chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Polycystic Ovarian Syndrome" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "History of stroke" (unspecified if ongoing); "Environmental allergies/asthma" (unspecified if ongoing); "Environmental allergies/asthma" (unspecified if ongoing); "Known allergies: Amoxicillin" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; METOPROLOL; ASPIRIN [ACETYLSALICYLIC ACID]; METFORMIN; ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]; LEXAPRO. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to its Lack of efficacy cannot be ruled out.
Presented in July 2009 with a 25 pound weight loss and a 2-3 month history of polyuria, polydipsia, weakness, and blurred vision. He was admitted for stabilization and initiation of insulin, and was then transferred back to the medical center. At time of diagnosis, pt's blood sugar level was >500 and pt's A1c was 16.8, without evidence of ketoacidosis. In August 2009, he tested antibody negative for both pancreatic islet cells and GAD-65 antibodies. IA-2 antibodies were not tested. Pt is currently taking bedtime LANTUS with supplemental NOVOLOG, taking 1 unit for every 15 grams of CHO, with an insulin sensitivity factor of 42. He has no evidence of diabetes-related complications. Pt denies a history of elevated glucose or blood pressure levels or history of hypertension prior to T1DM diagnosis. He was an avid runner with a normal BMI prior to diagnosis. Pt has no family history of diabetes. he denies any symptoms of acute infections between March 2009 and his diagnosis of T1DM in July.
On 08/23/19, patient said arm swelled up to the shoulder and down arm. Swollen the way a football does. Said a red streak too. Recommended patient to see a doctor to rule out infection or allergy. Patient had PCV13 before. Patient did say the swelling has gone down, but underscored again the importance of having a doctor take a look. Noted to patient that we will call her again to check up on her. Patient should have a doctor take a look.  On 08/24/19, checked up on patient. Patient said getting better. Was just swollen and tight. Patient said didn't check w/ doctor, but getting better.
Information has been received from a physician concerning a 25 year old female who was received a first dose of GARDASIL (lot # not reported) in her left arm on Friday, 20-MAR-2009. It was unknown whether the injection has been administered subcutaneously instead of intramuscularly. The patient's relevant medical history, concomitant medications, and relevant past drug history were unknown. On 24-MAR-2009, the patient noted the onset of itching and swelling (the size of a quarter) at the injection site. This progressed in size (doubling) by the time she was seen on 26-MAR-2009. On 26-MAR-2009, the site was reported as tender and also started o become necrotic. At the tine of the report, the patient's outcome was unknown. The patient was being referred to her primary care physician for further evaluation. It was reported that the physician was considering this patient related issue as an emergency. Additional information has been requested.
I experienced a bad reaction as if I had the symptoms of COVID for 12-hours after receiving the vaccine along with sores appeared on my neck and under arm on the right hand side near my back. Approximately 2 weeks later I had a sore on my hear at the crown and then where the neck meets my skull and at the base of my back which have since become worse. I went my normal appointment with my PCP and he referred me to a Orthopedist, Dermatologist, and Rheumatologist in reference to my symptoms. I went to the Orthopedist on 10/14/2021 and he performed  an X-ray which he thinks I have arthritis and a slightly dislocated vertebrate in my back. He told me to take over-the-counter Tylenol if the pain persists. He scheduled me for Physical Therapy so that my insurance company will approve the MRI (requires 6 sessions/appointments with the Physical Therapist).
Pt complains of right thigh pain.  Pain is present while walking and standing.  Pain is not present with sitting.  Pt works at  grocery store and stands most of the day.  Pt presented with pain on 04/17/21.
This is a 86 yr old female who does not look her stated age, comes to the ED due to shortness of breath and dry cough. The pt tested positive outpt for covid 4 days ago. In ther ER pt noted to have pulse ox of 84%. She was placed on 4 L Nc and oxygen improved to 97%. The chest xray revealed ground glass opacities. She tested positive for covid and is vaccinated plus the booster. In the ER she received IV rocephin and azithromax, IV solumedrol, albuterol tx and tylenol.
pt recvd vax & 1SEP93 & 2SEP93 devel fever, abdo pain, resp infect & cough, joint pain, sore throat, h/a, tender glands; pneumonia;, chest pain, sinusisits;
No adverse event; Received expired first primary dose after manufacturer date of expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first primary dose after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 (Spikevax) (batch no. 053B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first primary dose after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired first primary dose after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Received expired first primary dose after manufacturer date of expiry).    No concomitant medications were reported. Broken cartons was reported. Vial size: 5.5mL. The vial did not undergo any temperature excursions. No treatment medications were reported.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 16-SEP-2014, the patient was treated by a nurse practitioner for a vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed VALTREX for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Severe headache on the left side of my head.  Unable to turn my head to the left or to the right.  Crackling sound when I move my head.  On this day, April 22, my neck movement has improved, I still have a headache and I can still hear my head crack when I move my head to the left or right. and when I look up or down.
On Saturday, November 6, 2021 client (DOB: 03/13/1960 came for a Covid-19 Moderna booster dose. Per CDC guidelines, the parameter for a booster dose for Covid-19 Moderna vaccine is 6 months after second dose. Client received her first and second dose of Covid-19 Moderna vaccine on April 14, 2021 and May 12, 2021 respectively. Client received her Covid-19 Moderna booster (LOT #: 011F21A) at approximately 1:03 PM in her left arm. Client was vaccinated 6 days early than the six month mark. Lead RN texted Vaccine Operations Lead who confirmed that client would not need to repeat dose and an incident report, VAERs and VERP be submitted. Client experienced no adverse reaction while waiting in Observation Area and left vaccination site with a steady gait at approximately 1:20 PM.
Mother reports patient was in his usual state of health on 15 November 2016 and received his seasonal influenza vaccine (FLUARIX) in his left shoulder without immediate adverse reaction. On the morning of 16 November 2016 he was noted to have redness, swelling, and tenderness of his left upper arm just below the vaccination site. Mother denies a prior history of egg allergy and adverse vaccine reaction (he has previously received and tolerated vaccines to include influenza without adverse reaction). No current medications. No history of trauma to site. No use of contactants at affected site. Patient and his mother deny fever/chills, painful/swollen joints, aches, fatigue/malaise, rhinoconjunctival, laryngeal, pulmonary, GI, neurologic, and CV symptoms. No painful/swollen joints. Treated with supportive/symptomatic measures, oral antihistamine, and oral NSAID.
Dizziness, Headache, NauseaVomiting, chills, fatigue Narrative:  Other Relevant History:
Pain all over body, temp ranging from 100.8 to 101.5 Loss of appetite  Very sleepy headache
1/25/21 5PM-Fever chills , red hot arm. 830PM-Fever, increased chills, increased heat and pain to L arm until 0345 on 1/26/21., but then started with hot/cold sweats, and achy everywhere.  0900AM-started feeling very nauseated and dizzy, 10AM-couldn't stand up , arms and legs felt hot and kinda fluttery, then both hands "ceased up" and couldn't move fingers for about 10 minutes, increased anxiety, then started with complete cold sweat and hands started to relax, after 20 minutes symptoms subsided and felt like a covid headache and aches every where.  Husband took temperature throughout experience, hovered around 100.00. 1/26/21-2:00PM symptoms improving, still have headache, achy everywhere and increased fatigue. 1/27/21 0900AM-Felt like "I did a full body workout for 6 hours yesterday but much improved".
About a week after the first dose, (8-17-21), a sharp pain on my arm/neck/upper back began, but I presumed it would eventually go away.  I was due to return for second dose no earlier than 9/7/21.  I had second dose administered on 9-9-21 at the same place and took same vaccine (Pfizer).  I informed the nurse who did it the first time that my arm was STILL in pain.  I was told that it shouldn't have been, but it was.
The evening after vaccination, the patient developed pain in the left arm which his parents treated w/ scheduled motrin.  The following day, he developed high spiking fevers and worsening left shoulder pain.  He was taken to an urgent care and subsequently referred to an ER for admission.  The patient was admitted to hospital with an initial WBC count of 20,000 and fevers to 103F.  His initial exam was notable for lack of left shoulder movement.  The patient received IV antibiotics (clindamycin I believe) and was kept in house for 5 days.  His evaluation in the hospital included an ultrasound of the right shoulder which was negative for sterile abscess.  The patient's left shoulder pain gradually decreased and he was able to move the shoulder on discharge.   8/28/07 Received hospital medical records which reveal patient experienced fever, redness, swelling & urticaria of left deltoid where had received Tdap & Pneumovax.  Seen at Urgent Care on 8/18 & dx w/vaccine reaction.  D/C to home & developed shaking chills, increased fever, spreading warmth, redness, swelling & induration w/limited ROM of left upper arm/shoulder, headache & sore throat.  Returned to ER on 8/19 & was admitted 8/19-8/23/2007.  Tx w/IV antibiotics w/improvement.  D/C to home on continued oral antibiotics & f/u w/ID FINAL DX: left upper arm cellulitis vs Tdap reaction; history of recent recurrent skin infection suggestive of staph aureus.
Severe fever, chills, fatigue and body aches. Severe fever and chills subsided after about 4am (7 hours after onset).
Tired, muscle pain, headache, shivering, fever, nausea, dizziness and passing out.
This spontaneous report as received from a certified medical assistant, via a company representative, refers to 15 patients of unknown age and genders. No information on their medical history, concurrent conditions or concomitant drugs were provided. On an unknown dates in 2014, reportedly between 01-MAY-2014 and 01-JUL-2014, the patients were vaccinated with RECOMBIVAX HB which was improperly stored (doses, administration sites and routes, lot # and expiration dates were not reported). This is one of several reports from the same reporter.  Additional information has been requested.
Swelling, redness, pain to left arm since vaccination. Has swelling left arm, erythema, tenderness. No other changes.
Patient said she felt the meds going into her system after the vaccine was given and she became dizzy. Her vital signs were taken over a course of 30 minutes and her blood pressure kept getting higher and higher to 210/140/ Pulse 55 and O2 sat was 99%. Dr. was called and she recommended pt be taken to the ER by the ambulance. The ambulance was called but the pt ended up leaving in the car with her son. I called both Medical Center and Hospital but pt had not been admitted to the ER this afternoon.
Client received immunization 5-7-03. Late afternoon 5/8 started having low grade fever about 101. Had alot of nasal congestion- red throat and cried for 2 hours. 5-12-03 PCT to mother, child feeling better on antibiotics for ear infection and URI.
Numb/Pain in the left arm (Flucelvax) and wrist. Cant close hand as of today 9/30/20. Pt consulted PCP, and was told it is probably not a vaccine adverse effect and to ice the area plus take APAP. As of now, pt has some relief.
Muscle pain note to left arm, nausea reported on 6/30/15. Patient has taken TYLENOL as needed for muscle pain. No signs of infection noted to injection site.
1 1/2 after vaccination chest red rash, under breast to stomach to face chin and mouth at night changed color to darker red. Rash not raised, rash started to resolve next day. Benadryl dose for relief
Rash on arms, back and chest- small, red, itchy, pimple like
Initial local reaction of erythema, pain and swelling. The erythema and swelling subsided on 22 Jan 10. She presented on 28 Jan 10 with complaints of continued pain in the right arm that was radiating from the injection site both proximally and distally. She denies numbness/tingling. Exam revealed FROM of the right arm about the shoulder and elbow with no tenderness to palpation. There is no residual erythema or edema. The patient has been unable to treat herself with NSAIDs d/t an allergy (rash) to Ibuprofen and chronic kidney disease.  We treated her with some Amrix and moist heat to the area. I spoke with patient on 29 Jan 10 and the Amrix is giving her some relief but she is not 100 % better. We will follow her closely.
Patient administered higher than recommended dose because of error in mixing the vaccine with the diluent. The vaccine was only mixed with 0.8mL of the diluent instead of 1.8mL of the diluent, resulting in the concentrated form of the vaccine.
arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypertension. Concomitant products included OMEPRAZOLE for Gastric disorder, LISINOPRIL (SINOPRIL [LISINOPRIL]) and AMLODIPINE for Hypertension.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm sore). On 05-Jan-2021, PAIN IN EXTREMITY (arm sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
I had a sore throat, headache, mild fever, body ache, and cough. I was giving 2 different antibiotics. I was given Paxlovid to take for 5 days. I started feeling better.
PATIENT REPORTS FAINTING APPROXIMATELY 25 MINUTES AFTER THE INJECTION AND NOT FEELING WELL SINCE THE INJECTION. NO MEDICAL TREATMENT SOUGHT AT THE TIME AND PATIENT DID NOT REPORT THIS TO THE PHARMACY UNTIL TODAY (05/29/2018). HE WENT TO URGENT CARE TODAY BECAUSE HE DOESN'T FEEL WELL, POSSIBLY FOR AN UNRELATED ISSUE BASED ON MEDICATIONS PRESCRIBED, BUT HE SAYS IS NOT SURE WHY HE IS STILL NOT FEELING WELL. PATIENT SAYS HIS ARM WAS SORE FOR DAYS. THAT HAS RESOLVED.
No longer has symptoms, but 2 days after vaccination experienced swollen, and redness at injection site   What happened as a result of the adverse event? patient saw provider and was recommended to take benadryl and ibuprofen which has helped resolve symptoms
Patient presents with a potential reaction to the COVID19 vaccine. The patient reported mild central CP after her vaccine. She reports this a frequent anxiety symptom for her. A 12 lead EKG was completed by EMS which showed NSR without any ST changes. The patient felt well as soon as she was reassured by a normal EKG.
severe headache tempreature of 101 photosensitivity didn't want any lights on. fatigue
This spontaneous case reported by a consumer, describes the occurrence of feeling abnormal (I feel kinda yucky today), oropharyngeal pain (very sore throat) and dysphonia (possibly losing my voice) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jun 28, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 29, 2021, patient experienced feeling abnormal (I feel kinda yucky today), oropharyngeal pain (very sore throat). On an unknown date, the patient experienced oropharyngeal pain (very sore throat) and dysphonia (possibly losing my voice). At the time of the report, feeling abnormal (I feel kinda yucky today), oropharyngeal pain (very sore throat) and dysphonia (possibly losing my voice) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): not applicable. No concomitant medication or treatment information reported.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 3/11/2023 Discharge Date:  March 14th 2023  PRESENTING PROBLEM: Hypoxemia [R09.02] Influenza B [J10.1] Pneumonia of both lower lobes due to infectious organism [J18.9] COVID-19 [U07.1]   HOSPITAL COURSE: 76-year-old man with heart failure preserved ejection fraction, EF 60% persistent atrial fibrillation, status post TAVR, presented to the hospital with shortness of breath on 3/11/2023.  COVID-19/influenza B positive.  The patient was admitted to the medical service.  He did not require supplemental oxygen to maintain normal oxygen saturations.  Chest x-ray significant for patchy bibasilar airspace disease and status post TAVR. Dexamethasone/remdesivir were not given as patient was on RA.  The patient had increasing troponin 119 -> 157 -> 189, but without chest pain or electrocardiographic changes for acute coronary syndrome. Cardiology was consulted. They stated that it was likely demand ischemia due to COVID-19/influenza. Tamiflu and home medications were resumed as appropriate. Due to concern for possible myocarditis, a TTE was obtained on 3/13/2023. Echocardiogram revealed EF 63 % with mild concentric left ventricular hypertrophy No pericardial effusion appreciated on echocardiogram. Patient has remained on RA and vitals have been stable throughout admission.  Patient is asymptomatic this morning with increased tolerance to physical therapy.  At this time, recommend patient follow up with primary care provider and cardiologist at discharge.  Will arrange for outpatient stress testing.  He is currently medically stable for discharge. Plan of care discussed with the patient who is agreeable to the plan of care. Questions answered to his satisfaction.
Systemic: Allergic: Anaphylaxis-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild
localize reaction; This spontaneous case was reported by a nurse and describes the occurrence of LOCAL REACTION (localize reaction) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOCAL REACTION (localize reaction). At the time of the report, LOCAL REACTION (localize reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
PATIENT HAD RECEIVED J&J VACCINE BACK IN APRIL 2021 AT A DIFFERENT PHARMACY, WHICH WAS DISCOVERED UPON RUNNING THE MODERNA VACCINE HE HAD RECEIVED TODAY AT OUR PHARMACY THROUGH HIS INSURANCE. ON HIS CONSENT FORM, HE STATED THAT THIS WAS HIS FIRST COVID VACCINE WHICH WAS NOT TRUE. AT THIS TIME, WE HAVE NO REPORT OF SYMPTOMS OR SIDE EFFECTS FROM THE VACCINE.
This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients over 14 years of age received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this female (age unknown) was reported to be 1) 21-JUL-2015. No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.