chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 02/22/2000 the patient experienced a very high fever. Follow-up was received from a physician. She was seen in the physician's office 02/22/2000. The patient experienced 2 red papules "that did not appear to be chicken pox", a runny nose and a fever of 103F. She was diagnosed with cold symptoms. On 02/24/2000 the patient was diagnosed with chicken pox, which the physician felt had been modified by the administration of the vaccine. At this point, the patient's mother also had chickenpox. This was considered a case of secondary transmission. Because both the mother and the child developed chickenpox at the same time, the physician felt they must have both been exposed to the same source of wild type virus and that the child's chickenpox had been modified because of the vaccine. The mother was pregnant at the time. In July of 2000, the patient was seen in the physician's office for an 18 month visit. The mother and her baby were noted to have adverse events. No further information is available.
Blurred vision; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: E19266, expiration date not reported), via an unspecified route of administration, administered in the left arm on 16Feb2021 16:15 (at the age of 62-years-old), as first dose, single dose for COVID-19 immunisation. Medical history included shrimp allergy. The patient received an unspecified concomitant medication within two weeks of vaccination. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced blurred vision (reported as for 2 days) on 17Feb2021 13:00. No treatment was received as a result of the event. The outcome of event was recovered on 19Feb2021.  No follow-up attempts are possible. No further information is expected.
Comes to clinic requesting to be updated on vaccine for school entrance, needs vaccine and hearing vision and dental.  Given vaccines and states "I don't feel well".  Sitting upright in chair and head slumps forward, nurse immediately calls for assistance, head is brought to upright position and patient immediately arroused, looked around and responds "What Happened".  Grandparent in present. Child is diophoretic and pale in color.  Talking and oriented x 3.  Given fluids to drink, when questioned states he has not eaten all day.  Sat in exam room and observed x 20 minutes, states he feels better and can walk. Ambulated to waiting area and observed x 10 minutes.  Left amublatory with grandparent, gait is normal and
Small bowel obstruction - She had an NG placed and had resolution of her symptoms.  By the second day after admission she was starting to pass flatus and had stool the day prior to discharge.  She had her NG tube removed the afternoon prior to discharge and was able to tolerate oral intake and felt ready to return home. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Generalized urticarial eruption trunk/upper extremities w/o angioedema, wheezing or shortness of breath.  Pt treated w/ 50 mg IM Benadryl and observation.  Released to duty in good condition 2 hrs later.
This spontaneous report as received from a other health professional refers to multiple patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M009378, M017983, and M043731, for prophylaxis.; Sender's Comments:  US-009507513-1708USA012995: US-009507513-1708USA012863:
Stomach virus after the 1st dose; False positive COVID-19 test; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-May-2021 and was forwarded to Moderna on 01-Jun-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of GASTROENTERITIS VIRAL (Stomach virus after the 1st dose) and SUSPECTED COVID-19 (False positive COVID-19 test) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GASTROENTERITIS VIRAL (Stomach virus after the 1st dose) and SUSPECTED COVID-19 (False positive COVID-19 test). At the time of the report, GASTROENTERITIS VIRAL (Stomach virus after the 1st dose) and SUSPECTED COVID-19 (False positive COVID-19 test) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.  patient wanted to know if a false positive show up because of getting the vaccine last week.
Nausea, headache, fatigue, muscle aches, fever (100.3)    fever day one and 3. Headache muscle ache nausea and fatigue everyday so far.
48-72 hours after vaccination pt developed paresthesias of right arm and leg. Additional sensation of 'burning' throughout body. These symptoms have not resolved. She has tried gabapentin for symptomatic relief.
3 days after vaccine woke up complaining of foot pain in L foot, not wanting to bear weight.  Became more red and swollen around foot later in day, as well as faint macular rash on BLE; similar even in 2018 season, where foot pain and refusal to bear weight on same leg in which he received the flu vaccine
Prefilled syringe came broken; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Lot number: EJ4560, Expiration Date: 31Jul2023) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "Prefilled syringe came broken".  Additional information: Description of complaint Caller states that she is calling in regards to Prevnar 13. They had a previous order, in which one of the prefilled syringed came broken. The Top part of the syringe was broken, the part where they would attach the needle. Caller clarifies that needles do not come with the product. NDC 00005197102. Sample of the product is available to be returned. Packaging sealed and intact. Conclusion as of 03Feb2022: This complaint reported a broken syringe tip for a Prevnar/Prevenar 13V syringe. The product Fill Lot is DX7780. The investigation included a review of, batch and process records, a lot history a reserve sample re-view for the lot(s) in scope The complaint sample/photo was not returned for this complaint, the complaint is not confirmed. An evaluation of the complaint history confirmed a total of three com-plaints for the Filled Lot for complaint Class 'Container' of  which one complaint (the current com-plaint) was reported for complaints subclass  ''Container Broken/Cracked/Leaking Prior To Use'' A lot specific trend was not identified; therefore, the scope of this investigation  is limited to the (Withheld) Fill lot and no evidence was found to indicate that manufacturing activities at (Withheld) contributed to the reported complaint.  A quality review of complaints reporting 'Broken tip' concluded that the root cause for this defect is due to an inherent weakness in the glass resulting from the syringe manufacturing process. The patient risk associated with this defect is marginal to low.  Conclusion as of 17Feb2022: The complaint for 'Top part of the syringe was broken' of Prevnar 13V Injectable was investigated. The investigation included reviewing the involved batch records, deviation investigation, evaluation of retain samples, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ4560. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety. Agency concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that a regulatory notification was required. The reported defect could not be confirmed on the evaluation of retain sample. No root cause or CAPA were identified as the complaint was not confirmed.  No follow-up attempts are possible. No further information is expected.
Difficulty breathing; Chest pain; Upper back pain; This is a spontaneous report from a contactable consumer (patient).   A 24-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0191, expiration date: un-known) via an unspecified route of administration in Arm Right on 21Jun2021 at 04:30 PM (at the age of 24-year-old) as single dose for covid-19 immunization. Medical history included Congenital anamoly (ARSA), and No known allergies reported. Concomitant medications (taken within 2 weeks of vaccination) included Sertraline and Hydroxyzine. It was reported that patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested for COVID-19 since the vaccination. On 25Jun2021 at 10: PM, the patient experienced difficulty breathing, chest pain, and upper back pain. No therapeutics measures were taken for events. The events resulted to visit Emergency room/department or urgent care. Device Date: 27Jun2021. The outcome of the events was reported as not recovered.  Follow-up attempts were completed. No further information was expected.
Breakthrough case admission after 3 vaccines Moderna 3/7/21 lot 015M20A; Moderna 4/5/21 lot 025B21A; Moderna 9/11/21 lot 045C21A.
Initial information received on 31-Aug-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case is linked to case 2018SA251618. This case involves a three-years old patient who received 0.5 ml of FLUZONE QUADRIVALENT batch number: UI997AA on 31-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This is actual medication error case due to product storage error (received FLUZONE QUAD 0.5 mL and 0.25 mL syringes after the 48 hours shipping). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. Documents held by sender: none.
Client received first dost of Moderna vaccine on 2/10/21. On 2/16/21 client experienced itchy hives on her bilateral arms and bilateral upper thighs. Client was seen in urgent care on 2/20/21 and was prescribed oral prednisone and topical ointment. Client reports her hives lasted for two weeks.
More than 35 days between Moderna Covid-19 vaccinations/ did not get my second Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days between Moderna Covid-19 vaccinations/ did not get my second Moderna Covid-19 vaccine) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B31) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 35 days between Moderna Covid-19 vaccinations/ did not get my second Moderna Covid-19 vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days between Moderna Covid-19 vaccinations/ did not get my second Moderna Covid-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by reporter. Treatment information was not provided.   Reporter did not allow further contact
Information has been received from a physician and a woman in a physician's office concerning a 71 year old white female with hypertension, a seizure disorder and allergies to carbamazepine, phenytoin, and cefazolin sodium who on 10/25/02 (previously reported as 10/24/02) was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot # 642750/0210M). Concomitant therapy included phenobarbital, metoprolol tartrate and possibly influenza virus vaccine. On 10/25/02, the patient presented to a physician with right arm swelling (previously reported as swollen arm), chills, fever, joint pain, redness in her hand and heat from her shoulder down to her hand. Subsequently, the patient recovered from the right arm swelling, joint pain, redness in her hand and heat from her shoulder down to her hand. It was noted that the patient was vaccinated somewhere else and then presented to the reporting physician's office. The patient sought unspecified medical attention. Additional information is not expected.
Raised rash at the vaccination location, about 4" in length and 6" wide, dark pink and warm to the touch; slight fever with 99.3 degrees at one time; felt very tired for 24 hours and some nausea
Approx 4-5 hrs p/receiving DTP/HIB/OPV pt began w/fever up to 102, one episode of vomiting & unconsolable; irritability x 12 hrs; had questionable sz activity <5 min duration in evening; adm to hosp w/dx of strep D menigitis;
Severe body aches.  Sharp headache.  Profuse sweating for 24-48 hours after shot.  I had previously had Covid and recovered.  There was no need for the shot but my employer made me get it.  Sick as a dog for 2 days for no good reason.
Narrative:  Historical event reported by BP, patient developed anaphylaxis after influenza vaccine administration. Epinephrine was needed and used to relieve symptoms. Reported 02/09/2022, last influenza vaccine on file was 10/2007.
missed menstrual cycle after 2nd dose. has been 38 days since last cycle. not pregnant; This is a spontaneous report from a contactable other healthcare professional (hcp; patient herself). A 26-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, administered in left arm on 05Feb2021 as second dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of the event and vaccination. Patient received the first dose of bnt162b2 for covid-19 immunization on 15Jan2021 at 03:45 PM (at the age of 26 years old), intramuscular in the left arm. The patient previously took, azithromycin and had known allergies.  The patient had no Covid prior vaccination The patient had no other vaccine in four weeks. In Feb2021, patient had missed menstrual cycle after 2nd dose and has been 38 days since last cycle. Patient was not pregnant. Patient was not tested for Covid post vaccination. Patient did not receive any treatments for the event reported. The outcome of the event was not recovered.   Follow-up attempts completed. No further information expected.
On day 10 I noticed a large pink blotch on my arm surrounding the vaccination site.  I did not notice any blotch in the first 3 days after the injection and then had stopped checking.  It looks similar to the reaction I normally have when I get shots for my bee sting and environmental allergies.  It was  not itchy or painful, but was slightly swollen and seems to have faded some today.
Initial pain but that subsided in 2-3 days; What concerns me now is 10 days later I have redness around the shot that randomly showed up and it's still feels a little swollen and hard.  Wasn't red up until day 10.
I had hives on my chest and hands, then tongue became itchy and bad wheezy breathing. Same symptoms as when I have azithromyacin or shell fish. Took 2 Benadryl and symptoms lessened
Pt arrived at vaccine site  for second Pfizer COVID vaccine. Pt reported experiencing itching after the first vaccination.  However, she denied SOB, chest pain, dizziness, and N/V.   She reported non-anaphylactic response to egg and strawberry and indicated "that was a long time ago and it doesn't happen any more". I cleared pt for second injection (0.3 mL Pfizer Lot# EP7533) which was administered at 10:28 AM.  At 10:36AM I was alerted that she needed assistance.  She was in her car, drivers seat, with daughter in the passenger seat.  PPR she was experiencing constriction in the throat with difficulty breathing, chest pain and dizziness.  Pt was diaphoretic, labored breathing, BP: 110/80, HR: 72 bmp. pulse ox on site was broken.  I reclined the seat and elevated legs on the dashboard.  I administered 50mg Benadryl IM of left deltoid m. at 10:39 AM.  Patient was breathing and able to answer questions.  She had no apparent angioedema so I delayed administration of Epi pen to continue observation.  At 10:45 AM pt reported resolution of sensation of constriction of the throat however was still experiencing chest tightness and dizziness.  Bp: 130/82 HR: 76.  Pt continued to have intermittent chest tightness and dizziness.  She had a syncopal event lasting approximately 3 seconds at 10:54.  She was disoriented and unable to focus.  She continued to report having intermittent difficulty focusing, dizziness and chest discomfort.  "feeling fuzzy" I gave water and Chewy granola po at 11:02.   I called EMS as I felt she needed to be monitored for some time and we are not set up for this at the vaccine site. Due to her inattention I was not certain that this was psychosomatic.  Arrived shortly thereafter.  Evaluated patient and gave her the option of going home with daughter monitoring her or going to hospital. I confirmed daughter felt comfortable with this and new what s/s to be aware of.  Pt's daughter drove her home.
I basically started itching on my right shoulder and then my left elbow no rash just sever itching left wrist and top of my hand nap of my neck and down my spine to the center of my back along my waist. On the back of my head between my ears. 06JAN2023 I was prescribed a cream KENALOG twice daily for two weeks. A referral to another dermatologist on 10FEB2023 I was prescribed an ointment clobetasol propionate. 15MAR2023 my PCP had a follow up blood test with negative results.
1 1/2" across and 2" long - raised, red, warm whelp itchy at site of VARIVAX.
Red raised round  skin just under size of baseball.  persisted 2 to 3 days then resolved. patient had cold/flulike symptoms before resolution.
2- 2 1/2 hours after immunization face felt hot and was noted to be red.  Temperature 100.8 per ear thermometer.  Next day 20 hours after vaccine facial erythema, very mild and involved the cheeks (patient appeared "hot").  Also minimal cheek swelling, no shortness of breath/breathing difficulty or other problems.  Does note myalgias, muscle soreness in chest wall with deep inspiration.
The aches have moved into hands; Chills; Headache; Bad body aches; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734), via an unspecified route of administration in the right arm on 31Mar2021 at 08:45 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. Medical history included crohns, IBD, fibromyalgia, sleep apnea, rheumatoid arthritis and juvenile idiopathic arthritis (jia). Concomitant medications included vedolizumab (ENTYVIO), duloxetine (MANUFACTURER UNKNOWN), pregabalin (MANUFACTURER UNKNOWN), trazodone (MANUFACTURER UNKNOWN) and nifedipine (MANUFACTURER UNKNOWN) received within 2 weeks of vaccination. The patient previously took humira and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 14:00, the patient experienced chills along with bad body aches. The chills went away but still having body aches and a headache every hour. On an unknown date in Apr2021, the aches have moved into hands. No therapeutic measures were taken as a result of the events. 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 chills was recovered. The clinical outcome of the event bad body aches, headache and the aches have moved into hands were recovering at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 30-Nov-2021, EXPIRED PRODUCT ADMINISTERED had resolved. Not Provided.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No Treatment information was provided.
Pt recv vax on 4/2/98; on 4/4/98 pt exp headaches, pain behind eyes, protruding eyes; dx=posterior scleritis; tx=Prednisone & Aleve
Shortly after receiving  her 1st dose of Moderna, pt states she strted to have vaginal bleeding. Pt states she finally got diagnosed with uterine cancer, stage 3, in August of 2021.  Pt states she only had a history of hypertension  and takes one medicine for that. Pt has no family hx of any cancers in her family.
Pt called me on 12-20-16 to inform me she has had decreased mobility of her arm since the evening after her flu shot administration on 12-4-16, I advised pt to seek urgent care.