chrisvoncsefalvay/vaers-outcomes huggingface dataset:
scratchy throat; swollen throat; mild coughing; rash on chest; Had a very sore arm that day and night, almost like a charlie horse; very sore arm; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8730) via an unspecified route of administration in the left arm on 05Apr2021 at 11:30(at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included guillain barre syndrome (2005 - 2006- hospitalized for 3 months), stable aortic aneurysm, allergy to shellfish and allergy to peanuts(anaphylaxis - peanuts and potentially tree nuts). The patient did not receive any other medications within 2 weeks of COVID-19 vaccination. The patient previously took amoxocilian(MANUFACTURER UNKNOWN) and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 05Apr2021, that day and night the patient experienced very sore arm, almost like a charlie horse. On 06Apr2021, the arm was still slightly sore, but a lot better. On 07Apr2021 at 04:00, the patient woke up with a scratchy, swollen throat and mild coughing. On 07Apr2021about 16:00 - 17:00, the patient experienced rash on chest (right side only) and very slightly swollen throat. The patient received  treatment for the events scratchy, swollen throat and mild coughing which included Zyrtec and she did not receive treatment for the events sore arm, charlie horse and rash on chest. The clinical outcome of the events very sore arm, rash on chest and charlie horse were recovered on an unknown date in Apr2021, while that of scratchy, swollen throat and mild coughing were recovered on 07Apr2021 at the time of this report.   No follow-up attempts are needed. No further information is expected.
On return to clinic for follow up vaccines, 5/19/05, parent reported child demonstrates weakness in left leg since January immies, child observed limping. Follow up vaccines not given. Child referred to provider at a primary care clinic for evaluation.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with PEDVAX HB (lot # and expiration date not reported) (dosing regimen and frequency unknown) which was exposed to temperatures outside the prescribing information. No concomitant medications were reported. No adverse events were reported. This case is linked to case number 1403USA007008 and 1403USA005427. Follow up information as received for PEDVAX HB, lot # H015034, expiration date 19-DEC-2014. Additional information has been requested.
3-4 hours after being vaccinated pt. began having SOB and then palpitations with heart racing.  Pt. taken to ER and admitted with tachycardia and BBB.  Pt. diagnosed with Wolf-Parkinson-White Syndrome and treated with cardioablation and B-blocker therapy.  2/2/09 PCP records received for 18 yr old PE dated 1/7/09. PE WNL. Flu shot given.  F/U note that pt began having SOB and heart racing that pm. Dx: Wolfe-Parkinson-White syndrome and had a cardioablation and placed on B-blocker.     2/20/09 MR received for DOS 1/8-13/2009 with Final DX:  Atrial fibrillation.  Anxiety state.  Reflux disease. Pt presented with 1 day hx of intermittent palpitations with SOB. Atrial fib with rapid ventricular response noted on EKG on arrival in ED, one episode of SVT. Admitted and started on Beta blockers. Episode of bradycardia in the 40's on 1/11/09 and chest pressure that pm. CP likely GERD. AV node ablation performed with resolution of arrhythmia. D/C on Beta blocker.
Potential AE realized after call (possible drug interaction); This is a spontaneous report received from contactable consumer, Pfizer sponsored program CEP 159558 via medical information team.  A contactable male consumer (patient) of an unspecified age reported for himself that he received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization, patient also took aspirin [acetylsalicylic acid] (Batch/Lot number was not reported), via an unspecified route of administration from an unspecified date to an unspecified date, at 3 DF for headache. Medical history included headache from an unknown date and unknown if ongoing (he had a headache and took 3 pcs of aspirin 20 minutes before the vaccination). Concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. On an unspecified date, the patient experienced Potential AE realized after call (possible drug interaction). It was reported that, the patient received the Pfizer-BioNTech COVID-19 Vaccine second dose. On the way to get the vaccine, patient mentioned he had a headache and took 3 pcs of aspirin 20 minutes before the vaccination. Caller proceeded with the shot and was now asking if this would have compromised the efficacy of his vaccine. The patient was wondering if he ruined his vaccine due to taking aspirin. No information found on additional steps or a third dose and referred to HCP for guidance. Action taken with co-suspect aspirin was unknown. Outcome of the event was unknown.  There were not any unaddressed medical questions referred or forwarded to Medical Information. Unknown if the Reporter a Healthcare Professional (HCP). The Reporter contact information available to you or a sub-contracted party: Yes Unknown if the reporter the prescribing HCP.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.
pt recvd vax 18MAY95 & 20SEP95 pt exp fever over 101 7 20-30 vesicular lesions on scalp, palette, trunk & vagina;lesions were scattered w/cylindrical base w/papular centers;no report of rash noted @ time of vax
Information has been received from a physician concerning a 21 year old female who on 29-JUN-2009 was vaccinated with a dose of GARDASIL (dose, route and lot number not reported). Concomitant therapy included "birth control". It was reported that "on 01-JUL-2009", the patient came to the walk in clinic with nausea, headache, fatigue and sweating. No lab studies were performed. The patient sought unspecified medical attention. Additional information has been requested.
No additional AE; temperture excursion; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.  On 03-MAY-2023, the patient was vaccinated with one dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot#: W031815, expiration date: 05-OCT-2024; strength, dose, route of administration, and anatomical location were not reported) for prophylaxis. The vaccine administered experienced temperature excursion of 9F for 2 hours and 6 minutes (product storage error). No additional adverse events (AE) were reported (no adverse event).  This case was received from the same reporter with the case 2305USA001754.; Sender's Comments:  US-009507513-2305USA001754:
Information has been received from an 89 (also reported as 79 years old) year old retired physician. He reported that he was vaccinated with VARIVAX (Oka/Merck) (route, administration site, lot number not reported) in error instead of ZOSTAVAX (Oka/Merck) on 18-MAR-2008. The reporter felt fine and had no symptoms present at the time of the report. Additional information has been requested.
This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of not responding to therapy in a 26-year-old male subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). On an unspecified date, the subject received the 4th dose of hepatitis B vaccine (details unknown) and experienced extra dose administered. On 26 November 2010, 18 November 2010, the subject received 3rd dose and 2nd dose of hepatitis B vaccine (unknown details) and experienced drug dose administration level too short. On 12 November 2010 the subject received 1st dose of Hepatitis B vaccine (unknown details). Around March 2011, months after vaccination with 4th dose of Hepatitis B vaccine and 4 months after vaccination with 3rd, 2nd, and 1st doses of hepatitis B vaccine, the subject experienced not responding to therapy. The subject had hepatitis B serology titer testing performed around March 2011 and the results showed no detectable titers following 4 doses of hepatitis B vaccination. Relevant test results included Hepatitis B surface antibody test performed around March 2011 with results showing negative.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020L20A) for COVID-19 vaccination.     The patient's past medical history included Multiple myeloma and Bone marrow transplant NOS (bone marrow cancer) in 2007.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced MYALGIA (Sore arm). On 13-Feb-2021, MYALGIA (Sore arm) had resolved.            No relevant concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2021-320886, MOD-2021-320895 (Patient Link).
SARS-CoV-2 N gene Resp Ql NAA+probe~SARS-COV-2 (COVID-19) - CLINIC COLLECT KIT OR EXTERNAL KIT performed on 7/26/21 at 12:32. Test came back positive. Case investigation interview with patient has not been conducted as of the time of this note.
Received expired dose; Patients were administered a dose from a vial that was punctured and left at RT for 5 days.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose) and PRODUCT STORAGE ERROR (Patients were administered a dose from a vial that was punctured and left at RT for 5 days.) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1, Batch number: EL9264) on 03-Feb-2021, Pfizer (Dose 2 and Batch number: EN6201) on 24-Feb-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 01-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milligram. On 01-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose) and PRODUCT STORAGE ERROR (Patients were administered a dose from a vial that was punctured and left at RT for 5 days.). On 01-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Received expired dose) and PRODUCT STORAGE ERROR (Patients were administered a dose from a vial that was punctured and left at RT for 5 days.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No any concomitant medications were reported. No any treatment medications were reported.  Patient experienced No adverse event after taking the vaccine. Patient received the dose in the deltoid muscle. The vial did not undergo any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2022: Follow-up received: Patient demographics-race, ethnicity updated, Suspect drug details-route, body site and dosage regimen updated, Narrative updated: No adverse event occurred.
Information has been received from a registered nurse concerning a pt who was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Subsequently, the pt developed thrombocytopenia. Unspecified medical attention was sought. Additional info has been requested.
COVID arm. I woke 5 days after first injection to a red, golf ball sized, rash at the injection site. The rash was raised, red and warm to the touch. The rash also itches and is uncomfortable.
12 days after covid booster and 1 day after flu vaccine the patient's BCG vaccine scar in her L arm became red/hot/tender.
Body aches and fatigue about 5 hours after injection. Worsening body aches and head ache around 9pm on same day. 5am on 1/6 severe body aches and temperature  of 100.3
Bad chest pain, hard to take a deep breath, headache, dizziness, diarrhea. By the end of the day, because of chest pain and dizziness my doctor sent me to the ER. I was then referred to a cardiologist, who indicated he thinks these symptoms are from the second dose of vaccine. He has seen several patients with the same symptoms after the second vaccine dose. My family doctor now thinks the same thing for the same reasons.
Had sudden case of Afib with RVR with no preexisting conditions. No family history of heart issues, no previous personal history of heart issues. Went to ER and was placed on metoprolol and eliquis. Had echo, ekg, cardiac angiogram and holter monitor with all normal results no rationale for arrhythmia. Still having periodic heart rate elevations at rest.
Rash, UrticariaPruritus & arm and body rash that itched 4 days after shingrix,
This spontaneous report was received from a pharmacist refers to a multiple unspecified patients of unknown demographics. The patients' concurrent conditions and medical history were not provided. On multiple unspecified dates, the patients were "possibly" vaccinated with improperly stored PNEUMOVAX 23 lot # L019836 and expiration date 24-MAR-2017, (dose, route of administration and anatomical location were not reported). There were no concomitant medications provided. The PNEUMOVAX 23 vaccines were exposure to 34F for 295.75 hours. There was no previous excursion and no data logger issue. No adverse effects reported. No product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested.
No Adverse Events.  As I was entering the H1N1 vaccine into the computer after the H1N1 clinic was over, I found where this child had already received a dose of H1N1. The child's mother had told me I was giving her first dose. According to agency, the first dose was given on 2/5/2010.  The first dose was an injection (Sanofi).  The dose I gave was the mist (Medimmune).
Vaccinee experienced itching on the arm within 1 day post 1st inject. Approx 3 days post 1st dose: rash, dry skin & urticaria (spread to abdomen & entire body; rash became more pustular in nature "resembling a herpes type rash";
dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment information was provided. The patient had received the booster dose of the vaccine. No adverse event was reported. The vial had not undergone any temperature excursion issue. The vial was initially placed in the refrigerator on 26-Oct-2021. Many doses were administered from expired lots due to confusion with the expiration date printed in the label.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 02-NOV-2012 17:44, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Patient is a 73 y.o. female who was referred to the ED on 12/6/2022 with concern for pneumonia after presenting with 2 day complaint of cough, shortness of breath, and fevers. She was found to be SARS-C0V2 positive with admission requested with concern for associated pneumonia. She was admitted to the ICU with acute on chronic hypoxemic, hypercapnic respiratory failure. COPC assumed care with transferr out  of the ICU 12/11/2022. Acute on chronic hypoxemic, hypercapnic respiratory failure COVID 19 with superimposed bacterial pneumonia Tracheostomy present Baseline respiratory status includes tracheostomy placement in May 2022 following a prolonged hospitalization for  a ruptured splenic aneurysm  -She is maintained at 5-6 L/min via trach mask at home, she weaned to a FiO2 of 30% at 6-7 L from earlier need for ventilatory support via an exchanged her cuffless tracheostomy with a cuffed 6 shiley tracheostomy -Acute decompensation was believed multifactorial related to COVID-19, deconditioning , atelectasis and bacterial pneumonia -Treatment included dexamethasone and 7 days of antibiotics.   Enterococcus UTI Possible asymptomatic bacteruria, she received nitrofurantoin x 5 days given the nature of her acute presentation   COPD Continue inhaled bronchodilator therapy    Paroxysmal atrial fibrillation Rate controlled; continue diltiazem and apixaban   Anxiety and depression Continue buspirone
Pain, erythema, pruritus to (L) upper arm x 3 weeks. KEFLEX 500mg TID x 10 days, Prednisone 40mg QDx5 days.
Employee suddenly felt nauseous, dizzy, flush and was seeing "spots". She felt like she was going to pass out. She continued to complain of dizziness and nausea while in nurse office. Vital signs done at 1010 were blood pressure of 115/72, oral temperature of 97.8 degrees, pulse of 160 manually done and respirations of 22. Cool rags were applied to the back of her neck with little relief. Assessment of injection site noted no abnormalities. Employee attempted to lay down and then she stated she could not breath through her nose. Manual pulse done at at 1015 with result of 88. She then reported right sided, sharp pain in the mid-thorax area. Upon listening to heart tones and breath sounds, heart rate regular and breath sounds clear in all fields. She continued to have significant nasal congestion, which she reported as worse than earlier in the morning. Repeated manual pulse at 1020 with result of 120. Pulse regular and heart tones regular rate. Employee reports that seeing the spots has diminished as well as the nausea has improved. Gave her 240ml of water to drink. Employee had no issue with keeping down the water. Vital signs repeated at 1106 with results of pulse of 76 (manually), blood pressure of 116/79 and oral temperature of 97.8 degrees. Employee transported by family to emergency room for care at 1135.
Three days after receiving the Janssen booster dose, she vomited twice at 4:25 AM while in be supine in bed with the head elevated a few inches.  Amount was one large and one medium emesis, brown and watery. Temp. was 98.1. At 5:00 AM she vomited again, a small amount of the same description. Then at 6:00 AM she vomited again, a small amount of mainly saliva.  After cleaning her up, she was back asleep by 7:30 AM and no further problems.  Temp. 98.0. This is a major concern because my mother is not able to manage any emesis or call /signal for assistance, due to her Alzheimer's. She could have choked/aspirated.  I just happened to be watching her on camera from the next room, and noticed that something looked amiss.
Appendicitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the parent.  A 21 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Apr2021 (Lot number: EW0170) at the age of 20 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety depression" (unspecified if ongoing); "birth control" (unspecified if ongoing). Concomitant medication(s) included: JUNEL taken for contraception; ESCITALOPRAM taken for depression. Vaccination history included: Bnt162b2 (First Dose; lot: EW0153), administration date: 08Apr2021, when the patient was 20 years old, for Covid-19 Immunization. No prior vaccinations within 4 weeks. The following information was reported: APPENDICITIS (medically significant) with onset 04May2021, outcome "unknown", described as "Appendicitis". Clinical course: developed appendicitis 4 days after the second Covid shot and had to have emergency surgery, to remove her appendix. Therapeutic measures were taken as a result of appendicitis.  No follow-up attempts are possible. No further information is expected.
Headache 8/16-8/19. Vomiting 8/25 and Heart rate 52. Pain in arm not in injection site
I had a headache, body aches, fatigue, and a fever of 101.6
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 15Apr2021 as dose 2, single (Lot number: EW0162), in right arm, on 29Oct2021 as dose 3 (booster), single (Lot number: FD0809) and on 29Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: TOPIRAMATE; LAMOTRIGINE; ESTRADIOL; ESTRING; PANTOPRAZOLE; LEVOTHYROXINE; SIMVASTATIN; ARMODAFINIL. Past drug history included: Wellbutrin, reaction(s): "Known allergies: wellbutrin", notes: Known allergies: wellbutrin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Sep2022) Positive, notes: Positive home test 18Sep2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that patient received other medication in 2 weeks.Last dose of Paxlovid was 11Sep2022.
Within a couple hours I started breaking out in a rash that turned into hives and throat was closing. All my joints are swollen, headache, pain in my chest, nausea, muscles ache, can't hardly walk, short winded. That doesn't go away. I can't function and very fatigued.
8/16/13 - FLUMIST administered. 8/25/13 - (R) leg pain. 8/27/13 - Seen in office leg and knee pain. 9/2/13 - Lethargy and facial droop. 9/3/13 - Dx w/ Guillain-Barre.