chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 19-AUG-2010, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine was intended to prevent. In 2015 the patient was treated by a physician for the symptoms of a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient 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, and pain and suffering and other damages. Additional information has been requested.
Patient presented to the ED and was subsequently hospitalized for suicidal ideations and hallucinations within 6 weeks of receiving COVID vaccination.
having covid; This is a spontaneous report from a contactable Other HCP. This Other HCP reported that a 74-year-old female patient received palbociclib (IBRANCE, formulation: Film-coated tablet, strength: 125 mg, Batch/Lot number was not reported), via an unspecified route of administration from 29Jul2019 to an unspecified date, at 125 mg for an unspecified indication and bnt162b2 (BNT162B2, formulation: Solution for injection, Batch/Lot number was not reported, age at the time of vaccination was not provided), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported having Covid from 21Aug to 15Sep (unspecified year). she did have an ER visit for a shot for Covid and would be having an MRI tomorrow. The action taken in response to the event for palbociclib was unknown and for bnt162b2 was not applicable. The outcome of the event was reported as unknown.  No follow-up attempts are needed. No further information is expected.
Warm at the injection arm; itches at the injection arm; Redness at the injection arm; Swelling at the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm at the injection arm), VACCINATION SITE PRURITUS (itches at the injection arm), VACCINATION SITE ERYTHEMA (Redness at the injection arm) and VACCINATION SITE SWELLING (Swelling at the injection arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm at the injection arm), VACCINATION SITE PRURITUS (itches at the injection arm), VACCINATION SITE ERYTHEMA (Redness at the injection arm) and VACCINATION SITE SWELLING (Swelling at the injection arm). At the time of the report, VACCINATION SITE WARMTH (Warm at the injection arm), VACCINATION SITE PRURITUS (itches at the injection arm), VACCINATION SITE ERYTHEMA (Redness at the injection arm) and VACCINATION SITE SWELLING (Swelling at the injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.
See attached. Patient here with his mother and younger sister. Patient had KINRIX given yesterday for 4 year well child check. The event was upsetting to patient and he really tensed up at the time of the shot. Mother reports that the area immediately developed a bubble lateral to the actual injection site. Patient was upset following the shot and periodically complained of pain to this area. As his mother did not feel  that this was unexpected she consoled as needed. At bath time in the evening she noticed a very large area of warmth and redness spreading out from the area that initially bubbled up. At bedtime she gave him some ibuprofen and the area looked better the morning, sufficiently so the she contemplated canceling the visit but over course of the morning the area seemed to get worse again. Patient periodically complains of discomfort and does not want the area touched but overall his appetite, his energy and play levels are quite normal.
Confirmed with caller no other AE occurred.; a dose of MMRII was administered after the expiration date on 5/4/2023.; This spontaneous report was received from an administrator regarding a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 04-MAY-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, 1 dose, lot #U011993, expiration date: 15-APR-2023, administered as prophylaxis (strength, dosage regimen, anatomical location, and route of administration were not provided) (Expired product administered). No adverse events were reported.  .
VARICELLA VACCINE ADMINISTERED IN LEFT ANTERIOR THIGH ON 4/21/05. CALL FROM MOTHER ON 5/3/2005 REPORTING CHILD AWOKE WITH 10-15 "BUMPS" ON TRUNK, FACE, AND AT SITE OF INJECTION. DESCRIBED AS RED; SOME LOOKED LIKE BLISTERS; DENIED ITCHING.
Report A0365868A describes limb swelling in a 5 year old male who received Infanrix. The subject's medical history, concurrent conditions, and concurrent medications were not provided. The subject had no adverse experiences following receipt of prior immunizations. On an unspecified date, the subject received his fifth injection of Infanrix. Subsequently, on 4/13/02, he experienced "abnormal swelling of the arm." The event was reported to have resolved on an unspecified date and the reporting nurse considered the event to be related to Infanrix administration.
I suddenly felt dizziness and stomach pain and could not support myself. After a minute, my arms felt numb. Recovered after another minute. On the second day, I experienced fever, headache and fatigue.
Pain right shoulder, pain to touch and constant pain.  Disrupted sleep on that side.  Limited mobility.
serum sickness secondary to Hep B vax;swollen joints, sore joints, erythematous patchy rash entire body/face
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 25-SEP-2014 the patient was vaccinated with a dose of M-M-R II (route, strength, dose, frequency and lot # not reported) which had undergone an temperature excursion. This is one of several reports from the same source. Additional information has been requested.
he was experiencing side effects such as headache and fever; effects such as headache and fever; This is a spontaneous report from a contactable consumer or other non hcp via Pfizer sponsored program.   A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration on 24Mar2021 as SINGLE DOSE for COVID-19 immunisation. It was reported that the patient received his first dose before 3 weeks the 2nd dose. The patient medical history and the concomitant medications were not reported. After the second dose, the patient experienced side effects such as headache and fever. Patient wants to know which medicine he can take. At the time of this report the event outcome was unknown.   No follow-up attempts are needed. No further information is expected.
Fever, body aches, incessant need to urinate with significant production of urine each time
Information has been received from a mother who called to say her daughter received a dose of GARDASIL vaccine (yeast) a couple of months prior to the 18-JUL-2008 report date, and experienced muscle pain. The patient did not seek medical attention. The mother said she would call back if they found out this was caused by GARDASIL vaccine (yeast). At the time of report, the patient was recovering. No further information is available.
Dizzyness, feeling faint , lasted for 15 to 20 minutes.  Feel more sensitive to dizzyness if roll on ground or spin ever since.
This spontaneous report was received from a male patient of unknown age, who was reporting on himself. The patient's pertinent medical history was memory, spasm and prostate (as reported). He had no drug reactions or allergies. On an unknown date in July 2017, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque forming units (PFU) (dose, route of administration, lot# and expiration date were not provided) which was reconstituted with sterile diluent (manufacturer unknown) (strength, dose, frequency, route of administration, lot# and expiration date were not reported) in the back part on an unspecified arm, for prevention of shingles. Concomitant therapies included hydrochlorothiazide, carvedilol, ELIQUIS, digoxin, LIPITOR, PROSCAR, timolol maleate (manufacturer unknown), latanoprost, NAMENDA, primidone and losartan (manufacturer unknown). On an unknown date in 2017 (reported as "few weeks ago"), the patient noticed a bump where he received the vaccine. He went to an unspecified dermatologist on an unspecified date after he noticed the bump. The bump was removed by the dermatologist on an unspecified date. The dermatologist took a biopsy of the bump after the bump was removed and sent it for testing on an unknown date. At the time of the report, the patient was waiting for the results of the biopsy. He also reported that the bump was currently barely visible and the bump's spot was covered with a Band-Aid. The outcome of the event and the relatedness between the event and the suspect therapies were not provided.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), in Mar2022 as dose 3 (booster), single (Lot number: HFF8841) at the age of 55 years, in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing). Concomitant medication(s) included: ZYLOPRIM oral, start date: Jan2018; ACIPHEX oral. 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: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 included PF-07321332, ritonavir (PAXLOVID) with treatment start date: 11Aug2022, treatment stop date: 16Aug2022.
This is a spontaneous report from a contactable family medicine physician. This report was received via a Pfizer sales representative. A patient of unspecified age and gender received TRUMENBA, (lot number and expiration date not reported) and HPV vaccine (manufacturer unknown), both via unspecified routes of administration from unspecified dates at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced seizure on an unspecified date. The outcome of seizure was unknown. Information on the batch/lot number has been requested.
Full body ache/pain, headache, nausea, excessive bruising, shortness of breath, sores in and around mouth
gallbladder pain; pain; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of BILIARY COLIC (gallbladder pain), PAIN (pain), PYREXIA (fever) and CHILLS (chills) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 046B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced BILIARY COLIC (gallbladder pain), PAIN (pain), PYREXIA (fever) and CHILLS (chills). At the time of the report, BILIARY COLIC (gallbladder pain), PAIN (pain), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  No relevant concomitant medications were reported.   Treatment information was not provided.
Initial report received from a consumer on 02 October 2013. A 5 year old female received FLUZONE (Lot # 08AA1201BC, expiration date 01-May-2015) intramuscularly at left deltoid on 12-Sep-2013. Within 24 hours of vaccination, on 13-Sep-2013, the patent developed a 1/4 inch red, raised bump below the injection site. The bump then became itchy and that lasted for one week. The patient had history of environmental and food allergies. Documents held by sender: None.
Expired Engerix B administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a adult patient who received HBV (Engerix B adult) (batch number 4F472, expiry date 6th November 2022) for prophylaxis.   On 8th November 2022, the patient received Engerix B adult. On 8th November 2022, unknown after receiving Engerix B adult, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 09-NOV-2022 Reporter's Comment: The reporter reported that, a patient was administered an expired dose of Engerix-B. The reporter did not have any of the patient information at the time of reporting, just that it was an adult. The reporter consented to follow up.  Additional Supportive Information: The reporter reported that, a patient was administered an expired dose of Engerix-B, which led to expired vaccine used.
I woke up very nauseous and woozy. I walked into my sisters room and fell down due to weakness.   Expericed the following: Fever - 101.2, Chills, Nauseau, Sore Throat , Soreness, Acid Reflux, Headache.  Went to the ER because the soreness of my throat was extreme and did not fit the normal side effects.  The outcome was to take Tylenol for the fever and headache.  To follow up with doctor.
Complained of tingling of the lips and felt very nervous. Was assessed and BP and pulse were normal. Has hx of anxiety. Pt reassured and monitored for 1 hour and then left after reporting that she felt better. She texted back at 3 pm when she got home and said she was feeling better.  Took Allegra at home.
This spontaneous report was received from a registered nurse concerning an unknown number of patients of an unknown gender and age. Medical history and current conditions were not reported. On an unknown date, the patient's were vaccinated with a dose of (Oka/Merck) PROQUAD (dose, dose number and route were not reported) with lot number reported as K012929 expiration dates 28-FEB-2016, that was improperly stored. No adverse effects were reported. Additional information has been requested. This is one (1) of two (2) reports from the same source.
broke out with SHINGLES; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had the Shingles shot and two weeks later broke out with shingles. Additional supportive information: Follow-up would not possible as no contact details were available.
Information has been received from a pharmacist referring to a 77 year old female patient. The patient had no history of drug reaction or allergies. On 03-MAY-2016, the patient was vaccinated with a dose of ZOSTAVAX Lot # L035504 with expiration date of 16-DEC-2016 (dose was unspecified), subcutaneously on the inside of her left arm near the elbow. On 04-MAY-2016, the patient developed a 4 inch area of redness and warmth at the injection site. The patient came to pharmacy to seek medical attention. No treatment was given. No lab diagnostics study was performed. At the time of reporting, the patient was not recovered from the events. The relationship between the events and ZOSTAVAX was not reported. Additional information has been requested.
Patient was given Pfizer Covid 12+ instead of the Pfizer Covid Bivalent 12+  vaccine for her 4th dose.
Information has been received from a registered nurse concerning a 71 year old male patient. The patient's concurrent conditions included seasonal allergy and high cholesterol. There were no drug reactions. No pertinent medical history was reported. Concomitant therapies included CRESTOR and FLONASE. On 11-OCT-2016, the patient was vaccinated with an unspecified dose of PNEUMOVAX23 for prophylaxis (lot # M026317 with an expiration date of 11-JAN-2018) (dose, route, anatomical location of administration and expiration date were not reported). Other suspect medications were not reported. On an unspecified date in 2016, after receiving PNEUMOVAX23, the patient experienced redness and swelling around the injection site and was diagnosed with cellulitis. The patient sought medical attention by visiting the physician's office and he was treated with an unspecified antibiotic. No laboratory studies were performed nor product quality complaint was involved. On unknown date in 2016, the patient recovered from  the cellulitis. The relatedness between the event and therapy with PNEUMOVAX23 was not reported. Upon internal review, cellulitis was determined to be a medically significant event. This is a Corrected report. The field Potential Lot Check was marked as Yes, as the case meets the criteria for Adverse Event Quality Investigation Process. Follow up information has been received from the reporting nurse on 20-DEC-2016. On 11-OCT-2016 at 10:59, the patient was vaccinated with a dose of PNEUMOVAX23 via intramuscular in the right deltoid. On 13-OCT-2016 at 11:37, the patient experienced cellulitis, red and hot to touch. The patient was administered ZPACK as treatment. On 18-OCT-2016, the patient recovered from the event. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information was sent and received. Sender's Comments: US-009507513-1611USA007073: US-009507513-1611USA007088: US-009507513-1611USA007096: US-009507513-1611USA007131: MERCK 1611USA007077: Mfr number.
Redness, swelling, itching and pain at site - Advised to apply cold compress and take Ibuprofen PRN. If sx worsen to contact office or proceed to nearest ER.
Off-cycle menstrual/vaginal bleeding. Today is 7th day of heavy bleeding, about twice as heavy as a heavy flow day for a normal menses. Many large blood clots through the day and night.
Threw up; Flu like symptoms; This is a spontaneous report from a non-contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Feb2021 at 12:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and high cholesterol. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included levothyroxine (MANUFACTURER UNKNOWN) started on an unknown date taken for an unknown indication and unknown if ongoing. On 27Feb2021, the patient had threw up once about 24 hours after vaccine and from that point began feeling flu like symptoms. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events threw up and flu like symptoms was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After I received my first Covid vaccine (pfizer) I developed worsening tinnitus. It would come and go though. In November 2021, I received my booster (Moderna) and my tinnitus went from on and off to constant. Mostly in my right ear. The audiologist said that I had some hearing damage years ago and that possibily the vaccine and boosters had aggravated it. SHe said she had several cases of this.
all employees recvd 3 doses of Engerix-B; 5 who were tested did not respond;
Narrative:  Patient was administered the J&J COVID vaccine on 7/7/21 during inpatient hospitalization, by a medical professional who completed specific training for this vaccine. Patient was counseled about the reports of thrombosis with thrombocytopenia syndrome (TTS) and was provided with the required counseling and patient educational handouts and EUA fact sheet, Side Effects and Adverse Events Reporting Fact Sheet. After review of the risks/benefits patient consented to receiving the vaccine. Approximately 7/12/21 patient was reportedly admitted to Medical Center where a PE and thrombocytopenia were diagnosed (these records are not available for this writer's review). He was started on rivaroxaban 15mg BID. On 7/21/21 he was transferred to another hospital for inpatient psychiatric admission. Since 7/21, platelets have been WNL and trending up. Of note, patient is being treated for severe alcohol use disorder and was reportedly drinking heavily prior to admission, which can also potentially be associated with thrombosis and thrombocytopenia.
Lemon sized lumps on either side of injection site and very sore.  Pain persisted and radiated from injection site up into trapezius muscles.  Pain was unberable so I went to ER twice.  First ER trip was on 08/28/2012 and second ER was on 09/03/2012.  Examined both times and given pain medication and sent home afterwards.  Second ER trip they administered an ultrasound to make sure there were no blood clots.  (There were none found.  I was taking Ibuprofen every four hours for several weeks and decided I was taking too much and too often so I stopped the medication routine.  Pain has GRADUALLY subsided over a months time but still have pain if my arm and trapezius muscles get cold.  Some residual pain but bearable most of the time.
Patient was given 0.2 ml of undiluted Pfizer Monovalent vaccine. Family contacted the next day.  Child was experiencing normal side effects - local injection site discomfort.  Afebrile.  Mother had no concerns.