chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist and refers to a 75 year old male patient. The patient's relevant medical history included "huge cardiac history" (details were not provided). The patient did not have any drug reactions or allergies. On 17-OCT-2016, the patient was vaccinated with a dose of ZOSTAVAX injection (route and site of administration, dose, lot number and expiration date were not reported). The patient's concomitant medications were unknown. On 18-OCT-2016, the patient came into the emergency department of the reporter's hospital and was diagnosed with shingles. He was released from the hospital on the same day without being admitted. The reporter did not know if any treatment was provided or suggested to the patient for this event. On 19-OCT-2016, the patient returned to the same emergency department because of a "cardiac issue". He was admitted to the hospital and he needed to have an "interventional cath procedure" completed. It was unknown if any lab diagnostic studies were performed. Product quality complaint was not involved. The reporter was interested in Varicella Zoster Virus (VZV) analysis by polymerase chain reaction (PCR) and wanted to send the viral isolates. At the time of reporting, the pharmacist did not have any information regarding the outcome of the events of shingles and "cardiac issue". The relatedness between these events and the therapy with ZOSTAVAX was not reported. The reporting pharmacist considered the event of "cardiac issue" to be life-threatening and medically significant as "interventional cath procedure" was considered to be an intervention to prevent serious criteria. Additional information has been requested.
On day 1 post immunization @ 14 hours, I started to feel nauseated then developed  chills, flushing of face, body aches. On about 24 hours post immunization, I developed  temp. 100.9 , chills  and with  wet cough , headache. Post 24 hours, fevers, sweats, wet cough and  continued headache. On day 3 post immunization, no more fevers, wet cough, and  chills with sweats, head ache , body ache and pain at sight subsided.  As of date of reporting experiencing, sweats, chills and wet cough.   Starting taking Tylenol and Ibuprofen for symptom management.
Inflammation of veins of left leg in days following first vaccination. Vein inflammation worsened following second vaccination.
Inadvertently administered the boostrix vaccine following a temperature excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 48-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 55RY7, expiry date 17-OCT-2025) for prophylaxis.   On an unknown date, the patient received the 1st dose of Boostrix (left deltoid). On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Inadvertently administered the boostrix vaccine following a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 26-JUN-2023 The reporter reported that the patient was inadvertently administered the Boostrix vaccine following the temperature excursion. The reporter did consent to follow up. The Boostrix vaccine temperature was exposed to temperature excursion, which led to incorrect storage of drug. This case had been linked with US2023088646 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023088646:Same reporter
No past psychiatric history who was medically admitted for altered mental status and agitation following her second BNT162b2 vaccination. Symptoms began one day later, described as dizziness, headache, and memory impairment, with progression to decreased need for sleep and bizarre behaviors. She was medically admitted twice for evaluation of symptoms, with initial concern for delirium due to impaired attention, awareness, and behavioral change. She was ultimately discharged home, but she was increasingly labile, religiously preoccupied, and grandiose prompting readmission. At time of readmission, her clinical presentation did not appear to be consistent with delirium, as attention and awareness were intact. Developed symptoms of mania which resulted in multiple weeks of psychiatric hospitalization.
Patient developed a local reaction at the site of the injection (right proximal arm); arm was erythematous & hot to touch, slight wheal formed.  Treated with Benadryl and Ibuprofen.
Initial and follow-up information has been received from a health professional concerning a 5 month old white male with no past medical history or illness at the time of vaccination who on 29-SEP-2006 was vaccinated IM with one dose of PEDVAX HIB (OMPC) (lot # 652866/0083F).  There was no concomitant medication.  On 30-SEP-2006 the patient developed swelling and hardness at/around the injection site.  The area involved was greater than 2.5 cm.  The patient was treated with acetaminophen (TYLENOL).  Subsequently, the patient recovered from swelling at the injection site and hardness at the injection site.  In follow-up, it was noted that on 25-JAN-2007, the patient was vaccinated intramuscularly with a second dose of PEDVAX HIB (OMPC) (Lot # 653300/0277F) and that, on an unspecified date, the patient developed pain around the injection site.  It was not indicated with which vaccination the pain around the injection site occurred.  The outcome of the pain around the injection site was unknown.  Additional information is not expected.
Severe migraine 24 hours after the second vaccine Very swollen lymph nodes in the arm pit of the arm that received vaccine
Vaccine given approximately 5 minutes following injection patient states "anxiety feeling". Also stated burning at site of injection radiating all the way up into neck, dissipated within a few minutes.  However high anxiety feeling persisted for another 20 minutes. Recommended patient be seen in ED as symptoms of "anxiety" with feeing of intermittent burning in neck. Patient refuses and left clinic in the care of her husband.
Left arm real red, about 3.5-4 inch little soreness, swelling, itching, shortness of breath, rapid heart-beat, took c-pad shortness of breath. Took XANAX to stop it. Mild symptoms lasted for 3 days; but medication corrected it. Right now slight bit of weakness, circle of redness smaller.
Arm pain, inflammation, left arm hot, arm red x 3", neck pain, difficulty moving arm due to pain.
pain in his right arm down to his wrist across his chest and across his back; pain in his right arm down to his wrist across his chest and across his back; pain in his right arm down to his wrist across his chest and across his back; pain in his right arm down to his wrist across his chest and across his back; can't even pick up his tool bag; he cannot sleep on his right side; This is a spontaneous report from a contactable 61-year-old male consumer reported for himself via Medical Information Team. A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 21May2021 as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. He has been experiencing pain in his right arm down to his wrist across his chest and across his back. This was the same arm he received the vaccine in. He reported that he was a heating and air worker and he can't even pick up his tool bag because of the pain. He also reports that he cannot sleep on his right side. He also reports he was worried about his heart. Reporter considered events as non-serious. The outcome of events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Redness, hardening and hot to touch at injection site.   No treatment given, still present today. Redness is a bit larger. Still warm to touch and hardening is about the same.
Fell out of chair, eyes rolled up, stopped breathing, body stiff, face red and disoriented when she came to. She is extremely tired.
tired; chill; a fever of 100.9; This is a spontaneous report from a contactable other hcp (Patient). A 47-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 18Feb2021 16:00 (Age at vaccination: 47-years-old) as single dose for covid-19 immunization. (Vaccination facility: other: High School). No medical history and no concomitant medications were reported. Historical vaccine included first dose of bnt162b2 (Lot unknown: EL1283) in Left arm on 27Jan2021 16:00 for covid-19 immunization. Patient did not receive other vaccine in four weeks and also any other medications in two weeks. Patient was not diagnosed with covid prior to vaccination. Patient did not have Known allergies and also not pregnant at the time of vaccination. It was reported that on 11Mar2021 around 4 to 5PM she began to feel really tired and developed a chill. she got into bed and felt like a fever was coming on. she ended up with a fever of 100.9 by 6PM or so for several hours, it went down to 99.8 by 11PM, and her temperature was down to 96.6 then 97.1 then back to her normal of 97.7 by 7AM. she have no other symptoms so far, will continue to check for fever. she had a pulse oximeter she checked several times, and blood oxygen is constant at 97 percent. If any other symptoms show up she will go get tested and she was self-isolating. She is healthcare practitioner and have been wearing a mask and acting the same way she have for the past year even though vaccinated. she find it interesting her fever came on 3 weeks to the day and hour that received her second vaccination. She do not generally get sick or fevers often, nor did have any other symptoms. Patient did not receive treatment for the events. Patient was not tested for covid post vaccination. The patient underwent lab tests and procedures which included body temperature: 100.9, body temperature: 99.8, body temperature: 97.1, body temperature: 96.6, body temperature: 97.7, Blood oxygen: 97 percent. The outcome for the events was reported as unknown at the time of this report.   No follow-up attempts are possible. No further information is expected
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No concomitant medication was reported. No treatment medication was reported. It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration. This case contains information for the 163th of 190 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Patient reports day after vaccine, redness to arm, headache, fatigue, general body ached, Nausea.  Today patient came to clinic to show injection site.  Right arm redness noted approximately 13cm by 12cm hot to touch.
Covid vaccines pfizer 1st Dec 20,2020 , 2nd Jan 7th, 2021.  April 5th, 2021 Went to ER after numerous tests for stroke. DX: Bells Palsy Facial Paralysis TX: very expensive CT scan, Blood Work, EKG, medications, loss of work, acupuncture. Still have it.
Patient received Flu Vaccine on 10/13/08 in our office. Following evening developed fever 105 deg F and Febrile seizure requiring 911 activation of EMS and taken by ambulance to hospital
Patient reported intense pain on the evening of 12/3/2020 in the exact spot he received his first Shingrix vaccination on 11/2/2020. He described it as a sharp, sudden, excruciating pain that was so obvious that his son asked if he was okay. His son massaged the area firmly for a couple minutes and the patient said the pain disappeared almost as quickly as it came on after that.
Red, inflamed area at/near injection site, pain in joint (L Shoulder), diarrhea, pain in (L) hip, (L)knee, (L) ankle. Inflammation duration 1 week, Shoulder pain 5 days. Other joint pain < 5 days.
approximately ten minutes after getting shot the patient report hives on inner thighs. Also observed hives on face. Benadryl 50 MG IM was given. Hives improved. Patient requested water due to dry mouth. Was able to drink water without any problems. Vital signs were monitors. Initial bp 153/90 hr 89 resp  15. Vital signs remained in this range. Dischage vital signs  bp 146/91 hr 75 resp 15. Husband present and drove patient home. Informed to continue Benadryl 25mg every 4-6 hours today.
This was an administration error- Quadracel is not approved for children under the age of 4. No side effects were noticed. Parents were notified when the error was found.
This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The patient's current conditions or medical history were not reported. On 12-JUN-2007, the patient was vaccinated with the first dose of VAQTA 25/0.5 U/ml (route, indication, lot and expiration date were not reported). On 16-JAN-2008, the patient was vaccinated with the second dose of VAQTA 25/0.5 U/ml (route, indication, lot and expiration date were not reported). On 16-JAN-2014, the patient received a third dose of VAQTA 25/0.5 U/ml (route, indication, lot and expiration date were not reported). No adverse symptoms were reported. Follow-up information was received from the medical assistant regarding the 10 year old, female patient. The patient had tonsillitis at time of vaccination. On 16-JAN-2014 at 08:50 am the patient was vaccinated with the third dose of VAQTA (intramuscular, dose no 3 lot no. H012669 EXP 17-APR-2015) at a private doctor's office/hospital. It was reported that the provider order RECOMBIVAX HB, nurse gave VAQTA. The error was noticed before the patient left the office and correct immunization was given. The same day at 08:58 am the patient received RECOMBIVAX HB (intramuscular, left deltoid, dose 1; lot number J006511 EXP 28-JAN-2016: dosage unknown). The patient did not seek medical attention. The patient had no adverse reaction. Additional information is not expected.
wheezing, diff in breathing, severe cough, high pitch cry;ER visit & subsequent hosp of 5 days;resp 60 and dxed w/ RSV Bronchiolitis. Dx w/autism/ADD @ 2 1/2;
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; product storage error; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT STORAGE ERROR (product storage error).    It was reported that 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion. Concomitant medications were not reported.                                       No treatment information was provided by the reporter. This case is for 30th patient out of 77 patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:case
RN in vaccine clinic was administering two pediatric and one adult vaccine to same family and inadvertently gave one of the pediatric dose vaccine to the adult.
only one component of Pentacel was given to a 4 month old patient with no adverse event; Initial information received on 17-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old and unknown gender patient who was given only one component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Aug-2022, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, Suspension for injection (once, 1 day) (dose, strength, lot number: unknown) via intramuscular route in unknown administration site as prophylactic vaccination.  On 17-Aug-2022 (latency: same day), the patient developed a non-serious event "only one component of pentacel was given to a 4 month old patient with no adverse event" (product preparation error) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE. It is unknown if the patient experienced any additional symptoms/events.   It was reported that "there is no information provided which component of vaccine is given."  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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 the guidelines. 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.
daptacel vaccination instead of the adacel vaccination with no reported adverse event; Initial information received on 07-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11-year-old male patient who had DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] vaccination instead of the adacel vaccination with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (TET TOX) (MENQUADFI) for Prophylactic vaccination.  On 04-Aug-2023, the patient received 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection (strength: unknown) (lot: C5969AD, expiry date: 17-Feb-2024) via intramuscular route in the right deltoid for immunization.  On 04-Aug-2023, the patient had an event of daptacel vaccination instead of the adacel vaccination with no reported adverse event (wrong product administered) (latency: same day) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) 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.
Per pediatrician who saw Pt in office on 2-5-09 - noted 4 cm round Erythematous area to upper (L) arm. No induration or pain with palpation- no crust or scabs where seen- Appears to be a local reaction to the vaccine as opposed to infection.
This is a spontaneous report from a contactable other healthcare professional (patient herself). A 65-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: 59267-1000-02), via intramuscular route of administration on 23Feb2021 at 18:45 (at the age of 65-year-old) as 1st dose, single dose in left arm for COVID-19 immunization at pharmacy or drug store. The patient's medical history included thalassemia minor. Concomitant medications were not reported. Patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. On 23Feb2021 at 14:00, the patient experienced sore arm, queasiness in stomach 18 hours later, and loose stool. Patient did not received treatment for the adverse events. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the events was resolved on an unspecified date in Feb 2021. Follow-up attempts completed. No further information expected.