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 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), 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.   Concomitant medication information was not reported  Treatment information was not reported   This case was linked to MOD-2021-395985 (Patient Link).
fever of 103F; This spontaneous case was reported by an other and describes the occurrence of PYREXIA (fever of 103F) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced PYREXIA (fever of 103F). At the time of the report, PYREXIA (fever of 103F) outcome was unknown.            Treatment given included Aspirin and Tyelenol
Treatment of COVID-19; Treatment of COVID-19; Moderna Dose Number: 5 ... Pfizer / BioNTech  Dose Number: 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6203), in left arm, on 25Mar2021 as dose 2, single (Lot number: EN6207), in left arm and on 19Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 47 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Nov2021 as dose 3 (booster), single (Lot number: 033F), in right arm and on 14Oct2022 as dose 5 (booster), single (Lot number: 049D22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: seasonal allergies" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Raynaud's" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: Jan2019, stop date: 18Jan2023. Past drug history included: Known allergies: codeine, reaction(s): "Known allergies: codeine". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 14Oct2022, outcome "unknown", described as "Moderna Dose Number: 5 ... Pfizer / BioNTech  Dose Number: 4"; 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.
Right arm red, swollen and warm to touch on presentation after having received 2 vaccinations to right arm 2 days prior to visit - dx with ? cellulitis - tx with Augmentin ES 600 BID
Large splotches on legs (hives?). Fever of 102. Sniffles.
ED visit for dehydration, treated and discharged. ED to hospital for Severe sepsis; Primary malignant neoplasm of left lung metastatic to other site Treated and discharged to skilled nursing facility. Patient died on 11/7/2021. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Information has been received from a RN concerning a 12 month old white female pt with no known  allergies who on 16Jun2003 at 10:00AM was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live. Concomitant therapy included measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) and Streptococcus pneumoniae vaccine (PREVNAR). Illness at the time of vaccine was bilateral otitis media, sinusitis and an upper respiratory infection. On 25Jun2003 (previously reported as "several days later") the mother of the child called and stated that the pt developed a rash on the diaper area, behind the ears and on various parts of the body. The lesions were described as "some red bumps" with white centers.  The child's grandmother stated that it was chickenpox (also reported as "grandmother states it appeared to look like the beginning stages of chicken pox"). It was noted that the number of lesions were not documented. The child was given acetaminophen (Tylenol), diphenhydramine HC1 (Benadryl) and prescription drug therapy (unspecified) for treatment. The nurse mentioned that the office did not see the child, regarding rash, (also reported as unspecified medical attention was sought) The nurse indicated that it was unknown if the pt had recovered, that the mother didn't call back and there was no number to call the pt. No additional pt information was provided. No further information is expected.
Flu vaccine. Arm sore for days. Shoulder sore when moved a certain way.
Headache, Myalgia, Arthralgia, Night sweats, fatigue, sore throat, soreness at the injection site Narrative: 1/19 vaccine given. Side effects developed as follows: 1. Night sweats (the night after the injection) --09/20/2021, 1:00-3:00AM 2. Muscle/joint aches -- 09/20/2021, 1:00AM --current. 3. Generalized fatigue -- 09/20/2021, 1:00AM --current. 4. Mild headache alleviated by acetaminophen 1,000mg -- 09/19/2020, 2:30PM 5. Sore throat (mild). --09/20/2021 --8:00AM 6. Localized soreness to deltoid at the site of injection. -09/19/2021, 10:00AM- current 1/21 all symptoms resolved. Feels back to normal.
This case meets criteria for vaccine breakthrough review. SxS include SOB, cough, fatigue, rhinorrhea.  Tested positive 11/1 through facility.
COVID-19 Breakthrough. My husband tested positive the day before I did. I did a home test that morning and it was negative. I went to work and didn't have any symptoms besides my normal cough and shortness of breath. Then while I was there, early to mid afternoon. I noticed my throat was a little sore. I went to take my Flovent inhaler and noticed it hurt a lot and hurt to take a breath. That night at home I was really fatigue, my throat was getting more sore, headache. Body aches started 4 days in. I never really ran a fever, the closest was one day it was 100.6. Tylenol didn't seem to help much. For me it was really the fatigue, then I started to get a very tight chest from day 1 to day 4 by Monday it was a struggle to stay awake. I did have a home O2 monitor by that night my oxygen would drop temporarily to 91. On Tuesday I tried to get a doctors appointment to make sure either was no pneumonia because I am immunocompromised. By Wednesday I was able to contact them and they told me to go to urgent care and they sent me to the ER. I received treatment there. I got the Bebtelovimab treatment. The next day I felt a little better. I still have all my symptoms they are better than they were but still lingering.
Immediately within a second of giving the patient Dose 2 of the Pfizer vaccine, patient stated she did not feel good. She proceeded to grab her stomach and while sitting in the chair, she bent down with her head between her legs. Patient was alert and responsive and was experiencing syncope. Patient's symptoms self-resolved in less than 2 minutes as the patient sat upright thereafter and was using her cell phone.  Patient was assessed afterwards and noted she was doing fine. No other symptoms were noted.
The week after receiving my vaccine, I had bad joint pain. On a scale of 1-10, the joint pain was at an 8. I had been in remission for about 7 years from my rheumatoid arthritis pain so this was sudden joint pain. I called my doctor to let her know; she kind of let it go for a while thinking it would be a short reaction to the vaccine and would blow over. But about six months later, the prescribed ENBREL was no longer working to help aid my joint pain. So I went in for an examination, and it took about a year for them to find a prescription to help reduce the joint pain. Just beginning of this year, they found a biologic that aided me to find a drug to help reduce the pain. It's been about 3 months on this current new medication, and so far so good.
I was very tired with body aches. My left arm was sore and I had chest pains.
Started with back pain a week after second dose. Then pain spread to both side and abdonem. In October I began having neuropathy symptoms in left hand which quickly spread to all extremities. Nerve pain still continues today as well as tingling in hands, feet and body!
Breakthrough case admission after 2 vaccines Janssen 3/18/21 lot# 1802068;  Pfizer 11/18/21 Lot# 320308D
No additional AE/PQC to report; Consumer stated the pharmacist did not agitate the vaccine; Information has been received from a female patient of unknown age concerning herself. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 14-FEB-2020, the patient was vaccinated with the first of 3 scheduled doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided).  It was reported that before administered the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) the pharmacist did not agitate the vaccine (product preparation issue).  Consumer stated she did not have any side effects.
Patient reports tingling and paresthesias and slight pain throughout her left arm , hand, and left side of her face beginning immediately after receiving the vaccine. She has no change in motor ability or vision. This sensation continued Day 1, lessened on Day 2, and worsened on Day 3. She sought ED attention on Day 4 due to concerns for a stroke.
pt recvd vax 7JUN95 & parent reported that on 7JUN day of vax, pt cried inconsolably for 4 hrs, high pitched;immun site was red & swollen (quarter size), had low grade fever (100.6) 8JUN thru 11JUn pt was cranky & irritable (consolable);
Patient received the vaccine and approximately 5 minutes later, patient passed out and fell out of her chair onto the floor. 911 was called. Patient was unresponsive for approximately 30 seconds. She came to and was very disoriented and her pupils were extremely dilated. The paramedics came and did blood pressure checks and several other evaluations. They advised her to go with them by ambulance to the ER to be evaluated due to falling directly on her face/head. Patient went outside and was evaluated further in the ambulance but was not willing to go to the ER.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On the same unspecified day, the patient was vaccinated with 2 doses of VARIVAX (strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis.  No adverse symptoms reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
I have been having regular nose bleeds that are hard to stop and my right ankle has been swollen for the past week.
Intensification of sense of smell towards Onions, Garlic Aromatic foods, Bitterness aftertaste after eating most foods bearable but annoying.  First noticed after brushing teeth.
Pain in lower front armpit. When raising arm lower edge of scapula tender. A little swollen in front. Place where shot given doesn't hurt moving arm front to back make breast side of arm hurt.
On 1/17 awoke with sore neck and swollen and tender lymph nodes in left neck/shoulder/arm. Evaluated at hospital occupational health and received a prescription for steroids.
The pt experienced a fever, gave extra strength Tylenol and the fever dropped slightly. Gave 2 more extra strength Tylenol. The pt experienced vomiting and dizziness.
Narrative: COVID infection following COVID vaccine series 01/14, Moderna , dose #1 02/12, Moderna , dose #2 10/20 pt cc: chills, cough, diarrhea, fatigue, exposure: unknown 10/26 COVID swab, result: detected
the ActHib dilute did not get refrigerated when arrived, Dilute was left outside of refrigeration for several days and exposed to room temperature (75 F)/No AE; Initial information received on 24-Sep-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves an unknown age female patient.  It was reported that HIB (PRP/T) VACCINE [ACT-HIB] (Lot Number: u6789ab, expiration date: 21-Oct-2021) dilute did not get refrigerated when arrived. Dilute was left outside of refrigeration for several days and exposed to room temperature (75 Fahrenheit) (Product storage error).  Medical history, medical treatment, vaccination, concomitant therapy and family history were not provided.  This was a potential medication error case due to incorrect product storage.  It was unknown whether the vaccine was administered or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
patients administered Moderna vaccine while temperature excursion assessment was ongoing; patients administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 66-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.
Pt stated she was shaking and cold after getting vaccine. Nurse gave her water and took vitals Heart rate was 117. About 30 minutes later pt wanted us to call the EMS. EMS said vitals were normal and cleared her.
Student received vaccine at school located flu clinic. About 1/2 hour later, nurse called to classroom for fainting student. When she arrived he reported experiencing bad stomachache, rushing in ears, then loss of consciousness. Already awake and alert upon nurse arrival. Student was diaphretic. BP 90/64. Took by wheelchair to health 104/68. Stayed in health room for 1 hour and 15 min, color and energy came back. Monitored briefly and returned to class.
This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route and lot were not reported). On an unknown date, th patients received improperly stored RECOMBIVAX HB. No adverse symptoms reported. At the time of the report the action taken was not reported. All telephone attempts to obtain follow-up information have been unsuccessful.  Additional information was received from a registered nurse concerning a female patient: Patients birth weight was 8bls 12 oz with 0 siblings. Patient was vaccinated with RECOMBIVAX HB the same day that he was born (18-JUL-2014) at 16:42 PM. Lot number J012520; Exp. Date: 30-JUN-2016. The vaccine storage temp dropped to 0-1 on 18 different episodes between May 14 and July 21st (unspecified year) according to min/max. All recorded temps are within 2-8 degrees. Additional information is not expected since all follow ups requested to complete the case were received.
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. On multiple unspecified dates, the patients were administered improperly stored ROTATEQ, (lot# K005394, expiration date 23-FEB-2016; lot# K024700, expiration date 30-JUL-2016) (orally, dose and frequency not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Swelling at injection site (size of 1/2 of a dollar bill), sore to touch, redness. Had pt treat w/ ice (or) APAP and BENADRYL (or) also to try cool or warm compress which ever felt better.
"Janssen COVID-19 Vaccine EUA" 3/18 twitching of foot...severe leg pain  7:45 PM 3/19 involved in a motor vehicle accident with cardiac arrest and a dissecting aortic aneurysm   12;45 PM
This spontaneous report as received from a pharmacist refers to a 61 year old female patient. On 25-JUN-2015 the patient was vaccinated with ZOSTAVAX dose 0.65 ml once (route of administration and lot# were not provided). On 26-JUN-2015, following the administration of ZOSTAVAX, the patient experienced swelling, a red bump "the size of a fifty cent piece" and intermittent numbness at the injection site. No treatment was given for adverse events. The patient sought medical attention by calling the pharmacy. The outcome of swelling, a red bump "the size of a fifty cent piece" and intermittent numbness at the injection site was reported as not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.
Information has been received from a registered nurse concerning a female patient who was vaccinated with a first 0.5ml dose of Gardasil.  Subsequently, the patient fainted after receiving the vaccine.  Unspecified medical attention was sought.  On an unknown date, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Right arm soreness, reduced ROM despite daily exercises, hydration, tylenol, and benadryl. Symptoms have been ongoing daily and have been constant, worsened with ROM.  No loss of sensation or motor function.  Partial disability resulted in that pt is now using the alternate upper extremity to complete tasks that require UE gross motor funciton.
Pt recv vax on 10/22/98; pt given incorrect dosage (.5cc rather than .25cc)
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 77-year-old male patient. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.     On or about 08-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: Herpes Zoster. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).     Additional information has been requested.
Nausea, hyperventilation, anxiety, dizziness, and dry heaves 30 min after vaccination.
shingles; Chickenpox; i am in th ER with a rash that is itching and burning; i am in th ER with a rash that is itching and burning; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In July 2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, 10 days after receiving Shingles vaccine, the patient experienced shingles, chickenpox, itchy rash and burning sensation. On an unknown date, the outcome of the shingles, chickenpox, itchy rash and burning sensation were not recovered/not resolved.   The reporter considered the shingles, chickenpox, itchy rash and burning sensation to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's Comments: The patient received vaccine at the end of July from the reporting date and 10 days later he/she was in emergency room with a rash that was itching and burning. The reporter mentioned that, they took at least 4 cultures (some of which were not back ye), they were told him/her that he/she had shingles/chickenpox. The reporter mentioned, it looked like he/she got shingles/chickenpox from the 1st shot. The reporter asked if this would going to happen again if he/she would get the second shot and he/she scared to get it and he/she did not wanted to go through this again. The consent to follow-up was requested. Note: It was not clear whether patient had shingles or chickenpox, hence both events were captured conservatively.
Localized area of 2.25 x 3 inches with erythema, induration and heat. Localized discomfort.
Five minutes after receiving the vaccination on her left deltoid, she developed tingling over her left arm as well as her left lower s and her left hand, primarily over the dorsum of the second through fifth digits. Denies any shortness of breath, itching, counseling, facial swelling, no evidence of anaphylaxis.
No additional AE reported; patient inadvertently received a dose of PNEUMOVAX 23; This spontaneous report was received from a medical assistant concerning a 4-month-old male patient. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.   On 24-NOV-2021, the patient was inadvertently vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (Drug administered to patient of inappropriate age) (dosage regimen, route of administration, lot number and expiration date were not provided) as prophylaxis. No additional adverse events were reported.
I had bad headaches and light sensitive, could not contain many negative emotions, no types of respiratory issues, high blood pressure as well. Unable to concentrate and lack of focus.
Patient was given vaccine past "use by" date of 8/16/22. patient did not experience any adverse effects.
Had prolonged should pain. Primary care doctor referred me to a sports medicine clinic. Saw doctor and was diagnosed with Left Shoulder Impingement Syndrome. Given a cortisone injection and about to start Physical Therapy.