chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (Lot #: N021728, Exp Date: 06-FEB-2019) (Lot#: N022972, Exp Date: 19-FEB-2019) , (Lot#: N029878, Exp Date: 22-APR-2019) or (Lot#: N025929, Exp Date: 18-MAR-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of MERCK STERILE DILUENT (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA009899:Original Case : 1805USA006787 US-009507513-1805USA009900:Original Case : 1805USA006787 US-009507513-1805USA009901:Original Case : 1805USA006787 US-009507513-1805USA009902:Original Case : 1805USA006787 US-009507513-1805USA009903:Original Case : 1805USA006787 US-009507513-1805USA009904:Original Case : 1805USA006787 US-009507513-1805USA009905:Original Case : 1805USA006787 US-009507513-1805USA009906:Original Case : 1805USA006787 US-009507513-1805USA009907:Original Case : 1805USA006787 US-009507513-1805USA009908:Original Case : 1805USA006787 US-009507513-1805USA009909:Original Case : 1805USA006787 US-009507513-1805USA009910:Original Case : 1805USA006787 US-009507513-1805USA009911:Original Case : 1805USA006787 US-009507513-1805USA009912:Original Case : 1805USA006787 US-009507513-1805USA006787:Original Case : 1805USA006787 US-009507513-1805USA009914:Original Case : 1805USA006787 US-009507513-1805USA009915:Original Case : 1805USA006787 US-009507513-1805USA009916:Original Case : 1805USA006787 US-009507513-1805USA009917:Original Case : 1805USA006787 US-009507513-1805USA009918:Original Case : 1805USA006787 US-009507513-1805USA009919:Original Case : 1805USA006787 US-009507513-1805USA009920:Original Case : 1805USA006787 US-009507513-1805USA009921:Original Case : 1805USA006787 US-009507513-1805USA009922:Original Case : 1805USA006787 US-009507513-1805USA009923:Original Case : 1805USA006787 US-009507513-1805USA009924:Original Case : 1805USA006787 US-009507513-1805USA009925:Original Case : 1805USA006787 US-009507513-1805USA009926:Original Case : 1805USA006787 US-009507513-1805USA009927:Original Case : 1805USA006787 US-009507513-1805USA009928:Original Case : 1805USA006787 US-009507513-1805USA009929:Original Case : 1805USA006787 US-009507513-1805USA009930:Original Case : 1805USA006787 US-009507513-1805USA009931:Original Case : 1805USA006787 US-009507513-1805USA009932:Original Case : 1805USA006787 US-009507513-1805USA009933.
c/o rash, fever, fussy x 1 day. c/o swelling- symptoms began last night.
My son passed away; the cause of death was bilateral Pulmonary Thromboembolism due to deep vein thrombosis of lower extremity of undetermined Etiology; My son passed away; the cause of death was bilateral Pulmonary Thromboembolism due to deep vein thrombosis of lower extremity of undetermined Etiology; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the parent.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Lot number: PF2593) at the age of 23 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 2, LOT# EW0153), administration date: 28Apr2021, when the patient was 23-year-old, for COVID-19 Immunization; Bnt162b2 (Dose 1, LOT# EW0153), administration date: Apr2021, when the patient was 23 years old, for COVID-19 Immunization. The following information was reported: PULMONARY EMBOLISM (death, medically significant), DEEP VEIN THROMBOSIS (death, medically significant), outcome "fatal" and all described as "My son passed away; the cause of death was bilateral Pulmonary Thromboembolism due to deep vein thrombosis of lower extremity of undetermined Etiology". The patient date of death was 28Oct2022. Reported cause of death: "bilateral Pulmonary Thromboembolism due to deep vein thrombosis of lower extremity of undetermined Etiology". It was not reported if an autopsy was performed. Clinical course: the reporter just obtain the final test certification and all type of report and the patient was on a product made by Pfizer and when he was on the product he was on the vaccine, so he had not just receive the vaccine but he received the vaccine a month before. He was not taking any other medicine at that time. He had received COVID-19 vaccine made by Pfizer, he had received the vaccine back in Dec2021 that was the last booster that he receive but he passed away in Oct2022, so many months later but the reporter want to make sure that this case was reported and there was awareness he was not drawing any conclusion but want to make sure that was awareness of this event.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events: "Pulmonary embolism", "Deep vein thrombosis" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.; Reported Cause(s) of Death: bilateral Pulmonary Thromboembolism due to deep vein thrombosis of lower extremity of undetermined Etiology; bilateral Pulmonary Thromboembolism due to deep vein thrombosis of lower extremity of undetermined Etiology
Start Date/Time: [pfizer] 19-JAN-2021 01:00 PM/Start Date/Time: [pfizer] 23-DEC-2020 01:00 PM; right arm swelling; This is a spontaneous report from a contactable other HCP (patient). This 48-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 19Jan2021 13:00 at single dose on the right arm for covid-19 immunization. The patient medical history included diabetes mellitus (DM), hypertension (HTN), depression, obesity, known allergies: TB serum and hair dye. Patient took other medications the patient received within 2 weeks of vaccination. The patient previously took first dose of bnt162b2 via intramuscular on 23Dec2020 13:00 on the right arm for covid-19 immunization, took lisinopril and experienced drug allergy. Patient was not pregnant at the time of vaccination. Facility the most recent COVID-19 vaccine administered was public health clinic/veterans administration facility. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced right arm swelling in Jan2021. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No treatment received for the adverse event. Outcome of right arm swelling was recovering. The event was assessed as non-serious.  Information on the lot/batch number has been requested.
high total bilirubin; fever; Chills; fatigue; maternal exposure during pregnancy, second trimester; This is a spontaneous report from a contactable pharmacist (patient). A 38-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6203), via intramuscular, administered in Arm (Deltoid) on 05Mar2021 (at the age of 38-year-old) as single dose for COVID-19 immunization. Medical history included risk factors for adverse pregnancy outcomes including environmental or occupational exposures such as seasonal asthma. Concomitant medications included Parental vitamins (capsules) for Pregnancy at QD (once a day) orally from Dec2020 and ongoing; acetylsalicylic acid (ASPIRIN) taken for pregnancy from Dec2020 to Jul2021. The patient had no prior vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN5318), via intramuscular, administered in Deltoid on 12Feb2021 afternoon (at the age of 38-year-old) as single dose for COVID-19 immunization and experienced injection site pain. On 06Mar2021, the patient experienced fever/ chills in the morning and fatigue in the afternoon. The patient was pregnant at the time of vaccination. The first day of last menstrual period was in Oct2020 and estimated date of conception was in Nov2020. Gestation period at time of initial exposure was 3. The mother did not smoke, drink alcohol or did not use illicit drugs during this pregnancy. Obstetrical History included 3 previous pregnancies and 1 other child. She had 2 miscarriages/2 live births (one of the live births was preterm). Estimated delivery date was 21Jul2021 and the patient had scheduled c-section. It was full term live birth. Gestational age at birth was 39 weeks 4 days. The normal new born was female, weight at birth: 6 lbs 7 oz; length at birth: 19 in; head circumstance at birth: 34cm and Apgar score:1 min: 9; 5min: 9. The patient did not have any problem before delivery and during delivery (including delivery complications, fetal distress, amniotic fluid abnormal, abnormal placenta). After delivery she had high total bilirubin. Paternal information reported as follows: age of 45 years. Father did not have any exposure to products like any drugs (e.g., over-the-counter, medical prescription) during the mother's pregnancy. The father did not smoke during mother's pregnancy: he occasionally vaped. The father did not drink alcohol or did not use illicit drugs during mother's pregnancy. The patient did not receive any treatment for the events fever/ chills and fatigue. Outcome of the events fever, chills, fatigue was recovered in 2021; high total bilirubin was unknown.  Follow-up attempts are completed. No further information is expected.
Vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) and PYREXIA (Fever) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, the patient experienced VOMITING (Vomiting) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, VOMITING (Vomiting) and PYREXIA (Fever) outcome was unknown.
sore arm; she experienced a sore arm, fever, chills, wasn't feeling well; she experienced a sore arm, fever, chills, wasn't feeling well; she experienced a sore arm, fever, chills, wasn't feeling well; fatigue that has continued, and itching in her eyes; fatigue that has continued, and itching in her eyes; she had a panic attack; On 22 May a blood vessel burst in her left eye; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: CW0179 or EW0179), via an unspecified route of administration, administered in left arm on 09May2021 13:00 at the age of 63 years as single dose for covid-19 immunisation. The patient medical history was none. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (Lot number: ER8731) via an unspecified route of administration, administered in left arm on 18Apr2021 13:00 as single dose for covid-19 immunisation and experienced left toe swelling and she could hardly walk and fatigue. After dose two she experienced a sore arm, fever, chills, wasn't feeling well for about 2 days, fatigue that has continued, and itching in her eyes. The eye doctor said it was possible the eye itching was related but they were not sure. On 22May a blood vessel burst in her left eye and she was given antibiotic eye drops to use. On 24May she had a panic attack. She had her second Covid 19 vaccine on 09May2021 and she experienced a sore arm, fever, chills and she wasn't feeling well for about two days. The fatigue continued. She then experienced itching in her eyes like eye issues. She went to her eye doctor and the doctor told her her eye issues were possibly related to the Covid 19 vaccine but they weren't sure. Then this past Saturday, 22May2021 she had a blood vessel burst in her left eye. She was not sure if that was related to the Covid 19 vaccine but all these things were happening to her. She received her second Covid 19 vaccine on 09May2021 in the left arm. She reported she was on the fence about getting the Covid 19 vaccine but her daughter and her husband encour-aged her to get it. At her doctor's office she also had an EKG and a urinalysis done and everything came back ok. She ended up going to her doctor's office again because she was having a panic at-tack. She hadn't been feeling well and she thought it was affecting her mentally. She received an anti-biotic eye drop for her burst blood vessel. Ofloxacin 0.3% 1 drop in the left eye 3 times daily for 7 days. The antibiotic she received from the urgent care for her toe was Amoxicillin-Clavulanate 875-125mg, take one tablet every 12 hours for 5days. Itchy eyes, burst blood vessel in left eye, panic attack required a visit to physician office. Relevant Tests included bloodwork, urinalysis, EKG. Outcome of events was unknown.
This was dose #2.  (On Dose #1, on April 3, 2019,  I had immediate pain in my arm, from shoulder to finger tips.  For a full week, I had arm tenderness, particularly near vaccination site, and very limited range of motion. Then, it subsided. That's all I remember.)  But on Dose #2, which I received yesterday afternoon, all I had initially was severe stinging, as  the vaccine was administered, followed by arm soreness + tenderness, but, by bedtime, I also had muscle aches, headache, and nausea.  The headache + nausea have continued  intermittently today, but starting this morning, I've developed a few additional side effects: some joint pain (in addition to the muscle aches), shivers, and a temperature, so far, of 100.8 F.
Information has been received from a health professional concerning a 17 year old female who on 02-JAN-2007 was vaccinated IM with a 0.5 ml first dose of Gardasil (lot # 654741/0013U). Concomitant therapy included ZOLOFT and ADDERALL TABLETS. It was reported that since receiving her vaccination 02-JAN-2007 the patient has experienced premenstrual low abdominal cramping for a week prior to her menstrual period. The patient was examined by a physician on 12-MAR-2007 and there were no abnormal findings. No treatment was recommended. The reporter requested a lot check. Additional information has been requested.  The records of testing prior to release of the lot in question, have been rechecked and found to be satisfactory. The lot couples with the standards of the center, and was released.  The registered nurse reported that 3 other patients experiences after GARDASIL administration (WAES 0703USA02859, WAES 0703USA02815, WAES0703USA02840).  Additional information is not expected.
Dizziness, Arthralgia, Fever, ErythemaMultiform, NauseaVomiting, arm soreness Narrative:  Fever 100.6, arthralgia, nausea, dizzy, arm sore, reddened, swollen. Took Tylenol, better but still nausea and dizzy.
This spontaneous report as received from a medical assistant refers to 5 patients of unknown age and gender. On unknown dates, 4 patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L037554 exp date 25-DEC-2017) (dose and route not reported) and 1 patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # M011840 exp date 01-FEB-2018) (dose and route not reported). The temperature of excursion was 51 F for 144 hours. There was no previous temperature excursion. A data logger issue was reported. No adverse symptoms were reported.       This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA007073: US-009507513-1702USA001077:
Information has been received from a physician via medical records concerning a 12 month old male with umbilical hernia and a history of gastrooesophageal reflux disease, stridor inspiratory, mild laryngomalacia, bilateral true vocal fold nodules, diarrhea, irritability, pyloric stenosis, pylorectomy and facial rash (WAES #0801USA00092); and upper respiratory infection, possible coagulopathy, diaper rash, eczema, and gastroenteritis (all reported in WAES 0907USA05357) who on 29-JUN-2009, at 16:24, was vaccinated SQ in the right thigh with a first 0.5 ml dose of MMR II (Lot #663897/0153Y). Secondary suspect therapy included a first 0.5 ml dose of VARIVAX (Lot #663815/0266Y) administered SQ in the left thigh. Concomitant therapy included HAVRIX (Lot # AHAVB336D) IM in the right thigh. On 29-JUN-2009, at 17:31, the baby presented to the emergency room with head injury. Mother stated that aunt informed her the patient was walking and fell forward into a statue. Patient had been acting like himself. Patient was playful and running around in room. Parents concerned because the patient had small bruise to forehead. Physical examination showed mild ecchymosis to middle of forehead above nasal bridge. He was diagnosed with head injury. Since the patient's condition was stable, he was discharged to home on the same day, at 19:50. If symptoms worsened or changed, the patient would return to the emergency room. The patient was instructed to follow up with his primary care physician. The outcome of the patient was not reported. This is one of several reports regarding the same patient. Additional information is not expected.
Red itchy bumps over back of hands, wrists, knees, ankles, and elbows
Expanding arm rash around injection site, clearing center, hot, slightly itchy, non-painful. First noticed on March 1st,  Now noted between left shoulder to elbow, appears to be slowly fading today March 5,2021.
This spontaneous report was received from a registered nurse referring to a 19 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unspecified date, the patient was inadvertently vaccinated with a pediatric dose of VAQTA for prophylaxis (strength, route, lot # and expiration date were not reported). No adverse effects were reported.
February 5, 2021 in morning woke up with red scattered rashes down left arm, very itchy.  I called Moderna and they said it was delayed reaction to shot. Was 9 days later. Had been red but not the whole arm. Friday night go so bad, down both arms and across both shoulders, raised bumps, some on thigh, and face.   Doctor suggested I take Benadryl.  itching stopped, went to sleep. today, Feb. 6, only mild rash. concern about taking second shot. Appt. February 24, 2021.
A sister reported that her 7 year old brother received an injection of tetanus toxoid for a head wound in 1959 and reportedly developed complete paralysis from head to toes. He was hospitalized where a diagnosis of Guillain Barre Syndrome was made. The pt was intermittently hospitalized over 3 years. As of 1/5/00, no further information was available.
At 1pm, I started to feel nauseated.  Soon after I started to feel dizzy.  The dizziness elevated to extreme and I felt a hot/flushed sensation starting at the top of my head down.  Once the hot sensation was over, I felt a tingling sensation.  Once those sysmptoms had subsided, my legs became weak.  I did not actually have a docotor visit, however a physcian assistant examined me.  I went home early from work and took Motrin.  I had 2 more epsidodes of dizziness that evening, not as severe.  Today (the next day) I am not experiencing any of the above symptoms, however I feel a little off balance.
Fever of 101.6; Chills; Headache; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 10Apr2021 at 15:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included metformin (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), furosemide (MANUFACTURER UNKNOWN) and multi vitamin; all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 11Apr2021, the patient experienced a fever of 101.6 (unspecified units), chills and headache which lasted for 24 hours. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever of 101.6, chills and headache were resolved on 12Apr2021.  No follow-up attempts are needed. No further information is expected.
This case was reported by a healthcare professional and described the occurrence of pain all over in a 5-year-old male subject who was vaccinated with HAVRIX, GlaxoSmithKline.  Concurrent vaccination included the third dose of MMR II, administered on 07 March 2007.  There were no concurrent medications.  The subject's mother stated that it was "normal" for her son to develop a fever following vaccination(s).  On 07 March 2007 the subject received the first dose of HAVRIX (0.5 mL) administered intramuscularly, in the left arm.  At approximately 5:00 a.m. on 8 March 2007, one day after vaccination with HAVRIX, the subject awakened with pain all over and fever.  The subject's mother consulted his health care provider by telephone, who advised treatment with Ibuprofen.  Following administration of Ibuprofen, the subject had been "sleeping most of the day".  At the time of reporting, on 08 March 2007, the fever and pain were resolved.  The event of "sleeping a lot" was unresolved.  Follow-up information received on 28 March 2007 indicated that the events were completely resolved by 09 March 2007.  In the reporter's opinion, the events were not related to treatment with HAVRIX.
No other issues or concerns reported; GARDASIL 9 that was administered/Temperature: 72F; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 03-NOV-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot # U008315, expiry date 15-AUG-2023, for prophylaxis (route and location of administration were not reported), which was stored in a temperature of 72 degrees Fahrenheit for 120 hours (product storage error). No previous excursion was reported. The nurse inquired about stability of administered hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No other issues or concerns were reported (no adverse event).
The vaccine expires 6 hours after the vial is first punctured. The patient received 1 dose of the vaccine 72 hours after the vial had been punctured. The patient was observed for 15 minutes at the clinic after the vaccine was administered. The patient stated she felt "light headed" 5 minutes after the vaccine was administered. Patient was given water and then became asymptomatic. Patient was then discharged home. No other events have been reported by the patient at this time.