chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant and refers to a 7 months old patient of unknown gender. No information about the patient's medical history and concurrent conditions was provided. On 16-NOV-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # M044397 with an expiration date in 20-JUN-2018), orally, for prophylaxis, reconstituted with properly stored sterile diluent (manufacturer unknown), that underwent a temperature excursion from 9 degrees Celsius to 25 degrees Celsius during 20 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1801USA001570: US-009507513-1801USA001572: US-009507513-1801USA001565: US-009507513-1801USA001566: US-009507513-1801USA001567: US-009507513-1801USA001568: US-009507513-1801USA001569: US-009507513-1712USA003377.
I started with symptoms at the end of June with back pain, later I started feeling a lot of pain on my left leg, My whole left leg feels tired and numb, I have notice where I can't sit with my legs crossed nor sit on that foot at all,  I can't be sitting down nor standing up for long period of times. I must keep rotating positions specially at night.  Sometimes I feel my neck very tired and my a lot of pain. I was referred to therapy and to see a Neurologist. I have been going twice a week for therapy for 4 weeks only. I did feel some difference after therapy to control the pain.
Area of swelling 10.5 cm x 9.5 cm, firm, and warm to touch with pain.
This spontaneous report was received from a physician via company representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 19-JAN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot No. J007946; expiration date 24-MAR-2016). "TF 5mcg/0.5mL Te" (route of administration and anatomical location were not reported). On an unspecified dates, the RECOMBIVAX HB had four temperature excursions: 24 hours (Lowest recorded temperature was -1 F (-1 Celsius); 72 hours (Highest recorded temperature was 9 F (9 Celsius); 48 hours (Lowest recorded temperature was 0 F (0 Celsius) and 48 hours (Lowest recorded temperature was 1 F (1 Celsius). No adverse effects reported. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Patient became positive for COVID-19 50 days after receiving 2nd dose of full vaccine series.   Last dose vaccine 1/24/21.  Tested positive on 3/15/21.  NOT hospitalized.  "Symptoms reported: Runny nose and headache Symptoms onset: 3/12/2021"
Client vaccinated with Pfizer vaccines for Covid on March 20 and April 20 2021.  Became symptomatic for Covid on 8/2 and tested positive PCR for Covid on 8/2/2021.  Reported as a breakthrough Covid case in a fully vaccinated person.
Patient first noticed painful spots in his scalp then lesions appeared on the back of his neck, and around his ear (left). Patient sought medical treatment 3 days later-got Valtex and Vicodin.  2/13/07-patient had sharp pain in left arm-which is still present
Diarrhea, GI upset, "flare of Ulcerative Colitis". Patient reports symptoms began within 1h of vaccine administration.  Patient seen in acute care clinic the following day, and treated with esomeprazole, loperamide, mesalamine.  Patient recovered completely on day following treatment. Today, patient reports that he may have also had GI upset following a Tetanus immunization in the past. (not previously reported)
Baby had strong Moro reflex-like spasms that progressed into clusters of over 100 spasms. Baby was taken to ED and admitted. EEG +Hypsarrhythmia. Dx with Cryptogenic Infantile Spasms, currently on treatment with no + response. Baby is developmentally regressed. Recovery unknown at this time r/t no response to current treatment. On Topamax, clonazepam and B6. Failed prednisolone and ACTH.
I took PREVNAR 13 inj. 0.5ml on 12/15/2015. I experienced, increased heart rate and higher blood pressure, extreme COLD SWEATS all night long even when house temp was 62F. This was after taking 2 Advils 250 mg each.
Pain starting in injection site, left deltoid, to shoulder to mid-clavicle 2 hrs after injection of H1N1 vaccine. Using anti-inflammatory drugs. 3/23/10 still having occ. pain.
started to itch 4 hrs p/shot was given; no rash seen; pt itches placed on DPH & cortisone cream per MD;
In the course of administering the vaccine, there was a leakage.; Not sure if the patient recieved full dose?; A spontaneous report was received from a physician concerning a 58-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the events, inappropriate dose of vaccine administered and syringe leakage.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unreported date, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.  On an unreported date, The health Care professional stated that in the course of administering the vaccine, there was a leakage. Not sure if the patient received full dose or not. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not applicable.   The outcome of the events, inappropriate dose of vaccine administered and syringe leakage were considered resolved on an unreported date.; Reporter's Comments: This report refers to a case of Incorrect dose administered and syringe issue for mRNA-1273, with no associated AEs.
Sore arm for a week after injection. The following day, full body muscle aches, weakness, lack of appetite, excessive tiredness, feeling of injection throughout entire body and headache. Continuing headache/migraine everyday since injection. Regular neck pain.
Rash all over arms, legs, and feet; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash all over arms, legs, and feet) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concomitant products included CARVEDILOL, NICARDIPINE, ATORVASTATIN, LATANOPROST and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced RASH (Rash all over arms, legs, and feet). At the time of the report, RASH (Rash all over arms, legs, and feet) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment includes steroids cream (Triamcinolone acetonide cream usp.1%).
LOSS OF BALANCE; BREATHING PROBLEMS; PROBLEMS WITH TONGUE; HEADACHES; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (LOSS OF BALANCE), RESPIRATORY DISORDER (BREATHING PROBLEMS), TONGUE DISORDER (PROBLEMS WITH TONGUE) and HEADACHE (HEADACHES) in an elderly female 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 Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Sep-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) Solution for injection in pre-filled pen, Citrate Free. On an unknown date, the patient experienced BALANCE DISORDER (LOSS OF BALANCE), RESPIRATORY DISORDER (BREATHING PROBLEMS), TONGUE DISORDER (PROBLEMS WITH TONGUE) and HEADACHE (HEADACHES). At the time of the report, BALANCE DISORDER (LOSS OF BALANCE), RESPIRATORY DISORDER (BREATHING PROBLEMS), TONGUE DISORDER (PROBLEMS WITH TONGUE) and HEADACHE (HEADACHES) outcome was unknown.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2022: Upon internal review on 08-Sep-2022, non-significant correction was performed to uncheck Drug not administered check box for suspect.
WEIGHT LOSS; MALAISE; GENERALIZED JOINT PAIN; .This spontaneous report received from a parent concerned a 19 year old of unspecified sex. The patient's weight was 49.5 kilograms, and height was not reported. The patient's pre-existing medical conditions included the patient had no history of vaccine allergy and no pre-existing acute illness 30 days prior to vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unk) 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 APR-2021, the subject experienced weight loss. On APR-2021, the subject experienced malaise. On APR-2021, the subject experienced generalized joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the malaise, weight loss and generalized joint pain was not reported. This report was non-serious. This parent/child case is linked to.
This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 07-MAR-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M005974, expiration date 02-FEB-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine were exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because all information was obtained.; Sender's Comments: US-009507513-1611USA004113:
This spontaneous report as received from a other health professional and refers to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored ROTATEQ lot # M014318 for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius for 4 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA002611: US-009507513-1708USA002612:
I had extreme vaginal itching.  I used anti-itch cream, coconut milk soap to the area, and also took baking soda baths.
crying, fairly high temp but mom didn't check degree all noc p/inject; local react quite red & most of anterior thigh swollen;
Patient says injection administered too high and she believes the bursa. She now has bursitis that won't resolve. Patient states may need cortisone injection to resolve.
This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dryness in mouth and tongue), ABDOMINAL PAIN UPPER (Very slight stomach ache), PARAESTHESIA (One of the reactions tiny pins and needles in lower legs or top of feet), MYALGIA (Muscle soreness from left shoulder to left wrist) and CHILLS (I had some chills that lasted for only an hour or two each day) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported. 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 18-Mar-2021, the patient experienced DRY MOUTH (Dryness in mouth and tongue), MYALGIA (Muscle soreness from left shoulder to left wrist) and CHILLS (I had some chills that lasted for only an hour or two each day). On 19-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Very slight stomach ache) and PYREXIA (I had a slight fever). On 14-Apr-2021, the patient experienced PARAESTHESIA (One of the reactions tiny pins and needles in lower legs or top of feet). On 19-Mar-2021, DRY MOUTH (Dryness in mouth and tongue), ABDOMINAL PAIN UPPER (Very slight stomach ache), CHILLS (I had some chills that lasted for only an hour or two each day) and PYREXIA (I had a slight fever) had resolved. On 21-Mar-2021, MYALGIA (Muscle soreness from left shoulder to left wrist) had resolved. At the time of the report, PARAESTHESIA (One of the reactions tiny pins and needles in lower legs or top of feet) outcome was unknown. No concomitant medicines were reported. No treatment information were reported. Action taken with the drug in response to events was not applicable. This case was linked to US-MODERNATX, INC.-MOD-2021-082342 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-082342:2nd dose of vaccine.
Painful arm. Numbess all the way to my fingertips. Headache. Nausea. Hot and cold chills. Achy all over.
Client stated that next day on the 22nd of April that her joints began to hurt, starting with her hands feet and shoulders then the next few days it was her hips and stomach, one week in the rash started to appear in the joint areas ( client has pictures if they are needed), this continue on for 3 weeks till just yesterday 5/12 that the rash was to her neck and face, then swelling of the tongue which prompted an ER visit.  Client states she has tried Benadryl, Claritin and Zyrtec to remedy the rash with no success. Client gave birth on 10/13/2021 labor was 40 hours, water broke at home, she was Group B strep positive received antibiotics during labor and until birth of child as prescribed, Pitocin used for 2 days, Epidural given and Spinal which did not work for client, she was then sent for C-sec. 4 months after c-sec client had to go in for surgery due to tear in internal sutures from c-sec.
Smallpox cross inoculation. Tiny whitehead popped up directly beneath pustule.
received an expired dose of Havrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 38-year-old female patient who received HAV (Havrix) (batch number E9G4E, expiry date 29th December 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th January 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 10th January 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The office coordinator reported that, patient received an expired dose of Havrix, which led to expired vaccine used. The reporter consented to follow up.
Covid vaccine x 2. Tested positive for covid on 8/25/2022. Expired at Medical Center on 8/25/2022.
This spontaneous report as received from a medical assistant refers to a 10 week old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 14-SEP-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # N022015, expiry date: 10-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868; US-009507513-1902USA009324:Original Case : 1902USA009323; US-009507513-1902USA009323:Original Case : 1902USA009323; US-009507513-1902USA009326:Original Case : 1902USA009323.
Intense erythema, tenderness and induration at left deltoid with erythema around shot spot.
p/recv vax later that day pt devel axillary temp of 99.6f & mild to moderate diarrhea; diarrhea persisted 6 days;
This spontaneous report as received from a register nurse refers to a 4 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 03-FEB-2014, the patient was vaccinated with dose 2 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Flu like symptoms: all over body aches, tiredness, low grade fever 99.6.  Over the next few days experienced dizziness,lost ability to speak,think and was extremely agitated.  Brought to hospital by ambulance for possible stroke.  Numerous tests performed: 2 CAT's, 2 MRI's, EEG, Ultrasound of carotid artery, heart.  Spinal tap and numerous blood tests including Lyme.  All tests negative.  On antibiotics in the hospital for 4 days, symptoms gradually subsided.  Discharged with 90% speech and some difficulty problem solving. Expect full recovery. 10/26/2009 hospital ecords for admission 10/14-10/18/2009. Patient presents with c/o's flu-like sx, aphasia, both expressive and receptive with rt sided weakness. TX: Telemetry, Dx studies and lab normal . No DC Dx noted. 11/10/09 Medical records received for date 10/15/09. DX: Presented with c/o gradual onset of intermittent confusion/weakness.
temperature excursion that was intermittent; This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications were not reported.   Since 28-JUL-2020,  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) were improperly stored and had temperature excursions.   On 25-AUG-2020, the patient was vaccinated with  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)  0.5 ml for prophylaxis, lot #T009929 and expiration date reported as 16-SEP-2021, albumin status rHA.   The temperature excursion was reported from -14°C to -10°C (max -9.5°C), during a time frame of 38 hours and 30 minutes. There was previous temperature excursion.   A digital data logger was involved.
About 24 hrs p/immun pt exp some chest tightness w/emesis once; following this lt arm became very swollen for a short perio of time w/a rash following on lt arm; pt t101 x 2 days; pt didn't feel good;
Patient fully vaccinated (Moderna), but not boosted, admitted to the hospital on 1/13/22 with COVID-19 and associated hypoxia. Patient was discharged on 1/18/22.
Patient reported via a "side effects survey" that her "eye sight decreased drastically for 4 days" following vaccination (noted to have started within 4 hours of dose).  No other care sought for this reported side effect.
This spontaneous report was received from a pharmacist refers to a 60 year old male patient. The patient had no drug reaction/allergies. The patient had no pertinent medical history. On 03-OCT-2015, the patient was vaccinated with ZOSTAVAX lot # L002423, expiry date 23-APR-2016 in the right arm (dose, strength, dose number, route unspecified). Concomitant therapies included LIPITOR and an unspecified flu vaccine received in his left arm on 03-OCT-2015. Since the time of vaccination of ZOSTAVAX, the patient experienced tingling in his right arm from his elbow to his shoulder. The patient did not seek any medical attention. The patient was not treated for the adverse event. The outcome of paresthesia was reported as not recovered/not resolved. No product quality complaint was reported. Causality assessment was not provided. No further adverse event information was provided. Additional information has been requested.
hard of hearing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (Batch/Lot number: unknown) at the age of 74 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: 02Feb2021, when the patient was 74 years old, for COVID-19 Immunization. The following information was reported: HYPOACUSIS (non-serious) with onset 2021, outcome "unknown", described as "hard of hearing". Therapeutic measures were taken as a result of hypoacusis.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
5 minutes post vaccination, patient had syncopal episode with seizure-like activity lasting less than 10 seconds in duration. Mother assisted patient to ground; patient did not sustain any obvious physical trauma. Patient alert and oriented within seconds of episode. Transported via EMS for evaluation/monitoring. Vital signs remained stable.