chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE/No PQC.; Improperly stored administered PROQUAD. .; This spontaneous report was received from a LPN referring to a 4 year old patient of unspecified gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 02-SEP-2023 the patient was vaccinated with an improperly stored dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, unk, lot #X007087, expiration date: 04-SEP-2024, administered for prophylaxis (strength, and route of administration were not provided) (product storage error).   The administered dose of the vaccine experienced a temperature excursion of 29.8F for  9hours 12minutes. The vaccines had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved.
Reaction started the next morning, rash and arm swelled. Pt went to ER on Wed 6/22/16.
Vial was initially stored in refrigerator on 18-Oct-2022, vaccine use by date was 17-NOV-2022,dose was administered on 18-NOV-2022.; No adverse event; bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17-Nov-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17-Nov-2022), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 18-Oct-2022, vaccine use by date was 17-NOV-2022,dose was administered on 18-NOV-2022.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051d22a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 18-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17-Nov-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 18-Oct-2022, vaccine use by date was 17-NOV-2022,dose was administered on 18-NOV-2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17-Nov-2022), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 18-Oct-2022, vaccine use by date was 17-NOV-2022,dose was administered on 18-NOV-2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17-Nov-2022) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 18-Oct-2022, vaccine use by date was 17-NOV-2022,dose was administered on 18-NOV-2022.).    No concomitant medications were reported. Vial size was reported as 2.5mL.Vial was initially stored in the refrigerator on 18-Oct-2022.Vaccine use by date was 17-NOV-2022. Vial did not underwent any temperature excursions. No treatment information was provided. This case was reported for adult patient 6 out of 14 patients.   This case was linked to US-MODERNATX, INC.-MOD-2022-675260, US-MODERNATX, INC.-MOD-2022-675264, US-MODERNATX, INC.-MOD-2022-675268 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675260:Patient 6 US-MODERNATX, INC.-MOD-2022-675264:same reporter US-MODERNATX, INC.-MOD-2022-675268:Patient 6
ADVERSE REACTIONS; This spontaneous report received from a patient concerned multiple patients. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced adverse reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reactions was not reported. This report was non-serious.
Moderna and Pfizer vaccines administered-dose number unknown; Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pulmonary sarcoidosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "unknown", described as "COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "unknown"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna and Pfizer vaccines administered-dose number unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2023) Negative, notes: COVID rebound after testing negative for four straight days; (Apr2023) Negative; (Apr2023) Negative; (Apr2023) Negative, notes: COVID rebound after testing negative for four straight days including a negative PCR test on day 3. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300157745 same patient/product, different dose/event;
Received 1st and 2nd with incident. Received booster on 8/20/2021. Symptoms started on 8/22/2021. Redness, puffiness,  inflammation,  only on right side of face. Redness on inside of palate  on right side, rough to the touch. Went to doctor office, Nurse Practitioner diagnosed Herpes Zoster (Shingles.)
This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site erythema, injection site swelling, injection site pain and fever. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site pain and fever were unknown.  It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site pain to be related to Shingles vaccine. The reporter considered the fever to be related to Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got fever from the 1st shot of Shingles vaccine and had some redness, swelling and soreness on the injection site. The patient stated that the 2nd dose would be in next year. The follow-up would not be possible as no contact details were available.
approx 24hr p/vax pt devel clinical chickenpox, w/vesicular lesions on trunk, extremities & face;
Raised red rash; Red rash at injection site; It was itching near site; Some hives were forming; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (It was itching near site), INJECTION SITE URTICARIA (Some hives were forming), RASH PAPULAR (Raised red rash) and VACCINATION SITE ERYTHEMA (Red rash at injection site) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced INJECTION SITE PRURITUS (It was itching near site), INJECTION SITE URTICARIA (Some hives were forming) and VACCINATION SITE ERYTHEMA (Red rash at injection site). On an unknown date, the patient experienced RASH PAPULAR (Raised red rash). At the time of the report, INJECTION SITE PRURITUS (It was itching near site), INJECTION SITE URTICARIA (Some hives were forming), RASH PAPULAR (Raised red rash) and VACCINATION SITE ERYTHEMA (Red rash at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
JANSSEN COVID -19 VACCINE WAS ADMINISTERED TO PATIENT AT 10:20AM TODAY. PATIENT WAS DIRECTED TO WAIT FOR 15MINUTES AS REQUIRED BUT JUST WITHIN 2 MINUTES OF VACCINE ADMINISTRATION SHE COLLAPSED ON THE FLOOR. SHE WAS UNRESPONSSIVE FOR LESS THAN  A MINUTE THEN  BECAME RESPONSIVE. WHEN ASKED WHAT HAPPENED SHE STATED SHE FELT DIZZY AND SLIPPED TO THE FLOOR. SHE FELT COLD IN HER EXTREMITIES AND SWEATY. SHE WAS KEPT SUPINE, HER FEET WERE ELEVATED AND APPLIED A COLD COMPRESS ON HER FACE AND NECK AREA FOR A FEW MINUTES. SHE WAS KEPT ENGAGED WATCHED OVER FOR ABOUT 20MINUTES. SHE REFUSED US CALLING AMBULANCE. WHEN SHE SAID THAT SHE WAS NO LONGER FEELING SWEATY AND COLD IN HER HANDS SHE WAS ALLOWED TO SIT UP. SHE KEPT AND OBSERVED FOR UP TO ONE MORE  HOUR. SHE REQUESTED TO BE ALLOWED TO LEAVE AND WE LET HER GO HOME. SHE CALLED THE PHARMACY LATER AND INFORMED US THTA SHE WAS  DOING WELL.
On the 2nd or 3rd of October 2021 I had swollen lymph glands around my neck and throat area. It felt like I had flu like symptoms. I also had a sore throat. I had never developed a fever, and I didn't feel real bad just some difficulties swallowing from the sore throat.  I had went to the doctor on about 10/5/2021. The doctor said my throat was red and raspy and that my lymph glands were swollen. He said he can't confirm if my symptoms was related to the vaccine. I was prescribed antibiotics to take for 5 days. The sore throat and swollen lymph glands had went away. I still finished the round of antibiotics, and ever since then I have not experienced those symptoms anymore.
has administered adacel to a patient that leaked out and spilled on the patient's arm, with no reported adverse event; Initial information was received on 09-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 35 years old female patient who Was administered diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] that leaked out and spilled on the patient's arm, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included influenza vaccine RHA 3V (BACULOVIRUS) (Flublok) for Prophylactic vaccination.  On 07-Nov-2022, the patient received dose 5 of suspect standard diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection at a dosage of 0.5 ml once (lot U7624AA, Expiry date - 06-Dec-2024) via intramuscular route in the left deltoid for Immunization.  On 07-Nov-2022 the patient developed a non-serious event of Was administered diphtheria-2/tetanus/5 ac pertussis vaccine that leaked out and spilled on the patient's arm, with no reported adverse event (accidental exposure to product) (latency: same day) following the administration of vaccine.  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.
Patient has a history of myopericarditis in 11/2018.  Pt developed chest pain on 12/12 the day after his booster shot.  He was hospitalized  on 12/14/21 after being found to have troponin level of  141.  He was treated with colchicine and ibuprofen.  He was discharged home on the following day (12/15).
Fever/pain and redness at site of pneumonia vaccine. H1N1 was above that.
5/8 Mom reported area of varicella is red, flat and rash going up leg. Is spotty and feels hot; Size of golf ball. Giving BENADRYL. 5/9 looks about the same and has a knot in it.
Diarrhea 2-3 times daily x 2 days. Nausea, congestion and chills intermittent x 2 days.
On Saturday, April the 3rd,  my wife's left leg became numb, and she had a tingling feeling. I took her immediately to ER, where they perform CT and MRI. She was internally transferred to the hospital, where she stayed there until April the 14th, when she was transferred to (the Rehabilitation Institute) to begin physical and occupational therapy. As of today, mi wife doesn't have proprioception in  neither of her legs nor her belly (she has no control on bowel and bladder).
flu shot hurt a lot more than the COVID shot; Initial information was received on 20-Feb-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional (patient) via social media.  This case involves a patient (unknown demographics) who got hurt a lot more than the COVID shot (vaccination site pain), while he/she received INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (batch number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got hurt a lot more than the COVID shot (vaccination site pain) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as non-serious.  It was unknown if patient's physician provided consent to be contacted.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  The details of laboratory data were not reported   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the event.  There will be no information on batch number for this case.
Started with silver dollar size bump day after 6/11 - and was itchy. 6/12 - bigger and painful and a rash around it. Got steroid cream 6/14. Rash spread and got antibiotic.
Still experiencing tinnitis & hearing loss 3 weeks after 2nd Moderna vaccine.  I had an audiologist test my hearing and a physical exam by Dr. on March 4, 2021.  No treatment
Patient received an influenza vaccination at hospital sponsored clinic for employees at approximately 8:30am.  She began to experience itching of the hands approximately 2 hours later, developed generalized hives - seen by Nurse, immediately escorted to Emergency Dept - received IV fluids, IV solumedrol, oral benadryl, albuterol via neb(has asthma).  Discharged home after treatment.  Instructed to remain out of work for one additional day.
No adverse event; 20 patients who were over 65 years old. They were given today 25May2023 0.25; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 25-May-2023, the patient experienced UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25).    Concomitant product use was not provided by the reporter.  It was reported that on 25-May-2023, 20 patients who were over 65 years old was administered with 0.25 ml Moderna bivalent vaccine instead of 0.5 ml. All these patients had their monovalent and a previous booster dose of bivalent vaccine.  Treatment information was not provided.  This case contains information about patient 14th out of 20 elderly patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:Elderly Patient - 1
Very high fever (no measurement), vomiting, lack of sleep, fever gone in AM  99-100 following noon
No adverse event; HCP calling to report expired PROQUAD was administered to a patient inadvertently. HCP reports the vaccine had no previous temperature excursions. No side effects reported with the vaccine. No additional AE/PQC.; This spontaneous report as received from a medical assistant refers to a 2-year-old male patient. The patient's medical history, concurrent conditions were not reported. Concomitant therapies included STERILE DILUENT.  On 05-SEP-2023, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin)(PROQUAD), lot# W004026, expiration date: 02-AUG-2023, 0.5 milliliter (route of administration and anatomical location were not provided) for prophylaxis.  It was reported that expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was administered to a patient inadvertently (expired product administered). The vaccine had no previous temperature excursions. No side effects reported with the vaccine. No additional adverse event reported (no adverse event).  Lot number W004026 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) with albumin status rHA (recombinant Human albumin)(PROQUAD).
Severe Diarrhea, headache, fever, joint pain lethargy, abdominal cramping.
This spontaneous report as received from a consumer refers to himself, a 64 year and 10 month old male patient. Medical history, concurrent condition and concomitant medications were reported as none. On 11-APR-2018, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis. On 12-APR-2018, at 4 am the following day, he woke up with severe pain at the injection site (10 out of 10 on the pain scale). There is no swelling or mark at the injection site, and he did not had fever. He has tried to treat the pain unsuccessfully with TYLENOL 325mg and hot compresses. He has made an appointment with a neurologist but has not had an appointment yet. The outcome of vaccination site pain was reported as not recovered/not resolved. Causality assessment was not provided. No product quality complaint was present.
pt recvd vax;ashen colored,LOC & fell;pt hit her head & exp a tonic/clonic sz during which there were no resp & no detectable P;to er;CBC nl;dx as having a syncopal rxn;
Vaccine expired on 26-Feb-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administered on 15-Mar-2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 33-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administered on 15-Mar-2023).    No concomitant medications were reported.  This lot number 060B22A of vaccine was administered to patients with a count of in between 75 and 125. There were a total of 82 patients involved. The healthcare provider wanted to know if the vaccine administered on 15-MAR-2023 would be considered as valid for the patients.  It was also reported that there was potentially a second lot number of vials that had expired on 28-Feb-2023 and was administered to patients on 03-Mar-2023, but the healthcare provider did not have any details of that event at that time. The second potential lot was confirmed to not be used.  The vial size was reported as 10 dose vial.  The vial had not undergone any temperature excursions.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
She knows one person did die; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter mentioned that 'she knows one person did die' on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: She knows one person did die