chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired Bexsero administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 20-year-old female patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 22nd July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th August 2022, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 8th August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 08-AUG-2022 Reporter's Comment: The reporter stated that, an expired dose of Bexsero was administered to a patient at the time of reporting. Lot number was not available at time of call.  The reporter consented to follow up via postal. Additional Supportive Information: An expired dose of Bexsero was administered to a patient at the time of reporting, which led to expired vaccine used.
VERY DISORIENTED, FAINTED AND WAS NOT CONSCIOUS.  HAD TO BE RUSHED TO HOSPITAL AND WAS PUT IN THE ICU FOR A DAY.  ALSO HAD A VENTILATOR FOR SEVERAL HOURS.  WAS THEN KEPT IN HOSPITAL FOR THREE MORE DAYS.
Developed swelling to hands and feet as well as hives.  Symptoms occurred same day as vaccine administration day.  Symptoms lasted for 1 week.
After 2 days of 2nd shot, I started having sensation and rashes in my lower back, left hip and left waistline. In another 4 days it turned into shingles. It is extremely painful. I checked with my PCP and taking medications.
Inconsolable fussiness x 2 days after immunization no rash or other symptoms/signs of infection.
Lips started swelling, heart rate doubled, bright red hives from head to toe, profuse perspiration, tightness in chest and throat, numb mouth and throat and chest, blood pressure very high, difficulty breathing, fever, PVCs (detected by EKG from EMS); benadryl 62.5mg then EMS arrived and gave IV steroid 125mg; EMS transported to ED where another 25mg Benadryl was administered and Pepcid 20mg; symptoms improved enough to discharge patient
Complaint: Tingling lips approximately 5 minutes after COVID vaccine administration.  Treatment: None. Observed 30 minutes. Symptoms subsided
The evening of my first dose I began experiencing heart palpitations, chest pain, and was generally very aware of the sensation of my heart beating, and more slowly than normal. I felt like I was having palpitations every other minute. I was lightheaded but not to a debilitating degree.
Patient's left arm started hurting shortly after getting her flu vaccine, then she developed a warm, red rash on left arm. Patient took TYLENOL and the next day (8/28) her pain was better, but the rash was still present. Patient came into pharmacy to report the event. Right arm (pneumo vaccine arm) had no issues. Pharmacist consulted patient on supportive care (using hydrocortisone/BENADRYL for rash), continuing TYLENOL for soreness/pain. Also, what to watch out for, spreading rash, fever, hardness to call doctor/go to urgent care/ER immediately. Also, consulted pt on calling Dr to get assessed if they felt the need to be.
Injections given, first Hep A, then HPV, in left arm, then MENACTRA given in right arm. Went to dispose of syringe and get Depo when patient started laying back on table, then started shaking, arms, stiffened, eyes rolled back slightly. Stood next to patient to prevent falling. Called for help. Lasted approx 15 seconds.
This was my third booster shot and I did fine with the others. I had the shot at 4:oo pm and within 12 hours woke up with a severe pain in my stomach...not like a virus or upset stomach, but clearly like something I've never felt before. By Sunday, my daughter found out I had received the covid shot on Friday and found that a prolonged stomach ache could be appendicitis if the ache doesn't go away and is a severe reaction to the covid shot. I called the number she gave me on 11/9/22 and it was not working. Called my primary care doctor and they were not available on a Sunday. Called them back on Monday morning at 8:00 a.m. and got an appointment for 11:30 a.m.  Dr. saw me and immediately mentioned I likely have appendicitis from the covid shot. She felt my right side and said I need a CT scan. Sent me to Radiology for a CT scan and that Radiologist said i needed to go directly to the emergency room.  Had appendix removed that Monday night and spent one night in the hospital.
Arm has been sore for two weeks, patient says soreness is getting worse, feels like the joint hurts even, hurts when she moves her arm, pain wakes her up at night.
Information has been received from a registered nurse concerning a 19 year old female patient with AMOXICILLIN allergy who on 21-JUN-2008 was vaccinated  intramuscularly with a 0.5 ml first dose GARDASIL and experienced mild tenderness at the injection site for one day.  On 01-AUG-2008 she received the second dose of GARDASIL (LOT # 660557/0072X).  Following the second dose, the patient experienced an itchy hive-like rash at the injection site that lasted for 4 months, and fatigue and leg symptoms.  The reporter stated that the patient was not seen by a physician for the symptoms.  Additional information has been requested. This is in follow-up to reports previously submitted on 12/12/2008. Information has been received from a registered nurse concerning a 19 year old stundent female patient with amoxicillin allergy who on 2-JUN-2008 was vaccinated intramusculary in her left deltoid with a 0.5 ml first dose of GARDASIL (LOT #659183/1757U) and experienced mild tenderness at the injection site for one day. On 01-AUG-2008 she received intramusculary in her right deltoid the second dose of GARDASIL (LOT # 660557/0072X). Following the second dose, the patient experienced an itchy hive-like rash at the injection site that lasted for 4 months, and fatigue and leg symptoms. The reporter stated that the patient was not seen by a physician for the symptoms. Follow-up information has been received from a registered nurse concerning the patient who complained of experiencing rash and itch at the injection site for four weeks (previously reported as four months) after receiving the second dose of GARDASIL vaccine given on 01-AUG-2008. It was reported that the patient did not seek medical attention during that time and on 21-NOV-2008 she reported the event when she went back to receive the third dose of GARDASIL vaccine. The vaccination was deferred and on 12-DEC-2008 the patient received intramusculary in her left deltoid the third dose of GARDASIL (LOT #660616/0570X) along with Benadryl 50 mg. orally given 30 minutes prior vaccination as per patient's physician. The nurse stated that the patient's mom denied any itch or rash after the third vaccination with HPV vaccine. No further information is available.
She had little reaction like fever; This is a spontaneous report from a contactable consumer (patient's son/daughter) via Pfizer sponsored Program.   An 84-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose in Feb2021 (9 days before this report) for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient had little reaction like fever in Feb2021 and also went to the hospital. The event was considered life threatening. The outcome of event was unknown.  Reporter wanted to know if her reaction was related to the vaccine even though she received it 9 days before, if it was possible that she was exposed to the virus and since she already received the vaccine if it will test false positive, and if she tested positive will she still be able to receive the 2nd dose.  Information on the lot/batch number has been requested.
Patient received COVID vaccine Pfizer 2 dose series on 4/30/21 and 5/21/21. . Patient was on a cruise, returned 8/3/21. About 3-4 days after that she started having cough, headache, fevers, and mild chills. She tested positive for COVID-19 at a  testing center on 8/11/21. She since then has developed some diarrhea, headache, myalgias. She continues to have subjective fevers but this is improving. She denies much of anosmia, anorexia. She started having hypoxia down to mid-80s on home pulse oximetry and was admitted to our facility on 8/15/21 for COVID-19 severe pneumonia with acute hypoxic respiratory failure and acute hepatitis.  As of today (8/16), patient is still admitted.
Blood pressure is extremely high; Blood sugar is extremely high; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure is extremely high) and BLOOD GLUCOSE INCREASED (Blood sugar is extremely high) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure is extremely high) and BLOOD GLUCOSE INCREASED (Blood sugar is extremely high). At the time of the report, BLOOD PRESSURE INCREASED (Blood pressure is extremely high) and BLOOD GLUCOSE INCREASED (Blood sugar is extremely high) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Blood glucose increased: high Blood sugar is extremely high. On 14-Jan-2021, Blood pressure measurement: high Blood pressure is extremely high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a physician concerning a 2 month old male who on approximately 12-MAR-2008, was vaccinated PO with his first 2.0 ml dose of ROTATEQ.  On approximately 13-MAR-2008 the day after the vaccine was administered, the patient experienced vomiting.  On approximately 14-MAR-2008 the patient was diagnosed with RSV and was hospitalized for approximately 1 week.  The outcome was unknown.  There was no product quality complaint.  The events were also considered to be other important medical events by the physician.  Additional information has been requested.
She also have never pinch/pain and is on disability; gonna die, could not get out couch. I wouldn't get this vaccine if I were to know this; gonna die, could not get out couch. I wouldn't get this vaccine if I were to know this; This is a spontaneous report from a contactable consumer.A 61-years-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number, Expiry date was not reported), via an unspecified route of administration on 05Nov2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number, Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient stated, she received the second dose of the Pfizer covid vaccine last Friday, 05Nov2021. She was told that she may feel a little tired and aching in hand, but she said she felt like she is gonna die, could not get out couch. I wouldn't get this vaccine if I were to know this. She stated, its been 5 days and its more than she can handle. She also have never pinch/pain and is on disability. She stated, she just wanted to report about her experience. The clinical outcome of the events was unknown.
PATIENT CAME IN WITH SEVERE PAIN ON HER LEFT UPPER ARM WHERE SHE WAS GIVEN PREVNAR. THE AREA WAS HARD TO TOUCH BUT WAS NOT WARM OR RED. IT WAS SWOLLEN LITTLE BIT BUT NO INFLAMMATORY SIGNS WERE PRESENT. ADVISED PATIENT TO APPLY ICE AND TAKE NSAIDS AND REPORT IF NO CHANGE TO MD AFTER 3 DAYS.
Left side of body felt very warm and felt like it was melting; red rash on left side face, neck, chest, arm; Facial spasms; Fever; Confusion/lightheaded; Confusion/lightheaded; Palpitations; Feeling of being unwell; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on right arm single dose for COVID-19 immunization on 22Jan2021, 05:45 PM, at 28-year-old. Medical history included: COVID-19. No allergies to medications, food, or other products. Concomitant medications within 2 weeks of vaccination included: daily vitamins, lisdexamfetamine mesilate (VYVANSE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient left side of body felt very warm and felt like it was melting. The patient had red rash on left side face, neck, chest, arm. The patient had facial spasms, fever, confusion/lightheaded, palpitations, feeling of being unwell, fatigue. All on 22Jan2021, 06:45 PM, and was reported as non-serious and resulted in doctor or other healthcare professional office/clinic visit, no treatment received. Since the vaccination, the patient had not been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the event was resolving.  Information on the lot/batch number has been requested.
5min p/vax pt began wheezing w/increased work of breathing;pt was examined by Md;pt was advised to calm down;nebulization treatment was given to pt consisting of 0.5ccc albuterol/2cc nl saline for 15-20min;
pain in arm, mild redness,  progressing in severity and radiating dowm arm to wrist and up into shoulder and neck,  rash at injection site  extending dowm arm to cubital fossa mostly and then to wrist,scattered lesions elsewhere and inability to raise arm with severe weakness. given analgesics, zovirax, gabapentin, nsid
Information has been received from a physician concerning a 6 year old female who on 09/21/1999 was vaccinated with a dose of varicella virus vaccine live.  On 02/02/2005 the patient experienced mild chickenpox that lasted 5 days with about 20 lesions.  Subsequently, the patient recovered.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Feeling unwell; Bad case of vertigo; Dry heels; Couldn't get up; Pain in her stomach; Hurting all over; Really bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell), VERTIGO (Bad case of vertigo), LIMB DISCOMFORT (Dry heels), MOBILITY DECREASED (Couldn't get up) and ABDOMINAL PAIN UPPER (Pain in her stomach) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032h21a, 027a21a and 007m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer and Cancer surgery (breast cancer surgery) on 25-Jul-2019. Concomitant products included EXEMESTANE from 25-Jul-2019 to an unknown date for Breast cancer NOS, VITAMINS NOS, FISH OIL and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, the patient experienced MALAISE (Feeling unwell), VERTIGO (Bad case of vertigo), LIMB DISCOMFORT (Dry heels), MOBILITY DECREASED (Couldn't get up), ABDOMINAL PAIN UPPER (Pain in her stomach), PAIN (Hurting all over) and VACCINATION COMPLICATION (Really bad reaction). At the time of the report, MALAISE (Feeling unwell), VERTIGO (Bad case of vertigo), LIMB DISCOMFORT (Dry heels), MOBILITY DECREASED (Couldn't get up), ABDOMINAL PAIN UPPER (Pain in her stomach), PAIN (Hurting all over) and VACCINATION COMPLICATION (Really bad reaction) outcome was unknown.            No treatment information was provided.
Day after vaccine, patient was dizzy and had arm weakness. She had 3 days for dizziness, and AM was worse.  She also had pain in her L leg and knee.  She no strength in her left hand for a day.
Smallpox site checked on 09/03/2013 and was normal. On 9/5/2013 started to become red and very swollen with a raised break in middle of site. Seen in clinic and treated for possible infection on 9/6/2013 by Dr.
fever to 106 & 18 hrs to 24 hrs post inject fussy, excessive crying;
Arm was starting to swell around where it was bandaged/ it was a solid, red, raised square around the injection; A large, rash-y redness around all of it; Vaccination site itself looks like it has white looking pus on it; Information received on 13AUG2019 from a consumer.   A female consumer reported that her partner's arm was starting to swell around vaccination site, where it was bandaged/ it was a solid, red, raised square around the injection (PT: Injection site swelling), he had a large, rash-y redness around all of it (PT: Injection site erythema), and vaccination site itself looked like it had white looking pus on it (PT: Injection site pustule), following the administration of ACAM2000. He received ACAM2000 on approximately 01AUG2019. On an unknown date (reported as approximately 09AUG2019) the vaccination site on his arm started to swell around where it was bandaged, the area had a large, rash-y redness around all of it and the vaccination site itself looked like it had a white looking pus on it. On 16AUG2019 additional information was received and it was reported that the rash area was a solid, red, raised square around the injection.  Action taken was not applicable.  Company comment: The described events "injection site swelling, injection site erythema, injection site pustule" are known effects of ACAM2000 possibly caused by a robust take, and therefore are considered to be causally related to the administration of ACAM2000.; Sender's Comments: Company comment: The described events "injection site swelling, injection site erythema, injection site pustule" are known effects of ACAM2000 possibly cause by a robust take, and therefore are considered to be causally related to the administration of ACAM2000.
I have started to have uncontrolled hand tremors, It gets increasingly worse when actually using my motor skills. As a nurse this is very scary and effecting my job. For patients they do not want a nurse coming at them with a needle when I look like I have Parkinson's, or I am withdrawing . I have never in my life had this issue. I am starting to become very concerned as it is getting worse and not better. I didn't even think of connecting it to the vaccine until my doc and I started going over all the possible new things and I wrote every thing down. They pulled my vaccine record and it triggered me. I have no noting new no foods no meds, no health issues that happened prior to this.  I cannot do my job with my hands like this. I am very much pro vaccines, this is very scary for me.
Mom reported: 2 hrs. after receiving vaccine pt. felt warm, no temp taken. He then started talking funny not making sense - this lasted approx. 10 minutes. He later c/o feeling tired.
Was not aware that vaccine contained latex. Lightheartedness, Hives, Right Arm Swelling, Fever, Nausea, Hypo tension, Tachycardia Treated with IV Zoysin, Benadryl, Pepcid, IV Fluids, ER and Hospital Observation for 20 hours.
AFTER  2 WEEKS, redness, swelling, itching, warm to touch appeared.
The next day after the shot, he broke out in a full body rash (made his skin feel really rough, like a cat's tongue).
Client received Pfizer as a dose 2 and Moderna as dose 1 (5/5/2021)
Patient reported a rash broke out on left-hand side of back. It is raised, red, itchy, and 6in in diameter. Pt took a CLARITIN and will put BENADRYL cream on it.
No immediate affects noted. Patient lives in residential facility with mother and nursing staff, together they will continue to monitor patient.
Pain And discomfort of gums, teeth and upper jaw. Intermittent. Started 1.5 days after injection. Pain continuing 16 hours after it started. No history of gum disease or TMJ
Patient fainted a minute inside the vaccine waiting area after receiving the vaccine and hit his head on the ground but regained consciousness quickly after. Took patient's blood pressure and it read 104/60 which was low. Patient said he had a similar reaction to this when he received a tetanus vaccine back then but did not indicate that to us beforehand.  Patient chose to go to the ER via the ambulance to check out possible head injuries.
swelling; redness; This case was reported by a consumer and described the occurrence of swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling and erythema. On an unknown date, the outcome of the swelling and erythema were unknown.   It was unknown if the reporter considered the swelling and erythema to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient had a lot of redness and some swelling from 2nd dose of Shingrix.  The patient asked if anything need to be done for these reactions.