chrisvoncsefalvay/vaers-outcomes huggingface dataset:
23 yo FM who received first dose of Pfizer vaccine and then was noted to have shortness of breath and complaining tongue closing sensation immediately after at Vaccine Clinic --I was called to evaluate the patient. When I arrived patient was laying down on a chair with a friend, shaking with seizure like activity but alert and oriented to person place and time. Upon my arrival she was shaking, vomited x 1 and then complained about chest pain.   Vitals upon my arrival: HR 58, o2 100% RR appeared to be around 22-24 (hyperventilating) BP 88 systolic (manual)--repeated by medics upon arrival minutes later 110/72.   Given throat closing sensation, vomiting, shortness of breath I advised to call 911 and ordered Epinephrine x 1 which was given by RN immediately. Pt was then placed on the grown chin up, she continued to shake throughout entire body but continued to be alert and oriented. Medics then arrived on seen, started an IV, glucose by medics 84, IVF started by medics. Pt was transported to ER via medics.   Pt is not a patient, last visit 2017. Pt did state she has hx of POTS and DRESS syndrome to Lamictal. Reports taking cetirizine this AM, Zofran and Oxycodone and Baclofen (prescribed by external PCP?).   Prior to transport to ER pt continued to be alert oriented, but shaking and twitching throughout her body. MD verbally communicated to patient to not receive the 2nd dose given her severe anaphylaxis like reaction to the first dose of the vaccine. Pt can be referred to allergist after ER follow up by PCP.  Denied pregnancy.
9/25/07 - Patient developed falling when walking on left foot.  9/26/07 - Patient saw doctor - diagnosis given foot drop.  9/27/07 - Patient saw doctor - diagnosis Parsonage Turner Syndrome.  10/17/07 - Patient saw doctor, better but not 100% recovered. 12/18/07-records received for DOS 9/4/07-C/O injury to anke and tendinitis of her peroneal tendons on the right. Visit 9/26/07-Day prior to visit felt a pop in her foot and since then inabiity to raise the toes, some swelling and bruising in leg. Numbness down in her foot. DX: Spontaneous peroneal nerve injury left leg. PE: footdrop which is incomplete and partial. Visit 9/28/07-Antalgic gait consistent with footdroop and 3/5 tenderness and weakness. DX: Viral peroneal nerve-parsonage-turner syndrome. Visit 10/17/07-Regaining full strength.
Patient given 4th dose covid vaccine as a regular Pfizer instead of the bivalent Pfizer.  Administered appropriate 0.3 dose for 12+ age group but was not the bivalent as per guidelines. Patient had last Pfizer dose in the 11/2021 with no reaction. Spoke with patient provider, she feels it should not be an issue and patient can receive bivalent in recommended time frame post vaccine today.
The patient experienced hives 1 week after receiving the Zostavax vaccine on 5/1/2009. She went to urgent care and had her rings cut off because of the swelling on her hands.  The urgent care doctor described the hives as "swelling" and "migratory" where the reaction moves to different places on her body.  Only a physical exam was done.  Ever since then the hives has not cleared yet.  She has been following up with a doctor.  In her most recent visit on 6/29/09, she had some blood tests done with pending results.  She has been using Benadryl on and off to manage the hives.
Headache, chills, 101 degree temp, achy (body). 12/8/09 saw dr. No other treatment prescribed.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In 2016, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 06-JAN-2017 the patient was treated by a healthcare provider at a family practice for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 including 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. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
I woke up 2:00am my clothes were wet from high fever, and I was very confused. Then I realized I was feverish with chills then changed and went back to sleep. Woke up to another episode at 4:200am of wet clothes and fever changed and went back to sleep. Then I woke up at 9:00am for the day not wet like before. I took a COVID-19 test and it was positive. I work in the medical field, so I called my doctor, and medical health. When I called my doctor, I was instructed to isolate for at least 5 days and stay hydrated along with two prescriptions Paxlovid and Tessalon Perles. The doctor also told me to take Tylenol and Mucinex when needed because of my asthma.   I still have the insomnia issue but that's the only problem that I am having.
I got my first dose Mar 26th.  My last period began March 14th ended March 21st. And my cycle is spot on.  I haven't had my period yet.  After my second dose, 7 hrs after I got a slight headache that just wouldn't go away.  24 hrs later temp was 99.4 Tired and headache.  Other than that nothing else.  Still have a headache that goes away with aspirin.  Otherwise the first dose no side effects beside not period
The roof of my mouth was covered in canker sores for over a week.  This usually happens if I am getting the flu or some kind of virus.  I have never had it to this extent before.
administered expired acthib to a patient, with no reported adverse event; Initial information was received on 09-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 12 months old male patient who experienced administered expired acthib to a patient, with no reported adverse event while receiving vaccine hib (prp/t) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination.  On 07-Nov-2022, the patient received a DOSE 4 of suspect hib (prp/t) vaccine Powder and solvent for solution for injection at a dosage of 0.5 ml (lot UJ594AAA, expiry date - 26-Oct-2022) via intramuscular route in the right thigh for immunization.  On 07-Nov-2022 the patient developed a non-serious event of administered expired acthib to a patient, with no reported adverse event (expired product administered) (latency: same day) following the administration of hib (prp/t) vaccine.  Action taken with haemophilus type b (hib) vaccine (ACT-HIB) was not applicable.  It was not reported if the patient received a corrective treatment for the event (administered expired acthib to a patient, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event administered expired acthib to a patient, with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Patient evaluated in ED 04/26 for bilateral leg cramping, swelling that started just over a week prior. Reviewed records from that visit. Work up was significant for bilateral lower extremity DVTs and thrombocytopenia. Patient was started on Xarelto at that time. Patient does not have any significant risk factors for blood clots. He is not obese, denies tobacco use, recent procedures, recent travel, prolonged immobility, family history of bleeding or clotting disease, etc. He is up to date on cancer screenings based on age/family hx. He did receive the Johnson and Johnson vaccine on 04/07.
worse muscle pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (worse muscle pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (worse muscle pain). At the time of the report, MYALGIA (worse muscle pain) outcome was unknown.            No concomitant medications were reported.  No treatment medications were provided by the reporter.
Approximately ten days after receiving the booster, I began getting hives at night time.  As of January 12, 2022, I still get hives at night but they are isolated to my lower back and thighs.  On January, 11, 2022, I went to the doctor and was diagnosed with shingles. The rash began on Saturday, January 8 at approximately 10:00 am. The rash was not painful and I did not exhibit any additional symptoms.
Since receiving the 2nd COVID-19 vaccine on 2/11/2022 my daughter has a ring around the vaccine site where is looks like her skin pigment is gone.
feeling a weird reaction like a side effect, to her left eye, it was swollen and hurt she could hardly open her eyes and felt that pain would kill her; feeling a weird reaction like a side effect, to her left eye, it was swollen and hurt she could hardly open her eyes and felt that pain would kill her; feeling a weird reaction like a side effect, to her left eye, it was swollen and hurt she could hardly open her eyes and felt that pain would kill her; This is a spontaneous report from a contactable consumer (report for her mother). A 52-year-old female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EW0169, Expiration date, NDC and UPC number was unknown) via an unspecified route of administration, administered in left arm on 14May2021 as dose 2, single (at the age of 52-years-old) for COVID-19 immunisation. The patient medical history was not reported. Patient had not received concomitant medications. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported and Expiration date, NDC and UPC number was unknown) via an unspecified route of administration on an unspecified date as dose 1, single (at the age of 52-years-old) for COVID-19 immunisation. On 15May2021 (morning), patient was feeling a weird reaction like a side effect, to her left eye, it was swollen and hurt, she could hardly open her eyes and felt that pain would kill her. Patient received no treatment for all the events. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
very lethargic; sleep apnea; severe dizziness; slept many more hours than I normally do, in bed 12-14 hours after injection - normally 6-8 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 05Jan2022 at 13:00 as dose 3 (booster), single (Lot number: FD0809) at the age of 62 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis", start date: 01Jan2017 (unspecified if ongoing); "Spinal fusion" (unspecified if ongoing); "TKA Lt. Knee/TKA Rt. Knee" (unspecified if ongoing), notes: TKA Lt. Knee/TKA Rt. Knee. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single time: 10:00 am, Anatomical site of injection: Right upper arm, Route of administration: Intramuscular, Batch\lot number: ER8733), administration date: 26Mar2021, for COVID-19 Immunization, reaction(s): "Severe dizziness", "Very lethargic"; BNT162b2 (Dose 1, Single time: 10:00 am, Anatomical site of injection: Right upper arm, Route of administration: Intramuscular, Batch\lot number: ER8733), administration date: 26Mar2021, for COVID-19 immunisation, reaction(s): "Sleep apnea", "Every time she bends over, if her head gets below her shoulders to pick something up she will black out", "Fever", "queasy", "everything in her body ached", "she had vertigo", "very tired"; BNT162b2 (Dose 2, Single, Anatomical site of injection: Right upper arm, Route of administration: Intramuscular, Batch\lot number: EW0158), administration date: 16Apr2021, for COVID-19 immunisation, reaction(s): "Very lethargic", "Severe dizziness", "Sleep apnea", "She fell asleep in her sunroom and got up around 3:00PM/ Went to bed early plus slept many more hours", "COPD", "She felt like she was on a boat/ she was not feeling", "had soreness in her arm", "has zero energy", "fever", "everything in her body ached ", "She felt like she was on a boat/ she was not feeling right". The following information was reported: LETHARGY (non-serious), outcome "unknown", described as "very lethargic"; SLEEP APNOEA SYNDROME (non-serious), outcome "unknown", described as "sleep apnea"; DIZZINESS (non-serious), outcome "unknown", described as "severe dizziness"; HYPERSOMNIA (non-serious), outcome "unknown", described as "slept many more hours than I normally do, in bed 12-14 hours after injection - normally 6-8 hours". Clinical course: After each injection, he experienced severe dizziness, very lethargic. Went to bed early and slept many more hours than he normally do. In bed 12-14 hours. After injection - normally 6-8 hours. He had been diagnosed with sleep apnea plus COPD since he had the injections. Sender's Comments: Linked Report(s): US-PFIZER INC-2021435489 same patient/drug, different dose/event; US-PFIZER INC-2021435657 same patient/drug, different dose/event;
Received PNEUMOVAX23 in (R) deltoid approx 12:30. (R) arm sore in afternoon. At 10:30 pm noticed Rt deltoid area quite swollen, warm to touch. Took 2 Ibuprofen. No itching but took BENADRYL. 9-30-16 am swelling now behind shoulder blade.
Recurrence of Covid symptoms; Recurrence of Covid symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 at 10:00 as dose 1, single (Lot number: EN6203), in left arm and on 18Mar2021 at 11:00 as dose 2, single (Lot number: EN6207), in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "Breast Cancer" (unspecified if ongoing). Concomitant medication(s) included: TAMOXIFEN CITRATE, start date: Oct2015; OMEPRAZOLE, start date: Jun2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "Recurrence of Covid symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid from 19Jul2022 to 23Jul2022 for the treatment of COVID-19. Patient had recurrence of Covid symptoms (cough and sinus congestion) and positive PCR test 5 days after completing Paxlovid treatment on 28Jul2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201025686 Same patient, different product and event;
Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient feels tingling in the right arm, wrist, and fingers, and itchiness on right chest
Sudden loss of taste (especially sweet); This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm left on 07Apr2021 at 09:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any concomitant medications. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 20:00, the patient experienced sudden loss of taste (especially sweet). The event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of this event. The clinical outcome of the event sudden loss of taste (especially sweet) was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
This is a spontaneous report from a contactable consumer. A 72-year-old female patient received the second dose of PREVNAR 13, via an unspecified route of administration at single dose on 05Dec2016 15:30 for immunisation. The was given the flu shot in one arm and the PREVNAR 13 in the other arm. Medical history included colon cancer from Aug2015 to 03Sep2015, intraductal proliferative breast lesion on 16Jan2016, breast hyperplasia, hypothyroidism, dry eye, breast cancer, depression, anxiety, appetite disorder, sleep disorder. Concomitant medication included influenza vaccine on 05Dec2016 15:30 for immunisation, anastrozole (ARIMIDEX) from Oct2016 and ongoing for anti estrogen for breast cancer, levothyroxine sodium (SYNTHROID) from an unspecified date and ongoing for hypothyroidism, diazepam (VALIUM) from an unspecified date and ongoing  for depression and anxiety, mirtazapine (REMERON) from Feb2016 and ongoing for depression, anxiety, appetite and to sleep, diphenhydramine hydrochloride, paracetamol (TYLENOL PM) from Feb2016 and ongoing for sleep, escitalopram oxalate (LEXAPRO) from 2016 and ongoing, colecalciferol (VITAMIN D3) from an unspecified date and ongoing for low vitamin D, polycarbophil calcium (FIBER) from an unspecified date and ongoing for bowels. The patient may have received the first dose for immunization. On 06Dec2016, the patient experienced nausea, diarrhea, abdominal discomfort with outcome of not recovered. May have taken the PREVNAR 13 twice within 12 months.
Massive and painful swelling of armpit on left arm morning after injection. swelling has continued for over 24 hours so far.
pt exp poss rxn to 1st dose of vax so mom requested DTAP;pt recvd vax & cried uncontrollable & MD did not feel it was a true rxn would recommend DTAP;
Rec'd vaccine on 11.5.08. Started to experience muscle soreness on evening of 11.9.08.  11.10.08-fever, chills, nausea.  11.11.08-chills, flushed, loss of appetite, small red dots on body. 11.12.08-feeling okay, but developed dry cough.  11.13.08-fever, intense neck pain and body muscle aches. 11.14.08 - neck pain has radiated down to shoulders, intense body muscle aches. 11.15.08- 1 a.m. fever broke.  11.17.08 - large red warm splotches all over body.  As of 11.18.08--still loss of appetite, still intense shoulder pain/burning, still splotches, still dry cough. Dr appt scheduled for 11.19.08
Mom picked up daughter from dad's on Monday and child complained of "itchy bug bites" on arms. Rash progressed to full body. Mom reports she does not feel the rash has "pimples". Swollen eyes and lips. Mom will take daughter to physician today for evaluation.
Moderna 0.25ml booster shot after completed 2-dose series of Pfizer Covid vaccine. 8 hrs after injection, experienced uncontrollable all-body shakes and teeth chattering and muscle contractions for 1 hr. Thereafter, whole body aches in both muscles and joints, unrelieved by acetaminophen 500 mg every 4 hrs. 21 hrs after injection, showed low-grade fever (99.7 degrees, oral) and continued fatigue and whole-body ache. Unsteady when walking, making somewhat queasy, and unsafe to drive. Throughout this period, patient trying to rest at home.
patient diagnosed with covid shortly after recieving first dose; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer  reported for a patient that a patient of unspecified age and gender received bnt162b2 (Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced patient diagnosed with covid shortly after receiving first dose on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible. Information about Lot/batch number cannot be obtained. No further information is expected.
Nausea, chills, fever, body aches, headache, rash on arm
within 3 days she seizures and thereafter has had seizures and significant developmental delay that continue to this day. I was consulted as a geneticist to try to elicit a diagnosis for this young lady.  Mother told me this story, that I think deseves evaluating further. Severe mental retardation, intraitable seizures. How does mom apply for damage? Information from Annual Follow-up report states severely mentally retarded. How do I help mom receive compensation? How can I help in the evaluation of this patient?