chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PPV23 administered to pt by RN on 9/1/05. Immediate redness and localized swelling at site. Swelling marked and ice applied. 0715 9/2/05 site reddened, bicep swollen and hot to touch. Pt received Benadryl 25 mg po x1 and ice applied. Pt seen at 130 pm and started on prednisone taper. Pt was discharged and to follow up with MD.
Approx 2 days after vaccination, patient developed 6-8 small blisters around the injection site. Patient reports itching, swelling and tenderness as well.
Initial misuse report received from a healthcare professional on 21 OCT 2013. The case was received on 21 March 2014 at GPV. This is an invalid case as individual patient identifiers are not reported. The patient received expired dose of MENACTRA vaccine and a dose of YF-VAX vaccine on an unspecified date. No adverse event was reported. List of documents held by sender: none.
This spontaneous report as received from a pharmacist refers to unspecified patients of unknown age. Pharmacist mentioned that an unspecified number of patients after receiving ZOSTAVAX (lot # was not reported) on unspecified dates had experienced injection site reactions of swelling and inflammation. This is one of the reports from the same source. Additional information has been requested.
Tachycardia at 110, heartburn,  101F temperature, chills, body ache.
Shortly after last injection was administered patient slowly fell to what seem to be sleeping. Patient seemed very sleepy and would slightly open her eyes and would return to fall asleep. Per provider patient had good moro reflex, strong pulse and heartbeat on examination shortly after incident. Patient also good pupil reflex while sleeping. Provider/Staff monitored patient over 30 minutes, at that point patient woke up and was eating well.
arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 51-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  After receiving 1st dose of Shingrix, the patient experienced pain in arm. For tolerance with 2nd dose of Shingrix, refer linked case US2021AMR028893.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR028893:same reporter
I have a pacemaker, and the battery needed the replacement. I had a kidney stone in the end of November, and I was sent to a urologist and had the stone remove with a stint. The stone passed I was fine, I have been dealing with this for a while. I often suffer from urinary issues.
pain at injection site; redness at injection; swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 18th September 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema and injection site swelling. On 26th September 2019, the outcome of the injection site pain, injection site erythema and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had injection site pain, injection site erythema and injection site swelling. The reporter did not consent to follow up. Limited information was provided. The patient wanted to remain anonymous. This case linked with US2019GSK219143, reported by same reporter.
LYMPHNODE SWELLING AND PAIN IN AXILLARY REGION OF ARM THAT VACCINE WAS ADMINISTERED
A physician reported that a 44 year old pt received an injection of Pnu-Imune 23 on 2/28/00 and developed an injection site reaction described as 5 different swollen areas of the arm that resembled a vasculitis. The pt was treated with "Tequin", Claritin and Flonase. This is one of 2 pts from this facility who developed as injection site reaction following receipt of Pnu-Imune 23 lot 466785.
18 year old patient inadvertently received an adult dose of Engerix-B on 8-DEC-2022; 18 year old patient inadvertently received an adult dose of Engerix-B on 8-DEC-2022; This case was reported by a pharmacist via call center representative and described the occurrence of accidental overdose in a 18-year-old male patient who received HBV (Engerix B adult) (batch number AC397, expiry date 8th August 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th December 2022, the patient received the 1st dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 8th December 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced accidental overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the accidental overdose and inappropriate age at vaccine administration 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: 17-JAN-2023 Reporter's Comments: The pharmacist reported that, the patient inadvertently received an adult dose of Engerix B. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal mail. Additional Supportive Information: The patient received Engerix B adult inadvertently, which led to accidental overdose and inappropriate age at vaccine administration.
Patient tested positive for first time for anti nuclear antibodies and subsequently for the precursors to scleroderma at annual physical in June 2021. Vaccine was administered Feb/March 2021.
Sore arm; Muscle ache where the injection was, at the site; A spontaneous report was received from a consumer concerning a 66-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm/ pain in the extremity, the patient reported a muscle ache muscle ache where the injection was, at the site/ myalgia.  The patient's medical history included lung transplant in 2009. Concomitant medications reported were Alotyrenol, Entecavar, Indapamide, Losartan, Metoprolol, Losedapine, Tacrolimus for lung transplant.  On 6 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 16 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events sore arm, The patient reported a muscle ache muscle ache where the injection was, at the site.  Treatment details included none.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable. The outcome of events, sore arm, the patient reported a muscle ache muscle ache where the injection was, at the site was unknown.
Redness, irritated, rash, itchy, surrounding arm and below injection site, extending to chest area. Patient was advised to take Benadryl and watch for additional issues, none reported. Recovered, but site showed some bruising, that has faded.
1st dose taken in left shoulder; no adverse events  2nd dose taken in left shoulder: Sore shoulder lasted less than two weeks. An episode of diarrhea 24-48hours after dose: no thirst or dehydration, Just normal loss of digestive fluids. Also experienced wight loss of approximately 15lbs over the course of one week: could feel my thyroid gland more active than usual. Also felt as if digestive fluids were overactive. Approximate weight before 2nd dose: only 155LBS (normal)  Treatment: consuming more red meat protein. Also used powdered meal supplement daily
This spontaneous report as received from a consumer a 63-year-old patient refers to himself. There were no concomitant medications, concurrent conditions and medical history reported. On 03-NOV-2014, the patient was vaccinated with ZOSTAVAX, subcutaneous (dose, lot number and expiration date were not reported). In November 2014, reported as approximately 3 weeks after receiving ZOSTAVAX, the patient developed a rash over various parts of the body. The outcome of this event was unknown. The patient stated the rash "comes and goes" with the last episode being on 25-AUG-2015. The outcome of the last event was reported as not recovered, at the time of this report. The patient did not seek medical attention. The patient was treated with an unspecified over the counter medications. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Left side of face paralysis. Unable to close left eye or move any muscles on left side of face , and pain behind left ear .   Diagnosed by family practitioner as Bells Palsy
Arm feeling hot and swollen and a low grade fever. Patient reports taking Tylenol and feeling better afterward
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. On 25th August 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous). In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On 25th August 2018, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the injection site erythema and injection site swelling to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that patient received the SHINGRIX subcutaneously, which led to incorrect route of drug administration. Afterwards the patient experienced redness and swelling at the injection site and the surrounding arm area. The health care professional did not have detailed information because the administration occurred at a different location.
Menstruating one week early with changes in flow; Menstruating one week early with changes in flow; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 31-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Oct2021 17:30 (Lot number: FF8839) at the age of 31 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLUOXETINE. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot number: FF8839, Dose administration time: 17:30 PM, Dose vaccine location: Left arm), administration date: 16Sep2021, when the patient was 31 years old, for Covid-19 immunisation. The following information was reported: MENSTRUATION IRREGULAR (non-serious), MENSTRUAL DISORDER (non-serious) all with onset 18Oct2021 11:00, outcome "unknown" and all described as "Menstruating one week early with changes in flow". Therapeutic measures were not taken as a result of menstruation irregular, menstrual disorder.  Additional information: No other vaccine in four weeks. No covid prior vaccination. No known allergies. Facility type vaccine was pharmacy or drug store. No covid tested post vaccination. Serious was no.  Follow-up attempts are completed. No further information is expected.
No, adverse reaction reporting wrong dosage, patient was given 0.5mL instead of recommended dosage  of 0.3mL
No side effects after first dose in July. Second dose was extremely different. I have felt terrible for 4 days. The symptoms did not warrant a visit to a doctor. Symptoms: chills, major sweating while sleeping during first 2 days and headaches all 4 days.
As reported by mom to PHN, pt devel full body rash on 5th day following vax; afebrile; lump @ site of inject;
Urticaria all body from Tuesday night, I took benadryl  25mg, helps for couples hours, it last for 7 day
Initial information received on 10-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 21 years old male patient who was vaccinated with an 0.5 ml expired dose of MENACTRA (Batch number: U5523BA and expiry date: 08-Apr-2018) in the left deltoid (dose in series and route of administration were not reported) on 10-Aug-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to expired vaccine used because the vaccine was expired on 08-Apr-2018. It was also reported that the patient was kept for 20 minutes after the vaccination to watch for side effects. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. Documents held by the sender: None.
no further ae reported; Temp excursion reported 11/22/21; This spontaneous report was received from a nurse referring to a 25 years old, female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  Temperature excursion occurred on 22-NOV-2021. On 30-NOV-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously in the left arm (lot U020244, expiration date 28-JUN-2023) (strength and dose were not provided) and diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP) intramuscularly in the right arm (lot C5787AA, expiration date 01-OCT-2023) (strength and dose were not provided).  The temperature of storage and time frame of the excursion were 6° to 14° Fahrenheit (F) for 10 minutes and 14° to 46° F, for 3 hours respectively.  If a digital data logger was involved was not reported.  No adverse event.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA003515:
Swollen and tender lymph node near left collarbone.  Was about size of a quarter and tender when I first noticed. Has now reduced to the size of a pea or slightly smaller but remains tender.
pt recv vax 6JUN95 & 16JUN97 pt devel chickenpox;
Possible late 2nd Shingrix dose; This case was reported by a physician via sales rep and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 14th September 2022, the patient received the 2nd dose of Shingrix. On 14th September 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 14-Sep-2022 Reporter's comment: The sales representative submitted medical information inquiry on behalf of a physician, which contains a possible late 2nd dose of Shingrix. Email was sent to safety for sales representative contact information.  Adverse event contains all reported information. Additional Supportive Information: The 2nd dose of Shingrix possible late, which led to drug dose administration interval too long.
My husband became weak thought he had MS, was not able to ride his bike or go for 3 mile walks starting the end of March. He thought he might have pleurisy so he went to the Cardiologist. Dr ran test said he was retaining fluid and put him on diuretics. He starting to lose his grip strength and could not work. He found it difficult to breath and stumbles and dropped things. He woke up with numbness in his feet and it quickly spread to his hands, then his legs and arms he went to the ER they thought he had Dengi Fever could not help, we drove to ER they diagnosed him with  Guillan Barre syndrome intimated him and med evacuated him. While we were I was told they still didn't know what was wrong with him and that he would not die if he had Guillan Barre, they started IV IG therapy. He died in ICU on 16 May 2021. I have some of the same symptoms we had the same vaccine we went together on the same day and times. I have body reactive extreme anxiety. I feel as though I will not make it. My feet are becoming numb my arms are weaker. I notice a twitch in my limbs every now an then. I have heart palpatations and increased blood pressure it used to be consistently low. I have a dryness in the back of my mouth. I have balance issue from time to time. I have trouble thinking while I am at work. I am a dental hygienist. My husband was a prosthetist orthotist.
This is a prospective pregnancy case. This 36-year-old female subject was enrolled in an open label study. The subject received the 1st dose of BOOSTRIX .5 ml on 25th January 2018. Concurrent medical  conditions included miscarriage (February 2016 and November 2016) and crushing injury of finger. The subject's last menstrual period was on 4th January 2018 and estimated date of delivery was 11th October 2018. The subject received BOOSTRIX at week 3 of the pregnancy and during the first trimester of pregnancy. On an unknown date, less than a month after receiving BOOSTRIX, the subject developed hemorrhage in pregnancy. Serious criteria included GSK medically significant. Additional event(s) included subchorionic hemorrhage, vaccine exposure during pregnancy and vaccine administered at inappropriate site. The outcome of hemorrhage in pregnancy was unknown. The outcome(s) of the additional event(s) included subchorionic hemorrhage (unknown), vaccine exposure during pregnancy (unknown) and vaccine administered at inappropriate site (unknown). The pregnancy was ongoing. It was unknown if the investigator considered the hemorrhage in pregnancy and subchorionic hemorrhage to be related to BOOSTRIX. Relevant Tests: On an unknown date the patient undergone blood test which showed that the patient had a subchorionic hemorrhage and the patient also underwent pregnancy test was resulted positive. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Blood test result was see text unknown. On an unknown date, Pregnancy test result was Positive unknown. See case US2018GSK055433 for details regarding the baby case. Additional details were reported as follows: The patient called to tell that she saw information online that there might be a pregnancy registry for the vaccine. The patient wanted to know about the registry and participate in it. This case was previously reported to physician. The patient was unaware that she was pregnant before she received the vaccine. The patient already had 1 child. The patient mashed her finger and was given the vaccine since she had not been vaccinated for over 10 years. The patient had a blood test taken due to heavy bleeding. At that time, she was told that she had a subchorionic hemorrhage and that was when the pregnancy was noticed. The patient was six weeks pregnant at that moment. The patient had a six-month-old infant and had been breast feeding. There had been no issues with the pregnancy since the vaccine. The patient was told that the vaccine was usually given later during the pregnancy, but it should not affect the baby. The patient did not mind being contacted during the pregnancy. The patient did not provide the information for the OB/GYN doctor except one. The patient had an appointment this Thursday and would speak to him about being contacted by the company. See case US2018GSK055433 for details regarding the baby case.
This 23 month old baby has been having seizures since 08/12/2005. He had one febrile seizure on 6/18/05. He received DTaP #4 and ActHib #4 on 8/09/2005. And developed seizures without fever within 72 hours of vaccination. On Tegretol and Dilantin. Discharge summary states eyes rolling, limbs twitching. msv Per 60 day follow up report- Patient was still having seizures with anticonvulsants. The last seizure was for 1 minute on 1/11/06. Patient is under child neurologist's care now. Developmentally. mild speech delay (mom however said that her other daughter started talking late.) No further seizure since 3/06.  He is however on anticonvulcant TOPAMAX 50 mg BID).  Plan is to continue TOPAMAX X 2 years seizure free.