chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired dose of PENTACEL was administered to a patient today with no reported adverse event; Initial information regarding an unsolicited valid non-serious case  via health professional on 16-Sep-2022. Agency number: 01282761  This case involves a 4-month-old female patient to whom expired dose of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel] was administered to a patient today with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination; and Rotavirus Vaccine Live Reassort Oral 5V (Rotateq) for Prophylactic vaccination.  On 16-Sep-2022, the patient received expired 2nd dose of suspect Pentacel at dose 0.5ml once via intramuscular route in the left thigh (lot: UJ571AAA, expiry date: 11-Sep-2022) for Immunization with no reported adverse event (expired product administered) at same day latency.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown.    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.
Vaccine at 945 am Friday Calves of both legs cramped rock hard at 10 pm Friday and remained so for 18 hours.  Had to use heating pad and massage to help feet relax from en pointe position so I could walk to the bathroom.  Legs were sore after 18 hours but not cramped .  Also massive headache made my eyes light sensitive all day Saturday and Sunday until about 9PM.  Extreme exhaustion.  Recovering today, Monday.  Still tired an s slight residual headache at times but not bad enough for painkiller.
Information has been received from a nurse concerning a 16 year old female with allergies to sulfa, erythromycin ethylsuccinate (+) sulfisoxazole acetyl (PEDIAZOLE) and carbinoxamine maelate (+) pseudoephedrine hydrochloride (RONDEC) who was vaccinated intramuscularly in the deltoid on 19-Apr-2007 with first dose and on 19-Jun-2007 with a second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The nurse reported that the patient began experiencing headache 30 minutes after the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) was administered. The headaches were occurring daily for 1 to 2 months after receiving the 2nd dose. The patient's headache still persisted but had tapered somewhat and occurred intermittently. The patient had been concomitantly treating the headaches with acetaminophen (TYLENLOL), ibuprofen (MOTRIN) and bed rest. The patient did received unspecified medical attention, per the nurse the patient has not recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007. Information has been received from a nurse concerning a 16 year old female with no illnesses at the time of vaccination, allergies to sulfa, PEDIAZOLE and RONDEC who was vaccinated intramuscularly in the left deltoid on 19-Apr-2007 with a first dose of GARDASIL vaccine (lot#654510/0962F). On 19-Jan-2007, the patient was vaccinated intramuscularly in the right deltoid with a second dose of GARDASIL vaccine (lot#654510/0962F). The nurse reported that the patient began experiencing severe headaches 10 minutes (previously reported as 30 mins) after the second dose of GARDASL vaccine was administered. The headaches were occuring daily for 1 to 2 months after receiving second dose. The patient's headache still persisted but had tapered somewhat and occurred intermittently. The patient had been concomitantly treating the headaches with TYLENOL, MOTRIN, and had rest. The nurse stated that the patient had become unresponsive to TYLENOL, MOTRIN. No diagnostic test were performed due to the patient's lack of insurance. The patient did received unspecified medical attention, per the nurse the patient has not recovered. No additional information is expected. Additional information was received from a billing clerk on 16-Feb-2008 indicating that her daughter experienced a splitting headaches ten minutes after receiving her second dose of GARDASIL vaccine. The patient has been having problems with headaches ever since the secod dose was given and the patient's mother stated that she will not let her daughter receive the last dose of the series. No lot number was provided. The patient did received unspecified medical attention. The patient had not recovered at the time of reporting. No product quality complaint was involved. No further information was provided.
Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for Prophylactic vaccination.     Patient had no known allergies.  Previously administered products included for Product used for unknown indication: Flu Shot. Past adverse reactions to the above products included No adverse event with Flu Shot. Concurrent medical conditions included Drug abuse (Drug abuse of penicillin that increases Serotonin such as Tramadol (Pain medication).).    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills) and PYREXIA (Fever). At the time of the report, CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       No concomitant  medications were reported by the reporter.  Patient received covid-19 vaccine ad26.cov.s for  second dose on 07-Apr-2022on left arm with batch number 1855190 and experienced wobbling unsteady when walking, felt shaky, numbness around right ear and lightheadedness on the same day. It was reported that patient felt the Jansen and Jansen injection was given very high on the arm. Outcome of these events were not reported.  No Treatment medications were reported by the reporter
Pt received her 1st year immunizations on 21SEPT04.  Hep B, Hib 4, Pneumo 3, MMR1, Varicella: received 2 shots i each leg. She also received a PPD (Tb test) in her left arm. In the evening of 22SEPT04, pt developed a large, red, hot, hard swelling  in her right leg about the size of a baseball.
Guillain Barre Syndrome (GBS) and paroxysmal atrial fibrillation (PAF)
under the age of 65 were administered FLUZONE HD QIV instead of the FLUZONE QIV with no adverse event; under the age of 65 were administered FLUZONE HD QIV instead of the FLUZONE QIV with no adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to cases 2022SA447057(CLUSTER), 2022SA446385(CLUSTER) and 2022SA448075(CLUSTER).  This case involves a 54 years old male patient was under the age of 65 were administered influenza quadrival A-B high dose HV vaccine [fluzone high-dose quadrivalent] instead of the fluzone QIV with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 18-Oct-2022, the patient received suspect influenza quadrival A-B high dose HV vaccine at a dose of 0.7 ml once (lot UT7729CA, expiry date: 30-Jun-2023) via intramuscular route in the left deltoid for immunisation.  On 18-Oct-2022, the patient who was under the age of 65 were administered fluzone hd qiv instead of the fluzone qiv with no adverse event (wrong product administered, product administered to patient of inappropriate age, latency: same day).  Action taken: Not applicable.  Outcome: Unknown for both the events.   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.
My daughter developed a fever ranging from 101 - 104 and a headache. She was weak during times the fever was real high. She seemed out of it. Fever lasted for 3 days.
Bleeding & Anemia Narrative:  Patient developed menorrhagia in September 2021. On 10/8/21 her hemoglobin was 5/5 g/dL. She required an emergency blood transfusion. The patient underwent a DNC procedure on Oct. 2021 which helped to resolve the bleeding.
No additional AEs or PQCs reported in this case; This is an adverse event for use outside of the recommended dosing intervals in the prescribing information; This spontaneous report as received from a health care professional (also reported as administrator) to a patient of unknown age. There was no information about the patient's medical history, concurrent conditions or concomitant medication. On 25-SEP-2020 and 05-NOV-2020,  the patient was vaccinated with a first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9),dose :0 .5 milliliter for prophylaxis (routes of administration, lot numbers and expiration date were not reported).  It was reported that the patient received a third dose of of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9),dose :0 .5 milliliter for prophylaxis (route of administration, lot number and expiration date were not reported), on 26-JAN-2021, used outside of the recommended dosing intervals in the prescribing information. No additional AEs or PQCs reported in this case, and no further information was provided.
This case was reported by a nurse via call center representative and described the occurrence of nonarteritic anterior ischemic optic neuropathy in a 51-year-old male patient who received SHINGRIX for prophylaxis. On 17th December 2018, the patient received the 1st dose of SHINGRIX. On 24th December 2018, 7 days after receiving SHINGRIX, the patient experienced nonarteritic anterior ischemic optic neuropathy (serious criteria GSK medically significant) and abnormal vision. On an unknown date, the outcome of the nonarteritic anterior ischemic optic neuropathy and abnormal vision were not recovered/not resolved. It was unknown if the reporter considered the nonarteritic anterior ischemic optic neuropathy and abnormal vision to be related to SHINGRIX. Additional details were provided as follows: On 24th December 2018, the patient developed vision issues in the left eye. The patient was diagnosed with non-arteritic anterior ischemic optic neuropathy. No other information was provided.
This spontaneous report as received from a other health professional refers to patients of unknown age. In 2017 the patients were vaccinated with improperly stored doses of M-M-R II lot # L039613 for prophylaxis. Other suspect therapies included sterile diluent. No adverse event.; Sender's Comments:  US-009507513-1708USA011305: US-009507513-1708USA004309:
Swelling and redness observed at injection site, increasing in severity 18 hours after vaccine administered.  Patient experienced headache 18 hours after administration of vaccine; symptom lasted approx. 12-24 hours.  Redness continues to be observed on third day after vaccine administered.
Agitation (^), irritability/limp alternate., screaming/crying/unconsolable, (down)oral intake, (down) sleep...x 5 days.
No adverse event; 2 children received the adult version of the Spikevax 2023-2024 prefilled syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (2 children received the adult version of the Spikevax 2023-2024 prefilled syringe) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030355) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On 03-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced WRONG PRODUCT ADMINISTERED (2 children received the adult version of the Spikevax 2023-2024 prefilled syringe). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (2 children received the adult version of the Spikevax 2023-2024 prefilled syringe) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (2 children received the adult version of the Spikevax 2023-2024 prefilled syringe).    No concomitant medications were reported. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-743701.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743701:1st Child case
TINGLING IN LEFT ARM AND JAW.  THIS HAS HAPPENED BEFORE AND SHE IS CURRENTLY SEEING A NEUROLOGIST.  EMS CALLED  FOR FURTHER EVALUATION BUT PT REFUSED TO GO TO THE ER. PT DISCHARGE HOME WITH HUSBAND.
Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female patient with penicillin allergy and a history of preeclampsia in 2007 pregnancy and one full term delivery at 37 weeks gestation who on 21-OCT-2008, 12-FEB-2009 and 20-JUL-2009 was vaccinated IM with the first (lot# 661764/0650X), second (lot# 661952/1129X) and third (662300/0100Y) 0.5ml doses of GARDASIL respectively. On 14-AUG-2009, a urine pregnancy test was performed and the patient was determined to be pregnant. No problems reported. An ultrasound was performed for dating on 25-AUG-2009 and it showed pregnancy at 6 weeks and 5 days gestation. A maternal serum Alpha-Fetoprotein Screening was performed on 02-NOV-2009, and the result was within normal limits (WNL). The patient's last menstrual period was 20-JUN-2009. Expected date of delivery was 27-MAR-2010. Follow up information from a register nurse indicated that on 23-NOV-2009, an ultrasound was performed and showed echogenic focus left ventricle. On 30-NOV-2009, a level II ultrasound was performed and the result was not provided. On 09-APR-2010 (39 weeks from LMP), the patient delivered a normal male baby (6 lb 8 oz, 20 in length, head circumference 32 and APGAR score 9 at 1 minute/9 at 5 minutes). At the time of the report, the patient's status was unknown. The mother's experience has been captured in WAES# 0909USA01379. Additional information has been requested.
Initial information received on 11-Jan-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old male patient who received only the DTAP & IVP portion of vaccine PENTACEL without the HIB. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE; PREVNAR; and ROTAVIRUS VACCINE. On 19-Dec-2018, the patient received a third dose of suspect PENTACEL lot number not reported via unknown route in unknown administration site. It was a case of actual medication error due to Inappropriate reconstitution technique. Liquid portion of the PENTACEL was used only and didn't give the Lyophilized powder. It was reported that no adverse event occurred. 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 Directive and Module VI of the 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. List of documents held by sender: none.
I started having effects 1 hour and half after. I could not open my jaw for days. My left leg was numb and tingling, like a buzzer, continued off and on for a while. 3/24/2021, My hands were swollen, I was fatigued, joint pain, left foot itch, sharp pain in my Jaw. 4/11/2021, My calves, legs and abdomen. 7/2021, The swelling was still there with swollen tailbone. For months I had electrical shocks and itching in my cheeks, arms, neck and bottom of my left foot. In May2021, my eyes were getting blurry. 5/28/2021, constant ache and pain in hands and arms. My Jaw pain was checked out nothing was found. June 2021, I was having jitters, June 6th the right leg was tingling off and on June 12th the left arm had weakness and nerve pain. Both legs and mostly the left. My knee was swollen, and I was still having swelling and jaw pain. Things came and went from time to time. The right side and under eye were red for months. It was swollen. 09/2021, I was having hair loss and shortness of breath. Now I out of breath when I excerpt myself.  I am having joint pain in elbows.  My liver became elevated. I am seeing a pulmonologist now to receive testing. I am having a 2D echo, CT of my Chest. I have gastroparesis that has gotten worse, I am seeing a GI in few months. I am having a CT of the Pelvis. And I'm seeing a neurologist.
He had 1st Prevnar dose given on 12/11/00. He then developed a fever on 12/12/00, generalized seizure and apnea. He was given rescue breathing by father and EMS activated. He was evaluated in ER.
palsy after 1 week of taking moderna covid -19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (palsy after 1 week of taking moderna covid -19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARALYSIS (palsy after 1 week of taking moderna covid -19 vaccine) (seriousness criterion medically significant). At the time of the report, PARALYSIS (palsy after 1 week of taking moderna covid -19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     The patient experienced palsy a week after taking Moderna Covid-19 vaccine.  No treatment  or concomitant  medications were reported by the reporter.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Area of erythema and swelling 2.5 cm x 3 cm below injection site. Warm, mild tenderness and itching.  Resolved after 5 days
On 4/16/99, the pt received the 1st dose of Lymerix. The pt was found to be pregnant. The date LMP is 03/17/99. The date of the positive pregnancy test is 5/4/99 and the estimated delivery date is late December, 1999. The pt delivered a 4 lb 8.5 oz female on 12/9/99 after a 37 1/2 week gestation. The mother experienced retained placenta. The most recent information received on 5/11/00, reports the condition of the pt as unknown. Physician has sent a letter to pt requesting follow-up information and it will be available as soon as he receives it.
Pt presented day after getting above IMZ with a red rash on upper left arm, same arm as imz was given. Told pt to put cold compress on arm, which he had done the night before which helped.  Told pt to take OTC BENADRYL to aid in rash resolution. Told pt that red areas and rashes are possible side effects of any imz and to watch it closely. Contact MD if gets worse or spreads or pt experiences any other side effects. Said he felt fine and didn't hurt just had red swollen rash area on the upper arm. Told pt may take a few days to resolve completely.
Simple swelling and pain at the injection site; Simple swelling and pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 59-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Not available/provided to reporter at the time of report completion), via an unspecified route of administration, administered in left arm on 05Mar2021 12:30 as 1st dose, single for covid-19 immunisation. Facility type of vaccine was reported as other. The patient was not received other vaccine in four weeks. The patient was received unknown medications in two weeks. Medical history included Heart disease, asthma, hypertension, obesity and high col. The patient was allergic to Iodide based contrast, X-ray, dye and latex. Concomitant medications were not reported. The patient experienced simple swelling and pain at the injection site on 05Mar2021 01:00 PM. No other symptoms. The patient was not received treatment for adverse event. The was not tested prior and post vaccination. Outcome of the event was recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
patient was given the J&J vaccine on April 1st and then they realized that received the Modena's COVID-19 Vaccine as a first dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient was given the J&J vaccine on April 1st and then they realized that received the Modena's COVID-19 Vaccine as a first dose) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE for COVID-19 vaccination.    The patient's past medical history included No adverse event (Relevant medical history was not provided.).   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient received first dose of COVID-19 VACCINE (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced WRONG PRODUCT ADMINISTERED (patient was given the J&J vaccine on April 1st and then they realized that received the Modena's COVID-19 Vaccine as a first dose). On 01-Apr-2021, WRONG PRODUCT ADMINISTERED (patient was given the J&J vaccine on April 1st and then they realized that received the Modena's COVID-19 Vaccine as a first dose) had resolved. Not applicable    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use was not provided. Treatment information was not provided.   The patient didn't experienced any adverse reactions to the first dose or the second one and it's vital signs are stable according to the nurse.; Sender's Comments: This report refers to a case of Wrong vaccine administration error for mRNA 1273 with no associated AEs.