chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sinus arrhythmia; Night sweats; Heart rate low; Dyskinesia; This is a spontaneous report from a contactable nurse (patient).   This 36-year-old female patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at single dose in the left arm on 07Jan2021 10:00 for covid-19 immunisation. Medical history included hypotension, rheumatoid arthritis, asthma. Concomitant medication included clonazepam, methylprednisolone. On 07Jan2021 21:00, the patient experienced sinus arrhythmia, night sweats, heart rate low, dyskinesia, all with outcome of recovered with sequelae. Therapeutic measures were taken as a result of the events included Inderal 10mg. The events were assessed as congenital anomaly. 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 had not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be 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.
A nurse reported that a 7 month old male received his 1st injection of Prevnar on 4/17/00. On 4/18/00, his mother reported to the nurse that the infant had developed a fever. The infant recovered.
Started with muffled hearing after first shot, I thought I was losing my hearing in my right ear. Then tinnitus started in both ears and inner ear head pressure. Also experienced chronic headaches in the month following first two shots. Tinnitus got worse with second shot which was in March and over 9 month still exists but not as bad. Following Booster shot about 2-3 days after the tinnitus is louder than ever.
End of Feb 2021 noticed weakness and heaviness in legs Neurological exam revealed lower motor neuron signs. Physical exam revealed decreased muscle bulk and normal tone. Evidence of atrophy in legs and hands with fasiculations. Patient is unable to walk.
Severe swelling and large ?knot? at injection site. Knot  approx the size of golf ball. Knot is warm to touch, red, and extremely itchy. Knot lasted 5 days, starting day after injection.  Day after injection, woke up with pain in both hips which lasted 48 hours.  Two days after injection, woke up with muscle pain in both calves, which lasted 48 hours.   Day 2
warm to the touch; localized at the injection site and was rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch) and VACCINATION SITE RASH (localized at the injection site and was rash) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMINS NOS for an unknown indication.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch) and VACCINATION SITE RASH (localized at the injection site and was rash). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at a dose of 1 dosage form. On 27-Jan-2021, VACCINATION SITE WARMTH (warm to the touch) and VACCINATION SITE RASH (localized at the injection site and was rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt). At the time of the report, PAIN IN EXTREMITY (arm hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-333395 (Patient Link).
has been feeling like she has the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (has been feeling like she has the flu) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B211A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (has been feeling like she has the flu). At the time of the report, INFLUENZA LIKE ILLNESS (has been feeling like she has the flu) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications includes syrup and flu pills
Swollen lip, tongue, throat and face.  Unable to speak.  Numbness in both arms and feet.
He received his 2 month immunizations at 4:30 pm, he was extremely fussy and inconsolable. I was assured that this was normal due to vaccines. By Sunday morning, I found him unresponsive laying down. I called 911, administered CPR until paramedics arrived. Dark foam began coming out of his mouth. They pronounced him dead at the scene, stating that he had only been gone 10 to 30 minutes before I started CPR compressions. My son was born 8lbs 11oz. He was extremely healthy and full of smiles. Such a happy baby with absolutely no medical conditions.
Shortly after taking the vaccine she developed type I juvenile diabetes and also later had to have her gall bladder removed because it was not functioning properly. She was perfectly healthy until recieving the vaccine. She is now on an insulin pump for the diabetes.
Noted intense arthralgia at hips, knees, elbows, shoulders and thoracic spine with swelling of right shoulder joint and left knee. Onset within 24 hours of injection. Currently using Motrin for symptoms. Evaluated pt 1 week, post vax, and is still with symptoms.
Case number PHEH2015US022025, is an initial spontaneous report received from a health care professional on 27 Oct 2015. This report refers to a 13 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157004) intramuscularly and FLUZONE (other manufacturer, batch number: not reported) both administered about 12 days apart on 12 Oct 2015 and 26 Oct 2015 respectively. No adverse event was reported following this medication error.
Rash, severe itching since 10/24/03 until present have been to ER twice MD office on 12/16/03.
temp 103; BP 106/58; convulsion x 1; coma or marked level of consciousness;
I developed Bell's Palsy (droop of mouth and unable to close right eye) three weeks after COVID vaccine shot #1.  I went to the emergency room and was diagnosed and given a prescription for Prednisone. My doctor was out of town and the doctor on call added 3000 units of Valtrex. I was referred to another Dr., who indicated that this may be a result of the vaccine.  She conferred the treatment given.
This spontaneous report was received from a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 27-OCT-2014, the patient was vaccinated with an improperly stored dose of COMVAX (lot number J013884; expiration date 19-AUG-2016) 0.5 ml (route of administration and anatomical location were not reported). On an unspecified dates, the COMVAX had two temperature excursions, one of 72 hours and 40 hours. The lowest recorded temperature was 28 F (-2.222222222 Celsius) while the highest recorded temperature was 47 F (8.333333333 Celsius). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
fever; hot to the touch; pain,soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE PAIN (pain,soreness) and PYREXIA (fever) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (hot to the touch) and VACCINATION SITE PAIN (pain,soreness). On 14-Jan-2021, the patient experienced PYREXIA (fever). At the time of the report, VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE PAIN (pain,soreness) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Pyrexia: other His temperature was taking today and it showed he has a fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided.   Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
It has been almost six months since I had a flu shot at my place of work. I am unable to raise my left arm and any movement causes severe pain. I wake up at night when I move in bed and am not guarding my arm. The pain is excruciating.  The nurse who administered my flu shot, injected me in highest point of my deltoid. I felt pain with the injection. I felt pain driving home and by early evening I was taking a pain reliever. The pain was so severe I could not sleep on my left side (the arm that was injected). This is incredibly painful, to the point of nausea. I also have poor range of motion and am unable to lift with that arm. It is a serious injury.  To date, I have lingering shoulder pain, reduced range of motion, tingling of my entire body (especially during the night), numbness, muscle weakness and lack of coordination.  At times I do have difficulty walking or balancing and I my vision has become worse. I believe this pain is permanent.
Pt states she has a rash all over her back and left arm. Pt denies any difficulty swallowing or breathing. Pt states this also happened with her first dose. Pt took 50mg of her own benadryl. PT's vitals are stable. Pt states she is feeling better and wants to leave. Pt didn't require transport to the hospital.
Experience a cold sweat with considerable water dripping from my face and upper body. Not sure if this was from flu shot but one of my neighbors experienced the same system after getting her flu shot.  She was was also about 70
This report is being submitted by the guidance of the DOH. 12 patients were affected by storage and handling excursions.
Pt c/o "feeling  fuzzy" and/or "floaty".  Vitals taken 148/98; P-78; RR-18.  States last took dose of hydrocodone at 5 pm the day before.  States some lightheadedness, and noted beginnings of localized rash on neck, torso, and back.  Repeated vitals at 10:06: B/P-182/111 (auto) verified B/P manually- 170/100; P-81; dizziness/"fuzziness" worsening.  Paramedic administered 25 mg of Benadryl as ordered by Dr. (on site for event only).  Repeated vitals at 10:21- B/P- 158/104; P-81; repeat at 10:45- B/P 136/85; P-68; also checked Blood Sugar- 89.  Final vital check at 11:05- B/P- 146/96; P-82.  Pt refusing transport to ER.  Signed declination for Fire Department.  Significant other agreed to take pt to the Hospital at this time.
marked swelling & edema below lt eye & lt temporal region-w/redness & itching;
Sore throat evolved into swelling of the throat and difficulty swallowing, next day hives developed under both arms and arm pit areas as well as some on hands and feet.
Information has been received from a 71 years old female patient referring to herself with low blood pressure. The patient was allergic to a few unspecified antibiotics. The patient's concomitant medication included blood pressure medicine. On 15-JAN-2019 the patient was vaccinated with PNEUMOVAX 23 (route reported as "1 shot", lot # and expiration date unknown) for prevention of pneumococcal disease. On the same day within an hour of receiving her PNEUMOVAX 23 injection the patient experienced severe pain and her arm swelled up (south of the injection site) and doubled in size of her arm. The patient reported that she was unable to lift her arm. The patient had blood work and the result was not provided. The patient also reported that she spoke with her physician who recommended that ice be applied at the swelling location and the swelling was still present, but it had gotten better. The outcome of the events was recovering. Causality was not reported.
Hysterical crying since 1:30 PM after immunizations given. TYLENOL 40 mg at 4 PM without improvement. TYLENOL dose increased to maximum dose of 15mg/K (60mg).
Pt had both vaccines in upper left deltoid (marks still evident), he developed a swollen and red area on inside arm from 3 inches below shot area to elbow, and just on inside of arm. Location and presentation more like allergic rxn to bug bite or other substance. Pt said it was sore but not itchy.  recommended ice packs and acetaminophen, if it got very painful to contact dr. he only showed it to me today so not yet recovered.
Convuls, hypotonia-hyporesponsive episode; 20 seconds long; 4 hrs p/DTP inject;
Information has been received from a physician concerning a 14 year old female patient whose the family had a history of cervical cancer who on an unspecified date was vaccinated with the first dose of GARDASIL (lot # and expired date not reported), 0.5 ml. The physician stated that on an unspecified date, the patient experienced hives. The patient was given steroid as a treatment. The patient sought unspecified medical attention At the time of this report, patient's outcome was unknown. Additional information has been requested.
1 week post injection a 6x8 red rash and hematoma presented at my injection site.  This may have been there the entire time and was just not noticed.
Fever, Diarrhea, BODY ACHES, CHILLS Narrative:
Pain in lower back; Chills; Aches; too painful to sit upright or walk; too painful to sit upright or walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Aug2021 as dose 1, single (Lot number: EW0185), in left arm, on 01Sep2021 as dose 2, single (Lot number: EW0185), in left arm and on 20May2022 as dose 3 (booster), single (Lot number: 4JY989) at the age of 43 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Endometriosis" (unspecified if ongoing); "Sulfa Based Antibiotics" (unspecified if ongoing), notes: known allergies : Sulfa Based Antibiotics. There were no concomitant medications. The following information was reported: PAIN (non-serious) with onset 21May2022, outcome "recovering", described as "Aches"; CHILLS (non-serious) with onset 21May2022, outcome "recovering"; BACK PAIN (non-serious) with onset 21May2022, outcome "recovering", described as "Pain in lower back"; GAIT INABILITY (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) all with onset 21May2022, outcome "recovering" and all described as "too painful to sit upright or walk". Therapeutic measures were not taken as a result of back pain, chills, pain, gait inability, loss of personal independence in daily activities. Clinical course included No other medications in two weeks. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. known allergies included Sulfa Based Antibiotics. Chills, Aches, Pain in lower back  had to spend entire day in bed because it was too painful to sit upright or walk.
Urticarial rash; Hand swelling; This is a spontaneous report from a contactable physician. A 17-year-old female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 11Apr2021 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Medical history included depression. It was unknown if the patient was pregnant at the time of vaccination. Concomitant medications included sumatriptan (IMITREX) and escitalopram oxalate (LEXAPRO) for unknown indication from an unknown date. The patient previously received cefdinir (OMNICEF) for unknown indication on an unknown date and experienced drug allergy. 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. On 11Apr2021 at 10:00, the patient experienced urticarial rash and hand swelling. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with antihistamine (unspecified) on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events urticarial rash and hand swelling was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous case was retrieved on 29-Oct-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1783625-1), reported by other non-healthcare professional and concerned a 38-year-old, female patient. The patient's concurrent condition included migraine and she had no allergies. The patient's concomitant medications included Wellbutrin (bupropion hydrochloride), unspecified vitamin B, unspecified vitamin D and Zyrtec (cetirizine hydrochloride), all used for unreported indications. On 09-Oct-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose reported as 'one', route of administration: intramuscular, anatomical location: left arm and indication: not reported). The batch number reported was 308471. On 10-Oct-2021, one day after receiving Flucelvax Quadrivalent, the patient developed redness at injection site. In addition, the patient's cervical lymph nodes were hot, hard and painful, like three rocks by her collar bone. On an unknown day in Oct-2021, the patient experienced general feelings of malaise. On 12-Oct-2021, all the lymph nodes were swollen in her armpit and it hurt to put arm at her side. Also, general feeling of malaise continued. On 13-Oct-2021, lymph nodes were still swollen and painful. The patient had never had a reaction before. No laboratory analyses were performed. At the time of this report, the patient had not recovered from the events. The reporter did not provide a causality assessment. The events were assessed as non-serious. Company comment: A 38-year-old patient was vaccinated with Flucelvax Quadrivalent. One day after receiving Flucelvax Quadrivalent, the patient developed redness at vaccination site. In addition, the patient developed general malaise and her cervical lymph nodes were hot, hard and painful. Causal role of the suspect vaccine is assessed as possibly related for all events, considering plausible time relationship.; Sender's Comments: A 38-year-old patient was vaccinated with Flucelvax Quadrivalent. One day after receiving Flucelvax Quadrivalent, the patient developed redness at vaccination site. In addition, the patient developed general malaise and her cervical lymph nodes were hot, hard and painful. Causal role of the suspect vaccine is assessed as possibly related for all events, considering plausible time relationship.
Chest pain, elevated troponin, CRP at 1-2 day after 2nd dose of COVID vaccine
The first day, very painful vaccinated arm, felt achey, like flu - took tylenol & diphenhydramine to sleep. Second morning felt nauseated to the point of vomiting, very sore arm & body, like flu. No energy, went to bed for most of the day. Third day arm still pretty sore then a hot, red, rash about 4" long & 3" wide appeared below/around the injection site. Continuing to take tylenol & diphenhydramine as it helps pain & heat of rash. Fourth day better but still have a rash that is hot to the touch. Taking above meds to help. Fifth day, pain is much better but arm still aches & have smaller rash that itches & is warm to the touch, and low energy. Sixth day, arm aches and a small rash is still there and warm to the touch. Tylenol & diphenhydramine help a lot.
URTICARIA/HIVES- TREATMENT ATARAX 10 MG PER 5 ML-1 TEASPOON EVERY SIX HOURS. BAKING SODA OR OATMEAL BATHS.
Light Headed, Cold, burning sensation inside, nausea,  felt like she was going to pass out, rash on chest/neck, she could hear people talking but felt she didn't feel like she was  present - elevated BP 200/110.  Staff member took Metoprolol 25mg.  1/2 hour took medication feels better but feels foggy
Tinninitus and after 7 days large red circle around the injection area, very sore arm. With second dose on the second day, very nauseated, bad headaches, body aches , super tired. , very sore arm.