chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was inadvertently administered incorrect COVID vaccine. Due to age patient should have received Pfizer COVID vaccine, Janssem vaccine was administered. Attempted to call patient several times 8/2/21 no answer or on voice mail. Called pt. today grandmother answered pt. was home, informed grandmother of incident and she stated patient was doing well and no S&S of adverse reactions.,
sought and received third dose Moderna August 2 because he read "cancer patients should get it" He had diffuse B cell lymphoma treated with R-CHOP with CR in 2016, no recurrence, but platelets 100-120, 000 and stable since 2017 follow up labs as noted showed platelets to 60,000 less than a week later and 11, 000 by September. Completely asymptomatic and no other new meds or diseases. Awaits bone marrow biopsy and PET imaging, but nothing else to suggest lymphoma recurrence (highly symptomatic presentation in 2016) no thromboembolic signs or symptoms now
had the two other shots. Again, later! I had shingles/Suspected Vaccination failure; had shingles; rash; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included rash. Previously administered products included Zostavax with an associated reaction of herpes zoster (within the 3 months, had shingles).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the shot when only one was available and within 3 months, the patient had shingles. A couple years later, the patient had the 2 Shingles shots and again later had the shingles. Neither case was terrible or painful, the patient never had blisters either time just the rash. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Narrative: Patient admitted 2/19/2021 after receiving the 1st COVID-19 vaccine (Moderna; Lot# 031M20A; Exp 08/05/2021). Patient experienced minor reaction with inflammation/pain of the RUE and swelling. COVID-19 on 2/19/2021 negative, as well as CXR unremarkable. After review of discharge summary and notes during time of admission, Patient admitted for increase SOB and worsening LE edema, which is likely attributed to R sided heart failure exacerbation, OSA and COPD, and not COVID-19 vaccine (arm pain and rash resolved prior to admission). Severity of ADR related to COVID-19 vaccine deemed as mild as Patient did not require and treatment for ADR. Hospital admission not likely attributed to COVID-19 vaccine, but rather R sided heart failure exacerbation, OSA, and COPD.
Numbness in the soles of both feet, weak legs, fatigue, inability to walk for more than 20 minutes without resting, inability to run faster than a slow trot, inability to trot for more than 2 minutes without resting.  No treatment to date.  Condition has remained the same.
Pt developed a rash on the right deltoid area approx. 5 days after the vaccine administered. She also complained it was itchy and tender. The initial sore arm resolved two days after the vaccine but this started later. She has chronic HTN and her BP at the clinic was 148/100 which she reports is her normal. She had no other signs or symptoms. The arm was red with a raised rash, tender at the site and warm to the touch. Concern for cellulitis so given Keflex 250 mg QID for 7 days. Advised to report the information to her PCP.
Information has been received from a registered nurse concerning a 12 month old female patient with otitis media who on 12-MAY-2009 was vaccinated with VARIVAX (Merck). Concomitant therapy included OMNICEF and ZITHROMAX. On 01-JUN-2009 the patient experienced a raised induration on her right thigh that was pink and purple. The patient was treated for an ear infection at the time of vaccination. The nurse prescribed AUGMENTIN to treat the induration. The nurse later reported that the patient had cellulitis after receiving VARIVAX (Merck). The patient had not recovered at the time of reporting. Unspecified medical attention had been sought. Follow up information has been received from the registered nurse indicated that their practice has recently seen 5 cases of cellulitis with VARIVAX (Merck). One case was this report which the office feels may have been an allergic reaction. The site was itchy and 13cm of involvement. No specific lot check because the cases were different lot numbers (exact numbers unspecified) but all were single dose vials received after the recent backorder. Different nurses, facilities and circumstances and office never had cellulitis cases like this before. Follow up information has been received from the registered nurse concerning the 12 month old female patient who on 12-MAY-2009 was vaccinated with the first dose of VARIVAX (Merck) on the right thigh and the first dose of MMR II (MSD) on the left thigh. The patient was well at the time of vaccination. Patient came in office two weeks after vaccine with 1/2 inch induration (right thigh) that was pink-purple and started on 12-MAY-2009. The patient was prescribed AUGMENTIN for 10 days. The patient had recovered on 11-JUN-2009. This is one of several reports from the same source. No further information is available.
pt recvd 1 dose of Engerix-B & devel a rash;
Pt recv vax on 12/21/98; on same day pt exp fever, nausea, pain & fainting
presents with a cough feeling unwell COVID positive this is in the setting of hypokalemia and chest x-ray shows COVID pneumonia.  She appears well clinically she is in no respiratory distress she does have a fever were treating this with Tylenol she is on 2 L of nasal cannula oxygen now satting 93% on these 2 L.  We are giving her fluids she has had significant diarrhea associated with her COVID.
Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a medical office 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 of herpes zoster also known as shingles and other complications. In 2014, the patient was treated at a medical office for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
A nurse reported that the day after receiving vaccines the patient developed an injection site reaction on the right arm characterized by redness, swelling, and pain. This is 1 of 3 patients from this facility who experienced this event following receipt of Acel-Imune lot 472-653.
1 wk 4 days after inj had body aches with moderate pain & stiffness, next day migraine.  Yesterday 1 wk 6 days small raised rash in limited areas.  Today rash covers 75% of body with pruritus.
hives; Initial information was regarding an unsolicited valid serious case was received from a pharmacist (Reference number- 00809510) and transmitted to Sanofi on 12-Oct-2021.  This case involves an unknown demographic (unknown age and unknown gender) patient who experienced hives (urticaria), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious hives (urticaria) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  It was reported "his personal physician contacted him to say a patient had hives from the Fluzone High Dose this year and has received the product in years past without any issues".  At time of reporting, the patient was unknown for the event.  There will be no information available on the batch number for this case.
pt rcvd vax & became limp, pale, non responsive, lips were blue, eyes had a glassy stare; pt taken to ER & had tracheotomy and CPR was done; transfered to hospital & died at 9:02pm
Flat red rash appears on patient's right side of her neck with complaint of itchiness approximately 5-10 mins following administration of influenza vaccine. Denies any other sign or symptoms including difficulty breathing, wheezing, chest pain, & palpitation. Vital sign #1 @0943 am: BP-138/78, HR-86 R-16. @9:49 am patient was given one time dose of diphenhydramine HCL 25mg PO by registered nurse (RN).  RN observed patient x 30 mins, symptoms of rash on neck improved and no other symptoms noted.
Information has been received from a Doctor of Pharmacy concerning an approximately 51 year old female patient with no pertinent medical history and no drug reactions or allergies who in 1988 was vaccinated with the first dose of PNEUMOVAX 23, intramuscularly (lot number and dose not reported) with no adverse event reported. In 1996, the patient was vaccinated with the second dose of PNEUMOVAX 23, intramuscularly (lot number and dose not reported). When the patient got her second dose, in 1996, the patient had a local reaction. Also, it was reported that the patient had swelling and redness that last a few days. There were no other adverse events to report. It was unknown if the patient sought medical attention. No lab diagnostics studies were performed. At the time of the report, the patient had recovered in 1996. Additional information has been requested.
I do not know if this is related to the vaccine or is an vaccine Adverse Event; however, I experienced bronchospasm, relieved by two actuations of the albuterol inhaler about 25 minutes after injection.  Also experienced moderate, intermittent occipital headache for approximately 6-7 hours following injection.  Soreness in L. arm following two days.
pale pink macular rash that started on face 10 days p/vax; rash spread to chest, abdo, groin, & arms;
Received the first dose of Pfizer COVID Vaccine and then tested positive after receiving it; Received the first dose of Pfizer COVID Vaccine and then tested positive after receiving it; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of bnt162b2 (lot no. and expiry date were unknown), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of Pfizer COVID Vaccine and then tested positive after receiving it. He says it has been 14 days after he tested positive and he is wondering about getting his second dose. The outcome of the event was unknown.  Information on the Lot/batch number has been requested.
patient requested flu vaccine and filled out immunization form - technician explained to patient we did not have hd flu shot and patient confirmed she was ok and wanted it, PHARMACIST VERBALLY CONFIMED PATIENT WANTED FLU SHOT BEFORE ADMINISTERING. ONCE BATCHING INSURANCE DENIED CLAIM AS PATIENT RECIEVED VACCINE 10/3/2021
Tender angry looking red rash; This is a spontaneous report from a contactable pharmacist. A female patient (age: over 65, units: unknown) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at 0.5 ml, single for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tender angry looking red rash on an unspecified date. The outcome of the event was unknown. Event took place after use of product.  The information on the batch/lot number and expiration date has been requested.
Headache, Myalgia, Fever, NauseaVomiting, LYMPHADENOPATHY EDEMA,ERYTHEMIA AND PRURITIS AT INJECTION SITE Narrative:
Case number PHEH2014US003874 is an initial spontaneous report received from a consumer (who was a nurse) on 24 Fen 2014. This report refers to a 13-years old male patient. His medical history and concomitant medications were not reported. It was reported that this patients under 18 years of age was vaccinated with an intramuscular dose of FLUCELVAX (batch number: not reported) on an unknown date in Dec 2013. No adverse events were reported following the maladministration. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 24 Feb 2014: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
On September 2, 2007, patient's left leg became paralyzed.  She was taken to the emergency room and hospitalized for 13 days.  The doctors at hospital diagnosed her with non-infectious A.D.E.M.  04/11/2008 MR received from hospital for DOS 9/6-10/2008 where pt was sent for diagnostic testing to r/o AVM.  D/C DX: was Spinal cord anterior spinal artery infarct. Pt was transfered to another facility where Final DX was made. Pt initially had presented to local facility with sudden onset L lower extremity plegia.  04/28/2008 MR received for DOS 9/10-15/2007 with D/C DX: Acute Demyelinating Encephalomyelitis (ADEM). Urinary Tract infection. Pt admitted after transfer from above admission. Pt initially presented with Left leg weakness/paralysis and upper back pain. Upon admission pt was unable to void and later  had urinary incontinence. Tx with solumedrol and abx for UTI. At D/C pt still with decreased strength of LLE, depressed reflexes and unable to bear weight independantly. Using a walker. Will continue with Outpt rehab. 1/20/2010 Patient stil has not been able to walk or run normal. She is still receiving physical therapy 2x a week.  Follow-up Information 06-MAY-2008:
first dose>35 days ago; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose>35 days ago) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose>35 days ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose>35 days ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient received his first dose of Moderna COVID19 Vaccine on 24 Mar 2021. He did not received his second dose.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow-up received and contains no new information.
4JUL98 pt was eating & started choking while riding in car;it was reported that pt parent stuck a finger down child throat to stop choking & pt taken to ER;pt examined & found to have fever of 105 & hosp;MD felt exp not r/t HIB/HEP B vax;
he had been sweating profusely for almost 3 weeks; This is a spontaneous report from a contactable consumer (patient). This unknown age male patient received 1st dose of COVID-19 Vaccine BNT162B2 (Batch/lot number: Not Provided) at single dose for COVID-19 immunization. Medical history and concomitant drug were not reported. Reported he had his first COVID-19 Vaccine and had a weird reaction. He said he had been sweating profusely for almost 3 weeks. He said everyone kept telling him that his sweating doesn't make sense, and his sweating should only have lasted a few days. Outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Flu type symptoms on and off x 5 days fatigue, headache, chills, night sweats, low grade fever.
Patient started to feel light headed and sat in a chair.  EMS was called and determined that he had an episode of syncope related to the vaccine.  He was feeling better after 15 minutes and after a full assessment  by EMS patient felt well enough to walk and went home with his mother.
My daughter after flu shot has shown hives (red mapping raised skin) all over her body around 5:30 PM, 6 hours after her flu shot. Then the following day about 5:30 AM, and after being given children's Benadryl chewable tablets (2x) she woke up with tummy pain and threw up a clear but yellowish discharge.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 10-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants medication were reported. No treatment medication were reported. No adverse event reported. Vaccine administered had a preservative.  It was reported that the dose was administered 8 days after the first puncture of vial.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up received contains no new information.
patient had high blood pressure; had COVID very bad, a lot has happened; person receives Moderna as a 1st vaccine and as a 2nd vaccine dose another brand of COVID19 vaccine,; person receives Moderna as a 1st vaccine and as a 2nd vaccine dose another brand of COVID19 vaccine,; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (patient had high blood pressure), COVID-19 (had COVID very bad, a lot has happened), INTERCHANGE OF VACCINE PRODUCTS (person receives Moderna as a 1st vaccine and as a 2nd vaccine dose another brand of COVID19 vaccine,) and COVID-19 IMMUNISATION (person receives Moderna as a 1st vaccine and as a 2nd vaccine dose another brand of COVID19 vaccine,) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 VACCINE for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and second dose of COVID-19 VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (patient had high blood pressure), COVID-19 (had COVID very bad, a lot has happened), INTERCHANGE OF VACCINE PRODUCTS (person receives Moderna as a 1st vaccine and as a 2nd vaccine dose another brand of COVID19 vaccine,) and COVID-19 IMMUNISATION (person receives Moderna as a 1st vaccine and as a 2nd vaccine dose another brand of COVID19 vaccine,). At the time of the report, HYPERTENSION (patient had high blood pressure), COVID-19 (had COVID very bad, a lot has happened), INTERCHANGE OF VACCINE PRODUCTS (person receives Moderna as a 1st vaccine and as a 2nd vaccine dose another brand of COVID19 vaccine,) and COVID-19 IMMUNISATION (person receives Moderna as a 1st vaccine and as a 2nd vaccine dose another brand of COVID19 vaccine,) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. The reporter stated that the patient had COVID very bad, a lot has happened and patient had to be resuscitated and all of this happened after receiving the vaccine. Reporter was hospitalized and someone told them that patient received another brand of COVID19 vaccine as a second dose while looking through patients immunization records. Reporter stated that the patient had high blood pressure and that patient was at risk. Reporter wanted to know if was normal to receive another brand of COVID19 vaccine as a second dose. Treatment medication information was not provided.   Reporter did not allow further contact
Excessive fatigue, fever, chills, body aches, mild nausea coming in brief waves and passing quickly
This case was reported by a nurse via sales rep and described the occurrence of activities of daily living impaired in a adult patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a week after receiving Shingrix, the patient experienced activities of daily living impaired. On an unknown date, the outcome of the activities of daily living impaired was unknown. It was unknown if the reporter considered the activities of daily living impaired to be related to Shingrix. Additional details were provided as follows: This case was reported by the registered nurse for her coworker. The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The patient was unable to do activities over the weekend after receiving Shingrix. The reporting nurse had encouraged the patient to report what they experienced, however due to limited information unable to identify duplicate cases. This case has been linked with US2018GSK152035, reported by same reporter. The reporter did not agree to be followed up.