chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vestibular neuritis; ear fullness/pain; ear fullness/pain; eyesight changes; vertigo; dizziness; occipital neuralgia; This is a spontaneous report from a contactable other hcp.  A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date: not reported) via intramuscular, administered in arm left on Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history included sinus pain, hpv (oropharyngeal squamous cell carcinoma), osteoporosis from an unknown date and unknown if ongoing. No Known allergies was reported. Concomitant medication(s) included simvastatin (SIMVASTATIN), diphenhydramine hydrochloride (BENADRYL), vitamins nos (VITAMINS NOS), naproxen (NAPROXEN), taken for an unspecified indication, start and stop date were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date: not reported) via intramuscular, administered in arm left on Jan2021 as dose 1, single for COVID-19 immunization. It is reported that dose lot unknown reason: Unable to locate or read the details. No other vaccine in four weeks. No COVID prior to vaccination. COVID was tested post vaccination. AE resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. On an unspecified date in Apr2021, the patient experienced vestibular neuritis (medically significant), ear fullness/pain, eyesight changes, vertigo, dizziness, occipital neuralgia. The patient underwent lab tests and procedures which included COVID-19: negative on Sep2021 COVID test name post vaccination: Biofire. Therapeutic measures were taken as a result of all the events with AE treatment: antibiotics, physical therapy. The outcome of the events was not recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the events - Vestibular neuronitis, ear discomfort, ear pain, visual impairment, vertigo, dizziness, occipital neuralgia and the suspect drug "BNT162B2" cannot be completely excluded. 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.
onset of diffuse erythematous rash day 8 post vaccination that persisted for 2 weeks.  Prednisone and benadryl used
Pt had a positive COVID test on 12/27/21 from; 1/11/22 positive COVID test from Hospital 2/2/22 and 2/22/22 had positive COVID tests from Medical Center; 4/8/22 admitted to Hospital with fever, fatigue, SOB; dx with pneumonia secondary to pneumocystis; given ABX; hypoxic; noninvasive ventilation; DNR; inpatient hospice where pt passed away..
Information has been received from a registered pharmacist concerning a 67 year old female patient, who on 06-FEB-2011 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # 669192/145Z) SQ. The pharmacist reported that on 06-FEB-2011 the patient developed a rash, redness and swelling. The patient's physician prescribed acyclovir because of the reaction to ZOSTAVAX. The patient was also treated with TYLENOL. It was reported that the patient contacted pharmacist stated that it was just a local redness and swelling and not appeared to be shingles. At the time of the report, the patient had not recovered. Additional information is not expected.
patient was administered ACTHIB that was reconstituted with sterile water instead of the recommended ACTHIB 0.4% sodium chloride diluent with no reported adverse event; Initial information was received on 10-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was administered hib (prp/t) vaccine [ACT-HIB] that was reconstituted with sterile water instead of the recommended acthib 0.4% sodium chloride diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect hib (prp/t) vaccine powder and solvent for solution for injection lot number not reported via unknown route in unknown administration site (strength, dosage, frequency, expiry date: unknown) for Immunization.  On an unknown date the patient was administered hib (prp/t) vaccine that was reconstituted with sterile water instead of the recommended acthib 0.4% sodium chloride diluent with no reported adverse event (product preparation error) (unknown latency).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I was unable to sleep, had fever, headache, very sore arm.  Since then I have developed a bruise at the injection site and a rash in the same area.  Arm is still painful to touch two days late
Fluzone High-dose was given today (10 Apr 2019), EXP: 3/9/19; Initial information received on 10-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age patient who received and expired dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] on 10 Apr 2019 which was expired on 09-Mar-2019 (lot number not reported via unknown route.).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant therapy and family history were not provided.   It was of actual medication error due to expired vaccine used.  It was unknown whether adverse event was experienced.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Extreme weakness, pain in bones and muscles, shivering and felt cold, bad headache, heart pounding and fast pulse, then hot flash. Lasted until about 4:00am. Then went to sleep. Today mild headache and tired.
I contracted COVID-19 on 07/06/2022 with symptoms of headache, congestion, runny nose, sneezing, hot flashes, night sweats, cough, mucous, extreme fatigue, body aches, and lack of focus. My symptoms began to improve on 07/09/2022. I felt well enough to work remotely today 07/13/2022. I was not prescribed any medications for my symptoms. I still have a slight cough, but I am feeling recovered.
100+ degree fever, muscle fatigue, dizziness, stuffy nose, fatigue, heart palpitations multiple times a day for over two months, headache, high blood pressure with no prior history of high blood pressure, missed one period and then the next was incredibly heavy.
Nausea, abdominal cramping, abdominal pain, abdominal spasms.  Inability to eat foods that I normally eat.  Vomiting (2 times), including vomiting a large quantity of a very thick mucus like substance.  Change in bowel habits: a sudden change to very soft stools - multiple times a day.   Ongoing as of today: 10/4 Treating w/Bland diet, small meals, ginger-ale diluted w/water OTC fizzy antacid did not work Some relief w/Pepto Bismal chewables
Right hip ,having bone pain; Right hip ,having bone pain; hard time walking; This is a spontaneous report from a contactable consumer (patient). A 75-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: En6198, expiration date was not reported) via an unspecified route of administration, in left arm, on 03Mar2021 11:30 (at the age of 75-year-old), at dose 1, single for covid-19 immunization. Medical history included A fib (atrial fibrillation), high blood pressure, thyroid (as reported). The patient had known allergies to Prymedium (as reported), pain medication. The patient's concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 after the vaccination. The patient experienced right hip having bone pain and hard time walking on 07Mar2021 18:00. No treatment was administered for the events. The outcome of the events was not recovered.    No follow-up attempts are possible. No further information is expected.
pt recv vax 24MAR98 & 6APR98 devel red spots on soles & sides of feet spreading to ankle thighs called clinic;@ present scattered small spots arms, lower back;APRIL began having stomach cramps & went to PMD;erythematous papular,nonpruritic
Slight soreness 1 day after injection, however, on 11/15/15 experienced complete Left Arm soreness in which she could not lift her arm or pick anything up. She cannot drive either.
Received vaccines on 6-10-08 in AM and started vomiting in evening that continue through 6-11-08.  No fever or diarrhea.  Not fussy but napping more.  MD visit and unclear source of vomiting.
Fever; Pain at injection site; Chills; Joint pain; Muscle pain; Headache; Lightheaded; Tired; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Aug2021 at 17:00 (at the age of 29-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 COVID vaccine. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) for unspecified indication from an unknown date and experienced drug allergy and 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 03Aug2021 at 17:00 (at the age of 29-year-old), as a single dose for COVID-19 immunisation. On 25Aug2021 at 02:00, the patient experienced fever, pain at injection site, chills, joint pain, muscle pain, headache, lightheaded and tired. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, pain at injection site, chills, joint pain, muscle pain, headache, lightheaded and tired was resolving 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.
redness @ inject site p/each dose; p/3rd dose had fever of 102 for 24 hrs w/nausea & dizziness; malaise for up to 1 wk;
Information has been received from a mother and a registered nurse concerning a 12 month old female patient with no known drug allergies and no pertinent medical history who on 21-SEP-2004 was vaccinated with the initial dose of MMR II.  Concomitant therapy included pneumococcal vaccine (unspecified).  According to the mother, the patient developed full blown rubella.  She added that the patient "started developing the rashes 3 to 4 days after administration of the MMR II and she also developed high fever".  It was also reported that the mother and her husband brought the patient to the physician's office right away but the physician did not even bother to look at the patient that time.  The mother stated that the patient was brought to the clinic 3 times.  In the middle of October, 2004 the patient recovered.  According to the registered nurse the rash that the mother of the child described as "full blown rubella" was never confirmed by a physician.  She indicated that the medical records stated that the child was exposed to a rash.  Additional information has been requested.
Fifty hours after injection I had a mild nosebleed; This is a spontaneous report received from a Pfizer sponsored program from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6205), via an unspecified route of administration in the right arm on 10Mar2021 10:00 (at the age of 67-years-old) as single dose for COVID-19 immunization. Medical history included breast cancer, high blood pressure and drug allergy to some medications, all from an unknown date and unknown if ongoing. Prior to vaccination, the patient was diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included lisinopril and tamoxifen. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. The patient stated that fifty hours after injection (12Mar2021, 12 noon) she had a mild nosebleed. However, it was also reported that the mild nosebleed started on 12Mar2021 at 11:30 PM. At 11:30 (as reported), she was awakened with a gushing nosebleed. They couldn't get it stopped so they had to call the squad. The patient stayed in emergency room/department or urgent care for several hours to get it under control. The patient received some type of syringe medication reported as "Afrin packaging" as treatment for the event. The event of nosebleed was considered as non-serious by the reporter. The patient had no history of problems with nose bleeds. It just seems coincidental to receiving the vaccine. The patient wanted to make sure it was safe for her to get the second dose. The patient underwent COVID-19 test type post vaccination via nasal swab on 24Feb2021 which resulted to negative. The outcome of the event was recovered.  Follow up attempts are needed. Further information has been requested.
Vaccine had been in the refrigerator for more than 30 days, initially stored in refrigerator on 06 Sep 2022, date administered on 18 Oct 2022; No adverse event; patient received  monovalent Moderna Covid-19 vaccine that was past the 30 day use by date in the refrigerator.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received  monovalent Moderna Covid-19 vaccine that was past the 30 day use by date in the refrigerator.), PRODUCT STORAGE ERROR (Vaccine had been in the refrigerator for more than 30 days, initially stored in refrigerator on 06 Sep 2022, date administered on 18 Oct 2022) and NO ADVERSE EVENT (No adverse event) in a 9-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 064A22A and 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received  monovalent Moderna Covid-19 vaccine that was past the 30 day use by date in the refrigerator.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine had been in the refrigerator for more than 30 days, initially stored in refrigerator on 06 Sep 2022, date administered on 18 Oct 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received  monovalent Moderna Covid-19 vaccine that was past the 30 day use by date in the refrigerator.), PRODUCT STORAGE ERROR (Vaccine had been in the refrigerator for more than 30 days, initially stored in refrigerator on 06 Sep 2022, date administered on 18 Oct 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received  monovalent Moderna Covid-19 vaccine that was past the 30 day use by date in the refrigerator.) and PRODUCT STORAGE ERROR (Vaccine had been in the refrigerator for more than 30 days, initially stored in refrigerator on 06 Sep 2022, date administered on 18 Oct 2022).    Vial size was 2.5ml. The vial was initially stored in the refrigerator on 6-SEP-2022. The vial does not undergone any temperature excursions.  No concomitant and treatment medications was reported.
Brain bleed; Stroke; She has not received the second dose; This spontaneous case was reported by a non-health professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and CEREBRAL HAEMORRHAGE (Brain bleed) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion hospitalization). On an unknown date, the patient experienced CEREBRAL HAEMORRHAGE (Brain bleed) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (She has not received the second dose). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), CEREBRAL HAEMORRHAGE (Brain bleed) and PRODUCT DOSE OMISSION ISSUE (She has not received the second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start dates of the events of the serious, a causal relationship cannot be excluded.  It is likely the reported "stroke" and "brain bleed" are descriptions the same event but this is not definitively stated. This report also refers to an event of dose omission.  There were no AEs specifically associated with this medication error; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events of the serious, a causal relationship cannot be excluded.  It is likely the reported "stroke" and "brain bleed" are descriptions the same event but this is not definitively stated. This report also refers to an event of dose omission.  There were no AEs specifically associated with this medication error
Information has been received from a physician concerning her 18 year old son with family history of HLAB7 with cross reactive autoimmune phenomena to Salmonella and Shidella infection and history of migraine who in June 2010 (also reported as June 2011), was vaccinated intramuscularly (IM) with the first 0.5 ml dose of GARDASIL (lot number and dose not reported) and was vaccinated IM with the second 0.5 ml dose of GARDASIL (lot number, dose and route not reported) in August 2010 along with a second dose of meningococcal vaccine (unspecified). The physician reported that in July 2010, after receiving his first dose of GARDASIL her son traveled to another country during which time he had some gastrointestinal (GI) symptoms. After he received his second dose of GARDASIL he started college and went on a camping trip (during which time water filter broke) in September 2010. The GI symptoms worsened over the summer and early fall. On 17-SEP-2010, her son was admitted to an unspecified hospital for dizziness. The patient underwent "a bunch of tests" and it was determined he had a "salmonella issue" a diagnosis of salmonellosis was made. At that time he was also diagnosed with aortic insufficiency - on an autoimmune basis due to salmonella. After he was discharged from the hospital it was determined that the patient had an autoimmune condition called POTS (Postural orthostatic tachycardia syndrome) that caused him to have syncope while standing up. Since POTS can be an autoimmune phenomenon, the physician thought that her son case could be related to his Salmonella infection and subsequent autoimmune sequelae. It was reported that over a year ago the patient had recovered from the events. The third dose of the vaccine had not been administered because the patient's mother (physician) did not wish to, although she believed the patient's condition was not vaccine related. However, because of the temporal relationship to vaccination with the second dose of GARDASIL she wanted to inquire about any known relationship between POTS and vaccination. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a 4 year-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On 04-OCT-2017, the patient was vaccinated with VARIVAX (exact dose, dose number, route of administration were not reported; lot # M024683 with the expiration date of 18-MAY-2018), reconstituted with sterile diluent (lot # and expiration date were not reported), and PROQUAD (albumin status of recombinant human albumin (rHA), exact dose, dose number, route of administration were not reported; lot# M031945 with the expiration date of 21-DEC-2017), reconstituted with sterile diluent (lot # and expiration date were not reported), for prophylaxis. No adverse effects were reported.
This spontaneous report was received from a physician referring to 12-month-old female patient. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 30-MAY-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005274 and expiration date 03-APR-2018; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 25-APR-2017 until 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 54F for the period of up to 70 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter.; Sender's Comments: US-009507513-1709USA007325:
5/4-5/7 Progressive overall decline and continued to decline Dialysis.  5/7-passed away at 1420
The patient mentioned he experienced local redness, warmth, itching. Swelling tenderness on left arm. It got worse so he was treated by dr at the urgent care clinic. We've added this new allergy info in patient's allergy profile.