chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalized 11/11/2021-still currently admitted; COVID-19 positive 11/11/2021; fully vaccinated  Fatigue Subjective  HISTORY OF PRESENT ILLNESS: Patient is an 89-year-old man with severe dementia, hypertension, hyperlipidemia, seizures, AFib, depression and anxiety. Patient was brought from facility the ER due to increased fatigue, lethargy and being covered positive 11/09/2021.  Patient is too lethargic/demented to give any assistance for HPI.  His wife is also being admitted here and tells me that patient has been lethargic 8-10 hours a day for months now. I spoke with patient's son and he stated that his dad has been getting more lethargic for a few weeks now.  Recently saw PCP who did increase his Keppra thinking he was having partial seizures/postictal state causing lethargy.  Patient has not been started on this yet.  Son states though that can significantly worse and about Sunday.  Patient had a fall that at that time and then was seen on 11/0 9 he was tested positive for COVID-19 straight back home.  We discussed code status and son states patient is to be a full code, later on it determined brain dead hand and sister would determine when to ?pull the plug?. 11/13/2021 note: Discussed at length with patient's son and daughter.  We went over that hospice goals would be to not do any additional testing, medications or x-rays.  They are in agreement with this.  They reiterated that comfort care was their desire.  2. COVID.  Treatment has been stopped due to desire for hospice care.  11/18/2021 note: Discussed possible hospice at home vs facility. Initially told me they would be ok learning more about home hospice but have since told care mgmt that they would only be able to do facility and unable to care for him at home. Per CM, earliest would be 11/21 when out of iso.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 28-APR-2016, the patient was vaccinated with the second dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (which had a lot # of L009213 and an expiration date of 17-MAR-2017; however, dose, route of administration and anatomical location were not reported). No concomitant medications were reported. The vaccine experienced temperature excursions of 10.3 degrees C and 1 degree C for time frames of 4 hours and 42 minutes, and 42 minutes, respectively. Previously, it had experienced a temperature excursion of 10.30 degrees C for a time frame of 4 hours. These excursions were called out because of a data logger. Despite these excursions, no adverse effects were reported. This is one of several cases from the same reporter. Additional information is not expected because the reporter did not allow further contact.
28 patient received expired vaccine; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer vaccine (First dose was taken on 24-Mar-2021) on 24-Mar-2021 and Pfizer vaccine (second dose on 14-Apr-2021) on 14-Apr-2021. Past adverse reactions to the above products included No Adverse event with Pfizer vaccine; and No adverse event with Pfizer vaccine.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter No treatment medication was provided by the reporter
high fever, aching muscles, fatigue, nausea, headache, early menstrual cycle, lymph node swelling in injection arm, pain at injection site
-New onset Afib -Blood in urine after 1st dose, next day for 1 day
This spontaneous report was received from a health care professional refers to unspecified number of unspecified patients of unknown demographics. Approximately in 2016 (also reported as "unspecified dates starting on or after 23-FEB-2016") the patients were vaccinated with improperly stored VAQTA (dosing regimen unspecified) (lot L028666, expiry 04-NOV-2016; lot L023232, expiry 25-FEB-2017; lot L039659, expiry 15-MAR-2017; lot L041676, expiry 15-MAR-2017). Excursion details are as follows: which were exposed to the following conditions, were administered to unspecified patients: temperature: 1C, Time frame: 25 hours, there was no previous temperature excursion. It was a call because of a data logger. No adverse effect reported. GARDASIL 9 and MMR II appear in the product list as these products were involved in the excursion, however no improperly stored doses of GARDASIL 9 or MMR II were administered. No additional information was provided. This is one of two reports from the same reporter. Additional information has been requested.
Red swollen puffy very hot area around the injection.  Patient is very sluggish and low energy.  Skin feels tight and hot over the injection sight.
Bells palsy; This case was reported by a physician via sales rep and described the occurrence of bell's palsy in a female patient who received Rabies NVS (RabAvert) (batch number ARBA241B, expiry date 31st July 2022) for prophylaxis.   On an unknown date, the patient received RabAvert (intramuscular) 1 ml. On an unknown date, unknown after receiving RabAvert, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to RabAvert.  Additional details were provided as follows: The age at vaccination was not provided. It was unknown if the patient received RabAvert for pre or post exposure prophylaxis. The patient was given the Rabavert in her right deltoid, dose series unknown. The patient developed Bells Palsy.  Additional information was unspecified. The reporter consented to follow up.
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were unspecified. Pharmacist reported that the patient visited the pharmacy on 21-MAR-2016 with orders regarding series of RECOMBIVAX HB 40 microgram, intramuscular injection and administered the first dose on the same day (reported as day 0). The patient administered second dose on 28-MAR-2016 (reported as day 7) and third dose was yet to be administered on day 14. Pharmacist reported that the patient was on a list for a lung transplant, which was reason for the altered dose schedule of vaccination (inappropriate schedule of drug administration). No adverse effect was reported. Additional information has been requested.
received a dose from a Moderna COVID-19 vaccine vial that had expired 2 days prior.; received dose from vial that was more than 30 days refrigerated; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose from a Moderna COVID-19 vaccine vial that had expired 2 days prior.) and PRODUCT STORAGE ERROR (received dose from vial that was more than 30 days refrigerated) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-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 (received a dose from a Moderna COVID-19 vaccine vial that had expired 2 days prior.) and PRODUCT STORAGE ERROR (received dose from vial that was more than 30 days refrigerated). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose from a Moderna COVID-19 vaccine vial that had expired 2 days prior.) and PRODUCT STORAGE ERROR (received dose from vial that was more than 30 days refrigerated) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Follow up received on 05 oct 2021 contains non significant information .
arm now hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm now hurts) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included High cholesterol. Concurrent medical conditions included Hypertension. Concomitant products included SIMVASTATIN, AMLODIPINE, DIAZEPAM, METOPROLOL and CANDESARTAN for an unknown indication.    On 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm now hurts). At the time of the report, PAIN IN EXTREMITY (arm now hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       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; Reporter'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 recv vax 1995 & reported having elevated ALT, AST, HDL, & triglycerides results 2yr later 21APR97;
No Additional AE; HCP called to report that the patient was given PROQUAD instead of MMR II. The PROQUAD also suffered from a non supported temperature excursion. TE cases 02418202, 02418066.  HCP states they do not wish to be contacted about this and declines  any fo; The PROQUAD also suffered from a non supported temperature excursion; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 26-MAY-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) (dose and route of administration not reported) lot number w029552, expiration date 14-MAR-2024 for prophylaxis instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (interchange of vaccine products) that also suffered a temperature excursion of 8 degrees Celsius for 1536 hours (product storage error).  No adverse event was reported.
Hard time breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Hard time breathing) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUTICASONE PROPIONATE (FLOVENT HFA) for an unknown indication.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced DYSPNOEA (Hard time breathing). At the time of the report, DYSPNOEA (Hard time breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications was  provided by the reporter. Concomitant medication include OTC drugs.
I had a really bad headache, that is really different than my other headaches. It was like the one I had the last time I had COVID-19. I took a home COVID-19 test that came back positive. I had an e-visit and was prescribed PAXLOVID that I started taking immediately. In a couple of days, I started feeling better. It was worth the nasty taste in my mouth to feel better so quickly.
Sore red warm mildly swollen area at injection site.  home care apap warm compresses
I found out that my blood pressure was spiking as I was checking my blood pressure daily. In January they started to go up and are in the 150/90. I have also had a low grade headache since then with no known cause. Last winter, I had noticeable levels of fatigue and weakness. The provider ran a full blood panel and found no issues. She advised me to monitor it. I was placed on a different blood pressure med which did not work and I was placed back on the original medication and required to restrict salt in my diet. It has not helped. I am working through a prior authorization and going thru step therapy to see if I am able to go back to the original medications. The fatigue, weakness, and headaches have lessened. I am still experiencing elevated blood pressure numbers and fogginess.
one patient out of 12 pfizer first doses given received moderna vaccine and was documents as pfizer
Dizzy, lightheaded, vertigo, nausea, vision out of focus, unable to walk straight and have to stabilize myself on the wall. I have had 6 episodes lasting 3-24 hours. It has been over 2 weeks (since 12/26/2020 - now).
Moderna COVID-19 Vaccine booster was administered to the left arm. About 18 hours later a painful, palpable left axillary lymph node was noticed. At 48 hours after the booster, the enlarged, painful lymph node remains (Left axilla).
flu vaccine administered in left deltoid at 0954 and at 0955 became light headed and sat down.  At 10:05a client was in and out of conciousness and had a petite mal seizure lasting approx. 30 seconds in duration (paramedics on site).  Was transported to Hospital
Pt recvd 3 doses of Hep B vax NOV89; DEC89, & JUN90; First 2 doses w/Recombivax; Reporter indicated that pt "began their series on Recombivax-most had 2 of Recombivax & possibly 1 Engerix-B;
I started feeling unwell on 11/13/22 as I went to church, I just felt really tired like I needed a nap. As the week progressed, I could feel my glands had swollen, my head was hurting, my throat was sore, my oxygen was low. I went in to see my PCP on Thursday, they tested me for Influenza, COVID-19 and RSV. The RSV test came back positive. I was given a Z-PAK, benzonatate capsule, dexamethasone, I am starting to feel better but not close to 100 percent.
Fatigue  Body aches Fever Sore throat Headache  Sore arm
little soreness at injection site; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PAIN (little soreness at injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Allergy.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced INJECTION SITE PAIN (little soreness at injection site). At the time of the report, INJECTION SITE PAIN (little soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product included unspecified blood pressure and gout medication.  Treatment information was not provided.
pt recv vax; exp red raised rash around inject site approx 3cm in diam w/ itching, swelling, redness and warmth also at inject site; tx w/ dph & observed for 30 min; reporter felt that pt's exp were related to vax;
Fatigue, weakness, fever 101,sore joints, rash over body, low blood pressure
injection site has remained red and warm to the touch; injection site has remained red and warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site has remained red and warm to the touch) and VACCINATION SITE ERYTHEMA (injection site has remained red and warm to the touch) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE WARMTH (injection site has remained red and warm to the touch) and VACCINATION SITE ERYTHEMA (injection site has remained red and warm to the touch). At the time of the report, VACCINATION SITE WARMTH (injection site has remained red and warm to the touch) and VACCINATION SITE ERYTHEMA (injection site has remained red and warm to the touch) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
1st dose a year ago, 2nd not yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received over a year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose a year ago, 2nd not yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 21-MAR-2023 The pharmacist called to enquire, if patient should start Shingrix series again or get the second dose. The reporter (RPH) reported that a patient had not received the second dose. The RPH inquired any information available because they were talking about what the guidance would be to provide patient. The RPH was unable to provide any patient nor vaccine details. The reporter did not consent to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
4hrs p/vax pt noted to be tiwtching not reallyfull blown tonic-clonic sz;just twitching on & off was unresponsive for 20-30mins; pale yet breathing;
Severe , aching pain in arm, underarm, back. Tingling in fingers. Tired, sluggish
chest congestion; Dry cough; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6203) via an unspecified route of administration in the right arm on 14Mar2021 at 12:00 (at the age of 59-year-old), as single dose for COVID-19 immunisation. There were no allergies to medications, food, or other products. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient received other vaccine from Pfizer on same day of COVID-19(14Mar2021). The patient experienced dry cough and chest congestion on 17Mar2021 at 16:45. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The clinical outcome of dry cough and chest congestion were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
This case was reported by a other health professional via call center representative and described the occurrence of arm sore in a 56-year=old male patient who received FLUARIX QUADRIVALENT (batch number UNKNOWN, expiry date unknown). On 20th October 2014, the patient received FLUARIX QUADRIVALENT. On an unknown date, the dose was an unknown dose. On 21st October 2014, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced arm sore and erythema. On an unknown date, the outcome of the arm sore and erythema were recovered/resolved. The reporter considered the arm sore and erythema to be related to FLUARIX QUADRIVALENT. Additional information received: A patient received the FLUARIX QUADRIVALENT, and experienced arm soreness and redness the day after receiving his flu shot. The issues resolved at an unknown time after the injection. The exact dosage was unknown by the sales representative.
Case called office shortly after vaccine administered. States "I have had a significant increase in PAC's (pre atrial contractions) or atrial ectopic beats since getting the vaccine and I don't know if its related or not. I know companies do post marketing research on vaccines. I looked it up and didn't see this as a side effect. I asked case if he had any SOB wheezing, pain or swelling and he denied all. Instructed in SE of severe reaction and when to seek emergency attention and to please call me the next day to follow up or I would call him. I spoke to case on 9/1713 at 10 AM and case stated that "my PAC's got worse as the day went on at several per minute per ECG but I did not go into Afib". I do have a history of Afib. When asked if he went to ER or to primary MD case stated he had his own ECG machine at home which he purchased previously after having episodes of Afib. Case reports pulse was 68 and BP 135/78. Case denies any redness, swelling, pain, itching at site or any other rashes. Denies having any PAC's today. Informed case that I would file VAERS form.TC to case at 3 PM 9/17/13 to get information on previous medical hx and med's. Case reports feeling fine now. Meds: Amlodipine 5 mg qd, Losartan, 100 mg qd, Finasteride 5 mg qd, Prevacid 60mg qd, Atenolol 25-50 mg PRN for irregular heartbeat. Case did take Atenolol yesterday.
1 day p/vax pt devel an inj site rxn characterized by a 2-inch by 3-inch area of redness & induration;pt seen by MD:over next 2 days the redness & induration extended to elbow;rxn began to resolve, 4 days post vax;
In July 1999, the pt developed acute general weakness, weight loss, and shortness of breath.