chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain/stinging at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2019, the patient received Shingrix. On 17th October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age at vaccination was captured as adult as per Shingrix indication. The reporter mentioned that she gave 3 Shingrix vaccinations on day of reporting and all 3 patients had complained of pain/stinging during injection of the Shingrix dose. The reporter consent to follow up. This is 1 of the 3 linked cases reported by the same reporter. This case had been linked to the case US2019188954, reported by same reporter.
I21.4 ACUTE NON ST ELEVATION MI 3/18/2023 ANEMIA I21.4 ACUTE NON ST ELEVATION MI 3/18/2023 PNEUMONIA I21.4 ACUTE NON ST ELEVATION MI 3/18/2023 UTI (URINARY TRACT INFECTION) I21.4 ACUTE NON ST ELEVATION MI 3/18/2023 DIARRHEA I21.4 ACUTE NON ST ELEVATION MI 3/18/2023 PITUITARY MACROADENOMA I21.4 ACUTE NON ST ELEVATION MI 3/18/2023 ANEMIA DUE TO CKD STAGE 4 (GFR 15-29) I21.4 ACUTE NON ST ELEVATION MI 3/18/2023 PITUITARY MACROADENOMA
Patient states that approximately 30 minutes after the vaccine she developed itching in palms of hands and feet that later spread to the back of her legs. Pt then reports generalized body aches and later noticing red raised area at injection site that was painful and itching. Patient states that itching has overall resolved, but that she continues to have generalized body aches and the red area appears to be getting larger and is still raised. Patient unable to tell if area is warm to touch, but states that its is uncomfortable to touch. Patient reports taking diazepam and oxycodone for symptoms with relief.
I had the vaccine on Friday afternoon then woke up on Saturday morning with severe neck pain on the right side that is still going on...day 9 now.. I was unable to put my head back in my neck to insert eye drops and am having a hard time looking up and down and left and right. Pain is radiating down side of my neck into my upper shoulder blade. I am aware that pain normally lasts only 2-3 days but was wondering if it can last longer.  Thank you.
Immediately experienced light headedness, hot, slight nausea, low blood pressure, feeling like I was going to pass out which lasted for the remainder of the day only slightly diminishing throughout the day. First day after felt slightly better, still tired and slightly light headed. Second day symptoms worsened, feeling like I was going to pass out/faint, hot/cold chills, clammy, no fever, shortness of breath, culminating in numbness and tingling in arms, legs, then chest and then hands freezing up which resulted in a panic attack. Have never had a panic attack before. Emergency services called and after checking gave a sedative and went to the ER.
3 episodes of diarrhea after receiving COVID-19 Vaccine  Refused Evaluation in the UC or ER and reported will see her PCP if symptoms continued .
Extreme soreness of the area and arm, Rash & Haves, itching, redness, swollen area, hoarseness, fever and dizziness. tired and weak with headaches and stomach upset. These adverse reactions did not happen with the first SHINGRIX vaccination on April 6, 2018. I HAVE PHOTOS.
gen hives, 2hr p/vax;recv DPH & steroids @ ER;
Within 36 hrs of administration of DTap, left deltoid and upper and lower arm, chest were red and swollen, non-painful and afebrile.
The evening of my vaccination, I began to feel feverish, weak and achy. During the night I woke with heavy bleeding and found out the following morning I had miscarried my otherwise healthy pregnancy.
booster; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 44-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 23Nov2021 (Lot number: FJ1620) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 17Mar2021, when the patient was 43 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 07Apr2021, when the patient was 43 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 23Nov2021, outcome unknown; PAIN IN EXTREMITY (non-serious) with onset 23Nov2021, outcome recoverin. Therapeutic measures were not taken as a result of pain in extremity.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19.  Follow-up attempts are completed. No further information is expected.
Pt. described "hives" covering her entire trunk after second Twinrix vaccine (the only vaccine received at this time), she also states that she had a small amount of rash after the first dose on 2-4-04 (she also received polio, Td, typhoid and flu)but did not tell us.
40 year old male patient administered expired diluent with no adverse event; Initial information received on 13-Jul-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 40 year old male patient who was vaccinated with an expired diluent dose of suspect YELLOW FEVER VACCINE - US [YF-VAX].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 13-Jul-2021, the patient received a 0.5 ml dose of suspect YELLOW FEVER VACCINE - US (lot number: UJ386AA and expiry date: 22-Aug-2022, Diluent Lot number: U6309AA and expiry date: 30-Jun-2021) (Frequency: once) via an subcutaneous route in the left arm (Expired product administered) for prophylactic vaccination.  It was an actual medication error case due to Expired medical agent used (latency on 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.
Headache, Myalgia & Fever Narrative:  Fever/Chills, headache, muscle/body aches
Information has been received from a physician concerning four female patient's who were vaccinated with dose of GARDASIL. Subsequently the patients experienced postural hypotension. Unspecified medical attention was sought. At the time of this report, the outcomes were unknown. Follow up information was received from a physician concerning a female patient. The physician stated that after further discussions, it was decided that there was no relation to these events and the GARDASIL vaccination. The physician was confident that the patient was fine. This is one of several reports from the same source. No further information is available.
Information has been received from a nurse concerning a patient who on 01-SEP-2010 received the first dose of ROTATEQ and would get the second dose on 01-DEC-2010 (lot # not reported). No known adverse effect. It was unspecified if the patient sought medical attention. Follow up information has been received from a nurse reporting that the 24 week old female patient received the second dose of ROTATEQ (lot # 665274/0300Z) on 01-DEC-2010. Concomitant therapy included PEDIARIX (lot # AC21B248AA, left arm), ACTHIB (lot # SPUH157AA, right arm), PREVNAR 13 (lot # E72961, right arm). All the concomitant therapy was the second dose vaccinated on 01-DEC-2010. There was no adverse reaction with either dose of ROTATEQ. Additional information is not expected.
swelling on her arm; Chills,shivering; temp is 101; Headache; A spontaneous report was received from a  consumer concerning a 49 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swelling in the arm got vaccine/Peripheral swelling, chills, headaches, fever temp is 101, shivering/chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 8 Feb 2021, the patient experienced the event(s) swelling in the arm got vaccine, chills, headaches, fever temp is 101, shivering.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), swelling in the arm got vaccine, chills, headaches, fever temp is 101, shivering was unknown.
Information has been received from a physician concerning a 9 (also reported as 17) year old male who on 15-MAY-2001 was vaccinated with the first dose of MMR II.  On 30-DEC-2009 the patient experienced mumps.  Date of mumps diagnosis reported as 25-NOV-2009.  The patient was afebrile.  The patient had left and right parotitis.  Parotitis count was 72.  On 25-NOV-2009 the first blood work revealed IgM < 1:10, IgG 4.58, and serum amylase 73.  At the time of this report, the patient's outcome was not reported.  Follow-up information was received from the physician indicating that on 16-NOV-2009, the patient developed mumps.  It was diagnosed on 16-NOV-2009 that the patient had left facial swelling and right parotitis.  The patient also experienced vomiting.  On 16-NOV-2009, the first blood work revealed IgM < 1:10, IgG 2.05, and serum amylase 63.  No further information is available.
This spontaneous report as received from a nurse via a company representative refers to a 14 year old male patient. The patient's concurrent conditions included drug reactions or allergies to morphine (manufacturer unknown) and DILAUDID and also Crohn's disease. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (exact dose, route of administration, lot # and expiration date were not provided). On an unknown date, an unspecified time after vaccination, the patient felt thirsty and then his throat closing. The patient received EPIPEN as a treatment and he was taken to an unspecified hospital. It was reported, that the patient was at the hospital for 2 hours. The patient fully recovered on the same day. Causality assessment was not provided. Additional information is not expected because there was no consent to contact nurse.
This spontaneous report as received from a 64 year old female patient refers to herself. Pertinent medical history included arthritis and drug reaction/allergies penicillin (dosage/frequency/manufacturer unknown). On 03-OCT-2014 the patient was vaccinated with ZOSTAVAX (1 single shot, route of administration and dose was not reported). Unspecified blood pressure medication was reported as concomitant medication. On 18-OCT-2014, patient felt funny, stood up and urine just came pouring out of her. She also experienced profuse cold sweating. No treatment was given for adverse event. No lab diagnostic studies performed. Patient did not seek medical attention. The outcome of the events was reported as recovered/resolved on 18-OCT-2014. Relatedness between events and vaccination with ZOSTAVAX was not reported. Additional information has been requested.
A few hrs after the vaccine my right eye turned bloodshot red. About 7pm that evening my right eye got really itchy, red and swollen almost closed which continued for about 4-5 days. My PCP had me take Benadryl and antihistamine every 8 hrs to help with the symptoms. I was also prescribed tobramycin index methadone a steroid eye drop to help also. I have noticed this issue has arised 2 different times since receiving the vaccine and now I have to see a specialist to see if they can find out why I keep experiencing this periodic eye swelling.
I GAVE PATIENT AN EXTRA DOSE OF HEPATITIS A HAVRIX AND HEPATITIS B HEPLISAV. I REVEIWED TENNIS AND HIS VACCINES WERE NOT UPDATED IN THAT SYSTEM. I DIDN'T COMPARE HIS VACCINE RECORD FORM WERE HIS VACCINES WERE UPDATED TO HIS SCREEN AND MISSED THAT HE HAD ALREADY RECEVIED THE VACCINES.
1/31/22 The patient presents for shortness of breath.  He tested positive for Covid yesterday.  EMS reported O2 sats in the 70s when they transported the patient today.  The patient tells me his shortness of breath has been chronic but worse over the last 3 weeks.  He has had a cough but no fever and no chest pain.  On my assessment, he is awake and alert.  Skin color is normal.  There is no scleral icterus.  He is nontoxic-appearing Pt states he is always short of breath but has worsen since fall on Saturday. Pt has hx of falling for unknown reasons. Pt has been worked up for this. Pt fell Saturday where he broke ribs on his right side. Pt was seen at local hospital. Pt went home and had home health nurse do a covid swab on him which was positive. Pt has had vaccine but not booster. Pt has had a cough. Pt denies fever, sore throat, HA, sneezing/tearing from eyes, body aches, V/D, dysuria, or rash. Pt does bruise easily due to being on aspirin. Pt does smoke. Pt has hx of COPD. No home oxygen. Pt denies hitting head or other injuries from fall. Review of Systems  Constitutional: Negative for fever.  HENT: Negative for sore throat and sneezing.   Eyes: Negative for discharge.  Respiratory: Positive for cough and shortness of breath.   Cardiovascular: Positive for chest pain (ribs).  Gastrointestinal: Negative for diarrhea, nausea and vomiting.  Genitourinary: Negative for dysuria.  Musculoskeletal: Positive for back pain (posterior ribs).  Skin: Positive for color change.  Neurological: Negative for headaches.  Hematological: Bruises/bleeds easily.  2/2/22  Hospital Course:   From admission HPI: "85 y/o male with hx of COPD/emphysema, DM II, HTN, and a recent fall causing right sided rib fractures, presents to ED for evaluation of increasing SOB and cough.  Of note, patient is vaccinated and boostered, but did test + for COVID-19 last week.  He doesn't wear oxygen at home.  Denies fevers or chills. He still has pain in right lateral chest wall."   The following issues were addressed:   1) Acute hypoxic respiratory failure 2/2 community-acquired PNA: - COVID-19 positive but infiltrates on CT chest appear more consistent with bacterial PNA that what we typically see with COVID-19.  - s/p IV abx, discharge on PO to complete course - s/p IV dexamethasone for COVID, home on PO to complete 10 day total course - weaned off oxygen, does not qualify for home O2 per 6 min walk - WBC chronically elevated.   2) Prior R rib fractures: - pain seems to be improving   3) Uncontrolled T2DM with steroid-induced hyperglycemia: - resume metformin - A1c 6.0 so typically well controlled at home   4) Groin lesions: - appear consistent with condyloma acuminata, unclear chronicity - can f/u with PCP after discharge, she can pursue biopsy or removal if desired   5) Tobacco abuse: - requests Rx for nicotine patch
Almost a month after the 3rd vaccine my right hand began burning on the palm side between the pinky and the wrist.  The pain comes and goes. Diagnosed with neuropathy on 2/25/22.
got this soreness and it's getting better but the people call it COVID arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 67 year-old patient received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "got this soreness and it's getting better but the people call it COVID arm".  Additional information: Patient called in with questions about a letter that patient received regarding the medication Zoloft. And with a question about The Pfizer-BioNTech COVID-19 vaccine. During the call patient stated patient took the Pfizer COVID shot 10 days, lets see 12 not this Monday but the week before Monday its been 8, 9, 10, 11 days and now patient got this soreness and its getting better but the people call it COVID arm where after the shot patient have a sore arm. But it started getting sore 7 or 8 days after the shot, its getting better but patient didn't know if they knew about that or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Red, warm to touch, tender, fever, fluctuance face 4cm X 3cm. Treatment: Augmentin suspension 250mg/tsp 2; cold compresses. Has follow-up appt.
Unbearable pain 2-3 hours after vaccination on his arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Unbearable pain 2-3 hours after vaccination on his arm of injection) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis (Patient had arthritis on his shoulder for the last 5 years.).    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (Unbearable pain 2-3 hours after vaccination on his arm of injection). On 09-Apr-2021, PAIN IN EXTREMITY (Unbearable pain 2-3 hours after vaccination on his arm of injection) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication information was reported. The patient stated that he had a positive reaction as his arthritis went away.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up received on 27 May 2021 contains non-significant information.
respiratory failure; COVID-19 pneumonia; This literature-non-study case was reported in a literature article and describes the occurrence of RESPIRATORY FAILURE (respiratory failure) and COVID-19 PNEUMONIA (COVID-19 pneumonia) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       The patient's past medical history included Liver transplant.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RESPIRATORY FAILURE (respiratory failure) (seriousness criteria death and medically significant) and COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criterion medically significant). The patient died on an unknown date. The reported cause of death was Respiratory failure. It is unknown if an autopsy was performed. At the time of death, COVID-19 PNEUMONIA (COVID-19 pneumonia) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered RESPIRATORY FAILURE (respiratory failure) and COVID-19 PNEUMONIA (COVID-19 pneumonia) to be related.    No concomitant and Treatment medications were reported. This is a literature case concerning an 82-year-old male patient with medical history of liver transplant, who experienced the serious unexpected ADR of COVID-19 pneumonia and serious unexpected fatal event of respiratory failure. The events occurred 10 days after the second dose of the mRNA-1273 vaccine. Causality for the event of COVID-19 pneumonia was not applicable to the product administration and assessed as related for respiratory failure event. The rechallenge was not applicable due to the events outcome. Very limited information available on the medical history, disease course and treatment at this time. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Additional information has been requested.   This case was linked to MOD-2022-469625 (Patient Link).; Sender's Comments: This is a literature case concerning an 82-year-old male patient with medical history of liver transplant, who experienced the serious unexpected ADR of COVID-19 pneumonia and serious unexpected fatal event of respiratory failure. The events occurred 10 days after the second dose of the mRNA-1273 vaccine. Causality for the event of COVID-19 pneumonia was not applicable to the product administration and assessed as related for respiratory failure event. The rechallenge was not applicable due to the events outcome. Very limited information available on the medical history, disease course and treatment at this time. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Additional information has been requested.; Reported Cause(s) of Death: respiratory failure
severe vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (severe vertigo) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter. On 11-Mar-2021, the patient experienced VERTIGO (severe vertigo). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 13-Mar-2021, VERTIGO (severe vertigo) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
PATIENT STATES HE RECEIVED VACCINE IN HIS LEFT ARE, AND IS NOW EXPERIENCING MUSCLE TWITCHING AND TINGLING IN HIS RIGHT ARM
Rash small papules and pruritic - started on legs, spread to torso and then to arms.
had platelet count of 116,000; This is a spontaneous report from a contactable physician (patient). This report was received via a Pfizer sales representative. A 62-year-old female patient received bnt162b2, dose 1 via an unspecified route of administration on 21Jan2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient has no underlying conditions and has no current medications. The patient had platelet count of 116,000 on 08Feb2021 with outcome of unknown. The patient was scheduled for a surgical procedure on 17Mar2021. In the course of pre op labs, 08Feb2021, had platelet count of 116,000. This is 3 weeks after having first COVID 19 vaccine. No history of platelet disorders; have always had normal count of 180,000 - 200,000. Concerned about the possibility of there being a connection between vaccine and platelet dropping having had the second vaccine prior to surgical procedure. The patient received dose 2 via an unspecified route of administration on 11Feb2021 (Batch/Lot number was not reported) as single dose.  Information on the lot/batch number has been requested.