chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site reaction/Irritation/leave a very nice large bump; Injection site reaction/Irritation/leave a very nice large bump; This is a spontaneous report received from a contactable reporter (other HCP).  A patient (no qualifiers provided) received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE MASS (non-serious), VACCINATION SITE IRRITATION (non-serious), outcome "unknown" and all described as "Injection site reaction/Irritation/leave a very nice large bump". Additional information: The HCP reported that they know that where were they put the PCV13, it's going to leave a very nice large bump. They caution parents about that all the time.   The information on the batch/lot number for pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.
chills, fatigue, congestion, sinus pressure, sinus pain, diarrhea, nausea, myalgias, light-headedness, headaches
Continued joint pain in knees, fingers, ankles, wrists and toes for 3 months now.
Face flushed, hands numb and itchy, body became itchy, tongue feeling fat, some difficulty catching her breath, but not difficulty breathing. Went to full body itching legs, arms, and torso. Mental fuzziness/ cloudiness "out of body" experience". Took extra concentration for her. She had numbness to left side of her face that lasted to the left side of her face till 5 pm. fuzziness and fogginess dissipated around 5pm. Still episode of catching her breath, taking deep breaths here and there. Next day, most symptoms are gone, today she still has to take extra deep breaths.
A non-serious spontaneous report of administration of 2 doses of FLUMIST in one day was received from a health professional concerning a four-year-old female. On 10-Aug-2011, the patient inadvertently received two doses of FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Developed diffuse maculo-papular rash on both anterior thighs pruritic.
Hot, hurting, red mark where yellow fever shot was given continued for 1 month.  Still discoloration on this date.
DAY AFTER VAX., PT SEEN IN ER WITH HYPERVENTILATION, STIFF NECK, SEVERE NECK PAIN, DIFFICULTY SWALLOWING, SEVERE BACK PAIN AND LOSS OF SENSATION IN UPPER EXTREMITIES.
Began to experience itching on both legs including thighs on February 22, 2021. Raised red  spots then began to appear. Itching and spots then appeared on back and both arms a day later, a couple of which bled due to my scratching. Finally looked up on line (with pictures) and it appears it is a Covid rash. Treatment recommended was Benedryl and Cortizone itch cream. Started regiment 03/13/2121. Three weeks later (03/15/2121) it is still itching and raised although  my legs are better.
Pain on injection site, shivering, fever on same day of immunization up to 2 days after.
Twinrix that expired in September 2023 was administered to a patient today; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a male patient who received HAB (Twinrix) (expiry date SEP-2023) for prophylaxis.   On 07-NOV-2023, the patient received Twinrix. On 07-NOV-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Twinrix that expired in September 2023 was administered to a patient today). 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: 07-NOV-2023 The health care professional (HCP) stated to a patient today (on the day reporting) Twinrix that expired in September 2023 was administered, which led to expired vaccine used. The reporter did not consent to follow-up.
Fatigue, swollen lymph nodes/glands, blister like bumps on the back of my tongue and my throat started 3 days after 1st vaccine shot. Symptoms lasted for at least 3 weeks (bumps would come and go). Had just started going down when it was time for the 2nd shot on 5/3/21. Fatigue, swollen lymph nodes/glands, blister like bumps on my tongue and the back of my throat are still present. I did go to urgent care and my ear was irritated. Was tested for covid-19, flu, strep and mono, all tests were negative.  I went to my primary doctor and I have had 2 ultrasounds which showed nodules on my thyroid and supraclavicular glands. Waiting for a CT scan which my insurance hasn?t approved yet.  I am in pain everyday.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 86-year-old female patient who received SHINGRIX. Previously administered products included SHINGRIX (1st dose, vaccinated on the patient's unknown deltoid). On 12th April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 12th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain and injection site erythema were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional information was reported as follows: The patient reported that she had received her second SHINGRIX vaccine at a local pharmacy. When she had her second dose of SHINGRIX, the pharmacist gave her the vaccine intramuscularly on her triceps, which led to vaccine administered at inappropriate site. The patient was having pain and redness below the injection site, radiating down to her elbow. She also reported that her injection site was sore after vaccination with the 2nd dose. Her prescribing information had advised her to receive a third dose of the SHINGRIX to compensate her second dose that was not given in the right place. The details of the physician was provided.
This is a spontaneous report obtained from a contactable pharmacist. A 66 year old female patient received, on 22Apr2017, PREVNAR 13 (Lot. N97936, Expiration date: Jan2018, NDC number: 00055197101, UPC number: 300051971022) single dose, for immunization. Relevant medical history included penicillin allergy, dental issue and blood pressure. Concomitant medications included Losartan 100 mg /HCTZ 12.5 mg for blood pressure (ongoing); and chlorhexidine for dental issue. On 23Apr2017, the patient experienced itchy skin on the arms. On an unspecified date, in Apr2017, the patient started to become red hot and swollen from shoulder to elbow. Treatment  with hydrocortisone cream was received. Clinical outcome of the events was recovering at time of this report.
Pneumonia due to COVID-19 virus ; Had a lot of headaches; Had agitation/palpitations; Had muscle cramps; Hydroxyzine HCL; Amoxicillin; Acetaminophen.
Every inch of my body was so sore (but no fever or other symptoms) I didn't want to even turn over or move in any way in bed. Lasted two days.
Initial report received on 19 September 2012 from the Investigator participating in a post-marketing observational surveillance study. A case of pertussis disease in an 10-month-old male subject (initials not collected) was identified by the investigator based on review of data from the State Electronic Disease Surveillance System electronic database. The subject had received 3 doses of PENTACEL; lot number C3978AA received on 02 November 2011, lot number C3999AA received on 06 January 2012 and lot number C4131AA received on 29 February 2012 (routes and sites of administration not reported). The subject developed a cough on 16 July 2012, approximately 5 months after the last dose. On 18 July 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 21 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 21 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 14 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 29 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
10 cm diameter erythematous, hot wheal around injection site on L thigh where received DTaP.
Feels like he flu; Had a hard time sleeping because I was uncomfortable; Had a hard time sleeping because I was uncomfortable; Muscle aches; Head ache; Terrible; This is a spontaneous report from a non-contactable consumer. This consumer reported for a male patient (brother in law) A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration on 17Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced feels like he flu, had a hard time sleeping because i was uncomfortable, muscle aches, head ache, terrible, all in Jan2021 (about 8 hours after the shot). The event outcome was unknown.  Information on the lot/batch number has been requested.
Small and then large hives  on chest, groin, limp nodes and finally all over.
First shot got Shingles /Still have some shingles; Got second shot. Still have some shingles from first shot; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles and off label use. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the off label use was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received shingles vaccine and experienced shingles. The patient also got second dose of shingles vaccine when still had some shingles from first shot, which led to off label use. Nurse stated that some people had them for a couple of years.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR169586:same reporter
I find I have been given Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I find I have been given Covid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (I find I have been given Covid). At the time of the report, COVID-19 (I find I have been given Covid) outcome was unknown.            No concomitant drug information was given.  No treatment drug information was provided.  Company comment: This spontaneous case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected non-serious AESI of COVID-19 after receiving the 3rd dose of mRNA-1273 vaccine. The onset date of the event was not reported. Clinical course, laboratory and treatment details were not reported. The outcome of event was unknown. Patient received first 2 doses of mRNA-1273 vaccine (date not reported). The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed non-serious based on medical judgement.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected non-serious AESI of COVID-19 after receiving the 3rd dose of mRNA-1273 vaccine. The onset date of the event was not reported. Clinical course, laboratory and treatment details were not reported. The outcome of event was unknown. Patient received first 2 doses of mRNA-1273 vaccine (date not reported). The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed non-serious based on medical judgement.
STROKE, ABDOMINAL ANEURYSM, FATIGUE, VOMITING, FALL, HEADACHE, BODY ACHE
Parent returned to Health Department on 8/19/11 to show an area of redness and induration on her daughter arm - approx 1 1/2". Explained this was a common side effect of shots. She ha been applying ice. Reports that the day after the vaccine it was 4 inches in diameter. Parent requested it be reported as an adverse side effect.
1000 Administered injection. 1020 pt stated pain at site with some pain radiating down across clavicle area. 1030 taken to occupational health. Advised to go on to ER for evaluation. 1035 ER for triage. Was given MOTRIN at 1040.
Pfizer-BioNTech COVID-19 Vaccine EUA: Heart Arrhythmia, causing very low Bradycardia (as low as 31), as well as some palpitations, usually after the very low heart rate, like heart was trying to make up missed beats; 4 times felt after 1st dose, 12+ times felt after 2nd dose; called cardiologist office and told to go to emergency room, which I did on 4/16, admitted for observation on 4/17, discharged 4/17 after cardiologist visit and agreement to get nuclear stress test as outpatient. Nothing felt after 4/17; stress test on 5/6; only some usual PVCs and a couple PACs during successful stress test. Cleared by cardiologist for normal activities 5/24/21.
Late period. Typical cycle for years (recorded on phone app) is 25 days, never exceeding 29, and even 29 is very rare for me. Period cycle after second COVID vaccine was 31 days. Flow was normal and length but just very late compared to history. The latest ever in fact.
Information has been received from a physician concerning a 31 day old male who on 24-FEB-2011 was vaccinated with a dose of VAQTA (lot#: 669749/1628Z, exp on 18-OCT-2013) instead of hepatitis B virus vaccine. No adverse symptoms noted. The patient sought an unspecified medical attention. This is one of several reports from the same source. Additional information has been requested.
I pulled up our page in software system called Preventative Health where another staff had entered in his prior vaccine history.  That page noted he had not received his original series and so I spoke to his family who authorized the vaccine.  After vaccinating I pulled up another document I learned about in the same software which noted he had received his original series at clinic in 2021.  I notified his physician and noted to give him the Bivalent Booster in 2 months.
Autoinnoculation. Close to vaccination site - likely secondary to tape-related disruption of skin.
Pain after first shot was only mild dull pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 26Jan2021 at 10:00 (at the age of 45-years-old) (Lot Number: EN5318) as dose 1, single for COVID-19 immunisation. Medical history included known allergies to ibuprofen and amoxicillin. The patient's concomitant medications were not reported. The patient did not receive other vaccine in four weeks. No other medications were received in two weeks.  The patient did not have COVID prior to vaccination and had not been tested for COVID post-vaccination.  On an unspecified date, the patient experienced pain after first shot was only mild dull pain at injection site. No treatment was received for the event. The outcome of the event was recovering/resolving.  No follow-up attempts are needed. No further information is expected.
G47.33 OBSTRUCTIVE SLEEP APNEA 4/25/2023 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE G47.33 OBSTRUCTIVE SLEEP APNEA 4/25/2023 CHRONIC ATRIAL FIBRILLATION
Patient described waking up at 3am the morning after her injection hurting all over, fever, chills and headache.  Patient remained in this state all day after injection. Patient felt better two days after injection.
dry-heaves; severe chills; eat very little that day of the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 10:30 as dose 1, single (Lot number: HG4633) at the age of 72 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SIMVASTATIN; LISINOPRIL; AMLODIPINE. The following information was reported: DECREASED APPETITE (non-serious) with onset 02Oct2023, outcome "recovered" (Oct2023), described as "eat very little that day of the vaccine"; CHILLS (non-serious) with onset 02Oct2023 at 22:30, outcome "recovered" (03Oct2023 at 02:30), described as "severe chills"; RETCHING (non-serious) with onset 03Oct2023, outcome "recovered" (03Oct2023), described as "dry-heaves". Therapeutic measures were not taken as a result of chills, retching, decreased appetite. Additional information: Approximately 10:30 P.M, the patient experienced a 4-hour episode of severe chills, followed by about an hour of dry-heaves. Patient eat very little that day of the vaccine, which has been his routine since he developed this reaction.   The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Glass shattered and broke off cutting other hand; Glass shattered and broke off; This is a spontaneous case initially received from a pharmacist on 26-Nov-2018 (follow-up 2 received on 28-Nov-2018, processed together), concerning a female patient (pharmacist) of an unspecified age.  On an unspecified date in Nov-2018, the pharmacist when went to administer Afluria Quadrivalent (influenza vaccine) to a patient, she depressed the plunger and the glass shattered and broke off (explicitly coded as syringe broken) cutting her other hand (explicitly coded as device induced injury).  No adverse events were reported.  This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding product technical complaint (PTC) reference number was PR608951. As per the QA investigation report, due to the ambiguity of this complaint and due to the limited information provided, there was no assignable root cause. There were no CAPAs (corrective action and preventive action), therefore an effectiveness check is not required.  Non-significant follow-up received from the pharmacist on 09-Jan-2019: This case was considered as lost to follow up as the reporter could not be contacted to gather further information. Added reference number (Info Number: SEQ19-00182 and SEQ19-00018) in the additional information tab. No changes were made in the narrative.  Follow up received from the QA (Quality assurance) department on 06-Feb-2019: As per the QA investigation report, due to the limited information provided, there was no assignable root cause. There were no CAPAs, therefore an effectiveness check is not required. The narrative was amended accordingly.; Reporter's Comments: A female pharmacist of an unspecified age experienced device induced injury after the glass shattered and broke off the syringe of Afluria Quadrivalent (syringe broken and device induced injury). The company assessed the causality of the events as not related considering the incidental nature of the event syringe broken and the accidental nature of the event device induced injury.
What I thought was typical arm soreness continues to this date, 11/6/2014. Pain is high on the arm causing limited range of motion and discomfort even while sleeping.  It is slowly improving, but persists.
Information has been received from a health professional concerning a male over the age of 65 who in 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649696/0490P).  Subsequently the patient developed an injection site reaction, including hot, swollen, painful area at injection site.  The patient sought unspecified medical attention and was treated with acetaminophen (Tylenol) and fexofenadine hydrochloride (Allegra).  It was also reported that 2 other patients experienced adverse events following administration of pneumococcal 23v polysaccharide vaccine (lot 649696/0490P).  There was no product quality complaint involved.  Additional information has been requested.
Fever (100), chills, aches, stomach cramping, headache approx 24 hours
8 days after receiving the vaccine, she noticed itching, redness and swelling at the injection site that continue to worsen. No pain.
On the day of the vaccine, about 5 hours after, I started feeling fatigue. I felt like I had been awake for 24+ hours. That evening I was watching television, covered with a blanket, and my nose got very cold and tingly. I felt like I was breathing cold air. That did resolve later that evening. The next day I was really fatigued and felt dizzy. I felt this way all day. Later that day I started itching. My head, legs and arms were itching. At 11PM that night I called the Hospital and spoke with a nurse to see what I could take for the itching. I was told that since it was after 24 hours from the injection, I was able to take Benadryl. I had to take it every day for the week. I continued to have fatigue and dizziness for 2 days after receiving the vaccine. My psoriasis was healing and had almost gone away, but 2 days after the injection I had a flare. I stayed in psoriasis and psoriatic arthritis stayed in a flare until around 05/12/2021. I had to receive several steroid injections and B12 injections to calm everything down.
This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 16-OCT-2017, the patient was vaccinated with improperly stored doses of VARIVAX lot # N012131, expiration date 17-APR-2019 (dose and route of administration were not reported). The vaccine was reconstituted with sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 6 degrees Fahrenheit and 17 degrees Fahrenheit for 3 hours and 40 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007766.
Pain to entire right arm, difficult to move right arm due to pain. Rates pain as 9 out of 10. (this was the arm injected). No redness, no swelling, no induration, no temperature difference, grip strength equal, capillary refill quick and equal. This was the patient's 3rd and final Twinrix dose.
Within 12 hours of vaccination, developed fever 102-103, headache, and dizziness, weakness.