chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt was vaccinated 3 NOV 10. 13 NOV 10 Pt developed rash on hands. BENADRYL was given for pruritis. Generalized rash developed 14 DEC 10. Generalized rash was A/W perioral edema & sore throat. Pt was admitted. Received Iv steroids, ATARAX, TYLENOL & prophylactic Abx. Possible pericarditis for chest pain 16 NOV - resolved. INDOCIN, Aspirin given.
Prolonged sore arm for 4 wks with decreased range of motion of injected arm (LA).
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. The nurse reported that on unspecified date in approximately 2014, unspecified patients were vaccinated with (oka/merck) VARIVAX (subcutaneous injection, 0.5 ml once, subcutaneous, strength, lot #, expiration date and anatomical location not reported), that was improperly stored at a maximum of 7.5 degrees Fahrenheit for up to 11 hours in July 2014 and August 2014. Concomitant medications were not reported. No adverse effects reported. Follow up information has been received from medical assistant on 27-AUG-2014. The medical assistant was able to provide patient identifier, lot number and expiration dates of (oka/merck) VARIVAX that was administered to a 12 months old patient on 20-AUG-2014: lot# J013067 and expiration date: 16-OCT-2015. This is one several reports received from the same source. Additional information has been requested.
18JUN91 w/inc sleepiness, had to be awakened for feeds, lethargic; Taken to ER 19JUN where observed to be lethargic & shocky - sepsis work-up including sp tap done & ATB initiated x 36hrs;
This spontaneous report as received from a medical assistant refers to a 8 week old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 24-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.
Patient was administered an expired booster dose of Moderna COVID-19 vaccine.; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose of Moderna COVID-19 vaccine.) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 030L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose of Moderna COVID-19 vaccine.). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose of Moderna COVID-19 vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
Red area surrounding vaccination site x 3; pt describes as "warm and hard" surrounding vaccine site. Seen at ER.
Within a couple of hours right shoulder was very sore, hot and sore on outside but most painful inside socket especially with movement. I could not lift that arm to brush teeth or shower without a lot of pain. It was hard to sleep on that side. Symptoms persisted for over a week. I consulted with doctors office, applied ice and heat. Pain and stiffness moved beyond shoulder into lower neck and right shoulder blade. Shoulder pain diminished with time and active exercises although lower neck still stiff 2 months later.
Warmth, pain, red area at site of injection armpit pain 12 hrs after injection cool compress at site of injection.
Large welt/rash on arm in which I received the injection. Onset of symptom was 11 days after receiving the shot.
Strated itching about 30 minutes after injection. Then about an hour later was covered in red rash looking like hives and was itching bad. Took 50 mg of benadryl.
Redness, itching, and warmth at injection site exhibited as rash roughly 3 inches across by 2 inches long.
observed for 15 min after both vaccines and no reported issues after vaccination.  Patient did expire 2/25/2021 but cause of death unknown.
Information has been received from a registered nurse concerning a 6 year old white male weighing 54 lbs and height of 48 3/4 inches with no pre-existing medical history or illness at time of vaccination who on 08-NOV-2001 was vaccinated subcutaneously in the left thigh with a dose of varicella virus vaccine live (Oka/Merck) (lot# 638429/0426L) and subcutaneously in the left thigh with a dose of measles-mumps-rubella vaccine (lot # 640962/1095L). The nurse reported that on 03-MAY-2007 the patient developed lesions on the face, trunk, buttocks and legs in various stages. On 03-MAY-2007, the patient recovered. Additional information has been requested.
On 9/1/22 the provider ordered the incorrect vaccine for a patient.  Quadracel was ordered instead of pentacel.  Provider spoke with clinical educator who then reached out to the manufacturers and per CDC recommendations, patient does not need to repeat any vaccinations, but now needs to get the missing piece of the vaccine (the Hib part).  Provider spoke at length with the patient's mother about this and she was understanding and will be coming in for a nurse visit with son to get the vaccination.
This case occurred during a study. Initial SAE Report received on 28-Jun-2012. Case is medically confirmed. A 6-week-old female subject developed vomiting on 11 January 2012 after she had received the first dose of ROTATEQ (batch number not reported) on 09-Jan-2012. Route and site of administration were not reported. The subject developed vomiting leading to hospitalization on 11-Jan-2012.  A sample was performed on 12-Jan-2012. There was no result from the laboratory in hospital. The result for ELISA was negative. PCR result showed PCR G:pos Sequencing G: to be done PCR P: P[8]. Differentiation to be done. According to the co-investigator it was confirmed that the diagnosis was not an acute gastroenteritis. No treatment was reported and the patient was discharged on 12-Jan-2012. At the time of reporting, the outcome was not provided. No causality was provided. No further information expected.
Fatigue the following day and then my arm was red at site of injection and hot to touch beginning day 2 after shot and still occurring.
Heavy head; Had chills; Had body aches; Had fever of 99 degrees under the arm; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Heavy head), CHILLS (Had chills), MYALGIA (Had body aches) and PYREXIA (Had fever of 99 degrees under the arm) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. C10A21A and 03L20A) for COVID-19 vaccination.     No medical history were reported. .    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jun-2021, the patient experienced CHILLS (Had chills). 26-Jun-2021, the patient experienced MYALGIA (Had body aches) and PYREXIA (Had fever of 99 degrees under the arm). On 28-Jun-2021, the patient experienced HEAD DISCOMFORT (Heavy head). On 28-Jun-2021, HEAD DISCOMFORT (Heavy head), CHILLS (Had chills), MYALGIA (Had body aches) and PYREXIA (Had fever of 99 degrees under the arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jun-2021, Body temperature: 99.0 (normal) 99.0 Degrees.         No concomitant medications were reported. Treatment information was not provided.
Per Mom, patient has a red, raised hardened area (about 3 in diameter) around arm that's warm to touch. Minimal complaints of pain and no other symptoms.
Fever of 102.5. Headache. Nausea. Muscle aches, chills. Fatigue. Cough. Dark red, hot, sore, itchy spot on arm where injection site. Fever, chills lasted 30 hours. Nausea, fatigue headache lasted  72 hours. Arm redness, pain itchy lasted 5 days. Antihistamine for arm Tylenol for headache along with Advil for fever.
Headache; This is a spontaneous report from a non-contactable Other Health Professional (patient). A 25-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: Ej1685, expiration date was not reported), via an unspecified route of administration in the right arm, on 09Jan2021 08:45 at a single dose for COVID-19 immunization. Medical history included drug known allergies to penicillin (hives). Concomitant medication included bupropion, hydroxyzine, propranolol, levonorgestrel (MIRENA) and OCP (unspecified). Historical vaccine included first dose of PFIZER BIONTECH COVID 19 VACCINE (lot number: Ej1685) via an unspecified route of administration in the right arm, on 19Dec2020 08:30 at a single dose for COVID-19 immunization. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination and she has not been tested for COVID-19 post vaccination. The patient experienced headache on 09Jan2021 at 09:30 PM with outcome of not recovered. Therapeutic measures were taken as a result of headache with Tylenol.   No follow up attempts are possible. No further information is expected.
Patient tolerated vaccination well, however, when father was checking out, she passed out in the waiting room.
Numbness to right lower lip, part of top lip, right side of tongue, right thumb and forefinger.
pt had syncopal episodes after vaccination. pt is unsure of LOC or if he hit his head. no signs of hematoma or laceration noted to posterior head. pt vital signs stable HR 80 BP 122/70 7:35. vitals signs at 7:40- HR 81, BP 118/76. pt sts he is having difficulty thinking and answering questions, c/o headache.. report called to ED. pt stable on discharge, walked pt to brothers car. reported.
Information has been received from a physician concerning a pt who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot #647272/0664N). Subsequently, "in the past few weeks", in approximately 11/03, the pt developed cellulitis with redness and induration. The pt was treated with ice and ibuprofen. Subsequently, the condition has resolved.  It was also reported that 5 other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and also developed cellulitis (WAES #0309USA01513, 0309USA01722, 0309USA01723, 0309USA01724, 0311USA02366).  It was also noted that of the 6 total pt's 5 received a booster dose and one had the first vaccination with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Prior Hx of anaphylaxis. Tingly feeling bilateral of face/jaw described as moving up and down. Patient visibly anxious before and after vaccine administration.  Vital Signs: BP 151/121 HR 93 Resp 18 O2Sat 94  Skin Signs: Other - flush A/Ox4  Circulation: Cap refill <2sec  Respiratory: Diminished bilateral Initial Treatment: Observation. Family doctor: Dr. (local)  1:19 PM  Vital Signs: BP 136/90 HR 98 Resp 12 O2sat 96  Skin Signs: Other - flush, dry  Circulation: Cap refill <2sec  Respiratory: Breath sound clear bilaterally  Follow up Treatment: Continue observation. Patient visibly more calm. Hx of hives with influenza vaccine. A/Ox4. No obvious distress, No increased resp effort. Advised patient to have discussion with family doctor before second dose. Tingling reduced by 1:28 PM.  1:31 PM Vital Signs: BP 132/102 HR 88 Resp 12 O2Sat 96  Skin Signs: Warm and dry  Respiratory: Breath sound clear bilaterally  Follow up Treatment: 'Tingly' feeling moved to lower jaw and decreased in intensity at 1:34 PM. Notes: 1:43 PM call placed to Dr. - Related patients vitals to RN. 1:48 PM patient denies 'tingly' feeling. No SOB or difficulty swallowing. Stated she feels 'normal again'.  Disposition: Home with husband at 1:57 PM.
Hives/urticaria left bicep muscle, 4 erythematous plaque w edema present, worsen since yesterday. No angioedema. Prescribed antihistamines, H1 and H2 and also oral prednisone.
Severe joint pain (on scale of 1-10, intense level was 12); This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Severe joint pain (on scale of 1-10, intense level was 12)) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     Concurrent medical conditions included Polymyalgia rheumatica.   On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced ARTHRALGIA (Severe joint pain (on scale of 1-10, intense level was 12)). On 12-Apr-2021, ARTHRALGIA (Severe joint pain (on scale of 1-10, intense level was 12)) had resolved. Not Provided          No concomitant medications were reported.  The patient took prednisone twice a day for the joint pain.  The patient did not provide any information on her first dose
Aching of both knees, swelling of knees; Ansaid for 2 wks;
However, on the second day, she had a headache and still has a headache today that continues to get wors; She still has this banging in her head; This is a spontaneous report from a contactable consumer.   A female patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot number: not reported) via unspecified route of administration on unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. Patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot number: not reported) via unspecified route of administration on unspecified date as a single dose for COVID-19 immunization. The patient reported that first day after the second dose, she had no reaction, however, on the second day, she had a headache and still has a headache that continues to get worse. Patient received treatment medication ibuprofen once in a day for event headache and it was getting worse and it was not unbearable, but she still has this banging in her head. In a caller response the patient states that after the first shot, her headache went away after 2 days, however, after the second dose, she's still having the headache after the 6th day. Patient is asking what she should do. Outcome of the event headache was not recovered, head banging was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021130300 similar report from same reporter
This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (received vaccine 12 hours after the vial was punctured) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 051C21A) for COVID-19 immunization. No medical history reported. On Jun 19, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 19, 2021, patient administered expired product (received vaccine 12 hours after the vial was punctured). At the time of the report, administered expired product (received vaccine 12 hours after the vial was punctured) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Acute vomiting and diarrhea 12 days after injection. Episode lasted two hours.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Syncope-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: Bradycardia
Received MMR shot on 3/28/08, perfectly healthy with no problems prior to that date.  On 3/31/08 patient stopped eating, drinking & was fussy.  Morning of 4/1 she awoke with a high temp we were treating with ibuprofen.  She was very uncomfortable & cried most of the day - still not eating or drinking, although she would reach for food.  She was sitting on my lap crying (reaching for food then pushing it away) right before 7 pm when she made a gurgling noise, then slumped over and began seizing.  Her eyes went blank, her body shaking, gurgling noises, saliva bubbles from her mouth, she turned blue and was unresponsive for just under 5 minutes.  She was taken by ambulance to Medical Center where they ran some tests & treated her for febrile seizure & dehydration.
FAINT; SHAKING; CONFUSION; INCREASED HEART RATE; INCREASED BLOOD PRESSURE; ALLERGIC REACTION; This spontaneous report received from a patient concerned a not Hispanic or Latino white female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included Penicillin allergy, bee stings allergy, preservatives allergy, and MSG allergy.  The patient received Covid-19 vaccine ad26.cov2.s on left arm (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, 1 total administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-MAR-2021, after 10 minutes of vaccine administration, the patient experienced faint, shaking, confusion, increased heart rate, increased blood pressure and allergic reaction. The patient was sent to emergency room. The patient received dose of EpiPen for the treatment of allergic reaction and symptoms subsided and resolved as of now per caller. It was reported that HCP was notified. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from faint, shaking, confusion, increased heart rate, increased blood pressure, and allergic reaction on 15-MAR-2021. The reporter considered the causality between Janssen Covid-19 Vaccine and faint, shaking, confusion, increased heart rate, increased blood pressure, and allergic reaction was possible. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:21210328872-covid-19 vaccine ad26.cov2.s-Allergic reaction. This event is labeled and is therefore considered potentially related.  V0:21210328872-covid-19 vaccine ad26.cov2.s-Faint,shaking, confusion, increased heart rate, increase blood pressure. This event is considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
pt recvd vax;mom noticed pt cyanotic & not breathing;mom performed CPR & pt began to regain color;had previous sz to pertussis;14nov94 pt brought up pink streaked secretions & food when CPR performed;
The patient received her covid 19 Pfizer vaccine on 2/25./21. Later that day her daughter went to her home to check on her. Upon arriving, she found that her mother's skin was red and itchy, her face was swollen, and she was having trouble breathing. The patient was taken to the hospital thereafter. Her primary care physician is aware and does not want the patient receiving the second dose.
Patient experienced palpatations and chest tightness. She stated she didn't take her medication. EMS was called vitals BP 155/90  patient recovered and was released.
On 5/19/2021 client received her first dose of the Pfizer Covid-19 Vaccine (lot #EW0185, expiration 08/2022) at 12:42. Client was found sitting upright in her chair with her mother and appeared melancholy. Client was a 13-year-old female, alert and tracking with her eyes. Client had a chief complaint of headache at 12:48. EMT and RN responded. Client stated that she began to have a headache a few minutes after her observation had begun. This was the client's first dose of the Pfizer vaccine. Client's mother did not report any allergies or medical history. Assessment revealed no hives, rash, discoloration, shortness of breath or other signs of anaphylaxis. Client described a generalized headache with dizziness and stated that she had eaten breakfast this morning. Airway, breathing and circulation were intact. Client denied pain throughout the rest of her body. Vitals at 12:52 were blood pressure 122/74, pulse 84, respirations 18, O2 100% on room air, temperature 97.6*f, lung sounds clear bilaterally, and client was alert and oriented to person, place, date and time. Client's mother consented to allowing the client to lie down for 15 extra minutes but refused to remain for the entire 30-minute additional observation. Client's mother was instructed to seek emergency care or medical attention if condition becomes severe after leaving vaccination site. Client's final vitals were consistent at 13:07: blood pressure 118/78, pulse 84, O2 100% and respirations 18. Client's mother was provided with all vaccine related information and acknowledged that she already knew what signs and symptoms to look for as she was already vaccinated as well. departed facility with her mother at 13:07 with client's mother stating "I have another appointment."
Vomiting same evening, asthma attack same night, stuffy nose, body aches over next couple of weeks, cough, respiratory infection , sinus infection over next few weeks.
Narrative: Primary care nurse administered dose of COVID vaccine that had been prepared the previous day at 0700. BUD on syringe was 12 hours making it "expired" at 1900 on 6/2/2022. Dose was not turned into pharmacy properly for wasting and was administered the following morning around 1030 on 6/3/2022. No adverse effects to pt noted. Called manufacturer of vaccine for recommendation on effectiveness of dose given and whether it should be repeated. Awaiting analysis of the lot number to make clinical recommendation on repeating dose (3-5 business days for info per Moderna)
pt recv vax 1994 & pt exp creaking sounds in knees when squatted;
pt rcv vax;  couple of wk later pt devel fat necrosis @ the site of Tetramune inject, described as a decrease in the amount of the fat tissue.
pt c/o dizziness and palpitations v/s 99RA  75bpm,   19cpm  BP 148/81