chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via a company representative via social media (J and J corporate) concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on an unspecified date of MAY-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  The patient received Non-company suspect vaccine included: elasomeran (dose number in series 2) ( form of admin, route of admin and batch number were not reported) dose was not reported, administered on an unspecified date of DEC-2021 for covid-19 prophylaxis.  On an unspecified date of DEC-2021, the patient experienced revaccination with different covid-19 vaccine (dose number in series 2). On an unspecified date of  AUG-2022, the patient experienced headache, felt feverish hot with chills and a slight temperature and had confirmed covid-19 infection (dose number in series 2) and had confirmed clinical vaccination failure (dose number in series 1). Laboratory data included: COVID-19 virus test Positive. It was reported that, "i had covid the last week of august after being vaccinated j&j 5/21 and moderna 12/ 21and boosted. i live in a managed care a senior residence. The vaccine worked as promised, i didn't get seriously ill and i didn't die. i had a headache over night that wouldn't go away with my usual over the counter headache remedy. and i felt feverish hot with chills, a slight temp and the nursing staff swabbed my nose and said i was positive for covid, 19 and quarantined me to my room for five days. when the quarantine was lifted, they asked me to wear a mask in common areas, elevator, lobby, dining room. and that was about all resident that tested positive for covid. in this managed care facility. i am willing to wear a mask because it is more reliable protection along with social distancing than. a vaccine. and that is for every communicable disease out there. i may even skip the winter flu by doing so. i've done it this long, and can probably wait until covid19 doesn't retain its presence here . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220962983-covid-19 vaccine ad26.cov2.s- confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
A report was received from a health professional on 11/1/01 concerning a 72 year old male patient who experienced cellulitis 2 days after receiving the Fluvirin vaccine on 10/30/01. Relevant medical history includes Prostate cancer which started on an unknown date. Co-medications taken by the patient include Lupron and Pepcid. On 11/1/01, the patient experienced cellulitis of the entire right arm 2 days after receiving the Fluvirin vaccine. The Fluvirin administration was given in the right deltoid muscle. Therapeutic measures taken as a result of this event included Clindamycin and Diphenhydramine. The patient had not recovered at time of report. The reporter has assessed the relationship of the study medication to the event as possible. (OMIC)
This is spontaneous report from a contactable physician. This physician reported similar events for 4 patients. This is 2nd of 4 reports. A patient of unspecified age and gender received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pneumococcal infection and hemolytic uremic syndrome on an unspecified date with outcome of unknown. The information on the lot number has been requested. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate. Linked Report(s): US-PFIZER INC-2018410904 Same reporter/drug/event, different patient. (2 of 4).
Severe headache and fever of 99 and took off work that day. I started itching and pain on my arm at the injection site. Numbness and tingling in my arm and progressively got worse and went down to my fingers. Now this is radiating to my left arm. Bruising on back of my right knee and a large hematoma on Sept. 17th. I did take pictures. I just was able to get in to provider on 9/21/21. I had blood work drawn, and I am scheduled for a MRI of my cervical area to find out why I have numbness and tingling. I have had some weakness and lose of strength.  I have joint pain now all over and it's more so than normal. I go to Physical Therapy (Rehab) weekly and I have missed two appointments now due to my pain and joint swelling. I have constant itching of my skin all over my body so badly that I break open my skin from itching.
Pt didn't seem to have reaction until next morning. Starting with light red slightly itchy rash. Saturday night applied Caladryl clear. Itching cleared up. Sunday 11/10/13 morning rash now raised, very itchy, warm to touch. "Lump" is approximately 3 1/2" x 2". Monday 11/11/13 pt woke up at 5:30 AM rash appeared better. By 3:30 AM itching is worse. Dr. applied Caladryl clear. AM, itching much worse. Caladryl clear effects aren't seeming last as long. Pt reported reaction to Dr.
Janssen 3/5/21, 11/3/21. Positive on 8/9/22
p/vax pt exp 20 lesions on chest, back, face & behind the ears;the lesions were described as itchy, little pink welts;
Patient noted pruritis and hives 18 hours after immunization, which recurred daily since onset.  At time of exam on 09/16/2003, he had wheals on face, left side of neck (1), back (3), Lower left extremity (1).  He had not taken any meds yet.
Pt's face became red and hot. Eyes became ragged and swollen. Headache. Stomach pain.
She received her 1st shot of  vaccine a month ago and was diagnosed with crohn's disease after; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of unspecified age received BNT162B2 first dose on unspecified date in Jan2021 at single dose for covid-19 immunization. Medical history and concomitant medications were not reported. She received her 1st shot of vaccine a month ago and was diagnosed with crohn's disease after. She just took steroids 5 mg. Her 2nd shot of our vaccine is scheduled this Saturday and she is asking if it's okay. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Attendee received first dose Pfizer vaccine at 13:10 in the left arm.  Lot# FA3780. Attendee was directed to observation area.   At 13:15 voiced complaints of nausea and feeling hot. Chest discomfort 1/10. Attendee's skin was warm and dry.  Attendee assisted to the wheelchair and was taken to the cot to lie down.  Icepack applied to face and neck.     13:21 - Attendee still with nausea and feeling hot. No chest discomfort, at this time.   HR:  63   BP:  100/60   RR:   20   O2Sat%:  99   Temp:  97.4  13:35 - No voiced complaints- skin warm and dry.   HR: 82    BP:  102/60   RR:   18   O2Sat%:  99  13:45 -Denied complaints - skin warm and dry. 13:50 - Care Practitioner educated on home discharge/adverse reaction instructions and attendee was discharged to home with his partner.   Attendee did not have any reported escalation of symptoms and was able to walk out of clinic independently.
Case fully vaccinated with Moderna. Last dose on 2/26/2021. Tested positive for covid on 9/21/2021. Admitted to Medical Center on 9/27/2021. Expired on 10/01/2021 while still hospitalized.
Seen 11/14/02 with 2 week history of numbness of left leg and right, arms left and right. Spreading recently to right side of face. Started 1 week after flu vaccine. 12/13/2002 pt here for routine check-up and follow up. s/p
pt recvd vax ; pt taken to er & s&s of meningitis; H flu dx transferred to a different hosp;
Initial report received on 29/Aug/2006 from a healthcare professional. A 33-year-old male patient, with no illness at the time of vaccination, had received an intramuscular, left deltoid injection of Menactra, lot number U2139AA, on 23/Aug/2006. The following day, the patient experienced "pain in his left arm, a swollen gland in the axillary area and fever for 24 hours of 101 degrees Fahrenheit". The event did not necessitate examination by a physician. At the time of this report, the event was resolving. Follow-up information received on 15/Sep/2006, Per the reporter, the patient did not have any illnesses, and was not taking any other medications at the time of the vaccination on 23/Aug/2006. The patient did not have any relevant diagnostic test/laboratory data performed for these adverse events. No further information is expected.
Therapy non-responder.  This case was reported by a healthcare professional and described an adult female subject who did not respond to immunization to hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) for prophylaxis.  On an unspecified date before 03 October 2006, the subject received 3rd dose of Engerix-B.  On 03 October 2006, at an unspecified time after vaccination with Engerix-B, a hepatitis B surface antibody titer was negative.  Relevant test results included [laboratory results/hospital investigations].  At the time of reporting the outcome of the event was was unspecified.
Redness and tenderness and warmth at injection site. Will see doctor on 9-27-17 for antibiotics.
Myalgia, Arthralgia, inj site soreness x5 days, muscle aches, joint pain, barely able to walk x6 days Narrative:  inj site sore x5 days; muscle aches, joint pain, barely able to walk x6 days; self admin Advil with good effect on day 5 and 6
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. No pertinent medical history or drug reactions/allergies were provided. Pharmacist reported that the unspecified patient received GARDASIL INJ (dose, route and lot number not provided) for his first dose and CERVARIX as the second dose in the Human Papillomavirus (HPV) vaccination schedule (dates not specified). No adverse effect was reported. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Medical history was not reported. There were no drug reactions or allergies. In approximately July 2013 (reported as 3 months ago), the patient was vaccinated with ZOSTAVAX (lot, dose and route not reported). Concomitant medication was not reported. In 2013 (reported as "now"), the patient experienced an unspecified condition. Unspecified corticosteroid medication was given as a treatment for the event. The patient sought for medical attention (unspecified method). The outcome of unspecified condition was not reported. The reporter considered unspecified condition to be not related to ZOSTAVAX. Additional information is not expected.
On 2/9/2021 experienced headache, chills, and sore arm 0n 2/10/2021 still experiencing similar side effects but know light headed On 2/11/2-12: 930AM experienced a TIA . I totally believed it was a by product of the Covid shot - 1st dose. Had to go to ER and go through series of tests. Now on blood thinner. Since this occurred i know of 2 people that had similar results and experienced a stroke with 2 of them experiencing major stroke and died.  people had similar results Now I don't think I will take second dose - very scared NOTE: I was in great shape prior to this vaccine
CRIPPLE BY AUTOIMMUNE; This spontaneous report received from a patient via social media concerned a patient of unspecified age, sex, race, and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, 1 total administered, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient was cripple by autoimmune which patient battled more than two years. Patient stated that, "Hey J and J, just wanted to let you know I'm almost back to normal after 2 plus years of battling autoimmune that crippled me for a couple years after taking your poison shot you took off the shelves". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cripple by autoimmune. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230744932-cripple by autoimmune. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Patient was given vaccines approximately 3PM on 3/25/19. Per mother, patient slept a total of 15 hours. He woke up on 3/26/19 at 9:30AM. Had a slight fever, fussy, having off and on shaky and is rigid. Advised to take patient to ER ASAP.
lot of itching; hives all over body/ only a little bit of hives in the hands/patient broke out in hives/hives have been bad; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives all over body/ only a little bit of hives in the hands/patient broke out in hives/hives have been bad) and PRURITUS (lot of itching) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Nov-2021, the patient experienced URTICARIA (hives all over body/ only a little bit of hives in the hands/patient broke out in hives/hives have been bad). On an unknown date, the patient experienced PRURITUS (lot of itching). The patient was treated with CLONAZEPAM (KLONOPIN) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives all over body/ only a little bit of hives in the hands/patient broke out in hives/hives have been bad) was resolving and PRURITUS (lot of itching) outcome was unknown.            The patient reported after 10 days of getting the booster, the patient broke out in hives. The patient was better now, only a little bit of hives in the hands was remaining. Reportedly, the patient did not have soreness or inflammation.  No Concomitant product use was reported.
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with PROQUAD (Merck) which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a physician and a licensed practical nurse (LPN) regarding a 6 year old male patient (child). On 25-JUL-2014 at 12:43 PM, the patient might have been immunized with a dose of PROQUAD (Merck) lot number J015596, expiration date 05-JUN-2014, in the right thigh (dose number, route and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
Had the vax; got it anyway/Suspected vaccination failure; got it anyway; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received shingle shot and got it anyway. The follow up would not be possible as no contact details were available. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule and time to onset and laboratory confirmation for shingles were unknown.
feels off with no energy; could not sleep well; pain in left hip before the vaccination is gone after the first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feels off with no energy), INSOMNIA (could not sleep well) and THERAPEUTIC RESPONSE UNEXPECTED (pain in left hip before the vaccination is gone after the first vaccination) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (feels off with no energy), INSOMNIA (could not sleep well) and THERAPEUTIC RESPONSE UNEXPECTED (pain in left hip before the vaccination is gone after the first vaccination). At the time of the report, ASTHENIA (feels off with no energy), INSOMNIA (could not sleep well) and THERAPEUTIC RESPONSE UNEXPECTED (pain in left hip before the vaccination is gone after the first vaccination) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
pt recv vax;pt called c/o rxn related to vax;reported feeling nauseated & demonstrated blurring & tearing & swelling rt eye;6jul recv 2nd TD & exp same side effects;
Patient presented to sick call today, 2-3 days after administration of vaccine with a macular/papular eruption on both cheeks, no other location, no other know precipitating causes and first eruption-non-pustular. No other vaccine information is available.
back pain; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 20Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset 13Mar2021, outcome "not recovered", described as "back pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
swelling of the right ear; discoloration of right cheek; Itchy bump on the site of injection; swelling of glands in neck on injection side; Itchy bump on the site of injection; Itchy bump on the site of injection; Sore joints; This spontaneous case was reported by a consumer and describes the occurrence of EAR SWELLING (swelling of the right ear), SKIN DISCOLOURATION (discoloration of right cheek), VACCINATION SITE PRURITUS (Itchy bump on the site of injection), VACCINATION SITE SWELLING (Itchy bump on the site of injection) and ARTHRALGIA (Sore joints) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy bump on the site of injection), VACCINATION SITE SWELLING (Itchy bump on the site of injection) and ARTHRALGIA (Sore joints). On an unknown date, the patient experienced EAR SWELLING (swelling of the right ear), SKIN DISCOLOURATION (discoloration of right cheek), VACCINATION SITE INDURATION (Itchy bump on the site of injection) and VACCINATION SITE LYMPHADENOPATHY (swelling of glands in neck on injection side). At the time of the report, EAR SWELLING (swelling of the right ear), SKIN DISCOLOURATION (discoloration of right cheek), VACCINATION SITE PRURITUS (Itchy bump on the site of injection), VACCINATION SITE SWELLING (Itchy bump on the site of injection) and ARTHRALGIA (Sore joints) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Non significant follow up appendedNNI(NO NEW INFORMATION ) WAS ADDED.
One hour after injections developed focal L frontal headache x 6 hrs. Then experienced nausea, increased HR, flat rash on neck and chest, achiness. Painful swollen lymph nodes R axilla. Rash worse post two days, all over x/sx resolved. No Rx at ER visit.
PATIENT FAINTED APPROXIMATELY 5 MIN AFTER RECIEVING VACCINE, PATIENT BUMPED HEAD ON CHAIR
Case was admitted to hospital with symptoms of a possible heart attack on 03/17/2023. Cardia Catheterization was performed on 03/20/2023. Case tested positive in hospital.
11OCT95 pt phoned to report 1 1/2" redness around inj site;painful arm (required darvocet to help alleviate pain) during noc a/;12OCT95 f/u call to client-now feels muscle pull under the arm & redness has cont to enlarge 2" diameter;
Information has been received from a pharmacist referring to four to five patients (age and gender unknown). The patient's concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (strength, dose, frequency and route unknown). On unknown dates, the patients experienced injection site reactions with pain and soreness. The patients sought unspecified medical attention for the event. The outcome of the event and causality assessment were unknown. Additional information has been requested.
Rash to left lower thigh began 2 days after vaccination on 5/12/05. Mom states slight fever 2 hrs before appt on 5/19/05 T 98.3 at appt time. Observed rash.