chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Admit Date:  7/21/2022   Discharge Date:  7/27/2022    Principal Dx/ Final Dx: COVID-19   Relevant Inpt Dx: Principal Problem:   COVID-19 Active Problems:   Type 2 diabetes mellitus with kidney complication, without long-term current use of insulin   Numbness in both legs   HTN (hypertension)   PAD (peripheral artery disease)       Follow-up Recommendations: #1 please take medication as prescribed #2 please keep follow-up appointments   HPI: As per Doctor's Note:  "(the patient) is a 89 y.o. male with a history below who presented from a nursing home with the complaints of shortness of breath, bilateral lower extremity numbness. Not sure if the numbness is acute or chronic. Tells me that the numbness comes and goes. Poor historian. No family at bedside. Denies any shortness of breath on 2 L nasal cannula. Tested positive for covid 19.  Imaging revealed bilateral chronic DVT in the lower extremities with PAD. Denies any chest pain, abdominal pain, nausea, vomiting, fever or any other concerning symptoms. Admitted for further evaluation."   Hospital Course:   Patient presented with shortness of breath and bilateral lower extremity numbness. He was found to have Covid 19 but chest x-ray was negative for pneumonia.. Because of hypoxia he was started on Decadron and Remdecivir. Gradually his symptoms improved and he was weaned off the oxygen very quickly. Remdecivir and dexamethasone was stopped early because of significant improvement in his symptoms. He developed acute kidney injury during his inpatient stay which improved with fluid hydration.   During his hospital stay he was evaluated by neurology and vascular surgery for his bilateral lower extremity numbness. CT lumbar spine was done and his lower extremity numbness was attributed to spinal arthritis. Neurology recommended outpatient follow-up for neuropathy workup. He was cleared by vascular surgery without the need for any intervention at this time. With improved symptoms he wanted to go home. He was recommended to follow-up with the neurology, vascular surgery, and PCP as an outpatient.     Unresolved issues requiring follow up (w/ labs or studies): None
moderna covid-19 doses administered past manufacturers expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (moderna covid-19 doses administered past manufacturers expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (moderna covid-19 doses administered past manufacturers expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (moderna covid-19 doses administered past manufacturers expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment drugs were reported.
STARTED FEELING ILL WITH HEADACHE.  AT ABOUT 7 PM, COLLAPSED AT WORK ON THE FLOOR.  SUPERVISOR CAME AND PLACE CLOTH ON ME. SENT TO RESTING AREA.  WENT TO ER AND WAS TOLD TO STAY HOME. WEAK AND ILL FOR THREE DAYS.  STILL HAVING PERIODIC JITTERS.
Got 2nd shot on Tuesday my arm is still sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 7th June 2022, the patient received the 2nd dose of Shingles vaccine. In June 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 11-JUN-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient got shingles shot on Tuesday. The patient arm was still sore. The reporter stated that, it was better than getting shingles. Additional Supportive Information: The follow up would not possible as no contact details were available.
Patient woke up 9/27/22 at 2am with arm hurting, swollen and itching. Patient took benadryl then. 9/28/22 arm still hurt so she took tramadol she had on hand. Patient has been taking benadryl 3 times a day for the itching. As of 9/29/22 arm is still swollen, itching, and painful. Instructed patient to follow up with her dr for evaluation.
ANAPHYLAXIS, EPI, BenADRL TRANSPORT To ER Pt initially complained about feeling hot and then complained about weakness. Pt later developed a slight rash on the neck and complained about difficulty swallowing.
(1/31/33), who did not meet eligibility requirements, was administered a second booster of Pfizer vaccine at the  mobile-clinic.  is eligible for a second booster on August 13th, 2022.
5min post vax, both legs flushed red had raised white whelps, largest approx 5mm; had 2 whelps on lt wrist; No dyspnea;
According to her after the second dose the pain  is even more painful; pain radiates more out, further than the injection site; Lump in her right  arm; She woke up with pain,the soreness woke her up; Redness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (According to her after the second dose the pain  is even more painful), PAIN (pain radiates more out, further than the injection site), VACCINATION SITE MASS (Lump in her right  arm), VACCINATION SITE PAIN (She woke up with pain,the soreness woke her up) and VACCINATION SITE ERYTHEMA (Redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Oct-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness). On 28-Oct-2021, the patient experienced VACCINATION SITE MASS (Lump in her right  arm) and VACCINATION SITE PAIN (She woke up with pain,the soreness woke her up). On an unknown date, the patient experienced PAIN (According to her after the second dose the pain  is even more painful) and PAIN (pain radiates more out, further than the injection site). At the time of the report, PAIN (According to her after the second dose the pain  is even more painful), PAIN (pain radiates more out, further than the injection site), VACCINATION SITE MASS (Lump in her right  arm), VACCINATION SITE PAIN (She woke up with pain,the soreness woke her up) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.            Patient is taking muscle relaxer for her broken ribs.  No concomitant medications were provided.   This case was linked to MOD-2021-368091 (Patient Link).   Reporter did not allow further contact
symptoms: chills, muscle aches, headache, sore throat, nausea and vomiting, malaise starting from 2.00 AM on 11/20/2021 until 8.0 PM on 11/21/2021; chills  and fatigue continuing until 11/22/2021.  I could only relate these symptoms to prior influenza infections.   treatment: acetaminophen 500 mg .
Patient  felt shaky and short of breath  , patient slightly aggravated and noncompliant, patient refused care from medical response team then changed his mind and was treated Patient refused medical transport and signed AMA form  Patients symptoms resolved and drove self home
Flu vaccine administered elsewhere. Pt developed high fever and felt ill a couple of hours after vaccination. She then developed high pitched loud tinnitus in L ear and also lost hearing. Dx elsewhere (urgent care) with acute sensorineural hearing loss and given prednisone. She was seen by ENT who thought possibly related to flu vaccine given temporal proximity.
Information has been received from a nurse refers to a patient of unknown age and gender. On 19-OCT-2015 the patient was vaccinated with the first dose in the HPV series with GARDASIL (dose, lot #, route and application site were not reported). On 07-DEC-2015, the patient came to the office to receive the second dose in the HPV series with GARDASIL 9 (dose, lot #, route and application site were not reported) (interchange of vaccine products). No adverse effect reported. Additional information has been requested.
Patient received 2nd Pfizer vaccine, stated she felt palpitations HR in 180's. Transported to ED where she was asymptomatic. Administered fluids, EKG and labs unremarkable. Observed for 2 hours and discharged stable.
Bell's palsy; This initial spontaneous report was received from a lawyer on 13-MAR-2020, regarding a case in litigation and refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 18-JUL-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles. Shortly (on an unspecified date) after receiving the vaccine, the patient suffered sudden onset of facial numbness and was diagnosed with Bell's palsy. As a direct and proximate result of patient's vaccination, his symptoms resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. The patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  Upon internal review, Bell's palsy was considered to be medically significant.
HEPLISAV-B 4 Weeks Ago, Received a Dose of Engerix Today; Initial Report Received on 28-Apr-2023  A pharmacist reported that a patient (gender, age, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization 4 weeks prior to receiving a dose of "Energix".   Medical history, allergies, and concomitant medications at the time of vaccination were reported as unknown.   On 31-Mar-2023, the patient received a dose of HEPLISAV-B vaccine (Lot #, expiration date, and NDC # unknown) intramuscularly in the left deltoid. No side effects were reported.  On 28-Apr-2023, the patient received a dose of "Energix" (no details reported).   No additional information was provided.  Company Comment:  The company assessed the events as non-serious.; Sender's Comments: The company assessed the event as non-serious.
17SEP91 ear infect given Amoxicillin; 19SEP91 measle type rash-dx by MD; 20SEP91 temp ranging from 103-normal;
Within 1/2 hour after administration, pt experienced hives over entire body (except legs) and a fever. The pt's private physician nurse told the parent to take the child to the hospital. Within on hour the child was at the hospital with a temp of 104 and hives. Pt was given Benadryl and Motrin. Hives began to go away and fever remained until morning.
diarrhea for 5 days; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea for 5 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 15-Jan-2021, the patient experienced DIARRHOEA (diarrhea for 5 days). On 20-Jan-2021, DIARRHOEA (diarrhea for 5 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Left arm pain at injection site radiating to axilla began 3-4 hours after injection given. Streaks of erythema started next morning. Warmth also evident today 12/30. Erythema upper back/neck/chest/arms.
This case was reported by a healthcare professional and described the occurrence of a 48-year-old male subject not responding to therapy following vaccination with Engerix B for prophylaxis. Concurrent medical conditions included type II diabetes. Concurrent medications included Glyburide, Lisinopril, Metformin and Toprol XL. On 26 April 2004 and 10 October 2003 the subject received 4th dose and 3rd dose of Engerix B at 20 mcg. Dose 1 and dose 2 were administered at another facility and dates of vaccination were not known. The subject had an exposure in April of 2007 and a titer was negative. Following the booster dose of Engerix B administered on 26 April 2004, a titer was again drawn (11 July 2007) and found to be negative. The subject had not responded to therapy. At the time of reporting the event was unresolved.
Red blotching at injection site. Whelp on right inner arm. 5 min after varicella injection. Injection given at 1353pm. Rash on face, and left arm. Dr order BENADRYL 5 mL. Pt watched every 5 min until 1 hr. Pt recovered and discharged.
Skin rashes on my right arm, upper shoulder area, and a little circle on my chest about a day after taking the second shot. No pain, rather experienced itchiness and redness. I waited a week until going to the dermatologist, where they performed a biopsy. The dermatologist was able to identify that it was Shingles, and the biopsy results two weeks later confirmed it. I have been taking Valacyclovir HCL twice a day, with putting Triamcinolone cream on the skin rashes twice a day as well. It?s been fading over the last two weeks.
had the shots and had shingles/suspected vaccination failure; had the shots and had shingles; itching really get to me; pain really get to me; fatigue really get to me; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the shots and had shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: had the shots and had shingles), pruritus (Verbatim: itching really get to me), pain (Verbatim: pain really get to me) and fatigue (Verbatim: fatigue really get to me). The outcome of the vaccination failure was unknown and the outcome of the shingles, pruritus, pain and fatigue were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus, pain and fatigue to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles, pruritus, pain and fatigue to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2023 This case was reported by the patient via interactive digital media. The patient reported that he/she was on 3rd round of shingles, last had them on December 2022 and already one were ago started again and stated that Shingles shot did nothing for him/her. The patient reported that the itching, pain and fatigue really got to him/her. This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible, as no contact details were available.
24 hrs after vaccine had malaise, mild ST, then felt better. Then 48 hrs after vaccine, worsening ST, fever, chills, body aches, lymphadenopathy
Second pregnancy- uncomplicated, due 8/28/18. Vaccine given at 28 wk routine appointment. Got in 2007 prior to med school and then in late 2014 with first pregnancy (both no reaction). Woke next morning with headache, fever, chills, muscle ache, lightheadedness, mild nausea. TYLENOL 500 mg helped symptoms but needed dosing every 4 hours as symptoms returned. Had to skip work and in bed all day. Took TYLENOL 3AM 6/7. At work morning 6/7 had to leave patient room as lightheaded and felt hot (did eat light breakfast). Sat on  floor, had soda, took a last dose of TYLENOL. Able to finish rest of day- afebrile now still and improved.
Vial was stored on 17-Feb-2022, expired on 01-Apr-2022 and administered on 05-Apr-2022; 21 patients administered with expired vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines) and PRODUCT STORAGE ERROR (Vial was stored on 17-Feb-2022, expired on 01-Apr-2022 and administered on 05-Apr-2022) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored on 17-Feb-2022, expired on 01-Apr-2022 and administered on 05-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines) and PRODUCT STORAGE ERROR (Vial was stored on 17-Feb-2022, expired on 01-Apr-2022 and administered on 05-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported  Date when vaccine was initially stored in refrigerator on 17-Feb-2022 No temperature excursions reported No adverse reactions reported after the vaccination No Treatment medication reported   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow up received contains No NewInformation
Information has been received from a physician concerning a 40 year old white male with HIV + (described as well controlled) and a sulfa allergy who on 02/23/2004 was vaccinated with measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  On 02/25/2004 the patient had a PPD which was negative.  Subsequently, the patient repeatedly tested non-immune to measles and simply did not serovoncert to measles.  It was also reported that the patient lost immunity by 07/06/2004.  It was noted that the vaccine was well tolerated.  It was noted that the physician did not vaccinate, was vaccinated at other facility.  No further information is expected.
Vomitting (1x), fever for 2 days which fluctuated between 100 and 101, 3 episodes diarrhea.  I do not believe this was a stomach virus because no one else in my family caught it, including my other child.
Information has been received from an other health professional via other company (2018526629) referring to a 69 year old female patient. The patient's medical history, current condition and concomitant therapy were unknown. On an unknown date in 2006, the patient was vaccinated with PNEUMOVAX 23 (dose, strength, route, batch/lot number and expiration date were not provided) for prophylaxis. On an unknown date in 2006, the patient reacted to PNEUMOVAX 23 when last immunized. Response to PNEUMOVAX 23 , the patient had been shortness of breath (Vaccination failure) and swellin in her arm. The outcome of the events was unknown. The causality assessments between the events and PNEUMOVAX 23 was considered as responsible by the reporter.
It was reported that a 51 year old male received a TD on 9/20/99. On 9/21/99, the pt experienced a fever, achiness and a local reaction of redness and soreness at the site along with sweats. Pt was told to take Benadryl and apply ice to the site. From correspondence received on 10/4/99, it was reported that the pt recovered from this experience.
patient received Pentacel and Quadracel vaccine duplicate a couple days apart/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Medical Information (Reference number- 00341358) and transmitted to Sanofi on 02-Nov-2020 via call-center.  This case involves a 4-years-old female patient who received a vaccine duplicate a couple days apart  DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: UJ2678A and expiry date: 04-JUN-2021) on 22-Oct-2020 and 0.5 mL DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (strength: standard, frequency: once, lot number: C5772BA and expiry date: 17-Sep-2022 via an intramuscular route in left thigh) on 30-Oct-2020 (extra dose administered) for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   It was an actual medication error case due to extra dose administered (latency: unknown).  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
High-pitched crying for 8+ hours, fever 105, severe swelling of leg, seizure.