chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tiredness; arm pain; muscle weakness; intoxication; slurred speech; equilibrium off; feeling of euphoria; minor light head/dizziness/giddiness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), dose 1 via an unspecified route of administration, administered in left arm on 03Apr2021 09:30 as single dose for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. 2 hours after shot (03Apr2021 11:30), minor light head/dizziness. 3 hours after shot (03Apr2021 12:30), slurred speech, equilibrium off, feeling of euphoria, giddiness, intoxication, overall felt amazing.  7 hours after shot (03Apr2021 16:30), tiredness, arm pain, muscle weakness. 24 hours after shot (04Apr2021 09:30) no arm pain, feeling normal, still feel a sense of euphoria. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive ant list of any other medications within 2 weeks of vaccination. There was no treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There is no allergies to medications, food, or other products. There is no known allergies and other medical history. The outcome of the events was resolving.
THERE WAS MISS COMMUNICATION BETWEEN PHARMACIST, PARENT, AND PT. THE MOTHER CALLED IN (OTHER SON) AND PT CAME IN THE ROOM. I ASKED THE PT IF HE WAS (other son) AND HE CONFIRMED HE WAS. THE PFIZER ADULT DOSE OF 0.3ML WAS ADMINISTERED. ONCE PT WAS CALLED THE MOTHER SAID PT WAS THE 1ST CHILD THAT CAME IN WHICH IS WHERE WE BOTH CAUGHT THE ERROR. SHE TOLD ME THIS HAPPENS EVEN AT HOME REGULARLY ONE WILL COME IN THINKING THE OTHER CHILD WAS CALLED. I EXPLAINED I EVEN ASKED THE CHILD IF HE WAS (other son) AND HE SAID YES. SHE SAID IT WAS OKAY. I COUNSELED THE PTS MOTHER AND THE PT OF THE POSSIBLE SIDE EFFECTS. SHE DID MENTION AFTER THE FACT THAT HE HAD A RUNNY NOSE BUT WAS NOT RUNNING FEVER OR ANY OTHER PROBLEMS. I ALSO CAUTIONED THE MOTHER THAT IF THE CHILD STARTED FEELING PAIN IN HIS CHEST TO TAKE HIM IMMEDIATELY TO THE ER OR AN URGENT CARE AS IT MAY BE A FORM OF PERICARDITIS (INFLAMMATION OF THE HEARTS LINING) WHICH THEY SHOULD BE ABLE TO ADDRESS. I TOLD HER I WOULD DOCUMENT THIS INCIDENT IN HIS PROFILE AND IF SHE NEEDED ANYTHING FOR PT TO PLEASE DONT HESISTATE AND CALL. I RECOMMENDED CHILDRENS TYLENOL OR IBUPROFEN OTC IF SHE NEEDED FOR THE CHILDREN AND TO FOLLOW DIRECTIONS ON BACK OF THE PACKAGING. WILL FOLLOW UP IN 2 DAYS FROM TODAY-  12-2-21
No additional AE's; an improperly stored PROQUAD vaccine was administered; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions and allergies were not provided.  On 16-AUG-2022, the patient was vaccinated with improperly stored measles, mumps, rubella, and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, lot number U026800, expiration date 26-FEB-2023, for prophylaxis (strength, dosage, frequency, route were not provided) (product storage error).  Administered dose underwent a temperature excursion of -14 degrees Celsius (C) for 37 minutes. It was reported that there was not any previous temperature excursion. No additional adverse event was provided.
FEVER, CHILLS SINCE INJECTION , FEEL AWFUL SWELLING, CANCELLED ACTIVITIES, RASH,BURNING SENSATION, WARM
Horrible reaction to the 2nd dose; In bed for a few days after 2nd dose; Soaking wet with sweat after the 2nd dose; Constipated after the 2nd dose; Sore arm after 2nd dose; Had to be spoon fed after 2nd dose; Tired after 2nd dose; Headache after 2nd dose; Had a fever after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Horrible reaction to the 2nd dose), BED REST (In bed for a few days after 2nd dose), HYPERHIDROSIS (Soaking wet with sweat after the 2nd dose), CONSTIPATION (Constipated after the 2nd dose) and PAIN IN EXTREMITY (Sore arm after 2nd dose) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027c21a and 037b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dementia.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (Horrible reaction to the 2nd dose), BED REST (In bed for a few days after 2nd dose), HYPERHIDROSIS (Soaking wet with sweat after the 2nd dose), CONSTIPATION (Constipated after the 2nd dose), PAIN IN EXTREMITY (Sore arm after 2nd dose), FEEDING DISORDER (Had to be spoon fed after 2nd dose), FATIGUE (Tired after 2nd dose), HEADACHE (Headache after 2nd dose) and PYREXIA (Had a fever after the 2nd dose). At the time of the report, ADVERSE DRUG REACTION (Horrible reaction to the 2nd dose), BED REST (In bed for a few days after 2nd dose), HYPERHIDROSIS (Soaking wet with sweat after the 2nd dose), CONSTIPATION (Constipated after the 2nd dose), PAIN IN EXTREMITY (Sore arm after 2nd dose), FEEDING DISORDER (Had to be spoon fed after 2nd dose), FATIGUE (Tired after 2nd dose), HEADACHE (Headache after 2nd dose) and PYREXIA (Had a fever after the 2nd dose) outcome was unknown.            No concomitant medication were provided. Treatment information were not provided.  Action taken with mRNA-1273 was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-148194 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-148194:Son case
This case was reported by a lawyer and described the occurrence of hearing loss in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unk). At an unspecified time after vaccination with Lymerix, the subject experienced hearing loss, vertigo, flu like symptoms, headache, possible memory loss, possible nerve injury, possible autoimmune disease and activities of daily living impaired. This case was assessed as medically serious by manf (OMIC). At the time of reporting the outcome of the events was unspecified.
Patient's Left Arm where she received PNEUMOVAX 23 was red from elbow to wrist on 12/31/16. She went to a prompt care on 12/31/16, where they prescribed her a Medrol dosepak. She started the medication on Saturday 12/31/16. Patient reported that by Monday 1-2-17 she was "back to normal and everything was fine." rash resolved
Muscle cramp/spasms, fatigue, dizziness, slurred speech, imbalance, numb/tingling of limbs
None noted  Patient received a dose of Moderna on 6/16.   Received Jansen on 7/15 in error
COVID-19; COVID-19; This is a spontaneous report from a contactable nurse.   A 56 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular, administered in Deltoid Right on 31Mar2021 (Batch/Lot Number: ER8733) as DOSE 1, SINGLE (age at vaccination 56 years old) for covid-19 immunisation.  Medical history included type 2 diabetes mellitus from 05Feb2006 and ongoing, hypertension from 15Feb2006 and ongoing, diabetes mellitus from 15Feb2006 and ongoing , cerebrovascular accident (CVA) from 01Apr2012 and ongoing, depression from 21Aug2012 (also reported as "21Aug2021"). The patient's concomitant medications were not reported.   On 20Apr2021, the patient experienced COVID-19.  The patient received the BNT162B2 at the doctor's office/ urgent care. "There were no side effects for this event".  Relevant tests were none. The event did not require the initiation of new medication/other treatment/procedure. Outcome of the event COVID-19 was recovered in 2021. On 05Jul2021, the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), 2nd dose, intramuscular in the left deltoid, Batch number: EW0180.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness cannot be ruled out.
This spontaneous report was received from an approximately 65 year old female registered nurse (patient) regarding herself. Current conditions of the patient included atrial fibrillation, colon polyps, gastritis and TALWIN allergy which caused her hallucinations. The medical history of the patient included hysterectomy and gallbladder removal. On 08-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant therapies included RYTHMOL (150 milligrams, three times per day), aspirin (325 milligrams, daily), chondroitin sulfate sodium, glucosamine sulfate (reported as glucosamine with chondroitin), vitamin D (unspecified), calcium (unspecified) and vitamins (unspecified) (reported as multivitamin). On 09-JUL-2013, the patient developed a rash which she specified as little red bumps that were located below her elbow and her forearm after receiving ZOSTAVAX. It was reported that the little red bumps itched but the itching went away on an unspecified date. It was reported that the little red bumps were dried up at the time of report and she was recovering (reported as almost recovered). On 13-JUL-2013, she developed tearing in both of her eyes, the right eye being worse than the left. She sought medical attention. She went to an unspecified optometrist on 15-JUL-2013 due to her right eye being irritated and red. Optometrist diagnosed her with iritis of the right eye and prescribed her PRED FORTE and cyclopentolate hydrochloride for her right eye. On 18-JUL-2013, she called her physician and notified him over the phone about her eye. She stated that she was scheduled to see the optometrist again on 22-JUL-2013. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
The pt received the vax and the following day experienced a knot the size of a dime, hardness, some redness and is not getting better.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 20-DEC-2013 the patient received first dose of expired MMR II (HSA, lot # 671686/1874aA exp. date: 30-NOV-2013, dose, strength, site and route of administration not reported) which has expired for vaccination. No adverse event reported. This is one of two reports from the same reporter. Linked case MARRS # 1401USA003889. Additional information is not expected.
pt well when vax given, presented w/rom 5/2699 & vomiting. transferred to hosp where she died of pneumoccocal meningitis
Severe migraine headache, worst of my life. Never had a migraine before. Couldn?t drive, sensitivity to light and noise. Alleviated by migraine nasal spray prescribed by telehealth.
felt kind of crummy; lost appetite; not my energized self; stomach kind a thing; achy; nausea, nauseated; headache; a little fever; passed out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant). On an unknown date, the patient experienced FEELING ABNORMAL (felt kind of crummy), DECREASED APPETITE (lost appetite), ASTHENIA (not my energized self), ABDOMINAL DISCOMFORT (stomach kind a thing), PAIN (achy), NAUSEA (nausea, nauseated), HEADACHE (headache) and PYREXIA (a little fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 12-Feb-2021, LOSS OF CONSCIOUSNESS (passed out) had resolved. At the time of the report, FEELING ABNORMAL (felt kind of crummy), DECREASED APPETITE (lost appetite), ASTHENIA (not my energized self), ABDOMINAL DISCOMFORT (stomach kind a thing), PAIN (achy), NAUSEA (nausea, nauseated), HEADACHE (headache) and PYREXIA (a little fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood sodium: low (Low) sodium level was down.         No treatment medication details were provided.  No concomitant medication details were provided.  Vaccine was administered on the left nondominant arm. Reporter reported an ambulance took patient to the hospital were "they run all kind of tests" and everything was fine.  Company comment: This case concerns a  53-year-old, female patient with no relevant medical history, who experienced the unexpected event of Loss of consciousness. The event occurred approximately 1 day (few hours) after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable since event occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a  53-year-old, female patient with no relevant medical history, who experienced the unexpected event of Loss of consciousness. The event occurred approximately 1 day (few hours) after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable since event occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she doesn't feel good.) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (she doesn't feel good.) and PYREXIA (fever). At the time of the report, FEELING ABNORMAL (she doesn't feel good.) and PYREXIA (fever) outcome was unknown. No treatment medication was provided. Action taken with mRNA-1273 in response to the event was not applicable.
Developed a hive and itching on her face- right side of the cheek and ear. Had bug bite on her forehead. Has respiratory allergies which have been worse this week (itchy throat and eyes)  Had a previous reaction to Compazine.
Throwing up, sleeping and not waking for feedings, pulling on ears, crying and pulling legs up, diarrhea for two weeks leading to 102.6 fever. Fever started two weeks after vaccine. Diarrhea green and mucous filled.
This is a spontaneous report from a contactable consumer (patient's wife) via Medical Information Team. A male patient (husband) of age 90 (units unspecified) received first dose of BNT162B2 (Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history included immunodeficiency (reporter would like to know if it was safe for her husband to receive the second shot of the COVID-19 vaccine if he was immunocompromised), myasthenia gravis (reporter was reporting on behalf of her immunocompromised husband with a history of myasthenia gravis). Concomitant medications were not reported. The patient experienced sore throat on an unspecified date which was not there on Saturday. Caller would like to know what would happen if her husband does not receive his second shot of the COVID-19 vaccine. Outcome of the event was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Awoke with extreme "brain fog". Could not recall what day of the week it was, what ordinary objects were called, what I was supposed to be doing at work (office job), the date or anything basic - sense of recall was completely absent and I felt completely spaced out. Made a doctor's appointment who ordered fasting blood test which showed nothing. I thought I was having a stroke because I am normally very detail oriented and don't forget things easily. No medicine prescribed and returned to normal the next day, but I have seen reports of others experiencing similar things so thought I ought to report it - it was really weird at the time and I was worried
there is a muscle tear in the shoulder due to medication; labral tear; pain on the shoulder; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID.  A 44-year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown), in left deltoid muscle for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE RUPTURE (medically significant), outcome "unknown", described as "there is a muscle tear in the shoulder due to medication"; CARTILAGE INJURY (medically significant), outcome "unknown", described as "labral tear"; ARTHRALGIA (non-serious), outcome "unknown", described as "pain on the shoulder". Clinical course: the patient went back to the facility a week later complaining about pain in her shoulder. The patient called that there was a muscle tear in the shoulder due to medication. The patient had now a "labral tear".  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.; Sender's Comments: A possibly contributory role of the administration with PREVNAR 20 in triggering the onset of Muscle tear in the shoulder and labral tear might not be fully excluded, considering the temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Client c/o feeling lightheaded.  Medics alerted.  Vital signs=BP 150/109, pulse 83, oxygen sat 98% on room air. Blood Sugar 104, EKG within normal range, BP 166/106 on standing.  Medics advised transfer to ER for further med. evaluation and client refused transfer to ER.  Client stated he has a history of asthma and hypertension, stated he has not taken medication for either condition in approximately two weeks.
Pale, listless, lethary; Healing Varicella; 1st DTP; Family hx unavailable;
My face is numb around my mouth. It started about 25 minutes after I got the vaccine. I also had swollen nymph lodes last time I got the vaccine in February. It has been an hour since I got the vaccine and I still feel the numbness.
flare up of her guillain-barre; flare up of her guillain-barre; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Myasthenia Gravis" (unspecified if ongoing); "Hashimoto's disease" (unspecified if ongoing); "Guillain Barre syndrome" (ongoing); "over weight" (unspecified if ongoing); "COVID-19", start date: Mar2020 (unspecified if ongoing), notes: Had first symptoms of Covid Mar2020. Concomitant medication(s) included: METHYLPREDNISOLONE taken for guillain-barre syndrome, myasthenia gravis. Vaccination history included: Bnt162b2 (First Dose: Apr2021, she thinks, when they came out), administration date: Apr2021, when the patient was 52 years old, for COVID-19 immunization, reaction(s): "Has autonomic dysfunction and had an increase of that as well", "balance was off", "Her eyes, she had the miller fisher variant and her eyes got really wonky again", "areup of her guillain-barre", "after the first vaccine, her reflexes went away and that was it"; Bnt162b2 (First Dose: Apr2021), administration date: Apr2021, when the patient was 52 years old, for Covid-19 immunization, reaction(s): "Covid", "Covid". The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), CONDITION AGGRAVATED (medically significant), outcome "recovered" and all described as "flare up of her guillain-barre". The event "flare up of her guillain-barre" required physician office visit. The patient underwent the following laboratory tests and procedures: Influenza virus test: (09Dec2022) Positive, notes: Result: positive for Flu B; Unit: Not Provided; SARS-CoV-2 test: (09Dec2022) Positive, notes: Result: positive for Covid; Unit: Not Provided. Therapeutic measures were taken as a result of guillain-barre syndrome, condition aggravated.  Clinical Course: Stated with this vaccine and all others (unclear if received all pfizer covid 19 vaccines), she experienced a flareup of her guillain-barre. States before this she didnt have any symptoms for 30 years.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt had local tenderness, then experienced flu-like symptoms of aches, headaches, sore jaw. Took Tylenol with no relief. Went to ER. Duration about 1 week.
Initial unsolicited report received from a physician on 11 March 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (Fluzone QIV) (batch number: UI446AB, expiry date: 30 June 2016 and site of administration was not reported.) intramuscularly on 29 October 2015. Patient's medical history and concomitant medication was not reported. It was unknown whether the patient received any other vaccination on 29 October 2015. On 30 October 2015, one day following the vaccination in evening the patient experienced chills, fever, hip pain, weakness and low grade fever. Lab data was reported none. It was reported that patient didn't seek medical treatment and physician was unaware of any treatments or OTC medication patient may have taken. On 1 November 2015 the patient had recovered. List of documents held by sender: none.
Redness of left arm, developed 24-48 hours after vaccination (in the area of IPV vac ) No tenderness, mild pruritus only. Redness resolved by 4 days after vaccines.
Pt shortly after vaccine had throat itching, skin itching, severe nausea and vomiting, respiratory distress with coughing.  Arrived in the ED with no hypoxia on room air but possible wheeze.  Pt was given IM 0.3 mg of Epinephrine and IV diphenhydramine, dexamethasone, famotidine, and ondansetron. She was still vomiting and wretching and req additional ondansetron and more itching so another dose of diphenhydramine given.
Child was 17 at first dose. RN administering 2nd dose caught the error, and consulted with MD. Dr recommended patient get 2nd dose.  Parent was informed of error and education provided on lack of clinical studies in children. Agreed to get 2nd vaccine for child. No immediate adverse events noted.