chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no symptoms; on 3/2/2020 a patient was administered a dose of PNEUMOV AX 23 (lot S029542, expiration 6/10/2021); a shipment of PNEUMOVAX 23 (lot S029542, expiration 6/10/2021) was due to be delivered on 2/26/2020 but was not delivered until 2/27/2020; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.  Until 27-FEB-2020, a shipment of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # S029542 with expiration date 10-JUN-2021)was not delivered which was due to be delivered on 26-FEB-2020 (product distribution issue). On 02-MAR-2020, the patient was administered a dose of  pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # S029542 with expiration date 10-JUN-2021; dose detail, frequency and route were not reported) for prophylaxis (circumstance or information capable of leading to medication error). The patient experienced no symptoms. No further information provided.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S029542; expirationdate: 10-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2003USA004890:
SOB at 1500 seen by provider given Benadryl 25g PO, SXS resolved.
Patient's arms turned red and she stated her tongue felt like it was swelling.  Pt diaphoretic.  Oxygen saturation 97, Pulse 68,  B/p 104/60. Counseled on following up with PcP.
Tingling in tongue; Soreness in arm; Muscle pains; Low back pain; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 09Apr2021 at 11:15 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included postpartum depression and blood pressure high. The patient was allergic to nuts and psyllium. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) and bupropion hydrochloride (WELLBUTRIN). 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 09Apr2021 at 11:30, the patient experienced tingling in tongue approximately 15 minutes after vaccine lasting upwards of 6 hours, soreness in arm, muscle pains, low back pain and tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events tingling in tongue, soreness in arm, muscle pains, low back pain and tiredness were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient hospitalized for Coronary artery bypass grafting x4 - left internal mammary artery grafted to LAD and reverse saphenous vein grafts placed to diagonal, obtuse marginal and right posterior descending coronary arteries on cardiopulmonary bypass. this was within 6 weeks of receiving covid vaccination.
paroxysmal atrial fibrillation; acute on chronic diastolic (congestive) heart failure; hypertensive heart disease with heart failure; hypertensive heart disease with heart failure; shingles; Information has been received from a lawyer referring to a male patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 18-NOV-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) (date not reported), the patient suffered a painful itchy rash on his back and was diagnosed with shingles. The patient also experienced severe shortness of breath and was hospitalized and diagnosed with paroxysmal atrial fibrillation, acute on chronic diastolic (congestive) heart failure, and hypertensive heart disease with heart failure. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events shingles, paroxysmal atrial fibrillation, acute on chronic diastolic (congestive) heart failure and hypertensive heart disease with heart failure was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the events shingles, paroxysmal atrial fibrillation, acute on chronic diastolic (congestive) heart failure and hypertensive heart disease with heart failure to be disability. Upon internal review the events paroxysmal atrial fibrillation, acute on chronic diastolic (congestive) heart failure and hypertensive heart disease with heart failure was determined to be medically significant.
Pt found out a week later that she was pregnant. Also that she may have eczema after vaccination (23May06).
Only the diluent was administered to patient; Only the diluent was administered to patient; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 4KK43, expiry date 26th August 2023) for prophylaxis.   On 10th May 2022, the patient received Shingrix. On 10th May 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-MAY-2022 Reporter's comment:  The health care professional reported that only the Shingrix diluent was administered to patient.  The health care professional could not locate lot number and expiry date for the diluent.  The antigen lot was reported. No side effects were reported. The reporter consented to follow up. The vaccine administration facility was the same as primary reporter. Additional supportive information: Only the Shingrix diluent was administered to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Information has been received from a registered nurse concerning a 16 year old female who was vaccinated with Gardasil. Moments later the patient passed out. Unspecified medical attention was sought. Subsequently, the patient recovered from passing out. Additional information has been requested.
Significant flare up of rheumatoid arthritis after 2nd booster dose; almost 2 months after testing positive for Covid (early Feb)
Tdap given 08/02/2006, per mom, patient developed rash over the entire body one hour after immunization given.
Received Booster COVID vaccine on 11/17/21, less than 12 hours developed symptoms.  After receiving COVID booster developed left sided body pain and weakness.  Difficulty moving the left arm due to pain and left arm tightness.  Developed 99.9F Temp, treated with Tylenol and Motrin for 24 hours every 3-4 hours.  Reports weakness.  Reports symptoms lasted until Saturday 11/20/21.  Reports all symptoms resolved.
Dizziness, nausea after the dose.  Vitals; BP 135/70, pulse 91, O2 100%. After 10 minutes, both symptoms subsided
Patient requested Shingrix dose #2, stated she received dose #1 out of state.  Dose was given. Later discovered patient had completed the series in 2018
Caller is pharmacist that reports nursing student states she had a hepatitis B titer drawn and it was "too low (3.2)" after receiving a three dose series of hepatitis B vaccine as a child. Unknown manufacturer of hepatitis B vaccine. Unknown dates of; This spontaneous report was received from a pharmacist referring to a female patient of an unknown age. The patient's medical history, concurrent conditions, concomitant medications and previous drugs allergies or reactions were not reported.  On an unspecified date (reported as "as a child"), the patient was vaccinated with three dose series of hepatitis B vaccine (recombinant) (manufacturer unknown).  On an unspecified date (reported as "after receiving three dose series of hepatitis B vaccine"), the patient underwent the following laboratory test: hepatitis B titer drawn (hepatitis B surface antibody) that showed too low (3.2) (units not provided) (hepatitis B surface antibody negative). At the time of reporting, the outcome of the event was not reported.  The causal relationship between hepatitis B vaccine (recombinant) and the event was not reported.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received SHINGRIX for prophylaxis.  Concomitant products included atenolol and triamterene. On 7th June 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On 7th June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, injection site warmth and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site warmth were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the injection site erythema, injection site pain and injection site warmth to be related to SHINGRIX. Additonal details were reported as follows:  At 09:00, the patient received SHINGRIX on left arm. The patient received SHINGRIX at her physician's office the day before reporting and the nurse administered it subcutaneously instead of intramuscularly, which led to inappropriate route of vaccination. The nurse seemed to believe SHINGRIX should be given subcutaneously. Later the reporting day she developed redness, heat and soreness at the injection site. The reporting morning the red area was 3 inches wide by 2 inches long and was getting bigger. The reporter read in morning on the reporitng day that SHINGRIX was supposed to be given intramuscularly.
couldn't do anything; huge red mark from shoulder to elbow; patient received third booster; fever for 102 for 3 days; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't do anything), ERYTHEMA (huge red mark from shoulder to elbow), PYREXIA (fever for 102 for 3 days) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received third booster) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't do anything), ERYTHEMA (huge red mark from shoulder to elbow), PYREXIA (fever for 102 for 3 days) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received third booster). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't do anything), ERYTHEMA (huge red mark from shoulder to elbow) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received third booster) outcome was unknown and PYREXIA (fever for 102 for 3 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.         Concomitant drugs were not reported. It was reported that patient received a half dose for third booster dose. It was also reported that patient had a terrible time with the vaccine. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-649254 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-649254:Second booster
Patient was vaccinated against COVID-19 and presented to the ED where he was diagnosed with COVID infection leading to hospitalization
Adverse event was not vaccine related.   Vaccine 12/30/2020, 01/28/21 booster 10/21/21.  Developed CoVid 19 on 11/09/2021.  Low O2 levels and fatigue.  Received monoclonal antibodies 11/10/2021.  Fatigue and cough for 2 weeks.
Pt complaints of feeling dizziness, cold, clammy.  Right side of face felt numb, "emotional response"
approximately 30 min after patient received COVID vaccine #2, pt stated she started feeling "throat tightening". Denied difficulty breathing. BP162/88. Benadryl 50 IM injected to RD. 911 called-Volunteer Rescue Squad arrived within 2-3 min of call. Assessed patient. O2 sats on Room Air 99-100%. Ambulance services arrived 20 min after call placed. Pt was feeling some better; BP 112/80 HR 125. Pt declined EMS taki1105878-1 03/16/2021 Non-Serious Initial Report - Hng her to ER, but did consent to boyfriend taking her. Pt was discharged from ER at approximately 1300 hours after receiving "2 shots in ER" per patient. ER staff declined to give treatment information d/t HIPPA.
A report was received from a healthcare professional on 12/19/2005, regarding a 13 month old male vaccinee. No details were provided regarding the vaccinees medical history or concomitant medications. On 10/21/2005, the vaccinee received 0.25 ml of influenza vaccine. On 12/9/2005, the vaccinee received 0.25 ml of Fluvirin intramuscularly in the leg. On 12/11/2005, it was noted that the vaccinee was not bearing any weight on the leg that received the vaccination. No localized redness at injection site was reported. At the time of reporting the adverse event was continuing. Follow up information received on 2/1/2006: the vaccinee had no relevant past medical history and was receiving no concomitant medications. The vaccinee was diagnosed with transient synovitis in the left hip, hip pain and a fever. Onset of symptoms was within twenty four hours of receiving Fluvirin. X ray of the left hip and lower leg were negative and blood cultures and biochemistry were all within normal limits. The vaccinee was treated with Motrin (Ibuprofen). All symptoms were resolved within four weeks of vaccination.
rash; hives-like rash; This case was reported by a other health professional via sales rep and described the occurrence of rash in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 15th August 2022, the patient received the 1st dose of Bexsero, Bexsero Pre-Filled Syringe Device and Menveo. In August 2022, 1 week after receiving Bexsero, Bexsero Pre-Filled Syringe Device and Menveo, the patient experienced rash and hives. On an unknown date, the outcome of the rash and hives were recovered/resolved.   It was unknown if the reporter considered the rash and hives to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Menveo.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-SEP-2022 and 12- SEP-2022 Reporter's Comments: The patient received her first dose of Bexsero and dose of Menveo. A week later she developed a rash that looked like hives all over her body. The health care professional was not sure if it was related to the Bexsero and Menveo. She had nothing else to report. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us by National Guard. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call from  National Guard that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.
Patient started with small dots on evening after shots were given. They got worse overnight and was covered this next morning. The spots are itchy and raised red bumps. Patient also has a large raised red area at site of where Hep A vaccine was administered.
Days 1 & 2: soreness in arm. Day 3: Itching, swelling, redness in arm
1st shot received on 1/15/21. After 3 hours or so, severe pain began in arm. Could not lift arm. Symptoms lasted 3 days.  2nd dose on 2/12/21 at 9am. Around 5pm, chills, joint pain, myalgia and fever of 105 developed. Fever checked with multiple thermometers. Ibuprofen 400mg q6h only brought fever down to 102. Symptoms lasted 3 days.
Pt recieved 2 immunizations: HPV #2 in L arm followed by Influenza in R arm. Injections administered per office protocol and well tolerated.  Pt instructed to wait in office 15 min s/p injection for safety and to RTO in 4 mos for HPV #3. Pt did have syncopal episode wieth seizure-like behavior 5 min sp injection, put supine on exam table for safety. Supine BP 98/60 HR 56. Had pt sit up to re-eval vitals after laying down for 10 min.  Pt had second syncopal episode within a minute of sitting.  Placed pt back into supine position.  Pt diaphoretic and nauseated sp episode. After resting pt had VS rechecked while sitting with legs elevated.  BP 116/67 HR 60. Pt changed position to sitting with legs dependent, BP 84/37 HR 60, pt felt like she was going to faint again, developed pallor and diaphoresis. Had pt lay back down, pushing fluids. Recheck vitals after 3 8oz cups water: BP 102/60 HR 60. Pt standing for 2 min, vital signs rechecked: BP 109/62 HR 64. Pt cleared to leave department, request call back if any status change or concerns.
Dermatographia like rash along with hives, occurring with no stimulation. Itchy and recurrent daily symptoms.
Patient felt weak and collapsed for 1 second, patient felt better quickly.  Called 911 and paramedics checked vitals and left after five minutes. Patient stayed for 10 more minutes and felt fine and left.
8/31/21 pt had a positive COVID test from a Family Clinic; 9/10/22 pt admitted to a local Medical Center for complications due to COVID; treated with Remdesivir, Decadron; dc'd on RA; 9/20/22 pt back to hosp with increase in dyspnea and cough x 2-3 days; hypoxic with O2 sats 70% on RA; placed on O2 supplementation; pneumonia; negative COVID test; pt's condition continued to deteriorate; family transitioned pt to comfort care and he passed away in the hospital
Client here for second dose of Moderna 100mcg/0.5 ml vaccine  and received a dose of Pfizer30mcg/0.3ml.  Pt received a dose of Pfizer instead of the Moderna for a second dose.   Pt. asked the  medical assistant after being vaccinated  that ?I got a Moderna vaccine correct??  At that time the medical assistant informed her that she had received a Pfizer.  MA, states she had confirmed with the patient prior to starting the vaccination process that she was here to receive the Pfizer vaccine.   The client had said yes before beginning the vaccination process. staff also confirms that the client identified that they were here to receive the Pfizer vaccine.   Supervisor RN and Charge nurse RN were  made aware of situation by staff and responded to the Pfizer table.  Supervisor made an apology to the guest and explained that this should not have happened and will take steps to ensure that this is prevented in the future.  Supervisor explained and reassured the safety of having a different second dose will not harm her.
This spontaneous report was received from a Registered Nurse concerning an unknown number of patients of unknown age and gender. On unknown dates incorrectly stored doses of ROTATEQ lot # M004885, Exp date: 23-OCT-2017could have been administered. It was reported that, on an unknown date, the refrigerator was out of range for 22 hours, with a highest temperature of 48.6 F. Temperature was back in range at the time of call. The Registered Nurse that vaccines could have been administered before the excursion was identified. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Headache, Myalgia, pain injection site, left shoulder pain, chills, fatigue Narrative:
I am still having chills. I never had this effect and definitely this long. Few times a day.  Started taking Ibuprofen since 9/26 (1 pill 3 times a day)
pt recvd vax & 48 hrs later mom noticed large, swollen area lt arm; t102, c/o brain felt jiggly; arm area bruised;
TENSION; SHIVERS; HEADACHE; VOMITING; LETHARGIC; SORE ARM; MYALGIA; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure. The patient experienced drug allergy when treated with ibuprofen.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 27-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAR-2021, the subject experienced lethargic. On 27-MAR-2021, the subject experienced sore arm. On 27-MAR-2021, the subject experienced myalgia. On 30-MAR-2021, the subject experienced vomiting. On 31-MAR-2021, the subject experienced tension. On 31-MAR-2021, the subject experienced shivers. On 31-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lethargic, vomiting, myalgia, sore arm, shivers, headache, and tension. This report was non-serious.