chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 2:37 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 2:37 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 18.94. Concomitant products were not provided. On 15-Apr-2021, Excursion time was 09 AM, with temperature as 34. Total doses given for the day was 188 vials. Condition of vaccine prior to administration was not frozen. Vaccine was moved to fridge on 06-Apr-2021 and. Vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021. On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
pt recv vax & was pregnant (LMP 26JUL98);MD reported that pt had elective termination of 7wk from LMP;it was uncertain if the fetus had any complications or congenital anomalies;
A nurse reported that a male patient inadvertently received a dose of Prevnar on 07 MAR 2002, instead of Pnu-Imune 23 vaccine. At the date of the report, no adverse event was reported and no further information is available.
Lg. welt covering entire left upper arm, laterally (from proximal shoulder to elbow). Duration 2-3 days, resolved w/o further tx. Tx'd with ice application.
Afib for the first time in my life within 24 hurs after the booster.  Monitored heart rate 47 to 137 beats/ minute.  Had a cardio version that failed. Increased my Metoprolol Tartrate from 50mg BID to 75mg BID. My hair has been falling out at an alarming rate since increasing the Beta Blocker.
lost movement in left leg  urinary track infection  inflammation    Had injections for immune from dr  1000 each for 4 months   went to cranial sacral person.   went to acupuncture person  Dr sent me to physical therapy . went to kinesthesiologist   who gave me nutritional supplements to build immune in brain heart kidneys  .  This got my leg working  I have not been able to work
Itching, rash ( mild) on: arms, hands, stomach, feet, red face
yesterday patient was gave a flu vaccine that was last years with no reported adverse event; Initial information  was received on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP.  This case involves a female patient with unknown age who was gave Influenza Quadrival A-B Vaccine [Fluzone QIV] yesterday that was last years with no reported adverse event.  The patient received no other vaccines. The patient's past medical history, medical treatment(s) and family history were not provided.   On 26-Sep-2022, the patient received a dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection 0.5 ml via intramuscular route in the left deltoid (lot: UJ694AB, expiration date: 30-Jun-2022) for Immunization.  On 26-Sep-2022 the patient was gave a flu vaccine that was last years with no reported adverse event (expired product administered) (latency: same day).  No lab data was reported.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.   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.
Injection site reaction.  Itchy and inflamed size of half a chicken egg.  Swelling slowly increasing. Not on any current medicines, did not take any treatment medicines.
1 1/2" to 2" diameter  circle around inj;lump in center;hot to touch;very red;very itchy;started 24hr after;still red; same size, but starting to streak down arm;not as itchy & not hard lump;
Case number PHEH2014US012818 is an initial spontaneous report received from a nurse on 24 Jun 2014, with a follow up received from nurse on 21 Jul 2014. This report refers to a 10 year old female patient. Past medical history was none and concomitant medications were not reported. Her vaccination status was up to date (UTD). She was vaccinated with MENVEO (batch number: M13047) intramuscularly into the left deltoid at a dose of 0.5 ml on 23 Jun 2014, which was stored at a temperature of 10 Fahrenheit for two hours out of a 24 hour time period for which the vaccine was stored/exposed to below 36 Fahrenheit low temperature. The reporter stated that the vaccine was not frozen. She also received BOOSTRIX (other manufacturer, batch number: 3T549) into the right deltoid at a dose of 0.5 ml on 23 Jun 2014. No adverse events were reported following this medication error (incorrect storage of drug). Follow up received from nurse on 21 Jul 2014: Updated patient demographics, dose and site of vaccination of MENVEO and concomitant vaccine BOOSTRIX.
mom called 3 1/2 hrs p/vax given pt was very irritable & refusing bottle; also had t102.4;
Redness, pain & induration persisting over the past 7 days. Currently tender red, 4 cm nodule remains, with minor itching. No treatment.
Employee stated that she is allergic to multiple medications and was anxious that she may get a reaction to the vaccine. After sitting for about 1/2 hour after receiving the vaccine, she began to c/o of a sharp epigastric pain. Employee stated that she only had a banana to eat for breakfast. She was transferred over to the first responders area, where she was assessed.Her vitals were within normal range.  After few minutes on the stretcher employee stated that  the pain was slowly subsiding, she then opted to leave.
arm really sore/ arm hurt all night; "uncomfort" in his arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot number was not reported as patient did not card with him), via an unspecified route of administration, on an unspecified date (at age of 58-year-old) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration, on an unspecified date as single dose for covid-19 immunization. On an unspecified date, the patient stated that he woke up in the morning with a sore arm after receiving the second dose of the Pfizer COVID vaccine yesterday. He said that he did not have any issues with the first dose. The patient said that he talked to three people as wanted to know if this side effect was normal or if he should seek emergency care from a doctor. The patient had "uncomfort" in his arm and arm was sore. His arm was hurting all night and was uncomfortable. The patient was concerned because he had never experienced this before, and he did not know if he needed to see a doctor for the arm pain. The patient was informed about the role of Pfizer. When probed, patient stated that he was not at his home and did not have vaccination card with him. Product details (ndc# upc# and treatment) and pharmacy details could not be probed as he was unwilling to share further information. Hence, further probing could not be done and limited information available over the call. The outcome of the events was unknown.  Follow-up attempts are needed. Further information is expected.
Red rash at injection site- size of 50 cent piece.  States had raised red bumps. C/o itching at site.  States developed itching over entire body one week later.  States today  11/17/14 noticed red bumps over body.  State worse when took hot shower.
Initial unsolicited report received from a nurse on 20 October 2015. This case is linked with 2015SA169848, 2015SA169857, 2015SA169859, 2015SA169865 and 2015SA169870. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE QIV (batch number:U5321BA, expiry date: 30 June 2016, dose, dose in series, site and route of administration were not reported) on 16 October 2015. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed rash and localized reaction. Laboratory data and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none. Follow up information received from nurse on 30-Dec-2015. The patient details were amended and age of onset was reported as 58 years. It was reported that patient had no allergies and experienced pneumonia in Nov-2014. Father of the patient had a medical history of neck cancer. During the last 12 months patient's previous medication included multi-vitamins, ATIVAN and RESTORIL and patient had also performed physical examination by physician, mammogram, breast self-exam and Pap smear. It was reported that the patient did regular exercise. It was reported that patient had monthly medicine refill and visited urologist every 3 months. On 16-Oct-2015, same day following vaccination, patient also experienced slight pink left deltoid with minimal edema and pain. The outcome of the events were not reported. No additional information was provided. Follow up information received from nurse on 20 May 2016. On 16 October 2015 same day post vaccination the patient experienced rash and localized reaction. No additional information was reported.
Pt diagnosed with acute myocarditiits. Admitted for monitoring. No signs of clinical decompensation at this time.
This spontaneous report was received from a registered nurse concerning a 15 year old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On an unspecified day in July 2017 the patient was vaccinated with the first dose of GARDASIL 9 indicated as prophylaxis (route of administration, anatomical location, lot number and expiration date were not reported). On an unspecified day in July 2018, the patient received the second dose of GARDASIL 9 indicated as prophylaxis (route of administration, lot number, anatomical location and expiration date were not reported). There were no adverse events reported.
tingling started from feet and radiated to upper body .  paramedics was called right away. She refused to go to emergency as she started feeling better after paramedic came.
Per internal reported event: Patient came to ER with complaint of nausea/vomiting/dizziness/headache/double vision. Patient received the COVID-19 the day prior to admission.   Per chart review: received 1st dose; unsure of location where patient received dose. Reporting location affiliated with where patient received treatment (i.e., observational status)
Very rapid heartbeat and ringing in ears. Heartbeat was elevated for approximately 8 hours. It has come back periodically over the past 36 hours with ear ringing. Anxiety.
an horrible allergy; swelling in the face; swelling of the ears; swelling of the nose; gastritis; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (an horrible allergy), SWELLING FACE (swelling in the face), EAR SWELLING (swelling of the ears), SWELLING (swelling of the nose) and GASTRITIS (gastritis) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (an horrible allergy), SWELLING FACE (swelling in the face), EAR SWELLING (swelling of the ears), SWELLING (swelling of the nose), GASTRITIS (gastritis), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, HYPERSENSITIVITY (an horrible allergy), SWELLING FACE (swelling in the face), EAR SWELLING (swelling of the ears), SWELLING (swelling of the nose), GASTRITIS (gastritis), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. No treatment information was provided.
pt recvd vax & 24 hrs later devel sz that cont intermittently for 6 days; MRI showed small subdural hemorrhage w/o mass effect on brain;
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "87 YO-year-old male with h/o Afib on Eliquis, CAD, CVA, DVT, HTN, hyperlipidemia, T2DM, Depression who presented due to complaints of altered mental status and weakness.  The patient was initially found at home after failing to appear to telehealth visit by family.  On admission patient reported of sore throat started past Monday with dry cough and indicated he had a fever overnight however was unmeasured.  In the emergency department patient's vitals:  Febrile 103.1F, tachycardic 105, tachypneic 24, stabbing 97% on room air.  Lab work significant for WBC 2.7, HGB 13.9, procalcitonin 0.11, TSH 0.36, BNP 443, lactate 1.7.  COVID testing returned positive results for COVID-19, chest x-ray showed mild interstitial edema.  CT head showed no acute intracranial abnormalities, chronic microvascular ischemic changes, mild cerebral and cerebellar atrophy, partial opacification of mastoid air cells.  CTA showed no large vessel occlusions, hypoplastic right vertebral artery, 3.4 cm thyroid mass, atherosclerotic plaque.  Patient was given Ofirmev and admitted to the inpatient hospital team for further evaluation and management of COVID-19.  For his COVID-19 patient is not a candidate for dexamethasone as he was not hypoxic, fever control was achieved with scheduled Tylenol and ofirmev.  albuterol, Mucinex and aggressive pulmonary toileting was attempted however patient continued to have difficulty expelling oral secretions further acquiring p.r.n. suctioning.  During the course of patient's stay patient entered into AFib with RVR, rate control initially attempted with labetalol IV, digoxin, diltiazem with IV GTT (initially achieved rate control for a few moments) patient re-entered AFib with RVR additional doses of Digoxin+ diltiazem were able to convert patient once again however patient continued to return into RVR ultimately requiring amiodarone an additional dose of IV labetalol. (Cardiology curbside recommended attempting additional dig or labetalol)  Rapid response was called on patient we was noted to have worsening altered mental status, during rapid response patient was noted to have seizure-like activity biting his tongue  was given Ativan and Keppra.  Patient continued to become tachypneic using accessory respiratory muscles.  Concern for CNS infection was present however patient did not have any meningeal signs such as nuchal rigidity though as a precaution patient was started on IV vancomycin, ampicillin, ceftriaxone with orders for EEG, CT head, MRI in place.  Patient was do not resuscitate DNI and patient's family did not want to change his status as such.  Overnight patient's condition continued to worsen and patient's family decided to resort to comfort measures.  Shortly after conversion to comfort measures patient had passed, time of death called at 4:33 a.m., family at bedside."
The first sign of trouble was redness on the outer edges of both armpits that I noticed on Monday, January 18, 2010 in the morning.  I now believe that these were the so-called "herald patches" of pityriasis rosea.  I was diagnosed with that condition on Thursday, January 21 by my dermatologist.  That morning, I had noticed that my chest and abdomen were covered with numerous red welts resembling mosquito bites.  Further research on my part tells me that I do not have a severe case, as there has been no itching and I have minimal activity on my back.  My dermatologist prescribed triamcinolone ointment compounded with Lubriderm for the rash.  My condition has seemed to improve slightly over the past week.
Having sudden, unusual problems with my vision, especially left eye. Twice now I have lost vision for several minutes and prior to that see waves of colors in my left eye. I am scheduling an appt with my eye doctor, as I was just seen in early 2021 and had no issues with my eyes. Happens suddenly without warning and is very concerning.
Started 2 hrs after injection with left arm getting painful, had difficulty lifting arm. "Passed out" that night hitting head and left leg. Felt feverish the next day. Symptom mostly gone by 11/5/10. Checked below labs. No other treatment.
fear of death; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EN9581) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "accident" (unspecified if ongoing), notes: I have had a serious accident. The patient's concomitant medications were not reported. The following information was reported: FEAR OF DEATH (non-serious) with onset 2021, outcome "unknown".  Additional Information: It was reported that the patient was vegan and practiced yoga for 50 plus year doing fine even though she had a serious accident. She overcame all of that and reported that 3 shots took all of that away. She reported that it was never listed that the  underline diseases or effects of covid shots caused her fear of death and job loss and reported that she accepted the poison.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300146105 same reporter/patient/product, different dose/event;US-PFIZER INC-PV202300123303 same reporter/patient/product, different dose/event;
Genital boils occurred 6-weeks after injections.  Self-care with tea tree tincture (100% oil) & neosporin for 90+ days. Visited physician after multiple boils.  The problem was not going away.  The self-care treatment dried up the boils, however, more boils continued to appear.  Physician prescribed Amoxicillin to be taken twice daily for 10 days on April 20, 2022.  Boils reduced in size and started disappearing.  However, there are now small bumps occurring.  Which appear to be the beginning of new boils, if not treated with the tea tree oil & neosporin.  Planning another visit to the physician, if the tea tree oil & neosporin do not clear up the problem.
Severe high fever 104 and shaking uncontrollably. Major headache lower back pain, weakness, lethargic, nausea, blurred vision, neck pain, skin hurt, very sleepy, confused. Dizziness. Still getting bad headaches.
Injection site was very sore and little swollen. Unable to rest that pm due to discomfort, felt tingling in hand. Temperature started about 4am with stomach discomfort. 6:30 am Temp was 99.9, began having headaches and body aches along with dizziness. Temperature went up to 100.1. Hands were cold and clammy.  Took Tylenol throughout the day, missed work due to not feeling well.
Developed a rash; Allergic reaction to Afluria Quadrivalent; This spontaneous case, initially received from a pharmacist on 27-Sep-2018, concerns a 9-year-old, male child patient.   The patient had no relevant medical history. The patient had not received any concomitant medications.   On 15-Nov-2017, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number and expiry date: not reported] for influenza prophylaxis.  On an unspecified date in Nov-2017, 2-3 days after vaccination, the patient developed a rash. Reporter stated that, it was an allergic reaction to the vaccine and thought it was due to Neosporin. The patient was treated with hydrocortisone (reported as hidrocortisone) (hydrocortisone acetate).  The patient had recovered from the events.  The reporter assessed this case as non-serious and the causality as related to the suspect vaccine.  Update received on 02-Nov-2018: Non-significant case correction (27-Sep-2018): The sentence in the narrative was changed from 'the patient was treated with hydrocortisone (hydrocortisone acetate)' to ' the patient was treated with hydrocortisone (reported as hidrocortisone) (hydrocortisone acetate)'.  Update received on 05-Nov-2018: Non-significant case correction (27-Sep-2018): Treatment received for the event 'allergy to vaccine' was changed from 'unknown' to yes' in the event tab. No changes were made in the narrative.; Reporter's Comments: A 9-year-old, male patient developed a rash considering as allergic reaction, 2-3 days after vaccination with the suspect vaccine Afluria Quadrivalent. The company assessed the causality of the events as related to the suspect vaccine due to plausible temporal relationship between events and suspect vaccine.