chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalized (05/17/2022-05/19/2022); COVID-19 positive (05/17/2022); fully vaccinated plus booster  HOSPITAL COURSE: this is a very pleasant 88-year-old lady with past medical history as listed who presents to the ER from her nursing facility with concerns of hypoxia.  Patient states that she does not know why they brought her to the emergency department.  Patient states that she has tested positive for bad yesterday.  Patient is vaccinated and blistered.  Patient denies any fever chills sweats.  Patient has some nausea but denies any vomiting diarrhea.  Patient does have a dry cough.  Patient denies any chest pain or shortness of breath.  Patient was confirmed to have COVID-19.  Her sodium level was low and she was started on IV fluid hydration for dehydration.  On her right wrist assessment patient had very dry mucous membranes.  Per nursing and EMS patient was not hypoxic however they are having a hard time getting a good plaque.     Patient did well during her hospital course.  She did not require supplemental oxygen.  She was hydrated and was anxious to go back to her facility.  Patient will need repeat basic metabolic profile to monitor her sodium and renal function as well as a complete metabolic profile to monitor her white count.   1. Hyponatremia Secondary to dehydration.  Patient was adequately hydrated.  Repeat BMP at facility 2. COVID-19 Patient is vaccinated and boosted.  Will hold off on dexamethasone as it is not clear if patient was actually hypoxic and there could be an interaction with her medications.  Patient has not required supplemental oxygen. 3. Hypoxic Uncertain if event occurred.  Patient has not been hypoxic for EMS nursing or required supplemental oxygen. 4. Chronic kidney disease stage 3 Monitor renal function.  Avoid nephrotoxins.  Appears around baseline  5. Leukopenia Likely secondary to her meds related to multiple myeloma as well as her underlying infection.  Patient showed follow-up with her oncologist and have a complete blood count drawn at the facility to determine further workup 6. Pneumonia There was a question if patient had underlying bacterial pneumonia.  Patient will be discharged with Ceftin for 5 days.
In the afternoon of 02-21-2021, I began experiencing the following symptoms:  redness around the injection site, a swollen area about the size of my hand, warmth,  and itching.
Day 8 post Moderna 1st dose vaccination to my left arm: Pain in left axilla occured last night at about 6 pm, day 7 post vaccination. Today woke up with a large (about 4 cm in diameter), hard  painful lump under my left armpit (left axilla) , Difficult to hold my left arm down due to the lump (the lump is feeling like a bit smaller than a golf ball but as hard, mobile and moves deep inside tissue from side to side as a ligament) , it interferes with the left arm motion and making it uncomfortable to hold it in a neutral position down. Dull pain 2/10, no local temerature increase, Entire left axilla looks swelling comparing to the right side.
Information has been received from a physician via field representative referring to an unspecified number of patients of unknown demographics. Relevant medical history, concurrent conditions and drug reactions/allergies of these patients were not provided. Since an unknown date these patients were vaccinated with GARDASIL (strength, dose, frequency unspecified). Concomitant medications were not provided. Reporting physician noticed that the patients passed out due to syncope on unspecified dates after vaccine administration. Outcome of the event, syncope was unknown. Reporting physician did not assess the causality of the event with respect to vaccination with GARDASIL. Additional information is not expected as the reporter did not wish further contact.
Date on the vial was exp 17-May-2022; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Date on the vial was exp 17-May-2022) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Date on the vial was exp 17-May-2022). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Date on the vial was exp 17-May-2022) outcome was unknown.            No concomitant medications were reported. The reporter mother had the booster but the date on the vial was expiry of 17-May-2022 and reporter further asked should this have been used and was worried. No treatment medications were reported.
Patient received 2nd dose of Moderna vaccine on 2/26/2021 at 1630  Today she woke up 2/27/2021 feeling okay initially.  At 1145 she developed a shaking chill.  At 1215 she suddenly became short of breath.  Her husband called 911; EMS arrival room air oxygen saturation in the 80s, placed on CPAP.  Patient found to have lowgrade fever.   (Patient does have a history of OSA and CHF)
Suspected vaccination failure; Shingles bad; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles bad).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2023. This case was reported by a patient via interactive digital media. The patient stated that that was Shingles vaccine they gave me and had a shingles so bad that patient went to emergency room department. The follow-up could not be possible as no contact details were available.
diarrhea, vomiting, shivering, head-spinning & dizziness, weakness
Patient reports she did not experience any symptoms the day of the vaccination. Patient reports on Saturday she noticed the injection site became red, itchy, and puffy. Patient reports she has been scratching the area due to the area being itchy. Patient reports the puffiness has resolved but the redness did enlarge in size. Patient has not tried any OTC treatment for the redness or itching. Patient denies rash on any other part of her body.
Within four hours my tongue became numb like when you burn it from coffee; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Within four hours my tongue became numb like when you burn it from coffee) 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 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPOAESTHESIA ORAL (Within four hours my tongue became numb like when you burn it from coffee). At the time of the report, HYPOAESTHESIA ORAL (Within four hours my tongue became numb like when you burn it from coffee) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided   Reporter did not allow further contact
Three hours after the vaccine, I experienced a large facial hive on each cheek. At about 9 PM, I experienced shivering and could not get warm. I also felt achy.
It started on Feb 26th 2023 the symptoms started. It felt like a bad cold. Cough, congestion, headache, fatigue. But as the day progressed so did the symptoms. They got stronger and the chills began and fever. I slept very poorly that night and by the next morning I tested at home and it was positive. I contacted my doctor and I was given PAXLOVID. I started the dose the day after and within the next few days the symptoms improved each day. By March 4th, I had taken the last dose of PAXLOVID in the morning and I was feeling pretty much better and tested again on March 6th and the test showed negative. 2 days later the symptoms started again and so I retested and tested positive. This time I had all the symptoms but also had a loss of taste which was not originally one of my symptoms. On March 11th and 12th, I have slightly less appetite and fatigue. I am currently still testing positive and I am taking ibuprofen to help with my aches.
Chest pain, shortness of breath, fever, chills, headache, body aches, canker sores, and exhaustion within 12 hours of short. Within 24 hours, spotting, continued fever, body aches, sore throat and sinus congestion. Exhaustion, chills, canker sores and sinus pain have continued. Bruising and sore arm
PT IS 18 YRS OLD AND WAS GIVEN ADULT DOSE OF HAVRIX INSTEAD OF PEDIATRIC DOSE.  NO ADVERSE EFFECTS REPORTED.
He woke up, irritable, sweaty with a fever of 103.5 and abdominal pain.  He did not sleep that night until about 9 am the next day. He continues to have fever.  During the first two days, he would grunt slightly while breathing.  When he sleeps, he sleeps on his stomach with his legs pulled up under him, including tonight.  Prior to this incident, he would sleep on his back.  We have been treating him with fever reducers as necessary.  We went to the emergency room Sunday where they did not find any sign of infection.  He was constipated and was given glycerin suppositories which caused him to have a large bowel movement.  He was prescribed glycerin suppositories and Miralax for the next few days.  Since the onset of the fever, he has eaten almost nothing.  He does drink milk and fluids.
Bullous pemphigoid; This literature-non-study case was reported in a literature article and describes the occurrence of PEMPHIGOID (Bullous pemphigoid) in a 73-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.       No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PEMPHIGOID (Bullous pemphigoid) (seriousness criterion medically significant). At the time of the report, PEMPHIGOID (Bullous pemphigoid) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered PEMPHIGOID (Bullous pemphigoid) to be related.    No concomitant and treatment medications were reported. Company comment:  This literature-non-study case concerns a 73-year-old female patient, with no reported medical history, who experienced the unexpected serious (medically significant) event of PEMPHIGOID (reported as Bullous pemphigoid), which occurred after receiving the second dose of mRNA-1273 vaccine. Latency cannot be assessed, as vaccination date was not reported. No further information was disclosed to this date. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This literature-non-study case concerns a 73-year-old female patient, with no reported medical history, who experienced the unexpected serious (medically significant) event of PEMPHIGOID (reported as Bullous pemphigoid), which occurred after receiving the second dose of mRNA-1273 vaccine. Latency cannot be assessed, as vaccination date was not reported. No further information was disclosed to this date. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Alopecia Areata-significant hair loss in the month following the vaccine; Alopecia Areata-significant hair loss in the month following the vaccine; prev dose administration date 06Oct2021, prev dose dose number 1, Most recent dose: administration date 20Oct2021,dose number 2; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Oct2021 (Batch/Lot number: unknown) at the age of 12 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Pennicilin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 06Oct2021, when the patient was 12 years old, for COVID-19 immunization. The following information was reported: ALOPECIA AREATA (non-serious), ALOPECIA (non-serious) all with onset 17Nov2021, outcome "not recovered" and all described as "Alopecia Areata-significant hair loss in the month following the vaccine"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 20Oct2021, outcome "unknown", described as "prev dose administration date 06Oct2021, prev dose dose number 1, Most recent dose: administration date 20Oct2021,dose number 2". The event "alopecia areata-significant hair loss in the month following the vaccine" and "alopecia areata-significant hair loss in the month following the vaccine" was evaluated at the physician office visit. Therapeutic measures were taken as a result of alopecia areata, alopecia.  Additional information: the patient received treatment for the adverse event which included Steroid injections into scalp. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccination site rash; Vaccination site pruritus; Vaccination site rash; Vaccination site pruritus; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of VACCINATION SITE RASH (Vaccination site rash), the second episode of VACCINATION SITE RASH (Vaccination site rash), the first episode of VACCINATION SITE PRURITUS (Vaccination site pruritus) and the second episode of VACCINATION SITE PRURITUS (Vaccination site pruritus) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 044A21A) for COVID-19 vaccination.     no specified medical history was reported.  The patient's past medical history included Hives. Concurrent medical conditions included Chronic pain (back and leg pain) since 1989, Drug allergy (Augmentin), Drug allergy (Biaxin), Drug allergy (some anesthetics used for surgery), Drug allergy (Naperson), Dug allergy (Ibuprofen), Drug allergy (Indocin), Drug allergy (Feldene,), Hypersensitivity, Asthma and Hay fever. Concomitant products included OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]), GABAPENTIN, CETIRIZINE HYDROCHLORIDE (ZYRTEC R), ESTRADIOL (ESTROGEL), HCTZ, VITAMIN E NOS, FISH OIL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ATORVASTATIN, MAGNESIUM, BIOTIN and SALBUTAMOL (PROVENTIL [SALBUTAMOL]) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021 at 11:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 13-Feb-2021, the patient experienced the first episode of VACCINATION SITE RASH (Vaccination site rash) and the first episode of VACCINATION SITE PRURITUS (Vaccination site pruritus). On 15-Feb-2021, the patient experienced the second episode of VACCINATION SITE PRURITUS (Vaccination site pruritus). On 19-Feb-2021, the patient experienced the second episode of VACCINATION SITE RASH (Vaccination site rash). On 15-Feb-2021, last episode of VACCINATION SITE PRURITUS (Vaccination site pruritus) had resolved. At the time of the report, last episode of VACCINATION SITE RASH (Vaccination site rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient also uses unspecified fiber pill  as a  concomitant medication.  No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up received on 21-JUN-2021. Patient history added, concomitant medication information added.
Pt complained of limited R arm pain; fatigue, knees achy, poor sleep, feels body aches especially around joints back and neck. Vaccination site 0.5cm pustule with ? erythema.  Vioxx 50mg QD; tylenol; quarters X 48hrs.
Local site reaction. Redness 3 inch in diameter, slight firm centrally.  Nontender. Benadryl given every six hours for 48 hours.
the day after the shot i experienced fatigue, nausea, chills, and that evening another bout of Covid toes the following day felt much better
On 9/12/16 was given flu shot in my left arm at clinic during employee event. My arm had a big red inflammation around the site for over a month. It was also painful to touch. Also immediately, I was unable to use my left arm to put my seatbelt on in the car or use my usual arm exercises at the gym. Saw PCP on 1/13/17 and treated with steroids with temporary improvement. Continued to have intermittent pain that has worsened and is now affecting activities of daily living.
complete hearing loss in her right ear; This is a spontaneous report from a Pfizer-sponsored program. A contactable 77-year-old female consumer (patient) reported that she received second dose of bnt162b2 (COVID 19 Vaccine, mRNA, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included clopidogrel bisulfate (PLAVIX) and aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) for blood thinners (when she received the vaccine). Other concomitant medication included adalimumab (HUMIRA) taken for an unspecified indication, start and stop date were not reported. The patient was previously received as first dose of bnt162b2 (COVID 19 Vaccine, mRNA, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. She received both doses of COMIRNATY. After receiving her second dose at 10 AM, caller stated that, on an unspecified date, she had complete hearing loss in her right ear at 8 PM the same day. The event was serious (medically significant). Caller sought information on this side effect with COMIRNATY vaccine. Caller stated that she did not blame Pfizer, but she wished there was information out there whether or not she should take the booster dose. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Bumps on tongue; Body rash; Feeling bad and lethargic; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Feeling bad and lethargic), TONGUE DISORDER (Bumps on tongue) and RASH (Body rash) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravascular) 1 dosage form. On 20-Mar-2021, the patient experienced LETHARGY (Feeling bad and lethargic). On 21-Mar-2021, the patient experienced TONGUE DISORDER (Bumps on tongue) and RASH (Body rash). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 21-Mar-2021, LETHARGY (Feeling bad and lethargic) had resolved. At the time of the report, TONGUE DISORDER (Bumps on tongue) and RASH (Body rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intravascular) was unknown.       No relevant concomitant medication provided by Reporter.
Pt called saying she has a rash today (10/6) and was given a flu shot for the first time on 10/5. Pt asked if she had come into contact with plants/food/animals to cause allergy, she did not think so. Pt says not allergic to eggs. Pt told to take BENADRYL right away and if rash progresses or any rxn worsens to call Dr or go to ER.
a patient received a second dose of FLUZONE HD/ his first dose was administered one week ago and the patient received a second dose today; Initial information regarding an unsolicited valid non-serious case was received from a nurse via agency (Reference number- 00331139) and transmitted to Sanofi on 26-Oct-2020.  This case involves an 80-year-old male patient who was vaccinated with QUADRIVALENT INFLUENZA VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (suspension for injection), (batch number: UJ468AA and expiry date: 30-Jun-2021), (on right deltoid via intramuscular route the vaccine was administered) (Inappropriate schedule of product administration) on 26-Oct-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medication of the patient was not reported.  It was an actual medication error case due to inappropriate schedule of vaccine administered (latency: same day). His first dose of the vaccine was administered one week ago and the patient received a second dose today.  At the time of reporting, 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.  There will be no information available on the batch number for this case.
Hives on abdomen, arm, back the next morning. Lasted 24-36 hours. Hives resolved completely.
STARTED HAVING CHILLS AND ACHY WHICH SHE ATTRIBUTED TO THE AFLURIA SHOT ON THE MORNING OF 12/11/14, BUT THE REDNESS, SWELLING, AND WARM TO THE TOUCH ON HER RIGHT ARM DID NOT START UNTIL NOON OF 12/11/2014 AND HAS GOTTEN WORST TODAY 12/12/2014.
Soreness, redness, some swelling shot was given. The day (after), could not raise arm w/ shot and once my head or from left to right w/ pain (2) days. Also fatigue. On and off w/ hot and cold packs.
Gave MMRV proquad to PT which is not indicated for under 4 years old.
Pt had some typical viral symptoms for 2-3 days after vaccination and on day 7 starting having shortness of breath this worsenened until day on presentation to ED D Dimer was 5 and then multiple segmental pulmonary emboli were identified. Pt was started on therapeutic lovenox and transitioned to apixaban on discharge a hypercoaguable work-up is pending, but there is no family or personal history of clotting no trauma, infection, or other cause for PE.
Red rash at shot site, swollen and hard, itchy, pain on touch. Approximately 2 inches diameter. Back muscles ache. Chills.