chrisvoncsefalvay/vaers-outcomes huggingface dataset:
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications or treatment details were reported.  The patient received the first dose of Moderna on 13-Jan-2021 (Lot number: 041L20A)   This case was linked to MOD-2021-395985 (Patient Link).
pain at injection site has gotten progressively worse over time. injection done on 6/14/2021; pain has spread to entire body now. unable to get out of bed. physically weakened over time, progressively worse. at this time requiring assistance to get out of bed. patient just reporting adverse event to pharmacy on 2/14/22, seeking advise/help on how to get better.  unable to move physically. feeling weak physically since 6/14/2021; weakness has progressively gotten worse.  still experiencing weakness as of 2/14/22 - used to be active. used to be able to exercise, able to go on walks. Now, unable to get out of bed with out assistance
Within 24 hours redness, induration + warmth Seen 8/31/19 5 x 5.5 cm area redness warmth tenderness (L) humeral area
As stated by the patient: As the nurse was administering the vaccine into Left deltoid, I yelled aloud as it was painful. If felt as if the inj hit the bone. The nurse administering stated it felt hard to push the med into the arm.
Patient called the store on 8/30/2018, 3 days after the administration of SHINGRIX, said she experiences redness and swelling around the injection site, she also feels fatigue and weakness. She contacted her doctor office and they advised her that the site of injection was probably too low on her arm, and that she might have cellulitis. They wrote the Rx for KEFLEX and instructed her to take it if the area of swelling and redness keep getting bigger.
Pt was given Moderna as first Covid vaccine on 5/25/21, and then was given Pfizer in error as second dose on 6/22/21 by provider in clinic, NP.
red, warm to touch around injection site area.  Started on Sunday and keeps growing. doesn't hurt or itch but is warm to touch. pt has used alcohol and hydrocortisone
Case number PHEH2015US026907, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 25-years-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 07 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The nurse stated that, the reason was unknown for the refrigerator to be out of temperature range. There was no any further problem since the temperature excursion problem. No further information was provided. No adverse event was reported following this medication errors (incorrect storage of drug). Follow up report received from nurse on 26 Jan 2016: Updated reporters comments.
Subsequent to receiving one dose of varicella virus vaccine live on 5/31/95, the pt developed varicella with approximately 20 lesions, on 5/9/99. One lesion was cultured and revealed to be positive for varicella. The pt sought unspecified medical attention and he recovered.
WHILE WALKING TO OBSERVATION AREA, PATIENT FELT NAUTIOUS, DIZZY, LIGHT HEADED, BLURRED VISION, SHAKY AND CLAMMY, STATES SHE FELT LIKE SHE WAS GOING TO PASS OUT.  VITAL SIGNS WHILE IN OBSERVATION 100/60, 99% O2 SAT, 89 PULSE, GIVEN BOTTLED WATER, COLD COMPRESS ON NECK.  WITHIN 15 MINUTES, PATIENT STATED FELT FINE.  NO FURTHER MEDICAL CARE NEEDED AFTER THE 30 MINUTE OBSERVATION.
Diffuse erythema of the upper extremities and upper chest after vaccination in 30 minutes of being administered.
Diaphoretic, lightheadedness, blurred vision, pallor. H2O, snack, cool rag on neck.                                 Date: 3/22/2021  Problem: J&J Post-Vac Notes:  Time: 1555 Pt. Diaphoretic, light headedness, blurred-vision, and pallor. BP 193/89 HR 49, temp 97.0, RR 26. Gave pt H2O, a small snack, and a cool rag for back of patients neck. Monitored pt. No s/s of acute distress. Time: 1629  Pt reported clear vision and "feeling much better. " Pt teaching on s/s of allergic reaction. BP 179/66, HR 60, temp 97.6 F, SpO2 985. Pt ambulated out of facility building independently. No s/s of distress.
Breakthrough of COVID after vaccines. I had pressure in my chest and difficulty breathing. I went to the ER where I was told I had Bronchitis and swollen of the heart.
Major headache - significantly affected daily life for around 12 hours before taking Tylenol; subsided but still lasted a bit until the next morning, though definitely much more manageable the next day  Itchy, swollen rash at injection site and the nearby site of where a polio vaccine scar remained - became noticeable on the 30th and remains on May 1st. Not very itchy, but is noticeably red and swollen.
Breakthrough case admission after 2 vaccines Moderna 2/4/21 Lot# 007M20A;  Moderna 4/7/21 Lot# 018B21A
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: infection-Medium, Additional Details: swabbed with 1 alcholol pad the area for infection and then admistered vaccine. pt states the area of injection was not swabbed properly and got an  infection. used new alcholol pad and used gloves and sterile needle
Moderna COVID-19 Vaccine EUA.  Nausea and vomiting.
Friday evening fever, rash started 6/30 on back and arms, light on cheeks.
Pt. was vaccinated in the R Deltoid on Friday 8/10/07 and noticed on Saturday morning, redness and swelling near her R armpit, later that day and into Sunday pt. noticed a few more swellings, on her R arm, none of them where the vaccine was administered, one was on the backside of her are and one closer near her elbow.  The only other symptom pt. had was some fatigue on Saturday and soreness at the injection site.  Pt. states that she has been taking Motrin for the soreness and that these swellings have not gotten any worse and seem as though they are starting to go away.
Pt began having a migraine on the morning of 04/10/19 which lasted all day. Starting on 04/11/19 a large swelling appeared at the injection site. Patient applied a warm compress and the swelling subsided a few hours later.
shortness of breath and wheezing; went to Er 9 days after receiving the vaccine for these symptoms
red rash on face with redness around eyes, pt given solumedrol 40 mg IM and Benadryl oral no complications recovered fully
This spontaneous report as received from a 28 years old female registered nurse refers to herself. The patient was vaccinated with GARDASIL (lot number, expired date and injection site were not reported) (0.5 ml suspension, 0, 2 and 6 months, intramuscular injection) for prevention of HPV on an unknown date at the patient's age of 25. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient received 2 doses of GARDASIL at age 25 but did not complete the regimen and was "diagnosed with Cervical cancer at age 28". Unspecified treatment type was performed. The therapy was discontinued. The outcome of cervical cancer was reported as recovered on unspecified date. The reporter considered the cervical cancer was a life threatening event. The patient had sought unspecified medical attention. Additional information is not expected.
This case meets vaccine breakthrough criteria .  SXS INCLUDE RIGORS, BODY ACHES, CONGESTION, SOB
Pain upon administration  Pain beginning 2 weeks after shot and ongoing pain since.  Now radiating around to muscle and causing pain when I try to exercise, reach, sleep, lift, etc.
I went in to work at a building on 12-17-21. I wasn't feeling well.  The principal said to meet her as soon as I got there to get a Covid Test. After the test, I had to wait for results.  The results were delivered about 9:00 at which time I had to pack up my items and leave!  I had a headache by then.    I drove home.  I remember taking around 5 naps that day, in the course of 10 hours.  Over the next 15 days, I did not have energy, I lost my smell, I had a headache, aches and pains in the muscles of my arms, uncomfortableness in the toes of my feet, I was cold.        For the next 15 days, I did not do much at all except drink, eat what was brought to me, take Tylenol when needed, cover up with blankets, took naps when needed and hung out on the couch watching tv.  I didn't care that I missed parties.
Pt recvd 3rd hep B vax 13NOV90 & was determined to be not immune to hep B on 10JAN91.
PT APPEARED TO BE HAVING A SEIZURE  THE PHARMACIST WAS PREPARING THE EPI-PEN WHEN THE PATIENT CAME AROUND. THE PARAMEDICS WERE CALLED. WHEN THE PARAMEDICS ARRIVED PT WAS ORIENTED AS TO TIME AND PLACE WHILE PARAMEDICS WERE  TALKING TO THE PATIENT HE AGAIN APPEARED TO HAVE ANOTHER  EPISODE. AT THAT TIME THE DECISION WAS MADE TO TAKE THE PATIENT TO EMERGENCY DEPARTMENT
A temperature excursion of unknown cause at 0.7 Celsius for 25 hours and 24 minutes with no AE; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case received from an other health professional.   This case involves a 9 years old male patient for whom reported temperature excursion of unknown cause at 0.7 Celsius for 25 hours and 24 minutes (Product storage error), while he received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], ,MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], IPV (VERO) [IPOL], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination and INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] [lot UJ477AA and expiry date: 30-Jun-2021] via an intramuscular route at an unknown administration site for prophylactic vaccination on Dec-2021.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   It was a case of actual medication error due to product storage error temperature too low. [Latency: at the same time of vaccination].  Details of laboratory data not reported.  It was reported that, caller reported opened Ipol Multi dose vials and opened Fluzone quadrivalent MDVs. Caller reporting excursion occurring in Dece-2020. Caller reported 11 doses of Fluzone quadrivalent MDVs were administered post excursion. Caller with question on viability of administered vaccines.   It was not reported if the patient received a corrective treatment.  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.  There will be no information available on the batch number for this case.
swelling, discomfort, and heat redness; Ice and Ibuprofen, Benadryl at Nite-
This spontaneous report was received from a physician via a company representative referring to a female patient of unknown age. Concomitant therapies included influenza virus vaccine (unspecified). Information about concurrent condition and medical history was not provided. In October 2016 ("within the last month"), the patient was vaccinated with a dose of GARDASIL 9 (strength, dose, frequency, route, lot # and expiration date were not reported). Subsequently, on the same date, the patient experienced syncope while sitting on the exam table and fell forward. The patient experienced a neck injury and was taken to the emergency room. No treatment was given for the events. At the time of this report, the outcome of the events was unknown. The causality between the events and GARDASIL 9 was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Received moderna- unsure of lot information, wasn't administered here.  Localized hives; noted less than 24 hours after the second covid vaccine; no respiratory or GI symptoms reported; advised that she continue use of benadryl 50 mg every 6 hours as needed and may substitute benadryl with zyrtec in the mornings to reduce sedation; may apply sarna for comfort; prednisone would not be advisable as it may reduce the effectiveness of the vaccine
pain in injection arm.  Fever and fatigue for 48 hours past booster.  Far worse than a case of covid.
Top of left foot started to hurt the day after the shot. I did not injure myself or cause this. It just started hurting .
Diagnosed with COVID 19 on 4/4/21. She developed sinus congestion on 3/31 and loss of taste and smell on 4/2.
Body aches, fever, chills, headache, nausea, sore throat, left ear pain, COVID exposure w/in 14 days
Information has been received from a pharmacist concerning an approximately 60 year old female who on 25-Feb-2009 was vaccinated with ZOSTAVAX (Merck) that was reconstituted with PNEUMOVAX vaccine on 25-Feb-2009. The last couple of days in approximately February 2009, the patient developed swelling on her arm (unspecified arm), and had been in bed for a couple of days from not feeling well after vaccination. The pharmacist contacted the physician. At the time of this report, the patient's swelling of her arm, not feeling well and vomiting persisted. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (swelling at injection site) and INJECTION SITE PAIN (soreness at injection site) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE SWELLING (swelling at injection site) and INJECTION SITE PAIN (soreness at injection site). At the time of the report, INJECTION SITE SWELLING (swelling at injection site) and INJECTION SITE PAIN (soreness at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
This patient had immunizations given on 12/29/00. On 12/30/00, episodes of increased irritability alternating with, "staring off like he was some where else", no blinking of eyes, no movements for 1-2 minutes, increased temperature, and a rash for 3 days.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 64 year old white and not hispanic or latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included: lupus, dust allergy, animal dander allergy, bees allergy, reaction to some anesthesia (malignant hyperthermia), penicillin allergy, and adhesive allergy, and other pre-existing medical conditions included: Patient had allergies to Sulfa, Beta-blockers and nylon handles on recyclable plastic bags.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805031 expiry: 24-AUG-2021) dose was not reported, 1 total, administered on 16-MAR-2021 for prophylactic vaccination on left arm. Concomitant medications included hydroxychloroquine for lupus.  On 05-AUG-2021, the patient reported lack of antibodies (confirmed immunological vaccine failure). Laboratory data included: Antibody test (NR: not provided) negative. On 07-Oct-2021 the patient was placed in a covid-19 unit at the doctor's office during a lupus follow up, The patient was unknowingly scheduled an appointment with the primary care physician on a day that was reserved for covid-19 patients. She never had covid-19 or covid-19 symptoms and was very careful, so the patient was upset. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number: 90000196985.; Sender's Comments: V0: 20211020555-Covid-19 vaccine ad26.cov2.s -Confirmed immunological vaccine failure .This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
swelling in my face on two occasions, used cold compresses and they went down in 12 hours
Patient called pharmacy on 06/13/2021 01:20 P.M.. She complained of swelling from her left knee to her toe since getting her first dose of the Pfizer vaccine on 06/11/2021 in her right arm. Her arms were not swollen. Just her  left leg. Swelling started the night of 06/11/2021 and has not improved since then. She said she hadn't done any walking or any other movement that would cause this swelling. I told her to try putting on cold compresses and taking allergy medication to help with the swelling, and if it doesn't improve, to go see a doctor.
This case was reported by a pharmacist via sales rep and described the occurrence of chills in a 54-year-old patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020) for prophylaxis. On 15th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills. On an unknown date, the outcome of the chills was unknown. The reporter considered the chills to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported, however, it could be 53 or 54 years. The patient was a hospital employee. The patient did not have any previous vaccination with ZOSTAVAX. Concomitant medications, vaccination facility, and other specific details were unknown, as no further information was provided during the call. The reporter gave consent to be contacted for follow up information. This case was one of the 9 cases reported by the same reporter. The reporter stated over the phone that about half of the eight patients had experienced flu-like symptoms, one of which was another doctor who could not go to a work related event the next day because of the symptoms. It was unknown which of the eight patients was the concerned doctor.
This spontaneous report as received from a nurse 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 15-JAN-2019, the patient was vaccinated with improperly stored VARIVAX, lot # R022116, expiration date 02-AUG-2020, subcutaneously, diluted in properly stored sterile diluent for prophylaxis. The vaccine was stored in temperature ranges 15 Fahrenheit degrees to 46 Fahrenheit degrees for 45 minutes. Previous temperature excursion was also reported in ranges 6 Fahrenheit degrees to 14 Fahrenheit degrees for 30 minutes and 15 Fahrenheit degrees to 46 Fahrenheit degrees for 8 hours and 5 minutes. The temperature was measured by "data logger" No adverse effects reported. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1901USA006124; US-009507513-1902USA000278.
Information has been received from a registered nurse concerning a 12 month old female with no known drug allergies who on 3/29/04 was vaccinated SC with a first dose in the left thigh of varicella virus vaccine live (lot #646241/0548N). There was no illness at the time of vaccination. On 4/2/04, 3-4 days after injection, redness and firmness occurred on the left thigh. On 4/14/04, the patient came back to the office with a knot in her thigh at the injection site, which was very red and the size was somewhere between a quarter and a fifty cent piece (also described as redness increased to size of quarter with firmness 1.2 dollar size). There ere no laboratory diagnostic tests performed. It was noted that the redness had resolved on 5/5/04 but the firmness was still present, however, decreased in size. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Client called on 11/19/2010 @ 9 am to report that she was having severe swelling, redness, and pain in her right arm. She said "at first it was bubbly and puffy where I got the shot and then it got worse and became searing pain up to my armpit. I can't move my right arm." Client stated she was unable to work or go to school because of the pain. Public Health Nurse recommended a cold compress and take analgesic medication and to seek medical evaluation. Client stated she had already done the first aid activities and was scheduled to see a doctor on 11/19/2010.
I woke up and my eye was red on the white part of my eye. It didn't itch or anything it was just red. My doctor said it was a calloused part of my eye that was worsened by the vaccine. I was given an eye ointment, neomyc-polym-dexamet which helped when I put it on my eyelids.
like zoster rash; Injection site swelling; redness; fever; fatigue; Chills; Myalgia; heart palpitations; gastrointestinal upset; This case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. In April 2019, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, fever, fatigue, chills, myalgia, palpitation, gastrointestinal upset and rash zosteriform. In April 2019, the outcome of the injection site swelling, injection site erythema, fever, fatigue, chills, myalgia, palpitation and gastrointestinal upset were recovered/resolved. On an unknown date, the outcome of the rash zosteriform was recovering/resolving.   It was unknown if the reporter considered the injection site swelling, injection site erythema, fever, fatigue, chills, myalgia, palpitation, gastrointestinal upset and rash zosteriform to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that Within 72 hours post injection, the patient experienced swelling at injection site, redness, fever 102 degree F, chills, fatigue, myalgia, heart palpitations for 24 hours. The patient experienced GI upset for 48 hours post dose. The patient did get rash above right eye brow size of nickel that presented like zoster rash. Rash was healing, still vaguely present. The patient had tested for flu, the results were negative. The patient had consented to follow up.
48 hours subsequent to receiving varicella virus vaccine live the pt developed a rash. It was noted that the reporter did not ask the pt how many lesions were present or where the rash was located.
Severe arm pain, hurts at site and to lift arm. Low grade temp. feeling tired and weak.