chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt was 'floppy' per parents starting the evening on the day he received vaccines.  He was not walking as before.  Looking tired.  No fever.  Poor appetite.  Pt more weak after 3 days -> obtained CT & MRI.  MRI showed findings suggestive of acute demyelinating encephalomyelitis. 10/20/08-records received for DOS 9/30-10/5/08-Acute disseminated encephalomyelitis. Evening of vaccinations seemed dazed and had poor oral intake. Temperature 100.4, developed ataxia. Presented to Ed with mental status change and weakness. 1/27/2010 Patient continues with significant speech delays.
used saline diluent instead of the accompanying liquid conjugate vaccine; used saline diluent instead of the accompanying liquid conjugate vaccine; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 13-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA434A, expiry date unknown) for prophylaxis.   On 7th April 2021, the patient received the 1st dose of Menveo (intramuscular) .5 ml. On 7th April 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter administered the vaccine to the patient. She used saline diluent instead of the accompanying liquid conjugate vaccine component when reconstituting the vaccine, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The batch number provided could not be found in the system but it was what the reporter provided. The batch number corrected to AMVA434A from the reported AMVA43AA excluding typo error as per sales data sheet. The reporter consented to follow up.
After the first dose, I had a fever and a rash at injection site. The rash got to be as big as a grapefruit. It turned into the shape of a heart. I had some nausea as well. Since receiving the vaccine, I keep going into A-fib and have developed a new heart arrhythmia issue that has gotten worse, although I don't remember the name of the condition. I have ended up in the E.R. twice due to elevated heart rate and fluctuating blood pressure. They gave me an I.V. with medication that brought my numbers back to normal. The EMTs also gave me a nitroglycerin tablet for chest pain.
Pt reports on 5/21/21 (today's visit) while at appointment for 2nd Moderna vaccine...  That after 1st Moderna on 4/21/21 around 3hrs after injection she began feeling "off and not myself so I went to lay down" then she had an episode of LOC from a laying position on her bed for an estimate of 5 hrs at home with her children present. She reports that her family thought she was asleep. She woke up after the incident feeling very fatigued. Pt reports not having called her primary care provider, 911 or having went to the ER as instructed should an event like this occur. Reports not having done so because while drowsy and fatigued, she did not have any difficulty breathing or chest pain and began feeling better thereafter with no other symptoms.
Swollen at injection site Severe  itch.Occurred 71/2 days (approx) after vaccination
Positive COVID test; Positive COVID test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; 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 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE, start date: Jun2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jun2022, outcome "not recovered" and all described as "Positive COVID test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jun2022) Positive; (Jun2022) Negative; (15Jun2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Positive COVID test on 05Jun after sore throat starting on 04Jun2022 with headache, congestion, and fever. The patient was treated with Paxlovid from 05Jun2022 to 10Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Started with cramps in both legs and hands. Sharp pains in body, pain in left shoulder.
Following a meningitis shot, pt's arm was swollen "like a baseball", inflamed & tender. Pt. "didn't feel good." Afebrile - appetite ok.
administered Moderna Covid-19 vaccine after 30 day use by date; vial was initially stored in the refrigerator on 19-Jan-2022 and vaccine administered after 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccine after 30 day use by date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 19-Jan-2022 and vaccine administered after 30 day use by date) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A, 044B21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021 at 5:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2022 at 1:02 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In February 2022, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 19-Jan-2022 and vaccine administered after 30 day use by date). On 01-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccine after 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccine after 30 day use by date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 19-Jan-2022 and vaccine administered after 30 day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported..
her mother was unable to walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (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: GAIT INABILITY (non-serious), outcome "unknown", described as "her mother was unable to walk".  Additional information: Patient's dose 2 was scheduled on 06Apr2021 but she was not able to get the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
She ran a fever (101 degrees) with chills Friday night into Saturday. Also had a headache, fatigue, and joint & muscle pain. The fever broke early Saturday morning but the headache, pains & fatigue continued throughout Saturday. She felt better by Sunday, just a little fatigue but attribute that to the poor sleep from Friday & Saturday.
14 year old female presented with her mom for 2nd Pfizer vaccine. Pt filled out the pre-screening questionnaire indicating no acute COVID-19 status, no hx of anaphylaxis, and denied being pregnant. The vaccine was administered without incident.  Approximately 30 minutes later pt was leaving when she fainted in the parking lot. Her family was with her and caught her fall, no injuries from the fall. Nursing staff and management were notified. Pt was safely escorted inside the store, placed in Trendelenburg position, 911 was initiated by security. Pt remained conscious, awake, alert and oriented x3, no acute distress, no respiratory distress. She complained of nausea, bilateral lower abdominal pain/cramping. Pt stated she believed to be pregnant and had been stressed regarding needing to take a pregnancy test. Pt was provided with olfactory stimuli to relieve nausea in the form of rubbing alcohol. Pt was accompanied to the bathroom, ambulatory, +urination with no observed bleeding. No itching, coughing, tongue swelling, shortness of breath, or hives. She denied any hx of localized or systemic reaction to any vaccine in the past. No medical history, no allergies to food or medicine, no daily medications. She was observed until Fire and transporting unit from EMT arrived. Care was transferred to paramedics, and pt was transported via ambulance. The mother on scene reported pt had been evaluated in the emergency room for similar symptoms one week ago and released as the ER had no acute findings.
Information has been received from a pharmacist referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX23 (route, dose and lot# were unknown). On an unknown date the patient experienced an unspecified reaction. The outcome of the unspecified reaction was unknown. The causality was not reported. Additional information is not expected as no reporter's contact information.
Subsequent to receiving vax, pts under the age of one year, developed increased irritability, leg aches, fever of 103F and cellulitis. Unspecified medical attention was sought. Additional information has been requested.
Patient came in on 11/02/2023 saying her shoulder has been hurting since the vaccine and is not getting any better over time. She was advised to go to her local doctor for evaluation. She said she had been taking Motrin but it is not helping.
felt like she was going to faint/feel Dizzy; This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number MX2LT, expiry date 29th May 2021) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number GA5Z5, expiry date 3rd May 2020) for prophylaxis.   On 17th April 2019, the patient received Shingrix (intramuscular). On 22nd April 2019, the patient received Boostrix (intramuscular). On 22nd April 2019, 5 days after receiving Shingrix and immediately after receiving Boostrix, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was not recovered/not resolved.   It was unknown if the reporter considered the dizziness to be related to Shingrix and Boostrix.  Additional details were reported as follows: When the Bostrix was administered, the patient felt like she was going to faint, and continued to feel dizzy afterwards. The patient reported the symptoms about 15 min after the dose and the patient still felt dizzy at the time of reporting.
MD reported that a pt devel bumps @ the inject site following vax w/HIB; No further details were provided;
Dose 1 admin 1/7/21.  Dose 2  admin 1/28/21.  Covid symptoms started on 4/22.  Confirmation of covid infection on
Hives scalp and face, chest tightness, anxiety, headache, diaphoresis. Onset less than 30 min after immunization. No prior rxn to flu vaccine. Rx BENADRYL 50 po, epinephrine 1/1000 s.c. 0.3 mL. This patient had previous similar rxns to many antibiotics.
Sore Left arm; significant fatigue; general malaise; temperature of 100.6; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 30Mar2021 at 09:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included traumatic brain injury and major depression. The patient had drug allergy to Lexapro. Concomitant medications included fluticasone propionate (FLONASE), guaifenesin (MUCINEX), loratadine (CLARITIN) and vitamin d nos (VITAMIN D), all for unknown indications from an unknown date. 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 vaccination. On 30Mar2021 at 13:30, the patient experienced sore left arm, significant fatigue, general malaise and temperature of 100.6. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of pain in left arm, fatigue, general  malaise and low grade fever  was recovered on an unknown date.   No follow-up attempts are needed. No further information is expected.
PT FAINTED WITHIN 5 MINUTES AFTER RECEIVING FIRST DOSE OF MODERMA COVID VACCINE ON 5/21/21.  SHE HIT HER HEAD ON FLOOR FROM SEATED POSITION CAUSING A CUT IN HAIRLINE ABOVE FOREHEAD AND BLEEDING.  PT WAS DIZZY, WEAK , AND EXPERIENCED BLURRED VISION.  911 WAS CALLED.  PT REFUSED TO GO TO ER.  PT STAYED AT PHARMACY FOR ANOTHER 20 MINUTES AFTER PARAMEDICS LEFT AND ATE A BANANA .  SHE STATED SHE WAS FEELING BETTER, VISION WAS OK,  AND LEFT WITH HER FRIEND.  SHE WAS ADVISED TO CALL 911 OR GO TO ER IF NEEDED.
On 8/9 she had woken up with stiff muscles and achiness limited to the lower extremities. Between Tuesday and Monday noted to have increased soreness. The following Monday she had developed emesis and for the rest of the week she felt nauseated but all of her leg pain had resolved. There was no dysuria and no problems with stooling and also noted to have mild abdominal pain but no back pain at this time. She missed the rest of the week of school because of continued nausea. The following week of 8/24 she seemed fine and was back at school and she joined the cross-country team and was practicing with them. On 8/31 during practice she developed significant nausea with dry heaves and she describes severe abdominal pain. That night she describes the room spinning when she looked up- not sure if dizziness and vertigo. On 9/1 she developed headache and seemed to go away. Was noted to have some photosensitivity for a day to maybe 2 days and the sensation of 'vertigo' has lasted since then. Seen by ENT 2 days later and had an MRI which did not reveal any pathologic findings. On 9/7 went to the ED because of the dizziness was really bad. Thought not to be due to the inner ear. MRI was normal and noted to have a normal neuro exam. Nausea and photophobia had resolved, dizziness continued. She was seen in PT and seen 9/16 for PT for vertigo. Started developing twitching shortly after starting PT. Noted to have increased twitchiness while seeing the rheumatologist. She started twitching more frequently. Did the exercises for 3 days and she had problems with the right knee giving out. Seen by PCP in 9/23 and seen by ortho who did not demonstrate any pathology. Right knee was swollen and there was no swelling noted. Both knees are now painful. Last Monday developed temperatures of 100.8 to 101 throughout the day with increased perspiration. Today noted shin pain bilaterally- described as stabbing. Noted to have tingling of the hands and seemed to come and go. Twitching of the arms and legs has continued and become more progressive. She is unable to attend school and uses a wheelchair because she feels weak. Seen by Neuro who have not identified any abnormal pathology.
tachycardia.; This non-serious case was reported by a nurse via sales rep and described the occurrence of tachycardia in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced tachycardia (Verbatim: tachycardia.).  The patient was treated with metoprolol. The outcome of the tachycardia was not reported.   It was unknown if the reporter considered the tachycardia to be related to Arexvy.     It was unknown if the company considered the tachycardia to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-SEP-2023 The nurse mentioned that she had conducted a site for the Arexvy clinical trials. She mentioned that during the Arexvy trial a patient reported tachycardia. The patient was treated with metoprolol (a beta blocker) for a few days.
This spontaneous report as received from a registered nurse refers to a 13 year old female patient. On 17-MAY-2013, the patient was vaccinated with a 0.5 ml dose of GARDASIL (Lot # H016960, expiration date 02-DEC-2013)intramuscularly. The nurse reported that on 27-MAY-2013, the patient experienced burning and stinging in back of throat. The patient's mother informed nurse that on 03-SEP-2013, the patient had a growth on the back of her tongue. The patient did not receive treatment for the adverse events. The nurse had not seen the patient. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Evening of day of vaccination, had fever, chills high blood pressure and pulse.  Lasted all night and next day started to get less until Friday morning.  Feeling good that day and went to friends house for dinner.  At end of dinner felt like going to throw up but instead I passed out for 1-2 minutes (have never passed out in my life!).  Medics came and ran several tests but all was okay and I have had no trouble since.
Patient reports excessive arm stiffness, unable to use injection arm for 13 days post-vaccination. Patient reported to pharmacy staff at second appointment, arm had recovered at that time.
This spontaneous report as received from a pharmacy technician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot #, expiration date, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 72.68 degrees Fahrenheit for 84 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as no consent was given for further contact.
the patient received the fluzone quad instead of fluzone hd with no reported adverse event; Initial information received on 03-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 71 years old male patient who received the influenza quadrival a-b vaccine [fluzone qiv] instead of fluzone hd with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of 0.5 ml total of suspect influenza quadrival a-b vaccine (Suspension for injection) (lot: UT7751JA ; expiry date: 30-Jun-2023) via intramuscular route in right deltoid for Immunization.  On an unknown date the patient received the fluzone quad instead of fluzone hd with no reported adverse event (wrong product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   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.
On 2/3/00, the pt developed full-blown chicken pox with two vesicles under her arms and a temperature of 101 degrees. On 2/4/00 the pt's trunk and back were covered with multiple vesicles. On 2/10/00, the pt's lesions crusted over and she recovered. It was reported that the pt's brother had a similar experienced. No further information is expected.
This case was reported by a other health professional via call center representative and described the occurrence of headache in a male patient who received SHINGRIX for prophylaxis. On 17th December 2018, the patient received SHINGRIX. On 18th December 2018, 1 days after receiving SHINGRIX, the patient experienced headache, fever, chills and appetite absent. The patient was treated with analgesic, NOS (Pain Medication). On an unknown date, the outcome of the headache, fever, chills and appetite absent were unknown. It was unknown if the reporter considered the headache, fever, chills and appetite absent to be related to SHINGRIX. Additional information was provided as follows: The age at vaccination was not reported. The patient experienced horrific headache that lasted all week with a fever, chills and could not eat. The patient called the doctor on Friday, 21st December 2018 and went to see the her. They tested the patient for the flu which came back negative. The doctor thought it was some kind of virus going around. The patient was given a pain shot, which helped some. On Saturday, 22nd December 2018, the patient called the doctor again. She told the patient to go to the emergency room (ER). The patient got there and let them know that he had shingles vaccine. They tested the patient for the flu which was still negative and also ran a lot of blood work which also came back negative. They ran two different computerized tomogram (CT) scans. One was a regular one and another with dye which was also negative. They wanted to do a spinal tap and by that time the patient was too tired and said no. The reporter type was selected as other health professional as per specialty entered on source document.