chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose 3 yrs ago, 2nd not yet, missed; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 3 yrs ago, 2nd not yet, missed). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 08-MAR-2023  The reporter enquired for the recommendations for a missed second Shingrix dose. The reporter asked should we proceed with the second dose or start with first dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 10Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (ongoing); "Thyroid" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Blood cholesterol: High. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID 19 treatment was Paxlovid. Treatment start date was 10Jul2023 and treatment stop date was 14Jul2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300259273 same reporter/patient, different drug/event;
Starting after booster patient not acting like self, appeared in pain, pt non verbal at baseline and unable to tell symptoms.  Gave tylenol and sumatriptan for potential migraine, got Xrays of ribs and lumbar spine as pt seemed in pain when walking, X rays negative for fracture.  Pt continued to decline and became to have poor oral intake. Family took to urgent care 12/6/21 and was noted to have hypernatremia >160, Glucose >600 and UTI/sepsis.  Pt had A1C checked 7/2021 and it was only 6.3 and she was on no medications for diabetes.  Pt admitted to hospital where she was started on insulin and discharged on insulin. Patient discharged on hospice and developed Kennedy terminal ulcer.
This spontaneous report as received from a nurse refers to a patient of unknown age. On 22-JUL-2013 the patient was vaccinated with an expired dose of VARIVAX (Merck) (lot # reported as 1064AA, exp. 05-JUL-2013) (dose and route not reported). No adverse effects were reported. Additional information has been requested.
PATIENT STARTED OUT WITH MINOR RASH ON FRIDAY FEB. 23RD,2007 PER MOM. RASH WAS EVERYWHERE ON SAT. FEB. 24TH AND PATIENT WAS VERY FUSSY. MOMO TOOK HER TO ER AND THEY STATED THAT SHE HAD AN EAR INFECTION AND/OR VIRUS.RASH WORSENED AND WENT BACK TO ER ON SUNDAY,PEDATRIC RESIDENT TOLD MOM IT WAS THE MEASLES. PATIENT IS STILL HAVING INTERMITTENT FEVER.INSTRUCTED MOTHER TO GIVE MOTRIN AND /OR TYLENOL AS NEEDED FOR FEVER.
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in an unspecified number of patients who received BEXSERO. On an unknown date, the patients received BEXSERO at an unknown dose. On an unknown date, less than a day after receiving BEXSERO, the patients experienced injection site pain and injection site redness. On an unknown date, the outcome of the injection site pain and injection site redness were unknown. It was unknown if the reporter considered the injection site pain and injection site redness to be related to BEXSERO. Additional details were provided as follows: The age at vaccination of the patients were not reported. The reporter indicated that there were several patients who experienced pain and redness at the injection site right after the injection. The field representative was unable to provide any further details. The field representative advised to contact another nurse to obtain further details and the contact details were provided for the same. The nurse usually did not come in to the office until 3:00 pm.
Migraine headache, fatigue, menorrhagia, dysmenorrhea, decreased concentration
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 15-OCT-2014 the patient was vaccinated with a dose of PROQUAD (Merc) (lot#, strength, frequency unknown), 0.5 ml, subcutaneous, which was exposed to light, when stored outside of the box, in the freezer. No adverse effect was reported. Additional information has been requested.
Shortness of breath Heart palpitations/fluttering Dizzy Chest discomfort
1. injection site pain                        6. cough 2. throat itchiness                            7. dizziness 3. generalized aches                        8. hard to breath 4. joint pain 5. tiredness
Wednesday when I got the pneumonia and tetanus shot later that evening both my arms got red and hurt and I started feeling like I have the flu which I thought was normal but since then my left arm has gotten worse I have a golf ball size bump that is very painful and dark red the other side the welt has grown to the size of my hand and every day since I don?t feel good I?m nauseous ,headache , body aches, tired and I just wanted to know if this is normal .  Using cold compress and Ibuprofen
Case number PHEH2015US023396 is an initial spontaneous report received from a pharmacist on 09 Nov 2015. This report refers to a male patient whose age was not reported. Past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: not reported) multi dose vial (MRD) two times this flu season via intramuscular route on 05 Nov 2015. No adverse events following the inadvertent administration.
After work injury on 10/4/22, detected blood clot in lower left leg on 10/18/22. Injury to pes anserine plus small tear in medial meniscus. Doppler confirmed clot on 10/26/22. 5mg of Eliquis prescribed by Local Medical Center on 10/26/22. Drove to alternate Medical Center on 11/24 with pain. New clots detected in hospital. Now it was 4 clots in the lower left leg and 1 clot in the left wrist. Hospital said Eliquis failure. INR was 1.0.  Spent 6 days in hospital transitioning from heparin IV to Warfarin, 5mg given. INR climbed to 3.25, then warfarin lowered to 4mg. Current INR remains around 2.7. Next doppler to be given on 4/17/23, expect clots to be gone by then. Current orthopedic states that timing and
Patient had right sided numbness and tingling in the ulnar distribution of her forearm and hand. On my exam, there was no objective findings of weakness or decreased sensation. No specific treatments were prescribed
Headache that will not go away even with meds, nausea,body aches,neck stiffness
Greater than 12 hours after initial vial puncture; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Greater than 12 hours after initial vial puncture) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Greater than 12 hours after initial vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Greater than 12 hours after initial vial puncture) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Patient has dementia and is on dialysis.  He and his caretaker were instructed by his PCP to get a Covid-19 vaccine at our pharmacy.  We conducted a screening and he/his caretaker did not disclose that he received prior doses of vaccine.  He was monitored for 15 minutes and then went home.  When we went to bill the vaccine we had difficulty to Medicare and proceeded to look in the system where we saw he received a first dose on 3/16/21 at a dialysis center.  We contacted the patient and his caretaker and neither realized that had happened.  When we contacted the dialysis center they informed us they actually had given him doses on 3/16 and 4/13, meaning his dose on 5/12 was the 3rd Moderna vaccine.  The dialysis center said they gave the patient documentation on the vaccine- but because his caretaker was not allowed inside due to Covid it was never known to any one that he received these doses.  The patient did not recall receiving these doses.  The primary care provider,  MD , was notified and the patient and caregiver have been instructed to NOT come back for another dose.  PCP for more questions: Patient was monitored for side effects but reports no adverse outcomes from receiving a 3rd dose of vaccine.
2 inches of erythema which was warm, firm, and itchy. Benadryl 12.5 mg PO given and Hydrocortisone cream applied
High fever (102.6 F) - the following day after the booster; dizziness; Having underarm (left arm) lymph node enlarged and painful for four full days; Having underarm (left arm) lymph node enlarged and painful for four full days; Moderate nausea; Dose received: 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Dec2021 17:00 (Batch/Lot number: unknown) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Previous dose lot unknown reason=Not available/provided to reporter at the time of report completion,, Previous dose administration date: 08Jun2021, Previous dose Vaccine location: Left arm), administration date: 08Jun2021, when the patient was 51 years old, for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Previous dose lot unknown reason=Not available/provided to reporter at the time of report completion,, Previous dose administration date: 18May2021, Previous dose administration time: 11:00, Previous dose Vaccine location: Left arm), administration date: 18May2021, when the patient was 51 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 17:00, outcome "unknown", described as "Dose received: 3"; DIZZINESS (non-serious) with onset 16Dec2021 21:00, outcome "recovering", described as "dizziness"; LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 16Dec2021 21:00, outcome "recovering" and all described as "Having underarm (left arm) lymph node enlarged and painful for four full days"; NAUSEA (non-serious) with onset 16Dec2021 21:00, outcome "recovering", described as "Moderate nausea"; PYREXIA (non-serious) with onset 17Dec2021, outcome "recovering", described as "High fever (102.6 F) - the following day after the booster". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, lymph node pain, lymphadenopathy, nausea, pyrexia.  Additional information: The patient did not take any other vaccine in four weeks. The patient had Colonoscopy procedure with anaesthesia one week prior. The patient had moderate nausea and dizziness going into 4th day after receiving the booster by Pfizer. All of these side effects were more intense from those the patient dealt with after the previously received vaccines The patient did not have Covid prior vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101834750 similar report from same reporter
Psoriatic arthritis flare. Started about 5 days after vaccine. 2 months later I've had to double my dose of cosentyx and do 2 prednisone bursts.
This non-serious medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 19 year old male patient. On an unspeicifed date, the patient received AFLURIA (batch number not reported). On an unspecified date in 2013, the patient developed myositis in the left arm at the time of injection. It was not evaluated medically. Outcome was not reported. Linked to 2015018753.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hx stemi and stent", start date: 2014 (unspecified if ongoing), notes: Hx stemi and stent; "Hx stemi and stent", start date: 2014 (unspecified if ongoing), notes: Hx stemi and stent; "prediabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid from 05Aug2022 to 10Aug2022 for COVID-19 treatment. Reported Event: Rebound of COVID symptoms and Positive ag test 8 days after completion. The patient had no know allergies. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a consumer via call center representative and described the occurrence of phobia in a 22-year-old female patient who received RABAVERT. Co-suspect products included RABAVERT. Previously administered products included Tdap with an associated reaction of dizziness (see linked case US2018GSK078834). Concomitant products included Meclizine. On 26th September 2011, the patient received the 1st dose of RABAVERT (intramuscular) 1 ml. On an unknown date, the patient received the 5th dose of RABAVERT. On 26th September 2011, less than a day after receiving RABAVERT and not applicable after receiving RABAVERT, the patient experienced phobia, swallowing difficult and anxiety. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the phobia, swallowing difficult, anxiety and incomplete course of vaccination were unknown. It was unknown if the reporter considered the phobia, swallowing difficult and anxiety to be related to RABAVERT. Additional details were provided as follows: The patient reported that she had another possible exposure to an animal that had rabies and had her first injection of the series on 23rd April 2018 (the patient had another series at a different time from another rabies exposure on 26th September 2011). The patient required emergency room visit. The reporter also had questions about how much coverage she would have as when she has the vaccine years ago, she had 4 of the 5 series of doses (she did not complete the series). Thus, leading incomplete course of vaccination. No other information available. It was previously reported to manufacturer. This case has been linked with US2018GSK078833 and US2018GSK078834, reported by the same reporter for the same patient.
VACCINE ADMINISTRATION WAS GIVEN WITH A 5/8" NEEDLE.  A 1.5" NEEDLE SHOULD HAVE BEEN USED.   PATIENT WAS CONTACTED TWO DAYS LATER.  PATIENT HAD NO ADVERSE EFFECTS FROM THE SHORTER NEEDLE.   PATIENT FELT WELL AND HAD NO COMPLAINTS.
pt recvd flu vax & pt devel redness @ the inj site; later that month began to exp cramping & weakness & tingling in both feet;
Fever around 100.1  Body aches/chills Nausea and vomiting  Headache  Left arm achy after injection.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On an unknown date in 2014, PROQUAD (Merck) underwent a temperature excursion. On 21-AUG-2014, the patient was vaccinated with PROQUAD (Merck) 0.5 ml, subcutaneous. No adverse effect reported. This is one of several reports report from the same source. Additional information has been requested.
Headache, Fever, Myalgia, Nausea Information has been received from a registered nurse concerning a 34 year old black male who on 6-Aug-1999 was vaccinated IM via left deltoid with second dose of hepatitis b vaccine recombinant. On 6-Aug-1999 following vaccination the patient experienced headache with nausea, muscle aches and low-grade fever. Subsequently, the patient recovered from the episodes. It was indicated that the patient did not develop any adverse event following vaccination with the first dose of the vaccine. Two additional patients were reported with similar symptoms following vaccination with second dose of hepatitis b vaccine recombinant (WAES #99080961 and 99081095).
Dose 1/Dose 2/The day after my pregnant wife received the vaccine, the doctors identified concerns with the pregnancy (related to blood flow in the umbilical cord).; The day after my pregnant wife received the vaccine, the doctors identified concerns with the pregnancy (related to blood flow in the umbilical cord).; These concerns ultimately to my son being delivered at 29 weeks and ultimately passing away on the same day; This is a spontaneous report from a contactable consumer (parent).   This consumer reported for reported information for both mother and fetus. This is the fetal report.   A male fetal patient (reported as son) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date were not reported) transplacental on 23Aug2021 as dose 2, single for covid-19 immunisation. The mother received dose 1, single of BNT162B2, transplacental for Covid-19 immunization on an unspecified date. The patient's mother of unspecified age received BNT162B2 via an unspecified route of administration. The patient's and mother's medical history and concomitant medications were not reported. The mother had no other vaccine in four weeks. The patient's mother had no covid prior vaccination. The patient's mother had no known allergies. The day after the patient received the second dose of the vaccine, on 24Aug2021, the doctors identified concerns with the pregnancy (related to blood flow in the umbilical cord). These concerns ultimately to patient being delivered at 29 weeks and ultimately passing away on the same day. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization from 24Aug2021, life threatening illness (immediate risk of death from the event), disability or permanent damage, congenital anomaly or birth defect and death. The patient's mother was tested for covid post vaccination which included nasal swab (unknown results). The patient died on 24Aug2021. The causes of death were "the mother received the vaccine, the doctors identified concerns with the pregnancy (related to blood flow in the umbilical cord))" and "patient being delivered at 29 weeks".  It was unknown if an autopsy was performed.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101206741 mother case; Reported Cause(s) of Death: The day after my pregnant wife received the vaccine, the doctors identified concerns with the pregnancy (related to blood flow in the umbilical cord).; The day after my pregnant wife received the vaccine, the doctors identified concerns with the preg
Lost feeling, fell down. Transferred to Hospital. At first Doctors treated her for A-fib. Then neurologist seen her, diagnosed as Guillain Barre Syndrome.
She had a lump in her left arm; Redness; Broker her ribs; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (she had a lump in her left arm), RIB FRACTURE (Broker her ribs) and VACCINATION SITE ERYTHEMA (redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced RIB FRACTURE (Broker her ribs). On 22-Sep-2021, the patient experienced VACCINATION SITE MASS (she had a lump in her left arm) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, VACCINATION SITE MASS (she had a lump in her left arm), RIB FRACTURE (Broker her ribs) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient thought on the second day after vaccination, had a lump in left arm and redness. Also stated did not remember but broke her ribs, and was taking muscle relaxer for the same.  No concomitant medications were reported.   This case was linked to MOD-2021-367645 (Patient Link).   Reporter did not allow further contact
pt exp T101-104, v, crying, seen in ER; 2nd day eyes roll back-to ER;T inc admit to PICU;pt exp dec energy & appetite; dec wet diapers;sz like episode; hypopnea/hypothermia-tx w/02, ATB & heat;d/c dx: vax rxn vs. viral encephalitis