chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a diagnosis of pericarditis was made, and myocarditis was suspected; a diagnosis of pericarditis was made, and myocarditis was suspected; This is a literature report for the following literature source(s): A 19-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown manufacturer, DOSE 1), for COVID-19 immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant, life threatening), PERICARDITIS (hospitalization, medically significant, life threatening), all with latency 2 days after the suspect product(s) administration, outcome "recovered", and all described as "a diagnosis of pericarditis was made, and myocarditis was suspected". The events "a diagnosis of pericarditis was made, and myocarditis was suspected" required emergency room visit. The patient underwent the following laboratory tests and procedures: Aspartate aminotransferase: 106 IU/l; Chest X-ray: negative for any acute process; Ejection fraction: 45 %; 50 %; Electrocardiogram: diffuse ST elevation without reciprocal depression; a diagnosis of pericarditis was made, notes: and myocarditis was suspected; normalized; significant for a decreased, notes: left ventricular function with an ejection fraction estimated to be 45% to 50% and evidence of right heart strain consistent  with myocarditis with no prior echocardiogram for comparison; had no breakthrough chest pain for over, notes: 24 hours prior to discharge and did not develop any arrhythmias during admission; was no evidence of reduced ejection, notes: fraction or right heart strain; Influenza A virus test: Negative; Influenza B virus test: Negative; labs: pericarditis was made and, notes: myocarditis was suspected; SARS-CoV-2 test: Negative; Streptococcus test: Negative; Troponin: 1338 ng/L; White blood cell count: 10.91, notes: K/uL Elevated. Therapeutic measures were taken as a result of myocarditis, pericarditis.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 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., Linked Report(s): PFIZER INC-202201292766 Same article/drug/event and different patient.
SORENESS AT THE SITE, MALAISE, FATIGUE, HEADACHE, SORE THROAT, CHILLS AND FEVER.
Large erythema, tenderness (10cm), per pt. and pruritus. Initial symptoms 1 day after injection. Duration: 3 days, no re.
Fever, body aches, chills, extreme pain in lower extremities, excessive thirst, shortness of breath when laying supine.
Patient received her 2nd Pfizer vaccination dose around 11:45. Was observed for 15 minutes and then left the clinic. She returned to the clinic 30 minutes later with complaints of dizziness, chest pressure, and tingling on her tongue. She ambulated in with her husband. She also stated she has a history of anxiety and was not sure if this was related to that or not. Due to the ongoing chest pressure, she was advised to go to the ED for further assessment. Per ED note, patient left the ED prior to receiving a medical screening exam by provider.
Pt. got vaccine on 10/31 but did not notice rash or redness until 11/6. Pt. saw Dr and Dr said pt. had rxn but wouldn't give pt. a steroid because pt. can't take steroids. Dr recommended pt. watch site and as of 11/14 its almost gone.
Local irritation 1 day after injection, slight fever - started BENADRYL and ice pk - concerned with cellulitis - EK prescribed Cephalexin.
My breastfed 19 month old son began acting differently.  He has started being unable to sit alone and constantly grunts and requires 24/7 adult attention (holding). It changed almost overnight once I was vaccinated and fed him. He was always very content playing on his own but this is no longer the case. The repeating of sounds and constant frustration followed by grunting/yelling is especially concerning.
Vaccine was administered past the use date. Vaccine was given on 10/24/2023. No cause for concern .
My right arm was stiff in the muscle after 1st dose,, couldn't lift arm pass shoulder and exp tiredness (body) more than usual.
Pain at site of injection 12 hours after vaccine. Headache 48 hours after vaccine. Low grade fever, body aches, difficulty breathing started approximately 60 hrs after the first injection, the peak of symptoms was at approximately 64 hours after injection. Most symptoms went away after 72 hours except for difficulty breathing and coughing, which are still being experienced 84 hours after the vaccine.
Visit for: military services physical, ears/hearing exam. BP 129/79, HR;99, RR:21, T:97.9, SpO2:97%; Pain scale:0 Pain free. The chief complaint is pt at 1523 for 5-2 immunizations. Few minutes after YFYIPV and typhoid vaccines pt c/o itching all over and not feeling well. No SOB in the beginning. He came in very flushed and eyes were red. Urticaria of about 1x2 in. was noted in the left deltoid where the Yellow Fever vaccine was injected. BENADRYL 50 mg IM was given. Upon further observation. smaller hives was noted in the arms and few min later pt started c/o tightness in the chest and was sounding mucosy as he started coughing. Pt is 18 year old male. He reported itching in the eyes, eyes watering and bloodshot eyes. Chest pain or discomfort reported as discomfort. dyspnea. Nausea and vomiting. No abdominal pain. Rash: urticaria in both arms. No fever. No allergic Reaction. No otolaryngeal symptoms and no nasal discharge.Pt was very flushed from chest upwards to his face. SPO2 decreased from 97% to 94%. IN acute distress. Awake. ALert. Oriented to time, place, and person. Airway was patent. Pharynx was not inflamed. Wheezing was heard bilterally. Clear to auscultation. Heart Rate and Rhythm normal.
Patient fainted in her chair about 10 mins after vaccine was administered. Patient did not hit her head. Patient was given water, asked to lie down, and monitored for an additional 15 minutes until she felt better
Progressive lower extremity weakness and numbness with urinary retention.  Proven diagnosis of T6-7 transverse myelitis.
PARTIAL ADMINISTRATION OF VACCINE DUE TO SYRINGE DYSFUNCTION; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced partial administration of vaccine due to syringe dysfunction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial administration of vaccine due to syringe dysfunction was not reported. This report was non-serious.
sweating at night worse since the booster dose; This spontaneous case was reported by a nurse and describes the occurrence of HYPERHIDROSIS (sweating at night worse since the booster dose) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweating at night worse since the booster dose). At the time of the report, HYPERHIDROSIS (sweating at night worse since the booster dose) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.  Patient reported sweating at night since the first dose that got worse since the booster dose.   This case was linked to MOD-2022-478513 (Patient Link).   Reporter did not allow further contact
Diagnosed with COVID-19/coughing with light phlegm, sneezing, fever, chills, and body aches; Diagnosed with COVID-19/coughing with light phlegm, sneezing, fever, chills, and body aches; 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 74-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Lot number: EN6207) and in 2021 as dose 2, single (Lot number: WE0179) for covid-19 immunisation. The patient's relevant medical history included: "fatty liver disease" (unspecified if ongoing); "Lung cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Jan2023, outcome "recovering" and all described as "Diagnosed with COVID-19/coughing with light phlegm, sneezing, fever, chills, and body aches". The events "diagnosed with covid-19/coughing with light phlegm, sneezing, fever, chills, and body aches" required emergency room visit. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient reported receiving two doses of the Pfizer COVID-19 vaccine at different dates as a primary series in the year 2021, month and day not provided. The first dose was lot EN6207 and the second dose was lot WE0179. The patient stated he did not receive any booster doses of the COVID-19 vaccine because he did not want to get them. The patient woke up Friday morning, 06Jan2023, experiencing coughing with light phlegm, sneezing, fever, chills, and body aches. The patient went to the Emergency Room on Saturday, 07Jan2023, and was diagnosed with COVID-19 and prescribed Paxlovid. The patient reported feeling a little better on Saturday after starting Paxlovid and feeling much better today. The patient asked what else he could take to treat COVID-19 if he did not have Paxlovid; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021303294 same patient, different dose/event;
Flu like symptoms; Gastritis; GERD; NIGHT CRAMPS IN LEG; Constipation; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (GERD), MUSCLE SPASMS (NIGHT CRAMPS IN LEG), INFLUENZA LIKE ILLNESS (Flu like symptoms), GASTRITIS (Gastritis) and CONSTIPATION (Constipation) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 1st dose. In June 2022, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (GERD), MUSCLE SPASMS (NIGHT CRAMPS IN LEG) and GASTRITIS (Gastritis). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and CONSTIPATION (Constipation). At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (GERD) had not resolved, MUSCLE SPASMS (NIGHT CRAMPS IN LEG) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown and GASTRITIS (Gastritis) and CONSTIPATION (Constipation) had resolved.            Concomitant medication information was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Reporter causality was reported as probable for the event GERD and not reported for other events with respect to HUMIRA (Solution for injection in pre-filled pen) (ADALIMUMAB).  Treatment information was not provided by the reporter.
stomach ache; lethargic; dizzy; 102 fever; This is a spontaneous report from a contactable consumer(parent). This consumer (parent) reported for 12-years-old female (daughter) patient who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection; Batch/Lot Number: ER8736) via intramuscular on 11Jun2021 at 03:15 in right arm as a single dose for Covid-19 immunization. Medical history was reported as none. The patient's concomitant medications, past drug history and known allergies were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID or any other medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; lot number: EW0177) via intramuscular on 16May2021 at 12:00 in right arm for COVID-19 immunization. The patient experienced stomachache, 102 fever and she was lethargic and dizzy at 06:00 on 12Jun2021.The events were reported as non-serious. The patient did not receive any treatment. The patient underwent lab tests and procedures which included body temperature as 102 on 12Jun2021. The outcome of all events was resolved on an unspecified in Jun2021.
persistent high fever 102-104.7 since 21DEC95; fever not dec;seen in ER adm 23DEC95-25DEC95; given IV & Rocephin; fluid in ear;
Tunnel vision, near syncope, rapid heartbeat, rapid increase in blood pressure.  Lasted at least 30 minutes while I waited at the clinic.  Was given one Benadryl.  Symptoms cleared but was still not symptom free when I drove home.
Extreme fatigue/ fatigue is getting worse everyday; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Extreme fatigue/ fatigue is getting worse everyday) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076F21A, 030M20A and 048A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, ATORVASTATIN, BACLOFEN, SULINDAC and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Extreme fatigue/ fatigue is getting worse everyday). At the time of the report, FATIGUE (Extreme fatigue/ fatigue is getting worse everyday) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided.
My blood sugar has gone up by about 75-100 points since the day of the vaccine and has consistently stayed up even 7 months later. I have had diabetes since 2002 but I have managed it without any medications and only by diet and exercise. I check my blood sugar levels daily in the morning. They were about 150 every morning for 6 months prior to the vaccine. Since the first day of the vaccine and until today, my blood sugar levels are between 200 - 250. At first the doctor said that they will go down after a week or two of the vaccine, but that has not happened 7 months later. I would still take the vaccine if I had to do all over again, but wanted to inform you of this side effect. Also my sister in law who also has diabetes has also experienced the same side effects of elevated sugar levels since  she took the vaccine.
Erythematous-induration 8-10cm verses warm to touch-tender. Amoxicillin 260/5, 1 tsp twice daily for 10 days, Motrin 100/5, 2 tsp per mouth every 6 hours as needed for pain.
Upset stomach; Cannot lift her arms/cannot bend fingers; Difficulty walking; Severe sweating; Diarrhea; Greatest pain on right side; Excruciating pain in shoulder/excruciating pain in hands, through knees/pain in all joints, fingers; All joints in pain; Chills; This spontaneous case was reported by a physician and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), MOBILITY DECREASED (Cannot lift her arms/cannot bend fingers), GAIT DISTURBANCE (Difficulty walking), HYPERHIDROSIS (Severe sweating) and DIARRHOEA (Diarrhea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0173NA, 040A21A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Colectomy. Concurrent medical conditions included Immunocompromised.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), MOBILITY DECREASED (Cannot lift her arms/cannot bend fingers), GAIT DISTURBANCE (Difficulty walking), HYPERHIDROSIS (Severe sweating), DIARRHOEA (Diarrhea), PAIN (Greatest pain on right side), MYALGIA (Excruciating pain in shoulder/excruciating pain in hands, through knees/pain in all joints, fingers), ARTHRALGIA (All joints in pain) and CHILLS (Chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and MAGNESIUM SALICYLATE at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), MOBILITY DECREASED (Cannot lift her arms/cannot bend fingers), GAIT DISTURBANCE (Difficulty walking), HYPERHIDROSIS (Severe sweating), DIARRHOEA (Diarrhea), PAIN (Greatest pain on right side), MYALGIA (Excruciating pain in shoulder/excruciating pain in hands, through knees/pain in all joints, fingers), ARTHRALGIA (All joints in pain) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient is on no concomitant medications, but she takes a lot of vitamins.
Normal adverse events right after initial injection: Headache, fever, chills Day 3: Tinnitus - ongoing Day 12: rash (looks like cigarette burns) in multiple locations- ONGOING.  Currently one rash on each interior elbow, one on left ankle, one on left upper thigh, one on left glut.  VERY itchy.  Zyrtec and hydrocortisone being used as treatment.
This spontaneous report as received from a pharmacist refers to 28 years old patient of unknown gender. On an unkonwn date a few years ago, the patient was vaccinated with ZOSTAVAX, 0.65 ml, (lot number and expiry date unknown) subcutaneously. No adverse effects were reported. The outcome of 28 year old patient was administered a dose of ZOSTAVAX, and no adverse effects was unkonwn. No further information provided. Additional information has been requested.
On early morning of March 7th began having shortness of breath, lightheadedness, heart rate 168, blood pressure 72/38. Heart rate and blood pressure returned to normal after approximately 1 hour.
Case number PHHY2011US61987 is an initial up spontaneous report received from a nurse on 08 Jul 2011 and with the follow up report received on 09 Aug 2011. This report refers to a 12 years old female patient. Her concomitant medications included Tdap (batch number: AC52BD56B) 0.5 intramuscularly on 08 Jul 2011 and CLARITIN (batch number: unknown) on unspecified date. She was vaccinated with only the MenA lyophilized component of MENVEO (batch number M10047) reconstituted with sterile water instead of Men CYW liquid conjugate component 0.5ml to right arm intramuscularly on 08 Jul 2011. No other adverse reaction was reported. Follow up report received on 09 Aug 2011: The patient demographics, suspect drug information, concomitant medications and event outcome.
Information has been received from an RN concerning a 77 year old male pt who on 21JAN2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. No other vaccinations were administered at the same time. On 22JAN2004, the pt developed induration at the injection site. Medical attention was sought. The pt was prescribed warm packs. A product quality complaint was not involved. The reporter also mentioned three other pts who developed injection site reactions post vaccination with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
COVID-19 infection; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19 infection) 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 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced COVID-19 (COVID-19 infection). At the time of the report, COVID-19 (COVID-19 infection) 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.   Concomitant medication was not reported.  Treatment medication was not reported.
12/20/2020 morning: new left forefoot paresthesia. no weakness. I thought this might be due to the back pain I had been watching for 3 months, thinking it was due to running/physical therapy overuse injury 12/21/2020 sports medicine physician evaluation. numbness was gone, facet joint diagnosis, MRI lumbar ordered (still pending) 12/24/2020 9 pm - paresthesias both hands and feet, no weakness nor other symptoms those continued and were slightly worse 12/27/2020 morning, including face/teeth.  no other symptoms; 12/27/2020 afternoon: internal medicine physician evaluation, working diagnosis polyneuropathy