chrisvoncsefalvay/vaers-outcomes huggingface dataset:
41 yo female pt presented to receive a COVID-19 booster vaccination. Pt reported to vaccinator that she received Pfizer for her primary series and had a reaction 6 days after second dose that hospitalized pt. Pt reports she never received epinephrine after the first reaction but felt like her throat was closing and was treated with steroids in the hospital. Pt reports she was prescribed an epi-pen and was instructed by her doctor to get Moderna instead of Pfizer for her booster dose due to reaction. Pt received Moderna vaccine in right arm at 1232 and immediately developed redness at the injection site. Site Admin/EMT notified of reaction at 1245 and made pt contact at 1245. (continued) Pt airway patent, slightly increased work of breathing, and skin warm pink and dry. Injection site inspected and found to have red swollen hives that spanned approximately 1 inch surrounding injection site. Pt has no other complaints at this time. Pt denies CP, SOB, HA, NVD, dizziness, weakness, numbness, tingling, pain. EMT recommended that pt be further evaluated at the hospital and pt agreed to be transported by ambulance. EMT called emergency at 1255. Pt vitals assessed and monitored at 1259: BP 134/90 HR 87 SpO2 99% on RA. At 1302, Pt begins having difficulty swallowing and is speaking in one word increments. Injection site assessed and hives noted to have spread down to just before elbow. Hives also present behind right ear that continued down right side of neck. Vitals at 1304: HR 90 Spo2 98% RA with increased difficulty passing air and swallowing with lips tinged blue. Multi-system symptoms indicated anaphylaxis. EMT administered Epi-Pen Autoinjector 0.3mg (lot #1FM477, exp 6/2023) @ 1306 into right lateral thigh and held in for 10 seconds. EMT called emergency again at 1307 to provide pt update and get an ETA on ambulance. Pt immediately began to feel relief of throat swelling. Vitals at 1309: HR 96 Spo2 99% RA. Injection site and neck assessed and hives noted to have cleared up. Dispatch called back at 1312 to find out the appropriate entrance for EMS to enter. EMS arrived at 1314 and care transferred with full verbal report.
Fever of 102 on day after vaccine; day 2 after vaccine, broke out in hives, lasted 2 days
I?ve developed prettt extensive hives and a rash that won?t seem to go away just over a week after my 3rd dose of Moderna. Antihistamines and Prednisone have been prescribed, but aren?t fully helping. Nothing else has changed in my life- no new foods, personal care products, etc. the Vaccine has been the only change, and now the hives are pretty intense. Will be following up with an allergist.
Manifest the following day: dizziness, chest pain, fatigue, muscle fatigue, brain fog, high blood pressure (despite being controlled by medication).
Patient begin to display symptoms of allergic reaction (coughing, difficulty breathing, feeling hot). RN assessed and brought in NP as RN assessment was an allergic reaction.   Epinephrine injection, USP 1mg/mL given by NP, Oxygen applied at 100. 911 was called  Epinephrine Injection, USP 1mg/mL given by NP after 5-10 minutes after 1st dosage.  EMS came and assess patient vitals and educated patient on need to go to ER. Patient refused ER visit despite warning about allergic reactions and education on them. EMS took patient to ambulance for monitoring while husband was on the way to pick her up.
No adverse reaction reported by patient. Patient under the age of 50, as recommended/ required for first dose of Zoster.
Pt vaccinated with Influenza experienced low grade fever, cough, sx persist & atrial flutter fib, admitted to hosp w/pneumonia, CHF.
Not adverse event. Patient requested and was given a Moderna vaccine second dose but he should been given a Pfizer dose since he was given Pfizer as his first dose
RASH AT INJECTION SITE CONSISTENT WITH SIZE OF BANDAGE;MOVEMENT OF LIMBS (ARMS & LEGS) CAUSES PAIN; PELVIC AREA PAIN; HURTS TO BEND REPORT TO RPh ON DUTY
Vaccine administration Error: Patient received the Moderna Vaccine at age 16.  She received the first dose on 04/06/2021 and her second dose on 05/04/2021.  Pt reports arm soreness after second vaccine.  Denies any serious adverse symptoms or side effects from either vaccine.
12 months old patient received expired dose of Pentacel vaccine/no AE; Initial information was received on 30-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer or other non-professional.  This case involves a 12 month old female patient who received 0.5 mL expired dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [injection, lot UJ097AAA, expiry date: 19-Sep-2020] via an intramuscular route at the left thigh, on 30-Sep-2020 for prophylactic vaccination (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  On an unknown date patient received PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and FAIRVAX as concomitant medications.  It was a case of actual medication due to expired vaccine used. (Latency: at the same time of vaccination)  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
hyperglycaemia; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 05Apr2021 at 16:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient medical history included diabetes (continued to produce insulin though).The patient had no known allergies. Concomitant medications included metformin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and lisinopril dihydrate (LISI). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 08Mar2021 at 16:00 hours (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient was tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 15:00, the patient's experienced hyperglycemia. The patient sugar was very high and continued to be high during the week of this report which was getting better. On an unknown date in Apr2021, the patient underwent blood sugar test and the result was 300. On an unknown date in Apr2021, the patient underwent blood sugar level and the result was 160 to 180. On 07Jul2020, the patient underwent COVID-19 test (nasal swab) and the result was negative. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of adverse events. The clinical outcome of the event hyperglycemia and sugar was very high was resolving  at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Came to clinic 11/11/13 at 5:50 pm with redness, swelling size of grapefruit, warmth at site. Seen by FNP-C, Dx cellulitis, prescribed cephalexin 500 mg, one twice daily for 7 days, BENADRYL 50 mg once home. 11/12/13 4:00 pm follow up with PA-C, Dx. cellulitis finish cephalexin, alternate ice/heat. Can follow up 1-2 days if redness spreads outside lined pen area or fever. 11/15/13 patient cancelled follow up appointment.
Developed rash on my elbows first now all over my back, Trunck, both thigh buttock./ They are itchy and red; Itchy/ Developed rash on my elbows first now all over my back, Trunck, both thigh buttock./ They are itchy and red; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Jan2021 at 17:00(at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included cancer (reported as Cancer on medication). Concomitant medications included palbociclib (IBRANCE) and letrozole (MANUFACTURER UNKNOWN) for unknown indications from an unknown date. The patient had no known allergies to medications, food or other products. 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 vaccination. On 09Feb2021 the patient developed rash on elbows first and now all over the back, trunk, both thigh buttock. They were itchy and red. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events rash on elbows first and now all over the back, trunk, both thigh buttock, they were itchy and red was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
3:15 pm Injection, c/o dizziness afterwards and feeling weak.  Advised by Paramedics to wait in observation a bit longer.  Skin w/d, no diff breathing.  3:55 pm stated "feeling better".  Advised if dizziness returns pull over safety and dial 911.
Chest tightness, anxiety acutely with fatigue. Extreme feeling of panic and anxiety 1 - 2 days after receiving TRUMENBA.
Patient received Pfizer on 2/8/2021 and 3/1/2021. Patient was admitted to the hospital on 8/29/2021 for COVID pneumonia, and acute on chronic respiratory failure. Patient died on 9/8/2021.
Nighttime leg weakness only immediate symptom. Insidious onset resulting 3 months later of weight gain, increased abdominal girth, shortness of breath, palpitations, excessive tiredness.  Never before present.
This is a spontaneous report from a contactable consumer through a Pfizer sales representative. A 64-year-old female patient received PREVNAR 13, (lot # L04915, exp date Jul2016) IM at single dose at left deltoid on 24Mar2015 for immunization and asthma, at private Physician's office/hospital. The relevant medical history was not reported. No illness were present at time of vaccination. The and concomitant medication included FLU, (Sanofi, lot # UI190AF) IM at right deltoid on 24Mar2015 for immunization. No adverse events occurred following prior vaccination either in patient nor in siblings. On 24Mar2015 the patient experienced fever and deltoid muscle painful. On 25Mar2015, the patient experienced deltoid muscle red and swollen, and on 26Mar2015 hade swelling in her lymph nodes. The events were described as follows: By that night the deltoid muscle was red swollen, and painful and she had upstream lymph node was red and swollen. The AE did not require an emergency room or physician visit. The patient recovered on an unknown date. The reporter stated that the patient provided to him/her information regarding the reported adverse events with the use of the suspect. The Physician was unsure if there was a reasonable possibility that the event is related to suspect product.  The Physician was willing to be contacted again by Pfizer on the reported adverse events. Follow-up attempts are completed. No further information is expected. Follow-up (07Apr2015): New information obtained from a contactable consumer via Pfizer sales representative includes: new events and details. Follow-up (03Jun2015): Follow-up attempts completed. No further information expected. Follow up (08Feb2016): New information from a contactable consumer included: patient's age, onset date and events outcome. Follow up (21Mar2016): Follow-up attempts completed. No further information expected. Follow-up (28Oct2016): New information reported from a contactable Physician included: suspect and conmed details; reporter informed regarding the adverse events; course of events; reporter event causality assessment; reporter further contactability.
Nurse notified at approximately 2:30  Client taken to private recovery area RN also present in private recovery area Client initially stated that it felt like she had swelling in her jaw area and neck Client reports no difficulty breathing At 2:35 After further questions the client states that a better word would be tightness. No swelling noted Client reports left sided jaw tightness and tightness and stiffness  in the neck (just below her left ear) Vitals taken : BP 138/99, Pulse 106, O Sat 98 Client states that it feels like when she has TMJ Client reports feeling a flushed sensation go up her arm towards her jaw and neck after the injection At 2:40 Client reports that the pain/ tightness in her jaw has lessened  and no longer feels like its building Client was previously given water  Client reports no difficulty breathing and No sensation of her throat closing  At 2:42 Client states that when she has issues with TMJ she normally takes Benadryl which helps One  25mg tablet of Benadryl was given with a sip of water  Client is not driving and came with her husband. Her husband will drive Client reports feeling like its calming down  I let her know that she didn?t have to leave immediately and could still sit At 2:49 Client reports feeling better than when she arrived in the private recovery area Vitals taken: BP 134/105, Pulse 105, O Sat 99 A few minutes later her husband arrived At 2:57 Client reports feeling well enough to leave  Client was driven today by her husband  Client was advised to seek further care via call 911 if symptoms worsen or difficulty breathing Client able to ambulate to the car unassisted
After receiving the vaccines, patient complained of dizziness and nausea, gave apple juice and let her lay down for a few minutes until she reported feeling better, Per patient, she did not eat her breakfast and dinner last night,  discharged patient but on her way outside of the clinic together with her dad,  a care assistant called the staff and reported that the patient vomited, brought her back to the clinic and VS were taken, no distress noted and referred to the pediatrician for further evaluation and management.
This case was reported by a physician via call center representative and described the occurrence of general body pain in 17-year-old female patient who received BEXSERO (batch number 169701, expiry date 31st January 2019). The patient's past medical history included blood pressure decreased (Patient's BP was low once previously). On 29th May 2018, the patient received the 2nd dose of BEXSERO. On 29th May 2018, less than a day after receiving BEXSERO, the patient experienced injection site pain and injection site erythema. On 30th May 2018, the patient experienced general body pain, nausea, dizziness, fatigue and injection site swelling. On 31st May 2018, the patient experienced low blood pressure. On an unknown date, the outcome of the general body pain, nausea, dizziness, injection site pain, injection site erythema, fatigue and injection site swelling were recovering/resolving and the outcome of the low blood pressure was unknown. It was unknown if the reporter considered the general body pain, nausea, low blood pressure and dizziness to be related to BEXSERO. The reporter considered the injection site pain, injection site erythema, fatigue and injection site swelling to be probably related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO on left arm. On 30th May 2018, the patient began to experience body aches, dizziness, and nausea which were improving but not resolved at the time of the report. The health care professional additionally reported that the patient's blood pressure was on the lower end, 98/60. On 31st May 2018, the patient returned to the primary care practice for the symptoms, but no emergency room visit, intervention or hospitalization was required at the time of the report. Did not verify patient's usual blood pressure. The reporting health care professional was the patient's primary care physician. Upon escalation, as follow up to case US-CRC-0060888, the health care professional stated that patient also experienced pain at the injection site (still tenderness today), minimal swelling at the injection site, erythema at injection site, fatigue and feeling tired. The patient was feeling better on the day of reporting, the symptoms were resolving.
Some blood taste in mouth; Left underarm 1-10 sore at a 9; hot/warm and a bit swollen morning, noon and night one day following vaccination.; hot/warm and a bit swollen morning, noon and night one day following vaccination.; Bleeding gums; Off Label Use; Flu, other vaccine same date vaccine date = 02Nov2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Nov2021 17:00 (Batch/Lot number: unknown) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administered in arm right, administration date 02Nov2021 (Batch/Lot number: unknown) as dose 1, single. Relevant medical history included: "Kidney stones" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: D3. Vaccination history included: Bnt162b2 (Dose Number: 2, brand=Pfizer EN6204, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 08Mar2021, when the patient was 50 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN5318, Location of injection: Arm Right), administration date: 15Feb2021, when the patient was 50 years old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 02Nov2021, outcome "unknown", described as "Off Label Use"; PRODUCT USE ISSUE (non-serious) with onset 02Nov2021, outcome "unknown", described as "Flu, other vaccine same date vaccine date = 02Nov2021"; PAIN IN EXTREMITY (non-serious) with onset 03Nov2021 16:00, outcome "recovering", described as "Left underarm 1-10 sore at a 9"; FEELING HOT (non-serious), SWELLING (non-serious) all with onset 03Nov2021 16:00, outcome "recovering" and all described as "hot/warm and a bit swollen morning, noon and night one day following vaccination."; MOUTH HAEMORRHAGE (non-serious) with onset 03Nov2021 16:00, outcome "recovering", described as "Bleeding gums"; TASTE DISORDER (non-serious) with onset 04Nov2021, outcome "recovering", described as "Some blood taste in mouth". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity. Therapeutic measures were not taken as a result of feeling hot, swelling, mouth haemorrhage, taste disorder.  Additional information:  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received vaccination on 11/22/09. He states his arm swelled on 11/28/09, with numbness, tingling and pain. He called the pharmacy on 11/30/09 out of concern. We have asked him to visit a physician or urgent care.
Pt. states had onset rash "little red bumps" on both arms within 2 hrs after vaccine administered.  States rash was "itchy".  Took Claritin immediately.  Then took Benadryl at approx 11PM that night.  Took Benadryl and cortisone cream next day.  States symptoms resolved within 36 hours.
From initial information received on 4/20/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 49 year old female patient received a dose of TD ADS ADULT, lot number U1018BA, administered IM in the deltoid on 2/13/04. The following day, on 2/14/04, the patient experienced swelling and redness at the injection site and could not lay on her arm. The symptoms resolved after persisting for seven days. The reporter of this case is the same reporter of case 200401651.
pt experienced cough and swollen throat. Patient may or may not have had fever. Patient has been lethargic and has been sleeping a lot.
R arm swelling from elbow to neck. TX - BACTRIM 4 tsp po BID.
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Tinnitus-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: 5 minutes after the vaccine(s) Moderna and Flu were administered, patient began to experience sweating, chills, tinnitus, and nausea. Patient never lost consciousness and was talking the entire time. Blood pressure measured 110/40 bp.  Patient mother reported he experience this before the last time he had Moderna were he lost consciousness.  Patient recovered in about 10 minutes.
received her first dose of covid vaccine from  Moderna but she can't get her second dose because it's not available in her area; A spontaneous report was received from a consumer (patient) concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) but she can't get her second dose because it's not available in her area (product dose omission issue).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient reported that she received her first dose of COVID vaccine from  Moderna, but she could not get her second dose from  Moderna because it was not available in her area but she was able to receive the Pfizer COVID vaccine for her first dose and second dose.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.  The event of received her first dose of COVID vaccine from  Moderna but she can't get her second dose because it's not available in her area was considered resolved.; Reporter's Comments: This report refers to a case of  Missed Dose for mRNA-1273, lot # unknown  with no associated AEs.
Within 2 hours of vaccine: Itchy hives on injection site, hives on neck and chest.  Within 12 hours of vaccine: hard golf ball sized  lump and swelling on injection site, severe arm pain, fibromyalgia flare (pain and tenderness on entire body), fever, headache, sore throat.