chrisvoncsefalvay/vaers-outcomes huggingface dataset:
more joint pain than before.; This is a spontaneous report from a contactable consumer (patient). A 87-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EL9266) via an unspecified route of administration in arm left on 11Feb2021 (age at vaccination 87 year) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The historical vaccine included received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EL3247) via an unspecified route of administration on 21Jan2021 (age at vaccination 87 year) as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced more joint pain than before. The patient underwent lab tests and procedures which included laboratory test, result was unknown (labs done on 3 month diabetic check). The outcome of the event more joint pain was unknown.   No follow-up attempts are possible. No further information is expected.
After the vaccines lost temperature they were administered; A spontaneous report was received from a healthcare professional concerning a 74-year-old, White female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature.  On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, after the vaccines lost temperature they were administered, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 74-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: 027L20A), reporting Out of specification product use.
He was later diagnosed with Pleural effusion; This spontaneous case was reported by a consumer and describes the occurrence of PLEURAL EFFUSION (He was later diagnosed with Pleural effusion) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1), PFIZER BIONTECH COVID-19 VACCINE (1 Booster) and PFIZER BIONTECH COVID-19 VACCINE (Dose 2). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    In October 2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PLEURAL EFFUSION (He was later diagnosed with Pleural effusion). At the time of the report, PLEURAL EFFUSION (He was later diagnosed with Pleural effusion) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant Medication use information was not provided by reporter.  Patient received Moderna booster in October of 2022, and probably 4 to 6 weeks later he was misdiagnosed with bronchitis and then Pneumonia. He was later diagnosed with Pleural effusion. He went to the clinic and had every test under the sun. He had a medical mystery even in clinic. The CDC mentioned that the possibility of individuals developing plural effusion after having the vaccine or booster that was Moderna. Patient's wife also mentioned that he had been to clinic 3 times, and everything was ruled out. She went on to say that all their prior doses were Pfizer (2 initial vaccines, and 1 booster). It was mentioned that they believed strongly in the vaccines until now.   After Moderna booster vaccine patient had pleural effusion. Wife mentioned that the first time he was drained, they took 106 fluid ounces, that was when they thought it was pneumonia and told it would go away and it didn't. Wife also mentioned that she keeps hearing that the other individuals was sick with pleural effusion because of Moderna.   Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-734116 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734116:Other Individuals Invalid Case
I had been on weekly diflucan for toe fungus starting in late March.  I got the first Moderna shot April 13. On April 22 I had some chest tightness which I attributed to the Diflucan as it listed chest tightness as a side effect. On May 2nd the pain extended from the chest, neck, headache and all my teeth hurt and I ended up in the hospital for the first of 3 hospitalizations  Below is the summary of doctor?s notes on my hospitalizations.  They ran several tests to eliminate lupus, sjogrens, cancer, kidney issues, bacterial or fungus issues, etc.  It was not caused by the Diflucan side effect. They decided it might be viral.  Given the current report of some people getting pericarditis after the vaccine, my doctor and I felt we should report this incident.  Given the timing, it could have been the vaccine that caused the reaction.  I'm currently on prednisone for another month and colchicine for several more months and remain under the care of cardiology.   SUMMARY OF DOCTOR?S NOTES:   She presented to the ER 5/2/2021 with chest pain. When she presented, she had tachycardia with interior ST changes. CT showed no PE but there was a large pericardial effusion. Subsequently her blood pressure began dropping with narrowing pulse pressure and she was thought to have early tamponade physiology so was taken to the cath lab and pericardiocentesis was performed. She did well and was started on colchicine and ibuprofen.   5/14 When I saw her back, she was doing well. Since then, she has had back to back admissions:   5/24/2021-5/27/2021-CAP of LLL with bilateral pleural effusions and pericarditis treated with antibiotics but afterwards, felt to be viral. She was seen by Pulmonary at this hospital stay. Rheumatologist work up was started. ECHO was stable.  5/29 Second Moderna shot (was delayed 2 weeks due to concern about confusing the potential normal side effects with the pericarditis issues).    6/13/2021-6/15/2021-Serositis with tachycardia, cough and fever. Rheumatology did not see but was curb sided and recommended Prednisone (long taper) with clinic visit in the next 2 weeks. Limited ECHO was stable.     6/16 Patient is doing well. No chest pain. She is taking the Prednisone without issues. No GI upset and no loose stools.
It was reported that a 24 year old female pt received a TD Adult on 9/18/00 at 11:45. Reportedly, on 9/19/00, at 08:45, the pt noticed her right deltoid was very red and swollen with a knot that was warm to the touch. The pt was seen in the office for treatment on 9/22/00 of Benadryl and ice. Reportedly, the pt recovered from this experience. From additional information received on 2/1/01, the pt information and number of previous doses has been updated.
Pt was found dead at home, no s/s or complaints, pt had existing condition of severe arrhythmia, severe cardiac conditions;
had 3 lyophilized parts of the vaccine and no "diluents" / suspect /patients got the liquid adjuvant only; had 3 lyophilized parts of the vaccine and no "diluents" / suspect /patients got the liquid adjuvant only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The reporter was a pharmacy student. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The reporter stated that the patient might had been administered only the liquid adjuvant portion of the Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that they had lyophilized part of the vaccine and no diluent, so they suspect that patient got the liquid adjuvant only. The reporter consented to follow up by email as HCP had no details at time of reporting. This case had been linked with US2021084246 and US2021AMR084958, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR084958:same reporter US-GLAXOSMITHKLINE-US2021084246:same reporter
large (~ 3x1.5 inc) area of redness and soreness with slight swelling. temperature  of the redness area is as the same as the other body parts. No fever noted. I recommend patient to apply cold compress and take ibuprofen as need for sore and swelling. If the redness spreading outward, fever, she need to go see doctor
A few minutes after GARDASIL patient felt faint became pale & shaky - gave cake & layed patient down - vitals remained good - episode pasted in about 10 minutes.
I did not have an adverse event following my vaccine.  On 12/14/2022 I started feeling sick which I thought was a cold. I tested positive for COVID-19 on 12/16/2022.  I contacted my doctor and was advised to take zinc, stay hydrated and rest but to call if my symptoms got worse.  I still have nasal drip which causes me to cough. I had itchy patches on my skin when I had COVID-19 and it continues to come up.
This case was reported by a healthcare professional (pharmacy student) and described the occurrence of hive in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medications included REGLAN. On an unspecified date the subject received 1st dose of TWINRIX (details unknown). Less than one month after vaccination with TWINRIX, the subject experienced hive. The subject experienced hives for a month after receiving the injection. At the time of reporting the outcome of the event was unspecified.
Slight fever of 100.5, entire body had sore muscles, and tired the next day after vaccination. Lasted 1 day.
about 10min p/vax pt had mild tingling in throat;no other allergic sx;sx cleared p/administration of epi;pt watched for 2 1/4hr w/o sx;
High fever reported by parent to be 105.6 degrees F. Office temperature within normal limits 97.2 degrees F without other symptoms. Lab work completed and also within normal limits.
No additional AEs were reported; Expired PNEUMOVAX 23 was administered to a patient.; This spontaneous report was received from a pharmacist and refers to a patient of an unknown age.  The patient's medical history, concurrent conditions, concomitant therapies and previous drugs reactions or allergies were not reported.  On 24-JAN-2023, the patient was vaccinated with an expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot #U010533, expiration date: 29-OCT-2022, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional adverse event was reported.
This spontaneous report was received from a physician concerning a female patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (strength, lot number, expiration date and route were not reported) dose 1. Co-suspect and concomitant therapies were not reported. Physician reported that an unspecified patient experienced a sore throat "1 month after" receiving her 1st dos of GARDASIL. At the time of the report the outcome was unknown. Additional information has been requested.
I contracted guillian barre syndrome from a flu shot administered at work. I spent a month in the hospital being treated and rehabing. I then die 6 months of outpatient renhab and I am now receiving disability.  11/6/07 Reviewed hospital medical records which reveal patient experienced progressive numbness & weakness of all extremities x 4 days beginning 3 days s/p vaccine. Progressed to where patient could not even stand or walk.  Admitted to ER 11/15/2006 & transferred to higher level of care same day.  Exam revealed reduced reflexes.  Neuro consult obtained & LP done.  Records requested from transfer hospital. ER Dx: Guillain Barre syndrome. 12/7/07 Reviewed hospital medical records from transfer hospital which reveal patient experienced diarrhea, progressive weakness, aching & tingling, unsteady gait & trouble w/motor control of hands since 11/12/2006.  Admitted 11/16-11/21/2006.  Pulmonary consult done.  Tx w/IVIG x 5 doses.  Improved & transferred to rehab facility. FINAL DX: Guillian Barre syndrome. Per 60 day follow up: My hands have diminished strength and I must wear braces & crutches in order to walk now. I could not return to work and I new receive social security disability benefits & long term term disability from work. I have not had any health insurance since June 1, 2007 and will not be qualified for Medicare until June of 2009. This makes it very difficult to get any continuing health care. 1/13/2010 I still have weakness in my hands and need braces in order to walk.
Patient had ongoing shoulder pain after injection, lasted until she presented 11/11/21. Exam consistent with bursitis vs adhesive capsulitis.
Client was vaccinated with Pfizer vaccine that had not been reconstituted. Error was caught and address .
18APR98 arm sore;19aPR98 redness, feverish & warm to touch;large welt measure 7cm x 9cm, itching;
She says she is feeling very sluggish with low energy and having difficulty regulating her core temperature after receiving the COVID 19 vaccine. She says her body temperature got down to 94 degrees Fahrenheit last night and is fluctuating. Her injection site is tender and swollen. She says this seems to be a typical response to vaccines for her due to her autoimmune condition.
high pitch cry p/nap; seen 8PM cry-doing better by about 10PM; slept until 5AM; sleeping alot today but does arouse; fever 99.2 ax; APAP given;
pt has red swollen leg from knee area to hip; thigh area red & swollen @ warm to touch; pt c/o area being extremely sore; pt cannot stand for area to be touched;
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 09-NOV-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N019923 and expiration date 28-APR-2019) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709.
Hospitalization 5/17/22-5/20/22 fall, elevated cardiac enzymes, PNA,  rhabdomyolysis,
No adverse reactions reported.   In November 2022 our Immunization program did our every-other-year audits in both our offices. It was discovered at that time, that some Covid Vaccines were administered outside of the 10 week expiration date (which is calculated from the date the vaccines were received from the state.) The program directed us to fill out forms and send them to you. The state also counselled us that it was our providers + parents joint decision as to whether to re-vaccinate pts or not.  We only use Pfizer vaccines for Covid-and the listed lot #'s given outside the expiration date are listed below.  Lot #'s FM0698 (orange top), FM0698 (purple top), FL8095 (orange top), FL8094 (orange top), FM7552 (purple), FM0698 (purple), FP4554 (purple), FL8094 (orange), FL8095 (orange), FT1551 (orange).  Please see the attached forms, and feel free to contact the  office for further questions or concerns.
I24.8 DEMAND ISCHEMIA 4/21/2023 ACUTE EXACERBATION OF CHRONIC ASTHMATIC BRONCHITIS  J96.00 ACUTE RESPIRATORY FAILURE 4/22/2023 ACUTE EXACERBATION OF CHRONIC ASTHMATIC BRONCHITIS  J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/21/2023 ACUTE EXACERBATION OF CHRONIC ASTHMATIC BRONCHITIS  J96.10 CHRONIC RESPIRATORY FAILURE 4/22/2023 ACUTE EXACERBATION OF CHRONIC ASTHMATIC BRONCHITIS  R09.02 HYPOXIA 4/22/2023 ACUTE EXACERBATION OF CHRONIC ASTHMATIC BRONCHITIS
PATIENT RECEIVED JANNSEN VACCINE 3-6-21 AND FAILED TO REPORT TO IMMUNIZER
After taking the vaccine she didn't feel good. The next day she started to have heavy menstrual like bleeding heavy with big clots. She went to the ER and got medicine but it has not stop yet. She have been bleeding everyday since getting the vaccine for over a month.
Initial information received on 21-Dec-2018 regarding an unsolicited valid serious case received from a consumer. This case is linked to case 2017SA163839, same patient. This case involves an unknown age female patient who experienced C. diff colonizations, neck pain and swollen lymph nodes all over her body, cold and elevated BP while she received vaccine FLUZONE HIGH DOSE. The patients past medical history included 1 small swollen lymph node in her neck for 1 year and has C. Diff history - and told was completely resolved. The patient's concomitant medication and family history were not provided. The patient is highly allergic to lot of things. On 01-Nov-2018 or 04-Nov-2018 (patient could not recall), received injection of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number, expiry date not reported via unknown route in unknown administration site. On unknown date, the patient developed a serious C. diff colonizations (clostridium difficile infection) with unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. On unknown date, the patient developed a non-serious neck pain with unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On unknown date, the patient developed a non-serious swollen lymph nodes all over her body with unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was referred to health care professional. The patient told that recently after taking FLUZONE HD, the patient took COLD-EZE for her cold and her blood pressure became very elevated (latency and onset date unknown). Other relevant tests included - On unknown date - MRI - Which showed swollen lymph nodes all over body. Final diagnosis was swollen lymph nodes all over her body, neck pain, cold, blood pressure became very elevated and C. diff colonizations. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for all events. List of documents held by sender - none. Sender's Comments: This case concerns an patient with unknown age who developed C. diff colonizations, neck pain and swollen lymph nodes all over her body after vaccination with FLUZONE HIGH DOSE. The exact time to onset is unknown. The patient has previous history of swollen lymph node in her neck and C. Diff. However, patient's condition at the time of vaccination and lab tests ruling out alternate etiologies were not provided. May be present events related to previous history of patient. Based upon the reported information, the role of the vaccine cannot be assessed.
Extreme Arm pain, couldnto move arm or put pressure on it . Still felt 3 days later, A week later hot itchy and raised. large round  red welt where Injection site is.
Pt received the tetanus shot on 02/14/05 at 3:45PM. He returned to center on 02/17/05. His arm was red approx 6" in diameter around immunization sight. He stated it was painful. Also rash at sight, hot to touch. Also, complained of joint pain and headache. Donor went to the local emergency room and was told it was a reaction to the tetanus shot.
Site reaction, warm, red, rash. Blisters on back of thigh, no pain, itchy.
Significant arthralgia; Fatigue; Left arm soreness; Feverish; Feeling overall unwell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 12:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 3, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 21Sep2022 at 00:15, outcome "recovering"; MALAISE (non-serious) with onset 21Sep2022 at 00:15, outcome "recovering", described as "Feeling overall unwell"; PYREXIA (non-serious) with onset 21Sep2022 at 00:15, outcome "recovering", described as "Feverish"; PAIN IN EXTREMITY (non-serious) with onset 21Sep2022 at 00:15, outcome "recovering", described as "Left arm soreness"; ARTHRALGIA (non-serious) with onset 21Sep2022 at 00:15, outcome "recovering", described as "Significant arthralgia". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was meant to receive the Pfizer bivalent booster, but instead received the pfizer monovalent vaccine. Pfizer drug safety report reference number: D3VH0R6L