chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After he got the Moderna Covid 19 vaccine 2 years ago, he has been experiencing headache every day; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (After he got the Moderna Covid 19 vaccine 2 years ago, he has been experiencing headache every day) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (After he got the Moderna Covid 19 vaccine 2 years ago, he has been experiencing headache every day). At the time of the report, HEADACHE (After he got the Moderna Covid 19 vaccine 2 years ago, he has been experiencing headache every day) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medication use information was not provided by reporter.  Patient confirmed that it was not a vaccine of clinical trial.   Treatment Medication use information was not provided by reporter.
Soreness to injection site including redness and minor swelling  and feeling of malaise which  did not start until more than a week after the injection.
High dose Fluzone flu vaccine given to a 61 year old male. No reactions noted.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 20-NOV-2015 at time- 12:50, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose#, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.4 and 2.5 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved This is one of several reports received from same reporter. Additional information has been requested.
My period isn?t due for 5 days. I so bleeding light pink and have tissue discharge. This has NEVER happened before.
Swelling of throat; Tongue tingling; metal taste on tongue; Congestion; coughing; This is a spontaneous report from a contactable consumer or other non hcp. A 54-years-old non-pregnant female patient received bnt162b2 (COMIRNATY,Solution for injection,Batch/Lot number was not reported),administered in Arm Left on Mar2021 03:00 PM as Dose 1 SINGLE for covid-19 immunisation. Patient was not diagnosed with covid prior vaccination. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.  Medical history included osteoporosis ,bursitis ,mastectomy,hysterectomy,appendicectomy, sciatica, radiculopathy ,anxiety, depression from an unknown date and unknown if ongoing and had allergies to shellfish, dander, pollen, milk, flowers, chilli powder. Concomitant medications within 2 weeks included cetirizine hydrochloride(ZYRTEC ALLERGY) and levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient experienced swelling of throat, tongue tingling, metal taste on tongue ,congestion and cough on Mar2021.The patient underwent lab tests and procedures which included polymerase chain reaction: negative on Apr2021. The patient did not receive any treatment for the events. The outcome of events was resolved on an unspecified date.  Information about lot/batch number is requested.
Cold sores decreased after schedule; Covid 19; This case was reported by a pharmacist via call center representative and described the occurrence of cold sores in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cold sores (cold sores were very usual for patient). Previously administered products included Shingrix (1st dose received 2 to 3 years ago from reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced cold sores and covid-19. On an unknown date, the outcome of the cold sores and covid-19 were unknown.   It was unknown if the reporter considered the cold sores and covid-19 to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that, the patient had continued to develop cold sore after completing a dosing schedule of Shingrix over two or three years ago.  The cold sores were very usual for patient but decreased after Shingrix.  The patient contracted Covid-19 and started to develop more cold sores again.  Due to the reporter's nature and limited interactions with agent, no further probing was done to obtain more adverse event report details. The pharmacist did agree to follow-up but refused to provide any personal information, so no way for contact could be done.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Jan2021 at 12:00 as dose 1, single (Lot number: EL3246), in left arm, on 06Feb2021 at 16:00 as dose 2, single (Lot number: EL9262), in left arm and on 17Aug2021 at 12:00 as dose 3 (booster), single (Lot number: FC3180), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Covid returned about a week later. Not as sick but after 19 days I'm still testing positive and have a head cold.
Lymph node swelling in left axilla, pain in lymph node,  left shoulder pain, left scapula pain and still continuing.  This has been going on for 5 days.  At the time of report, still having the same symptoms.
Initial information received on 02-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 6 months old female patient who received a dose of ACT-HIB diluted with water without reconstituted with the DTaP-IPV portion. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included KINRIX for Immunisation; FLUBLOK for Immunisation; and PREVNAR for Immunisation. On 28-Dec-2018, the patient received a 0.5 ml single dose of suspect ACT-HIB lot U1905AA (expiry date: 17-Nov-2019) via intramuscular route in the right thigh. It was a case of actual medication error due to Inappropriate reconstitution technique. It was unknown if adverse event occurred. 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 Directive and Module VI of the 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. List of documents held by sender: none.
The pt experienced swelling, warmth and erythema to the right arm around the site of vaccination.
Mother called to report that the pt had a reaction to the vax. She noticed swelling of the left thigh injection area. There was a large red area that was hard and the size of a grapefruit. She called the ER and was instructed to apply ice. There was no decrease in the swelling. Ther was no fever. The MD thought the swelling was cellulitis related to the DTAP vax
Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient was inoculated with ZOSTAVAX vaccine for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. As a result the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. As a direct and proximate result of ZOSTAVAX the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using ZOSTAVAX. The patient sustained severe and permanent personal injuries. Further permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. As a direct and proximate consequence, the patient sustained serious personal injuries and related losses including but not limited to the following: The patient required and will continue to require healthcare and services. The patient incurred and will continue to incur medical and related expenses. The patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life and other losses and damages. Vaccination failure and herpes zoster were reported to be disabling. Additional information has been requested.
This spontaneous report has been received from the medical assistant refers to a 12 months old female patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies administered to them included Diluent Mrk Inj used to reconstitute the VARIVAX was properly stored. On 11-JUN-2018, the patient was vaccinated with improperly stored doses of VARIVAX (dose, units and frequency not reported) (lot# N031001 and expiration date 03-NOV-2019), subcutaneously. The doses of VARIVAX were exposed to a temperature excursion of 6 degrees Fahrenheit (degrees F) to 14 degrees F (also reported as "9F") for a time frame of 10 minutes; and of 15 degrees F to 46 degrees F (also reported as "25F") for 20 minutes. The temperature excursion was not detected by the Digital Data Logger. There was no previous temperature excursion either. No adverse effects or product quality complaints were reported. This is one of the multiple reports received from the same reporter. Sender's Comments: US-009507513-1806USA001756.
Vertigo- one quick wave of vertigo a day after then consistent mild vertigo from Aug 13- until current (8/25)
no adverse reaction was noted, no treatment required, patient had positive outcome with no problems associated with the error.
shortly p/3 hrs of receiving vax pt awoke from nap crying w/pain in lt ear & soreness in lt arm; apparently the crying episode was severe & uncontrollable, according to mom; pt taken to MD & examined & treated w/Septra;
Patient received vaccine and within 5 minutes he lost consciousness. He came to and was oriented to place and time. Called 911. He was monitored and refused to go to hospital. He left pharmacy about 30-45 minutes later and felt ok.
Asthma attack, swelling face & throat, matted & crusty eyes, sinus pressure, high fever.
PATIENT RECEIVED VACCINE THAT EXPERIENCED A TEMPERATURE EXCURSION, VACCINE WAS KEPT IN THE REFRIGERATOR FOR MORE THAN 30 DAYS. NO SIDE EFFECTS LISTED
Pt. presented in office with rash of less than 50 lesions starting 3 days prior.
This spontaneous report was received from an advance registered nurse practitioner refers to a 84 years old female patient who on 13-SEP-2012, was vaccinated subcutaneously on her upper right arm with a 0.65 ml dose of ZOSTAVAX (lot number 667609/1354Z) that was expired. The vaccine expired on 26-OCT-2011. No adverse effects were reported. Additional information is not expected.
TIA; right side of the face and head she had a tingling feeling; complex migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 30Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TRANSIENT ISCHAEMIC ATTACK (medically significant), outcome "unknown", described as "TIA"; PARAESTHESIA (non-serious), outcome "unknown", described as "right side of the face and head she had a tingling feeling"; MIGRAINE (non-serious), outcome "unknown", described as "complex migraine". It was reported that She received her first vaccine 30Jan2021 and few weeks later on the right side of the face and head she had a tingling feeling that travelled down, and the doctor mentioned it might be a possible TIA (ministroke) or a complex migraine after the second dose she felt sheer exhaustion. she felt all those side effects again after receiving the booster dose on 29Dec2021. within 3-4 days after booster, she had sheer exhaustion that is unbelievable, and it is 20Jan2022 now and she still feel the Throbbing on her face and back of her head. she is scheduled for EEG of her Head to see what's wrong. with all the side affects her job is suffering, she couldn't concentrate for months, and these side effects never went away, there is always a discomfort on the side and back of the head. she takes tylenol for it, but she wants to stop that as she doesn't want to affect her Liver. So, what can you do for me? : E-transmitting potential duplicate AE, additional information was not gathered as she mentioned she filed a report and pfizer has contacted her multiple times to follow up with her symptoms, but no one is doing anything to help her. Caller states that she made a report regarding her AE a year ago and wants to know what Pfizer's recommendation is as her doctor has no advice for her. She has had enough. she has been through hell with this vaccine and booster and the neurologist doesn't know what to do as the doctor said, " we do not have any information to know if this is caused by the vaccine". at first, she refused to provide more information about her AE as she already filed a report and insisted that i would pull out the report from last time. she asked me to read from the report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
slightly elevated wbc; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT INCREASED (slightly elevated wbc) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WHITE BLOOD CELL COUNT INCREASED (slightly elevated wbc). At the time of the report, WHITE BLOOD CELL COUNT INCREASED (slightly elevated wbc) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: elevated (abnormal) Elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
unspecified number of patients were vaccinated with improperly stored vaccines; No adverse symptoms; This spontaneous report has been received from a business professional referring to an unspecified number of patients of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On an unknown date, the patients were vaccinated with hepatitis a vaccine, inactivated(VAQTA); rotavirus vaccine, live, oral, pentavalent(ROTATEQ), quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL); and varicella virus vaccine live (oka/merck)(VARIVAX) (strength, frequency, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis.     The vaccines were exposed to a temperature below 36°F (2°C) (30°F) during a time frame of 67 hours. No previous temperature excursions. No adverse effects.
Caller reports patient was administered ROTATEQ on 07-MAR-2023; started experiencing toruble with digestion; Cramping; break out in sweats; Also reported having one stool that was "thicker, smaller, and mucus-y; Also reported having one stool that was "thicker, smaller, and mucus-y; This spontaneous report as received from a nurse and refers to a 4-month-old female patient. No information about patient medical history, concurrent conditions and concomitant medications was provided.     On 07-MAR-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1938950, 2 milliliter, oral for prophylaxis (product administered to patient of inappropriate age).        On 10-MAR-2023, the patient experienced dyspepsia, mucous stools, abnormal faeces, hyperhidrosis and muscle spasms. The outcome of dyspepsia, mucous stools, abnormal faeces, hyperhidrosis and muscle spasms is unknown. Action taken regarding events was not applicable  The causality between events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided; Sender's Comments:  US-009507513-2303USA004774:
4-5 days after first dose of Pfizer COVID19 vaccine developed circular erythematous rash over trunk and arms. Still persistent now 8-10 days later. Mild itching. No fever, chills, sweats, shortness of breath, wheezing.
I was itching pretty good and broke out in hives all over my body.  I started running fever and chills real bad.
"Covid Arm". Had severe swelling/edema and redness area on should under site of injection. Area hot to touch and painful and started a week after vaccination. Went to physician at prompt care and was instructed to take Claritin and Pepcid and acetaminophen. Raised area started to reduce in swelling fade after about 48 hours and fully resolved after about a week.
This case was reported by a nurse via call center representative and described the occurrence of jitteriness in a 27-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. Concurrent medical conditions included food allergy (allergy to sunflower oil/product).  On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season at an unknown dose. On an unknown date, 1 hr after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced jitteriness, heart pounding, feeling anxious and throat irritation. On an unknown date, the outcome of the jitteriness, heart pounding, feeling anxious and throat irritation were recovered/resolved. It was unknown if the reporter considered the jitteriness, heart pounding, feeling anxious and throat irritation to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The cae was reported by the nurse who was the patient. The patient received the vaccine in 2018. The patient was experiencing feelings of anxiousness, heart pounding, jitteriness and scratchy throat after 1 to 2 hours of vaccination. The patient took Benadryl shortly after noticing symptoms and reported relief within about 10 to 15 minutes. At the reporting time, all symptoms were resolved and no further details were reported regarding the event.
Injection given in AM at visit. Sometime in the PM she developed a Fever of 102, was given Tylenol. Temp did go down to 100, pt had chills, generalized weakness & unable to ambulate. Adm to Hosp with Dx of cellulitis RUE where vaccine was given. Tx with IV antibiotics
Pt recvd 3 doses of Engerix-B 3JAN91, 3FEB91 & 8JUL91 & it was determined that pt did not respond;
A large amount of swelling, redness and hot to touch where shot was given for about a week. Entire arm was sore. Much worse after second shot.
Hospitalized 05/09/2022-05/20/2022; COVID-19 positive 05/10/2022; fully vaccinated plus booster  Discharge Provider:  Primary Care Provider: MD Admission Date: 5/9/2022 Discharge Date: May 20, 2022 PRESENTING PROBLEM: COVID [U07.1] COVID-19 [U07.1]   HOSPITAL COURSE: The patient  is a 56 y.o. male with past medical history of of end-stage renal disease, bilateral AKA, spinal bifida status post VP shunt with paraplegia, colostomy, urostomy, history of aortic stenosis, ischemic cardiomyopathy who presented with a fall and was found to have sepsis 2/2 COVID infection. CTA thorax was performed which was negative for PE but did show bilateral patchy infiltrates consistent with COVID pneumonia.    He was noted to have an abnormal CTA thorax with findings of worsening right supraclavicular, mediastinal and hilar adenopathy. DDX includes pneumonia, congestive heart failure and chronic right brachiocephalic vein occlusion, lymphoma.  He was treated for COVID-19 pneumonia in addition to superimposed bacterial pneumonia and volume overload secondary to end-stage renal disease.  He was placed on ampicillin/sulbactam/azithromycin/dexamethasone.  His respiratory status improved to baseline oxygen support (CPAP at night).   Due to active covid, will recommend a follow-up CT chest with intravenous contrast in 1-2 months to document resolution of lymphadenopathy.  If it versus, that time then lymph node biopsy may be considered.   He was followed by Nephrology for routine hemodialysis.   Patient was discharged back to his facility in stable condition.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Additional Details: felt unwell, fell out of recovery chair and hit head. Patient monitored on floor with feet elevated until rescue came and took patient to ER and was monitored. Went home same day and returned to work the next day, feeling better
This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 21st June 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by the patient for himself/herself. The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked if he/she still could get the second shot even though it had been just beyond six months since the first one. The follow-up could not be possible as no contact details were available.
MYALGIAS, ARTHRALGIAS, FEVER, HEADACHE  Narrative:
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.