chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was initially stored in the refrigerator on 16JAN2023; No adverse event; adult patient received expired Bivalent Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (adult patient received expired Bivalent Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16JAN2023) 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. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Mar-2023, 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 13-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (adult patient received expired Bivalent Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16JAN2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (adult patient received expired Bivalent Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16JAN2023) 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 (adult patient received expired Bivalent Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16JAN2023).    No concomitant medications were reported.  It was reported that 6 Adult patients received the expired Bivalent booster dose from 16-Feb-2023 to 13-Mar-2023. 1 Patient received on 16-Feb-2023, 2 Patients on 22-Feb-2023, 2 Patients on 05-Mar-2023 and 1 patient received vaccine on 13-Mar-2023. There were Intact cartons of vial size 2.5 ml. The vial was initially stored in the refrigerator on 16-Jan-2023. The vial did not undergo any temperature excursions.  No treatment details were reported. This case contains information for the 6th of 6th adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-717807, US-MODERNATX, INC.-MOD-2023-717808, US-MODERNATX, INC.-MOD-2023-717809, US-MODERNATX, INC.-MOD-2023-717810, US-MODERNATX, INC.-MOD-2023-717811 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717807: US-MODERNATX, INC.-MOD-2023-717808: US-MODERNATX, INC.-MOD-2023-717809: US-MODERNATX, INC.-MOD-2023-717810: US-MODERNATX, INC.-MOD-2023-717811:
Report received from a pharmacist (via a company partner, 1010USA00940). An 80 year old female patient received AFLURIA by intramuscular injection on 07-SEP-2010 for seasonal flu prevention. The batch number was 09949121B with an expiry of 30-JUN-2011. The patient had a pertinent medical history including hypothyroidism, osteoporosis and high blood pressure. Concomitant medications included FOSAMAX, PREMARIN, DIAZIDE, and SYNTHROID. Doses are unknown. The patient had no allergies. On 14-SEP-2010, 8 days following AFLURIA vaccination, the patient developed increased blood pressure, a racing heart rate and fever. The patient sought medical attention. The physician recommended to avoid any further flu injections. The patient outcome was reported as recovered on an unknown date. This case was considered serious due to medical significance. The events were considered possible to the suspect drug AFLURIA, however the patient had pre-existing hypertension. Information derived from this AE report does not change the current safety profile of the product.
Itchy rash on chest, arm pits, neck, back, steadily spread until widespread on stomach, thighs; full body rash; Fine rash, like hives, like fine bumps all over; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash on chest, arm pits, neck, back, steadily spread until widespread on stomach, thighs; full body rash) and URTICARIA (Fine rash, like hives, like fine bumps all over) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 03iL20A) for COVID-19 vaccination.     The patient's past medical history included Allergy test (I have a history of topical allergies, the results of one allergy test is included.). Concurrent medical conditions included Allergy to chemicals (NA56 Quaternium 15, Formaldehyde, thiuram mix, ethyl cyanoacrylate, mercaptobenzothiazole, colophony, propolis), Allergy to topical drugs (Tixocortol 21 pivalate), Reaction to preservatives (methylisothiazolinone, methylchloroisothiazolinone together with methylisothiazolinone, methyldibromo glutaronitrile, Iodopropynyl butylcarbamate, 2-Bromo-2-nitropropane 1,3-diol, sorbic acid), Plastic sensitivity (plastics) and Topical adhesive reaction (adhesives, glues).   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH PRURITIC (Itchy rash on chest, arm pits, neck, back, steadily spread until widespread on stomach, thighs; full body rash) (seriousness criterion medically significant) and URTICARIA (Fine rash, like hives, like fine bumps all over) (seriousness criterion medically significant). At the time of the report, RASH PRURITIC (Itchy rash on chest, arm pits, neck, back, steadily spread until widespread on stomach, thighs; full body rash) and URTICARIA (Fine rash, like hives, like fine bumps all over) had not resolved.            Treatment was 6-day course of prednisone 10 milligrams in decreasing amounts, and then prednisone 20 milligrams for 16 days in decreasing amounts. The rash improved during treatment but returned when dose was decreased.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Consumer reported events met serious criteria of Intervention/Medically Important
swelling under arm, axillary area / swelling in her arm pit area; redness at injection site; a little fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (a little fever), INJECTION SITE ERYTHEMA (redness at injection site) and LYMPHADENOPATHY (swelling under arm, axillary area / swelling in her arm pit area) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced PYREXIA (a little fever). On 14-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (redness at injection site). On 15-Mar-2021, the patient experienced LYMPHADENOPATHY (swelling under arm, axillary area / swelling in her arm pit area). On 13-Mar-2021, PYREXIA (a little fever) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (redness at injection site) and LYMPHADENOPATHY (swelling under arm, axillary area / swelling in her arm pit area) outcome was unknown.            No concomitant medications were provided.  No treatment was reported for the events.
At approx 13:35, patient, 38 year old, female, with C/o pressure in the chest which began while the Jansssen Vaccine was being administrated by LPN. This nurse was informed of this event a few minutes later and went over to assess patient. on a scale of 1-10, patient described the chest pressure as 2 or 3. She denied any other symptoms. No s/s of resp. distress notes. BP taken noted at 106/72, Pulse 71 pulse Ox on room air 99%.  Within a few minutes more of observing patient, she reported complete resolution of her chest pressure. She remained in observation area for a total of 30 minutes. BP notes at 96/67, PR 70. This nurse suggested for patient to eat some chips and hydrate to increase her BP but patient 97/67 BP was a normal for her since she was vegan. She probably couldn't have the chips. Also informed patient if symptoms  reoccur she should see medical attention. patient verbalized understanding.
15MAY96 devel rash on back w/low fever on 16 & 17;itching;mom gave 1/2 tsp DPH on 17 & 18 consulted w/family MD on 17MAY;mom states pt is recovering
died; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that an 83-year-old female patient (reporter mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history included hospice care and dementia. The patient's concomitant medications were not reported. The patient died one day after getting vaccine. She was reportedly in good health the day before receiving vaccine. She was on hospice, frail, but in good condition and checked by a hospice nurse the day before which she reported her in good health considering. She was with dementia but stable in her health. The reporter read investigating 23 deaths of people receiving vaccine in similar conditions. The patient died on an unspecified date.  It was not reported if an autopsy was performed.; Reported Cause(s) of Death: died
Pt complains of severe lethargy since injection (6 days).  Severe enough that he is unable to leave the house as is his usual custom.  Denies fever.  Reports blood sugars lower than normal and he's had to adjust his insulin intake in response to this.  Some nausea, but no vomiting.  Denies fever.
Hip issues after COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ARTHROPATHY (Hip issues after COVID vaccine) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease and Ulcerative colitis.    No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced ARTHROPATHY (Hip issues after COVID vaccine). At the time of the report, ARTHROPATHY (Hip issues after COVID vaccine) outcome was unknown.            No concomitant medications was reported.   It was unknown if patient was enrolled in a COVID-19 vaccine trial.   No treatment medications was reported.  The reporter's causality for the event of hip issues after covid vaccine with Humira was not provided. The reporter assessed event hip issues after covid vaccine as probably related to Moderna COVID-19 vaccine.
Numbness in face, hands, & abdomen, nausea, vomiting x4.
Swelling of the right deltoid region with mild erythema.  No limitation of movement.
"It seems like not all of the vaccine went into the patient"; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE ("It seems like not all of the vaccine went into the patient") in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE ("It seems like not all of the vaccine went into the patient"). On 14-May-2021, ACCIDENTAL UNDERDOSE ("It seems like not all of the vaccine went into the patient") had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment history was reported .
Patient was given his immunization very high up on his arm and is experiencing pain enough to keep him awake at night a month later. Shoulder pain.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 IMMUNISATION; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 IMMUNISATION. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 28Sep2023 to 02Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300330606 same patient, different SD/AE;
25Feb85 pt vax w/ MMR; 12Jan91 devel measles.
Information has been received from an other health professional concerning a female patient who on an unspecified date, was vaccinated with a dose of PNEUMOVAX 23 (lot# not reported). It was reported that on an unspecified date, the patient experienced soreness and swelling. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. No further information is available.
81 Y female with hx of HTN, HLD, MDD, pulmonary HTN, bedbound status due to severe obesity and hip/knee arthritis, recent hospitalization 12/3-12/15/21 for acute cholecystitis s/p cholecystostomy on 12/4/21 c/b bacteremia, buttock wounds and R leg cellulitis, COVID-19 positive on 12/25/21, who presented with nausea and malaise. Remained non-hypoxic, received remesivir x3 days to prevent severe disease per ID recs. Was noted to be neutropenic fever likely due to COVID. Labs not suggestive of DIC. HIT labs pending, SQ heparin held. Urine cx grew enterococcus cloacae and VRE but was asymptomatic, likely colonized urine. Patient and family opted to bring patient home with home health PT, declined SNF. Patient safe to be off isolation now per current guidelines.  #CORONAVIRUS COVID-19 DISEASE Received first dose Moderna vaccine on 12/14/21. Symptom onset on ~12/17/21, COVID positive on 12/25/21. Last known fever on 12/29/21. Except for cough and malaise, no respiratory symptoms, satting well on room air. No oxygen requirement. CRP mildly elevated. Risk factors: obesity. Patient remained nonhypoxic. Was treated with remdesivir for 3 days (12/29-12/31) given she has risk factor (obesity) and for prevention to severe disease per ID recommendations    #NEUTROPENIC FEVER #LEUKOPENIA  #THROMBOCYTOPENIA, UNSPECIFIED  Neutropenia secondary to COVID. DIC labs negative. Patient was on SQ heparin at SNF and last hospitalization. 4T score for HIT is 2 points: low probability for HIT. Noted to have neutropenic fever on 12/31. Source of fever likely COVID. Blood cultures no growth. Dc'ed abx given likely from COVID. Cell lines stable. -repeat cbc in 1 week -f/u HIT serologies -hold SQH   #UTI asymptomatic and ucx growing enterococcus cloacae and VRE -asymptomatic and not septic, likely colonized, hold off on tx   #NAUSEA  #CONSTIPATION  Patient has baseline nausea even during prior hospitalization. Likely worsened by COVID infection. Ct showed no obstruction and no evidence of cholecystitis or other acute abnormalities. No abdominal pain or peritoneal signs. -f/u general surgery for chole drain   #NONTRAUMATIC ACUTE KIDNEY INJURY  Cr 1.37 from baseline ~1, likely from dehydration. Resolved after fluids. -daily chem7 Reason for Hospital Admission (Admitting Diagnosis):  COVID-19 disease, AKI
Had a headache really bad; Nauseous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter reported same events under the same product for 3 patients. This is one of the 3 reports.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Had a headache really bad"; NAUSEA (non-serious), outcome "unknown", described as "Nauseous".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Three days post vax, the patient developed left arm and shoulder pain that occasionally radiates to the left hand. The patient was seen on 11/23/2001 by the physician for these symptoms.
Stomach cramps; sore left arm; upset stomach; very little energy; weak; Hot flashes; This is a spontaneous report from a contactable consumer. This 78-years-old male consumer reported for himself that. A 78-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 22Jan2021 12:00 (Batch/Lot Number: EL9262) as DOSE 1 SINGLE for covid-19 immunization(Age at time of vaccination 78). The patient past Medical history included emphysema from 1999 and ongoing, chronic bronchitis from 1999 and ongoing. After receiving the first dose of the Pfizer covid vaccine. On 22Jan2021 the patient experienced sore arm and, in the evening, he had an upset stomach. On day two when he got up, he was very confused, he had slept all day, he got up and went to the restroom and went back to lay down then woke up later that evening and he was confused since he slept the day through. He was confused because when he went to sleep it was daylight and woke up at night. At the end of day two, he had extreme stomach cramps, they were really bad, he used the restroom a couple of times. It was the worst stomach cramps he ever had on 23Jan202. Since the vaccine he has had very little energy and has felt very weak on an unspecified date in Jan2021. He normally does not take naps; he has noticed since taking the vaccine he will be sitting in his chair and then ends up waking up from taking a nap which is unusual for him. By the end of day two most of the soreness in his arm went away. He has continued to have stomach issues, slightly upset to queasy stomach, not fully recovered, stomach is still out of whack. His stomach cramps were the worst on day two, by day three it was slight cramps and then he has not had them since. He first noticed feeling rather weak and lack of energy when he woke up on the second day after receiving the injection, after sleeping all day not realizing he did sleep all day. The patient is treated with Pepto Bismol for stomach. States it is unusual for him to be having hot flashes and the hot flashes started a week post vaccine and they are persisting. He researched it last night and learned the men and women could get hot flashes. He is concerned since tomorrow will be day 21 post his first vaccine, he has nothing to tell him to go back to facility and no information given about second dose. It is very cold and will be very cold tomorrow and the next day. Advised to contact facility. The event outcome was recovered for sore left arm and Stomach cramps on an unspecified date in Jan2021 and Not recovered for rest of the events.
Arms limited on usage and later that night running a high fever, severe headache and body ache, fatigue, dizziness. Had to leave work and visit the doctor the next day. Fever lasted from 1030 PM until 300 PM. Still not able to use the arm fully and now have swelling and red spots around injection site .
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 55 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 25Mar2021 as dose 2, single (Lot number: ER8727), in left arm and on 15Nov2021 as dose 3 (booster), single (Lot number: FD0809), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. COVID 19 Treatment start date was on 22May2023 and stop date was on 26May2023. The patient has no known allergies and no other medical history.
chills; I felt crappy; red and itchy; bumpy on my chest; red and itchy; allergic reaction to the shot; Rash  on my groin area/ it spread to my neck, and a couple spots on my chest; This spontaneous case was reported by a non-health professional and describes the occurrence of FEELING ABNORMAL (I felt crappy), RASH ERYTHEMATOUS (red and itchy), RASH PAPULAR (bumpy on my chest), RASH PRURITIC (red and itchy) and VACCINATION SITE REACTION (allergic reaction to the shot) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced RASH (Rash  on my groin area/ it spread to my neck, and a couple spots on my chest). On 24-Mar-2021, the patient experienced FEELING ABNORMAL (I felt crappy), RASH ERYTHEMATOUS (red and itchy), RASH PAPULAR (bumpy on my chest), RASH PRURITIC (red and itchy) and VACCINATION SITE REACTION (allergic reaction to the shot). On 25-Mar-2021, the patient experienced CHILLS (chills). At the time of the report, FEELING ABNORMAL (I felt crappy), RASH ERYTHEMATOUS (red and itchy), RASH PAPULAR (bumpy on my chest), RASH PRURITIC (red and itchy), VACCINATION SITE REACTION (allergic reaction to the shot), RASH (Rash  on my groin area/ it spread to my neck, and a couple spots on my chest) and CHILLS (chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided.  Treatment included Benadryl and Prednisone   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: F/U 1 : AE details and outcome
Approximately 2 months after my 4th dose vaccination I contracted COVID-19 and experienced the following symptoms: Fatigue; Cold like symptoms; Fever; Sore throat. I was prescribed with Paxlovid for 5 days (3 pills in the morning and 3 pills at night) and so far it did help with my symptoms and as of 07/15/2022 I feel fine and have tested negative for COVID-19.