chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects; patient was vaccinated with improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 28-MAR-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # R008031 and expiration date 18-MAR-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). Other suspect therapy was sterile diluent for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, and for sterile diluent experienced a temperature excursion above 1.18 degrees Celsius for 33 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 10:47 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 10:47 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 59.07.  Concomitant products were not reported.  On 14-Feb-2021, At excursion time 09:00 AM, temperature was 32, total doses given for the day was 162 and at 10:00 AM, temperature was 32, at 11:00 AM, temperature was 32, at 02:00 PM, temperature was 35, at 03:00 PM, temperature was 35, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Resident was hospitalized on 1/17 after having multiple falls and change in condition. Resident returned to facility on 1/20- continued to be unable to ambulate as previous baseline. Son brought resident back to Hospital on 1/21 for further testing. Resident now being treated for Guillan Barre after having lumbar puncture and MRI. She has received  IV IG treatments. Resident remains hospitalized.
Information has been received from a 68 year old female patient with IVP dye allergy, esophageal problem requiring surgery in November 2010 and hypertension who on 09-OCT-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # and route not reported). Concomitant therapy included aspirin, CRESTOR and "medication for hypertension" (unspecified). The consumer reported that despite vaccination, she had developed shingles. The rash was on her face and eyes and included numbness in her neck. She had seen a pain management specialist and an ophthalmologist. She was initially prescribed with NEURONTIN and then changed to LYRICA. The consumer reported that she had not seen improvement of her condition since it started. The reporter felt that shingles needed intervention to prevent serious criteria and were significant disability or incapacity. Additional information has been requested.
No immediate adverse reaction but patient is a 4 year old girl and received Pfizer vaccine for 5-11 year old. Call mom, she has a sore arm so far.
pt given vax 15AUG97 & that evening exp chills, fever to 101.5, nausea, aching all over;sx lasted 36-48hr;took APAP q 4hr w/good relief;
18 hours after getting vaccine in my left arm, I had body aches, headache and chills which lasted off & on for 3 days. 48 hours after getting vaccine in my left arm I developed a faint pink, itchy rash that ran from my shoulder down to my elbow.  At the same time, I developed swollen lymph nodes in my left armpit. As of 04/28/2021, the lymph nodes are no longer swollen but the rash is still pink and itchy.
Tongue was tingling; Arms and chest has a itchy feeling with no hives; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8732) via an unspecified route of administration in the right arm on 26Mar2021 at 14:15 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma, breast cancer 8 years ago and sulfonamide allergy. Concomitant medications included amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (ADDERALL), vitamin d nos (MANUFACTURER UNKNOWN) and daily vitamins. Prior to the 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 vaccines within 4 weeks prior to the COVID vaccine. On 26Mar2021 at 14:30, about 5 minutes after first shot the patient's tongue was tingling and shortly after that about 45 minutes to 1 hour, arms and chest had an itchy feeling with no hives and lasted for 6 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient took her singulair allergy medication and itchy feeling seemed to subside and no other therapeutic measures were taken for the reported events. The clinical outcome of the event tingling tongue was recovered on an unknown date and the event itchy feeling with no hives that lasted for 6 hours, was recovered on 26Mar2021.    No follow-up attempts are needed. No further information is expected.
Information has bee received  from a registered nurse concerning a 70 year old male patient who in approximately March 2008, was vaccinated with a dose of ZOSTER vaccine (lot # not provided). In approximately March 2008, within 5 days of getting vaccinated with ZOSTER vaccine, the patient developed shingles. The patient sought medical attention, he was "treated and sent to dermatologist" The registered nurse felt that shingles was related to therapy with ZOSTER vaccine. Additional information has been requested.
Major rash on my right front stomach and right middle back occurred 23 days after my first shot on 4/8/21.
COVID-19; Suspected COVID-19; Pneumonia; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4330897-00.  A 59 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 59 years as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "COVID-19"; SUSPECTED COVID-19 (medically significant), outcome "recovering", described as "Suspected COVID-19"; PNEUMONIA (medically significant), outcome "recovering", described as "Pneumonia". The action taken for adalimumab was unknown.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of pneumonia and COVID with Humira (Adalimumab) was no reasonable possibility.  The reporter's assessment of the causal relationship of the DRUG INEFFECTIVE, Suspected COVID-19, PNEUMONIA with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of Suspected COVID-19, Drug ineffective and Pneumonia The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Client phoned stating that she started having redness, swelling and discomfort approximately 3" below injection site of vaccine on left arm.  C/o warm to touch.  Denied fever, chills, nausea or vomiting or drainage to site.  S/S started 5/16/10.  5/20/10 TC.  Swelling has resolved and almost back to normal.  Did see MD after coming to Unit and was told to apply ice.
Pt c/o dizziness, nausea.  BP 111/67, HR 89, RR 20.  Pt stable and released from the vaccination site.
tinnitus; loosing hearing in right ear; Experienced strange medical condition in Feb/Mar2019; experienced shaking uncontrollably, fever ,diagnosed as a viral infection; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus), HYPOACUSIS (loosing hearing in right ear) and VIRAL INFECTION (Experienced strange medical condition in Feb/Mar2019; experienced shaking uncontrollably, fever ,diagnosed as a viral infection) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 15-Mar-2021, the patient experienced TINNITUS (tinnitus), HYPOACUSIS (loosing hearing in right ear) and VIRAL INFECTION (Experienced strange medical condition in Feb/Mar2019; experienced shaking uncontrollably, fever ,diagnosed as a viral infection). At the time of the report, TINNITUS (tinnitus), HYPOACUSIS (loosing hearing in right ear) and VIRAL INFECTION (Experienced strange medical condition in Feb/Mar2019; experienced shaking uncontrollably, fever ,diagnosed as a viral infection) outcome was unknown.            No concomitant medications were provided Treatment for the events included amoxicillin
Left deltoid- red, hot to touch mild induration 6X5 cm. Benadryl/ cool compress
Pt found with blue lips and forehead, which resolved spontaneously when mother repositioned. Was evaluated in ED and diagnosed with BRUE.
Arm hurt; Low grade temperature; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade temperature) and PAIN IN EXTREMITY (Arm hurt) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In 2021, the patient experienced PYREXIA (Low grade temperature). On 01-Aug-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt). At the time of the report, PYREXIA (Low grade temperature) had resolved and PAIN IN EXTREMITY (Arm hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: Low grade temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Patient reported events of non-serious Low grade temperature and Arm hurt with HUMIRA (ADALIMUMAB).   MODERNA COVID-19 VACCINE (COVID-19 VACCINE MRNA (MRNA 1273)) was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Generalized pruritus; rash on left deltoid; This is a spontaneous report from a contactable other HCP (patient). A 40-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection) dose 2, via an unspecified route of administration on 16Jan2021 at 12:45 PM on right arm (Batch/Lot Number: EL3246) as SINGLE DOSE for COVID-19 immunization. Medical history included Sjogren's syndrome, osteoporosis, renal tubular acidosis and lactose allergy. The patient previously took bnt162b2 (BNT162B2) dose 1, via unspecified route of administration on 28Dec2020 at 02:45 PM on left arm (Batch/Lot Number: EK5730) as single dose for COVID-19 immunization. Concomitant medication received within 2 weeks of vaccination. The patient experienced generalized pruritus and rash on left deltoid on 18Jan2021. The events were reported as non-serious. COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not tested for COVID-19. The patient did not receive treatment for the events. Outcome of the events was not recovered.   Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.
Advised that Pfizer Covid Vaccine adminstered was not handled and stored consistent with manufacturing guidelines but viablitly is not assessed  62 patients effected
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A, 016M20A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Sep-2015, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported vaccine administered to patient on SEP 01 2021 as a third dose without any adverse effect
Patient complained of dizziness. Finger stick for glucose was 100. Taken by ambulance to Emergency Room. BP was 190/84, 172/80.
I noticed a small lump near my collar bone on Saturaday 2/6/21.  I looked up the lymph nodes in that area, and then called my practitioners office on Monday.  I was transfered to an Epidemelogy Nurse Answering service and received a call back shortly after from a Covid Vaccine Hotline nurse.  By Monday, another smaller bump came out right next to the first one.  I told her that I had swollen lymph nodes near my collar bone.  She asked how big, I can feel all around the larger one with the tip of 2 fingers.  She told me that it is normal to get swollen lymph nodes after any vaccine and I shouldn't worry about it.  She told me to watch it and if it got larger or didn't go away, to call my practitioner again.  Currently they lympth nodes haven't changed, but I have my booster in a week an a half, so I thought I should report this reaction, as it seems to be on the rare side of common side effects from the Pfizer vaccine from what I have read.
Baby had some fever at home. Next day, 1/27/05 Baby had some twitching, mostly on the right side of the body, stiffening of the arms, approximately for 10 minutes.
This spontaneous case reported by a consumer, describes the occurrence of pain (body soreness) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jul 30, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Aug 27, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 27, 2021, patient experienced pain (body soreness). At the time of the report, pain (body soreness) outcome: unknown. No concomitant medication or treatment information reported.
Information has been received from a health professional concerning a female patient who was vaccinated with a first 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The next morning, the patient felt sick to her stomach. It was noted that once she went to school she felt better. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Pt began with severe headaches for the first few days after 6 weeks of vaccine, then began to feel dizzy, unbalanced, and would walk into things like walls without having voluntary control. Pt was falling, uncoordinated for weeks, went to 4 or 5 different hospitals and said MRI and ct of the head are normal and MRI of spine normal was told to see the neuro specialist. Pt went to see Neuro and ENT and was diagnosed with vestibular neuritis. Was given prednisone for 2 weeks with little improvement, pt continued to deteriorate mother finally took the pt. to another HCF and was taken to a local hospital and admitted for 6 days he had more MRI of head and spine, normal labs normal. lumbar puncture normal was diagnosed with Conversion Disorder by neurologist. Was discharged home last week woth PT and OT orders
I got my second vaccine on 4/7/2021, I saw my doctor on 5/12/2021 blood work was done because I was breaking out a rash on my face and my blood pressure was up for the first time ever, but I feel pretty fine, the doctor is trying to figure out why my bloodwork was off and to see what may be causing the rash. The dermatologist has no idea what it is, another specialist is working on it because they still do not know what it is or why my blood work is off. I have a follow up next month with the doctor.
No adverse events reported. Advised by Agency to submit to VAERS due to booster given after FDA EUA given to bivalent booster. Bivalent booster was not received in pharmacy until 9/8/2022.
Patient was sitting and waiting her 15 minute waiting period. patient stood up and fell on floor in pharmacy waiting area. Patient hit her head and starting crying for help. Technician and pharmacist went to patients help. Pharmacist examined patient and observed patient was experiencing vasovagal syncope. Another technician called 911. Patient was taken to hospital by ems.
One hour after receiving the shot I was extremely exhausted. Slept for 5 hours. Woke up with 99.8. Felt like I had been drugged. Next day felt groggy with headache.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Patient had no known allergies. The patient took concomitant medications (within 2 weeks of vaccination). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: product=COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient started Paxlovid on 23Aug2022 for covid 19 treatment and stopped on 27Aug2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events Drug ineffective, Covid 19  and suspect drug BNT162B2 cannot be excluded.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 27Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 37 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), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: experienced Covid rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Addition ifnoamtion: Other medication in 2weeks was unknown. Treatment start date was 22May2022. Treatment stop date was27May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient came in to get a "first dose" of Moderna vaccine on 9/21/21 after already receiving first and second doses on 3/1/21 and 3/31/21. She then came in again on 11/4/21 to get a booster, reporting only the first two doses on 3/1/21 and 3/31/21. Patient was contacted and stated she did not realize she had gotten too many shots and did not have any adverse effects from any of them.