chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On Oct 29, 2018, pt began complaining of pain in her left leg. She continued to play and baby the leg slightly. We looked at it to see if there was a bump, bruise or mark, but we did not see anything. The next day, Oct 30th, 2018, pt woke up in pain, saying her knee/leg hurt. She had a lot of trouble putting weight on it and I noticed she was hot, so I took her temp and she had a low fever. I gave her Tylenol, and within 30 min she was walking normally and her fever had gone down. She went to school, because there were no signs of any congestion, cough, sore throat, or anything respiratory- besides the leg pain and very low fever (100.1-100.3). I picked her up from school that day and the teach told me she had been fine all day - playing and acting normal, until she woke up from her nap (2:15 end of the day). I walked in and she was on the floor, telling me she couldn't walk. I asked her where it hurt and she said her leg. So I picked her up and carried her out. When we got home her fever was higher than before - 101.5-101.8. I gave her Tylenol once again and about an hour later her pain was gone and so was the fever. She was walking around and playing like normal. She went to bed and woke the next morning (Oct 31st) and has some pain and low fever (100.1-100.4), but was walking. She went to play at the museum in town, had lunch and went down for a nap. When she woke up around 3pm she was in  a lot of pain. We decided to take her into Urgent Care because it was day 3 and did not seem to be getting any better. They sent us to the local hospital and we were seen right away. The began an IV and took blood. They saw elevated white blood cell counts and told us it was indicative of an infection somewhere in the body. They gave her Tylenol and transferred us to Hospital. We checked into the ER and were seen by several doctors - they too took blood and confirmed the high white blood cell count and elevated CRP levels in her blood - indicating infection. They decided to keep her overnight to watch her. The next day, Nov. 1st they began running blood tests for bacterial infection and an infectious disease doctor and Oncologist came in to assess pt and sort of get the history of what had been happening with her. The next day, Nov. 2nd, we began IV antibiotics. We continued on the antibiotics and are still currently on them via PICC line. Over the next days Nov 3-9, we did two MRI's, a CT scan, bone marrow biopsy, PICC line insertion and the only thing they could find was that the bone marrow appeared to be darkened on the MRI - in the same place on both MRI's. There was no abscess, or "highlighted" areas on the scans to indicate "infection", however they would treat this as Osteomyelitis, since the antibiotics did seem to space her fever out further, and make the pain go almost completely away as well. We left on 11/11/18 with the PICC line and order of IV of antibiotics to complete at home over the next 3 weeks. We go for our follow up visit today, 11/15/18 to read further blood test results, etc.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: he fell
Petechiae. Very low platelet count (2,000). Diagnosed with idiopathic thrombocytopenic purpura (ITP). Hospitalized for a week.
Janssen COVID-19 Vaccine EUA: patient in clinic to establish care. COVID-19 infection in January 2020. Reports one week after immunization experienced increased heart rate and shortness of breath while on vacation out of state. Patient went to emergency department (ED) and diagnosed with heart arrhythmia. Patient left hospital before heart echo could be performed. Continues to have some shortness of breath at times but no palpitations.
Information has been received via company employee from a friend of company employee referring to a female patient of unknown age. In late December 2015 the patient was vaccinated with a dose of ZOSTAVAX (route, lot# and dose were unknown). Immediately after vaccination the patient developed flu like symptoms. After several months of illness, the patient was diagnosed with meningitis type A in her optic nerves which an unspecified physician referred to as a "rare side effect of the vaccine." The patient saw a neurological ophthalmologist. It was not known if she was admitted to the hospital. She was recovering but was still having vision problems. The experience caused her to leave work for a semester (disability). On an unspecified date, the patient was hospitalized at an unspecified location for dehydration. The outcome of dehydration was reported as recovering/resolving. The causality was not reported. Upon internal review, meningitis was considered to be medically significant. Additional information has been requested.
Itching and tingling is mouth & lips very flushed & hot feeling. Pain in left arm below site & itching to face.
Right posterior arm shows an approximately 8-cm x 6-cm indeviated red plaque at site of recent Zoster vaccine.
Patient presented to ER department with  s/s of stroke. He was transferred from Hospital to another hospital
Information has been received from pharmacy student concerning a 60 year old patient who was vaccinated with VARIVAX. The pharmacy student reported that the patient was given VARIVAX instead of ZOSTAVAX. Medical error. The patient is not experiencing  any known symptoms. There was no product quality complaint. Additional information is not expected.
pt recv vax & exp dizziness & nausea for a few hr immed following vax; pt was treated & discharged from ER; sx resolved; LMP 6APR95; ultrasound determined that pt is approx 3months pregnant & fetus is deformed & has no heartbeat;
Pain started immediately with vaccination; localized to left shoulder with pain shooting down arm to elbow, wrist and thumb; injection given near top of left shoulder. Pain x 4 months.
TESTED POSITIVE FOR COVID-19; This spontaneous report received from a parent concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-DEC-2021, the patient experienced tested positive for covid-19. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid-19 was not reported. This report was non-serious. This case, from the same reporter is linked to 20211261116.
Feb 20, per par, received Tdap (R) deltoid - began having localized pain & swelling within 24 hours. Limited use of arm. Negligible amounts of analgesics.
On 11/5/21, 54 year old male client (patient) arrived to vaccination site and asked to receive Janssen Booster COVID-19 dose. He reports and shows documentation of completing 2-dose series of Pfizer COVID-19 vaccines in February/March 2021.  Client reports history of pericarditis "years ago", and reports experiencing symptoms of pericarditis which included inflammation and swelling, especially after receiving 2nd dose of Pfizer.  Client reports consulting with his cardiologist in the past for pericarditis symptoms, and reports that his cardiologist recommended that client take "Naproxen" when these symptoms arise (client reports symptoms last occurring "years ago".  Client reports taking Naproxen (BID) for a few days, and reports that swelling/inflammation subsided.     Client requests to receive Janssen booster, instead of Pfizer booster dose at this time.     Elevated inquiry to Clinical Supervisor, who receives approval from Medical Provider Dr. to administer Janssen booster dose to client at this time. This nurse explained  to client risks/benefits/emergency precautions post-observation.  Client verbalizes understanding and provides consent to receive Janssen booster (Lot #1855194), which was administered by this nurse at 1:16 PM on 11/5/21.  - RN.    No Adverse reactions noted during 15-minute post-observation period.  Explained potential risks and side effects to client, explained emergency protocol to client.  Client verbalized understanding. - RN.
Unexplainable bad mood. This also happened w/ flu shot in 2011. Headache after shot but may be unrelated.
Non stated. 8/18/09 spoke w/pt says had swelling under left armpit to include chest, triceps and a red spotty rash across chest, symptoms went away with no treatment.
it looked slightly swollen after administration; MMRII was given intramuscularly instead of subcutaneously; The patient is 38 years old; This spontaneous report was received from pharmacist and referred to a 38-year-old female patient who was no pregnant. The patient had no pertinent medical history or drug reactions/allergies. The patient's concomitant medications was unknown.  On 06-DEC-2021, the patient was vaccinated with her second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (0.5ml, lot #T034389, expiration date: 08-OCT-2022) for prophylaxis due to travel (product administered to patient of inappropriate age), and sterile diluent (STERILE DILUENT) (strength, dose, lot# and expiration date were not reported) administered intramuscularly. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) was given intramuscularly instead of subcutaneously (incorrect route of product administration)   The reporter stated it looked slightly swollen on 24-MAY-2022 after administration but otherwise the patient had no symptoms or adverse effects of administration intramuscularly. No lab diagnostics/ studies were performed. The patient had not sought medical attention. No treatment was given for event. The outcome of slightly swollen was not reported.   The causality between suspect products and the event slightly swollen was not reported.
First dose was administered on 18-Feb-2021 and second dose was administered on 03-Mar-2021; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 18-Feb-2021 and second dose was administered on 03-Mar-2021) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 700632007 and 7006320005) for COVID-19 vaccination.     Concurrent medical conditions included Milk allergy, Food allergy (Corn) and Eosinophilic esophagitis.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 18-Feb-2021 and second dose was administered on 03-Mar-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 18-Feb-2021 and second dose was administered on 03-Mar-2021) outcome was unknown.            Concomitant medications included unspecified medication for eosinophilic esophagitis.  It was reported that patient was part of the clinical trials of the Moderna COVID-19 vaccine and received the second booster dose.  No treatment medication was reported   This case was linked to MOD-2022-609215 (Patient Link).
No adverse event; The bivalent vaccine was given after the 30 day beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The bivalent vaccine was given after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 30-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 07-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 07-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The bivalent vaccine was given after the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The bivalent vaccine was given after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The bivalent vaccine was given after the 30 day beyond use date).    No concomitant medications were provided. Patient has received first dose of the Moderna COVID-19 vaccine by intramuscular injection on 23-MAR-2021 ( lot number 008B21A, expiration date unknown), second dose of the Moderna COVID-19 vaccine by intramuscular injection on 20-APR-2021 ( lot number 039A21A, expiration date 4-SEP-2021), third dose of the Moderna COVID-19 vaccine by intramuscular injection on 16-NOV-2021 ( lot number 051F21A, expiration date 5-DEC-2021). Vial size was 2.5 mL. Date the vial was initially stored in the refrigerator was unknown. BUD expiration date was written as 5-NOV-2022. The vial did not undergo any temperature excursions. The pharmacy listed an expiration date on the vials of 5-NOV-2022. Reporter used the online expiration date tool which listed it as 19-MAY-2023.  The vaccine vials were thawed. Patient has no reported symptoms.  Patient has no additional doses, medications, or treatments.
pt developed severe myalgia throughout his entire body approximately 24 hrs. following his 2nd dose of Moderna COVID vaccine that was not given through our clinic - I have contacted the patient to find out where he had his vaccine administered and what was the lot number.  He had a sore arm for 24-48 hrs. with the first dose of Moderna COVID vaccine.  The myalgia persisted and he was seen and evaluated in our office on 8/4/21.  Labs (CBC, CMP, lactic acid, CPK, and CRP) were drawn - all were normal except for CRP elevated at 13.6 and glucose of 129.  His pravastatin was held.  On 8/25 we spoke with patient and he was continuing to have severe muscle pains in trunk, arms, and legs.  Prednisone was started at per day.  Within 24 hrs. his symptoms were tremendously improved.  He finished a five day course of prednisone and within 48 hrs. his symptoms were returning.  On 9/1/21 he was given the diagnosis of polymyalgia rheumatica and was restarted on 20 mg daily of prednisone.  His CRP at that time was down to 2.33.  His HgbA1C was stable at 6.3.  He will continue to follow-up in our office.
Mild-grade fever of 101 for two days, moderate to severe muscle aches for three days, and extreme fatigue for three days.
Tingling; Very mild numbing sensation in the vaccinated arm (left arm); Left hand started warming up; Heart rate became rapid; Shaking uncontrollably; muscles became incredibly weak; panic attack; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 29-year-old non pregnant female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch no: not reported/ Lot number: unknown) via an unspecified route of administration in left arm on 08May2021 at 17:00 (at the age of 29-years-old) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 from an unknown date to unknown stop date. Concomitant medications were not reported. Prior to vaccination, patient was diagnosed with COVID-19 and Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other medications within 2 weeks of vaccination and did not receive any other vaccines within 4 weeks prior to the vaccination. After receiving first vaccination, the patient was ushered to the waiting room to wait 15 minutes. On 08May2021 at 17:05, about after 5 minutes after sitting in chair, the patient noticed slight tingling and very mild numbing sensation in the vaccinated arm which was left arm. Then the patient had started warming up and the sensation progressed to the left side of face. The sensation did not proceed to move to the right side of the body. However, the patient's heart rate became rapid, was shaking uncontrollably and muscles became incredibly weak. The patient stated against the will of her muscles she was shaking like a person with Parkinson's disease. The patient made it to the counter to alert the nurse. The patient stated to nurse that she might be having a panic attack but had no idea what would have triggered it and she never experienced anything on this level. The staff proceeded to set patient back down in chair and fan was switched on. The patient did not need it as by that time, literally only about 4 minutes into this episode, the patient's body was beginning to calm down and was totally fine over after 30 minutes. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events slight tingling and very mild numbing sensation, warming up and the sensation progressed to the left side of face, shaking uncontrollably, muscles became incredibly weak and panic attack were resolved on 08May2021 at 17:35.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Diarrhea, occurred the day after receiving 1st vaccine, in the morning. Also had it again after eating dinner two or three times.; Then proceeded to vomit once; This is a spontaneous report from a contactable consumer, the patient. A 12-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the right arm on 14May2021 at 12:00 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. The patient had no known allergies. The patient did not receive concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 15May2021 at 08:00 the patient experienced diarrhea, occurred the day after receiving 1st vaccine, in the morning.  Also had it again after eating dinner two or three times. Then vomited once. Do not know how long it was last. Patient had a hope it will resolve itself tomorrow. Elisa is 12 years old had received vaccine within a few days of vaccinations opening to her age group. Therapeutic measures were not taken as a result of the reported event(s). The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event diarrhea, occurred the day after receiving 1st vaccine, in the morning and then vomit once was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Patient reports feeling dizzy spells and tunnel vision. Was not temperature related. As he was working, he felt dizzy enough that he may fall down. Started 24-32 hours after dose, and is still going 5 days later. Referred patient to care or emergency room.
CLIENT RECEIVED  PFIZER VACCINE AS THIRD DOSE. CLIENT PREVIOUSLY RECEIVED 2 DOSES OF MODERNA. AT THE TIME OF PFIZER ADMINISTRATION VACCINE MIX/MATCH HAD NOT BEEN APPROVED.
pt began crying inconsolably 24SEP96 & limping, favoring lt leg;parents gave APAP & fever not present;1OCT96 mom called pt ran temp 4-5hr fever remainder of 25SEP96 but was afeb & w/o discomfort on 26SEP96;
Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 82 years old male patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE lot UJ004AA via intramuscular route in the left deltoid (expiry date not reported) on 25 Sep 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to vaccine underdose. It was also a case of syringe issue. It was reported that giving the vaccine to a patient and liquid leaked out the compartment between the needle and the part of the syringe where the vaccine is. They believe that patient received the majority of it but need to know if he should be vaccinated again. It was unknown whether patient experienced any adverse reaction after the vaccination. 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. Documents held by sender: none.
feeling of extreme warmth or heat in the center of her chest /The warmth was not like a hot flash, nor was it like any kind of digestive issue, it was cardiac related.; feeling of extreme warmth or heat in the center of her chest /The warmth was not like a hot flash, nor was it like any kind of digestive issue, it was cardiac related.; heart rate started pounding; lightheaded and dizzy feeling; shaking all over; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205), via an unspecified route of administration, administered in arm left on 02Mar2021 12:45 as a single dose (at the age of 63-years-old) for covid-19 immunisation. Medical history included high blood pressure that was treated with metoprolol from an unknown date. The patient had known allergies to penicillin. The patient was not pregnant at the time of vaccination. Concomitant medications included metoprolol succinate taken for high blood pressure, start and stop date were not reported; escitalopram taken for an unspecified indication, start and stop date were not reported. The patient previously took prednisone and ciprofloxacin and experienced drug allergy. At about 25 minutes after receiving the vaccine (02Mar2021 13:15 as reported), the patient had a feeling of extreme warmth or heat in the center of her chest (about where her sternum was). It was a sudden feeling that started radiating outward, seemingly along her arteries and at the same time, her heart rate started pounding, accompanied by a lightheaded and dizzy feeling. The warmth was not like a hot flash, nor was it like any kind of digestive issue, it was cardiac related. It wasn't a panic attack either. The patient started shaking all over while was driving up and immediately looked for a place to pull over, and began texting someone close by (her brother) to let him know what was happening. No treatment was received for the reported events. The reported events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was unknown.