chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a 17 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 27-JUN-2014 the patient was vaccinated with second dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J005010, expiry date: 23-OCT-2015) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, , 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA01304 (same reporter link).
Patient received her second Pfizer Covid vaccine 4/12/2021 at 3:24 pm as noted in medical record.  At approx. 3: 25 PM pt c/o dizziness, headache, severe nausea and blurred vision. She had beads of perspiration on forehead, and a cool cloth was applied to back of neck. Water was also given. B/P was 210/140 Left arm. Pt states she takes B/P medication but did not take it today. She states she last ate at 11 AM.  Pt states she did not have any SOB or difficult breathing. Respirations slightly shallow. She states she did not have any untoward response to first vaccine. She also denies any numbness or tingling of lips, difficulty breathing or thickness of tongue, itching or double vision. She states she did have blurred vision initially but denies any at present.  At 3:40 PM transported Pt to Emergency Department via wheelchair for further observation and care. Pt verbalized agreement and notified her spouse via cell phone.
Two days after the second vaccine was administered, my severe Trigeminal Neuralgia returned.; This is a spontaneous report from a contactable consumer (patient). A 43-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection, Lot Number: ER8734), dose 2 via an unspecified route of administration, administered in Arm Right on 30Mar2021 15:30 (at the age of 43-Years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient did not have covid prior vaccination. Covid was tested post vaccination. Patient did not have other vaccine in four weeks. Patient was not pregnant during vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection, Lot Number: EN6199), dose 1 via an unspecified route of administration, administered in Arm Right on 09Mar2021 04:00 pm (at the age of 43-Years-old) as DOSE 1, SINGLE for covid-19 immunisation. On 01Apr2021, it was reported that two days after the second vaccine was administered, her severe trigeminal neuralgia returned. Event resulted in doctor or other healthcare professional office/clinic visit. As a treatment it was reported that patient had to go up to the maximum dose of her medication. The patient underwent lab tests and procedures which included sars-cov-2 test by saliva and was negative on 23Apr2021. Therapeutic measures were taken as a result of event. At the time of this report, the outcome of event was not recovered.  No follow-up attempts are needed. No further information is expected
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: FINASTERIDE; LOSARTAN; VYVANSE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: equally intense Ag results; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: The patient had other medications in 2 weeks were Finasteride, Losartan and Vyvanse. The patient took Paxlovid from 12Jul2022 to 17Jul2022 as a treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
4-6 hours post vax, the pt started getting itchy spots/bumps on his back. They were white surrounded by red. Roughly 24 hours later, he had no symptoms. Occasionally, he will get a couple of spots that go away in a couple of hours.
Varicella - Information has been received from a nurse practitioner concerning a 4 year old male patient with a history of varicella exposure who on 17 Apr 2000 was vaccinated with a fist dose of varicella virus vaccine live SC in the left arm.  Concomitant vaccinations that same day included a second dose of measles mumps rubella vaccine (MSD) SC in the right arm, a fifth dose of diphtheria toxid (+) pertussis vaccine (+) tetanus toxoid Lot number: 40034ca im in the left thigh, and a fifth dose of poliovirus vaccine inactivated lot number f0905 im in the right thigh.  On 20 apr 2000, the patient developed disseminated chickenpox.   The patient's fater felt that his son may have been exposed to varicella at school where there had been an outbreak.  The patient sought unspecified medical attention.  Follow up information from a nurse practitioner indicated that subsequently. the patient recovered.
I started getting a headache later that evening and some nausea. The nausea gradually went away but the headache got worse. I continued to take Tylenol hoping they would get better. By July, the headache was so bad, I missed days at work. My first appointment with my doctor was July 14. I was back again July 23. In the ER August 17. Doctors appointment August 20. Neurologist August 28, September 13, October 5 and October 8; back in the ER on October 12. They admitted for further testing.
Pt developed a fever, redness around injection site, warm to touch. Pt went to ED unable to tell if it represented a local reaction or possible allergic reaction. Pt treated with antibiotic and BENADRYL.
This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 01-MAY-2017, the patient was vaccinated with an improperly stored dose of VARIVAX (lot number M042496 with expiration date of 19-OCT-2018; strength, dose, route, and anatomical location were not provided), for prophylaxis. The physician stated that the VARIVAX was reconstituted with properly stored sterile diluent (reported as DILUENT MRK) (lot number reported as M023895 with expiration date of 18-JAN-2019). It was also reported that the administered dose experienced a temperature excursion during 30 minutes at a temperature between -14 degrees Celsius and -10 degrees Celsius on an unspecified date. In addition, the administered dose also experienced a temperature excursion during 6 hours and 30 minutes (reported as 6.5 hours) at a temperature between -9 degrees Celsius and 8 degrees Celsius on an unknown date. A data logger issue was involved. No previous temperature excursion and no adverse events were reported. Additional information has been requested.
This initial spontaneous case was received on 29-Sep-2017, reported by a pharmacist and concerning 42-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On 29-Sep-2017, pharmacist while administering FLUAD (dose: 0.5 ml, batch number: 178601, expiry: Apr-2018, PTC number: 1024959, route of administration and indication was not reported) to a patient the syringe tip cracked and it squirted into her eye (explicitly coded as occupational exposure while administering product) caused headache and blurred vision. The pharmacist wanted to know what to do. As a treatment, the pharmacist flushed her eyes with refreshed eye drops. It was reported that, no vaccine was administered or squirted onto the patient. As per the PTC (product technical complaint) investigation performed, package condition, syringe were not damaged and no crack in hub, no signs of leakage was observed and it was concluded that, FLUAD batch 178601 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. The sample was not available for analysis. No trends were identified, and that remained the only complaint for FLUAD batch 178601. As a result, no internal root cause had been determined as the most likely root cause and the complaint was considered as not determinable. Since internal root cause was ruled out. Outcome of the events were not reported. This reporter considered the events as non-serious. Non-significant follow-up report received on 29-Sep-2017: PTC reference number (1024959) was updated. Amended narrative accordingly. Follow up received on 20-Nov-2017: The PTC investigation results were update. The narrative was amended accordingly.
Breakthrough case of COVID-19 after fully vaccinated with mRNA vaccine.  Individual received prescription for nirmatrelvir/ritonavir 8/13/2022
Patient was given incorrect vaccine for age group. Patient received vaccine for age group 5-11yrs. No allergic reaction has been reported for patient.
Patient was inadvertently given the Pfizer COVID-19 product instead of the intended Pfizer Bivalent booster product.
Developed rash on forearms of both arms, itchy but not painful, has since subsided on 3/29/18.
ED visit for insomnia; treated and released. ED visit to hospital admission 17 days later for Acute on chronic systolic CHF. Patient was hospitalized and did well with IV diuresis Lasix 60mg IV BID and symptoms were much improved and he was ready and requesting to be discharged to home. ED visits and hospital admission within 6 weeks of receiving the COVID vaccine.
Large red, hardened, swollen, warm. painful spot on injection arm.  Appeared yesterday, no better today
Headache, Myalgia, Arthralgia, CoughWheeze, Diarrhea, Syncope, chills, body ache, fatigue Narrative:
Cough, fever, swollen lymph nodes,  pain at injection site. Tiredness,
Received Samllpox vaccine along with Anthrax and Hep B vaccine on 8/25/09 and 2 days later had node under rt. arm, 7 days later had flu like symptoms, headache, fever, sweating, rash at site of smallpox vaccine and loss of appetite and then developed severe mid-sternum chest pain.
GUILLAIN BARRE SYNDROME 7/17/2022 -- RECURRENCE OF SAME SYMPTOMS
This is a spontaneous report received from a non-contactable consumer. This female consumer (patient) reported that the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT number: unknown), via an unspecified route of administration on an 02Apr2021 at single dose for Covid-19 immunization. The patient's concomitant medication and medical history was not reported. On 06Apr2021 the patient tested positive for covid 19. The patient is all finished with quarantine and has no signs or symptoms. The patient also enquired that is it safe to receive her second dose due 4/23. Outcome of the event Unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report has been received from a medical assistant and 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 VARIVAX lot # N012131, expiration date 17-APR-2019 (dose and route of administration were not reported). The vaccines were reconstituted with properly stored sterile diluent (MERCK). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 6 to 14 degrees Fahrenheit for 2 hours. There were previous excursions reported: between 6 to 14 degrees Fahrenheit for 6 hours and 30 minutes. Digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA011066.
Benadryl 1 tsp PO one time. Rash started about 24 hours post vaccine on entire body.
Eye began twitching on left side several days after vaccine and continues to twitch. No preexisting instances of eye twitching.
Infection to left thigh where IPV and DTaP given Warm, Red, Induration. TX CEPHALEXIN 250/5ml/5ml tid (three times a day) for 10 days 150ml.
Invalid dose, pediatric dose administered to an adult. No adverse reaction occurred however patient will need to be revaccinated.
Paralysis, numbness, tingling. Still have symptoms. Shock treatment. Nerve testing, ?.
Patient was registered by parent to have the baby moderna bivalent vaccine. Parent of patient verbally confirmed that the patient was to receive the baby moderna bivalent vaccine. Patient labeling indicated that baby moderna bivalent vaccine was to be administered. Baby moderna bivalent vaccine was administered on 1/20/23. It was discovered that the patient was to receive the 2nd dose of baby moderna monovalent vaccine. Recipient?s parent informed.
Chronic spontaneous Urticaria- itching began within 24 hours, resulting in 3 large patches and several smaller patches on my right breast, right arm, and neck/chest.  I have taken Benadryl and avoided inflammatory foods and beverages, symptoms are improved but return if I stop taking Benadryl and avoiding food and drink that did not cause any issues for me prior to this booster dose.  I have not sought medical care, as others who experienced this same condition recommended topical cream and Benadryl, and this improved symptoms significantly, but it seems temporarily, as I have now experienced a return of red itchy skin  on my face and neck twice when I have tried to stop taking Benadryl.
pt described rash at injection site that was raised followed by rash on trunk area as well as right arm. Pt used triamcinolone cream for rash on trunk and right arm and went away in 24 hours. Swelling and rash at injection site also went away after 48 hrs of injection.
I am two days out from having the booster, starting the night of the vaccine, had such pain it was difficult to find a position to sleep and get comfortable to even stay asleep. The pain was an 8/10. By the next morning around 7AM I took two Aleve, there was no improvements, so I took a 1,000 mg of Tylenol and still felt no relief. I contacted my doctor to see about getting pain medication because the pain was so bad. I had 1 600mg ibuprofen left already at home that I had from something previously. I took that and it helped me tremendously and carried through the evening. That night I took 2 more Aleve to help me sleep through the night. As of today, my lymph nodes under my arm are swollen and it hurts to touch under my arm. The pain today is about 7/10, I took 3 Aleve about 7:45AM and it has helped me today. The pain still hurts but if I sit still and don't move the pain if very tolerable and doesn't hurt much at all. I cannot put my left arm all the way down because it puts pressure under my arm, and it hurts. I am limited as to what I can do because of the pain.
Client received vaccines at clinic. Client left the clinic showing no signs of swelling. Approx 3-3.5 hours later client noticed swelling on right side of lips. The swelling progressed to left side. Client went to the ER. Per her report she received BENADRYL & "a steroid."
Post vax, the pt was prescribed a 10 day course of amoxicillin for the treatment of sinusitis at the time of IZ. On 3/27/2000, he returned to the MD's office after he developed a fever, rash on trunk and extremities, cough, congestion and two loose stools. The rash was described as initially small red dots, then progressed to a large area with itching. On 3/28/2000, he was hospitalized where a dx of serum sickness was made. Follow-up information received on 4/25/00 indicated that the pt developed an urticarial rash, fever, and swelling of the feet and was hospitalized. He was treated with Solu-Medrol and his symptoms rapidly improved.
Narrative: Back of neck swelling x up to 42 days post 2nd dose.
Information has been received from a physician concerning a 20 year old female patient who was vaccinated with a third dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). On 26-JUN-2007, the patient developed a rash, itching and redness at the injection site. Unspecified medical attention was sought, At the time of this report, the patient's outcome was unknown. It was reported that the patient did not have this experience with the first and second dose. No product quality complaint was involved. Additional information has been requested.
PEDVAX HIB had a temperature excursion and was administered; This spontaneous report was received from a nurse referring to a 6-month-old patient of unknown gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 19-FEB-2021, the patient was vaccinated with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot # T020614 with an expiration date on 12-MAR-2023) (strength, dose, anatomical location, and route of administration were not reported) for prophylaxis which had a temperature excursión of 34.5 degrees Fahrenheit (°F) for 29 minutes (product storage error).      There were previous temperature excursions of 34.2 °F and 35.4°F for 15 minutes which was recorded by a data logger.  No product quality complaint (PQC) reported.
Patient reported swelling in right arm from elbow to wrist starting the day following Prevnar20 vaccination.
undiluted vaccine was administered, so the patient received more concentration of the vaccine than that was authorized; undiluted vaccine was administered, so the patient received more concentration of the vaccine than that was authorized; This is a spontaneous report from a contactable pharmacist. A 30-years-old female patient received unspecified dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: FF2588; Expiration Date: Dec2021) via an unspecified route of administration on unspecified date (at the age of 30-years-old) in arm left as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The Patient had not used other products. On unspecified date, the patient experienced undiluted vaccine was administered, so the patient received more concentration of the vaccine than that was authorized. Pharmacist stated, so he was told to call this number as he is working in Walgreens Pharmacy right now and one of her technician administer a dose of Pfizer vaccine that was undiluted. On paraphrasing the concern: Pharmacist stated, my concern is that the undiluted vaccine was administered, so the patient received more concentration of the vaccine than that was authorized." Vaccine: Pfizer, Covid-19 Vaccine. Pharmacist was informed about the role of Pfizer Drug Safety. Pharmacist stated, where are you at. Pharmacist was informed that this is the global routing system and call landed to India. Age at the time of event: Pharmacist stated, 31 (further not clarified) Height and Weight: Pharmacist stated, he don't have it. Anatomical site of vaccination: Pharmacist stated, Left Arm. Other medication condition: Pharmacist stated, No they were not suffering from any other medical condition. Concomitant medication: Pharmacist stated, "No, not that he can see. Lab test: Pharmacist stated, he don't know, he don't think so. (further not clarified) Treatment: Pharmacist stated, Not that he aware of. Pharmacist stated, Are you a Pharmacist? he was trying to get for information in terms of what he want to tell this patient, in terms of like what if she would be concerned about or if there was a reason to be concerned about it taking 5 times the recommended dosage and he wondered if she has any, in terms of like concerns the patient may have about taken 5 times the dosage of you know of the vaccine like what they need to know in terms of the next dose right. Whether they should wait until they take their next dose or in terms of things to be concerned about in terms of just the experience right now what they might could get. So question was in terms of patient counselling. Do you know anywhere else he would to go where he can get this information. Pharmacist was informed about the Pfizer Medical Information Department.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events Overdose and Product preparation error cannot be excluded.