chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Discharge Provider: Primary Care Provider at Discharge: Admission Date: 4/12/2023 Discharge Date: 4/19/2023    DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Generalized weakness [R53.1] COVID-19 [U07.1]   HOSPITAL COURSE: The patient is a 69-year-old gentleman who presented the hospital complaints of weakness.  The patient has multiple recent hospitalizations related to heart failure and chronic obstructive pulmonary disease exacerbation.  Patient on presentation was stable from a respiratory standpoint but was noted to be testing positive for COVID-19.  Patient's respiratory status remained stable throughout his hospitalization.  No medication intervention was necessary related to patient's COVID-19.  Patient was noted to have significant weakness during his hospitalization.  Recommendations from physical and occupational therapy were for the patient to be sent for subacute rehab.  Despite our recommendations and our concern for his ability to care for himself at home, the patient's insurance company did not authorize financial coverage for subacute rehab.  Subsequent plan is to discharge patient home with home health services. During the patient's hospitalization he was noted to have some significant hyperkalemia.  Patient's home Cozaar and Aldactone along with supplementary potassium were placed on hold.  Patient's blood pressure remained stable and in an appropriate range without administration of Cozaar and Aldactone.  Cozaar, Aldactone, and supplementary potassium are being held at discharge.  Recommend a repeat BMP in follow-up. Additionally, the patient was noted to have erythema and swelling surrounding his IV site.  Concern was noted for possible cellulitis.  Patient was started on IV doxycycline and had significant improvement of traced area of erythema.  Patient will be discharged home to complete a 1 week antibiotic course for suspected cellulitis of the left antecubital space. Patient is felt to be in stable condition at this time and is being discharged home with home health services
This spontaneous report was received from a physician via company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 30-JUL-2015, the patient was vaccinated with an improperly stored PEDVAXHIB Single Dose Vaccine, lot number K004541, expiration date 04-DEC-2016, (dose, route and anatomical location were not reported). The improperly stored PEDVAXHIB was in a Refrigerator, and, the highest temperature of excursion was 47 Fahrenheit degrees (8.33 Celsius degrees) with a sum of 24 hours of excursion. No adverse effects were reported and no product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.
devel hives @ site of DTAP, neck, ankles;blotchy rash on back;
I had congestion, and a cough. The next morning, I developed a headache, laryngitis, and I felt really bad.   I took an at home COVID-19 test that day and it came back positive. I called my doctor and he gave me Paxlovid. I started the medication and that night my symptoms had gotten better. I took it for 5 days and the only symptom I had while on the medication was a bad taste in my mouth.
Pt vaccinated with DTP/OPV developed rectal temp to 104 approx 7 hrs after vaccination.  No other reported symptoms.
Patient was given an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given an expired dose) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given an expired dose). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient was given an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that a vaccination provider gave an expired booster dose to an immunocompromised patient. The dose came from a vial that had been punctured 48 earlier, on 08Nov2021.  No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-385906 (Patient Link).
This case was reported by a nurse via sales rep and described the occurrence of red rash in a male patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced red rash. On an unknown date, the outcome of the red rash was unknown. It was unknown if the reporter considered the red rash to be related to BEXSERO. Additional details were provided as follows: The patient had red rash all over the body including face. The reporter agreed to follow up from GSK. No further information was available.
Patient received 4 vaccinations at approximately 3:55pm on 9/28/2018. Two immunizations were injected intramuscularly in the right detoid (SHINGRIX and FLUZONE-HD), while the other two immunizations were injected intramuscularly in the left deltoid (BOOSTRIX and PNEUMOVAX). Patient's husband called pharmacy around 10am on 9/30/2018 to notify of wife's swollen deltoid area of right arm; stated it was warm to touch, red, and painful. Other vaccines patient received that day were BOOSTRIX and PNEUMOVAX on her left arm (with no issues, no swelling, etc).
both shots and got shingles / suspected Vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In May 2021, 6 weeks after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient received both shots and got shingles 6 weeks after the second in May of 21. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation was unknown at the time of reporting. The follow up was not required. This case has been linked with US2021AMR199553 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR199553:same patient, same reporter
After the third booster she had a lot of pain in her arm, booster hurt way more than any of the shots she had previously; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: EW0150) at the age of 62 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "After the third booster she had a lot of pain in her arm, booster hurt way more than any of the shots she had previously".  Additional information: Patient had one vaccine and three boosters. After the third booster, she had a lot of pain in her arm, booster hurt way more than any of the shots she had previously. Lot of pain in her arm lasted 5 to 7 days. She clarified she thought she had 4 doses total but she only had three doses. She got the vaccine it's all over news and commercials said it was available now for all persons over the age of 50 and a great idea to get it now. That is why she went to get it.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201117917 same reporter/patient, different dose/events;US-PFIZER INC-202201118307 same reporter/patient, different dose/events;US-PFIZER INC-202201118308 same reporter/patient, different dose/events;
PATIENT FAINTED AFTER 4 MINUTES AFTER VACCINE WAS ADMINISTERED, HE WAS TALKING AND SUDDENLY FELL DOWN, HE REGAINED CONSCIOUSNESS WITHIN FEW SECONDS. PARAMEDICS CAME IN AND FOUND OUT THAT HIS GLUCOSE LEVEL WAS LOW. THEY GAVE HIM LIQUID GLUCOSE AND HE BECAME ALRIGHT.
FEELING BEARISH; MINOR ACHES; MODERATE CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported 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 an unspecified date, the subject experienced feeling bearish, minor aches, and moderate chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the moderate chills, feeling bearish and minor aches was not reported. This report was non-serious.
She had chest pain and dizziness and local swelling left arm 15 min after injection.
Dizzy; Blood pressure increased; This spontaneous case was reported by a non-health professional and describes the occurrence of DIZZINESS (Dizzy) and BLOOD PRESSURE INCREASED (Blood pressure increased) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Doesnt have @ this time) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DIZZINESS (Dizzy) and BLOOD PRESSURE INCREASED (Blood pressure increased). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) at an unspecified dose and frequency. On 01-Mar-2021, DIZZINESS (Dizzy) and BLOOD PRESSURE INCREASED (Blood pressure increased) had resolved. Not Provided      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.
Patient called me to inform us that the doctor diagnosed her with Bursitis in her left shoulder and indicated that the cause was the flu shot she received on 9/27/2019. She stated that the doctor prescribed Diclofenac Gel to be applied to shoulder to help with pain.
shingles; ring at injection site; condition aggravated; This case was reported by a pharmacist via other manufacturer and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (previously had Shingles had it vaginally in the outer).   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles, injection site reaction and condition aggravated. On an unknown date, the outcome of the shingles, injection site reaction and condition aggravated were unknown.   It was unknown if the reporter considered the shingles, injection site reaction and condition aggravated to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had a severe ring at the injection side for several days afterwards, but the big thing was that the patient said that she also previously when she had it vaginally in the outer. The reporter said that it was ongoing and she said that has also reactivated.
expired dose of IPOL was administered to a patient, no AE; Initial information received on 11-Dec-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to case 2020SA357481 (same reporter).  This case involves a 13 years old male patient who was vaccinated with an expired 0.5 ml dose of IPV (VERO) [IPOL](lot P1F49M and expiration date :30-Nov-2020) via intramuscular route in the right deltoid for prophylactic vaccination on 03-Dec-2020 (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (same day latency).   No adverse event reported at the time of reporting.   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.
Presented to ED w c/o headache and low BP; incidental finding of COVID+, asymptomatic
This spontaneous report as received from a nurse refers to a 19 year old patient. No information about medical history concurrent conditions and concomitant medications were reported. The reporter stated that on 23-MAY-2014 the patient was vaccinated with pediatric dose of VAQTA, dose 0.5 ml, route intramuscular. No adverse effect reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
This non-serious initial spontaneous case was received on 25-Sep-2017, from other health professional, concerning a female patient of an unspecified age. The patient's medical and concomitant medications were not reported. On 25-Sep-2017, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml, batch number: 1720801 (as reported), expiry date: April-2018, route of administration and anatomical location: not reported. On the same day, the patient had Allergic reaction, which might be itchiness and was treated with BENADRYL. On an unspecified date, the patient got better. At the time of this report, the outcome of the event was recovering. The reporter assessed the report as non-serious.
Narrative: Hospitalization-fully vaccinated, COVID negative on admission for right sided weakness found to be positive on day 3 of hospitalization for rehab transfer (asymptomatic).
Day 2 post vaccination, swollen glands         Day 3 post vaccination Chills, aches      Day 4 post vaccination dizziness, vomiting, headache Day 5 post vaccination headache, dizziness, flu-like, sleepiness  Day 6 post vaccination glands still swollen, headache, tiredness  Day 7 post vaccination, glands still swollen but much improvement overall  Day 8, continuing to improve
Vasovagal episode following vaccination. Spontaneous resolution once placed in supine position. Paramedics on site. No treatment required.
Pt developed vesicular, variclla rash over face, hand, shoulders, and arms 2-3 days following varicella vaccination. Pt had no fever but decreased appetite and malaise for 3-4 days as lesions popped and crusted over.
Vaccine given one day past use by date in the refrigerator.  Pfizer notified.  Physician notified then notified parent.  no further action at this time
severe swelling in hands and feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "exposed to Covid 19" (unspecified if ongoing), notes: was given the Regeneron infusion. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose:1, Starting with the first dose she experienced a side effect of severe swelling in hands and feet), administration date: 28Dec2020, for COVID-19 Immunization, reaction(s): "Starting with the first dose she experienced a side effect of severe swelling in hands and feet", "Starting with the first dose she experienced a side effect of severe swelling in hands and feet". The following information was reported: PERIPHERAL SWELLING (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 2021, outcome "not recovered" and all described as "severe swelling in hands and feet"; EXPOSURE TO SARS-COV-2 (non-serious) with onset Aug2021, outcome "unknown", described as "exposed to Covid 19". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reason for no lot number: of Pfizer covid vaccine: Caller unwilling to complete the report Expiry Date of Pfizer covid vaccine: Not Provided. Reporter stated that the patient is currently 68 years old but she was 67 when she received her vaccines. Reporter stated that her sister was in a nursing home in (with held) and she was her sisters power of attorney and she lived in (with held). She relays that her sister received the first dose of the Pfizer Covid 19 vaccine on 28DEC2020 and the second dose in Jan2021. Starting with the first dose she experienced a side effect of severe swelling in hands and feet, to the point that she was unable to bend her fingers and could not place her feet in wide slippers. She has never experienced this prior. The reaction stayed for weeks and after a long time it went away. In Aug2021 she was exposed to Covid 19 and she was given the Regeneron infusion. Now there have been cases of the new Covid 29 variant in her nursing home and they would like to give her a booster dose. Her sister refuses. The reporter stated that since she is the POA she has to make the decision if she should get a booster or not? She would like to know if this side effect of the hands and feet swelling has been reported and if she can safely get a booster dose after that reaction. Response was given per PI section 4 Contraindications. This report was not related to a study or programme. Caller was unwilling to complete the report expiry date of Pfizer covid vaccine. Investigation Assessment: Not Provided.   The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Patient said he received Td booster at place of employment 11/20/06. He has developed chronic pain in upper arm, muscle fasciculation.
Patient called pharmacy 5/14/21 and stated he developed a rash from the vaccine 5/13/21; He stated the rash got worse and he developed hives by 5/14/21. Pharmacist consulted patient to seek medical attention right away since rash has worsen since vaccine.
Patient stated she began to get nerve pain down her back, hip, and leg about 20 days after receiving the vaccine. She was given one day of valacyclovir treatment as well as gabapentin.
On 3/13/00 the pt received vaccine. On 3/14/00 at 13:00, pt experienced hand numbness and tingling on left hand. Unable to make fist. Tightness in left hand and pain in wrist. Trouble grasping items. By 3/16/00 PM, symptoms had resolved. A follow up report received 8/9/2000 adds: Pt developed the same symptoms one month after the onset of the initial symptoms. The symptoms involved both upper extremities. Her physician evaluated her and it was his opinion that she suffers from carpal tunnel syndrome. She is receiving treatment for this.
Flare up of all arthritis pain,  fever , sweating, chills.  Took normal medications , plus Tylenol,  went to bed early, fatigue on  Friday
Pain in arm (of immunization), (B) leg pain, lethargic. Mom had to lift patient to assist out of bed.
3 to 5 patients received expired Moderna Covid-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 to 5 patients received expired Moderna Covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    In September 2021, 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 (3 to 5 patients received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 to 5 patients received expired Moderna Covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the reporter's facility also had been using a Moderna COVID-19 vaccine with a lot number of 021C21A with an expiration date of 21-Oct-2021.  Some of the vaccine administrators mixed up the expiration dates of the two vaccines and vaccines that expired on 18-Sept-2021 were administered to 3 to 5 patients on 21-Sept-2021 and 22-Sep-2021  No relevant concomitant medications were reported.  No treatment information was provided.
1/27/2021- Fatigue 1/28/2021 around 2 AM- Coughing, Difficulty breathing had to use breathing machine and inhaler, hoarse voice, fatigue. Ended up sleeping over 12 hours  Went to lung doctor 1/29/2021- Still feeling same symptoms as 1/28/2021. Said had an adverse reaction to vaccine, prescribed to keep using inhaler and breathing treatments as needed, also prescribed AZITHROMYCIN 1/30/2021- Started to feel a little better, not as hoarse.  1/31/2021- Significantly Better than before. Still coughing  2/1/2021- About 70% better still coughing a little but improved
stinging when the medication enters the muscle; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of stinging in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced stinging (Verbatim: stinging when the medication enters the muscle). The outcome of the stinging was not reported.   It was unknown if the reporter considered the stinging to be related to Shingrix.     It was unknown if the company considered the stinging to be related to Shingrix.   Additional Information: GSK receipt date: 07-NOV-2023 The pharmacist stated that some people have reported stinging when the medication enters the muscle, but not from the needle. He mentioned that he noticed it as well when he received his first dose of Shingrix. The reporter consented to follow up via postal. The vaccine administration facility is the same as primary reporter.  No patient demographics just mentioned some patients.  This case is linked with US2023154447, same reporter.; Sender's Comments:  US-GSK-US2023154447:CASE FOR REPORTER/SAME PRODUCT/SAME EVENT
Large red area about 7 inches long and 4 inches wide with raised edges especially at bottom constant deep tenderness and armpit pain