chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Substantial elevation in anxiety; Panic attacks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Apr2021 15:00 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: KLONOPIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: UNKNOWN), administration date: 2021, when the patient was 43 years old, for COVID-19 immunisation. The following information was reported: ANXIETY (non-serious) with onset 25Apr2021 15:00, outcome "not recovered", described as "Substantial elevation in anxiety"; PANIC ATTACK (non-serious) with onset 25Apr2021 15:00, outcome "not recovered", described as "Panic attacks". The events "substantial elevation in anxiety" and "panic attacks" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of anxiety, panic attack.  Additional Information:The patients medical history was not reported. He had no known allergies. Concomitant medications included clonazepam (KLONOPIN), taken from an unknown date for an unspecified indication. Prior to the vaccination, he was not diagnosed with COVID-19. Since the vaccination, he had been tested for COVID-19. He did not receive any other vaccines within four weeks prior to the vaccination. On 25Apr2021 at 15:00, he experienced substantial elevation in anxiety and panic attacks and had continued post one month after the second dose. The events resulted in doctor or other healthcare professional office/clinic visit. On 17May2021, the patient underwent Binax COVID-19 test (nasal swab) and was tested negative. The clinical outcome of the events substantial elevation in anxiety and panic attacks were not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Swollen lymph node in axillary area of the left side of the body. Significantly visible. Tender to the touch. Sore. Started ~12 hours after vaccine. Still swollen and tender 24-48 hours after. No other major symptoms to report.
Received vaccine 330 PM on 5/22 and 6-7 PM while driving home got chest tightness - lasted approximately 1 hour.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 20-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 40 and 72 hours, the lowest recorded temperature was 28F (-2.222 Celsius) and the highest was 47F (8.333 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 25-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EM9809), on 10Mar2021 as dose 2, single (Lot number: EN6204), in left arm, on 25Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 18May2022 as dose 4 (booster), single (Lot number: FF2593) at the age of 73 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 10Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 10Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jun2022) Positive, notes: 10Jun2022 positive test; (16Jun2022) Negative, notes: 16Jun2022 negative test; (22Jun2022) Positive, notes: positive test; (22Jun2022) Negative, notes: negative test; (22Jun2022) Positive, notes: tested positive with more severe symptoms; (23Jun2022) Positive, notes: 23Jun2022 tested positive with more severe symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19.Clinical course: No other medication in 2weeks. Product Paxlovid Treatment started on 15Jun2022 to Treatment stopped on 20Jun2022 for COVID 19 Treatment. 10Jun2022 positive test and treated with Paxlovid. 23Jun2022 tested positive with more severe symptoms. Congestion, coughing, headache, rash on right cheek, rash under left arm, rash/hives between fingers. Adverse events start date: 22Jun2022.
Patient's friend reported to pharmacy symptoms of a seizure (fainted, shaking, spasms). Patient did not go to an emergency room and was not seen by a provider following the episode.
PNEUMOVAX administered SQ R arm on 3/11/09. Developed edema, erythema, warmth from upper 1/3 arm to elbow.  Accompanied by pain & stiffness of elbow.
7AUG98 100's of bumps upper legs-shin colored;10AUG98 still some brownish spots-some bled a little;11AUG98 spots fading (bumps not checked by medical provider);
A report has been received from a Health Professional concerning a 10 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on 27-Jan-2014. It was reported that patient was inadvertently administered expired FLUMIST QUADRIVALENT which started on 27-Jan-2014. The outcome of the event of inadvertently administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
The swelling and a rash at the injection site that appeared the next morning (01/11). The patient reported to the pharmacy the day following (01/12) the appearance of the rash and by that point the rash had decreased in size. The rash was red and about the size of one's palm and there was some firmness to the touch. There also was a small bruise right at the site of the injection. The patient stated that they had used topical benadryl as well as a benadryl tablet at night and this seemed to help with rash. I advised the patient to continue with these meds and that I would follow up the next day. Following up with the patient the next day (01/13) she reported that the rash had decreased in size even further with continued benadryl usage. The patient stated that they felt they were on the right track and I advised them to call back if they noticed the rash worsening.
On Tuesday, 1/4/22, Patient came to ECC Covid-19 Vaccination Site for his Pfizer Covid-19 second dose. Per CDC guidelines, adult Pfizer is eligible for ages 12 and up. Client is 12 years old and eligible for a Pfizer dose indicated for 12 years and older. During assessment of client's vaccination card, RN noticed client was vaccinated with Pfizer pediatric first dose on 12/2/2021 instead of Pfizer dose indicated for 12 years and older. Lead RN was made aware of situation who explained to parents client will be receiving Pfizer indicated for 12 years and older for his second dose. Parent verbally understood. Client denied any allergies or medications and was to be a 15 minute observation. At 3:43 PM, Client was vaccinated with Pfizer indicated for 12 years and older (LOT #: FL3197) in his left deltoid. Client and client's parent was educated by a second RN on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client's parents were also encouraged to sign-up on v-safe. Client experienced no adverse reaction while waiting in Observation Area and left vaccination site with a steady gait at 4:00 PM.
Bi-lateral breast pain. I have not had much breast pain with my fibrocystic disease as I have gotten older but for 6 weeks after the second dose it felt as bad as it ever has. It kept me up at night and I had to take OTC pain relievers.
pt said the arm is itchy red and swollen. around the size of an egg. happened around 24 hours after she recieved the immunization
Patient got flu 16 years ago; Initial information was received on 16-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involved an unknown age patient who got flu 16 years ago (Influenza), after 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 (reportedly 16 years ago), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site.   On an unknown date, it was reported that patient got flu 16 years ago (Influenza), unknown latency following the administration of INFLUENZA VACCINE.  Laboratory test included COVID-19 test.  No relevant laboratory test was reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Numbness to hands, feet, mouth.  Severe weakness in legs, elevated blood pressure, trouble walking. EMG test was done to confirm GBS.  Plasmapheresis treatments done with PCAD in place.
Itching, hives, pains in chest, shortness of breath, digestive issues and elevated blood sugars.  Prescribed hydroxyzine 25 mg  Took over the counter allergy medication  Missed three days of work
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 17-SEP-2012, the patient was inoculated with the ZOSTAVAX vaccine (lot number, dosage and route of administration not provided), at a medical center/hospital (by an unspecified healthcare professional) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2015, the patient was treated (by an unspecified health care professional) at a healthcare facility for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, 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 reporter considered the events to be related to ZOSTAVAX.  The outcome of the events is unknown. Additional information has been requested.
Headache, body aches and pain, lower back pain, high blood pressure, injection site soreness
Pt became diaphoretic, dizzy , lightheaded and weak - vasovagal
With everything going on in the pharmacy, I neglected to draw up medication into the syringe. I had to stick patient twice so she could get the dose.
Erythema of the left thigh measures 4 x 4 inches slight induration associated warmness, tenderness and inflammation of affected side.
Other complications following immunization, not elsewhere classified, initial encounter on 2023-03-31.
This spontaneous report as received from medical assistant refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N004799, expiry 15-NOV-2019 (dose and route not reported) for prophylaxis. It was reported that on unspecified dates, the vaccine was exposed to a temperature between 2 Centigrade degrees and 8 Centigrade degrees (1.8C) for 42 minutes. There was previous temperature excursion between 0 Centigrade degrees and 1 Centigrade degree for 1 hour and 56 minutes and another excursion between 9 and 25 Centigrade degrees (11.4C) for 1 hour and 41 minutes. The call was placed because of a Digital Data logger report. No adverse effects reported. As of 01-SEP-2017, all telephone attempts to obtain follow up information had been unsuccessful. Follow up information has been received from the medical assistant on 05-SEP-2017. The patient's age was confirmed as 12 years. It was also confirmed that on 14-JUL-2017 the patient was vaccinated with the improperly stored GARDASIL 9 lot # M044717 (previously reported as lot # N004799). This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA005738: US-009507513-1709USA005739: US-009507513-1709USA005748: US-009507513-1709USA005741: US-009507513-1709USA005742: US-009507513-1709USA005743: US-009507513-1709USA005744: US-009507513-1709USA005745: US-009507513-1709USA005746: US-009507513-1709USA005747: US-009507513-1709USA005737: US-009507513-1709USA005736: US-009507513-1708USA001768: US-009507513-1709USA005740:
This case was reported in a literature article and described the occurrence of pneumonia in a subject of unspecified age and gender born between 1974 and 2008 who was vaccinated with Influenza vaccine (manufacturer unspecified), varicella virus vaccine (non-gsk) and MMR vaccine (non-gsk). Concurrent medical conditions included DiGeorge's syndrome and had a chromosome 22q11.2 microdeletion detected by fluorescence in situ hybridization assay. No further information on the subject's medical, family history or concurrent medication is available. On an unspecified date, the subject received an unspecified dose of Influenza vaccine (administration site and route unknown, batch number not provided), an unspecified dose of Varicella virus vaccine (Non-GSK) (unknown) and an unspecified dose of MMR vaccine (Non-GSK) (unknown). 54 days after vaccination with Influenza vaccine and Varicella virus vaccine (Non-GSK), the subject experienced pneumonia. The authors mentioned that the same subject developed a rash 9 days after being vaccinated against MMR but they did not specify if this occurred on or after this event. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the events was unspecified. According to the Modified WHO Causality Criteria, pneumonia was unlikely related to vaccination with varicella vaccine, the rash was probably related to vaccination with MMR vaccine. The author's conclusion stated that their data expanded the findings of smaller studies indicating that live vaccination of patients with DGS with mild-to-moderate immunosuppression was well-tolerated. Prospective studies are needed to confirm their findings and offer guidance for live vaccination. Because this study included few patients with DGS with severe immunosuppression, further retrospective investigation of this population is warranted. This case is one of the 18 cases reported in the same literature article.
patient was administered with an expired Fluzone; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer via nurse.  This case involves a 35 year old male patient who received an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number: unknown, expiry date: 30-Jun-2019), via unknown route.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to expired product administered. It was reported that the patient administered with an expired Fluzone. At the time of the report, it is unknown if Fluzone was continued or not. Reporter could not verify the type of Fluzone given, if it's the Fluzone High-Dose or Fluzone Quadrivalent.  At the time of reporting, no adverse event was reported.  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.  Information on the batch number was requested.
Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year-old trainees and among others were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 20-24-year-old male patient who had received MENOMUNE A/C/Y/W-135 (lot number, route, site and date of administration not reported) and 15 months after vaccination developed meningococcal meningitis and sepsis, year reported as 2008 (Q 4). Neisseria meningitidis serogroup was determined to be serogroup Y. Treatments were not reported. No further information was available at the time of report. The patient's outcome was fatal. The reporter for this case is the same as for cases 2012-08240, -08241, -08242, -08243, -08244, -08245, -08246, -08247, -08249, -08250, -08251, -08252, -08253, -08254, -08255, and -08256. Documents held by sender: None.
Herpes Zoster; Information has been received from a lawyer regarding a case in litigation concerning a currently 64-year-old female patient (pt). No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication. On or about 26-AUG-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) injection (lot number, dose, vaccination site and route of administration were not provided) by a pharmacist for long-term prevention of shingles and zoster-related conditions. On an unknown date, the pt was treated at a physician's office for the following injuries resulting from the zoster vaccine live (ZOSTAVAX) use: herpes zoster. The outcome of the event was unknown.    Additional information has been requested
I have had both doses of Moderna.  I now have Bell?s Palsy on the right side of my face within two weeks of the second dose.  Had to go to ER, as I thought I might be having a stroke.  On steroids and antivirals.  Face paralysis, neck and head pain.
she just felt dizzy so fast and passed out; passed out; She hurt her ankle from it; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 05Apr2021 08:45 (Batch/Lot Number: EP7534) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing hypertension, atrial fibrillation from Aug2020 and ongoing , cystitis. Concomitant medications included sulfamethoxazole, trimethoprim taken for cystitis from 27Mar2021 to 02Apr2021; apixaban (ELIQUIS) taken for atrial fibrillation from an unspecified start date and ongoing; atenolol (ATENOLOL) taken for Blood pressure from an unspecified start date and ongoing. The patient received first dose of bnt162b2 for COVID-19 immunization on 15Mar2021 lot number: EN6202, Expiry date: 30Jun2021. The patient received the second dose of the Covid vaccine around 8:45 a.m. and states that she "felt fabulous." On 06Apr2021 she felt fabulous. She said that she had a doctors appointment at 1200 06Apr2021 and her blood pressure was good. She said that she was also taking an antibiotic prior to that week. She asked the doctors about taking vaccines after taking the antibiotic since the medication said that you should avoid vaccines while taking the antibiotic, and they all said that it was fine. She came home about 1330 06Apr2021 and she passed out while making her lunch. She hurt her ankle from it and she is not a happy camper.  She said that all her vitals were good and her blood was good. That was all taken 2 hours before she passed out. The weird thing was she never felt better that day after she passed out. She said that she had no reaction after the first shot. Prior to this she felt good and there was no warning, she just felt dizzy so fast and passed out. Caller said that her ankle is getting better and she hurt her toe too, but it is getting better. She treated the ankle with ice. She said that it could have been worse. She said that she did not understand this and had no side effects previously. The event passed out was assessed as serious (medically significant). The patient underwent lab tests and procedures which included blood test: good on an unspecified date her blood was good. Therapeutic measures were taken as a result of she hurt her ankle from it (arthralgia). The outcome of the event passed out was recovered with sequel on 06Apr2021, unknown for the other events.
I suffer from an unknown abdominal pain but since the vaccine my symptoms have worsening. Within 12-14 hours after the vaccine I had severe body aches, headaches that was all over without any concentrated pain locations and backaches. I also experience nausea which causes me to not have an appetite and I only can drink cold drinks. I am experiencing an increased heart rate of over 100 BPM which is not normal for me. I am experiencing kidney and lower back pain. Because I experienced this adverse event before I am taking Tylenol for pain and Zofran for my nausea. I am still experiencing these symptoms and have not been able to go to work.