chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated.) and NO ADVERSE EVENT (No adverse event) in a 10-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Apr-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 22-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated.).    Concomitant medication was not provided.  Patient was administered with Monovalent Moderna vaccine as first dose on 20-Mar-2023, at a dose of 25mcg with batch no: AS1903B.  Patient was given with appropriate vaccine or scheduled as per CDC.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2023: Follow-up received, contains non-significant information. On 20-Jul-2023: Follow-up received and added patient initials and details, added secondary reporter, added primary reporter information, added dosage information of suspect, added onset date of event and I narrative updated.
Excessive crying at time of event until subsequent lethargy and poor responsiveness. Hard to arouse for about 30 minutes after injection. Pale.
Initial report received on 11/Jul/2006 from a health care professional. A 31 year old female patient with a past medical history that includes the current pregnancy, allergy to Penicillin, and two previous pregnancies that resulted in the delivery of one normal/viable infant per pregnancy had received a 0.5ml intra muscular dose of Adacel, lot number C2340AA, in the left deltoid, on 11/Jul/2006. The patient had been vaccinated with Adacel for an injury she received to her toe. Her last menstrual period was on 14/Dec/2005. Her expected date of delivery was not provided. Per the reporter, the subject has not experienced any adverse events since the vaccination with Adacel on 11/Jul/2006. Follow up information received on 06 November 2006. The completed Pregnancy report form was received. The patient had the following significant medical conditions. Diabetes Mellitus II, Ovarian cancer and obesity. The date of her last menstrual period was 04 Dec 2005 and her estimated date of delivery was 26 Sept 2006. She had 3 previous pregnancies, 2 of which resulted in live births, with no congenital anomalies and 1 of which resulted in a spontaneous abortion prior to 20 weeks gestation. The patient also exposed to the following drugs. Prenatal vitamins with Iron for an intrauterine pregnancy indication-taken per os at the start of the pregnancy and Zyrtec for an allergy indication taken per os at 20 weeks of the pregnancy. Her current pregnancy history consisted of Group B strep and gestational diabetes mellitus at 34 weeks with normal results. The patient gave birth vaginally on 18 Sept 2006, at 39 gestational weeks, to one female, live child with no congenital anomaly. The child's weight was 5 lbs, 10.8 oz and her length was 18 1/2 inches. Her apgar scores were 8 at 1 minute and 9 at 5 minutes. Follow up information received on 05 January 2007. The baby continues to do well. Follow up information received on 29 January 2007. After internal review, case upgraded to serious status. The patient had 3 ultrasounds and they were all normal. She had gestational diabetes prior to receiving Adacel. Her blood sugar at the time of injection was 81. She is not obese and dose not have ovarian cancer.
Information has been received from a pharmacist concerning a 63 year old patient who on 14 Dec 2006 was vaccinated SC by the pharmacist with a dose of Zostavax (lot #654604/1406F). After vaccination, there was fluid leakage from the injection site. The pharmacist reported that he used a 5/8 inch needle and he gave the injection at a 45 degree angle. AS of 02 Jan 2007, the reporter noted that the patient has not reported any adverse experiences. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Daily hives & itchiness. The location varies and has been on the lower portion of my scalp by my neck, neck & upper back, torso, armpits, back, upper thighs by groin, palms of hands, and bottom of feet. The itchy, hot, tingly feelings starts first, and I scratch my skin as a result. Minimal itching produces red, raised welted bumps, scratch marks or larger areas that last an hour or more and eventually go away if I don?t scratch the area again. I?ve never once had hives in my life and had only heard about them from others (therefor realized what they were when seeing them & looked it up on the internet). Been taking 24 hour Zyrtek, which has helped helped, but the symptoms return after about 24 hours.
Patient states that his blood pressure has been high ever since he got the shot. He also stated that he's been having heart pains. Patient stated that he has a doctors appointment on Thursday 08/12. Patient has not recovered from adverse events.
Patient became very dizzy, lightheaded, lost balance, sweating. emergency services was contacted and was evalualted by EMS. EMS left scene, patient felt  completely recovered after waiting in the store for 45 mins and left facility . Patient mentioned after the incident that this has occured with other vaccines. Patient did not indicate this  history prior to covid vaccine adminsitration or episode
Pain and lump noticed 10/15/2012 evening. 10/16/2012 redness 1 in around injection site.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039E21A and 01421A) for COVID-19 vaccination.     Concurrent medical conditions included Depression since 2010 and Diabetes. Concomitant products included ARIPIPRAZOLE (ABILIFY), VORTIOXETINE HYDROBROMIDE (TRINTELLIX) and ALPRAZOLAM (ZENAX) for Depression, METFORMIN for Diabetes.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-085244 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: TCR from follow up received and outcome of event was resolved
On May 22, 1999 the pt was seen by a physician and confirmed to have chickenpox, with less than 100 lesions.
discomfort on my legs arms and hands; This case was reported by a consumer and described the occurrence of leg discomfort in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included poison ivy rash (at the time of the shot had beginning of a poison ivy reaction occurring on my forearm).   On 5th June 2020, the patient received the 1st dose of Shingrix. In June 2020, less than a week after receiving Shingrix and an unknown time after starting triamcinolone, the patient experienced leg discomfort. The patient was treated with triamcinolone and prednisone. On an unknown date, the outcome of the leg discomfort was not recovered/not resolved.   It was unknown if the reporter considered the leg discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had poison ivy reaction and levels of discomfort on my legs, arms and hands. The reporter suggested topical triamcinolone acetate cream versus an intermuscular shot or oral prednisone due to the concerns of the effect of introducing systemic steroids and its adverse effect regarding the vaccines ability to prompt my body to create antibodies relative to the herpes zoster virus. The reporter asked at what point the patient receive systemic corticosteroids to treat my worsening reaction, inflammatory response to the poison ivy so as not to interfere with the efficacy of the vaccine.
Body started to shut down/ Can't open the eyes; Can't do anything, can't feed herself and can't go to bathroom; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of ILL-DEFINED DISORDER (Body started to shut down/ Can't open the eyes) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't do anything, can't feed herself and can't go to bathroom) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILL-DEFINED DISORDER (Body started to shut down/ Can't open the eyes) (seriousness criteria hospitalization and life threatening) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't do anything, can't feed herself and can't go to bathroom) (seriousness criteria hospitalization and life threatening). At the time of the report, ILL-DEFINED DISORDER (Body started to shut down/ Can't open the eyes) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't do anything, can't feed herself and can't go to bathroom) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case concerns a 92-year-old female hospitalized with serious unexpected events of ill-defined disorder and loss of personal independence in daily activities. Event onset with unknown latency after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: This case concerns a 92-year-old female hospitalized with serious unexpected events of ill-defined disorder and loss of personal independence in daily activities. Event onset with unknown latency after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Extreme discomfort when shot administered.  Sore injection site, with large senstitive lump and grapefruit-sized red area, lasted four days.  Unable to participate in mandatory fitness program.
I noticed around the injection site it was red, hot to the touch, and itchy. I put some anti-itch cream on it. Then I noticed a red, round, baseball sized bumb on the front of my left arm not near the inject site. It stayed there for 4 days then it started to go down after 7 days. I just took some anti-itch medicine, but it didn't help. It eventually went away after about 10 days.
lost taste and smell; lost taste and smell; This is a spontaneous report from a contactable consumer (patient) or other non hcp reported. A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 2 via an unspecified route of administration on 28Jan2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunisation (the patient works for Doctor's office). The patient received the first dose of BNT162B2 on 06Jan2021, and had headache and was tired. The patient medical history and concomitant medications were not reported. The patient experienced lost taste and smell on an unknown date in Jan2021 (3 days after she lost taste and smell and are still gone. The patient feel fine. The patient just wish she could taste food and smell the perfume). She was wondering if we have any information on how long this might last. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Notice painful bump/knot and redness in right arm 2/24/2021 Narrative:
Here today for concern for immunization reaction. She received MMR and Tdap to her right arm on 8/5/22.  Starting Sunday night, she started to notice some red, mildly painful spots to both hands and feet. Had evaluation at urgent care following, didn't think it was HFMD.  No fevers.  Today she has 2 spots to left hand, 2 spots to right hand, 10 spots to left foot, 5 spots to right foot. These continue to be mildly painful. Have not changed since first noticed: no papule development or blister formation.  Typically participates in gymnastics: they stayed at home in case of HFMD.
Fever for 3 days at this point - 100, worst is joint pain, all on my right side (shot was on left side).  Right wrist and forearm feels like it was broken - pain, and inability to put any pressure on my right hand/wrist - extreme pain from simple touch like touching a kleenex to my nose, lifting an empty plastic glass, even touching my wrist in the bed when sleeping.   Pain in my right hip, right shoulder, a  previously broken toe - bizarre.  Have worn a wrist brace.  Dizziness, grogginess extreme exhaustion.
Information has been received from a 75 year old female patient who on 30-JUN-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# unknown). On 02-JUL-2010 the patient experienced a rash at the injection site. The patient's rash at the injection site persisted. The patient sought unspecified medical attention. Additional information has been requested.
muscle soreness at injection site; Chills; fever (100.5F); This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, administered in Arm Left on 18Feb2021 10:00 (at the age of 34-years-old) as single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications included Ibuprofen at 600 mg, as needed and vitamin d3. The patient's medical history was not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, administered in Arm Left on 27Jan2021 02:00 PM (at the age of 34-years-old) as single dose for covid-19 immunisation and experienced muscle soreness at injection site starting 1 day after injection and lasting 3 days. On 18Feb2021, the patient experienced muscle soreness at injection site starting day of vaccination and lasting 3 days, chills and fever (100.5F) starting 12 hours post-vaccination and lasting until about 30 hours post-vaccination. The patient underwent lab tests and procedures which included body temperature: 100.5 Fahrenheit on 18Feb2021. The patient did not receive any treatment for the adverse events. The outcome of the events was recovered on an unspecified date.   Follow-up attempts completed. No further information expected.
About 3am on 3/30/21 (12 hours after the shot) I became nauseous. Suffered a small panic attack.  Became lightheaded, tired. I sat on the floor had a granola bar and a soda and that helped. During the course of the night my skin turned sensitive, muscles joints and neck became achy and I was experiencing a fever and chills. Upon waking still felt nauseous, tired,  still feverish and achy. Took temp it was 100.2.  Took 400mg advil. Felt blood sugar drops throughout the day and felt best after having fast sugars.  Injection site grew to about 3 inches in diameter was raised and hard.  By 3/31/21 no longer achy, but very tired and blood sugar continued to dip easily. Injection site still raised and hard and a smaller circle, approx 1.5 inches in diameter, within the larger circle developed and showed signs of peeling.  04/1/21 Still easily fatigued fever down to 99 degrees. Injection site still raised and hard but softening.
In the process of vaccination, a small amount of the vaccine leaked out between the hub of the needle and syringe. This was a booster vaccine dose given.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 31-JAN-2013, the patient was administered with a dose VARIVAX (Lot # 1909AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Headache, chills/fever, bone pain (in long bones, not joint pain), nausea, fatigue
Right after shot was given. Instantly tasted, throat was dry. Around 6 p.m. my right ear starting hurting, then headache. After waking up at 3:30 a.m. body aches, full headache, upset stomach, just felt like a major fog.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 43-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "known allergies: Second generation cephalosporins" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid treatment from 01Nov2023 to 05Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a vaccine varies individually and can be affected by different factors including product potency. However, a contributory role of bnt162b2 omi xbb.1.5 to the events Vaccination failure and Covid-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300367219 same patient/vaccine, different drug/event (Paxlovid case);
5 days after 1st vaccine, experienced sync opal event at home. .Arrived at work 12/28/2020 feeling slightly lightheaded and tachy. went home.
Every since i got the second shot my entire right arm has been numb. I sought medical treatment and was told get a EMG done. Got the EMG done still no one can tell me what is wrong.
Bad chills [under 6 blankets, with electric blanket], fever of at least 38.8C, migraines, diarrhea, nausea, dizziness, arm pain/swelling for ~36 hours. Slept finally. Woke up soaked in sweat, fever broke, now is Sunday evening and I feel mostly good!
chills, fever 102, rash (eruption & urticaria), malaise, arthralgia, thrombcytopenia, leukopenia, anemia;
H1N1 admin at school setting-patient returned c/o "numbness to left hand and rash to hand"- hands cold- bil equal- left hand blotchy no rash. No rash to trunk abdomen back no edema to face no dyspnea-Benadryl 2 tsp adm. Patient responded with relief within 5 min.
Several red welt like pimples on my cheek (face) and on my chest : Red dot rash in under abdomen skin.
Patient was inadvertently administered 2 doses of Pfizer Bivalent covid vaccine.  This is a report of the vaccine error only. Patient has not reported any adverse effects.
Patient was given vaccination at about 1:55PM with no problem. Husband told me following morning around 5:00am she experienced nausea, feet swelling, tongue swelling, pain in sternum and BP of 90/60. Patient went to the ER and received Prednisone 20mg - 2 tabs twice daily for four days.
Right thigh swelling, increase warmth, mild hyperemia and tenderness, Ice, Ibuprofen.