chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 38-year-old male. Neither medical history nor concomitant medications were reported. On an unspecified date in Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.
I was called onto the scene around 1:25pm and was told by the manager on site to help with a patient who was feeling lightheaded. I went with one of the workers in the building who was able to obtain information from the patient that she had a history of epileptic seizures and directed me to the patient with a wheelchair. When I arrived on scene, which was a few hundred yards away in the convention center, there was a bystander there to help the patient and security a few yards away.  I asked the patient how she was feeling and she stated that she was feeling weak and light-headed. I brought her over to a dark lighted area, via wheel chair, 10 yards away and laid her in on the ground to get maximum amount of blood flow to the brain. I was able to get her history, which she did not have allergies, and gave me the the information regarding her seizures that occurred every month to two months. As I asked about her medications for the seizures, first focal epileptic seizure started. The patient was away from all anything that could obstruct her and the seizure lasted for one minute. After this, colleagues and two EMS personnel from the convention center came on scene and the colleague dialed 911 after I stated that the patient had a seizure. The patient recovered, was able to obtain pulse, which was just over 100 bpm, and asked her questions regarding her name, time, place, and event and the patient was able to correctly respond. The patients skin was warm and was only brought to a sitting position when she needed to sip on water. I was able to give information to the dispatch during the call and monitored pulse and breathing. She was willing to go to the hospital when EMS arrived. The second focal epileptic seizure was five to seven minutes after the first one and again lasted for a minute. Again, the patient was alert and oriented to name, time, place and event. The patient was able to give me her ID and as I was getting her pulse and further information, a third focal epileptic seizure took place and this is when the EMS unit came on scene. They were able to take care of the patient and obtain vitals (130/90 blood pressure, just over 100 glucose). The patient was carefully sat up from the ground, laid on the cot, and the EMS unit transported the patient to a hospital. I signed witness to the security as to what happened and actions taken.
Resident was on Hospice Care due to declining health.  Resident expired at 9:30am on 1/6/2022
PATIENT REPORTED 2 WEEKS AFTER VACCINATION SHE HAD AN ITCHY RASH. NEEDED TO GET OINTMENT FROM PRIMARY CARE DOCTOR . THE RASH ALSO SPREAD TO HER ABDOMEN. TOOK ABOUT 1 WEEK TO RESOLVE
Narrative: Dose given to wrong patient was known yesterday per NP and was not reported by the nurse LPN. The patient chart has documentation of receiving both dose 1 and 2 of primary series moderna and moderna booster prior to this error dose.
Anaphylaxis within 2 minutes. 02/05/07-records received and reviewed for DOS 10/2-10/3/06. DC DX: Anaphylactic reaction to DTaP HX:CHD and one episode of anaphylaxis 2/2 influenza vaccine. Previous reaction occurred after his third dose of influenza vaccine. No food allergies. Latex allergy confirmed in 6/30/06 with IgE elevated 1.59. Allergy to gelatin. HX of tricuspid atresia with hypoplastic right ventricle repair.  Current medications: aspirin. Admitted after anaphylactic episode within 2 minutes of receiving MMR-V and DTaP. Reaction began with swelling and 'small white bumps' on feet bilateral, progressing to include the face with intense swelling of lips. Periorbital edema with tearing and c/o diffuse pruitis especially around face. Tachypnea. Treated with epinephrine. Hypotension 87/37 treated with NS. Emesis times 1 in ED.
here been 2 weeks so weak; This case was reported by a consumer via interactive digital media and described the occurrence of weakness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced weakness. On an unknown date, the outcome of the weakness was recovered/resolved.   It was unknown if the reporter considered the weakness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that he or she had been 2 weeks so weak never again.
Fever; Fatigue; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), FATIGUE (Fatigue) and PAIN (body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), FATIGUE (Fatigue) and PAIN (body aches). At the time of the report, PYREXIA (Fever), FATIGUE (Fatigue) and PAIN (body aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Patient received MMR vaccine at 1131 and Varicella vaccine at 1138. Unsure which vaccine caused the reaction. At 1146, patient complained of itchy, swollen hands, tingling of the tongue, and erythema to hands, feet, upper extremities, neck, and chest. No SOB or difficulty swallowing. Patient given 50 mcg of benadryl PO at 1155. Patient began to complain of increased swelling to lips and tongue with itchy red eyes, and voice changes, mild tachycardia initially but otherwise vital signs stable. Given 0.5 mg epinephrine IM at 1207. Swelling did not continue to progress. Given second dose of epinephrine 0.5 mg IM at 1231, as patient continued to have swelling of the tongue and lips. By 1300, swelling much improved, vital signs stable. By 1430, patient felt that she was back to normal.
Approximately 1 minute after injecting vaccine, patient complained of feeling flush, hot, and general body itch. Observed redness around the eyes and eyes were watering. Gave the patient a cold compress and 25mg of diphenhydramine. Approximately 5 minutes later the patient said she was feeling better. After another 15 minutes she was still feeling ok and left the pharmacy with her parents. I advised the parents to keep an eye on their daughter and continue the diphenhydramine. If the patient's condition got worse or lasted the next day I advised them to take her to the emergency room. I call the patient's mother the next day and she reported that the patient had fully recovered.
Patient reported injection site reaction (pain, erythema, swelling). Swelling has since decreased.
It is over a year since I had my first dose of Shingrix.; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 21-May-2022 Reporter's comments: This case was reported by the patient via interactive digital media. It was over a year since the patient had 1st dose of Shingrix. The patient asked that if he or she needed to start over with 1st dose. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
I26.99 ACUTE PULMONARY EMBOLISM 4/4/2023 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/30/2023 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE R09.02 HYPOXEMIA 3/30/2023 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE
Approx 5 min after receiving flu shot patient began to sweat profusely. When asked, pt denied feeling dizzy, faint or nauseous but stated his arms felt "tingly". Medics were called (via 911) pt. declined medical treatment or hospital transport. Pt. remarked that he feared needles and sight of his own blood. Pt was allowed to leave and advised to call 911 if further incident occurs.
Patient was administered first dose Moderna Vaccine at this pharmacy () on 5/14/21.  He returned to the pharmacy for his second dose on 7/10/21.  This is beyond the recommended time period between vaccine doses and so it is being reported as an adverse event.
vaccine administered after beeing in the fridge for 40 days; stored in the fridge for 40 days so 10 days over our recommended storage; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered after beeing in the fridge for 40 days) and PRODUCT STORAGE ERROR (stored in the fridge for 40 days so 10 days over our recommended storage) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 31-Aug-2021, the patient 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 an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered after beeing in the fridge for 40 days) and PRODUCT STORAGE ERROR (stored in the fridge for 40 days so 10 days over our recommended storage). On 31-Aug-2021, EXPIRED PRODUCT ADMINISTERED (vaccine administered after beeing in the fridge for 40 days) and PRODUCT STORAGE ERROR (stored in the fridge for 40 days so 10 days over our recommended storage) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug was not reported. Treatment medication was not reported.  It was reported that the vial was stored initially in refrigerator from 21-Aug-2021 and didn't undergo any temperature excursion. The temperature range the vaccine was exposed was 8° to 25°C= 46° to 77° F(3hrs). The vaccine was administered to 10 patients.; Sender's Comments: Product storage and administration errors are assessed as "not applicable", by convention, with respect as determined causality. No specific adverse events associated with the errors were reported
This spontaneous report was posted on the internet from a consumer and was received via a company representative referring to a female patient of unknown age. The patient's medical history or concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dosage, dose number, route of administration, lot number and expiration date were not provided). No other suspect or concomitants therapies were reported. On an unknown date, the reporter stated that "2 of my friends daughters (linked case 1606USA014108) have had serious issues from the GARDASIL". However, it was not reported whether a treatment was given or if laboratory diagnostics were performed. At the time of the report, the outcome of the adverse event was unknown. The reporter stated that the adverse events were related to GARDASIL. Upon internal review, the serious issues were considered as medically significant. This is one of several reports received from the same reporter. Additional information has been requested.
My last injection was on 1/28/21.  That day and few days after I had no site pain.  I did have aches and pains and bad headache and chest pressure for hours during the night which I reported and which disappeared next day.  However, the site pain in my right arm continues and is pretty bad temporarily and also periodically.  Not a big deal but decided to report it.  Seems very odd since it's been so long.
Soreness at the injection site; Swelling; Tingling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site), SWELLING (Swelling) and PARAESTHESIA (Tingling) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site), SWELLING (Swelling) and PARAESTHESIA (Tingling). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site), SWELLING (Swelling) and PARAESTHESIA (Tingling) was resolving.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
tested positive for Covid; Fever 102; Chills; Her arm also felt sore at the injection site; Headache; Strange Sensation; Light Headed; inside of her nose was really dry; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Strange Sensation), DIZZINESS (Light Headed), NASAL DRYNESS (inside of her nose was really dry), SARS-COV-2 TEST POSITIVE (tested positive for Covid) and HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced DISCOMFORT (Strange Sensation), DIZZINESS (Light Headed), NASAL DRYNESS (inside of her nose was really dry), HEADACHE (Headache) and VACCINATION SITE PAIN (Her arm also felt sore at the injection site). On 12-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid), PYREXIA (Fever 102) and CHILLS (Chills). At the time of the report, DISCOMFORT (Strange Sensation), DIZZINESS (Light Headed), NASAL DRYNESS (inside of her nose was really dry), SARS-COV-2 TEST POSITIVE (tested positive for Covid), HEADACHE (Headache), PYREXIA (Fever 102), CHILLS (Chills) and VACCINATION SITE PAIN (Her arm also felt sore at the injection site) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Body temperature: 102 (High) fever. On 12-Jan-2021, SARS-CoV-2 test: positive (abnormal) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
It was reported, "The mother of a 2 month old femate reported that her daughter received her 1st dose of Rota Shield, DTP, HIB and IPV vaccines and subsequently, developed constipation. The infant completed the Rota Shield primary series, and continued to experience chronic constipation. From follow up #1 corresnpondence received on 5/25/01, it was reported that the pt recovered from this experience. This case is closed.
This was a vaccination error, the Gardasil was given in error.  Patient was 27 weeks gestation at time Gardasil was given.  EDD  is 3/13/2022.  No adverse reaction has been reported.  Reporting due to patient pregnancy status, has not yet delivered.
Case number PHHY2011US37917 is an initial spontaneous report received from a vaccines sales specialist (non health care professional) on 03 May 2011. This report refers to an 11 years old female patient. She was given only the CYW-135 liquid component of MENVEO (batch number M10028) intramuscularly on 28 Apr 2011. A few hours later, she received the fully reconstituted dose of MENVEO. No other adverse reaction was reported.
This spontaneous reprot as received from a physician via a field representative refers to two patients of unknown age and gender. The patient's concurrent condition and medical history were not reported. On unspecified dates, the patients were each administered two doses of VARIVAX (Merck) (unknown strength, rout and dose). Concomitant medications were no reported. On unspecified dates, each had titers drawn on unspecified dates which were negative for immunity to varicella. The outcome of the event was unknown. No treatment was received in response to the event. Causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
Child Took Vax on 11/22. On 11/24 woke up fever 100.5, a few hours later started vomiting quite often, sneezing, coughing. felt better next day.
08/15/07 Woke up with redness, swelling to site, approximately 5cm. Circumference went to doctor - area was marked. 8/16/07 area was larger, but less red. Size was approximately 10cm - circumference warm. No pain at site. Patient taking Benadryl every 6 hours - no itching.
Swelling, redness over left deltoid started 1 day post vaccination.  Increased swelling next day.  1 time per day with liquid aclavil.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 45-year-old male. Neither medical history nor concomitant medications were reported. On 17-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.
Redness, swelling and itching at the site of injection 1 week after she received the injection .  She has been applying hydrocortisone for the past 2 days -  no changes so far.
Rt leg became very swollen but cool compresses relieved; Pt extremely fussy w/constant whimpering & screamed every 1/2 hr starting approx 230PM; t101.4 despite APAP q4hrs; Pt slept approx 1 hrs & continued w/above s&s until 4-430 6JUN91;
Carditis, unusual palpitations, thumping heart beat, chest pain, chest tightness, chest pressure, shortness of breath, swelling of left chest. All onset approx 24-48hrs after vaccination.  Treated with rest, and Ibuprofen. Symptoms diminished after 4 days of treatment, but re-emerged a week later after exercise recommensed. Additional treatment involved rest for 4 weeks, and Ibuprofen at higher dose for 2 weeks (2,000mg per day, divided into 3 doses)  until no longer tolerable due to severe GI discomfort. Symptoms mostly gone after the 4th week of rest. Only occasional unusual palpitation / heart thumping remaining thereafter (& now at time of reporting).
Chills; Muscle pain; Sore arm; Tired; Lightheaded; Nausea; 3rd booster dose; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 14Oct2021 at 16:30 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient received influenza vaccine (MANUFACTURER UNKNOWN) via an unspecified route of administration on 27Sep2021 for immunisation within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration on 23Jan2021 (at the age of 66-year-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the right arm on 13Feb2021 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. On 15Oct2021 at 08:00, the patient experienced chills, muscle pain, sore arm, tired, lightheaded and nausea. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, muscle pain, sore arm, tired, lightheaded and nausea was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Pt presented to office today with redness at injection site of Tdap given 11/12/15. Arm is red, itchy and painful. Area is 6 in x 3 in around injection site. Dr examined pt, no signs of infection. Instructed pt to take BENADRYL and use cold compresses.
dizziness, throat & tongue & glands in neck swelling, difficulty breathing, numbness in face & lips, metallic taste in mouth; no treatment was given by MD;
This is a spontaneous report obtained from a contactable consumer (mother). A 19 year old female patient received the first dose of TRUMENBA on 26Aug2016; the second dose on an unspecified date and the third dose on 05Mar2017, all at single dose, for immunization. Relevant medical history was unknown. Concomitant medications were none. On an unspecified date, the patient experienced flu like symptoms and her arm was sore after the administration of the first dose of TRUMENBA and only her arm hurt after the second and the third dose. Clinical outcome of the events was unknown at time of this report.