chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bexsero that already expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 15-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB39AC, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 4th August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-Aug-2022 Reporter's Comments: Registered nurse reported on 4th August 2022 that patient received on 4th August 2022, a dose of Bexsero that had already expired on 31st July 2022. The reporter did not consent to follow-up. The Vaccine Administration Facility is the same as Primary Reporter. Additional Supportive Information: The patient was administered with Bexsero vaccine, which was already expired, which led to expired vaccine used.
Patient received Pfizer for second dose inadvertently when they should have received Moderna.  No adverse effects noted.
Pt developed vomiting and bloody stools on 12/22. He was evaluated in the ED and found to have intussusception. He had an air enema, which reduced the affected area. He was monitored in the hospital overnight, did well and was discharged home.
10PM fainted as was leaving clinic p/receiving vax; hit head on door as fell; pt was out of it; advised to call 911 & was taken to ER:
Tongue painful & swelling, bad sore throat, cough, hot & cold feeling, painful eyes, headache, ringing in ears, temperature, increased heart rate, difficulty breathing.
muscular aches, feverish feeling without actual fever, chills, runny nose lasting one week. Similar to symptoms of a generic "cold" Treatment: occasional acetaminophen, pseudoephedrine, lots of bed rest
He is a co worker and he passed away in his sleep I heard.  One of 3 nurses that died in the medical center since the vaccine roll out
Headaches, fatigue, body aches and low grade fever of 99.7 for 36 hours after the shot. Headaches continued until Sunday. My period finally came on the Sunday before the 2nd dose.
*Moderna COVID-19 Vaccine EUA*  Pt received vaccine at 8:55am on 2/12/21 and was observed for adverse events for 15 minutes after.  Pt reported driving home and then about 20 minutes later experiencing eye swelling.  She decided to go the the ER and was treated with prednisone and was sent home with the recommendation to not receive the second dose of the vaccine.
This spontaneous report was received from a vaccine coordinator, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with an improperly stored dose of VAQTA (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. The temperature of the VAQTA was between 9 °C and 22 °C for a time frame of 25 hours and 48 minutes (reported as "25.8 hours") and between 0 °C and 1 °C for a time frame of 25 hours and 48 minutes (reported as "25.8 hours"). No previous temperature excursion occurred, and data logger was involved. No adverse effects were reported. This is one of three reports received from the same source.  Additional information has been requested.; Sender's Comments:  US-009507513-1706USA002794: US-009507513-1706USA002899:
Initial report received on 06 November 2013 from a health care professional. An unknown  age pf female patient, medical history and concomitant medications were not reported, received a dose of FLUZONE (lot # unknown) intramuscular on an 17 October 2013. It was reported that a patient had local reaction unspecified systems with FLUZONE. Patient also had FLUZONE last year. Event outcome was unknown at the time of report. List of documents held by sender: none.
Patient developed redness and pain at injection site. Evaluated by provider as cellulitis. Treated with CEPHALEXIN for 7 days. Re- evaluated one week later. Cellulitis resolved.
severe headache like nail being pounded in to head numerous floaters, wormlike floaters, and flashing lights in left eye lasting one week
was getting report from staff and noted tingling and swelling in her lip and extreme itching in her varicose veins of legs. This started 45 minutes after receiving flu vaccine. Co worker gave her Benadryl and symptoms subsided within 30 minutes experienced extreme fatigue for 4 days following episode. Did not seek medical attention. Reported only.
Information had been received on 21-FEB-2017 from a medical assistant who reported that an expired dose of ZOSTAVAX vial 19400 PFU (lot# L040443, expiration 15-JAN-2017) was administered subcutaneously to a 60 year old male patient today, 21-FEB-2017. The patient has not experienced an adverse effect. No additional information was provided. Additional information has been requested.
Patient's received 2nd dose of Moderna vaccine Friday 3/12.  Her husband reported she had not unexpected fatigue,  malaise, and fever for 1 day but better after that.  On Monday she began complaining of shortness of breath.  This progressively worsened and she started having presyncopal episodes.  On Saturday she was unable to come down the stairs in the house so husband planned to take her to the hospital but she stood up and passed out and woke up quickly.  He decided to call EMS.  By the time she presented to our hospital she was cyanotic and agonal breathing.  On moving her from EMS stretcher to ED bed she had PEA cardiac arrest.  She underwent mechanical device CPR with only brief (<1 min) ROSC x1.  She at some point did have a shockable rhythm.  Cath lab was notified and she was taken emergently to the cath lab with ongoing mechanical device CPR.  Peripheral VA ECMO was placed after about 1.5 hours.  Pulmonary angiogram was done which showed massive saddle PE with near complete obliteration of the right pulmonary tree and some filling defects in the left tree as well.  At that time she had severe mixed respiratory and metabolic acidosis with a lactate of 24.  She also had no gag or corneal reflex, minimally responsive pupils, and no response to noxious stimuli.  Mechanical thrombectomy was attempted with some result.  She was transferred to the SICU with increasing pressor requirement, and DIC.  Ultimately, the venous catheter of the ECMO circuit malfunctioned thought to be secondary propagating IVC thrombosis.  Family decided to withdraw care and she passed away.
This spontaneous case, initially received from other non-health professional on 21-Feb-2018, concerning an adult female patient. The patient's current condition included: hypothyroid, high blood pressure, osteopenia and arthritis. The patient was allergic to sulfa drugs. Concomitant medications included: multivitamin, SYNTHROID and unspecified blood pressure medications. On an unspecified date in Oct-2014, the patient received INN Flu Vaccine Seasonal (anatomical location: right arm, dose, route of administration, batch number, expiry date, trade name and manufacturer: not reported). On an unspecified date, the patient experienced a pinched nerve with pain radiating from the injection site (right arm) to the base of my skull. The pain lasted for over several months and hence, the patient was sent for physical therapy on an unspecified date in May-2015 until the pain ended. The patient had recovered from all the events. The reporter assessed the events as non-serious.
Patient received injection fine.  We asked them to sit and about 3 or 4 minutes later the patient's mom  came back to ask for help, Patient was passing out.  She sat him in chair and then asked for wet rags.  I got the wet paper towels and an ice pack.  Patient did pass out and had a vasovagal reaction.  He came in and out of consciousness.  Patients twin brother had the same reaction at the same time.  We used the ice pack on his neck, wrists and forehead.  He then seemed to come back together and we used the wet paper towels on him.  Then his color returned and we had him sit longer while his brother recovered.
80-year-old female presented to the hospital with nausea and congestion.  Patient played dominoes in her apartment complex with some friends a little over a week ago that friend was positive called her over the weekend to let her know she was positive however patient went for her mohs surgery to her left lateral forehead on the eighth.  Patient had mild congestion at that time.  Congestion progressed and Wednesday patient tested herself on the 10th and tested positive for COVID.  Patient states she thought it was all with cold.  She denied any sore throat but she admits to significant head congestion.  Patient came to the emergency room on the 14th.  Patient spoke with her primary received prescription for Paxlovid. Patient states she took the pills on Wednesday she took half the pills on Thursday and then stopped because they made her nauseated.  Patient presented over the weekend.  Initially was placed on oxygen but is currently on room air.  She received hydration in the emergency room and patient is feeling better infectious disease has been asked to comment. ID service does not recommend steroids or antivirals. Patient stable from a cardiac standpoint without plans for any further cardiac work-up/intervention, follow-up with primary cardiologist upon discharge for further treatment.
Information has been received from a physician concerning a 13 year old female who on 11-SEP-2008 was vaccinated with the first dose of GARDASIL (lot # not provided), intramuscular, 0.5mL. On 12-SEP-2008 the patient developed flu like symptoms. The patient sought for medical attention. Subsequently, the patient recovered from flu like symptoms. Additional information has been requested.
I went into the room to explain to mom what shots both of her sons were due for . Mom agreed to the getting their shots and signed the paper . I put my gloves on and cleaned brother's arm and gave him the  vaccines he was due for  which was Dtap , Hep B and Hep A . After I finished his vaccines I asked mom would she like patient's vaccines  both in the same leg or one vaccine in each leg since he was under 20lbs . Mom stated that she wanted both in one leg which was patient's left leg. So i put my gloves on , and being to clean his left leg to  give him the vaccines he cried a little . They left the office around 2:30pm 07/30/2019 around 3:37pm mom called and stated patient was having a seziure and it was contuining . So she brung his in when mom got here we put them in a room called 911 . The child was still in a seziure at  3:48pm when peramedics arrived . We checked oxygen leave , pulse , child was a wake.
Information has been received from a pharmacist and a pharmacy technician concerning a 68 year old Caucasian female with no known allergies and no pertinent medical history who on 04-SEP-2007 was vaccinated with Zostavax to prevent shingles (Lot # 658085/0882U) SQ. Concomitant therapy included TOPROL XL and ezetimibe. On 04-SEP-2007 the patient developed a red spot at the injection site. As of 07-SEP-2007, the patient was recovering. In follow-up the pharmacist reported that on 05-SEP-2007 the patient experience "rash, fever at injection site" until 08-SEP-2007. Additional information was requested.
Severe headache in the morning.  It was less severe as the day went by.  Muscle aches and fatigue.  I was able to work that evening despite the symptoms.
her left leg hurt real bad/really bad side effects/the most painful; she was in a walker for a week; trouble to sleep due to pain; leg eggs really bad muscle you can hardly walk not even step down, pain she was in a walker for a week; she can't even walk for a while; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (her left leg hurt real bad/really bad side effects/the most painful), WALKING AID USER (she was in a walker for a week), GAIT INABILITY (she can't even walk for a while), INSOMNIA (trouble to sleep due to pain) and MUSCLE DISCOMFORT (leg eggs really bad muscle you can hardly walk not even step down, pain she was in a walker for a week) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy and Food allergy. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced GAIT INABILITY (she can't even walk for a while). On 18-Feb-2022, the patient experienced PAIN IN EXTREMITY (her left leg hurt real bad/really bad side effects/the most painful), WALKING AID USER (she was in a walker for a week), INSOMNIA (trouble to sleep due to pain) and MUSCLE DISCOMFORT (leg eggs really bad muscle you can hardly walk not even step down, pain she was in a walker for a week). The patient was treated with TRAMADOL for Pain, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (her left leg hurt real bad/really bad side effects/the most painful), WALKING AID USER (she was in a walker for a week), GAIT INABILITY (she can't even walk for a while), INSOMNIA (trouble to sleep due to pain) and MUSCLE DISCOMFORT (leg eggs really bad muscle you can hardly walk not even step down, pain she was in a walker for a week) was resolving.            The concomitant medications were not reported.  Patient was approximately 50% recovered. Others treatment medication  was taken by patient, but was not able to report. She visited a pain medicine doctor.Patient was improving very slowly. Patient has not tested positive for Covid-19. Patient had not medical history related to events or any chronic illness at the time of vaccination.   This case was linked to MOD-2022-658243, MOD-2022-658249 (Patient Link).
Vaccines administered on 1/4/08. Pt reported 'fever, reaction, cellulitis, and infection" via voice mail on 1/7/08. States he went to a ER at a different hospital over the weekend for treatment with antibiotics. Symptoms were reported in the (L) arm however additional vaccines were administered in the (R).  3/11/08 Reviewed hospital medical records for admission 1/7-1/9/2007. FINAL DX: streptococcal cellulits LUE & recent immunization LUE. Records reveal patient experienced fever, chills, nausea, pain, swelling, tenderness & red band like area in LUE w/decreased ROM beginning 1 day s/p vaccines.  Seen in ER on 1/6 & tx w/IV antibiotics & d/c home on oral antibiotics.  No improvement & returned for admission.  ID consult done.  Tx w/IV antibiotics & improved.  D/C to home on continued oral antibiotics & f/u by ID.
Mom on Tegretol for sz since age 15; pt had a similar episode before when got real upset; limp & lifeless for 5 minutes;
ED visit 4/19/21, reports she had a Covid vaccine last Tuesday (4/13) and reports that she went into anaphylactic shock and went to the Hospital be treated, she was then discharged on a course of steroids, she says steroids made her vision blurry, so she stopped them, some of her blurry vision is persisting and she now feels like she has cramping/spasms in her calf muscles bilaterally. She also complains of some generalized fatigue and weakness.  Labs showed leukocytosis, suspect it is secondary to the prednisone or the immune response/anaphylactic reaction. No need for additional treatment at this time. Recommended she follow-up with PCP as warranted. Discharged from ED.
Later the same night and the entire next day, left arm pain to the point it hurt to lift my arm, Headache.  Both went away the next day.  10 days post vaccine, local reaction that?s red, itchy, warm to touch, and significantly lower on the arm than the injection site.  Has lasted 3 days so far and still current.
Insomnia for several days; This is a spontaneous report from a non-contactable consumer. A 39-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies which were unspecified. It was unknown if the patient was pregnant at the time vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. On an unknown date, the patient experienced insomnia for several days. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event insomnia for several days was recovered on an unknown date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt diagnosed and hospitalized x 2days with positive COVID test prior to this hosp admission; pt presented to ED with fever, chills, fatigue and increasing SOB, placed on Airvo; hx of DM and RA; eventually placed on BiPAP; alternated with BiPAP and Airvo; pt was tiring and requested intubation; placed in prone position most of the time; family requested no CPR; developed Shock, renal failure related to COVID sepsis; pt's condition worsened and he expired in the hospital
Vaccine given 8/24/07. Started vomiting 9/23/07, no fever, no diarrhea initially - diagnosed with viral gastroenteritis. On 9/25/07 had large bloody bowel movement - seen in local ER, transferred to another hospital where diagnosed with intussusception and underwent surgical correction/resection.  Hospital records received from PCP for DOS 9/26-30/2007 for DX Incarcerated Intussusception.  Infant presented with lethargy, mental status changes, decreased po intake and a large bloody bowel movement.  PE significant for T=100.6'F, listness and acutely ill appearing, dry mucus membranes, minimal response to painful stimuli, rectal exam (+) for gross blood. Reduction failed by air contrast enema and infant taken to OR for Exploratory Lap with small bowel resection for IS.  Pt tolerated advancing diet and was d/c home on 9/30/2007.   10/23/2007 Vax record received and correlates with VAERS submission. Per 60 day follow up: Patient underwent exploratory laparotomy with small bowel resection for incarcerated intussusception.
dose prepared from vial that was stored in the freezer at -25 C to -15 C for a total of 19 days which exceeds the allowed duration at such temperature. Per pfizer temperature excursion guideline, total days is 17 days
This case was reported by a consumer via call center representative and described the occurrence of weakness in a 75-year-old female patient who received SHINGRIX. On 19th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 19th February 2018, 6 hrs. after receiving SHINGRIX, the patient experienced weakness, injection site pain, injection site lump and tiredness. On an unknown date, the outcome of the weakness, injection site pain, injection site lump and tiredness were recovering/resolving. The reporter considered the weakness, injection site pain, injection site lump and tiredness to be related to SHINGRIX. Additional information was received as follows: This case was reported by patient's husband. The patient had an unknown medication as a concomitant product. At noon on 19th February 2018, the patient received SHINGRIX on left arm. The patient developed tremendous weakness and tiredness. She was never checked for a fever and did not have any shivering. This case has been linked to the case US2018029337, reported by same reporter.
Redness and tender to touch since last night. No induration 3" x 4" at erythema.
This case involves a patient (unknown demographic) receiving YELLOW FEVER VACCINE - US [YF-VAX] she accidentally administered YF-vax in the patient's deltoid (product administered at inappropriate site). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included TYPHOID VACCINE and MENINGOCOCCAL VACCINE for Prophylactic vaccination. On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE - US [lot number and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination. It was reported "Caller stated that she was administering vaccines to a patient who will be traveling outside of the United States. Caller stated while administering vaccines, she accidentally administered YF-VAX in the patient's deltoid. Caller asking if this is okay or what she should do. The caller states that she is not sure what to ask. She states that the YF-VAX may not have been given subcutaneously and she is concerned. She states that the patient is going outside of the US and she wanted to make sure the patient is going to be safe with the yellow fever vaccine and that she is still going to get immunity even though the vaccine was given in her deltoid." It was a case of an actual medication error due to Vaccine administered at inappropriate site (latency same day). At the time of report, no adverse event 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 the 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.