chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Local swelling , redness, warmth 1in below injection site, 2.5x3in, oral BENADRYL + MOLTRIN, BENADRYL cream to site.
pt recvd Hep B vax & w/in 1/2 hour to 45 mins exp hypertension & tingling up through arm; tx w/DPH in ER; no epi given; reporter indicated events were immed life-threatening;
no adverse event; product storage error; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 08-OCT-2019, the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (strength, dose, indication, lot/ batch number and expiry date were not reported) and on 20-FEB-2020, the patient was vaccinated with another dose of rotavirus vaccine, live, oral, pentavalent (therapy type: Digital Data Logger) (ROTATEQ) which was improperly stored for prophylaxis (lot # 1660112, expiration date reported as 18-OCT-2020, strength, dose, route were not reported) (product storage error). There were no adverse effects reported. The administered dose of the vaccine experienced multiple temperature excursions below 2 degree Celsius (1.28 Celsius) for 2 hours and 30 hours as recorded by a data logger. The vaccines had no previous temperature excursion. No product quality complaint was reported.The outcome of product storage error was unknown.
My son I could recall about an hour later became Jandice. His skin was yellowing as well as his eyes. He became lithargic and was difficult to Breast feed him since he had little control over his body. He was injected with the Vitamin K shot.
ON 5/14/2020 STARTED FEELING TIRED, AND THEN HAD DIARRHEA, NAUSEA, KNEES ACHE,PAIN IN R UPPER ABDOMEN, WEAKNESS, TEMPERATURE WAS 98.4( USUAL TEMP IS 96.9 ). STOOL AND URINE ARE NORMAL COLORS. EXPOSURE TO HEP A WAS ON MAY 1, 2020. CLIENT SPOKE WITH PMD AND WILL HOLD VIDEO APPOINTMENT TOMORROW.
This spontaneous report as received from a Licensed Practice Nurse refers to a 66 year old patient. On 29-JAN-2014 the patient was vaccinated subcutaneously in the left deltoid with 0.65 mL ZOSTAVAX, the lot number was reported as J005849, with expiry date 17-AUG-2014. The ZOSTAVAX dose was reconstituted with expired sterile diluent (lot number E010688, expiry date 29-FEB-2012). No adverse effect was observed or reported. Additional information has been requested.
Body aches, fever 100 deg or more, 30 hours post vaccine. Then ok for several days, normal activity. One week post 4/13/21 more symptoms: body aches, joint and muscle pain, fatigue, ear ringing, headache, fever, chills.
I got the shot on Monday, felt all-over body chills on Tuesday, was fine on Wednesday. Thursday I started spotting (red, not brown; this was fresh blood), and Friday I started bleeding to fill a super-size tampon within 2 hours. That continued for 5 days (I went through a full box of tampons in a weekend.) Given that I'm 54 and hadn't had a period for 6 months, I thought I was post-menopausal. The bleeding finally subsided on day 7.
Arm turned red and itchy and getting worse by the hour. Area appears to be a perfect obtuse angle and not a random shape.
8/6/21: Pt presents to ED. CC generalized weakness, back pain, and diarrhea. Pt lives in and denies any history of trauma, states back pain x 1 month, worsening the past few days in severity and pt unable to ambulate. Pt states she has PN at baseline and does not notice any worsening n/t. She locates the pain primarily on the right side and radiating down the right leg. She is able to move her extremities and denies bowel/bladder symptoms. Also reports intermittent cough and phlegm, fatugue and poor appetite.  Also bouts of explosive diarrhea.  8/7/21: Pt tests positive for COVID19 Of note, pt received Pfizer COVID vaccine, last admin Feb 2021 8/9/21: Pt discharged home
Felt a little constipated and over the course of a couple of days had pain and issues with it. On 12/7 contacted doctor and visited next day. He checked my abdomen and was advised to ER. There was 2 test, CT scan and Blood work which found the Acute Diverticulitis w/ Abscess issue. Was hospitalized and given IV antibiotics for 3 or 4 days, then continuing with amox/clav antibiotics and continued to take it until 12/23. During course of antibiotics I a was discharged from Hospital on 12/16.
I had fatigue, fever, body aches and constant headaches. I had a rash that showed up after four or five days.
Radiating pain built for days in left arm following vaccine administration. Pt is debilitated cannot exercise, open car door, difficulty dressing. Pt complains of weakness & pain from elbow to shoulder, not specific at administration site. Recommend neurologist as has no GP.
JOINT PAIN; CHILLS; FEVER 103.1; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 05-MAR-2021, the subject experienced joint pain. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced fever 103.1. On 05-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 103.1 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain, chills, fever 103.1, and headache. This report was non-serious.
Admission Date: 10/15/2022 Discharge Date: 10/18/2022 PROCEDURES PERFORMED:  Vaginal delivery Tubal ligation:  No   HOSPITAL COURSE: Patient underwent an uncomplicated vaginal delivery and was discharged home in stable condition.  DELIVERY TYPE: Vaginal, Vacuum (Extractor)    ESTIMATED DUE DATE: Estimated Date of Delivery: 11/4/22 GESTATIONAL AGE AT DELIVERY: 37w2d  G1P0000  FINDINGS: NEWBORN STATUS: Living  NEWBORN SEX:  girl     Delivery Date/Time:  10/16/22  9:53 AM           WEIGHT:   APGAR:  1 minutes 5 minutes 10 minutes  8  9        RESCUSITATION: Tactile stimulation  PLACENTA REMOVAL: Spontaneous  CORD VESSELS: 3 Vessels  CORD COMPLICATIONS: Nuchal  ANALGESIA METHOD: Epidural   DELIVERY COURSE: Patiet is a 31 y.o. G1P0000 female who presented to L&D at 37 weeks gestation for induction of labor due to fetal growth restriction. Pregnancy was complicated by maternal POTS, asthma, thrombocytopenia. Labor course included vaginal cytotec. Labor course complicated by category II fetal heart tones after epidural which improved somewhat with intrauterine resuscitation and IV phenylephrine. She progressed to complete at 0900. She pushed well with contractions. Category II fetal heart tones noted with intermittent deep late and prolonged decelerations. With fetus at 3+ station, fetal heart rate dropped to the 70s. Patient was consented to operative vaginal delivery with vacuum. Kiwi omnicup was applied to flexion point on fetal head, ensuring that maternal tissue was excluded. Traction was applied along with maternal effort over one contraction to bring fetal head to a crown. There were no pop offs. The vacuum was removed and patient continued to push. She went on to deliver the fetal head in a controlled fashion.  Head restituted to face maternal left. No  nuchal palpated. Anterior shoulder delivered with gentle downward traction of the head, followed by the posterior shoulder. Rest of the body followed with ease. Time of delivery was 0953. NICU was present at the delivery due to operative delivery and fetal growth restriction.  A female infant was placed on the maternal abdomen and dried by RN.  Delayed cord clamping was performed for 60 seconds and then the cord was clamped x2 and cut by the patient. The infant was then placed skin to skin on maternal chest.  APGARS 8 and 9 . Mixed cord blood was obtained. Arterial and venous blood gases were obtained. Placenta delivered with fundal massage and gentle downward traction on the cord.  Placenta appears intact and a three vessel cord is present. Pitocin infusion started to actively manage the third stage. Active bleeding noted. Uterine massage performed, small amount of clots evacuated from uterine cavity. 1g IV TXA administered. Active bleeding noted from left sided vaginal wall laceration, this was repaired in running locked fashion with 3-0 Vicryl and good hemostasis achieved. A shallow second degree perineal laceration was repaired in usual fashion using 3-0 vicryl. QBL 500 ml. Mother and baby remain skin to skin and bonding in the immediate postpartum period. Sponge, instrument and sharp counts were correct. Mother plans to breastfeed.
Shingrix administered after temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comment: The registered pharmacist reported that the patient received a dose of Shingrix vaccine, and which was exposed down to 28 Fahrenheit for 8 hours. The reporter stated that there were no prior excursions. The reporter asked about Shingrix stability and wanted to know any recommendation on revaccination. The reporter was unable to provide any vaccine or patient details at this moment. The reporter did not consent to follow up. Additional supportive information: The patient received a dose of Shingrix vaccine, and which was exposed down to 28 Fahrenheit for 8 hours, which led to incorrect storage of drug. This case was one of 8 cases reported by same reporter.; Sender's Comments:  US-GSK-US2022140236:Same reporter US-GSK-US2022140235:Same reporter US-GSK-US2022140227:Same reporter US-GSK-US2022140234:Same reporter US-GSK-US2022140239:Same reporter US-GSK-US2022140240:Same reporter US-GSK-US2022140241:Same reporter
Rebound symptoms and a positive covid test a week after treatment finished/ COVID 19 Treatment; Rebound symptoms and a positive covid test a week after treatment finished/ 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 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Apr2021 as dose 2, single (Lot number: ER2613), in left arm and on 16Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; VITAMIN D [VITAMIN D NOS]; GLUCOSAMINE; LIPITOR; AREDS 2 VISUAL ADVANTAGE; COQ10 [UBIDECARENONE]; PSEUDOPHED. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Rebound symptoms and a positive covid test a week after treatment finished/ COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) positive, notes: a week after treatment finished. Therapeutic measures were taken as a result of covid-19. Clinical course: COVID 19 Treatment: Paxlovid, treatment start date: 09May2022 and stop date: 13May2022. On 18May2022, Rebound symptoms and a positive covid test a week after treatment finished. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. Information regarding the patient's past medical history, concurrent conditions, or concomitant medication was not provided. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 29-APR-2015, as recommended for routine adult health maintenance for the prevention of shingles. It was reported that the ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 23-JUN-2016, the patient was treated for a painful rash that was diagnosed as herpes zoster dermatome. On or about 26-JUL-2016, the patient was treated for postherpetic neuralgia. On or about 09-AUG-2016, he was treated for a condition diagnosed as a complication of herpes zoster. While shingles and post herpetic neuralgia is an incurable condition, he was prescribed acyclovir to manage his symptoms outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Dizziness that began about 5 days after the first dose of the vaccine. The room felt like it was spinning. I went to sleep, and woke up this morning with the same feeling.
tested positive for covid after receive the Moderna Covid-19 Vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for covid after receive the Moderna Covid-19 Vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for covid after receive the Moderna Covid-19 Vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for covid after receive the Moderna Covid-19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   No treatment information was provided.
BODY ACHES; TOOTH PAIN; CHILLS; SORE ARM; HEADACHE; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced flu like symptoms. On 15-MAR-2021, the subject experienced body aches. On 15-MAR-2021, the subject experienced tooth pain. On 15-MAR-2021, the subject experienced chills. On 15-MAR-2021, the subject experienced sore arm. On 15-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, tooth pain, chills, sore arm, and headache on 18-MAR-2021, and the outcome of flu like symptoms was not reported. This report was non-serious.
Site was red, swollen, and hot to touch on left upper arm. Pt has no fever, site has no drainage, no difficulty in ROM or breathing. Swelling increased within 72 hours, MD prescribed Omnicef 250/5 suspension: 1 tsp BID for 5 days, and 1 tab of Benadryl QHS. Advised father to take temp daily and return to Health Dept on Monday AM.
sleeps all the time; muscle pain in legs, shoulder/ bad aches all over the body; tired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SOMNOLENCE (sleeps all the time), MYALGIA (muscle pain in legs, shoulder/ bad aches all over the body) and FATIGUE (tired) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (sleeps all the time), MYALGIA (muscle pain in legs, shoulder/ bad aches all over the body) and FATIGUE (tired). At the time of the report, SOMNOLENCE (sleeps all the time), MYALGIA (muscle pain in legs, shoulder/ bad aches all over the body) and FATIGUE (tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: normal (normal) Normal. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medications were reported. Reporter's friend's wife who had the Moderna Covid-19 vaccine experienced the same problems as of reporter. Patient was transported to the hospital where they ran some tests on patient. No treatment drugs were reported   This case was linked to MOD-2022-568297 (Patient Link).
4 days after 1st shot my husband became ,confused,garbled ,speech,,did not know who the president was or what year it was.admitted to Hospital .Released with a diagnosis of TIA.Went back to work .Sent home due to garbled speech and confusion .Second shot given.Sick for 10 days .Fever 101,diarrhea ,slurred speech ,confusion .awaiting to get second MRI.
felt lousy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Lot number: HG4680) for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "felt lousy". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: the patient got the Covid19 Vaccine and mentioned that after getting it felt lousy so did a test for Covid and it was negative.   No follow-up attempts are possible. No further information is expected.
pt c/o very painful throat, hurts to swallow; no problem breathing or speaking sudden onset 7PM; painful w/swallowing; no fever or chills; recvd flu shot this afternoon;
Information has been received from a registered nurse concerning a patient who on approximately 20-APR-2011 was vaccinated with the first dose of ROTATEQ. On 06-JUL-2011 the patient experienced received the second dose vaccine 11 weeks later. The nurse reported that the patient was in the office on 06-JUL-2011 for a second dose of ROTATEQ and the first dose was administered 11 weeks ago. The nurse did not think the patient was going to continued the series. No adverse effect was reported. It was unknown if the patient sought medical attention. Additional information is not expected.
She had headache after receiving the vaccine, about 30min after, her BP was 150/86, pulse 74; there was no redness or swelling, non-tender, no warmth
Fever of 102 noted the next day, however pt felt fever approx 3-4 hours after dose.  Had fever for up to 4 days post vaccine.  Pt had HA approx 4 hours after vaccine and described as severe, continued for several weeks.  Pt reports peri-ocular pain that started in conjunction with generalized myalgia.  Then developed polyarthraglia 4-5 days post vaccine.  Pt has had muscle cramping as well.  Symptoms have been prolonged and are still present today (7/24/2023).  Pt has also had itching on extremities, no rash.
11Apr91 pt vax;  week later exp flu-like sx & prolonged h/a.  Flu sx resolved but h/a remains.
Headache,  dry throat,  dry eyes,  fever,  chills, achy joints, upset stomach,  dizziness,  tired,  nauseous.
RN DID NOT CREATE A WHEAL WITH HER FIRST DOSE OF VACCINE, SO SHE SWITCHED ARMS AND CREATED A WHEAL ON HER SECOND ATTEMPT.
This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 18Aug2021 (Batch/Lot Number: FC3181) as dose 3, single for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient received first dose and second dose of BNT162B2 on an unknown date for covid-19 immunisation. On an unknown date the patient experienced head spinning, muscle pain, chills, I feel kind of sick in my stomach and feeling lots to vomit. The patient reported that got the Pfizer vaccine the booster yesterday from the Health department. The patient got this shot yesterday guess about 3 or 4 and was about to go in the car and the head spinning and had muscle pain and chills and feels kind of sick in stomach and want know what needs to be done. Patient was going to a graduation today and cant handle the Chills and the headache and feel like going to vomit and muscle pain wondering if needed to get out or not or if needed to quarantine or what. The patient asked whether or not to get out to go to the graduation today. Patient was informed about Pfizer Medical Information Department and Shared the number. Patient asked that if had to quarantine. The outcome of all the events was unknown. Follow-up attempts are completed. No further information expected.
ITCHY AT THE INJECTION SITE (LEFT ARM); RED RASH ON CHEST THAT IS BURNING/ITCHY; BURNING AT THE INJECTION SITE (LEFT ARM); This spontaneous report received from a patient concerned a male of unspecified age. 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 was not reported, administered on 06-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-NOV-2021, the patient experienced itchy at the injection site (left arm). On 07-NOV-2021, the patient experienced red rash on chest that is burning/itchy. On 07-NOV-2021, the patient experienced burning at the injection site (left arm). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red rash on chest that is burning/itchy, burning at the injection site (left arm), and itchy at the injection site (left arm). This report was non-serious.