chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About an hour after the vaccine couldnt turn head to the left. It lasted for about 4 hours and then went away.; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 2613) via an unspecified route of administration in the left arm on 05May2021 at 12:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included epilepsy, bipolar disorder, high blood pressure, high cholesterol and known allergies to NSAIDS. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included topiramate (TOPAMAX), gabapentin (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN), clopidogrel bisulfate (PLAVIX), escitalopram oxalate (LEXAPRO) and trihexyphenidyl hydrochloride/chlorpromazine hydrochloride/trifluoperazine hydrochloride (SER); all taken for unknown indications from an unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05May2021 at 13:00 the patient experienced about an hour after the vaccine could not turn her head to the left, lasted for about 4 hours and then went away. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event about an hour after the vaccine could not turn head to the left, lasted for about 4 hours and then went away was resolved on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.
Cough, wheezing, shortness of breath, tachycardia and BP elevation. Rx'd Solu-Medrol and Cardizem.
Approx 48 hours after my 2nd dose of the Pfizer Covid-19 vaccine, my nursing 2 year old son developed a fever of 102°F and chills. He has had a fever for approx 12 hours now, it is currently at 100.2°F, he no longer appears to be experiencing chills. I have not yet administered any medication to my son yo treat the fever.  As these symptoms are similar to those that a vaccinated person would have I wanted to make sure to report it in hopes that it can help research of possible antibody production in nursing children of vaccinated mothers.
This spontaneous report was received from a medical assistant refers to unspecified patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # K009105, exp. 21-JAN-2016). No concomitant therapy was reported. No adverse effect was reported. The outcome of the events was unknown. No product quality issue was involved. This is one of the two reports from the same reporter. Additional information has been requested.
Peripheral neuropathy; robotic movement when she tried to make a fist; Having popping/lock on my fingers. Similar to trigger finger; This is a spontaneous report from a contactable consumer (patient).   A 34-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 11:00 (Lot Number: EN6205), as SINGLE DOSE for COVID-19 immunisation.  Medical history included depression and anxiety. The patient is not pregnant at the time of vaccination. The patient did not have COVID-19 prior vaccination. The patient received dose 1 on 03Feb2021 in left arm (lot number: EL9269) and experienced popping/lock on fingers, similar to trigger finger/robotic movement when she tried to make a fist. There were no concomitant medications.  After the first shot, patient started having popping/lock on fingers, similar to trigger finger. A robotic movement when she tried to make a fist. It almost went away. The patient took the second shot and it came back. This time she has been having several symptoms: tingling on her hands and feet, numbness on left arm, hands and feet, pain on hands, loss of strength on left arm. The doctors are told the patient that is peripheral neuropathy. The patient underwent nasal swab (COVID-test post vaccination with negative result. The outcome of the events was not recovered. Treatment for the event includes pregabalin and etoricoxib.
administered 2 day after the expiry date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 2 day after the expiry date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 2 day after the expiry date). On 19-Jun-2021, EXPIRED PRODUCT ADMINISTERED (administered 2 day after the expiry date) 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.   Description of Event or Problem: A total of 10 patients received the vaccine on 19Jun2021 from Lot number 036C21A at the pharmacy. Pharmacist does not know if any patients has symptoms but is planning to do a flow up call with the patients. No concomitants were reported. No treatment was reported.
had side effects and she realized that she was administered with the gray cap formulation; patient still did not feel well; central nervous system side effects; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, purple cap and tolerate it well.), administration date: Sep2021, for COVID-19 immunization, reaction(s): "tolerate it well"; Bnt162b2 (Dose 2, single, purple cap), administration date: Sep2021, for COVID-19 immunization, reaction(s): "tolerate it well". The following information was reported: NERVOUS SYSTEM DISORDER (medically significant) with onset 16May2022, outcome "recovering", described as "central nervous system side effects"; DRUG INTOLERANCE (non-serious), outcome "unknown", described as "had side effects and she realized that she was administered with the gray cap formulation"; MALAISE (non-serious), outcome "recovering", described as "patient still did not feel well".  Clinical course: Patient weight was about 140 pounds. Her first two in September were Covid19 vaccine purple cap and she tolerated them well. She chose Pfizer's because the buffer was little salts that were quite innocuous. She didn't know they had switched to gray cap that has Tromethamine buffer. She did not tolerate the gray cap due to the buffer, but tolerated the purple cap Covid19 vaccine. When they switched to Tromethamine the amines can be biologically activated. Caller clarified the Covid19 Vaccine gray cap has the Tromethamine buffer. She wanted to make sure they know people are not reacting well to the Tromethamine. Caller was a retired doctor of pharmacy. They weren't typical immunological side effects like with the immune system. They were more central nervous system side effects. That was why it was concerning. When they switched to Tromethamine the amines can be biologically activated. She is not sure how big of a population will not tolerate the Tromethamine. Seriousness Criteria: serious enough that she was considered contacting an ambulance. Patient clarified that she felt it was medically significant. Outcome of event: patient still did not feel well. The side effects was ongoing. She felt better than she did that night, but still has residual. Causality: the side effects were caused by the Covid19 Vaccine. The gray cap, the buffer.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Central nervous system disorder and the suspect drug cannot be established, hence the causality was kept as Unrelated. The case will be reassessed once new information is available.
Myalgia Headache, body soreness, sore throat, runny nose Narrative:
Possible vaccine failure.   Acute Hep B - HBsAg positive. HBeAB positive HBeAg negative Testing done on 3/29/05
Potential allergy as evidenced by facial hives (2) & red swollen ear noted on 3/11/04. Also had red, swollen left arm.  MD gave client Augmentin 3/11/04 for poss. injection site infection.  Ear swelling increased on 3/12. Pt. received Rocephin 3/12. Improvement Left arm noted on 3/13 visit.  Decreased ear swelling noted 3/13.
Pfizer Side Effects Received 1st dose of the Pfizer vaccine on Monday, March 29, 2021 Side Effects: Arm sore and lasted until Tuesday, March 30, 2021 Wednesday, March 31, 2021 was un-eventful Thursday, April 1, 2021and Friday April 2, 2021, I was totally bedridden With chills and fever.  I did not eat or drink for those two days Saturday, April 3, 2021 I manage to sit in my lounge chair Managed to eat some oatmeal, the day was good. On Sunday, April 4, 2021, I managed to check my mail box but after 4pm things changed From 5 to 10, I had severe shaking, after that things were calm and  Monday, April 5, 2021 at about 130 am ate a can of beans A couple of hours later I had cold chills and shaking It lasted to about 7 am
Awoke today fine, took multivitamins, then noted marked edema of left cheek and pain with mild erythema. On exam, left parotid gland is enlarged and mildly tender.
Patient is 5 years old and was accidentally given the Pfizer dosage for the age group 6 months-4 years.  Parent is aware. According to CDC, advised redosing after 8 weeks of lower dosage administered.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patients pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored M-M-R II (strength, dose, frequency and lot # were not reported). No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. This is one of the several reports from the same reporter. Additional information has been requested.
Pt started running a low-grade fever 24 hours, post vax. Temperature was around 100F-101F and ran a fever for approx. 12 days. She was seen by a physician and nothing was found and was sent home. She did have a febrile seizure X 1. Seen in ER. Pt was given Rocephin in the event of meningitis. Recovered with no residue problems.
Patient was administered fluzone HD  on 8/23/21, but reported to the pharmacy on 9/15/21. Patient said arm was swollen and had rash all over her arm. Patient did state that she did go to her physician when she had the reaction.
Hundreds of little itchy red bumps all over hands and legs. Took loratadine and applied hydrocortisone 1% cream. Lasted for 10 days.
About 2 weeks after 2nd dose, I noticed I couldn?t taste much. Some meals I don?t taste any flavors, and other meals I slightly taste the flavor.
Reporter indicated that 28 pts recvd the Engerix-B series; 8 pts have tested neg (3 pts tested pos p/1st booster dose;
(R) trapezius pain x 2 wks. s/p Tdap (R) deltoid.
pt received first dose with mom at a school clinic on 12/6/21. Dad brought children in for a first dose on 12/18/2021. He received both doses with only a 13 day window, not a 21 day window.
Fever, chills, body, muscle aches 1st day. Large swelling of muscle, redness progressing left arm then into right arm. Then heat and dark coloration at size of both muscles. Dr. said it was some type of infection spreading.
Significant increase in existing mild tinnitus duration and volume (loudness). Sound is now constant and louder than previously. Loudness occasionally decreases to pre-vaccination level.
GRAVES' DISEASE; This is a literature report for the following literature source(s): "TWO CASES OF GRAVES' DISEASE IN ADOLESCENTS FOLLOWING COVID-19 VACCINATIONS", Thyroid.  A 15-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BASEDOW'S DISEASE (medically significant), outcome "recovering", described as "GRAVES' DISEASE". The patient underwent the following laboratory tests and procedures: Blood thyroid stimulating hormone: less than 0.005, notes: Unit: uI/mL suppressed; less than 0.005, notes: Unit: uI/mL Repeat bloodwork a month later; normal thyroid function; Heart rate: 130, notes: unit: bpm tachycardia while resting; greater than 200, notes: during exercise; TSI: unknown result; decreasing, notes: subsequent bloodwork; undetectable, notes: 3 months after initiating treatment; Thyroxine: 12.8, notes: Unit: mcg/dL Repeat bloodwork a month later; improvement, notes: subsequent bloodwork; normal thyroid function, notes: 3 months after initiating treatment; Thyroxine free: 2.57 ng/dL; improvement, notes: subsequent bloodwork; normal thyroid function, notes: 3 months after initiating treatment; Tri-iodothyronine: 223 ng/dL, notes: Repeat bloodwork a month later; improvement, notes: subsequent bloodwork; normal thyroid function, notes: 3 months after initiating treatment. Therapeutic measures were taken as a result of basedow's disease.  Clinical course: Presented to her pediatrician for evaluation of distorted vision upon standing. She received her first and second Pfizer-BioNTech COVID-19 vaccines two months and one month before presentation, respectively.She was started on Methimazole; subsequent bloodwork showed improvement in her thyroid function tests, decreasing TSI, and improvement in symptoms. The patient was taken off Methimazole 3 months after initiating treatment and her most recent bloodwork showed undetectable TSI with normal thyroid function.case series is the first to demonstrate Graves' disease after COVID-19 vaccination in the pediatric population. Given this possibility, pediatricians need to be watchful for symptoms of Graves' disease post-vaccination to prevent treatment delays.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Basedow's disease and the suspect product BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.,Linked Report(s) : US-PFIZER INC-202201277498 Same article/drug/event different patient.;
I don't want to file two reports. I had an episode of feeling very dizzy and when I laid down for an hour and I got up I couldn't remember names of anyone, went to hospital to rule out stroke. EEG and double echo both normal. MRA and MRI, no evidence of stroke, transient global amnesia, it took a couple hours for me to get back to normal. I also had a shingles outbreak 10 days post both vaccines.
pt recvd vax 23AUG94 & 3-4 hrs later went limp, pale & eyes rolled up;no tonic-clonic movements observed;MD visit pt crying & drowsy;BP nl, t100.6;hospitalized 4 days;CAT scan & EEG done;no signs of sz activity;pt recovered;
Approximately one  (1) hour after injection, I experienced extreme fatigue and fell asleep for about 2 hours. Upon awakening I was disoriented and dizzy. Upon awakening the next morning (8/29/2020) and subsequently my symptoms are flu-like. For example I have headache, fatigue, nausea, and body aches. Also, I have pain, redness and swelling at the vaccine injection site (right arm).
Light-headed; Pressure in my chest; Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head; Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head; Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head; Arm was sore; Had light headache; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982) via an unspecified route of administration on 22Jan2021 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included aspirin (ASPIRIN [ACETYLSALICYLIC ACID]) taken daily. The patient experienced light headedness and pressure in her chest that went to her left shoulder and jaw. Patient had light headache, pain in chest, and pain in jaw. She woke up this morning feeling better but still had slight pain in jaw. Wondering if side effects are from vaccine and will she be ok. Patient stated, "I have the first dose of the vaccine on 22Jan2021, I didn't have any side effect, my arm was sore but nothing big. But yesterday I feel light headed, like pressure in my chest, kind of pressure on my jaw and shoulder, my left shoulder, and my vitals were okay like my blood pressure, my heart rate and everything was normal. Further she explained this morning I felt better I didn't have pressure on my chest or anything but the pressure on my jaw that go up to my head. Is that related to the vaccine or is something that I have to worry about?" Consumer stated, "The second one is going to be on 12Feb2021, this Friday." Patient stated, "No, I was calling because today I feel better, I don't have the pressure on my chest. But I still have the pressure on my jaw and on my kind of my head. But no I have not called anybody. It's not like an emergency, I am calling because I was not sure about this is related to the vaccine." For treatment consumer stated, "No, today I took some Tylenol, that's all." No investigation assessment. The outcome of the event 'Light-headed' was recovering, the patient recovered from the event 'Pressure in my chest' on an unspecified date, was not recovered form Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head and was unknown for other events.  No follow-up attempts needed. No further information expected.
4in by 4in redness surrounding vaccine site. Itchy and a little sore. Started about 24hrs after vaccine.
Fever; Body aches; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MYALGIA (Body aches), HEADACHE (Headache) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PYREXIA (Fever), MYALGIA (Body aches), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, PYREXIA (Fever), MYALGIA (Body aches), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment or concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-022474, US-MODERNATX, INC.-MOD-2021-047944 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-047944:Crosslinked (MOD21-018119) US-MODERNATX, INC.-MOD-2021-022474:Crosslinked (MOD21-018119)
Injection site reaction/raised red mark appearing about 24 hrs after administration and so far clearing up on its own without treatment.
Area around injection was still itchy, red, swollen, and painful a week after injection was given. It had improved over time.
Patient called in the evening explaining she had severe swelling and pain, and it has worsened to the point of swelling from upper arm to elbow and now is in a sling because she cant handle the pain if she moves her arm.
Unclear of exact date of first adverse event complaint since she went to the ER with this complaint prior to reporting effects to PCP. She declines redness or swelling at injection side. Complaints of pain down left arm s/p injection. Pain radiated throughout deltoid muscle for >1 month.
healthy 2 m.o. who presented 10/1 with emesis, fever, and bloody diarrhea.   had emesis of every bottle he had that was NBNB. He was seen by his PCP who gave a script for AUS and told mom to present to ED if course worsened. He was then febrile to Tmax 100.6 rectally and began having bloody diarrhea so mom took him to ED.   At  hopsital his workup was notable for rotavirus positive and an abdominal ultrasound showing RLQ intussusception. He was transferred to for further workup.  In the ED here, he remained afebrile. Lactate was 1.5. He was ordered for cefoxitin but this was discontinued before he received it. He received a lactated ringers bolus and was started on mIVF with d5 normal saline.  US intestines with thickening of the wall of the cecum and the terminal ileum and edema and thickening of the ileocecal valve are which in transverse plane resembles appearance of a small intussusception. There is no ileocolic intussusception at the time of the examination.  He transitioned off IV fluids and discharged home 10/3.
indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: EW0164), on 06May2021 as dose 2, single (Lot number: EW0182) and on 02Dec2021 as dose 3 (booster) single (Lot number: 330308D) at the age of 32 years for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL; OMEPRAZOLE; AMLODIPINE; PAXIL [PIROXICAM]; FENOFIBRATE. Past drug history included: Cipro iv, reaction(s): "Known allergies: Cipro IV". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04May2022, outcome "not recovered" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04May2022) positive; (08May2022) Negative; (10May2022) Negative; (18May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
mom states pt stopped breathing @ 630PM while w/grandfather;grandfather did CPR & called EMT's & EMT responded for pt choking pt not taken to hosp;mom states child  T104 since episode;fever secondary to shot;febrile convuls 2nd to fever;
Fainting, including cyanosis.  Appeared to quit breathing for a short period of time.  Came to on her own with no complaints of pain.  After about 20 minutes of monitoring Pt. vomited.  Pt ate a granola bar and felt better.
26OCT91 pt exp severe nasal congestion w/sl fever which lasted until 7NOV91; 7NOV91 broke out in a rash; 8NOV91 had grand mal sz; taken to hosp dx febrile seizure; 22NOV91 had nasal congestion & fever, had 2nd sz taken to hosp; dx OM;