chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FluLaval administered to a 4-month-old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 95ZA7, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th November 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 15th November 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. The action taken with FluLaval Quadrivalent 2022-2023 season was unknown. 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: GSK receipt date: 28-Nov-2022 Reporter's comment: The reporter gave permission for follow-up. Additional supportive information: The patient received a dose of FluLaval at inappropriate age, which led to inappropriate age at vaccine administration.
The morning after I got my vaccination I got up to go to the bathroom and start to get ready. Within seconds of getting up to go to the bathroom I felt like my heart was racing and my chest started to hurt so I checked my HR on the pluseox and it said my HR was 158. I immediately went and laid back down. While laying in bed and focusing on my breathing I was able to get my HR down to the 110-130 range. But as soon as I would get up to anything (even just walking to the bathroom) it would shoot back up to the 140-150 range. So later in the morning I called my PCP and they got me an appointment to see me that afternoon. At that appointment they sent me to the ER. At the ER they did EKG, ran a ton of labs, gave me some aspirin and did a CT scan to rule out a PE (they did rule out PE, but did inadvertently find that I have a splenic aneurysm-- totally unrelated to the vaccine). They could not find anything else wrong other than the tachycardia, and by that time was starting to slowly trend back down, so they discharged me to self monitor at home. I had to take it very slow the rest of the weekend and was not able to do normal daily activities for myself without my HR jumping up to 110-120 until Sunday (10/2/2022). And since that Sunday I have been back to normal for the most part. I will follow up with my PCP on Friday 10/7/2022.
Information has been received from a registered nurse concerning a patient who was vaccinated with their second dose of varicella virus vaccine live (Oka/Merck) (lot # 657758/0642U). On an unspecified date the patient experienced cellulitis. There were six cases of cellulitis with the same lot number. 2 cases were bad enough that they needed antibiotics. It was unknown whether medical attention was sought. The patient's outcome was unknown. A product quality complaint was not involved. This is one of several reports from the same source. Additional information has been requested.
became dizzy, clammy diaphoretic and nauseated at the end of her 15 minutes.  This was her second dose and had no problems with the first COVID vaccine dose.  Continued nausea with lightheadness and started to see visual spots when lifting head.  Benadryl 25 mg 1 tab given by mouth at 1258 pm.  At 1345 pm attempted to have her stand at stretcher and she continued seeing spots, dizzy.  At 1406 transported to the ED for evaluation.  She was seen, evaluated and released to home from the ED.
About 15 min after vaccine administration, patient stated the she did not "feel Well".  She stated her heart was pounding. One of the nurses administering vaccines checked her heart rate and it was 102 bpm. While waiting on a wheelchair to take her to the ER, it was noted her ears became red and she developed a rash on the chest and the back of her neck.  She was monitored in the ED for 1 1/2 hours. She was put on telemetry but received no medications and no Iv was started. During the period she was monitored, her heart rate returned to normal and the rash resolved.
Apparently, broke out w/varicella, even though vaccinated previously, several years ago.
Patient became dizzy and hot on the way home in the car.  Pulse 120/Respiration 6.  Called 911, EMT stated glucose 88, pulse 80 doing better.  At ER was given script for Benadryl. Per 60 day follow up: Approx. 50% of strength recovered in legs; hands? Still in physical therapy 3 x/week. Extreme pain in knees-R>L instantly with standing ->walking -> movement. Neg evalaution with rheumatologist. MRI March 17, 07 pending appoint with orthopedic, MD. Continues to be on Medical leave from job. On egg free diet due to allergic rex to eggs in hospital, carries EPI-PEN. On daily medication for pain and stomach (ZANTAC) prevention. Multiple MD appts continue, as does pain, imability to sleep through the night, particpate in activities involving physicial movement/action/walking. Especially difficult being without any compensation due to medical leave from work.
chest pressure 4/10, elevated heart rate, shortness of breath, dizzy/lightheaded, EMS evaluated, patient refused transport
On 09/15/2022, I had gotten my 6th Covid vaccine booster and my yearly flu vaccine. (Details below,)  Felt very tired. I went to bed and as I was sitting in bed, reading, my hands started shaking violently. It wasn't like an essential tremor. I sat there in shock, trying to control my hands, but they kept shaking for about 5 minutes. The shaking stopped, and has not returned.  I'm hesitant to get a booster for Covid.
Developed shingles 3 months after second vaccination. I?ve seen similar reports online so I thought I should share.
Patient reports she felt hot, dizzy and nauseated. She did have a syncopal episode which she has had in the past during stressful experiences.  She reports some chest tightness.  Patient was transferred via EMS to hospital after being given Zofran 4mg IVP for nausea. She was administered Decadron 8mg IVP at the hospital along with K-tab 20mEq for hypokalemia. She was released and stated she felt better.
came to see me 3 days after his first Pfizer Covid vaccine and had been having a subjective fever, bad headache and stomach ache since the day the vaccine was administered. He incidentally had some weight loss noted at the visit over the previous 6 months for which I did some lab work. The lab work was normal except for his platelet count which was 111,000. A repeat platelet count done a week later was normal at 273,000. Because of the transient decrease in platelet count and the 3 days of bad headache after the vaccine, I decided to hold off on  getting a second Covid vaccine. Additionally and possibly of no significance, his mother apparently had a history of ITP during her childhood.
right arm was hot; right arm was itching; right arm started to get red; right arm was swollen; right arm was hurting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (right arm was hot), VACCINATION SITE PRURITUS (right arm was itching), VACCINATION SITE ERYTHEMA (right arm started to get red), VACCINATION SITE SWELLING (right arm was swollen) and VACCINATION SITE PAIN (right arm was hurting) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010MZ0A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.). Concomitant products included CALCITONIN (CALCITRIN), CALCIUM, LOSARTAN, DENOSUMAB (PROLIA), RALOXIFENE, TRAZODONE, CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) and CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE WARMTH (right arm was hot), VACCINATION SITE PRURITUS (right arm was itching), VACCINATION SITE ERYTHEMA (right arm started to get red), VACCINATION SITE SWELLING (right arm was swollen) and VACCINATION SITE PAIN (right arm was hurting). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE WARMTH (right arm was hot), VACCINATION SITE PRURITUS (right arm was itching), VACCINATION SITE ERYTHEMA (right arm started to get red), VACCINATION SITE SWELLING (right arm was swollen) and VACCINATION SITE PAIN (right arm was hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2016, a healthcare provider at a healthcare facility/office administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). Later in 2016, the patient was treated by a healthcare provider at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, 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 (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Patient became lightheaded and fainted in her chair in the observation room post injection. BP 103/71, HR 66, R 16, O2 sat 100%. Patient was given water and graham crackers. Continued to monitor patient; at 1003, BP 106/70, HR 73, R 16, O2 sat 100%. Patient stated that she was feeling better and was ready to leave. Patient was discharged to mother to go home.
It?s been over 2 weeks & right eyelid STILL swollen & looks very bad!! Had chills, fatigue, head felt real heavy & almost fell to floor when using bathroom the next morning 4-8-21 after 2nd dose 4-7-21, had severe headache all day (took 2 Tylenol  every 4-6 hours. Headache finally went away the next day.
Client received vaccines at approx 9:45 AM. Parents brought client back to clinic at 1:00 PM stating "her eyes are swollen since 45 min after vaccines given". Instr. to take to Emergency Room. Phoned Dad next day - he states "she is fine today" - Dr. said it was from a food allergy".
Pt presented with itchy rash. Red base with clear vesicles increasing in number. No fever. The follow up received on 11/14/03 states, "pt received the vaccine in a foreign country. We have no information on it."
About two days before our trip, on the 10th of June, my husband and I were in isolation for 5 days, my husband was symptomatic and I was still coughing.  I had tested negative twice, but my husband tested positive.  My symptoms began on June 10th.  I had a sore throat, nasal congestion and mild coughing and fatigue.  I did not have fever.  By the 3rd day I was improving.  I continued to drink water and use cough drops to help cough.  I took a decongestant for congestion and Tylenol.  The main symptom that lingered was my coughing.  I would have cough spasms for another 10 days.
slow labored breathing; rapid heartbeat; blurry vision; swollen lymph nodes; fever; chills; extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the right arm on 05Apr2021 at 11:45 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, asthma, attention deficit hyperactivity disorder (ADHD) and pollen allergy. Concomitant medications included amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (ADDERALL) for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the right arm on 12Mar2021 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. 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 05Apr2021 at 12:30, the patient experienced extreme fatigue, chills, fever, slow labored breathing, rapid heartbeat, swollen lymph nodes and blurry vision. Therapeutic measures were taken as a result of adverse events and included treatment with ibuprofen on day two and three of adverse effects. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 05Apr2021, the patient underwent nasal swab test and the result was negative. The clinical outcome of the event extreme fatigue, chills, fever, slow labored breathing, rapid heartbeat, swollen lymph nodes and blurry vision was recovered with lasting effects on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
No additional adverse effect reported.; M-M-R II, VAQTA and GARDASIL 9 that underwent a temperature excursion (case 01907249) were administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On 17-FEB-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot #: T013204, expiration date: 03-DEC-2021 or lot #: T013546, expiration date: 28-OCT-2021 (two lot# of vaccines have been reported, no information of which one was administrated to the patient); dose, strength and route were not reported) for prophylaxis.          The vaccines underwent temperature excursions and were stored at 9 degree Celsius (C) to 25 C (8.7 C) for 30 minutes, 2 C to 8 C (8.2 C) for 30 minutes and 9 C to 25 C (9.43 C) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved. No additional adverse effect reported.   This is one of 20 reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013546; expirationdate: 28-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002970: US-009507513-2104USA002944: US-009507513-2104USA002971: US-009507513-2104USA002963: US-009507513-2104USA002972: US-009507513-2104USA002974: US-009507513-2104USA002975: US-009507513-2104USA002976: US-009507513-2104USA002978: US-009507513-2104USA002980: US-009507513-2104USA002981: US-009507513-2104USA002982: US-009507513-2104USA002983: US-009507513-2104USA002984: US-009507513-2104USA002985: US-009507513-2104USA002986: US-009507513-2104USA002987: US-009507513-2104USA002988: US-009507513-2104USA002989:
Information has been received from a physician, via a company representative, concerning a 17 year old female patient, who on 27-FEB-2007 was vaccinated IM, with the first dose of Gardasil (Lot # not provided). There was no concomitant medication. On approximately 27-FEB-2007 ("after getting her first dose"), the patient reported feeling a "little woozy." Later on (onset date not specified), she experienced depression that was significant enough to require counseling. With counseling, the depression cleared (date not specified). On approximately 25-MAY-2007, she was vaccinated IM with the second dose of Gardasil (Lot # not provided). On 25-MAY-2007, following the vaccination, she felt lightheaded, and again "went into depression (onset date not reported); counseling was reinitiated. At the time of this report, the outcome of feeling woozy, feeling lightheaded, and the second episode of depression were unknown. The physician considered the episodes of depression to be significantly disabling or incapacitating. Additional information has been requested.
Passed out  and fell from the exam table.   Woke up and said he felt dizzy.  Was able to get up from floor with help of nurses and lay down on table.   Was given juice and crackers  to eat and cool cloth placed to head.   He answered that he felt normal once again after 5 minutes.
Fever; felt bad overall; A spontaneous report was received from a consumer concerning a 66-year-old,patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed pyrexia and feeling abnormal.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included losartan, otc allergy medicine,b12 supplement, multivitamin.  On 08 Feb 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot 043L70A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 09 Feb 2021, the patient developed feeling abnormal. On 10 Feb 2021,the patient developed pyrexia. Treatment for the event included Tylenol.  Action taken with mRNA-1273 in response to the event was not applicable.   The outcome of the event, pyrexia and feeling bad, was considered unknown
100 hours after injection I had to be escorted off golf course. Intense muscle pain, shaking, sweating, freezing. Almost passed out.
Pityriasis rosea, rash presented 5 days after vaccination. Asymptomatic besides being red and slightly raised. Still present as of 12/22/2021
This is a spontaneous report from a contactable consumer. A 73-year-old male patient (husband) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: Unknown, Expiration Date: unknown), dose 1 via an unspecified route of administration on 04Jan2021 (at the age of 73-year-old) as dose 1, single for COVID-19 immunization. Medical history included prostate cancer (He is winning a battle against prostate cancer) and sensitive with food sometimes from an unknown date and unknown if ongoing. There were no concomitant medications (Other Products: No). He was winning a battle against prostate cancer. He had been doing well. Reporter stated, on Saturday he ate a piece of fish. He was sensitive with food sometimes. If there were bacteria, he gets a nausea feeling and he had to dry heave sort of. Well, he had to do that a little bit on Saturday when he ate this fish. He had paused and then kept eating. So, reporter was wondering if this onset was from that. It would have been 48 hours after. It could be possible. He had the dry heaving for about 3-4 mins. Then he kept eating. Normally that feeling was acute and will not eat. But he did not feel it again. On 04Jan2021, patient experienced exhaustion. Reporter stated, after his first dose he was exhausted for about a day. He did not get the vaccine in his providers office, he got it from the staff where they were giving the vaccine. The hospital was giving them. He only experienced the exhaustion for one day and recovered completely. No treatment received for the event. There was no investigation assessment. The outcome of event was recovered on 05Jan2021.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Had a syncopal event the day of the initial HPV vaccine and has had syncopal events since.  Incident disclosed on 9/14/12.
Information has been received from a physician concerning a 23 year old female with a sulfonamide and penicillin allergy and no other pertinent medical history who on an unspecified date received her second dose of Gardasil. Subsequently, she had joint pain. She was seen by a rheumatologist, but unspecified tests came back negative. Subsequently, she recovered. on 28-AUG-2007 the patient was vaccinated with her third dose of Gardasil, 0.5 mL (Lot # 658556/1060U). Concomitant therapy included lamotrigine (LAMICTAL) and varenicline tartrate (CHANTIX). On 29-AUG-2007 after receiving her third dose of Gardasil, the patient complained of generalized joint and muscle pain. The pain was so strong that she could not walk. She had to stay in bed and was not able to go to work. The physician noted the patient had no problems with the first dose of Gardasil and only had joint pain after second dose and after the third dose, pain reappeared all over her body. The patient called the physician and sought medical attention. Patient Quality Complaints (PQC) were not involved. The physician considered generalized joint and muscle pain to be disabling because the patient could not walk. Additional information has been requested.  In follow-up it was reported by the physician, that the patient a 23 year old, female with a sulfonamide and penicillin allergy and no pertinent medical history and no illness at the time of vaccination who on 28-AUG-2007 was vaccinated intramuscularly into the left arm with the third dose of GARDASIL, (Lot # 658556/1060U). It was reported that on 29-AUG-2007, the patient at first had joint pain in both hands and then generalized muscle pain and joint pain throughout the whole body. It was reported that the patient felt better and recovered on 31-AUG-2007. Additional information has been requested.