chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had a swollen spot near injection site; Gave an injection of Flucelvax to an employee and part of the injection ran down patient's arm. Administered another vaccine; Gave an injection of Flucelvax to an employee and part of the injection ran down patient's arm. Administered another vaccine; This spontaneous case  was received on 05-Oct-2022 from other health care professional (nurse) via Agency (reference number: SEQW22-04073) with additional information received on 07-Oct-2022 from Seqirus' manufacturing quality assurance department (being processed together), and concerned a 51-year-old, male patient.  The patient's medical history and concomitant medications were not reported.  On 01-Oct-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration: intramuscular; anatomical location: not reported) for influenza prophylaxis. The batch number reported was 348368 and the expiry date was 30-Jun-2023. The nurse gave an injection of Flucelvax to an employee, and part of the injection ran down patient's arm (explicitly coded as 'accidental exposure while administering drug'). The nurse  administered another vaccine to the patient (explicitly coded as 'incorrect dose administered'). The nurse stated that she attached the needle to some pre-filled syringe (PFS) prior to administration and when she was administrating the vaccine she didn't check the needle again.   On 03-Oct-2022, two days after receiving Flucelvax Quadrivalent, the patient experienced a swollen spot near injection site.  On 05-Oct-2022, the patient recovered from the event of vaccination site swelling.   The reporter assessed the event of fluid leak as not related to the Luer Lok Syringe. As reported, nurse did not want to report a product complaint because she thinks that the problem is from the needles and not from Seqirus syringes. She stated that when she changed the needle brand to BD needles the problem didn't happen again.  The case was assessed as non-serious.  This case has been entered onto Seqirus's manufacturing quality assurance tracking database and allocated reference number 1111212.  Company comment: The event of vaccination site swelling is assessed as possibly related to Flucelvax Quadrivalent due to a plausible temporal relationship. The events of accidental exposure while administering drug and incorrect dose administered are assessed as not related to Flucelvax Quadrivalent as per company conventions.; Reporter's Comments: The reporter assessed the event of fluid leak as not related to the Luer Lok Syringe. As reported, nurse did not want to report a product complaint because she thinks that the problem is from the needles and not from Seqirus syringes. She stated that when she changed the needle brand to BD needles the problem didn't happen again.; Sender's Comments: The event of vaccination site swelling is assessed as possibly related to Flucelvax Quadrivalent due to a plausible temporal relationship. The events of accidental exposure while administering drug and incorrect dose administered are assessed as not related to Flucelvax Quadrivalent as per company conventions.
after their first booster they had minor side effect minor soreness, where got the vaccine; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (after their first booster they had minor side effect minor soreness, where got the vaccine) and FATIGUE (Tiredness) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 71f21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Previously administered products included for Product used for unknown indication: Pfizer (Dose 2) and Pfizer (Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Allergic reaction to bee sting.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (after their first booster they had minor side effect minor soreness, where got the vaccine) and FATIGUE (Tiredness). At the time of the report, VACCINATION SITE PAIN (after their first booster they had minor side effect minor soreness, where got the vaccine) and FATIGUE (Tiredness) outcome was unknown.            No concomitant medication was reported.  After the first booster the patient had minor side effect minor soreness and tiredness. By the third day the patient had soreness on the left side, where got the vaccine.  No treatment medication was reported.   This case was linked to MOD-2022-576257 (Patient Link).
rescheduling of appointments; tooth that is infected; This is a spontaneous report from contactable consumer the patient from Pfizer-sponsored program. A 71-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9261, Expiration Date: 31May2021) via an unspecified route of administration on 04Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced infected implant during receiving her first dose tooth that is infected, second dose was schedule on 01Mar2021, which is a little more than 3 weeks and also schedule for oral surgery on 02Mar2021. The patient enquired if she the shot on 01Mar2021 would that still be okay. (rescheduling of appointments). The event considered non serious. The outcome of the event was unknown.
Torticuli, stiff neck associated with headache and body ache lasting approximately 6 weeks.
Patient states she developed redness, swelling, warmth, and pain to the injection site. States it felt like "there was a bubble under the skin." Denies fever. States it lasted a total of 5 days post administration. Took PO Benadryl with good relief.
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 26-APR-2013, the patient was vaccinated with a dose of VAQTA, (lot # 0100AE, expiry date OCT-2014), with the same lot of improperly stored VAQTA. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
2 days following administration of this vaccine patient presents to walk in clinic due to shortness of breath, back pain, chest discomfort and increased heart rate. Since the administration of the 3rd dose of GARDASIL on 8/15/2016 this patient has been diagnosed with Amplified Pain Syndrome. This patient is unable to perform many of the physical activities she could perform prior to the administration of this vaccine due to the pain she experiences. Patient does now follow with specialty clinic due to pain.
This spontaneous report as received from a physician via a company employee refers to a patient of unknown age. The physician reported multiple unspecified patients received one or two doses of GARDASIL per recommended dosing interval and finished the 3 dose series, with receiving one or two doses of GARDASIL 9 to equal a total of 3 doses of the HVP vaccine with recommended dosing interval, which was outside of the prescribing information. No adverse effects were reported.
Initial unsolicited report was received from a consumer, who is also the patient, on 05 January 2015. A 65 year-old female with a history of hypothyroidism had received on 24 November 2014 FLUZONE HD (lot number and administration details not reported) and PNEUMOVAX (lot number and administration details not reported) and six days later on 30 November 2014 (also reported as 01 December 2014), experienced swelling of her lips and throat and her lips became all red and chapped. Patient was evaluated by a nurse practitioner who did not tell the patient that this was or could have  been caused by the vaccines. Treatment included BENADRYL, steroids and amoxicillin. No further information was available at the time of the report. Outcome was unknown. Documents held by sender: none.
TDaP was administered 5/15/17 in office. With 24 hrs. patient reports local (Left upper arm) swelling and warmth. Hive of the arms and wide spread itching has worsened by now 48 hrs. No shortness of breath, swelling of face or mouth or lips or throat.
The pt experienced idiopathic thrombocytopenia purpura which was diagnosed on 2/5/01.
Excruciating ovary pain 15 days after 2nd vaccine. Lasted several hrs. ER, waited 4 hrs but no ER beds available. Saw my doctor following day. CT scan results 2.4 cm dermoid mass on left ovary with possible torsion. Bloodwork done. Ultrasound scheduled 9-13/2021.
heart racing; abdomen pain; vomiting; neck pain; headache; dizziness; injection site pain; fever; A spontaneous report was received from a consumer concerning herself, a 51-year-old, female patient who received Moderna's Covid-19 Vaccine (mRNA-1273) and who experienced her heart racing, pain in abdomen area, vomiting, neck pain, severe headache, dizziness, pain at injection site and fever of 100.9.   The patient's medical history included being diagnosed with Covid-19 in Sep 2020. Concomitant product use was not provided by the reporter.   On 31 Dec 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number 025J20A) intramuscularly for prophylaxis of COVID-19 infection.   The patient reported (translated by husband) that she is not feeling well due to symptoms occurring after taking the Moderna Covid-19 vaccine. She received the vaccine the day before and started experiencing heart racing, pain in abdomen area, vomiting, neck pain, severe headache, dizziness, pain at injection site, and fever of 100.9.   Treatment for the event included tramadol for a severe headache.   Action taken with mRNA-1273 in response to the events was unknown.   The outcomes of the events,  heart racing, pain in abdomen area, vomiting, neck pain, severe headache, dizziness, pain at injection site and fever of 100.9, was unknown.; Reporter'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.
Employee present on 10/10/19 with 3 raised red areas on her left deltoid and 1 raised area to her left cheek. . denies shortness of breath, trouble breathing or other respiratory issues. employee stated she noted the reaction the previous day while in the shower. Declined medical attention at this time and was asked to call facility if medical attention was required.  On 10/11/19 the employee went to health Center for worsened reaction. she was seen by provider. she was diagnosed with Left arm flu shot reaction  (T80.69XD) and cellulitis of the left upper limb (L03.114). she was given Benadryl 25 mg every 6 hours until next evaluation and Claritin. the employee was also given PCN for which she stated she took 1 dose and had an allergic reaction. The employee stated she had red raised marks on her entire body and her right hand was swollen, after the PCN. She stopped taking  the PCN and returned to NP on 10/15/19 at this time she was told to remain out of work until her follow up on 10/17/19 and to continue the Benadryl 25 MG every 6 hours .
ARM SORENESS; VOMITING; This spontaneous report received from a consumer concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced arm soreness, and vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting and arm soreness was not reported. This report was non-serious. .This case, from the same reporter is linked to 20220126579 and 20220126642.
One week after the injection of SHINGRIX, at Pharmacy. I experienced severe vertigo and phoned 911 for emergency transport to Medical Center. A CT scan  of head was done and I eventually was given ANTIVERT PO 25 mg Tab. After 4-5 hours I was sent home with a prescription for same and instructions to see my primary physician. I saw Dr. the same day in the afternoon. I do not know but I wonder if the vertigo was caused by SHINRIX and if the 2nd dose should be administered.
hoarse; This is a spontaneous report received from contactable reporter(s) (Other Health Professional and Consumer) for a Pfizer sponsored program.  An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "chronic obstructive pulmonary disease" (unspecified if ongoing); "pulmonary fibrosis" (unspecified if ongoing); "rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2, dose 1 for covid-19 immunisation. The following information was reported: DYSPHONIA (non-serious), outcome "unknown", described as "hoarse". Additional information: Patient reported being hoarse, and noticing it end of Feb2021 or mid-Mar2021. No exact date provided. Patient reported having had her second dose of Pfizer vaccine in Feb2021 and not long after she started feeling hoarse. Patient reported some days are worse than other days. Patient was seen by ear, nose and throat md, and no cancer was seen. No exact date provided.   No follow-up attempts are possible. No further information is expected.
Information has been received from a licensed visiting nurse (LVN) concerning a 4-week-old patient who on approximately 21-Sep-2006 was vaccinated PO with the first dose of Rotateq vaccine live (human-bovine). It was unknown if medical attention was sought. No reaction had been reported. Additional information has been requested.
Information has been received from a medical assistant, concerning patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with VARIVAX (dose, strength, frequency, route of administration, anatomical location, lot# and expiration date were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature greater than 47°F but less than 77°F for 52 hours, at temperature greater than 15°F but less than 46°F for 3.5 hours and at temperature greater than 6°F but less than 14°F for 30 minutes without any previous temperature excursion. It was unknown if this information was registered in a digital data logger. No adverse effects were reported. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1707USA007535:
For Quadracel, it was the 4th DTaP and IPV, but first time having Quadracel. For Proquad, it was the second time getting Proquad. She received both at her well visit in the office. They left the office, were driving away and within 10-15 minutes of the vaccines, she was seen to seize up and rhythmically shake in her car seat in the back seat and have difficulty breathing. She was unable to be brought out of it when Mom went to her. The event was over within 30 seconds. She was tired, but coherent after they brought her back in to the office. She had a normal neurological exam. She was afebrile with normal BP and oxygen saturations. She was monitored for 2 hours, during which she mostly slept. When they left, she was back to her baseline energy level. She required no intervention and had no further seizure-like activity.
Information has been received from a physician concerning a 10-year-old hispanic male patient with an allergy to amoxicillin and no illness at the time of vaccination, who on 24-OCT-1997 (also reported as about one month prior to the report, on approximately 23-FEB-2006) was vaccinated with a dose of Varivax. There were no concomitant medications. The vaccination was not given in the reporting physician's office. On 01-MAR-2006 (also reported as in the week prior to the report, on approximately 16-MAR-2006) the patient developed a rash on his chest, abdomen and back along with mild itching. It was reported that the patient did not have a fever. He was seen in the physician's office on 03-MAR-2006 and was diagnosed with a mild case of chickenpox. The outcome was unknown. No product quality complaint was involved. No additional information is expected.
Within approximately 2-3 days of receiving the flu shot, I had small "waves of dizziness" that occurred daily for weeks.  On 10/14/22 I began having a high heart rate, dizziness, heart palpitations, and high blood pressure.  Over the months that followed I also had extreme insomnia, extreme anxiety, and sensorineural hearing loss which resulted in permanent partial hearing loss in my right ear (diagnosed 11/29/22, but ear fullness and pressure and hearing loss began approx. 10/19/22).
Within 3-5 days of receiving first vaccine, I developed lymphadenopathy in the axillary of the arm used for injection. I then also began to notice that my (previously diagnosed, treated, and under control) eczema began to manifest. It has persisted and is only marginally under control with previous prescription steroid ointment.
patient received expired dose of ACT-HIB  inadvertently, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Agency (Reference number- 00649513) and transmitted to Sanofi on 21-Jun-2021.  This case involves a 15 months old male patient who inadvertently administered with a 0.5 mL expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ318AB and expiry date: 18-Jun-2021) via intramuscular route in the right thigh (expired product administered) for prophylactic vaccination on 21-Jun-2021.  The patient's medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) via intramuscular route for immunization.  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, the patient experienced no adverse 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.
patient wanted moderna bivalent vaccine but got moderna booster vaccine instead ndc 807770275990.5ml lot 064a22a
This spontaneous report as received from a pharmacy technician refers to a patient of unknown age. Concomitant medication and pertinent medical history is not provided. On 22-APR-2014, an expired dose of ZOSTAVAX (dose and lot number were unknown) was vaccinated on the patient for the first time, subcutaneously. On 02-MAY-2014, a repeat dose of ZOSTAVAX (lot number not reported) was administered 10 days subcutaneously after the first dose. No adverse effect was reported. Additional information has been requested.
Sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 25Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 26Mar2021, outcome "recovering", described as "Sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Increased cough, productive since vaccine administration. No current medications. History of slight cough and history of tobacco use, cigarettes. Afebrile resident pt. Reports difficulty breathing, SOB since day after vaccine. Complains of chest congestion and pressure at this time.
Pt vaccinated with Meruvax II developed general malaise, sore throat, enlarged axillary lymph node, headache, aching in hands & wrist. Stiff painful fingers, & swollen painful hands & wrist.  Small "shotty nodes, synovial inflammation.
about an hr or so after inj.....severe hand/arm tremors  followed by complete incoherence,,, muscles like jelly, no use of anything. this total out  of it occurence lasted about 12 hrs followed by days of weakness, achy, sleepiness, off and on foggy.  general blah feeling
This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. Information on pertinent medical history and concurrent condition was not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (route, dose, strength, lot # and expiry date not reported) for prophylaxis. Concomitant therapies included sterile diluent. The pharmacist reported that the patient received 3 doses of PNEUMOVAX 23, each dose on a different unspecified date (extra dose administered). No adverse effects reported. This is one of the 2 reports received from the same reporter. Additional information has been requested.
Case number PHEH2013US018409, is an initial spontaneous report received from a healthcare professional on 28 AUG 2013, with a follow-up received on 13 NOV 2013. This case refers to a 13 years old female patient. She received only Men A lyophilized conjugate component of MENVEO (batch number: A12092), reconstituted with sterile diluent at a dose of 0.5 ml intramuscularly into left deltoid on 26 AUG 2013 (at 3:30 PM). No adverse reaction was reported following this administration error.  Follow-up was received on 13 NOV 2013. Patient demographics, vaccination site, vaccination time and changed batch number (A12092) was updated.
Patient developed headache and joint pain (elbow, knees, shoulders) as well as fever 1 day after vaccination. Tmax 100.5 patient also developed rash, papular, erythematous scattered to face, arms and chest area 5 days after vaccination. Non pruritic.
Pt was brought to hospital due to slurred speech and right-sided weakness.  Pt has had shortness of breath.  Pt was found to be COVID-19 positive.
This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route and lot were not reported). On an unknown date, the patients received improperly stored   RECOMBIVAX HB. No adverse symptoms reported. At the time of the report the action was not reported. All telephone attempts to obtain follow-up information have been unsuccessful.  Additional information was received from a registered nurse concerning a 1 day male patient. Patient's birth weight was 6 lb 13 oz with 1 siblings. Patient was vaccinated with RECOMBIVAX HB the same day that he was born (29-MAY-2014) at 19:05 PM. Lot number J012520; Exp. Date: 30-JAN-2016.  The vaccine storage temp dropped to 0-1 degrees on 18 different episodes between May 14th and July 21st (unspecified year) according to min/max. All recorded temps are within 2-8 degrees. Additional information is not expected since all follow ups requested to complete the case were received.
Per spouse, the patient began dragging his feet in the middle of April after having his Janssen shot 03/25/2021. The spouse believed the patient got his flu shot as well,  but I see no record of it in system or the Immunization Record. Per the spouse, the patient then had a stroke in June and passed away in July 2021.