chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sixth nerve palsy right eye; Horizontal double vision/diagnosed with diplopia; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 30Dec2021 09:30 (Lot number: 33130BA) at the age of 59 years as dose 2, single for COVID-19 immunization. Relevant medical history included: "Hypertension" (unspecified if ongoing). Patient had no allergies. Concomitant medication included: LISINOPRIL. Vaccination history included: Bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (DOSE 1, SINGLE, Lot number: FJ8762, Administration time: 01:00 PM, Vaccine location: Left arm), administration date: 09Dec2021, when the patient was 59 years old, for COVID-19 Immunization. The following information was reported: VITH NERVE PARALYSIS (medically significant) with onset 03Jan2022, outcome "not recovered", described as "sixth nerve palsy right eye"; DIPLOPIA (non-serious) with onset 03Jan2022, outcome "not recovered", described as "Horizontal double vision/diagnosed with diplopia". The events "sixth nerve palsy right eye" and "horizontal double vision/diagnosed with diplopia" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of vith nerve paralysis, diplopia. Clinical course: After 72 hours patient began experiencing horizontal double vision. It has become more pronounced since injection. Patient went to emergency room and was seen by urgent care physician and an ophthalmologist. Patient was diagnosed with diplopia and sixth nerve palsy right eye. Later notified by ophthalmologist that vaccination could be the cause of diplopia. The patient  again went to emergency room and was seen by the ophthalmologist for further medical help for the events. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
My daughter is 17 weeks pregnant, had her 2nd shot on 06/27/2007,and concieved on her next ovulation which was 07/18/2007 (about)... She recieved the Gardisil shot, We had the quad screen done because of the concerns of having the shot. Her test results came back showing Positive for Down Syndrome a ratio of 1:9 which is very high. I am very concerned that this could have been caused by this shot. Since there is no family history on either sides of ever having children born with any birth defects. We are going to see a peri-natoligist next week to confirm the diagnoses. I read were there had been studies done and showed some birth anomalies? Do you know what these anomalies may have been.
PATIENT ARM FROM SHOULDER TO ELBOW BECAME INFLAMED AND SWOLLEN. PT WAS HAVING TROUBLE MOVING ARM ON 10/5. REACTION WAS BEGINNING TO SUBSIDE ON 10/6.
covid positive on 9/9/2121, had symptoms of myalgia, headache and nasal congestion
Found out on 18May2023 that the participant tested positive for COVID that day; Found out on 18May2023 that the participant tested positive for COVID that day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 65-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18May2023, outcome "recovering" and all described as "Found out on 18May2023 that the participant tested positive for COVID that day". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received vaccine at clinic. Reporter stated that the patient received 2 dose series manufactured by Pfizer around Jan2021 and believed that patient had also received booster doses, reporter was not sure how many or which manufacturer. Reporter found out on 18May2023 that the participant tested positive for COVID that day, after feeling under the weather. Reporter did not know the exact symptoms or onset of symptoms. The participant was prescribed Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The vaccine was given outside of the normal 12 hour window after the first puncture, but within 24 hours. The manufacturer was contacted, the dose was verified as viable, but the patient should monitor for injection site reactions and signs of infection. No adverse reactions reported at this time.
I had a delayed allergic reaction. My left upper arm was reddened and irritated. In addition, I have two raised areas, 'bumps', on my upper arm. They somewhat resemble mosquito bites but they are not reddened. The redness and irritation of my arm faded after about five days, but the two bumps remain. They are less prominent but are still present. They do  not itch, and are not fluid-filled but are solid bumps.
No adverse effects; A patient (E.L.) received an improperly stored PEDVAXHIB; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications, drug reactions or allergies were not reported.  On 04-NOV-2019 or 05-NOV-2019, the patient was vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # S000352 with expiration date of 17-OCT-2021 (dose and route of administration were not reported).  Administered dose of vaccine experienced the temperature excursion below 36 degrees Fahrenheit (2 degrees Celsius) for 2 hours and 18 minutes. Digital data logger was involved. There were no previous excursions reported. There were no pertinent adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA002033: US-009507513-1911USA001926: US-009507513-1911USA002053: US-009507513-1911USA002263: US-009507513-1911USA002388: US-009507513-1911USA002198: US-009507513-1911USA002043: US-009507513-1911USA001946: US-009507513-1911USA001917:
12/4/2012Patient had pain at the injection site, temperature of 102 with rigors. 12/5/2012 patient seen in clinic with complaint of severe pain at injection site. MD note slight swelling and warmth. 12/6/2012 Patient seen in clinic with three areas of erythema tender and very warm. Patient on augmentin for another infection changed to Cipro and Bactrim.
Pt adm Zostavax on 4/22/07. On 4/25/07 noted rash which was pruritic on her back. Office eval 4/26 am revealed faint mac/pap rash lower back which crossed midline. No vesicles. No a shingles ves.
I was snowed in over the weekend. When I got home I was not feeling well, I took a home COVID-19 test that came back positive. I called the on-call nurse practitioner because I was having such a hard time breathing. She advised me to go to the emergency room. I went to the emergency where they did a blood test, prescribed PAXLOVID and albuterol for the breathing. I'm not feeling as bad but I have only had two doses so far.
Felt abdominal pains, nausea, and felt faint. I did not loose consciousness. Only lesser abdominal pains were experienced during following 3 doses.
Info has been received from a mother concerning her 7 year old daughter who had an unremarkable medical history and no allergies who on 1/26/01 was vaccinated with a dose of varicella virus vaccine live (lot 535607/1153K). The pt's mother reported that on 1/17/06, her daughter had a severe breakthrough of over 400 lesions on her body. The pt was seen by her physician who prescribed ibuprofen (Motrin) and diphenhydramine (Benadryl), but no lab/diagnostic tests were performed. As of 1/20/06, the pt was noted to be slightly improved. Additional info has been requested. 05/16/2007 Information has been received from a mother concerning her 7-year-old daughter who had an unremarkable medical history and no allergies who on 26-JAN-2001 was vaccinated with the first dose of VARIVAX (Oka/Merck) (Lot #635607/1153K). There was no illness at the time of vaccination. The patient's mother reported that on 17-JAN-2006, at 0730, her daughter had a severe breakthrough of over 400 lesions on her body characterized by severe itching. The patient was afebrile. (It was noted that on 03-JAN-2006, the patient was exposed to approximately five children with chicken pox on their first day of onset of symptoms). The patient was seen by her physician who prescribed MOTRIN and BENADRYL, but no laboratory/diagnostic tests were performed. As of 20-JAN-2006, the patient was noted to be slightly improved. On 25-JAN-2006, the patient's chicken pox resolved. Additional information is not expected.
This spontaneous report as received from a register nurse refers to a 17 year old patient of unknown gender with allergy to specific antibiotics. On 12-MAR-2014, the patient was vaccinated with first dose of GARDASIL lot # J013324; expiration date: 12-FEB-2016, 0.5 ml, intramuscular. Secondary and concomitant therapies were not reported. Nurse stated that the patient's mother reported pain at injection site after first dose GARDASIL in March 2014. Nurse stated no other effect to report. Nurse stated that pain was enough for the mother to ask for a type of analgesic for second dose scheduled for 07-AUG-2014 (reported as today). The outcome of pain at injection site was not reported. Additional information has been requested.
Pharmacy offered me a flu shot and I accepted. Wasn't told it was a new mixture. First two days had red, hot, swollen knot at injection site. Second night started severe vomiting, stomach cramps, gas, diarrhea and temp 100.3. Took the shot on Tuesday and to Sunday and still having awful diarrhea and temp. Today is Monday and feel very week. I will definitely never take this vaccine again.
Received two primary doses of the Moderna covid19 vaccine, and is immunocompromised, and he did not got the third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received two primary doses of the Moderna covid19 vaccine, and is immunocompromised, and he did not got the third dose) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received two primary doses of the Moderna covid19 vaccine, and is immunocompromised, and he did not got the third dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received two primary doses of the Moderna covid19 vaccine, and is immunocompromised, and he did not got the third dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided. The patient had no allergies and medical history related to AE, acute and chronic illnesses at the time of vaccination..  The patient choose to get the booster and now he wants to get the third dose.  No treatment medication was provided.
This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 63-year-old male patient who received SHINGRIX for prophylaxis. On 7th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced generalized pruritus. On an unknown date, the outcome of the generalized pruritus was unknown. It was unknown if the reporter considered the generalized pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient had been experiencing itching throughout the body at night from his back to stomach and to his legs. The patient did live in humid environment, so he thinks it might also be weather related. Did not consent to follow-up.
covid virus; covid virus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An elderly female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (ongoing). Concomitant medication(s) included: ENBREL unknown; HUMIRA subcutaneous taken for rheumatoid arthritis, start date: 2021. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "covid virus".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Craps, Pains, Shakes, Chills, Pulsing Pain , Lost of taste
This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex and ethnic origin. 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 (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose, start therapy date were not reported, 1 total 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, 4 weeks after the vaccination, the patient experienced confirmed immunological vaccine failure. Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) No antibodies. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with a product quality complaint number 90000225275. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the  evaluation/investigation performed. Sender's Comments: V0:20220417828-COVID-19 VACCINE Ad26.COV2.S- Confirmed immunological vaccination failure. The event(s) has an unknown/unclear 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. Therefore, this event(s) is considered not related.
Patient started to exhibit signs of excessive crying and irritability 24 hours after the shot was administered. Patient continued to be excessively irritable and inconsolable for a few days following the start of symptoms.
Severe shoulder pain on the side of the injection, with symptoms consistent with acute bursitis - limited abduction of the left arm, worsening of pain at night). The injection site was very high and the nurse reported feeling some resistance with the injection and told me to "relax".
Patient received HPV shot and within minutes she complained of feeling faint and dizzy.  Patient was placed in an exam room and examined by Dr. Patient was in the office approximately 30 minutes before the family felt comfortable to leave.  Parent called office again today stating that the patient is still complaining of soreness in her arm.
absence seizure; we just saw a rheumatologist for followup after an expansive blood and urine test finding the Anca antibody; hemorrhagic stroke; stroke; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (005570).  A male patient received BNT162b2 (BNT162B2), on 17Dec2021 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization complete, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (1st booster, Manufacturer unknown), for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 18Dec2021, outcome "unknown", described as "stroke"; HAEMORRHAGIC STROKE (medically significant) with onset 07Jan2022, outcome "unknown", described as "hemorrhagic stroke"; PETIT MAL EPILEPSY (medically significant), outcome "unknown", described as "absence seizure"; ANTINEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE (non-serious), outcome "unknown", described as "we just saw a rheumatologist for followup after an expansive blood and urine test finding the Anca antibody". The events "we just saw a rheumatologist for followup after an expansive blood and urine test finding the anca antibody" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood Test: (unspecified date) Anca antibody; Magnetic resonance imaging: (03Jul2022) amyloid angiopathy; Urine analysis: (unspecified date) Anca antibody.  Clinical information: The reporter stated, regarding my Husband having a stroke the day after having the 2nd Pfizer booster shot 17Dec2021. Then 07Jan2022, it was a haemorrhagic stroke the following month after having the absence seizure. Today, we just saw a rheumatologist for follow up after an expansive blood and urine test finding the Anca antibody. Prior to today MRI 03Jul2022 results Radiology's impression saying possibly amyloid angiopathy until further test are done, which shortly after showed the ANCA antibody. Needs to be reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After the vaccine was administered, the following day patient developed nucchal rigidity, stiff neck, headaches, and fever. He continually had low grade fevers, headaches and muscle aches for months following the vaccine. Mom brought him in on multiple occasions to the office to be seen following the vaccine for these same symptoms. Prior to the vaccine he had not exhibited these symptoms.
This spontaneous report was received from a licensed practical nurse refers to a patient of an unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant medication included sterile diluent. On 24-DEC-2018, the patient was vaccinated with an improperly stored dose of PROQUAD injection, therapy type: rHA, lot# R018779 (expiration date: 29-DEC-2019) for prophylaxis (anatomical location, route and dosage details were not reported). The vaccine was reconstituted using properly stored sterile diluent (lot and expiration date were not reported). The vaccine underwent a temperature excursion of 15 degree Fahrenheit (F) to 46 degree F for 44 minutes of time frame. The patient did not experience any adverse effects. The call was because of a "data logger". No previous temperature excursion was reported. No product quality complaint (PQC) was involved.
Report 20010046361 describes burning (sensation) at the injection site in a 50 year old female who received hep B vaccine (recombinant) Engerix-B for prophylaxis of hep B. The vaccinee is allergic to sulfa. Reportedly, she has no medical history and takes no concomitant medications. On 01/08/2001, the vaccinee received her first "pediatric" left deltoid dose of Engerix-B. Post vaccination, in the "pm" of 01/08/2001, the vaccinee experienced nausea and diarrhea. these adverse events resolved within 24 hours. On 02/20/2001, the vaccinee received her second "pediatric" left deltoid dose of Engerix B. Two hours later, she experienced itching and burning at the injection site. As of 02/20/2001, the itching and burning at the injection site are unresolved.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 20-OCT-2014, the patient was inadvertently vaccinated with expired PNEUMOVAX 23, lot # J010654, expiry date 17-OCT-2014, 0.5 ml (millimeter), intramuscularly, for an unknown indication. No concomitants were reported. No adverse effects reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
Pt. was given Moderna for first two doses and then given pfizer 3rd dose on 9/17/2021 @ 1400. no A/R noted during  observation period. Pt instructed to report allergic reactions
11/17/2021  Patient called Health Department re: leg pain and swelling s/p J&J COVID vaccine on 11/04/2021.     Patient reports receiving J&J vaccine at Health Department on 11/04/2021. Developed left lower leg pain on 11/16/2021. Describes as "hot, painful, bruised, heavy, warm, springy, skin feeling tight, "spot" on skin. Denies injury or trauma. Reports slight improvement in pain since onset of symptoms.      Patient reports she is uninsured and does not have PCP.      Advised patient of possibility of blood clot based on reported symptoms. Advised patient to go to nearest Emergency Room for evaluation and treatment of symptoms. Explained to patient importance of ruling out blood clot and severity of illness and outcome, including death, if symptoms related to blood clot. Patient hesitant to go to Emergency Room due to financial situation, assured her that she would not be turned away and re-iterated importance of prompt evaluation.      Opportunity provided for questions, understanding verbalized.      11/19/21  Patient called for follow up, no answer, LMOM to return call.     11/22/21  Patient called for follow up, no answer, LMOM to return call.      VAERS report submitted with limited information.
This spontaneous report as received from a physician refers to a 61 year old male patient with no pertinent medical history and no drug reactions or drug allergies. On 30-SEP-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot number, indication, dose, route and site of administration were not reported). Approximately on 01-OCT-2013 (reported as one to 2 days after vaccination) the patient experienced bronchospasm, upper respiratory infection and asthma. The patient sought medical attention via contacting physician. The inhaled steroids (unspecified) were given as a treatment for adverse events. The patient did not recover from bronchospasm, upper respiratory infection and asthma at the time of report. The relatedness between vaccination with ZOSTAVAX and bronchospasm, upper respiratory infection and asthma was not reported. Additional information has been requested.
Rash on Face, pt came to Student Health Clinic @ 11:30 am to be evaluated. Pt prescribed Benadryl 25mg one every 6 hours prn. Return to clinic or ER if symptoms worsen.
This case was reported by a consumer and described the occurrence of pneumonia in a male subject of unspecified age who was vaccinated with influenza virus vaccine (manufacturer unspecified) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Influenza virus vaccine (unknown). At an unspecified time after vaccination with Influenza virus vaccine, the subject experienced pneumonia. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.