chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received both doses of the moderna vaccine 14 days apart; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received both doses of the moderna vaccine 14 days apart) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027D21A and 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received both doses of the moderna vaccine 14 days apart). On 12-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received both doses of the moderna vaccine 14 days apart) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Follow up received included phone number and fax number of reporter was added.
STROKE; This spontaneous report received from a patient via a company representative via social media concerned a 75 year old patient of unspecified sex, race and ethnic origin. 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 (dose number in series 1) (suspension for injection, route of admin was not reported, and batch number: unknown expiry: unknown) dose was not reported, 01 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On APR-2021, 5 hours after vaccination the patient went to the emergency room with a stroke. The doctor said that the stroke was because of the patient's age and not because of the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20211248815-Covid-19 vaccine ad26.CoV-2.s- Stroke. This event is considered unassessable. 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.
Adverse Events: Redness, elevated temperature to touch at injection site, extreme swelling and pain in 3 inch diameter around injection site Treatment:  Iced multiple times for 10-15 minute intervals.
Bloody nose three days in a row. April 4, 5, 6, 2021. Chills, fever, aches and pains, tired. Administered for 2nd COVID vaccination.  Administration was at supermarket
really intense bad Charlie horses for ages/  Charlie horses are now very slight and not constant; a weird taste in my mouth; brain stuff; Legs Hurt; Legs Swollen; Diarrhea; Vaccination site pain; Body pain Increased; Fatigue Increased; Headache a weird different kind of headache; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Legs Hurt), PERIPHERAL SWELLING (Legs Swollen), DIARRHOEA (Diarrhea), VACCINATION SITE PAIN (Vaccination site pain) and MYALGIA (Body pain Increased) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fatigue and Pain.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), VACCINATION SITE PAIN (Vaccination site pain), MYALGIA (Body pain Increased), FATIGUE (Fatigue Increased), HEADACHE (Headache a weird different kind of headache), CHILLS (chills) and NAUSEA (nausea). On 09-May-2021, the patient experienced PAIN IN EXTREMITY (Legs Hurt) and PERIPHERAL SWELLING (Legs Swollen). On an unknown date, the patient experienced MUSCLE SPASMS (really intense bad Charlie horses for ages/  Charlie horses are now very slight and not constant), DYSGEUSIA (a weird taste in my mouth) and CEREBRAL DISORDER (brain stuff). On 09-May-2021, DIARRHOEA (Diarrhea) had resolved. On 25-May-2021, PAIN IN EXTREMITY (Legs Hurt), VACCINATION SITE PAIN (Vaccination site pain), MYALGIA (Body pain Increased), FATIGUE (Fatigue Increased), HEADACHE (Headache a weird different kind of headache), CHILLS (chills) and NAUSEA (nausea) had resolved, PERIPHERAL SWELLING (Legs Swollen) had not resolved. At the time of the report, MUSCLE SPASMS (really intense bad Charlie horses for ages/  Charlie horses are now very slight and not constant) had not resolved and DYSGEUSIA (a weird taste in my mouth) and CEREBRAL DISORDER (brain stuff) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided by the reporter no treatment information reported by the reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No new information added. On 22-Jul-2021: Follow-up  information received contains significant information - Updated  lab test information :patient received an Echo and Ultrasound of her legs On 10-MAY-2021.
1/6 vaccination Almost immediately, my arm started hurting really quick. The heaviness I felt in R ear and R side of face; cheek and chin. Vitals were ok. Symptoms lasted for 30 minutes and subsided.
POST Vaccine and for years of feeling as if I was dying or becoming paralyzed -- Musculoskeletal and connective tissue disorders.  Symptoms described to Doctors included terms like "full body paralysis, limb paralysis, buzzing feeling, tingling in arms and legs, feeling of being crushed.  Enlarged lymph nodes.
it was rpt fr MD concerning pt who was vax in 1997 & in 25dec98 pt devel herpes zoster. pt rpt quite sick w/headache & fever. addl info requested
Received COVID-19 Vaccine on Wednesday 01/27/2021. On Thursday 01/28/2021; I woke up with a Severe Headache; Fatigue; and site pain. My temp was 99.5.
4PM pt recvd MMR vax then stated didn't feel good, appeared to be having a sz; turned blue in color; c/o numbness in fingers & both hands;
I had my flu shot and developed bad joint pain the day after and over the last two days, I have developed neck, hand, and foot pain.  My hands and feet develop numbness and tingling through the night and are swollen by the morning.
Using another diluent than recommended; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution 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: 09-Aug-2022 Reporter comment: A nurse reported that a box of Rotarix vaccines had an extra diluent. The nurse explained that the potential risk of a patient who may be administered with Rotarix using another diluent than recommended. The nurse was not sure if the vaccine was administered orally or using another route. The reporter consented to follow up. Additional Supportive Information: Rotarix reconstituted with another diluent than recommend, which led to wrong solution used in drug reconstitution.
pt screamed incessantly from 8PM to 1230AM; starting 2 1/2 hrs p/vax; warm to touch APAP given & repeated p/tc to md; lunp & bruise @ DTP site;
chills; fever; fatigue; face hot to touch; blotchy skin.; Eyes watering; burning of face.; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unspecified date in Mar2021 at 13:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included pre-diabetic and hypothyroidism. The patient had no known allergies. Concomitant medications included metformin (MANUFACTURER UNKNOWN), semaglutide (OZEMPIC) and levothyroxine sodium (SYNTHROID). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. On an unknown date in Mar2021 at 21:30, the patient experienced chills, fever, and fatigue for the first 2 days, hot to touch and blotchy skin on the fourth day. The patient experienced eyes watering from the burning of face. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatments for the events. The clinical outcomes of the events chills, fever, fatigue, face hot to touch, watering eyes, skin blotches and burning of face were recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Had the expected fatigue headache but two days later on Saturday I lost taste and smell as of today still have not returned.  Fatigue and headache still present as well.  Sinus congestion
Client presented to Flu Vaccine Clinic. Client received intradermal preservative free influenza vaccine. Shortly after receiving vaccine, client stated she was not feeling well. Client stated she felt dizzy, has an odd sensation in her face and a bad taste in her mouth. Client stated that at first she felt her vision change when she was light headed. Client denies any rapid heart beats, itching, swelling, or shortness of breath. Client stated she did eat breakfast this morning before coming to the clinic. Client denies fear of injections or needles. RN waited with client for 20 minutes. Clients pulse and temperature taken. Pulse 72 | Temp(Src) 95.8 °F (35.4 °C) (Oral). Client given a glass of cold water to drink. After resting for 10 minutes client stated she was feeling better, her vision had returned to normal, the taste in her mouth diminished. RN had client wait an additional 5 minutes after stating she felt better. Client stated that she was recently diagnosed with a peanut allergy, client denies any other allergies. RN explained allergic reaction symptoms to client and encouraged client to call 911 should any of the symptoms present. Client was able to repeat back information. Client encouraged to take a Benadryl tablet when she returns to home to help control her symptoms. Client left with her 1 year old son to drive herself home. Client had no other questions or concerns at this time.  RN called client at 11:30 am to verify that client was doing well at home and has not developed additional symptoms. Client states she is feeling much better. Client reports that she ate lunch. Client states that she still has a slight abnormal taste in her mouth, but otherwise the symptoms have subsided. Client encouraged to notify her primary MD of event at her next appointment.
Numbness in hands and feet during the day but most sever at nights when trying to sleep. Constant itchiness in forearms all day on and off. The only thing that I found to help relieve the itchiness is Aloe Vera gel. Sensitivity to outdoor lighting when I go outside. I have to where sunglasses. Anxiety when driving. It feels like a tense pressure is put on my chest.
Caller reports that to her knowledge no other adverse effects were experienced by this patient.; Caller reports that a 15 year old received PROQUAD in error on 16Feb2023.; This spontaneous report has been received from a registered nurse, regarding a 15-years-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 16-FEB-2023, the patient was vaccinated in error with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous injection as prophylaxis (lot number: W024549, which was determined to be valid, with an expiration date on 31-JAN-2024) (strength, dose, scheme, route of administration was not reported) (Product administered to patient of inappropriate age).   Caller reports that to her knowledge no other adverse effects were experienced by this patient and inquired if this could be counted as a valid dose in MMR &/or Varicella series.   This case is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2303USA001739:
Arm pain 7 days after injection. Injection was given too high up on the arm.  Possibly now bursitis.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild
07May2022 AG test (Positive); 07May2022 AG test (Positive); sore throat; cough; headache; hoarse voice; squeezing; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EL3247), on 15Mar2021 as dose 2, single (Lot number: EL3247), on 23Nov2021 as dose 3 (booster), single (Lot number: FF2589) and on 08Apr2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07May2022, outcome "recovering" and all described as "07May2022 AG test (Positive)"; COUGH (non-serious) with onset 07May2022, outcome "recovering"; HEADACHE (non-serious) with onset 07May2022, outcome "recovering"; DYSPHONIA (non-serious) with onset 07May2022, outcome "recovering", described as "hoarse voice"; OROPHARYNGEAL PAIN (non-serious) with onset 07May2022, outcome "recovering", described as "sore throat"; FEELING ABNORMAL (non-serious) with onset 07May2022, outcome "recovering", described as "squeezing". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Positive, notes: 07May2022 AG test (positive). It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, oropharyngeal pain, cough, headache, dysphonia, feeling abnormal. Clinical course: Facility type vaccine reported as Workplace clinic. If other vaccine in four weeks reported as Unknown. If other vaccine in four weeks reported Unknown. If COVID tested post vaccination reported as Unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was exposed to his wife who started feeling bad on Thursday and tested positive for Covid-19 on Friday 12-OCT-2021. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration not reported, batch number: 204B219, expiry: unknown) dose was not reported, 01 total administered on 15-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-DEC-2021, the patient experienced suspected covid-19 (coronavirus disease) infection. Patient stated that on 12-DEC-2021 late in the afternoon, he started experiencing symptoms which included cough, nasal congestion, fever, loss of smell, loss of taste and body aches. On same day patient underwent COVID-19 (coronavirus disease) rapid test which was found to be positive (suspected clinical vaccination failure). Reportedly, on an unspecified date in DEC-2021 patient was also underwent to COVID-19 PCR (polymerase chain reaction) test and awaiting for PCR test results. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000206881 and 90000207019. The suspected product quality complaint has been confirmed to be not voided. The reported allegation could not be confirmed and a manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20211230245-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Patient reports he started with "red dots" on both feet the same morning he received the covid shot.  As the day progressed the red dots moved to his thighs, then his stomach, his right arm, a little on the left arm and his right neck.  He referred to the rash as "hives."  States he was very itchy.  He took Zyrtec daily.  Had the rash for about 5 days.  Did not seek any medical attention for this rash/reaction.
patient forget to get his second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 2nd October 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-JUL-2022 Reporter's Comments: The pharmacist reported that the patient forget to get his second dose of Shingrix. The pharmacist was unable to provide further information. The data regarding Shingrix was no longer in system. The VAERS details reported for 1st dose of Shingrix. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Pt accidentally received 2 KINRIX vaccines - was supposed to get 1 KINRIX and 1 PROQUAD - once the MA realized his mistake the Dr was notified, poison control was called to make sure no side effects - parents notified.
My skin feels like it?s burning from the inside and I constantly feel like I have a fever, but I have no temperature, I can?t sleep at night and have the night sweats, and get nauseous after I eat, and have a constant feeling of unease and brain fog. Symptoms set in about 7 hours after injection.
9 days p/vax pt exp chickenpox w/several hundred generalized lesions over body.
Patient sent from her PCP to our ED with painless peripheral purpura in toes of both feet  first noticed 4 days after vaccination. Also to found to have buccal petechial lesions on exam. Patient is otherwise healthy but states that she has son who had similar symptoms with a childhood vaccine and developed ITP at the time (MRN: 3326224)
Macular rash on face, neck, trunk, arms.  Face hot to touch & swollen.
Patient reported that when she removed bandaid from site the next morning, it was red , warm with hardened area.  Today 7/29/2019, RN looked at area.  Now pink, slight warm to touch and small hardened area.  Patient reports tenderness.  Patient reports improvement in area
Tdap and Ipol were administered first to left deltoid and then Gardasil to the right deltoid, Pt. was sitting in chair in nurses office for administration. About 15-30 seconds after all immunizations were administered patient fainted. Patient's mother, interpreter, and 2 nurses were present with patient. Patient was unconscious for less that 15 seconds and then appeared drowsy afterwards. Patient was monitored by nurse for 30 minutes, cold wet towels applied to patients forehead and neck. Patient was also given a coke to drink. After about 30 minutes patient requested to use the bathroom and was assisted by the nurse to the restroom. After using the restroom patient stated that she was feeling better and left with her mother.  Patient was assisted out to the car in the parking lot by the interpreter.
Report left thumb pain started with 15 minutes of receiving the vaccine and resolved 15 minutes after receiving the vaccine. Report today 4/22/21 constant pain of the left thumb, report pain with movement, and mild swelling. Treatment: Tylenol with no improvement. Outcome: Does not interfere with ADLs, will continue to monitor and follow-up with primary doctor if worsens
Pt was administered Influenza high dose vaccine, although had already had one 33 days prior at a different facility. The plan was for pt. to receive a pneumococcal vaccination, and medical assistant made error in selecting correct vaccine. Influenza high dose was also given to this patient on 9/29/17 in left deltoid with Lot# UI830AA per State registry information. Pt. developed cellulitis, saw Dr. on 11/02/17 and was prescribed cephalexin 500 mg for 10 days. Pt presented to ER and admitted on 11/04/17 with swelling and cellulitis of right upper extremity, discharged 11/05/17. Was given (in addition to current ciprofloxacin) metronidazole prescription for 10 days.
Because I have Stage 4 CKD i get monthly blood tests to check my  Creatinine level. My Creatinine level had been hovering around 5. Following my vaccination it spiked to 5.89, which might have required me to  start dialysis. However in two subsequent blood tests it has been moving back down toward 5. A chronology of my blood test creatinine and my Covid vaccinations follows: Creatinine EGFR and  Vaccine Date  Creatinine EGFR 11/30/2020 5.18  10 1/2/2021 4.88  10 2/4/2021 5.01  10 2/5/2021 First Pfizer Vaccination 2/26/2021 Second Pfizer Vaccination 3/4/2021 5.89  8 4/8/2021 5.56  9 4/22/2021 5.14  10
This 22 year old reports receiving his PPD on 5/20/2005 to the left forearm.  It was read 3 days later as negative with no rash, redness, induration, nodule noted.  Approximately two days later he noticed a red streak bumpy rash about the PPD site.  There was minimal pruritis, no swelling, nodules or blisters noted. He denies use of a bandaid to the site, new detergents, soaps, clothing or being bitten by any insect.  He was afebrile without red streaks.  This "bump" became 3 small streaks on 6/3/05.  He contacted allergy and immunology who referred him to the HC for evaluation. He also received HEP A #2 and IPV vaccination w/o complaints.