chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030B21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021 at 4:08 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 4:10 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Age of patient was reported as 65.89 for dose administered on 03-Mar-2021 and 65.97 for dose administered on 31-Mar-2021. No concomitant medications were reported. Batch number 014M20A underwent temperature excursion on 03-Mar-2021 with temperature 35 degrees Fahrenheit from 01:00 PM to 05:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 03-Mar-2021. Batch number 030B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit from 01:00 PM to 05:00 PM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 31-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. No treatment medications were reported.
urticaria began 24hr p/vax;tx w/DPH & prelone then vistaril;pt improved but sx still present 4 days p/their onset;
Redness, Warmth, Swelling, tender, itchy at site left 6cm x 5cm, Right 1cm x 1cm.
After about 24 hours I experienced a rash and lump at the injection site. It is warm to the touch. It is what has been referred to as "covid" arm on other adverse event reporting. I do believe it is starting to subside at this point.
Vial was expired on 13-Aug-2022, initially stored on 12-Sep-2022 and administered to the patient on 13-SeBC p-2022/Expired vaccine stored in refrigerator; No adverse event; Vial was expired on 13-Aug-2022, and administered to the patient on 13-Sep-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-Aug-2022, and administered to the patient on 13-Sep-2022), PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 12-Sep-2022 and administered to the patient on 13-Sep-2022/Expired vaccine stored in refrigerator) and NO ADVERSE EVENT (No adverse event) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 vaccine (First dose), COVID-19 vaccine (First booster dose), COVID-19 vaccine (Third dose) and COVID-19 vaccine (Second dose). Past adverse reactions to the above products included No adverse event with COVID-19 vaccine, COVID-19 vaccine, COVID-19 vaccine and COVID-19 vaccine.    On 13-Sep-2022 at 9:24 AM, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Sep-2022 at 9:24 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-Aug-2022, and administered to the patient on 13-Sep-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 12-Sep-2022 and administered to the patient on 13-Sep-2022/Expired vaccine stored in refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-Aug-2022, and administered to the patient on 13-Sep-2022), PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 12-Sep-2022 and administered to the patient on 13-Sep-2022/Expired vaccine stored in refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-Aug-2022, and administered to the patient on 13-Sep-2022) and PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 12-Sep-2022 and administered to the patient on 13-Sep-2022/Expired vaccine stored in refrigerator).    No concomitant medications were reported.  The vaccine was delivered and placed into the freezer on 18-Apr-2022.  Therefore, for administration on 13-Sep-2022, vial was removed from the freezer and placed into the refrigerator on 12-Sep-2022. The vial did not undergo any temperature excursion.  No treatment details were reported.
got sicker; injection site swelled bigger than golf ball hot and red raised about 1/2"; Initial information received on 21-Nov-2020 regarding an unsolicited valid non-serious case received from a patient.  This case involves a patient of unknown demographics who got sicker (illness) and injection site swelled bigger than golf ball hot and red raised about 1/2" (vaccination site inflammation), while he/she received vaccine influenza vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On an unknown date (years ago), the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (lot number and expiration date unknown) via unknown route in unknown administration site for prophylaxis vaccination.  On an unknown date (years ago), after initiation of suspect vaccine therapy, patient's injection site swelled bigger than golf ball hot and red raised about 1/2" (vaccination site inflammation). Patient got sicker (illness) that year than ever had been and did not normally catch all that goes around and It was patient's last.   No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown for both events.     There will be no information available on the batch number for this case.
Pt reported lightheadedness following vaccination which resolved after sitting for approximately 5-10 minutes. Patient did not have any allergy symptoms. The husband reported the next day that she did not have any lingering issues or effects. Today (10/27/2021) the patient presented at the pharmacy and received a prescription for prednisone due to left ear swelling that she is attributing to the flu shot. I explained that we should report this information to VAERs and she agreed.
Information has been received from a consumer concerning herself, a 67 year old female with lupus erythematosus and fibromyalgia who on 15-SEP-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (LOT# not reported). Concomitant therapy included LORTAB, LORAZEPAN (generic unspecified), fexofenadine hydrochloride, CELEBREX, ENAPRIL, LIPITOR, COUMADIN, metoprolol and amlodipine. About one week after receiving the vaccine, on 22-SEP-2009 the patient experienced muscle pain in her legs and then later the pain started to move to her buttocks and arms. The consumer reported that she saw her physician about the pain and she had some blood work done which showed she was positive for lupus. The consumer stated that the physician did other tests, which the names were unspecified, and they came back negative. The consumer reported that recently she saw a rheumatologist who was thinking she may have fibromyalgia. The consumer reported that she still has muscle pain. At the time of reporting, the outcome of the events was reported as recovering. The lupus was considered to be an other important medical event. Additional information has been requested.
This spontaneous report was received from a Licensed Practical Nurse refers to a 4 year old male patient. The patient previously received one dose of M-M-R, one dose of varicella virus vaccine live (unspecified), 4 doses of diphtheria toxoid pertussis acellular vaccine (unspecified) tetanus toxoid and 3 doses of poliovirus vaccine inactivated (unspecified). On 25-JUL-2018 the patient was vaccinated with PROQUAD from lot R003292 dose 1, subcutaneous in the left deltoid for prophylaxis.  On the same day, the patient was also vaccinated with KINRIX from lot 95FR9 dose 1, intramuscular in the right deltoid for prophylaxis. The sterile diluent (manufacturer unknown) (lot# M012716 with expiration date 20-AUG-2018, lot # N030577 with expiration date 19-APR-2019, lot# N027783 with expiration date 17-NOV-2019,lot# M013220 with expiration date 24-SEP-2018, lot# M035268 with expiration date 19-APR-2019; lot # N006322 with expiration date 11-JUL-2019, lot # M012718 with expiration date 10-NOV-2018, lot # N004190 with expiration date 04-JUL-2019, lot # N022038 with expiration date 27-NOV-2019, lot# N030574 with expiration date 05-JUN-2020, lot# N030178 with expiration date 15-JUL-2020) used to reconstitute the vaccines was properly stored. The medical assistant was not sure which sterile diluent (manufacturer unknown) lot numbers were used.  The vaccines were exposed to temperature excursion of -14 degree Celsius up to -10 degree Celsius for 5 hours total (including the previous exposure to temperature excursion). Data logger was involved. No product quality complaint (PQC) was involved in this case. No symptoms were reported. This is one of the several reports linked via same reporter link.; Sender's Comments: US-009507513-1807USA007589:
One week later had redness, slight swelling and slight itching at injection site in one place about the size of 3 quarters and one small place above that about the size of a Lima  bean. Was same size, but less itchy the following day. I can?t be 100% sure it was not from an insect bite, but looked more like hives.
Constant break through bleeding; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Constant break through bleeding) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ALPRAZOLAM and TRAZODONE.   On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Constant break through bleeding). At the time of the report, HEAVY MENSTRUAL BLEEDING (Constant break through bleeding) outcome was unknown.            No treatment information was provided.   This case was linked to MOD-2021-316165 (Patient Link).
headache; fatigue; body aches; joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache, fatigue, body aches and joint pain. The events lasted for 1 week. The patient recovered from all the events on an unspecified date.  Information on the lot/batch number has been requested.
had fever, chills, body aches?..a rough night.  Still have body aches beyond just the arm
Fever 103 for less than 24 hours. Muscle aches chills, nausea, weakness, fatigue, for 4 days.Did not seek medical attention. Fully recovered.
Pain at injection site started 12/02 at 5:40pm; fever/chills started 12/03 around 6 am; pain, swelling, erythema of injection site and entire deltoid from 12/02-12/06; tender at injection site from 12/02-current.
Mother was untruthful about age until after vaccine was administered.  She told us he was 16 and signed for him to get it. We caught it once we figured his age.
Patient received the vaccine on 12/11/19 at approximately 4:15pm.  He was in the pharmacy today and reported that following the vaccine he developed an increased heart rate which lasted for approximately 8 hours.
Red streak, hot to touch, headache, neck pain, flushed, light headed no fever. Tx with KEFLEX. (LD)
BELOW 18 YEARS OLD GOT THE JNJ COVID 19 VACCINE; OFF LABEL USE; This spontaneous report received from a pharmacist 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced below 18 years old got the JNJ covid 19 vaccine, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and below 18 years old got the JNJ covid 19 vaccine was not reported. This report was non-serious.
Patient hospitalized for Malignant neoplasm of colon, laparoscopic sigmoidectomy within 6 weeks of receiving Covid-19 vaccination.
Patient is currently pregnant, unknown to pharmacy/pharmacist estimated date of delivery.  Patient did NOT experience any adverse event in the 20 minutes following vaccination. This report is to file the mis-administration of a Moderna second dose after a Pfizer first dose.
Diarrhea on 2nd day., Duration approx 6 hours Vomited on 3rd day. One time/ PM.
Arm pain immediately after receiving vaccine. Fever, chills and body aches began 12 hours after receiving the vaccine and lasted 24 hours after that.
received a dose of the vaccine on 7sep2022 and received another dose of the vaccine on 25oct2022 with no reported adverse event; Initial information received on 25-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 69 years old male patient who received a dose of the vaccine on 07-Sep-2022 and received another dose of the vaccine on 25-Oct-2022 with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Sep-2022, the patient received 0.7 mL total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE once (formulation and strength not reported; lot UJ917AD) via intramuscular route in unknown administration site for prophylactic vaccination.  On 25-Oct-2022, he also received 0.7 mL total dose of the same vaccine once (formulation and strength not reported; lot UJ917AD) via intramuscular route in the left arm for prophylactic vaccination.  On 25-Oct-2022, the patient received a dose of the vaccine on 7sep2022 and received another dose of the vaccine on 25oct2022 with no reported adverse event (inappropriate schedule of product administration) (latency: same day of dose 2) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported, a patient received a dose of the vaccine on 7SEP2022 and received another dose of the vaccine today 25OCT2022.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the 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.
I've developed several tender, itchy bumps at various spots on my body at this time.  It's been 5 days since my 2nd injection of Moderna. I'm currently just applying hot compresses on the bumps to relieve the itch.  I don't know the outcome, since I may develop more bumps. I have 3 of them currently, and none are at the injection site.
development of "lump" at injection site in the week following vaccine, which patient states is very tender to touch
Dizziness and chills beginning 3 hrs after shot. Lasting for 8 hours
[after second dose] incoherent; [after second dose] no strength, no nothing; severe reaction to second dose/"off the wall" reaction; This spontaneous case was reported by a consumer and describes the occurrence of INCOHERENT ([after second dose] incoherent), ASTHENIA ([after second dose] no strength, no nothing) and VACCINATION COMPLICATION (severe reaction to second dose/"off the wall" reaction) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Irritable bowel syndrome, Hypertension, Coronary artery disease, GERD and Cholesterol. Concomitant products included ATORVASTATIN for Cholesterol, CLOPIDOGREL for Coronary artery disease, METFORMIN HYDROCHLORIDE (METFORMIN ER) and EMPAGLIFLOZIN (JARDIANCE) for Diabetes, PANTOPRAZOLE for GERD, LOSARTAN and HCTZ for Hypertension, CHOLESTYRAMINE and NORTRIPTYLINE for Irritable bowel syndrome, METOPROLOL for an unknown indication.    On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INCOHERENT ([after second dose] incoherent), ASTHENIA ([after second dose] no strength, no nothing) and VACCINATION COMPLICATION (severe reaction to second dose/"off the wall" reaction). At the time of the report, INCOHERENT ([after second dose] incoherent), ASTHENIA ([after second dose] no strength, no nothing) and VACCINATION COMPLICATION (severe reaction to second dose/"off the wall" reaction) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. The patient was almost incoherent, no strength, no nothing for 24 hours gradually it faded.   This case was linked to MOD-2021-377774, MOD-2021-370410 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Non-Significant follow-up appended On 05-Nov-2021: Upon follow-up receipt: Additional reporter added HCP added, patient demographic details added, medical history added, concomitants added, events start/stop added, events outcome updated. On 08-Nov-2021: Upon follow-up receipt: Non significant follow up
This spontaneous report as received from a registered nurse refers to a 20 year old patient. On unknown date (as a child) the patient received 2 doses of VARIVAX (Merck) and 3 doses of RECOMBIVAX HB. The reporter stated that the patient recently had titer's drawn for varicella and hepatitis B (reported in MARRS# 1307USA006271) both of which came back negative. Treatment for this consisted of booster doses of VARIVAX (Merck) and RECOMBIVAX HB. The outcome was not reported. The relatedness between VARIVAX (Merck) and the event was not reported. Some patient link MARRS#1307USA006271. Additional information has been requested.
Reports slight nausea, dizziness, tingling in both arms ~ 15 post admin. Vitals HR 92, RR 18, BP 142/98, O2 100%. Admin 10mg cetirizine with return to baseline ~ 15 med admin.  Vitals upon discharge HR 62, RR 15, BP 114/82, )2 100%.
aches (2nd dose) for a few days/pains (2nd dose) for a few days; sneezing episodes/will sneeze for 5 or 6 times in a row; eyes will water; nose will run; left arm hurt (2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches (2nd dose) for a few days/pains (2nd dose) for a few days), SNEEZING (sneezing episodes/will sneeze for 5 or 6 times in a row), LACRIMATION INCREASED (eyes will water), RHINORRHOEA (nose will run) and VACCINATION SITE PAIN (left arm hurt (2nd dose)) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 041B21A and 045A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu vaccine. Past adverse reactions to the above products included No adverse event with flu vaccine. Concurrent medical conditions included Cataract (patient is using eye drops to treat cataract.), Seasonal allergy, Overweight (patient stated that she is in pretty good shape except for being overweight), Depressed mood (sometimes patient gets depressed), Myalgia and Stress (patient gets stressed out occasionally). Concomitant products included FISH OIL, ZINC and VITAMINS NOS for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PAIN (aches (2nd dose) for a few days/pains (2nd dose) for a few days), SNEEZING (sneezing episodes/will sneeze for 5 or 6 times in a row), LACRIMATION INCREASED (eyes will water), RHINORRHOEA (nose will run) and VACCINATION SITE PAIN (left arm hurt (2nd dose)). At the time of the report, PAIN (aches (2nd dose) for a few days/pains (2nd dose) for a few days), LACRIMATION INCREASED (eyes will water), RHINORRHOEA (nose will run) and VACCINATION SITE PAIN (left arm hurt (2nd dose)) outcome was unknown and SNEEZING (sneezing episodes/will sneeze for 5 or 6 times in a row) had not resolved.            It was reported that patient had gone to the dentist and teeth were normal. Patient used to take a fluid pill but stopped taking it. Sneezing episodes are not constant but is ongoing Other concomitant medications include eye drops. .No treatment medications were reported.   This case was linked to MOD-2021-420621, MOD-2021-420632 (Patient Link).
84 year old on chemotherapy for gastric CA, admitted with lethargy ,wekaness and change in mental status.
Headache sore throat, fatigue Narrative:  DOB not specified and event date not specified.