chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pneumonia; vertigo optic neuritis; ischemic optic neuropathy; OTITIS MEDIA; acute labyrinthitis; acute sinusitis; acute bronchitis; nuclear sclerosis; vertigo optic neuritis; 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. On or around August 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine), the patient suffered various injuries, including, but not limited to, a lung infection, hearing problems, vision problems, loss of balance and weakness. As a result of the zoster vaccine live (ZOSTAVAX) vaccine, the patient was diagnosed with otitis media, acute labyrinthitis, acute sinusitis, acute bronchitis, pneumonia, vertigo optic neuritis, nuclear sclerosis, and ischemic optic neuropathy. The patient had undergone extensive medical treatment and suffered from blindness in his left eye. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of all the events was considered not recovered/not resolved. The reporter considered all the events were related to zoster vaccine live (ZOSTAVAX).  The reporter considered all the events to be disability.   Upon internal review, pneumonia, optic neuritis and optic ischaemic neuropathy were considered to be medically significant.
Redness and swelling of entire (R) thigh, Tx with BENADRYL and TYLENOL; increased warmth of extremity.
This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored VAQTA (dose, lot # and route of administration were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
patient had injection site pain/redness/swelling during observation period after injection.  patient observed with no other symptoms occuring.
shoulder pain; soft tissue cyst; This case was reported by a other health professional via call center representative and described the occurrence of shoulder pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced shoulder pain and cyst. On an unknown date, the outcome of the shoulder pain and cyst were unknown.   It was unknown if the reporter considered the shoulder pain and cyst to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-MAY-2022 Reporter's Comments:  The reporter reported that in August 2020 administered the 1st Shingrix vaccine to patient. The reporter called patient after the 2 months waiting period to schedule the 2nd dose and was informed that patient was not going to take it due to having significant shoulder pain. The reporter received a legal notice on 23rd May 2022 that the patient had less than 2 years after vaccination developed a soft tissue cyst that had to be surgically removed. The reporter asked was this a problem that had previously noted with this product.
R Arm became painful, tender to touch, red, warm and swollen. Was treated with ice, Benadryl and hydrocodone. Pain and tenderness lasted 2 days, redness and swelling lasted another 4 days.
RIGHT THIGH CELLULITIS WITH ERYTHEMA, SWELLING, WARMTH, & TENDER TO PALPATION DOUBLING IN SIZE OVER 24 HOURS MEASURING 14 X 11 CM.
She had chills and started with 2 bumps on face and then a high fever of 104F for 2 weeks. She had 2 spots on her body. She started to have a nonproductive cough and was not sleeping well. Then was put in the hospital, given IV fluid hydration secondary to poor oral intake and the doctor did all kinds of test and then I was told it was an allergic reaction to Hep-B shot and was given Tylenol and Advil every 3 hours (alternately). Not completely recovered yet. Had erythema nodosum caused by the fever of 104F. She also had shoddy adenopathy of less than .5cm in size to 3.5cm in size. These are palpable subcutaneous appearing nodules. She had also been pale and lethargic before hospitalization.     Per doc 205739, still has not been dismissed.
Not sick but stomach feels kind of queasy real lump in the throat she could get sick; queasiness seems like unusual; Not sick but stomach feels kind of queasy real lump in the throat she could get sick; queasiness seems like unusual; arm hurt; Head just kind of off as she put it and she did fall; Her arm hurt she thinks where she fell; Light-headed; Didn't sleep well and had horrible dreams; Didn't sleep well and had horrible dreams; This is a spontaneous report from a contactable consumer. A 93-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 08Jan2021 at unknown age at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient got the COVID vaccine on Friday (08Jan2021) and in the middle of the night like Friday night it's like Saturday morning (Jan2021), she got up because of the bathroom with very light headed and almost fell and she was able to get up and she got back to bed and they didn't need to anything emergency but she was very light headed and her head was just kind of off as she put it and she did fall, and now this was Tuesday on 12Jan2021 and didn't know if it related, she said she didn't sleep well and she had all these horrible dreams in Jan2021 and then this morning on 12Jan2021 well her arm hurt, she thought where she fell and the other thing, she said her stomach she had not got sick but her stomach felt real kind of queasy and kind of real lump in the throat like she could get sick but she had not, and so they were assuming that this was all related to vaccine but the fact was this queasiness she didn't get till today on 12Jan2021 seem like little unusual. The only question was if these were actual symptoms, side effects from the vaccine should she got the second shot (vaccine). The outcome of the events was unknown.   Information on lot/batch number has been requested.
Approximately 24 hours after the vaccination, patient reported chills, fever up to 102 degrees F, severe headache and muscle aches and muscle weakness. 2 episodes of diarrhea.  This lasted approximately 5 days with resolution.
The patient states she received vaccine at 8:30am and we she got home she had some swelling as the day moved on she had a Red Line about finger width all around her arm just below vaccine site.  Throughout the day she said she was fine but her swelling  extended from her arm up to her neck by 6:30 pm that day. She went to the emergency room and received pepcid AC and benadryl. She states she had already taken some benadryl.  She says she stayed at hospital for 2 and 1/2 hours then was sent home with a prescription for Prednisone. She says she did get dizzy and lightheaded but that passed and she did not have any discomfort only swelling on her arm. She says she is fine now but did want for someone to report her occurence. She states she had Prevnar vaccine last year with issues. Her flu vaccines have always been ok.
Kinrix to a 19 month old patient; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 19-month-old male patient who received DTPa-IPV (Kinrix) (batch number PP9L5, expiry date 16th October 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th August 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 10th August 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The nurse reported that another nurse assistant administered Kinrix to a 19 month old patient, which led to inappropriate age at vaccine administration. This case was linked with US2020AMR130607, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR130607:same reporter
on 9/2/2021, day after shot, patient presented to ER with  --   left fascial droop, mild left weakness of the upper and lower extremities and dysarthria, and found to have  Right basal ganglia/cenrum semiovale acute infarct likely from small vessel vs embolic disease
2 weeks after receiving 1st dose in May 2021, my hair started shedding. After 2nd dose hair loss increased. Saw Dermatologist in Sept and we did steroid injections for 5 months, no improvements. Saw primary care doctor, did a ton of lab work, nothing abnormal. Caught covid in Jan 2022 and was sick for 3 weeks. Saw a Rheumatologist, nothing he could do for me. Saw a different Derm, started oral steroids. They made me sick, discontinued treatment. Now with Immunologist/Derm at Clinic. She had me do more labs. All normal. Wants to start me on Xeljanz (an inhibitor) but I am concerned about all the side effects. I have had total body hair loss as of June 2022. I am now Alopecia Univeralis.
Client reported Lymphadenopathy on the Left side of his neck along with having a sore throat, and ear pain. These signs and symptoms started approximately 10-12 hours after receiving the vaccine.
Left arm - pain in left arm all the way down to elbow. Muscles hurt, raised, red patches. Warm to the touch. Wheezing started yesterday afternoon.
Was overly sleepy, not as alert, sucking issues (started to take the paci less and less milk via breast and pumped bottles). Started to consume 40% less ounces, drink one or two ounces than scream in pain. Feeds were exhausting.  Feedings declined and screamed in pain randomly. Reflux diagnosis at the same clinic on 2/7/2011. Reflux meds worked shortly. Had reflux issues for 2 to 4 months following vaccination. On 2/21/2011 baby had little rash on back, and seemed ill, went to emergency room to receive viral infection diagnosis, no treatment. On and off colds for 2 months post vaccination. Has not been vaccinated since, once recovered, no further adverse events.
w/in 2hr of vax pt had an asthma attack followed by 6 days of flu-like illness (joint pain, redness & swelling & diarrhea);joint pain did not resolve, nor did bowel sx;also exp fatigue;
Patient called pharmacy at 6:50 complaining of her arm swelling and itching.  She mentioned the size between a golf ball and tennis ball.    The pharmacist recommended she see a physician.   This was the only sympton mentioned no swelling of face hands or tongue.   The pharmacist called back to her house with number on file to check and she has not answered the phone.  called at 7  and 8 pm on 6/17/2019 and call at 9 AM on 6/18/2019.
Hives on breasts, under breasts, stomach, chest, lower stomach, on back, under both arms. Went to Urgent Care, Sunday 01/31/2021 and was prescribed Predisone. Was also told to take Benadryl for the itch
In evening of the day the pt was given immunization,the pt had T of 104.8-had szs.Was taken to ER 7 days later T again-went up to 104.8-developed a rash. Was taken to MD who did blood test & mom was told the pt had measles.
pt devel flu-like sx w/in 24-48 hrs of receiving Engerix;
08/11/2011 Moderate, Other. Presyncope, lightheaded, dizzy, nauseous.
I had my Moderna booster on 11/19. 12/2 Noticed some itchiness around my neck in the morning but resolved on it?s own. 12/3 My palms became extremely itchy throughout the entire day so started using OTC hydrocortisone cream. 12/4 Broke out in hives on my forearms and it spread to my stomach and upper thigh area, so took Benadryl. Since then the hives have spread to my neck, chest, back, shoulders, hips, behind the knees, & calves. The hives come and go several times a day, just popping up in random areas. Continued to use the hydrocortisone cream during the day and Benadryl at night. I cannot think of anything I ate or any changes to what I use that would cause this, so I thought it was just from stress. 12/9 Took Claritin-D while at work for break out of hives on by back but it did not seem to help much, at home tried using cold compress on my back which seemed to improve the itchiness.  12/13 took Zyrtec instead to see if this helps prevent further hives this week.
Intense intermittent itching and redness, mainly on tops of feet and occasionally on wrists and arms. On 7th day, hives with raised red bumps and welts and intense burning itch appeared on lower legs. These gradually spread to upper legs and abdomen over several hours. After taking OTC antihistamine, itching subsided. Rash was gone the following day.
Admit from emergency center for fatigues, diarrhea for 2 days, bloating, nausea w/o vomited 2-3 days after vaccination. discharged in stable condition on 9/3
Pt said bumps under his arm shortly after the shot -- pt came in for medication to treat the bumps today (8 days after the vaccination)
Dizzy; sometime like unsteady; headache on the left side of my head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10May2021 (Lot number: EW0153) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic kidney disease" (ongoing); "pulmonary embolism" (unspecified if ongoing); "blood clots" (unspecified if ongoing); "Immune compromised" (ongoing). Concomitant medication(s) included: IMURAN [AZATHIOPRINE] (ongoing); PREDNISONE (ongoing); COUMADIN taken for anticoagulant therapy; WARFARIN taken for anticoagulant therapy. The following information was reported: DIZZINESS (non-serious) with onset 11May2021 04:00, outcome "not recovered", described as "Dizzy"; BALANCE DISORDER (non-serious) with onset 11May2021 04:00, outcome "not recovered", described as "sometime like unsteady"; HEADACHE (non-serious) with onset 11May2021, outcome "not recovered", described as "headache on the left side of my head". Therapeutic measures were not taken as a result of dizziness, balance disorder, headache.  No follow-up attempts are possible. No further information is expected.; Reporter's Comments: Batch/lot number
experiencing severe diarrhea have been taking non diarrhea tablets it clears it up for about a day and the diarrhea returns.  Im experiencing dehydration as well.
abcess cellulitis was hospitalized on Jan 05, 2008 1/11/08-records received for DOS 1/5/08-and as of 1/10/08 patient remains in hospital. Admitted through ED with diagnosis of cellulitis of right deltoid area. Abdominal pain. Day after vaccination developed arm pain and welt in arm, tenderness, warmth and redness. Area of fluctuance at injection site. Fevers 101-104. Suprapubic abdominal pain with some headache and back pain. Vomiting.  2/19/08-DC summary received for DOS 1/5-1/8/08. DC DX: Right upper extremity cellulitis. Adverse vaccine reaction.
This spontaneous report has been received from a pharmacy intern, concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # N014942 and expiration date 02-FEB-2018 (dose, frequency and route of administration were not provided) for prophylaxis, which was reconstituted with a sterile diluent (manufacturer unknown) that not had a temperature excursion prior to administration. The vaccine was stored at a temperature of -10.6 grade Celsius, time frame of 10 hours and no previous temperature excursion. Digital Data logger was involved.
Began as mild nausea, headache, pain in spine, cramping in abdomen.  Symptoms increased the next day to include rapid heartbeat, feeling of not getting enough oxygen, fever of 102, weakness, exhaustion, previous symptoms also increased.
Fever of 102.4; chills; full body muscle aches; fatigue; nausea; injection site pain; swollen lymph nodes; This is a spontaneous report from a contactable healthcare professional. A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/lot number: ek5730, intramuscular in the left arm on 21Dec2020 08:45 at single dose for COVID-19 immunization. Medical history included COVID-19 diagnosed prior vaccination. The patient has no known allergies. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient experienced fever of 102.4, chills, full body muscle aches, fatigue, nausea, injection site pain, and swollen lymph nodes on 21Dec2020 at 19:00. No treatment was given for the events. The vaccine was administered at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications was received within 2 weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
Hives covering about 75% of her body (Back, chest, neck, ears, arms, hands, and feet) for 6 days, low grade fever of 101 for first 3 days. On night 2, she had a few spots in her mouth and said her throat was dry. Treatment was benadryl, ibuprofen, cortisone cream, calamine lotion, and ice packs. Resolved on days 6-7.
on 7/31/2020 with 1 dose / due to COVID  second dose was not administered; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (first dose of shingrix received on 31st July 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were reported as follows: Age at vaccination not applicabe for this report. Due to covid pandemic situation, second dose of shingrix was not administered to the patient yet. The reporter consented to follow up. The VARES details pertains to 1st dose of Shingrix.
2 patients were inadvertently injected with 1.0 mL, instead of 0.5 mL, of Moderna COVID vaccine; A spontaneous report  was received from a health care professional (Physician) concerning two patients who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced accidental overdose.  The patients' medical history was not provided. Concomitant products were not provided.  On an unknown date, the patients received their doses of mRNA-1273 (Lot number unknown) for prophylaxis of COVID-19 infection (route of administration and injection site unknown).   The HCP stated that, the patients were inadvertently injected with 1.0mL, instead of 0.5mL of the vaccine.   Treatments for these events were not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, accidental overdose was considered resolved.; Reporter's Comments: This report refers to a case of accidental overdose for mRNA-1273.  There were no reported adverse events associated with this case.
PT REPORTED APPROXIMATELY 30 MINUTES AFTER RECEIVING IMMUNIZATION THAT SHE WAS EXPERIENCING NUMBNESS IN LEFT ARM AND WAS VERY SLEEPY AND DID NOT FEEL RIGHT. ESCORTED PT BACK TO IMMUNIZATION ROOM AND OFFERED HER WATER, PT REPORTED NOT HAVING ANY WATER IN SEVERAL HOURS,  GAVE HER WATER AND PT TOOK A SMALL SIP. PT QUICKLY BECAME EXTREMELY DROWSY WAS IN AND OUT OF CONSCIOUSNESS, BRIEFLY CRIED AND SNORED. 911 WAS CALLED AND PT DID NOT GET ANY BETTER, WAS GIVEN ONE DOSE OF EPINEPHRINE 0.3MG , EMS CAME APPROXIMATELY 10 MINUTES LATER AND ADMINISTERED ONE DOSE OF NARCAN AND PLACED IV FOR NORMAL SALINE. TRANSPORTED TO EMERGENCY ROOM
Redness, swelling and tenderness at injection site 4 - 5 days post injection.
5-15-14 pt started with (L) arm swelling and pain from shoulder to elbow.
PT was administered a Bivalent Covid Vaccine that is 6 days past BUD.  Beyond use date as 06/02/2023 and the vaccine was administered on 06/08/2023 Pt did not report any adverse symptoms
pt recv vax;  she exp a fever which went from 100.5 to 102.5 & pt sought unspecified medical attention;fever lasted 3d; 9/18/96 pt adm to hosp;fever remained 102, pt recv atb & was disch  Annual follow-up received on 11/27/00 provided no additional data.
inappropriate schedule of vaccine administered; arm pain; fever; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 92-year-old female patient who received Herpes zoster (Shingrix) (batch number H7JY4, expiry date 1st July 2021) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 17th April 2019, the patient received the 2nd dose of Shingrix. In April 2019, less than a week after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced pain in arm and fever. On 17th April 2019, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the pain in arm, fever and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the pain in arm and fever to be related to Shingrix.  Additional details were reported as follows: On 23rd February 2019, the patient received the 1st dose of Shingrix. On 17th April 2019, the patient received the 2nd dose of Shingrix on left deltoid, which led to shortening of the vaccination schedule. The patient was concerned because she got the 2nd dose 6 days early.
Moderna COVID-19 Vaccine  Very sore left upper arm that started a few hours after the shot and gradually faded over the next 3 days.  Not a problem overall.  No problems for a while.  Starting approximately 4/7 (~9 days after shot), red rash at injection site on arm, has been growing in size, itchy, warm to the touch, and now (4/12) getting sore, along with lower arm.  Mild headache on left side of head starting today.  Rash was 4 inches diameter evening of 4/11, has grown by half an inch or more all around as of 4/12 evening and darkened in pink color.