chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received an expired dose of Flublok Quadrivalent/ No AE; Initial information received on 08-Jun-2021 regarding an unsolicited valid non-serious case received from nurse via call center via Medical Information (Reference number- 00632994).  This case involves a patient of (unknown demographics) who was vaccinated with an expired dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was an actual medication error case due to expired vaccine used (latency: same day).  Potential Product Technique Complain: Nurse asked that if this was counted as a valid dose and if there are adverse reactions they should look out for. The nurse said she will ask her manager. She said her manager did not answer her and she preferred not to provide the information. Opening hours: 8 am to 6 pm from Monday to Wednesday; 8 am to 8 pm on Thursday and 8 am to 5 pm on Friday.  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.
On approximately 02/26/2001, post vax, the patient broke out "with a full rash of over 150 lesions. the patient's mother reported that the patient's sibling had broken out approximately 2 weeks ago. The patient did not seek medical attention.
Headache, Myalgia, Fever & CoughWheeze Narrative:  Employee took cough medications. (Robitussin, Day Quill)
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 32-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 4 (booter), single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "bipolar II" (unspecified if ongoing). No Known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment Paxlovid from 08Mar2023 to 12Mar2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Caller reported no additional AE/PQC at time of call; an expired dose of MMRlI was administered to a patient; This spontaneous report was received from a registered nurse and refers to a 18-month-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 18-MAY-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 0.5 milliliter (lot # S013719, expiration date 05-MAY-2021), (route of administration, was not reported) for prophylaxis. The vaccine had no known temperature excursions. The patient experienced no adverse event.
hospitalized with viral meningitis; Headaches; fever; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 24Jan2021 at 12:15 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The patient experienced headaches and fever on 26Jan2021. The patient experienced viral meningitis on 01Feb2021 and was hospitalized with viral meningitis. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment was received for the adverse events. The no days of hospitalization was 8. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
pt recv half dose of vax 23JUN98 because pt has a hx of tetanus rxn as a child;1wk later pt devel muscle/spasms/fasciculations;pt also exp muscle cramping which eventually was found to be r/t a drug unspecified for asthma;
SLIGHTLY ELEVATED BLOOD PRESSURE; COULD FEEL BODY FIGHTING VACCINE; RAPID HEART BEAT; IRREGULAR HEART BEAT EVERY ONCE IN A WHILE; This spontaneous report received from a patient concerned a 63 year old male. The patient's weight was 210 pounds, and height was 187 centimeters. The patient's concurrent conditions included: asthma, non smoker, dust allergy, and alcohol user, and other pre-existing medical conditions included: Patient was on prostate medication slowmax exercises every week. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included budesonide for asthma, and salbutamol for asthma. On APR-2021, the patient experienced irregular heart beat every once in a while. On 12-APR-2021, the patient experienced rapid heart beat, and could feel body fighting vaccine. On 13-APR-2021, the patient experienced slightly elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) Little high, and Heart rate (NR: not provided) little high. Laboratory data (dates unspecified) included: Cardiac monitoring (NR: not provided) Data inconclusive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heart beat on 14-APR-2021, had not recovered from irregular heart beat every once in a while, and the outcome of could feel body fighting vaccine and slightly elevated blood pressure was not reported. This report was non-serious.
pt recv vax in AM later in afternoon pt exp a rash around site of inj;around 8PM sx included moderate to severe h/a, itch all over feeling hot all over w/redness of the ears;gen urticaria-urticaria allergies;
Pt reported today 1/21/15- she states that she noticed the redness on 1/17/15.  No other symptoms reported.  She said she's fine.
Narrative: 12/15/22 - Pt with a medical history of hyperlipidemia, history of TIA, spinal stenosis, suspected GCA (negative biopsy, on steroids), plantar fascial fibromatosis, tobacco abuse who presents to the ED complaining of increased fatigue, weakness x 1 week, decline in appetite, and purulent draining hand wound. Chills noted today. Pt also reports left sided chest pain. Wife noted Pt had acute onset of congestion, he is pale, and not performing his ADLs as usual (onset within past 24hrs). Pt tested COVID+ and was admitted to hospital 12/15/22 (with discharge on 12/29/22). PRINCIPAL DIAGNOSIS (Reason for admission after study): covid 19 with hypoxia ADDITIONAL DIAGNOSES: dementia ,chronic benign prostatic hypertrophy hyperlipidemia mild normocytic anemia mild hyponatremia hard of hearing. HOSPITAL COURSE: Pt admitted to the floor. dx covid with hypoxia. pt started on steroids. cont supplemental oxygen. pt monitored. did not need oxygen the next day. pt hearing aids and glasses at home. PT eval done and recs were 24/7 care at home. wife currently on chemo and unable to provide this. ppd placed. pt started on remdesivir by pharm d on 12/22. pt also restarted on steroids. pt completed 3 days of remdesivir and 7 days of dexamethasone. pt tolerated medications. pt communication improved with use of amplifyer. pt completed 10 days of isolation. sws working on STR for pt. due to abnormal imaging pulm consulted - will try wixella and triotropium due concern for underlying pulm ds. pt stable for discharged 12/29/22.
my arm at the injection site swelled up; the lymph nodes of my neck are swollen; dizzy; trouble standing up; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (my arm at the injection site swelled up), LYMPHADENOPATHY (the lymph nodes of my neck are swollen), DIZZINESS (dizzy) and MOVEMENT DISORDER (trouble standing up) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE SWELLING (my arm at the injection site swelled up), LYMPHADENOPATHY (the lymph nodes of my neck are swollen), DIZZINESS (dizzy) and MOVEMENT DISORDER (trouble standing up). At the time of the report, VACCINATION SITE SWELLING (my arm at the injection site swelled up), LYMPHADENOPATHY (the lymph nodes of my neck are swollen), DIZZINESS (dizzy) and MOVEMENT DISORDER (trouble standing up) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include High blood pressure medication, Nerve pain medication, Depression medication and Thyroid medication.  No treatment medications were reported.
Vaccine lot # had been extended and had remained frozen until date of administration.  Was given 2 days post expiration date. Moderna consulted and they deemed the vaccine still viable so revaccination was not required.  Patient did not report any adverse side effects.
Pt recvd Hep B vax 2AUG91 & on 16AUG91 exp sharp bilateral pain in joints of hands & fingers; pain persisted for a few days; later recovered;
After waking up abruptly early in morning with a fever, afterward in the the morning, I did wake up with a migraine and sharp chest pain. I did then end up going to ER right after waking up. At the ER they did hook me up to various monitors, they did state that I was dehydrated and the ER physician stated that I may have Myocarditis that had occurred. They did prescribe me both ibuprofen extra strength and another prescription to help with stomach acid issues. I did not have any more episodes afterwards. Every once in a while I did have some chest pain however, nowhere near the amount of pain as the first day.
Vomiting; Diarrhea; Rash that started at her elbow and extended to just below the injection site; Tiredness; Pain in injection arm that went from elbow to her neck; Pain in injection arm that went from elbow to her neck; Pain in injection arm that went from elbow to her neck; This case was reported by a pharmacist via call center representative and described the occurrence of vomiting in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 49n3s, expiry date 24th August 2023) for prophylaxis.   On 6th July 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th July 2022, several hours after receiving Shingrix, the patient experienced vomiting, diarrhea, rash, tiredness, neck pain, pain in elbow and pain in arm. On an unknown date, the outcome of the vomiting, diarrhea, tiredness, neck pain, pain in elbow and pain in arm were recovered/resolved and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the vomiting, diarrhea, rash, tiredness, neck pain, pain in elbow and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 11-Jul-2022 Reporter's Comments: The patient received Shingrix vaccine in left arm. The patient stated that several hours after getting the vaccine, the patient started with vomiting, diarrhea, and tiredness. These symptoms had been resolved. The patient also reported that she had pain in the injection arm that went from elbow to her neck and a rash that started at her elbow and extended to just below the injection site. The pain had subsided, but the rash was still there. The consent to follow up was given.
eye balls have swelled, they were hard and large; eye balls have swelled, they were hard and large; eye ball seemed to have taken excessive light; had a sight headache; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 29Mar2021 (Lot number: P217012) at the age of 74 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "cataract" (unspecified if ongoing); "macular degeneration" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162B2 (dose 1, manufacturer unknown), for COVID-19 immunisation. The following information was reported: EYE SWELLING (non-serious), EYE DISORDER (non-serious) all with onset 30Mar2021, outcome "recovering" and all described as "eye balls have swelled, they were hard and large"; PHOTOPHOBIA (non-serious) with onset 30Mar2021, outcome "recovering", described as "eye ball seemed to have taken excessive light"; HEADACHE (non-serious) with onset 30Mar2021, outcome "recovering", described as "had a sight headache". Therapeutic measures were taken as a result of eye swelling, eye disorder, photophobia, headache.  Additional information: The reporter stated she could not read the lot number. She stated "P and it looks like P217012." The patient have taken diphenhydramine hydrochloride (BENADRYL) 25 mg 2 tablets and aspirin for the events. One of her eye ball seemed to have taken excessive light so she put a patch over her eye.  No follow-up attempts are possible. No further information is expected.
After taking the 4th Typhoid capsule I had severe abdominal pain all night and diarrhea all nest morning. (the first 23 capsule did not react).
2 months after 2nd covid vaccine, developed sudden onset atrial fibrillation.  unclear what triggered this in otherwise fairly healthy 1 yr old. wanted to report it just in case it was a possible late effect of the covid vaccine.
7/25/2021: Patient is a 58 year old female who presented to the ED with acute onset shortness of breath which started a couple days prior to admission. She tested positive for COVID-19 on 07/23/2021.  Patient was found with an SpO2 of 79% on room air at which point she was transitioned to heated high-flow but ultimately required BiPAP to maintain saturation greater than 92% and was transferred to the ICU for further care. Diagnosed with acute hypoxic resp failure, COVID19 pneumonia. Note: was previously vaccinated with COVID-19 J&J vaccine on 4/7/21. 7/30/21: patient is still admitted at the time of this form submission.
pt recv vax & devel inj site rxn characterized by swelling & induration;pt also exp ecchymosis @ the inj site (3 x 5 area);pt was recovered as of the date of this report;
Patient: "I feel warm and clammy" BP 102/67 HR 66; Observed for 45 minutes.
Chest pain and pressure, elevated resting heart rate (increase from around 80 to 95 bpm)  Only reporting this because all the literature seemed to only discuss elevated heart rate in the context of an immediate anaphylactic reaction
72 year old female complained of fatigue, general myalgia, arthralgia and fever day after she received pneumovax. CPK was elevated at 1244, C3 mildly high, C4 normal. Zocor was stopped which she had been taking for one year. CPU levels returned back to normal within 1 week. But she continues to spike fever, developed proximal muscle weakness in external HCl, EIR 108 mm/hr and higher, muscle biopsy suggestive of medium vs vasculitis. ANCA was fine.
Pt called on PM shift approximately 6 hr after TDaP vaccine. pt called to complain of (R) arm swelling and "dot". No SOB. Inst. to go to ER. Went to MD dx petechia.
12 hours after the booster, I experienced chills and fever. The next day in the afternoon the fever was 100.5F. I had pain in both my arm pits, but particularly in the left, the side that was vaccinated. By the next morning 10/27 I felt completely fine except for some minor pain in my underarm. By the evening of the 28th I noticed a bruise under my arm below the lymph node that was swollen. It appeared to be subcutaneous bleeding, about 4" x 2" in an arc shape above the bra line. I continued to have swelling which diminished until 11/1. The bruising is nearly gone at 11/4.
Patient reported increased heart rate and anxiety within 15 minutes of vaccination.  BP 204/80 P 122.  BP and pulse decreased slightly while waiting.  Patient transported to ER by EMS.
Widespread joint pain and stiffness. Presently   Joint tenderness. Difficult walking..pain
Weird taste / Metal like taste; This case was reported by a consumer and described the occurrence of taste peculiar in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 5th January 2021, the patient received the 1st dose of Shingles vaccine. On 5th January 2021, 5 min after receiving Shingles vaccine, the patient experienced taste peculiar. On an unknown date, the outcome of the taste peculiar was not recovered/not resolved.   It was unknown if the reporter considered the taste peculiar to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and about 5 minutes later started getting a weird taste in mouth.  Since had the vaccine the metal like taste had not gone away. The reporter was concerned about this and trying to find out if there was anything should did.
Arthralgias, Myalgias developed overnight.  Mild-moderate in severity, have been present for greater than 8 hours and continue currently.
I started having hives 10 days after the shot - about midnight.  It has been spreading around my body, changing locations, but has now lasted for almost 48 hours.  Last night it was around my ears, eyes and mouth, the first night around my bra and panty lines.  Today it is affecting mostly my arms and hands. I'm not having any difficulty breathing, but I have noticed that my Raynauds has worsened since I got the shot.  It was very bad of course when I had the chills and shakes 12 hours after being vaccinated. I am taking Benadryl and my doctor said she could prescribe me zyrtech so that I can work.  I can't wear any clothes because any contact seems to make the hives worse.
Information has been received from a nurse concerning a patient who was vaccinated with a 0.5 ml dose of Pneumovax 23 (lot # 654982/0675F). Subsequently the patient experienced severe localized reactions which included welts and a rash on the extremity that was vaccinated, but not necessarily at the injection site. The reaction was reported "from the shoulder to the elbow." It was reported that there was "firm tissue" that extended from the was reported that there was "firm tissue" that extended from the elbow to the wrist. The patient sought unspecified medical attention. It was reported that the lot # would not be used and there was concern expressed regarding the lot number. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the government agency and was released by the regulatory agency. Additional information has been requested.
patient reported entire body itching with some rash beginning shortly after vaccination and continuing until time reported on 11/11/2020 at 2:30pm
Pain, redness and swelling in the injection site, also reporting rash for 3 days and now it has not gone away.
Information has been received from a patient complained to a pharmacist concerning a 60 year old female patient who on approximately 19-AUG-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot Unknown). In August-2010 developed soreness, bruises, and swelling at the site. It was reported that the patient recovered from bruises and swelling, resolved but not the soreness. Patient did not seek medical attention. Additional information has been requested.
flu-like symptoms; cough; difficulty breathing; Hot; Chills; COVID-19; lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), COUGH (cough), DYSPNOEA (difficulty breathing), FEELING HOT (Hot) and DRUG INEFFECTIVE (lack of drug effect) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, the patient experienced DRUG INEFFECTIVE (lack of drug effect) and COVID-19 (COVID-19). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), COUGH (cough), DYSPNOEA (difficulty breathing), FEELING HOT (Hot) and CHILLS (Chills). The patient was treated with AMOXICILLIN for COVID-19, at a dose of 500 mg twice a day. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), COUGH (cough), DYSPNOEA (difficulty breathing), FEELING HOT (Hot), CHILLS (Chills) and COVID-19 (COVID-19) was resolving and DRUG INEFFECTIVE (lack of drug effect) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that second was taken 30 days after the first dose. No concomitant medication information were reported.; Sender's Comments: This case concerns a 77 year old male with no reported history who experienced the non-serious unlisted events of Flu like illness and COVID-19 and the Drug ineffective. The patient reports having dose 1 and dose 2 thirty days apart and the events occurred greater than 15 days after the second dose of mRNA-1273. Re-challenge is not applicable as this was the second dose and unknown for the first dose as no information is reported. Benefit-risk of mRNA-1273 is not affected by this report.