chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 3 wks after 2nd dose felt extreme increas in frequency, duration and intensity of arrhythmias; Heart thumping  kept me awake; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Lot number: 30135BA) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "osteoporosis/osteopenia" (unspecified if ongoing); "infrequent SVT" (unspecified if ongoing); "Mild PVCs PACs" (unspecified if ongoing); "known allergies; Contrast dye, sulfa" (unspecified if ongoing); "known allergies; Contrast dye, sulfa" (unspecified if ongoing). Concomitant medication(s) included: ACEBUTOLOL; ALENDRONATE. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EN6203, Location of injection: Arm Left, Vaccine Administration Time: 01:30 PM), administration date: 04Mar2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL9267, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 11Feb2021, when the patient was 68-year-old, for COVID-19 immunization. The following information was reported: ARRHYTHMIA (medically significant), outcome "recovering", described as "About 3 wks after 2nd dose felt extreme increas in frequency, duration and intensity of arrhythmias"; PALPITATIONS (non-serious), outcome "recovering", described as "Heart thumping kept me awake". The events "about 3 wks after 2nd dose felt extreme increas in frequency, duration and intensity of arrhythmias" and "heart thumping kept me awake" required physician office visit. Therapeutic measures were not taken as a result of arrhythmia, palpitations. Clinical information: There was no other vaccine in four weeks. Other medications in two weeks was Acebutolol, Alendronate. I've had mild PVCs, PACs and 3 occasions of SVT in the past 30 yrs. so on Acebutolol. About 3 wks. after 2nd dose felt extreme increase in frequency, duration and intensity of arrhythmias. Heart thumping kept me awake. Abated some by 6 mos when I got 3rd. 15 days later it all started again. Abating some now but still more frequent and intense than before shots. There was no covid prior vaccination. There was no covid tested post vaccination. Known allergies was Contrast dye, sulfa. Other medical history included Mild PVCs PACs, infrequent SVT, osteoporosis/osteopenia.  No follow-up attempts are possible. No further information is expected.
On 6/13, 4 days after imms, patient developed red wheals on same leg as imms site but not directly around the site. Over the next 3 days the wheals spread to include the whole body and face; some minor lesions on palms and soles. No oral lesions; Low grade fever. Given Benadryl
I  was approached by a person in the center at approx 1000 stating she had an employee that received their first COVID vaccine and was not feeling well. I went over to find the employee sitting in the person's office in a chair. She was able to tell me she received her first COVID vaccine approx 30 mins ago. She stated she stayed there for the 15 mins after the vaccine with no reaction. She is now having ringing in her ears, feeling lightheaded, hot, nauseaus, and "I feel like I am in a cloud." She denies allergies or past hx of vaccine reactions. Denies hx of anaphylaxis. She denied any sob or chest pain. Employee was holding her head. She stated she had only had some coffee and juice today and was feeling hot. BP was taken and was 112/90 and she is not tachy and no resp distress observed. Patient was able to speak to me in full complete sentences initially. Another person came over and the employee was asked if she could stand and walk. Employee stated she felt she could stand and walk and when she did this she had to hold onto something to avoid falling and she was sat back down. Emergency services was called and employees speech was slow and almost slurred at times. Emergency services arrived and transported employee.
Sore muscle; A bit tired; This is a spontaneous report from a contactable consumer reporting for herself. A 62-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on 10Mar2021 09:45 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines in four weeks and any other medications in two weeks. Patient was not tested for covid prior or post vaccination. On 10Mar2021 16:00 the patient experienced sore muscle, and a bit tired. Patient did not receive any treatment. The clinical outcome of events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Was here for physical on 11/11 and had 3 vaccines. covid booster, shingles, tetanus. Then felt a little run down the next few days. Was able to do the normal routine. Then on Saturday felt like scalp was "weirdly tender." with brushing hair. Then felt prickly/tingling sensation on back of ear. Then Monday/tuesday woke up with sore throat, headache, ear ache and right neck muscles have been sore. And has been like that since then.    Then yesterday started getting tingling in the eye and went to patient first. Took a look and gave valtrex. Has taken 2 pills. Gave abx drops for ear, but recommended holding off for now until seen today.  Does have blisters forming.
Patient received Prevnar on 3/5/2015. Patient developed increasing nausea/vomiting/abdominal discomfort over subsequent days. No diarrhea prior admit. Elevated liver enzymes at admit. No recent medication changes in past several months, except for Prevnar administration 5 days prior to admission on 3/10/15. Patient's prior to admission hydrochlorothiazide was held during admit, as was her warfarin (for supratherapeutic INR). She received IV fluid hydration. Symptoms and liver enzymes improved over next few days and patient was discharged on 3/13/15. Patient reports no alcohol intake.
Recurring Hives all over body. Feeling of tiredness. Very itchy. They appear and then disappear and the reappear somewhere else multiple times through the day.  Completed the course of prednisone and hydroxyzine for 6 days Took xysal for 3 days in the night. Applying calamine lotion 3-4 times a day
Pt recvd 3 Hep B vax on 3AUG89, 6SEP89 & 25JAN90 following these titer was neg; 4th dose of Engerix-B vax recvd on 10AUG90 following this titer was neg;
Itching, redness hand Narrative: Pt observed in the C-19 Vaccine clinic for 2hours, 30min post administration of PO Benadryl. VS stable. No resp distress on RA, no hives or rash noted. slight redness to 4th and 5th digits of left hand.
I now have frequent premature heartbeats / heart palpitations while resting. They do not hurt but are disconcerting and distracting. They usually happen in the evening but occasionally throughout the day. They have not subsided.
Loss of appetite; low grade fever; Chills; Nausea; Muscle pain; Pounding headache; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), PYREXIA (low grade fever), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Muscle pain) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (COVID- 19 positive.) in November 2020. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and OMEPRAZOLE for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced DECREASED APPETITE (Loss of appetite), PYREXIA (low grade fever), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Muscle pain) and HEADACHE (Pounding headache). At the time of the report, DECREASED APPETITE (Loss of appetite), PYREXIA (low grade fever), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Muscle pain) and HEADACHE (Pounding headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Moderna COVID-19 Vaccine EUA about 12 hours after injections, shivering alternating with sweating associated with elevated temperature (99.9, no higher than 100.1), general lethargy and body aches  very similar to flu symptoms
Patient called complaining of significant left upper arm pain with swelling stating that she had a flu shot and pneumonia shot in the same arm yesterday. Scheduled patient for nurse visit same morning. Observed patient holding left arm stating that her arm was heavy. Noted swelling at injection sites in left deltoid that continued down halfway of upper arm. The area was warm to touch and patient indicated the pain was a 9 on scale 1-10. Patient was afebrile and denied difficulty breathing, however, did complain of itching on same upper arm. Patient advised that she tried ice pack last night, but without relief. Dr. was consulted and patient evaluation by provider was performed. Labs were ordered and patient was prescribed Benadryl and Medrol Dose Pack.
arms swelled up to like twice the size; turned all red; it was hot; reddish; turned all red; it was hot; reddish; felt little nauseous; Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), on 26Sep2018 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years for pneumococcal immunisation; for pneumococcal immunisation. The patient's relevant medical history included: "MS" (unspecified if ongoing); "chronic illness" (unspecified if ongoing); "allergic" (unspecified if ongoing), notes: allergic to certain things. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset Sep2018, outcome "unknown", described as "Fever"; PERIPHERAL SWELLING (non-serious) with onset Sep2018, outcome "unknown", described as "arms swelled up to like twice the size"; NAUSEA (non-serious) with onset Sep2018, outcome "unknown", described as "felt little nauseous"; ERYTHEMA (non-serious), FEELING HOT (non-serious) all with onset Sep2018, outcome "unknown" and all described as "turned all red; it was hot; reddish". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of peripheral swelling, erythema, feeling hot, nausea, pyrexia.  Additional information: Reporter was patient, who calling in and asking about the RSV (Abrysvo) shot. She mentioned that she has MS and for some strange reason when she got the Pneumonia shot back in 2018, she had a reaction and she is trying to find out if that has the same ingredients as the Pneumonia shot. She said that she wanted to get the shot but she don't want to have a reaction. Patient would like to report an adverse event with the product Prevnar 13. The patient received a dose of Prevnar 13, last 2018 and she developed a reaction after the administration of the drug (Prevnar 13) but she did not specify the symptoms of the reactions that she had. Reporter stated, It didn't happen right away, it happened like her arms swelled up to like twice the size, it turned all red, it was hot, and she had a fever and felt little nauseous. It was hot and reddish. Other Medical Condition and Concomitant medications, Patient stated, she had and that is why it was important for her to get all shots, so she was told to get them, but she mean that is the only chronic illness that she have. No Prior vaccinations. Treatment included just Tylenol and warm compression that is it.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht crm197 protein) has been requested and will be submitted if and when received.
Arm red, inflammed, swollen with demarkation.  Low grade fevers still at day 6 after immunication.  Now feeling weak and tired along with above effecting the whole right upper arm to 1 inch distal to elbow.
This spontaneous report as received from a other health professional refers to unspecified patients of unknown age. In 2017 the patients were vaccinated with M-M-R II lot # M000768 for prophylaxis.    Concomitant therapies included sterile diluent. In 2017 the patient experienced incorrect product storage. The outcome of incorrect product storage is unknown. The reporter considered incorrect product storage to be not related to M-M-R II. Sender's Comments: US-009507513-1709USA009319.
This spontaneous report as received from a pharmacist refers to a currently 53 years old patient of unknown gender. Patient's medical history, concurrent conditions and drug reactions/allergies were unknown by the reporter. On an unknown date, the patient was vaccinated with a dose of (wistar ra 27-3) M-M-R II  (Concentration, dose, lot#, expiration date and route were unknown by the reporter). Patient's concomitant therapy was unknown by the reporter. On an unknown date, the patient experienced viral titre decrease reported as "the patient had low titers", the pharmacist stated that the patient asked to receive a booster dose of (wistar ra 27-3) M-M-R II, which was needed for her employment. It was unknown by the reporter if lab diagnostics studies were performed to the patient and also if there was treatment given for the event. The outcome of viral titre decreased was unknown. The relationship regarding (wistar ra 27-3) M-M-R II and viral titre decreased was unknown. A product quality complaint was not involved. Additional information has been requested.
Hives that are still ascending after 24 hours, swelling around rash, swelling and puffiness on ears and face.
PATIENT STARTED FEELING DIZZINESS/VERTIGO ABOUT 1 WEEK AFTER THE SHOT AND HAS BEEN HAVING SPELLS OFF AND ON.  PATIENT WAS TOLD TO SEE PRIMARY CARE PHYSICIAN.
has thrown up today; fever; chills; Fever chills was reported as worsened.; body ache; she couldn't sleep; This is a spontaneous report received from a contactable consumer (patient's mother).  A 17-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0196), via an unspecified route of administration in arm left on 27Jun2021 (at the age of 17-years-old) as dose 1, single for COVID-19 immunization. The patient's medical history included migraine since an unknown date. Concomitant medication included topiramate (TOPIRAMATE) 25mg, 2 tablet by mouth at bedtime, nortriptyline (NORTRIPTYLINE) and meloxicam (MELOXICAM) 15mg 1 tab by mouth daily taken for an unspecified indication, start and stop date were not reported. On 27Jun2021 15:00, the consumer reported that the patient received the 1st dose of Pfizer Covid Vaccine yesterday and experienced fever, chills, body ache, and has thrown up today on28Jun2021. Consumer wanted to know if these symptoms were normal for her daughter's age. Consumer wanted to know how long will her daughter's symptoms last and when will her daughter function normally again. The patient was vaccinated yesterday with the covid vaccine and she was having a fever now, she has been giving her Tylenol. The fever started late last night, as well as chills and she couldn't sleep. She did throw up a few minutes ago. Her daughter only threw up today, it was just one episode today. The First Dose was yesterday 27Jun2021 between 12:30 and 12:45 during the day. The fever and chills started yesterday around 3PM. On an unknown date, the patient underwent lab tests and procedures which included Temperature: 100.9 Fahrenheit. The patient received treatment for adverse events. Her temperature was higher but she feels the same, no chills today, the temperature was rising even with the Tylenol. The Last taken temperature was 100.9F, it was taken today an hour and a half ago. The outcome of events fever, chills and fever chills was reported as worsened. was not recovered and unknown for events body ache, has thrown up today, she couldn't sleep.  Follow-up (28Jun2021): This is a follow-up spontaneous report received from a contactable consumer (patient's mother). This report is not related to study or programme. No new events added.   Follow-Up (23Jul2021): Follow-up attempts are completed. No further information is expected.
Itchiness (immediate) followed by swelling (half dollar size) and turned reddish colour. Also dizzy and sluggish condition. As of this morning is pinkish colour.
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M020101, expiration date: 07-MAR-2019) (dose and route of administration were not reported). There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of the two reports received from the same reporter. Additional information has been requested.
no adverse event; PROQUAD and MMR II both vaccines were inadvertenly administered at the same time to a 12 month old patient; This spontaneous report was received from a medical assistant (conflicting information also reported a nurse) referring to a 12-month-old patient of unknown gender. The patient concurrent conditions, medical history, concomitant therapies, drug reactions or allergies were not reported.  On 30-MAR-2021, the patient was vaccinated with the first doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 milliliter injection (strength, route of administration were not ; lot# was T029099 and expiration date was 23-FEB-2022); and on the same date, with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 milliliter injection, (strength, route of administration were not provided; lot# was S037498 and expiration date was 20-NOV-2021) for prophylaxis. On the same date, the patient was inadvertently administered with both suspect vaccines at the same time. No additional adverse events occurred (AEs). No further information was reported.  The causal relationship between the event and the suspect vaccines was not reported.
Vaccine administered at 1215 pm. In waiting area around 1225 pt felt very faint sitting in chair next to grandmother. Patient appeared to have seizure like activity and paramedic called immediately. After 1 to 2 minutes patient started responded well and just stated she felt very faint. Paramedics arrived and waiting for patient to fully recovered. They did state her blood pressure decreased to below baseline but quickly came back up to normal as patient started feeling better. They deemed patient to be stable and didn't think it was from the vaccine itself versus receiving an injectable vaccine as patient often feels faint after giving blood. They walked patient and grandmother to their personal car so she coudl be taken home.
Fever, irritablity and rash about 9 days after the well visit on 04/14/09.  Patient seen in office on 04/24/09 for rash- five petechial on neck and chest.
This spontaneous report was received from an office manager refers to patient of unknown age and gender. On 14-AUG-2013, the patient was vaccinated with a dose of GARDASIL (lot#J002641, expiration date 10-DEC-2015) that underwent unsupported temperature excursions. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Abnormal menstruation immediately after receiving each does of the vaccine. I'm specifically reporting the second vaccine dose because of how abnormal menstruation was.  The second does I menstruated starting the day after I received my vaccine for 6 days (normal length of cycle and bleeding quantity). 7 days after stopping menstruating I seemed to menstruate again for 1 day (medium quantity of bleeding). Bleeding stopped for an additional 5 days. I then started menstruating again for 13 days.  My normal cycle lasts 7 days on average. I very rarely menstruate every month (usually it's every 2 months or more) and I've never before menstruated twice within a month.  I also experience swollen lymph nodes in my underarm on the left side of my body (same side as injection site) the day after my vaccine.
Patient reports that same evening she broke out in a rash starting at the neck which then spread downward over her body.  Her husband who's a physician gave her Benadryl and she was better.
This spontaneous report as received from a 82 year old female patient refers to herself with a reaction to a pain medication. On an unknown date in June 2012 the patient was vaccinated with ZOSTAVAX (lot # was not reported). On 14-FEB-2013 the patient experienced developed shingles. It started as a pain in her side; then she saw a rash. The rash reached from around her chest to her back. There was a burning sensation, though she said it was fading. There was no lab diagnostic studies performed. The patient went to clinic for medical attention. Treatment was given for the adverse event. The outcome of consumer developed shingles was unknown. Additional information has been requested.
PALE; SWEATS; FEVER; POUNDING HEADACHE; SICK STOMACH; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 15-JUN-2021 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 16-JUN-2021, the subject experienced pale. On 16-JUN-2021, the subject experienced sweats. On 16-JUN-2021, the subject experienced fever. On 16-JUN-2021, the subject experienced pounding headache. On 16-JUN-2021, the subject experienced sick stomach. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pale, fever, sweats, pounding headache and sick stomach was not reported. This report was non-serious.
This case involves an unknown age and unknown gender patient who experienced every time I got it, I got the flu while receiving vaccine INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date the patient every time I got it, I got the flu (influenza) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (Every time I got it I got the flu). At time of reporting, the outcome was Unknown for the event every time I got it I got the flu.