chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hidradenitis suppurativa; This is a solicited report based on information received by Pfizer from Manufacturer (Manufacturer Control Number: 21K-163-3939738-00) from a contactable 69-year-old female Consumer reported for herself.   A 69-year-old female patient received first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneous from 2019 (Batch/Lot number was not reported) and ongoing, at 40mg/0.4ml, cyclic (Citrate free,40mg 1 in 2 weeks) for Moderate to severe adult Crohn's disease. Medical history included alcohol use/beer, wine, occasionally from 1969 to 2019, tobacco use/six cigarettes per day from 1971 to 1971, hip replacement, high blood pressure, high cholesterol, thyroid disorder (unspecified thyroid medication that was part of her concomitant medications). Concomitant medications included lisinopril taken for high blood pressure; atorvastatin calcium (LIPITOR) taken for high cholesterol and unspecified thyroid medication that was part of her concomitant medications. The patient experienced hidradenitis suppurativa on 07Apr2021. On 27May2021, she had outpatient surgery for cysts on buttocks that were actually Hidradenitis suppurativa. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient underwent lab tests and procedures which included colonoscopy: unknown results on 07Apr2021, computerised tomogram: unknown results on unknown date, magnetic resonance imaging: unknown results on unknown date. The action taken in response to the event for adalimumab was dose not changed. The outcome of event was recovering.  Causality about adalimumab for event Hidradenitis suppurativa as per reporter (Drug/Vaccine): Not assessable; Causality as per Mfr.(Drug/Vaccine): No reasonable possibility; Causality about BNT162B2 for hidradenitis suppurativa as per reporter (Drug/Vaccine): Not Related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: In agreement with the reporter, the Company deems the reported Hidradenitis suppurativa unrelated to COVID 19 vaccine, BNT162B2.
Right arm hurts really bad; Right shoulder hurts; Right neck hurts; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: ER8731), via an unspecified route of administration, administered in Arm Right on 15Apr2021 09:30 (at the age of 54-years-old) as a single dose for covid-19 immunization. Medical history included ongoing diabetes mellitus - diagnosed 15 years ago, lower limb fracture -in a wheelchair because she broke her leg that had nothing to do with the Pfizer Covid 19 vaccine. Stated that she got the Pfizer Covid 19 vaccine after she broke her leg. Concomitant medication(s) included insulin aspart (NOVOLOG) taken for diabetes mellitus. On 15Apr2021 12:30, the patient had first shot 13 days ago, her right arm hurts really bad. Stated also her right shoulder and right side of her neck hurts. Stated that she is supposed to get it on 06 May. Stated that she is getting the second one and wanted to know if she should get it in the same arm. Patient is very grateful for the vaccine. Stated that her right arm, shoulder and neck started hurting in the first 3 hours. The adverse event did not resulted in any visit emergency room or physician office. Outcome of the event right shoulder hurts was unknown and rest was not recovered, at the time of this report. No follow-up attempts are needed. No further information is expected.
The morning after the injection, I did not feel well, but was able to do regular activities. As the day progressed, symptoms did as well and it became a chore to do anything.  By 24 hrs after injection, I had a fever of 101.2, a severe headache, was shivering and extremely fatigued. I took 600mg ibuprofen, went to bed, and woke up without symptoms. I was warned this could happen, but I am reporting these adverse events because the literature I was given stated that this happens to 1 in 6 individuals, and were more common in younger people. Perhaps that ratio needs to be revised, and the definition of "younger people" needs definition (I am only 3 weeks shy of turning 60).
HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXIA
Patient developed erythematous maculopapular rash diffusely over chest/neck (rest of body not exposed due to patient being wheel chair bound and limitations of quadriplegia and concerns for lowering patient's seizure threshold).  Patient was monitored for several minutes and did not improve, so Epinephrine 0.3mg IM to left arm was given.  Symptoms improved, but decided to give loratadine 10mg via g-tube 5-10 minutes later.  Patient's symptoms completely resolved at time of entry of this note, has not been discharged from clinic yet.
Pain-loss of use of left arm-breathing shallow-lots pain-arm-neck-head. Hospital.
I am allergic to penicillin, and indoor and outdoor mold.  My 1st dose caused a golf ball sized knot and baseball sized red rash.  This lasted 5 days and just now went down.  Benadryl, did not help
they decided not to get the 2nd primary dose. Today, 11JAN2023, Five months after the first primary dose; The next day the baby tested positive for COVID; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (The next day the baby tested positive for COVID) and PRODUCT ADMINISTRATION INTERRUPTED (they decided not to get the 2nd primary dose. Today, 11JAN2023, Five months after the first primary dose) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jul-2022, the patient experienced COVID-19 (The next day the baby tested positive for COVID). On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (they decided not to get the 2nd primary dose. Today, 11JAN2023, Five months after the first primary dose). At the time of the report, COVID-19 (The next day the baby tested positive for COVID) had resolved and PRODUCT ADMINISTRATION INTERRUPTED (they decided not to get the 2nd primary dose. Today, 11JAN2023, Five months after the first primary dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PRODUCT ADMINISTRATION INTERRUPTED (they decided not to get the 2nd primary dose. Today, 11JAN2023, Five months after the first primary dose) to be not related. No further causality assessment was provided for COVID-19 (The next day the baby tested positive for COVID).    No concomitant medication was provided by reporter.  A 3-year-old patient received 1 primary dose of Moderna COVID-19 vaccine in 06JUL2022 from a blue cap magenta border vial. The next day the baby tested positive for COVID (not confirmed), so they decided not to get the 2nd primary dose. Today, 11-Jan-2023, Five months after the first primary dose.  No treatment medication was provided by reporter.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with improperly stored PEDVAXHIB (strength, dose, frequency and route were not reported) lot # L012835 with an expiry date of 11-MAR-2018. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. This is one of the several reports received from the same reporter. Additional information has been requested.
Frequent urination; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Frequent urination) and VACCINATION SITE PAIN (soreness at the injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). On 02-Feb-2021, the patient experienced POLLAKIURIA (Frequent urination). At the time of the report, POLLAKIURIA (Frequent urination) and VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
18:50 Patient receives vaccine 18:51 Patient arrives in the observation area accompanied by her mother and the nurse assigned to the observation area who explains to both the patient and her mother that the patient will be observed for fifteen minutes and explains the common side effects and what to do should any of them occur in the next 24-48 hours. Both the patient and the mother verbalized understanding. 18:53  Patient signs for and receives incentive, also gets a pack of fruit snacks. 18:57 - Patient states she does not feel well and looks pale, patient was also diaphoretic. LPN monitoring the observation area approaches the young lady and she immediately slumps to the right in her chair and appears to lose consciousness.. LPN and another nurse transfer the patient from the chair to the stretcher and use a capsule of spirit of ammonia that is broken and waved under the patient?s nose and she immediately responds. 18:58 Vital signs are taken: BP-90/58, P-80, R-18, O2 sat-99-100%. Patient is verbally responsive and able to state her name and recognize her mother. Patient denies difficulty swallowing, breathing or feeling itchy. On physical observation patient does not have any redness or rash appearing on her face, neck, upper extremities or torso. Her upper extremities are warm and dry to touch. 19:03  Patient placed in an upright/seated position, denies feeling dizzy or lightheaded and is offered some water. Able to follow commands and swallow without difficulty. Monitoring continues by RN on site. Patient offered a granola bar and is able to eat without difficulty 19:06- VS taken: BP-100/60, P-101, O2 sat 100%. Monitoring continued in the observation area by RN. Patient is alert and oriented, denying any discomfort/difficulties.  19:23 ? Patient leaves the observation area/clinic accompanied by her mother after informing and instructing the mother of s/s to observe for throughout the night and when to call 911 or seek medical attention. The mother and daughter verbalize understanding the information. Patient was able to ambulate without difficulty or assistance.
Patient having pronounced fever, currently 5 days with increase 103 degrees every night.  Patient also having vomiting and diarrhea x2 days now.  Fever started the day after vaccinations.
After receiving the vaccine around in the afternoon, I developed extreme body aches, fatigue, night sweats, headache, dizziness, and chills around 10pm. Along with these side effects I also developed an extreme ringing in my ears. The ringing is so constant that it's difficult to sleep and even think. The ringing has shown no signs of improvement and can best be described as a high pitch sibilant sound.
Multiple symptoms: flu-like body aches;fatigue;weakness in hands;tingling, pins and needles burning sensation in upper and lower extremities; shortness of breath at rest; heaviness in mid chest;heart racing,beating harder than normal;muscle spasms.
On multiple unspecified dates, multiple unspecified patientes received improperly stored vaccine; No adverse effect; This spontaneous report has been received from a medical assistant, concerning an 8-week-old female patient.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 11-APR-2019, the patient was vaccinated with improper stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, frequency, route of administration unknown) Lot#R016790 and expiration date 20-APR-2020 for prophylaxis. No adverse effects reported.  Additionally, temperature for vaccines were total time and highest temperature above 9°C (9.9 C); time frame: 4 hours; with no previous temperature excursion. The error was identified via a data logger. ; Sender's Comments:  US-009507513-1903USA013366:
Pt was making verbal sounds and then stopped at the age of 15 months. He developed PDD symptoms at the age of 2 years. Now he is 3 years old and is still not speaking and continues with PDD symptoms. Dx'd with PDD.
HA/pain/erythema with streaking/lymphangitis. Tx: Tylenol/Motrin prn. Keflex 250 bid x 3 days.
didn't feel well; my arm was hurting; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 76-year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: XELJANZ XR. The following information was reported: MALAISE (non-serious) with onset 2021, outcome "unknown", described as "didn't feel well"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "my arm was hurting".  Additional Information: The patient received COVID-19 vaccine a few weeks ago (2021) and then didn't feel well and her arm was hurting. She was supposed to get her second dose soon but would like to postpone it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt advised post vaccine 5 days experienced stomach pain that has continued 5 days, but has decreased each day in severity.
Patient experienced dizziness, shortness of breath, and a rapid heartbeat within 5 minutes of receiving the flu shot. Patient was taken to the emergency room where she was monitored for about 1 hour and then released.
This spontaneous report as received from a pharmacist refers to 3 patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with ZOSTAVAX, lot #L044529 with expiry date on 09-FEB-2017, (dose, strength and anatomical site were not reported). Subsequently within 24 hours, each of patients developed a swollen, red zone encircling the injection site. At the time of this report, the outcome of injection site edema and injection site erythema was reported as recovering. The relatedness between the events and vaccination with ZOSTAVAX was not reported. No product quality complaint was involved. Additional information has been requested.
Cutaneous dry treatment erythema multiform.  Rash started Sunday 3-23-08.  Patient evaluated Monday 3/24.  Started on Pediapned 5ml 2 tsp BID for 5 days.
Since the second shot, I have experienced minor hot flashes and numbness/tingling and heightened sensitivity to hot and cold on my hands and forearms, nothing debilitating, and could also Be attributed to periomenopause?
Generalized itching especially palms and scalp. Few urticarial lesions. Received influenza and meningococcal vaccine 10/18/00. No difficulty breathing. Treated with Claritin 10mg at 12:30PM and to take Zyrtec after HS for itching. Developed serum sickness 10/23/00. Treated by doctor with Prednisone, Zyrtec, Singular, Prevacol, and Benadrul
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 13-year-old male patient who received FLUARIX QUADRIVALENT (batch number 572KT, expiry date 26th May 2018). On 27th January 2018 14:30, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 28th January 2018, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain and injection site swelling. The patient was treated with BENADRYL (NOS), BENADRYL Cream. On an unknown date, the outcome of the injection site pain and injection site swelling were recovered/resolved. The reporter considered the injection site pain and injection site swelling to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The reporter was the patient's mother. The patient received FLUARIX QUADRIVALENT vaccine on right deltoid. On the next day, the patient's entire deltoid was swollen and sore. BENADRYL cream was rubbed on his arm and the symptoms were resolved after a couple of days.
26SEP98 child woke up w/raised welts, blotchy skin (uticaria per MD office);saw allergist 28SEP98 because of swollen hands, face & feet;rx clariton & lidex;
Patient with history of 3 COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "72 YO male with h/o h/o chronic obstructive pulmonary disease on intermittent use of 2 L of oxygen, tobacco abuse, small-cell lung cancer in 2017 treated with chemo and radiation, a new lung cancer about to undergo radiation therapy once bronchoscopy is performed, AFib on Eliquis, AA with graft repair, dyslipidemia, PVD, chronic back pain, BPH admitted 12/18 for generalized weakness in setting of recent COVID infection as well as hyponatremia.  Hyponatremia responded to increasing his salt tablets from 1 g 2 times a day to 2 g 3 times a day to get him back to his baseline around one hundred twenty-eight compared to 01/20-120 to earlier in the hospitalization.  Patient has longstanding generalized weakness from his comorbidities only worsened by COVID infection with poor oral intake during that time although oral intake during hospitalization improved to the point that were patient was eating about of his meals or more each time.  Therapies recommended skilled nursing facility as he was only able to take a couple steps with assistance and maybe later transition to a chair at bedside.  Both patient and daughter declined skilled nursing facility placement and status side to discharge to home with home care.  Will continue the salt tablets at 2 g 3 times a day and have BMP checked in 1 week (to be collected by home care).  Noted the patient did have a couple episodes of  mild confusion in the nighttime hours and I advised daughter to consider withholding oxybutynin if continues to have episodes of confusion at home.  Patient time of discharge stable on his home 2 L of oxygen and fully alert oriented and looking"
This case was reported by a consumer via call center representative and described the occurrence of abdominal pain in a 65-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. In January 2019, the patient received the 2nd dose of SHINGRIX. On 23rd January 2019, less than a month after receiving SHINGRIX, the patient experienced abdominal pain, spleen enlarged and liver enlargement. On an unknown date, the outcome of the abdominal pain and liver enlargement were not recovered/not resolved and the outcome of the spleen enlarged was unknown. It was unknown if the reporter considered the abdominal pain, spleen enlarged and liver enlargement to be related to SHINGRIX. Additional details were received as follows: The patient received 1st dose of SHINGRIX in November 2018. About 2 weeks ago from the reporting date, the patient received 2nd dose of SHINGRIX. The patient was experiencing abdominal pain. The patient's sonogram results were an enlarged liver, and an enlarged spleen which was twice its normal sized. The symptoms began about 2 weeks ago from the reporting date. The patient had computed tomography (CT) scans, blood tests, and other labs and there was nothing remarkable. Consented to follow up.
Right upper arm with 60 cm area of erythema, mildly induration increased warmth. Got Tdap 11/8/14 came in on 11/17/14 after 4 days of vaccination. Came in today 11/19/14 put her on antibiotics.
Five patients being administered doses from a vial left out overnight from 12/20/21 to 12/21/21; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Five patients being administered doses from a vial left out overnight from 12/20/21 to 12/21/21) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032h21a) for COVID-19 vaccination.     Concurrent medical conditions included Obesity, Obstructive sleep apnea syndrome, Depression and Alcohol abuse. Concomitant products included LISINOPRIL, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (DESCOVY) and ESCITALOPRAM for an unknown indication.    On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Five patients being administered doses from a vial left out overnight from 12/20/21 to 12/21/21). On 21-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Five patients being administered doses from a vial left out overnight from 12/20/21 to 12/21/21) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported. Age at vaccination: 32 years 4 months. Patient had no known drug allergies.   This case was linked to MOD-2021-422292 (Patient Link).
on top of injection site and under, arm is black and blue, blue got bigger and bigger above and below; arm is swollen; arm itched; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (on top of injection site and under, arm is black and blue, blue got bigger and bigger above and below), VACCINATION SITE SWELLING (arm is swollen) and VACCINATION SITE PRURITUS (arm itched) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 015M20A and 013L20A) for COVID-19 vaccination.     medical history was not reported by the reporter.  Concomitant products included WARFARIN, LEVOTHYROXINE SODIUM (SYNTHROID), DIGOXIN, ATENOLOL, OMEPRAZOLE, AMLODIPINE and SIMVASTATIN (SIMVASTATIN +PHARMA) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced VACCINATION SITE DISCOLOURATION (on top of injection site and under, arm is black and blue, blue got bigger and bigger above and below), VACCINATION SITE SWELLING (arm is swollen) and VACCINATION SITE PRURITUS (arm itched). At the time of the report, VACCINATION SITE DISCOLOURATION (on top of injection site and under, arm is black and blue, blue got bigger and bigger above and below), VACCINATION SITE SWELLING (arm is swollen) and VACCINATION SITE PRURITUS (arm itched) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: non significant follow up received added reporter details.
Local injection site reaction no systemic symptoms. Tx w/ antihistamine & NSAID.
Bilat numbness above knee to feet. Bilat feet with constant neuropathy and sensation of always cold when the feet are warm to touch. Stumbling mild intermittent muscle weakness bilat