chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient had third dose (two doses of Menactra prior to MENQUADFI that he was given today) with no reported adverse event; Initial information received on 20-Jun-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 18 years old male patient who received third dose (two doses of menactra prior to meningococcal A-C-Y-W135 (T conj) vaccine [Menquadfi] that he was given today) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV vaccine (HPV vaccine) for Immunisation.  On 20-Jun-2023, the patient received 0.5 mL dose 3 of suspect meningococcal A-C-Y-W135 (T conj) vaccine, solution for injection (batch number: U7616AB; expiry date: 11-Apr-2025) via intramuscular route in the right deltoid for immunization (two doses of menactra prior to menquadfi that he was given today) with no reported adverse event (extra dose administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event patient had third dose (two doses of menactra prior to menquadfi that he was given today) with no reported adverse event.  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 guidelines. 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.
16 year old vaccinated; A spontaneous reportwas received from a Pharmacist regarding 16-year-old individual, unknown race, and ethnicity, who was administered first dose of Moderna Covid-19 vaccine on 19-FEB-2021 (Inappropriate age at vaccine administration).  The patient's medical history was not provided. No concomitant medications were reported. No information on allergies.  On 19-FEB-2021, individual received first of two planned doses of Moderna Covid-19 vaccine intramuscularly for the prophylaxis of Covid-19 infection. (Lot : 029L20A).   It was not known whether the individual experienced any adverse event after vaccination.   Action taken with 2nd dose of vaccine was not reported.  The outcome of the event inappropriate age at vaccination was recovered.; Reporter's Comments: This report refers to a case of 'Inappropriate age at vaccine administration'  for mRNA-1273, Lot : 029L20A with no associated AEs. Causality for the medication error is not applicable.
100 degree fever, chills, sweating, heart racing, tightness in chest, headache, full body aches and nausea. Symptoms began late Sunday night (more than 48 hrs after booster vaccine). Monday & Tuesday was able to be out of bed for only short periods before needing to lay back down. Caused night panic attacks Monday & Tuesday night. Wednesday woke up with no fever feeling much better but very weak. Was able to work most of the day but needed a nap in the middle of the day. Thursday (today) I feel mostly better though still feel very weak and winded after walking up a flight of stairs, or being up for more than 15-20 minutes. Other than a slight tightness in my chest and headache, I have no other symptoms.
Received phone report from teen client's mother.  Teen had fever  and chills 3 to 4 hours after injection. This AM teen is having chest pain.  Regular breathing  without difficultly, no fever, and is sleeping.  Pediatrician will visit them in home this PM. Advised  if worse symptoms before pediatrcian visit to go to ER.
This spontaneous report was received a female patient of unknown age reporting on herself. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 07-OCT-2017, also reported as "this past Saturday" the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unspecified date in October 2017, also reported as "now" the patient experienced an streaky, painful rash about 2 inches below the injection site on an unspecified arm. The outcome of the event painful rash about 2 inches below the injection site was reported as not resolved. Additionally, the reporter did not provide causality assessment between the events and therapy with PNEUMOVAX 23.
Right arm/shoulder pain when pulling up pants, taking off bra or tucking in shirt. No redness, No swelling, No nodules, Not in the shoulder its right where they shot was given.
Soreness of skin on abdomen and legs.  Draining blister lesions on left side of back at beltline and Left leg blister lesions. From Shingles vaccine by Merck.
Can not stand straight on her own; Feels like she have covid again; red knot on arm; Coughing real bad; Fever; Chills; Headache; Can't get out of bed; Hurting all over; Arm hurting; Dragging; Weak and can't move around; Shortness of breath; Can barely open her eyes; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Can't get out of bed), MYALGIA (Hurting all over), PAIN IN EXTREMITY (Arm hurting), VACCINATION COMPLICATION (Dragging) and ASTHENIA (Weak and can't move around) in a 57-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.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LETHARGY (Can't get out of bed), MYALGIA (Hurting all over), PAIN IN EXTREMITY (Arm hurting), VACCINATION COMPLICATION (Dragging), ASTHENIA (Weak and can't move around), DYSPNOEA (Shortness of breath), OCULAR DISCOMFORT (Can barely open her eyes), DYSSTASIA (Can not stand straight on her own), SUSPECTED COVID-19 (Feels like she have covid again), VACCINATION SITE MASS (red knot on arm), COUGH (Coughing real bad), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, LETHARGY (Can't get out of bed), MYALGIA (Hurting all over), PAIN IN EXTREMITY (Arm hurting), VACCINATION COMPLICATION (Dragging), ASTHENIA (Weak and can't move around), DYSPNOEA (Shortness of breath), OCULAR DISCOMFORT (Can barely open her eyes), DYSSTASIA (Can not stand straight on her own), SUSPECTED COVID-19 (Feels like she have covid again), VACCINATION SITE MASS (red knot on arm), COUGH (Coughing real bad), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
flu-like symptoms; achy; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), MYALGIA (achy) and FATIGUE (fatigue) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), MYALGIA (achy) and FATIGUE (fatigue). In March 2021, INFLUENZA LIKE ILLNESS (flu-like symptoms), MYALGIA (achy) and FATIGUE (fatigue) had resolved.            No Concomitant medications were provided. No treatment medications were provided   This case was linked to MOD-2021-406186 (Patient Link).
adverse event; A spontaneous report was received from a Consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced adverse event.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) for prophylaxis of COVID-19 infection.  On an unknown date, the patient developed adverse event.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, adverse event was unknown.; Reporter's Comments: This is a case of a consumer who experienced 'adverse event' event. No specific S/AE was reported. This case is being returned to provide a named event, otherwise this will be an invalid case.
Real tightness in chest, nervousness, not able to breath ,deep breath. could not go up stairs. after 2nd day went to urgent care.
I received the vaccine on February 10, 2021. Then I awoke with a sever pain in my lower left side, and called my doctor. After examining me, Dr. decided that I should go to local Hospital for an Ultrasound and a CT Scan.
Inj given right deltoid.  Right axilla irregularly swollen, burning, red, painful.  Took Benadryl 25mg po.  Redness subsided in 72 hrs.
Had severe reaction to flu shot and was down for 1 month. I called the health dept to report it but no one would believe me. I know several who also had reaction to shot. Flu shot stirred up my chronic bronchitis.
The child had an appt. scheduled on Tuesday 11/1/22 at 3:30pm for a COVID-19 Booster. Clinic that day for myself being the nurse scheduled had been busy/hectic. The Nursing Assistant offered to help me & went to the pharmacy to remove a vial of the 5yr-11yr. COVID-19 vaccine from the refrigerator for me to dilute & draw up the appropriate dose for the child. The child was due for her first Bivalent booster. I, the nurse, had trusted that the nursing assistant had removed the correct vial of 5yr-11r Bivalent vaccine. The vaccine was brought to my clinic room along with sterile diluent. I noticed that the diluent was the incorrect kind that was needed & I took the covid vaccine with me to the pharmacy & I obtained the normal saline diluent that I needed to dilute the covid vaccine. I diluted per covid protocol & then drew up the correct dose for the child. I administered the dose & had the child to wait with her guardian the allotted time after administration for 15 minutes. It was then I had realized when I was filling out the Pfizer covid sheet & the new covid vaccine card that I had diluted a monovalent 5yr-11yr covid vaccine instead of the Bivalent for the child's booster. I immediately notified my Nursing Supervisor of the incident occurrence & was further instructed to notify the guardian. I told the guardian of what had taken place & apologized to her. The guardian completely understood & wasn't upset, but wanted to know when the child would be able to receive the correct Bivalent booster for her age. My supervisor called the Nursing Director & she confirmed in 2 months the child would be able to receive the correct booster. The guardian verbalized all understanding & scheduled an appt. to receive in January 2023. The child has had no reaction or complication to the incorrect booster.
Throat tightness; Swelling lips; Numbness of the body; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Throat tightness) and HYPOAESTHESIA (Numbness of the body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced THROAT TIGHTNESS (Throat tightness) and HYPOAESTHESIA (Numbness of the body). The patient was treated with PREDNISONE at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, THROAT TIGHTNESS (Throat tightness) and HYPOAESTHESIA (Numbness of the body) outcome was unknown.            This case was linked to MOD21-052205 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Apr-2021: Patient Email added; 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.
Patient complained of a itchy, painful rash begining the day after the injection was recieved
No additional AEs; Caller reported vaccine administered after temperature excursions.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On 03-AUG-2023, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) injection rHA (0.5 mL, intramuscularly, lot #W038809, expiration date 04-JUN-2024, anatomical location was not provided) for prophylaxis (Product storage error).  On unknown day, the suspect vaccine experienced a temperature excursion of 18.3 degrees Fahrenheit for 1 hour and 5 minutes. There was no reported previous temperature excursion. No additional adverse events (AEs) or product quality complaints (PQC)reported. No additional information provided.
Felt dizzy and short of breath. While driving lights were blurry. Went to ER and got breathing treatment, discovered had bronchitis in airways, had tingling also.
small lump & soreness @ inject site; rx w/ice & APAP; resolved in a few days;
2 bouts of PAT.  Had not had arrhythmia since 48 hours after MI 8/18. Episodes caused pulse rate of 150  with drop io in BP  to 86/50 and slight SOB. First episode lasted 5 min, second 3 min appox 10 min apart. Seemed to respond to carotid massage. Reported to cardiologist. (I am retired RN)
This spontaneous report was received from a female patient of unknown age who refers to herself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 02-NOV-2017, the patient was vaccinated with dose of PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported) for prevention of pneumonia. On the same day, the patient experienced pain and swelling at the injection site. The patient did not seek medical attention and no treatment was given for the adverse events. The outcome of the events was reported as recovered on an unknown date in November 2017. The relatedness between the events and the vaccination with PNEUMOVAX 23 was not reported.
Patient received single J&J vaccine on 12/29/22. NP misinterpreted information on CDC interim covid-19 immunization schedule, so instructed LPN to administer full dose of Moderna rather than booster dose of Moderna.
PATIENT REPORTS PAIN IN ARM SWELLING, REDNESS, HEADACHE, BACK PAIN, EXTREME FATIGUE
the day of I had a really bad headache, the next two morning my body was in so much pain it felt like I was working out for hours just trying to sit up. on the 7th I went and got a tattoo and my skin was puffy the moment the needle touched my skin, the ink wouldn't stick, the artist said this also happenedd to someone else who got their second dose I've been taking Tylenol since the day I was vaccinated
I got really sick for nearly two days after getting the shot.; had one shot of the Moderna vaccine, but it was eight months ago.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I got really sick for nearly two days after getting the shot.) and PRODUCT DOSE OMISSION ISSUE (had one shot of the Moderna vaccine, but it was eight months ago.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I got really sick for nearly two days after getting the shot.) and PRODUCT DOSE OMISSION ISSUE (had one shot of the Moderna vaccine, but it was eight months ago.). At the time of the report, ILLNESS (I got really sick for nearly two days after getting the shot.) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (had one shot of the Moderna vaccine, but it was eight months ago.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided. Reported that patient had COVID-19 3 months prior to receiving vaccine. No treatment medication were provided.
Have been unable to lift or use my right arm since receiving my second shot, in severe pain have been to 3 different doctors received various medications ( steroids, pain meds anti inflammatory meds and cortisone shots. Also every joint, muscle and bone in my whole body is and has been in severe pain.  The shot has seemed to agrivate my arthritis and I can not function or do normal everyday life.  I was told my shot was given into my bursa muscle and is due to lack of experience but that doesn't help with all the pain I am in. I need help getting dressed and I have to shower every time I have a bowl movement because it hurts so bad that I can not put my arm back to wipe myself.  It has really destroyed my life and the arm could have been avoided if only the person giving the shot was trained properly.  I am still going to doctors, I was told to see a rheumatologist.  Alot of doctors visits money and medications  and still no relief.
Approx. 4 months after receiving ZOSTAVAX vaccine, diagnosed with bad case of shingles - large red painful rash around L trunk.  Severe pain after blisters heated.  Pt said it took 7-8 wks to fully recover.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, three months after initial dose, the patient was vaccinated too early with a second dose of VAQTA intramuscularly (dose not reported, lot# R009799, expiration date 02-JUN-2019) for prophylaxis. No adverse effects were reported.
Received #5 DTaP and #4 IPV and #2 MMR on 08/19/03 after going home received call that child had hives. Mother gave Benadryl for age, did subside but returned. Week later with hives and meds received.
Member diagnosed with SARS-COV-19 on 4/15/2021 after being fully vaccinated.
pt recv vax; w/in 1/2 hr, started crying for 7 hr; poor appetite;
ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 6/22/2021 PALLIATIVE CARE ACUTE DVT, UNSPECIFIED VEIN 6/29/2021 PALLIATIVE CARE
Information has been received from a pharmacist concerning a female patient 50-60 years old, with penicillin allergy, who in early June 2006 was vaccinated (route unknown) with a dose of Pneumovax 23 (Lot # unknown). One to two days after vaccination, the patient experienced systemic rash. She was treated as an outpatient with diphenhydramine hydrochloride (BENADRYL) and prednisone. At the time of the report the patient was currently in the emergency room. The patient's status was reported as not recovered. No product quality control was involved. No further information is available.
Rash, hot to touch, swollen from injection site down my arm to my wrist and up to my neck. This also wrapped around my arm part way. Very very tender to touch. Numbness in my extremities (arms). Worse in the hands than in the arms. The rash went away in  7-8 days after the shots. The numbness in extremities (arms) continues and is fluctuates on the severity.
Information has been received from a physician's assistant concerning her 6 year old son who in December 1995 was vaccinated with varicella vaccine. On approximately 05/17/2001 the pt developed 60-80 vesicular lesions. No other symptoms were noted. Unspecified medical attention was sought. The reporter also mentioned a similar case. Additional info has been requested.
A report has been received from a Health Professional concerning a 1 year old, female subject, who had been receiving FLUMIST QUADRIVALENT.  FLUMIST QUADRIVALENT started on 08-OCT-2014. A 16 month old received FLUMIST QUADRIVALENT. The outcome of the event of 16 month old received FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Pox; Pox; This case was reported by a pharmacist via sales rep and described the occurrence of red spotty rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced red spotty rash and blister. On an unknown date, the outcome of the red spotty rash and blister were unknown.   It was unknown if the reporter considered the red spotty rash and blister to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that she received 1st dose of Shingrix and experienced pox. No other information was available. The reporter did not consented to follow up.
Developed rheumatoid arthritis.  First joint to get inflamed was the sternoclavicular on 05/15/2021
Injection Site Infection - Information has been received from a physician concerning a 12 month old female patient who on 22 Mar 2000 was vaccinated SC with the first dose of varicella virus vaccinelive (Lot #631068/1345J) in the left thigh.  On 30 Mar 2000 the patient developed three dime size lesion (pustules) around the injection site.  The patient sought unspecified medical attention on the unspecified date the patient recovered.  No further information is available.
w/in 1/2hr of vax pt exp high fever (101 axillary) & listlessness;pt seen in office later in day T102 ax, pt lethargic;neck supple, no sz activity;
Injection received at 10:45 AM on 10-6-11 in Left deltoid.  Immediately started burning and burning sensation ran up arm and down her back. On Friday 10-7-11 had swelling of left axillary area and left side of chest including breast.  Swelling of breast has subsided but still having some swelling of axillary region.  Had some muscle spasms under left arm for about 3 days.
Exhaustion, chest pain, coughing, difficulty catching breath, nausea,  lasted 3 days, and of course sore L arm.
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. Concurrent conditions and medical history were not reported. No known allergies. On 12-DEC-2014 (reported as 10 days ago), the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously, (strength, frequency, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. Pharmacist stated that physician wanted to place patient, on methotrexate therapy for rheumatoid arthritis on an unspecified date in December 2014. Pharmacist stated that to her knowledge, patient did not have pre-existing history of rheumatoid arthritis. It was reported that treatment with methotrexate was given for the adverse event, and it was unspecified if the patient sought medical attention. The outcome of rheumatoid arthritis was unknown. The relatedness between the event and therapy with ZOSTAVAX was not reported. Additional information is not expected. The reporter did not consent contact for further follow up.