chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 62-year-old male patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced itchy rash, hives and erythematous rash. On an unknown date, the outcome of the itchy rash was not recovered/not resolved and the outcome of the hives and erythematous rash were unknown. The reporter considered the itchy rash to be related to SHINGRIX. It was unknown if the reporter considered the hives and erythematous rash to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX in the left arm. The patient experienced the rash on arms and legs. The patient described the rash as little red bumps that are itchy and could possibly be hives. The patient stated that the rash went away and came back and on morning of the reporting day, the rash was on both arms.
I contracted COVID-19 on 06/13/2022 with symptoms of headache, muscle aches, sore throat, low grade fever, and congestion. I was prescribed Paxlovid on 06/14/2022. I was ill for 4 days before my symptoms resolved. I did experience rebound COVID-19 that returned on 06/26/2022, and I was ill for 6 days before my symptoms resolved again. I am fully recovered now with no lingering symptoms.
Child had a syncope attack while receiving vaccines.  Hepatitis A,  Hepatitis B, Inactivated Polio, Influenza vaccine, HPV9,and  MMRV.  had been administered.  Tdap that was scheduled to be given had been drawn but could not be given as child had a reaction.   The episode lasted for about 2 minutes.   BP 86/54 P-62.  Benadryl 125mg/5ml   5mls po was given stat.  .  Child was kept in the clinic for observation for 2 hours.  Father was instructed to take the child to the ER   a letter to take to the ER  describing the incident was given to child's  father.  All information was given to  child's father in his native language using a interpreter.  Father voiced understanding of all information given.   Child was in stable condition when he left the clinic.  he was walking and denied any other problems.       On December 23rd 2020 the father was contacted  by telephone on  the contact number on file at the clinic .  The call was answered by the family friend  who took patient and his father to the ER the day of the incident.   Family Friend stated that the child was seen in the ER the same day of the incident, nothing abnormal was noted.  He  reported that the  child was sent home the same day with no further treatment.
I don't know if this qualifies as an adverse event, I contracted covid a couple weeks after my 4th booster.  that's it, nothing else to report.
Began itching on upper body.  Now with facial rash, especially on cheeks and forehead.  Hot, red, and itchy across forehead and cheeks.
THE PATIENT WAS GIB=VEN JANSSEN VACCINE.  HOWEVER, HE IS UNDER AGE
Slightly painful node/protrusion in front-left side of neck - above the clavicle. Nodule is tender to the touch and can be moved slightly.
This spontaneous report was received from a certified medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concomitant medication were not reported. On 02-Nov-2016 or 03-NOV-2016, the patients were vaccinated with a dose of improperly stored  PEDVAXHIB (dose, frequency, route of administration, lot# and expiration date were not reported). There was no adverse effect reported. The call was made due to digital data logger. The dose of the administered vaccine was exposed to temperature of 9.5 degrees Celsius for 28 hours. The vaccine was exposed to previous temperature excursion. There was no product quality complaint involved. This is one of several reports received from the same reported. Additional information has been requested.
rash the next day, 16Feb2021, where the vaccine was administered; itchy; This is a spontaneous report from a contactable consumer or other non HCP. This consumer reported for a patient (wife).   A 72-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6201, Expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 15Feb2021 at 13:20 (at the age of 72-years-old) as a DOSE 1, SINGLE for covid-19 immunization. The patient medical history included ongoing parkinson's disease. Concomitant medications reported as none. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) were none. Prior Vaccinations within 4 weeks were None. events following prior vaccinations was reported as, she usually gets a rash following vaccinations where she gets the rash. It usually goes away as it is one of the side effects. On 16Feb2021, 10 hrs 40 min, the patient experienced rash the next day, 16Feb2021, where the vaccine was administered and itchy. he reported that she had the vaccine on 15Feb2021, and she had a reaction after the vaccine. she had a rash the next day, 16Feb2021, where the vaccine was administered it seems to be getting better, but it was still itchy. she did not have a reaction right away (date unspecified). Patient had Parkinson's and wanted to know if she could put a cream on there or what. It was reported that, the rash looks like a little light red, not as red now as it was. the caller said that his wife has Parkinson's and said that she takes a lot of different medications when queried. The reporter said that was covering her upper arm where she got the vaccination. The reporter clarified that the rash is on his wife's right arm. next vaccination was planned on 08Mar2021. family Medical History relevant to AE was none. relevant tests done were None. Events did not require a visit to, emergency Room or Physician Office. Outcome of both the events were recovering.  Follow-up attempts completed. No further information expected
Bruising on legs; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Oct2021 (Lot number: FF2589) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Low Potassium" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Cipro, reaction(s): "Allergy: Cipro". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: UJ724AA, Location of injection: Arm Left), administration date: 02Oct2021, when the patient was 35 years old, for Covid-19 Immunization. The following information was reported: CONTUSION (non-serious) with onset 15Nov2021, outcome "recovered" (2021), described as "Bruising on legs". It was unknown if therapeutic measures were taken as a result of contusion. Additional information: The patient not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19.  No follow-up at tempts are possible. No further information is expected.
Pt noted redness at injection site - L upper triceps area - size of baseball on 7/1/10 - eve and had low-grade fever, and 7/3/10 - eve had 103 degree temp and outer L arm redness extended to elbow - with swelling and "hot to touch, painful on 7-4-10 went to ER and was admitted to hospital.
Administered 3 vaccines on 3/7/23.  Client reports feeling extreme pain in left upper arm on 3/11/23 beginning in AM and getting "better" throughout the day; on 3/14/23 extreme pain returned in AM and continued getting worse throughout day until client went to ER on morning of 3/15/23.  ER MD took X-rays told client it was Bursitis; gave client pain medications and steroids.  Client told to wear affected (left) arm in sling until pain subsides.  Called client on 3/16/23; client states left upper arm tender to touch, wearing arm in sling, and on pain medications/steroids.  As of phone conversation with client on 3/16/23 client still having pain in affected limb.
Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium, Additional Details: 10:28 - Following administration of vaccine, patient while still sitting in the chair had an episode of syncope with seizure-like activities  which lasted for 10 secs. 10:30 - Patient regained consciousness at which point EMS was activated and call placed to patient's mother to notify her of the situation. Serial vital signs done with HR noted to be in the low 30's to 40's. (See vital sign documentation). Patient admitted to having a cardiac defect-Bicupsid Aortic. recovered,EMS released home
Vaccination was on Sunday 10-23-2005 at approx 4:00pm.  At approximately 1:00am 10-24-2005 patient was experencing high fever, chills and shaking, slight headache.  Advil reduced fever and seemed to calm the shaking.  Patient visited family physician as a precaution. If fever doesn't go away after 24 hours doctor instructed the patient to get a chest x-ray and blood work.
Dose 1 administered on 8-Mar-2021 and dose 2 administered on 21-Nov-2021 that is after 258 days.; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 8-Mar-2021 and dose 2 administered on 21-Nov-2021 that is after 258 days.) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B and 1805031) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 8-Mar-2021 and dose 2 administered on 21-Nov-2021 that is after 258 days.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 8-Mar-2021 and dose 2 administered on 21-Nov-2021 that is after 258 days.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was provided.   This case was linked to MOD-2022-592920 (Patient Link).
Left arm area of MMR injection, red, swollen, warm to touch. Atarax syrup ordered per CNP.
Patient was in school and developed tenderness, redness and swelling of L arm at injection site. Was iced at school and swelling decreased leaving an area of redness, induration and tenderness of 3 cm diameter around injection site when seen by MD at 4PM Area examined by MD and patient encouraged to keep icing area and started on Benadryl for swelling and skin reaction as well as ibuprofen for pain.
p/vax pt devel chickenpox w/12 small, sl pimply lesions & no rash involved;8/21/98 4 to 5 more lesions were noted;pt seen by MD who dx chickenpox modified by varicella vax;
Pronounced edema at and around injection site. Edema extended down arm nearly to elbow. No fever, nausea, vomiting or systemic symptoms.
I was given the 3 series GARDASIL Vaccines as directed by my MD and was diagnosed w/the HPV virus - CIN Grades 1 & 2, VaIN 1 and/or 2 -. I do understand it may not cover all forms of the virus, but I think it is important for the FDA to know that in spite of women being given the vaccine series they are being diagnosed w/the virus.
I feel like I"m getting a cold after first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (I feel like I"m getting a cold after first dose) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (I feel like I"m getting a cold after first dose). At the time of the report, NASOPHARYNGITIS (I feel like I"m getting a cold after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment medication information were not provided.
5/15/2021, 10:45 am-Twinge in left side of neck muscle; 1:30 pm-mild headache, lower back pain left side only; 3:30 pm-plantar fasciitis pain left foot only; 5:39 pm- mild body aches left side only; overnight during sleep-moderate body aches entire body. 5/16/2021- woke up with severe headache, moderate body aches whole body, mild chills whole body; plantar fasciitis pain left foot only continued; 1:30 pm-fever 100.2; mild to moderate nausea througout rest of day;these symptoms continued for about 24 hours. 5/17/2021- previous days symptoms subsided late morning; 11:00 am-feel like left collar bruised; 4:00 pm-discover lump left side of neck above collar bone.  5/18/2021-Wake up with moderate headache and nausea which supplies by late morning. Lamp on left side of neck by collarbone still there.  5/19/2021-lump on left side of neck still there; pain underneath left arm,.  5/20/2021-lump on left side of neck still there; pain underneath left arm, tweaking pain inside left thigh, left armpit near lymph node occasional pain and tender.  5/22/2021-woke up to severe headache and nausea which subsided by noontime. L ump on left side of neck still there.
Patient reported a persistent pain in upper arm ever since FLUZONE Hi Dose was administered on 10/30/17. Patient says dose may have been administered "too high" on arm and is concerned about possible damage to arm joint.
Pt in office around 3:30pm. Right arm developed a baseball size area that was red, swollen, and painful. Decreased range of motion in right arm. No fever. Pt given Motrin, Benadryl, and Augmentin for cellulitis.
On 1/22/02, the vaccinee received his first injection of LYMErix. Later that day, an unspecified time post-vax, he experienced hives. He sought medical attention; treatment of the event was not specified. The hives resolved on 1/23/02, 10 hrs after onset. Medical history, concurrent conditions, and concurrent medications were not provided.
pt came in for her second dose of Pfizer and received Moderna. She has not reported any adverse reactions yet.  This report is for reference only.
inadvertently gave patient Dtap instead of Tdap on 01/03/2023 at approximately 11:30am.
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild
First pins & needles in both hands & fingers. Then numbness in both hands and fingers. It?s worse in my left hand and my left pinky & ring finger then in my other fingers. It?s almost September and the numbness is still there
Lightheaded, tunnel vision, then syncopal episode. Vasovagal reaction, monitored for 30 mins, offered PO fluids, released with BP and symptoms improved.
lethargy 25JUN photophobia 26JUN; sore throat, low grade fever, blotchy rash began 27JUN; h/a, lymphadenopathy; arthralgias 28JUN, 29JUN;
pain in my left arm lasting for about 24 hours; After Vaccine #2 also experienced flu/cold-like symptoms; Body aches/pain; sneezing; running/stuffy nose; running/stuffy nose; This is a spontaneous report from a contactable consumer (patient).  A 45-year-old male patient received bnt162b2  (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in arm left on 10May2021 11:30 (Lot Number: EW0173) at age of 45-year-old at single dose for COVID-19 immunization at facility of Health Clinic. Medical history included multiple Chemical Sensitivities, polyneuropathy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine or any other medications the patient received within 2 weeks of vaccination. The patient previously took first dose of bnt162b2 (Lot number: EW0161) on 19Apr2021 18:30 in left arm and experienced pain in left arm and lasting for about 24 hours. After second dose, the patient experienced pain in his left arm, flu/cold-like symptoms , body aches/pain, sneezing, running/stuffy nose, all on 10May2021 23:00. The events were serious for disability. There was no treatment for the events. Body aches slowly started to disappear on 11May2021. Other symptoms lessened over the course of next 10 days but never really gone away. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the body aches/pain was resolved on 11May2021, the rest events was resolving.
Case number PHEH2014US003801, is an initial spontaneous report from a pharmacist received on 21 FEB 2014. This report refers to a 14-year-old female patient. Past medical history and concomitant medications were not reported. She was inadvertently vaccinated with FLUCELVAX 2013/2014 (batch number: 006031A) at a dose of 0.5 ml intramuscularly on 08 JAN 2014. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
DRAINS IN SINUS; STUFFY NOSE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808982, expiry: 21-SEP-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced drains in sinus, and stuffy nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stuffy nose, and the outcome of drains in sinus was not reported. This report was non-serious. This case, from the same reporter is linked to 20220201810.
I lost my smell for several days like I did when I had covid 19 several months back. However when I had Covid, I regained my sense of smell. I have yet to fully regain my sense of smell from the Covid; This is a spontaneous report from a contactable consumer. A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered on the left arm, on 05Apr2021 11:00 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included allergy to shellfish from an unknown date and unknown if ongoing. Concomitant medications included cetirizine hydrochloride (ZIRTEC) and spironolactone (SPIRONOLACTONE); both taken for an unspecified indication, start and stop date were not reported. The patient previously took cephalosporin nos and experienced drug hypersensitivity. On 06Apr2021, the patient stated, "I lost my smell for several days like I did when I had covid 19 several months back. However when I had Covid, I regained my sense of smell. I have yet to fully regain my sense of smell from the Covid 19 vaccine. I can smell most things now, but stronger smells just smell like bleach still after 2 months". The event resulted in disability or permanent damage. The outcome of the event was recovered with sequelae.  Information about lot and batch number has been requested.
I experience pain in my left leg  I also had fever and was in bed all day .On 04/11/2021 called my Dr. and he informed me to take IB profrin. Pain in my leg was completely gone in 10 days.
18 year old male patient was administered an expired dose of Menactra, no AE; Initial information received on 06-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 year old male patient who was vaccinated with an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B (MENINGOCOCCAL VACCINE B) for Immunisation.  On 05-Oct-2020, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6365AA and expiry date: 24-Sep-2020) via an intramuscular route in the right arm for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
Full body/muscle aches, headache, nausea, fatigue, generalized weakness, dizziness, tiredness (distinct from fatigue), injection site pain, chills AND overheating, polydipsia, and joint pain.
This spontaneous report has been received from a Certified Medical Assistant (C.M.A.) referring to unspecified patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB, (lot #, strength, route of administration and dose were not provided). No adverse experiences were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.