chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician and refers to multiple unspecified patients of unknown age and gender. There was no concurrent condition, medical history or concomitant medication reported for the patients. On an unknown date, improperly stored diluent (manufacturer unknown) (dose, frequency, route, lot #, expiration date and indication were not reported) was used to reconstitute unspecified vaccines which were then administered to multiple unspecified patients. No adverse effects were reported. Follow up information has been received from the physician on 19-JAN-2016. The reporter stated that, on unknown dates, improperly stored doses of GARDASIL lot # K011562, expiration date 08-APR-2017, (dose, frequency and route were not reported) were administered to an unspecified number of patients. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
1 week after covid 19 shot at site  of vaccine in left arm is sore,red and itchy.
Per telephone call, Mom reported pt had developed an itchy rash on her leg. I advised her to FU in Urgent Care or ER. FU call later, pt had applied cream and rash improved.  Did not FU with MD.
Extremely itchy for almost a week. No rash; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration in left arm on 29Mar2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic to iodine. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 since the vaccination. On 31Mar2021, the patient experienced extremely itchy for almost a week, but no rash. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as the result of adverse event. The clinical outcome of the event itchy was not recovered at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Left thigh at the site of Pediarix localized reaction with round penny size induration, non tender. Placed on Augmentin and warm compress.
A few minutes after the vaccines were administered and patient was waiting for paperwork he experience a syncopal event. He fell off exam table and briefly lost consciousness.  He maintained breath and 02 sats were 99%.  He was out for 30 seconds or less, when he aroused he was confused and did not know exactly what happened.  His b/p was low 100/40, pale and tachycardic. He was escorted to a chair given a juice and allowed to sit.  At this time he complained of headache and was confused about what had happened.  15 minutes with observation and ongoing assessment later- color returned, b/p  and heart rate normalized.   No medications were administered.  He left the clinic on his own.  Mother was informed of events.  She had states his father had similar adverse events.
wasn't feelin good; tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid) and MALAISE (wasn't feelin good) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced COVID-19 (tested positive for Covid). On an unknown date, the patient experienced MALAISE (wasn't feelin good). At the time of the report, COVID-19 (tested positive for Covid) and MALAISE (wasn't feelin good) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Aug-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter   Reporter did not allow further contact
"The patient is a 73 y.o. female, presented on 2/14/2022 with the above. The symptoms/labs were thought to be marked in severity and unstable. Onset several days ago. Associated symptoms include fatigue . Alleviated by none. The patient has a history of pericardial effusion and afib for which she is on warfarin. She also has a history of GI bleed and had an EGD on 8/4/21 with ablation of gastric AVM's. She had a C.scope on 1/27/22 with poor prep but a polyp was noted in the transverse colon and she had some diverticulosis. The patient states that she has had some shortness of breath and weakness for several days. She was seen here on the 10th and was found to be covid 19 positive. She was discharged for outpatient management. Since that time she states that she has felt worse and she has noted melena when she uses the bathroom. She came back to the ED today and was noted to have a Sodium of 124 with a cr of 1.4 and a serum osmolality of 256. She also had  A hemoglobin of 6.4 and an INR of 6.9.her hemoglobin on the 10th was 10.6.  She deneis any bright red blood per rectum. She has had some pain in her abdomen to touch on the left side of her abdomen. CT of the abdomen pelvis showed a subacute hematoma in the rectus sheath. She was also noted to have a dilated IVC and ascities. The patient is currently on 3 liters. She states that she is on 3 liters at home. She has been admitted for further management."   Hospital Course:  The patient was admitted to the hospital and was evaluated and treated per below.      * Acute blood loss anemia o Acute blood loss anemia. Upper endoscopy done showing hiatal hernia and chronic gastritis with no evidence of any active GI bleeding.  Hgb 7.7 today, remains stable/unchanged. She will need further GI evaluation on outpatient basis. Follow-up with GI. Discharge home today with home health. Patient changed her mind and does not want inpatient rehabilitation. o COVID-19 virus infection. Remdesivir course done. Remains on 3 L of oxygen by nasal cannula. Continue to monitor. o INR was elevated on admission. Coumadin was held due to acute blood loss anemia. Needed to vitamin K. INR is trending down. Continue to hold Coumadin and resume when cleared by cardiology and GI. o Atrial fibrillation. Controlled. Continue current treatment and monitor on telemetry. o Anasarca. Controlled on oral diuretics.  o Diabetes mellitus type 2. Continue with same home regimen/equivalent. Monitor blood sugar and cover with insulin sliding scale. o Hypertension. Controlled. Continue same treatment. Follow up daily labs.  o Physical deconditioning. Patient changed her mind and does not want inpatient rehabilitation. Discharge home with home health.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patient was vaccinated with first and second dose of GARDASIL for prophylaxis (dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patient was vaccinated inadvertently with an expired third dose of GARDASIL lot #K001500 with an expiration date 06-NOV-2016 for prophylaxis (dose and route of administration were not reported). There was no adverse effect reported. Product quality complaint (PQC) was not reported.      Additional information has been requested.
Booster dose of Pfizer COVID 19 vaccine given. Patient had previously received Moderna for first two doses. No adverse reactions noted.
22M hx asthma recieved Moderna dose #2 on 6/10. Within 12 hrs developed shortness of breath, and chest pain. Presented to this hospital's ED in this setting.  On arrival he was not exhibiting symptoms of asthma exacerbation. The chest pain improved with sitting up and leaning forward.
Within hours of vaccines, patient began with involuntary movements of head and lip smacking, back arching and jerking motions of arms. Temp 101.8. Admitted to hosp. to R/O seizure. Thought to be secondary to vaccines. 1/15/09-records received for DOS 11/8-11/10/08- DC DX:Involuntary jerking movement. Lip smacking. Presented to ED with intermittent jerking movements,head to left. Lip smacking. Temperature 101.8, irritability.
Woke up itching and breaking out in hives on my legs, back, and stomach.  My ears and eyes were slightly red and itching/swelling a little. My upper lip was also swollen.  It was a mild reaction.
Received Pfizer vaccine on January 7 at approximately 5:20PM.  This morning on January 13 at 5:20 AM, I noticed a rash on my left upper arm/deltoid at the vaccine site. Rash is flat and red, approximately 8 cm x 8 cm, but not circular.
Patient received the non-bivalent Pfizer dose in error instead of the bivalent dose
No symptoms reported.; Caller reported AE for improperly stored administered VARIVAX. TE Filed (Case #02453472). No symptoms reported. Obtained consent contact HCP. No additional AE/PQC. Product: VARIVAX-- Supported Lot: W021743 Exp: 7/10/2024 Temperature: 29F / 14°F up t; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 15-AUG-2023, the patient was vaccinated with an improperly storage varicella virus vaccine live (OKA/MERCK) (VARIVAX) subcutaneous injection, 0.5 milliliter, valid lot #W021743, expiration date: 10-JUL-2024, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). Temperature excursion occurred at 29 Fahrenheit (F) (14 F up to 46 F) for 6 hours and 20 minutes. No previous temperature excursion was reported. No symptoms were reported.
Pruritic rash across arms and torso several hours later developed, lasting now several days.
Feeling sick; Information received from a case in litigation (case# 2003USA009785) regarding with a male concerning a patient of unknown age. In 2018, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown)  for prophylaxis (dose, route of administration, lot number and expiration date were not reported). It was reported that the patient was really sick for 24 hours. The outcome was recovered on unspecified date in 2018. The causal relationship between the event and therapy with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown)  were not reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA009785:
Started with itchy left eye 6 days (Friday) after 2nd shot then within the next 2 days I developed a painful rash around the left eye and left forehead going up to hairline.  Next day rash became blistery so I went to see my PCP and she said I have shingles, ordered Valtrex and gabapentin.
Tongue Swelling, Dizziness,  Upset Stomach,  Anaphylaxis
there's still some areas is sensitive to touch; rash is healing now; Shingles 2 weeks ago on left side of my leg and buttock area; very painful to walk and to sit; Sick for a week; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In July 2022, the patient received the 1st dose of Shingles vaccine. In September 2022, between 2 and 3 months after receiving Shingles vaccine, the patient experienced shingles, pain upon movement and rash. On an unknown date, the patient experienced sickness and touch sensitivity increased. The patient was treated with antivirals nos. On an unknown date, the outcome of the shingles and pain upon movement were unknown and the outcome of the sickness was recovered/resolved and the outcome of the rash was recovering/resolving and the outcome of the touch sensitivity increased was not recovered/not resolved.   It was unknown if the reporter considered the shingles, pain upon movement, sickness, rash and touch sensitivity increased to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 06-Oct-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient had shingles 2 weeks ago on left side of his/her leg and buttock area it was very painful to walk and to sit.  The antiviral medicine and cream helped a lot from the pain and spreading of the rash.  The patient had single vaccine shot 3 months ago.  The patient was sick for a week after the vaccine. The patient never got the second shot.  The patient had a rash which was healing but, there was still some areas which were sensitive to touch. Additional supportive information: Less than 3 months after vaccination the patient had sickness and touch sensitivity increased.   The follow-up would not possible, as no contact details were available.
Headache; nausea; Soreness at the injection site; This is a spontaneous report from a contactable consumer. A 43-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in left arm on 11Feb2021 at 11:45 (at the of the 43-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history reported as none. No concomitant medication was reported. The patient was not pregnant at the time of vaccination. Patient had no known allergies. No other vaccine in four weeks. Other medications in two weeks: Birth Control. No COVID prior vaccination. On 11Feb2021 at 20:00, the patient experienced headache, nausea and soreness at the injection site. No treatment received for the adverse event. No COVID tested post vaccination. The outcome of the events were recovered on 2021.  Follow-up attempts are completed. No further information is expected.
Hot flashes; This is a spontaneous report from a contactable consumer or other non healthcare professional. This is the first case out of two cases in which the reporter is reporting for herself. A 79-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL3249) via an unspecified route of administration on 09Jan2021 as dose 1, single and received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9267) via an unspecified route of administration on 09Feb2021 as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported that she never had hot flashes like am having now, when are you going to tell the public about your adverse experiences with this shot. It is not safe, please get it out there, the people know what they are getting into and I had my 1st shot January and my 2nd shot in February and I have been having hot flashes and hot flashes and more hot flashes on Jan2021 and also my husband is having hot flashes from the shot and yes, the Covid vaccine gave me and my husband hot flashes. The outcome of the event was not recovered.
In the evening following the injection pt noticed significant pain at injection site- thought it was normal- no bruising or changes in color or swelling noted. The next day pt had significant headache, lethargy, and achiness "like having the flu". Pain continued in arm but started to travel from injection site down to elbow "its like a straight line from injection site to the outside bone of the elbow", pt started to have difficulty opening jars and lifting heavy objects- injection was not in dominant arm-sometimes wakes at night from stiffness and achiness- still has localized pain in deltoid at injection site but also pain down to elbow and localized pain at elbow as well- made appt with her MD-oh-ibuprofen does take care of the pain.
7/3/21 PMH of DVT on eliquis, L carotid aneurysm, HTN, skin cancer, hypothyroid; presented for a CC of unresponsive episode
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 10-AUG-2012, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of zoster causing severe eye disorders. Beginning on 15-JAN-2015, the patient was treated for eye  disorders,  that were then identified as corneal band keratopathy. Throughout 2015, the patient was treated  over the course of twelve medical encounters for treatment of severe and worsening disorder, diagnosed as corneal band keratopathy, herpetic uveitis, scarring and opacity, corneal band nuclear sclerosis of both eyes, blisters on the eye, corneal edema, corneal ulcer, and Edta chelation, which doctors observed had flared up after her vaccination when she broke out with shingles in 2013 which has spread to her eyes, causing secondary complications from zoster infections in the eye. The patient underwent multiple surgeries to remove corneal epithelium and eventually sustained a corneal transplant in attempts to curb her condition and vision loss. The patient has continued to suffer, and was treated throughout seven encounters and procedures in 2016  for continued treatment of her condition. On or about 21-APR-2017, she began to suffer facial pain in addition to her eye disorders, which was then diagnosed as post-herpetic neuralgia of the face, a chronic  condition of nerve damage and residual and secondary to zoster  infections. The patient has sustained additional treatments on eight  additional medical encounters in 2017 for treatment of these extensive  zoster complications and vision. In addition to aggressive treatments and surgical interventions, she has been prescribed dorzolamide hydrochloride, timolol maleate (COSOPT), difuprednate (DUREZOL), acyclovir, prednisolone acetate, ofloaxin, prednisolone acetate (PRED FORTE), ofloxacin (OCUFLOX), brimonidine, moxifloxacin hydrochloride (VIGAMOX),  "sistane"  ointment, and artificial tears for management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, she has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant  medical expenses, pain and suffering, and other damages. Upon internal review, zoster infections in the eye, corneal opacity, corneal ulcer, herpetic uvetis, Edta chelation, vision loss, multiple surgeries to remove epithelium, corneal transplant, were determined medically significant. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of injection site redness in a 42-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 18 November 2011 at 13:00 the subject received a booster dose of BOOSTRIX (unknown route, left arm). On 18 November 2011 (around 14:00 to 14:30) approximately one hour after vaccination with BOOSTRIX, the subject experienced injection site redness, swelling at injection site, and flu like symptoms. At the time of reporting the events were worse. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX.
Diagnosed of Spontaneous Miscarriage at 8 weeks pregnancy after H1N1 vaccination.
nausea; fatigue; arm sore; This is a spontaneous report from a non-contactable non-healthcare professional, the patient. A 30-year-old female patient received the first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: er2613) via an unspecified route of administration in the left arm on 17Mar2021 at 04:30 P.M. (at the age of 30-year-old) as dose 1, single for covid-19 immunization. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications included metformin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and vitamins (MANUFACTURER UNKNOWN) all for unknown indications from unknown dates and unknown if ongoing. On 17Mar2021, patient experienced nausea, fatigue and arm sore. Therapeutic measures were not taken as a result of events nausea, fatigue and arm sore. The clinical outcome of the events was recovering at the time of reporting.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Report (patient) information, patient tab, product tab, concomitant medication information and narrative were amended.  No follow-up attempts are needed. No further information is expected.
no adverse event; received a second dose of PNEUMOVAX 23 instead of the PREVNAR 13; This initial spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.     On 26-AUG-2016, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 milliliter; lot #, expiration date and route were unknown) for prophylaxis. On 12-MAY-2020, the patient was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 milliliter; lot # S033516, expiration date 29-JUN-2021; route was unknown) instead of pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (wrong product administered). No additional adverse effects were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S033516; expirationdate: 29-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
This spontaneous report as received from a licensed vocational nurse refers to an unspecified number of patients of unknown demographics. The patients's concurrent conditions or medical history were not reported. On unspecified dates, unspecified number of improperly stored (Oka/Merck) VARIVAX doses, lot numbers K005426 with expiration date 15-APR-2016 and L004649 with expiration date 11-FEB-2017, were administered to an unspecified number orf patients. No adverse effects reported. No additional information provided. Additional information has been requested.