chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-MAY-2012, the patient was inoculated by a pharmacist with the ZOSTAVAX (lot number, dosage and route of administration not provided) to obtain permanent prevention and protection against shingles and zoster related injuries. On or about 22-DEC-2014, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Myalgia fatigue, shortness of air, chills Narrative:  Presented to EOH 4 hrs after vaccination with body aches, fatigue and SOA, developed chills, shaking and sore arm later; no fever; (-) COVID test. Symptoms continued, but resolved in 96 hrs.
Watery diarrhea; Fatigue; Malaise; Nausea; Vomiting; Arm soreness; Headache; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 03Apr2021 at 08:30 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on 21Dec2020, hypertension (HTN) and hyperlipidemia. The patient did not have allergies to medications, food, or other products. Concomitant medications were not reported. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination On 04Apr2021 at 08:00, the patient experienced watery diarrhea, fatigue, malaise, nausea, vomiting, arm soreness and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. The patient did not receive any treatment for the events. The clinical outcome of the events watery diarrhea, fatigue, malaise, nausea, vomiting, arm soreness and headache was recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Approximately 4-5 diameter hot erythematous reaction on left deltoid-Benadryl 2 tsps every 4-6 hrs for reaction prescribed.
Received the flu shot on 10/23/20. Had localized irritation at the time of injection (redness, some muscle pain, bleeding). The muscle pain / pain at site of injection lasted for approximately 24- 36 hours. When bandaid was removed, was able to see puncture site. approximately 4 days later began having itching at the site and sloughing of skin accompanied with redness. Skin would continue sloughing until tissue was "raw", at which time the skin would then begin to form a scab. After a few days this area would be completely scabbed over. After a few days the scab fell off and the process would repeat. This has occurred approximately 3 times by this time point. The area appears to be scarring at this time, however, it is still giving the sensation of itching so it is believed the cycle will occur again
Developed pain in left shoulder impacting range of motion.  Initial consideration was bursitis.  In March rec'd diagnosis of adhesive capsulitis.  Currently taking Ibuprofen.  Scheduled for cortisone injection on 4/11 with physical therapy to begin in May.
Patient fainted ~30 seconds after administration of vaccine. Also, the patient appeared to have some sort of muscle spasm/seizures. 911 was called and the paramedics came and took the patient to the hospital.
Mother stated she started seeing pimples at injection site 1/28/07, pt noted to have induration around injection site, mom states pt appetite has not been as it usually is. No distress to pt.
Fever, chills, headache, bodyache, exhaustion, injection site inflamed and swollen. Last approx 48 hours.
Swollen lymph nodes under (R) arm, inner (R) arm redness + redness on side of (R) breast. Fatigue and headache. I still have redness in those areas and under arm in painful. Joint pain I had milder case after 1st booster
Received MMR vaccine at 3:31 PM. Parents brought pt back to office within 15 minutes. Pt. had hives and itchiness. Gave BENADRYL, EPINEPHINE, XOPENEX nebulizer treatment and sent to ER by ambulance.
Client called hospital on 9/17/08, States still has a bump size of penny where received MMR vaccine on 9/5/08. States was red x 1 day and and noticed swelling. States swelling x 2 days but still bas bump which has decreased in size. Denies fever.
This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown gender who would be 16 months old. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M023384 and expiration date on 20-JUL-2018 of lot # M033906 with expiration date on 06-JUN-2019 (dose and route of administration were not reported) for prophylaxis. The reporter could not provide details of which lot number the patient received. The doses of VARIVAX were exposed to a temperature excursion of 14.9 degrees Fahrenheit (°F) during a time frame of 11 hours, which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported. This is one of the several reports received from the same source.; Sender's Comments: US-009507513-1710USA008686: US-009507513-1710USA008693: US-009507513-1710USA008688: US-009507513-1710USA008689: US-009507513-1710USA008690: US-009507513-1710USA008691: US-009507513-1710USA008692: US-009507513-1710USA008685: US-009507513-1710USA008684: US-009507513-1710USA001141:
After getting vaccine, patient was standing and fainted and was unconscious for a few seconds. Mom was next to him holding him, pharmacy staff called 911, patient awoke and was sweaty, nauseous, pale, dizzy. Sat up and began to feel normal in a couple minutes. The paramedics did come just to check him out and after checking pulse and talking with patient, everything seemed normal but they went out to ambulance to run EKG just to make sure no abnormalities were detected.
On 10/27/2009 Dr. reported to me (pharmacist) that his patient had a low grade fever, mild cellulitis in most of the right arm; redness in the injection site.
After the second dose of the vaccine I had two side effects:  - nausea  - peripheral neuropathy in my feet (feeling of permanent cold and tingling)   I didn't have these side effects prior to the vaccination.   As of today, 3/30/2021 nausea subsided, but I still have problems with peripheral neuropathy. I am a physician and tried to manage it on my own, as I do not believe that any PCP or Internal Medicine would help.
Information has been received from a health care professional concerning a patient with a history of slight immunocomprimise who was vaccinated with a dose of MMR II. Subsequently "a couple of weeks ago" in March 2007 the patient developed measles. The patient was administered immunoglobulin. The patient's present status was unknown. There was no product quality complaint involved. Additional information has been requested.
FLUZONE was administered to two patients, with no reported adverse event; exposed to 15.8F for 30 minutes, with no reported adverse event; Initial information received on 23-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 years old male patient and it was reported influenza quadrival A-B vaccine [Fluzone quadrivalent] was exposed to 15.8f for 30 minutes and fluzone was administered to two patients, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitants and family history were not provided.  On 01-Mar-2023, influenza quadrival A-B vaccine [Fluzone quadrivalent] suspension for injection (batch/lot number: UT7683NA and expiry date: 30-Jun-2023; Strength = standard; Frequency once) exposed to 15.8f for 30 minutes, with no reported adverse event (product storage error) (latency: unknown).  On 17-Mar-2023, 0.5 mL of suspect influenza quadrival A-B vaccine [Fluzone quadrivalent] was administered to two patients via intramuscular route in the deltoid NOS for immunization (poor quality product administered) (latency: same day).  Action taken: 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.; Sender's Comments:  01545413: 01545335:
This spontaneous report as received from a physician refers to a 63 year old female patient. On 23-OCT-2013 the patient was vaccinated with dose 2 of PNEUMOVAX23 (lot # J006242, 0.5 ml). The reporter reported patient was administered PNEUMOVAX23 which was less than 5 years after administration of first dose, dated 01-DEC-2013. Patient was experiencing severe localized reaction, which began sometime during the evening of injections on 23-OCT-2013, involving swelling, redness and pain surrounding the injection site. The patient sought medical attention from the physician and got no treatment. The outcome of the adverse events was reported as not recovered.  Additional information has been requested.
The shot area is swollen to the size of a tennis ball, and it is feverish, red, swollen, it itches, and it hurts.
Watery (R) eye/abdominal pain syncope about 10 min after immunization
Bilateral facial/eye swelling; hives from scalp to tip of toes, hives on Fupa & lips, hives/welts worse on chest, bilateral arms, neck & back, left sided headache from behind eye to base of neck
From telephone contact received on 03/19/02 at 1pm, it was reported that a 31 year old male received a dose of Yellow Fever vaccine. Patient developed immediate rash at injection site. It grew from small, red area then extended from shoulder to elbow, area red and warm. A half inch wheal noted at injection site, no signs and symptoms of respiratory distress but patient felt a lump in his throat. No known allergies except hayfever. Patient had prior Yellow Fever Vaccine 10 years ago with no significant reactions. He is in the military and returned to the health clinic approximately 45 minutes after receipt of dose. He was observed and instructed to take Benadryl, then referred to his private MD. His blood pressure went up to 140/110from prior reading at the clinic (reading not known). Patient will be moving at the end of this month. He is scheduled to see an allergist on 03/27/02 to follow-up due to his need for future doses of Yellow Fever Vaccine. Patient also received Typhim Vi and Tetanus  vaccine in the left arm and PPD in the left forearm on 02/10/02.
syncope began about 1 minute post vaccination, lasted a few seconds, paramedics called due to patient hitting head on floor
couple of places, rash formed; feeling cruddy; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash and feeling unwell. On an unknown date, the outcome of the rash and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the rash and feeling unwell to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR083958   Additional Information: GSK Receipt Date: 21-May-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The Shingles vaccine had a pretty high rate of side effects.  The patient had a few hours of feeling cruddy with the first dose and a couple of places where a rash formed. Additional Supportive Information: For tolerance of 2nd dose of Shingles vaccine, refer linked case US2022AMR083958, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR083958:Same reporter
Soreness in right shoulder did not dissipate, has since become painful to move and lift or reach for items. Also range of motion has been significantly impaired. Attended physical therapy sessions with little to no improvement. Referral has been made to an orthopedic doctor.
It feels like I had pulled a muscle and noticed pain in movement and lack of strength.; Pain in arm; It feels like I had pulled a muscle and noticed pain in movement and lack of strength.; It feels like I had pulled a muscle and noticed pain in movement and lack of strength.; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7533), via an unspecified route of administration in the left arm on 23Mar2021 at 18:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications of the patient included atorvastatin (MANUFACTURER UNKNOWN) 20 mg and acetylsalicylic acid (ASPIRIN) low dose for unknown indication from an unknown date. The patient did not have allergies to food, medications, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021, the patient experienced pain in arm, loss of strength, pulled muscle, pain upon movement. The patient reported pain in the left arm which persisted until the day. It felt like he had pulled a muscle and noticed pain in movement and lack of strength and felt like someone had repeatedly punched his upper arm. The pain was persisted for 6 days so far. The patient did not receive treatment for the reported events.  The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain in arm, loss of strength, pulled muscle, pain upon movement was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
Nausea and throwing up. Migraine. Body aches(sore arm). Fever 102.4 at peak. Swollen lymph node on same side as injection. Swollen arm.
Deltoid swelling and erythema 14.5 cm x 15.5 cm.
Diagnosed with Squamous cell carcinoma of right tonsil HPV positive Symptoms. the feeling of gum irritation and loose teeth Signs: bleeding from throat,  Treatment: ongoing
having a bruise now for over a week or so; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Jun-2021 and was forwarded to Moderna on 09-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (having a bruise now for over a week or so) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONTUSION (having a bruise now for over a week or so). At the time of the report, CONTUSION (having a bruise now for over a week or so) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported
Information has been received from a nurse referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with the first dose of GARDASIL 9 injection (dose, lot # and route were not reported). On an unknown date, the patient was inadvertently administered a dose of GARDASIL (dose, lot # and route were not reported) instead of an intended second dose of GARDASIL 9. No adverse effect was reported. No product confusion was reported. Additional information has been requested.
patient given mishandled dose / punctured vial in the refrigerator for 22 hours.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient given mishandled dose / punctured vial in the refrigerator for 22 hours.) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient given mishandled dose / punctured vial in the refrigerator for 22 hours.). On 13-Jul-2021, EXPIRED PRODUCT ADMINISTERED (patient given mishandled dose / punctured vial in the refrigerator for 22 hours.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not provided.  Treatment information not provided.
This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age. It was reported that doses of ROTATEQ that were exposed to temperatures out of range on 02-JUN-2014 were administered to an unspecified number of unspecified patients on unspecified dates (approximately in June 2014). No other concomitant therapies reported. The temperature excursion was supported. No adverse effect has been observed or reported. The outcome of the events was unknown. No PQC reported. The case has been linked with cases (same reporter link) # 1406USA012405, 1406USA12409 and 1406USA011663.
diarrhea; She woke up this morning and fell asleep for more 4 hours; her heart was palpitating; staggering all over the house; getting really dizzy while lying down; A spontaneous report was received from a consumer concerning a 62-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events getting really dizzy while lying down, had a lot of diarrhea, staggering all over the house, her heart was palpitating, she woke up this morning and fell asleep for more 4 hours.  The patient's medical history was not provided. Concomitant medications reported were Progesterone, estradiol patch, gabapentin 400mg, ibuprofen, vitamin D 500mg or 1000mg for drug use for unknown indication.  On 12 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 015M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) getting really dizzy while lying down. had a lot of diarrhea, staggering all over the house, her heart was palpitating, she woke up this morning and fell asleep for more 4 hours.  Treatment details included None.  Action taken with mRNA-1273 in response to the events were not applicable.  The outcome of event(s), getting really dizzy while lying down, had a lot of diarrhea,staggering all over the house,her heart was palpitating,she woke up this morning and fell asleep for more 4 hours was unknown.
Patient reported to pharmacy to tell the pharmacist he had been having some pain in his chest (pectoral muscle) and armpit radiating to his back. He explained that he has lung issues from an injury he received as a younger man so he thought it may have been associated with that. I asked him if the pain felt muscular or internal/visceral, he said it felt muscular and noted that it really started after doing his 40 push ups for the morning, but that it has been 2 weeks since his second dose of Moderna covid-19 vaccine. I advised him to try acetaminophen for the pain and to reach out to his doctor if it does not get any better or if it worsens.
Four days following vaccination, around 11:00 am while I work I developed a severe headache. Following lunch I took an Advil, which did not relieve the pain. I began feeling faint around 1:30pm and went to lie down. While lying down, I began to experience uncontrollable full body convulsions while still in a state of partial consciousness. This episode of full-body convulsions was reported to me to have lasted about 15 minutes. Following this episode I returned to normal, with even the headache gone. The next day, I woke up with a severe migraine that lasted for 11 hours, causing nausea and vomiting. I have never had such a severe and long migraine.
Info has been received from an RN concerning a 10 year old male who on 9/1/98 was vaccinated with a dose of varicella virus vaccine live (lot 626961/0848H). The RN reported that on approximately 11/15/05, the pt developed breakthrough chickenpox characterized by about 60 lesions and a fever of 101.9F. Unspecified medical attention was sought. In 11/05, the pt's chickenpox resolved. No further info is available.
Patient reports she developed a fever and a headache in the evening after receiving the Tdap (8/29/18). She stated the headache and fever were worse the next day (8/30/18). When she was seen in the clinic her temperature was 101.3F. Recommended patient take Tylenol for her symptoms.
I received the 1st round of Gardasil July 7, 2008. Towards the end of August 2009 a lesion formed on my tongue. I have been diagnosed with Oral Cancer. I have had 2 surgeries and will be completing Radiation and Chemo. 8/20/09 GYN medical records received. Annual GYN Exam.   8/20/09 GYN medical records received. Annual GYN Exam.   9/8/09 Head & Neck Clinic consultation records DOS 12/19/08 to 8/14/09 Assessment: Recurrent T2N2cM0 Squamous Cell Carcinoma of the left lateral oral tongue with extracapsular spread. Patient presented with a sore area on her tongue which was persistant and progressed. Intraoral partial glossectomy, modified neck dissection. T2N1M0 squamous cell carcinoma. Left and right sided neck mass. Left parotidectomy and bilateral neck dissections.