chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist and refers to a 76-year-old male patient. No information regarding the patient's pertinent medical history and concomitant therapies was provided. The patient had no known drug reactions or allergies. On 04-OCT-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route of administration, lot # and expiry date were not reported). On an unknown date in October 2017, within 48 hours of PNEUMOVAX 23 vaccination, the patient developed cellulitis on the left arm. On 06-OCT-2017, the patient was seen in an unspecified physician's office. No lab diagnostics or studies were performed. It was unknown if treatment was given for the event. The outcome of the event was reported as recovering. The relatedness between the event and PNEUMOVAX 23 was not reported. Upon internal review, the event of cellulitis was considered to be medically significant.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 08-JUL-2016 a dose of improperly stored M-M-R II (lot# L027591, rHA, expiration date 23-JUL-2017) was given to the patient. No adverse effects reported. The temperature excursion was 48 degree Fahrenheit for 24 hours, data logger was used. There was no prior excursion. The temperature was back in range at the time of reporting. This is one of several reports received from the same source. Additional information is not expected as there is no consent to contact the physician.
Pain in left side/lower back that has persisted from 12/18/2020 til 2nd dose on 01/08/2021
Patient is a 83 y.o. female patient of DO with history of COPD, hypertension, DM type 2, CAD, CKD presented to Hospital with AMS .   AMS Likely multifactorial with COVID, hypoglycemia Slurred speech and slow to respond reported by family, glucose by medics 101 Febrile T max 100.8  CT head negative for acute intracranial abnormality, moderate large amount of chronic microvascular ischemic change in supratentorial white matter UDS - negative  S/b Neurology AMS likely from covid and hypoglycemia  No indication for MRI Brain    Acute Hypoxic Respiratory Failure No home o2 at baseline RA 88% 2L NC on admission Supportive care as below  Now on room air.   Covid-19 Virus Infection Date of onset of symptoms: 11/24/2022 Symptoms present on admission: fever, cough  Date of covid positive test: 11/24/2022 Vaccination status: vaccinated Imaging: CXR cardiomegaly, pulmonary vascular congestion  Oxygen requirements on admission: 2L Current oxygen requirements: 2L Medical therapy: steroids and remdesivir Consultants following: ID Anticipated special isolation end date: 12/4/2022 Completed 5-day course of remdesivir. Switch to oral dexamethasone to 6 mg daily for 4 more days to complete a 10-day course.   COPD Exacerbation In setting of COVID and tobacco abuse  Diffuse wheezing on exam VBG 7.41 co2 45 po2 102 Hco3 28 Requiring 2L nc on admission Completed Zithromax dose.   DM type 2 Episode Hypoglycemia  Glucose in ED 41 treated with dextrose repeat 500 likely inaccurate  Repeat chem 128  Resume home regimen.  Elevated Troponin  CAD HFpEF Echo 1/2020 EF 60%, mild diastolic dysfunction Trop 27 ECG non ischemic  CXR pulm vascular congestion, bilateral lower extremity edema Was on 40 mg IV lasix daily, now on hold due to elevated creatinine Repeat 2D echocardiogram on 1128 showed EF of 50 to 60% and grade 2 diastolic dysfunction. Continue to monitor on tele, delta essentially flat Continue Lipitor   AKI on CKD stage 3 Creatine 1.26 on admission Slightly better then baseline (2.23-1.52) Avoid nephrotoxic medications  Cr 1.6 - monitor Creatinine back to baseline   Tobacco Abuse Continues to smoke NRT  Debility. PT and OT recommended home with home health. She will be discharged home today.
SORENESS AT SITE, TIREDNESS, DIZZINESS, MUSCLE SORENESS, TROUBLE SLEEPING
2 years later had shingles/suspected vaccination failure; 2 years later had shingles; Horrible and painful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-May-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient got the vaccine, 2 years later had shingles, the doctor said it would had been worse if the patient had not got the vaccine, the patient thought it was horrible and painful. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
Redness, tenderness, swelling on left arm from deltoid to elbow 24 hrs post injection.  S/S extending to upper forearm 48 hrs post injection.  Received treatment  at urgent care.  Rx: ZPAK and LORATADINE 10m = Resolution
Rash to neck area, difficulty swallowing. Patient vitals are normal. Patient did wait her 30mins and had no reaction but once she started to leave the building she had symptoms return. Administered 50mg PO of Benadryl and monitored for additional 30 mins. Patient improved and declined transport and further care
Red, swollen area at injection site - 10 x 12 cms, 24 hours post injection of left arm.
ulcers of mouth Narrative: Received first dose COVID-19 vaccine (Pfizer) on 4/19/21 at 08:30. Around 23:00 began to notice swelling of tongue. Patient wen to ED. Denied pain, rash, SOB, lightheadedness, or other concerns. Given IV famotidine, IV diphenhydramine, IV dexamethasone, and oral ibuprofen. Tryptase drawn during this visit, resulted at 4.2 mcg/L. Patient discharged home. Three days later on 04/24/21, patient re-presented to ED with new complaints of oral blisters and hives on legs. RN notes no tongue swelling. Treated with IV diphenhydramine, IV prednisone, IV famotidine and given scripts for oral diphenhydramine and oral prednisone. CRP drawn during this ED visit, resulted at 15.0 mg/L (high).
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 23-OCT-2012 ZOSTAVAX (lot# H0111048 / expiry date 09-MAY-2013) was reconstituted with expired sterile diluent (lot #E010687 / expiry date February 2012)(subcutaneous) and administered to the patient. Dose and dose number were  not reported. No adverse symptoms were reported. This case is linked to cases MARRS#: 1302USA008550, 1303USA003573, 1303USA003574 and 1303USA003575 (same reporter link). Additional information has been requested.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown 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 UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    Dose was reported as Additional Booster. No concomitant medications was reported. No treatment medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live non-significant follow up appended
Information has been received from a physician concerning a female who during the week of 05-AUG-2007 was vaccinated with 0.5mL Gardasil.  The patient became extremely dizzy after receiving Gardasil.  Subsequently, the patient recovered that same week.  Additional information has been requested.
This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on unspecified date at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got lightheaded and a decrease in the blood pressure that got her to the ER for monitoring during 1 h. Outcome of events was unknown.  Follow-up attempts are completed. The following information on the batch number has been requested.
This case was reported by a healthcare professional, via a sales representative, via an other manufacturer, and described the occurrence of rash in a subject of unknown gender who received DTAP (unknown manufacturer) injection for prophylaxis. On an unknown date in childhood, the subject received DTAP (single dose). AT an unknown time following administration of DTAP, the subject experienced a severe rash. At the time of reporting, the outcome of the event was unknown.
Since my 2nd dose I am having constant body ache and pain. I am also having extreme fatigue. Constantly tired and fatigued. I have pain in my legs like there are swollen. There is no fluid on them or anything, they constantly ache. I am not sleeping well and needing to nap to how tired I am all the time. I am seeing a doctor in a few weeks to see further what is wrong.
Eye lids were puffy; Slept for about 15 hours; Achy; This is a spontaneous report from a contactable consumer.   A non-pregnant 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on right arm on 07May2021 16:30 (Batch/Lot number was not reported) as 2nd dose, single dose (at the age of 48 years old) for COVID-19 immunisation.  Medical history included ongoing migraine, seasonal outdoor allergies and COVID-19 from 26Feb2021. Concomitant medications included sumatriptan (SUMATRIPTAN) taken for migraine. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection),  dose 1, at 16:45 on the right arm on 15Apr2021 for COVID-19 immunisation The patient stated, "the next morning and couple days following, my eye lids were puffy. I took BENADRYL. 24 hours after the shot, I was achy and slept for about 15 hours. Overall, the 2nd dose reactions were better than having COVID". The outcome of the events was recovered on May2021.   Information on the lot/batch number has been requested.
pt recvd vax & exp nausea & devel slight fever; pt failed to seroconvert w 3rd dose;
pt recvd vax; pt exp'd pain & tenderness at inject site, myalgia, arthralgia, & a frozen left shoulder; pt dx w/ adhesive capsulitis;
Around noon, I had flu-like symptoms - very tired, chills (no fever) and very achy. I was exhausted. That lasted through the evening. And a little bit on the 5th. By the night of the 5th, I was fine - it was completely gone other than the hives that I was still dealing with from first vaccine adverse symptoms. Because the hives were still going on, I started taking (on Saturday) Ambien - 10 mg; and  Prednisone - 20 mg and then by Monday, the 8th)I increased it to 30 mg.  Friday, the 12th, Xolair injection - one injection each arm - 150 ml. Because the hives were still breaking out. These did not help right away with the hives. That injection is every four week and I had the second one on March 12th and an appt with my allergist to talk about all of this. As of yesterday,  March 18, I had the first day of NO BREAKTHROUGH HIVES. Note: A couple of days before  one week after the second vaccine  - I started to having a shaky/jittery feeling. I talked to my doctors, and they think that may have come from the Prednisone and the Levothyroxine .
1 day post vax, the pt developed a generalized macular rash to the face, trunk, and extremities. No fever, vomiting or diarrhea.
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited validnon-serious case received from  other health professional.  This case is linked to cases 2023SA057733(CLUSTER) and 2023SA057309(CLUSTER).  This case involves Adult patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It was unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (latency: unknown)  (poor quality product administered) (latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   It was unknown if the patient experienced any additional symptoms/events   It was unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported 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.  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
After receiving all three vaccines (HPV, MCV4 and Tdap) patient fainted. Patient was awaken by RN that administered the vaccine by using an alcohol swab and when the patient was stable he was taken to the nurses office by RN. Vital signs were taken B/P: 116/74 and HR: 101. Patient was given to juices and the RN stated the patient did complain about ringing in the ears otherwise was feeling better. Patient was picked up by his grandmother and she explained to the RN that he is afraid of needles.
Spoke with patient regarding symptoms. Per patient symptoms presented after Jynneos vaccine. Patient stated Tuesday 7/12/22 he developed oral sores, a fever, swollen lymph nodes on the left and right side of his neck.  Patient stated had a fever from Monday 7/12/22 to Saturday 7/16/22. Per patient stated never took his temperature Monday 7/12/22 thru Friday 7/15/22 but felt warm. Patient stated on Saturday 7/16/22 he went to the Urgent Care. Per patient is not aware of the urgent care name. Patient states temperature when taken at urgent care was T- 100.0. Patient states was tested for Strep, Flu, and COVID. Per patient does not remember other test that were performed. Patient states the only positive test was the Strep test. Patient states was given a shot of penicillin for treatment. Patient states currently has a pain level of 8-9/10. Patient encourage to follow up with pcp. Per patient could not get a appointment with PCP until tomorrow. Patient encourage to follow-up with urgent care/emergency services as needed. Patient verbalized understanding. Patient states will call urgent care today where he was seen on 7/16/22. Patient states currently has multiple mouth sores, nerve pain at the gums, a sore on the right cheek that started as a pimple, and a sore on the chin right below the lip. Patient states not currently experiencing as fever. Patient states alternating Tylenol and Ibuprofen. Patient encourage to follow up with PCP or MD regarding Tylenol and Ibuprofen dosing. Patient verbalized understanding. Patient encouraged to keep PCP appointment tomorrow 7/20/22. Patient verbalized understanding. Patient states that he is ok with a healthcare professional from the Health Department communicating regarding his symptoms with his PCP to confirm continuity of care. A Health Department healthcare professional to follow-up with patient tomorrow.
Had my first shot on 1/2/21 and 2/3/21 and with second shot a 103.5 F. within 12 hours with a head ache/pulling for 5 days. Shooting pains in head and out fingers and feet. Was extremely tired as well for 5 days. 12/15/21- Had my booster and within 30 min had pulling on head. On 12/16/21 I developed a head ache on left side that traveled across forehead to above right eye and was stabbing. Set off my migraine for 5 days and had to leave work due to fluttering in eyes, I could see screen. I had a 100 F. degree temp that last about 2 days. I developed on day 5 a dry cough and sore throat that is still going today. I couldn't cough to get anything up and felt like I was choking to clear my throat. I developed at that time quarter size lymph nodes that are still there today (day 26) but are now dime size. I lost my voice for 7 days at that time and when I tried to speak I had pain in my neck. My voice is still hoarse today with a lump in my throat. I still get twinges of pain on the side of my head and twinges in my fingers. My heartbeat has started to flutter, I have never had this before and it started on 1/10/22. I have a constant running nose, had this from the date of shot and I am still coughing every so often. I am still after 26 days getting headaches and pain with my migraine. My lymph nodes continue to be a dime size and are mainly on left side of body where I had shot. I have taken 5 rapid test, all neg and saw my doctor via virtual as I wasn't allowed at the office on 12/30 and nothing could be done to assist with the symptoms. She told me that I had a severe inflammatory response to the shot. She also informed me that they are seeing this alot.
Mom called our office today stating that she believes starting yesterday, patient has large red rash on left deltoid area where he received vaccine. I requested that she send photos to our secure triage email and I had Dr. review them. Per Dr., looks more like an allergy type reaction to the vaccine and luckily, we will not have to provide him with another Kinrix in his lifetime. Mom given signs and symptoms to monitor for advancing allergic reaction or injection site infection as well. Zyrtec, Benadryl and Topical Hydrocortisone 1% advised for treatment and to call if anything changes/worsens.
Pt's daughter reports that after the patient received her second dose of the Moderna vaccine on Friday, April 23, 2021, on Saturday, April 24, 2021 around 3:00pm the patient started having trouble lifting her foot, she was also having trouble standing; the pt's daughter evaluated her on Sunday and thought she was having a neurodeficit.  The patient was taken to the hospital on Monday evening (4/26/21) and a CT scan revealed the pt had a stroke. The pt is anticipated to recover.
This case meets criteria for vaccine breakthrough review.  Tested COVID+ at hospital on 11/12/2021. SxS include generalized weakness.
Left arm cellulitis < 3 cm abscess with diffuse redness and erythema extending to elbow.
PATIENT DEVELOPED RED RASH OVER BODY. HAD BRIEF COURSE OF STEROIDS WITH IMPROVEMENT. ULTIMATELY PRESNTED TO HOSPITAL  WITH HYPOTENSION AND RASH. THEN DEVELOPED BLISTERING. SKIN BIOPSY C/F BULLOUS PEMPHIGOID
Patient admitted to hospital on 10/24 with complaints of myalgias sore throat cough of 3 days duration and was found to have rapid COVID-19 positive.  Multiple family members at home sick with COVID-19.  Patient states he did take single dose vaccine by Johnson and Johnson in June of this year.  His CXR and CTA chest were suggestive of viral pneumonitis there was concern about ongoing CHF also.  Patient was hypoxic and placed on 2 L O2 nasal cannula with O2 saturations in 94%.  He was started on Decadron as well as remdesivir and IV antibiotics.  His EKG again shows bradycardia with AV disassociation which upon my review concerning for third-degree heart block.  Patient overnight at this facility noticed to have severe bradycardia with heart rate dropping to 35 bpm however patient remains asymptomatic with it. Reviewed case again with cardiologist who recommended patient be transferred to higher level of care for EP evaluation and possible pacemaker placement.  Patient was transferred to outside hospital on 10/25/2021 for placement of permanent pacemaker.  He completed 5 days of remdesivir, course of IV antibiotics (for UTI), and steroids.  He was discharged to an ECF on 11/4/2021.
Day 1-2 typical immune response with fatigue, arm soreness, low grade fever.  Day 6 post vaccination severe chest pain, palpitations, irregular heart rhythm, shortness of breath Day 7 continued day 6 symptoms, upon arrival to nursing job placed myself on cardiac monitor and I have having frequent PVCs, trigeminy.  Trigeminy has continued since.  I also have joint pain, edema legs and hands, and extreme fatigue.  Multiple failed medications to control PVCs.  Scheduled for electrophysiology study with PVC ablation 12/15/2021.  Rheumatology work up confirmed severe reaction to vaccine.
diarrhea; allergies; nausea; highfever; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 12Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021 after 1st shot the patient experienced diarrhea, allergies, nausea, and high fever. The clinical outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Pt recv vax on 11/17/98; on 11/20/98 pt exp itchy rash over trunk & limbs x 1 wk; tx=Benadryl
Information has been received from a 66 year old male who in approximately November 2007, was vaccinated with ZOSTAVAX (Oka/Merck). Subsequently the patient experienced rash and swelling in genital area. The patient was seen by the physician for these adverse events. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/24/2008. In follow up the patient that the allergic reaction that he had was excessive antibiotics and has been corrected. There was no connection with the zoster vaccine live inoculation. No further information is available.