chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Nurse Practitioner concerning an approximately 12 month old male patient who was vaccinated orally with the first, second and third dose of ROTATEQ on 01-APR-2010 (Lot #664883/1523Y), 02-JUN-2010 (Lot #665259/0202Z) and 02-AUG-2010 (Lot#667461/0500Z) respectively. The nurse reported that "a few weeks ago" (approximately on 17-JAN-2011), the patient had a moderate case of diarrhea with no vomiting, which on 17-JAN-2011 tested positive for Rotavirus. At the time of the report patient's outcome was not reported. Patient sought unspecified medical attention. Follow up information has been received from medical records and a physician concerning a 7 month old female patient (initially reported as 12 month old male) with no previous pre-existing allergies, birth defects or medical conditions who on 02-AUG-2010 was vaccinated with her third dose of ROTATEQ (Lot # 664883/1523Y, conflicting information initially reported as Lot # 667461/0500Z). Concomitant medications were RECOMBIVAX HB (Lot # 1482Y) administered intramuscular left site (02-AUG-2010) and had (two previous doses) and PENTACEL (Lot # C3513B4) administered intramuscular left site (02-AUG-2010) and had (two previous doses). On 17-JAN-2011, the patient was evaluated in the emergency room for diarrhea (six to seven watery stools a day without blood or vomiting noted). The patient had a increased temperature of a hundred and one for twenty four hours. On 18-JAN-2011, the patient had the following stool diagnostic tests performed: negative for Fecal leukocytes; negative for Fecal occult blood; Aerobic culture negative for Salmonella, Campylobacter, Shiga toxin 1 and 2, and Giardia and Cryptosporidium; negative for Clostridium difficile Toxin A/B; and positive for rotavirus. The patient's caregiver was noted as having similar symptoms a week prior to the patient's own symptoms. On "02-JUN-2011", the patient's previous immunization (conflicting information as initially noted the patient's second dose of vaccine was administered on 02-JUN-2010), it was noted that she had two days of nasal congestion. The patient had no other illnesses to any of her well clinic visits. The patient recovered from her symptoms on 31-JAN-2011. All telephone attempts to obtain follow-up information have been unsuccessful. All available medical records will be provided upon request. Additional information has been requested.
Mom calls, reports patient have vaccine administered in left arm around 6 pm and at 1 am patient woke her up because the "itching was unbearable" and she had hives all over back / both arms / both shoulders, left arm was warmer than the rest of her body, fever of 100.7, and fatigue. Mom gave 50 mg BENADRYL, a dose of TYLENOL, and a cool cloth to her back - patient then went to sleep. Patient woke up at 8 am and another dose of 25 mg of BENADRYL was given - patient's hives had decreased, no longer had a fever, arm no longer warm, but still had fatigue. At last contact, patient was sleeping. Never had any airway problems or swelling. Mom advised to monitor patient at home and no need to be seen in the clinic.
pt recv vax 9APR96 & 10APR96 pt exp gen itchy rash on all extremities, back, & shoulders;body aches;joint aches;12APR96 pt exp of body aches & joint aches resolved;rash was subsiding @ the time of the report;palms cont to be erythematous;
Sore throat fatigue fever 99 on ibuprofen very sore in general.
pt. fully vaccinated with Pfizer vaccine. Dose 1: 3/17/21 EN6270; Dose 2: 4/14/21 EW0161. S/O 8/15/21, + test 8/16/21.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On unspecified dates, the patients were vaccinated with an unspecified number of doses GARDASIL (dose, frequency, route and lot# were not reported), which were improperly stored. No adverse experiences were reported. This is one of several cases from the same reporter. Additional information has been requested.
The day and following my son had a sore arm all night, complaining of being too warm yet no fever, his back itches now yet no breakouts yet, and he complained of stomach ache even though good size BM had already occurred. This was after he was reported as out of sorts all day at school. Weeks later, for a couple of weeks he's been saying his face itches. There is no rash or any different foods here. His face gets red and he complains. This morning he asked "Why are my boy bits itchy again"? I do not have an answer but he seems histamine challenged. At 2 AM he woke up with coughing fit for almost two hours with post nasal drip "My throat tickles mom". His usual gasp for air in addition to coughing for the night while sleeping propped up on pillow or me.
This spontaneous report as received from a Licensed Vocational Nurse refers to unspecified number of patients of unknown age and gender. It was reported that unspecified number of doses of GARDASIL was exposed to a total of 72 hours with a highest temperature of 57F. These doses were administered to an unspecified number of patients on unspecified dates (doses, routes and lot # not reported). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sharp pains in jaw the night he was given the Tetanus shot. Pain moves around the jaw.
Injection site reaction; Swelling of the lymph nodes; Tenderness; Pain; Pinkness/redness; Hardness; itching; A spontaneous report was received from a Consumer concerning a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events injection site reaction, swelling of the lymph nodes, tenderness, pain, pinkness redness, hardness and itching.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21-Jan-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  Patient had an injection site reaction, swelling of the lymph nodes, tenderness, pain, and some pinkness/redness. She would like to know how long these effects last. She no longer has pain or tenderness, but still swelling, hardness, pinkness/redness, and itching.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, injection site reaction was unknown,. The outcome of events, swelling of the lymph nodes, pinkness redness, hardness, itching was not recovered. The outcome of events, tenderness and pain was recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
received flu mist followed by hpv vaccine after 5 min. complaining of nausea and requested to lie down, upon standing patient collapsed, lots consciousness went into grand maul seizure lasting 1 min., second mild seizure after the first, regained consciousness
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Dental implantation (Dental implant). Concurrent medical conditions included Migraine. Concomitant products included GALCANEZUMAB GNLM (EMGALITY [GALCANEZUMAB GNLM]) for Migraine, DEXAMETHASONE (DECADRON [DEXAMETHASONE]) for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) outcome was unknown. Not Provided          Treatment information not provided. Action taken with mRNA-1273 in response to the events was not applicable.
Red swollen area to right upper arm. Upon assessment, he has a raised, red, whelp that is hardened and warm to touch. Area measures 5.5 cm W x 4.5 cm L. He pulled his arm away and states, "hurts" when touched.
Immediate hot flashes after both shots; Chest pressure; palpitations and shortness of breath immediately after 2nd shot; palpitations and shortness of breath immediately after 2nd shot; extreme body aches; internal burning sensation while simultaneously freezing; uncontrolled shaking; throwing up; Pain was so bad; Fever; could not sleep; This is a spontaneous report from a non-contactable consumer (reported for herself). A 28-years-old female non-pregnant patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6206/Batch number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 10Mar2021 (at the age of 28-years-old) as dose 2, single for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing and drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included ethinylestradiol, norgestimate (TRI-PREVIFEM) taken for oral contraception, start and stop date were not reported and fluticasone furoate (ARNUITY ELLIPTA) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, it was unknown if patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received amoxicillin and experienced drug hypersensitivity, azithromicin and experienced drug hypersensitivity, ceftin [ceftriaxone] and experienced drug hypersensitivity, sudafed [xylometazoline hydrochloride] and experienced palpitations, benzyol peroxide and flu vaccine preservative for immunization. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9266/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 02Feb2021 at 08:15 AM (at the age of 28-years-old) as dose 1, single for covid-19 immunisation and experienced immediately painful as went into arm and hot flashes. On 10Mar2021 at 20:00, the patient experienced immediate hot flashes after both shots, chest pressure, palpitations and shortness of breath immediately after 2nd shot, extreme body aches, internal burning sensation while simultaneously freezing, uncontrolled shaking, throwing up, pain was so bad, fever and could not sleep. No treatment was given for the events. The outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
DIZZINESS; WEAKNESS; FEVER; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and batch number: 180609 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. On 18-MAR-2021, the subject experienced dizziness. On 18-MAR-2021, the subject experienced weakness. On 18-MAR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: ondansetron hydrochloride, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, dizziness, and weakness. This report was non-serious.
This spontaneous report as received from a pharmacist refers to a currently 54 year old female patient with none medical history and none drug reactions/allergies. On an unknown date, (reported as "when the patient was a child") the patient was vaccinated with a dose of MMR II (lot number, dose and route were not reported). No concomitant medications were reported. On an unknown date reported as "recently" the patient experienced low antibody titer to one of the components of MMR II. The pharmacist did not know which of the MMR II components showed the low antibody titer. The outcome of low antibody titer to one of the components of MMR II was not reported. The relatedness between the event and MMR II was not reported. Additional information has been requested.
kidney disease; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 35 year-old male patient received bnt162b2 (BNT162B2), administration date 14Jul2021 (Lot number: EW0186) at the age of 34 years as dose 2, single and administration date 23Jun2021 (Lot number: EW0186) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NEPHROPATHY (non-serious), outcome "unknown", described as "kidney disease". The event "kidney disease" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After the first dose, his kidney valued changed from being totally normally to decreased and doctor said he had stage one kidney disease. After the second dose, his kidney value also dipped down and doctor stated he had stage two kidney disease.   Follow-up attempts are completed. No further information is expected.
Very Very Sick. - Had really bad chills that were out of control. I thought I was having a hear attack. High fever. My arm was numb and it lasted for almost 3 hours. I ended up not going to work and the next day around 5 p.m it started all over again with the chills and wanted to get sick.  It's been almost a week and my heart still hurts and my stomach hurts.
Patient said after the Pfizer COVID booster shot (3rd dose) on 11/23/2021 she broke out with severe itchy rash. She was very tired, felt cold. She has a lot of pain in the arm and shoulder at the injection site.  This pain was never recovered. Currently, she still cannot raise her arm or put it behind her back. She has been admitted to the hospital, ER, and seen providers continuously since May 2022
Low grade fever, 15 lesions.  Diagnosed with Varicella.  Treated with Acyclovir.
Student reported on 4/23/12 that he experienced soreness and body aches, an itchy rash which formed bumps and scabs on his abdomen, head, chest, and arms which lasted a week.  The soreness at injection site lasted 3 weeks from day of injection.  He did't return to the clinic at that time, but reported the information at an immunization screening for the 2nd Varicella.  He doesn't know if he had a fever or not.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with dose 1 GARDASIL on an unknown date and 2 GARDASIL on 12-SEP-2012 and dose 3 of GARDASIL on 13-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse events were reported. Additional information has been requested.
devel unusual high pitched scream 3 hrs p/vax; t102 R was highest recorded;
This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (his arm was tender and red and had a rash on it), VACCINATION SITE ERYTHEMA (his arm was tender and red and had a rash on it) and VACCINATION SITE RASH (his arm was tender and red and had a rash on it) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (his arm was tender and red and had a rash on it), VACCINATION SITE ERYTHEMA (his arm was tender and red and had a rash on it) and VACCINATION SITE RASH (his arm was tender and red and had a rash on it). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (his arm was tender and red and had a rash on it), VACCINATION SITE ERYTHEMA (his arm was tender and red and had a rash on it) and VACCINATION SITE RASH (his arm was tender and red and had a rash on it) was resolving. 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. Concomitant product included Benadryl. Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up was received on 03 Jun 2021 included reporter details was updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
No sleep; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (No sleep) and PYREXIA (Low grade fever) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concomitant products included LETROZOLE and HYDROXYZINE HYDROCHLORIDE (ATARAX [HYDROXYZINE HYDROCHLORIDE]) for an unknown indication.  On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 04-Feb-2021, the patient experienced INSOMNIA (No sleep) and PYREXIA (Low grade fever).   At the time of the report, INSOMNIA (No sleep) and PYREXIA (Low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 99.9 (High) Patient had fever of 99.9 F.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Event outcome updated. Patient denied consent for further follow up.
Patient found to be COVID positive though not hypoxemic. Patient started on remdesivir but not dexamethasone. He was also noted on CT scan of abdomen to have a gallstone stuck in the neck of the gallbladder as well as intra/extra hepatic ductal dilation and CBD dilation. GI consult placed but next day after review with GI it was felt patient would not benefit from consult and would need a general surgery consult. General surgery consulted on 10/5 and no plan for surgery as he does not have cholecystitis. IR consulted for biliary drain and discussed with patient how to manage at home. Patient satisfied with consultations and cleared for DC home.
PT described tightness in through, chest tightness, asthma, Pt took personal pro-air rescue inhaler  No fainting, few hives noted, able to speak on phone clearly, no LOC  Observe, monitor VS, pulse, ooregular, BP 140/100, cest clear  Outcome: PT transported to ER via EMS
headaches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300034302 Same reporter/ drug/ event for different patients;
pt recvd Engerix-B & 2 hrs later became hysterical & inconsolable for 5 hrs; pt is fine p/being treated w/DPP;
This spontaneous report as received from a medical assistant refers to multiple unspecified patients. No information regarding their pertinent medical history, concomitant medications, drug reactions, or allergies was provided. Since 08-SEP-201 to 12-OCT-2016, the patients were vaccinated with improperly stored doses of ROTATEQ oral liquid (orally; dose, lot# and expiration date were not provided). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 15 degrees Celsius for 3 hours and 40 minutes. There was no previous temperature excursion. Digital Data Logger was involved. This is one of several reports received from the same reporter. Follow up information was received from the medical assistant on 27-DEC-2016. She was going to fax the patients' identifiers, dates of vaccination, lot# and expiration dates. Additional information has been requested.; Sender's Comments: US-009507513-1612USA014131: US-009507513-1610USA008206: US-009507513-1612USA014130:
Information has been received from a 49 year old female registered nurse with multiple sclerosis who received one dose of hepatitis b vax. The nurse inquired about any information on hepatitis b vax and multiple sclerosis. No adverse experience was noted.
Pt received influenza vaccine on 12/30 and then on 12/31 his left arm was red, warm, swollen, (double in size).
She had increase in pain in elbows, wrists and hands after each dose.; She had increase in pain in elbows, wrists and hands after each dose.; knee pain and they feel hot; This is a spontaneous report from a contactable Other Health Professional and consumer Specialty Pharmacy. This 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on May2021 (at the age of 54-years-old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing, blood pressure readings went high from Nov2020 to an unknown date (patient reports in Nov2020 her blood pressure readings went high in the 180 over102-104 range). Concomitant medication included tofacitinib citrate (XELJANZ) taken for rheumatoid arthritis from 2019 and ongoing. The patient had she had increase in pain in elbows, wrists and hands after each dose on an unspecified date in May2021 and knee pain and they feel hot on an unspecified date in 2021. Patient reports when she was off XELJANZ for 10 days following each covid vaccine in May2021 and Jun2021. She had increase in pain in elbows, wrists and hands after each dose. patient reports in Nov2020 her blood pressure readings went high in the 180 over102-104 range, her md put her on medication and her readings are now 145/77. No other readings given. Patient states md believes it was from XELJANZ. Patient now states she has bilateral knee pain and they feel hot, she reports she ices them and puts on biofreeze. Registered nurse encouraged to update md. Patient agreed. No further details. The patient underwent lab tests and procedures which included blood pressure measurement: 180 on Nov2020 Patient reports in Nov2020 her blood pressure readings went high in the 180 over102-104 range, her md put her on medication and her readings are now 145/77, blood pressure measurement: 145/77 on 2021 Patient reports in Nov2020 her blood pressure readings went high in the 180 over102-104 range, her md put her on medication and her readings are now 145/77. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021906600