chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; The patient got half dose of the bivalent booster, not full dose. T; This spontaneous case was reported by a pharmacist and describes the occurrence of NO ADVERSE EVENT (No adverse event) and UNDERDOSE (The patient got half dose of the bivalent booster, not full dose. T) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 017H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Nov-2022, the patient experienced NO ADVERSE EVENT (No adverse event) and UNDERDOSE (The patient got half dose of the bivalent booster, not full dose. T). At the time of the report, NO ADVERSE EVENT (No adverse event) and UNDERDOSE (The patient got half dose of the bivalent booster, not full dose. T) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (The patient got half dose of the bivalent booster, not full dose. T).    Concomitant medications were not reported.                                       No treatment information was provided by the reporter.
Pt recv vax on 1/7/99; on 1/9/99 pt exp redness & swelling of Rt arm to elbow w/ ecchymosis & bruising at vax site
No adverse effects were reported; Was administered a dose of imporperly stored vaccines; This spontaneous report was received from a Certified Medical Assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided.      On 09-JUL-2019, the patient was vaccinated with improperly stored doses of hepatitis a vaccine, inactivated (VAQTA) lot # R035227 expiration date on 01-JAN-2020 and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live  recombinant human albumin (rHA)(M-M-R II) lot # R014355 expiration date on 21-MAY-2020 (route of vaccination, strength and dose number were not provided) for prophylaxis.  It was stated that, the Hepatitis A Vaccine, Inactivated (VAQTA) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II), were exposed to a temperature excursion of above 47°F (92.3°F) for 13 hours 11 minutes and above 47°F (73°F) for 9 hours. The vaccines were not involved in any previous temperature excursion, and report was made due to a data logger. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA012634: US-009507513-1907USA012633: US-009507513-1907USA012635: US-009507513-1907USA005377:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 13Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (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 drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax;3 varicella like lesions on thorax & lt abd wall, 2 noted on lt knee;crusting on knee;tx w/ zovirax;
10:24 am Patient received his 2nd dose of MODERNA. After the orientation offered, the patient was very anxious. Emotional support is offered on several occasions, after multiple interruptions by the patient, he gets vaccinated with Pfizer. However, due to multiple interruptions by the patient, I skipped a step of revaluating the vaccine. Patient goes out to the observation area and during the process the nurses realize the mistake made. The Nursing Director and Medical Director were notified. Consultation was make with the Department of Health. An attempt was made to guide the patient on the process. The patient left. A call was make to the patient after two hours to evaluate symptoms and make an appointment for next Monday, July 26, 2021 for evaluation and follow-up. Patient agrees to go to the medical facility.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via social media  via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number series-1) (suspension for injection, route of admin, and batch number were not reported) dose not reported, 1 total, start therapy date not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s and had Covid right now and was sick" which concluded as suspect covid-19 vaccination failure, and suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000207769.; Sender's Comments: V0: 20211242067-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. Previously the patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the reporter reported that one of her patients had to go to emergency room because he was vaccinated from second one, he had white blister breakout on his right leg. The outcome of the event was reported as unknown.   No follow up attempts possible. No further information is expected. Lot/batch number was not provided and unable to obtain.
Patient presented 12 Sep with several days of altered taste, facial droop, pain anterior to left mastoid, found to have left 7th nerve peripheral palsy (Bell's Palsy).  Began prednisone, valcyclovir, pt to have MRI with contrast, consult to neurologist (who patient sees for epilepsy) for second opinion
lower back and upper right leg pain; lower back and upper right leg pain; This is a spontaneous report received from a contactable consumer (patient). A 50-year-old female patient received the second dose of BNT162B2 (COMIRNATY, batch/lot number and expiration date not provided), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced lower back and upper right leg pain 24 hours after 2nd vaccine administration. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a registered nurse concerning a 27 year old female with no drug allergies, who on 04-DEC-2007 was vaccinated intramuscularly with a 0.5mL first dose of GARDASIL (Lot# 655619/1427F). There were no concomitant medications. Subsequently, the patient was 21 weeks pregnant at the time of this first dose. The patient was not experiencing any known symptoms. The patient was seen in our office. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. This was the patient's first pregnancy. Follow up information was received from a nurse practitioner that the LMP of the patient was 08-JUL-2007; EDD was 15-APR-2008. Ultrasounds were done on 30-NOV-2007 and 30-JAN-2008 for size/date and review of systems which were born within normal limits. The patient took prenatal vitamins during pregnancy. She was diagnosed with hypertension later in pregnancy, she was prescribed no medications. On 09-APR-2008 (41 weeks 3 day from LMP) the patient delivered a normal, healthy female baby weighing 6lb. 4oz., length was 31.5 cm, head circumference was "49 cm". The infant was considered normal; no congenital anomalies or complications were noted. APGAR score was 8/9. The pregnancy and delivery were considered as having no complications. Additional information is not expected.
The headache started 7-17-07 PM,  low grade fever started 7-18-07,  confusion started 7-18-07 PM, also minor twitches in arms and legs.   Brought to ER 7-18-07 late PM they did CT scan, blood work - drawn from two soruces, and lumbar puncture. They started IV fluid and antibiotics.  Admitted to hospital. Confusion, headache and fever continued through 7-19-07. By noon 7-20-07 he was feeling better.  He didn't have a fever, headache or confusion.  Released from hospital 7-21-07.and presumed viral meningitis.  8/16/07-Records received for DOS 7/18-7/21/07-DC DX:Viral meningitis. Situs inversus, total.  Admitted through ER with headache, confusion, nuchal rigidity. Began to get ill yesterday morning when he woke up with severe headache. Parents could not understand his gibberish. Fevers 100 to 101.
13 days after vaccine pt developed fever up to 102 degrees. The next day he developed vesicles on neck and back (total lesions - 10) and continued to have fever. On day 3, pt feeling better.
3 red papules on face, 2 on trunk; 1 on rt knee, 2 on rt arm, 1 on back;
Pt became hypotensive, bradycardic, and diaphoretic. Monitored BP, HR, pulse ox, water, lollipop and trendelenberg about 45 min to recovery.
Patient was only give the HIB portion of Pentacel. Contacted Sanofi Pasteur because the HIB was reconstituted with a MERCK Diluent for MMR & Varicella. The nurse from Sanofi states that it would need to be readministered due to the fact that the DTAP-IPV could not be administered standalone. Patient was called and is scheduled to have the PENTACEL readministered.
This is a spontaneous report from a contactable pharmacist (patient's parent). A 17-year-old male patient receive the 1st dose of TRUMENBA, via an unspecified route of administration, on 04Mar2019, at single dose, for immunisation. Medical history and concomitant medications were none. The patient experienced left arm warm, swollen, and red in a circle on 04Mar2019 with outcome of not recovered and local allergic reaction with a  diameter around 3 inches by 5 inches on an unspecified date with outcome of unknown. The information on the lot number has been requested.
Slight rise in temperature; Body aches; This is a spontaneous report received from a contactable reporter(Consumer). The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) at the age of 70 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN, start date: 2015 (ongoing). Vaccination history included: Bnt162b2 (Dose 1;Time of Onset: 15:00), for COVID-19 immunisation, reaction(s): "Slight itch", "Redness at injection site", "Rash itch around injection site", "Rash itch around injection site". The following information was reported: BODY TEMPERATURE INCREASED (non-serious), outcome "recovered", described as "Slight rise in temperature"; PAIN (non-serious), outcome "recovered", described as "Body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of body temperature increased, pain. Additional information: Time of Onset of Body ache, slight rise in temperature was 14:00 No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021122500 Same patient and drug, Different dose and event
Information has been received from a registered nurse concerning a 60 year old male patient with diabetes, hyperlipidaemia, hypertension and no drug allergies who on 04-MAR-2011 was vaccinated SC with 0.65 ml ZOSTAVAX (Merck) (lot # not reported). Concomitant therapy included DIOVAN, CLARITIN and aspirin. On 04-MAR-2011, 4 to 5 hours post administration, the patient experienced nausea, chills and his body was violently shaking. The shaking lasted all night and on 05-MAR-2011 ("the next day") his muscles were sore. No treatment was given to the patient. Lab diagnostics studies were not performed. At the time of reporting, the patient was recovering but the symptoms had not subsided. The patient did not seek medical attention. Follow up information has been received from a certified medical assistant concerning the patient who on 04-MAR-2011 at 12:16 PM was vaccinated SC with his first dose of ZOSTAVAX (Merck) (lot # 669191/1456Z) in the left arm. On 04-MAR-2011 around 4:00 PM the patient started feeling not himself and tired. Around 5:00 PM he felt sleepy with severe shivering and chills. By the morning of 05-MAR-2011, the patient recovered from the adverse events. Additional information has been requested.
This spontaneous report as received via Teva Pharmaceuticals from a consumer refers to a 54 year old female patient with multiple sclerosis. On an unknown date in approximately June 2012, reported as eight months ago (reporting date 06-FEB-2013) the patient was vaccinated with varicella virus vaccine live (manufacturer unknown) (route, dose, lot number unknown). Other suspect therapies included COPAXONE which was started on 15-FEB-2000 for multiple sclerosis. No concomitant medication reported. The patient shares that on an unspecified date in approximately June 2012, reported as eight months ago (reporting date 06-FEB-2013) she had a "mini flare up" (medically significant by reporting manufacturer) after her physician advised her to get a Shingles vaccine. The evening after the vaccine injection, she became achy, didn't feel well and very weak. She could barely walk. She went to the ER for 4 hours and they didn't do anything to help her, told her to 'go home and let it wear off'. The patient got to a point in which she couldn't walk and thought she was paralyzed for a few days. It took her 1.5 months to feel better. She believes the vaccine caused an MS flare up and was disappointed that the nurse at the clinic didn't discuss potential side effects with her. The nurse at the clinic told her she was having a 'secondary reaction' (medically significant by reporting manufacturer) to the vaccine. The outcome of MS flare up and secondary reaction to shingles vaccine was reported as recovered/resolved. Action taken with varicella virus vaccine live (manufacturer unknown) was not applicable. The patient considered MS flare up and secondary reaction to shingles vaccine to be related to varicella virus vaccine live (manufacturer unknown). Additional information has been requested.
No signs or symptoms reported; Excursions occured; This spontaneous report was received from an administrator referring to a patient (age and gender unspecified). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 21-APR-2021, the patient was vaccinated with an improperly stored dose of yeast)(GARDASIL 9) prefilled syringe, dose and frequency reported as 1 time dose with lot # T026168 (expiration date: 04-DEC-2022) or 1691180 (expiration date: 15-NOV-2022) for prophylaxis (dose and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of  49 and 48 degrees Fahrenheit on 09-APR-2021 and on 23-APR-2021 respectively  for 1 hours/ 15minutes. It was not recorded by a data logger and not previous temperature excursion was reported. No signs or symptoms reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Information has been received from a physician and the mother of a 12 year old female who in November 2006, was vaccinated intramuscularly with the first dose of Gardasil. It was reported that the patient returned to the physician's office to receive her second dose of Gardasil and the patient's mother mentioned to the physician that her daughter had recently complained of always being thirsty, frequent urination and her blood sugar was noted as 674. In January 2007, the patient was diagnosed with diabetes and was hospitalized. The patient was in the hospital for several days and was released (date unknown). At the time of this report, the outcome of the event was unknown. It was unknown if the patient received her second dose of Gardasil. Additional information has been requested.
Approximately 6 hrs after the shot, the brother states a small swelling and bruise appeared. It improved with ice. 3 days later is 80% better.
Flashes of light and floaters in right eye. Diagnosed as posterior vitreous separation.
The patient reported no prior reactions to vaccinations and had no symptoms immediately after vaccination. She grabbed her belongings and headed out of the building and across the parking lot to walk home. Upon reaching the far side of the parking lot she fell backwards hitting her head and losing consciousness. 9-1-1 was called and she was taken away by ambulance. I was not there when the incident happened but was told that as she was leaving she did tell friends she was feeling dizzy.
Ear ache, sounds amplified and sound robotic, ringing and rumbling in ears.
ACUTE MI 8/4/2022 RIGHT ANKLE FX INIT  HYPOTENSION 8/3/2022 RIGHT ANKLE FX INIT  ACUTE RESPIRATORY FAILURE 8/17/2022 RIGHT ANKLE FX INIT  ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/5/2022 RIGHT ANKLE FX INIT  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/4/2022 RIGHT ANKLE FX INIT  ACUTE MI 8/4/2022 PERIPHERAL VASCULAR DISEASE, UNSPECIFIED TYPE  HYPOTENSION 8/3/2022 PERIPHERAL VASCULAR DISEASE, UNSPECIFIED TYPE  ACUTE RESPIRATORY FAILURE 8/17/2022 PERIPHERAL VASCULAR DISEASE, UNSPECIFIED TYPE  ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/5/2022 PERIPHERAL VASCULAR DISEASE, UNSPECIFIED TYPE  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/4/2022 PERIPHERAL VASCULAR DISEASE, UNSPECIFIED TYPE  ACUTE MI 8/4/2022 PREOP CARDIOVASCULAR EXAM  HYPOTENSION 8/3/2022 PREOP CARDIOVASCULAR EXAM  ACUTE RESPIRATORY FAILURE 8/17/2022 PREOP CARDIOVASCULAR EXAM  ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/5/2022 PREOP CARDIOVASCULAR EXAM  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/4/2022 PREOP CARDIOVASCULAR EXAM  ACUTE MI 8/4/2022 ATHEROSCLEROSIS OF RIGHT LEG W PAIN AT REST  HYPOTENSION 8/3/2022 ATHEROSCLEROSIS OF RIGHT LEG W PAIN AT REST  ACUTE RESPIRATORY FAILURE 8/17/2022 ATHEROSCLEROSIS OF RIGHT LEG W PAIN AT REST  ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/5/2022 ATHEROSCLEROSIS OF RIGHT LEG W PAIN AT REST  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/4/2022 ATHEROSCLEROSIS OF RIGHT LEG W PAIN AT REST  ACUTE MI 8/4/2022 RIGHT LEG ISCHEMIA    RIGHT LEG ISCHEMIC LIMB PAIN  HYPOTENSION 8/3/2022 RIGHT LEG ISCHEMIA    RIGHT LEG ISCHEMIC LIMB PAIN  ACUTE RESPIRATORY FAILURE 8/17/2022 RIGHT LEG ISCHEMIA    RIGHT LEG ISCHEMIC LIMB PAIN  ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/5/2022 RIGHT LEG ISCHEMIA    RIGHT LEG ISCHEMIC LIMB PAIN  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/4/2022 RIGHT LEG ISCHEMIA    RIGHT LEG ISCHEMIC LIMB PAIN  ACUTE MI 8/4/2022 ACUTE NON ST ELEVATION MI  HYPOTENSION 8/3/2022 ACUTE NON ST ELEVATION MI  ACUTE RESPIRATORY FAILURE 8/17/2022 ACUTE NON ST ELEVATION MI  ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/5/2022 ACUTE NON ST ELEVATION MI  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/4/2022 ACUTE NON ST ELEVATION MI  ACUTE MI 8/4/2022 RIGHT ANKLE FX SEQUELA  HYPOTENSION 8/3/2022 RIGHT ANKLE FX SEQUELA  ACUTE RESPIRATORY FAILURE 8/17/2022 RIGHT ANKLE FX SEQUELA  ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/5/2022 RIGHT ANKLE FX SEQUELA  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/4/2022 RIGHT ANKLE FX SEQUELA
Information has been received from a licensed visiting nurse concerning a female who was vaccinated with a dose of GARDASIL (dose, route and lot# not reported). The nurse reported that the patient developed a severe headache after receiving GARDASIL. The patient was first seen by the school nurse, who advised evaluation in an emergency room or the physician's office. The patient was seen the next day at the physician's office and then sent to an unspecified emergency room and admitted to this hospital. The patient was diagnosed with a brain aneurysm. On an unspecified date, the patient recovered from brain aneurysm. Additional information has been requested.
Received H1N1 vaccine inject. on 11/4/09. On 11/5/09 developed hives/rash on L side of face (cheek and above eye) and at site of injection.
red ,swollen left arm at injection site and surrounding area.  18 hours after injection nausea, vomiting .headache, muscle and joint pain, extreme chills, fever 101.9,fatigue  stayed in bed for 2 days. On the third day fever and chills were gone but my lymph glands were swollen in my neck, throat. Resting heart rate was up to 90-100 bpm, My normal is 74-76 bpm.
This is a spontaneous report based on information received by Pfizer from Merck & Co., Inc. (manufacturer control number: 00569760) from a contactable consumer, reporting for son. A 47-year-old male patient of an unspecified ethnicity received the PREVNAR, via an unspecified route of administration on an unspecified date at a single dose for immunization. The consumer was completely certain that her son did not receive PNEUMOVAX 23. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced drug ineffective as the patient developed pneumonia. The clinical outcome of the events, drug ineffective and pneumonia, was unknown. No follow-up attempts are possible. No further information is expected.
C/O Dizziness and removed mask. LVN stood behind patient with arms under patient arms and patient slowly became limp. LVN assisted patient to floor. RN responded with E Kit. Patient did not lose full consciousness and remained responsive to verbal stimuli. Patient was laid supine with feet elevated above heart. BP taken 111/80, hear rate 96. Patient remained responsive and stated dizziness was gone. Patient assisted to sitting on floor for 5 minutes and then sitting in chair for 5 additional minutes before being cleared to leave site at 5:15pm by Charge Nurse, RN.