chrisvoncsefalvay/vaers-outcomes huggingface dataset:
States there was a pharmacist in from a temp agency and that pharmacist took an expired vial(expired one week prior) and diluted and gave to 6 patients; Tiredness; This is a spontaneous report from Medical Information Team. A contactable pharmacist reported that a 35-year-old (at the age of 35 years old) male patient received bnt162b2 (BNT162B2, Solution for injection, lot number :EW0178) via intramuscular on arm left on 22May21 as dose 1 single 09:35 and bnt162b2 (BNT162B2, Solution for injection, lot number: EW0170) via intramuscular on arm left on 14Apr21 as dose 1 single 09:22 for COVID-19 immunisation. Medical history included ongoing Citalopram 20mg for mood,ongoing Lisinopril 40mg, for blood pressure and concomitant medications LEXAPRO, PRINIVIL. Caller stated she was a pharmacist speaking about the Pfizer COVID-19 vaccine. Stated there was a pharmacist in from a temp agency and that pharmacist took an expired vial (expired one week prior) and diluted and gave to 6 patients. This was patient if one of 6 patients. Caller stated the vaccine had no other excursions while being stored. She would like to know if the patients need to be revaccinated. pharmacist pulled an expired vaccine from refrigerator (clearly marked expired and sequential awaiting destruction permission to destroy), reconstituted and administered the vaccine to 6 separate patient. The vaccine was 7 Days expired. The Patients reported no adverse effect only normal side effects (tiredness in this case) and elected not to get another dosage. Outcome of the event was unknown.   No follow-up attempts possible. No further information expected. Information on the lot/batch has been requested.  Follow-up (06Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Follow-up (23Jul2021): This is a follow-up spontaneous report from a contactable Pharmacist. This Pharmacist reported in response to HCP letter sent that included: Medical history updated, dose details updated, clinical course updated.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021716440 same drug/reporter /events different patient
Pt 2ND Moderna Vaccine pt complained of upset stomach followed by vomiting. Emesis bag was given and vital signs obtained 96/62 98% r/a 107, 20. Vomiting stopped and nursing home staff stated pt has been vomiting since last night. Pt was observed for 15 mins and discharged to nursing home staff.
This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L048237, expiration date 08-MAY-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 31 degrees Fahrenheit for 6 minutes. This is one of two reports received from the same reporter. Additional information is not expected as there was no consent for follow up.
Patient received Hep A vaccine (HAVRIX) on 24 March 10 Patient broke out in hive 25 March 10. Patient was seeing in Pediatric Clinic 25 March and again on 26 March. Patient was prescribed Zyrtec and Orapred med.
1 dose was administered from a vial that was 30 days past the use by date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose was administered from a vial that was 30 days past the use by date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose was administered from a vial that was 30 days past the use by date). In September 2021, EXPIRED PRODUCT ADMINISTERED (1 dose was administered from a vial that was 30 days past the use by date) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications was reported. Treatment information was not provided.  1st dose information was not provided,Number of doses/vials used 1 dose from  1 vial,Date the vial was initially stored in the refrigerator on 9-sep-2021.Vail was not undergone any temperature excursions.
Patient states he developed muscle weakness in the region where the buttocks and thighs meet. It still has not resolved and patient states he saw his pcp. He was prescribed anti-inflammatory/pain relief medications.
Pt came in upper arm swelling, warm to touch with some induration. Pt c/o some itching, denies pain. Advised to use cold compress and take BENADRYL. Pt given Rx for AUGMENTIN 400mg - 51mg 15mL oral susp. to avoid infection.
bad flu; I couldn't stand anymore; no appetite; getting hot and cold; dizzy; really tired; sore shoulder; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (bad flu), ASTHENIA (I couldn't stand anymore), DECREASED APPETITE (no appetite), FEELING OF BODY TEMPERATURE CHANGE (getting hot and cold) and DIZZINESS (dizzy) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included FERROUS FUMARATE, VITAMINS NOS (FLINTSTONE VITAMINS WITH IRON) and CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced INFLUENZA (bad flu), ASTHENIA (I couldn't stand anymore), DECREASED APPETITE (no appetite), FEELING OF BODY TEMPERATURE CHANGE (getting hot and cold), DIZZINESS (dizzy), FATIGUE (really tired), ARTHRALGIA (sore shoulder) and HEADACHE (headache). On 28-Feb-2021, INFLUENZA (bad flu), ASTHENIA (I couldn't stand anymore), DECREASED APPETITE (no appetite), FEELING OF BODY TEMPERATURE CHANGE (getting hot and cold), FATIGUE (really tired) and ARTHRALGIA (sore shoulder) had resolved. On 01-Mar-2021, DIZZINESS (dizzy) and HEADACHE (headache) had resolved.            No treatment medications  were provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Non significant follow up
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 17-APR-2013 the patient was vaccinated with the first dose of VAQTA (Lot # not reported) (Dose, route not reported). No other co suspects were reported. No concomitant therapy was reported. The registered nurse reported that the second dose of VAQTA was administered on 17-APR-2013. No adverse effect reported. Additional information has been requested.
Low resting heart rate 58bpm; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Sep2021 at 18:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included sleep apnea and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. On 14Sep2021 at 16:00, the patient had low resting heart rate 58bpm. It was reported that normal for the patient was middle 80s. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported event. The clinical outcome of the event low resting heart rate 58bpm was not recovered at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
injection site has been itchy since i got the shot. i noticed about four days ago that my lymph nodes in my left armpit were super tender. about six days after injection left neck lymph nodes became extremely swollen and tender. on day seven i noticed a rash all over my upper left arm from top of shoulder to about half way down my upper arm. extremely red and super itchy.
THE DOSE ADMINISTERD  WAS LESS THAN HALF THE 0.5ML BECAUSE MOST OF THE DOSE WAS LOST DURING ADMINISTRATION DUE TO FAULTY NEEDLE ATTACHING TO THE SYRINGE
Major dizziness, tightness of the chest, diarrhea, difficulty breathing, rapid heart beat, the symptoms began to show after the vaccination in 4 hours. At first, it was only pain in the arm where the injection occurred. Now, there is also swelling of the arm when the injection occurred.
pt recv vax SEP96 which was not properly refrigerated & recv vax again OCT96 & devel a cluster of about 20 vesicles on an erythematous base on the mid posterior lateral forearm;vesicles were painful & itchy;exp paresthesia;
headache; fatigue/tiredness; muscle pain; pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; FATIGUE (non-serious), outcome "unknown", described as "fatigue/tiredness"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at the injection site".  Additional information: Reporter states that 2-3 hours after he received the 1st and 2nd doses of the vaccine, he experienced the expected side effects of headache, tiredness, fatigue, and pain at the injection site. He just got the 3rd booster dose yesterday, and is just now noticing those same expected side effects the day after the vaccine. Have people been reporting that? States that he did not report his side effects after the 1st and 2nd dose because he knew that was going to occur; he knew he was going to get the side effects.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101326581 same suspect drug, similar events, different patient
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concomitant therapies, medical histories and drug reactions or allergies. On unknown dates from 01-FEB-2017 to 18-APR-2017, the patients were vaccinated with improperly stored doses of VAQTA lot#: M033611 expiry date: 02-MAR-2018 (dose and route of administration not provided) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 8 hours 10 minutes. Data logger was NOT used to capture temperature excursions. There were no previous excursions. No Product Quality Complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA008219: US-009507513-1705USA003082: US-009507513-1705USA003083.
Information has been received from a pharmacist and a registered nurse concerning a 50 year old female with sickle cell anaemia who was vaccinated with Pneumovax 23 (Lot # 654982/0675F). Subsequently the patient developed excessive swelling in the mid upper arm injection site, that was all the way down to the elbow that was 1 and 1/2 times the size of the normal circumference of the arm. The arm was warm to the touch, tender and there was pain with the swelling. There was no fever and no induration at the site of injection. The patient was instructed to take acetaminophen or nonsteroidal anti-inflammatory drug (unspecified) (NSAIDs) to manage the discomfort. The patient sought unspecified medical attention. At the time of the report, it was unknown if the patient recovered. Additional information has been requested.
INFANRIX instead of BOOSTRIX; 11 year old received infanrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa (Infanrix) (batch number 5RM39, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th February 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 7th February 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that the patient was administered the Infanrix vaccine instead of the Boostrix vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter confirmed that the lot number 5RM39 was for Infanrix instead of Boostrix. The reporter stated he/she was not present during the administration. The reporter consented to follow up.
experience drops in their energy levels/ feeling down/big drop" in energy / Low energy levels; Burning in legs; leg pain; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (experience drops in their energy levels/ feeling down/big drop" in energy / Low energy levels), BURNING SENSATION (Burning in legs), PAIN IN EXTREMITY (leg pain) and INJECTION SITE ERYTHEMA (Redness at injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031M204) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included ATENOLOL for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (experience drops in their energy levels/ feeling down/big drop" in energy / Low energy levels), BURNING SENSATION (Burning in legs), PAIN IN EXTREMITY (leg pain) and INJECTION SITE ERYTHEMA (Redness at injection site). The patient was treated with IBUPROFEN for Adverse reaction, at a dose of UNK dosage form. At the time of the report, ASTHENIA (experience drops in their energy levels/ feeling down/big drop" in energy / Low energy levels), BURNING SENSATION (Burning in legs), PAIN IN EXTREMITY (leg pain) and INJECTION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter reported that the symptoms started gradually after the second dose Reported that she had to quit walking because of symptoms  Patient and her husband  were not overweight, stay very  active, exercises atleast 4 days a week and eats healthy food. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), was not applicable.   This case was linked to MOD-2021-241681 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up information received and contains significant information- Date of birth added
Medical Assistant reporting a temperature excursion for GARDASIL 9; This spontaneous report was received from a Medical Assistant referring to an 11 year old patient. Information regrading the patient's pertinent medical history concurrent conditions, known allergies and concomitant therapies was not provided.      It was reported that, on 06-AUG-2021, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) with lot # T026323 and expiration date on 22-FEB-2023, was exposed to a temperature excursion of 47F for a time frame of 47 minutes and that, on 10-AUG-2021, the patient was vaccinated with it on a dose of 0.5 milliliter by intramuscular route for prophylaxis.  Also, it was reported that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not involved in previous temperature excursion. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck; devicelotnumber: T026323; expirationdate: 22-FEB-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
24-year-old male patient with no past medical history received Johnson & Johnson Covid vaccine on April 7 presented to ED with abdominal pain and was found to have portal vein, splenic vein, superior mesenteric vein thrombosis.  Patient was also found to be thrombocytopenic he was admitted to the stepdown unit placed on bivalirudin.   Patient remains hospitalized at the time of this report.
Fluzone administered 11:40 AM 02/23/2005.  From 2:00 to 6:30PM same day, complained of subjective throat tightness, dyspnea and itching.  Objective findings minimal.  No apparent distress, no stridor, lungs clear to ascultation with wheeze.  Developed 2-3 macular, itchy erythematous patches.  Treated with Benadryl  and observed for 2 hours.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (Received 1st Moderna vaccine, has been sick since), OROPHARYNGEAL PAIN (sore throat), DIARRHOEA (diarrhea), CHILLS (chills) and NAUSEA (nausea) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high, Shellfish allergy, Penicillin allergy, Drug allergy (Allergy to Keppra), Sulfonamide allergy (Allergy to sulfa) and Latex allergy. On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced ILLNESS (Received 1st Moderna vaccine, has been sick since), OROPHARYNGEAL PAIN (sore throat), DIARRHOEA (diarrhea), CHILLS (chills), NAUSEA (nausea), MYALGIA (body aches) and PYREXIA (fever). At the time of the report, ILLNESS (Received 1st Moderna vaccine, has been sick since), OROPHARYNGEAL PAIN (sore throat), DIARRHOEA (diarrhea), CHILLS (chills), NAUSEA (nausea) and MYALGIA (body aches) outcome was unknown and PYREXIA (fever) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test negative: Took 2 Covid tests which were negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use and treatment information was not provided. The reporter (patient's wife) gave consent for follow up.
4x4 area, red & inflammed around inject site, hot to touch; 24 hrs p/immun, still progressing;
This spontaneous report was received from a registered nurse and refers to a 14 year old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with the first dose of RECOMBIVAX HB 10mcg/ml, 1 ml (route, lot number and expiration date were not provided). On an unknown date, reported as separated by three months from the first dose, the patient was vaccinated with the second dose of RECOMBIVAX HB 10 mcg/ml, 1 ml (route, lot number and expiration date were not provided). Concomitant therapy information was not provided. On an unknown date, there was an inappropriate schedule of drug administration as the patient received a RECOMBIVAX HB series of 2 doses separated by 3 months. No adverse event was reported. It was unknown if the patient sought medical attention. At the time of the report, the patient status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Now I have the flu; Initial information was received on 11-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender patient who experienced now flu while receiving vaccine influenza vaccine.  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 vaccine produced by unknown manufacturer (lot number: not reported) via unknown route in unknown administration site (form, strength, expiry date: unknown) for flu vaccination.  On an unknown date the patient developed a non-serious event of flu (influenza) (latency: unknown) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Approximately 90 minutes after immunization of TdaP, she started to feel more pain in the shoulder. It continued to hurt more that the typical immunization and about 4-5 days later had severe increase in left shoulder pain with pain with movement. She tried occasional otc NSAID and heat with no significant improvement and came back into the office on April 13 with significant pain and severely limited range of motion.  She was asked to take NSAIDs regularly and start gentle range of motion exercises. She was referred to physical therapist. A follow up appointment was scheduled with orthopedics.
Pt mom states entire right thigh swelling after immunizations and fever 3 nights ago. Swelling much improved. M.D. noted 2 x 2 cm red, induration right thigh and small amount of swelling noted.
Approximately 17 hours in - nausea, body aches, chills. Continued throughout day and night, as well as an increasing fever that maxed at 100.7. Vomiting began approximately 38 hours after injection and lasted for approximately 2 hours. Fever and chills subsided by the time vomiting began. Nausea and bodyaches subsided approximately 42 hours after injection. Treatment included OTC alternating Tylenol and Advil. Ginger tea, ginger ale, and soup for nausea and vomiting.