chrisvoncsefalvay/vaers-outcomes huggingface dataset:
autoimmune disease; patient received cortisone injections the same day that she received her second dose of the Pfizer BioNTech COVID-19 vaccine.; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and Expiry date: not reported), via an unspecified route of administration on an unspecified date in Mar2021 as dose 2, single for covid-19 immunization; hydrocortisone (CORTISONE [HYDROCORTISONE]), via an unspecified route of administration on an unspecified date in Mar2021 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for an unspecified indication. The patient medical history was not reported. Concomitant medications included prednisone 10 mg taken daily from an unknown date for an unspecified indication. Previously the patient received first dose of bnt162b2 (Lot number not reported), via an unspecified route of administration on an unknown date for covid-19 immunization. In Mar2021, the patient received cortisone injections on the same day she received her second dose of the Pfizer BioNTech COVID-19 vaccine. She has a lot of autoimmune and was getting cortisone injections. Her rheumatologist was not aware at that time. She drained her knee and did a Cortisone injection and she just carried on. She did not know it would affect this. She told her to just get the shot in. Her Primary Care Provider would like her to get third dose now as she had no antibodies and had no injections or infusions. As she also had an autoimmune disease and discussed her situation with her HCP, but nobody is ready to give her the third dose. So a response was provided for her regarding the third dose that the need for a booster dose of Pfizer-BioNTech COVID-19 vaccine based on duration of protection or impact of variant strains has not yet been determined. On 25Feb2021, Pfizer and BioNTech announced they initiated an evaluation of the safety and immunogenicity of a potential third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to understand the effect of a booster on immunity against COVID-19 caused by the currently circulating and potential newly emerging variants. It is important to have a vaccine technology that allows us to both provide boosting doses if needed and to address potential changes in the virus itself if a new variant emerges that the vaccine does not protect against. While we have not seen any evidence that the circulating variants result in a loss of protection provided by our vaccine in our laboratory studies, we are taking multiple steps to be ready in case a strain becomes resistant to the vaccine. The administration of more than a 2-dose series of Pfizer BioNTech COVID-19 Vaccine is not approved. Pfizer is unable to make any recommendations regarding administration of a booster dose of Pfizer-BioNTech COVID-19 Vaccine; Pfizer does not suggest or recommend the use of the vaccine in any manner other than as described in the authorized EUA Prescribing. The clinical outcome of the events was unknown.  Information related to batch/Lot no. was requested.
Seizure like event, for about 45 to 55 seconds, jerking with pallor afterwards. Sitting position, held her to prevent falling, after it subsided, she cried a bit. Denied any headache, pain, dizziness, mother refused ambulance to have daughter checked, had her sitting in front of me for 20 minutes. Explained to mother that I would be filling an adverse report and someone may be contacting her.
Presented to the hospital on 8/29/21 with chronic/moderate/constant weakness that had worsened throughout the week with associated shortness of breath early that morning. Patient was brought to hospital by ambulance from an assisted living facility. Nurse at the nursing home stated that the patient was not looking well. Patient stated that he could not get up from bed. Denied chest pain or shortness of breath. Patient required 2L of oxygen to elevate oxygen saturation. He received PTA via saline and demonstrating atrial fibrillation with RVR. The patient has a past medical history of LBBB and CAD. Patient wasn't sure of his current medications since it is provided to him by the assisted living facility. The patient is fully vaccinated for COVID-19 with moderna in April and May.   In the ED, the patient was febrile with a temperature of 100.7, tachycardiac at 125, BP 141/66 with a WBC of 18.8. The patient met SIRS criteria and placed on 2L of O2, CRP 122, BNP 1350, creatinine wnl, BUN 25. EKG demonstrated atrial fibrillation with RVR and the patient was given cardizem 20 mg IV for rate control. The patient was also started on Vanc + Zosyn due to the suspicion of possible secondary pneumonia. Respiratory cultures, culture for Legionella and S. Pneumoniae antigen, MRS PCR, blood gases, ferritin, fibrinogen, lactic acid, lactate dehydrogenase, PT, CBC, and electrolyte studies were obtained.    During hospital course the patient was started on Remdesivir 200 mg qhs then switched the second day to 100 mg for a total of 4 days. He was started on Decadron 6 mg for 10 days. He received Mucinex 600 bid prn and albuterol 4 puffs q6h prn. For the patiens history of atrial fibrillation with RVR he received a single dose of cardizem 20 mg IV and then was started on metoprolol tartrate 2.5 mg IV q6h and xarelto 15 mg qd was restarted. For his chronic diastolic he was given lasix 40 mg IV and then daily dosed. Patients' hypokalemia was managed by started him on Klor-Con 20 meq bid to raise the level above 4. For his history of CAD s/p cath/HLD/HTN he continued his home medication of fenofibrate 160 mg, lisinopril HCTZ 10-12.5. Also received his nightly BIPAP treatment.    Throughout his continuation of the hospital course he began to have difficulty swallowing and choking on food. Speech therapy performed an evaluation and recommended that the patient to be put on a cardiac diet with thin liquids. Due to the patient being on vancomycin since admission it was discontinued due to elevated levels and was switched to Levaquin 750 mg received on 9/1 then a second dose to be given on 9/3, due to being renally dosed. Patients potassium began to elevated and Klor-Con 20 meq was put on hold.   Patient was discharged on a second dose of Levaquin 750 mg to be on Friday, 9/3/2021, Decadron 6 mg qd for 5 more days, Mucinex bid, albuterol q4h.
passed away; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 94-year-old female patient (reporter's mother) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient passed away on an unspecified date. It was unknown if an autopsy was performed. The reporter said that patient died because she is 94 years old and not with the vaccine.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information, this female patient death is attributed to her advanced age  (94 years old) and assessed unrelated to BNT162B2 vaccine.; Reported Cause(s) of Death: passed away
Fever 100.5-101 starting 18 hours after shot lasting for about 8 hours.   Moderate to severe muscle aches. Neither responded to Tylenol.  Ears ringing.  Fever of 99 degrees and malaise  returned at 48 hours and  responded to Tylenol.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown gender and age. No information regarding the patient's concurrent conditions, medical history, or concomitant medication was provided. On 21-FEB-2017, the patient received an expired dose of PNEUMOVAX 23 injection (dose and route of administration were not provided; lot number: K021578, expiration date 25-JUN-2016) for prophylaxis. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Developed petechiae rash and complained of hip pain, blood was tested for several other conditions, no reasoning for the development of the rash which took a few months to disappear.
Leg cramps; This spontaneous case from was received on 09-Mar-2021 from other health professional and concerned a 32-year-old female, pregnant patient of body weight: 129 lbs, height: 64 inches and body mass index (BMI): 22.1  The patient's medical history was not reported. The patient's concomitant medication included Vitafol (ferric pyrophosphate, folic acid, vitamin B nos) for healthy pregnancy.  The patient's obstetrical history included one previous pregnancy with spontaneous abortion. The patient had no maternal or paternal history with major congenital malformation (MCM). The patient did not consume tobacco, alcohol and illicit drugs during pregnancy.  On 03-Sep-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; indication, dose, route of administration and anatomical location: not reported). The batch number was P100239705.  The patient's last menstrual period (LMP) date was 18-Oct-2020, and estimated delivery date (EDD) was reported as 25-Jul-2021. The corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton.  On an unknown date, an unknown amount of time after receiving Afluria Quadrivalent, the patient experienced leg cramps.  On 15-Jan-2021, the first trimester screen and MaterniT 21 revealed no MCM.  On 13-Feb-2021, alpha 1 foetoprotein (AFP1) revealed no MCM.  On the same day, the patient started treatment for leg cramps with Caltrate 600 D plus minerals (boron, calcium carbonate, colecalciferol, copper, magnesium, manganese, zinc) at a dose of 600 mg, every day, administered orally.  The outcome of the event of leg cramps was not reported.  The reporter did not provide a causality assessment.  Company comment:The patient developed muscle spasms on an unknown date and an unknown amount of time after receiving Afluria Quadrivalent. Chronology is unclear. Underlying pregnancy may have contributed to development of the event. Causality is assessed as not related.; Sender's Comments: The patient developed muscle spasms on an unknown date and an unknown amount of time after receiving Afluria Quadrivalent. Chronology is unclear. Underlying pregnancy may have contributed to development of the event. Causality is assessed as not related.
Pt was in for a well child check at 6 weeks of age and was given DTAP, IPV, HIB/HEP-B(comvax) at approximately 14:30. Pt tolerated well. Then mom called on 1/10/00 at 16:00 with reports of pt being less alert, limp, unable to hold head up, staring, unable to focus. No fever. Baby was fed at 15:00. Sleeping after. Advised mom to call 911 if color blue. Wake for feedings. Doctor thought it could be DTAP. Mom called on 1/11/2000, stated baby was fine.
Within 3 minutes of receiving the H1N1 vaccine the patient/employee displayed the following symptoms: dizziness, perfuse sweating, redness, rash, chills and feeling faint. This lasted about 45 minutes. The employee didn't require treated.
Employee received second dose of Moderna vaccine on 1/28/21. Within 30- 45 minutes she started to feel chills, dizzy, headachy, foggy vision & nauseated. Symptoms persisted/worsened and she then began to experience a scratchy throat. Patient given Benadryl IM. Many symptoms still persisted but no furthering of anaphylactic symptoms and eventual reduction in these symptoms as well. Patient stabilized after about 3 hours and was allowed to be taken home by a family member and advised to continue monitoring for any urgent symptoms and seek emergent care as needed.
Headache; left arm and back pain; left arm and back pain; everything hurt; This is a spontaneous report from a contactable consumer (patient). This 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK4176; dose 1) via an unspecified route of administration on 23Jan2021 at 16:00 (at the age of 72-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included a dental appointment in Jan2021; the patient had no other conditions. Concomitant medications were not reported. The patient previously took penicillin and had a reaction when he was younger. The patient had not had adverse events from prior vaccinations. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 24Jan2021 the patient experienced headache, left arm and back pain, everything hurt. The patient said that "it" didn't bother him at all that day (23Jan2021) but on 24Jan2021 he had headaches, left arm and back pain and everything hurt. It was worse "yesterday" but "today" (on an unknown date) his arm and back still hurt. The events did not require a visit to the emergency room or physicians office. The patient underwent lab tests and procedures which included a new dental crown put on on 25Jan2021. The clinical outcome of headache was recovering. The outcome of left arm and back pain and everything hurt was not recovered.  No follow-up attempts are needed. No further information is expected.
nerve pain in her left arm and her hand and the top of the shoulder; she have severe nerve and muscle damage; she have severe nerve and muscle damage; excruciating pain like live electricity running up from her arm to the fingers; excruciating pain like live electricity running up from her arm to the fingers; This spontaneous case was reported by a patient and describes the occurrence of NEURALGIA (nerve pain in her left arm and her hand and the top of the shoulder), NERVE INJURY (she have severe nerve and muscle damage), MUSCLE INJURY (she have severe nerve and muscle damage), PAIN (excruciating pain like live electricity running up from her arm to the fingers) and PAIN IN EXTREMITY (excruciating pain like live electricity running up from her arm to the fingers) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEURALGIA (nerve pain in her left arm and her hand and the top of the shoulder), NERVE INJURY (she have severe nerve and muscle damage), MUSCLE INJURY (she have severe nerve and muscle damage), PAIN (excruciating pain like live electricity running up from her arm to the fingers) and PAIN IN EXTREMITY (excruciating pain like live electricity running up from her arm to the fingers). At the time of the report, NEURALGIA (nerve pain in her left arm and her hand and the top of the shoulder), NERVE INJURY (she have severe nerve and muscle damage), MUSCLE INJURY (she have severe nerve and muscle damage), PAIN (excruciating pain like live electricity running up from her arm to the fingers) and PAIN IN EXTREMITY (excruciating pain like live electricity running up from her arm to the fingers) had not resolved.            Concomitant medications was not provided by the reporter. Patient mentioned she did not experience any symptoms after 1st and 2nd primary series. It was reported that the patient may require surgery in her spine. Treatment included physical therapy, unknown if any other treatment was given.   Reporter did not allow further contact
LEFT SIDE OF NECK ITCHING, BEGINNING OF SLIGHT RASH; BY THE AM THE RASH WAS MORE PRONOUNCED- LARGE RED, ITCHING, BURNING BUMPS. THIS PROGRESSED THROUGHOUT THE DAY. ON THE AM OF 7/12/12 I WENT TO THE URGENT CARE AT MY DOCTORS OFFICE. SHE COULD FIND NO OTHER EXPLANATION FOR THE RASH THAN THE VACCINE. IT IS STILL LIMITED TO THE LEFT SIDE OF THE NECK, AND LEFT EARLOBE. I RECEIVED A PRESCRIPTION FOR FAMCICLOVIR- 7 DAY COURSE OF EVERY 8 HRS. FIRST DOSE TAKEN ABOUT 1000AM.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2022 at 10:15 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Feb-2022 at 10:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient had received booster dose. It was reported that patient had received lot 066H21A past its 30 days expiry date. No treatment medications were provided.
This case was reported by a healthcare professional (the subject's mother), via a GSK representative, and described the occurrence of rotavirus in an infant male subject (less than 1 year old) who was vaccinated with Rotavirus vaccine (manufacturer unspecified). The subject's medical history included bell's palsy. On an unspecified date in 2011 the subject received 2nd dose of Rotavirus vaccine (oral). On an unspecified date in 2011, less than one year after vaccination with Rotavirus vaccine, the subject experienced rotavirus and vaccination failure. The subject was hospitalised for 5 days and the healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were resolved. This case was reported as a vaccination failure. However, the time to onset since last dose and confirmatory laboratory results were not provided. Therefore the case does not meet GSK criteria of vaccination failure.
Patient reported a grand mal seizure the next day after her second COVID injection. Provider and patient believe that seizure activity has worsen since COVID vaccines. Is already on the maximum dose of Topiramate and seizures were reported well controlled since 2012 and patient reports worsening of seizure activity starting in March 2021. Patient was referred to specified hospital for continued treatment with neurology in April 2022. Hospitalization at that hospital 06/17/2022 - 06/22/22. First COVID vaccine Moderna given 02/12/2021 without incident. Following Covid Booster Moderna given 11/19/21. Seasonal Flu vaccine given 10/13/21.
Nausea; Loss of taste; This is a spontaneous report from Pfizer Sponsored Patient Support Program regulatory authority. A contactable consumer (patient's husband) reported for patient (reporter's wife). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry dates were not reported), via an unspecified route of administration, on 10Apr2021, as a DOSE 1, SINGLE and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry dates were not reported), via an unspecified route of administration, on 01May2021, as a DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced nausea and loss of taste on an unspecified date. Outcome of the events were unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021422131
had congestion for 30-36 hours, is still running "some temperature 1 to 3 degrees, slight headache for 24-48 hours.
Patient received MMR 11/22/02 and 1/28/03; received varicella 11/22/02 and 1/28/03. Experienced high fever day after second set of shots.
We mistakenly administered vaccine to a person younger than 16 years old.  We will NOT be administering second dose per our department of health.
PATIENT  FIRST DOSE WAS PFIZER THE PATIENT WAS GIVEN MODERNA FOR THE SECOND DOSE, THERE WERE NO SYMPTOMS AND SIGNS AT GIVEN TIME
Headache, Myalgia, Chills, sweats, fatigue, pain at injection site Narrative:  Other Relevant History:
While injecting, I noted bright red blood in hole - I removed the needle syringe, pushed the sm amt blood out, used a new needle and re-injected at a different (L) deltoid site. There were no apparent adverse effects.
5 min after receiving vaccine pt reported dizziness, and diaphoresis, pt denies sx of HA, CP.  BP on initial reading was 76/50.  After about 5 min pt was BP was monitored and pt remained on site for about 30 min for monitoring.  BP came back up to 98/60.
On April 1, 2021 started to get a pain where her injection shot is and the pain went from her upper arm to her fingers. Left arm was weak and she couldn't move it was very swollen. Left arm is very numb all the time and it's painful for her to move it. In May went to the hospital and they gave her pain medicine naproxen and methocarbamol.
No adverse effects; PQC Present?: Yes; the boxes that the vaccines come in are all blue and white and look similar; one dose of PROQUAD was inadvertently administered to the patient; This spontaneous report as received from a medical assistant refers to a 28-year-old female patient. Pertinent medical history, drug reactions and allergies were not reported.  On 20-AUG-2019, the patient was inadvertently vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number: S012472, expiration date: 20-OCT-2020, albumin status: rHA; dose was not reported) administered subcutaneously diluted in sterile diluent (wrong product administered). It was reported that the boxes the vaccines come in were all blue and white and looked similar (product packaging confusion). Product quality complaint (PQC) was filled. No adverse effects were reported.  The outcome of PQC was unknown.  The relatedness between PQC and the vaccine was not reported.