chrisvoncsefalvay/vaers-outcomes huggingface dataset:
immediatly upon getting immun pt turned pale & then turn ash color became clammy; crying was grunting cry-stared into space; pt then became pale but dry, appeared sleepy;
Weakness; Tingling in arm that was vaccine was given; Fever; Extreme fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EC1284), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced extreme fatigue, tingling in arm that was vaccine was given, fever, and weakness on 30Dec2020. No treatment was given for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. The outcome of the events was unknown.
Quarter size red spot swollen and hot to the touch. Sore and itchy, or about a week. After 11th day spot is faded.
Achey stiff upper body, sore at site of injection, loss of appetite, headache, feeling ?out of it?, fatigue
Swelling at injection site 1/2 hour after receiving the dose and lasting over 4 days.
Patient became ill on 10/30/21 with cold symptoms. She reports worsening cough over the past two days, as well as nausea, vomiting, and diarrhea. She is currently experiencing shortness of breath requiring 2 L O2 by nasal cannula. Current BP is 95/56. The patient will receive 6 mg dexamethasone. She will be admitted to the hospital.
This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL (lot # K007264 and expiration date 02-MAR-2017) (dose and route were not reported).  No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
About 45 minutes after receiving ZOSTAVAX vaccine I started itching on my leg and discovered hives forming. The hives eventually appeared on trunk and arms. I saw family doctor and treated with BENADRYL.
Had shingles after getting the shots/ suspected vaccination failure; Shingles; Thinking she is going to die; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shingles after getting the shots/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and impending doom (Verbatim: Thinking she is going to die). The outcome of the vaccination failure was unknown and the outcome of the shingles and impending doom were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and impending doom to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and impending doom to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-MAR-2023 This case was reported by a patient friend via interactive digital media. The reporter reported that his or her friend received Shingles vaccine due to suggested and experienced shingles. The reporter stated that the patient had bad reaction and she ended up in the emergency room for three times and thought she was going to die. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR054617:Same Reporter US-GSK-US2023AMR054618:Same reporter US-GSK-US2023AMR054624:Same reporter
This case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a adult female patient who received Flu trivalent vaccine. On an unknown date, the patient received Flu trivalent vaccine at an unknown dose. On an unknown date, less than a year after receiving Flu trivalent vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was recovered/resolved. It was unknown if the reporter considered the vaccination failure and influenza to be related to Flu trivalent vaccine. Additional details were provided as follows: The age at vaccination was not reported. About 5 years ago from the date of reporting, the patient took the flu vaccine and experienced the flu. The patient did not report any hospitalization. At the time of this report, the patient had recovered from flu episode. The patient clarified, of all the times she had taken the vaccine, she twice got the flu anyway. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule and lab test confirmation for targeted disease was unknown. This case has been linked with case US2018GSK035098, (case of next dose, for the same patient).
itchiness of the eyes lids, under the eyes, eyebrows; Itchiness of forehead; Redness and burning of the eyes; Redness and burning of the eyes; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the right arm on 06May2021 at 09:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06May2021, the patient experienced itchiness of the eyes lids, under the eyes, eyebrows and forehead as well as redness and burning of the eyes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events itchiness of the eyes lids, under the eyes, eyebrows and forehead as well as redness and burning of the eyes were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
19 y/o female had appointment for a Covid 19 vaccination.  The vaccine was administered ~9:40 AM, immediately client began to complaint of her left arm hurting (opposite arm that the vaccine was administered) and that her chest was feeling tight.  EMS and nurse was with client.  Vitals were BP 150/84, P 78.  Client was smiling and constantly on her cell phone during the assessment.  Client did not appear to be in distress.  Client stated that she had a migraine and chest tight.  Vitals retaken about 15 minutes later BP 139/86 and P72.  EMT asked how she was and she said that she thought she needed to go to ER via ambulance.  Ambulance was called and taken to Hospital.
2FEB93 pt was administered @ 10AM cried p/getting inject by 11AM according to pt's mom, began screaming, high pitched crying , inconsolable & persisting from 11AM til 7PM, t101 R, lt ant thigh, red, hot to touch;
Information has been received from a physician concerning a 14 month old patient (gender unspecified) who on 23-MAR-2009 was vaccinated with 2 ml of the first dose of ROTATEQ (Lot number 663359/1661X) orally and on 15-MAY-2009 the patient received 2 ml of the second dose of ROTATEQ (Lot number 663461/0285Y) orally. On 01-MAY-2010 the patient became ill and was hospitalized. On an unspecified date the patient was positive for rotavirus antigen. A of 05-MAY-2010, the patient's was still hospitalized and not recovered. This is one report from two reports from the same source, the twin patient's experienced was reported on WAES 1005USA00434. Became ill and positive for rotavirus antigen were considered as other important medical event. Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA Monday, March 15th around 9:30/10:00am I began to feel nauseous, had a headache, felt cold and overall tired. I had to stop working and I laid down to rest and slept for 4-5 hrs. Continued to feel weak with a loss of appetite for the remainder of the day and slept through the night.  Tuesday, March 16th I began work around 8am and by 9:20am I had to stop due to a pounding headache and extreme nausea and muscle aches in my back. My eyes were sensitive to light, my head hurt and felt a lot of pressure in the front of my head and back of my neck and my  ears were beginning to hurt and ring. I took acetaminophen and slept for 3-4hrs. When I woke up the nausea had subsided but I still had a lingering headache, just not as terrible, and took additional acetaminophen 500mg. This headache continued for the rest of the day into the night, waking me up to the point of needing another 500mg acetaminophen and waking up the next morning Wednesday, March 17th with still a slight lingering headache, slight sensitivity to light, light nausea, light muscle/body ache, and general feeling of weakness.
11/5/22 I woke up with a mild sore throat. I took a home COVID test which was positive. My symptoms were extremely mild. I had congestion. I had telehealth visit at 1:00PM. The nurse practitioner suggested I take PAXLOVID, the lighter dose. That evening I had chills and woke up the next morning feeling almost normal. I took the 5-day regimen. I tested negative for COVID after the 5 days. Within a few days after that, I had nasal congestion again, like a cold. I tested positive for COVID that day. The rebound lasted another 5-6 days with nasal congestion only. By the last week of November, I was better.
Information has been received from a physician concerning a 16 or more years old female patient who over one year ago was vaccinated with her first dose of GARDASIL. The same day post vaccination, the patient experienced headache, vomiting and abdominal pain. Subsequently, the patient recovered. Additional information has been requested.
Arm redness within 48 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient family member or friend and describes the occurrence of ERYTHEMA (Arm redness within 48 hours) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced ERYTHEMA (Arm redness within 48 hours). At the time of the report, ERYTHEMA (Arm redness within 48 hours) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided.   This case was linked to MOD21-078675 (E2B Linked Report).; Sender's Comments:  MOD21-078675:
Chills, low fever, tiredness, headache, iffy stomach.  Was fine the next morning.
Swollen left knee with stiffness lasting one week. I was seen for congestion, cough, and sore throat. Diagnosed with sinusitis and bronchitis. I'm not sure this had anything to do with the vaccine though. Given doxycycline antibiotic. Cough congestion started the day after the vaccine was given.
Serious bone marrow atrophy, headaches, tendonitis, synovitis, insomnia swelling on arm of vaccine for 1 month, remained in L hand large lump on wrist, loss of movement remained. Lump surgically removed, stabilization implant inserted. Physical therapy 2-3 times a week currently. Cannot sustain weight/pressure, pushups. Total loss of movement/strength occurred by Mar 09.
no adverse event; vaccines were administered after the excursion; This spontaneous report as received from an office manager refers to a patient of unknown age and gender.  On 12-NOV-2021, the patient was vaccinated with a 0.5 mL dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # U017140 exp date 28-NOV-2012) rHA after the excursion. Concomitant therapy included sterile diluent. The temperature of excursion was 6 °F up to 14 °F for 4 hours and 14°F up to 46°F for 4 hours 45 minutes. There was no previous temperature excursion.  The office manager also stated that she did not have any patient information and that 10 patients received the vaccine after the excursion. The excursion was identified right away and there were no reported adverse events.  This is one of several cases received from the same source.; Sender's Comments:  US-009507513-2203USA001850: US-009507513-2203USA001841: US-009507513-2203USA001716: US-009507513-2203USA001578: US-009507513-2203USA001612: US-009507513-2203USA001688: US-009507513-2203USA001728: US-009507513-2203USA001890:
Fatigue approx 3 days, brain fog/inability to experience normal thought processing approx 10 days
Age was entered incorrectly and showed patient was 18 years old. Patient was actually 17 years old at time of vaccine
YF-Vax was mixed with sterile water instead of the diluent and administered to a patient with no reported adverse event; Initial information received on 06-Jun-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an unknown age and unknown gender patient where yellow fever vaccine [YF-vax] mixed with sterile water instead of the diluent and administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect yellow fever vaccine. Solution for injection lot number not reported via unknown route in unknown administration site (dose, frequency, strength and expiration date: not provided) for prophylactic vaccination, Information on the batch number was requested and YF-Vax was mixed with sterile water instead of the diluent and administered to a patient with no reported adverse event (product preparation error) (latency- same day) following the administration of yellow fever vaccine.  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the guidelines. 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.
pt recv vax 6JUN97 &  5 days post vax pt parent c/o devel of a rash;rash was unresponsive to DPH;rash consisted of red, maculo-papular spots scattered throughout the body, a few w/clean centers, & confluent in several patches of trunk;
low grade flu; body pain; pain at injection site; fatigue; muscle pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (low grade flu), PAIN (body pain), VACCINATION SITE PAIN (pain at injection site), FATIGUE (fatigue) and MYALGIA (muscle pain) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Disability (disability in both feet) and Autoimmune disorder NOS.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (low grade flu), PAIN (body pain), VACCINATION SITE PAIN (pain at injection site), FATIGUE (fatigue), MYALGIA (muscle pain) and CHILLS (chills). At the time of the report, INFLUENZA LIKE ILLNESS (low grade flu), PAIN (body pain), VACCINATION SITE PAIN (pain at injection site), FATIGUE (fatigue), MYALGIA (muscle pain) and CHILLS (chills) 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.   No relevant concomitant medications reported.  No treatment information was provided.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unspecified date, the patient was inadvertently vaccinated with a dose of PNEUMOVAX23 (lot # L024129, expiration date 21-JAN-2017, dose and route of administration was not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Site: Pain at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Fainting / Unresponsive-Medium
This spontaneous report received from a patient concerned an 80 year old female.  The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies and was not pregnant at the time of vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported,1 total administered on 10-MAR-2021 for prophylactic vaccination (dose series 1).   Non-company suspect vaccine included: MRNA 1273 (batch number: 071F21A expiry: UNKNOWN, form of admin, route of admin, and were not reported) dose was not reported, administered on 28-OCT-2021 for prophylactic vaccination (dose series 2). No concomitant medications were reported.  On 03-NOV-2021 following vaccination with  MRNA 1273, the patient experienced some hives which was getting worse and also had swollen face, scaly face, hives on face and arm and hives were causing very bad itching (dose series 2) for which patient applied  water, Vaseline, cream and possibly milk.  The action taken with covid-19 vaccine ad26.cov2.s and  MRNA 1273 was not applicable.  The patient had not recovered from hives on face and arm / hives causing bad itching, swollen face, and scaly face.  This report was non-serious.
Soreness in arm; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ERO729) via an unspecified route of administration in the left arm on 06Apr2021 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on an unknown date in Mar2021 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021 at 14:00, the patient experienced soreness in arm and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with Tylenol. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events soreness in arm and headache was recovered on an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected.
sore arm; feeling like eh after the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FEELING ABNORMAL (feeling like eh after the booster dose) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and FEELING ABNORMAL (feeling like eh after the booster dose). At the time of the report, PAIN IN EXTREMITY (sore arm) and FEELING ABNORMAL (feeling like eh after the booster dose) outcome was unknown.            No concomitant medication information was provided. No treatment medication information was provided.   This case was linked to MOD-2022-505839 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Mar-2022: Follow-up received Email doc attached to the initial version.
pt recv vax 31JAN97 & same day pt had a sz (cont body jerking) while sleeping which lasted about 10 hr;pt was not adm to hosp & was arousable;sz did not recur;
This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows: This case was reported by medical assistant. The age at vaccination was not reported. The patient brought SHINGRIX in from pharmacy and in office the patient received only adjuvant only because they thought box had both doses inside, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter agreed to follow up from GlaxoSmithKline.