chrisvoncsefalvay/vaers-outcomes huggingface dataset:
my liver enzymes are high; my lower right side is hurting constantly making it hard to keep food down etc.; hard to keep food down; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC ENZYME INCREASED (my liver enzymes are high), ABDOMINAL PAIN LOWER (my lower right side is hurting constantly making it hard to keep food down etc.) and VOMITING (hard to keep food down) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEPATIC ENZYME INCREASED (my liver enzymes are high), ABDOMINAL PAIN LOWER (my lower right side is hurting constantly making it hard to keep food down etc.) and VOMITING (hard to keep food down). At the time of the report, HEPATIC ENZYME INCREASED (my liver enzymes are high), ABDOMINAL PAIN LOWER (my lower right side is hurting constantly making it hard to keep food down etc.) and VOMITING (hard to keep food down) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hepatic enzyme abnormal: liver enzymes are high.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicine were reported. The patient stated that the other two boosters was fine. No treatment medicine were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Feb-2023: Live Significant Follow up appended - event, Narrative updated
SORENESS, REDNESS AND SWELLING FOR THREE DAYS, FEVER, ACHES, HEADACHE, ITCHING, FATIGUE.
DEVIATION IN DOSAGE: Client received less than half of the required dose due to malfunction of the syringe.  The dose was repeated per CDC guidelines. Therefore client ultimately received approximately 0.4 ml of the Pfizer Covid-19 vaccine.
Patients have been administered from vaccines that experienced a temperature excursion; Patients have been administered from vaccines that underwent a temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that underwent a temperature excursion) in a 41-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 14-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that underwent a temperature excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date of temperature excursion was 10-Mar-2022. Maximum or minimum temperatures reached was 64 degrees Fahrenheit. Excursion duration was approximately 7 hours. The vaccine was stored in refrigerator at the time of the excursion. There were no changes in visual inspection. Pertinent details: At the time they were unpunctured. Vaccine was administered on 14-Mar-2022 and vials were returned to the refrigerator. Tran date was 15-Mar-2022.The patient did not experience any adverse events post injection.  No treatment medications were reported.
The same day post vax, this pt experienced nausea and vomiting, headache, and malaise within 2 hours post vax. She also experienced a large local reaction the next day. She reportedly recovered.
It started the same night I got the vaccine. My whole body was in so much pain I couldn?t move. I was running a fever and hot yet I was having chills and my teeth were clattering. I would not stop shaking. I took some Tylenol and then my shaking finally stopped even though my body was still in pain. I woke up today with the same symptoms after Tylenol wore off. I took some more and went back to bed. I am now starting to feel better the day after my vaccine but we will see if it gets bad again.
4/16/18 resident's knees became weak with ambulation and she was lowered to the floor-immediate complaints of right knee pain. She is noted to have twitching of the left upper extremity (same site of injection) and increased pain with limited range of motion to the right lower extremity.
pt recvd vax;exp rxn around groin area;tx w/ soaks & ASA;unk if pt has contraindication to pertussis;
patient was administered the PENTACEL, then came and told her it was expired  no reported adverse event; Initial information received on 25-Oct-2021 regarding an unsolicited valid non-serious case received from a other health professional and non-health care professional via Medical Information number: 00826991.   This case involves a 24 months old male patient who was administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number: UJ411AA and expiry date not reported via intramuscular route in the right thigh prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  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.
I started to have issues with my blood pressure in March of 2022. It was crazy high. It was I went to an urgent care and my blood pressure was 200/94. I was advised to go home and rest and stop taking ibuprofen and to follow up with my doctor. My doctor scheduled me an appointment to come in and I did on March 02, 2022. I was prescribed blood pressure medicine amlodipine. I also was diagnosed with non-alcoholic fatty liver during an annual exam in November 03, 2021. This was discovered through an annual blood panel. I was diagnosed with DVT-Deep Vein Thrombosis. I went to my doctor on July 8 because my knee was still bothering me. They did ultrasound on my knee and everything came back normal. Then on August 30, 2022 my knee was better but it was weird in appearance like kankles. I had another ultrasound and was diagnosed with DVT. I was placed on blood thinners XARELTO and advised to exercise more. I no longer have the pain in my foot. I was also Heterozygous prothrombin gene mutation G20210A. I am currently awaiting follow up from my provider regarding what this means. I am no longer having the issues with my blood pressure since being placed on the amlodipine. The last check was 128/78. I am required to take the blood thinners for 6 months and be re-evaluated.
LOW PLATELET COUNT; RASH ON LEGS AND FEET WHICH SPREAD TO GROIN AND ABDOMEN; NAUSEA; This spontaneous report received from a consumer (company representative) concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry Date: UNKNOWN) dose was not reported, 1 total, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 19-APR-2021, the patient developed rash on legs and feet. On 20-APR-2021, the rash spread to groin and abdomen. The patient visited the Emergency Room. The patient's platelet counts were low. There was no thrombosis reported. Patient was admitted to ICU on 20-APR-2021 to investigate about the low platelet counts. On an unspecified date in APR-2021, the patient undergone an antibody test which was found to be negative. IVIG treatment was administered in ICU. The patient got discharged on the 23-APR-2021. The patient was fine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low platelet count, rash on legs and feet which spread to groin and abdomen, and nausea on APR-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210452143-Covid-19 vaccine ad26.cov2.s-Low platelet count. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
10/29/19 Received phone call at 1515 that client received flu shot that morning and her face is red with rash and itching. no rash or redness anywhere else. Stated her legs are starting to itch but no rash, instructed her to go to PCP. Phone call made to RN regarding phone call from client, can refer to PCP or ER. Called client back and informed her to go to PCP or ER, she stated her PCP was in another city, instructed to go to ER. 10/30/19 Follow up phone call to client, she stated she felt a little woozy after shot, she stated she went to class and someone told me my face was red, she stated the redness lasted 30 minutes and was gone, She stated her breathing was fine, stated redness was from nose to eyebrows. She said her daughter was Dr, she sent her a picture and she told her to take balladry,  by the time she got home redness was gone so she did not take benadryl. She states she is fine today and no problems
about 12 hours after injection patient developed body aches,  chills sensitivity to light, headache and nausea that lasted until 6/14/20 night.  red rash developed 6" below the injection site 6/14/20 and continues to grow when seen in the clinic. 6/15/20 rash has double in size, numbness and tingly in arm and fingers, constant ache from the top of the left shoulder to the top of the neck.
Diagnosed with Guillain-Barre Syndrome. Received 5 doses of IVIG. Paralysis in extremities, trunk, and face. Loss of ability to swallow & extreme difficulty breathing.
Left shoulder pain and decreased mobility that started the night of the vaccine and has persisted for almost two months. I diagnosed it as "SIRVA" after seeing her today. I am referring her for physical therapy, and a steroid injection for the pain.
Information has been received from a healthcare worker reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions/allergies, pertinent medical history or concomitant medication. On 02-NOV-2017, the patient received an improperly stored dose of PEDVAXHIB lot # N012120, expiration date 30-JAN-2020 or lot # N000235, expiration date 26-OCT-2019 or lot # N007749, expiration date 29-NOV-2019 for prophylaxis (dose, anatomical location and route of administration were not reported). It was reported that on an unspecified date, the vaccine was exposed to a temperature between 9 Celsius degrees and 25 Celsius degrees for 47 hours and 39 minutes. The vaccine did not undergo a previous temperature excursion. The call was placed because of a Digital Data logger report. No adverse effects were reported. This report is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1711USA006083: US-009507513-1711USA013916: US-009507513-1711USA013917: US-009507513-1711USA013918: US-009507513-1711USA013919: US-009507513-1711USA013921: US-009507513-1711USA013913: US-009507513-1711USA013914: US-009507513-1711USA013915.
Patient injected with undiluted pediatric Pfizer vaccine 0.2mL. Patient's mom and MD informed. MD suggested mom to monitor patient. If necessary seek medical attention. The mom said for now both kids doing fine.
Child presents with rash (hives) to face and forehead. Diphenhydramine 12.5 mg oral liquid 3 ml given.
Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Feeling unwell; This is a spontaneous report from a contactable other HCP (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Unknown), via an unspecified route of administration, administered left arm on 19Jan2021 09:30 AM (at the age of 70-years-old) at single dose for covid-19 immunization. The patient was not pregnant. Other vaccine details were First dose Pfizer biotech Covid-19 vaccine EUA with vaccination date 26Jan2021 (Other vaccine same date vaccine date) at left arm. Patient's medical history included 6 months post chemo for lymphoma. No known allergies reported. The patient's concomitant medications were not reported. Patient did not receive other vaccine in four weeks. On 27Jan2021 01:00 AM the patient experienced tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell. No covid prior vaccination. No covid tested post vaccination. No treatment received for events. The outcome of event was recovering.  Information about lot/batch number has been requested.
Arm swelled at injection site. The night it was given (6/13/14) she was unable to sleep on that arm that night. It swelled to grapefruit sized with a pimple head that started to recede Monday 6/16/14. Also had rash and fever. She sent pictures to her Dr. who diagnosed shingles.
severe chills; feeling hot at night; Headache; General body ache.; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration on the left arm on 30Mar2021 (at the age of 25-year-old) at 13:30, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as none. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration on the left arm on 09Mar2021, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not tested with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 31Mar2021 at 04:00, the patient experienced severe chills, feeling hot, headache and general body pains. Therapeutic measures were taken for all the events severe chills, feeling hot, headache and general body pains with advil 400mg only one time. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events severe chills, feeling hot, headache and general body pains were recovering.  No follow-up attempts are needed. No further information is expected.
Received the full dose instead of half with booster dose. Wheezing, was provided additional inhaler by healthcare provider.
Information has been received on 8/20/02 concerning a 3 year old male who was vaccinated with third dose of Tripedia (U0548AA) in the right thigh, third dose of IPOL (U1233-2) in the left thigh, third dose of Hep B (5206A) in the right thigh, and hep A (708E9) in the left thigh on 8/12/02. The pt developed an area of induration to the right thigh on 8/13/02. No other signs and symptoms were reported. The pt's mother was instructed to give pt Benadryl. The pt recovered. See case U2002-00773 and U2002-00775 same reporter.
possible not enough dose received. Patient was part of tracking for same vaccinator when it was brought to attention.
The patient received vaccine after being more than 30 days stored in the fridge; No adverse event; The patient received vaccine after being more than 30 days stored in the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received vaccine after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received vaccine after being more than 30 days stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received vaccine after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient received vaccine after being more than 30 days stored in the fridge) and PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication of the patient was not reported.  It was reported that the vaccine dose would be either 1st or 2nd. Vaccines were stored in the fridge on 30-Jun-2021 and best used date was reported as 30-Jul-2021.  The patient did not report any side effects.  No treatment information was provided by the reporter.
Swelling in left arm from injection site to elbow measuring 8" long + 8-9" in cir/dia 8 inches. Tx-Benadryl x 3 qd, ice, Report x 3d to re-check 7/19/07-medical records that document a hospitalization from 9/23-9/24/06. Case status changed to serious. DC DX:Left thigh cellulitis secondary to immunization, mild metabolic acidosis. Swelling and redness of left thigh 24 hours prior to presentation to ED.
Uncontrolled shivering. Lasted for 3 1/2 hours. Room temp 77 deg F. Under blanket and comforter at 10 PM.
This spontaneous report was received from a pharmacist via a company representative refers to a 74 years old male patient. The patient's medical history included shingles on an unspecified date in the past. On 11-NOV-2012, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX(lot#, expiry, dose not reported). No concomitant medications were reported. On 19-NOV-2012, the patient had developed a rash on his back after receiving the ZOSTAVAX. No treatment was given for the rash. The pharmacist advised the patient to see his physician for treatment. The outcome of rash on his back was reported as not recovered. The relatedness for rash on his back was unknown for ZOSTAVAX. Additional information is not expected.
Approx. 10-15 minutes after injection patient started to break out in an erythematous rash on arms then spread to legs. Rash was warm to touch and caused urticaria.
This is a spontaneous report from a contactable physician reported for herself. This female patient of unknown age and race/ethnicity received a single dose of PREVNAR 13 for immunization on an unknown date. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced pleural effusion and acute angle glaucoma with PREVNAR 13 and had to go to the ER. Outcome was unknown. She was wondering if it was safe to get the flu vaccine. Sender's Comments: The information is very limited and does not allow a medically meaningful evaluation, especially lack of the following: patient's demographics, complete medical history, concomitant medications and clinical course for both events. Based on the information currently available, the serious event acute angle glaucoma more likely represents an intercurrent medical condition unrelated to the vaccination with PREVENAR 13. Currently no details is provided on pleural effusion as to the specific medical condition leading to pleural effusion. Full diagnostic workup for pleural effusion such as the isolation of infectious pathogen due to lung infection, being cancerous, or coming from leakage of origin secondary to heart, liver and kidney failure, are needed for further medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Resides in a household with 2 positive cases, first one tested positive on 7/7/21. Sx onset 7/13/21 with sore throat, muscle aches, headache, fatigue & nausea. Tested on 7/17/21 for COVID-19 which returned as positive.
Swelling and large red rash at injection site. It gives off heat. And been having massive headache since the day after injection.
Patient received only one dose on 2018; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 11-MAY-2022 Reporter's Comments: The pharmacist reported that patient only received first dose of Shingrix vaccine. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
MMR vax given on 30SEP91 & pt devl t101 on 8OCT91; rash on face & neck 10OCT91; no tx-watch;