chrisvoncsefalvay/vaers-outcomes huggingface dataset:
was accidentally administered last year's Fluarix influenza vaccine (Fluarix, 2022-23 season vaccine, expiration date earlier this year 2023; packaging looks very similar for last season's Fluarix versus this season's Fluarix; This non-serious case was reported by a nurse and described the occurrence of expired vaccine used in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis.   In OCT-2023, the patient received Fluarix Quadrivalent 2022-2023 season. In OCT-2023, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced expired vaccine used (Verbatim: was accidentally administered last year's Fluarix influenza vaccine (Fluarix, 2022-23 season vaccine, expiration date earlier this year 2023) and product packaging confusion (Verbatim: packaging looks very similar for last season's Fluarix versus this season's Fluarix).  The outcome of the expired vaccine used and product packaging confusion were 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 10 Oct 2023: The nurse reported that they were administering influenza vaccines for the 2023-24 influenza season to their advanced home care staff. Earlier this month in October, 2023, a female staff member, age unknown, was accidentally administered last year's Fluarix influenza vaccine (Fluarix, 2022-23 season vaccine, expiration date earlier this year 2023, lot number unknown). There was some of the previous season's Fluarix still left in the refrigerator and it was mistakenly given to the patient, citing that the packaging looks very similar for last season's Fluarix versus this season's Fluarix., which led to expired vaccine used and product packaging confusion. They plan to administer this season's Fluarix to the patient in the next few days. The outcome of the maladministered Fluarix was unknown. The permission to follow up was not requested.
pt recv vax & devel an intense, burning pain @ the inj site which lasted about 10min;pt also screamed for a good 10min
c/o dizziness & chills, tx'd w/Motrin 800mg;
Left arm was red with a circle; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (left arm was red with a circle) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (left arm was red with a circle). At the time of the report, ERYTHEMA (left arm was red with a circle) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Antibody test: positive (Positive) Positive. In January 2021, SARS-CoV-2 test: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications was not provided by the reporter. Treatment information was not provided.  About a month ago, the patient felt weird where the patient did a home test and result came back positive. The patient queried how the vaccine works and how can it make antibodies.   This case was linked to MOD-2021-345547 (Patient Link).
Redness, swelling, and itching to vaccine site and surrounding area of upper left arm.  Under arm there is also occasional pain.  The reaction comes and goes on its own.  I don?t do anything to treat it.   Reaction happens every other day or so lasting at least 12 hours.
pain in his foot; This is a spontaneous report from the sponsored program. A contactable consumer (patient himself) reported that a male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 21Mar2021 at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on an unspecified date for COVID-19 immunisation. The patient experienced pain in his foot and asked if he can take naproxen. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Went to sit down & legs gave out I slid to the floor.  Lying on my back I couldn't't move not able to sit up or turn over.  After 3 hours able to get help to my bed.  I had lost all strength and my body was very painful when picked up.  The next morning everything started to return to normal.
Approximately 4-5 hours after administration parent noted excessive crying lasting approximately 12 hours, no significant fever (temps 99-100 rectal), able to feed, normal urination and stooling, calm at times.  Crying described as 'hysterical'.  Also noted faint red rash at back that had disappeared by morning.
This spontaneous report as received from a nurse refers to a unspecified number of patients of unknown age. The patients medical history was not reported. On 12-MAY-2014, the patients were vaccinated with 3 doses of GARDASIL (lot # J010668, Expiry date: 29-APR-2016) that were stored outside of recommended storage temperature. The concomitant medications were not reported. No adverse effects were reported. The outcome of vaccinated with above temperature excursion and no adverse effects reported was unknown. This case is linked to Case # 1405USA007228. Additional information has been requested.
Erythema, mild edema at and inferior to injection site on (L) deltoid. Negative pruritis, dyspnea, syncope, pain, fever Tx: family regularly uses hyperbaric O2 chamber.
Patient received 3 vaccinations on 8/15/2020 around 2pm. Patient recived Pneumovax in Right arm and Fluarix and Shingrix in the left arm. Patient noticed that her right arm became markedly swollen (about the size of a softball) and red and painful to the touch around the injection sites. Patient took some Benadryl on 8/17/2020 and claims that the swelling and pain has started to subside.
This spontaneous report as received from a licensed vocational nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients received improperly stored doses of VARIVAX (Merck) (lot # not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
if_vaccine_received Yes/vaccine_brand=Pfizer / BioNTech/product=COVID 19 Treatment, brand=Paxlovid; if_vaccine_received Yes/vaccine_brand=Pfizer / BioNTech/product=COVID 19 Treatment, brand=Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 01Nov2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FAMOTIDINE.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "if_vaccine_received Yes/vaccine_brand=Pfizer / BioNTech/product=COVID 19 Treatment, brand=Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I tested positive once again for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received COVID 19 Treatment which included treatment with Paxlovid (from 18ASpr2022 to 22Apr2022). Patient started Paxlovid treatment 3 days after onset of COVID symptoms. Symptoms disappeared two days after beginning Paxlovid treatment. 5 days after stopping the 5-day course of Paxlovid treatment, symptoms returned and I tested positive once again for COVID. It has been 4 days since symptoms have returned, and symptoms have significantly improved, but some minor symptoms still linger.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient scheduled herself an appointment for CVM1 (1st dose) of Moderna. report printed on 04/28/2021 prior to patient arrival at clinic did not show patient had a COVID vaccine of any kind. After Moderna vaccine was administered, patient stated she had previously had a Pfizer vaccine at pharmacy asked where her vaccination card was she stated "at home". She later asked during observation could she go and see if her vaccination card was in her car. Patient went out to her car and came back in with copy of pharmacy vaccination card that stated patient received a Pfizer vaccine on 3/26/2021. Patient completed 15 minute post vaccination observation period without any signs or symptoms of reaction. No adverse outcome was observed. Public Health District Immunization Coordinator, District Director of Nursing, and District Risk Manager were notified.
Rash and swelling on inside right forearm lasting about 15 min. occurring about an hour to hour and a half after injection.
THE JANSSEN COVID 19 VACCINE WAS REFROZEN AND ADMINISTERED; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned a 59 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced the janssen covid 19 vaccine was refrozen and administered, and out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the janssen covid 19 vaccine was refrozen and administered and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20220538428, 20220538297, 20220538573, 20220538480, 20220538149, 20220537683, 20220538379, 20220538437, 20220539045, 20220538666, 20220538693, 20220540435, 20220540524, 20220537548, 20220537688, 20220540474, 20220538890, 20220540853, 20220540611 and 20220541180.
severe itching and pain; severe itching and pain; developed a rash on my back; stomach felt like fire ants were crawling and biting me; stomach felt like fire ants were crawling and biting me; This is a spontaneous report from a contactable other healthcare professional (patient). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3246) via an unspecified route of administration on the left arm on 21Jan2021 13:00 at a single dose for COVID-19 immunization. Medical history included diabetes, asthma and known allergies: neutrogena products. Concomitant medication included metformin and ibuprofen (ADVIL [IBUPROFEN]). On 22Jan2021 01:20 am the patient woke up from severe itching and pain. The patient had developed a rash on her back and stomach felt like fire ants were crawling and biting her. The only thing that came to her mind was taking an oral antihistamine so she took diphenhydramine (BENADRYL), the rash and itching was gone in the morning on Friday she had a discussion with the physician she worked with to let him know what had happened, to get his opinion on if she should get the 2nd vaccine. She took another diphenhydramine the Friday night just in case no itching didn't take diphenhydramine on Saturday however the itching returned on Sunday the late afternoon approx at 4pm took another diphenhydramine but still feeling a little itching the back and stomach (no new foods lotions soaps or supplements were started so it had to be the vaccine). The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering.
This spontaneous report as received from a physician refers to a 75 year old male patient. Medical history and concurrent conditions were not reported. On 18-MAY-2012 the patient was vaccinated with ZOSTAVAX, 1 shot subcutaneous. Lot number and expiration date were not provided. Approximately, on 15-JUN-2016 ("two weeks ago") the patient broke out in a significant case of Shingles; the outbreak appeared on his left groin to his back, where he developed blisters (Herpes zoster). The reporter stated that the patient was currently immunocompromised, but was not at the time of vaccination. Additionally, the patient recently had a laparoscopic surgery for dysphagia and was under stress. He was not hospitalized and was on an unspecified treatment regimen. The outcome of immunodeficiency was reported as not recovered, the outcome of Herpes zoster was reported as recovering and the outcome of dysphagia and stress was unknown. The causality between the events and the therapy with ZOSTAVAX was not reported. Upon internal review immunodeficiency was considered to be medically significant event. Additionally, dysphagia was considered to be medically significant event since a laparoscopic surgery was required. Additional information has been requested.
Headache and dizziness.  Treatment for ongoing dizziness is meclizine prescribed by PCP.
TIGHTNESS IN HIS THROAT WITH DIFFICULTY BREATHING AND FULL BODY PRURITIS.
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 06-APR-2017 and 01-MAY-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M016193, expiration date 24-APR-2018, intramuscularly (dose was not reported) in immunization series. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 34.5 degrees Fahrenheit for 1 hour and 53 minute and of 34.7 degrees Fahrenheit for 1 hour and 25 minutes. There were no previous temperature excursions reported. A Digital Data Logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007706: US-009507513-1705USA007707: US-009507513-1705USA007708: US-009507513-1705USA007709: US-009507513-1705USA007710: US-009507513-1705USA007711: US-009507513-1705USA007712: US-009507513-1705USA000781.
rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient experienced rash after receiving Shingrix the following day. The reporter did not consent to follow up. The HCP was in a hurry and provided a few details of the case. This case linked with US2020182652, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020182652:same reporter
Child woke up at 0800 on 7/31/14; mom noticed a small rash on chin area. By the afternoon, rash moved to face, neck, trunk and legs. Rash associated with itching. No fever. Child given BENADRYL orally.
Extreme  Tiredness; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was unknown.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows: The patient demographic details were not provided. The patient received dose of Shingrix, on monday at about 3pm. The patient asked, an average how long would the fatigue continue and also ask if need to really get for the 2nd dose.
Patient reports tingling in the mouth and sudden pruritis appnx. 15 minutes after the vaccination. VS taken, (WNL) 113/62, HR of 94 and O2 sat of 97%. Patient states she will self medicate when she gets home w/Benadryl. Patient stated feelings have subsided and has been discharged 11:10am.
Patient developed clustered vesicular rash in umbilical area less than 48 hrs after vaccination. Rash was determined to be shingles and started treatment. (VALTREX).
This spontaneous report was received from a health professional and refers to a patient of unknown age. On an unknown date, the patient was vaccinated with PROQUAD lot # N022954 for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date, the patient experienced expired product administered and no adverse event. The outcome of expired product administered and no adverse event was unknown. The reporter considered expired product administered and no adverse event to be not assessed to PROQUAD.
Upon verifying the vaccine information was documented correctly in our system we discovered that the patient has received another 2 dose series at another location.  The patient did not disclose this information to us at any point while filling out his consent form.
Came to ER and admitted on 10/29/21. admitted on 10/29 with COVID-19 infection and generalized weakness.  Chest x-ray showed right-sided pleural effusion.  Pulmonology, Infectious Disease was consulted.  Patient was started on Rocephin, Zithromax, Decadron and remdesivir.  Patient underwent a right-sided thoracentesis for large right pleural effusion on 10/29 and approximately 2400 cc of straw-colored fluid was removed. thoracentesis was repeated on 10/30.  Cytology shows single cluster of atypical cells with background reactive mesothelial cells, cannot completely exclude malignancy.  Chest x-ray on November 3  Showed moderate-size right hydropneumothorax. I was told my case management that family decided on hospice and back to where he came from. Pt discharged.
This is a 64y.o.female with history of COPD, hypertension who presents secondary to fatigue. She states her whole family has been diagnosed with covid at home. She is fully vaccinated. She still smokes 1 pack of cigarettes per day. WBC elevated at 14.8, hemoglobin-12.3, platelet-96,covid positive, blood cultures pending,CT negative for any pulmonary embolism, multifocal groundglass and reticular airspace opacities concerning for underlying atypical infectious process. Similar near complete atelectasis of the left lower lobe. No significant change in nonspecific mediastinal adenopathy. Chest x-ray bibasilar streaky opacities which could represent subsegmental atelectasis or an acute infectious inflammatory process in the appropriate clinical setting. Small left pleural effusion. She was started on Decadron. Infectious disease has been consulted. Started on high flow nasal cannula. This morning she states she feels significantly improved. Asking about discharge home.
Swollen lymph node left underarm; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 13:30 (Lot number: 30145BA) at the age of 32 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Type one diabetes" (unspecified if ongoing), notes: Type one diabetes; "Fibromyalgia" (unspecified if ongoing), notes: Fibromyalgia. Concomitant medication(s) included: METFORMIN; HUMALOG; CELEXA [CELECOXIB]; TRAMADOL. Vaccination history included: Bnt162b2 (Dose Number: 1, product=COVID 19, brand=Pfizer, Batch/Lot No: EH9899, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 18Dec2020, when the patient was 32 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, product=COVID 19, brand=Pfizer, Batch/Lot No: EL1284, Location of injection: Arm Left, Vaccine Administration Time: 11:15 AM), administration date: 06Jan2021, when the patient was 32 years old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 02Oct2021, outcome "not recovered", described as "Swollen lymph node left underarm". The event "swollen lymph node left underarm" was evaluated at the physician office visit. Additional Information- Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with covid-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination No follow-up attempts are possible. No further information is expected.
Patient called pharmacy with complaint regarding vaccine received 5/15/17. Said she feeling tingling in/on her lips, also said lips turned black and cracked. Using VASELINE to moisten lips; will take BENADRYL at night and stay hydrated- MD notified.
Participant confirmed they never had a flu shot before, and when they instructed to wait around a bit. They went to there office which was in view of the screening area. Nurse observed participant as pale and dizzy. He was laid on the ground with his legs elevated. He was chilled with diaphoresis. BP was 102/72. At biometric screening before shot it was 128/78. 10 mintues later, participant still complains of feeling "weird". Nurse suggested he go to walk-in clinic. Co-worker takes him. Nurse gives co-worker phone number so she can be updated on outcome: participant feeling much better and was diagnosed with vascular response to the injection.   Urgent care the participant went to is unknown. Participant can be contacted if that information is needed.
got up about 5:15AM to use the restroom, parents heard a huge crash and we came running - he had collapsed and fainted in the bathroom, against the toilet, (with shelves and glass crashing down him - he grabbed the shelves and had a few cuts and bruises), was unresponsive, no color in his face, could not stand or move, could barely speak - slumped against the toilet.  Parents called 911 and tried to get him to respond, he was listless but opened his eyes - we lifted him and moved him to recliner in living room.  Fire Dept./EMT's arrived within a few minutes, blood pressure was 87/43, glucose was normal.  EMT's determined it was a reaction to the vaccine and asked if he wanted an ambulance or if parents should drive him for further care - he opted for us to drive him (his Mom called the Dr. on staff first - Dr. said it was a reaction to the vaccine and he should not get a 2nd dose).  Patient's Dad took him to Urgent Care - they ran an EKG (normal), and stayed there until his blood pressure showed (although still low)  normal/acceptable again.  I looked at the CDC website for covid anaphylaxis and it appears it was an allergic reaction (cardiovascular), on the site, he had these symptoms:  "Cardiovascular: fainting; hypotension (abnormally low blood pressure); pallor.  ... Symptoms of anaphylaxis often occur within 15-30 minutes of vaccination, though it can sometimes take several hours for symptoms to appear."