chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Peeling; Small swollen area; Itching; Developed redarea; Fever; Fatigue; Arm soreness; This is a spontaneous report from a contactable consumer, the patient.  A 74-year-old non-pregnant female patient received second dose of BNTI62b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 23Feb2021 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimotos thyroiditis and osteoporosis. The patient had allergy to lactose intolerance. The patient previously received chlorthalidone (MANUFACTURER UNKNOWN) for unspecified indication and experienced drug allergy. The patient had received other unspecified medications in two weeks of vaccination. The patient previously received first dose of BNTI62b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via an unspecified route of administration in the left arm on 30Jan2021 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 24Feb2021, the patient experienced arm soreness several days and fatigue first four days. On 24Feb2021, (next day) the patient experienced fever 99.4 degrees. On 25Feb2021, (second day) the patient developed red area. On 26Feb2021, (third day) the patient experienced itching which lasted a week and small swollen area on the same day. On 27Feb2021, (fifth day) small peeling began which lasted about four days. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures taken for the adverse event included hydrocortisone cream and ZYRTREC which did not help. The clinical outcome of fatigue was recovered on 28Feb2021. The clinical outcome of the events arm soreness, swelling and fever were recovered on an unknown date. The clinical outcome of red, itching and peeling were recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Developed urticaria all over body 3 days after receiving vaccinations.  Also on a new med - flonase, and has tried a new food - cherries, so etiology unclear.  No breathing distress, fever, or difficulty swallowing.  Given benadryl.
Thursday evening I was fine; woke to soreness in (R) shoulder on Friday a.m. Began feeling nauseated with extreme fatigue throughout day. Significant redness puffiness(2in. in diameter around injection sight). Ice & ibuprofen helped but these symptoms lasted for 3 days. Tenderness persists today-day # 4.
At 9pm on 3/30/21 my left ear was red and very warm to the touch leading up to going to bed around 1030pm. The next day around 10am I felt a tingling in the lower left side of my face it felt like novocaine was wearing off after being at the dentist. My mouth and cheek were slightly numb. The next day I noticed that nothing had changed in my face but my left hand fingers were also slightly numb along with my left shoulder blade.  Arm was sore at injection site throughout. I went to see my primary Dr. at 3:30pm on 4/1/21 and after having me do facial exercises she said I had a mild case of Bell's Palsy and prescribed a steroid and an anti-viral since I had recently been sick the week prior.
Information has been received from a medical assistant concerning unspecified number of patients with unknown age and gender. No current or historical condition were reported. On an unknown date, the patients were vaccinated with RECOMBIVAX HB (route, dose, Lot# and expiration date not reported). The doses of RECOMBIVAX HB were improperly stored. No adverse effects were reported. This is one of two reports received from the same reporter. The other report is MARRS# 1503USA000906. Additional information has been requested.
Patient was accidental given Pfizer as a second dose instead of Moderna.  Quality of care report was completed and also Incident report. Patient was assessed and RN cleared patient at 11:55 am. The were no signs or reactions since administering of vaccine was done at 11:25 am until 11:55 when patient was cleared.
started w/fever & a rash on both arms a couple of days p/vax;fever controlled w/APAP-rash has now spread over entire body;child active & eating well;
Information has been received from a female pharmacist who in March 1998, was vaccinated with a dose of varicella virus vaccine live. On approximately 25Apr2003, a titer was drawn and was negative. The pt noted that it was important because she wants to become pregnant soon. Unspecified medical attention was sought. It was noted that a product quality complaint was not involved. Additional information is not expected.
Weakness; Tinitis; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness) and TINNITUS (Tinitis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced ASTHENIA (Weakness) and TINNITUS (Tinitis). At the time of the report, ASTHENIA (Weakness) and TINNITUS (Tinitis) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly male patient who received Shingrix for prophylaxis. Co-suspect products included Shingrix for prophylaxis. In March 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms and product supply issue. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported but could be 65 years or 66 years. In the first week of March 2018, the patient received 1st dose of Shingrix. The patient experienced flu like symptoms which lasted for total of 2 days. The patient reported that it had been more than 6 months from the 1st dose and he was not able to find the second dose anywhere (product supply issue). The reporter did not consent to follow-up. No further details were provided.
22SEP91 1st oral dose; 24SEP91 2nd dose diarrhea p/dinner then 2AM, diarrhea nausea, retching; 3AM to ER got IV for dehydration;
bloating; Initial information received on 20-Sep-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age female patient who experienced bloating after receiving vaccine Diphtheria, tetanus and acellular pertussis vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In June 2011, the patient received a dose of suspect Diphtheria, tetanus and acellular pertussis vaccine(dose, strength, formulation, lot details: unknown) produced by unknown manufacturer via unknown route in unknown administration site for immunization.  Pharmacist calling in asking if Adacel contains any eggs or gluten. Pharmacist reports patient experienced bloating (abdominal distension) following the Tdap (Diphtheria, tetanus and acellular pertussis vaccine) vaccine in June 2011 and patient asked if she should go to the emergency room for evaluation. Pharmacist confirms patient was not admitted in the hospital at this time. Outbound call made to reporter to verify if patient had a Tdap AE from ADACEL. Pharmacist states patient did not receive the mentioned Tdap vaccine at the in June 2011, states information she is seeing in the system is pulling from an outside source and unable to verify if patient had a AE from ADACEL or another Tdap vaccine manufactured by another company.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (bloating).  At time of reporting, the outcome was Unknown for the event bloating.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients. On an unspecified date, an unspecified number of patients received an unspecified number of doses of improperly stored ZOSTAVAX (lot#K010646; exp date: 30-OCT-2015) (dose, frequency and route of administration not provided). No adverse effect reported and no PQC involved. Additional information has been requested.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 20-FEB-2018 at 20:59, Oka/Merck VARIVAX was shipped from a wholesaler. On 23-FEB-2018 at 11:00, the vaccine arrived to the reporter's office. On 26-FEB-2018, the patient was subsequently vaccinated with Oka/Merck VARIVAX (dose and route of administration were not reported) lot # N030406 with expiration date 30-OCT-2019, for prophylaxis, "that was in transit to the office too long". No adverse symptoms were reported.
Approximately 4 hours after the vaccine, I left chilled and had diarrhea. This continued and worsened over the course of the day. By evening, I was very cold, had horrible stomach pains and was very achy. I never experienced a fever but felt extremely chilled. Approximately 12 hours after the vaccine (10p), I began to experience a sore throat and tingly in my mouth, tongue and lips. I began to feel pins and needles across my body, like a skin tingly feeling. I took advil to help with the pain and chills, which helped. And then I took Benadryl when the tingling began and that helped as well.  Today, I am still experiencing stomach pain and nausea.
Fever 100.6, pain, redness at injection site starting on 8/22.  She developed body aches and headache.  Patient has been using ibuprofen.
contracted Covid-19; contracted Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the parent.  An adult female patient received BNT162b2 (BNT162B2), 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's relevant medical history included: "Down Syndrome" (unspecified if ongoing); "open heart surgery" (unspecified if ongoing), notes: when she was 3 months old and that she is a minor. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 13Jun2022, outcome "unknown" and all described as "contracted Covid-19".  Clinical course: The seriousness of the events was reported as non-serious. The patient had no fever just swollen throat and headaches.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Narrative: This is a 73 yo M patient with PMH of CAD s/p CABG x3 v ,CHF ? EF, Hypothyroidism, Arrhythmia s/p Pacemaker /AICD,BPH , Vit D def, chronic Debility Nursing Home Resident admitted after sent by Cardiologist to ED for COVID + and LLE cellulitis 06/25/2021.He is admitted to COVID Unit and placed on droplet precaution. HOSPITAL COURSE: Patient admitted to hospital for treatment of COVID pneumonia and lower leg cellulitis. Administered antibiotics for cellulitis, Remdesevir and dexamethasone for COVID-19. Patient recovered to baseline and was discharged to a long-term skilled nursing facility.
I tested positive for COVID 3 months after my 4th dose of Pfizer. I went to Urgent Care and they prescribed Paxlovid.
developed Bell's Palsy on the right side of my face; This is a spontaneous report from a contactable consumer (patient) This 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot Number: EW0164), dose 1, via an unspecified route of administration in the left arm on 16Apr2021 at 14:00 (at the age of 44-years-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included seizure from an unknown date and unknown if ongoing (Seizure disorder-7 years no seizure, 5 years no medication) and penicillin allergy from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromycin [erythromycin estolate] and experienced hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021 at 14:00, the patient developed Bell's palsy on the right said of her face. The event resulted in an emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab) (03May2021): pending results. Therapeutic measures taken included unspecified steroids and unspecified anti-viral medications. Clinical outcome of the event developed Bell's palsy was not resolved.
Pt recvd MMR vax & immediately devel a reddened & inflamed inject site;
Pt recvd DTP/OPV/MMR/HIB on 16MAY91; On 17MAY91 approx 7PM pt c/o soreness, redness & swelling of rt arm near elbow area; Mom took pt to ER to be seen by MD who prescribed Cephaloxin;
Patient presented to the ER on 6/8 with less than 12 hours of vomiting and bloody diarrhea and had been well prior to this. Mom reported intermittent currant jelly stools since the morning on the 8th.  Ultrasound was obtained and consistent with intussusception.  He was taken to the OR emergently due to failure with the barium enema.  Of note, film array was + for C.diff and rotavirus, however the C.diff was not treated due to the patient's age and likely colonization.
pt recvd vax & devel redness & swelling at inject site; pt had fever & chills & also had pain in arm which extends to the neck, chest & back;
No additional AE reported; expired dose of PNEUMOVAX23 was administered; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information concerning the patient's concurrent conditions, pertinent medical history and concomitant medications was not provided.   On 16-JUL-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), (Lot # S034299, expiration date 01-JUL-2021), dose, route of administration, and anatomical location were not reported  for prophylaxis. No additional adverse event and no product quality complaint (PQC) were reported. Combination product report: Yes; brand name: PNEUMOVAX23 SYRINGE (DEVICE); common device name: Pneumococcal Vaccine, Polyvalent (23-valent); product code: FMF; device type: SYRINGE, PISTON (FMF); manufacturer name: Merck Sharp & Dohme Corp.; device lot number: S034299; expiration date: 01-JUL-2021; device age and unit: 0 ; malfunction: Unknown; device usage: Initial; reason for non eval: 81 Other; labeled single use device: No; mdcp reportability: No; mdcp rep rationale: Case information does not meet criteria for reportability
Waited 15 minutes in clinic after receiving flu vaccine and other vaccines. When mother and pt left clinic another 10 minutes passed per mother. At this time pt's face blue and stopped breathing x 45 seconds per mother. Pt began breathing on own. Was taken to ER, monitored and given TYLENOL then discharged same day.
Reddish purple, warm to touch, firm area approximately 4 inch diameter on upper left thigh.
Initial medication error report received on 02 December 2013 from nurse.  A 3 year child patient whose gender, medical history and concomitant medications were not reported, received a dose of FLUZONE (route, lot number and site of vaccination was not reported) on an unknown date. Reporter stated that child received two doses of 0.25 ml instead of 0.5 ml one month. Patient did not have any adverse events. List of documents held by sender: none.
Within hours my beast milk stopped and I had horrible mastitis? a horrific ovary/uterine lining  infection kind of like yeast but it was not. Immediately got very heavy period for 5 months straight. My cycles are still off and I?m still having pain in my ovaries and discomfort like a yeast infection yet it is not. My entire reproductive system is totally off. I wanted to have another child but I?m not getting pregnant. The breast milk never returned in my right breast and it has never been the same since mastitis. It is very lumpy and not right. I just had cancer scare over the mass I had a ton of tests and now I watch it for changes. The second shot has been worse than a c section. 18 months later I am still uncomfortable and I fear my body will never go back to how it was before I took that shot. It was immediate. I?ve taken round after round of anti biotics for these issues but they do not improve.
Mild rash began 11/13/19, seen in office 11/20/19. Fine, pink (faint) blotchy rash on trunk, shoulders, thighs). Asymptomatic
difficulty breathing; throat swelling; rash; swelling; This is a spontaneous report from a contactable pharmacist. A 66-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe), via an unspecified route of administration on 18Jul2021 (Batch/Lot Number: df1307; Expiration Date: 30Aug2022) (at the age of 66-year-old) as single dose for immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported that the patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) on 18Jul2021 and 30 minutes after she experienced a rash, swelling and throat swelling with difficulty breathing and after 1 or 2 hours it went away, no epinephrine needed. The patient is a doctor. The outcome of the events was recovered on 18Jul2021. The pharmacist asked how long pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) is good once the needle is attached, and the pharmacist also asked of what other vaccines are contraindicated if a patient had an anaphylactic reaction to pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). The pharmacist also asked for stability information for Pneumovax 23.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the close temporal relationship, the association between the events difficulty breathing and throat swelling with PREVNAR 13 can not be fully excluded.  The impact 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.
Throat felt like it was closing up; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE and Batch/Lot Number: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 08Apr2021 14:30 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included fibromyalgia from an unknown date and unknown if ongoing Other medical history: Fibromyalgia. The patient had unspecified allergy. The patient received other vaccine same date vaccine on 08Apr2021. The patient did not have any other vaccine in four weeks. The patient received unspecified Other medications in two weeks. The patient did not had COVID prior vaccination and COVID tested post vaccination. The patient experienced throat felt like it was closing up on 08Apr2021 15:00. The patient did not received treatment for events. On an unspecified date in 2021, the event was resolved.
Swollen lymph  nodes; pain in armpit; headache; temperature 38.7; muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01May2021 09:00 (Lot number: EWO175) at the age of 35 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 01May2021 19:00, outcome "not recovered", described as "Swollen lymph  nodes"; AXILLARY PAIN (non-serious) with onset 01May2021 19:00, outcome "not recovered", described as "pain in armpit"; HEADACHE (non-serious) with onset 01May2021 19:00, outcome "not recovered", described as "headache"; PYREXIA (non-serious) with onset 01May2021 19:00, outcome "not recovered", described as "temperature 38.7"; MYALGIA (non-serious) with onset 01May2021 19:00, outcome "not recovered", described as "muscle pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, axillary pain, headache, pyrexia, myalgia.  Additional information: No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Swelling; Redness; Muscle Aches; Joint Aches; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (Swelling), ERYTHEMA (Redness), MYALGIA (Muscle Aches), ARTHRALGIA (Joint Aches) and FATIGUE (Fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 043B21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL and LEVOTHYROXINE for an unknown indication.   On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING (Swelling), ERYTHEMA (Redness), MYALGIA (Muscle Aches), ARTHRALGIA (Joint Aches) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, SWELLING (Swelling), ERYTHEMA (Redness), MYALGIA (Muscle Aches), ARTHRALGIA (Joint Aches) and FATIGUE (Fatigue) outcome was unknown.            Treatment details were not provided.   This case was linked to MOD-2021-231082 (Patient Link).
2/27 Muscle aches,headache,nausea, lasting 2 weeks  3/6 Covid arm lasting 1 week   3/9 Jitteriness,dry heaves