chrisvoncsefalvay/vaers-outcomes huggingface dataset:
THURSDAY, JUNE 4TH, RIGHT SIDE OF FACE STARTED SWELLING. PARENT TOOK HER INTO EMERGENCY ROOM. BY THE TIME THE M.D. GOT THERE SHE WAS ALERT AND ACTIVE. E.R. STAFF SAID SHE SEEMED LIKE A NORMAL BABY AND THEY COULDN'T NOTICE THE SWELLING BUT PARENT COULD. THEY DISCHARGED HER TO HOME THURSDAY NIGHT. FRIDAY, JUNE 5TH, SHE WENT TO HER REGULAR DR. FOR HER ROUTINE 4 MO. CHECK UP AND WAS FINE THERE. THEN AT 3:00 P.M. SHE STARTED HAVING SEIZURES, RIGHT EYE WAS DROOPING AND SHE WAS SHAKING. PROBABLY HAD 15 SEIZURES AT HOME PER MOM, AND HAD ABOUT 5 SEIZURES ON WAY TO HOSPITAL. ER STAFF TOOK HER INTO TRAUMA ROOM AND CHECK-IN NURSE SAW A SEIZURE. THEY DREW BLOOD AND DID A SPINAL TAP AND ADMITTED HER. SHE KEPT ON HAVING SEIZURES THROUGH OUT NIGHT. DID EEG ON SAT JUNE 6TH AND THEY CAUGHT A SEIZURE AND PUT HER ON PHENOBARBITAL. SUNDAY JUNE 7TH SHE HAD THREE MORE SEIZURES. THEY KEPT HER ON EEG MACHINE UNTIL MONDAY MORNING JUNE 8TH. THEN MONDAY MORNING SHE GOT AN MRI DONE. NO MORE SEIZURES SINCE SUNDAY JUNE 7TH. MRI CAME BACK NORMAL. TUESDAY DID ANOTHER SPINAL TAP, FIRST CULTURE HAD BACTERIA IN IT BUT THOUGHT IT WAS CONTAMINATION BECAUSE IT WAS JUST A LITTLE BIT. 2ND SPINAL CAME BACK NORMAL. WEDNESDAY JUNE 10TH SHE WAS RELEASED HOME AND NOTHING HAS HAPPENED SINCE WITH SEIZURE ACTIVITY. SHE IS ON PHENOBARBITAL 20 MG. AMT: 1 AND 1/2 TSP. QD PO. THE NEUROLOGIST SAID IF NO MORE SEIZURE ACTIVITY FOR 6 MONTHS, WILL TRY TO WEAN HER OFF MED.  7/1/09 Hospital records received DOS 6/6/09 to 6/10/09. Assessment: New onset seizures. Patient presented with multi episodes of eye blinking, unresponsiveness, drooling. Twitching, eyes rolling back. Tachycardic. Stares to right. Rash lower extremities. Hyperreflexia, clonus.  7/16/09 ICD-9 Codes: 780.39, 987.8
(R) upper arm became edematous, red, hot to the touch and painful M.D. ordered Naproxen 500 mg BID and pt instructed to apply ice.
Swelling at injection site and extremely hot to touch and formed a hard mass for over one week and started within an hour of injection. 24 hours later, fatigue, fever, shakes, headache and aches set in. The second night all the previous mentioned symptoms continued but at an elevated state. This integrity lasted for three days. One week post injection, still suffering headaches, nausea, fatigue, shortness of breath, aches and sweats. Two weeks post injection, still suffering from previously mentioned symptoms.
Crashed 15 days to the hour of receiving shot - All systems crashed - Blood, organs, bones, brain skin - finally diagnosed SLE-CNS.
Shingles in the lower back.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 14:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to food, medication and other products. On 08Apr2021 at 09:00, the patient experienced shingles in the lower back and the patient never experienced shingles or herpes and did not had sexual relationships. The patient was healthy and did not take any medications. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with antibiotic cream (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles in the lower back was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Right leg pain. He also had some generalized shaking to his face, his chin started to quiver. He had another episode of ten to 15 minutes where he was not focusing. He seemed to be looking right through his parents. His mother thought his pupils looked large and asymmetrical. No generalized shaking. No loss of consciousness. No obvious postictal stage. No prior neurological problems.
This spontaneous prospective pregnancy report was received from a medical assistant concerning a 32 year old female patient. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, route and lot # not reported) while pregnant. The patient's last menstrual period and her estimated date of delivery were unknown. The pregnancy outcome was pending. Additional information is not expected as there is no contact information.
Retuned with an area of redness and warmth which just started today. Vaccine given 7 days prior in the deltoid, area of redness approx 15cm x 30 cm.
Shoulder gradually got more sore and stiff around the joint where he received his injection (Left arm). Not terribly painful, just sore and stiff. Most bothersome at night when trying to sleep. Sore for a couple of weeks.
Extreme fatigue; nausea and vomiting; 103.4 F fever; joint and muscle soreness; uncontrollable shivering
A non-serious spontaneous report of one side of my nose completely blocked and lot of sinus pressure has been received from a consumer concerning a patient (age and gender unknown), subsequent to FLUMIST. The patient's past medical history includes deviated nasal septum. No concomitant medications have been reported for this patient. The patient received FLUMIST on 20-Oct-2009 for unknown indication. Two days after receiving FLUMIST, one side of the patient's nose was completed blocked and the patient had a lot of sinus pressure. Treatment for the events was not provided. The outcome of the events was not reported.
RECEIVED COVID-19 VACCINE AND TESTED POSITIVE TO COVID ON 8/17/21
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information on medical history, concurrent conditions or concomitant drugs was provided. The patient was vaccinated with PNEUMOVAX 23, (dose, route and site of administration not reported) lot # H014283 and expiration date 17-APR-2014 on 02-MAY-2014. There was no adverse reaction reported. This is one of several reports from the same reporter. Additional information has been requested.
Wife called & informed me that husband was admitted to hospital on 04/02/2021 with blood clots (2) in right lung. Husband had been in good health prior. Will be seeing a hematologist soon
Patient stated with all Moderna doses, the most recent booster doses given 10/25/2021 and 4/12/2022, her blood pressure dropped low within 3 hours of vaccination. This lasted for several days after vaccination. It stayed low and she felt really bad/sluggish for those few days. She consulted her doctor regarding previous vaccinations of Moderna. When her blood pressure begins to drop, she does not take her blood pressure medicine for those 2 to 3 days, and it stays low. Within 3 hours of last vaccination on 4/12/2022, her BP was 96/57, then 116/68 the next morning and 104/62 by 10:23 am. Once her blood pressure goes back up to the 150/90 range, she resumes her blood pressure medications.
This spontaneous report was received from a regisetred nurse referring to an unspecified number of patients of unspecified demographics.  On 06-MAR-2017, the the patients received improperly stored doses of PROQUAD administered subcutaneously (lot number M031944, expiration date 27-DEC-2017, dose was not reported). No adverse events were reported. The doses of vaccine experienced a temperature excursion of 61F and 47F to 77F for 27.5 hours which was detected by a digital datalogger. There was no previous excursion reported. No product quality complaint (PQC) was reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA014442:
Within 72 hours, lost voice, lost my ability to swallow thin liquids with frank aspiration of water, difficulty breathing Dx: L laryngeal palsy (unknown origin) could not rule out inflammatory reaction secondary to Covid vaccine
Patient has history of seizures. She had been seizure free for over 3 months after switching drugs. She had two seizures 3 days after vaccination.
Immediately following vaccination, the pt experienced tremors and 48 hours later became dizzy. She sought unspecified medical attention. No further information is available.
allergic to PEG; allergic to PEG; GI tract episode; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): 2022NVX-US-000003978 (ProPharma Group on behalf of Novavax.).  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer biontech covid-19 vaccine (dose 1, single), for covid-19 immunisation. The following information was reported: REACTION TO EXCIPIENT (non-serious), POLYMERS ALLERGY (non-serious), outcome "unknown" and all described as "allergic to PEG"; GASTROINTESTINAL PAIN (non-serious), outcome "unknown", described as "GI tract episode". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: It was reported the individual experienced GI tract episode but at that time it was not known it was related to the Pfizer vaccine. The individual then had to prep for colonoscopy and the individual was told that it was 100% due to Polyethylene Glycol (PEG). The individual had a super severe reaction and they had to abort the further testing. Then the pharmacy said the individual need to figure that out before getting the Pfizer booster. The individual went to an immunologist and got tested and it was reported that the individual was allergic to PEG. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021 at 4:28 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Oct-2021 at 4:28 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The age of patient was provided as 43.08.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  On 22-OCT-2021, Excursion time was 08 AM temperature was 32, Excursion time was 09 AM temperature was 32, Excursion time was 10 AM temperature was 32, total doses given for the day was 05, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 29-SEP-2021, vial was moved to clinic on 22-OCT-2021. 01 vials were sent to clinic. Vaccine BUD date was 29-OCT-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
No adverse effects; was administered intramuscularly versus subcutaneously; This spontaneous report was received from a registered nurse and refers to a 60-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 01-AUG-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S004120, expiration date 11-FEB-2021, intramuscularly versus subcutaneously (exact dose and site of administration were not reported) for prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was reconstituted with sterile diluent. The outcome of the events was unknown.
Act-hib was expired by two days and administered with no reported adverse event; Initial information received on 08-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient and reporter stated that HIB (PRP/T) VACCINE [ACT-HIB]was expired by two days and administered with no reported adverse event.   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) VACCINE (strength, formulation, frequency, lot number and expiry date was unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious event of act-hib was expired by two days and administered with no reported adverse event (expired product administered) (latency: same day) following the administration of HIB (PRP/T) VACCINE.  Action taken : not applicable.  Outcome: Unknown   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 the 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.
Child in father's lap to receive vaccine. Father placed child standing next to mother. Mother states that she saw child fall to floor. Nurse did not see child fall. Nurse saw child lying on floor, with knees bent and eyes open. Father picked child up, and held in his lap. Child appeared dazed for several minutes. Normally responsive in about 15 minutes. No visible injury. Parents encouraged to follow up for possible head injury. The mother called the next day at 10:58AM, and stated that "Everything is OK. "The child is OK".
Headache, Arthralgia, Nausea Vomiting, weakness, fatigue
COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 at 18:00 as dose 4 (booster), single (batch/lot number: unknown) at the age of 47 years, in right arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (batch/lot number: unknown), as dose 2, single (batch/lot number: unknown) and as dose 3 (booster), single (batch/lot number: unknown) for covid-19 immuniation. The patient's relevant medical history included: "bandage adhesive allergies" (unspecified if ongoing). Concomitant medications included: PROGESTERONE, start date: 01Nov2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: Covid-19 test: positive, notes: treatment of COVID-19; negative, notes: completed the round of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid with treatment start date 28Dec2022 and treatment stop date 02Jan2023. . The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Before going to bed the day of vaccine, I noticed my left shoulder/collarbone area was hurting and did not sleep well that night even though I was tired. When I woke up the next day, I was in some discomfort around my collarbone and felts a small lump. I waited until Wednesday and did a virtual visit with a doctor and they said it is probably the lymph nodes. There has been no change in the size of the lump nor has it moved to a new spot.
A few hours after getting my second dose I started getting a swollen arm. The next day early in morning I started feeling the chills fatigue a stomach ache light headed body ache and my arm was super swollen and on fire. Could not lift it I was in so much pain the next few days I've never felt anything like what I felt. I never get sick and this was the worst
Information has been received from a nurse concerning a 17 year old female with chronic unspecified abdominal pain who on 16-JUL-2009 was vaccinated with her first dose of GARDASIL (lot# 659655/0940X, IM, 0.5 ml, site: arm). Concomitant therapy included MENACTRA. On 17-JUL-2009 the patient felt nauseated and hot, and then fainted. The patient sought medical attention. On 18-JUL-2009 the patient recovered. Follow-up information has been followed from the registered nurse concerning a 17 year old female student who on 16-JUL-2009 was vaccinated with the first dose of GARDASIL (lot# 659655/0940X) in her arm. Concomitant therapy included a first dose of MENACTRA (U2918AA) in her arm. The patient complained of dizziness and weakness 12 hours after the vaccination and lasted to 48 hours after the vaccination. There was no diagnostic laboratory test. The patient recovered on 18-JUL-2009. No further information is available.
Chills, temp 101, headache, sore throat began on Thursday.  Neck stiffness, swollen glands and temp 103 on Friday into Saturday.   Mom treated with Tylenol over the weekend. Back to school today, 12/21/2009.  Afebrile, slight sore throat.
Nurse grabbed MMRV PROQUAD from freezer, intending to administer MMR. MMRV was administered to patient. Error was not caught until after patient left, when vaccine was put into EHR.
66 year old female patient inadvertently received an expired dose of Fluzone high dose, no AE; Initial information received on 16-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer .  This case involves a 66 year old female patient who vaccinated with an expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] inadvertently (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.   Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) for Immunisation.  On 16-Sep-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ306AA and expiry date: 24-Jun-2020) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  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.
A few minutes after pt had been given the vaccine she appeared to have a panic attack- shortness of breath, felt like she was going to pass put ringing in ears
After the vaccine on Feb 2nd,  i have not been able to raise my left arm, Its been so much PAIN for some time now, I have been trying to exercise and stretch the arm to no avail. The worse is the pain that radiate between  my left shoulder, arm and neck. The first dose I got in January 12 and have just swollen lymph nodes and was ok after a week but have not recover from the 2nd dose. Its tough because i cannot lift anything with my left arm at this point and i have no medical insurance because i lost my full time job.  I do not know if its as a result of the vaccine itself or the position of the injection but am really suffering. I will appreciate information on anything I can do to help my situation.
site soreness; headache; major chills/chills and more chills; fatigue; This is a spontaneous report from a contactable consumer (patient himself). An elderly male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 27Jan2021 (at the age of 67-year-old) as SINGLE DOSE for covid-19 immunization. Medical history included High blood pressure. Allergies to medications, food, or other products was not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Concomitant medications were reported as none. On an unspecified date, the patient experienced site soreness, headache, major chills/chills and more chills and fatigue. Seriousness criteria reported as none. Patient not diagnosed COVID 19 prior to vaccination. Since the vaccination, patient not been tested for COVID-19. Patient did not received any treatment for the adverse event. At the time of this report event outcome was recovering.  Information on the lot/batch number has been requested.  Follow-up (15Apr2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made.   Follow-up attempts have been completed and no further information is expected.
Chills, dizzy, headache, fatigue, drowsy, nausea, decreased appetite. Inj site warm, red and started swelling night of injection. Patient did not call office until 11/16/2016 to be seen, where she was noted to have cellulitis from inj site to elbow on right arm.
Shortly after receiving vaccine my mother began to suffer dizziness,  blackouts, and a headache that would not stop no matter what she did. Tylenol, ibuprofen,  fainting spells and brain fog like amnesia.  There were recent visits to the emergency room and never before but the er  had difficulty stopping bleeding from trying to start an iv then sudden death october 24th body found in apartment at 930 pm pacific time.
On 04/04/2002 child awakened at 8:00am with pain and discomfort to right arm. Right arm got red, raise area approx 5cm x 4cm and smaller inside area 4cm x 3 ccm with vesicles, surrounding injection site. Left arm with reddened area approx 6.5cm x 5cm. Pt is afebrile. Referred to private physician for further evaluation.