chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Constipation, fussy. Very fussy, hard to soft stools, soft stools for 2 d. Temp 99.5. A 60-day follow up report received 7/29/2003 adds: pt recovered 7/25/2003. No gross motor delays. The follow up received on 9/9/02 states child's temp checked by parent at home-100 degrees rectal. Monitored at home-no Rx not admitted, not seen in office.
terrible reaction after she got the 2nd dose of the vaccine; fluid retention; Bloatingness; difficulty of breathing; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (terrible reaction after she got the 2nd dose of the vaccine), DYSPNOEA (difficulty of breathing), FLUID RETENTION (fluid retention) and ABDOMINAL DISTENSION (Bloatingness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 015M20A) for COVID-19 vaccination.     The patient's past medical history included Heart failure (NOS) in 2018 and Atrial fibrillation in 2018. Concurrent medical conditions included Penicillin allergy. Concomitant products included METOPROLOL, LISINOPRIL and RIVAROXABAN (XARELTO) for Atrial fibrillation and Heart failure (NOS).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced DYSPNOEA (difficulty of breathing). On an unknown date, the patient experienced VACCINATION COMPLICATION (terrible reaction after she got the 2nd dose of the vaccine), FLUID RETENTION (fluid retention) and ABDOMINAL DISTENSION (Bloatingness). At the time of the report, VACCINATION COMPLICATION (terrible reaction after she got the 2nd dose of the vaccine), DYSPNOEA (difficulty of breathing), FLUID RETENTION (fluid retention) and ABDOMINAL DISTENSION (Bloatingness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: normal (normal) normal. On an unknown date, Ultrasound Doppler: heart was fine and healthy (normal) heart was fine and healthy.         Patient was quite hesitant to take the booster dose. She reports that on the night after she got the 2nd dose (10-Mar-20221), she had difficulty of breathing. She went to her PCP who ignored it and then 2 weeks later she went to her cardiologist. Symptoms started on the night when 2nd dose of the Moderna Covid-19 vaccine was given and symptoms resolved after taking diuretics.  There was no history of COVID-19 infection nor Myocarditis and pericarditis  For treatment diuretics was taken.
Upon arriving for vaccine, patient and mother voiced his nervousness about vaccines.  Administering nurse used precautions after vaccine administration by laying patient back for 10 minutes.  Patient was conscious throughout this observation period and after 10 minutes felt well enough.  Nurse sat him up for an additional 5 minutes to monitor.  He sat in chair beside exam table while sibling received vaccination.  While sitting there, patient was verbal and playing on cell phone.  After sibling was observed for 10 minutes, patient then complained of feeling hot.  Mother provided him with water and after taking a few sips, his upper body began with light tremors, stopped, and then he was noted to be in a blank stare - all lasting about 30 seconds. Provider was called into the room.  Mother denied history or seizures.  Vitals were obtained.  No LOC occurred.  Patient was oriented and answering questions.  BP was reportedly low.  Consulted provider reported AOx3, with reports of dizziness and sweats.  Hypotensive at 77/45, tachycardic at 109, POX 99%.  Brief neurologic, cardiac, and pulm exam were within normal limits.  positioned supine with feet elevated.  Given water, crackers, and candy.  Repeat BP was 86/51, HR 54, then 93/57, HR 66. Decision by provider was to transport patient to ED for further evaluation with seizure like reaction.
Lymphedema after second dose; This is a spontaneous report from a contactable consumer reported for female patient (lady) that is also a patient in physical therapy. A female patient of unspecified age received second dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot number: Unknown, Expiry date: Not provided), via an unspecified route on an unspecified date, as a single dose for covid-19 immunization. Medical history included breast cancer. The patient concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection), as a single dose for covid-19 immunization. On an unknown date, 5 to 7 days after second dose, patient developed lymphedema and they had to increase her Lasix. Reporter stated that when she signed in for Physical Therapy, the girl told her that about 30 percent of her patients were all from the second Covid vaccine and it all happened within the same time frame (within 5-7 days after the second COVID Vaccine). All of these people had lymphedema, and another thing they had in common was that they all had radiation treatment for cancer. Reporter was just wondering if Pfizer's studies included any people who had radiation treatments because it seems like the 30% in the physical therapy class that had the Pfizer vaccine all had radiation. Reporter has questions about the paperwork she received. She said she had to go through Occupational Therapy because of this. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
7/15/2022 patient presented to ER after children found her at home on the couch covered in feces. Admitted to the hospital for confusion, rhabdomyolysis, hypovelemia, and alcohol withdrawal.
prescription for FLUZONE HIGH DOSE but she is only 62 years old, with no reported AE; prescription for a patient that is immunocompromised (stage 3 kidney disease), with no AE; they did give it to her last year, with no reported AE; Initial information received on 18-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional via Medical Information (Reference number- 00817250)..  This case involves a 62-year-old female patient who is immunocompromised for whom the prescription of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] was provided and gave it to her last year (Product prescribing issue, Contraindicated product prescribed  and product administered to patient of inappropriate age).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Renal disorder and Immunodeficiency.   It was reported "her doctor has prescribed her to get the Fluzone High Dose which they plan to give her but are calling to get information that it is OK to do so. Caller states they did give it to her last year but they want information this time. States the consumer has Stage 3 kidney disease."  It was a case of potential medication error due Product prescribing issue, Contraindicated product prescribed  and product administered to patient of inappropriate age.  At time of reporting, no adverse event was 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 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.
Caller reported VAXELIS was administered instead of the intended VARICELLA vaccination.; This non-serious spontaneous safety report with reference number # 2023SA031533 (Inquiry # 01465069) was received by a partner on 26-JAN-2023 and forwarded on 27-JAN-2023 from a health care professional.  Due to the nature of the event, the causality between the event "Caller reported VAXELIS was administered instead of the intended VARICELLA vaccination." and Vaxelis was not applicable.  Further information is expected.  FOLLOW-UP INFORMATION was received from the health care professional, by Fax, on 24-FEB-2023.  No adverse event was reported.   Due to the nature of the event, the causal relationship between Vaxelis and the event "Caller reported VAXELIS was administered instead of the intended VARICELLA vaccination" was not applicable.  No further information is expected.
Symptoms started upon wakening the morning after getting the Moderna vaccine. Symptoms include a headache, nausea, fever/chills, and pain at injection site. Vitals stable.
shakes; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes) and PYREXIA (Fever) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 25-Jan-2021.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced TREMOR (shakes) and PYREXIA (Fever). At the time of the report, TREMOR (shakes) and PYREXIA (Fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
sore throat, h/a, low grade fever, acne looking bumps on face, w/in 72hr bumps on torso, went to hosp, clinicians unsure what pt had until they took cult & blood test;given some prescription to dec sx & DPH;prescription to relieve itching;
About 1 hour after the vaccine, I developed watery eyes, itchy, runny nose, sneezing, itchy throat. This lasted throughout the day and required 50mg of Benadryl before symptoms finally subsided around 9pm that night.
12 hours after injection had chills Temp of 100, severe body and joint pain, headache,  fatigue for 12 hours Headache lasted for 48 hours   I did have the virus in April.   Took 7 months to fully recover
positive SARS-CoV 2 antibody test after second dose; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (positive SARS-CoV 2 antibody test after second dose), PYREXIA (fever) and CHILLS (chills) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced COVID-19 (positive SARS-CoV 2 antibody test after second dose). At the time of the report, COVID-19 (positive SARS-CoV 2 antibody test after second dose), PYREXIA (fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) patient had a positive SARS-CoV 2 antibody test after his second dose.         No Concomitant product use was reported.  The patient received their second dose of Moderna Covid-19 vaccine in Mar-2021 and had a fever and chills after their second dose vaccine. It was also reported that the patient had a positive SARS-CoV 2 antibody test after their second dose in the primary series of the Moderna Covid-19 vaccine.  No treatment information was provided.  Company Comment: This spontaneous case concerns a 32-year-old male patient, with no medical history reported, who experienced the unexpected events of COVID-19 (AESI) and the expected events of Pyrexia and Chills. The events occurred on the same month after receiving the second dose of mRNA-1273 Vaccine. The outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-563510, MOD-2021-040897 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2022: Follow-up received contains non significant information.; Sender's Comments: This spontaneous case concerns a 32-year-old male patient, with no medical history reported, who experienced the unexpected events of COVID-19 (AESI) and the expected events of Pyrexia and Chills. The events occurred on the same month after receiving the second dose of mRNA-1273 Vaccine. The outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 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. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "adhd" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No Known allergies. Paxlovid, treatment start date=25Jan2023, treatment stop date=30Jan2023.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unspecified date, in September 2015, reported as "sometime during the month of September 2015", the patient's were vaccinated with unspecified improperly stored doses of GARDASIL, lot # H021861 and expiration date 09-OCT-2015, lot # J008423 expiration date 21-JAN-2016 and lot # K010215 expiration date 05-MAY-2017, (dose, route of administration and anatomical location were not provided). There were not concomitant medications reported. There was not product quality issue involved. This is one case of several cases from the same reporter. Additional information has been requested.
Intermittent fevers for 12 days, Tmax 104.6, cough, coryza.  Day 6 developed bilat cheek erythma.  Day 10 developed papular erythematous rash on trunk and cheeks, T104.2, dehydration.  WBC 14k, normal CXR.  Never oral lesions.  Tx as viral illness and supportive (antipyretics).  Overall, 3 clinic visits and 3 ER visits in 12 days, plus numerous phone calls.
Could not breathe/even with my 24/7 oxygen.  Heart Racing to 156 160 beats had terrible shaking and chills fever when rescue got me to hospital
Got the shot; got PP anyway.; Got the shot; got PP anyway.; This is a spontaneous report received from a contactable reporter (consumer) for a Pfizer sponsored program. The reporter is the patient.  A 70-year-old male patient received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant) and PNEUMONIA PNEUMOCOCCAL (hospitalization, medically significant), outcome "unknown" and all described as "Got the shot; got PP anyway." The patient was hospitalized for drug ineffective and pneumonia pneumococcal (hospitalization duration: 9 days). Clinical course: The patient reported that he got the shot in May but got the PP (as reported) anyway. He was hospitalized in August for 9 days.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Began as aches in legs on the 4th. Night time extreme chills, nasal congestion and fever. This continued for three nights. Turned into extreme chest congestion. At time of report still has effects. Tired and drained overall feeling.
This spontaneous report was received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. These patients' concomitant medication, pertinent medical history and drug reactions were not reported. On an unspecified date, these patients were administered improperly stored PNEUMOVAX 23 (lot # M036728 with expiration date 20-MAY-2018 and lot# M043987 with expiration date 30-JUN-2018, dose and route not reported) for prophylaxis. The vaccine was exposed to temperature excursion of 47 to 77 Fahrenheit (F) for 1 hour. The vaccine was previously exposed to temperature excursion of 47 to 77 Fahrenheit (F) (48 F) for 30 minutes. The data logger was involved. No adverse effect was reported.
She has redness, swelling and bruising around the area of injection posterior (L) arm. No surface lesions or drainage patient was very tense & had to be held down for the shot.
Nausea pain in all my body - head to toe jaw & teeth hurt, shaking hands (tremors) ears hurt, lasted about 2 days but worse the first day.
pt recv vax 13OCT98 & exp arm pain, facial paralysis, paresthesia & unspecified paralysis;23OCT98 seen by neurologist dx GBS & hosp;tx w/plasmapheresis;improved & D/C 10/30/98
Double Vision which came on suddenly one morning.  Over a 2 month time period the symptoms have receded slowly each day.  I am almost 95% better.
Testicular ache; chills; headache; SI joint pain bilaterally; Fatigue; This is a spontaneous report from a contactable 51-year-old male Health care professional reported for himself. A 51-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration from 24Jan2021, 14:00 at SINGLE DOSE (second dose, left arm) for covid-19 immunisation, administered on a hospital. Medical history included history of chronic hives; no issues x 1 year from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 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 previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown) on 03Jan2021 at 12:00 PM on the right arm for Covid-19 Immunization (Age of vaccination was 51 years old). The patient previously took Asa and experienced drug hypersensitivity and hives (known allergies: Asa - hives). Concomitant medication included celecoxib (CELEXA), and cetirizine hydrochloride (ZYRTEC), therapy dates and indication unspecified. The patient experienced testicular ache, chills, headache, si joint pain bilaterally, and fatigue on 25Jan2021 04:00. No treatment was given. Outcome of the events was recovered. Seriousness criteria was reported as non-serious.  Information on the lot/batch number has been requested
After pt was informed he had been vaccinated, he developed a yellowish pallor & passed out for a few seconds. He was initially disoriented to place. He declined food & blood pressure monitoring, he drank water. He did not c/o difficulty breathing. He left at 4:35 w/his mom.
nausea and dizziness/dizziness and nausea went pretty extreme; nausea and dizziness/dizziness and nausea went pretty extreme; This is a spontaneous report from a contactable consumer (husband of patient). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number, expiration date unspecified), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 13Jan2021, 2 days after vaccination, patient experienced nausea and dizziness, that went away. Until yesterday, 19Jan2021, her dizziness and nausea went pretty extreme. She was scheduled for a second dose in about 2 weeks, on 09Feb2021. Outcome of events was not recovered.  Information on the lot/batch number has been requested.
Information has been received from a physician concerning a 43-month-old female who on 12/15/1998 was vaccinated with Varicella virus vaccine live. On 04/03/1998, the patient developed a fever and 04/05/2001 broke out with a rash. It was reported that the child had a case of chicken pox with 50-100 lesions including a lesion in the mouth. The child was happy and not scratching the lesions. Additional information has been requested.
Patient received 5-11 formulation of pediatric pfizer at age 3. Error discovered 10/11 when counting waste. Reached out to parent 10/11 and confirmed that child was in good health at time of call.
Information has been received from a physician concerning an 17 year old white male student who on 20Aug1998, 28Sep98 and 19Feb1999 was vaccinated in the left deltoid with the first, second and third doses, respectively, of hep B virus vaccine rHBsAg (yeast) (lot 625398/0112H, 625718/0434H and 628746/1667H, respectively). There was no illness at the time of vaccination. The physician reported that on 05May04, while donating blood, the pt's screens were positive for hep B surface antigens and neg for hep B antibodies. At that time, the pt was informed the he was positive for hep B. Unspecified medical attention was sought, but no treatment required. At the time of this report, the outcome of the pt's hep b was unk but it was noted that the he was fine and was being monitored by a pediatrician. Additional information has been requested.
Information has been received from a physician concerning a 2 month old female who on 13-MAR-2007 was vaccinated with a 2 mL PO dose of Rotateq. Concomitant vaccination administered that day a dose of included Pediarix, a dose of Prevnar and a dose of Hib (manufacturer unknown). On 15-MAR-2007 the patient developed severe diarrhea two days after vaccination. The patient was taken to the emergency room. Subsequently, the patient recovered. The patient's severe diarrhea was considered to be an other important medical event. Additional information has been requested.
The evening after I got the shot my arms/elbows were very itchy.  The next morning, I had red circles/small "welts" on my forearms and elbows.  They were very itchy.
This spontaneous report has been received from a physician refers to a 17 weeks old patient. Medical history and current condition of the patient were not reported. On 22-JAN-2015 (approximately 17 weeks post birth), the patient was vaccinated with the first dose of ROTATEQ, oral, 2 ml, orally (lot#, expiry date unspecified), which was outside of the 6-12 week time frame indicated for 1st dosing in physician's prescribing information. No adverse effects reported. No product quality complaint (PQC) involved. Additional information has been requested.