chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sneezing; Coughing; Runny nose; Felt sick; Body aches; This is a spontaneous case, initially received from other non-health professional on 18-Dec-2018, concerning a 79-year-old, elderly, female patient.  The patient did not have any relevant medical history. The concomitant medications of the patient were not provided.   On 10-Dec-2018, the patient was administered Fluad (TIV) (Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, anatomical location: left deltoid, batch number: 250800, expiry date: 31-May-2019 and route of administration: intramuscular) for protection against seasonal influenza.  On 11-Dec-2018, 1 day after vaccination, the patient experienced body aches and felt sick. On 12-Dec-2018, 2 days after vaccination, the patient experienced coughing, sneezing, and a runny nose. The patient did not receive any treatment for the events.   On an unknown date (reported as in a couple of days), all the events were resolved.   The reporter assessed the case as non-serious and causality of the events as related (adverse reactions).; Reporter's Comments: A 79-year-old female patient experienced ache and sickness one day after the administration of the suspect vaccine Fluad (TIV) and coughing, sneezing, runny nose two days after the administration of the suspect vaccine. The company assessed the causality as related due to plausible temporal relationship between the suspect vaccine and the events.
I started to have trouble breathing and exercising, started feeling light headed within three months sometime in February and March, I was thinking it was related to distant heart issues. I had had a procedure and had problems after the vaccine. I started to become asymptomatic, light SOB, was not able to do what I could do, my heart rate was extremely low. They did a stress echo test, then they did catheterization and they did put me a pacemaker and this would now allow me to work how I did and thus I had to retire out. I do not know if the procedure I received caused these symptoms.
Initial information received on 08-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. The case was linked with 2018SA312242 (same reporter). This case involves a 30 years old patient (gender not reported) who was vaccinated with an expired dose of TYPHIM VI (batch number, expiration date, dose, route and site of administration was not reported) on 07-Nov-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used. The vaccine was used 14 days post expiration date. No side effects 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.
approx 48 hrs p/vax pt c/o sore arm no other problems; took PM nap got up w/fever of 105 was given Advil; dx poss react to pertussis;
8 hours after shot developed fever (102) with chills/nausea/headache that has lasted 24 hours
This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain and fever. On an unknown date, the outcome of the general body pain and fever were recovered/resolved. It was unknown if the reporter considered the general body pain and fever to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The pharmacist stated that the patient picked up a prescription for SHINGRIX and went to the physician's office to had SHINGRIX administered. The pharmacist stated the patient said that body aches and fever lasted about 2 days and resolved on the 3rd day. The healthcare professional did not have any additional details.
Patient reported feeling tired and dizzy this morning. She reported that she took her temperature and it was 99 degrees Fahrenheit. She reports that she fainted this morning, but is feeling better now. She reports that symptoms have improved. Advised patient to make her primary care physician aware. Will continue to monitor. Advised patient to call us back with additional questions or if symptoms persist.
Within one week of my second COVID19 immunization (Moderna), severe vestibular-like symptoms started and increased over the next few weeks.  Symptoms started with difficulties eye tracking, particular when using computers, smartphones, and watching television.  I experienced severe nausea when using these devices.  Symptoms seem to be brought on due to the motion/scrolling, not as much the backlit screen.  I also started experiencing motion-sickness with driving/riding in a car.  Over the next few weeks, additional symptoms became apparent, including migraine-like headaches (no prior headache history), tinnitus in both ears, blurred and distorted vision, persistent dizziness, balance issues, and difficulties with rapid eye movements and focusing.  I am unable to carry on many life functions and unable to work.  Treatments to date have included vestibular migraine medications (Verapamil and Topiramate), motion sickness medications (Scopolamine patches and Meclizine), Methylprednisolone, and vestibular rehabilitation therapy.   All have proven ineffective in improving or eliminating symptoms.
This spontaneous report as received from a physician refers to a female patient of unknown age. The patient was vaccinated intramuscularly with the second dose of 0.5 ml GARDASIL (schedule reported as 0, 2 months, 6 months, intramuscular injection, lot # was unknown) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient called and reported pain in left arm and was told to take ADVIL, then called back a week later and said that she had a loss of sensation in her left arm and pain behind her left eyeball. Initially the patient was told to take ADVIL, then she was told to go to an optometrist and have an magnetic resonance imaging (MRI) done. At the time of this report, the outcome of the events was unknown. The reporter considered one or more of these events to be significant disability. Additional information is not expected.
The patient has tested covid positive post vaccination; The patient has tested covid positive post vaccination; Shingles; This is a spontaneous report from a contactable (Patient). A 39-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 05Feb2021 (Batch/Lot Number: EL9269) as SINGLE DOSE, dose 2 via an unspecified route of administration, administered in Arm Right on 26Feb2021 (Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient did not had covid prior to vaccination. The patient has tested covid positive post vaccination on an unspecified date and shingles on 24Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on an unspecified date. The outcome of the events were unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the narrative information provided, there is a reasonable possibility that the reported events COVID-19, Drug Ineffective and Herpes zoster is related to BNT162B2 (COVID-19 mRNA VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Information has been received from a mother concerning her 15 (also reported as 16) year old daughter who on approximately 25-OCT-2007 was vaccinated intramuscularly with a dose of GARDASIL vaccine (yeast). On approximately 25-OCT-2007 the patient's voice was different and her arm was sore. The mother was advised to contact the primary medical doctor or consider the emergency department. At the time of the report  the patient's outcome was unknown. Additional information has been requested.
Symptoms got worse; Abdominal pain/ Abdominal pain on his left and right side that is still going on; Headache; Rash on both legs/then on his right side on 11Jun2021 and then the rash on the right too; dizziness; Nausea/ Nauseous; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) via an unspecified route of administration on 11Jun2021 (Batch/Lot number was not reported) as second dose, single for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient previously received first dose of bnt162b2 on 21May2021 for Covid-19 Immunization and experienced abdominal pain, headache, dizziness, nausea and rash on both legs/left side of the leg. On an unspecified date in 2021, the patient experienced abdominal pain/ abdominal pain on his left and right side that is still going on, headache, rash on both legs/then on his right side on 11Jun2021 and then the rash on the right too, dizziness, nausea/ nauseous. On 11Jun2021, the symptoms got worse. It was reported that patient received the vaccine on 21May2021 and the second dose on 11Jun2021 and basically his symptoms were severe abdominal pain, rashes on legs, dizziness, nausea, and headaches that were severe and still going on. Then, he got the second dose 11Jun2021 and his symptoms got worse. They were still going on. Patient added it was his left side of leg and severe headache and nauseous and it was his left side of leg but then on his right side on 11Jun2021 and then the rash on the right too. Outcome of the events was not recovered.  Information related to batch/Lot no. was requested.
felt numbness in both upper arms and lips. It progressed to part of my tongue; felt numbness in both upper arms and lips. It progressed to part of my tongue; This is a spontaneous report from a contactable health care professional nurse, the patient (patient). A 68-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL8982), via an unspecified route of administration in the left arm on 15Feb2021 at 09:00 (at the age of 68 years old) as a single dose, for COVID-19 immunisation. The facility in which the vaccination was administered was a hospital. Medical history included Lung cancer, prior strokes from an unknown date and unknown if ongoing. The patient has no known allergies. Concomitant medications include Protonix, Lexapro, Atenolol, ASA, Crestor.  No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 15Feb2021 at 09:15 the patient experienced felt numbness in both upper arms and lips. It progressed to part of my tongue. The clinical course is as follows Within 20 minutes after receiving the vaccine. Patient felt numbness in both upper arms and lips. It progresses to part of her tongue. The numbness in my upper arms was fleeting. The numbness in lips and tongue dissipated approximately 7 hours later. There was no progression of oral numbness. The adverse event resulted in an emergency room visit. No Treatment was given. The clinical outcome of the events numbness in both upper arms and lips. it progressed to part of my tongue was recovered on 15Feb2021.      .
Area feels warm to the touch; Itching around injection site 1 week after 1st dose; Redness around injection site. Area has gotten larger; Area is slightly tender to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Area feels warm to the touch), VACCINATION SITE PRURITUS (Itching around injection site 1 week after 1st dose), VACCINATION SITE ERYTHEMA (Redness around injection site. Area has gotten larger) and VACCINATION SITE PAIN (Area is slightly tender to touch) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031l20a) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching around injection site 1 week after 1st dose), VACCINATION SITE ERYTHEMA (Redness around injection site. Area has gotten larger) and VACCINATION SITE PAIN (Area is slightly tender to touch). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Area feels warm to the touch). At the time of the report, VACCINATION SITE WARMTH (Area feels warm to the touch), VACCINATION SITE PRURITUS (Itching around injection site 1 week after 1st dose), VACCINATION SITE ERYTHEMA (Redness around injection site. Area has gotten larger) and VACCINATION SITE PAIN (Area is slightly tender to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment include ice twice.
expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039c21a) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Patient received FLUZONE HD in left deltoid on 9/9/16. Patient began to experience redness, rash by injection site that is about 3 inches in diameter. Patient states it itches her and she is currently applying hydrocortisone cream on the site for relief.
arm got swollen, more than regular; Initial information received on 28-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional.  This case is linked with 2021SA003747 (same reporter).  This case involves a female patient of unknown age whose arm got swollen, more than regular (peripheral swelling), while she received vaccine TYPHOID VACCINE.  The patient's medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing allergies.   On an unknown date, the patient received a dose of suspect TYPHOID VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient's arm got swollen, more than regular (peripheral swelling) (Unknown latency; non-serious) following the administration of TYPHOID VACCINE.  Case Detail: It was reported that patient wanted to know if she was safe to take PFIZER-BIONTECH COVID-19 VACCINE since she has allergies. Mentioned that when she took other vaccines (smallpox and rubella) she had to go to the hospital and get a spinal tap and was informed that she cannot get those vaccines. When she was, was not given any vaccines but received 2 rounds of anthrax. Her lip got very swollen the next day and was given Benadryl. She was TB positive and did not complete her INH treatment due to her joint hurting. When she got a booster for Hep A, she had to be given epinephrine. And for meningococcal she had a small reaction. At the time of report, she had rhabdomyolysis and malignant hyperthermia, she also added if it could be due to other vaccines being live vaccines.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
High fever 103 unrelieved by tylenol, explosive headache, piercing eye pain, blurry vision, double vision, heart pain, kidney pain, muscle and joint pain.
Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine( diphtheria crml97 protein) injection) was received from a physician regarding a 5 month old female pt who developed fever ( unknown degree), was " very fussy" and had generalized macular papular, erythematous rash, that" looked like a viral rash". The pt received her 2nd dose on 08/05/04. Event Details: On 08/11/2004, the child was brought back to the DR office. She had a fever (unknown degree) and a generalized, macluar-papular, erythematous rash, that " looked like a viral rash" . The child was also " very fussy". No medical treatments were given for the rash. As of 09/08/2004, the child still had " remnants of erythema" Information regarding this event has been forwarded to Aventis, manufacturers of the concomitantly administered vaccine. No additional information was available at the time of this report.
Patient returned post vaccine 2 hrs stating nausea, flushing approx 1/2 p. vaccine then stated she developed some numbness and tingling on facial area -> to ER.
she got the shingles; condition was bad; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unknown date in 2021, as dose 2, single for COVID-19 immunization. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unknown date in 2021, as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient got the shingles on an unspecified date in Jul2021 and her condition was bad. The patient had lingering effects of shingles. With that, consumer wanted to know if his friend should wait until she recovered before getting the booster dose. Consumer also wants to know if there is any way to test the levels of antibody after receiving the vaccine. His friend discussed her condition with the doctor, she had her antibody levels tested. The patient underwent lab tests and procedures which included antibody test: lower. She found out that she only had 5 or 6 which was lower than expected. The outcome of the event was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Fever overnight but heart has been racing. Normal resting heart rate is about 78 for me; since 1am it?s been over 100 consistently and as high as 129. I?m not sure if this is normal with the vaccine or fever
Flu-like symptoms (resolved prior to patient being seen). Rash affecting L deltoid area, L underarm, L under breast, R under breast, and R underarm. Consulted with consulting physician Dr. who advised ZYRTEC and cool compresses and to follow up with pt's PCP if no improvement.
Low grade temp, chills, body aches, nausea and diarrhea, headache
Presented to ER after sustaining a ground level fall and experiencing left hip pain.  Patient states that she was opening the refrigerator and when she stepped back she fell backwards.  Patient states that she was unable to get back up on the left leg and however she did not have her Life Alert necklace on was able to drag herself across the house to the phone. Found to have COVID19 at this time. Admitted for closed fracture of neck of left femur. Patient was asymptomatic throughout stay for COVID10
This spontaneous report as received from a pharmacist refers to a 87 years old female patient. The patient was vaccinated with ZOSTAVAX on 27-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On 27-NOV-2012 the patient experienced injection site burning immediately afterwards. No treatment information was reported. The pharmacist monitored the patient post vaccination. The patient reported she was feeling better. The pharmacist will also follow up with the patient tomorrow. Additional information has been requested.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received dose after its expiration date 13-Jul-2022).    No relevant concomitant medications were reported.  The vial did not undergo any temperature excursions. Dose administered after 30-day Use By Date or after manufacturer date of expiry. No treatment information was provided.
Pain at site of vaccination without hives at shot - fever, swelling, body aches within 24 hours  - without rash left deltoid.
Dizziness, Hard to Focus eyes, extreme fatigue, severe arm pain (unable to life arm without pain) (began that evening-lasted two full days)
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EL3247), in left arm, on 25Feb2021 as dose 2, single (Lot number: EL9265), in left arm and on 31Aug2021 as dose 3 (booster), single (Lot number: ew0187) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 31Mar2022 as dose 4 (booster), single (Lot number: 002m21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected