chrisvoncsefalvay/vaers-outcomes huggingface dataset:
possibly frozen FLUZONE QUDRIVALENT HIGH-DOSE and FLUZONE QUADRIVALENT were administered on accident after a shipment of FLUZONE HIGH-DOSE and FLUZONE QUADRIVALENT arrived frozen with no reported adverse event; Initial information received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/ non-healthcare professional via Medical Information (MI) number: 00814937.  This case involves a 79 years old male patient who was administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product storage error).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On 15-Oct-2021 01:59, the patient received a0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number: UJ716AA and expiry date: 30-JUN-2022 via intramuscular route in unknown administration site and a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number and expiry date not reported via intramuscular route in unknown administration site for prophylactic vaccination respectively.  It was case of an actual medication error due to Product storage error temperature too low (latency: same day).  It was reported "The caller reported that the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen; that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time; that 2- FLUZONE QUADRIVALENT doses and 13- FLUZONE HIGH-DOSE doses were administered from the frozen shipment."  At the time of reporting, no adverse event was 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.
2? x 1-1/2? area of red rash, swelling, heat, itching. Also chills and fatigue.
Hearing Loss in both ears/ almost complete hearing loss in left ear; Ear Infection; Fluid Behind Ear Drum; Tinnuitis; This case was reported by a consumer via call center representative and described the occurrence of hearing loss bilateral in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received in 2017, was of other manufacturer's).   On 7th October 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, less than 2 weeks after receiving Shingrix, the patient experienced hearing loss bilateral (serious criteria GSK medically significant), ear infection, fluid in middle ear and tinnitus. On an unknown date, the outcome of the hearing loss bilateral and tinnitus were not recovered/not resolved and the outcome of the ear infection and fluid in middle ear were resolved with sequelae.   It was unknown if the reporter considered the hearing loss bilateral, ear infection, fluid in middle ear and tinnitus to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in her left arm. Within 2 weeks of vaccination, the patient developed an ear infection and fluid behind ear drum which was resolved. The patient stated, this resulted in hearing loss in both ears and almost complete hearing loss in left ear. The patient's hearing test was done by an audiologist and noted unusual patterns of hearing loss with 40 percent in left ear and 30 percent in right ear. The hearing loss persisted up until approximately 2 weeks before the reporting date but she stated hearing loss in her left ear and tinnitus would never return to baseline. The patient consented to follow up and provided her physician's details.      Lab Comments: Noted unusual patterns of hearing loss with 40% in left ear and 30% in right ear.
Prolonged (2 weeks) light menstruation in post/peri menopausal woman that stated <1  month after Moderna booster.   Unanticipated menstruation in last-minute cancellation of annual ob/gyn appt that had been scheduled >1 year in advance.    As a relatively healthy adult <50 yo, I would not have gotten boosted if not but for public health nonresponse and/or misinformation in light of Omicron, including CDC erroneously reporting ?73%? Omicron for sequenced covid samples and ableist public authorities not caring about preventable deaths of people who ?were unwell anyway.?     Post-vaccination anxiety due to credible experts reporting emerging evidence of original antigenic sin, in addn to potential called out by credible experts in late November 2021, but no public/transparent program discussion of actual risks/benefits of booster recommendation (or of Pfizer boosters for younger adolescents, despite FDA prolonged reticence re Moderna booster for younger adolescents).
INCREASED SWELLING IN THROAT; swelling in face; itchiness in throat; metallic flavor in mouth; Increased Jaw numbness; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (INCREASED SWELLING IN THROAT), SWELLING FACE (swelling in face), THROAT IRRITATION (itchiness in throat), DYSGEUSIA (metallic flavor in mouth) and HYPOAESTHESIA (Increased Jaw numbness) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Sulfa.) and Allergy to antibiotic.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced PHARYNGEAL SWELLING (INCREASED SWELLING IN THROAT), SWELLING FACE (swelling in face), THROAT IRRITATION (itchiness in throat), DYSGEUSIA (metallic flavor in mouth) and HYPOAESTHESIA (Increased Jaw numbness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 10-Apr-2021, PHARYNGEAL SWELLING (INCREASED SWELLING IN THROAT), SWELLING FACE (swelling in face), THROAT IRRITATION (itchiness in throat), DYSGEUSIA (metallic flavor in mouth) and HYPOAESTHESIA (Increased Jaw numbness) had resolved.            No concomitant medications provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-075014 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075014:cross linked to Dose 1
PATIENT STARTED TO FEEL NUMBNESS IN TOUNGE AND FACE.  PATIENT STATED BLURRY VISION WHEN LOOKING AT LIGHTS. PATIENT WAS GIVEN BENADRYL WATER AND PREZTELS.  PATIENT STARTED TO FEEL BETTER BUT THEN STARTED TO FEEL NUMBNESS/TINGLING IN LEFT SIDE OF FACE, LEFT FOOT, AND LEFT LEG. PATIENT WAS TAKEN TO EMERGENCY ROOM AFTER SPEAKING WITH HER PRIMARY CARE DOCTOR.
01JUN95  purulent rt OM, febrile sz, runny nose preceding day; sz tonic clonic, 2 1/2 mins, witnessed in clinic; next day gait appropriate but parents state less steady than usual; paralysis present p/sz; Todd's paralysis;
pt recvd vax & exp lump in throat, wheezing & numbness across the chest; dx anaphylaxis by ER MD;
3 doses of primary series vaccine administered after the 30 day beyond use date.; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 doses of primary series vaccine administered after the 30 day beyond use date.) and NO ADVERSE EVENT (No Adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 doses of primary series vaccine administered after the 30 day beyond use date.) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 doses of primary series vaccine administered after the 30 day beyond use date.) had not resolved and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (3 doses of primary series vaccine administered after the 30 day beyond use date.).    No concomitant medication was reported. No treatment medication was reported.
Patient was mistakingly given a pediatric Pfizer (orange-cap) dose instead of the approved 12+ Pfizer (Purple Cap) dosage.  No other adverse reactions or events to report.
Breakthrough COVID-19 case with unknown symptom status. Death 8/19/21. From Vital Records COD = CARDIOPULMONARY ARREST, COVID 19, END STAGE RENAL FAILURE. Per vital records, COD ICD Codes include: Not yet coded ; Other Significant Conditions include: None listed. place of death: HOSPITAL-INPATIENT,  HOSPITAL; certified by: PRONOUNCING AND CERTIFYING PHYSICIAN; occ/ind: COMANPY
Developed shingles. I am mostly recovered, with just some residual redness of skin where rash was and some residual pain twinges and itching.
Patient experienced a small seizure the day after Moderna second dose which resulted in extreme exhaustion and unable to get out of bed for 36 hours. Patient did not follow-up with doctor and continues to take Keppra ER daily. Patient's seizures have been controlled for 3 years until second dose of Moderna.
Reason for Appointment  1. Rash  History of Present Illness  Patient presents with left breast rash under the breast for 4 days. Patient noticed rash in the back first then under the breast +itching. Of note, patient has been using firming lotion and had been using tanning cream mixed with it. Patient tried ammoniun hydroxide lotion which helped. Patient received Zostavax shot 3 weeks ago.   Examination  Torso left breast vesicular rash and on the left upper back. Assessment  1. Shingles - 053.9 (Primary)  Treatment  1. Shingles   Start Valtrex tablet, 1 g, 1 tab(s), orally, every 12 hours, 7 day(s), 14, Refills 0 Start Zyrtec tablet, 10 mg, 1 tab(s), orally, once a day, 30 days, 30, Refills 0
Patient returned to clinic 1 day after vaccine with redness and swelling a the sit eof injection measuring 4cmx4cm. Patient also reports tenderness.
Unable to lift arm, pain in arm, pain awakes me from sleep (***unsure of type of flu shot, manufacturer, given in workplace via employee health and documentation does not specify details requested above***).
Patient called on 5/16 when we opened and explained that she got the vaccine yesterday, she did not have any symptoms/side effects besides sore arm yesterday.  She said symptoms presented in the AM of 5/16 and her arm developed a red rash about 2-3 in around the injection side, it was painful to touch, swollen and hurt when she would move it.  She reported that she did not have any itching.  Told patient she could take some tylenol for the pain, apply ice and also take benadryl to help if it was a histamine response to the vaccine.  Will follow up with her tomorrow and told patient if not better in 2-3 days to call the MD.
Within 24 hours of the vaccine, patient reports that shingles-like rash developed on her left buttock and extended down the back of her left leg toward her knee. At urgent care, it was confirmed to be shingles, and she was immediately started on antiviral treatment.
devel swelling of tongue;acute angioedema;tx epi & solumedrol, pred;
Patient received expired Moderna COVID-19 Vaccine on 03/31/2022, vaccine expired on 03/27/2022.
Initial report was received 30 September 2008 from a health care professional. A cluster of two unidentified patients had each received an intramuscular left deltoid injection of ADACEL, lot number C2995BA and an injection of PNEUMOVAX, lot number 0803U (manufacturer Merck, route and site not reported) on an unspecified date and four days later, developed pain and tenderness, swelling, increased redness, warmth, and an erythematic lesion (with no blisters) at the left deltoid injection site. The patients had no concurrent illness at the time of vaccination and had not received any other vaccines within four weeks of ADACEL and PNEUMOVAX. The patients were evaluated by their physician and were diagnosed with Cellulitis. Corrective treatments consisted of warm compress application for two to three days, MOTRIN prn, and KEFLEX for seven to ten days. The recovery status for each patient was unknown at the time of the report. Follow-up information was received 03 October 2008 from a health care professional who provided patient identifiers for both unidentified patients. This case shall reference the adult female patient with a reported date of birth of //1949. The reporter confirmed the patient had received PNEUMOVAX lot number 0803U and ADACEL, lot number C2995BA. No additional information was provided at the time of the report. The second patient referenced is captured in case number 2008-03037.
Information has been received from a physician concerning a female (age not reported) who on 02-JUL-2008 was vaccinated with a dose of GARDASIL vaccine (lot not reported). On 02-JUL-2008 after vaccination, the patient experienced pain in her legs. The patient's outcome was reported as recovering. Additional information has been requested.
Redness; Sore arm / soreness has worsened; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 3E279, expiry date 19th March 2022) for prophylaxis.   On 14th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 14th November 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 20th November 2019, the patient experienced erythema of extremities. On an unknown date, the outcome of the pain in arm and erythema of extremities were recovering/resolving.   It was unknown if the reporter considered the pain in arm and erythema of extremities to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient after vaccination within a day noted soreness, which was initially only painful if she bumped it or touched the area and also experienced redness. The reporter consented to follow up.
Expired diluent administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA585A, expiry date 30th April 2023) and (batch number AMAA585A, expiry date 31st August 2022) for prophylaxis.   On 21st September 2022, the patient received Menveo. On an unknown date, the dose was an unknown dose. On 21st September 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-Sep-2022 Reporter's Comments: The reporter was a medical assistant. The reporter stated that administration of expired dose, diluent expired 31st Aug 2022. The reporter consented to follow up. Additional Supportive Information: The patient received expired Menveo vaccine which led to expire vaccine used.
From initial info received on 7/6/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 21 year old female pt received her 2nd dose of JE-VAX, lot BJN213A, administered SC, in the left arm on 7/1/04. After receiving the 2nd dose at the beach by a relative, the pt reported (to this reporter who administered the 1st dose) that she experienced stomach pain, nausea and vomiting. The events resolved the same day without medical intervention. The pt recovered from these events.
Systemic: hyperglycemia-Severe, Additional Details: patient's father came in 8/9/21, said his son's blood glucose level went up to 400 about 6 hours after getting 1 vaccine pfizer
dizziness; high fever; chills; body aches; This case was reported by a nurse via call center representative and described the occurrence of dizziness in a 19-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On 13th May 2019, the patient received the 1st dose of Bexsero (intramuscular). On 13th May 2019, less than a day after receiving Bexsero, the patient experienced dizziness, fever, chills and general body pain. On 15th May 2019, the outcome of the dizziness, fever, chills and general body pain were recovered/resolved.   It was unknown if the reporter considered the dizziness, fever, chills and general body pain to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported but it could be 18 years or 19 years. Within hours after receiving Bexsero, the patient experienced dizziness, fever, chills and body aches, which resolved within 2 days. The reporter consented for follow up.
Pt. c/o pain at the site of inj. to (L) deltoid starting 8-10 hrs. after inj. Pain was described as "debilitating". No other symptoms.
(L) arm - red, swollen, hot to touch, tender to the touch 5 cm x 5 cm.
It made me sick; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: unknown),via an unspecified route of administration on 28Apr2021 as a single dose for COVID-19 immunization. Patient reported he was rested from Covid only to take Pfizer vaccine. Medical history included Long COVID and he was already tested positive for Covid in January. Patient also had cardiac arrest twice in 90days wait time for vaccine, and bilateral pulmonary embolism(PE), and four upper extremity DVT from COVID. No family history of adverse effect. Concomitant medication included ELIQUIS 2.5mg tablet taken in the morning and night to prevent blood clot. The patient reported vaccine made him sick and it's normal because he had Covid. Patient underwent lab tests and procedures which included sars-cov-2 test: positive on Jan2021. Investigation assessment reported as yes. The clinical outcome of event was unknown.
Information has been received from a registered nurse concerning a 18 week old infant who was vaccinated on 13-Nov-2006 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information in not expected.
pt recv vax & exp an inj site rxn characterized by swelling, redness, induration & pain;
Patient became unresponsive, hypotensive after approximately 15 minutes.  911 was called and patient was transported to acute hospital.
Patient received HD flu vaccine approximately noon 9/17/2012, at 11:00 AM 9/18/2012 patient became ill with nausea and vomiting. Went to the Emergency Room about 1:00pm on 9/18/2012. Was told it was a viral illness but the patient also received diagnosis of vertical vertigo. Had lab work and CT scan done. Received Meclizine and PHENERGAN. Sent home. 9/20/2012 patient is feeling better but remains dizzy of head.
patient took the Shingles shot & ended up with severe cases of the Shingles/ suspected vaccination failure; 2 friends who took the Shingles shot & both ended up with severe cases of the Shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient received the shingles shot and ended up with severe case of shingles. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided. This case had been linked with case US2021AMR091437, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR091437:same reporter (patient 2 of 2)
Mother notified us over phone about reaction to the vaccine, patient's leg was swollen where vaccine was administered. Told mom to come into clinic for Dr. to exam. BENADRYL, MOTRIN and ice pack for treatment, will follow up on next day.
Swollen left arm under injection site.  Warm and slightly blotchy red.  Much redder the next day and arm still swollen. Swelling looks like edema.
Pt noted swelling and severe pain beginning several hrs after shot. By evening, was painful to lift arm to remove shirt. Next day was 50% better. On 3rd day was 50% more better. So within 48 hours pt was about 85% better. As of 2-18-16 pt is completely recovered.
Pt received Covid vaccine  complained of pounding headache, dizziness, chest pressure, feeling hot all over. BP 131/87. HR 82, RR 18, O2 sat 98%, temp 98.3. Pt taken to Emergency Department to further care required.
AFTER THE PT RECEIVED THE VACCINE, HE CAME TO REGISTER TO SIGN FOR IT. THEN HE WAS TOLD TO SIT FOR 15 MINUTES TO MAKE SURE HE DOESNT HAVE ANY ALLERGIC OR ADVERSE REACTIONS. HE WAS  LOOKING AROUND THE STORE WHEN HE ALL OF THE SUDDEN HAD SEIZURE AND FELL ON THE FLOOR. WE CALLED EMS RIGHT AWAY HOWEVER HE WOKE UP AND BOTH HIM AND HIS FRIEND TOLD US TO DISCONNECT WITH EMS. HIS FRIEND TOLD US THAT HE HAS EPILEPSY AND HE HAS EPISODES LIKE THIS TIME TO TIME. THE PT EXPERIENCED SOME CUTS ROUND HIS FORHEAD AND HIS (L )EYEBROW WHICH WE HELPED CLEAN UP WITH DISINFECTANT AND BANDAID.  AFTER HE LEFT WITH HIS FREIND (WHO WAS THE DRIVER), WE FOLLOWED UP WITH HIM AND HIS FREIND AND THEY SAID HE IS DOING WELL.
Gave a 3rd Flu vaccine. Vaccine assessment sheet only had 1st dose given. #2 dose given 2-22-11.