chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received the 1st dose / on 03Sep2018 and is late for the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on 3rd September 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that the patient was late for the 2nd dose and did not receive it, which led to incomplete course of vaccination. The reporter consented to follow up.
Urticarial rash 24 hours after receiving vaccine.  Persistent for 4 days; Prescribed Benadryl, Hydroxyzine.
Client is breastfeeding and received the H1N1 FLUMIST because she did not know that breastfeeding mom's should take the H1N1 injection.
This spontaneous report was received from a licensed practical nurse concerning a patient of unknown age and gender. On 10-DEC-2012, the patient was vaccinated subcutaneously with an expired dose of 0.65 milliliter ZOSTAVAX (lot number 671018/0748AA and expiry date 18-AUG-2012). No concomitant medications were reported. No adverse effect was reported. Additional information is not expected.
Patient received Pfizer Bivalent vaccination before it had been two months since the last dose of the previous series. Patient should have received the Pfizer Bivalent vaccination on/after 09/16/2022 and instead received it 09/10/2022
Muscle weakness to bilateral upper extremities.  Started the day after and has still persisted 4-5 days later with no changes.
Soreness at injection site starting about 8 hours after vaccination; Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-years-old male patient received third dose of bnt162b2 (BNT162B2, Batch/Lot number: FH8027)  administered in arm left, administration date 24Nov2021 (at 12:00) (age at the time of vaccination was 64-years-old) as DOSE 3 (booster), SINGLE for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII, administration date 10Nov2021; ATORVASTATIN; LISINOPRIL. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 24Mar2021, when the patient was 63 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 03Mar2021, when the patient was 63 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 24Nov2021 14:00, outcome "unknown", described as "Dose Number: 3"; VACCINATION SITE PAIN (non-serious) with onset 24Nov2021 22:00, outcome "recovering", described as "Soreness at injection site starting about 8 hours after vaccination". Therapeutic measures were not taken as a result of vaccination site pain.  Follow-up attempts are completed. No further information is expected.
Administered vaccine BUD 04/07/22 on 04/23/2022. Pfizer could not provide stability data beyond 04/09/2022 and recommended  another Booster administered 05/10/2022.
Patient is disoriented, very sleepy, and is experiencing unilateral (right sided) kidney pain. Is following up with her physician.
Initial report was received 20 May 2013 from a health care professional. A female patient had received an injection of TYPHIM VI in 2010 (Sanofi Pasteur, lot number unknown; route, site of administration, and exact date of administration not provided). Following vaccination, the patient experienced hives and throat tightening. The patient was hospitalized for the symptoms. The reporter did not have any other information since the patient had received the vaccine at another facility and wasn't their patient at that time. The patient's outcome was reported as recovered. Documents held by sender: None.
Patient received covid vaccine.  She was near the end of her 30 min wait time due to nausea after the 1st injection.  Patient was reporting nausea.  Patient began to feel lightheaded and felt like she was going to pass out.  Cart was obtained. Patient passed out and was unresponsive.  EMS was called.  Patient lifted to cart.  Patient not arousing to her name being called.  Sternal rub performed to arouse her.  BP 117/89  HR 88  O2 Sat 100.  Patient awake but confused. Reporting headache and chest pain.  BP 125/92 HR 84 EMS arrived.  Patient taken to ER.
My adverse event started on 10/01/2022 in the afternoon I had chest pain and weakness. I felt like I was having a panic attack. I had arm numbness on the left and facial numbness right). On 10/01/2022 I went to the urgent care chest pain. On 10/31/2022 I went to the ER for migraines. On 01/09/2023 I will be going to my doctor's office for a visit. The pain comes and goes. The last time I had the panic attack lasted for 3 hours.
Woke up and the injection site above left elbow, is swollen/red and very warm to the touch.  I used a ice pack for the entire day, rested all day, did not go to work. Napping and did not feel well. 6/11/2016 still red/swollen and not feeling well/ sleeping more than usual, less warm at the site. I do not have allergies, I am physically in good shape for my age.
Sever chills (teeth chattering), fever, major aching, nausea and fatigue through much of the night 1/3-4.  Next day severe fatigue.  ilder fatigue for the next three days.
significant swelling to lymph nodes under armpit of injection side (L arm); This is a spontaneous report from a contactable consumer.  A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at the left arm on 09Jan2021 08:00 at SINGLE DOSE for COVID-19 immunization at a hospital.  Medical history included asthma, food allergy with peanuts and pine nuts. No known medication allergy. The concomitant medications included albuterol and unspecified multivitamin. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) at the left arm on 19Dec2020 08:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for it since the vaccination. The patient was not pregnant. On 10Jan2021 16:00, the patient noted significant swelling to lymph nodes under armpit of injection side, swelling in the left armpit lymph nodes began approximately 32 hours after injection. Swelling measuring approximately size of a ping pong ball. At time of this reporting (approximately 40 hours post-injection) lymph node swelling still persists, with no change in size. The patient did not receive any treatment for the events. The patient has not recovered from the events.   No follow-up attempts are needed. No further information expected.
I'm getting headaches that come on strongly; This is a spontaneous report received from a contactable consumer(patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,  solution for injection; lot number: Fc3181 and expiry date not reported) via an unspecified route of administration, at the age of 46-year-old, on 24Aug2021, at the left  arm, at dose 1, single for covid-19 immunisation in a Pharmacy/drug store. Relevant medical history included Lupus and Hypothyroidism. The patient had no known allergies. Concomitant medications in two weeks included hydroxychloroquine, celecoxib, codeine phosphate, paracetamol (APA CODEINE) and trazadone hydrochloride (TRAZO).  The patient is not pregnant at the time of vaccination. The patient did not have other vaccine in four weeks. The patient did not have prior COVID vaccination and was not tested post vaccination. On 25Aug2021, the patient experienced headaches that come on strongly in the same place. It comes and goes but when it comes it's on top of her head and it was a strong headache. The patient did not receive treatment in response to the events. The outcome of the events was not recovered at the time of report.
Had MMR, Varivax on 10/9/06, parent reports site red, hard at site x 24 hours. Child developed fever increase 102 starting 10/18. Child developed red papular rash that resolved by time child seen 10/20.
There was an excursion from the freezer; administered to 118 patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.No Medical History information was reported. On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients). On 08-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No Concomitant medications were reported.No Treatment medications were reported.There was an excursion from their freezer on 01-Oct-2021. They used the excursion tool but there is no option for the excursion they experienced. The tool only gives options for excursions above one hour and not less than, so she does not knowhow to do the analysis. She states that her team already knows the recommended temperatures and wants to know if the vials were still okay to be used because they were administered to 118 patients.
C/O FINGER TINGLING, AND NUMBNESS 177/87, DID NOT TAKE MEDS, 100, 97% BS 96
Period symptoms dragged on and menstrual cycle was a full week late. Cycle is very regular typically.
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium
Initial unsolicited misuse report received from a non-healthcare professional (Pharmacy Account Specialist) on 09 February 2015. A female patient (age unknown) had received a dose of FLUZONE (batch number, dose number, route and site of administration were not reported) on an unspecified date. The patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. It was reported that the patient might have been administered vaccine into bursa resulting in incorrect route of drug administration. On an unspecified date, the patient had bone bruising. MRI was done and showed bone bruising and corrective treatments were not reported. At the time of this report, the patient outcome was unknown. Documents held by sender: None.
Infant developed fever 100.4 approx. 24 hrs post vaccination. Also developed 2 cm area erythema, mild warmth, and induration at injection site ((L) superior thigh).
body ache; fever; muscle soreness; chills; no appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 15Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart Attack" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; MYALGIA (non-serious), outcome "unknown", described as "muscle soreness"; PAIN (non-serious), outcome "unknown", described as "body ache"; CHILLS (non-serious), outcome "unknown", described as "chills"; DECREASED APPETITE (non-serious), outcome "unknown", described as "no appetite".  Additional information: 1st dose 15Jul - Had several adverse events including fever, muscle soreness, body ache, chills, and no appetite. Events lasted about three days. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Beginning 3/1/06 swelling and redness of L arm at location of pneumococcal polysach vaccine. Fever and headache started 3/1/06. Fever cont'd thru 3/4. Headache persist, L arm pain persists as of 3/8/06.
SEVERE COUGHING CONGESTION LIQUID IN RIGHT EAR TO DATE I HAVE NOT BEEN ABLE TO RECOVER FROM THE CONGESTION AND IT IS NOW DEC. 8, 2021 I WAS GIVEN THE SHOTT ON 10/25/2021
The patient had a swollen and red arm that appeared later on the same day after the vaccination. She saw her PCP for treatment 2 days later. She was started on BENADRYL and triamcinolone 0.1% ointment.
A nurse reported that a 19 month old female received Prevnar and ActHIB (Aventis Pasteur SA) vaccines on 8/23/00. Two days, post vax, she developed redness and swelling at the site of Prevnar administration and a generalized rash. The physician recommended treatment with diphenhydramine and applications of cold compresses. This is 1 of 5 pts from this facility who had an adverse experience following receipt of Prevnar lot 471654.
Tightness in my chest day of vaccine but it's worse the day after, severe dizziness moring after injection,  feeling out of breath day after injection
Ear pain, head ache, flu like symptoms, red rash and large red lump at injection site, chills, low grade fever.  Started almost 24 hours after injection and is still ongoing.
This spontaneous report was received from a pharmacist concerning to a 68 year old patient of unknown gender. Patient's pertinent medical history, drug allergies/reactions and concomitant medication were reported as none. On 31-JUL-2017, the patient was vaccinated with PNEUMOVAX 23 lot # M043424 (expiry date: 06-JUL-2018, dose, route and frequency not reported). The patient complained of "flu like symptoms, swelling and redness at the injection site". On 02-AUG-2017, the patient visited their primary care physician and was diagnosed with cellulitis, prescribed an unspecified antibiotic. It was not known at this time if the patient had recovered. The outcome of cellulitis was unknown. No further information to provide. The causal relationship between the event and PNEUMOVAX23 was not reported. Product quality complaint (PQC) was not involved. Upon internal review, the event cellulitis was determined as medically significant. This is one of the two patients report received from the same reporter (linked case#1708USA003034).
Patient had petechiae all over the body three weeks after vaccination. Pt was diagnosed as "Idiopathic Thrombocytopenic Purpura" in hospital. Patient's platelet count was between 20,000 to 30,000 for 1 month, checked bone marrow sample, there was no abnormality for producing platelet. On 18Sept2012 patient's primary care doctor suggested Pt's mother to vaccinate patient just one vaccine at a time, to identify if that was from immunization. Hospital will monitor patient's CBC after vaccine.
This case was reported by a physician via call center representative and described the occurrence of pain in arm in a female patient who received BEXSERO (batch number 146101A, expiry date 30th April 2016). On 24th May 2016, the patient received BEXSERO .5 ml. In May 2016, less than a week after receiving BEXSERO, the patient experienced pain in arm. On 24th May 2016, the patient experienced expired vaccine used. On an unknown date, the outcome of the pain in arm and expired vaccine used were unknown. It was unknown if the reporter considered the pain in arm to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. On 24th May 2016, the patient received a dose of BEXSERO, which was already expired on 30th April 2016. At the date of reporting, the patient called the other healthcare professional with complaints of a shooting pain down arm to wrist. No further information was provided regarding the event. At the time of reporting, the other healthcare professional was not feeling comfortable for providing further patient identifying information.
Moderna COVID?19 Vaccine EUA Severe swelling, redness, and itching/burning under eyes less than 2 days later, tiny knots appearing around upper lip, 2 flat red lesions appearing on face,  Has lasted 6 days so far, and does not seem to be getting better.
Redness at and around injection site 6-8cm, itching, erythema, urticaria and induration. Tx'd with Benadryl 25mg 11/6/99-11/9/99, Resolved.
Patient received a re frozen dose of the vaccine; Patient received a re frozen dose of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a re frozen dose of the vaccine) and PRODUCT STORAGE ERROR (Patient received a re frozen dose of the vaccine) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a re frozen dose of the vaccine) and PRODUCT STORAGE ERROR (Patient received a re frozen dose of the vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a re frozen dose of the vaccine) and PRODUCT STORAGE ERROR (Patient received a re frozen dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.; Sender's Comments: This case concerns a 75 year old patient, unknown gender, with no known medical history, who experienced the non-serious events of expired product administered and product storage error. The events occurred  on unknown date after the third dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.
breakthrough of shingles; This case was reported by a other health professional via sales rep and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had a breakthrough of shingles after receiving the first dose of Shingrix vaccine. No further details were provided. This case has been linked with US2019229315, reported by same reporter.
Vesicular 3-4 mm papule on neck with an erythematous base.  Did not progress to pustule.  Probably Dx. erythema multiforme
Information has been received from a physician concerning a 4 year old male who was vaccinated with a single dose of Varivax. Subsequently the patient broke out with chickenpox. Unspecified medical attention was sought. No product quality complaint was involved. The patient's three brothers experienced chickenpox following vaccination with Varivax (WAES# 0606USA01456, 0606USA01457, and 0606USA01458). Additional information has been requested.
The patient got sick every year after getting her flu shot; This spontaneous case was received on 02-Jan-2021 from other non-health professional (consumer) via Unither (reference number: UNT-2020-019368) and concerned a female patient of unknown age.  The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; indication, dose, route of administration and anatomical location: not reported). The batch number was not reported.  On an unknown date, an unknown amount of time after receiving influenza virus vaccine polyvalent, the patient got sick every year.  The outcome of the event of 'sickness' was not reported.  The reporter did not provide a causality assessment.  Company comment: The event of 'sickness' is assessed as unassessable to influenza virus vaccine polyvalent.; Sender's Comments: The event of 'sickness' is assessed as unassessable  to influenza virus vaccine polyvalent.
About a week and a half after the vaccine I suddenly developed high pitched very loud tinnitus in both ears. This persisted until April 5th when I woke up with an extremely loud jet engine sound in the left ear. The hearing had diminished 97% overnight. After tests at ENT specialists I was put on Prednisone and scheduled for an MRI. After taking the course of Prednisone there is no improvement. The hearing loss was experienced on the side that the vaccine was administered. The MRI showed nothing unusual. I continue to have loud tinnitus and no hearing in the left ear.
hypotonic episode 48 hrs p/rcvd vax; drug screen neg; afebrile observed in hosp x 24 hrs;
Injection site red/swollen/golf ball size, very dizzy, feeling "flu like symptoms, poorly, out of it" Dizziness subsided then reappeared 06/18/2012. Patient also reported that about 06/16/2012 he had an increase in night time urinary urgency, he had hourly urination episodes for 3 or 4 nights.  Patient attended his previously scheduled physician visit on 06/21/2012 with his physician. We did email info regarding this incident to Dr. prior to patient's visit with Dr.  Our email to Dr. did not mention the urinary frequency report from patient.
Patient felt dizzy and lightheaded and felt as if he was going to faint.  He laid down on a bed for about an hour but he  still felt like he was going to faint so he was evaluated by EMT and transported to an ER by ambulance
Developed rash all over body 2-3 days post vaccination. Employee instructed to see physician and saw physician 11/11/09.
Extreme Fatigue and Brain Fog / Memory Issues / Tremors have increased / gait problems (have trouble walking in a straight line)
After sitting for about 15 minutes in observation the recipient reported feeling a dull headache on the top of her head. Pt had a special watch on that checked her BP, HR, and oxygen saturation. Recipient reported all was normal. Recipient chatted with observation staff for 15 minutes. BP stable at 130/80 on clinic automated cuff. Headache resolved. No other symptoms developed. Pt reported feeling better. Pt declined EMS evaluation. ED precautions given to recipient who verbalized understanding.
Immediate reaction, within 15 min of vaccination = dizzy, very dry mouth, slight swelling of throat, altered attention level Delayed reaction, starting approximately 3 hr after vaccination = soreness at site of vaccination (upper R arm) extending downward to fingers, and radiating to back and chest; alternating chills and sweating; dizzy and weak feeling; nausea 12-36 hr post vaccination = continued dizzy and nausea; tingling and numbness of R arm; back pain and minor chest pain. Missed work the day after vaccination, able to report to work the following day. Did not seek medical attention as of this writing.