chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 month old patient was given Quadracel by mistake; the wrong product had been given, intended product was Pentacel; Initial information received on 16-May-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 2 months old female patient who received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot number not reported via unknown route in the left thigh.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered. It was reported that 2 month old patient was given Quadracel by mistake and the wrong product had been given as intended product was Pentacel.  It was unknown if the patient had any adverse 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 Directive and Module VI of the 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.  Information on the batch number was requested.  List of documents held by sender: none.
COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 52-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing); "Chronic right hand infection" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE; ALBUTEROL [SALBUTAMOL]; HYDROXYCHLOROQUINE; ALEVE; DICLOFENAC; FOLIC ACID. Past drug history included: Cefazolin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Missed 2 weeks of xeljanz xr  because of covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Information has been received from a registered pharmacist concerning a female patient in her 60's who on 18-JUN-2012 was vaccinated with a dose of ZOSTAVAX (Merck) (lot#, dose and route not reported). Later in June 2012, the patient came back to see the pharmacist and was concerned because she had a rash at the injection site. There was also a small amount of bruising and the rash felt warm to the touch. The pharmacist suggested her to take some TYLENOL and BENADRYL for the symptoms. At the time of the report, the patient's outcome was unknown. Follow-up information was received from a pharmacist refers to a 62 years old female patient (also reported as 64) who on 18-JUN-2012 at 09:51 AM, was vaccinated with the first dose of ZOSTAVAX (Merck), subcutaneously (SQ.) (dose and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on 20-JUN-2012 PM (2 days after the injection), the patient experienced a circular rash about 3 inches diameter, center of which was bruised and felt warmth to touch. At the time of report, the patient's outcome was recovered. The related for the patient's events was not reported for ZOSTAVAX. Additional information is not expected.
Pt experienced an inject site rxn which included redness, swelling & tenderness w/in 3 days p/immun; also had a red streak down the arm; Tx Ceftin po BID for 7 days; physical assessment-questionable allergic rxn;
Parent states diarrhea,  projectile vomiting and "high" fever beginning at 3 AM today. Child is listless with dark circles under his eyes and unable to keep retain fluids including Tylenol.
Child developed, clinical varicella post vaccination. As per the annual follow up report: reporter phoned to add the following information to her report. Childs PCP vaccine provider does not believe this AE was due to the vaccine because the initial onset of the lesions was within 24 hours of the vaccine. Child was seen by a 2nd physician three days later who was unaware of the onset date and felt perhaps the lesions were the result of the vaccine and requested the reporter file a VAERS report. Child has since been fomally diagnosed with chickenpox and PCP feels their AE report was unnecessary.
My symptoms started on March 30, 2021 I experienced an extreme red itch I had a really bad rash. I was using hydrocortisone which did not help.
Pain and stiffness across top of shoulders and back of neck, down both arms and into both hands. Treatment was 2 aspirin twice a day and Tramadol once per day.
Narrative: Myalgia, Diarrhea, lymphadenopathy, fatigue, arm pain
On 03/06/2023, I started coughing with congestion and a low-grade fever. I took an at-home COVID-19 test on 03/07/2023 which came back positive. I called my doctor immediately after where my husband and I were both prescribed Paxlovid for treatment since we both tested positive. We were told to start taking our first dose immediately once picking up our prescription. We completed our prescription, and I'm currently doing well but still testing positive unfortunately. My symptoms are practically gone at this point.
Ten minutes post vax the pt reported to the school nurse complaining of dizziness, lightheadedness, and congestion. The pt stated that he was jittery and felt like he was having an allergy attack. He was treated with Benadryl, and given orange juice. The nurse stated that there was no rash or acute reaction, no wheezing, his lungs were clear to auscultation, and his skin was warm and dry. He subsequently recovered from his experience. The pt had no problems following the initial dose of hep B vaccine. No further information is available.
Nausea/Vomiting x 1 for 2 hours, Extreme sleepiness, Fever of 101.5 for 24 hours, then 102.5 for 8 hours, Redness at injection site, extreme swelling, heat and extremely red and hot.
Tingling sensation in  upper lip all the way down to upper chest./ had giggling bf in hands and knee caps; I had a feeling of a lump stuck in my throat.; Burning sensation on right side on abdomen; Itching feeling on left arm near elbow but not for long; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ERS731) via an unspecified route of administration in the arm right on 10May2021 at 17:30 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine and allergy to tree nuts.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG201) via an unspecified route of administration in the right arm on 19Apr2021 at 15:30 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. On 10May2021 at 17:45, the patient experienced tingling sensation in upper lip all the way down to upper chest, lump stuck in throat, burning sensation on right side of the abdomen. The patient had itching feeling on the left arm near elbow but not for long. The patient had giggling bf in hands and knee caps. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included treatment with dexamethasone (MANUFACTURER UNKNOWN) and diphenhydramine (BENADRYL).  The clinical outcome of the events of tingling sensation in upper lip all the way down to upper chest, lump stuck in throat, burning sensation on right side abdomen, itching feeling on left arm near elbow but not for long and giggling bf in hands and knee caps were recovered on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.
Two days after immunizations pt called answering service with c/o redness at immunization site as wide as thigh and 3 inches in ht. Pt c/o redness hot and hardness and itching (left thigh).
Redness at injection site on both arms R > L Patient reports similar reaction to penicillin injections.
headache; fatigue; dyspnea; chest pain; RV infarction; a large amount of clot in the RCA; This is a spontaneous report from a contactable physician.  A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05May2021 as single dose for COVID-19 immunization. Medical history included chronic smoker 2 packs per day. Patient was not pregnant at the time of vaccination. Concomitant medications within 2 weeks of vaccination included paracetamol (TYLENOL) and ibuprofen. Patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as single dose for COVID-19 immunization. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Patient developed headache, fatigue, dyspnea, and chest pain for 3 days. She was admitted to hospital on 08May2021 with a completed right ventricular (RV) infarction. Angio in May2021 showed clean coronaries with the exception of a large amount of clot in the right coronary artery(RCA). Given correlation to vaccine administration, unclear if this was related (as reported). Device Date: 11May2021 (as reported). The adverse events resulted in emergency room/department or urgent care. The events were assessed as serious, hospitalization and life-threatening. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events at the time of last observation was recovering.  Information on Lot/Batch number has been requested.; Sender's Comments: As a cautionary measure and considering the drug-event temporal relationship of three days, the company cannot completely exclude a causal association between the administration of the PFIZER-BIONTECH COVID-19 VACCINE BNT162B2 and the onset of all the reported events. Medical history of chronic smoker (2 packs per day) cannot be also excluded as contributing factor and additional information of medical history and concomitant medications concerning possible risk factors for cardiovascular diseases, should be also useful for an overall assessment of the case.  The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Information has been received from a health professional concerning a 75 year old male with hypertension, arthritis, atrial fibrillation and hypothyroidism and with a recent history of shingles, gout and no drug allergies, who on 20-OCT-2007 was vaccinated intramuscularly with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot# 651331/0577R). Concomitant vaccinations included influenza virus vaccine (unspecified). Concomitant therapies included COUMADIN, INDOCIN, LYRICA, LIDODERM, VALTREX. On 21-OCT-2007 the patient experienced fever, injection site soreness, body aches, and felt very ill. The patient was treated with TYLENOL, MOTRIN, hydrocodone, and cool compresses to the injection site. The patient was seen in the office. No laboratory diagnostics were performed. At the time of the report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Fever; Chills; Aches and pains; hurting all over; Headache like my head was going to explode; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL3302; expiration date: unknown) at vaccination age of 74-year-old via an unspecified route of administration on 19Jan2021 at a single dose for covid-19 immunization. Medical history included type 2 diabetes, autoimmune thyroid disease and complex migraine (migraine chronic, complex migraine). The patient's concomitant medications were not reported. The patient reported that last Friday (29Jan2021, also reported as two weeks later), she got a fever, chills, aches and pains. She was hurting all over and she had a headache like her head was going to explode. So, she wanted to know could that be a delayed reaction to the shot (vaccine). The patient mentioned that treatment for the problems included acetaminophen, butalbital, and caffeine (FIORICET). The outcome of the events was unknown.
I woke up this morning 3/24/21  with a raised rash at the injection site 14 days after receiving the Moderna vaccine.
Pt recvd vax & exp swelling accurred over 1/3 of thigh area; not heated to touch; pt started crying soon p/inject & cried for 1 1/2 hrs w/stopping a/;
1x Moderna, Booster was hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (1x Moderna, Booster was hard) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Biontech (Dose 2) and Biontech (Dose 1). Past adverse reactions to the above products included No adverse event with Biontech and Biontech.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (1x Moderna, Booster was hard). At the time of the report, VACCINATION COMPLICATION (1x Moderna, Booster was hard) outcome was unknown.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant product use was reported.   No treatment information was provided.
Large area of ecchymosis beginning within 1-2 days of injection.  Now at 1 month from injection has persistent aching pain and tenderness in triceps and deltoid muscles underlying injection site.  No palpable mass, abscess or other abnormality.  No neurologic changes in arm
Multidrug resistant infection; Aspiration Pneumonia; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PNEUMONIA ASPIRATION (Aspiration Pneumonia) and PATHOGEN RESISTANCE (Multidrug resistant infection) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 immunization.     The patient's past medical history included Aspiration (Patient has history of recurrent aspiration) since an unknown date. Concurrent medical conditions included Drug allergy (Cepacol), Cerebral palsy, Spastic quadriplegia, Seizures and Mental disability.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PNEUMONIA ASPIRATION (Aspiration Pneumonia) (seriousness criterion hospitalization). On an unknown date, the patient experienced PATHOGEN RESISTANCE (Multidrug resistant infection) (seriousness criterion hospitalization). The patient was hospitalized from 12-Mar-2021 to 16-Mar-2021 due to PATHOGEN RESISTANCE and PNEUMONIA ASPIRATION. On 16-Mar-2021, PNEUMONIA ASPIRATION (Aspiration Pneumonia) outcome was unknown. At the time of the report, PATHOGEN RESISTANCE (Multidrug resistant infection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use was not reported. Patient was transferred to a  facility for long-term antibiotic treatment.  Regarding Aspiration pneumonia, based on the 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.  Regarding Multidrug resistant infection, very limited information has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-076748 (Patient Link).; Sender's Comments: Regarding Aspiration pneumonia, based on the 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.  Regarding Multidrug resistant infection, very limited information has been provided at this time.  Further information has been requested.
Eye floaters - large increase in floaters. Vision blurriness, decreased clarity. Allergic symptoms not going away, runny and stuffy nose, itchy throat, red eyes, some itching at injection site.
Myalgia, UrticariaPruritus, Diarrhea, chills, fatigue, weakness Narrative:  Per nursing report: "took 2nd Moderna on 2-22-21. States later on 2-22 started having chills and on Wednesday [2/24] and Thursday [2/25] c/o fatigue and weakness. States did not work on Wednesday and Thursday due to not feeling well. Also c/o body aches,muscle stiffness and diarrhea. Employee states developed blisters between her toes. Shes states they are going away now. Employee states returned to work today."  Other Relevant History:
unknown- patient tested positive for Covid 8/27/2022 at the Hospital and was admitted from 8/27/22-8/31/22
Evening following HEP B, had fever to 103 and headache.  Fever lasted 3 days.  Day 2 following shot both knee pain and redness/swelling, temperature 102.  Day 3 temperature 100.0.  No other illnesses.
Could hardly move; Bruised; Loss of appetite; Fatigue; Sore everywhere/Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Could hardly move), CONTUSION (Bruised), DECREASED APPETITE (Loss of appetite), FATIGUE (Fatigue) and MYALGIA (Sore everywhere/Muscle ache) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 027B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALBUTEROL [SALBUTAMOL] and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced MOBILITY DECREASED (Could hardly move), CONTUSION (Bruised), DECREASED APPETITE (Loss of appetite), FATIGUE (Fatigue) and MYALGIA (Sore everywhere/Muscle ache). On 26-May-2021, MOBILITY DECREASED (Could hardly move), CONTUSION (Bruised), DECREASED APPETITE (Loss of appetite) and FATIGUE (Fatigue) had resolved.      Treatment medication was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable..   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Itching on his head, arms and back; This spontaneous case was received on 09-Oct-2020 from a physician via Health Authority (reference number: SEQW20-03298) and concerned an adult, male patient. At time of this report, the patient was 46-years-old.  The patient's medical history and concomitant medications were not reported.    On an unspecified date in 2019, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, indication, dose, route of administration and anatomical location: not reported). The batch number reported was 261198.   On the same day, one hour after receiving Flucelvax QIV, the patient started to have itching on his head, arms and back. There was no visible rash though.  The outcome of event was not reported.  The reporter did not provide a causality assessment.   Company comment: The event of 'itching' was considered as related to Flucelvax QIV.; Sender's Comments: The event of 'itching' was considered as related to Flucelvax QIV.
Headaches; Neck stiffness; Coughing; Pain; Flu; This non-serious case was reported by a consumer and described the occurrence of cough in a 64-year-old male patient who received Men ACWY-CRM NVS (Meningitis ACWY vaccine (potential Menveo)) for prophylaxis.   On 29-MAY-2023, the patient received Meningitis ACWY vaccine (potential Menveo). On 31-MAY-2023, 2 days after receiving Meningitis ACWY vaccine (potential Menveo), the patient experienced cough (Verbatim: Coughing), pain (Verbatim: Pain) and influenza (Verbatim: Flu). On an unknown date, the patient experienced headache (Verbatim: Headaches) and stiff neck (Verbatim: Neck stiffness). The patient was treated with amoxicillin and benzonatate. The outcome of the cough, pain and influenza were not resolved and the outcome of the headache and stiff neck were not reported.   It was unknown if the reporter considered the cough, pain, influenza, headache and stiff neck to be related to Meningitis ACWY vaccine (potential Menveo).     It was unknown if the company considered the cough, pain, influenza, headache and stiff neck to be related to Meningitis ACWY vaccine (potential Menveo).   Additional Information: GSK Receipt Date: 16-JUN-2023 The reporter reported that the patient received meningitis combo shot vaccine and 2 days after received vaccine experienced coughing, pain and flu. On unknown date, patient experienced headache and neck stiffness and stated that the pain was worse in extreme at night from 8 pm to 1. The patient received Amoxicillin 875 mg tablet and Benzonatate 200 mg as a treatment. The reporter did consent to follow up via email.
As per wife since patient was not feeling well, he came home on Friday (9/29) around 12pm and said he wasn't feeling well and decided to take some Tylenol. Patient's wife states that he could not remember her and he struggled to find the words to create sentences which is not his baseline and very apparent of a change in mental status. At this time patient was also having a stomach  ache and possible vomiting episode. He was brought to the hospital on 9/30. Noted to be agitated in the hospital requiring Ativan. During hospital course, neurology ruled out stroke with MRI of head on 10/1, showing no infarcts or any other intracranial abnormalities. Noted to be febrile on 10/2. New findings today include pain in the knee which is not a chronic issue.