chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This was the 2nd in the HPV series of shots.  My daughter had terrible headaches and was throwing up three days after her first vaccine.  She never ran a high fever, and missed a week of school.  Three weeks to the day after her 2nd shot she began to fill ill.  Headache, body ache etc.  By the following afternoon she had a stiff neck, the "worst headache she had ever had".  We were out of town and she insisted we see a doctor instead of self treat at the hotel.  We went to a walk in center where they recorded a low grade fever (101) and because of the stiff neck and headache sent us to the ER for fear of meningitis.  My daughter was kept in the ER overnight and given morphine for the pain, had spinal fluid taken, blood tests run etc.  She was admitted to the Pediatric Ward where she remained until Tuesday, April 13th.  She was tested for Strep Throat, neurological disorders, mono, migranes etc. She was finally released when the doctors felt like we could handle her headache pain with prescriptions and then over the counter medicines.  The only thing offered us was it was "viral". The initial doctor in the PED Ward said it was her 3rd case with these symptoms - all coming in looking like meningitis initially - with no conclusions being drawn after a battery of tests.
A report has been received from a health professional (LPN), concerning a 6 month old female patient. No relevant history, concomitant disease or concomitant medications of the patient were reported. The 6 month old patient had received nasal FLUMIST QUADRIVALENT (Intranasal), administered on 23-Aug-2013. It was reported that the patient had symptoms of cough and congestion on 25-Sep-2013. She was diagnosed with bronchiolitis and reactive airway on 03-Oct-2013. Action taken with FLUMIST QUADRIVALENT was not applicable. The patient recovered from the events of bronchiolitis and reactive airway on 10-Oct-2013 and the outcome of the event of inadvertently gave FLUMIST QUADRIVALENT to a 6 month old was unknown. The reporter assessed the event of inadvertently gave FLUMIST QUADRIVALENT to a 6 month old to be non-serious. The events of bronchiolitis and reactive airway have been identified by the company physician from the source documents and added as adverse events and considered them as non-serious.
"By Friday evening I had a bad headache and hardly slept at all Friday evening. Chills, slight fever, aching and just feeling bad was what I experienced all Friday evening into mid-morning on Saturday. Saturday I was exhausted and fatigued and just layed around all day (very much unlike me.) Sunday was better but the shot site was still very sore. I was not able to sleep on my left side for at least 3 nights."
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, an unspecified number of patients were vaccination with unknown number of doses of PROQUAD, (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was involved. Follow up information was received from a certified medical assistant during a phone call on 25-MAR-2015. The certified medical assistant was unavailable at the time of the call. The call was transferred to the manager who indicated that the PROQUAD lot # was K002483 with expiration date: 18-AUG-2015 (also reported as 08-AUG-2015) and indicated that the patient identification information was not readily available at the time of the call. Additionally, the reporter indicated that there had been no reports of adverse events following the administration of PROQUAD vaccinations. The office was in the process of contacting the patients for revaccination. The correspondence process was reviewed and telephone number was provided should information become available. This is one of several reports received from the same reporter. Additional information has been requested.
I had covid late 2020. I tested my antibodies and had a lot of antibodies a year later. I received the pfizer vaccine despite having natural immnity 2 days later I was reading then all of a sudden I had severe migraine pain and physically couldn't read anymore like my brain stopped working. I laid down and started uncontrollably shaking. Migraine pain so bad that I was screaming in agony. I was driven to the hospital. I puked 3 times in the hospital from the pain. I was giving chest scans and sent home with diagnosis of "headache". I was unable to work for two weeks due to my inability to even perform my job due to decreased cognitive ability and severe migraines. I have had tightness in chest, brain fog and migraines ever since the vaccine. Never have I had ever these symptoms in my life before the vaccine. Everyday is a struggle at work.
Patient came in to receive the COVID-19 booster vaccine (Pfizer discussed the day prior when she brought in her spouse). Forms given and filled out by patient. I reviewed patient's COVID-19 card, and never made the connection her card has Moderna listed for first 2 doses. At time of administration, I reviewed with patient if she had any problems with the first 2 doses. I do not recall if I reemphasized "Pfizer" at that point, but I administered the dose. After 15 min wait period, my technician went to scan-out the customer; hand her receipts and COVID-19 card; when she noticed the card mismatch. Third dose administered as Pfizer, not Moderna.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 14-JUN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M001152 (exact dose, expiration date, therapy type and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Vertigo, headaches, vision worsening, brain fog, worse tinnitus, dizziness. From May 19-current (8/7/21). Been going to PT for vertigo, helping but still have general dizziness, headaches, neck soreness, brain fog. Some days are better than others. Took low dose Valium fir a bit but no help. Meclazine, just knocked me out. Massage therapy and PT and sleep seem to help the best, but it just won?t go away.
Sever underarm pain after 24 hours. Pain subside with Tylenol dose. pain keep coming back after every 8-10 hours.  Redness and itchy reaction after 48 hours.
Patient complains of tingling of the fingertips on her left hand. Denies weakness, numbness,  dizziness, headache, sob and chest pain.  Denies lip/throat tingling/swelling.
Nosebleed; Vascular Carotid Surgery; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 01Jul2021 as dose 2, single (Lot number: EW0217) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: CLOPIDOGREL, start date: 2021 (ongoing); LISINOPRIL taken for hypertension, start date: 2021 (ongoing); LASIX [FUROSEMIDE], start date: 2021 (ongoing); LIPITOR, start date: 2021 (ongoing); ASPIRIN 81, start date: 2021 (ongoing). Vaccination history included: BNT162b2 (Dose Number: 1, Lot Number: EW0191), administration date: 07Jun2021, when the patient was 71-year-old, for Covid-19 Immunization. The following information was reported: CAROTID ARTERY DISEASE (medically significant) with onset Nov2021, outcome "unknown", described as "Vascular Carotid Surgery"; EPISTAXIS (non-serious), outcome "unknown", described as "Nosebleed". The events "vascular carotid surgery" and "nosebleed" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of carotid artery disease, epistaxis.  Clinical course: Caller was a consumer was calling about the Pfizer Covid 19 Vaccine. The caller received the first, second, and booster doses of the vaccine. After the second dose and the booster dose the caller had nosebleeds. Caller was asking for information related to the vaccine and blood thinners. Caller stated that these occurred after her second dose and booster dose of the vaccine. Stated that it wasn't severe. She would feel something in her nose and then when she would blow it there would be blood. Caller stated that she took Vitamin C, so she increased her Vitamin C at that time and the nosebleed went away after several days. Caller stated that the nosebleed was more after the second dose of the vaccine than the booster dose of the vaccine. Caller stated that she was going to call sooner. When she realized she will probably need a second booster she thought she would call and ask about this. She was somewhat surprised that it happened with her booster dose. Caller stated that she was on several medications. Initially stated that her question was related to Lipitor, which she stated she thought was a blood thinner. Caller then corrected herself, stated the blood thinner she was thinking of was Plavix, Clopidogrel; not Lipitor. Caller stated that her Clopidogrel was in a pharmacy vial. Caller mentioned that she was on Lipitor. Stated that she was thinking Lipitor was an Aspirin, then said no, maybe its a Calcium. Caller provided no further information related to her Lipitor. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was reported as none. Relevant tests were reported as none.
Red rash covering upper arm from deltoid almost to elbow on injection arm. Painful. Difficult to lift or move arm. Had to keep arm raised or caused increased discomfort.. Lasted about 2 weeks. Also had 3 day fever even with nsaids.
Pt. received d/t booster in ER on 11-24. On 11-25, reported injection site reaction of : red, warm, and itching. Nurse practitioner observed 6" x 6" raised, red, circular site. Given ZYRTEC and betamethasone cream. Also reported to VAERS.
Office Visit  10/19/2021 Urgent Care   CRNP  Family Medicine Cough +3 more  Dx Cough  ? Fever ? Sinusitis  Reason for Visit  MDM See HPI and physical exam to review pertinent information regarding visit. Patient meet criteria to test for COVID-19, Doubt sepsis ort her serious bacterial infections. Is other wise appearing with acceptable vitals and reassuring physical exam. Pt was informed that we will call with test results once received. Pt directed on return precautions and instructions on self-isolation/quarantine and anticipatory guidance. Supportive care recommendations were reviewed in light of the patient's age, past medical history and comorbidities. Plan of care agreed with patient/parent.      Patient tested positive for COVID-19.  Spoke to Covid navigator and unfortunately the patient does not meet qualifications to receive the Mab infusion at this time.  Notify the patient of these results.   Patient Education    There are no Patient Instructions on file for this visit.     History Chief Complaint Patient presents with ? Cough     symptoms started on Sunday  ? Fever ? Sinusitis     Patient is a 61 y.o. female    HPI   Pt presents with concerns of possible Covid 19. Pt reports the following symptoms that started 2 days ago. Sinus pain and pressure Yes Fever/ chills Yes Headache Yes Body aches Yes Cough Yes Sob Yes Sore throat No Nausea/ vomiting/ diarrhea. No Loss of taste or smell No Medications used:Yes Nyquil liquid Tolerating fluids:Yes Tolerating. solids:Yes Smoke exposure:No Exposed to someone who tested positive for COVID 19: No History of asthma, bronchitis, pneumonia. No Pt received COVID vaccination.
I have like heart burn stomach pain; I have like heart burn stomach pain; I have frequent urination; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on 06Aug2021 13:20 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced frequent urination on an unspecified date in Aug2021 and like heart burn stomach pain on 07Aug2021. It was reported that, patient felt fine on the day of vaccination and didn't have any symptoms, patient got up this morning and had two, patient did not know two things that occurred that did not have yesterday, one was patient had frequent urination had to go every two hours and peed every two hours, with normally patient did not pee like every 4 to 5 hours so, did not know that was reaction to the shot or vaccine and the second one, patient had like heart burn stomach pain and patient had like stomach seen since, woke up this morning it growls all the time like need to fed, like had ache in the wall but patient eat like every 4 hours and did not have that problem yet today after the shot but that just started this morning. Patient thought may be could find out if that was the a reaction to Pfizer COVID shot and wanted to know if it had anything to do with this vaccine. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Slight nausea; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3248), via an unspecified route of administration on the left arm, on 13Jan2021 at 10:15, at a single dose for Covid-19 immunization.  Medical history included vertebral artery occlusion. The patient did not receive other vaccines in four weeks. Concomitant medications included metoprolol, amlodipine, tramadol, and hydrochlorothiazide. The patient previously took oxycodone hydrochloride;paracetamol (PERCOCET), acetylsalicylic acid;oxycodone hydrochloride (PERCODAN) and hydrocodone and experienced allergies.  On 13Jan2021, at 11:30, the patient experienced slight nausea.  The patient did not receive any treatment for the event. Outcome of the event was not recovered.
This spontaneous report as received from a consumer reporting on herself a 69 years old female (also reported as male) patient with esophageal cancer and no drug reactions or allergies, who is 2007 was vaccinated subcutaneously with dose 1 live ZOSTAVAX (Dose and lot # not provided). No other co-suspects were reported. Concomitant medications included NEXIUM, herbs (unspecified) (Herbal) and CREON. Consumer stated he had vaccination with live ZOSTAVAX, then years later on 01-JAN-2013, got shingles. He had the outbreak as stated, on his right side from his scalp to his cheek. The patient sought medical attention and was treated with antivirals (unspecified) by 10 days and gabapentin, it has since cleared up with the antivirals prescribed. Labs diagnostics were not performed. The outcome of shingles on his right side from his scalp to his cheek was reported as recovering/resolving. The relatedness for shingles on his right side from his scalp to his cheek is unknown for live ZOSTAVAX. Additional information has been requested.
Experienced hives, itching face and extremities, and throat tightness. Txt = Prednisone and antihistamine per FNP.
no adverse event; inadverent administration of vaccine past its expiry; This spontaneous report as received from nurse practitioner refer to a 4-year-old male patient.  The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 27-JUN-2019, the patient was inadvertently vaccinated with second dose of expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # R011801, expiry date:19-MAY-2019) (therapy type was rha) via subcutaneous route for prophylaxis. No adverse effects were reported.  The outcome of expired product administered and no adverse event was unknown.
On Oct. 12, stores received an internal Urgent Removal Notice regarding Pfizer COVID-19 Vaccine- Pediatric 5-11 Years Tris-sucrose, Lot #FL2757 with manufacturer?s expiration date of Sept. 30.
Nov 11th, Began with pain in hip joints and shoulder joints and pain level being about a 6, became disoriented and extremely fatigued, then got a fever of 102.6., fever continued thru Nov 12th, by afternoon it stayed around 100. I slept about 12 hours and felt achy and fatigued, fever was gone on the 13th and I felt better. the 15th AM I had a return of upper body aches that are manageable.  At the injection site on the 11th I had a 2 in. round, painful, hot, red, welt, 12th increased to about 3 inches round, painful, red, hot, welt, 13th increased to about a 4 inch painful, red, hot, welt, 14th- 15th looks a little bigger but not as painful, red or hot, but about half of it had a bruised appearance and is very itchy.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) and from product quality group. The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 11Feb2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 08Sep2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 14Apr2022 at 09:30 as dose 4 (booster), single (Lot number: FM9992) at the age of 67 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history (patient had no known allergies and no other medical history). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 included received anti-viral product Paxlovid from 30Jun2022 to 05Jul2022. Investigation result conclusion: Lot-# (CR): FM9992. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): "For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 7142695 (see File attachment in this investigation record) The complaint for "PFIZERBIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FM9992. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Manufacturing facility  concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Good afternoon Our MA gave an expired Td Wrong or expired product- VFC TD single dose 0.5 mL, vaccine -expired XX/XX/2021 Lot # U6265AA Manufacture - Sanofi Pasteur
Pt. reports of redness from elbow to armpit and approx. 6 inch diameter of blistering. Also low-grade fever. Onset 11/12/15 that evening. Cleared up 11/16/15 with remaining redness.
Of note, patient was also found to be COVID-positive during this admission and was treated with remdesivir which she completed.
sx began @ 430PM, vax recvd 2OCT92 930AM pt felt dizzy, aching, fever, warm to touch, syncopal episode; called hosp ER & was advised to take Tylenol & drink fluids;
Heavier than normal menstrual cycle, more menstrual pain than usual, more intense emotional symptoms than usual  cycles, longer cycle than usual.
Numbness in left arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in left arm) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B212A and 004C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced HYPOAESTHESIA (Numbness in left arm). At the time of the report, HYPOAESTHESIA (Numbness in left arm) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Patient demographics were added.Second dose details were added.Outcome of the  event was updated.
1hr p/immun, lips blue, shaking for 3 min, tonic-clonic sz, CPR given, transported by car to ER;
Numbness of arms and legs, back pain, body aches. Went to ER 4 days after receiving vaccination. Don't know outcome yet.
SPONTANEOUS CEREBROSPINAL FLUID LEAKAGE; This spontaneous report received from a patient via other company (Pfizer) concerned a 33 year old female of unspecified race and ethic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not ill at the time of vaccination and had no known medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Z03AZIA, expiry: UNKNOWN) dose was not reported, 1 total administered on 12-APR-2021 to right arm for prophylactic vaccination. Concomitant medications included ethinylestradiol/norgestimate for birth control.  On 28-JUN-2021, the patient diagnosed with a spontaneous cerebrospinal fluid leakage (CSF leak), and was hospitalized (date unspecified). Duration of hospitalization was not reported. On 05-JUL-2021, Laboratory data included: Magnetic resonance imaging spinal (NR: not provided) abnormal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spontaneous cerebrospinal fluid leakage. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211029187-Covid-19 vaccine ad26.cov2.s - spontaneous cerebrospinal fluid leakage. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
?sz;pt went limp & pale w/shallow breathing x 30seconds;lt arm shook however no tonic-clonic activity;eyes rolled back;pt never turned blue;no tx necessary;pt sleepy most of afternoon but otherwise acted nl;