chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Anti-MDA5 dermatomyositis; This is a literature report.  A 28-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "Brooke-Spiegler syndrome" (unspecified if ongoing), notes: a rare, autosomal dominant condition associated with nodular, adnexal tumors. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, Single 21 days prior), for COVID-19 immunisation. The following information was reported: DERMATOMYOSITIS (medically significant), 14 days after the suspect product(s) administration, outcome "recovered", described as "Anti-MDA5 dermatomyositis". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase (normal high range 40): 55 IU/l; Aldolase: normal; Antibody test: resulted strongly positive for both MDA5 and TIF-, notes: gamma; Antinuclear antibody: negative; Biopsy: unknown results; Biopsy skin: showed findings consistent with dermatomyositis; Blood creatine phosphokinase: normal; Blood lactate dehydrogenase: normal; Chest X-ray: confirming no lung involvement; Computerised tomogram thorax: confirming no lung involvement; Dermoscopy: revealed dilated capillary, notes: loops and ragged cuticles with periungual erythema ; Full blood count: normal; Metabolic function test: elevated; Neurological examination: 4/5, notes: on deltoid as well as iliopsoas with moderate difficulty rising from a seated position with the rest of the muscle strength within normal limits; Physical exam: revealed erythema and, notes: scaling of entire scalp, forehead, cheeks, nose (diffuse Gottron's sign) with V-sign over the chest, and Gottron's papules seen overlying bilateral MCPs and IP joints of hands; Red blood cell sedimentation rate: normal; Weight: loss. Therapeutic measures were taken as a result of dermatomyositis.  The lot number for BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available   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.,Linked Report(s) : US-PFIZER INC-PV202200000729 same article/drug/event, different patient;
This spontaneous report was received from a medical assist concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, unspecified patients were vaccinated with improperly stored doss of (Oka/Merck) VARIVAX (dose, route, Lot No. and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Provider administered covid-19 Bivalent Booster 0.2 mL (NDC 80777-0283-99) instead of Moderna Bivalent dose 0.25 mL (NDC 80777-282-99) as first dose in primary series. No adverse reaction.
Interval dosing error. First dose given 4/21/2021. Second dose given 5/9/21. Patient had a sore arm.
Patient received Smallpox vaccination to right deltoid on 21 March 06 at 1430 hours.  Patient presented to this Immunization Clinic on 27 March 06 at 11:09 hours to confirm blister was visible and no other reactions noted at that time.  Patient awoke 29 March 06 and noted redness and heat to Smallpox vaccination site, but did not seek medical treatment at that time.  On 31 March 06 at 0740 hours patient noted increased redness, swelling, and heat to site along with having developed a rash overnight.  The rash extends over the upper anterior and posterior portions of patient's trunk with itching, especially to patient's back.  Patient presented to this Immunization Clinic today at 0820 hours and was seen by RPA-C.
May 14 application of the vaccine, May 15 severe headache, May 16 tingling and itching in the extremities of my body and head, face, tongue, loss of strength in my fingers on my left hand. Today is May 28 and the symptoms continue with less improvement. I feel burning in my hands and feet.
Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine; No adverse event; doses administered after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine) and NO ADVERSE EVENT (No adverse event) in a 57-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine).    Concomitant medications details were not reported by the reporter.  Reportedly, Pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. the excursion was found out in an audit and all the vaccines were viable.  Treatment details were not reported by the reporter.
This was the second shot. First shot no adverse reaction. Around 2 PM extremely tired and then headache.   Went to bed around 8 had the following symptoms: chills, then hot, headache and teeth hurting, sharp pains in body that only lasted a short time. Next day slight headache and fatigue. Third day fatigue. Forth day feeling  like self.
Pt recvd vax & 2 days p/vax exp paresthesias of the hands & feet, insomnia, lethargy, numbness of the back, face & neck, ataxia, hip pain & myalgia; pt was dx w/polyneuritis; tx Relafen for muscle soreness;
He contracted Covid-19 in August; He contracted Covid-19 in August; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on Mar2021 as dose 1, single and a second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via unspecified route of administration on 22Mar2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller was a consumer calling to report a breakthrough case of the Pfizer vaccine. Caller stated that he received the first dose in March and second dose in 22March2021. Caller stated that on Aug2019 he contracted Covid-19 in August. The events assessed as serious (medically significant). The outcome of the events was reported as unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Hives; pain; allergy; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 40-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 01Jun2021 15:00 (Batch/Lot Number: EWO180) as dose 2, single for covid-19 immunisation at the age of 40-year-old. Medical history included ongoing type 2 diabetes mellitus. Concomitant medications included dapagliflozin propanediol monohydrate (FARXIGA); metformin; lisinopril; vitamin D. No other vaccine received in four weeks. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 11May2021 15:00 (Batch/Lot Number: EWO179) as dose 1, single for covid-19 immunisation at the age of 40-year-old. The patient experienced hives, pain, allergy on 10Jun2021 20:00 (also reported as 20Jun2021). Therapeutic measures were taken as a result of hives, pain, allergy. The events were resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and hospitalization. The outcome of events was not recovered. Clinical course was reported as: the patient experienced severe hives all over the body. Started on 20Jun2021 and the patient was taken to Emergency Room on 10Jul2021 with unbearable pain and hives spreading from head to toe. Initially the patient realized this might be an allergy, but the hives did not subside for more than 4 weeks. Per consultation from allergist the patient took Benadryl and then Allegra, however the hives continues to trouble him and he was in lot of pain. At ER ROOM, the patient was given Decadron and Benadryl. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19.
Extreme chills, drowsy, fatigue. All lasted about 5 hours but still some fatigue 10/5/03.
3/2/2022 (day of immunizations): fever onset at 18:30.  Around 11:40 that night, 60-90 sec of convulsions, self-resolved, T102.4.   Parents called EMS and infant was transported to local ED. Febrile on arrival (T101.5) to ED.  No further convulsions and normal neurological exam.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe
Dry cough; This is a spontaneous report from a contactable other Hcp (patient herself). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and Lot Number: EK5730) via intramuscular in Left Arm on 26Jan2021 as single dose and second dose via an unspecified route of administration on 18Feb2021 09:00 (Lot Number: EL3249) as single dose for COVID-19 immunization. Medical history included Hypothyroid. Concomitant medications included levothyroxine and liothyronine. On 26Jan2021, he patient experienced dry cough for about five days after first dose of vaccine. On 18Feb2021 at around 9 am, second dose was given and again she started dry cough late that night and it was persisting through today. Patient did not receive any treatment. The outcome of the event was not recovered.  No follow up attempts are possible. No further information is expected.
11/6/07 Temp of 101, papules and eruptions inside of arms chest and upper legs - seen in office by doctor for itchy rash treated with Benadryl and Aveeno baths and keep isolated. 11/7/07 papules increased to further up legs, temp continues, no papules on back per phone follow up by nurse. Instructed to observe 11/8/07 Progress report - afebrile today not as itchy 4-5 new eruptions on neck reported ----> doctor dx Varicella after Varivax.
Itching around the injection site; Redness around the injection site; Around the injection site is swollen; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PRURITUS (Itching around the injection site), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE SWELLING (Around the injection site is swollen) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Intraocular pressure high. Concomitant products included DORZOLAMIDE HYDROCHLORIDE (DORZOLAMIDE [DORZOLAMIDE HYDROCHLORIDE]) and BIMATOPROST (LUMIGAN PF) for Intraocular pressure high, VITAMIN D NOS and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching around the injection site), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE SWELLING (Around the injection site is swollen). At the time of the report, VACCINATION SITE PRURITUS (Itching around the injection site), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE SWELLING (Around the injection site is swollen) outcome was unknown.        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.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Vomiting, diarrhea, severe headache,  swelling  under arm of injection,  extreme fatigue, and changes in menstrual cycle since first dose. Cycle has come 2x a month 7 out of the last twelve months.
injection site swelling. 2 in by 1.5 in in diameter, red and itchy. hard to touch, visible rounded lump on R upper arm. I noticed it yesterday morning and the swelling has not gone down since.
04/15/2016 16 months toddler who developed a fever yesterday temperature was 100.8 AX, URI symptoms, HX of vomiting X 6 times, no diarrhea, mom gave MORTIN and TYLENOL, unsure if anything hurts, decreased appetite. 04/19/2016 Patient was seen in the office for well visit on April 13, 2016 for well visit. Patient received that the hepatitis A vaccine and Haemophilus influenza type b vaccine. Mother states that within a day of receiving the vaccines he developed fever. He was seen in our office on April 15, 2016 with a history of fever from the day before. URI symptoms, vomiting without diarrhea. Patient was found to be tachycardic to about 170 bpm with a temperature of 102.6 axillary. Patient was sent to the pediatric emergency room for further management due to the persistent vomiting and tachycardia. According to the mother that temperature at there when as high as 105.5 F. And the heart rate was over 200. Also upon arriving to the hospital patient had developed some hives. According to the mother the patient received IV fluids. Final diagnosis was fever, influenza-like illness and dehydration. The influenza test and RSV test came back negative. According to the mother the patient received one dose of TAMIFLU in the emergency room for suspected influenza. Upon leaving the emergency room the mother states that he developed hives on the face and also started having some swelling of the tongue. Mother gave the patient BENADRYL and did not take her back to the emergency room. Patient did improve with the treatment. Mother continued giving antipyretics to the patient until the day prior to the visit. Not further fever documented according to the mother since discharge from the emergency room but she was given the antipyretics around the clock. Mother also notice a faint rash appearing 1 day ago that is clearing now. Does not seem to be bothering her.
Injection site reaction, area was very red, firm and weeping following injection. No treatment given.
Headache, NauseaVomiting, chills, fatigue, rash on abdomen Narrative:
Information has been received from a registered nurse concerning unspecified patients of unknown age and gender. On an unknown date, unspecified patients were vaccinated with multiple doses of (Oka/Merck) VARIVAX (dose, strength, route not reported, indication) which were all post supported temperature excursion. No adverse effects were reported by any patient. This is one of the several reports from the same reporter. (Linked to MARRS# 1502USA004718). Additional information has been requested.
pt recvd vax 19FEB93 & started twitching approx 20 sec; pt ok until 23FEB93 started twitching whole body; pt seen by MD;
Mild COVID infection with cough. Treated with paxlovid. Improvement in 24 hours. Symptom free in 48 hours.
General Flu-like symptoms and left arm pain immediately following the injection.  Left arm pain with muscle weakness has never gone away and has gotten much worse as of early January 2021.  Simple everyday tasks such as putting on and removing off my belt and driving are very painful and are getting worse.  I have had several follow up appointments (5/26/2019 and 9/28/2019) for this lingering issue.
Had a deep chest cough, high fever, chills, congestion and fatigue for 2 days. Took Home COVID-19 test and was positive. Contacted doctor and was prescribed Paxlovid. Tested negative one week later. Then 2 weeks later tested positive for COVID-19 again. Was sick for a week, then tested negative for COVID-19 1 week later.
Patient presented with mother for appointment for Covid vaccination. Covid vaccinations in our system were incorrectly entered from the Information System and corrected which caused initial confusion. Patient had two Moderna vaccines and needed her Moderna Bivalent. Patient given Moderna 6mo-5yr Monovalent in error. Per CDC, this is a delineation from the prescribed schedule, however patient can still receive Bivalent Moderna vaccine in 2 months. Mother informed during visit of error and advised to come back or go elsewhere to receive Moderna Bivalent 6mo-5yr in 8 weeks or more.
pt recvd vax on 20JAN93 & pt devel fever of 104 & was advised by MD to report adverse effect;
2 days after i felt sick nervious, shaking, cannot drive, had a car accidents, cannot eat loat 20 lbs, cannot work, cannot walk steady, cannot go out, cannot cook or clean
Information has been received from a medical assistant referring to a 34 year old patient of unknown gender. Information about concomitant medication, concurrent condition, and medical history was not reported. On 23-AUG-2018, the patient was inadvertently administered with PROQUAD, lot # R011804 (expiration date 21-OCT-2019), subcutaneously for prophylaxis. No adverse effect reported.
Seen 2/24/09 at 2pm due to rash over entire body which started 2/23/09.  Received vaccines 2/6/09.
Swelling at left side of the neck. Hard area at injection site.  Prescribed diphenhydramine and prednisone
faint; slightly dizzy; weak; This is a spontaneous report from a contactable nurse (patient). A 92-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL9262), intramuscular in the left arm on 01Feb2021 12:30 at a single dose for covid-19 immunization. The patient has no medical history and concomitant medications. On 02Feb2021 16:00, the patient faint, slightly dizzy, weak and had to grab counter. Within 5-10 minutes it was gone and she was feeling fine. The patient added that it would have been serious if she hit the floor, but she did not. The outcome of the events was recovered on 02Feb2021.; Sender's Comments: Based on the close temporal relationship, the association between the events faint, slightly dizzy and weak with BNT162b2 can not be completely 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.
On 02/25/2005 infant had hives around DTAP site- right leg and also on face.  Also, had some difficulty swallowing and had non-stop fussing and crying, per Mom.  Taken to ER that same evening, he was given a dose of Tylenol and a dose of Atarax in the ER for what was described as a vesiculopapular rash and discharged that same evening with no acute distress.
difficult to stand up; so fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (difficult to stand up) and FATIGUE (so fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSSTASIA (difficult to stand up) and FATIGUE (so fatigue). At the time of the report, DYSSTASIA (difficult to stand up) and FATIGUE (so fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided Action taken with mRNA-1273 in response to the event was unknown
No history of seizure. Received 1st dose COVID-19 Pfizer 4/22 Admitted to hospital 4/24 due to seizure. Stay 1 day. Discharge with med (unknown). Doing better currently. Need to schedule/plan to schedule Neurologie for further assistant.
37yo male with no cardiac risk factors had spontaneous dissection of rt coronary artery 5 days post vaccination w associated MI requiring 3 drug eluting stents and "extreme" clot burden on cath requiring tPA.
At about 3:13am, approximately 12 hours after the injection, I awoke with a level 7 headache, some joint discomfort and feeling warm. At 6:13, my temperature was 101.7, BP was 141/88, Blood O2 94% and pulse rate of 97bpm with headache increased to level 9, all joints ached, very little energy and utterly fatigued.  As of 9:13pm on 7/30, headache is at a 5, fever has reduced to very low grade at 97.6, BP was down to 124/81, blood O2 was 97% and pulse rate was 67 after staying in bed nearly 30 hours.
ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY CRYPTOGENIC STROKE