chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance and for the long term prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
pt recvd vax;1 day later,devel tender,redness & induration around inject site;tx w/ dph;
Patient reported itchy hives developing all over her body and numbness in her lower lip. She also reported a headache and arm soreness.
Patient felt lightheaded and dizzy during the day on 9/27/23. She fainted around 5 pm on 9/27/23 and was taken by ambulance to ER..
patient had a medication error of expired vaccines given to a patient, with no reported adverse event; Initial information regarding this unsolicited valid non-serious case was received from other health care professional and transmitted to Sanofi on 25-Feb-2021.  This case involves a child patient for whom it was reported patient had a medication error of expired vaccine given (expired product administered) for HIB (PRP/T) VACCINE [ACT-HIB] (batch number: unknown and expiration date: 21-Jun-2020) via unknown route and unknown site for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not reported.  It was an actual medication error due to the expired vaccine used (latency: unknown).  It was also reported that the staff actually read the expiration day incorrectly so instead of 21June20 being read as June 21, 2020 they interpreted as being June 20 2021. With the years being so close 20 and 21 it was really confusing. When I looked at other manufacturers exp. Dates they all have the year as 4 digits.  At the time of reporting, the patient had no adverse event.  Disclaimer: 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.  There will be no information available regarding batch number in this case.
MMRV was given instead of Varicella vaccine, in addition to another MMR vaccine. Continuing to monitor for outcomes, but this increases the risk of febrile seizures.
Approximately 12 hours after injection,  I began running a low grade fever of 98.9 degrees, started experiencing  extreme nausea, muscle aches, fatigue and gastrointestinal motility. The fever, nausea, and muscle aches were gone the next day. The gastrointestinal motility resulted in 48 hours of intense gas (belching and passing gas) and diarrhea, which were finally relieved after taking Imodium. My controlled GERD has flared, and the fatigue, while less than initial, remains.
Pt passed out after a few minutes of getting vaccine. We called 911. Pt came to within a few seconds but was disoriented. Gave patient some water and crackers. Was feeling better when EMS showed up Did not go to hospital walked out under own power.
pleural effusion; This is a spontaneous report from a contactable health care professional (patient).  A 39-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL 0142) in the hospital via an unspecified route of administration on 06Jan2021 at 11:15 AM at a single dose on the right arm for COVID-19 immunization.  The patient's medical history was not reported.  Concomitant medication included escitalopram oxalate (LEXAPRO), calcium carbonate, magnesium carbonate, magnesium trisilicate (TUMS) and ibuprofen (manufacturer unknown) which was given 8 hours before (as reported). The patient previously took morphine and experienced allergies. The patient did not have COVID-19 prior to vaccination. The patient reported that she ended up on the ER on the day of the report diagnosed with a pleural effusion which was reported to have started on 14Jan2021 at 08:00 AM. The doctors are unsure whether it could be related to the vaccine, but she was only 39 years old and have never had something like this happen before. The patient was given azithromycin as treatment for the event. The patient had not recovered from the event.  The patient had not been tested for COVID-19 post vaccination.
59-year-old employee was getting mandatory influenza vaccination on 10/13/2020. She reports that the next day in the afternoon she developed profound redness and swelling and felt hot to touch about the injection site and presented to employer health clinic. She was started on Ibuprofen and feels that she is somewhat improved. She rates her pain 4/10 at rest which waxes and wanes, and is made worse with direct pressure. She reports the redness and swelling resolved and denies any numbness, tingling, further redness or swelling.
Pain and aching in my legs. Left leg & foot swelled. Veins in legs, arms and body bursting and causing lumps under my skin and big bruises. A rash on my left foot and leg. It looked like little blood bursts all over my foot and on my leg.
2/2/99, pt received her first round of vaccines; Polio, DTaP, Comvax. Ran a fever all day of 101, looked and felt clammy and pale, slept all day, no appetite, that evening the injection site on both legs were sore and looked swollen and she cried a lot that evening. The next 2 days (2/3 & 2/4) she had a rash all over her body, cried all day, didn't have much of an appetite. Pt is 3 1/2 years old and will always have a life threading allergy to peanuts and tree nuts. Also allergic to PCN.
PATIENT EXPERIENCED REDNESS, ITCHING, AND SOME PAIN. SHE WENT TO MD AND WAS TOLD SHE HAD INFECTION.
Patient developed fatigue 3 hrs post injection. The following day, developed fever to 103F, nausea and vomiting, dizziness and pleuritic chest pain, difficulty breathing.  fever last for 2 days. Went to ED for evaluation on day 3 (7/1). Symptoms ultimately resolved, but then developed facial hives and facial swelling on day 5 post vaccine.
FEVER; MUSCLE ACHES; INTERMITTENT HEADACHES; INTERMITTANT NAUSEA; SORE ARM AT VACCINATION SITE; SWOLLEN ARM AT VACCINATION SITE (LUA); BODY ACHE; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included celiac disease, high blood pressure, and allergic to penicillin, and other pre-existing medical conditions included patient has a sore and swollen area at vaccine administration arm site that was similar to what she experiences with the annual flu shot. The patient experienced drug allergy when treated with hydrochlorothiazide. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: 25-MAY-2021) .5 ml, administered on 05-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced muscle aches. On 06-MAR-2021, the subject experienced intermittent headaches. On 06-MAR-2021, the subject experienced intermittant nausea. On 06-MAR-2021, the subject experienced sore arm at vaccination site. On 06-MAR-2021, the subject experienced swollen arm at vaccination site (lua). On 06-MAR-2021, the subject experienced body ache. On 06-MAR-2021, the subject experienced fatigue. Laboratory data included: Body temperature increased (NR: not provided) 101.5 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, muscle aches, intermittent headaches, intermittant nausea, sore arm at vaccination site, swollen arm at vaccination site (lua), body ache, and fatigue. This report was non-serious.
Flu shot administered too high in shoulder area resulted in pain both down the patient's arm and up into shoulder and neck regions.
2nd vaccine : I am still waiting to start my period. I am over 2 weeks late , bad cramping for over 2 weeks; 2nd vaccine : I am still waiting to start my period. I am over 2 weeks late , bad cramping for over 2 weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Mar2021 12:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "latex" (unspecified if ongoing), notes: Known allergies: Latex. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), when the patient was 49 years old, for Covid-19 immunisation, reaction(s): "first vaccine- my period came more a week early". The following information was reported: MUSCLE SPASMS (non-serious), OLIGOMENORRHOEA (non-serious) all with onset 23Apr2021, outcome "not recovered" and all described as "2nd vaccine : I am still waiting to start my period. I am over 2 weeks late , bad cramping for over 2 weeks". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of muscle spasms, oligomenorrhoea.  Additional Information: She was not able to locate or read the details. The patient did not receive any other vaccine in four weeks. The patient did not receive other medications in two weeks. The patient did not have covid prior vaccination. The patient was tested for covid post vaccination. Known allergies: Latex  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
She said that she within 36 hours after her Moderna booster, she started to feel woozy and her blood glucose increased to over 500. She had to increase her insulin to get it back down.
Morning after vaccine, open sore with puss/blood and below that was a fluid filled blister. No fever or pain but mild itching. By the third day blister had white half moon shaped striation on top of it surrounded by dry flakey skin.
sick with the flu every year; Initial information was received on 24-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient (unknown demographics) who had sick with the flu every year(Illness), while received INFLUENZA VACCINE.  Medical history, past medical treatment, vaccination, family history and concomitant medications were not provided.  On an unknown date, the patient received an INFLUENZA VACCINE (Produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, patient had been sick (illness) (unknown latency), following the administration of INFLUENZA VACCINE. It was reported that because of job the patient used to got the flu shot every year and was sick with flu every year. Currently the patient is retired since 2010 (reported as 10 years ago) and it was reported that the patient had stopped getting the shot and did not been sick one day.  Details of laboratory data not reported.  Corrective treatment and outcome were unknown at the time of reporting.  There will be no information available on the batch number for this case.
This spontaneous report was received from a nurse, via a company representative, regarding a 12 years old female patient. The patient had no pertinent medical history and was unknown if the patient had previous drug allergies. On 26-JUL-2016, the patient was vaccinated with GARDASIL 9, injection, "one time" (strength, dose, lot number, expiration date, route and anatomical location of administration were not reported). The patient had no concomitant therapies. On 26-JUL-2016, 20 minutes after onset of therapy, the patient broke out in hives (urticarial), BENADRYL was provided and hives went away. The patient did not seek medical attention and no laboratory diagnostics were performed. No product quality complaint was involved. The outcome of urticarial was reported as recovered in approximately July 2016. The causal relationship between the urticarial and GARDASIL 9 was not provided. Additional information has been requested.
This spontaneous report as received from a licensed practical nurse refers to a 2-year-old patient of unknown gender. No information regarding the patient's medical history or concurrent conditions was provided. On 23-JUN-2017, the patient was inadvertently vaccinated with a dose of PROQUAD injection (lot# M033209, expiry date 09-JAN-2018; exact dose and route of administration were not reported) instead of a dose of M-M-R II injection (dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Side effects persisting 9days now:  Exhaustion (physical and mental), headache, brainfog, difficulty concentrating, also developed cyst-like bump on right thumb (palm-side) approx 7 days after vax.
Headache, Myalgia, Fever, SkinRash, Rash, mild symptoms Narrative:  employee reports recovering from side effects, but developed rash she feels similar to shingles she had in the past
A report has been received from a Pharmacist concerning a 5 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started during Oct-2012. The patient experienced pneumonia, cough and sinusitis which started during Oct-2012. The patient recovered from the event of pneumonia and cough on an unspecified date and the outcome of the event of sinusitis is unknown. The report was considered to be non-serious.
Information has been received from a Registered Pharmacist concerning an approximately 68 year old female patient with no pertinent medical history and with allergies to penicillin, iodines and latex who "in the past" (date unspecified) was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot # unspecified) and a dose of AFLURIA (manufacturer unknown) (dose, route and lot # unspecified). Subsequently the patient "had a reaction". On an unspecified date, the patient recovered. It was unspecified if patient sought medical attention. Follow up information has been received from a Registered Pharmacist, concerning about the 68 year old female patient. The pharmacist reported not having more knowledge of this event. No further information is available.
Zostavax was the vaccine administered. Itching after administration and next day swelling of arm with redness.
feeling ill / just not feeling well; Chills; Fever; Nausea; overall lethargy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 59-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 18:00 as dose number unknown (booster), single (Lot number: GJ5342) at the age of 59 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 immunization, reaction(s): "Adverse events unspecified"; Flu (took a flu shot in March (unspecified year)), for Immunization, reaction(s): "Adverse events unspecified". The following information was reported: CHILLS (non-serious) with onset 11Oct2022, outcome "unknown"; PYREXIA (non-serious) with onset 11Oct2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset 11Oct2022, outcome "unknown"; MALAISE (non-serious) with onset 11Oct2022, outcome "unknown", described as "feeling ill / just not feeling well"; LETHARGY (non-serious) with onset 11Oct2022, outcome "unknown", described as "overall lethargy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of malaise, chills, pyrexia, nausea, lethargy. Additional information: Consumer reported that he and his wife both took the Bivalent Pfizer COVID-19 vaccine booster on 03Oct at approximate 6 PM and today starting this morning, both of them started feeling ill. By the afternoon, they both have chills, fever, nausea, just overall lethargy and just not feeling well. The patient (wife) took a test and it was negative but they just found it odd that the side effects took a one whole week to take effect. Normally, side effects have come in on the past with their vaccinations, side effects they have been very mild or they started within 24 to 48 hours. But this is an entire week, an entire week has gone by. Treatment for side effects included Ibuprofen.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201221622 Same product and event, different patient;
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 17-APR-2014 the patient was vaccinated with an expired dose of M-M-R II (dose and strength not reported, lot # 02878AE is an invalid lot number for M-M-R II, expiry date 01-FEB-2014). The reporter stated the M-M-R II has had no previous temperature excursions. The reporter did not state what dose this was in the M-M-R II series. No adverse symptoms reported. Additional information has been requested.
Per patient "I am about 50 hrs. removed and am still having a pretty robust reaction at the injection site: redness, hard swelling, itching, and skin is warm to the touch. Are you aware of how common this reaction is and should it be a cause for concern? The soreness has subsided a bit, but all of the aforementioned symptoms are still quite present. "
blood clot; This is a spontaneous report from a contactable physician via a sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient experienced blood clot after receiving Pfizer COVID vaccine on an unspecified date. Event took place after use of product. The outcome of event was unknown.   Information about lot/batch number is requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event thrombosis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
1. Vertigo   Referral to Otolaryngology Adult   Referral to Vestibular Testing 30 YO man with acute sustained vertigo x 24 hours.   There is a positional component which is more noticeable at onset yesterday which might suggest BPV.  Suspect vestibular neuritis.  No risk factors for cerebellar lesion - normal exam,  young age, normotensive, normal lipid panel 2019, no HA or other focal neurologic defict, normal gait.  It is reassuring that there is improvement today in severity.  No recent illness to suggest a viral etiology.  He did complete cov-2 vaccination series 2 wk ago - ? Vaccine related.  Both doses of vaccine well-tolerated other than fatigue x 24 hours after 2nd dose.       -Antivert  tid prn.  Sedation precautions. -Referral urgent to ENT.   -Advise to go to UMHS ER if there is escalation of symptoms or HA/other focal neurologic defict.   -He may try Brandt-Daroff exercises in the case vertigo is due to BPV - however, there is not a definite positional component.   -Agree with avoiding dental procedural work until vertigo resolves- ok for consultations as tolerating.
Initial unsolicited case received from a nurse on 13 Feb 2017. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (HD) (Batch number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. The patient relevant medical history and concomitant medications were not reported. On an unknown date after the vaccination the patient developed Guillain-Barre. The patient relevant lab tests and corrective treatment was not reported. The outcome of the events was not reported. Upon internal review the company decided to consider the event as serious due to important medical event Guillain-Barre syndrome. List of documents held by sender: none.; Sender's Comments: This case is poorly documented. No information is provided on time to onset, symptoms and their evolution. Further information regarding Guillain-Barre syndrome diagnosis confirmation (cerebrospinal fluid and electrophysiological analyses, absence of tendon reflexes, information on limbs weakness, information on the development of the disease i.e. monophasic pattern or not) and infectious work up to confirm the reported absence of concurrent infection are needed for complete assessment of the case.
On 5/21/02 child c/o red, itching rt upper arm (to mother). Also c/o dizziness (which roller skating). On 5/23/02 mother brought child to center. 40 x 60mm erythematous macular, papular indurated confluent lesion on rt upper outer arm. Pruritic by history. A single vesicular lesion (pruritic) noted on outer chest area. Referred for medical evaluation if condition worsens.
Received shot 7/28/03 and less than 24 hours later developed pins/needles in right index finger and thumb, numbness up to shoulder, red spots, shoulder pain.  I have been having unexplained neurological symptoms ever since.  Several doctors have mentioned MS, but tests have ruled that out.  It is now two years later and I still have symptoms of MS and it seems to flare up when around mold. Per follow up report- seizures, muscle spasms, tremors, dizziness, sensitivity to heat/cold, acid reflux, pins/needles, fever that won't go away (not known if related but no one knows what's causing it.  Pt has seen many doctors for it.)  Physicians still doing tests.  Has been ever since pt. had the shot. Information from medical records state anxiety, joint disease, hallucinations. msv Per annual report-must take medicine. Getting much better though after 2 years. Numbness, pins/needles only on occasion now. Before it was constant. On meds for seizures. Occasioinal muscle spasms, but now it's rarely. Patient had all symptoms of MD for two years following the Rabavert vaccination. Day after shot, patient had pins/needles in fingers. After two years patient gradually started getting better.