chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nurse that administered VAXELIS and IPOL at the same day and at the same time (with no reported adverse event); Initial information received on 06-Nov-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2023SA341553(CLUSTER).  This case involves a 2 months old and unknown gender patient who's nurse administered VAXELIS and IPV (VERO) [IPOL] at the same day and at the same time (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown dose of both the suspect IPV (VERO) (Suspension for injection) (lot V1B902M and expiry date: 02-Jun-2024) and VAXELIS not produced by Sanofi Pasteur (lot number and expiry not reported) at the same day and at the same time (with no reported adverse event) (extra dose administered) (latency: same day) with an unknown route and unknown administration site for prophylactic vaccination (Immunization).    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 the 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.
pt recv vax 5AUG96 & exp discomfort @ the time of vax &  recovered;
Local erythema and increased warmth 12 x 14 cm left upper arm. Motrin prn.
Information has been received from a pt's husband concerning a 39 year old female with penicillin allergy who on 4/4/01 was vaccinated with Hep-B recombinant (yeast). Concomitant therapy included quetiapine fumarate (Seroquel) and "other medications" that the husband was unable to recall. On 4/5/01, the pt began to experience "flu-like symptoms". She had a fever, headache, upset stomach, vomiting, belching, cough, dizziness, nasal and chest congestion. The husband reported the pt could not stand by herself. The husband stated that the pt was "very sick". At the time of the report, the pt's condition had not improved. The husband did report the flu virus had been "going around" his wife's place of employment. The pt saw her physician who administered an unspecified injection in her back on 4/11/01 to help her with nausea and vomiting. Upon internal review, the pt not being able to stand by herself was determined to be an "Other Medical Event". Additional information has been requested.
1 cm clear vesicle without erythema or warmth discovered the morning after the vaccine.
Patient described having tingling in the face on the right side of the mouth and tingling in her right arm. Pt did not report any swelling in face or lips or troubled breathing. Pt was given a dose of benadryl at her request. She did not want to go to the hospital and left approximately 3 hours after her vaccine when she started feeling better.
vesicular rash under hair line above left ear, does not respond to Clobetasol ointment, originally thought it was just a manifestation of psoriatic arthritis/psoriasis. Have just been living with it, wasn't sure what else to do. Just saw Medscape article today regarding series of HZ flares after mRNA vaccination in people with auto-immune diseases with a 1.5% incidence rate, incidence is 0% in control patients with normal immune systems.
This is the first of two spontaneous reports from a contactable consumer (patient) or other non-healthcare professional (HCP). A 38-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EW0151), at the age of 38, via an unspecified route of administration, in left arm, on Apr 5, 2021, at 12:00, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. No known allergies. On an unspecified date in Apr 2021, patient experienced urinary tract infections, blood in urine and irregular period. Reportedly, patient had urinary tract infections after first and second shots (negative culture tests), blood in urine and also skipped period (after first shot). Therapeutic measures taken for urinary tract infection included treatment with cipro antibiotics for 10 days. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures, which included urine culture test on an unknown date, with negative result and urine analysis revealed blood in urine on an unspecified date. The outcome of urinary tract infections, irregular period: recovering; and of blood in urine: unknown at the time of this report. No follow-up attempts needed. No further information expected.
YF-Vax was administered with a different diluent with no reported adverse event; Initial information was received on 25-May-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age and gender patient who was administered with a different diluent with no reported adverse event after receiving yellow fever vaccine [Yf-Vax].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect yellow fever vaccine Solution for injection (lot: UJ81AAA, expiry date: 18-Apr-2024, strength: unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient was administered with a different diluent with no reported adverse event (product preparation error) (unknown latency) following the administration of yellow fever vaccine.  Caller asked if the 0.7 ml Sterile water that they used as diluent was compatible to YF-VAX.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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 the guidelines. 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.
Patient received Menactra instead of Menveo and patient administered it without considering if the two vaccines were interchangeable/No AE; Initial information was received on 23-Jun-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 27 years old female patient who on 19-Jun-2020, received 0.5 mL first dose of  MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6560BA and expiry date 02-Apr-2021) via intramuscular route at an unknown administration site for prophylactic vaccination instead of second dose of suspect MENINGOCOCCAL VACCINE A/C/Y/W CONJ (CRM197) [MENVEO] not produced by Sanofi Pasteur (lot number and expiry date not reported) and patient administered it without considering if the two vaccines were interchangeable (wrong product administered)  The patient's past vaccination(s) included MENVEO (first dose about 6 months ago). The patient's medical history, past medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing myasthenia gravis and immunodeficiency (due to myasthenia gravis).    Case details: The reporter stated that the pharmacist reports that a patient presented in order to take meningitis immunization and patient had received Menveo about six months ago, but her HCP wanted her to receive two immunization series for immunocompromised status due to myasthenia gravis. Pharmacist states that their pharmacy did not use Menveo, they use Menactra, and she administered it without considering if the second vaccines were interchangeable. Then the patient's physician's office called her and said they were not interchangeable. Pharmacist contacted the local board of health, and was told that the two vaccines are interchangeable.  Details of laboratory data was not reported.  It was an actual medication error case due to wrong product administered.   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 holders 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.
Had subarachnoid hemorrhage 1 hour after getting shot.  Ended up in hospital for 13 days. Had drain placed in head and multiple CT scans and MRI exams while there. Discharged with home PT and neurologist follow ups.  Experiencing left side weakness and head fogginess still.
More trouble moving her arm and it is more painful; Pain in her shoulder where the shot was given; This spontaneous case was retrieved on 07-Mar-2022 from physician via Agency (reference number: SEQW22-00858) and concerned a 73-year-old female patient.  The patient's relevant medical history and concomitant medications were not reported.  On 02-Nov-2021, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: 0.5 ml, anatomical location, route of administration and indication: not reported). The batch number reported was P100369129.  On the same day, after receiving Afluria Quadrivalent, the patient experienced pain in her shoulder where the shot was given.  On 15-Nov-2021, the patient had more trouble moving her arm and it was more painful, but she could still use her arm.  At the time of initial reporting, the patient had not recovered from the events.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 73-year-old female patient experienced arthralgia and decreased injected limb mobility on the same day after receiving Afluria Quadrivalent vaccine. Causality for the reported events is assessed as possibly related due to plausible temporal relationship.; Sender's Comments: A 73-year-old female patient experienced arthralgia and decreased injected limb mobility on the same day after receiving Afluria Quadrivalent vaccine. Causality for the reported events is assessed as possibly related due to plausible temporal relationship.
Upon administration of second vaccine, HPV, patient stated he was lightheaded and had a syncopal episode. Assisted patient on laying on bed, patient was alert within seconds and instructed to lay with knees bent. Patient sat up within 5 minutes and given water. Patient was observed by mother and nurses. Patient stated he wanted to go home and it was determined that he was able to ambulate on his own. He was accompanied outside walking by mother. Patient's color was back to normal and was alert and oriented.
Received Pfizer COVID-19 Vaccine (1st shot) at 10:20am. Dizziness for 5 minutes after receiving injection then it disappeared. When I arrived at home an hour and a half later I was dizzy again and experienced rapid heart beats. Symptoms lasted for 30 minutes and then the symptoms stopped. While I didn?t experience any more side effects today, I did notice that the are around the injection site is significantly swollen and sore. I?m using an ice pack to help bring the swelling down.
pt recv vax 14MAR97 & devel fever of 104, myalgia, malaise, & lethargy;also devel an inj site rxn characterized by redness & swelling which progressed to involved the entire arm;tx w/prelone, APAP, Motrin, & DPH;pt recovered p/48hr;
The student received a flu shot during a school-based clinic. Immediately after receiving the flu vaccine, he appeared to have a vasovagal reaction, slumping down in his chair and immediately perking up. He returned to class. The school nurse checked on him, and he said he was fine. Student teacher then brought him down to the health room later to rest. He returned to class. Adults and mom reported he seemed tired the rest of the day. Next day was back to normal.
redness & swelling & pain @ inj site 24hr p/vax;tx hot cloth to site;took APAP;little relief;
Patient feeling lightheaded, haven't eaten all day. Seen by EMS. Released at 17:35 p.m.
Patient upon receiving vaccination went to the bathroom after 30 minutes of wait time 2/2 history of allergic rx with penicillin developed a rash. Rash over abdominal region and b/l forearms. Papular in nature. Felt a little warm however attributed it to her sweater and jacket. One bout of diarrhea. However states she had change on diet time in the AM. Overall improved with no other symptoms.
Arm swelling and stiffness. I have a raised red splotch below the injection site. It's about 2 inches in diameter.
was in bed all day; fever; fatigue; muscle aches; sleeplessness; This non-serious case was reported by a consumer via call center representative and described the occurrence of sleeplessness in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28-JUL-2023, the patient received the 1st dose of Shingrix. In JUL-2023, 5 hrs after receiving Shingrix, the patient experienced sleeplessness (Verbatim: sleeplessness). On 28-JUL-2023, the patient experienced fatigue (Verbatim: fatigue), muscle pain (Verbatim: muscle aches) and fever (Verbatim: fever). On 30-JUL-2023, the patient experienced bedridden (Verbatim: was in bed all day). The outcome of the sleeplessness, fatigue, muscle pain, bedridden and fever were resolved.   It was unknown if the reporter considered the sleeplessness, fatigue, muscle pain, bedridden and fever to be related to Shingrix.     It was unknown if the company considered the sleeplessness, fatigue, muscle pain, bedridden and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-JUL-2023 The reporter stated patient had administered the first dose of Shingrix and had reactions about 5 hours after vaccination. She was then bed ridden all the day. She was recovered from all the symptoms she had. She wanted to know if she administer the 2nd dose of shingrix will it give her the same reactions or not. The reporter consented to follow up.
Employee tested COVID positive after completing COVID vaccine series.  She was tested for asymptomatic prevalence testing as she works in long term care.
Red swollen ring around injection site, looks like a bullseye. Soreness and sensitivity. Rash-like bumps in the red circle around site.  Size is approximately 1.5 inch in diameter (fairly small), but occurred within 18 hours or less of shot (was sleeping and noticed upon waking up).
Severe vertigo 6 days post vaxx, lasted about 6 hours; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN62V6), via an unspecified route of administration in the left arm on 14Mar2021 at 08:45 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. Medical history included migraine. Concomitant medications included birth control (unspecified) and cetirizine hydrochloride (ZYRTEC) from unknown date for unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL9267), via an unspecified route of administration in the left arm on 21Feb2021 at 05:45 (at the age of 34-years-old), as a single dose for COVID-19 immunisation and ibuprofen (MANUFACTURER UNKNOWN) on unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021 at 08:00, 6 days post vaccination, the patient experienced severe vertigo that lasted about 6 hours. The patient did not receive any treatment for vertigo. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event vertigo was recovered on 20Mar2021 at 14:00.   No follow-up attempts are needed. No further information is expected.
Patient presents to clinic after developing symptoms of illness the day after her second covid vaccine on 5/6. On 5/7 she reports that she developed a sore throat, congestion, facial pain and pressure, headache, and fatigue. She also reports productive "deep" cough in the am. Denies chills/fever/body aches. Mucus is yellow/green in morning.  She has taken OTC decongestants and mucinex which helped some however patient still feels unwell and has symptoms for 10 days.   Patient was prescribed a 10 day course of Augmentin 875, take one tablet every 12 hours x 10 days for acute bacterial sinusitis. She also prescribed Mucinex 600mg.  Highly unlikely to be covid as patient had confirmed case within the last 90 days and has been vaccinated. Take antibiotics as prescribed, with food, due to length of symptoms. Do not take decongestants > 5 days as they may cause rebound congestion. If you do not improve or develop signs of evolving infection such as fever, increase in severity of symptoms, or SOB RTO or seek care immediately.
High fever 1 day after received RABIPUR #2. No medical Rx except TYLENOL.
MUSCLE ACHE; NECK PAIN; ARM PAIN (PAIN SCALE OF 8/10); FEVER; ACHINESS (SHE NORMALLY HAS BUT IT GOT WORSE); RIGHT SHOULDER PAIN; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight was 260 pounds, and height was 172.72 centimeters. The patient's concurrent conditions included high blood pressure, acid reflux, thyroid issue, non alcoholic, non smoker, and achiness (she normally has but it got worse), and other pre-existing medical conditions included patient had no known drug allergy, and no history of illicit drug use. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced achiness (she normally has but it got worse). On 08-APR-2021, the subject experienced right shoulder pain. On 08-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99-100 F. On 12-APR-2021, the subject experienced neck pain. On 12-APR-2021, the subject experienced arm pain (pain scale of 8/10). Laboratory data included: Pain scale (NR: not provided) 8/10. On an unspecified date, the subject experienced muscle ache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 08-APR-2021, and had not recovered from neck pain, right shoulder pain, achiness (she normally has but it got worse), arm pain (pain scale of 8/10), and muscle ache. This report was non-serious.
Information has been received from a pharmacist concerning a female patient "in her early 20s" who "in early 2008" was vaccinated with 3 doses of GARDASIL (lot number not reported). The patient received her doses from another facility. About one year after dose 3 was administered, in 2009, the patient began to experience myalgia and tiredness. Unspecified medical contact was sought. The patient did have lab work done but the pharmacist doesn't know which ones. At the time of the report, the patient had not recovered. The Pharmacist contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination/therapy, dose number, lot number, date of event and recovery status. The Pharmacist was waiting to speak with the doctor regarding these patients and would provide more information later. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a female patient of unkonwn age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot# were not reported). On an unknown date the patient experienced rashes. The outcome of rashes was unknown. Causality was not reported. This is one of the reports from the same source. Additional information has been requested.
Patient complaining of face swelling on same side as injection arm that began the day after received vaccination. No other symptoms present. Patient denies pain or trouble breathing.
Client passed out after shot. Client stated she was afraid of needles & did not like to watch. She didn't watch, but got lightheaded after injection.
5hr p/vax pt had a limp spell on which passed out became pale & motionless but cont to breathe;pt then slept x 1 1/2hr & awakened w/good color;@ the time of limp spell appeared to gag briefly;no cyanosis, sx or fever;
SHARP SHOOTING PAIN IN THE STOMACH, PAIN IN LEFT LEG & HEADACHES
1/14, 2 pm - soreness in left arm and itching at injection site 1/14 evening - gradually increasing fatigue and chills 1/14-15 overnight - fatigue, chills, headache, body aches all worsening, fever up to 101 degrees at 6:30 am All symptoms persisting at this time (1/15, 9 am), fever 100.2
Patient contracted COVID 19 and tested + less than 14 days after receiving vaccine. Vaccine received 3/26/21.  Symptom onset 4/3/21, tested + 4/6/2021
Pins & needles in fingers and toes. Started in the days following my Covid Shot (J&J) and has lasted about 4 months, although it seems like it's been going away gradually. I can barely feel it anymore, but still a bit.  It was at its worst about a month after the vaccine shot. My left fingers were the worst. I went to Urgent Care and saw my doctor, but they couldn't explain it. In the news this morning I read about Guillain-Barré syndrome from the J&J vaccine, so thought I should write in case it's of any help.
Red rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash) 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 RASH ERYTHEMATOUS (Red rash). At the time of the report, RASH ERYTHEMATOUS (Red rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.