chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received for a physician (local reference number MK8901, case number US12-057036) regarding the 6 year old female patient. This physician reported currently six year old female consumer started VARIVAX, of unknown date dose and frequency, on an unknown date, when she was one year old for an unknown indication. The patient's relevant medical history included allergies and asthma. The patient had no relevant concomitant medications. The patient's relevant past drug history was unknown. On 23-NOV-2012, this physician reported that this consumer received first dose of VARIVAX (merck) when she was one year old. She possibly received the second VARIVAX (merck) dose when she was 4 years old but the physician was not sure if she received it or not. In November 2012, about two weeks ago (approximately on 09-NOV-2012), the patient received a dose of VARIVAX (merck). In November 2012, about two days after the VARIVAX (merck) injection, she developed a rash on both of her lower extremities. The rash lasted a few days and it resolved. In November 2012, about a week after vaccination with VARIVAX (merck), the consumer developed a low grade fever, which lasted over-night, and then resolved. In November 2012, a few days ago, the consumer developed blisters on her face and on her chest. There was no relevant laboratory data. As of 23-NOV-2012, it was unknown if the consumer continued to receive VARIVAX (merck), she no longer experienced fever and rash, and she continued to experience blisters on her face and her chest. The physician did not have lot number and the expiration date of VARIVAX (merck) that was administered to this patient. Additional information has been requested.
Substernal Chest Pain with elevated Cardiac enzymes and EKG changes noted consistent with myocarditis.  Treated with colchine and Motrin.
Pt C/o cheeks felling swollen then her lips, and then her throat. Lasted approx. 2 minutes and then it subsided for 2-3 minutes and then felt same sensation again for another 2 minutes. Subsided and did not return after the second time.
Narrative:  Pt called COVID-19 Vaccine Adverse Event hotline to report experiencing a fever (does not have a thermometer) after receiving the Pfizer vaccine on 2/18/21. Pt feeling well otherwise and reports no other symptoms.
Patient fainted for a few seconds (briefly) after shot was administered. She quickly woke up and was given a cool compress, ibuprofen, and Gatorade. She stayed seated for 1/2 hour afterwards. No serious injuries occurred.
Small rash on right chest, sore pectoral muscle near right armpit, sore muscle on back of right shoulder, sore muscle on right side of lower abdomen.
Multiple apnea and bradycardia events requiring increased oxygen and ventilatory support less than 12 hours after given and continued for around 12 hours.
Tremors/Chills hours after 2nd injection.  Feeling of no circulation in forearms, hands, feet, sometimes entire body.  Very uncomfortable feeling that isn't going away since approx 3rd-4th day of the injection.
Pt found in crib arrested not able to resuscitate suspected SIDS by med examiner;
While administering an Influenza vaccine,ordered, vaccine solution leaked around the base near luer lock, where the needle attaches to the prefilled syringe. When noticed, CMA immediately withdrew the needle and safety engaged on needle. No obvious defect in syringe or needle. Patient did not experience any discomfort or immediate ill effects due to this issue. Needle was noted to be secured to the syringe tightly and verified by RN. Unknown amount leaked down the patient's arm and collected in the threads of the syringe. Dr notified immediately. Pt agreed to a second Influenza vaccine, per Dr.'s recommendations. Vaccine was administered at 11:20a.m. lot # 371597.
while I was driving I blacked out and was in a accident in my car; while I was driving I blacked out and was in a accident in my car; dizzy; very sick; soreness in my joints; headache; bodyaches; First dose of BNT162B2 was administered on 16Feb2021 12:00 PM and the second dose was on 31Mar2021 13:00; First dose of BNT162B2 was administered on 16Feb2021 12:00 PM and the second dose was on 31Mar2021 13:00; This is a spontaneous report from a contactable other health professional (patient). A 62-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly administered into the right arm on 31Mar2021 13:00  (at the age of 62-years-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took morphine and experienced drug allergy. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly administered into the right arm on 16Feb2021 12:00 PM  (at the age of 62-years-old) for COVID-19 immunization. It was reported that the first dose of BNT162B2 was administered on 16Feb2021 12:00 PM and the second dose was on 31Mar2021 13:00. On 01Apr2021, patient experienced soreness in his joints, headache and body aches. On 06Apr2021 07:00, while driving patient blacked out and was in an accident in his car, he was also dizzy and very sick. The patient received treatment for the events "while i was driving i blacked out and was in a accident in my car" and did not receive treatment for all other events reported. Outcome of events recovered on an unspecified date.   Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  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.
This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant drugs were not reported. On 11-FEB-2019, the patient was vaccinated with improperly stored dose of VARIVAX subcutaneously, lot# R008393, expiration date 20-MAR-2020 (exact dose, frequency and site of administration were not reported) for prophylaxis. Vaccine was diluted with properly stored sterile diluent. Temperature excursion was detected by digital data logger. No details were provided. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1902USA005484.
Provider ordered Covid -19 Monovalent 12 + for patient who was 11 years, and vaccine was administered.
Congested toward one side of face; Sinus infection; A Spontaneous report was received from a consumer concerning a 31 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a sinus infection and congestion.   The patient's medical history and relevant concomitant medications were Azithromycin.   On 26 Dec 2020, approximately five days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 2020, The patient experienced a sinus infection.  On 05 Jan 2021, she was feeling congested. Treatment for the event included Azithromycin.  Action taken with mRNA-1273 in response to the events was not reported .   The outcome of the event(s) sinus infection and congestion were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Upper respiratory infection; Bad cold; Started with sneezing; Bad Cough/coughing up mucus; Laying down having pressure on chest; I'm not in the 28 days anymore; A little bit of a headache when coughing; This spontaneous case was reported by a consumer and describes the occurrence of UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection), NASOPHARYNGITIS (Bad cold), SNEEZING (Started with sneezing), PRODUCTIVE COUGH (Bad Cough/coughing up mucus) and CHEST DISCOMFORT (Laying down having pressure on chest) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection), NASOPHARYNGITIS (Bad cold), SNEEZING (Started with sneezing), PRODUCTIVE COUGH (Bad Cough/coughing up mucus), CHEST DISCOMFORT (Laying down having pressure on chest), PRODUCT DOSE OMISSION ISSUE (I'm not in the 28 days anymore) and HEADACHE (A little bit of a headache when coughing). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Adverse event, at a dose of 1 UNK; GUAIFENESIN (MUCINEX) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection), NASOPHARYNGITIS (Bad cold), SNEEZING (Started with sneezing), PRODUCTIVE COUGH (Bad Cough/coughing up mucus), CHEST DISCOMFORT (Laying down having pressure on chest) and HEADACHE (A little bit of a headache when coughing) was resolving and PRODUCT DOSE OMISSION ISSUE (I'm not in the 28 days anymore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
BLOOD CLOT; This spontaneous report received from a consumer who heard about a male patient of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose and start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot from the vaccine. This was not confirmed if it was the Janssen Covid-19 vaccine which the person received, it was just implied. The action taken with covid-19 vaccine was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210827109- Covid-19 vaccine-  Blood clot. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Tingling immediately in my feet. It moved into my legs with periods of numbness. Mostly pins and needles feeling or as if there were droplets of water. After two weeks, it moved into the right side of my face. Teeth hurt and extreme sinus pressure. Some numbness in tongue. Legs, lower legs and feet and behind knees, continued to have pins and needles sensation for seven weeks. Some small itchy bumps on legs. Also dizziness occurring during the first two weeks after dose one. I have not received dose two. I have delayed it on my own without consultation from doctors.
The night after army second does I started breaking out in bumps on my chest and face.  Over the next couple days I the rash increased on my face and chest, and spread to my neck, behind my ears, on one ear, and also a small patch on my neck, as well as few on y arms and fingers.   Rash was of varying size,  clustered as well as single, and  extremely itchy. Today is the fifth day, and I don?t appear to have any new bumps.
Two hours after receiving the shot in my left arm, my shoulder began to freeze up.  It extend from the clavical to the left wing of the shoulder.  It produced a pain level of 9 being 10 the worst.  The arm from the shoulder to the elbow became 3 times its normal size.  To control the pain I took the codene/ibebrophane drug at least 2 times a day.  Tylonel did nothing for me.  The swelling subsided after 3 days and the level of pain was reduced to about a 6 or 7.  After 5 days my shoulder loosened somewhat but I have limited mobility in the shoulder and still need pain killer trying to stay within a limit of 2 a day.  If this can help anyone, I wish it could.  I would have not gotten the shot and risked my probability of pneumonia.  A bad experience indeed!
After the vaccine everything was fine, I had normal muscle pain and fever, but then a month later, during holiday, I contracted COVID-19, I had mild symptoms that have been alleviated with medication. I did a home test that confirmed COVID-19, I called the doctor, and he prescribed the medication.
Shaking and had clenching, muscular rigidity of extremities, looking "out of it" for 30 min.
red blotches lt thigh; leg swollen from hip to knee; t101; reluctance to walk; lt leg;
Information has been received from a nurse referring to a patient of unknown age. The patient's concurrent condition, historical drugs, medical history and concomitant therapies were not reported. On 22-JUL-2016, the patient received the first dose of GARDASIL 9 (dose detail, strength, lot #, and expiration date were not reported) via intramuscular for prophylaxis. On 13-AUG-2018, the patient received the second dose of GARDASIL 9 (dose detail, strength, lot #, and expiration date were not reported) via intramuscular for prophylaxis. The patient did not get the third dose yet. No adverse effect was reported.
body aches; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced general body pain and upset stomach. On an unknown date, the outcome of the general body pain and upset stomach were unknown.   It was unknown if the reporter considered the general body pain and upset stomach to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had general body pain and upset stomach. The reporter asked how long might the side effects last.
fever; general malaise; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: er8737), via an unspecified route of administration on 19Apr2021 (at the age of 44-year-old) as dose number unknown, single for COVID-19 immunization. There were no medical history and concomitant medications. The patient did not receive any other vaccine in four weeks and any other medications in two weeks. The patient had no known allergies. The patient had no covid prior vaccination and had not tested covid post vaccination. On 20Apr2021, the patient experienced fever, general malaise. The patient did not receive any treatment for the events. The outcome of both the events was recovering.  No follow-up attempts are possible. No further information is expected.
About 24 hours after receiving the first shot I had a really bad migraine. The migraine would completely debilitate me, and loss of vision, After a couple weeks of not being able to get rid of it with over counter pain meds, I went to the doctor. My blood pressure was sky high, after blood work and a hospital visit, I still have no real answers. My blood thickened I am now on a blood thinner, Several anti inflammatory medications, my heart rate is irregular and skipping a beat, my stomach and the pain in my stomach is unbearable. I was so swollen for weeks, even to walk hurt.  I have so much pain in my legs and arms, I feel as though I am getting beat up daily. I have daily headaches and have not felt the same or close to it since.
Information has been received from a healthcare worker (also reported as an office administrator) referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received improperly stored ROTATEQ (lot # L033694, expiration date 16-JUN-2017, dose unknown) orally. The vaccines were exposed under 49 Fahrenheit degree (F) for 24 hours. No digital data logger was involved. There was no prior temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Excruciating pain in left hip, lower back, and middle of back for the past two weeks. Coughing, tiredness, and headaches for the past two weeks.
70 year old client received Tdap recommended maximum age is 64 Adacel.
patient passed out less than 5 minutes after receiving the moderna booster vaccine (0.25mL) and the influenza vaccine (flulaval quadrivalent). He had received the first two moderna shots in the past and had no issues. They were both administered in the left deltoid muscle. After I administered both vaccines a couple minutes later, the patient lost all color in face and began to seize (no history of seizures in the past). His arms began to shake, he made a loud moan, and starting moving his head around. Patient was sitting in a chair at the time and so I lowered him slowly and safely to the floor and laid him on his left side supporting his head. He lost consciousness for about 30 seconds (thats how long the seizure lasted) and afterwards regained consciousness. Was alert and able to answer questions correctly, but expressed that he didnt know what had occurred but that he felt disoriented. Two to three minutes went by and he began to seize again for the next 30 seconds. paramedics were called. no injury to the patient. trasnferred to the hospital to get checked out. documented accordingly in VAERS report and in patients chart. Patient should not receive another moderna vaccine or another flulaval vaccine in the future.
horribly sick; Initial information received on 29-Nov-2020 regarding an unsolicited valid non-serious case from a non-health care professional (patient) via social media.  This case involves an adult patient with an unknown demographics who was horribly sick (illness), while being vaccinated with influenza vaccine.  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 suspect influenza vaccine (produced by unknown manufacturer) (batch number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date (latency: unknown) after starting the suspect vaccine therapy, the patient was  horribly sick (illness).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment. At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case. No further relevant information was reported.
painful knees; red bumpy rash on face; itchy eyelids, eyebrows; Mild headache; nausea; fatigue; This is spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EM9810), via an unspecified route of administration on arm Left on 10Feb2021 12:00 PM at single dose for COVID-19 immunization. The patient medical history included Systemic lupus, RA, Minimal Stage Kidney Disease, mild heart failure, allergic asthma and allergies to Nafcillin, cleocin, celebrex, fluorescein dye, lasix, bactrim, flecanide. 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 Concomitant medications included Prednisone 5mg, Plaquenil 200mg, APIXABAN (Eliquis), METOPROLOL SUCCINATE (Toprolxl) taken in two weeks. The patient did not receive any other vaccine in 4 weeks prior to the COVID vaccine. On 10Feb2021 05:00 PM, the patient experienced mild headache, nausea, painful knees, fatigue, red bumpy rash on face, itchy eyelids and eyebrows. The patient did not receive any treatment for the events. The outcome of the events was recovered.
Lethargy began 04/06/2002 followed by high pitched screaming 12 hrs later, she did not have a bowel movement for one full week (previously she had no trouble with BM's) suffered from constipation and diarrhea, sensory processing disorder and related maladies from then on diagnosed with autism.  Per annual report-autism, pervasive developmental delay, sensory integrative disorder please see attached. Per annual report-autism and gastrointestinal problems
having some left arm pain really hard; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 23Feb2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 12Mar2021, outcome "unknown", described as "having some left arm pain really hard".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Injection site right arm muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the right arm on 02Mar2021 at 15:15 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included Type 2 diabetes. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included metformin (MANUFACTURER UNKNOWN) and sitagliptin phosphate (JANUVIA); both from unknown dates for unknown indications and unknown if ongoing. On 03Mar2021 at 00:00, the patient experienced injection site right arm muscle pain. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event injection site right arm muscle pain was unknown at the time of the report.  No follow-up attempts are possible. No further information is expected.