chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 73 year old white female with an aspirin allergy and a penicillin allergy, hypertension (stable), hyperlipidemia (stable), and osteoarthritis (stable) who on 11/24/04 was vaccinated IM in the left deltoid with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot # 647681/0986N). Concomitant medications included levothyroxine sodium, simvastatin, valdecoxib, and a multivitamin. Subsequently, the patient developed a mild local reaction. The patient was seen in the office on 11/26/04 and treated with moxifloxacin hydrochloride as a prophylaxis. The reporter indicated that on 11/24/04 the patient's husband also received pneumococcal 23v polysaccharide vaccine from the same vial, and developed cellulitis (WAES0412USA00518). The reporter stated that other patient's also received pneumococcal 23v polysaccharide vaccine from the same vial, and did not experience adverse symptoms. The patient's outcome was unknown. Follow up information indicated that the patient returned to the office on 11/26/04 with a localized area of redness, swelling, and discomfort over the injection site in the left deltoid. Diagnosis was cellulitis versus local reaction to pneumococcal 23v polysaccharide vaccine. The patient was treated with warm compresses, ibuprofen PRN and moxifloxacin hydrochloride. The patient recovered. The redness, swelling and discomfort at the injection site were considered other important medical event (OMIC). Additional information is not expected.
Red itchy area the size of a palm and bump at the injection site. Bump at not raised or warm. Local reaction only. No fever.
Started getting real bad body aches the night of the vaccine.  Aching, and Pain in lower back and sick feeling has lasted two weeks now? I dont know for sure if this is vaccine adverse conditon for sure, but all started after getting it? Could vaccine have affected my leukemia???
Redness, swelling and pain at site of injection. She was treated with Benadryl. Prednisone and Levaquin.
(R) UE swelling, redness, pain, from shoulder down into forearm. Seen in office 1-8-18 then patient admitted for IV fluids, antibiotics, BENADRYL, ice, elevation -> improved overnight.
jaundice,abd cramps,chills,nausea 15FEB96 recv Havrix inj
a patient?s  wife received  Shingrix on 7/1/19. He said she had a large bruise from the injection and after 2 weeks it finally disappeared.
BRIEF OVERVIEW: Discharge Provider: MD Primary Care Physician at Discharge: None Physician, DO None Admission Date: 8/25/2023   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Severe sepsis [A41.9, R65.20]   HOSPITAL COURSE: 78-year-old gentleman with dementia presented with hypernatremia and a positive COVID test found at his ECF.  Ultimately diagnosed here with severe sepsis, COVID, PNA, UTI, respiratory failure, bilateral DVTs, hypernatremia, AKI.  Family elected comfort care. He ultimately succumbed to his illness 8/27/23 at 1915 with family at bedside.
Caller states Daptacel was given instead of Adacel; Initial information received on 28-Oct-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 11 year old male patient who was administered diphtheria-15/tetanus/5 ac pertussis vaccine (Daptacel)  instead of diphtheria, tetanus, and acellular pertussis (Adacel) (wrong product administered) on 26-Oct-2020, (lot: C5621AA, expiry date unknown) at a dose of 0.5 ml (dose series:5) via via intramuscular route in left deltoid for prophylactic vaccination.  Concomitant medications included meningococcal vaccine a/c/y/w conj (DIP TOX) (Menactra); and Hpv Vaccine.  This was an actual medication error case due to the wrong product administered (latency: same day).  At the time of reporting, no adverse event was reported.  No laboratory data was reported.  Disclaimer: 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 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.
20Mar98 pt recv vax & devel temp & rash;3 other pt reported WAES98032507,98040053,98040055
5 minutes after vaccine injection reported bilateral arm tingling. Then proceeded to only left arm and leg numbness and tingling. Subsequently, left facial numbness with left side body weakness and numbness.
Flu like symptoms, redness and swelling Thursday.  Golf size lump and redness.  Seen in office again on Friday 06/24/2005.  Given Zyrtec for allergic type reaction.
Superficial blood clot; it was bigger after the first dose; Very painful to touch/arm was in pain; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Superficial blood clot) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Superficial blood clot) (seriousness criterion medically significant), VACCINATION SITE SWELLING (it was bigger after the first dose) and VACCINATION SITE PAIN (Very painful to touch/arm was in pain). At the time of the report, THROMBOSIS (Superficial blood clot), VACCINATION SITE SWELLING (it was bigger after the first dose) and VACCINATION SITE PAIN (Very painful to touch/arm was in pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.
Patient fainted after administration of 3rd vaccine (HPV-4). Pt was standing, fell forward onto exam table, then onto knees and onto floor. Immediately regained consciousness. Was put into sitting position with head between knees.
warm red patches in the injected arm; Welts in the injected arm; itching in the injected arm; soreness in the injected arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (warm red patches in the injected arm), URTICARIA (Welts in the injected arm), PRURITUS (itching in the injected arm) and PAIN IN EXTREMITY (soreness in the injected arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced ERYTHEMA (warm red patches in the injected arm), URTICARIA (Welts in the injected arm), PRURITUS (itching in the injected arm) and PAIN IN EXTREMITY (soreness in the injected arm). At the time of the report, ERYTHEMA (warm red patches in the injected arm), URTICARIA (Welts in the injected arm), PRURITUS (itching in the injected arm) and PAIN IN EXTREMITY (soreness in the injected arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Treatment medication and conmeds were not provided by the reporter.
SUPER SICK FOR LIKE THIRTY SOME HOURS, A DAY AND A HALF; BODY ACHE; CHILLS; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 (suspension for injection, route of admin not reported, batch number: Unknown) 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 patient experienced super sick for like thirty some hours, a day and a half, body ache, chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from super sick for like thirty some hours, a day and a half, and the outcome of chills, headache and body ache was not reported. This report was non-serious.
Information has been received from a pharmacist concerning a 18 year old female patient with no pertinent medical history who was vaccinated with the first and second dose of GARDASIL (lot number 658490/0802U for both doses) in 2008. After receiving her second dose in 2008 she experienced swelling, redness and pain in her left shoulder where she received the vaccination. She had pain when she moved. The patient did not seek medical attention. No treatment required. The patient recovered about 1 week after vaccination. Additional information has been requested.
MENSTRUAL CYCLE PREVIOUSLY HAD BEEN OCCURRING EVERY 23-24 DAYS; HOWEVER AFTER THE VACCINE, IT IS NOW >5 WEEKS BETWEEN.
Half hour from injection, vision started to become unfocused. Vision off and headache. Lightheaded; Half hour from injection, vision started to become unfocused. Vision off and headache. Lightheaded; Half hour from injection, vision started to become unfocused. Vision off and headache. Lightheaded; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 58-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) (Batch/Lot Number: FC3180) via an unspecified route of administration, administered in Arm Left on 14Aug2021 at 10:00 (Age at vaccination: 58-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. There were no concomitant medications. The patient had no allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. On 14Aug2021 at 10:30, The patient experienced half hour from injection, vision started to become unfocused. vision off and headache,Lightheaded. Hospitalization Prolonged was reported as no. Treatment received was reported as no. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Headache, chills, fatigue Narrative: Given 2 L IVF and discharged from ED
Information regarding PREVNAR was received from a healthcare professional regarding a 4-month-old male patient who experienced injection site abscess. The patient received a second dose on 24-Sep-2007.  The patient also received a dose of Haemophilus Influenzae B (manufacturer unknown) and a dose of BOOSTRIX (GlaxoSmithKline) on 24-Sep-2007. The patient received a second dose of PREVNAR on 24-Sep-2007. On 05-Nov-2007, while at the doctors for a cold, the patient was diagnosed with an injection site abscess in his right thigh. Treatment was not reported. The patient recovered, "but left permanent 5cm at site". See related case (s): US-WYE-H03233908 (adverse event, non-expedited). No additional information was available at the time of this report
On the evening of March 16th, pain started down the left side of neck and shoulder On the morning of March 17th, pain began to intensify down the neck, shoulder, shoulder blade area, and pectoral area  - went to urgent care where an X-Ray was taken.  I also given a prescription for a Tizandine, Naproxen, and Gabapentin On March 22nd, I went to my Primary Care Physician so the pain continued, he changed my prescription to Gabapentin and Prednisone.  - I stopped taking Tizandine and Naproxen,  From March 22 through April 1, the pain continued.  On April 2nd, I took an EMG Test The pain continued, on April 7th I went for an MRI Test
Pulsatile Tinnitus, First developed  2 days after second vaccination. Went to see an ENT doctor, he gave me hearing test, mine came out to have normal hearing,  he prescribed me to take steroids for 6 days, it did not improve the symptoms. Then he ordered the MRI, the MRI report showed no major concern. Then I went to see doctor for second opinion? he  reviews the MRI images on the computer for us to see together, MRI was fine, he said there's nothing he could do, there's no cure for tinnitus. Then he mentioned he had other patients came to see him for tinnitus, those were all happened after the vaccination.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Feb2021 at 13:00 as dose 1, single (Lot number: EN-5318), in left arm, on 06Mar2021 at 15:00 as dose 2, single (Lot number: EL-3246), in left arm and on 30Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FNI7553) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 19Nov2021 at 12:00 as dose 3 (booster), single (Lot number: 032F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "pneumothorax" (unspecified if ongoing), notes: History of recurring pneumothorax and pleurodesis; "pleurodesis" (unspecified if ongoing), notes: History of recurring pneumothorax and pleurodesis. The patient had no known allergies. Concomitant medication(s) included: VIVELLE DOT. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Pt received Pfizzer vaccine dose #1 in left deltoid on 01/11/22 at 9:30 AM. On 01/12/22 at 8:00 PM Pt and her mother noticed a rash on her left arm that mom described as being like eczema. Mom states, "she has eczema and the rash is like eczema". States that it is reddened and bumpy in patches on her arm. States that the patches of bumps are swollen, painful and itchy. States that patient has a few bumps on her right arm.  Mom has given Pt Benadryl and put a barrier cream over the rash. Mom states that she will call patient's provider if rash or swelling worsens.
This  86  year old    male received the Covid shot on  2/17/21    and went to the ED on 4/20 with abnormal lab of hypercalcemia and again on 4/25 with altered mental status  and was admitted  on   4/25 and died on 4/25/21.  Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
Soreness at injection site, full body aches and nausea one day after shot (9/28/2019).  Entire day.
Tiredness, headache, muscle pain, chills, fever, nausea, feeling unwell
In 1994, the vaccinee received an injection of Engerix-B. An unspecified time, post vax, the vaccinee experienced fever greater than 100.5F and an injection site reaction characterized by swelling. She was reportedly confined to bed for 4 days. She was not hospitalized; treatment was not specified. The IZ series was discontinued. The reporter stated that currently, the vaccinee's immune status is negligible. The events resolved after an unspecified period of time. The reporter stated that the events were probably related to Engerix-B administration.
Information has been received from a nurse practitioner concerning a 42 year old male with no known allergies who on 19-APR-2007 was vaccinated in the right deltoid with a dose of Pneumovax 23 (lot #654977/0888F).  Concomitant therapy included vaccination into the left deltoid with a dose of MENACTRA (lot#U2234AA).  On 11-APR-2007, at 11:00, the patient developed localized swelling in the right arm and a lump which measured 3 cm.  After 24 hours, symptoms were resolving.  No further information is available.
ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 3/31/2023 HX OF ACUTE KIDNEY INJURY ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 3/31/2023 BPH (BENIGN PROSTATIC HYPERPLASIA)
Patient did have an underlying medical condition of a mitochondrial disease at the time of his vaccine. Within about 7 days of receiving the vaccine he started running a fever, by day 7 he started with a rash, by day 10 he was covered head to toe in a measles rash, within a couple days his fever had spiked to 106 and he began vomiting, was hospitalized overnight. Prior to vaccine, babbling, smiling, happy. Within 2 weeks of vaccine he never smiled, babbled, or made eye contact again. It has been 18 months and he has now been diagnosed with low functioning autism.
This spontaneous report was received from a female consumer (age not reported) regarding on herself. On an unknown date the patient was vaccinated with a "one time vaccination" dose of ZOSTAVAX (Lot number, dose and site not reported), route reported as "vaccine". On an unknown date, after getting the ZOSTAVAX the patient got shingles. The outcome of shingles was unknown. The relationship between shingles and therapy with ZOSTAVAX was not reported. Additional information is not expected as no contact information is available.
onset approx 1/2 hr p/vax given;pt became flushed, gen weakness, felt as if going to pass out, & c/o severe abd cramping;lasted 1/2hr;nausea cont into evening;
I don't know. I received a telephone message saying that I  needed to  fill this out.  Since the COVID vax, I've been diagnosed with IBS in July 2021. Which I wasn't having an issue with before the vax. I was having issues with  constipation and then going to much. I have since been given dicyclomine 10mg which has  fixed everything.
Patient is here for a rash that Foster Mom noticed had started on his face this morning and has spread to his arms and abdomen. Foster Mom wonders if this is a reaction to immunizations he received 4 days ago: PREVNAR 13, INFANRIX, MMR, HAVRIX, ACTHIB and VARIVAX or a dairy allergy. He has not been on any ABx recently. Has not travelled outside the country in the last 30 days. Denies fever, chills, fatigue, severe headache, nausea or vomiting, diarrhea, abdominal pain, nonproductive cough or sore throat in the last 24 hrs.
Sore arm, shot site hard, swolen Chills, Fever, Malaise for 48 hours. Unable to sleep for extended time.
Vertigo after 2nd dose; Balance issues after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo after 2nd dose) and BALANCE DISORDER (Balance issues after 2nd dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 011J20A) for COVID-19 vaccination.     The patient's past medical history included Vertigo.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced VERTIGO (Vertigo after 2nd dose) and BALANCE DISORDER (Balance issues after 2nd dose). On 09-Mar-2021, VERTIGO (Vertigo after 2nd dose) and BALANCE DISORDER (Balance issues after 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2021, Antibody test: greater than 20 (Inconclusive) Greater than 20. On 10-Dec-2021, Antibody test: 13.5 (High) 13.5.         No Concomitant product use was reported.  The patient stated that within a month after 2nd dose, the patient had vertigo and balance issues for 1 week. The patient stated that they had a medical history of vertigo and was not sure if the vaccine caused it. On 27-May-2021 an antibody test result came back greater than 20 and on 10-Dec-2021 the antibody test result was 13.5 which was still pretty high but very good for almost a year after vaccination.  No treatment information was provided.   This case was linked to MOD-2022-441875 (Patient Link).
nurses administered a PENTACEL vaccine that was expired with no reported adverse event; administration of the medication through subcutaneous route with no reported adverse event; Initial information received on 23-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient who was administered a Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] that was expired and administration of the medication through subcutaneous route with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Oct-2023, the patient received 0.5 ml total (1 X) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ786AA) (Expiry date: 12-Oct-2023) (Strength: Standard) (Frequency: once) via subcutaneous route in the right thigh (Right Vastus Lateralis) for immunization.  On 20-Oct-2023, the patient was administered a Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine that was expired and administration of the medication through subcutaneous route with no reported adverse event (expired product administered) (incorrect route of product administration) (latency: same day).  It was reported, Caller stated last Friday one of their nurses administered a PENTACEL vaccine that was expired. She said it was only about 8 days past the expiration date and is asking if there is any kind of "grace period" MIA told her that it is not recommended by Sanofi to use any expired products, no matter how far past the expiration date. Nurse supervisor reporting that an expired PENTACEL was administered and is seeking guidance. This situation is reported as a medication error due to the administration of an expired vaccine. This situation is reported as an off-label use as per local labelling due to the administration of the medication through an unapproved route. subcutaneous.  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.
The RN picked up an empty syringe and administered to the patient before realizing there was no vaccine in the syringe.  The patient was subsequently vaccinated correctly after the error was discovered (within a short time).  The patient did not experience and adverse reaction to the vaccine once received.
Left facial paralysis, headache, left ear pain. Prescribed Prednisone and valacyclovir
The morning after my vaccination I felt a little itchy that continued to get worse throughout the day. That same Saturday night I was so itchy I could not sleep, Sunday morning I took a Levocetirizine and in about one hour the itching wren a way I also experience upper right quadrant pain during this time