chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 19-week old male with no pertinent medical history and no drug reactions/allergies who on 23-AUG-2011 and 24-OCT-2011 was vaccinated orally with the first and second dose of ROTATEQ respectively (2ml for each dose) (Lot number 670237/0919AA). Concomitant therapy included unspecified multivitamins. On 02-NOV-2011 the patient had blood in his stools after receiving the second dose for ROTATEQ. The patient sought medical attention via contacting the physician. No treatment was given for the event. There was no laboratory test performed. At the time of the report, the patient was recovering from the event. Additional information has been requested. Follow up information has been received from the registered nurse concerning the patient who on 23-AUG-2011 was vaccinated the first dose of ROTATEQ (lot number 669992/0287AA) and on 24-OCT-2011 was vaccinated with the second dose of ROTATEQ. Concomitantly on 24-OCT-2011 the patient was administered the second dose of DAPTACEL, ACTHIB, IPOL, and a dose of PREVNAR. On 02-NOV-2011, the patient was seen in the office, no stool to test. The patient had no other symptoms and no treatment provided. On 07-NOV-2011, the patient was recovered. Follow up information has been received from a registered nurse concerning the 4 month old male patient (previously reported as 19 week old) above who on 24-OCT-2011 10:00 AM was vaccinated orally with the second dose of ROTATEQ. On 02-NOV-2011, patient was seen in office with complaint of blood (small amount) in stool. On 07-NOV-2011 follow up call was placed, his mother reported no more blood was seen. On 03-NOV-2011 (previously reported as 07-NOV-2011) the patient was recovered. The patient experienced no adverse event following prior vaccination. The patient had no illness at the time of vaccination. No further information is available.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Shortly after vaccination, the patient became lethargic and slow to respond. Immunizing technician immediately called the RPh over to assess the patient. RPh instructed technician to grab blood pressure (BP) cuff and bottled water. BP did not register on cuff, the patient's pulse was 54. After a brief unresponsive episode, the patient became responsive & drank water. Then became sweaty and unresponsive 2 more times. RPh monitored for 30 minutes and will check in on 5/8/2021.
1st day muscle aches around injection area (L. arm) later moving lower left arm muscle pain. 2nd day aches in left arm pit and left rib cage. Felt like I had a ball in my arm pit. The pain was steady. Clinic advise treatment by ice packs. Used ice packs for three days.
I tested for Covid on 04/27 and tested negative and the next day I decided to test again on that tuesday and tested positive. I felt a little tired and fatigue, had a slight runny nose and a mild cough. They prescribed me Paxlovid for my telehealth visit.
Redness and tenderness in the area of IPV (upper part of left arm) Started 24 hours after vaccines administered. No 6cm. Resolved in 5 days.
extremely tired; extreme arm pain; This is a spontaneous report from a contactable nurse (patient). A 76-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date (two weeks ago) as a single dose for COVID-19 immunization. Medical history included chemotherapy. The patient's concomitant medications were not reported. On an unspecified date the patient experienced multiple ongoing adverse events (AEs). She experienced extreme arm pain, felt extremely tired and stayed in bed for the first 7 days. Now she could only get up and do things every other day. The patient was treated with paracetamol (TYLENOL)  which did not give her any relief from her extreme arm pain. The outcomes of extreme arm pain and felt extremely tired were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient stated that on Thursday, April 15th, the top of her arm, shoulder became extremely painful where she could not move it. On Friday, she could not go to work due to the inability to move her arm and the pain, then on Saturday, she went to the ER due to the extreme pain. Dr. ordered an xray. Patient stated that pain has lessened but her arm still has no mobility. She has missed two days of work.
Initial unsolicited report received from a non-healthcare professional on 28-SEP-2016. This case is linked to case 2016SA182419 (same event, same reporter). This case involves a patient (age and gender not reported) who was vaccinated with a dose of Adacel and a dose of Pentacel (batch number, expiry date, route and site of administration: not reported for both administration) on an unspecified date. Patient's medical history was not reported. Information about patients pertussis immunizations was unknown. Concomitant medication was not reported. On an unspecified date, post vaccination patient was diagnosed with Pertussis. Laboratory data and corrective treatment was reported. Outcome of the event was not reported. Upon internal review, the case was considered as serious due to important medical event: pertussis. List of documents held by sender: none. Sender's Comments: Based on the information on unknown date patient received both vaccines PENTACEL and ADACEL and experienced pertussis on unknown date. Doses of pertussis received by the patient was not known, This case is therefore not a vaccination failure. The latency between the last dose of the vaccine administered and the occurrence of first symptoms is however not reported. However details regarding relevant medical history, date of vaccination for ADACEL and PENTACEL, date of occurrence of first symptoms, investigation reports confirming the diagnosis, age and gender of patient are needed for complete assessment of the case.
SIDS;2wk physical exam normal;15JUN97 hosp;16JUN97 discharged form hosp w/colitis, bloody diarrhea probably d/t milk allergy, changed formula to soy;
Persistent subjective fever, myalgia, and mild headache few hrs. post second dose on 05/20/2021.   Moderna COVID19 dose #1 Lot #020B21 on 04/22/2021 at Health Center.
had inject in AM started breaking out w/red dots around site of inject & other arm about 1-2 hrs p/inject; went to local ER @ 130PM: seen by MD told it was a reaction to Td-given DPH inject;
Pt states "2 hrs after receiving vaccine I got so sick". C/o fever 104, body aches, nausea, dizziness, wheezing x 3 days. R arm 2" below  inj. site became red, swollen, hot and painful. At this time R upper arm below inj. site. Approx 2"x4" red, hot, hard to the touch. States "I'm feeling better today. Referred to Dr. Advised to go to ER for resp. diff. Supervisor also assessed pt.
Initial report was received on 13 November 2012 from a healthcare professional. This case was originally part of a cluster of approximately 17 patients (six elderly patients, two adolescent patients and approximately nine unidentified patients) who tested PCR positive for INFLUENZA A/H3N2. The two adolescent patients were captured in case number 2012-05659 and the ten unidentified patients (previously reported as nine patients) were captured in case numbers 2012-05660, 2012-06067, 2012-06068, 2012-06069, 2012-06070, 2012-06071, 2012-06072, 2012-06073. In addition this case was previously part of the six elderly patient's case 2012-05658. The other elderly patient cases have been captured in case numbers 2012-10691, 2012-10692, 2012-10693 and 2012-10695. An 89 year-old female patient had received on 11 October 2011 a dose of FLUZONE, lot number UH454AC (route and site of administration not reported). The patient participated in an influenza surveillance program. The patient's approximate treatment date and "collection date" was 29 February 2012. According to the reporter, the type of influenza was flu A and the subtype of influenza was H3N2. Treatments were not reported. No further information was available at the time of the report. The patient's outcome was recovered (date not reported). Documents held by sender: None.
Mom stated that child was in a daze at the daycare with no appetite and began vomiting and became unconscious, after arriving home. Transported to ER via EMS. Tests done without significant findings per mom.
Menstrual cycle every 2 weeks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 10Sep2021 (Lot number: 301308A) at the age of 28 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (COVID-19 Vaccine: First dose: , Date: 18Aug2021, Manufacturer: Pfizer , NDC/EXP: Unknown , LOT: EW0217; states the person who documented this lot number has terrible handwriting. , Route: Upper left arm, right below the shoulder. , Formulation: injection/shot), administration date: 18Aug2021, when the patient was 28 years old, for Covid-19 Immunization.  The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 2021, outcome "unknown", described as "Menstrual cycle every 2 weeks". The event "menstrual cycle every 2 weeks" was evaluated at the physician office visit. Therapeutic measures were taken as a result of menstruation irregular.   Additional information: The patient began a menstrual cycle on 11Sep2021, by Oct2021, she started realizing her menstrual cycles were not normal.  Menstrual cycles were lasting longer than normal, 8-9 days. She went to her gynecologist two weeks ago and was given a pill. It was a 10 day pill. Caller's gynecologist stated it would stop the bleeding and hopefully restart caller's menstrual cycle.  Caller was told this pill is like taking 2 birth control pills at once. Caller states she was a psychopath on birth control. Caller does not provide any product names for the birth control she mentioned. She took one of these pills her gynecologist gave her and didn't take any more. States this was not this past week, but the week before. Caller started her menstrual cycle again today. The patient did not take any other vaccines within four weeks Prior Vaccinations.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101850382 same reporter and event, different patients
Three days after shot began having problems with right leg behind the knee to the point that "it cannot be moved; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ARTHROPATHY (non-serious), outcome "unknown", described as "Three days after shot began having problems with right leg behind the knee to the point that "it cannot be moved".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
the left upper arm (injected side); rash on chest across the left shoulder, and back.; This case was reported by a nurse via call center representative and described the occurrence of injection site rash in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th June 2020, the patient received the 2nd dose of Shingrix. On 21st June 2020, 4 days after receiving Shingrix, the patient experienced injection site rash and varicella-like rash. On an unknown date, the outcome of the injection site rash and varicella-like rash were unknown.   It was unknown if the reporter considered the injection site rash and varicella-like rash to be related to Shingrix.  Additional information was provided as follows: The patient  developed a rash (similar appearance to chicken pox) on the left upper arm (injected side), chest, across the left shoulder and back. The reporter consented to follow up
Pt received a Td on Fri 9/24/04 at 1PM. Had no pain at first, but experienced pain in left deltoid area since. Does not feel she had a fever. Area feels warm to touch and is tender. Hurts when arm is raised. Pain continues on 9/27/04.
About 24 hours after administration the patient noticed a rash on her right elbow about the size of a golf ball that was itching.  The next day she noticed a rash on her left elbow about the size of a baseball that is also itchy.  Patient has been washing with mild soap and water and applying lotion.  She has not been using any OTC or prescription products for itching.
Difficulty Breathing; diarrhea; body aches; Fever; Chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty Breathing), DIARRHOEA (diarrhea), PAIN (body aches), PYREXIA (Fever) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-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 DYSPNOEA (Difficulty Breathing), DIARRHOEA (diarrhea), PAIN (body aches), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (fatigue). At the time of the report, DYSPNOEA (Difficulty Breathing), DIARRHOEA (diarrhea), PAIN (body aches), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported were blood thinners.  No treatment information was provided.  Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product. US-MODERNATX, INC.-MOD-2021-154538:Wife's case
No additional AE information provided; an unspecified number of patients were administered an improperly stored dose of VARIVAX since 2/27/2020; This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions and allergies were unknown. Concomitant therapies included sterile diluent.  Since 27-FEB-2020, the patients were vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) with lot # S010297, expiration date 03-APR-2021 (dose number, frequency, route of administration, anatomical location were not reported) for prophylaxis (product storage error).  Temperature excursion of this vaccine was minus 14 degrees Celsius to minus 10 degrees Celsius (minus 10.4 degree Celsius) for 6 hours 2 minutes. There was no previous temperature excursion. No additional adverse event was reported. Data logger was involved.  This is a non-valid case due to lack of patient identifiers and unspecified number of patients.  Follow up information has been received on 29-JUL-2020, the medical assistant was not about to talk due to office being busy. Telephone call and fax numbers were provided.  Follow-up information has been received from the medical assistant on 26-AUG-2020.  The case is valid. The identifiers of 8 patients were provided.  The patient was 4 years old. On 17-MAR-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of the eight reports from the same reporter.; Sender's Comments:  US-009507513-2003USA007542: US-009507513-2008USA013494: US-009507513-2008USA013491: US-009507513-2008USA013492: US-009507513-2008USA013493: US-009507513-2008USA013488: US-009507513-2008USA013490:
light to moderate headache starting about 24 hours after inoculation, still persisting 24 hours later; Tylenol helps to some extent. THIS IS BY NO MEANS an acute situation; but it was suggested that I report it, nevertheless.
We administered the Johnson and Johnson COVID vaccine to a 31 year old male, we instructed him to remain in the store for at least 15 minutes. A few minutes after receiving the vaccine the gentleman got up, walked a little and did a few squats in order to look at some items on the shelf, he ended up passing out a few moments later. We administered the EpiPen and 30 seconds later he was conscious again. We called 911 and an ambulance showed up within 5 minutes of him receiving the EpiPen. Although the patient seemed to be okay, we advised him to go to the hospital for a check up anyway and he walked out with the EMT technicians.
Patient described loud ringing in his left ear whenever he presses the inject site on his left arm. No visible bump or redness at the site of injection. The injection appears to be close patient's shoulder blade area. The patient stated the ringing started about 5 to 6 months after he got the 4th Moderna vaccine. Since then, he had one other Moderna vaccine but the symptom remain the same, no worse. Administered another Moderna shot to patient today on his right arm.
Moderna Covid19 Vaccine EUA Redness and itching the spread at the injection site which started 7 days after administration which lasted  for 5 days. Ice packs applied and Benadryl taken  throughout the course of event
Within 1-3 days following vaccination and continuing to date, shoulder joint pain in the arm receiving the shot. Stiffness, limited mobility and pain in left shoulder. There has been improvement but all symptoms, through less intense, continue. Shoulder is improving slowly.
Pt recvd a series of 3 doses of Engerix-B given 25MAY90, 26JUN90, & 15NOV90; 6MAR91 titer for ANTI-HBS was 7; 4th dose given 21MAR91;
Patient complained initially of being sluggish, weak, lightheaded and felt like she was "about to pass out." Patient had not eaten since yesterday. Given orange juice. Patient began experiencing slight altered mental status (appeared to be losing consciousness in-and-out). EMS treating patient and transported patient to ED.
Mother of patient reported he had shortness of breath in night after receiving the vaccine and was rushed to the hospital. Doctors at hospital prescribed him Proair and prednisone.
Information has been received from a pharmacist concerning a 5 year old male who was vaccinated with MMR II. Subsequently, the pt experienced an "unknown reaction to the vaccination." It was unknown if the pt sought medical attention. Additional info ahs been requested.
unknown site gave influenza vaccination 1hr prior to arrival at Urgent care 10/15. Reaction described as pain/swelling at injection site and burning throat. Patient was given Benadryl 25mg po and decadron 8mg po and instructed to go to emergency department should symptoms return. 10/16 @ 1458 patient presents to ED with throat swelling. It is reported that patient had been taking Benadryl 25mg po q6h. patient was given 125mg solu-Medrol, 20mg famotidine while in ED with resolution of symptoms.
Patient has been having problem moving his arm since he received the vaccine and it has been 3 month with no improvement.
pt recv vax 1OCT96 & felt fine for first 15min post vax then exp numbness & tingling in extremities especially fingertips;good capillary refill, & BP & all other vitals signs were nl;exp allerg rxn;
woke up 2:00 am 3/19 with abdominal cramps; stomach discomfort, vague nausea, intestinal cramps. Had 2 bowel movements, soft but not diarrhea, slight sweats. Most of the night had difficulty sleeping, very restless. Upon waking, still very tired, fuzzy feeling, but no more abdominal issues.
Visual flashes; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPSIA (Visual flashes) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PHOTOPSIA (Visual flashes). At the time of the report, PHOTOPSIA (Visual flashes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medications  were not reported  Treatment was not specified     This case was linked to MOD-2021-069575 (E2B Linked Report).; Sender's Comments:  MOD-2021-069575:Wife case
Hives on January 31st, took Benadryl.  Hives from trunk, leg, and arms.  Low grade fever (100) Fatigue entire time.  On 1/5/21 arm was fine, on 1/7/21, approx. 3" welt at the injection site (Right Deltoid). Fever continues.
Became fatigued, headache, nauseous, extremely sore at injection site, body soreness
Baby seen for 4 month physical 1/25/11 and given ROTATEQ, PREVNAR 13 & PENTACEL - started with T 103.1 at 1am - in office WBC 20.4.
Patient stated that the day after her vaccine she was feeling very fatigued, nauseous, and lightheaded. She also reported that the lymph nodes in her armpit began to swell and become hard and painful. She stated she could barely move her arm due to the pain. She went to her doctor today to check on the lymph node since she is still swollen, but did report that her swelling and pain have decreased since the weekend.
Information has been received from medical assistant concerning a female patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck). It was reported that the patient developed widespread pruritus "about three weeks" after receiving ZOSTAVAX (Merck). It was reported that the patient contacted the office by phone. There was no laboratory diagnostic tests performed. It was reported that the patient had not recovered at the time of the report. Additional information has been requested.
Report #20000228319-1 describes lack of response in a pt unspecified age who rec'd Engerix-B for prophylaxis of hepatitis B. Allergies, medical history and concomitant medications are not specified. In 1/00, 2/00, and 8/00, the pt rec'd her subsequently, she was found to be a non-responder. No antibodies were found on titer. As of 9/21/00, the outcome of the event is unknown.
Pt recvd Engerix-B vax series; Reporter indicated that pt did not devel a good titer; pt was immuno-suppressed due to steroids & it has been decided by MD to wait until pt is off steroids a/series is repeated;
Swollen/tender left axillar lymph node on 11/11/15 (similar to previous 2-3 years). On 11/12/15 also developed an enlarged left clavicular lymph node that became tender, warm, and erythematous. On 11/13/15 she also developed erythema and swelling of the left lateral neck, no specific lymph node was appreciated. All symptoms resolved by 11/21/15.
It was reported that a 22 month old patient received TriHIBit and an IPOL vaccination on 5/10/01. Reportedly sometime after the vaccination (date not specified) the patient developed a large local reaction. From mailed correspondence received on 7/19/01 it was reported that the patient recovered from this experience. Additional patient, vaccine administrator and responsible physician information was also provided. From telephone contact on 8/7/01 it was reported that the patient developed a red, swollen, hard, warm area at the injection site in the deltoid, 10-20mm in diameter. This reaction resolved. This case is closed.