chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe bronchitis; cough; chills; body aches; loss of taste and smell; fever; loss of taste and smell; breathing difficulty; This case was reported by a consumer via call center representative and described the occurrence of bronchitis in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (first dose of the Shingrix vaccine about 2.5 months ago, refer case US2020236573).   On 15th November 2020, the patient received the 2nd dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced cough, chills, general body pain, loss of smell, fever, taste loss and difficulty breathing. On 27th November 2020, the patient experienced bronchitis. The patient was treated with azithromycin and steroids nos (Steroids). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the bronchitis, chills, general body pain, loss of smell, fever, taste loss and difficulty breathing were recovering/resolving and the outcome of the cough was not recovered/not resolved.   It was unknown if the reporter considered the bronchitis, cough, chills, general body pain, loss of smell, fever, taste loss and difficulty breathing to be related to Shingrix.  Additional details were provided as follows: The patient had the chills, body aches and cough. In 4-5 days the cough became worse, had fever for a couple of hours, breathing difficulty, loss of taste and smell.  On 24th November 2020, the patient did a COVID test and she was positive. On 27th November 2020, the patient did a rapid COVID test and it was negative. The patient was seen at the emergency on 27th November 2020 at around 2 pm and was discharged at around 10 pm. She was diagnosed to have severe bronchitis and she was given Azithromycin and steroid. Customer states she was feeling better now and only had the cough. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020236573:1st dose
chest pain, low grade fever, chills/sweats, slight body aches, vomited all night long, hallucinations, and said her kidneys hurt. Pt did not go to the ER. Pts mother contacted me this AM via email. Pt better today with APAP PRN and rest
Fever at 101F, chills, full-body ache, fingertip ache, joints ache for 36 hours. Took Advil and Tylenol to reduce the pain and fever.
Mom brought two boys to imm clinic-mom requested only wanting to administer only 1-2 shots per visit as she was afraid of vaccines-after administering the 5 yo a HBV and MMR I began screening the two year old-mom then began asking questions about vaccines-I spent 15-20 minutes educating her on the risk of VPD's-then she changed her mind and asked that all shots be given to both boys that were needed-the boys were running around the room-the mom was accompanied by another woman who also was afraid of vaccines-they were conversing-the room was chaotic-I then administered all shots to 2 you-then returned to the 5yo to finish his additional shots that were needed-I left room to get those vaccines-I then administered the remaining shots including a second HBV-good news is that both boys left up to date with immunizations.
felt like she had the flu; Fever; slept all day; a little headache; felt tired; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like she had the flu), PYREXIA (Fever), SOMNOLENCE (slept all day), HEADACHE (a little headache) and FATIGUE (felt tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013203A and 030MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), CETIRIZINE, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION), ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like she had the flu), PYREXIA (Fever), SOMNOLENCE (slept all day), HEADACHE (a little headache), FATIGUE (felt tired) and OROPHARYNGEAL PAIN (sore throat). The patient was treated with AMOXICILLIN for Sore throat, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (felt like she had the flu), PYREXIA (Fever), SOMNOLENCE (slept all day), HEADACHE (a little headache), FATIGUE (felt tired) and OROPHARYNGEAL PAIN (sore throat) outcome was unknown.
Patient stated he had a seizure four hours after receiving the first dose and fell and hit his head. He was life flighted and was hospitalized for several days. He does not know if this was a reaction to the vaccine and said the hospital was not sure either, but he has never had a seizure before.
Patient passed out in front of store after receiving flu vaccine. Front end management called paramedics to the store and had pharmacist come to assess patient while waiting. Patient was conscious and given sips of orange juice and water while waiting in a chair. Mother admitted patient hadn't really eaten much and was nervous before shot. She also had not slept a lot the night before. Paramedics checked patient and said her blood sugar was low and released her to leave with her mother.
administered a dose of Kinrix to a 3 year old patient; fourth DTaP dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old female patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   Previously administered products included Pediarix (received 1st dose on 27 July 2020), Pediarix (received 2nd dose on 22 September 2020) and Pediarix (received 3rd dose on 24 November 2020).   On 31-JUL-2023, the patient received the 4th dose of Kinrix. On 31-JUL-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administered a dose of Kinrix to a 3 year old patient) and inappropriate schedule of vaccine administered (Verbatim: fourth DTaP dose). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were 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: 07-AUG-2023 Supervisor reported that a nurse at their clinic administered a dose of Kinrix to a patient. The patient had previously had three Pediarix doses (27 July 2020, 22 September 2020, and 24 November 2020), so this was their fourth IPV and DTaP dose. The vaccine administration facility was the same as primary reporter. A 3 year old patient received Kinrix, which led to inappropriate age at vaccine administration. The patient received Kinrix as a 4th dose of DTaP dose, which led to inappropriate schedule of vaccine administered of DTaP. The reporter consented to follow up.
Pt reports anxiety during monitoring post vaccination. Pt assessed in treatment area. 11:52am first set of VS taken- BP: 122/88, HR: 80 RR 16 O2 Sat: 97% RA. Pt reports feeling anxious. Vitals rechecked at 12:02pm BP: 120/82 HR: 74 RR: 17  O2: 99%RA. Pt reports feeling better and "anxiety may be stemmed from problems at home" Pt is escorted to car at 12:07pm by RN.
Partial loss of smell; Loss of taste; Arm is sore; A spontaneous report  was received from a consumer concerning herself, a 50-year-old female patient, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced partial loss of smell [Anosmia], loss of taste [Ageusia] and a sore arm [Injection site pain].   The patient's medical history included high blood pressure, Graves' disease and an autoimmune system "that is too high or too low". Concomitant product use included lisinopril 20 mg daily.   On 30-Dec-2020, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot 025L30A) intramuscularly in an unknown injection site for prophylaxis of COVID-19 infection.   On 31-Dec-2020, the patient reported experiencing a partial loss of smell and loss of taste.  She reported she could smell beans that her husband opened but could not smell the coffee in the morning. Additionally, she reported that her arm was sore. Treatment for the events was not provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was unknown.; Reporter'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. Further information has been requested
fainted at 5 am following her second Moderna Covid vaccine taken the day prior.  This is the second time this occurred in that she fainted the next day when she took the first Covid shot30 days  ago.  Paramedics were called, her vitals were normal and it was recommended that we do not transport her to the hospital.    When this occurred the first time, she was taken to her neurologist who diagnose a syncope for the incident.
injection sites  soreness for 2 days fatique for 1 day swollen lymph node in left underarm (Pfizer booster site)
Confused; Kind of dizzy; I dont have my balance; Really dont feel well enough to walk in to another room; Felt super super tired/Tired/really really tired; I got really sick/Feeling very very sick/I feel sick; Running a fever/still feel like I might have a low grade fever; Aching; Chills; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. On 21Jul2021, yesterday, patient got really sick/feeling very sick/i feel sick and had a running a fever/still feel like might have a low-grade fever, patient don't know exactly how high it was because the battery was dead in thermometer. But aching, chills, just really feeling very sick, so patient live alone and just basically felt super tired and went to bed, patient just got up a little while ago and patient still feel like patient might had a low-grade fever but like patient said the battery was dead, so patient cant check it to give you a number, so that part patient guess it's better. Okay the fever did go down, but patient still felt just out of it like super just confused and tired, really tired, kind of dizzy like patient didn't have balance and just felt sick. When patient was asked about immunisation card, patient stated don't feel well enough to walk into another room. Patient reported that the first vaccination didn't do this. At the time of this report, the outcome of event running a fever/still feel like i might have a low-grade fever was recovering and other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse event; Patient was accidentally administered dose of Moderna COVID-19 Vaccine on 4-APR-2023 after the expiration date of 01-APR-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was accidentally administered dose of Moderna COVID-19 Vaccine on 4-APR-2023 after the expiration date of 01-APR-2023) and NO ADVERSE EVENT (No adverse event) in a 19-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Apr-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Apr-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was accidentally administered dose of Moderna COVID-19 Vaccine on 4-APR-2023 after the expiration date of 01-APR-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was accidentally administered dose of Moderna COVID-19 Vaccine on 4-APR-2023 after the expiration date of 01-APR-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was accidentally administered dose of Moderna COVID-19 Vaccine on 4-APR-2023 after the expiration date of 01-APR-2023).    No concomitant medications were reported. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient did not report any adverse events No treatment information was provided.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01May2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 63 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE, start date: Jan2013, stop date: Jan2013; VITAMIND3 VICOTRAT, start date: Jan2015, stop date: Jan2015; CETIRIZINE, start date: Dec2019, stop date: Dec2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (22Oct2022) Negative; (23Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Conclusion of Previously Completed Investigation: The complaint for PFIZERBIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FK9893. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. (Name withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.  Clinical information: The patient received other medication in 2weeks product are Aller-Tec, start date: Dec2019, and lot number 1ME1971C.
temperature reached negative 2.1c from 07Mar2022 until 31Mar2022: no adverse events; Initial information received on 19-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional via call center.  This case involves a 57 years old female patient who experienced temperature reached negative 2.1c from 07-Mar-2022 until 31-Mar-2022: no adverse events  while receiving vaccine diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included varicella zoster vaccine rge (cho) (Shingrix)for Immunisation.  On 22-Mar-2022, the patient received a dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine(batch lot C5873AA Expiry date :30-June-2023)(unknown strength and formulation)0.5 ml via intramuscular route in the right deltoid for immunization.  On 22-MAR-2022 (latency :same day) the patient developed a non-serious event of temperature reached negative 2.1c from 07-Mar-2022 until 31-Mar-2022: no adverse events (product storage error) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event .  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.
I am starting  to have a rash all over my body.  It started 8 days after vaccination.
Initial pregnancy report received from a healthcare professional on 11 July 2013. A female patient whose age and date of birth was not reported, had received an intramuscular dose of ADACEL vaccine (Lot number: U4617AA, dose number and site of vaccination was not reported) on an unspecified date. The patient's health during pregnancy, concomitant medications and medical history were not reported. The patient had no risk factors at the time of vaccination. The patient was pregnant. The patient's last menstrual period date was on 29 October 2012 and the estimated date of delivery was 06 August 2013. As of 11 July 2013, the patient had no experienced any adverse events. Laboratory investigations were not reported. Documents held by sender: none.
Pt recvd vax & exp bell's palsy several dasy p/vax w/in a wk; pt had itchy eyes, no taste, mucous production in throat; seems to be gtting better;
Feb. 10:  Moderna Vaccination #1 Administered (arm) Feb. 11-Feb. 19:  Developed a cough which worsened, weakness, confusion, could not follow instruction, fell, no appetite, fever of 102.8 on Feb. 19, no taste Feb. 20: Emergency Room with diagnosis of Covid pneumonia.  Given usual Covid treatment.  Became very confused, combatative, etc. Feb. 21:  Placed on ventilator Mar. 1:  Ventilator removed.  Patient expired.
Two days after, I got an early period that lasted longer than usual. Eight days after, my left arm is itchy, red, swollen, and warm.
Arm cannot lift; pain is spreading to her arm; pain is spreading in the lower part of her neck; pain is spreading at the back of her shoulder; sharp and stabbing pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm cannot lift), PAIN (pain is spreading to her arm), NECK PAIN (pain is spreading in the lower part of her neck), ARTHRALGIA (pain is spreading at the back of her shoulder) and VACCINATION SITE PAIN (sharp and stabbing pain in the injection site) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and COPD. Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (sharp and stabbing pain in the injection site). On 21-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm cannot lift), PAIN (pain is spreading to her arm), NECK PAIN (pain is spreading in the lower part of her neck) and ARTHRALGIA (pain is spreading at the back of her shoulder). At the time of the report, PAIN IN EXTREMITY (Arm cannot lift), PAIN (pain is spreading to her arm), NECK PAIN (pain is spreading in the lower part of her neck), ARTHRALGIA (pain is spreading at the back of her shoulder) and VACCINATION SITE PAIN (sharp and stabbing pain in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Developed itching, rash on forehead 10/17/04. Rash was spread to face, lips, trunk, arms. Also has fever. Was diagnosed with Varicella by PCP 10/20/2004 and placed on acyclovir.
First symptom was swelling of legs/feet on 10/30/2021. This was followed low grade fever, some muscle aches, some shortness of breath, increased heart rate. Saw internist on 11/09/2021 and she ordered ultrasound of legs and blood work. Blood work from 11/11/2021 came back 11/12/2021 indicating hyperthyroidism. Heart rate increased and patient concerned that atrial fibrillation may develop. Went to ER on 11/14/21. No atrial fibrillation but cardiac enzyme troponin was borderline elevated. Rx given of propanolol to decrease heart rate and thyroid activity. Admitted. Follow up troponin in hospital normal. Thyroid and heart ultrasounds, and radioiodine uptake and scan performed while in hospital and after discharge (on 11/15/2021). Grave's disease diagnosed and Methimazole prescribed on 11/22/21.
Administered Tdap inadvertently instead of Pediarix.  Called Health Department Kitsap who recommended defer Pediarix for 2-4 weeks, then begin.  Mom in agreement plan.  Advised no adverse events ef
Fever 100 degrees, myalgia, ache, chills. Tylenol
Swelling & redness started in Rt. deltoid, 3-4 hours after vaccinatination.  Swelling & redness from deltoid to elbow.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative concerned multiple patients. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 11-JUL-2021, the patients experienced suspected covid-19 infection. The reporter stated that 10 days in & her parents still getting their asses kicked hard by Covid and experienced excruciating bone & body pain, cough, extreme fatigue, zero appetite, nausea, insane headaches. On an unspecified date, the patient experienced suspected clinical vaccination failure. 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 vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000187633; Sender's Comments: V0: 20210749603-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