chrisvoncsefalvay/vaers-outcomes huggingface dataset:
As I waited to be called the tec who would administer the shot came to my location to lead me to the small room where the shots are given. As we approached the door a couple male and female were exiting the room where they had been apparently unsupervised. Once in the room and seated I saw the syringe with the vaccine. Inside lying plainly on the counter in front of where I sat to be injected. I asked the tec was that the shot for myself and it was. Somewhat distracted I didn't sense alarmed but later that evening I recalled the entire scenario and became disturbed. Why was this tec in such a rush to walk outof the medical space to get me after filling a syringe laying it in plain sight and leave two clients or client and a friend alone in the room. I think this is a violation of proper practice at least. Now I'm not sure of what was put into my arm. What does your agency advise me to do
Huge red area; Swollen area; Painful; Feverish; didn't take the 2nd one; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (1st dose received on an unknown date).   On an unknown date, the patient received the 1st dose of Shingrix and did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced erythema (Verbatim: Huge red area), swelling (Verbatim: Swollen area), pain (Verbatim: Painful), fever (Verbatim: Feverish) and incomplete course of vaccination (Verbatim: didn't take the 2nd one). The outcome of the erythema, swelling, pain and fever were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the erythema, swelling, pain and fever to be related to Shingrix.     It was unknown if the company considered the erythema, swelling, pain and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-MAR-2023 This case was reported by a patient via interactive digital media. The patient had huge red and swollen area that was painful and feverish over a week, so the patient did not receive second dose of Shingrix vaccine.  The patient was good. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. Follow-up would not possible as no contact details were available.
Rash on chest and stomach; Rash on right deltoid (injection site); This spontaneous case was reported by a nurse and describes the occurrence of RASH (Rash on chest and stomach) and VACCINATION SITE RASH (Rash on right deltoid (injection site)) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Obesity, Allergy to antibiotic (Patient is allergic to Amoxicillin.) and Drug allergy (Patient is allergic to Decadron.).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced RASH (Rash on chest and stomach) and VACCINATION SITE RASH (Rash on right deltoid (injection site)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) 09-Mar-2021 at a dose of 25 milligram once a day. At the time of the report, RASH (Rash on chest and stomach) and VACCINATION SITE RASH (Rash on right deltoid (injection site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up received on 04-May-2021 included HCP information,Patient's Initials "SS", Date of Birth, Medical history, Vaccine dose no and route of administration and Vaccine facility.
Received vaccine without complication.  Has a known seizure disorder secondary to brain injury.  Seizures often triggered by stress.  During observation period, RN was made aware that patient had decreased responsiveness.   States this is common activity for absent seizures which he has several per week.  First set of vitals: HR 70, RR 20, SpO2 95% on RA.  He was taken to tent where he became more alert and was A&O x 3 and recovered quickly.  Second vital set taken 10 mins after first: HR 70, RR 16, BP 140/96, 97% on RA.  Evaluated by provider: clear lung sounds, no signs of stridor or difficulty breathing denied any rash, SOB, CP, swelling of mouth or throat.  Returned to baseline within 10 mins.  Recommended to be evaluated at the ER though left AMA.
Patient lost conscious.  Feet elevated,  0.3 ml Amonia inhalant provided. Pt regain consciousness after receiving respiratory stimulant. Powerade drink given ,paramedic staff  assess patient.  After 5 minutes ,Patient stated" feeling better"  family menber came to tent and took patient home.
This spontaneous report as received from a consumer's wife refers to a 77 year old diabetic male patient. At the time of this report, the patient had no known allergies. On 24-JUN-2014 the patient was vaccinated with ZOSTAVAX (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). Concomitant medications included an unspecified medication for diabetes. On an unspecified date in 2014, the patient developed a case of shingles. The reporter described the rash as vesicular, with three long vertical bands going across the patient's hip. The patient had no pain with this outbreak. On 10-OCT-2014, the patient was seen by his physician and was diagnosed with shingles. It was unspecified if treatment was given for the adverse event. Laboratory diagnostics studies performed were unspecified. The outcome of shingles was reported as not recovered/not resolved. The relatedness between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Fever and very red/sore arm (per nurse). Patient did not return phone call to pharmacy. Nurse said patient already had pneumonia vaccine in 2012 but patient wasn't aware.
Nausea, sort of breath, tingling around lips with odd taste.  Patient was given oxygen and Benadryl PO and reported complete resolution of symptoms at 9:25am.
EMS evaluated treated and transported- Difficulty breathing, tongue swelling, flushing, airway swelling 12:22 patient received covid 19 Pfizer vaccine 12:23 EMS called off to assess  patient c/o of difficulty breathing, tongue swelling, flushing. 12:28: 50 mg IV diphenhydramine - some improvement seen- patient transferred to higher level of care per EMS
Temperature at 101.5F or 101.2F; No appetite; Muscle weakness; Chills; Joint pain; Nausea; vomiting; Big Headache; A spontaneous report was received from a 56 year old, female, dietician who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, temperature of 101.5F or 101.2F, no appetite, muscle weakness, joint pain, nausea, vomiting and a big headache.   The patient's medical history, as provided by the reporter, included no comorbidities and no allergies. The patient reported taking no concomitant medications.   On 28 Dec 2020, approximately 4 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026120A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient reported side effects of chills, temperature of 101.5F or 101.2F, no appetite eating nothing for the last few days, muscle weakness, joint pain, nausea, vomiting and a big headache. The patient was surprised the vaccine hit her this way as she does not really get sick, has no comorbidity, takes no medications and has no allergies. She consented to follow up from safety and her HCP.   Treatment for the events included Tylenol (acetaminophen) and Motrin (ibuprofen) but the patient stated they were bothering her stomach. She mentioned that she also vomited some blood.   Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events, chills, temperature of 101.5F or 101.2F, no appetite, muscle weakness, joint pain, nausea, vomiting and a big headache, were not reported.; Reporter'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.
pt  was given vaccine at approximately 6:26pm and he was monitored based on his previous history of fainting after a vaccine. He sat in his chair and after about 4 to 5 minutes, he began to pass out. His father caught him and held him up, and he quickly came back to. He was flushed and felt warm. His temp was within normal range. A cold pack was applied to his neck and he was given water. He felt better shortly after. He was observed for 20 more minutes and looked well. He left with his parent/family.
Severe pain 10/10 redness 4-5 inches long 2 inches wide at injection site. 7-5-18 dx cellulitis-given doxycycline, BENADRYL.
Different hurt. It only hurts when they touch it and that's a reaction you actually get with the injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Mar2021 15:30 (Lot number: EN6199) at the age of 82 years as dose 1, single and intramuscular, administered in arm left, administration date 24Mar2021 15:15 (Lot number: EP6955) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Different hurt. It only hurts when they touch it and that's a reaction you actually get with the injection". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had no prior vaccinations.   No follow-up attempts are possible. No further information is expected.
significant and sharp pain from just below my left ear all the way down to my left fingers (could not lift arm above ribcage,) serious tension headache, insomnia, fever of 100 degrees, upset stomach, lower back pain, fatigue
Adult dose given instead of pediatric dose. Patient monitored for ~20 minutes post administration and no signs/symptoms noted.
8 hrs after the vaccination my son experienced violent shaking and rigor, extreme discomfort because of the muscle cramps. Headache, high fever (102F), nasal congestion, nasal discharge and generalized body pain. He took multiple Tylenol and Motrin however the fever did not decrease for many hours and low grade fever (100F) continued into the next day. He had pain on the entire left side of the body.  He felt increased sensitivity to touch and even the shower water was hurting. The fever and body pain stayed till the next day evening and needed round the clock Tylenols and Motrins to feel better. He inly felt better 2 days after the vaccination.
heart palpitations 2 hours post vaccination lasting  for approximately 10 minutes lower back pain altered coordination/balance chest pain on and off
temp of 99.5; headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 4th March 2020, unknown after receiving Shingrix, the patient experienced fever and headache. On an unknown date, the outcome of the fever and headache were unknown.   It was unknown if the reporter considered the fever and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporting day was the second day. The patient still had a temperture of 99.5 degree F and a headache. The patient enquired how long would the side effects last.
Received phone call at about 4:30 PM with complaint of generalizes flushing starting from face and spreading down to all over the body. No history of nausea and vomitting, noncranky, nonirritable, no fever and tolerating feeding.  All of those symtoms occured about 30 minutes after injection Mother was to bring patient back to clinic and assessment was done. Vital sigs were Temperature 97.7 F, Heart rates 120/min, Respiratory rate 38-40/min. Patient is active and alert, not in distress, Lungs are clear and no wheezing, Heart has no murmur, abdomen is soft and no abnormal mass and bowel sound present and active. Extremities are normal, no cyanosis and no other abnormality. Flushing all over the body with maculo-papular rash, mild itchyness. No lession at injection site
All of the below occurred after Pfizer shot #2 administered on 4/1/2021. Pfizer shot #1 was administered on 3/12/2021 with minimal effects lasting less than 24 hours (arm soreness, flu-like symptoms, etc.).  1) Severe worsening of costochondritis (chronic chest pain) to the point of breathing difficulty and inability to lie down. Began 4/1/2021 and became unbearable the evening of 4/7/2021, requiring an ER trip the same night (see Item 19). This pain has since continued to come and go, worse than I ever had it before the vaccine.  2) Very severe worsening of tinnitus (ringing/pulsing in ears) - lasted 1.5 months, from 4/1/2021 to around 5/15/2021.  3) Severe hormone imbalance symptoms (waves of severe nausea occurring several times daily, extremely late and painful/heavy period, swelling in ankles & feet, etc.) for ~1.5 months, from late April 2021 to around 5/15/2021. I cannot identify any other changes or life factors besides the vaccine that would have caused these issues.
Slur; Bell's Palsy; Thought he was having a stroke; Face was tensed; Ear infection; Ear pain; Jaw pain; Was a little off; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's Palsy) and CEREBROVASCULAR ACCIDENT (Thought he was having a stroke) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter. No treatment information was provided.  Concomitant products included HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE 1A PHARMA) for Blood pressure.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced FATIGUE (Was a little off). On 08-Jun-2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (Thought he was having a stroke) (seriousness criterion medically significant) and REDUCED FACIAL EXPRESSION (Face was tensed). In June 2021, the patient experienced EAR INFECTION (Ear infection), EAR PAIN (Ear pain) and PAIN IN JAW (Jaw pain). On an unknown date, the patient experienced DYSARTHRIA (Slur). The patient was treated with PREDNISONE ongoing since an unknown date at a dose of 1 dosage form. In May 2021, FATIGUE (Was a little off) outcome was unknown. At the time of the report, BELL'S PALSY (Bell's Palsy), CEREBROVASCULAR ACCIDENT (Thought he was having a stroke), DYSARTHRIA (Slur), REDUCED FACIAL EXPRESSION (Face was tensed), EAR INFECTION (Ear infection), EAR PAIN (Ear pain) and PAIN IN JAW (Jaw pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, Computerised tomogram: normal (normal) normal. On an unknown date, Lyme disease: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient face was tensed and his face was seized. The left side of his face was drooping he had trouble closing his left eye. Water was dripping out of his mouth when he tried to drank he felt that something was not right and his eye was watering that morning constantly. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-229259 (Patient Link).; 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
localized lt deltoid edema, x24-48hr lt axillary tender adenopathy, low grade T99.5 oral;
hive on my chin; left side of tongue was a bit swollen; face numbness sensations; This case was reported by a consumer via call center representative and described the occurrence of hives in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st June 2022, the patient received the 1st dose of Shingrix. On 2nd June 2022, 1 days after receiving Shingrix, the patient experienced hives, swollen tongue and numbness facial. On an unknown date, the outcome of the hives, swollen tongue and numbness facial were recovered/resolved.   It was unknown if the reporter considered the hives, swollen tongue and numbness facial to be related to Shingrix.     Additional Information: GSK Receipt Date: 6-JUN-2022 Reporter's Comment: The patient experienced a hive on his/her chin and then also felt like left side of tongue was a bit swollen and some face numbness sensations. On an unknown date in June 2022, the outcome of the hives, swollen tongue and numbness facial were recovered/resolved. The patient would like to talk to someone to determine if it was safe for him/her to get 2nd dose. The reporter stated that she reported to her doctor but they seemed uncertain. The patient also stated that she laked with her doctor's office that day, but she thought it prudent to saw what GlaxoSmithKline may think since GlaxoSmithKline knew best probably how reactions had gone with others. The patient enquired even to knew if it might be better to take the 2nd dose closer to the 6 month mark rather than the 2 months in hopes if there were to be another experience it might remain mild. Additional supportive information:  The follow-up would not possible as no contact details were available.
Developed small red raised areas on elbows - back - stomach - legs..1 to 2 lesions occurring per area. Itchy, burning sensation about dime sized prescribed hydroxyzine & steroid topical cream
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 as dose 5 (booster), single (Lot number: GL6665) at the age of 51 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No Known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 05Apr2023 to 10Apr2023. No follow-up attempts are possible. No further information is expected.
T-100.8 day after vaccines. Baby fussy, cool compresses, TYLENOL as needed. Monitor and call if sx change/worse.
This spontaneous report was received from a nurse (also reported as healthcare worker) refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. Since 04-FEB-2015, an unspecified number of patients were vaccinated with a dose of PEDVAXHIB, (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were incorrect stored. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a 18 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 13-SEP-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours on 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1809USA002868: Original Case : 1809USA002868 US-009507513-1902USA009324: Original Case : 1902USA009323  US-009507513-1902USA009325: Original Case : 1902USA009323 US-009507513-1902USA009326: Original Case : 1902USA009323.
31 years old female received Fluzone High Dose, no AE; 31 years old female received Fluzone High Dose, no AE; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 31 years old female breast feeding patient who received 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ238AB (Expiry date 14-Apr-2020) via unknown route in unknown administration site on 19-Sep-2019.  This case inked with case 2019SA268841 (baby case).  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate age at vaccine administration and overdose.   At a time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
legs & feet swelled huge; Fever; chills; sleepy; legs & feet swelled huge; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 29Apr2021, as dose 2, single for COVID-19 Immunisation. The patient age at vaccination was 64 years. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose single for COVID-19 Immunisation. On an unknown date after 2nd vaccination, the patient experienced fever, chills, sleepy, last couple weeks, legs and feet swelled huge and can't put on shoes. The outcome of the events was unknown.  Follow-up attempts are needed. Further information is expected.
Swollen and painful left arm. Went to the emergency room and a prescription for NORCO 3/325 mg for prescribed.