chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dispensed 28 doses of expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. No Medical History information was reported. On 08-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine) outcome was unknown.     or mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported that patient had no known allergies.  Concomitant medication was not reported.  Reporter reported that they dispensed 28 doses of expired Moderna Covid-19 vaccine. These were administered on 06Apr2022 & 08Apr2022 with Lot: 012H21B and expiration date:18Mar2022.  No treatment medications were reported   This case was linked to MOD-2022-541343, MOD-2022-544282, MOD-2022-544310 (Patient Link).
I95.9 HYPOTENSION 4/18/2021 PERICARDIAL EFFUSION I95.9 HYPOTENSION 4/18/2021 BIPOLAR DISORDER, UNSPECIFIED TYPE
Worsening Urine Incontinence; Worsening weaknes; Soreness at injection site/at the injection sites; This spontaneous case was reported by a consumer and describes the occurrence of URINARY INCONTINENCE (Worsening Urine Incontinence), ASTHENIA (Worsening weaknes) and VACCINATION SITE PAIN (Soreness at injection site/at the injection sites) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Mobility decreased (Not able to lift leg), Fall, Rotator cuff tear and Upper respiratory infection. Concurrent medical conditions included Allergy to antibiotic (Allergy to Cipro), Restless leg syndrome, Urine incontinence, COVID-19, Memory impaired (Memory difficulties), Weakness (Worsening weakness) and Balance difficulty (Worsening balance). Concomitant products included VITAMIN D3, VITAMIN C [ASCORBIC ACID], CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM & VITAMIN D3) and BACLOFEN for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, the patient experienced URINARY INCONTINENCE (Worsening Urine Incontinence), ASTHENIA (Worsening weaknes) and VACCINATION SITE PAIN (Soreness at injection site/at the injection sites). At the time of the report, URINARY INCONTINENCE (Worsening Urine Incontinence), ASTHENIA (Worsening weaknes) and VACCINATION SITE PAIN (Soreness at injection site/at the injection sites) outcome was unknown.            Treatment information was not reported.
(L) ear Hearing Loss:  hearing loss occurred after both vaccinations. After Vaccination #1-1/28/2021: Hearing loss occurred on Friday 1/29/2021 about 0200-0300 then returned 100% by Saturday afternoon. Then after vaccination #2 - 2/19/2021: hearing loss occurred on Friday 0200-0300 as of 2/22/2021 hearing loss is approximately 90% returned.
02/03/2021 The next day after the Covid 19 (Moderna) injection my dad felt chills thru out his body around 7:00 pm he took a Tylenol we assumed it was just a side effect from vaccine. At on or around 8:45 PM my dad called my sister that he was having trouble breathing and felt very short of breath. My sister was there in about 7min by the time she got to him my dad was gasping for air he would lift his head up trying to breath. They got him to the hospital shorty after about a 7 min drive. My dad was taken into hospital we were not able to go in due to restrictions.
This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and unknown gender. On an unspecified dates, the unspecified patients were vaccinated with doses of ZOSTAVAX (dose, frequency and route were not reported) which had been exposed to temperatures outside of the recommended range. No adverse effects were reported. Additional information has been requested.
pt recv vax 16APR97 & devel a significant local rxn including 11x11cm erythema, warmth, & induration;sx lasted 2 days p/inj;
Pt c/o @ 10:43am about itching in the left arm antecubital area.  No visible rash or skin irritation noted.  Benadryl 25 mg po administered per protocol.  The itching later began in the right palm at approximately 11:07am.  EMS called at 11:09 am and arrived at 11:14 am.  Pt now being monitored by Nurse and EMS x2.  11:18 am another Benadryl 25mg po administered.  Pt offered transport to ER by EMS, but pt refused transport to ER @ 11:27am.  Pt left walking home (lives approximately 2-3 blocks behind the health dept).
Symptoms started same day as vaccine.Patient called Saturday, Feb. 16, 2013 to state he was a red, irritated rash that was painful to the touch. Pt, had no trouble breathing or swallowing. He was told to use a marker around the rash & use a cold compress and consider an oral antihistamine. Pharmacist and doctor had the same recommendations. Has not called back since Sat. morning.
For about 6 days I had swelling about three inches in a round circle, redness went other my arm about nine inches long and six inches across. The first day I had a headache. My arm hurt for four days. I called my doctor office. The nurse told me to use cold compress.
Child presented for 11 year PE on 5/21/05. Menactra administered IM right deltoid. Td administered IM left deltoid. Onset fever Saturday PM; increased to 103.6 oral. No other symptoms. Patient seen in office on 5/23/05. Exam NL with 2" red, warm area right bicep; tender to palp.
Anthrax Vaccine #2 given on Monday 27 JAN 2003, Normal burning sensation associated with shot. On Tuesday 28 JAN 2003 local area was sore and irritated. Wed 29 JAN upper extremities of arm was swollen, red and was hot to touch, very irritated. On 30 JAN swelling went slightly below elbow, swelling resulted in the appearance of no elbow, red, hot to touch and irritating. 31 JAN swelling extended down to the wrist, same symptoms. 1 FEB the hand is swollen with same symptoms. Swelling in upper extremeties is still there. On WED 29 JAN AM hours, I consulted the physician responsible for vaccination. Was told this was normal to keep watching. As swelling increased throughout the day, consulted the physician in the PM, said continue to watch. On 30 Jan AM and PM hours consulted the physician with new developments and concerns, continue to watch. Friday 31 JAN consulted physician again, received Ibuprofen, 800mg every 6 hours, Dicloxacillin to take 4 times a day, and Triamcinolone 0.1% TOP applied when needed. Needless to say its not working.
About 1 hour after injection developed a bad head ache. The following day c/o severe chills and fever 104. Area of injection looked like a pimple. Achy all over, arm very sore, difficult to move due to pain. Reported to us on day 3 arm some better. Can lift it. She c/o swollen area above collar bone too.
TIA (TRANSIENT ISCHAEMIC ATTACK); This spontaneous report received from a patient via social media through a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26. cov2 (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26. cov2 (unspecified manufacturer) (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, one week after second vaccine, the patient experienced TIA (transient ischaemic attack) (Dose number in series 2). It was reported as "Same thing happened to me with Vaccine and booster. I got a TIA one week after second vaccine- no more for me." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of TIA (transient ischaemic attack) was not reported. This report was serious (Other Medically Important Condition). This case is a duplicate of 20221257765. Sender's Comments: V0-20221257757-  TIA (transient ischaemic attack)- The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
A DTaP immunization was due for patient 11/05/2021. Chief complaint correctly identifies DTaP to be given. However, TDAP was given (or at least that's what was documented).
NAUSEAS ON AND OFF; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced nausea on and off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of nausea on and off was not reported. This report was non-serious.
Similar, milder version of diffuse urticaria rash developed lasting 10-14 days accompanied by several days of fatigue. This was similar reaction to that developed when I had covid 19 10/2020; however, much milder reaction.  Rash is now healed/resolved on 1/4/21.
1:50 Called into observation room by RN. for assistance with this patient. Pt had Dose 2 of Phizer at 1: 16 pm and was now complaining of nausea and lightheadedness.  Pt asissted to floor, legs elevated up on a chair. Pt is alert .He stated, his name is (unlisted). Skin: pale, hands diaphoretic. Immediately, pt 's chest was pounding;HR was elevated , pt's eyes closed and he appeared attempt to answer this RN's questions as to how he feels, however, could not. Would not/could not open eyes. It appeared that he was shaking/mild jerking  as with the chills, however, this RN was discerning if it was seizure like activity. Upper body flushed/red. This lasted about 30-45 seconds.  Then pt.'s shakiness slowed down, heart pounding resolved and he opened his eyes. Able to squeeze nurse hand.   1:53 pm DPN   Came to assist.Ice pack to forehead  Pt was still shaky, but now responding.  Still w/ complaints of nausea, lightheadedness.   2:05 still lying on floor with legs elevated. 2:10 Sat up for 5 minutes. C/o nausea. Placed in wheelchair. Within 1 minute, pt. Is pale, shakiness returns, and c/o nausea. Returned to the floor , legs elevated and 9-1-1 initiated. HR steady, respirations -steady. MOC now present.Pt. now responding to MOC or RN's commands to squeeze hand or  Speak. Eyes closed. HR and RR steady.   9-11 arrived at 2: 15 pm and pt. Left facility with paramedics and MOC.
Menstrual Cycle Change. Previously near exact 28 day regular cycle to a longer (33-40 day) irregular cycle.
Body aches; Chills; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Body aches) and CHILLS (Chills) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 036B21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, MYALGIA (Body aches) and CHILLS (Chills) had resolved.     No concomitant medications were reported.  It was reported that patient took both the vaccines on shoulder.  It was reported that event did not cause the patient to seek medical care. There was no other potential causes for the event to occur.  No treatment medications were reported.   This case was linked to MOD-2022-656236, MOD-2022-654618 (Patient Link).
Left arm redness and swelling after receiving DTaP and IPV in that arm. Area about 16cmx10cm.
Chills, nausea, fatigue. Patient did vomit. Occurred when patient awoke the morning after received the injection.
Vaccine was administered high and towards the back of the upper left arm.  Retired, older lady was giving the shot, she didn't squeeze the arm muscle or check the arm for correct placement.  Longer needle than was needed was used.  Arm was relaxed during the entire duration of injection.  As soon as the injection went in, deep pain was felt down to the wrist and mentioned to those administering the vaccine.  They instructed me to move my arm as I left the area.  I experienced immediate pain in the shoulder, never had arm muscle pain.  Shoulder pain became excruciating over the next 2 weeks.  Went to orthopedic walk-in clinic, they took x-rays and diagnosed me with impingement syndrome based off of my symptoms of pain and decreased range of motion.  I started physical therapy April 26, 2021 and continue to present.  Physical therapy has helped to increase range of motion and build some strength in the shoulder, but specific areas of pain (front and top/outside of shoulder area) continue to disrupt daily activities and interrupt sleep at night.
The day after my 2nd vaccine, I experienced a headache and mild cough.   I took two extra-strength Tylenol and it helped.  I took two more Tylenol before bed, and by Sunday morning felt fine.
I had a sore arm for a few days after receiving the vaccine. I have a history of AFIB for about a year and had no symptoms for nine months. I started having symptoms again on 05/09/2023.  I had an appointment with my doctor and my medicine was increased to help my symptoms. I am scheduled for a cardioversion tomorrow 5/11/2023.
37 wk fetal demise - did not feel baby move for a few days. 12/3, 12/4, 12/11 Medical records and discharge summary received for DOS 11/25/09. Final dx: IUP, extremely poorly controlled diabetes, probable mild DKA Intrauterine pregnancy, fetal death.  Pre-pregnancy diabetes.  LMP 3/3/09.  EDC 12/7/09.  PE on 10/8/09  cervix closed. Vulvovaginitis. Candida. Glucose increased. 11/23 decreased fetal movement. Neg FHT.
This case was considered medically important. Information regarding PREVNAR was received from a physician, who is the neighbor of a 4-month-old patient who experienced possible febrile seizure. At 4 months of age, the patient received the second dose on an unspecified date. The patient previously experienced febrile convulsion while PREVNAR at 2 months of age (see case # US-WYE-H01604507). Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications included several unspecified vaccines. The patient experienced possible febrile seizure on an unknown date. Several unspecified vaccines were administered on the same day. The outcome is unknown. No additional information is anticipated. See related case (s): US-WYE-H0160507 (adverse event, expedited).
An expired Covid-19 pfizer vaccine was administered to the patient on 4/18/22.  The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22 at 7:51am, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to. Spoke with patient's daughter on 5/10 and will consider bringing her mom in to get revaccinated.
This spontaneous report was received from a other health professional refers to a male patient of unknown age. On 07-OCT-2014 the patient was vaccinated with GARDASIL lot # H021862, expiry: 09-OCT-2015 (dose, dose # and route unspecified). No concomitant medications were reported. On 07-OCT-2014 (also reported as shortly after), patient received a dose of GARDASIL and felt dizzy shortly after but they believe it was because the patient did not eat and also he saw blood. Healthcare worker reports that the patient recovered within a half an hour on 07-OCT-2014. The outcome of saw blood and patient received a dose of the GARDASIL on 10/07/2014 and felt dizzy shortly after was reported as recovered/resolved. The outcome of patient received doses that were exposed to temperatures outside of the proper storage was unknown. Causality assessment was not provided for the events. There was no product quality complaint (PQC) involved. Additional information has been requested.
This spontaneous report was received from a healthcare worker regarding a female patient of unknown age. The patient's concurrent conditions, medical history and concurrent conditions were not reported. On 06-SEP-1991, the patient was vaccinated with MMR II dose 1, subcutaneous (dose, lot # and expiration date unknown) and again on 06-JUN-1995, the patient received vaccination with MMR II dose 2, subcutaneous (dose, lot # and expiration date unknown) to prevent MMR II. On an unspecified date after the vaccination, a blood titer was drawn and the patient was found to be negative for rubella antibodies. The patient's status at the time of this report was not specified. The outcome of the event was unknown. Causality was not provided by the reporter. Additional information has been requested.
This spontaneous report as received from a licensed practical nurse refers to a multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown date, unspecified patients were vaccinated with doses of improperly stored MMRII lot # K024036, expiry date 26-NOV-2015 or lot # L024265, expiry date 01-JUL-2017 (routes and sites of administration, doses were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever at 100, massive headache, crucial body aches, fatigue for  5 days and still not able to go to work. Dizziness and nausea..  the appearance of a clot between my neck and shoulder..
Screamed x 3 hours inconsolable - "stopped breathing" per mother taken to ER admitted - stable ER/pediatrics thought breath holding spell.
pt recvd vax & 5 days later was admitted to hosp w/ thrombocytopenia manifested by hematuria & tarry stools;
pt recvd vax;1MAR95 soreness at site of inject;2mar95 swelling inc in arm,tingling in fingers;swelling below elbow; T 100.6;dph given;
Vaccine given 10/15/2021 @ 330pm Headache 20 minutes after vaccine Weird head fog 20 minutes after vaccine Shooting pain right kidney area at 5pm Metallic Taste in mouth 530pm Sleeping at 8pm Up every 2 hours or so throughout the night Achy body 1030- painful aches, shivers, hurts to move Fell asleep at 1130am Woke up at 430 feeling light headed, less achy, hot/cold, sweaty Bed at 8pm- noticed pain in right armpit. fell asleep at 830- up every 3 hours with pain Woke up at 630- pain in armpit worse, swollen, side pain
Excruciating pain on my neck right side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 (Lot number: EN6208, Expiration Date: 30Jun2021) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Mild asthma" (unspecified if ongoing), notes: Verbatim: Mild asthma; "Rheumatoid arthritis" (unspecified if ongoing), notes: Verbatim: Rheumatoid arthritis; "Hyperlipidaemia" (unspecified if ongoing), notes: Verbatim: Hyperlipidaemia; "Glaucoma" (unspecified if ongoing), notes: Verbatim: Glaucoma in both eyes; "Eczema" (unspecified if ongoing), notes: Verbatim: Eczema; "Vitamin D deficiency" (unspecified if ongoing), notes: Verbatim: Vitamin D deficiency; "Mitral valve prolapse" (unspecified if ongoing), notes: Verbatim: Mitral valve prolapse; "Essential hypertension" (unspecified if ongoing), notes: Verbatim: Essential hypertension; "Oedema" (unspecified if ongoing), notes: Verbatim: Edema; "Blood cholesterol increased" (unspecified if ongoing), notes: Verbatim: High cholesterol. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; VITAMIN D3 taken for vitamin d deficiency; BENADRYL; LATANOPROST taken for glaucoma; TIMOLOL MALEATE; ALBUTEROL SULFATE; MOBIC; SIMVASTATIN; HYDROCHLOROTHIAZIDE; FLUTICASONE PROPIONATE; OMEPRAZOLE; CALCIUM D3; VITAMIN C [ASCORBIC ACID]. Vaccination history included: Bnt162b2 (Dose 1, Single. Lot Number: EL9266, Expiry date: 31May2021, Anatomical approach site: Arm Left), administration date: 26Mar2021, for COVID-19 immunisation. The following information was reported: NECK PAIN (non-serious) with onset 27Apr2021, outcome "unknown", described as "Excruciating pain on my neck right side". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of neck pain.  Additional information: I have Digestive belly probiotic that I take. It is one tablet a day.There is a explanation point, EBS neutrophils 9.50. I see the result but the doctor hasn't called me back to discuss with me. So, I am looking at the value that came in the test. It gives the range." The patient took Multivitamins. The Patient took Prednisone, methocarbamol , lidocaine the patch and physical therapy   No follow-up attempts are possible. No further information is expected.
Received flu shot and TB screen on 10/29/18 at 1615. Head to toe rash discovered 10/30 at 0830.