chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient experienced flare of oral graft versus host disease symptoms manifesting as problems swallowing/mouth soreness and large patches of skin coming off tongue, lip sores not improving, Also developed rash on foreskin on penis which may have been manifestation of flare of skin GVHD. Patient was started on topical triamcinolone for rash (now resolved), and dexamethasone swish and spit for mouth, then ultimately treated with prednisone 1 mg/kg and then tapper off over a month.
stroke; couldn't speak; feeling tired; diarrhea; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a stroke (medically significant) after the first shot and couldn't speak, was feeling tired as well and diarrhea. She wanted to know if she could still take the second shot. Patient does not want to give any information. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number could not be requested.
Three (3) HPV, lot # (J013324) had been exposed to the out of range temperature and needed to be returned. These three vaccines were mistakenly and in administered to three (3) patients. Whoever the staff person was who administered 3 doses of the HPV that should not been used, clicked on the new lot number (J012212) instead of the old lot # (J013324). We have been unable to identify the three patients who received the vaccines exposed to the out of range temp. I have been identify the 12 patients who administered HPV vaccine between the dates of 2/12 - 2/18/14 under lot number (J012212).
2nd vaccine dose received March 19 2021 April I noticed gum bleeding when brushing teeth.  Sept. I saw dentist due to increase bleeding and pain and tenderness of gums. Was sent to  oral surgeon for gum biopsy on October 13. Diagnosed with rare autoimmune disease mucus membrane pemphigoid. Diagnosis confirmed with second biopsy and evaluation with dermatologist at
Patient is an 82 y.o. female with a PMH of COPD (not on O2 supplementation), adenocarcinoma s/p LUL lobectomy 2014, pHTN, HTN, HLD, atrial arrhythmias, hypothyriodism presenting with complaints of shortness of breath. Found to be COVID+ and NC O2 supplementation.  CXR was negative for acute cardiopulmonary process.  Patient was started on decadron, remdesivir, and COVID vitamins and admitted to the hospital for further management.  Pt did very well during admission, was able to be weaned to baseline O2.  Pt was sent home with course of steroids and educated on symptomatic management of symptoms.     Discharge Diagnoses: Acute Hypoxemic Respiratory Failure Covid  COPD Pulmonary Hypertension Hx of Adenocarcinoma s/p LUL Lobectomy 2014 Tobacco Abuse   - Finish course of PO decadron at home - If any new or worsening symptoms, pt encouraged to return to ED for evaluation - Follow up with PCP and Pulmonologist
Left shoulder inflammation of the shoulder capsule lasting more than a week after vaccination injection.; This is a spontaneous report from a contactable Other HCP reported for herself  A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EL3248 on 06Jan2021 09:15 Intramuscular at single dose for COVID-19 immunization, vaccine location: left arm, dose number:1, facility type vaccine: hospital. The patient medical history and concomitant medications were not reported. The patient previously took zithromax and sulfa and experienced drug hypersensitivity. On 08Jan2021 13:00 the patient experienced left shoulder inflammation of the shoulder capsule lasting more than a week after vaccination injection with outcome of not recovered. The action taken was not applicable. The patient was treated with steroid medication orally.
It was reported that a male patient received an IPOL, a Hibtiter, a Hepatitis B, and an Acel-Imune vaccination on 04/04/01. Reportedly two days after vaccinations the patient expired. The patient was put down for a nap, The patient's mother went to check on him, the patient wasn't breathing; she called 911. Cause of death SIDS.
Febrile seizure with fever over 104. No other symptoms present. Taken by ambulance to ER, IV fluids, TYLENOL administered. Rapid heartbeat over 190 bpm observed. Released after normalization of temperature and heart rate lowered.
This spontaneous report as received from a nurse, a health care worker refers to patients of unknown age and gender. The patients concurrent conditions and medical history were not reported. The reporter stated that on an unspecified date, the patients were vaccinated with improperly stored VARIVAX Lot # L002871 EXP: 27-JAN-2017, Lot # L015047 EXP: 29-APR-2017 and Lot # L008272 EXP: 11-MAR-2017 (unknown how many). No adverse effects reported. No product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Started with malaise; but fever on 4/21 to 100F; moderate frontal headache 4/21 with fever to 103.9F on 4/22 with mild, dry cough, without other signs or symptoms.  Rx: naprosyn with response.
Started with cold symptoms. Runny nose on 8/3/00 and right jowl swollen and left testicle swollen. Had a fever of 105F at the highest. Sick from 8/1/00 to 8/5/00.
Information has been received from a health professional concerning a 15 year old female with a history of asthma who on 20 february 2008 was vaccinated intramuscularly in the left arm with her first does of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot # 657006/0188U).  Concommitanttherapy included vaccination in the left arm with meningococcal ACYN conj vaccine (dip toxoid) (MENACTRA).  On 20 february 2008 the patient experienced shortness of breath, chest pain and light headedness.  Thepatient sought unspecified medical treatment.  The patient recovered after she laid down and took a puff of her albuterol inhaler.  Subsequently, the patient recovered from shortness of breath, chest pain and light headedness.  No further information is available.  Additional information has been requested.
neuropathy in feet & legs;herpes lesion circumoral area;c/o numbness face & hands;MD dx GBS; Annual FU: still suffers from significant numbness and pain in his lower extremities. Also has impaired gait because of this.
Immediate head fogginess and headache (< 15 min) Fatigue and nausea  Body numbness (entire right side of body went numb 1-12 hours) Difficulty breathing (1-12 hours) Difficulty swallowing (1-12 hours) Swollen face, swollen eyes, swollen lips (6-12 hours) Neck and back pain (6-12 hours)
Mom reports temp up to 101.5, diarrhea x 24 hrs; very irritable; would cry & fuss when put down, but able to be soothed & quieted where held; Taken to ER because of temp; MD advised it was probably viral in nature;
Initial and follow-up information has been received from a registered nurse, concerning a patient of unknown age and gender, who on 16-AUG-2013, was vaccinated with a dose of VARIVAX (Merck), 0.5 ml, subcutaneously (lot # reported as J003225, ex: 15-MAR-2015) which was improperly stored. The nurse reported that VARIVAX (Merck) was exposed to a temperature of 10F for 264 hours from 06-AUG-2013 to 16-AUG-2013. The nurse reported that the overall average temperature for the VARIVAX (Merck) did not remain between -58F and 5F. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Vaccination sites (both) still bleed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01May2021 13:15 (Lot number: ew0170) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergies Mold" (unspecified if ongoing), notes: Known allergies: mold; "abdominal Planar damage from hernia" (unspecified if ongoing); "hypertansion" (unspecified if ongoing); "permanent plastic implant effects immune system in unusual ways" (unspecified if ongoing); "permanent plastic implant effects immune system in unusual ways" (unspecified if ongoing); "Known allergies: Sulfur" (unspecified if ongoing), notes: Known allergies: Sulfur. Concomitant medication(s) included: CARVEDILOL. Past drug history included: Erythromycin, reaction(s): "Known allergies", notes: Known allergies: Erythromycin. The following information was reported: VACCINATION SITE HAEMORRHAGE (non-serious) with onset 02May2021 14:00, outcome "recovered with sequelae", described as "Vaccination sites (both) still bleed". The event "vaccination sites (both) still bleed" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of vaccination site hemorrhage.  Additional information includes Other medications in two weeks included Coreg. No treatment received for AE. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination.   No follow-up attempts are possible. No further information is expected.
Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadedness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Medium.
Constant, sore armpit pain; Pain temporarily radiates; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Apr2021 at 13:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Mar2021 at 13:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 13Apr2021 at 14:00, the patient experienced constant, sore armpit pain which started on the second day, after her second dose. There was no noticeable swelling. Pain temporarily radiated randomly, 4 weeks later bit did not linger. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events, sore armpit pain and pain temporarily radiated was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling in her shoulder; experienced pain in the armpit of the injection site left arm; wife received an expired Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling in her shoulder), EXPIRED PRODUCT ADMINISTERED (wife received an expired Moderna Covid-19 vaccine) and AXILLARY PAIN (experienced pain in the armpit of the injection site left arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced SWELLING (Swelling in her shoulder) and AXILLARY PAIN (experienced pain in the armpit of the injection site left arm). On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (wife received an expired Moderna Covid-19 vaccine). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (wife received an expired Moderna Covid-19 vaccine) had resolved. At the time of the report, SWELLING (Swelling in her shoulder) and AXILLARY PAIN (experienced pain in the armpit of the injection site left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-367460 (Patient Link).
Developed swelling in the arm along with a bruise and arm pain. There is now limited range of motion of the left arm that has not improved since vaccination. Seen by employee health for treatment and will follow up with primary care.
approximately 0.1 mL leaked; A spontaneous report was received from a Pharmacist regarding an unidentifiable individual who was administered Moderna covid-19 vaccine and when giving the vaccine to a patient, approximately 0.1 mL  leaked, so the patient received 0.4 mL (Vaccine underdose).  The patient's medical history was not provided. No concomitant medications were reported. No information on allergies.  On an unspecified date, prior to the onset of events, individual received (first or second dose is not specified) Moderna Covid-19 vaccine for the prophylaxis of Covid-19 infection. (Lot: Unknown). During the administration 0.1ml leaked and only 0.4 ml was given to the patient (Vaccine underdose).  She wants to know if they could administer to the patient the 0.1 mL.  Action taken with 2nd dose of vaccine was not reported.  The outcome was resolved for event.; Reporter's Comments: This report refers to a case of a patient who was administered Moderna covid-19 vaccine and when giving the vaccine to a patient, approximately 0.1 mL leaked, (Vaccine under dose). (Lot # not provided). No associated AEs were reported.
Myalgia in L deltoid, with reduced active ROM. Denies paresthesia. Myalgia and reduced ROM have been slowly improving. Now has almost full active ROM with minimal discomfort.
pt recvd vax;cyanotic spell that lasted 30 secs acompanied by rolling eyes & shaking  mvmts of extremities;fever of 102;
Left upper extremity swelling and severe pain and itching. Treated with diphenhydramine, local measures.
Initial misuse report received from a healthcare professional (nurse) on 29 October 2013 and the case was received on 21 March 2014. A 54-year-old patient (gender was not reported) had received a dose of FLUZONE HD (batch number, route and site of administration was not reported) on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Severe joint pain limiting mobility Minor fever Extreme chills/shaking lasting over 2 hours Extreme fatigue next day
Left deltoid: 4 inch in circumference redness and swelling and pain. Follow up on 10/28/2003: "Vaccine provider is another clinic.  Came to this clinic to report occurence."
BODY ACHES; FEVER; This spontaneous report received from a patient concerned a 43 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: 202A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-APR-2021 08:45 to right arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, and fever. This report was non-serious.
No adverse event; Patient receive a pediatric monovalent dose for 6 years to 11 years instead of the primary dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient receive a pediatric monovalent dose for 6 years to 11 years instead of the primary dose) and NO ADVERSE EVENT (No adverse event) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     It was unknown patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient did not experienced any relevant medical history or conditions, allergy, concomitant diseases and risk factor.     On 17-Mar-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Patient receive a pediatric monovalent dose for 6 years to 11 years instead of the primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient receive a pediatric monovalent dose for 6 years to 11 years instead of the primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient receive a pediatric monovalent dose for 6 years to 11 years instead of the primary dose).    No concomitant medications was provided. No treatment medications was provided.
Approximately 6 days after my second dose, I began getting red splotchy bumps on my left forearm. 7 days after the 2nd dose these spots had spread up my arm and were appearing on my left Tricep area and shoulder. The lesions are tender to the touch with a mild burning sensation, they are mildly itchy.
Vaccination error (Medication error) A non-serious spontaneous report of patient given only half a dose of FLUMIST was received from a registered nurse in the USA concerning a male child. Neither medical history nor concomitant medications have been reported. The nurse who administered the FLUMIST forgot to remove the divider clip from the plunger of the spray device and delivered only half a dose to the patient. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
patient developed mumps two weeks after receiving M-M-R II; This spontaneous report was received from a nurse prescriber, referring to an adult male patient of whose age was not specified. The patient's pertinent medical history, drug reactions, allergies, concomitant medications and concurrent conditions were not disclosed.   On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) injection, as prophylaxis (administered dose, dose number, route and anatomical location of vaccination were not reported; reported lot number R000552 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), expiration date reported as 08-JAN-2020); which was prepared with Merck sterile diluent (lot number and expiration date were not provided).  The reporter stated that, two weeks after receiving the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), the patient developed mumps. The outcome of mumps , as well as the reporter's causality assessment between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) administration and mumps occurrence, was not reported.
Within 4 or 5 minutes of vaccinations child complained of tummy ache, become pale, and passed out. Heart rate increased 96/regular and strong. Child unresponsive for 30 seconds  both eyes remained open/almost laughing//arms went into fence position. Remained pale, nauseated for 10 minutes after woke up.
dry flaky skin on face and ears; dry skin on face and ears; This case was reported by a consumer via call center representative and described the occurrence of flaking skin in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 months after receiving Shingrix, the patient experienced flaking skin and dry skin. On an unknown date, the outcome of the flaking skin and dry skin were not recovered/not resolved.   It was unknown if the reporter considered the flaking skin and dry skin to be related to Shingrix.     Additional Information: GSK Receipt Date: 11-JAN-2023 Reporter's Comment: The patient self-reported this case. The patient reported that she received Shingrix vaccine. The patient stated that 2 months after receiving Shingrix vaccine she experienced dry flaky skin on her face and ears. The reporter did not consent to follow up.
Patient experienced severe pain and immobility in her neck, back and shoulder. The pain was so intense that she couldn't eat, and she only got out of bed to use the bathroom.
My arm and shoulder where the shot was given began to hurt, which I thought was normal, until, over the next few weeks, the pain became excruciating, and I couldn't move it without intense pain.  Acupuncture (12/22?) took the pain down from a 10 to a 3, but then it started increasing again over the next few days.  Now, almost 2.5 months later, although the pain has decreased, it still hurts with a number of different movements, including trying to remove shirts.  I actually can't use it to disrobe; I can barely put pressure from my right arm to lift my left arm for this task.  This is completely ridiculous.  I am never getting another flu shot again.  Just for the record, I believe the pharmacist administering it did the best job she could, and I don't feel she was negligent.
patient experienced pain in the arm where the vaccine was given (Left arm); Body aches, everything hurts, all over; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received on an unknown date, refer case US2023AMR029771).   On 20th February 2023, the patient received the 2nd dose of Shingrix. In February 2023, unknown after receiving Shingrix, the patient experienced pain in arm and general body pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and general body pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2023AMR029771   Additional Information: GSK receipt date: 21-FEB-2023 Reporter comment: The reporter was the patient. The patient received the second dose of shingrix and experienced pain in the arm where the vaccine was given (Left arm).    The patient also experiences aches all over her body. The patient experienced the same events from the first vaccine (arm pain and body aches), but the body aches are more over body (aches all over everything hurts) with the second dose. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023AMR029771:Same reporter
Rash, UrticariaPruritus, RASH ABOVE LEFT DELTOID AND FOREARM, NERVOUS, DIAPHORETIC  Narrative:
W/in 12 hrs p/immun, child experienced a fever of 105 & an inject site reaction which included erythema & tenderness. W/in 72 hrs p/immun, child was asymptomatic.