chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the following Wednesday 23Jun2021 started developing a complaint of humming in her right ear or head that is intermittent in occurrence and still continues to this day; the following Wednesday 23Jun2021 started developing a complaint of humming in her right ear or head that is intermittent in occurrence and still continues to this day; This is a spontaneous report from a contactable consumer or other non hcp(patient).   A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, formulation: solution for injection, Batch/Lot number and Expiry Date was not reported), via an unspecified route of administration on 19Jun2021 as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Other products was reported as Not provided. The patient received the first dose of the Pfizer Covid-19 vaccine on 19Jun2021 and On 23Jun2021(wednesday), the patient experienced developing a complaint of humming in her right ear or head that is intermittent in occurrence and still continues to this day. She is unable to receive the second dose of the Pfizer Covid-19 vaccine and was asked "Should I get the second dose?" Response included: As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. The patient reported that She received the 1st dose on 19Jun2021 and a week later, in the middle of that next week, she got, and it is still there, a humming in her right ear. She doesn't know if it is in her ear or in her head. It is real light and she is wondering if this could be a side effect and she just wants to know if anyone else has had this side effect. The outcome of the events was not recovered.  Information on Lot/Batch information has been requested.
Itching; Rash; This is a spontaneous report from a contactable consumer (reporter's daughter). A 12-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Unknown), via an unspecified route of administration on an unspecified date in Jun2021 as a 1st single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient went for Pfizer vaccine, last, two weeks back and she got the first dose of Pfizer and after 3 or 4 days, she was getting itching and rash on an unspecified date in Jun2021. So, still it was coming out going away even though the vaccine took like a three weeks back. Patient second dose was next Tuesday which was like 22Jun2021, reporter questioned that as still patient was getting rashes, reporter wants to know that if patient could get second dose or hold it on. Reporter seriousness for itching and rash was unspecified. The outcome of all events was not recovered.  Information about batch/lot number has been requested.
Shot was very painful; This is a spontaneous report from a Pfizer-sponsored program. A contactable healthcare professional reported that a male patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (Diphtheria CRM 197 Protein) (PREVNAR 13; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose, for invasive pneumococcal disease (immunization). The patient's medical history and concomitant medications were not reported. The patient received pneumococcal 13-valent conjugate vaccine (Diphtheria CRM 197 Protein) and the shot was very painful on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are needed; information about batch number cannot be obtained. No further information is expected.
After receiving the vaccine I experienced vaginal bleeding that I didn't have before during my pregnancy.  Also, feeling fatigue and needing to rest.
Hospitalized with acute encephalopathy and UTI incidentally found to be COVID 19 positive without respiratory symptoms.
Ultimately, I had a shingles outbreak. A few days after my second dose, I had not recovered from the flu-like side effects. I continued to improve a bit, but feel very run-down. Then, parts of my face started to go numb, and I slowly developed extreme throbbing pain in my jaw day-by-day. Over the course of a few weeks after my vaccine, I had mild-to-deep pain symptoms of a shingles outbreak, and the visual affects started to come out on May 26 in the form of blisters. My shingles outbreak happened on the left side of my face - the trigeminal nerve. My hearing and vision have been affected. I am mostly recovered not, but cannot feel parts of my face after nerve damage, and I still experience pain but it is manageable. I do want to say that I have kept my suspicions that this has been a vaccine side effect to myself apart from discussions I've had with my doctors. I don't want to hype up any vaccine skepticism with people.
The patient received H1N1 IIV on APR 17 2010. He states 4-5 days later he experienced (L) shoulder blade pain, sharp, of such severity he could not sleep. He self-treated with ibuprofen which did not help. He started to experience left arm paralysis and muscle atrophy. He could not move his fingers. He saw an orthopedist on 23 July 2010 who documented onset report as 8 days after receipt. POC was conservative. Pt saw ortho again on 17 SEP 2010 due to worsening weakness and atrophy. The ortho ordered nerve conduction studies which demonstrated damage to his brachial nerve plexus. He was diagnosed with Parsonage Turner syndrome. 22 Nov 2013 neurology eval did not detect residual deficits, although patient states continued mild sensory deficits and currently states shoulder pain he thinks may be due to secondary injury (doing PT pushups with weakness).
Information has been received from a RN concerning a 66 yr old female with allergies to cephalexin, lidocaine, and clenodomycin who on 28Sep05 was vaccinated IM in the left deltoid with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649979/0531P). Concomitant therapy included risedronate sodium (Actonel), beta carotene, vitamin B (unspecified), vitamin E, calcium (unspecified), ascorbic acid, lorazepam, and diphenhydramine HC1 (Benadryl). Two days after vaccination, on 30Sep05, the pt presented to the physician's office with erythema at the injection site and a fever of 102. The pt was treated with diphenhydramine HC1 (Benadryl) and acetaminophen (Tylenol) as needed. No diagnostic laboratory tests were performed. At the time of the report, the pt was recovering. A product quality complaint was not involved. Erythema at the injection site and a fever of 102 were considered to be other important medical events (OMIC) by the nurse. Additional information has been requested.
This is a 21 year old female who reported to the emergency department on 5/17/21 at 0917 with complaints of intermittent chest pain since the previous Tuesday (5/11/21).  She described it as light in pressure, pain 4/10, in the right upper chest/right breast area.  The patient believed her chronic anxiety may be playing a role since she has recently started a new job that involves public speaking and she had stopped her paxil due to adverse effects.  No pleuritic pain described, no pain on exertion described.  Differential diagnosis included low risk for ACS, PE given oral contraceptives, anxiety.  Given no evidence of abnormality in labs/work-up, the patient was discharged home with instructions to follow-up with PCP for any ongoing symptoms/anxiety.
After last appt, about 12 hours later, starting with room spinning vertigo. Laid down and slept for 24 hours. Got up, drank some water and then vomited. Has had very poor appetite, low back started hurting, feeling chilled, clammy then started with diarrhea. Has no strength. Has been able to keep down water today and a little diet pepsi.
Upper left arm swollen (noticible) red (size 16cm long by 8cm wide), warm to touch. Applied ice and within 30 minutes arm felt much better. Benadryl 2tsp at 6pm. Resolved within 12 hours. Mom reports younger sister hitting brother in area of shot. Afebrile.
03Apr2022: Tested positive for Covid; 03Apr2022: Tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 10Oct2021 at 15:45 as dose 3 (booster), single (Lot number: EW0202) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 03Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 03Apr2022, outcome "recovered" (25Apr2022) and all described as "03Apr2022: Tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Apr2022) Positive; (13Apr2022) Negative; (19Apr2022) Positive; (23Apr2022) Positive, notes: Symptom free; still test positive for Covid; (25Apr2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient did not received other medication in 2weeks. Patients symptoms returned 7 days after completing my course of Paxlovid. On 03Apr2022: Tested positive for Covid. 04Apr2022 Started Paxlovid and Finished Paxlovid on 09Apr2022. On 10Apr2022, Symptom free - felt great. On 13Apr2022 Tested negative for Covid, 16Apr2022, Covid symptoms re-emerge. On 19Apr2022, Tested positive for Covid and  23Apr2022, Symptom free; still test positive for Covid. On 25Apr2022, Test negative for Covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Intermittent pain from R upper arm radiating to R upper back using Motrin states no relief, no neuro, circulatory or muscular deficit.
feels very sick; Body is still presenting with some side effects until today; bad headache; fever; my throat is starting to ache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (feels very sick), VACCINATION COMPLICATION (Body is still presenting with some side effects until today), HEADACHE (bad headache), PYREXIA (fever) and OROPHARYNGEAL PAIN (my throat is starting to ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced ILLNESS (feels very sick), VACCINATION COMPLICATION (Body is still presenting with some side effects until today), HEADACHE (bad headache), PYREXIA (fever) and OROPHARYNGEAL PAIN (my throat is starting to ache). At the time of the report, ILLNESS (feels very sick), VACCINATION COMPLICATION (Body is still presenting with some side effects until today), HEADACHE (bad headache), PYREXIA (fever) and OROPHARYNGEAL PAIN (my throat is starting to ache) outcome was unknown.            no concomitant drugs included no treatment drugs included
Left eye swollen; Rash on left arm from injection site down to elbow for 5 days.; Lymph nodes swollen.; This is a spontaneous report from a contactable Other HCP. A 39-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262) via intramuscular route of administration in left arm on 22Jan2021 06:45 as single dose for Covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient has known allergies of bactrum and cellebrex. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via unspecified route of administration on unspecified date as single dose for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 22Jan2021 at 11:00 left eye swollen shut about 4 hours after receiving second dose. Rash on left arm from injection site down to elbow for 5 days. Lymph nodes swollen. Patient received treatment for the events with 2 doses of Benadryl. Outcome of the events were recovered with lasting effects.   No follow-up attempts are possible. Information about batch number cannot be obtained. No further information is expected.
pt reported immed p/vax had tingling in lt fingers states arm cont to feel tingly & heavy;states nauseated since inj;14ARP99 talked w/pt on phone said it is not any worse or any better;pt can use lt arm but cant pick up anything heavy;
About three weeks after the shot, small bruises began to appear on patient's left arm. More popped up each day without explanation.
Pt had redness and swollen on left arm. Pt came to pharmacy today 10/1/18. Pt is doing ok and just have little pain now. Pt has been taking TYLENOL for the pain. Advise pt to take IBU or TYLENOL and put ice for inflammation/pain. Consult PCP if getting worse.
itchy throat and chest redness patient received Benadryl 25mg PO x 1 and symptoms resolved within 10 - 15 minutes.
This case was reported by a pharmacist via sales rep and described the occurrence of neurological symptom in a 51-year-old female patient who received SHINGRIX (batch number 539A2, expiry date unknown) for prophylaxis. On 11th March 2018, the patient received the 1st dose of SHINGRIX. On 11th March 2018, immediately after receiving SHINGRIX, the patient experienced injection site rash. On an unknown date, the patient experienced neurological symptom (serious criteria hospitalization) and facial droop (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the neurological symptom and facial droop were recovering/resolving and the outcome of the injection site rash was unknown. It was unknown if the reporter considered the neurological symptom, facial droop and injection site rash to be related to SHINGRIX. Additional details were provided as follows: The patient experienced rash at injection site the size of a softball right after receiving SHINGRIX. The patient was taken to emergency room within one month after receiving SHINGRIX with neurological symptoms, face drooping on one side which resulted in hospitalization for work up. The patient had been gradually improving. They did rule out stroke. The reporter agreed to be followed up.
Lymphadenopathy R cervical & submand. nodes torticolis TYLENOL & Ibuprofen.
Vomiting 4X at 5:20AM - (1/24/17) warm to the touch as per mom at 4AM.
Patient was given vaccine that was expired by 8 days. Manufacturer notified and advised vaccine was adequate and does not need to be readministered. Patient had no ill effects.
This is a spontaneous report from a non-contactable consumer communicated to a Pfizer colleague.  A patient of unspecified age and gender received bnt162b2 (COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration from an unspecified date at a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced sore injection site on an unspecified date. Outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a medical assistant, concerning unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unspecified dates, the patients were inadvertently vaccinated with improperly stored doses of varicella VARIVAX lot # N022996, expiry 23-AUG-2018; LIQUID PEDVAXHIB, lot # L051123, expiry 13-OCT-2018; GARDASIL 9, lot # N020353, expiry 28-APR-2020 and ROTATEQ, orally, lot # N005617 and expiry 03-OCT-2018. The vaccines were administered for prophylaxis (doses, routes of administration and anatomical locations were not reported); it was reported that the MERCK STERILE DILUENT used to reconstitute VARIVAX was properly stored. The administered doses of the vaccines experienced a temperature excursion of 10.9 degrees Celsius (°C) for 30 minutes, as recorded by a data logger. The vaccines had a previous temperature excursion of -3.5°C for 660 hours. There was no adverse effect reported. No product quality complaint was involved. This is a non-valid report due to lack of patient identifiers. Upon receipt of follow-up information it was determined that this case is now valid because the patient identifiers were received. Follow-up information has been received from medical assistant on 14-NOV-2018. On 14-NOV-2018, a call was placed to medical assistant. It was reported that, 5 patients received effected vaccines, out of which 2 patients were vaccinated with VARIVAX and 3 patients with GARDASIL 9. Age range of patients who were administered vaccinations was 6 months to 15 years. This report refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with VARIVAX. It was also reported that, there have been no adverse events reported since the time of administration. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1811USA010211:Original Case : 1808USA005930 US-009507513-1811USA010213: US-009507513-1811USA010215: US-009507513-1811USA010214.
4 month old was given quadracel instead of pentacle (1 ml instead of 0.5ml) with no reported adverse event; 4 month old was given quadracel instead of pentacle (1 ml instead of 0.5ml) with no reported adverse event; Initial information received on 01-Nov-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 4-month-old female patient who was given DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (1 ml instead of 0.5ml) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE (HIB), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation..  On 01-Nov-2022, the patient received suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (strength, formulation, dose, route: unknown) (lot number: C5916AA and expiry date: unknown) via intramuscular route in the left thigh for prophylactic vaccination and on the same day 4 month old was given quadracel instead of pentacle (1 ml instead of 0.5ml) with no reported adverse event (extra dose administered), (wrong product administered) (latency same day).   Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE (QUADRACEL) and DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable.  At time of reporting, the outcome was Unknown for both events    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.
chills and getting chills again; warming back up; This is a spontaneous report from a Pfizer sponsored program reported from a contactable consumer (patient's wife).  A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration on 08Feb2021 as single along with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 18Jan2021 as single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The reporter reported that the patient was getting chills and warming back up and getting chills again on an unspecified date of 2021. Reporter stated after each dose her husband experienced chills. The outcome was unknown for the event.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had some muscle pain with previous shots.; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Patient had some muscle pain with previous shots.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 007C21A) for COVID-19 prophylaxis.     The patient's past medical history included Influenza (30 years ago).   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Patient had some muscle pain with previous shots.). At the time of the report, MYALGIA (Patient had some muscle pain with previous shots.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not have family history of arthritis.  No concomitant medication was reported.  No treatment information was reported.   This case was linked to MOD-2023-722963 (Patient Link).