chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First dose: Severe flushing; First dose: Tingling in upper lip and tongue; First dose: Pain at the injection site of her right upper arm; This is a spontaneous report from a contactable consumer (patient).  A 36-years-old female patient received bnt162b2 (BNT162B2,Solution for injection,Batch/Lot Number: ER8729,Expiry date was unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 05Apr2021 15:30  as DOSE 1,SINGLE for covid-19 immunisation (At the age of vaccination-36 yrs).  Medical history included immune system disorder (previously had compromised immune system but not for about 2 years now), drug hypersensitivity (penicillin), respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity and lot of drug allergies from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took heptitis A vaccine on an unknown date other than several years ago and experienced got hives. 05Apr2021 at 15:30 She reported at 15:30, immediately after injection she experienced pain at the injection site of her right upper arm. She thought it was just a muscle reaction; it was not swollen or hard. The Nurse examined her about 10 minutes later and asked her to stay longer so patient stayed another 30 minutes. Within that 30 minutes she had onset of severe flushing-clarified time of onset about 20 minutes after injection administered so around 15:50. She was administered 25mg of Benadryl oral. Also around 15:50 the flushing progressed to a little tingling in upper lip and tongue. She was sent to the emergency room and administered another 25mg of Benadryl and 20mg Pepcid oral. She was not admitted to the hospital, she was monitored and kept under observation in the hospital emergency room for a couple of hours and then released. She recovered completely from all of these events within about 24 hours of onset. Therapeutic measures were taken as a result of first dose: pain at the injection site of her right upper arm, severe flushing, tingling in upper lip and tongue. On 14Sep2021 she was pre-medicated with 25mg of Benadryl and 20mg of Pepcid. She was administered second dose of Pfizer Covid-19 Vaccine on 14Sep2021 at 10:23. She started to flush slightly around 10:40. She was administered 25mg of Benadryl and that resolved the event of started to flush slightly. She had no further incidents, was able to tolerate the second dose. She recovered completely from this event within about 24 hours also. They did not send her to the emergency room this time, they felt that the reaction was well controlled with the antihistamines. The patient visited emergency room and physician office. On 06Apr2021 the clinical outcome of the event was recovered.   No follow-up attempts are needed. No further information is expected.
Baby received Pentacel and Prevnar at a well child visit at 2 pm.  Mom reports that the baby was sleepy and fussy that evening, and had a low grade fever.  He seemed uncomfortable and possibly in pain.  The next morning Mom noted that his anterior fontanelle was full/bulging.  She took a photo which does show a bulging fontanelle.  She reports that this improved over the course of the day.  I saw him in person the following day and his fontanelle was normal both upright and supine, although reported that it had looked full first thing in the morning.  Baby's exam was normal and he was not in distress.
Rash on stomach; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on stomach) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash on stomach). At the time of the report, RASH (Rash on stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Steroid shot as a treatment information provided. No concomitant medication provided. Paitent want to know advisementon the second dose, efficacy of first dose.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 1/16/2023 Discharge Date: 01/24/2023  COVID positive 01/16/2023 PRESENTING PROBLEM: Dysarthria [R47.1] Malignant neoplasm of esophagus, unspecified location (HCC) [C15.9] COVID-19 [U07.1]   HOSPITAL COURSE: This is a 77 year old male with PMHx of metastatic esophageal adenocarcinoma s/p esophagectomy 2016 with brain mets s/p craniectomy and whole brain radiation/chemotherapy who was admitted for weakness and confusion.   It is reported on New Year's Day the patient had difficulties with balance leaning to the right while sitting. He has been described as "being off" in the time since, with episodes of weakness (b/l lower extremities), poor speech, falls and poor activity. On the day of admission at approximately 0530 he was found laying on the floor on the stairs unaware how he got there. He denies any history of seizures but family reports some concern for seizures throughout the last few years. It was reported he drinks 4 12oz beers/day.   Work up revealed some resolution of previous noted stokes, otherwise stable previous noted chronic changes. He was started on aspirin and statin, noting previous myalgias he agreed to starting low and increasing over time. His course was complicated by failure to thrive with poor urine output and caloric intake. He slowly improved with time, suspected some encephalopathy was due to incidental COVID (not requiring any treatment or O2). He was able to be discharge in stable condition to facility.   Other work up that was nonrevealing included hematuria. When patient was more orientated it was revealed to be from squeezing his penis too hard to prevent his historic incontinence. This resolved in further UAs. Also, treatment for his HFrEF mild was attempted but this caused hypotension.
Initial information received on 21-Dec-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2018SA395249 (same reporter). This case involves a 13 years old patient (gender not reported) who was vaccinated with a dose of wrong vaccine FLUZONE QUADRIVALENT (lot number, Exp. Date, route and anatomical site of administration not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to wrong vaccine administered. It was unknown whether the patient experienced any adverse 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 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. List of documents held by sender: none.
Pt. report about passed out 10-15 min after injection. Pt diaphoretic, BP 200/100, P 112, R 28. 911 called.
This case was reported by a other health professional via call center representative and described the occurrence of injection site bruising in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site bruising, injection site rash and product supply issue. On an unknown date, the outcome of the injection site bruising and injection site rash were recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the injection site bruising and injection site rash to be related to SHINGRIX. It was unknown if the reporter considered the product supply issue to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported the case for herself. The healthcare professional had concerned about being late for the second dose of the SHINGRIX series due to the product supply issue. The healthcare professional reported that she had developed a rash and bruising near the injection site 1 to 2 days after the first dose of the SHINGRIX series. The healthcare professional did not have supply vaccine information.
Underaged patient (17yrs, 9 months)  received Janssen COVID 19 vaccine which is indicated for 18+
Immediate rash, face, chest forearm, extreme exhaustion , body aches, muddled thinking, still continuing month and a half  since shot
Swelling of upper arm left hot and red. Chills, aching all over body, muscle soreness.
muscle aches, itching & h/a p/1st dose;given DPH & advil a/2nd dose;unk if bitten or scratched by known rabid animal;no RIG given;
11 patients received dose from expired vial/ Should a patient be revaccinated if they received lot 033C21A on 10/28/21  note the vial expiration date printed is 10/27/21; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (11 patients received dose from expired vial/ Should a patient be revaccinated if they received lot 033C21A on 10/28/21  note the vial expiration date printed is 10/27/21) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (11 patients received dose from expired vial/ Should a patient be revaccinated if they received lot 033C21A on 10/28/21  note the vial expiration date printed is 10/27/21). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (11 patients received dose from expired vial/ Should a patient be revaccinated if they received lot 033C21A on 10/28/21  note the vial expiration date printed is 10/27/21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication  were reported. No Treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Non-Significant Follow up received.Email attached.
SOB, nausea, sweats, shakes, sensation of throat closing.  She came to the Employee Health office 90 mins after onset for evaluation; by this time she was almost completely normal.
Patient received shots at around 15:00 06/24/2003.  That night began turning pink at left thigh skin, gradually up size yeast/mild warm to touch, 17cm x 13 cm a widest areas now tender.  Lungs clear, heart rate at mrg.  Happy/active.  Benadryl .5 tsp per mouth.  Coll washcloth.
Covid Arm- large red hive at injection sight 8 days after injection. Itchy and warm to the touch.
Rapid onset swelling, erythema, pruritus of (R) upper arm within 30 minutes of injection.
BUMP IN THE LEFT WRIST; TINGLING AND NUMBNESS IN THE LEFT ARM; PAIN AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient does not want to disclose anything about his medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On an unspecified date, the subject experienced bump in the left wrist, tingling and numbness in the left arm, and pain at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at the injection site, and tingling and numbness in the left arm, and the outcome of bump in the left wrist was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant during both vaccinations) and MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding since) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 026L20A) for COVID-19 vaccination. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 05-Dec-2020 to an unknown date and FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication. On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021 at 8:10 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 17-May-2020 and the estimated date of delivery was 24-Feb-2021. On 23-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant during both vaccinations). On 25-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding since). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy. The vaginal delivery occurred on 25-Feb-2021, which was reported as Full-term. For neonate 1, the birth weight was 3560 grams (7lbs 14oz) with an APGAR score of 8 and 9 at (1, 5 minutes). The outcome was reported as Term Birth NOS. Baby's length was 53.3 cm and head circumference was 33 cm.. There was no fetal abnormalities at the time of delivery or after 1 month pot-partum. On 25-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant during both vaccinations) had resolved. At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding since) had resolved.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jun-2020, Pregnancy test: positive (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Patient stated that she had known pregnancy prior to vaccination. There were no complications with pregnancy, delivery, or infant. She is breast feeding the infant. Patient also stated that that there is no adverse event caused to her child after breastfeeding. This case was linked to MOD-2021-120553 (Parent-Child Link). See case MOD-2021-120553 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up received on 21-Jul-2021 contains significant information. The primary reporter details were updated. The lab data has been added.  New event has been added.
pt recv vax & exp coughing, nausea, aching joints, congestion & aching all over w/inset 2 days p/vax;
There is no place above to name the COVID-19 Johnson & Johnson that I got ! I already did this above as thought you had forgotten it, like the J & J vaccine ! fatigue for a week - so far, body hurt wherever it touched the bed, after3 hours I took acetamenaphin & it was soon OK.
I called pt's mother to inform her that I gave the incorrect vaccine today. Pt was supposed to get MMR, Varicella, and Influenza vaccines. Instead pt was given MMRV, Varicella, and Influenza. I informed her that per NP pt may develop a fever, rash, or local reaction at the site. Due to pt having 3 vaccines, the MMRV and Varicella were both given in the same leg which was the left thigh. I expressed my deepest apologies and mother accepted. She will inform the clinic if any further questions or concerns arise.
This spontaneous report was received from a nurse via a company representative refers to an approximately 78 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 18-MAY-2015, the patient was vaccinated with PNEUMOVAX23 (lot # 1001311, expiry date 16-JUL-2016) in the left arm. On an unknown date in May 2015, when the patient took the vaccine in the left arm it became swollen, red, painful, and warm to the touch around the sight of the injection. The patient was treated with KENALOG, prednisone and erythromycin (unspecified manufacturers). The outcome of the events was unknown. The reporter did not provide the relatedness of the events with PNEUMOVAX23. Additional information has been requested.
Rapid pulse; fuzzy overall feeling; roaring in ears; tried to stand and was shaky.  Fainted for a brief moment or two, ended up on my left side on the floor.  EMT's called - they checked my vitals. BP and blood sugar fine; pulse a little elevated at about 101. Advised not to drive. Called OB next morning. Advised to report to VAERS.   11/10/09 medical records received. OB/GYN notes. DSO 11/6/09 One day s/p vaccine pregnant patient fainted in restaurant bathroom after feeling hazy and hot. Flushed. . BS 132, BP 120/86. Pulse 110.  Fell on her side. Fetal movement felt during episode. Possible vaccine rxn. EDD 2/11/2010. LMP 4/11/09.
6/23 37y.o. G3P2002 at 39w0d presenting to triage for scheduled repeat C-section 6/23 C-Section
on 10/5 in the morning the patient woke up with: severe weakness could not sit up, fatigue, muscle pain, temperature of 99.8, unable to eat food due to the extreme weakness No nausea, no vomiting, no diarrhea  patient and family were advised to contact their physician to report the event and family did so and they called again today 10/6/22 to report patient was much improved
No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 11-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Left arm very swollen for 5 days following injection; pain and itching in left arm.
Blood sugar won't control ;  using 4x insulin and can't get Blood sugar below 250; Pulse rate over 110 in morni gs; Delayed inj site pain After 2 days --- Hot / Cold sensation --- Vision narrowed --- difficult mental focus focus --- Blood sugar won't control ;  using 4x insulin and can't get Blood sugar below 250 -; Delayed inj site pain After 2 days --- Hot / Cold sensation --- Vision narrowed --- difficult mental focus focus --- Blood sugar won't control ;  using 4x insulin and can't get Blood sugar below 250 -; Delayed inj site pain After 2 days --- Hot / Cold sensation --- Vision narrowed --- difficult mental focus focus --- Blood sugar won't control ;  using 4x insulin and can't get Blood sugar below 250 -; Difficult mental focus; Unusual headach; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 76-year-old male patient received first dose of bnt162b2 via an unspecified route of administration, administered in right arm on 13Feb2021 09:00 AM (Batch/Lot Number: EN 6201), the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 13Mar2021 15:00 (Age at vaccination was 75 years) (Batch/Lot Number: EN 6208) as 2nd dose, single for covid-19 immunization. The patient's medical history included atrial fibrillation, cardiac disorder (bypasses stints), Right lower leg amputation, insulin dependent Diabetes (type 1 diabetes mellitus), Right eye Prosthetic. The patient was allergic to erythromycin keflex all benzo's all codeins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient's concomitant medication included clopidogrel (CLOPIDOGREL), digoxin (DIGOXIN), gabapentin (GABAPENTIN), warfarin (WARFARIN), insulin human (NOVOLIN). On 17Mar2021, 2 days after the vaccination the patient experienced delayed Injection site pain, Hot / Cold sensation, Vision narrowed, Difficult mental focus, Blood sugar would not control, using 4x insulin and could not get Blood sugar below 250, Pulse rate over 110 in mornings and unusual headache. The patient used Metoprolaaol as a treatment to pulse rate over 110. The patient's BP 110 / 55 Temp 97.3 Fahrenheit was well controlled until vaccination +2 days. The patient underwent lab tests and procedures which included blood pressure measurement: 110/55 and body temperature: 97.3 Fahrenheit on an unspecified date. The events Blood sugar would not control, using 4x insulin and could not get Blood sugar below 250, Pulse rate over 110 in mornings was considered as medically significant, the other events were reported as non-serious. The outcome of the events was not recovered.
A non-serious spontaneous report of spray from patient's nostril went into eye of nurse was received from a health professional concerning a 36-year-old female. Neither the patient's past medical history nor concomitant medications were reported. As the nurse was administering FLUMIST into the patient's nostril, as it hit the nostril, some of the FLUMIST sprayed into the nurse's eye. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information was received on 15-SEP-2011: there were no late-occurring adverse events.
Fever with 101 degree temperature, aching body, red rash on neck, temper.
exteremely heavy period like never before.period was 20 days early. period started within 24 hours of the time the vaccine was taken. extremely sore and itchy arm even a week after the vaccine. the period side effects of the vaccine are quite common and are not listed as a side effect from the FDA.
Cellulitis to left upper thigh. Induration, erythema, and warmth to site. Approximately 10cm x 10cm. DTAP and Hep A were administered to (L) thigh.