chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 11AUG98 & approx 2wk later became ill, weak progressed to being unable to walk;saw MD x2;then hosp 8JUL98 to29AUG98 w/dx of GBS;still unable to walk;
On Sunday night, my hands became very itchy; overnight my entire body became itchy; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), via unspecified route of administration on right arm on 20Mar2021 (at the age of 60-year-old) at 11:15 AM as a single dose for COVID-19 immunisation. Medical history included asthma and Chronic obstructive pulmonary disease (COPD). The patient reported no known allergies to medications, food, or other products  Concomitant medications included spiriva (MANUFACTURER UNKNOWN), SYMBICORT, montelukast (MANUFACTURER UNKNOWN), FLONASE and prednisone (MANUFACTURER UNKNOWN) for unspecified indications. 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 not tested for COVID post vaccination. On 21Mar2021 at 08:30 PM patient experienced generalised itching. It was reported that on Sunday night, the patients hands had become very itchy; overnight her entire body became itchy but she did not develop a rash or hives and her breathing was fine. Although it was Tuesday and she still had itchiness. Therapeutic measures were taken as a result of event and included self-treatment with benadryl. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event generalised itching was not recovered.   Information about lot/batch number has been requested.
No additional AE details; Just fount out they had another TE  / Varivax has been administered; This spontaneous report was received from an unspecified reporter (customer, reported as "Other") referring to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  The reporter informed about a temperature excursion (TE) "1 week ago" for vaccines of varicella virus vaccine live (Oka/Merck) (VARIVAX), as follows: temperature -14 Celsius degrees up to -10 Celsius degrees for 2 hours 5 minutes 0 seconds; -10 Celsius degrees up to 8 Celsius degrees (-0.4C) for 1 hour 25 minutes 0 seconds; previous temperature excursion: -14 Celsius degrees up to -10 Celsius degrees (-12C) for 0 hours 50 minutes 0 seconds.   On an unknown date between 11-MAY-2022 and 24-MAY-2022, the patient was administered a dose of these varicella virus vaccine live (Oka/Merck) (VARIVAX) vaccines (lot # U039949 has been verified to be a valid lot number, expiration date: 16-DEC-2023; dose and route of administration not reported) administered for prophylaxis (Product storage error); additional product reported included sterile diluent (MERCK STERILE DILUENT) (reported as "DILUENT MRK"). There were no additional adverse event (AE) details provided (No adverse event). There was no product quality complaint (PQC).
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 2014, the patient was inoculated at a pharmacy with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. In approximately October 2016, the patient was treated for her zoster related symptoms and was diagnosed with shingles. The patient was subsequently treated for shingles and zoster related injuries as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles and zoster-related injuries, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Hospitalization: 12/26/2022 - 12/28/2022 (2 days) Presentation to the ED: dry mouth.  COVID + date: 12/16/2022  Treatment: none specific to COVID. Discharge to: home.   ER8737 4/6/2021 EW0153 5/4/2021
UPPER SPINE WAS VERY TENDER; COLD SWEAT; COULD NOT STAND UP FROM FLOOR; SEVERE DIARRHEA; FELT LIKE SOMETHING HAPPENED; ARM PAIN; BURNING HEAT OFF BODY; BRUISING AT UPPER SPINE/YELLOW BRUISING DOWN LOWER LEFT LEG; SEVERE PAIN UP NECK AND DOWN  BACK; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sensitive to antibiotics, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 and expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAR-2021, the subject experienced bruising at upper spine/yellow bruising down lower left leg. On 04-MAR-2021, the subject experienced severe pain up neck and down back. On 04-MAR-2021 14:00, the subject experienced burning heat off body. On 05-MAR-2021, the subject experienced arm pain. On 07-MAR-2021, the subject experienced cold sweat. On 07-MAR-2021, the subject experienced could not stand up from floor. On 07-MAR-2021, the subject experienced severe diarrhea. On 07-MAR-2021, the subject experienced felt like something happened. On 19-MAR-2021, the subject experienced upper spine was very tender. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from upper spine was very tender, bruising at upper spine/yellow bruising down lower left leg, and severe pain up neck and down back on 07-APR-2021, burning heat off body on 04-MAR-2021, and cold sweat, could not stand up from floor, and severe diarrhea on 07-MAR-2021, and the outcome of arm pain and felt like something happened was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Big knot (injection site); Rash (injection site); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Big knot (injection site)) and VACCINATION SITE RASH (Rash (injection site)) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE MASS (Big knot (injection site)) and VACCINATION SITE RASH (Rash (injection site)). At the time of the report, VACCINATION SITE MASS (Big knot (injection site)) and VACCINATION SITE RASH (Rash (injection site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Initial misuse report received from a healthcare professional on 20-NOV-2013. An adult patient (no other information was provided regarding patient) had administered of ADACEL and TENIVAC. Both vaccines administered within 6 weeks of each other to an adult patient. No adverse event was reported. List of documents held by sender: none
Once he started driving but he didn't why he was driving; One week after 2nd dose, patient reports that he started dreaming strange; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL DREAMS (One week after 2nd dose, patient reports that he started dreaming strange) and FEELING ABNORMAL (Once he started driving but he didn't why he was driving) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 01-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced ABNORMAL DREAMS (One week after 2nd dose, patient reports that he started dreaming strange). On an unknown date, the patient experienced FEELING ABNORMAL (Once he started driving but he didn't why he was driving). At the time of the report, ABNORMAL DREAMS (One week after 2nd dose, patient reports that he started dreaming strange) and FEELING ABNORMAL (Once he started driving but he didn't why he was driving) was resolving.            No treatment medication was reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: TCR form was added, and event outcome was updated in recent follow-up.
pt received 4 vaccines on 9/25/08.  PNEUM0VAX + FLUZONE on (L) arm, HAVRIX + BOOSTRIX on R arm.  On 9/26/08 pt developed fever of 102 degrees - 9/27/08.  On 9/28 swelling started on (R) arm.  Today at 11:50 am area of erythema + induration on deltoid 100mm + 2 inches below are of erythema + induration 64mm.
First shot:  all over body itchiness for 24 hours; left underarm swollen lymph node; fever; body aches.  Second shot:  Approximately 3 weeks after the second shot, I developed red angry patches.  Very itchy.  Painful. Felt burning in the area of the itchy patches.  At first the red itchy patches (resembled mosquito bites) developed on my right arm.  Within days they developed on my left arm.  As days passed those subsided and new ones developed on face and neck.  Each day I develop new ones on both legs and now my lower back, hands, fingers and top of left foot.  These are extremely itchy.  this began 12/31.  Today is 1/14/2022 and I am still experiencing new red, itchy patches every day.
PAIN AT SITE OF INJECTION RADIATING DOWN LEFT ARM TO THUMB WITH LIGHTHEADEDNESS
This spontaneous report was received from a physician refers to an approximately 51 year old female patient. The patient's medical history included hysterectomy prior to taking ZOSTAVAX. Drug reactions/allergies: none. On 23-MAY-2015 the patient was vaccinated with ZOSTAVAX (route, dose, frequency and lot # unspecified by reporter). Physician reported that patient experienced redness at the injection area on 24-MAY-2015. Physician reported patient had 10-15 vesicles around the injection site on 26-MAY-2015 described as blisters with clear fluid inside. No treatment given for the events but the patient saw the physician. Lab diagnostics studies were not performed. VZV packet faxed. No additional information to report. The outcome of vaccination site vesicles and vaccination site erythema was reported as not resolved. Causality assessment was not reported. No product quality complaint involved. Additional information has been requested.
pt recv vax 19APR99 & 26APR99 pt found drooling, floppy & unable to walk;to ER w/dx of post infect cerebellitis;pt then has 4 more days of very similar episodes lasting up to 45min;
Patient received full dose (0.5mL) for 4th dose instead of half dose (0.25mL). He was informed on the same date once the error was discovered. He reported no side effects outside of normal/expected first-second day side effects (tiredness, achiness, etc.). He reported no additional side effects after day 2.
Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 95 years old male patient who received 2 doses of FLUZONE, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route. 1 other doses were administered on unknown dates for suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was a case of actual medication error due to extra dose administered. The patient outcome is reported as Not Applicable for 95 year old male, received 2 doses of FLUZONE. 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 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.
Headache; Feeling a little off/unwell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 80-years-old female patient received bnt162b2 (BNT162B2), administration date 29Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADVIL. Vaccination history included: Bnt162b2 (First dose), when the patient was 80 years old, for COVID-19 immunization, reaction(s): "NO adverse event". The following information was reported: HEADACHE (non-serious) with onset 30Mar2021, outcome "unknown", described as "Headache"; MALAISE (non-serious) with onset 30Mar2021, outcome "unknown", described as "Feeling a little off/unwell".  Additional Information: Caller who was 80-years-old female received second dose of the PFIZER BIONTECH COVID-19 Vaccine yesterday. Today, she was feeling a little off/unwell and had a bit of a headache. She takes ELDERBERRY to boost her immune system. She saw online that you are not supposed to take TYLENOL or ADVIL before you get the COVID-19 Vaccine, but she did not see that on the fact sheets. She took ADVIL the morning of the vaccine (for chronic pain that she has) around 7am and had her vaccine around 12pm. She asked if does TYLENOL or IBUPROFEN affect the vaccine and why was the TYLENOL or IBUPROFEN CDC recommendations not on the Patient Fact Sheet. She was confused why it was on the Internet but no one was given any warning about it on the paperwork. She drank alcohol after her first dose and asked if does this affect the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Local Reaction to Anthrax Vaccination: Anthrax #4 (Left arm-deltoid area)Hep B #3 (Right arm) 29 Sept 03 Received vaccinations on this date.  No complaints.    30 Sept 03 Erythematous, edematous ring started to develop around site of anthrax vaccination.  Site tender to touch.  Service member reports no strenuous use of this arm since receiving the vaccination.  Denies any problems with previous 3 Anthrax vaccinations.  01 Oct 03 Enrolled in VHC services for evaluation.  Reports that the swelling and redness have decreased since the previous day.  No other complaints.   Treatment:  1. Ibuprofen 800mg po q8 hrs prn and diprolene topical steroid cream bid x 3-5 days. 2. Give future doses of anthrax vaccine via intramuscular route into deltoid muscle. 3. Pre-treat injection site with diprolene (or equivalent) topical steroid cream 1 hour prior to vaccination and bid x 3-5 days afterwards. 4. Ibuprofen 800 mg (or equivalent NSAID) 2 hours before receiving vaccine and tid x 3-5 days afterwards.   5. Avoid strenuous exercise for 24 to 48 hours after next dose to avoid aggravating local reaction.
top of both her arms had little red blisters and they were rough and slightly itchy; top of both her arms had little red blisters and they were rough and slightly itchy; top of both her arms had little red blisters and they were rough and slightly itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (top of both her arms had little red blisters and they were rough and slightly itchy), PRURITUS (top of both her arms had little red blisters and they were rough and slightly itchy) and BLISTER (top of both her arms had little red blisters and they were rough and slightly itchy) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced ERYTHEMA (top of both her arms had little red blisters and they were rough and slightly itchy), PRURITUS (top of both her arms had little red blisters and they were rough and slightly itchy) and BLISTER (top of both her arms had little red blisters and they were rough and slightly itchy). At the time of the report, ERYTHEMA (top of both her arms had little red blisters and they were rough and slightly itchy), PRURITUS (top of both her arms had little red blisters and they were rough and slightly itchy) and BLISTER (top of both her arms had little red blisters and they were rough and slightly itchy) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
6hours after vaccine I developed mild chills, joint pain, moderate weakness, and a bit disoriented. Day 2 of vaccine all symptoms gone only swelling and pain to left arm where vaccine was administered.
Patient broke out in blisters near her lips or nose after receiving the second dose. Recommended patient to see primary physician.
A vial of  vaccine was punctured at 10:00 am on 7/22/2021. Vial was in refrigerator and stayed there between 8 and 30 degrees Celsius until 4:47 pm on the same day. At 4:47 pm, 2 doses were drawn from vial and administered one to patient, and one to another patient. 4:47 pm was 47 minutes past the 6 hour use by time listed on the fact sheet from the CDC and the manufacturer. Per CDC guidance on their "COVID-19 Vaccine Administration Errors and Deviations" fact sheet, Pfizer manufacturer was contacted on 7/22/2021, and again on 7/23/2021. On 7/23/2021, a representative of Pfizer's medical team was spoken with. She verified that according to Pfizer's studies, the Pfizer COVID-19 vaccine maintains viability for up to 24 hours at 8-30 degrees Celsius in refrigerator. Additionally she stated that I, and my colleagues should use our clinical judgement due to this information being outside of the fact sheet recommendations, as to if patient's dose of Pfizer's COVID-19 is valid, or needs to be repeated. No adverse effects were stated although a report was escalated to Pfizer's safety department out of an abundance of caution, and waiting to hear back.
Patient was administered her Pfizer Covid 19 vaccination and waited 30 mins  after dosage. Patient phoned the facility nurse describing left side throat swelling  and nasal discomfort 15 mins after leaving the facility and headed home. Nurse then told patient to a Benadryl for the reaction. The follow up with the Physician patient denied any continued swelling or discomfort 30mins after; she was advised to take another Benadryl if it returned and to contact the Emergency Department.
Swelling, redness, and heat in the injection area up to softball size per patient's daughter.
Patient went to a Primary Urgent Care. Experienced pain, swelling, redness and injection site. Patient told by MD at Urgent care facility that the injection site may be infected and give antibiotics to treat.
PATIENT HAS HISTORY OF DEMENTIA. VOLUNTEER SERVICE SENT HER TO GET VACCINE AT CLINIC NOT KNOWING SHE HAD HER FIRST DOSE ALREADY AT NURSING HOME, WHICH WAS THE PFIZER VACCINE. SHE STATED "I GOT A SHOT BUT DONT KNOW WHAT I HAD". UNAWARE OF WHAT SHE HAD, NURSE WHO TOOK CARE OF HER ON FLOOR WAS ABLE TO CONFIRM FIRST DOSE OF PFIZER WITH PHARMACIST AND EMPLOYEE HEALTH NURSE. VAERS REPORT PLACED DUE TO MIXED DOSES AND INTERNAL ERROR. CLINIC STAFF UNAWARE THAT PATIENT, AS WELL AS PATIENT, SHE HAD THE PFIZER VACCINE BEFORE COMING INTO THE COVID MODERNA CLINIC. NO ADVERSE REACTIONS NOTED WITH MODERNA VACCINE GIVEN.
This spontaneous report as received from a physician via a company representative refers to a 70 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 09-NOV-2016, the patient was vaccinated with PNEUMOVAX 23 lot # M037669, expiry date 09-MAY-2016 (dose, route and site of administration were not reported). On 10-NOV-2016, the patient called the physician's office to informed that they experienced redness, swelling and warmth at the injection site and to seek medical attention. The patient received unspecified treatment for the events. The outcome of the events was not reported. The relatedness between the events and PNEUMOVAX 23 was not provided. The reporter requested lot check due to another patient having the same adverse reactions after receiving PNEUMOVAX 23 with the same lot #. This is one of two cases received from the same reporter. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine product; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 53-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FJ5682) at the age of 53 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Feb2021 as dose 1, single (Lot number: 006M20A), in left arm, on 18Mar2021 as dose 2, single (Lot number: 038A21A), in left arm, on 31Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 16Sep2022 as dose 5 (booster), single (Lot number: 017AOC), in left arm for covid-19 immunisation. The patient's relevant medical history included: "cardiovascular disease" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Apr2022, outcome "unknown", described as "Interchange of vaccine product"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received COVID 19 treatment with Paxlovid, treatment start date: 18Dec2022, treatment stop date: 23Dec2022. Patient had no known allergies.