chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ag positive Feb2022 and no symptoms; Ag positive Feb2022 and no symptoms; Exposed on 2/17; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 32 year-old male patient received bnt162b2 (BNT162B2), administration date 12Nov2021 (Lot number: FF2589) at the age of 32 years as dose 3 (booster), single, administration date 16Feb2021 (Lot number: EL3247) as dose 2, single and administration date 26Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), ASYMPTOMATIC COVID-19 (medically significant) all with onset 22Feb2022, outcome "unknown" and all described as "Ag positive Feb2022 and no symptoms"; EXPOSURE TO SARS-COV-2 (non-serious) with onset 17Feb2022, outcome "unknown", described as "Exposed on 2/17". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Feb2022) negative, notes: Other; (22Feb2022) positive, notes: Other. It was unknown if therapeutic measures were taken as a result of vaccination failure, asymptomatic covid-19, exposure to sars-cov-2. It was unknown the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination.  Since the vaccination, the patient had been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
Besides the typical symptoms; general tenderness/soreness, I did feel that it had an extra cringe to it. After the next 3 days, noticed that the pain was still lingering and in fact, noticed to that it also was painful to stretch out or up my arm along with a needling pain at the site as well still.
Patient received a booster of Moderna without any incidence. Aproximately 20 minutes post vaccination patient stated felt dizzy and lightheaded. Had patient sit in chair and gave a cup of water. Did eat about 4-5 hours prior to incident. Patient stated had a headache and did vomit not long before feeling dizzy. After another 5-10minutes stated felt worse and was getting up from chair when patient had syncopal episode and fell down. LOC about 30sec or less. Was verbal and moving everything after, no tremors/shaking/incontinence noted during or after. Patient recalled everything after. Did have some diaphoresis and HR 100-120 until EMS arrived 5 minutes later.
upper arm pain which makes it painful to move arms along with hip pain.; upper arm pain which makes it painful to move arms along with hip pain.; painful to move arms/ it wakes me from deep sleep and can hardly move.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 06Aug2021 as DOSE 2, SINGLE for COVID-19 immunization. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had received 2nd shot on 06Aug2021 with no reaction until 5 days. Later after 5 days on 11Aug2021 it was reported that, patient have upper arm pain which makes it painful to move arms along with hip pain. Patient enquired could this just be a reaction. As patient continue to move throughout the day the pain becomes easier to deal with; but first thing in the morning it wakes patient from deep sleep and can hardly move. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Vomiting black, low oxygen saturation, nausea, diarrhea, arm pain
Patient was given injection subcutaneous instead of intramuscularly and had an injection site reaction. The area around the injection site is red, inflammed, and very painful.
Patient received TWINRIX and TDaP on 3-18-08.  Soon after that, he noticed right upper arm became numb only at night.  No tingling, no color change.  Arm recovers in AM.
This case was reported by a consumer via call center representative and described the occurrence of fall in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. Co-suspect products included belimumab (Benlysta) solution for injection in pre-filled pen (batch number EX7Y, expiry date 2nd November 2020) for product used for unknown indication. On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season at an unknown dose. In October 2018, the patient started Benlysta (subcutaneous) 200 mg weekly. In 2018, not applicable after receiving Influenza vaccine Quadrivalent 2018-2019 season and unknown after starting Benlysta, the patient experienced missed dose. In November 2018, the patient experienced fall and contusion of thigh. The action taken with Benlysta was unknown. In November 2018, the outcome of the fall was recovered/resolved. On an unknown date, the outcome of the contusion of thigh and missed dose were unknown. It was unknown if the reporter considered the fall and contusion of thigh to be related to Influenza vaccine Quadrivalent 2018-2019 season and Benlysta. Additional details were provided as follows: The age at vaccination was not provided. The patient who had been on weekly Benlysta subcutaneous (SC) injections using the auto Injector for the last four months. Her last injection was the first or second week of October. She had missed doses since she received her flu vaccination. About one week ago from the reporting date, she had a fall and then developed a bruise about the size of her fist on her thigh. The patient gave consented to follow up.
Chest pain with elevated troponin but normal EKG and echo 3 days after second COVID 19 vaccine.
reports adverse event of increased arthritis discomfort; This is a spontaneous report received from a contactable other health care professional.  A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE (Lot number was not reported) and received second dose via an unspecified route of administration on an unspecified date (Lot number was not reported) as DOSE 2, SINGLE (at the age of 58-year-old) for COVID-19 immunization. The patient medical history included ongoing Rheumatoid Arthritis. Patient's concomitant medications were not reported. on an unspecified date, the patient experienced increased arthritis discomfort. It was reported that patient reports missed one month of therapy on hold due to receiving two doses of COVID-19 vaccine, as instructed by MD and reports adverse event of increased arthritis discomfort from missed doses reports symptoms have improved since restarted xeljanz and reports was really worried about the side effects of xeljanz, would avoid taking medications at all if possible and confirm that MD aware about it. Outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Within first 24 hrs: mild fever & fatigue Next 24 hrs: fever subsided but the injection site is red, inflamed and very warm to touch. Also tender. It?s about a 6 inch X 8 inch area  Next 24hrs: swelling is reduced a bit and the injection site is still warm and very itchy
UrticariaPruritus VERY SLIGHT SHORTNESS OF BREATH, PRURITUS DEVELOPED WITHIN 1 HOUR OF RECEIVING VACCINE Narrative:
severe tinnitus symptoms; His are very debilitating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "severe tinnitus symptoms"; ASTHENIA (non-serious), outcome "unknown", described as "His are very debilitating".  Additional information: the reporter and her husband (patient) received the covid vaccine and we are both experiencing severe tinnitus symptoms. His are very debilitating. The wife would like to know if they woulll they ease up and is there something they can do for help and relief. Its been over 10 days.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
A nurse reported that a female employee of a long-term facility received a dose of flu shield in November 2001. Within 24-48 hrs, the employee developed "flu-like symptoms" that resolved approx. 48 hrs after onset. No further info was available at the date of this report.
Swelling and pain in the area. That evening had body chills fever, headache, fatigue , diarrhea and dizziness days following
Very large red swollen area appeared at injection site 7 days post injection. Once the swelling and redness dissipated (approx 48 hours later) I had tingling in the left arm. The tingling spread to both arms then both legs and back over the course of 2 days. The symptoms peaked after 2 days then got better. Today is about 10 days since those symptoms first started and it is almost gone
Approximately 10 minutes after patient received vaccine, patient reported facial tingling/swelling/pressure, scratchy throat with vocal changes, and some shortness of breath. Patient given Epinephrine 0.3mg IM, IV placed, diphenhydramine 50 mg IV given, and normal saline infusing IV. Pt still c/o having pressure and tingling of face, son (caregiver) reports patient is not responding like she normally does to him and patient appeared more lethargic prior to the dose of diphenhydramine. Patient given 2nd dose of Epinephrine 0.3mg IM approximately 10 minutes after 1st dose of Epinephrine.  Approximately 5 minutes after 2nd dose of Epinephrine IM, patient reported feeling better, no shortness of breath and limited facial tingling. Patient was transported to ER for further evaluation and treatment.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical histories, concomitant medications and drug reactions or allergies reported. On an unknown date, the patients were vaccinated with an improperly stored dose of PEDVAXHIB (lot# L035880, expiration date 11-AUG-2018, dose, anatomical location and route of administration were not reported). No adverse event reported. There was no temperature excursion and time frame was 11.7 Celsius degree for 1 hour, 30 minutes; -1 Celsius degree for 2 hours, 50 minutes; 11.6 Celsius degree for 4 hours, 20 minutes and -2.3 Celsius degree for 63 hours, 10 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Patient reported full body joint aching stating that she could barely move the night of her vaccination. The aching is slowly resolving.
This is a spontaneous report from contactable consumer reporting for herself and from a contactable pharmacist. This 68-year-old female patient received PREVNAR 13 Batch/Lot M13067), intramuscular in left arm, in early afternoon on 05Nov2015, at a single dose. Relevant medical history and concomitant medications were not reported. The patient received pneumococcal vaccine the year before, with no adverse event. On 05Nov2015 the vaccine injection was very painful at the time of administration and the patient also experienced limited left arm movements (pain when moving her arm out to the side or opening a car door, no pain when moving her arm in front of her and up). Her orthopedic doctor advised her to take heavy doses of pain medicine or get a cortisone shot. The patient recovered from pain without any treatment on an unspecified date, she took ALEVE for limited left arm movements but she continued to experience it. Follow-up (08Apr2016): New information reported from the same contactable consumer includes: details on treatment and updated outcome for the event pain. Follow-up (17May2016): New information reported from the contactable pharmacist includes lot number and route of vaccine. Follow up attempts completed. No further information expected.
gasping for air, bluish lips - could not breathe (afebrile)-went to sleep on 16Dec90 approx 430 pm, occurred 3 X next day-saw MD->hosp-EEG, CAT, BA swallow-all normal-did sleep study, on Pb 45 mg qd
The pt had swelling and redness around injection site on her right arm that started after getting vaccinated on 8/12/19.  She said the swelling started after she got home and the redness started a few days after that. She returned to the pharmacy on 8/18/19 to ask about the reaction.  She said the arm had been swollen and red for a few days but the swelling had gone down the and redness was not as bad as it had been the day before.  She had been using an ice pack and hydrocortisone at home before coming to the pharmacy.
PATIENT DID NOT FEEL ADVERSE EVENTS UNTIL AFTER SHE LEFT OUR FACILITY AND HAD BEEN HOME AT ONSET. ADVERSE EVENTS INCLUDED FAINTING (WITH A FALL), LOW BLOOD PRESSURE (80s/60s; MEASURED AT HOME), AND BLUE COLORATION OF LIPS. PATIENT RECOVERED FROM FAINTING AND HAD DINNER. SHE SLEPT POORLY OVERNIGHT AND VOMITTED UPON WAKING UP THIS MORNING. SHE IS FEELING MUCH BETTER TODAY AND BLUE COLORATION OF LIPS IS COMPLETELY GONE. HOWEVER SHE CONTINUES TO BE HYPOTENSIVE.
A health professional was received on 1/25/02 concerning a patient of unknown demography who was inadvertently administered an overdose of Fluvirin vaccine in late November/early December 2001. The patient received a 1ml dose of Fluvirin in late November/early December 2001 and did not complain of any adverse event at the time of administration. The patients medical history was not reported. The reporter assessed the causality to be unclassifiable.
After giving 2nd dose of Moderna Vaccine, Clerk was putting in ImmTrac System and she noticed that the vaccine had expired the day before.
Pt recv vax on 10/12/98; on 10/14/98 pt exp warm/ itchy/ red vax site
13 x 10 cm area of erythema, swelling from shoulder to elbow.
has had covid 3 times; has had covid 3 times; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "has had covid 3 times". Seriousness reported as: No. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a Licensed Practical Nurse refers to a patient of unknown age and gender. The nurse was reporting that the patient was inadvertently administered 5 doses of GARDASIL. The first dose of 0.5 ml of GARDASIL was administered on 29-JUL-2009 intramuscularly, the second dose of GARDASIL was administered on 02-OCT-2009, the third dose of GARDASIL was administered on 25-FEB-2011, a fourth dose of GARDASIL was administered 26-JUL-2013, and a fifth dose of GARDASIL was administered on 17-OCT-2013. No adverse effects reported. Additional information has been requested.
Malaise at 21.5 hours after vaccination. Fever, shaking chills, nausea and vomiting, fatigue started 25 hours after vaccination.  Slept for 24 hours.
Myalgia & Fever Narrative:  Hx of prior Covid infection on 12-4-20. Reported fever, chills, and myalgias.
I awoke at 3 pm with a mild pain/ tingling of nerve from left elbow to fingers that is constant that increases in intensity if my arm hands down at side (feels like the sensation after striking your elbow).  Can?t stop thinking about this sensation/pain no matter what I am doing.
Fever starting approximately 7/6/18 (subjective, did not measure temp), also feels dizzy, delusional. Sat 7/7/18 developed red bumps on chest, back, and face which has stayed since then, no spread, not itchy. No pus out of lesions, however some have pus appearance. Of note received varicella vaccine on 6/21/18.
Chills, fever, sensation of coldness of hands and feet, sweating, severe headache, nausea, vomiting. Denies redness or swelling of inject site. Sx resolved spontaneously w/in 24 hours.
This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions of the patients were reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored doses of GARDASIL lot # K005083, expiration date 04-NOV-2016 (dose and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
muscle aches; joint pain; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2022, the patient received the 2nd dose of Shingrix. In August 2022, less than a week after receiving Shingrix, the patient experienced muscle pain and joint pain. On an unknown date, the outcome of the muscle pain and joint pain were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain and joint pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 30-AUG-2022 Reporter's comment: The patient self-reported this case. The patient received dose of Shingrix vaccine yesterday (day before reporting) and was now experiencing muscle aches and joint pain. The reporter did not consent to follow-up.
Onset of itchy hives 1 hour after yellow fever vaccine given. Pt had also just worked out. No SOB, dysphagia or wheezing. Responded well to Benadryl 25 po.
pain and swelling in toes and fingertips. red rash on feet and palms.  Sores, and rash on head, similar to Eczema or seborrheic Dermatitis on scalp. (Both of which I have never had occur before.)
They were sick for two days when receiving the vaccines; side effects too awful/ they experienced terrible side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (They were sick for two days when receiving the vaccines) and FEELING ABNORMAL (side effects too awful/ they experienced terrible side effects) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was unknown if patient experienced allergies (medications, food and other products). The patient did not tested or diagnosed with COVID-19. It was unknown if the history was related to mentioned event and both Acute and Chronic illnesses at the time of vaccination. It was unknown if patient received other vaccines within 1 month prior to Moderna COVID-19 vaccine.     On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced ILLNESS (They were sick for two days when receiving the vaccines) and FEELING ABNORMAL (side effects too awful/ they experienced terrible side effects). On 09-Apr-2021, ILLNESS (They were sick for two days when receiving the vaccines) and FEELING ABNORMAL (side effects too awful/ they experienced terrible side effects) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was unknown that patient had prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination or at the time of adverse event.  Patient had received dose 2 on 05-May-2021, Body site right arm and experienced the same events started on 05-May-2021 and recovered on 07-May-2021.  It was reported that the patient experienced terrible side effetcs and was sick for two days when receiving the vaccines and side effects too awful and would not get another one.  It was reported that the adverse event did not cause patient to seek medical care and there were no other potential causes.   It was reported that the patient did not experienced similar event in past.   Treatment medication was not provided by the reporter.   This case was linked to MOD-2022-640217 (Patient Link).
Eczema flare up. Last flare up was following a vaccine as well. No changes in food or routines.
was supposed to receive the 2nd dose this last Thursday but tested positive for Covid; was supposed to receive the 2nd dose this last Thursday but tested positive for Covid; This is a spontaneous report via a Pfizer-sponsored program Support from contactable consumer (patient). A male patient of unknown age received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on unknown date in Feb2021 as single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. It was reported that the patient received the 1st dose of vaccine the end of Feb2021 and was supposed to receive the 2nd dose this last Thursday but tested positive for Covid in 2021. The outcome of events was unknown.  Information on the lot/batch number has been requested.
approx 36 hours had fatigue, achy, headache. at 48 hours still feel bad.  Just want to sleep.
Terrible muscle and joint pain.   The pain was so bad I was unable to get out of bed and go to work.
did not feel good for about 4-5 days; sore arm; This is a spontaneous report from a Pfizer sponsored program  received from a contactable consumer(patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number: EW0168 and expiration date: not reported), via an unspecified route of administration, on 13Jun2021 (at the age of 57-year-old), as DOSE 1, SINGLE for covid-19 immunization. Medical history included covid-19 in Nov2020. The patient's concomitant medications were not reported. After the first dose, for about 4-5 days patient did not feel good, had sore arm and felt like she is coming down with something but never did. The patient's second dose is scheduled on July 6, She would like to know if she can take her second dose earlier than 06Jul.The patient would also like to know about antibodies after covid infection and vaccination. The outcome of the event 'did not feel good for about 4-5 days' was recovered in Jun2021 and that of sore arm was unknown at the time of reporting.