chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse practitioner, via a sales representative, refers to a 13 year old female patient. The patient's pertinent medical history, drug reactions/allergies were not provided. It was reported that on 09-SEP-2014, patient received a dose of ZOSTAVAX (route, lot # and expiration date were not provided) instead of second dose of (Oka/Merck) VARIVAX. The nurse while preparing to give a vaccination to another unspecified patient, nurse realized that a former 13 year old female patient received ZOSTAVAX instead of (Oka/Merck) VARIVAX. The nurse practitioner stated that three was product confusion in the labeling of the two vaccines. The patient on 09-SEP-2014 was coming in for the second dose of (Oka/Merck) VARIVAX and was given ZOSTAVAX in error. Additional information has been requested.
Pt recvd a dose of Engerix-B 25OCT91 & 27OCT91 2 days later pt exp pain radiating to lt shoulder; Event persisting as 6NOV91;
No adverse event; Adult Patient received 0.5 ml of pediatric vaccine instead of a bivalent Booster dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Adult Patient received 0.5 ml of pediatric vaccine instead of a bivalent Booster dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Adult Patient received 0.5 ml of pediatric vaccine instead of a bivalent Booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Adult Patient received 0.5 ml of pediatric vaccine instead of a bivalent Booster dose) 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 WRONG PRODUCT ADMINISTERED (Adult Patient received 0.5 ml of pediatric vaccine instead of a bivalent Booster dose).    No concomitant medications were reported. It was reported that, the vaccine administrator inadvertently grabbed the underage Moderna 6 months to 5 years age vaccine and administered to the adult patient. It was reported that the CDC had recommended to immediately repeat that dose with the correct bivalent vaccine or discuss with the patient and wait 2 months for the bivalent.  This case contains information for the 4th of 5 Adult patient described by the reporter. No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-650478, US-MODERNATX, INC.-MOD-2022-650481, US-MODERNATX, INC.-MOD-2022-650482, US-MODERNATX, INC.-MOD-2022-650485 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-650478: US-MODERNATX, INC.-MOD-2022-650481: US-MODERNATX, INC.-MOD-2022-650482: US-MODERNATX, INC.-MOD-2022-650485:
Spiked a fever of 102.9  2 days after injection that lasted 4 days Lips and fingers turned purple on 3rd day post injection for an hr or so Rash on face neck 6 days post injection  Mood/personality extremely altered/cranky throughout
Information has been received from a published article, title as stated above. This literature case was initially reported on 29-MAR-2010. This article concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean age of patients was 29 years). The patients received a RECOMBIVAX HB, manufacturer, batch number, route and site not reported, on unreported dates. This report concerns patient # 29 of 32, a 26 year old female. On an unreported date between 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccination in 15 patients, after the second vaccination in three patients and after the third vaccination in three patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second doses of vaccine. One patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. A 26 year old female on an unspecified date was vaccinated with the first and the second dose of RECOMBIVAX HB (lot number, route and site not reported) respectively. There was no concomitant medication. One day after the first dose and one day after the second dose vaccination, the patient developed uveitis. At the time of the report, the patient's outcome was not reported. The patient also experienced symptoms of dizziness, fatigue and nausea. The authors stated the RECOMBIVAX HB may have a possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential pathogenic mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. Additional information has been requested. The article also discussed the experience of an additional 31 patients while on therapy with RECOMBIVAX HB (WAES #1004USA01716, WAES # 1004USA02327 to WAES # 1004USA02353, WAES # 1004USA02355 to WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
No taste, no smell, fatigue, dry eyes, no saliva, extra dry skin, sore joints and muscles. Immune system attacking
patients were administered the temperature excursion doses; patients were administered the temperature excursion doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (patients were administered the temperature excursion doses) and EXPIRED PRODUCT ADMINISTERED (patients were administered the temperature excursion doses) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) 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 PRODUCT STORAGE ERROR (patients were administered the temperature excursion doses) and EXPIRED PRODUCT ADMINISTERED (patients were administered the temperature excursion doses). At the time of the report, PRODUCT STORAGE ERROR (patients were administered the temperature excursion doses) and EXPIRED PRODUCT ADMINISTERED (patients were administered the temperature excursion doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information was unknown
1/5/21 -10:45 AM - Received vaccine.  1/5/21 - 10:30 PM - 1/6/21 - 3:00 PM - Generalized 7-8/10 pain in muscles and joints, weakness and 100- 101F temp.  1/6/21 - ~1:00 - 5:00 AM -  4 or 5 SEVERE full body muscle spasm from my neck/jaw to toes preceded by cold chills.  I was unable to move or break away as my muscles were being painfully squeezed-lasted roughly 10-15 seconds or more.  It was painful and terrifying.   I was also incredibly thirsty.    1/6/21 - 3:00 PM - Sore muscles and 3 areas on my spine feeling tender, moderate numbness and tingling down my right leg and foot.
they administered 7 booster doses of the Moderna Covid-19 Vaccine on 22Apr2022 from a vial refrigerated on 11Mar2022; they administered 7 booster doses of the Moderna Covid-19 Vaccine on 22Apr2022 from a vial refrigerated on 11Mar2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they administered 7 booster doses of the Moderna Covid-19 Vaccine on 22Apr2022 from a vial refrigerated on 11Mar2022) and PRODUCT STORAGE ERROR (they administered 7 booster doses of the Moderna Covid-19 Vaccine on 22Apr2022 from a vial refrigerated on 11Mar2022) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (they administered 7 booster doses of the Moderna Covid-19 Vaccine on 22Apr2022 from a vial refrigerated on 11Mar2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (they administered 7 booster doses of the Moderna Covid-19 Vaccine on 22Apr2022 from a vial refrigerated on 11Mar2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they administered 7 booster doses of the Moderna Covid-19 Vaccine on 22Apr2022 from a vial refrigerated on 11Mar2022) and PRODUCT STORAGE ERROR (they administered 7 booster doses of the Moderna Covid-19 Vaccine on 22Apr2022 from a vial refrigerated on 11Mar2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. On 11Mar2022, the vial was initially stored in the refrigerator. The vial does not undergone any temperature excursions. Treatment information was not provided.
content leaked out, other dose administered; plunger issue/syringe leak/looked like the plunger was loose/content leaked out; Pharmaceutical product complaint; This case was reported by a other health professional via sales rep and described the occurrence of accidental underdose in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number 9722R, expiry date unknown) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced accidental underdose, syringe issue and pharmaceutical product complaint. On an unknown date, the outcome of the accidental underdose, syringe issue and pharmaceutical product complaint 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: 25-OCT-2022 Reporter's Comment: The reporter reported that the patient received a dose of Flulaval pre filled syringe where the vaccine ran out while she was depressing the plunger. The one nurse shared that it looked like it leaked out below the where you attach the syringe. The reporter started to report this as a quality issue at the GRC, case #01528098, on 13th October 2022. At that time, the reporter had limited information and it was not clear if this happened while the nurses were preparing the vaccine dose or while they were administering the dose. The reporter finally received feedback from the nurses that administered the vaccines, and they shared that the incidents happened while they were administering the vaccines.  The nurses said that it looked like the plunger was loose. Two times the vaccine contents leaked out of the top and 2 times the vaccine contents leaked out of the bottom.  The nurses shared that each time they felt that the patient did not receive any of the dose and it was a failed attempt, so they threw the dose away and administered another dose. The reporter shared that the patient did not have any reaction to the dose given. Although the patient did not have reactions to the vaccine dose given, the reporter reporting this in case it falls into the category of maladministration. The reporter did not consent to follow up. This was two of four cases, reported by the same reporter. Additional Supportive Information: The vaccine leaked out and had plunger issue, looked like the plunger was loose and other dose was administered, which led to accidental underdose, syringe issue and pharmaceutical product complaint.; Sender's Comments:  US-GSK-US2022AMR154589:Same Reporter US-GSK-US2022AMR154684:Same Reporter US-GSK-US2022AMR154685:Same Reporter
L shoulder pain progressed to inability to move/abduct/rotate, now improving 1.5 months later however not at baseline, seems rotator cuff tendonopathy related
02/26/22 presents to ED for "fall at home". PMHx of "HTN, MI/CAD s/p PCI (most recently May 2015), HLD, CVA, DM type 2 insulin dependent, falls, and hypothyroidism"
COVID-19 Treatment; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: EN6207), on 26Apr2021 as dose 2, single (Lot number: EW0176), in left arm and on 31Aug2021 as dose 3 (booster), single (Lot number: EW0187) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20May2022 as dose 4 (booster), single (Lot number: 004M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sjogrens Syndrome" (unspecified if ongoing), notes: Sjogrens Syndrome. Concomitant medication(s) included: XIIDRA, start date: 03Jan2022. Past drug history included: Lamisil, reaction(s): "known allergies: Lamisil". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "COVID-19 Treatment"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical information: The patient received other medication in 2weeks. Patient had COVID 19 treatment with Paxlovid with start date 25May2022.  No follow-up attempts are possible. No further information is expected.
Pt got 4 shots Sunday - on Monday he was sick had fever was weak and couldn't eat and had swollen left arm with itchy burning rash. Rash was worse on Tuesday but he was feeling better and could eat.
SHORTNESS OF BREATH; FELT LIKE I TOOK SPEED; NAUSEA; FEVERISH; TIREDNESS; NUMBNESS; DIZZY; BACK PAIN; BODY HEAVY; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's past medical history included fibroids, and endometriosis.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 023AZIA expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced back pain. On 11-APR-2021, the subject experienced body heavy. On 11-APR-2021, the subject experienced numbness. On 11-APR-2021, the subject experienced dizzy. On 11-APR-2021, the subject experienced tiredness. On 11-APR-2021, the subject experienced feverish. On 13-APR-2021, the subject experienced shortness of breath. On 13-APR-2021, the subject experienced felt like i took speed. On 13-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feverish on 12-APR-2021, was recovering from back pain, and body heavy, had not recovered from tiredness, dizzy, shortness of breath, numbness, and felt like i took speed, and the outcome of nausea was not reported. This report was non-serious.
Muscle soreness at the injection; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of INJECTION SITE PAIN (Muscle soreness at the injection) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 33-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 049D22A, 031H21A, 028A21A and 012A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. On 13-Oct-2022, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 13-Oct-2022, the patient experienced INJECTION SITE PAIN (Muscle soreness at the injection) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 13-Oct-2022, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, INJECTION SITE PAIN (Muscle soreness at the injection) outcome was unknown.            Concomitant and treatment medications were not provided.  Company Comment: This is a spontaneous case concerning a 33-year-old female patient with no reported medical history, who experienced the unexpected, non-serious event of Maternal exposure during pregnancy, after receiving the fourth dose of mRNA-1273 vaccine (mRNA-1273.222). The patient also reported to have injection site pain. Gestational age during exposure was not provided in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 33-year-old female patient with no reported medical history, who experienced the unexpected, non-serious event of Maternal exposure during pregnancy, after receiving the fourth dose of mRNA-1273 vaccine (mRNA-1273.222). The patient also reported to have injection site pain. Gestational age during exposure was not provided in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Fever 102.1 ,chills ,aches ,headache ,nausea Lack of appetite,malaise.
After 5 minutes some redness next to admin site and some burning. We iced it to see if it will go down but after 5 more minutes it got bigger. Patient given meloxicam, CLARITIN and PEPCID.
soreness in muscle; This is a spontaneous report from a contactable physician via a company representative. An adolescent patient of an unspecified gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration in leg muscle on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced soreness in muscle (non-serious) on an unspecified date with outcome of unknown.   Information on the lot/batch number has been requested.
patient who was starting the process of ln vitro fertilization was administered V ARIV AX, the patient took pregnancy test which was positive.; No additional adverse events; This spontaneous prospective pregnancy report was received from a nurse, who refers to a 29-year-old female patient, who was starting the process of in vitro fertilization. The patient's pertinent medical history included depression and anxiety and she had no known allergies. Her concomitant therapies included bupropion (BUPROPION) and unspecified prenatal vitamins. On an unknown date, the patient became pregnant. Based on pregnancy gestation, the patient's last menstrual period (LMP) was calculated on 28-APR-2020 and the estimated date of delivery (EED) was calculated on 02-FEB-2021. The pregnancy outcome was pending. Fetal outcome was unknown at the time of the report. On 02-JUN-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, subcutaneously, for prophylaxis, lot # S036636, expiration date 14-NOV-2021 (strength, dose, frequency were not reported), the vaccine was reconstituted with sterile diluent. On the same date, reported as later that afternoon, the patient took a home pregnancy test, which was positive. Initial exposure to varicella virus vaccine live (oka/merck) (VARIVAX) was at 5 weeks of gestation period. No additional adverse events were reported. The patient had no lab diagnostics or studies performed. The patient sought medical attention and she took advantage of counseling.
cry severely noc to morning borke out w/rash w/inc fever t104R;
he developed "a nosebleed yesterday and today.; This is a spontaneous report received from a contactable consumer (patient's wife). A 85-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry dates were not reported), via an unspecified route of administration, in left arm, on 18Feb2021, as single dose for COVID-19 immunisation. Patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry dates were not reported), via an unspecified route of administration, on an unknown date, as single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. It was reported that on 20Feb2021, the patient developed a nosebleed. It lasted about 10 min to maybe 30 min with pressure and gauze applied. He might have just blown his nose too hard, or it could be the cold weather. Patient's wife was not sure that it was from the vaccine. Outcome of the event was unknown.  Follow-up attempts are completed. Information about Lot/batch requested.
Pt reports developing a rash on the skin days after 1st dose of covid vaccine Moderna. Per PCP pre-medicate pt with diphenhydramine 20-30 min before vaccination with 30min obs.
This is a spontaneous report from a contactable HCP through a company representative. A 67 year old female received PREVNAR13 single dose intramuscular in the arm on unspecified date in FEB2015. The patient went to doctor, in 3 days later after she received the vaccine and was reported to have redness and swelling on the arm that she had the vaccine administered in. The HCP did not say which arm it was. The outcome of the events was unknown.