chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Maculopapular rash; seizures X 2 and fever. Dx'd with Status Epilepticus and treated with Ativan. Per F/U 4/12/01: On the day prior to admission; 1st seizure was generalized but the 2nd one began with shaking of the right arm progressing to generalized convulsions. After her was given IV Ativan, he became apneic, required intubation. During intubation, an incisor was broken and the fragment was never found. He had 1 foul smelling stool in his diaper and he was then transferred, intubated, to another facility. In the ICU, he was more alert and extubated. Ceftriaxone and vancomycin were continued. When he was stable, he was transferred to the ward and did well. He was discharged home on no medications, when cultures were negative, to be followed by Pediatrics Neurology and by his local physician.
stored at a minimum of -0.6C and a highest of 53F over a month; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included HAV (Havrix) for prophylaxis, Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Shingrix, Havrix, Bexsero, Bexsero Pre-Filled Syringe Device and Engerix B. On an unknown date, unknown after receiving Shingrix, Havrix, Bexsero, Bexsero Pre-Filled Syringe Device and Engerix B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 13-MAY-2022 Reporter's comment: The vaccine coordinator reported that the vaccines involved were Shingrix, Bexsero, Havrix, Engerix B stored at a minimum temperature of minus 0.6 Degree Celsius and a highest of 53 Fahrenheit over a month.  The reporter reported that some of the vaccines were administered, and reporter was not aware of how many patient or which vaccines were used.  The reporter stated that the HCP (health care professional) would call with all the information needed. Agent accidentally forgot to ask for consent to FU (follow up). Additional Supportive Information: The reporter reported that the vaccines involved were Shingrix, Bexsero, Havrix, Engerix B stored at a minimum temperature of minus 0.6 Degree Celsius and a highest of 53 Fahrenheit over a month, which led to incorrect storage of drug.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR078653:same reporter
Patients were given shots during excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients were given shots during excursions) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A and 045C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 09-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 09-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients were given shots during excursions). On 09-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients were given shots during excursions) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information provided.
Extreme fatigue. At approximately 6:30 PM on the same evening of the vaccination, I was unable to stay awake. I fell asleep at the dinner table. A household member assisted me in getting to bed for the evening. The following morning I was fine and there were no more effects.
GONE THROUGH HELL TODAY; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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 not reported, batch number: Unk) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 08-MAY-2021, the subject experienced gone through hell today. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of gone through hell today was not reported. This report was non-serious.
Pt recvd 3 doses of Recomb 3APR & exp localized swelling 2-4 inc in diameter), rash & felt throat was closing; reporter stated event was immediately life threatening; 6APR92 exp upper resp infect; recvd Epi & DPH in ER;
Cough, fatigue, runny nose, and body aches starting 1/21/22.
pt recv vax 26OCT95 & 25MAR96 pt exp chicken pox w/over 300 lesions across body;it was unk whether the child had been exposed to varicella;no further details were provided;
Patient is a 53 year old man with a past medical history of follicular lymphoma diagnosed in 2008, more recently with DLBCL with CNS involvement (involving hypothalamus; dx 8/2018; s/p HD MTX, s/p BMT- followed by Dr.), autoimmune hepatitis, obesity, adipic DI, central hypothyroidism and type 2 DM who presented to Hospital via EMS after a  fall at home with multisystem organ failure leading to intubation in the ED and subsequent transfer to Oncology ICU for further management.   He was in his usual state if health until Sunday. On Saturday he got COVID vaccine at 4pm, that evening he had no issues. Sunday night around 10pm he didn't make complete sense and his wife was concerned because of his history of DM and treated CNS lymphoma. BG was 320-340 at that time. Monday he was good and Monday night he started to have shaking of his left hand. Tuesday he had one episode of diarrhea. Later he was more shaky in the shower and he started to fall and his wife was unable to grab him and he slid down the wall and could not get up.  Family was called to help and he was not making sense so they called EMS.  Wife reports that he was down approximately 3 hours before EMS was able to get him up. In EMS he was noted to have a large area of skin desquamation from the right posterior knee to the ankle. His GCS was 15. He had stable blood pressure and heart rate. He was hypoxia to the 50s and oxygen was applied.   In the ED he was found to be in multisystem organ failure and was intubated and had rapid progression of shock requiring  Epinephrine, Levophed and Vasopressin. Crash lines were placed and he was sent to hospital.  Upon arrival he was noted to have a cold pulseless right lower extremity and surgery was called. He was evaluated by Trauma Surgery, Orthopedic surgery and Vascular surgery and eventually underwent above the knee amputation. Unfortunately they were not able to remove all nonviable tissue and he continued to deteriorate. He was taken level 1 back to the OR and an additional 10 cm of nonviable tissue was removed. Unfortunately upon arrive he suffered cardiac arrest in the setting of severe lactic acidosis and hyperkalemia.
Incident occurred from possible inviable covid-19 pfizer-purple dose (booster) being administered to the patient.Patient reported no adverse events other than typical ones from covid vaccine. Patient accepted offer to come back to receive a replacement booster dose.
not able to urinate naturally and to empty bladder completely resulting in pain; Bladder incontinence; not able to urinate naturally and to empty bladder completely resulting in pain; was not able to urinate naturally and to empty bladder completely resulting in pain; pain in the muscle of both legs that progressed to paralyzed both legs; pain in the muscle of both legs that progressed to paralyzed both legs; back pain; This serious case was reported by a consumer via call center representative and described the occurrence of leg paralysis in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-FEB-2023, the patient received the 1st dose of Shingrix. In MAY-2023, between 2 and 3 months after receiving Shingrix, the patient experienced leg paralysis (Verbatim: pain in the muscle of both legs that progressed to paralyzed both legs) (serious criteria GSK medically significant), myalgia of lower extremities (Verbatim: pain in the muscle of both legs that progressed to paralyzed both legs) and back pain (Verbatim: back pain). On an unknown date, the patient experienced unable to urinate (Verbatim: not able to urinate naturally and to empty bladder completely resulting in pain) (serious criteria GSK medically significant), bladder incontinence (Verbatim: Bladder incontinence), bladder pain (Verbatim: not able to urinate naturally and to empty bladder completely resulting in pain) and painful urination (Verbatim: was not able to urinate naturally and to empty bladder completely resulting in pain). The outcome of the leg paralysis, unable to urinate, bladder incontinence, bladder pain, myalgia of lower extremities and back pain were unknown and the outcome of the painful urination was not reported.   It was unknown if the reporter considered the leg paralysis, unable to urinate, bladder incontinence, bladder pain, myalgia of lower extremities, back pain and painful urination to be related to Shingrix.     It was unknown if the company considered the leg paralysis, unable to urinate, bladder incontinence, bladder pain, myalgia of lower extremities, back pain and painful urination to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-JUL-2023 On behalf of patient, reporter stated that his girlfriend received the first dose of Shingrix, after couple of weeks later experienced bladder incontinence. She was not able to urinate naturally and to empty her bladder which resulted in pain. She visited the doctor to check kidneys, which were fine. In May 2023 she had developed with back pain and pain in the muscle of both legs that progressed to paralyzed both her legs. Since the patient was in rehab. The reporter consented to follow up.
The patient came in on 3/19/19 and stated she had been having awful pains in her arm since the date of the injection. She has had decreased range of motion in her left arm, especially when moving her arm behind her or over her head. She reported no swelling or redness at the injection site and no bleeding.
Pt was seen in ED with abdominal pain, distention, and vomiting. Was flown to another Hospital. Unknown until notification of death. No other information known.
a sore/swollen arm; a sore/swollen arm; upset stomach; This is a spontaneous from a contactable consumer (patient). This report is based on the information received by Pfizer (Manufacturer Control No: 2021-00909871).  A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a Dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a Dose 1, single for COVID-19 immunization. Patient reports that she recently received her 2nd COVID vaccine and had experienced a sore/swollen arm and an upset stomach. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.
pain at the injection site; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient) received from Pfizer medical information team. A male patient of an unspecified age received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 22Sep2021 at dose 3 (booster), single for covid-19 immunisation. Medical history included family history of cardiac issues. Concomitant medication included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported. Reporter asking if the Eliquis he takes could have a negative interaction with the Pfizer BioNTech Covid-19 Vaccine. Patient previously received first dose and second dose of bnt162b2 vaccine for covid-19 immunization on an unspecified date in Jan2021 and got the flu vac-cine a month ago and is scheduled for a pneumonia vaccine in Oct2021 or Nov2021. Reporter asking if there is a conflict with getting the Pfizer BioNTech Covid-19 Vaccine around the same time as other vaccines. On an unspecified date in Sep2021 the patient experienced pain at the injection site and fatigue. Reporter asking what percentage of individuals experienced myocarditis and pericarditis after get-ting the Pfizer BioNTech Covid-19 Vaccine. Reporter stated he has a family history of cardiac issues. Reporter stated he received a booster dose of Pfizer BioNTech Covid-19 Vaccine yesterday (22Sep2021) after receiving his primary vaccination series of Pfizer BioNTech Covid-19 Vaccine in Jan2021. Reporter stated he has experienced pain at the injection site and fatigue since receiving the booster dose. Reporter asking what percentage of individuals experienced fatigue after getting the booster dose of Pfizer BioNTech Covid-19 Vaccine. Reporter stated he is aware that the Pfizer BioNTech Covid-19 Vaccine booster dose is available for individuals 65 and older. Reporter asking if that means people less than 65 years old cannot get it. Briefly mentioned some fatigue but was in another part of what the caller was saying. Could be related to the booster shot. Outcome of the events was unknown.  Batch/ lot number not provided, it will be requested during follow-up activities.
WORST HANGOVER HAVE EVER HAD (DON'T KNOW IF DRINK) TIMES IT BY 10; MESSED UP; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number. No concomitant medications were reported. On an unspecified date, the patient experienced worst hangover have ever had (don't know if drink) times it by 10, messed up, and chills. The action taken with covid-19 vaccine was not applicable. The patient recovered from messed up, and the outcome of worst hangover have ever had (don't know if drink) times it by 10 and chills was not reported. This report was non-serious.
Patient described the site of injection started in the same day after she vaccine. The location was bruises and felt pain when she touch. The diameter of the bruises was around 2 inches. The bruises were dark, and it got better until today 10/20/2021. Patient had no other side effects.
SICK FOR THREE MONTHS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced sick for three months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick for three months was not reported. This report was non-serious.
Rash on legs, arms, chest  (hives?) for 6 days.   Moderate discomfort.   I am not sure if it is from the vaccine.  NP prescribed Prednisone and suggested reporting symptoms.  NP should be able to provide more detail as to the rash (diagnosis was e-visit through photos and phone).  Injection sight had no issues (no pain\rash at injection site)
The patient stated he was fine after the shot and went home.  Soon after he was home he became "extremely tired" and "had a hard time getting up from his chair".  He went to the ER and was evaluated with blood work, EKG, and urine analysis that all returned negative, according to the patient.  The patient stated he "was given steroids and IV fluids" and was hospitalized overnight and released the next day with the no specific diagnosis except" reaction to the vaccines".  He had to be catherterized and wife claims he was "paralyzed". He was released fully able to walk, talk, swallow, and eat.  He admits to a "decrease in stamina". He is able to continue with his work.
Information has been received from a physician through a pregnancy registry concerning a 37 year old female with a history of pregnancy who in March 2006 was vaccinated with Varivax, subcutaneous administration. In April 2006, the patient received a second dose of Varivax. In 2006, "many months after the second dose," the patient became pregnant. The OB/GYN ordered antibody titers that revealed that the patient failed to show antibodies. Patient outcome was not reported. Additional information has been requested.
Lung nodules; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult patient received BNT162b2 (BNT162B2), on 08Apr2021 as dose 2, single (Lot number: ER8729) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "Blood Pressure" (unspecified if ongoing); "neck Pain" (unspecified if ongoing); "Family history of stroke" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE HCL oral taken for anxiety (ongoing); HYDROCHLOROTHIAZIDE oral taken for blood pressure abnormal (ongoing); IBUPROFEN oral taken for neck pain (ongoing); ASPIRIN [ACETYLSALICYLIC ACID] oral taken for cerebrovascular accident (ongoing). Vaccination history included: BNT162b2 (1st dose:, Anatomical site of injection: Left Arm, Batch/Lot number: EN6207), administration date: 18Mar2021, when the patient was 59-year-old, for COVID-19 immunization, reaction(s): "Lung nodule". The following information was reported: PULMONARY MASS (medically significant) with onset 04May2021, outcome "unknown", described as "Lung nodules". The patient underwent the following laboratory tests and procedures: Computerised tomogram: (11Mar2020) Lung cancer screen pulmonary nodules: None; (04May2021) Lung cancer screen pulmonary nodules: multiple; (16Sep2022) Lung cancer screen pulmonary multiple new nodules, notes: Lung cancer screen pulmonary multiple new nodules (5.8x3.2). Therapeutic measures were not taken as a result of pulmonary mass.  Clinical course: Test: CT Scan. Date: 17Mar2023 Next appointment. Dose 3, Date: 11Oct2021, Anatomical site of injection: Left Arm, Batch Lot number: 301558A. Dose 4, Date: 20Apr2022, Anatomical site of injection: Left Arm, Batch Lot number: FJ4991.
a cousin of mine, 79 years old, it didn't protect him; a cousin of mine, 79 years old, it didn't protect him; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 79-year-old male 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "a cousin of mine, 79 years old, it didn't protect him". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.  Additional information: It was reported that, reporter's cousin was an ageing person and then they also said that the symptoms of the disease or very mild for everyone. Reporter was unwilling to complete the report. No further probing was done. Hence, limited information was available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received MENACTRA immunization. He laid on the table for approximately 10 minutes then sat up. Patient and mother were informed to stay 15 minutes. It was unclear how long the child sat on the bed before leaving for check out. During checkout the patient fainted. He bumped his head on the wall. Physicians and nurse were with him immediately. Dr. stayed with him until the child was stable.
11/28/2022, I started off by having sneezing and then head congestion, runny nose. Then I had a fever. I felt like I was cold and shivering, and I had muscle aches. I started testing with a COVID-19 home test, every day from 11/24/2022 through 11/29/2022 because I was going to a wedding, and all the results were all negative. I was not having symptoms, till 11/28/2022. On 11/30/2022, I tested with a COVID-19 home test and the results were positive. I had a virtual appointment on 12/01/2022, I asked if I could be prescribed PAXLOVID and my doctor agreed to prescribe it because of my age and because I am overweight. I started feeling better 12/05/2022. Through my place of employment, I was getting tested every week since January 2021. Also, I did not have a PAXLOVID rebound. It worked. I never had symptoms again and I never tested positive after the first bout of COVID.
No energy; Shortness of breath; Could hardly walk; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (No energy), DYSPNOEA (Shortness of breath) and MOBILITY DECREASED (Could hardly walk) in a 56-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received 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 ASTHENIA (No energy), DYSPNOEA (Shortness of breath) and MOBILITY DECREASED (Could hardly walk). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form as required. At the time of the report, ASTHENIA (No energy), DYSPNOEA (Shortness of breath) and MOBILITY DECREASED (Could hardly walk) was resolving.            The concomitant medications were not reported.  Patient stated that she did not experience any injection site reactions with the second shot.  It was also reported that patient still have side effects ever since he took shot he said he feels like there is no energy.   This case was linked to MOD-2021-090319 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: TCR received on 25-Jul-2021 narrative was updated and further follow up declined.