chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received undiluted doses; received undiluted doses; Depression with Anxiety; Depression with Anxiety; This is a spontaneous report received from contactable reporter(s) (Pharmacist and Other HCP) from medical information team.  A 36 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in deltoid right, administration date 05Jan2022 10:58 (Lot number: FF2587) at the age of 36 years as dose 1, 0.3 ml single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administration date 05Jan2022 (Batch/Lot number: unknown) as dose number unknown, single for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP VACCINE), administration date 05Jan2022 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM; HYDROXYZINE; MIRTAZAPINE; RISPERIDONE. The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious) with onset 05Jan2022, outcome "unknown", described as "Received undiluted doses"; OVERDOSE (non-serious) with onset 05Jan2022, outcome "unknown", described as "received undiluted doses"; DEPRESSION (non-serious), ANXIETY (non-serious) all with onset 05Jan2022, outcome "not recovered" and all described as "Depression with Anxiety".  Additional information: Prior vaccinations (within 4 weeks), relevant tests and specific relevant test for thromboembolic events with thrombocytopenia were reported as none. It was reported that the patient received undiluted dose. Preparation and administration is where the event occurred. Vaccine was not diluted with NaCl 0.9 percent. Nurse Forgot to dilute the vaccine. No clinical consequences were noted after the vaccine. Patient was not hospitalized. No follow up treatment was needed. No adverse effects. Patient was informed about the error.  Follow-up (23Feb2022): This is a spontaneous follow-up report from a contactable nurse. This nurse reported in response to HCP letter sent to another pharmacist. Updated information included: New reporter in reporter slider 3 and 4, added new events (Depression with Anxiety) updated narrative.  No follow-up attempts are possible. No further information is expected.
Immunization: COVID-19 Moderna, External Administration - Moderna vaccine was administered outside of our facility - reported by patient  I95.89 CHRONIC HYPOTENSION 6/13/2022 RECTAL BLEEDING I95.89 CHRONIC HYPOTENSION 6/13/2022 GROSS HEMATURIA I95.89 CHRONIC HYPOTENSION 6/13/2022 PANCREATIC INSUFFICIENCY I95.89 CHRONIC HYPOTENSION 6/13/2022 PALLIATIVE CARE
Patient started having a fever on 08/09/2023 with the highest temp of 105. She has had a runny nose and cough. Eating less than usual. No bowel movement . Where the wrong vaccine was given the leg is bruised and swollen, redness around the area.
It hurt right away. Even the needle unlike the 1st dose. Red, swelling, pain, fever later the same night. Shivering. Stomach pain. Everything hurts. Can?t lay on left side. The 1st needle I wouldn?t even have known I had one. With this one I have every side effect that is listed.
Fever; This case was reported by a consumer and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced fever. The reporter did not consent to follow up. The reporter did not provide any other information.
Per pt; on 10/26/00, approx. 16:30, pt started to feel funny and not feeling well. She napped on the bus ride home and woke up with chills. After getting home, pt rested 3 hours and all of a sudden she had profuse sinus drainage, runny nose and eyes. Pt took 25mg of Benadryl. At approx. 19:30, pt had an upset stomach and took (4) papaya enzymes and 1 Pepcid. Pt reports she got very hot and itchy all over. Hives appeared and became patches on inner forearms, chest, stomach, back, buttocks (upper ext) and scalp itching and continued to become more intense. She developed instant throat pain and felt her throat closing and had trouble breathing. Called "911" and EMS arrived at pt's home and IV with Benadryl and O2 were given. Transported to hospital and observed for 2-3 hours. Dx: severe reaction to something. Rx: Prednisone, Zantac and Atarax. Epi-pen prescribed to carry at all times. Pt informed RN on 10/30/00, that she had swelling on forehead, upper and lower eyelids (especially right side) since Saturday 10/28/00. Pt contacted PMD and was prescribed Tavist-D OTC and within 24 hours, swelling was gone. Pt has had no other reaction since then.
A side effect/ Had a reaction that lasted longer than several wks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (A side effect/ Had a reaction that lasted longer than several wks) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (A side effect/ Had a reaction that lasted longer than several wks). At the time of the report, VACCINATION COMPLICATION (A side effect/ Had a reaction that lasted longer than several wks) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Non Significant Follow-up Append
a 15 month old patient was administered kinrix vaccine inadvertently; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th January 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 8th January 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were provided as follows: The patient inadvertently received a dose of Kinrix at the age of 15 months, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
punctalz reddened aras on the hard palate. Papule (L) upper arm
There was no side effects, or bad outcome. We erroneously gave vaccine earlier than recommended 4 months gap from the last Booster
Night of first shot: injection site pain, chills; Day following first shot: fatigue, headache, muscle pain, chills, joint pain, nausea, felt unwell, injection site pain; Lasted 24 hours; Night of second shot: injection site pain, fever, chills, fatigue Day following second shot: Fatigue, headache, chills, nausea, injection site pain; Lasted 24 hours
Left arm is red, warm, pain, swollen currently taking Ibuprofen. 1 day after getting injection and still currently.
32/89 failed to maintain adequate titers 27-mo post vax w/rabies vax;
Dizziness, headache (no relief), nausea, ringing in ears, fatigue, flu like symptoms, aching joints. Treatment meclazine.
Coughing; feeling dizzy and Lightheadedness; Weakness; Trouble Walking; This is a spontaneous report from a contactable consumer reporting for herself.    A 70-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 11:40 (Batch/Lot Number: ER8733) as single dose  for covid-19 immunisation (age at vaccination 70 years) .  The patient medical history and  concomitant medications were not reported.  The patient experienced coughing  on 27Mar2021 with outcome of recovered on the same day , feeling dizzy and lightheadedness  on 27Mar2021 with outcome of recovered on the same day , weakness  on 27Mar2021 with outcome of recovered on the same day, trouble walking  on 27Mar2021 with outcome of recovered on the same day.  Course of the event: The patient  stated that five to seven minutes after the shot, she started coughing. She started talking to the nurse in the waiting room and she said lets have you sit down. The patient stated she then started feeling dizzy and lightheaded, and needed to lie down. They had no cots in the clinic, so she had to lie on the floor. The patient stated she had weakness and trouble walking. The patient stated this was all over in 3 hours and her family took her back to her care and she drove herself home. The patient  stated she had a severe reaction to the first shot and the clinic refused to give her the second dose.  No follow-up attempts are needed. No further information is expected.
Patient registered with an incorrect date of birth (11/20/2004) implying her age was 16 years and not 15 years old. Patient was vaccinated as public health staff believed she was 16 years old.
Patient developed hives/rash/welts to upper torso,  tx with steroid shot, oral prescriptions to be taken for 1 month include Claritin, Prednisone x7 days, Pepcid.  Next morning patient describes hives/rash/welts are completely gone; no itching.
Information has been received from a consumer concerning a 7 year old female who on 28-FEB-2000 was vaccinated with a dose of Varivax. On approximately 30-JUN-2006, the patient experienced a rash over her trunk and genitals. On 01-JUL-2006 the patient was triaged by the office, started on the chickenpox protocol and BENADRYL dosing. On 06-JUL-2006 the patient was triaged by the office and the rash had almost resolved, with two pox not scabbing over on leg and buttock. On 10-JUL-2006 the patient was triaged with pox not scabbing on buttock, between fingers and between toes. It was reported that there were greater than 100 pox throughout the course. Subsequently the patient recovered. The patient's siblings (WAES # 0608USA04849 and 0608USA04853) also had adverse experiences after vaccination. Additional information is not expected.
Mother refers "adolescent remained with pain in arm and gave Advil. 30 minutes after Advil, eyes became swollen. Notified doctor but an appointment was given for 1/25/2023.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a male 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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 007M20A) for COVID-19 immunisation.     The patient's past medical history included No adverse event (No reported medical histor). Concomitant products included VITAMIN 15, CINNAMON [CINNAMOMUM VERUM], TIMOLOL and MAGNESIUM for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (arm was sore). At the time of the report, PAIN IN EXTREMITY (arm was sore) had not resolved.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable.
enlarged lymph node under his left armpit after previous doses; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (enlarged lymph node under his left armpit after previous doses) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Cancer (Cancer survivor).    On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (enlarged lymph node under his left armpit after previous doses). At the time of the report, LYMPHADENOPATHY (enlarged lymph node under his left armpit after previous doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2021-350286 (Patient Link).
pt vax 10MAY95; pt describes a delayed rxn starting 15MAY w/rash on neck & face; 22MAY devel ear pain & swollen glands; 22MAY devel joint swelling, fever & chills; 25MAY & 26MAY generalized swelling described as a flare up of arthritis;
Pt is a teenager, he was wrongly administered Jassesn Covid-19 vaccine thought to be  another Cpvid-19 vaccine appropriate for age 12 years and older.
Intense ache in all joints, most severe where OA is severest.  Ankle and hand swelling, red splotches around ankles, shins and calves over next 24 hours.  Unable to close fists or grab anything without shooting pain; burning sensation, numbness, electric like current running through fingers and thumbs.  Wrists tightness and sore.  Began Ibuprofen 800mg with Hydrocodone 5-325 to keep pain and swelling in check.  ER change to Indocin 50mg.  Found elevated LFT and INR.
Developed tingling/numbness of hands/feet-peripheral neuropathy - dx by Dr neurology group; Dr at university.  Saw also Dr at clinic.  Received VitBiz; IV methylprednisone. 4/10/08-office records received- 3/7/07-C/O numbness and tingling hands/feet.  Now C/O discoloration of toes. 6/8/07-peripheral neuropathy.  8/13/07-received serial doses of solu medrol. for idosyncratic reaction to gardasil per rheumatologist. 10/7/88-now on INH for positive PPD. C/O chest pain rapid heart beat. Did not complete the course of INH. 4/14/08-complete medical records received-DX: Small fiber sensory neuropathy, mild. Pain. history of human papilloma virus positivity. tachycardia felt to be paroxysmal supraventricular tachycardia in the setting of treatment with Solu-Medrol. Three months after received frist HPV vaccine C/O tingling, pins and needles sensations in fingertips  or right hand. Over next few months progressed to left and and toes of both feet. Some difficulties with balance. 1/8/08-C/O right hand feels entirely numb after an episode of pain and burning in wrist area. Burning, throbbing and tingling in left hand. Numbness in both feet. Lost balance, unsteady on feet. Orthostatic light-headedness.
She was tested positive even though she got the vaccine; She was tested positive even though she got the vaccine; This is a spontaneous report received from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable nurse reported that a female patient of an unspecified age received BNT162B2 (reported as COVID-19 Vaccine, Batch/lot number: Unknown), via an unspecified route of administration on an unspecified date in Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The Nurse was calling on behalf of the patient, the patient got Covid test back in Dec2020 and in last week of Dec2020 she received a positive Covid test. So she got the Covid vaccine back in Dec2020 and then a couple of weeks later which was last week of Dec2020 she got a Covid test and then she was tested positive even though she got the vaccine. The event outcome was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information, a causal relationship between event "tested positive even though she got the vaccine" (coded to Drug ineffective / SARS-CoV-2 test positive) and BNT162B2 vaccine cannot be completely excluded.
10/6/2022,  onset of neck pain followed by rash on left side neck/upper back/ chest wall, and headache.  On 10/10/2022, patient had an office visit with PCP. PCP prescribed Gabapentin capsule 300 mg  1 capsule, three times daily, as needed and Valacyclovir HCl 1 gm,  1 pill three times daily for 7 days. On 10/14/2022, patient notified office his is in uncontrolled/severe pain and severe headaches.
This case was received from a health professional on 10 July 2009, and involves a subject enrolled in an investigator-sponsored study. Subject ID: 1-08-08925. A 15-year-old female subject, with a history of appendectomy, received an injection of FLUZONE SV 2008-2009 (lot number U2849AC) on 20 November 2008. At the time of vaccination, she was confirmed to be 8 weeks pregnant; date of last menstrual period was 15 September 2008. Prior to vaccination, on 16 November 2008, the subject had presented to the emergency room with complaints of spotting bright red blood and pain on urination. Physical exam revealed suprapubic tenderness and left costal-vertebral tenderness, and urine analysis was consistent with a urinary tract infection. A transvaginal ultrasound revealed a viable fetus with a fetal heart rate of 150 beats per minute. The subject was given the discharge diagnosis of healthy pregnancy with urinary tract infection, and was prescribed antibiotics. She received study vaccine on 20 November 2008. On 17 December 2008, 27 days post-vaccination, the subject presented to the hospital with a three-day history of increasing abdominal cramping and spotting. The subject reported that she had never taken the antibiotics prescribed for her urinary tract infection. A transvaginal ultrasound showed no intrauterine pregnancy. Fluid was noted in the uterus, and tissue was present at the os of the cervix. She was discharged home to follow-up with her obstetrician, and final diagnosis was complete spontaneous miscarriage. According to the reporter, the event was not related to FLUZONE. Documents held by sender: None.
This spontaneous report as received from an about 50 years old female pharmacist via a company representative refers to herself. On 10-OCT-2012 or 11-OCT-2012 the patient was vaccinated subcutaneously with single dose of 0.65 ml ZOSTAVAX (lot # not reported). It was reported that when the patient was vaccinated with ZOSTAVAX, her "right arm at the injection site was itching and there was redness and a raised induration that lasted 3 to 4 days". It was unspecified whether the patient sought for medical attention. On an unspecified date the patient was recovered. Additional information is not expected.
COULDN'T SLEEP/WOKE UP; SHIVERING; FEVER; TROUBLE BREATHING (FELT LIKE A CAT WAS SITTING ON CHEST BUT NOT TOO MUCH PRESSURE); LYMPH NODE SWELLING UNDER THE ARM WHERE GOT A SHOT; This spontaneous report received from a patient concerned a 21 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no health conditions and had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and batch number: 213D21A expiry: 11-APR-2022) dose was not reported, administered on 09-FEB-2022 18:30 for prophylactic vaccination. No concomitant medications were reported. On FEB-2022, the patient experienced lymph node swelling under the arm where got a shot. Laboratory data included: Oxygen saturation (NR: not provided) 96 %. On 09-FEB-2022, the patient experienced trouble breathing (felt like a cat was sitting on chest but not too much pressure). On 10-FEB-2022, the patient experienced couldn't sleep/woke up, shivering, and fever. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, had not recovered from lymph node swelling under the arm where got a shot, and the outcome of shivering, couldn't sleep/woke up and trouble breathing (felt like a cat was sitting on chest but not too much pressure) was not reported. This report was non-serious.
sibling patient who received FLUZONE QUADRIVALENT twice with no reported adverse event; Initial information received on 09-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA312142(CLUSTER).  This case involves a 6 years old male patient who received Influenza Quadrival A-B Vaccine [Fluzone Qiv] twice with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Sep-2023, the patient received Dose 1 of suspect Influenza quadrival a-b vaccine Suspension for injection (lot number: UT8144LA) (Expiry date: 30-Jun-2024) via unknown route in unknown administration site for immunisation. On 07-Oct-2023 he also received Dose 2 of the same vaccine via unknown route in unknown administration site.  On 07-Oct-2023, the patient received Influenza Quadrival A-B Vaccine twice with no reported adverse event (extra dose administered) (latency: same day).  It was reported, called stating that they have sibling patient who received FLUZONE QUADRIVALENT twice and would like to know what to do moving forward and what to look for. Nurse stated that siblings came Saturday, 07Oct2023 and was given FLUZONE QUADRIVALENT The 8-month old patient was has her first flu shot 16Sept2023 and second 07Oct2023 which is just 3 weeks apart The 6-year-old patient had his first injection 08Sep2023 and the second 07Oct2023. Nurse would like to know what to look for and whether they need to revaccinate the patients.  Action taken: not applicable.  Outcome: Unknown   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 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.
Within 5 minutes of receiving the vaccination patient reported flush, hot, tingling through whole body, heart racing, light headed, "full" feeling.  Dr. reported swelling face, no trouble with swallowing, breathing.   Vital signs taken.  HR/BP elevated.  Benedryl 25 mg po given.  continued to monitor bp/hr returned to normal.  Monitored for 30 minutes and then walked back to department. Pt worked rest of day and when home reported chills, body aches,  she took a nap and ibuprofen 800 mg and then after nap all symptoms resolved by 2000.