chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lips are still swollen; tongue is still numb; she has no feeling in her mouth and cheeks; lymph nodes in her neck got swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (002191).  A female patient received bnt162b2 (BNT162B2), administration date Jun2021 (Batch/Lot number: unknown) as dose 1, single and administration date Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Cardura has been able to regulate her blood pressure. The patient's concomitant medications were not reported. The following information was reported: LIP SWELLING (non-serious) with onset 2021, outcome "not recovered", described as "lips are still swollen"; HYPOAESTHESIA ORAL (non-serious) with onset 2021, outcome "not recovered", described as "tongue is still numb"; HYPOAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "she has no feeling in her mouth and cheeks"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovered" (2021), described as "lymph nodes in her neck got swollen".  Additional information: It was reported that brand Cardura has been able to regulate her blood pressure as she has reactions to the generic because of fillers. She's never had pain in her arm like other people. Her lymph nodes in her neck got swollen, but it's now dissipated.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
devel diffuse hives 24hr p/vax;hives still present 28OCT;saw MD tx w/DPH;
I experienced early morning subjective fevers and documented fever (99.8) and chills. Mild to moderate myalgias. I also experienced acute weakness and lightheadedness and suffered a vasovagal syncope that morning. I now have a tension headache throughout the day.
Report received from a consumer on 14-Dec-2009.  An adult female patient received H1N1 vaccine, lot number 00349611A by intra-muscular injection for immunization on 03-Dec-2009.  On 05-Dec-2009, 2 days post-vaccination, the patient felt like she was going to pass out, hearing was muffled, she was pale and experienced tunnel vision.  The patient reports she recovered on the same day (05-Dec-2009).  The company considers events possible to PANVAX administration, however, pending follow-up information.  Information derived from this AE report does not change the current safety profile of the product.  Follow-up information received 21-Dec-2009.  Patient provided age as 27 years.  Concomitant medication: Levonorgestrel and Ethinyl Estradiol for birth control.  On 05-DEC-2009 at approximately 10:00 AM, the patient (also reporter) developed tunnel vision, hearing loss and could not speak.  The events lasted approximately 5 minutes.  The patient outcome is recovered.  The patient did not notify her PCP (primary care physician).  No further information is expected.  Batch review request received for 00349611A on 29-DEC-2009.  On completion of this investigation, it has been determined that all deviations related to the manufacture of this lot were assessed as having no impact on product quality.  All QC testing was satisfactory with no out of specification results reported.  There are no outstanding issues related to this lot that would potentially affect product quality.  In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event reported.
Arm was sore; Itchy; Swollen to the size of a golf ball / swollen to size of tennis ball; Red; A spontaneous report  was received from a nurse concerning a 61-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, arm was sore / pain in extremity, red / erythema, itchy / pruritus, swollen to the size of a golf ball, swollen to the size of a tennis ball / peripheral swelling.  The patient's medical history was not provided. Concomitant medications reported were atenolol, lisinopril- HCTZ, conjugated estrogens for drug use for unknown indication, oxycodone hydrochloride - paracetamol for pain from back surgery, gabapentin for fibromyalgia, and vitamin D for drug use for unknown indication.  On 11 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 037K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) arm was sore, red, itchy, swollen to the size of a golf ball. The events were fading but it later got worsen. On an unknown date, the patient experienced the event swollen to the size of a tennis ball.  Treatment details included diphenhydramine HCl but was not effective.  Action taken with mRNA-1273 in response to the events was not reported.   On 13 Feb 2021 the event, sore arm got resolved. The outcome of event(s), red, itchy, swollen to the size of a golf ball, swollen to the size of a tennis ball was unknown.
10AUG98 pt recv vax pt had swelling w/in 24hr which circumvented lt upper arm;pt also w/dec grade temp, redness approx 4" in length around arm;3 small pinhead size bumps on leg, neck & groin;
Began with itching and red bumps on wrists.  Patient woke up at 2:00 am on 11/3/15 with severe itching under chin, swollen eyes, and a bumpy red rash in streaks on his face.  Dr. prescribed oral and injected steroids.
Erythema multiforme, 40-50 lesions by 8/18, treated with 2 weeks of prednisone
This spontaneous report as received from a pharmacist refers to a 79 years old female patient. Patient had no pertinent medical history  but was allergic to penicillin, unspecified sulfas and KEFLEX. On 02-FEB-2015 the patient was vaccinated with ZOSTAVAX lot # K014834 and expiry: 14-DEC-2015, 0.65 ml, subcutaneous. She was taking "a lot" of unspecified concomitant medications. On an unknown date in February 2015 the patient experienced redness and swelling at the injection site after receiving the suspect vaccine. The patient sought medical attention and called the pharmacist. There was no treatment given for the events and no lab diagnostics studies were performed. The reporter was unaware of the patient's physician name. The patient did not recovered from redness and swelling at the injection site. Relatedness between the events and ZOSTAVAX was not specified. Additional information has been requested.
Few hours after immunizations, developed swelling left deltoid injection site. This is where influenza vaccine and Tdap were given. Also noted fairly diffuse joint pain, felt feverish. No rash except around injection site Saw PA-C, 11-30-11; returned yesterday because of increased size of erythema. After 1st dose of prednisone yesterday, pain and swelling decreased markedly, but they recrudesced today, worse than at onset. No dyspnea.
Within 1 week of receiving vaccines, pt developed a raised, pale line from ankle to knee, was tender initially and grad. became non tender
Left, upper arm began to swell and redness noted. Unable to move arm. Arm very painful. Chest area felt like something pulling when shot given for pain was administered by center.
It is unknown if the patient recieved a .25mL or .5mL dose of Moderna. The vaccinator at first did not remember if he had taken a 1st dose series amount. The tally sheet showed correct amount of boosters and full doses going out that day, and it was charted as patient recieving a full dose of moderna. The vaccinator reports that he was pretty sure he did the correct dose. I left that day and still do think that patient recieved the correct dose, but I have now sufficent evidence to be unsure of the dosage the patient recieved. I attempted to do a report and contact the patient today, however it was the wrong patient information I had. I have sent an email to the patient and will attempt to call her tomorrow during the day.
Super intense body aches, aspirin and naproxen sodium, after around 12-15 hours, the body aches went away.
pt recvd vax;had fever, but went away;returned 23nov to MD for febrile seizure & resp arrest; hospitalized 5 days; t 105 for 3 days; dx: viral infection;
sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 08:45 (Lot number: Er2613) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "tonsillectomy" (unspecified if ongoing); "cholecystectomy" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3. Past drug history included: Bactrim, reaction(s): "known allergies: lip itch", notes: Bactrim - lip itch is the result. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21Mar2021, outcome "unknown", described as "sore arm".  Additional information: The patient took second dose of BNT162B2 (Lot number: Ew0151) on 11Apr2021 8:45 AM in arm left and experienced with a 24-hour onset of sore arm, body aches and chill. On around 06/06 patient developed an itchy lesion on patient inner thigh believed to resemble yeast or bacterial infections. patient treated this with over-the-counter topical yeast medications. 3 weeks later patient developed lesions on both breasts also resembling what patient believed was yeast and attempted to treat it the same way, but it did not go away.  After developing more lesions on patient back, legs, breast, arms patient decided to visit a dermatologist 23Jul2021, patient had a punch biopsy completed using samples from my arm and back. These samples came back as lichen Planus on 08Apr2021. It's now aggressively widespread and not responding to treatment. The patient did not take any other vaccine in four weeks prior to vaccination. The patient's other medications in two weeks were women's multi-vitamin. The patient signed up for vaccine side effects - reporting symptoms and incorrectly selected no side effects because she thought that her lesions were yeast induced. The patient did not have COVID prior vaccination and did not test COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
9 days after I had vaccine my arm where vaccine was given has a red, raised area about 1/4 inch high that is hot and ichy.  My arm hurts.  I also have a sore neck and have had that since recieving the vaccine.  I took a benadryl last night.  Red area has reduced in height but is the same size.  Iches more today.
tested positive 6 days after receiving vaccine; tested positive 6 days after receiving vaccine; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program Pfizer First Connect. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient tested positive 6 days after receiving vaccine on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the events was unknown.  Information about the batch/lot number has been requested.
she is immobilized; My balance is off, I can only walk for about of 30 seconds and I feel I'm going to fall down; difficulty in standing for just 1-2 min/could hardly get up; Can hardly walk; More than 35 days passed from the first dose; I'm in pain; Severe fatigue; This spontaneous case was reported by a consumer and describes the occurrence of IMMOBILE (she is immobilized) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PENTOXIFYLLINE, TRAMADOL, RIVAROXABAN (XARELTO) and DIGOXIN for an unknown indication.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced IMMOBILE (she is immobilized) (seriousness criterion medically significant), BALANCE DISORDER (My balance is off, I can only walk for about of 30 seconds and I feel I'm going to fall down), DYSSTASIA (difficulty in standing for just 1-2 min/could hardly get up), GAIT DISTURBANCE (Can hardly walk), PRODUCT DOSE OMISSION ISSUE (More than 35 days passed from the first dose), PAIN (I'm in pain) and FATIGUE (Severe fatigue). On 29-Apr-2021, DYSSTASIA (difficulty in standing for just 1-2 min/could hardly get up) had resolved. At the time of the report, IMMOBILE (she is immobilized), BALANCE DISORDER (My balance is off, I can only walk for about of 30 seconds and I feel I'm going to fall down), GAIT DISTURBANCE (Can hardly walk), PRODUCT DOSE OMISSION ISSUE (More than 35 days passed from the first dose), PAIN (I'm in pain) and FATIGUE (Severe fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Blood pressure medicine was also reported as a concomitant drug.  No treatment information was reported. No adverse event as Medical History was reported.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This report refers to a case of Product dose omission issue for mRNA-1273, lot # 001C21A with associated AEs; Immobile, Balance disorder, Dysstasia, Gait disturbance, Pain and Fatigue.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Significant follow up received; batch no of drug, events updated with onset dates, resolved date to one event On 10-Jun-2021: Upon internal review on 08-Dec-2022 non-significant corrections performed to update "case received from field" to blank; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This report refers to a case of Product dose omission issue for mRNA-1273, lot # 001C21A with associated AEs; Immobile, Balance disorder, Dysstasia, Gait disturbance, Pain and Fatigue.
Pt incorrectly received expired Pfizer dose on 12/1/21. Staff contacted Pfizer to inquire if lot of vaccines were still viable at time of vaccination. Following discussion with Mfr,  pt did not need to be revaccinated as Pfizer Mfr had stability data to support this excursion for 1 day post expiry from manufacturing data.
Redness and swelling left uppr arm, pain to left side of ribs.  Vaccine was given 2/1/07 1500 and symptoms started 02/2/07 Treated with Keflex, symptoms resoloved after 2 doses.
taken to MD for skin rash 14 days /p immun & T. Started on abd, chest, arms, face red raised 1-2 cm red patches, given Benadryl by MD, lab work done, also has possible herpes simplex on face
On an unknown date, the patient got her Covid (corona virus disease) vaccine and the site was red, itchy, sore and warm to the touch.; On an unknown date, the patient got her Covid (corona virus disease) vaccine and the site was red, itchy, sore and warm to the touch.; On an unknown date, the patient got her Covid (corona virus disease) vaccine and the site was red, itchy, sore and warm to the touch.; On an unknown date, the patient got her Covid (corona virus disease) vaccine and the site was red, itchy, sore and warm to the touch.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 84 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing). Concomitant medication(s) included: ENBREL taken for rheumatoid arthritis, start date: Jan2021 (ongoing). The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE WARMTH (non-serious), outcome "unknown" and all described as "On an unknown date, the patient got her Covid (corona virus disease) vaccine and the site was red, itchy, sore and warm to the touch."  Additional information: It was reported that on an unknown date, the patient got her Covid (corona virus disease) vaccine and the site was red, itchy, sore and warm to the touch. The reporter declined consent for follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Diagnosed with acute disseminated encephalomyelitis.  Manifested as stuttering neurological symptoms, but then culminating in right-sided ataxic-hemiparesis.  Symptoms peaked about 23-24 days after onset (i.e. 03-04 Jul 2010).  Treated with IV solumedrol, and since with gradual improvement, though continues with mild residual.
No additional AE reported.; the vaccine was administered Intramuscular (IM) instead of Subcutaneous (SC); This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender.      The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 23-SEP-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # T018893 with expiration date of 02-JUN-2022, at dose of 0.5 (unit not provided), intramuscularly instead of subcutaneously (incorrect route of product administration), for prophylaxis. No additional AE reported.
I woke up after 3 1/2 hours of sleep and then every hour, peeing< > being thirsty, burning with a fever and every cell and goose bump of my body hurting. My head, my eyes, my joints, my skin, every injury I have ever had, my hands, fingers, toes, tendons, intestines. And chills. Never been this sick in years, except for when I got the first one of these. And cannot lift my arm at all. Lymph nodes sore, besides the muscles themselves. Cracking headache and shooting pains in my head. Trying to move around to make the time go by and get some things done, but absolutely sick and MISERABLE! It is really quite extreme. I never get a fever, even when I have a flu (or other immunizations)! Having a truly violent reaction to it.
MENVEO injection looked cloudy. (12-3) 3AM patient had fever/sweating/chills/headache. Temp at 9AM 102.4, gave alternating doses of APAP and Ibuprofen to get fever to 99.6 at 1045AM - continued through day. Patient also had headache, redness/swelling at FLUVIRIN site. Both arms sore. (12-4) Day 2 - night chills/sweats 2AM took 2 Xstr TYLENOL temp 8AM 101.1 alternated TYLENOL/Ibu all day general malaise. (12-4) Massive headache and sore neck, nausea, fever. Continued TYLENOL/Ibuprofen. Day 3 (12-5) temp normal, mild headache FLUVIRIN arm still red & sore feeling better though.
Experienced rapid heartbeat; difficulty breathing; This is a spontaneous report from a non-contactable consumer reporting for sister-in-law. A 57-year-old female patient received the first dose of BNT162B2 (BNT162B2, Solution for injection, lot number: EL9264), via an unspecified route of administration, on 03Mar2021 at a single dose for COVID-19 immunization. The patient did not receive any other vaccine in four weeks prior to receiving BNT162B2.  Medical history and concomitant medications were not reported. The patient was not pregnant. The patient experienced rapid heartbeat and difficulty breathing 5 minutes after receiving vaccine on 03Mar2021. The adverse events did not require a visit to emergency room of physician office/clinic. No treatment was received for the adverse events. The patient recovered from the events on an unspecified date. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
No additional adverse events reported; Caller reported that the currently 21-month-old received the first dose of VAQTA ON 19-APR-21, and the second on 28-JUL21; it was administered before the recommended interval due to the lack of immunization record at the time of administation; This spontaneous report has been received from a registered nurse, concerning a currently 21-month-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions and previous drug reactions or allergies.  On 19-APR-2021, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) (strength, vaccination scheme frequency, route and anatomical location of administration, lot number and expiration date were not reported); and on 28-JUL-2021, the patient received the second dose, 0.5 milliliters (ml) (lot number T035721, expiration date 15-APR-2022, which were determined to be valid) (route and anatomical location of administration were not reported); both as prophylaxis. The nurse stated that the second dose was administered before the recommended interval due to the lack of immunization records at the time of administration (inappropriate schedule of product administration). No additional adverse events were reported  nor product quality complain involved. . combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: T035721; expirationdate: 15-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability