicable.  The outcome of the events, low grade fever, sweats were Recovered/Resolved. The outcome of the other events were were not known.; Reporter'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.
The patient developed a swollen right upper arm immediately after the injections. The patient's arm got worse the next day. The patient was seen in the ER and treated with Keflex for 10 days.
Patient received vaccine 9/20/16 approximately 7 PM. No reaction after vaccine. Patient called 9/22/16 stating he had a minor seizure 9/21/16 for approximately 10 mins. He is doing okay now.
Patient complained of nausea and dizziness after receiving vaccine. Noted to be hypotensive. Monitored for 1 hour. VSS, patient tolerating liquids, oriented x3. Discharged to home accompanied by wife.
Adacel was given to a 19 month old male patient instead of Daptacel / no AE; Adacel was given to a 19 month old male patient instead of Daptacel / no AE; Initial information was received on 03-Feb-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 19 months old male patient who received a 0.5 mL dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, past medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of concomitant HEPATITIS A VACCINE (HEPATITIS A) and INFLUENZA VACCINE (FLUZONE) (lot number and expiry date not reported) via unknown route and administration site.  On 31-Jan-2020, the patient received a 0.5 mL dose (forth dose of DTP) of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6307AA, expiry date: 31-May-2021), via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of actual medication error due to wrong product administered and inappropriate age at vaccine administration.  At the time of report, 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 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.
No adverse event; our fridge being out of range on 12/02/22 for one hour and and minimum temperature reached was 1.2°C.; patient vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (our fridge being out of range on 12/02/22 for one hour and and minimum temperature reached was 1.2°C.), POOR QUALITY PRODUCT ADMINISTERED (patient vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 02-Dec-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (our fridge being out of range on 12/02/22 for one hour and and minimum temperature reached was 1.2°C.). In December 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (our fridge being out of range on 12/02/22 for one hour and and minimum temperature reached was 1.2°C.), POOR QUALITY PRODUCT ADMINISTERED (patient vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (our fridge being out of range on 12/02/22 for one hour and and minimum temperature reached was 1.2°C.) and POOR QUALITY PRODUCT ADMINISTERED (patient vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened).    10 pediatric patients from 6 months to 5 years were vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened. Excursion happened on 02 Dec 2022 for 1 hour reand minimum temperature reached was 1.2°C. No AEs were reported  Concomitant medication not reported. Treatment medication not reported.   This case was linked to MODERNATX, INC.-MOD-2023-695843, MODERNATX, INC.-MOD-2023-695862, MODERNATX, INC.-MOD-2023-695870 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jan-2023: Live-follow-up: Non-Significant follow-up received.; Sender's Comments:  MODERNATX, INC.-MOD-2023-695843:Same reporter MODERNATX, INC.-MOD-2023-695862:Same reporter MODERNATX, INC.-MOD-2023-695870:Same reporter
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent condition and medical history reported. On an unknown date, the unspecified number of patients were vaccinated with improperly stored ROTATEQ orally (dose, lot# and expiration date not reported). There was no adverse effects reported. Additional information is not expected.
Three or four days after my second shot, I began to itch.  With it being "dry air season" I didn't think much of it.  Day by day, no matter what I was doing, the itching was getting uncontrollably worse.  After about day7 or 8 , I began to have outbreaks of rash in a multiple, random areas on my body.  I bough some creams still thinking it was dry skin.  Nothing was helping,  the rash was spreading, it was keepin me up at night.  After a few more days of treating, assuming that I was losing this battle,  I went to the doctor.  After inspection of all of the spots of bleeding rash all over my body I went through the standard array of questions,  trying to narrow down a possible exposure to the possible source of the itch.  Not a single question I answered even provided an avenue for discovery.  Didn't stay in a bed other than my own, no house guests, hotels, clothing donations, laundry soap change,  nothing at all.  Even asked how often I washed my bedding.  Once a week was the answer...   So,  based on the lack of available information the doctor said she believed that it was Scabies.  I don't have scabies.  I don't believe that for a moment.  I was given some creams and steroids which have relieved the itch somewhat but it still exists and at this moment I am not sure how it will be after I am off the meds.  Tomorrow will be the first day for that so we shall see.
Sinus infection; Humira citrate free did not work, felt like had not been taken in a while; Felt like body has not had Humira so long; Moody; Muscle ache; Feeling cold; This spontaneous case was reported by a physician and describes the occurrence of SINUSITIS (Sinus infection), DRUG INEFFECTIVE (Humira citrate free did not work, felt like had not been taken in a while), FEELING COLD (Feeling cold), FEELING ABNORMAL (Felt like body has not had Humira so long) and MOOD ALTERED (Moody) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 24-Apr-2021, the patient experienced FEELING COLD (Feeling cold). On an unknown date, the patient experienced SINUSITIS (Sinus infection), DRUG INEFFECTIVE (Humira citrate free did not work, felt like had not been taken in a while), FEELING ABNORMAL (Felt like body has not had Humira so long), MOOD ALTERED (Moody) and MYALGIA (Muscle ache). At the time of the report, SINUSITIS (Sinus infection), FEELING COLD (Feeling cold), FEELING ABNORMAL (Felt like body has not had Humira so long) and MOOD ALTERED (Moody) outcome was unknown, DRUG INEFFECTIVE (Humira citrate free did not work, felt like had not been taken in a while) had resolved and MYALGIA (Muscle ache) had not resolved.        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.   Treatment information included Aleve. The reporter's causality for the event(s) of felt cold, felt like body has not had humira so long, moody, muscle aching, and sinus infection was not provided. The reporter's causality for the event(s) of Humira citrate free did notwork/felt like had not been taken in a while with Humira (Adalimumab) was a reasonable possibility.  Company Comment: 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.; 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.
Severe Left Arm Pain; Weakness in the entire Left Arm (Left Shoulder to hand); This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Severe Left Arm Pain) and MUSCULAR WEAKNESS (Weakness in the entire Left Arm (Left Shoulder to hand)) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (Severe Left Arm Pain) and MUSCULAR WEAKNESS (Weakness in the entire Left Arm (Left Shoulder to hand)). The patient was treated with GABAPENTIN for Pain, at a dose of 300mg AM and 200mg HS; Physical therapy for Pain in extremity and Physical therapy for Muscular weakness. At the time of the report, PAIN IN EXTREMITY (Severe Left Arm Pain) and MUSCULAR WEAKNESS (Weakness in the entire Left Arm (Left Shoulder to hand)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal normal. On an unknown date, Nerve conduction studies: normal normal.     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.   Treatment medication Gabapentin 300mg AM and 200mg HS (500mg/day), which reduced the pain from 10/10 to a 4/10. The patient also tried physical therapy, however that discontinued as patient was financially unable to continue.
5-6 hours after the shot I got chills and could not get warm. I went to bed and had mild aches and had to wear a jacket to keep warm. Woke up 4am because could not sleep and was ok with only mild aches
Left arm swelling and erythema by patient report; Keflex 500 QID x 7d
Patient turned pale a minute after receiving all 4 vaccines, then her lips turned blue 1/2 minute later, she had a seizure, with her eyes flipping upwards, then arms were shaking. The whole episode lasted 1-1/2 minutes. She had same reaction 3 yrs ago, when blood was taken for lab tests.
Chills, body aches began in early morning By 6am headaches (intense pressure all around the front and sides of head), ongoing body aches - symptoms last about 12 hours Around 6pm, headaches become acute, right side temple, intense nausea followed by vomiting (2-4x) Around 10pm, 500mg paracetamol taken orally, by midnight symptoms begin to finally subside Unable to work all day, spend the majority of the day in bed The following day characterized by extreme fatigue - forced myself to work, but was challenging
Report (verbal) received that patients arm was red, swollen with "knot" at injection site.  Call received 05/23/2003.  Also report of fever, and "red streaks" on arm.  Symptoms lasted one week.
The patient experienced a syncopal episode, and passed out for about 30 seconds, one minute post-vaccination.  The observation period was extended. The patient vomited 3 times within the 2 hours observation period, with a small amount of yellow-colored liquid. Stated he has a history of vasovagal with a blood draw. Refused to activate EMS. Verbalized feeling better and left the site at 5:35 pm accompanied by his partner.
Started feeling tingly and pins and needles then hives on my stomach. The next had a raising heart where it threw me into a panic attack. Hives and tingly got progressively worse throughout the week.
Felt unwell, tired, then headache which transitioned to a migraine with a total of 3 more days of symptoms including some mental confusion.
This spontaneous report as received from a registered nurse refers to patients of unknown age. It was reported that PNEUMOVAX 23 (dose and lot# not reported) experienced an excursion of 1.7C for 3 hours, as well as a prior excursion of 0 C for 8 hours. Excursion supported. Both products have been administered post excursion. No adverse effects reported. This is one of the reports from the same reporter (lined with MARRS# 1409USA010969). Additional information has been requested.
DEATH; This spontaneous report received from a consumer through a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity. 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, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died and cause of death was not reported. It was unspecified if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220833399-covid-19 vaccine ad26.cov2.s-Death. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
itching on hands, feet, chest advised to take DPH & get into see MD if sx inc;
This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (second shot of modern a is awful - feel this bad) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced FEELING ABNORMAL (second shot of modern a is awful - feel this bad). The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Reporter did not allow further contact.
Had sore throat several days before receiving second group of vaccines on 07/12/2003.  07/12/2002 received: Td/Yellow Fever/MMR.  Presented same day to sick with complaints of difficulty swallowing, diarrhea, started that day, lasting several days.  On 07/13/2003 "found on floor of squad bay" in "obvious respiratory distress".  See attached notes:  17 year old female patient complained of light-headedness/dizzyness/shortness of breath for 15 minutes.  Patient found on floor of squad bay upon entry of dispensory personnel in obvious respiratory distress.  Applied 15c NRB decreased to 2L after 3 min.  Instructed patient to control breathing which was successful.  Patient discharged without incident.  Diagnosis: Febrile, Upper Respiratory Infection.
flu like symptoms; positive COVID test; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received first dose of BNT162B2 (solution for injection) via an unspecified route of administration on 23Apr2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. On an unspecified date it was reported that patient received first dose of vaccine on 23Apr2021. Wednesday patient started feeling flu like symptoms. 01May2021 patient received a positive COVID test. Second dose is scheduled for 14May2021. Patient would like to know if she can still get second dose of vaccine. Patient didn't receive any treatment for the events. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
No additional AE/PQC; five doses of the VARIVAX that underwent the temperature excursion were administered; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 14-MAY-2020, the varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # S008695 has been verified to be a valid lot number for varicella virus vaccine live (Oka/Merck), expiration date not reported, but upon internal validation established as 21-MAR-2021,0.5 ml once, for prophylaxis; route was not reported) that underwent the temperature excursion was administered. According to the reporter, the temperature excursions were below 9.2 degrees Celsius (°C) for 30 minutes; below 14 °C to below 10 °C (below 14.3) for 30 minutes, without any previous temperature excursion. No additional adverse effect was reported. The call was because of digital data logger. No product quality complaint reported.  This is one of the several reports from the same reporter.; Sender's Comments:  US-009507513-2008USA011114: US-009507513-2008USA011215: US-009507513-2008USA011596:
This case was reported in a literature article and described the occurrence of a cutaneous lymphoid hyperplasia in a 55 year old female subject who was vaccinated with influenza virus vaccine (manufacturer unspecified) for prophylaxis. On an unspecified date the subject received 1st dose of influenza vaccine (unknown, right deltoid). Within days of vaccination with Influenza vaccine, the subject developed an erythematous, non tender 1cm nodule within the inoculation site. Over the ensuing eighteen months, it gradually enlarged, and became pruritic and indurated. A biopsy revealed marginal zone B cell lymphoma. A staging evaluation including computed tomography scans of the chest and abdomen had no evidence of disease beyond the deltoid area. A four week course of radiotherapy resulted in a complete clinical regression. The patient developed recurrent disease on the contralateral anterior shoulder eighteen months after her initial presentation. She was not aware of any predisposing events localized to this site. The 1 CM recurrent lesions was excised with no further treatment. Histopathologically, both tumors had similar findings. the nodular proliferation's were characterized by a cellular lymphoplasmatic perivascular and periadnexal infiltration with mild cytologic atypia. Both tumors occupied the full thickness of the reticular dermis. There were no well formed germinal centers. The infiltrations were composed of small to medium sized lymphocytes, histiocytes and sheets of peripherally located plasma cells. Classic marginal zone of monocytoid lymphocytes were not conspicuous. The majority of the lymphoid cell were positive for the pan T cell markers CD3 and CD5. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the events were resolved. The author considered the events were related to vaccination with influenza vaccine.
experienced pain in chest muscle on left side.  it only bothered me at night - no other side effects to vaccine just the soreness in the chest muscle.  it occasionally flair up. not everyday
On 6/4/03 mother reported that pt had a high fever (undocumented) and was very lethargic the afternoon/evening of her vaccination on 4/2. She had a "mild" seizure. The following day she acted like she usually does after her vaccinations. She was not evaluated by her regular physician. Family did call hospital for advice. "Seizure" lasted 5 seconds.
TELEPHONE CALL FROM MOM STATING VARICELLA INJECTION SITE ITCHY, SIZE OF SOFTBALL, REDDENED AND SWOLLEN APPROX 1/2" HIGH. MENINGOCOCCAL INJECTION SITE REDDENED ABOUT 1/2 DOLLAR SIZED, SWOLLEN, AND ACHY. INSTRUCTED TO APPLY ICE AND GIVE BENADRYL AND TO COME TO OFFICE IF SYMPTOMS WORSEN, OR FEVER OR RASH APPEARS.