chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax;local rxn at site of injection to rt thigh w/ pain, swelling, inc warmth; no abcess; t 99.2 R; duration 2 days;
Patient slumped over with eyes open in a vacant stare and then facial twitching started.
cellulitis below injection site; This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 29-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular). On an unknown date, less than 2 years after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis was recovered/resolved.   It was unknown if the reporter considered the cellulitis to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided are as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient received Fluarix in 2019 in left arm and had cellulitis right below injection site on left arm after getting Fluarix. The patient stated that she had a reaction to Fluarix. The reporter consented to follow-up.
One and one half months post vax, pts laboratory results revealed a negative hepatitis A antibody titer.
Information has been received from a registered nurse referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On 27-MAR-2015 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K000326, expiration date 27-FEB-2015; dose and route were not reported). No adverse effects were reported. It was unspecified if the patient sought any medical attention. Additional information has been requested.
Pt states "woke up with heart racing" CoVID booster received on 12/21. Hx of anxiety, high cholesterol and hypotension.
Lots of leg pain  Swollen foot and back of knees  Lower back pain   4 days total with symptoms.
This case was reported by a consumer and described the occurrence of arm pain in a female subject of unspecified age who was vaccinated with Influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. In 2013 the subject, received unspecified dose of Influenza vaccine unspecified (unknown route, injection site and batch number). In 2013, at an unspecified time after vaccination with Influenza vaccine unspecified, the subject experienced arm pain. At the time of reporting the event was unresolved.
Localized rash approximately 6 cm x 4 cm at injection site of redness, swelling, itching, pain, hives. Did not treat but will use an antihistamine if worsens.
Narrative:  COVID-19 positive after receiving both doses of Moderna in Jan/Feb 2021 and booster 8/24/21
Welts appeared  on his back the day after vaccination, followed by rough, raised scaly patches appearing on legs, back the following day.
Injection site pain Tiredness Severe headache Brain fog Muscle pain Joint pain Chills Hot sweats Fever (101) more than 24 hrs Nausea Sore throat
By the evening pounding headache not relieved by Tylenol. Body hurts nausea still dizziness restless
During injection she felt it burning; Her Blood Pressure went up to 255; She felt weakness and Nausea; Became unaware of her surroundings.
Case number PHEH2013US024159 is an initial spontaneous report received from a nurse on 15 Nov 2013. This report refers to a patient of unknown age and gender. The patient was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly on 15 Nov 2013. It was reported that this vaccine was previously exposed to temperature of 62 Fahrenheit overnight. No adverse event was reported following medication error.
Acute ischemic stroke, TPA given, patient hospitalized for right sided weakness and dysarthria.
FEVER 100.1-101.9, CHILLS, SWEATING, BODY ACHES, SLIGHT HEADACHE, LASTING 12-15 HOURS, BED REST.  I TAKE ADVIL AND TRAMODOL FOR OTHER MEDICAL ISSUES.  I DID NOT TAKE ADDITIONAL MEDICATION.  FULL RECOVERY.
vaccine received on 1/8/21. On 1/13/21 left arm pit lymphnode has begun to swell. It is very tender to the touch and visibly noticeable
Information has been received from registered nurse referring to a 14 year old male patient. No concurrent condition, medical history or concomitant therapy was reported. On 13-APR-2016 (reported as "today"), the patient was inadvertently vaccinated with a 0.5 ml dose of PROQUAD (Merck) (lot # L044055 with expiration date 02-MAY-2017, therapy type: RHA, subcutaneous) in the left arm (inappropriate schedule of drug administration), instead of VARIVAX (Merck) and M-M-R II (wrong drug administered). No adverse effects were reported. Additional information is not expected due to no consent to do follow-up.
Information has been received from a registered nurse (R.N.) concerning a patient who was vaccinated with a dose of PNEUMOVAX (lot # 662100/0742X with expiration date of 06-MAR-2010) on an unspecified date. There was no concomitant medication. Subsequently the patient developed cellulitis on an unspecified date. At the time of reporting, the outcome of the event was unknown. The patient sought unspecified medical attention. This is one of several reports from the same source. Additional information has been requested.
pain on the left side of the stomach; pain in the left leg; dizzy; feeling tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 30Apr2021 (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: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "pain on the left side of the stomach"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in the left leg"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; FATIGUE (non-serious), outcome "unknown", described as "feeling tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extreme weakness, fever, hives, low B.P., chills, shortness of breath, started 3 days after vaccine - hospital stay 4 days.
received expired doses of ADACEL with no AE; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2020SA287830 (same reporter).  This case involves a 11 year old female patient who was vaccinated with expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE (MENINGOCOCCAL VACCINE).  On 15-Sep-2020, the patient received a 0.5 ml first dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot C5519BA and expiry date: 12-sep-2020) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used. (latency on same day).  At the time of reporting, patient had no adverse event.  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.
PRODUCT STORAGE ERROR; THE JANSSEN COVID 19 VACCINE WAS  REFROZEN AND ADMINISTERED TO PATIENT; This spontaneous report received from a health care professional concerned a 41 year old female. 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, batch number: 1821286, expiry: 20-MAR-2022) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. Age at time of vaccination 41 years old. No concomitant medications were reported. On 30-AUG-2021, the patient experienced the janssen covid 19 vaccine was refrozen and administered to patient. On an unspecified date, the patient experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the janssen covid 19 vaccine was refrozen and administered to patient and product storage error was not reported. This report was non-serious. This case, from the same reporter is linked to 20220538292, 20220538693, 20220537341, 20220537356, 20220537444, 20220537548, 20220538210, 20220538297, 20220538316, 20220538425, 20220538428, 20220538437, 20220538480, 20220538573, 20220538627, 20220538666, 20220538758, 20220538890, 20220539045, 20220540324, 20220540420, 20220540474, 20220540536, 20220540570, 20220540611, 20220540642, 20220537507, 20220537683, 20220537532, 20220538146, 20220538149, 20220538238, 20220538347, 20220538411, 20220540435, 20220540816, 20220540814, 20220540765, 20220540688, 20220541085, 20220541180, 20220541401, 20220538379, 20220540853 and 20220541506.
patient called on 05-04-2021 to report swelling on feet below ankle  that had started about 5 days  ealier .and says she had swelling on face day after vaccine <but did not call pharmacy since swelling receded / advised patient to call PCP  and make an appointment  as soon as possible  and inform PCP and inform PCP  regarding date vaccine given and the swelling issues  . Pharmacy will follow up with patient
Allergic Rx to shot Lt arm VS cellulitis. Rx for BENADRYL, antibiotic KEFLEX 250/5ml.
Patient developed a rash on the right side of his body. His doctor gave him a cortisone shot and he has an appointment with an allergist.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. From 09-MAR-2016 to 01-APR-2016, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) lot # L008354, expiration date 11-SEP-2016, lot # L040412, expiration date 13-APR-2017 and lot # L030587, expiration date 10-FEB-2017 (albumin status, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 7.4 degrees Fahrenheit for 12 hours and 40 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Plan:  IMM ADMN SARSCOV2 30MCG/0.3M L 1ST DOSE Pfizer (Z23); Pfizer COVID Vaccine (Z23) Manufacturer Pfizer Lot EW0173 Expiring 08/31/2021
Chills, achey, minor fever, lethargy. Symptoms lasted about 12 hrs after 1st shot and 24 hrs after 2nd shot.
pt recv vax & area became red & hot in approx 2inch area had diff w/lifting arm;instructed to apply warm moist compresses & call MD;
They have not been tested enough andall shots made the patient extremely ill; Patient had long term attects; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (They have not been tested enough andall shots made the patient extremely ill) and VACCINATION SITE REACTION (Patient had long term attects) in a 48-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (They have not been tested enough andall shots made the patient extremely ill) and VACCINATION SITE REACTION (Patient had long term attects). At the time of the report, ILLNESS (They have not been tested enough andall shots made the patient extremely ill) and VACCINATION SITE REACTION (Patient had long term attects) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The treatment medication was not reported. The concomitant medication was not reported.  The case belongs to patient number 24 out of 63 patients  (monovalent).   This case was linked to US-MODERNATX, INC.-MOD-2023-714580 (E2B Linked Report). This case was linked to MOD-2023-714802 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714580:Master case
Booster shot, previous 2 doses were also Pfizer with no adverse effects. Waited at facility the required 15 minutes and left. About 5 minutes after that (about 20 minutes after receiving dose), part of the left side of my face back to my ear (same side as vaccine) started feeling tingly and partially numb. I can still feel things and there isn't any weakness or non-response from that side of my face, and I otherwise feel normal. I am still feeling this a couple hours later (as of 1:55pm).
This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 61-year-old male patient who received SHINGRIX (batch number ZY3X4, expiry date 28th April 20200. On 9th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th April 2018, unknown after receiving SHINGRIX, the patient experienced vaccination error. On an unknown date, the patient experienced pain in arm and incorrect storage of drug. On an unknown date, the outcome of the pain in arm, incorrect storage of drug and vaccination error were unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in unknown deltoid. The patient received a SHINGRIX vaccine that had been frozen, which led to incorrect storage of vaccine and vaccination error. In 2018, less than a month after vaccination, the patient experienced soreness in arm. Nurse reported that, the office gave 10 patients SHINGRIX vaccine that had been frozen. The nurse reports this has been reported to their sales representative and another sales representative made a visit and had a physician from GlaxoSmithKline contact the practice as well. The nurse reported 8 of the 10 patients had been revaccinated. The last 2 were waiting a time period due to the other vaccines being given. The reported batch number of SHINGRIX was DY3X4 which does not exists as per sales data sheet and was updated to ZY3X4. The was one of the 10 linked cases reported by the same reporter.
no adverse event; Vaccines administered experienced a temperature excursion; This spontaneous report was received from a other health professional and refers to a patient (age and gender was unknown)  The patient's medical history, concurrent condition, and concomitant therapies were not reported.  On 19-JUN-2023, the patient was vaccinated with diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, (lot #U7374BA, expiration date: 06-MAY-2025), administered for prophylaxis (strength, and route of administration were not provided); and  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, (lot #W026137, expiration date: 05-FEB-2024), administered orally for prophylaxis (strength was not provided), after vaccines experienced a temperature excursion (8.74 C, time frame: 35 Minutes, had no previous temperature excursion) (Product storage error).  There was no side effect reported (No adverse event), and no product quality complaint (PQC).
administration of an expired Twinrix dose to patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 50-year-old male patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 11-OCT-2023, the patient received Twinrix. On 11-OCT-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: administration of an expired Twinrix dose to patient).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-OCT-2023 A pharmacist called to report the administration of an expired Twinrix dose to patient, which led to expired vaccine used.  The healthcare professional asked how to proceed with this patient. The reporter consented to follow up.
woke up on 3/23 with left facial paralysis; confirmed no balance, cognitive or motor function loss Met with Dr on 3/24. Confirmed Bells Palsy.  Started on Valtrax (7 days) and Prednisone (10 days) Now 6 weeks post-event; have some movement on left side of face; estimate 40% recovery so far No plans for additional medication No plans for 2nd dose due to uncertainty on how it will impact current condition
Patient stated she went to the ER on 8/18/21 with complaint of redness, hot area on site of injection, Covid 19 Moderna shot (left arm). The ER physician prescribed Amoxicillin 500mg to be taken twice daily. She later presented to the pharmacy letting us know she was diagnosed with cellulitis at the site of injection. Injection was given on 8/9/21.
Patient was ordered polio IM but given rotarix mixed with MMR diluent and given IM. No adverse effects seen yet
Pt describes lingering pain in the muscle at the injection site. She describes as pinch/pain sensation in muscle on (L) deltoid.
This spontaneous report as received from a physician refers to a late 60 years old female patient. On approximately January 2013, the patient was vaccinated with ZOSTAVAX (lot#, dose and route not reported). The patient stated that on an unknown date, after receiving ZOSTAVAX she developed pain in both her sides of her trunk. The patient sought medical attention. The patient was treated with XANAX. The outcome of the event was not provided. The relatedness of the event with ZOSTAVAX was not provided. Additional information has been requested.
Vaccine was administered too high in the arm, near the shoulder region.  Not in the deltoid muscle. Injection was immediately painful followed by increased pain and very limited arm mobility within 3 hours.   Follow up appt with medical office within 2 weeks, with no resolution after a prescribed course of prednisone.
PATIENT MENTION THAT SHE HAD SOME KIND OF PANIC ATTACK AND ANXIETY 5 MINUTES AFTER THE VACCINE. PATIENT MENTION THAT SHE FELT THAT HER HEART RATE WHERE HIGH FOR FEW SECOND AND ALSO FEELING NAUSEA AND VOMITING. PATIENT VOMITED INTO HER MASK AND IN THE RESTROOM NEXT TO THE PHARMACY. PATIENT MENTION THAT ALL THIS SYMPTOMS LASTED FOR 5 MINUTES AND SHE WAS COMPLETELY FINE AFTER THAT.
This case was reported by a physician and described the occurrence of allergy in a 4-year-old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Dtpa, manufacturer unspecified). The reporter is the mother of the subject. The mother "has allergies to tetanus." There were no concurrent medications. On an unspecified date in July 2001, the subject received a dose of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline; dose number and lot number not reported). At an unspecified time following receipt of Infanrix, in July 2001, the subject experienced injection site redness and swelling injection site. The events resolved on an unspecified date in July 2001. On an unspecified date in 2004, the sujbect received a dose of Dtpa (unknown manufacturer; dose number and lot number not reported). At an unspecified time following receipt of Dtpa, on an unspecified date in 2004, the subject again experienced injection site redness and swelling injection site. The reporter stated that, "they believe my daughter may be allergic to one of the components of the vaccine." The outcome of the injection site reaction in 2004 and the allergy were not reported. The reporter considered the events were related to vaccination with Dtpa and Infanrix.
Injection site Itchy; Injection site Red; Injection site swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site Itchy), VACCINATION SITE ERYTHEMA (Injection site Red) and VACCINATION SITE SWELLING (Injection site swollen) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site Itchy), VACCINATION SITE ERYTHEMA (Injection site Red) and VACCINATION SITE SWELLING (Injection site swollen). At the time of the report, VACCINATION SITE PRURITUS (Injection site Itchy), VACCINATION SITE ERYTHEMA (Injection site Red) and VACCINATION SITE SWELLING (Injection site swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was taking concomitant medications which were not specified.  Treatment information was not provided.
pains in lower abd & both legs, red rash, burning on urination, temp?, fever & chills;hosp on 2NOV97 dc 4NOV97;
Fever achey bones muscles hard to breathe sever shape / acute head pain. Whole body aches pain chills couldn?t stay awake had to sleep continued through sunday at time of report with only some relief was told to rest and take Advil by pcp
This spontaneous report was received from a other health professional referring to unspecified patients of unknown age and gender. On an unknown dale the patients were vaccinated with PEDVAX after being improperly stored at 33F. (for an unspecified amount of time) (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the event was unknown. No PQC reported. The case has been linked with the cases(same reporter link) 1406USA008470, 1406USA008474, 1406USA008476 and 1406USA008158. Additional information is not expected.
Can the Moderna vaccine cause stomach issues?; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Can the Moderna vaccine cause stomach issues?) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 ABDOMINAL DISCOMFORT (Can the Moderna vaccine cause stomach issues?). At the time of the report, ABDOMINAL DISCOMFORT (Can the Moderna vaccine cause stomach issues?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       . No concomitant medications reported. No treatment reported