chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diagnosed expressive aphasia; Developed new onset stuttering about 2 - 3 weeks after the second dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administration date 03May2021 (Lot number: EW0165) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number=EW0161, prev dose lot unknown=False, prev dose administration date=12Apr2021, prev dose dose number=1), administration date: 12Apr2021, when the patient was 60 years old, for COVID-19 Immunization. The following information was reported: APHASIA (medically significant) with onset May2021, outcome "not recovered", described as "diagnosed expressive aphasia"; DYSPHEMIA (medically significant) with onset May2021, outcome "not recovered", described as "Developed new onset stuttering about 2 - 3 weeks after the second dose.". The events "diagnosed expressive aphasia" and "developed new onset stuttering about 2 - 3 weeks after the second dose." were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: imaging procedure: (2021) diagnosed expressive aphasia, notes: Evaluations, including imaging, diagnosed expressive aphasia; investigation: (2021) unknown results, notes: Evaluations, including imaging, diagnosed expressive aphasia. Therapeutic measures were taken as a result of aphasia, dysphemia. Patient was treated with speech therapy. Patient did not received any other vaccine in four weeks. Patient did not received other medications in two weeks. Patient did not experienced COVID-19 prior vaccination. Patient not tested positive post vaccination. No known allergies were present.  Follow-up attempts are completed. No further information is expected.
Mild edema with induration, mild erythema, non-tender to palpation.
I experienced chest and lung pain and had to be immediately rushed to the hospital. The ER doctor ordered tests to look at my lungs to find out why I was experiencing an adverse reaction the vaccine. I was admitted to the hospital and was there for 4 days. My lungs were bleeding and there was bacteria in them. I am getting ready to have another series of tests done on my lungs and my doctor suspects that the vaccine is what caused my lungs to flare up. My breathing is really bad and the pulmonologist stated that my lungs are continuing to bleed. I am on 4 nebulizers and other medications.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 79-year-old female patient who received SHINGRIX for prophylaxis. On 7th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 7th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema and pain in arm. On an unknown date, the outcome of the injection site erythema and pain in arm were recovered/resolved. It was unknown if the reporter considered the injection site erythema and pain in arm to be related to SHINGRIX. Additional information was reported as follows: The patient reported that she experienced soreness at the injection site after receiving the SHINGRIX vaccine. The soreness continued for about one week from her elbow and up and it was red and sore. The patient has denied permission to contact their physician.
Staring about 12 hours after the injection and persisting at least 12 hours (current time) I have mild disequilibrium such as I just stepped off a merry-go-round. It is not frank vertigo and does not impair my ability to walk or drive but is noticible.
Systemic redness, itching, malaise;  1 Benadryl given priod to injection due to reaction to flu shot 2018
Patient received a 3rd dose of Moderna. 1st dose on 1/8/21, 2nd dose on 2/5/21, and 3rd dose on 7/14/21.
Patient was brought back to room after nearly fainting in lobby at checkout. She reported to mom that everything went black and she didn't feel good. Mom noticed she was wobbly and caught her as she was unsteady on her feet. Reported she was pale and white. Also felt warm on forehead. Nurse confirmed pallor. When I saw her she did seem more pale than during our visit. She was alert and awake. She had normal vital signs and a normal exam. She was given juice and cookies and observed for approximately 20 minutes. Her color improved and mom reports she looked better. She was discharged home with return precautions. I spoke to mom today who said she didn't feel quite herself yet.
Pt recvd 1st dose of vax on 8MAR91 @ approx 830AM & @ 11PM on the day of the vax pt went to ER c/o feeling "out of control" & rapid breathing; vomited twice; given meds; pt recvd 2nd dose of vax w/no problems;
Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 09-Jul-2022; No adverse event; Administered the vaccine to patient after the 30 day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 09-Jul-2022).    Concomitant medication information was not provided by the reporter.  Patient received half dose.  Vial was initially stored in the refrigerator on 4-Jun-2022. Vial did not undergone any temperature excursions.  Treatment information was not provided by the reporter.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 4 (booster), single (Lot number: GH9U93) at the age of 55 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8734), in left arm, on 23Apr2021 as dose 2, single (Lot number: EW0151), in left arm and on 02Dec2021 as dose 3 (booster), single (Lot number: FJ8757), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19: Paxlovid from 29Mar2023 to 03Apr2023.
itching all over body and large blisters have developed in my hands.  multiple wounds from contant scratching, legs,m arms, genitals, chest, neck area.
Within 1 day, the pt had a knot with soreness in arm. By day 2 a defined red area at injection site was experienced. The pt experienced intense soreness. The pt experienced numbness in right leg and then soreness in all leg muscles which started on day 2 and lasted until day 7. No physical activity would have warranted the leg soreness. A follow up report received 1/10/2001 adds: Pt states he is partially recovered. Mild soreness in left triceps area where shot was administered. Has missed 8 days of work.
upset stomach; vomiting; diarrhea; high temp; This is a spontaneous report from a Pfizer . A contactable consumer reported that a 19-year-old male patient (reporter's son) received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 13Mar2021 (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient started experiencing upset stomach, vomiting, has diarrhea and a high temp on 14Mar2021, 24 hours from receiving the first dose of the vaccine. The patient took Tylenol for event high temp. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Discharge Provider: MD Primary Care Provider at Discharge: DO Admission Date: 5/13/2022 Discharge Date: 5/19/2022  PRESENTING PROBLEM: Elevated C-reactive protein (CRP)  Elevated brain natriuretic peptide (BNP) level History of MRSA infection Other acute osteomyelitis of left foot (HCC)  Stage 3b chronic kidney disease (HCC)  COVID-19  Osteomyelitis (HCC)    HOSPITAL COURSE: 74-year-old with osteomyelitis of left 5th metatarsal head admitted for IV antibiotics and Podiatry consultation and resulting surgery.  Patient also with COVID.  Has remained on room air during his entire stay.   Patient with osteomyelitis on presentation.  Patient underwent  partial-amputation of left 5th ray on May 15th:.  Patient was maintained on IV vancomycin because of previous culture showing MRSA infection.  Repeat cultures did grow out Staph aureus.  Bone biopsies done during her surgery did not show any evidence osteomyelitis within the 5th metatarsal.     Infectious Disease was consulted they recommended using doxycycline for a total of 14 days of treatment.  Patient completed 4 days of treatment or hospitalization.  Patient will be discharged on 10 days of doxycycline.  Overall patient is doing well.  He received a dressing change this morning.  Patient will have home health care for further dressing changes per Podiatry recommendations.  Patient has been given a dose of doxycycline during hospitalization because of a previous questionable allergy to tetracycline.  If tolerates, will discharge home antibiotics as outlined above.
had an infection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFECTION (non-serious), outcome "unknown", described as "had an infection".  Additional information: Caller asked if Pfizer still makes zithromax. Also wanted to confirm the NDC # of Zithromax. Caller also mentioned that she's been vaccinated with the Pfizer COVID 19 vaccines and had an infection. Cold Transferred - Created and submitted Manual AE form # because caller mentioned that she had infection after getting the Pfizer COVID-19 vaccines. Medical Information: Forwarded: Yes, medical inquiry was forwarded.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient complained of severe pain in left upper arm approximately 24 hours of administration of PNEUMOVAX. Arm was red, swollen, and warm to the touch. Patient was afebrile with temperature of 96.7 and devoid of chills or sweats. Treated with PRN APAP and cool compress QID for 30 min PRN. Followed up with nursing home on 8/4/2017 and administrator reported that symptoms of pain and swelling had subsided.
Large bump very tender 10 cm x 5 cm @ site of immun 7 days post vax; 1t102-103 10 days later bump went away about 2 wks post vax;
This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, frequency, route and site of administration, lot# and expiration date were not reported) for prophylaxis (reported as FDA approved indication). On an unknown date the patient experienced postural orthostatic tachycardia syndrome. The outcome of the event was unknown. Causality assessment was not reported.
The next day, pt woke up in upper R arm pain, which worsened for a few days. The day after, she noticed some swelling and tenderness in the R supraclavicular fossa. No erythema. Starting a few days later, all symptoms started to improve. Continues to have a 3cmx2cm indurated area subcutaneously at the R upper arm on 9/11.
Initial and follow up information has been received from a licensed practical nurse through the manufacturer pregnancy registry concerning a 24 year old female with a history of two miscarriages in the past and not planning on being pregnant, a spontaneous abortion (March 2006) and no known allergies reported. On 20 Nov 2006, the patient was vaccinated intramuscularly in the left deltoid with the first 0.5ml dose of HPV vaccine (lot #653978/0955F). On 20 Nov 2006, the patient had a pelvic ultrasound performed due to pelvic pain. The pelvic ultrasound revealed fluid in pelvis and no intrauterine pregnancy was seen (previously reported as was negative for pregnancy). On an unspecified date, post vaccination, the patient presented to the office stating that she took a urine home pregnancy test and it was positive. On 04 Dec 2006, the patient had blood work drawn which revealed positive for pregnancy. The patient was approximately 6 weeks gestation with last menstrual period noted as approximately 21 Oct 2006. The patient was scheduled for a follow up blood test on 07 Dec 2006 and an ultrasound and blood lab was scheduled on 11 Dec 2006. On 17 Dec 2006 the patient experienced spontaneous abortion. The patient sought unspecified medical attention. At the time of this report, the outcome of the event was unknown. Upon internal review, the spontaneous abortion was considered to be an other important medical event (OMIC).
Pt was transferred to Hospital on 5/10/08 after presenting to a different hospital with fever and seizures.  At hospital, she was loaded with phenobarbital to stop her seizures.  MRI performed without contrast was a normal MRI of the brain.  EEG showed posterior ictal spikes and waves with some slowing.  Due to the patient's fever, blood cultures and urine cultures were sent at the outside hospital, both of which were no growth  final.  CSF was drawn and CSF cultures were sent, as well as protein and glucose, all of which were within normal limits.  The  CSF from the outside hospital was requested to hospital in order to run a HSV PCR on the sample.  HSV PCR was performed at hospital and was negative, at which time the ceftriaxone and acyclovir which was started on admission were both discontinued.  7/15/08 Reviewed hospital medical records for 5/10-5/13/2008 FINAL DX: new onset seizure disorder Records reveal patient experienced fever, staring, tonic movement of extremities, unresponsiveness lasting approx 5 min 1 day after vaccination.  Temp max 103.  Seen in outlying ER where additional seizure like activity observed & transfered to higher level of care.  Seizures observed during admission process & loaded w/antiseizure meds.  No further seizures noted.  D/C to home on continued antiseizure meds w/neuro f/u.
death as described above. No clear association to vaccination. COVID-19 positive  Asymptomatic by report Possible diagnosis of Marfan Syndrome
Within 6 hours, the pt developed arm swelling more than double size, warmth, redness and pain which extended to her shoulder. She self-treated with warm compressed and self medicated with Tylenol and Advil. The symptoms resolved within 48 hours. This is 1 of 2 reports from this site of adverse experiences following receipt of Pnu-Imune-23. Additional information received Nov 8, 1999 from the physician indicated that the pt developed an allergic inflammatory reaction involving the entire arm and shoulder area, described as swollen, red, warm, and tender. Additional information received 04/20/2000 indicated that the pt developed a severe allergic reaction which extended to the lower part of her neck. Additional information also included the correct onset date of the adverse event and the correct county where vaccine was administered.
Pregnant patient received the first dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 11-Jun-2020 and the estimated date of delivery was 23-Mar-2021. On 20-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 20-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided. No treatment medication was provided.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 33-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Information has been received from a physician referring to a 14 year old adolescent (also reported as adult) female patient. There was no medical history or concurrent condition reported. On an unknown date the physician reported the patient was vaccinated with GARDASIL 9 (dose, strength, route and lot # were not reported) too soon (inappropriate schedule of vaccine administered). There was no concomitant medication reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
A pediatrician reported that 3 patients (age 12 - 15 months) who received Prevnar, MMR, and Varicella vaccine experienced various adverse reactions. The reactions included vasculitis, bruising, soreness, and joint swelling. Individual patient info and  vaccination dates / history were not provided.
Systemic: Fainting / Unresponsive-Moderate, Systemic: Visual Changes/Disturbances-Mild
I have a patient that got both doses of the Moderna Covid-19 vaccine, but the 2nd was 21 days apart.; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have a patient that got both doses of the Moderna Covid-19 vaccine, but the 2nd was 21 days apart.) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have a patient that got both doses of the Moderna Covid-19 vaccine, but the 2nd was 21 days apart.). On 29-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have a patient that got both doses of the Moderna Covid-19 vaccine, but the 2nd was 21 days apart.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported.
his wife is experiencing "a bump underneath her skin, red, and its painful."/redness and a little bump and lot of pain; his wife is experiencing "a bump underneath her skin, red, and its painful."/redness and a little bump and lot of pain; his wife is experiencing "a bump underneath her skin, red, and its painful."/redness and a little bump and lot of pain; This is a spontaneous report from a contactable consumer (Patient's husband) via Medical Information Team.   A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6200; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in right arm on 17Feb2021 (at the age of 78-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history included a broken arm couple of years ago and lost the use of that arm and the hand anyways, that's why we have to put the shot in her right arm and reporter does not know about treatment. The patient takes a lot of unspecified concomitant medications. On an unspecified date in Feb2021, the patient experienced a bump underneath her skin, red, and its painful, redness and a little bump and lot of pain. The reporter clarified that his wife was experiencing this at the injection site and has been going on for the last two days and has been taking Advil PM for this reaction. The patient was scheduled to have second dose on 10Mar2021. The reporter asked if patient would react differently with the second dose. The patient received treatment for the events. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Herpes Zoster; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced an episode of shingles that resolved less than 4 weeks before the reporting date. No additional details provided.  The lot number and expiration date not provided.
Was given Hep A then HPV. He said ouch and then fainted. He fell off the exam table and hit the floor. Very sweaty and not feeling well afterward. By report had approx. 10 seconds of lower leg movements when he fell. He got up off the floor on his own and climb back on the table.