chrisvoncsefalvay/vaers-outcomes huggingface dataset:
boostrix underwent above temp excur and was administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 26-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number n254c, expiry date 23rd November 2023) for prophylaxis.   On 2nd March 2022, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were reported as follows: The reporter reported that the Boostrix underwent above temperature excursion with high: 67 F time: 14 days and was administered to the patient, which let to incorrect storage of drug. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. This was 1 of the 6 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022040253:Same reporter US-GLAXOSMITHKLINE-US2022040254:Same reporter US-GLAXOSMITHKLINE-US2022040251:Same reporter US-GLAXOSMITHKLINE-US2022040252:Same reporter US-GLAXOSMITHKLINE-US2022040248:same reporter
Pt stated that she woke up on 6/20 with rash, hives all over her body. Pt is now taking Diphenhydramine for itching and Calamine lotion.
A nurse reported that a 4 year old female received a dose of Prevnar vaccine on 9/27/02. The child has a cochlear implant and received Prevnar to decrease the risk of meningitis. On 10/3/02, she developed hives covering her body, swollen hands and feet. Additional information received from the reporter on 10/28/02, changed the date of event onset, gender and provided clarifying information about event. The reporter stated that urticaria was generalized but was more evident at the injection site.
No adverse event. Patient received vaccination outside of recommended age range of 18+, but to date (12/11/2020), has not experienced any adverse events.
Pt given TD in L deltoid. Pt hx: foot laceration to vl thigh and ///. ///.
was sick; body aches; headache; fatigue; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (was sick), PAIN (body aches), HEADACHE (headache), FATIGUE (fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (was sick), PAIN (body aches), HEADACHE (headache), FATIGUE (fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, ILLNESS (was sick), PAIN (body aches), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. Not Provided          Patient reported "I just rested. But it makes me feel safer, somehow. Still follow precautions- washing hands, wearing mask inside the stores, etc. I can't wait for it to be over".  No concomitant products were reported.  No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jan-2022: Followup received on 02-jan-2022.events were updated, contains significant information.
Minutes after being vaccinated; patient felt flushed and arms and back and chest developed hives/rash.  Hyperventilation with throat tightness.  Healthcare worker was immediately transported to the Emergency Department and was treated  with Benadryl, Epinephrine, Solu-medrol, Pepcid and Ativan.
Information has been received from a physician concerning a patient who was vaccinated with GARDASIL.  Subsequently the patient experienced atypical headaches and neurological disorder.  The outcome of the patient was unknown.  Atypical headaches and neurological disorder were considered to be disabling.  This is one of several reports received from the same source.  Additional information has been requested.
Narrative: COVID infection following COVID vaccine series 01/13, Pfizer, dose #1 (non-Facility) 02/03, Pfizer, dose #2 08/12 pt cc: cough, fatigue, rhinorrhea, sore throat exposure: unknown 08/13 - 08/20 Pt symptoms continue 08/12 COVID swab, result: detected 08/12 SARS-COV-2 LINEAGE result: B.1.617.2 08/12 SARS-COV-2 CLADE result: 21A 08/21 clinically resolved
Pt developed white raised area around the site of injection. It doesn't hurt but is just apparent and was still present when 2nd dose was given on 6/16/01.
Dizziness/Lightheadedness; Headache; Sore Arm/Body Aches; Chills; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Dizziness/Lightheadedness), HEADACHE (Headache), MYALGIA (Sore Arm/Body Aches), CHILLS (Chills) and NAUSEA (Nausea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced DIZZINESS (Dizziness/Lightheadedness), HEADACHE (Headache), MYALGIA (Sore Arm/Body Aches), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness/Lightheadedness), HEADACHE (Headache), MYALGIA (Sore Arm/Body Aches), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Patient said he was feeling weak and sick.  Reported problems with diabetes and hypotension in the past - blood glucose was checked using patient's machine and was 200.  HR 88, BP 78/40 (family reported normal systolic is in the 80s).  EMS was called and recommended transport to the ED, but patient/family refused. Symptoms reported at 1415, EMS on site at 1430 and patient left site at 1445.
Child received DTap-IPV portion (liquid portion) only of ordered Pentacel vaccine; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 2 months old patient who received DTap-IPV portion only of ordered vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (DTap-IPV lot U6137AB; expiry date: 16-Oct-2020; ActHIB lot UJ065AA, expiry date: 16-Oct-2020) via intramuscular route in the right thigh on 12-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation on 12-Jul-2019.  It was a case of actual medication error due to inappropriate reconstitution technique.  It was unknown whether the patient had any adverse event.  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.  Documents held by sender: none.
Difficulty in walking; pain in arm; Back pain; Rash; Cold; Drug effect incomplete; This spontaneous case was reported by a physician and describes the occurrence of GAIT DISTURBANCE (Difficulty in walking), PAIN IN EXTREMITY (pain in arm), BACK PAIN (Back pain), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete) and NASOPHARYNGITIS (Cold) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB injection for Rheumatoid arthritis.    There was no reported medical history.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (Subcutaneous) 1 dosage form. On 30-Apr-2021, the patient experienced THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete). On 22-Jun-2021, the patient experienced NASOPHARYNGITIS (Cold). On an unknown date, the patient experienced GAIT DISTURBANCE (Difficulty in walking), PAIN IN EXTREMITY (pain in arm), BACK PAIN (Back pain) and RASH (Rash). At the time of the report, GAIT DISTURBANCE (Difficulty in walking) and BACK PAIN (Back pain) had resolved and PAIN IN EXTREMITY (pain in arm), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete), NASOPHARYNGITIS (Cold) and RASH (Rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter. 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.; Sender's Comments: C
w/in 1-2hr of vax pt exp mod cephalgia, mainly on rt side of face & behind eye ball;denies visual loss or numbness;still has residual sx @ time of this report;
Mid grade fever 100.7. Chills, achy Joints (especially Rt. knee) tingling feeling all over. Lasted till 09-08-2014.  Treated with 650 Tylenol.
Postherpetic neuralgia; Hypogammaglobulinemia; Herpes zoster; Information has been received from a lawyer concerning a case in litigation and refers to a female patient of an unknown age. The patient's medical history, historical drugs and concomitant therapies were not reported.   On or about 07-MAR-2018, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prevention of shingles (herpes zoster) (dose, route, lot number and expiration date were not reported).  On an unknown date (reported as "shortly after receiving zoster vaccine live (ZOSTAVAX)), she suffered from vesicular rash on the left side of her back along with chronic fatigue and pain. She was diagnosed with herpes zoster, postherpetic neuralgia and hypogammaglobulinemia. The patient suffered symptoms that resulted in physical limitations. Also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition, and sustained severe and permanent personal injuries. The outcome of the events was unknown. The causal relationship between the events and zoster vaccine live(ZOSTAVAX) was related.   The events were considered to be disabling events and the event of hypogammaglobulinaemia was considered medically significant.
71 y/o male, BMI 31, PMHx of CAD, HTN, hyperlipidemia, CA, DM, and chronic lung disease, admitted for SOB, cough, fever, chills, and weakness on 8/28/21. Chest x-ray revealed multifocal pneumonia in the lungs bilaterally. Covid pneumonia treated with remdesivir, decadron, and supportive measures. Pt was intubed on 9/1/21 and extubated on 9/10/21. Pt discharged to skilled nursing facility on 9/15/21.
sitter w/pt & stated pt had several epiosdes of unusual type inconsolable crying which lasted for 10 mins & occurred x 3 episodes; pt was excessively sleepy;
multiple outbreaks of herpes zoster; This spontaneous report was received from a lawyer, regarding a case in litigation and refers to a male patient (pt) of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, site of administration, lot #, and expiry date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the pt suffered multiple outbreaks of herpes zoster. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt 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 pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not resolved. The reporter determined the event to be related to zoster vaccine live (ZOSTAVAX).  The event was considered to be disabling by a reporter.
Mom calls office - Right thigh has red area that is warm to touch. Appt. made. Doctors note right thigh has large area of erythema with induration. Area is tender and warm to touch and seemed to be getting larger. AUGMENTIN prescribed.
Patient experienced disorientation starting about 30 minutes after getting shot, and lasted the entire rest of the day.  Patient also experienced fever in the evening
Fever of 101.5 reported by patient about 12 hours after the dose. Fever lasted until about 12pm noon the following day, 07/31/18.
The HIB itself was ok with exp date of 04/01/2023 but the diluent had an expiration date of 03/05/2023 with no reported adverse event; Initial information received on 26-Apr-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1-year-old male patient, the hib (HIB (PRP/T) VACCINE [ACT-HIB]) itself was ok with exp (expiry) date of 04/01/2023 but the diluent had an expiration date of 03/05/2023 with no reported adverse event.  The patient had no medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On 14-Mar-2023, the patient received a dose number: 3  of an unknown dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (strength: unknown) (expiry date: o4-Jan-2023) (lot: UJ646AA / U7251AA) via intramuscular route in unknown administration site for prophylactic vaccination.  On 20-Mar-2023 the patient had an event of the hib itself was ok with exp date of 04/01/2023 but the diluent had an expiration date of 03/05/2023 with no reported adverse event (expired product administered) (latency: 6 days) following the administration of HIB (PRP/T) VACCINE.  There were no lab data/results available.  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  Outcome: Unknown.  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 the 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.
After the patient got home the injection site became red, warm, "swollen", painful (size of the patient's hand). Today she is improved but still slightly swollen, little warm and less painful. TX: ice and TYLENOL.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Patient received flu and covid vaccine today at 1:56.  3 minutes post-injection, patients mother called my attention stating that patient was feeling hot and dizzy.  Patient was sweaty upon arrival and felt warm to the touch, but forehead thermometer read 96.2 degrees F.  Patient stated that he had no trouble breathing and pulse was 52 BPM.  We provided ice packs, wet towels. and a trash can as the patient felt nauseous and dizzy. Pt began to feel better within 10 minutes and left at 12:46.
Pt recvd 2 doses of Hep B vax 21MAY91 & 23JUN91 & exp shoulder pain to point where felt was angina; cardiac workup was neg; tx Motrin & icy hot packs;
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history was not reported. On 20-JUL-2015, the patient was inadvertently vaccinated with an expired dose of MMR II (dose, route, site of administration, lot #, expiration date and therapy type were not reported). No adverse effects were reported. Additional information has been requested.
Multiple blisters on buttocks and genital area started to appear 2 days after vaccination, several of which burst and are red and angry looking. Fever of 102.6F (rectal) 9 days after the vaccination which required 1 dose of Tylenol.
Information has been received from a physician concerning his wife who has asthma and no history of drug reaction/allergies. She was vaccinated subcutaneously with Zostavax. Concomitant therapy included montelukast sodium and PULMICORT. Within 24 hours of receiving zoster, the patient experienced myalgia in chest area. The patient sought medical attention. No lab testing was performed. Subsequently, the patient recovered in about 24 hours. Additional information has been requested. This is one of several reports from the same reporter.
I had right upper arm pain with right neck pain with right sided facial pain, right jaw pain that persisited for 5 days at the site of a wisdom tooth that had not caused pain previously.
17 year old was administered Fluzone High Dose, no AE; 17 year old was administered Fluzone High Dose, no AE; Initial and follow up information received on 06-Sep-2019 and 10-Sep-2019 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case is linked to cases 2019SA251863 and 2019SA251864 (same reporter).  This case involves a 17 years old male patient who was received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ232AA, Exp. Date 10-Apr-2020) via intramuscular route in the left deltoid on 05-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration.  It was also a case of overdose.  At the time of reporting no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender: none.
blanching red rash macular in nature all over, head, trunk, abd, arm, leg, back, buttock
Arm pain, red raised lump dx as cellulitis. HA fatigue.. completing PO ABX
it was just mild fever; Pain in arm; sluggishness lasted for two days/sluggish for two days; she is very tired; This is a spontaneous report from a contactable consumer (parent). A 14-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0196, 14-years-old at the time of vaccination), intramuscular, administered in arm left on 26Jun2021 10:30 as single for covid-19 immunisation. Medical history included asthmatic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included salbutamol sulfate (ALBUTEROL SULFATE) taken for asthma. Patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0186, at the age of 14-year-old), intramuscular, administered in arm left on 21May2021 12:30 as single for covid-19 immunisation and experienced four days late for her monthly menstrual cycle. On an unknown date in 2021 patient experienced mild fever, pain in her arm, sluggishness lasted for two days and she was very tired and sluggish for two days. Patient did not receive any treatment for the events. On an unknown date in 2021 events were resolved.  Follow-up attempts are needed. Further information is requested.
cold symptoms; leg pain; Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient received the first dose of Covid vaccine on 03Jan2021 and tested positive for COVID on 05Jan2021. She further reported that she is still experiencing some cold symptoms and leg pain on an unspecified date. She is scheduled for second dose on 24Jan2021. She is still on precautions. She does not think she should get it.  The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 05Jan2021. Therapeutic measures were taken as a result of the events which included treatment with Tylenol. The patient did not recover from cold symptoms and leg pain while the outcome of the other events was unknown.  Information on the lot/batch number has been requested.