chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bell Palsy; Headache on  left side of his head; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell Palsy) in a 71-year-old male 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.     Concurrent medical conditions included Hypertension.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jul-2021, the patient experienced BELL'S PALSY (Bell Palsy) (seriousness criterion medically significant) and HEADACHE (Headache on  left side of his head). The patient was treated with PREDNISONE for Bell's palsy, at a dose of UNK dosage form. At the time of the report, BELL'S PALSY (Bell Palsy) and HEADACHE (Headache on  left side of his head) had resolved.            Concomitant medications included hypertension medication, unspecified.  The patient experienced mild Bell Palsy after the second dose and described the symptoms as left side of his face was numb and felt similar to when a dentist works on one side of the face which makes that side numb (left side of face muscles were numb for a while), droopy eye, and  he could smile only on his right side of the face. Patient also reported headache on left side of his head. The symptoms started on 07 Jul 2021 and stopped after finishing Prednisolone that was prescribed by his doctor.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report was received from a healthcare worker and refers to a 14 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 01-OCT-2015, the patient was vaccinated with improperly stored doses of M-M-R II (lot # K000738, expiration date 16-JAN-2016, exact dose and route of administration were not reported) and VARIVAX (Merck) (lot # K002046, expiration date 10-FEB-2016, exact dose and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a consumer concerning her 14 year old daughter with no pertinent medical history and drug reactions/allergies who on 01-AUG-2011 was vaccinated with the first dose of GARDASIL subcutaneously. Concomitant therapy included SOLODYN. On 30-AUG-2011 (reported as 29 days after receiving the first shot) the patient had a seizure. The patient was taken to the hospital and released. Cat scan and blood work was performed (results not reported). The caller was following up with the patient's primary physician to decide if they would continue the therapy. It was also reported that the therapy with GARDASIL was not reintroduced. At the time of report, the patient was recovering. Follow up information has been received from a physician's office assistant who read from the patient's chart and stated that GARDASIL lot # was 669265/0181AA. The patient did not receive any concomitant vaccinations. Follow up information was also received from a medical assistant from the physician's office who stated that the patient did not have a family history of seizures. The medical assistant did not know if the patient was referred to a Neurologist. The medical assistant stated that the physician had documented that she had spoken to the patient's mother and explained that the patient would not receive anymore doses of GARDASIL. The patient would resume her other scheduled vaccinations excluding GARDASIL. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 28th March 2019, the patient received the 1st dose of SHINGRIX. On 28th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 29th March 2019, the patient experienced headache, general body pain, chilliness, facial flushing, influenza-like symptoms and fatigue. The patient was treated with TYLENOL. On an unknown date, the outcome of the headache, general body pain, injection site pain, facial flushing, influenza-like symptoms and fatigue were not recovered/not resolved and the outcome of the chilliness was unknown. It was unknown if the reporter considered the headache, general body pain, chilliness, injection site pain, facial flushing, influenza-like symptoms and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine the day before reporting date and experienced minor side effects. The patient reported additional details regarding adverse events those were body aches started this morning, headaches, face flushing around eyes and around cheeks, flu Symptoms, fatigue started in the morning of reporting day and pain at injection site started on the day before reporting date. The patient also reported that she was taking TYLENOL to ease her symptoms. The patient asked do I need to be concerned about being around grandchildren and her pregnant daughter. The reporter was told this was not a live virus but what to make sure the patient not exposing them to anything.
Fatigue the evening after and for 2 days following the 2nd dose.  Rash around injection site noticed 5/16/2021 (5 days after the 2nd dose).  Rash feels bruised below injection site.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 01-DEC-2017, the patient was administered an improperly stored dose of GARDASIL 9 injection, lot # N015089 with expiration date on 20-OCT-2019 (dose and route of administration were not reported). The administered dose of vaccine underwent a temperature excursion of 47.6 degrees Fahrenheit, which lasted for an unspecified time. There was no previous temperature excursion. A digital data logger was not involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1712USA008158: US-009507513-1712USA008159: US-009507513-1712USA008160: US-009507513-1712USA008161: US-009507513-1712USA008162: US-009507513-1712USA002258:
RASH ON FACE, CHEST, FOREHEAD, FOREARMS, HANDS IN  BETWEEN FINGERS; This spontaneous report received from a patient concerned a 77 year old female. 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: 1808980, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced rash on face, chest, forehead, forearms, hands in between fingers. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rash on face, chest, forehead, forearms, hands in between fingers. This report was non-serious.; Sender's Comments: v0-Medical assessment comment not required according to standard operating procedure.
Had hives and rash 2 hours after vaccine. Improved with BENADRYL. She had erythematous hive-like lesions on knees, and upper extremities.
From initial information received on 27Aug04 from manf (HQWYE739228JUN04) from information received from a physician regarding an adverse event occurring. It was reported that a two month old female pt received an Acthib vaccination, lot UE212AA, route and site of admin not reported on 09Jun04. The same day the pt developed a few hives on the face. The pt recovered from this event. From additional information received on 19Oct04 from the reporting physician, it was reported that Acthib vaccine was administered in the left leg. The pt also received a first dose of Prevnar, lot 495248, administered in the right leg on 09Jul04. The pt's mother called the physician's office later that same day after noticing three to four hives on the infants face at home. She was told to administer Benadryl. Approx a half hour later, the pt's mother called back and reported that the hives had faded without medication. No further problems were reported. The pt has since received additional Acthib and Prevnar vaccinations without any adverse reaction. No further information is anticipated, this case is considered closed.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2007, a healthcare provider at a county health department (public) administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 22-MAY-2018, the patient was treated by a healthcare provider at a county health department (public) for shingles. The patient was diagnosed with shingles and or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (not specified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
after the patient got Afluria shot in about 7-10 minutes he fainted/had seizure according to parents + woke up in few seconds by the time Rph got to the aisle the pt. was ok + responsive. Paramedics were contacted + arrived + took care of pt.
The next morning patient woke up with pain and swelling in the right arm. The swelling was all the way down to her hand and she had tingling in that hand as well. She was unable to move the arm without having extreme pain. Also reported a headache. She was advised to use cold compresses to decrease swelling. She could take up to 600 mg Ibuprofen every 6 hours.
The case has the two records. Unable to see both records at that time. Found the record later and discovered that the child had COVID booster BIV already. No sign and symptoms and adverse reactions seen.
Severe vomiting, diarrhea, fever (102 degrees), prolonged loss of appetite.
Within hours of the second injection I felt fatigued, several hours after the injection (later at night) I vomited for about 6 hours, then experienced 3 days of fevers, chills, body aches, and exhaustion. I could not get out of bed for 3 days.
Patient took benadryl 50 mg prior to administration -dose administered at 3:50 pm -mild itching started ~4:15 pm -chest heaviness and throat feeling "chunky" at ~4:50 pm -at about 5:45 pm pt stating throat feeling better but chest heaviness still occurring -epi offered multiple times throughout monitoring patient, but patient declined and, left AMA
received the first dose of shindrex on September 29, 2019 and forgot about the second dose / received the vaccine May 3; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 29th September 2019).   On 3rd May 2020, the patient received the 2nd dose of Shingrix. On 3rd May 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional information was provided as follows: The age at vaccination was not reported. The patient received 1st dose and forgot about 2nd dose. The physician asked patient to start over after the 1st dose and pharmacist asked not to have both doses. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. The patient wated to know who was correct. The reporter consented to follow up.
The patient was administered a Pfizer COVID-19, 5-11 y/o monovalent vaccine as a booster instead of the bivalent vaccine. The patient did not experience any side effects and was monitored for 15 minutes. The parents were informed on 10/17/22 of the incident and recommended for the patient to return and receive the bivalent pediatric booster after 2 months, per the CDC vaccine errors and deviation document. The parents were understanding of the situation. Nursing staff has been provided additional training regarding the incident.
15 minutes after being vaccinated I got a burning feeling from head to toe, began to itch, was dizzy and eyes were glossy and developed hives and had more swelling than normal at the injection site, accompanied with a fever and six hours later I had a seizure.
had vaccine at schedule 0 and 6; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 24-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: This case was reported by the patient for herself. The age at vaccination was not reported. The patient reported that she had the Twinrix vaccine at schedule 0 and 6 instead of the intended 0, 1, 6. So I'd like to know what was the coverage and if next dose required, which led to drug dose administration interval too long. The patient also inquired about insurance coverage. The patient answered online questionair as she was not comfortable to share contact number but she was ready to share her email.
VOMITING; ACHES; NAUSEA; This spontaneous report received from a patient concerned a female 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) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On 17-MAR-2021, the subject experienced vomiting. On 17-MAR-2021, the subject experienced aches. On 17-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, vomiting and aches was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
patient took expired ACTHIB vaccine, with no reported adverse event; Initial information received on 04-Nov-2022 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case is linked to case 2022SA460139.  This case involves a 1 years old female patient who took expired vaccine HIB (PRP/T) VACCINE [ACT-HIB] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL); and INFLUENZA VACCINE (INFLUENZA) for Immunisation.  On 02-Nov-2022, the patient received 0.5 ml dose of suspect HIB (PRP/T) VACCINE (Powder and solvent for solution for injection) (lot UJ600AAB and expiry date: 29-Oct-2022) via intramuscular route in the left thigh for Immunization.  On 02-Nov-2022 (latency: same day), the patient took expired HIB (PRP/T) VACCINE, with no reported adverse event (expired product administered).   It was reported that "A nurse looked at the actual powder component which expires on 30Nov2022. This was realized after the injection."    Action taken: not applicable.  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 guidelines. 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.
The Patient walked out of the vaccination room and sat down for the 15-minute observation period but fall off his chair and fainted. He had pulse and was breathing but sweeting profusely. I wanted to call 911 but he got up and signaled me not to call 911.RR was 68 and BP 110/70. Gave him a bottle of cold water and he later admitted that he had not eaten breakfast yet.
W/in 2 days of shot arm had a red swollen area 9x10 cm; grew to 12x12 cm (6in x 6in); seen by MD who prescribed Ibuprofren; Rash resolved in 48 hrs;
Complained of itchy throat and was clearing throat.  Then said tongue felt thick and swollen.  Po Bendaryl and Epi 0.3mg IM given.  EMS called. Pt refused transport after leaving clinic on stretcher.
08/06/2004 pt returned to office with reddened warm oral area on left arm at injection site- measuring 3"x3"- ?Rxn vs. Cellulitis-Advised to use Tylenol, warm compresses-Rev on 8/9 redness and warmth.
Diarrhea; No energy; Cough; Fever; Feeling terrible; This case was reported by a other health professional via sales rep and described the occurrence of fever in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date refer case US2020AMR211574).   On 6th October 2020, the patient received the 2nd dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced fever and feels awful. On 22nd October 2020, the patient experienced diarrhea, loss of energy and cough. On an unknown date, the outcome of the fever and feels awful were recovered/resolved and the outcome of the diarrhea was recovering/resolving and the outcome of the loss of energy and cough were not recovered/not resolved.   It was unknown if the reporter considered the fever, feels awful, diarrhea, loss of energy and cough to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. A patient received her 2nd dose on 06th October 2020 and within 36 hours of receiving it she got a fever and was in bed for a couple of days feeling terrible.  That had resided but still currently had diarrhea that had slightly improved but not much along with no energy and a cough.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR211574:same patient, 1st dose
palpitations; nauseous; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 29Dec2020 08:30 at a single dose on left arm for COVID-19 immunization. Medical history included hypertension and obesity. The patient's concomitant medications were not reported. The patient previously took Dilaudid and experienced allergies. With first shot-immediately after (on 29Dec2020) had palpitations. Was nauseous times 24 hours on an unspecified date. The outcome of the events was unknown. The patient was not pregnant. Facility type vaccine was Hospital. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not COVID tested post vaccination.
sore arm; This is a spontaneous report from a contactable consumer (patient, reported for self). A 66-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot/Batch number: UNKNOWN), via unspecified route of administration as dose number unknown, single for COVID-19 immunization. The patient medical history was not reported. The patient had received Ibrance (100 mg) taken for an unspecified indication and unknown if ongoing. The patient reported, "I got the Covid 19 Vaccine. I did not have any side effects, except for a sore arm." The event was non-serious. The outcome of the event sore arm was unknown.  Information on the lot/batch number has been requested.
A few hours after vaccination there we symptoms of: extreme fatigue, headache no energy whatsoever. Muscle aching, bone aching in the entire body; sleepiness; an overall feeling of heaviness; shallow breathing; an overall feeling of being sick; The symptoms continue even a WEEK later (today). NyQuil alleviates some of the symptoms for a few hours, only for the symptoms to return.
IN CHRONOLOGICAL ORDER: HEADACHE, DIZZINESS, NAUSEA, FEELING OF WEAKNESS, INJECTION SITE PAIN AND REDNESS, MYALGIA, ARTHRALGIA.
3wk p/vax pt had a cold/flu & ran a high fever (102) @ 4AM;had a convuls for 2 1/2min & was gagging;threw up & then took pt to ER where examined & found nothing wrong;
9 days after receiving the booster dose of the Moderna vaccine (I also received Moderna for the first two doses on February 2 and March 2), I started experiencing itchiness all over my body, from the back of my head down to the tops of my feet. It's not severe enough that it prevents me from doing everyday tasks, but it is annoying and concerning enough that I scheduled an appointment with my doctor on Friday morning (December 10). He recommended taking a daily dose of a 24 hour antihistamine (I chose the generic form of Claritin to start) and it is helping to manage the symptoms, but they never go away completely.  I have no real evidence that any of this is happening because of the vaccine, but I have never had any diagnosed allergies and I haven't done anything else unusual in the last couple weeks, so I figured it was suspicious enough to at least report it.
Myalgia & NauseaVomiting Narrative:  Other Relevant History: