chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer / BioNTech: Dose Number: 4; Paxlovid: Treatment of COVID-19; Pfizer / BioNTech: Dose Number: 4; Paxlovid: 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 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 71 years, in left arm 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. No known allergies. The patient's relevant medical history included: "atrial fibrillation" (unspecified if ongoing), notes: Very rare instances (less than 1 per year) of atrial fibrillation. Concomitant medication(s) included: VALACYCLOVIR [VALACICLOVIR], start date: 20Jan2022, stop date: 12May2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech: Dose Number: 4; Paxlovid: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of suspected covid-19 included Paxlovid.  Clinical course: Treatment: Paxlovid, on 13May2022 to 14May2022.  Follow-up attempts completed. No further information is expected.
Fever of 101 degrees and tiredness. Red lumps/rash on my upper lip similar to herpes but all over.
congestion from crying, irritability, cried continuously for 15 hrs; Septra work up-neg;
Patient states at he woke and felt feverish, joints aching, cold/chills, sweaty, S/B told him he felt like skin was burning - did not assess temp. He took ibuprofen at that time and went back to bed. He got up at 8 AM and no longer felt feverish and had no body aches, he rested until 10 AM at which time he felt achy again, he then took 800 mg ibuprofen and rested most of day and night, he continued resting. Sunday AM 10-8-17 he stated he woke and felt "normal", he started doing household chores, at midday, he began feeling achy and fatigued again. He states by evening Sunday, he was feeling "normal" again but yesterday Tuesday 10-10-17 he had a "stiff neck" and "my trapezius muscles felt tight he states it "cleared up" as the day went on. He denies further complaints after yesterday.
The next day I had extreme nausea. Have had it almost everyday since. It comes in waves.   I have never vomited but have been too nauseous to do much of anything other than work. This is not constant but will hit me all it once at times
Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "overweight" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Pfizer covid vaccine (She received both doses. She did not know which arm and she does not have a lot or expiration.  It was the Pfizer COVID vaccine.), for Covid-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  Additional information: Patient did not know her height, weight and her age. Reporter said patient is overweight but healthy. Complainant does not have the product with them at the time of call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report by a non-contactable consumer. The female consumer reported that her 4-year-oldson received the third dose of PREVNAR 13 injection on 08Sep2009 at the age of 4-months. First dose was administered on 30Jun2009 and second dose on 24Aug2009. Relevant medical history and concomitant medications and vaccines were unknown. On 08Sep2009 she mentioned that her son was accidentally administered third dose of PREVNAR 13 too early. On an unkown date the reporter suspect PREVNAR 13 poisoning due to accidental dose as her son experienced language delayed. Relevant lab data and outcome were unknown. No follow-up attempts possible. No further information expected.
Information has been received regarding a case in litigation from a lawyer regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On or about 14-NOV-2012, the patient was vaccinated with ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries as recommended by the healthcare professional. On an unknown date, the patient experienced shingles and on or about 2015, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages, as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient had not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
hemorrhagic stroke; This is a spontaneous report from a Non-contactable consumer Via Pfizer sales representative. A 60-years-old and female patient received the second dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER7449 and expiry date: 30Jun2021), via an unspecified route on 22Apr2021 at single dose for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER1741 and expiry date unknown,) via unspecified route on 28Feb2021 as single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. There was no known allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 post vaccination. On 08Apr2021, the patient had a hemorrhagic stroke on an island off the coast. She had taken to provincials and life flighted to a hospital for emergency brain surgery. The adverse resulted the patient emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient was 14 days of hospitalization. On the same date, COVID test was negative. The patient did not receive any treatment for the event. Outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
Inappropriate schedule of vaccine administered; Soreness at the injection site; Chills; Fatigue; Low grade fever (up to 100.6 F); This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received second dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in left arm on 19Mar2021 at 12:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer and the patient had known penicillin allergy. The patient previously received first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration in left arm on 02Mar2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient received the first dose on 02Mar2021 and second dose on 19Mar2021 (inappropriate schedule of vaccine administration). Prior to 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 4 weeks prior to the COVID vaccine. Concomitant medications included acetaminophen (TYLENOL), ibuprofen (ADVIL), melatonin (MANUFACTURER UNKNOWN), all taken for unknown indication and from unspecified dates. On 19Mar2021 at 21:00, the patient experienced soreness at the injection site, fatigue and low-grade fever (up to 100.6 F) beginning at the night of vaccine and continued for about 48 hours. It was reported that the patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of soreness at the injection site, fatigue, chills and low-grade fever was resolved on 21Mar2021. No follow-up attempts are needed. No further information is expected.
Brought in from ED, family concerned for altered mental status, hyperthermia, Tmax in 105.  The patient stated that after the covid-19 vaccine on Friday, he experienced acute onset of R shoulder pain, constant, associated with decreased ROM. On PM Monday, he noticed first episode of chills, that lasted a few minutes, accompanied with sweating. This episode recurred 4 times over the week, then the family started noticed the patient was unable to answer questions and was somnolent. Blood Cultures in the ED were positive for MRSA 2:2. He was positive for endocarditis (previous dental work). Acute metabolic encephalopathy due to severe sepsis most likely 2/2 MRSA bacteremia complicated by NSTEMI and AKI in setting of newly diagnosed aortic valve endocarditis complicated by septic emboli to the bilateral cerebral hemispheres
Redness and swelling noted around L eye going down L jaw in front of L ear.  C/O itching.  No shortness of breath or wheezing noted. No hives noted.
We received on 12 FEB 2008 from a healthcare professional the following information: A 7-year-old male patient, born on 21 JUN 2000 was vaccinated with FLUVIRIN (batch no. unknown) on 19 NOV 2007. The patient was killed in an automobile traffic accident on 01 FEB 2008. The subject had participated in a clinical trial sponsored by MedImmune. FLUVIRIN was used in that trial as a control, and Novartis Vaccine & Diagnostics (NVD) has donated the FLUVIRIN, but other than that has not been involved. Although the event did not occur during the duration of the trial, and the investigator did not see any causal relationship to the vaccination with FLUVIRIN, he reported the event to the IRB and NVD because the child had died.
no adverse effects; a patient was administered an improperly stored ROTATEQ; This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender. No pertinent details regarding the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies were provided. On 06-JUN-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R022223, expiration date 24-MAY-2019, orally (dose, strength and dose number were not reported) for prophylaxis. The vaccine was exposed to the temperature above 47 degrees Fahrenheit / 9 degrees Celsius (8.8 degrees Celsius) for 15 minutes and to the temperature below 36 degrees Fahrenheit / 2 degrees Celsius (-1.4 degrees Celsius) for 3 hours and 30 minutes. No previous temperature excursions were reported. A digital data logger was not involved. No adverse effects were reported.
Patient experienced numbness of the arm shortly after vaccination was administered (less than 5 min after administration)  and later developed into numbness of the leg and lips.  Patient was asked how she was feeling and stated that the numbness was slowly going away.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a patient who received SHINGRIX. On 25th January 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On 25th January 2018, 2 hrs after receiving SHINGRIX, the patient experienced injection site erythema and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema was recovering/resolving and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the injection site erythema and intramuscular formulation administered by other route to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that patient received SHINGRIX subcutaneously instead of intramuscularly, which led to inappropriate route of vaccination. The patient experienced redness of 6-inch diameter after receiving vaccination. The reporter stated that it occurred within hours of the vaccine, but unsure of specifics. No lot number, expiry date and patient details were provided. The reporter was not 100 percent certain about the vaccination date and thought it was last Thursday before the reporting date. The health care professional had limited information about the adverse event. The health care professional was the pharmacist who dispensed the vaccine, but did not administer.
Bottle of Pfizer pediatric 5-11 years was not diluted and 0.2ML was administered to the patient undiluted. The patients parents were called in multiple times to see if the patient presented any symptoms and to explain the events but have not yet been able to contact them.
Pt developed long segment ileocecal intussusception requiring open laparotomy to reduce.
Had immunizations on 9-17-04, developed fever within 24 hours of immunizations, went to ER, elevated WBC, admitted to hospital. Mom states no problems noted at injection site.
This spontaneous report as received from a registered nurse refers to an unknown number of unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. In June 2016 (reported as "starting on or after 01-JUN-2016" until the reporting time of 13-JUN-2016), the patients were vaccinated with improperly stored VARIVAX (lot # L041207, expiration date 20-OCT-2017, dose and route not reported). It was reported that the vaccines were stored at -10.4 centigrade degree for 45 minutes. There was no previous excursion. No adverse effect reported. This case was reported because of a digital data logger issue. Additional information has been requested.
w/in 24hr of vax pt devel gen urticaria;pt was treated w/oral pred;this is 1 of 3 pt from this facility of adverse exp p/vax;
Chest tightness; Unable to sleep; Inappropriate Age for vaccine; This case was reported by a consumer via call center representative and described the occurrence of chest tightness in a adult female patient who received DTPa (Infanrix) for prophylaxis.   Concomitant products included DTPa (Infanrix), PNEUMOCOCCAL VACCINE (PREVNAR-13), PNEUMOCOCCAL VACCINE (PREVNAR-13) and protonix (nos) (Protonix).   In January 2019, the patient received the 2nd dose of Infanrix. On an unknown date, less than a year after receiving Infanrix, the patient experienced chest tightness, sleeplessness and inappropriate age at vaccine administration. On an unknown date, the outcome of the chest tightness, sleeplessness and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the chest tightness and sleeplessness to be related to Infanrix.  Additional details were reported as follows: The age at vaccination was not reported. The member of public reported that she received a puncture from a rusty nail and was given Dtap and Prevnar 13 in November and then again in January.   The patient reported that she had been unable to sleep and that she had tightness in the chest since the 2nd dose of the vaccines.  The patient stated there were other symptoms but did not supply them when requested. The patient reported being seem medically but not hospitalization for symptoms.   No additional details were provided. MOP had a hard time sticking to the patient and wanted medical advice or for someone to call her physician to make them state they gave 2 doses of the vaccine.  The primary care physician (PCP) information was not given when requested.
Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case is linked to case 2018SA313571and 2018SA314539. This case involves an two-months old patient (gender not reported) who received only liquid portion of PENTACEL, while received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to Inappropriate reconstitution technique. (It was reported that the patient received only liquid portion of PENTACEL). It was not reported that the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.
Information has been received from a pharmacist concerning an adult patient who was vaccinated with a dose of varicella virus vaccine live. The pharmacist reported that, three weeks after being vaccinated, the patient experienced muscle spasms of the neck and arm. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.   This is in follow up to report previously submitted on 05/14/2004. Information has been received from a pharmacist and a registered nurse concerning a 31 year old white female LPN with scoliosis and who is a nursing mother who on Dec 29 2003 was vaccinated subcutaenously in the right arm with a first dose of varicella vaccine live lot 646237/0545N and on Feb 4 2004 was vaccinated subcutaneously in the left arm with a second dose of varicella virus vaccine live lot 547242/0895N. The patient had a questionable mild URI at the time of vaccination. It was reported that the patient had two episodes following vaccination. On Feb 13 0004 (also reported as approximately 2 weeks after the vaccination), she began to have back muscle pain and fatigue. The patient also experienced muscle spasms of the neck and arm. On Apr 12 2004 information was received that noted that the patient now complains of myalgias, paresthsis of the left arm, skin dryness, pimples, dry eyes, fatigue, mastitis (nursing mother, and small lymph nodes that are palpable in the fasia. Unspecified medical attention was sought. Diagnostic lab test included a CBC and ESR which were reported as OK and a RF which was negative. The patient has not yet recovered. It was also reported that the patient had a similar reaction to the first does of varicella virus vaccine live but not as severe. Additional information has been requested.
pt recv vax FEB97 & APR97 & in AUG97 lab eval revealed a lack of seroconversion;
Fever, Headache, Fatigue Took Tylenol PM Symptoms resolved after about 24 hours
Received second dose on day 38; episodes of dizziness; episodes of vertigo; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose on day 38), DIZZINESS (episodes of dizziness) and VERTIGO (episodes of vertigo) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose on day 38), DIZZINESS (episodes of dizziness) and VERTIGO (episodes of vertigo). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose on day 38) had resolved and DIZZINESS (episodes of dizziness) and VERTIGO (episodes of vertigo) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
During data entry I found this individual to have 4 doses of COVID vaccine.  3 full doses of Pfizer received on dates 1/26/21, 2/16/21, and 8/4/21. 1 Full dose of Moderna received on 12/15/21 at our vaccine clinic. to total 4 doses.
FEELING TIRED; LOW ENERGY; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820096, expiry: UNKNOWN) dose was not reported, administered on 23-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-JUL-2021, treatment medications included: paracetamol. On 24-JUL-2021, the subject experienced feeling tired. On 24-JUL-2021, the subject experienced low energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling tired, and low energy. This report was non-serious.