chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered patient 0.3 milliliters of undiluted vaccine. Discovered error approx. 10 mins after administering vaccine by other pharmacist. Told patient of error and requested patient be placed under observation by a healthcare facility. Patient declined. Patient also noted no immediate adverse reactions. I advised patient of possible increased side effects and injection site pain. I gave patient our phone number and told him to call with any questions and to seek emergency care if adverse reactions are severe. Patient has an appointment with his doctor tomorrow and will follow up with them to get an update on adverse reactions if any. Patient was not aware of MD contact information for me to follow-up. I will follow-up with patient daily to get updates on his status.
This spontaneous report has been received from a Registered Nurse concerning an unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. Some doses of VAQTA, (Lot # L007559, exp. date 01-JUN-2017), (strength, route of administration and dose were not provided), which were exposed to temperatures outside of the recommended range, have been administered to unspecified patients on unspecified dates since 28-AUG-2015. No adverse experience had been reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Woke at 3am with severe body aches, headache, fever of 101.3 and nausea. Symptoms persisted throughout the day with max temp of 103. Also had swelling at injection site with redness the size of a baseball and extreme tenderness to upper arm.
Headache, Fever, Diarrhea, temp 99.0 very achey, sweating
This spontaneous report was received from a health care professional refers to a multiple unspecified patients of unknown demographics. On an unknown date the patient was vaccinated with VARIVAX (Merck) (lot # K009756; 09-JUL-2016) (dose, route and frequency unspecified). No concomitant medications were reported. The primary reporter states that on multiple unspecified dates, multiple unspecified patients were administered improperly stored VARIVAX (Merck). No adverse effects reported. The outcome of medication error was unknown. Additional information has been requested.
Sore, red, swollen at injection site; 2 inch radius. Swollen glands under left arm, fever, body aches, headache, fatigue, with muscle and bone pain.
Swelling at injection site (approx 2.5 inches across); redness; muscle pain; tenderness; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 26Feb2021 at 13:30 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included tocopherol (VITAMIN E), probiotics (MANUFACTURER UNKNOWN) and multivitamins (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 05Feb2021 at 09:45 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. On 27Feb2021 at 10:00, the patient experienced swelling at injection site (approximately 2.5 inches across), redness, muscle paint and tenderness. 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 adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swelling at injection site, redness, muscle pain and tenderness were recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Two days post vax the pt developed an injection site reaction at the Pnu-Imune 23 site described as "a large red wheal 3 inches in diameter that became sore radiating down to the elbow." Note: This is 1 of 2 pts reported by the same reporter. See HQ6352724JAN2001 for the report on the other pt.
I had the shot done at 11 o?clock in the morning. I had no side effects until around 6 PM that evening. My left arm was in severe pain. I couldn?t even lift it to my shoulder. It was the worst pain I have ever had in my entire life. I couldn?t lift my arm to even wash my hair or brush my teeth. I did some research and found out that the injection was given not in my muscle but in the bursa. According to my research I had an inflammatory effect from the vaccine administration to the subdeltoid bursa instead of the muscle. The severe pain lasted at least four days and I still have pain if I sleep on that arm incorrectly or if I try and use it for extended periods of time. I had no other ill effects from the vaccine.
This spontaneous report was received from a physician via a company representative refers to 3 unspecified patients of unknown demographics. On an unknown date the patient was vaccinated with ZOSTAVAX refrigerated subcutaneous injection. No concomitant therapies were reported. Approximately on an unknown date in 2012 (also reported as within the past two years) the patient experienced shingles. The physician reported to the representative that three anonymous patients experienced shingles while using ZOSTAVAX, within the past two years. No demographics were provided for the patient. Unspecified treatment was provided. The outcome of shingles was reported as recovered/resolved on an unknown date. There was no product quality complaint (PQC) involved. Patient sought medical attention and visited doctor. Causality assessment was not provided. Additional information is not expected.
SWOLLEN AXILLARY LYMPH NODE IN RIGHT ARM WHERE INJECTION WAS GIVEN
PATIENT COMPLAINED OF BIG RED SORE SPOT THAT FELT VERY HOT. SHE ALSO HAD FLU-LIKE SYMPTOMS (FEVER, WEAKNESS, MALAISE).
Red, swollen, line going down, very warm. MD said maybe some type of infection. Pt was given clindamycin.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and skin discomfort. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and skin discomfort were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles and skin discomfort to be related to Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient was vaccinated with Shingles vaccine and still had them. The patient still felt like he/she had a live wire running through his/her skin. The patient stated that it was terrible and could lasted forever. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided. The follow-up could not be possible as no contact details were available.
Sore rt arm and difficulty raising arm because of pain.  Fever.  Tmax 102.
This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown demographics. On an unknown date the patients were vaccinated with PNEUMOVAX23 (dosing regimen unsecured). No concomitant medications were reported. Approximately on an unknown date in 2014 it was reported that an unspecified number of patients were administered doses of PNEUMOVAX23 on unspecified dates that were improperly stored since 20-AUG-2014. No adverse events were reported. The outcome of improper stored  vaccine were administered to unspecified number of patients is unknown. There was no product quality complaint involved. Additional information has been requested.
Swollen L clavicular lymph node 3 x 2 cm; This is a spontaneous report from a contactable healthcare professional (patient). A 20-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685; Expiration date was not reported) on 28Dec2020 (08:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included asthma; allergies with raw fruits and vegetables; allergies with almonds; and allergies with shellfish. Concomitant medications included venlafaxine; and ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN). On 03Jan2021, the patient had swollen left clavicular lymph node (3x2 cm). The adverse event resulted in doctor/healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. COVID test was negative on 01Jan2021. The outcome of the event, swollen left clavicular lymph node (3x2 cm), was recovering.
Patient received 2nd Shingrix dose today.  Within 1 minute of administration, patient became dizzy and sat on the chair and eventually sat on the floor and laid on the floor of the immunization room.  She was conscious the whole time and had a conversation with me.  She refused 911.  She felt dizzy.  So I stayed in the room to keep her company and to make sure she was doing ok.  As were were talking, she stated that she didn't eat much during lunch and that was at 11AM and had a lot of stress today.  We are not entirely sure what caused it, it could have been the vaccine or the stress and not eating since 11AM.  She came outside of the IMZ room to try to check her blood pressure but was dizzy again so she came back to IMZ room to rest.  Then she ate some food and had juice and felt better.  By then her husband arrived.  She checked her blood pressure before leaving at the machine and it was ok.  She will follow up with PCP.  She hasn't gone yet but stated she will see PCP.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13 (lot number and expiry date unknown), intramuscular at single dose. The patient medical history and concomitant medications were not reported. The patient experienced injection site cellulitis/cellulitis at injection site and fever on an unspecified date with outcome of unknown.
sick so many times; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case is linked to cases 2020SA294157, 2020SA294158, 2020SA294166, 2020SA294144, 2020SA294173 and 2020SA294145 (same reporter).  This case involves a patient of unknown demographics who got sick so many times (illness), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick so many times (illness) (non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  On an unknown date, the patient was recovered from the event.  There will be no information on the batch number for this case.
Patient has a history of a febrile seizure at 10 months old. Developed fever for 9 days after MMR. Had a prolonged seizure with apnea. Was demonstrating decerebrate posturing following posticital phase.
SHE DEVELOPED A GENERALIZED TONIC-CLONIC SEIZURE THAT EVENING AROUND 7 PM.  SHE WAS TAKEN TO ER BY AMBULANCE.  CT SCAN WAS NEGATIVE.
Day after injection- diarrhea for two days and sore arm. Five days after injection left arm so sore I couldn't use it. Prescribed Motrin 600. Pain gone in two days.
PLAQUE PSORIASIS FLARE UP/SKIN BROKE OUT WITH PSORIASIS; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (PLAQUE PSORIASIS FLARE UP/SKIN BROKE OUT WITH PSORIASIS) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    NO KNOWN ALLERGIES.  Concurrent medical conditions included Plaque psoriasis.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In November 2021, the patient experienced PSORIASIS (PLAQUE PSORIASIS FLARE UP/SKIN BROKE OUT WITH PSORIASIS). At the time of the report, PSORIASIS (PLAQUE PSORIASIS FLARE UP/SKIN BROKE OUT WITH PSORIASIS) had resolved.            No relevant concomitant medications were reported.  The reporter's causality for the event of plaque psoriasis flare up/skin broke out with psoriasis with humira(adalimumab) was a reasonable possibility.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Primary reporter did not have the lot number information, because the packaging was discarded.   No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2022: Significant follow up received included event verbatim updated, narrative updated.
Localized site reaction with swelling and redness; a nodule present at 4 month well child (2 months later); Localized site reaction with swelling and redness; Localized site reaction with swelling and redness; This case was retrieved during monitoring on 12-APR-2023 with the following Primary ID 2598701-1. The original narrative from the sender is as follows:  Localized site reaction with swelling and redness, improved over time but still has a nodule present at 4 month well child (2 months later).  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Localized site reaction with swelling and redness, and a nodule present at 4 months well child (2 months later)".  No further information is expected.
fever started w/in 12hrs of vax-t102-103 x 7 days;mom states pt was listless, fussy & sleepy for 4-5days;APAP was given but fever would shoot up again when next dose was due;pt now has neurological delays;
Immunizing technician did not dilute pediatric pfizer vaccine vial and administered the undluted vaccine to the patient. Patient's mom was contacted when pharmacy found the event and was informed about the possible side effects/risks. Patient has no adverse reactions.
Full-body, itchy rash that presents in raised welts and hives, especially when skin is touched. The rash flares up and then vanishes within 30 minutes to an hour. Zyrtec and Pepcid relieve the itch, but does not stop the rash from flaring up. Doctor-prescribed Prednisone did not help. Rash is still flaring up a month after first incident.
Right after 2nd dose the next day around the  afternoon , I had about 101 fever and I was just very tired and had almost like flu like symptoms that lasted 24-36 hours. Most of it was fatigue, some soreness, fever, for about 24 hours. I didn't seek any medical care because I did anticipate some type of reaction. It lasted around 24-36 hours at the most. The next day I no longer had a fever.
pt recv vax; devel grouped vesicles that were painful on dorsal surface of rt upper extremity & extended down to arm;dx of herpes zoster by PED
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 2016, the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving ZOSTAVAX, the patient suffered hearing and vision loss.  As a direct and proximate result of ZOSTVAX, the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of 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 were not resolved. Causality assessment was related. Hearing and vision loss were considered disabling. Upon internal review, hearing and vision loss were considered to be medically significant. Additional information has been requested.
On May 19, 2022 when I got back from a vacation, I started feeling like I had allergies. I also had a scratchy throat. On May 22nd, I tested positive for covid. It felt like I had a mild cold. I went to the ER on May 23rd because my heart rate dropped really low. My vitals were okay. The doctor reduced my Metoprolol medication from 50mg 2xday to 25mg 2xday. My covid symptoms feel worse today.
Hypertension-Lotrel 5/10mg to maintain my blood pressure, I have a 10% VA compensation; weight gain. I increase dramatically in weight a total of 75 pounds; chills, I suffered of spontaneous chills for an undetermined lapse of time; allergies, I started suffering of allergies and was medicated in the hospital; headaches, I suffer of headaches almost everyday; heart murmur, During various examinations this was dx'd.; liver abnormal, I was dx'd with cytomegalovirus. I received 3 more shots of Anthrax on the following dates: 4/1/03, 5/24/02, 1/23/04. They were all administered by military facilities during my military service. I have a 10% VA compensation.
5 minutes after the Covid 19 Vaccine was given, the patient started to have reactions. Patient started shivering, break into hive, sweating, nausea and vomiting, and also very pale. Ambulance was called after the reaction started. When they arrived, they checked blood pressure/heart rate and both were very high. After the examination, patient was released. Patient was okay to leave with his mother without being transported to hospital.
This spontaneous report was received from a Registered nurse regarding a 16 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Chills, woken up with uncontrolled shivering at 3 AM that lasted for 20 minutes. Difficulty ambulating or controlling movements during shivering. Took ibuprofen 800mg. After shivering, returned to sleep. Woke up with excessive sweating wetting the bed sheets. Felt "under the weather" and sore for another 24-36 hours.
Vaccine was kept in refrigerator on 22-Sep-2021 and administrated on 18-Nov-2021; expired dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was kept in refrigerator on 22-Sep-2021 and administrated on 18-Nov-2021) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was kept in refrigerator on 22-Sep-2021 and administrated on 18-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was kept in refrigerator on 22-Sep-2021 and administrated on 18-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment information was provided.  No adverse event was reported. The vial had not undergone any temperature excursion issue. The vial was initially placed in the refrigerator on 22-Sep-2021. Many doses were administered from expired lots due to confusion with the expiration date printed in the carton.
Varicella vaccine was administered 12/30/2020 and within 24 hours of vaccine patient started dragging left leg and favoring the right side. Prior to vaccination patient was able to crawl and walk a few steps without having to drag the left leg.
pt recvd DTP/HBOC/OPV on 5NOV92; exp no local or systemic reactions; pt found dead 4 days later 9NOV92; pronounced dead on arrival in ER: No known risk factors for SIDS; tentative dx SIDS;
It wasnt immediately, but that evening the arm was very sore, and a large swollen red area appeared. Lasted for about 6 days, put aloe vera on it, but did not seek additional medical attention.
Given Varicella vaccine on 9/27/02. Vesicles noted on back and right ankle on 10/11/02. Also erythema at injection site.
I am experiencing hot flashes, cold shivers, fever, full-body muscle soreness, headache, and vomiting. Vomiting only happened once during a really bad hot flash.   Onset of event was roughly 12 hours after receiving second dose, and has continued through for almost 48+ hours on and off.
50 YEAR OLD MALE FELT NAUSEAUS AND DIAPHORETIC AFTER RECEIVING TODAYS DOSE. ON SITE EMS RESPONDED AND VITALS ARE BELOW.  HE WAS MONITORED, FELT BETTER AND RELEASED TO HOME
Persistant, unconsolable crying for 8 hrs. Fever (unmeasured). Bulging anterior fontanel. Swelling, tenderness throughout rt thigh.