chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Janssen (J&J) COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 03/12/2021 and 04/7/2021. Patient presented to another facility on 8/1/2021 for shortness of breath and cough. Patient received dexamethasone, remdesivir, levofloxacin with continuous BiPAP. Patient was then transfered to hospital on 8/5/2021 for higher level of care. Patient received remdesivir, dexamethasone, methylprednisolone, baricitinib, zinc, vitamin c, and ivermectin. Patient continued to decompensate and expired on 8/19/2021.
Vaccine at 11:30 am 3/25/21. First symptoms at 7:30am 3/26/21. Fever, chills, aches , sleepiness, fatigue.  Effects subsided about 8 pm 3/26/21. Felt fine by the next morning 3/27/21.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetes" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 20Sep2023 to 24Sep2023. The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
broke up in hives; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of URTICARIA (broke up in hives) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 25J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-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 URTICARIA (broke up in hives). At the time of the report, URTICARIA (broke up in hives) 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.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt vaccinated with TD developed fever, pain in area, swelling in area, increased warmth, local adenopathy; Given Dicloxacillin 250mg qidx7d.
PATIENT COMPLAINED OF MODERATE LEVEL OF ITCHINESS LOCALIZED AT SITE OF INJECT.  ALSO HAD SOME SLIGHT RASH AND FORMATION OF PAPULE.  EVENT OCCURED ON 10/09 FOLLOWING INJECTION ON 10/07. SEEMS TO HAVE IMPROVED TODAY. DID NOT EXPERIENCE SAME REACTION TO RSV VACCINE PT RECEIVED IN LEFT ARM.
Woke up the next morning with slurred speech, right side weakness, illegible writing, balance issues.  Next day all symptoms worse. Went to Urgent Care, was transferred to Hospital.  Diagnosed with stroke.
Pericarditis.  Patient has had multiple visits to ER and clinic for chest pain/dyspnea.  Previously healthy
Missed second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-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 (Missed second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
pt recv vax 27OCT95 & devel pain & erythema @ the inj site;pt also devel neuropathy, characterized by daily, radiating pain down arm  & into the wrist;
No adverse event.  After vaccine given, discovered this was patients 4th pfizer shot.  Patient was fully aware he was not following protocol.   Said the media says he needs boosters so had given misinformation on consent form.
Expired Product Used; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number unknown, expiry date 2nd September 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st December 2022, the patient received the 3rd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 1st December 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02 DEC 2022 Reporter's comment:  This case was reported by physician. The physician reported that the patient administered a dose of Pediarix on 1st December 2022 and it was then discovered the dose had an expiration date of 2nd September 2022. This was the patient's third dose in the series. At the time of reporting, the Physician did not have the lot number available. Additional supportive information: As patient received the expired vaccine which led to expired vaccine used. Reporter consented to follow up.
Severe nausea and vomiting, unable to swallow water , chills  Unable to walk steady. Barely to the bathroom. Dehydration.  My physician diagnosed as side effect of Moderna vaccine and prescribed Zofran . Today is 4 th day after symptoms started and relief is little and very slow. Still nauseated and unable to walk steady. Vomiting stopped after one day.  Waiting to get back to normal and don?t know how long it will take.
ACHY FLU-LIKE PAIN; JOINT PAIN; NO ENERGY; KNEE PAIN/ ARTHRITIC TYPE ACHE; WEAKNESS; HEADACHE; EXHAUSTION; NERVE PAIN ON HEAD; RIGHT SIDE EYE INFLAMMATION; SLEEP MORE THAN NORMAL-HAVE A HARD TIME GETTING UP; PAIN IN MY BODY; PAIN IN LOWER BACK; This spontaneous report received from a patient via a company representative concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included torn meniscus of the left knee, minor brain blockage, fibromyalgia, cervical spinal stenosis, degenerative disk disease, disabled, overweight, mild egg allergy, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802068 expiry: not reported) dose was not reported, administered on 08-MAR-2021 to left deltoid for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for minor brain blockage. On 2021, treatment medications included: cannabidiol. On MAR-2021, the subject experienced sleep more than normal-have a hard time getting up. On MAR-2021, the subject experienced pain in my body. On MAR-2021, the subject experienced pain in lower back. On MAR-2021, the subject experienced nerve pain on head. On MAR-2021, the subject experienced right side eye inflammation. On MAR-2021, the subject experienced weakness. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced exhaustion. On 11-MAR-2021, the subject experienced knee pain/ arthritic type ache. On 08-APR-2021, the subject experienced achy flu-like pain. On 08-APR-2021, the subject experienced joint pain. On 08-APR-2021, the subject experienced no energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in lower back on 2021, and right side eye inflammation, had not recovered from knee pain/ arthritic type ache, and the outcome of headache, pain in my body, weakness, sleep more than normal-have a hard time getting up, exhaustion, achy flu-like pain, nerve pain on head, joint pain and no energy was not reported. This report was non-serious.
Pt recvd 3rd dose of vax & exp earache; No further details were provided;
I was doing dishes and all of a sudden my left ear started ringing and then was followed by decreased hearing. Ringing occurs intermittently but 2 days later I have not recovered me full hearing back.
On 5th day, I started with headaches that continued for 6 days, woke up tired and wanted to go back to sleep in the daytime. Also developed hard red hot patch on left arm above the injection site that also lasted about 6 days.
Patient received expired first dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired first dose of the Moderna vaccine) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired first dose of the Moderna vaccine). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired first dose of the Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment information was provided by reporter.   This case was linked to MOD-2021-338604 (Patient Link).
Felt very weak, very, very weak; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 94-year-old female patient received BNT162b2 (BNT162B2), on 02May2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 94 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "Covid" (unspecified if ongoing), notes: The caller was diagnosed with Covid in the very beginning, two years ago. Concomitant medication(s) included: AMLODIPINE taken for blood pressure measurement; LOSARTAN taken for blood pressure measurement; LABETALOL taken for blood pressure measurement. Vaccination history included: BNT162b2 (DOSE: 1, lot Number: EL9269, expiration: unknown, route of administration: right arm, Vaccine Name: Pfizer Covid Vaccine), administration date: 10Feb2021, when the patient was 93-year-old, for COVID-19 immunization; BNT162b2 (DOSE: 2, lot Number: EL9289, expiration: unknown, route of administration: right arm, Vaccine Name: Pfizer Covid Vaccine), administration date: 03Mar2021, when the patient was 93-year-old, for Covid-19 immunization; BNT162b2 (DOSE: 3, lot: FF8841, expiration: unknown, route of administration: right arm, Vaccine Name: Pfizer Covid Vaccine), administration date: 25Oct2021, when the patient was 93-year-old, for Covid-19 immunization. The following information was reported: ASTHENIA (non-serious), outcome "not recovered", described as "Felt very weak, very, very weak". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The number was unknown ,the patient did not received any other vaccine within 4 week to covid vaccination and did not received any other vaccine on same date. The patient was well prior to vaccination. The reporter inquired that about the fourth dose Pfizer Covid Vaccine stronger than the third dose Pfizer Covid Vaccine and had anybody else complained of being weak after receiving Pfizer Covid Vaccine.  No follow-up attempts are possible. No further information is expected.
Patient reported pain radiating down to elbow and up to shoulder, was originally warm to the touch. At time of report on 10/4/19 no longer warm, not red, not swollen
Client called health dept to report being hospitalized for pneumonia after vaccine administration.  Reports being hospitalized about 3 weeks and pulmologist and others doctors states it is from covid vaccine per client. Client is to not get 2nd shot according to Lung Doctor due to lungs being too weak. Client still recovering at this time but no linger hospitalized.
Patient stated on 07/11/2022 he experienced fatigue and sore throat at 6pm. He stated he took a COVID-19 test and it was negative. He stated he took OTC such as Tylenol. Patient stated 07/12/2022 at 3am he was experiencing Shivers, muscle ache and 107F fever. Patient stated that on 07/13/2022 he went to ER and was sent home, due to his symptoms he made an appointment with the NP in Hospital and is pending for Lab orders. He stated that he has lesions in his mouth about 3cm big and swollen lymph nodes since 07/13/2022. He stated he retested  for COVID-19 and results are negative. Patient stated that on 07/13/2022 at 4pm reports a body temperature of 97.9 F.
Pfizer vial was mixed with 1.5 mL of sodium chloride 0.9% instead of the 1.8mL
few hours after vaccination, I started to have severe headache, dizzy and abdominal pain. The headache and abdominal pain reached to their peak at night on the same day, and I took extra strength tylenol. I felt better after two hours. I still took the tylenol the following day since the severe headache and abdominal pain came back. It was relieved after a couple hours. The following five days, I had minor headache, felt dizzy and very tired.  I did not any more medicine. I got recovered a week since vaccination date.
I have not had a period or any period related symptoms for 13 months and had considered myself, by definition to be in Menopause. 13 days after the vaccine  I started having lower back pain, cramps and headaches. I didn't know what it was as I hadn't considered it to be PMS. The next day, day 14 post vaccine, I got my period and ended up in bed with lower back pain, heavier than previous bleeding and headaches. Today, is day five of the menstrual bleeding. While the bleeding is lessening, the cramps and headaches are not. This is not typical for me based on my recollection of PMS/MS. I am concerned that the cramping and headaches have not subsided and I am concerned as to why I am having a period after 13 consecutive months of nothing.
a 5 months and 22 days old female patient received a dose of Fluzone Quadrivalent/No AE; Initial information received on 14-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case is linked to case 2019SA320134.  This case involves a five months and 22 days old female patient who received a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot UT6656NA, expiry date: 30-Jun-2020 via intramuscular route in the right thigh On an unknown date.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  It was an actual medication error due to inappropriate age at vaccine administration.  No side effect were noted.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
three friends die; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 39-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "three friends die". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. For the query of the caller, Can you tell me where I can get Comirnaty vaccine, not the biotech labeled product', it was answered that my daughter is being forced to take a vaccine they say is Comirnaty but I don't get that because the labeled product is not available'. According to the CDC website that she last looked at this past Friday they specifically state that the Comirnaty would not be available until all EUA products not available.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200835906 same reporter/drug/event for different patients.;US-PFIZER INC-202200835907 same reporter/drug/event for different patients.;; Reported Cause(s) of Death: three friends die
suspected vaccination failure; had shingles a few months ago and they would have been worse without the vaccine; This case was reported by a consumer via interactive digital media (Facebook) 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 had reported this case for him/herself. The age at vaccination was not reported. The patient got shingles a few months before the date of reporting. The patient stated, he/she was so glad to have the vaccine otherwise shingles would had been worse without the vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Patient received a 3rd site of vaccine.  DTAP, Hep B, HIB, intramuscularly.  I noted baby had stiffness and some cough with fever this AM.  Mother said she woke up with it.  Mother returned with complaint of red rash in baby's tummy and back.  (red raised), temperature  96.8.
Information has been received from a registered nurse concerning a 50 year old female employee with penicillin and codeine allergies and an unspecified medical history who on 06-JUN-2008 was vaccinated SQ with the first dose of MMR II (lot # 658516/0215X). Concomitant vaccinations on the same day included a first IM dose of ADACEL (lot # C2767AA) and a first ID dose of APLISOL (lot # 62412) (also reported as being administered on 03-JUN-2008). Concomitant medication included PLAQUENIL. On 11-JUN-2008 the employee was seen for a second "TST". Subsequently, "1.5 days after vaccination" on approximately 08-JUN-2008, the patient developed blisters starting on her legs and later on one arm. The patient broke out on her legs and arms with tiny blisters that became a large quarter-size rash. The patient was seen in the ER and was given steroids and a referral to a dermatologist. The dermatologist was unable to provide a diagnosis. The patient was recently seen by the nurse who described smooth areas the size of a quarter that looked like bruised areas on her legs. The patient was told that she had been in the sun too long. However, the patient had not been outside. The patient was referred to a dermatologist. By the time the patient got her appointment, the rash was flat and there was nothing to biopsy. The dermatologist did not give her a diagnosis. There was no rash on the patient legs, but her legs were marked with areas that were round, quarter-size and at a glance appeared to be bruised, but they were not. The patient felt they were scarred, but they did not appear to be. On 08-JUN-2008 the patient had a mumps titer drawn. The results were positive. At the time of the report, the patient recovered on an unspecified date. It was noted that the patient's legs were rash free, but there were still some faint "shadowing" where the spots were. Follow-up information has been received from a registered nurse concerning this 50 year old female employee with the same blistery rash, some in circular form came to the reporter's office. The patient stated she had been off for seven days, came back to work and on the second night started to itch and it then developed into a rash. The reporter encouraged her to go straight to the dermatologist that she had seen the last time this had happened. The patient did and the doctor was able to take a biopsy of the blisters. The dermatologist also told the patient it was not contagious, and felt it could be viral in nature. The reporter indicated it was not related to MMR II. No further information is available. This is in follow-up report(s) previously submitted on 5/29/2009. Follow-up information has been received from a registered nurse who saw the employee on 19-JUN-2009. The nurse stated they felt the patient's reaction was caused by Gain Detergent. The patient's sister had recently moved in and washed some their cloths together. After the practice was stopped, there was no more rash. No further information is available.
rash on the buttocks or upper thigh; ecchymotic appearance; This is a spontaneous report from a contactable Other Health Professional (nurse practitioner). This Other Health Professional reported similar events for four patients (4 workers). This is the second of four reports.  A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (unknown age at time of vaccination) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient developed a rash on the buttocks or upper thigh within a few days to a week after getting a Pfizer COVID-19 vaccine. The rash begins with an appearance similar to shingles. After about a week the lesions are flat with an ecchymotic appearance. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : PFIZER INC-2021375425 same drug, event, different patient
Severe COVID arm. Below injection site is very red and swollen. Skin feels tight and warm in the area and is itchy. Still experiencing fever and swollen glands as of the date of this reporting. Developed some canker sores in mouth.
One week after shots (mmr and Chicken pox) moderate fever and small raised bumps on torso and face. Temperature was normal after 12 hours and bumps dissappeared in 48 hours.