chrisvoncsefalvay/vaers-outcomes huggingface dataset:
adapter piece snapped off the syringe and like couldn't use that vaccine/adapter broke/syringe containing sterile water with screw adapter piece on it,when he screwed it on,it broke off from syringe; would not let any of the sterile water go into the vial and ended up just like squirting out all over the counter; adapter piece snapped off the syringe and like couldn't use that vaccine/adapter broke/syringe containing sterile water with screw adapter piece on it,when he screwed it on,it broke off from syringe; patient received ABRYSVO via subcutaneous route; This is a spontaneous report received from a contactable reporter (Pharmacist), Program ID:.  A 68-year-old female patient received PF-06928316 (ABRYSVO, NDC number: 0069-0344-01), on 28Aug2023 at 03:30 as dose number unknown, 0.5 ml single (Lot number: HF7708, Expiration Date: Feb2025) at the age of 68 years subcutaneous, in right arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), DEVICE USE ISSUE (non-serious) all with onset 28Aug2023 at 03:30 and all described as "adapter piece snapped off the syringe and like couldn't use that vaccine/adapter broke/syringe containing sterile water with screw adapter piece on it,when he screwed it on,it broke off from syringe"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 28Aug2023 at 03:30, described as "patient received ABRYSVO via subcutaneous route"; DEVICE LEAKAGE (non-serious) with onset 28Aug2023 at 03:30, described as "would not let any of the sterile water go into the vial and ended up just like squirting out all over the counter". Additional information: The pharmacist was trying to give Abrysvo vaccine to a patient, but the adapter piece snapped off the syringe and like he couldn't use that vaccine, so he had to open another one to give it to the patient. The pharmacist just wanted to report that. The pharmacist further reported that the adapter piece snapped off of the syringe piece, so it torn the vaccine and he had to give the patient another one. The adapter broke, so the syringe containing sterile water with the screw adapter piece on it, when he screwed it on, it broke off from the syringe and then would not let any of the sterile water go into the vial and ended up just like squirting out all over the counter. The reporter stated that the vaccine was for RSV. The pharmacist gave the vaccine shot at his pharmacy. The reporter was informed not to discard the product as the report would be forwarded for review by the Quality department and if it was determined that the sample would be needed for further evaluation, a pre-paid might be sent within 3 to 10 business days. The pharmacist confirmed that a sample of the product was available to be returned, if requested. The packaging was not sealed and intact, because he opened it up to trying give up the vaccine. The pharmacist kept the box, the syringe, and the adapter and everything that broke.
Ringing Ears all day long (Tinnitus?) Occurred after  3 days to a week. Affecting quality of sleep.  Worse at around Bed time.  Also noticeable fatigue.  Running at about 80-90% of my previous normal.
On 11/23/2022 the patient was given Pfizer Monovalent Vaccine when they should have received Pfizer Bivalent Vaccine. Patient mentioned that they have had some recent vision issues but was informed that there is no incident of the vaccine causing vision issues. Patient was told the vision issue could be due to something else.
Spots & Dizziness. Passed out the following morning. Continued to feel like she would pass-out. Was transferred to the Emergency Dept. Has Lyme disease.
After getting the shot, I felt great and normal, not expecting to get side effects. Exactly a week after getting the shot, I woke up with a fever of 101.2. The night before, I was experiencing lower right back pain, thinking it was a pulled muscle, but the pain was still present in the morning and it was painful. The rest of the day I had chills, fatigue, fever, lower back pain,  and no appetite. The next day I experienced the same things, plus headache. I was able to control my fever wit Mortin. The 3rd day I woke up with pain in intestine area  as well in my back. I had realized that I had not pooped for several days and I feel that I might have been constipated. I was feeling better on that third day,  with on and off fevers and fatigue. The 4th day I only experienced a fever and it went away throughout the day which was promising. 5th day I woke up feeling great and completely normal. So I experienced Flu like symptoms, plus back and muscles aches and constipation. I took 2 extra strength tylenol everyday along with 1 Motrin and sudafed Claritin D. I drank lots of water and hot teas. 4 days till i felt better.
Patient developed Guillain-Barre syndrome3 weeks after receiving dT; B12 deficiency. Annual follow up on 01/28/04: "Pt has recovered from adverse events".
Low fever; chills; incredibly achy; exhaustion; other vaccine same date product=Prevnar 20; pain at injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Jun2022 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation; pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 16Jun2022 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "frequent sinus" (unspecified if ongoing); "ear infections" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE; LAMOTRIGINE; DULOXETINE; L-METHYLFOLATE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown, Unable to locate or read the details), administration date: Apr2021, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown, Unable to locate or read the details), administration date: Mar2021, for Covid-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 16Jun2022, outcome "unknown", described as "other vaccine same date product=Prevnar 20"; VACCINATION SITE PAIN (non-serious) with onset 16Jun2022, outcome "not recovered", described as "pain at injection site"; PYREXIA (non-serious) with onset 17Jun2022 at 12:00, outcome "not recovered", described as "Low fever"; CHILLS (non-serious) with onset 17Jun2022 at 12:00, outcome "not recovered"; FATIGUE (non-serious) with onset 17Jun2022 at 12:00, outcome "not recovered", described as "exhaustion"; PAIN (non-serious) with onset 17Jun2022 at 12:00, outcome "not recovered", described as "incredibly achy". Therapeutic measures were not taken as a result of pyrexia, chills, pain, vaccination site pain, fatigue.  Follow-up attempts are completed. No further information is expected.
Menstrual Cramping after vaccination; Excessive Bleeding after vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSMENORRHOEA (Menstrual Cramping after vaccination) and HEAVY MENSTRUAL BLEEDING (Excessive Bleeding after vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DYSMENORRHOEA (Menstrual Cramping after vaccination) and HEAVY MENSTRUAL BLEEDING (Excessive Bleeding after vaccination). At the time of the report, DYSMENORRHOEA (Menstrual Cramping after vaccination) and HEAVY MENSTRUAL BLEEDING (Excessive Bleeding after vaccination) 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 provided by the reporter. Treatment information was not provided.
After receiving his COVID vaccine on 21Mar he has been unable to breathe without oxygen 24/7 at 8 LPM.; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (Patient's wife) reported for a male patient (Reporter's husband) an unspecified age who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on 21Mar2021 as unknown single dose for COVID-19 immunization. Medical history included pulmonary fibrosis from 2018 to an unknown date. The patient's concomitant medications were not reported. It was reported that, after receiving his COVID vaccine on 21Mar2021 he has been unable to breathe without oxygen 24/7 at 8 LPM on an unspecified date in Mar2021. Therapeutic measures were taken as a result of after receiving his COVID vaccine on 21mar he has been unable to breathe without oxygen 24/7 at 8 LPM. Reporter enquired as, this was side effect of vaccine or not. The outcome of event was unknown.  Information on lot /batch number has been requested
No adverse event; Patient have been administered vaccine after the published expiration date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient have been administered vaccine after the published expiration date.) and NO ADVERSE EVENT (No adverse event) in a 49-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Aug-2023 at 2:44 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 26-Aug-2023 at 2:44 PM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient have been administered vaccine after the published expiration date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient have been administered vaccine after the published expiration date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient have been administered vaccine after the published expiration date.).    Concomitant product use was not provided by the reporter. Patient has no acute illnesses at the time of vaccination and up to one month before. It has been reported that vaccines were in special deep freezer setup for the storage. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-739012 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739012:Same reporter ((Patient initial -C-L Gender- Female))
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was placed in the refrigerator on 17-NOV-2021 Vial did not undergone any temperature excursion. No adverse event was reported. No treatment medications were reported.
The 12+ Pfizer COVID vaccine was given 5 days after the 10 week expiration date in the fridge. The 10 week expiration date out of the freezer was 7/19/23 and the vaccine was given on 7/24/2023.
INJECTION SITE PAIN AND TENDERNESS, PEAKING DAY 1/DAY2 AFTER INJECTION AND WANING.   MUSCLE/JOINT PAIN, FATIGUE, CHEST HEAVINESS, PEAKING DAY 2 AFTER INJECTION AND WANING , RESIDUAL EFFECTS FELT LAST ON DAY 5.
This lot expired in the refrigerator on 1/17/2022, the vaccine was given after that date
This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Scheduled to receive the second vaccine dose on 20Mar2021, but never went to receive it and did not receive it as of yet.) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. No Medical History information was reported. On 17-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 PRODUCT DOSE OMISSION ISSUE (Scheduled to receive the second vaccine dose on 20Mar2021, but never went to receive it and did not receive it as of yet.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Scheduled to receive the second vaccine dose on 20Mar2021, but never went to receive it and did not receive it as of yet.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. Treatment information was not provided.
Administered expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  HCP administer expired vaccine to patients, after the manufacture date of expiration and wanted an assessments on the case.  Number of doses/vials:168 doses Date the vial was initially stored in the refrigerator was unknown. Date(s) of administration of vaccine 10-Nov-2021 and 11-Nov-2021. The vial did not undergo any temperature excursions.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information
Pt was exposed to her husband who was vaccinated with one dose of varicella virus vaccine live. The pt developed a rash and itching. The physician reported that the pt transmitted the itching to co-workers within hours of contact and also to other pts.
Redness/Rash on arm that vaccines were given in appeared the day after vaccination. Hard to tell for sure which vaccine caused reaction. Patient was seen by physician and he told her he did think it was a reaction to vaccine that would clear up on it's own with no needed treatment.
Information has been received from a registered nurse referring to multiple unspecified patients. Information about concurrent condition, medical history and drug reactions/allergies was not provided. On unknown dates, the patients were administered improperly stored doses of ROTATEQ (dose was unknown, lot L033545, expiration date 30-MAY-2017, lot # M014544, expiration date 27-NOV-2017) orally. These vaccines were exposed to 0.4 degree centigrade for 6 hours 30 min. A data logger was used to log temperatures and there were no prior excursions. No adverse effects were reported. Additional information has been requested. This is one of several reports received from the same source.
Started getting lightheaded immediately after, after another minuet I started having spotty vision and slowly faded to complete blindness. In addition to that I could not hear anything, complete deafness. Profusely sweating, slow breathing, and overall restlessness. When the paramedics arrived my vitals were fine except blood pressure had dropped into the low 50s which is very abnormal.
Patient presented to the Medical Clinic on 7/13/07 for routine visit and was noted with redness 4 inches in diameter around 3rd anthrax site. Diagnosed as adverse reaction to anthrax vaccination and was given Claritin and Triamcinolone cream.
Information has been received from a nurse, female consumer, who "sometime in 2003" was vaccinated, "sometime in 2003," with a dose of pneumococcal 23v polysaccharide vaccine (Lot # unknown). Subsequently, on an unknown date in 2003, the patient experienced a large swollen area on her arm, the size larger than a golf ball. The swollen area appeared to be pear shaped, and the vaccination was close to its expiration date. Subsequently, on an unknown date, the patient recovered from large swollen area. Unspecified medical attention was sought. No product quality complaint was involved. This is one of several reports from the same source. No further information is available.
Several months post vax, the pt developed migratory arthralgias and intermittent swelling of lips and face. Follow up states missing information is unknown.
This spontaneous report was received from a pharmacist via poison and drug center regarding a currently 26-year-old male patient. Information on the patient's relevant medical history, concomitant medications, concurrent condition and past drug history were unknown by the reporter. On an unknown date in 2009, the patient was vaccinated with the first dose of GARDASIL 9 via unknown route of administration with lot # R008165, expiry date 12-NOV-2018 for prophylaxis (strength, dose, frequency were not provided). It was reported that the patient never received the full series of GARDASIL 9 and only received one dose in 2009. On 17-SEP-2018, the patient was vaccinated with the second dose of GARDASIL 9 via unknown route of administration for prophylaxis (strength, dose, frequency, batch/lot # and expiration dates were not provided) (inappropriate schedule of drug administration). As of 17-SEP-2018, the patient continues on the GARDASIL 9.
T/C from parent on 5/8/07 reporting rash all over infants body, head to feet. Denies fever, reports some GI vomiting of formula. Had child evaluated by Dr. who dx. rash as reaction to flu#2 vaccine received on 5/1/07. Parent recalls that a mild rash followed the first flu shot administered back in March, but at that time was much less and she thought it was probably a heat rash and did not relate rash to vaccines received on 3-20-07 (Flu#1, Dtap#3, IPV#3, Prevnar#3)
Mildly sore arm at injection site.  Headache and chills.  Redness and rash with terrible itching on upper arm near injection site and across chest, collar bone, neck and chin.  Took Benedryl , Allegra, and Tylenol for 24 hours.  Symptoms mostly resolved by 4:00pm on 1/8/21.
This spontaneous report was received from a nurse concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 07-SEP-2016, the patient was inadvertently vaccinated with an expired dose of M-M-R II with Lot # M001200 Expiration date: 28-AUG-2016 (dose and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of two reports received from the same source. Additional information has been requested.
RED BLOTCHY RASH; ITCHY RASH ON RIGHT LEG; PROGRESSIVELY GOTTEN MORE; MOST AGGRESSIVE ITCHY RASH HAD AND IT WAS SCALDED; ITCHING; SWELLING FOR A COUPLE OF DAYS; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight was 155 pounds, and height was 65 inches. The patient's concurrent conditions included: high blood pressure, angiotensin converting enzyme inhibitors allergy, and alcohol use, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage and patient was non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUN-2021, the patient experienced swelling for a couple of days.  On NOV-2021, the patient experienced itching, red blotchy rash, itchy rash on right leg, progressively gotten more, and most aggressive itchy rash had and it was scalded. Treatment medications (dates unspecified) included: prednisone, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling for a couple of days, and had not recovered from itching, red blotchy rash, itchy rash on right leg, progressively gotten more, and most aggressive itchy rash had and it was scalded. This report was non-serious.
pt recv vax 4FEB97 & pt became acutely ill & required hosp;MD states that it is unclear whether illness & immunization are related;pt also exp trouble breathing, fussy, not eating, cyanotic;
Localized rash on area around injection site. Pt took BENADRYL - rash subsided. 4" x 6" area tender to touch.
Presented on 2/24/23 for fast HR after 12hrs of vomiting & diarrhea.  was found to be in a-fib.  Treated with 2L IVF.   Had CT chest & abdomen &CXR.  Started on a heparin drip & rec'd a bolus of Cardizem, did not convert to SR, given a 2nd bolus of cardizem & continuous drip started..  Admitted to telemetry unit.  on 2/25/23, cardizem drip adjusted.  was in & out of SR.  started on po metoprolol 50mg bid & eliquis 5mg bid. on 2/26,  cardizem stopped.  rec'd a bolus of amiodarone & then drip started.  converted to SR.  on 2/27/23, amiodarone drip stopped & started on po amiodarone tid.  discharged to home later that day.  Norvasc was dc'd.  New meds were amiodarone 200mg x15day the 200mg daily, ASA EC 81mg daily & Eliquis 5mg q12hr, Metoprolol 50mg q12hr