chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired Havrix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 51-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 16-MAR-2023, the patient received Havrix. On 16-MAR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Havrix administered). 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: 16-MAR-2023 The nurse reported the case for a patient. The reporter reported that a patient was administered with a dose of expired Havrix vaccine. The reporter consented to follow up. Patient received a dose of Havrix on 16th March 2023 which was expired on 30th January 2023, which led to expired vaccine used
Tremors, fever, body aches, headaches, nausea, lightheaded,  dizzy and feeling weak
Swelling, pruritus. Pt is taking prednisone 10 mg as directed by Dr and AUGMENTIN 875 mg twice daily from the same dr. to bring down the swelling and prevent infection.
HEADACHE, NAUSEA, JOINT INFLAMMATION, EXCESSIVE NASAL MUCOUS DRAINAGE, DISORIENTATION, DIZZINESS, HYPERSENSITIVITY TO LIGHT AND NOISE, LACK OF URINATION, BOUTS OF DIARREAH, CHILLS WITH SKIN ICE COLD TO TOUCH, FREEZING FEET, UNABLE TO DRINK LIQUIDS; COULD NOT EAT FOR 3 DAYS; NO FEVER
body temperature is still high at 37.8 degrees Celsius for 3days now; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (body temperature is still high at 37.8 degrees Celsius for 3days now) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 014C21A) for COVID-19 vaccination.     No medication history was provided.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2. On 20-May-2021, the patient experienced BODY TEMPERATURE INCREASED (body temperature is still high at 37.8 degrees Celsius for 3days now). At the time of the report, BODY TEMPERATURE INCREASED (body temperature is still high at 37.8 degrees Celsius for 3days now) outcome was unknown.            No known allergies, is not taking any concomitant medication. The patient did not informed his physician.
After my son received his booster shot for chicken pox, within 6 months he had got shingles. He also ran a high temp. with the shingles.....
Dr. was seen for pretravel consultation on 7/26/23 and received Hepatitis A, yellow fever vaccines and advised to complete oral typhoid vaccination series of 4 capsules that the patient self-administers.  Dr. completed the oral typhoid as directed finishing the fourth dose on 8/2/23.  The following day, 8/3/23 she noted loose diarrheal stools, abdominal cramping and one of the stools was streaked with red blood.  She called this afternoon and spoke with RN and I am returning the call now at 4 pm.   Dr. confirmed the above information during our call and reported that this morning, 8/4, she again noticed a loose stool that was streaked with blood.  She has not had any stools this afternoon and has been able to work.  She denies any other systemic symptoms, specifically no fever, chills or vomiting.   I reviewed with Dr., who advised patient be seen on Monday, 8/7/23 for evaluation and consideration of potential need to receive treatment for typhoid (given this is an attenuated bacterial vaccine).  It is noteworthy that if it is decided to treat for typhoid, the patient would have had the time to develop antibody protection and would not need to be revaccinated with injectable typhoid.  Patient understands that if her symptoms progress such as fever, chills or other systemic symptoms suggestive of infection, she should seek evaluation if the ED over the weekend.   I have asked my staff to arrange a patient appointment for Dr. on the calendar for Monday, 8/7/23 afternoon and to notify the Dr. of the time.
April 10th around 5pm I started to feel tingling on my face which lasted the remainder of the night.  April 11th around 10am I noticed my nose tingling and feeling numb as well as my cheeks. Shortly after my hands started with the same feeling and also a feeling of hotness both on my nose and hands.
p/vax pt froze up-eyes rolled up in back in head;seemed to stop breathing & fainted;sx w/syncope;
Vaxelis and Engerix-B administered on the same day; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 6-month-old male patient who received HBV (Engerix B) (batch number YY2R3, expiry date 12th May 2024) for prophylaxis.   Co-suspect products included VAXELIS for prophylaxis.   Previously administered products included Engerix-B (The first dose was received on an unknown date).   On 24th October 2022, the patient received the 2nd dose of Engerix B and VAXELIS. On 24th October 2022, unknown after receiving Engerix B, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.   Additional Information: GSK Receipt Date: 28-OCT-2022. Reporter's Comments: The medical assistant had reported that a child patient was given Vaxelis (manufacture- Sanofi) and a 2nd dose of Engerix-B on the same day 24th October 2022. The vaccine administration facility was the same as primary reporter. The reporter had consented to follow-up. Additional supportive information: The patient had received the second dose of Engerix-B and Vaxelis on the same day, which had led to overdose of hepatitis B component.
Became shaky, weak.  Had not eaten breakfast.  Ate crackers, became nauseated.  Did not feel well enough to remain at school and was picked up by parent.  Returned to school on 12/8/09.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 02-DEC-2015 at time- 12:31, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L025738 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.5 and 2.4 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
On 1/3/02 in morning , pt. noticed slight swelling of lymph nodes in his neck and slight sore throat. These 2 signs & symptoms continued to 1/4/02. Pt. denies fever, cough, nasal congestion, rash and general malaise. Advised to call physician if S/S increased.  1/7/02 spoke with pt. no swollen lymph nodes, no fever, but still has slight sore throat and nasal discharge
itching at injection site; chills; fatigue; Injection site warmth; redness surrounding injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included spondylolysis. Concomitant products included phentermine, topiramate (Qsymia).   On 4th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 5th September 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema, chills, fatigue and injection site warmth. On 8th September 2019, the patient experienced injection site itching. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the injection site itching, chills, fatigue and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema, injection site itching, chills, fatigue and injection site warmth to be related to Shingrix.  Additional information received were as follows: At around noon, the patient received Shingrix. The day after vaccination, the patient experienced redness at the injection site. The day after vaccination, the patient experienced chills and fatigue. The patient reported that the redness surrounding the injection has become larger, described as about 4 by 4 inches. The site had become itchy. The patient reported that she was given Symia loading doses in May 2019 but stopped in the summer, around June with her new physician. The redness was not improved and becoming worse at time of report. The reporter consented to follow up.
This spontaneous report as received from a 65 years old male consumer with high cholesterol and no drug reactions or allergies reporting on himself. The consumer was vaccinated with a dose of live ZOSTAVAX (Lot # not reported) SQ on 29-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. The consumer reported that on 31-JAN-2013, the patient experienced a knot about half dollar sized around the injection site. He also stated it had fever around the site. The patient did not receive treatment for the adverse events. There were no lab diagnosis or studies performed. The consumer stated it had not gone away, but had subsided. The relatedness for know about half dollar sized around the injection site and fever around the site was unknown for live ZOSTAVAX. Additional information is not expected.
After 5 minutes post vaccine, patient started vomiting and became dizzy. patient symptoms were not resolving so paramedics were called.
Patient has a fainting incident on 2/6/22 the morning after the 3rd covid vaccine shot.  Mother found him on floor dizzy and bump in back of head.  Shortly thereafter had another incident.  Went to the lab to have blood drawn and had a 3rd incident of dizziness.
Person was administered vaccine dose that was given 81 minutes after the 6 hour time frame.  No adverse event reported from patient at this time.  Had normal reaction, sore arm, that occurred with first two doses.
Report 2000035544-1 describes carpal tunnel syndrome in an 18-year-old female who received hepatitis-B vaccine.  Medical history is significant for a positive anti-nuclear antibody titer and possible lupus erythematosus. Concurrent medications were not specified. The reporter stated the the family history is significant for leg weakness, unspecified infection, arm weakness and arm numbness in this patient's father following receipt of the hepatitis-B vaccine (see case 2000035528-1). The patient received her first injection of the hepatitis-B vaccine in July, 2000 (exact date not provided). At some later date (not specified), the patient experienced pain in all her joints and numbness in her feet.  She received her second injection of the hepatitis-B vaccine in September, 2000 (exact date not provided). At some later date (not specified), she developed arthritis-like symptoms. Reportedly, a diagnosis of carpal tunnel syndrome was made. As of 06 December 2000, the outcome of the event was unknown
Broke out in shingles on forehead and in the right eye.  Took shingles medication, Gabapentine and prednsone eye drops.  Seeing an Ophthalmologist and primary Doctor regularly.  Right eye only opens half way due to nerve damage and waters constantly.   Cannot drive or read, and very sensitive to light.  Expected to take months to recover.
Arm was Hurting; swollen lymph node on the collar bode; Pain in the lymph nodes; Tenderness under the armpits; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (Pain in the lymph nodes), TENDERNESS (Tenderness under the armpits), PAIN IN EXTREMITY (Arm was Hurting) and LYMPHADENOPATHY (swollen lymph node on the collar bode) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced LYMPH NODE PAIN (Pain in the lymph nodes), TENDERNESS (Tenderness under the armpits) and LYMPHADENOPATHY (swollen lymph node on the collar bode). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was Hurting). At the time of the report, LYMPH NODE PAIN (Pain in the lymph nodes), TENDERNESS (Tenderness under the armpits) and LYMPHADENOPATHY (swollen lymph node on the collar bode) had not resolved and PAIN IN EXTREMITY (Arm was Hurting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Expiration date and Event added
Developed cellulitis, large erythematous rash within 48 hours of receiving anthrax vaccination
Patient given vaccine at CPE on 9/10/15, reports onset of full body hives on 9/11/-9/14/15.
After getting my first dose of Pfizer vaccine I developed ringing in my ears that same day.  It has now been a week since my vaccine and the ringing has not stopped, it is constant.
Information has been received from a registered nurse concerning unspecified number of patients of unknown age and gender. The patients' concurrent condition, concomitant medication and medical history were not provided. On unknown dates, the patients were administered improperly stored doses of RECOMBIVAX HB (lot # L039660, expiration date 04-FEB-2018; lot # M022077, expiration date 10-MAR-2019) (strength, dose and route were not reported). It was reported that the vaccines were exposed to a temperature excursion of 14.3 Celsius degree for 10 hours 42 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
slept more & was hard to wake up same afternoon immun given; temp up to 103 & fussy;
Vertigo and Dizziness.  About 3 months after 2nd shot.   I have had Vertigo BPPV in the past and was given the Epley Maneuver ...however it did not work this time....this was a completely different Vertigo accompanied with Dizziness and Nausa. that did not respond to the normal PT exercises for BPPV. I took Dramamine....which only made me want to sleep. Then Cortisone for Inflamation of inner ear.... And then Meloxicam....for inflamation....for the inner ear I was told and to help with the Arthritic pain.   I also had Accupuncture,,,which did help but since only x amount of treatments are covered with insurance and once I stopped the vertigo/dizziness resumed.  I was told to take Allerga thinking it was fluid in an inner ear issue. Am still as of today 10/26/2021 still having issues.  Some days it is just Dizziness reaching down to pick something up ...getting out of bed too quickly....other days full fledged Vertigo. It comes and goes....be fine for a few days then back with a vengence.
DTAP given in left deltoid and within 30 minutes, mother returned to clinic and child had redness (slightly raised) and warm area surrounding DTAP injection site extending up to clavicle. No distress. Use ice. Seen by PMD.
Redness, pain, tenderness, heat at the injection site and around about 2-3" in radius. Treatment - BENADRYL.
The patient presented to the ED with community acquired pneumonia 14 days after receiving PPSV 23 vaccine. Cough wheeze. Moxifloxacin 400 mg every day.
Mother reported several hours after injection redness and swelling just lateral to locations of injections (ie 1-2 cm from where the injection was given), that progressed in size and swelling. Right was particularly swollen. Given its progression, they went to ED where diagnosed with cellulitis for which given oral Keflex and topical hydrocortisone, with resolution within 1-2 days of starting this.
Patient administered moderna covid vaccine while temperature excursion was ongoing; Patient administered moderna covid vaccine while temperature excursion was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing) in an 86-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that no adverse reactions were reported by patient.  No concomitant medications were reported.  No treatment information was reported.
Injection site was itchy; Injection site was red; Injection site was swollen; Injection site was little sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Injection site was itchy), INJECTION SITE ERYTHEMA (Injection site was red), INJECTION SITE SWELLING (Injection site was swollen) and INJECTION SITE PAIN (Injection site was little sore) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 127L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical conditions were reported).    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Injection site was itchy), INJECTION SITE ERYTHEMA (Injection site was red), INJECTION SITE SWELLING (Injection site was swollen) and INJECTION SITE PAIN (Injection site was little sore). At the time of the report, INJECTION SITE PRURITUS (Injection site was itchy), INJECTION SITE ERYTHEMA (Injection site was red), INJECTION SITE SWELLING (Injection site was swollen) and INJECTION SITE PAIN (Injection site was little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient states she has had a nodule at the injection site accompanied by itching that stretches all the way down into her fingertips since a few hours after injection. She first notified the pharmacy of the continuing irritation on 11/17/12.
Client was sitting in a 15 minute observation when he reported feeling lightheaded and dizzy. Stated he felt the room was darkening. Denied any other symptoms such as chest pain, dyspnea, urticaria or nausea. Client was observed for an additional 30 minutes and vitals signs were taken which were all within normal range.  Client stated he feels this way when he is dehydrated and that he hadn't enough water. Client was offered a water bottle which he drank. At the end of the observation he stated symptoms were resolved and he left the site by self ambulation with a steady gait.
Patient fainted several minutes after receiving vaccination.  She was sitting in the waiting area at the time.
HEADACHE, NAUSEA, BODY ACHES, INJECTION SITE PAIN, MALAISE
Heart palpitations several times a day.  The palpitations continued every day until approximately 2 week after the second shot.
Patient reports she was immediately feeling strange immediately after the vaccine. She didn't think much of it and did not mention it to us at the time. She got to her car where she started to feel very unwell. She drove herself to the Emergency Room where she was told she had low Blood Pressure, stuttering speech and low O2 Sat.
side effects 14 days after the second shot/non severe side effects appearing weeks after the second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects 14 days after the second shot/non severe side effects appearing weeks after the second shot) 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 VACCINATION COMPLICATION (side effects 14 days after the second shot/non severe side effects appearing weeks after the second shot). At the time of the report, VACCINATION COMPLICATION (side effects 14 days after the second shot/non severe side effects appearing weeks after the second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment drugs are not provided by reporter.
Administration of a pediatric dose of Engerix-B to an adult patient; Administration of a pediatric dose of Engerix-B to an adult patient; The dose had expired on 05Feb2021; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 27-year-old patient who received HBV (Engerix B pediatric) (batch number 97Y27, expiry date 5th February 2021) for prophylaxis.   On 10th May 2021, the patient received Engerix B pediatric. On 10th May 2021, unknown after receiving Engerix B pediatric, the patient experienced underdose, adult use of a child product and expired vaccine used. On an unknown date, the outcome of the underdose, adult use of a child product and expired vaccine used were unknown.  Additional details were provided as follows: The pediatric dose of Engerix-B was given to the adult patient, which led to underdose and  adult use of child product. During reconciliation of adverse event data, it was found that the dose of administered vaccine was expired, which led to expired vaccine used. The HCP (Health Care Professional) shared limited information of patient. The reporter consented to follow up.
Headache, chills, generalized muscle aches, arm pain, fatigue, nausea, stomach pain, congestion, rapid heart rate and breathing.
Started with metallic taste in mouth that evening after 2nd shot, then chills for a solid couple of days. Metallic taste came back and chills went away. On Saturday, June 19th I got violently sick throwing up with diarrhea. The next week I had same event. I have since dealt with a metallic taste in my mouth again and  gallbladder pains and pains in my intestines, with issues having bowel movements. When I eat the metallic taste increases and have more severe pains. I'm currently involved in a CT scan, Ultrasound, and now waiting to schedule a nuclear med test. I have been researching  now that more people have reported gallbladder issues as well as the metallic taste.