chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feet pain; feet swelling; This case was reported by a consumer via call center representative and described the occurrence of foot pain in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th August 2019, less than a day after receiving Shingrix, the patient experienced foot pain and swelling of feet. On an unknown date, the outcome of the foot pain and swelling of feet were not recovered/not resolved.   It was unknown if the reporter considered the foot pain and swelling of feet to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The patient reported that, several hours after vaccination with Shingrix, experienced left foot pain and swelling. The patient stated that, next day after vaccination, experienced right foot pain and swelling. Till the date of reporting, both feets were painful and swollen. The patient did not consent to follow up.
Fatigue; Body Aches/Soreness; Chills; Swollen and Sore Tongue; Swollen and Sore Tongue; Diarrhea; Loss of Appetite; Throat swelling; Headache; Malaise; Shortness of Breath; Thick Mucus in Nose & Throat; Thick Mucus in Nose and Throat; Horseness and Sore Throat; Horseness and Sore Throat; This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on right arm on31Jan2021 08:30 at single dose for COVID-19 immunisation. Medical history included autoimmune, tachycardia, acid reflux, penicillin allergy, walnuts allergy. Concomitant medication included estradiol and levothyroxine. The patient previously took lanolin and erythromycin and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Feb2021 patient experienced fatigue, body aches/ soreness, chills, swollen and sore tongue, diarrhea, loss of appetite, throat swelling requiring 2 visits to the ER (emergency room). Culminating in Steroid injection and oral Prednisone. Headache, malaise, shortness of breath, thick mucus in nose and throat, hoarseness and sore throat. The adverse events result in Doctor or other healthcare professional office/ clinic visit and Emergency room/department or urgent care. The seriousness of the events was assessed as non-serious by the reporter. Therapeutic measurements were received for the events with steroid injection at the ER and oral Prednisone. The outcome of the events was reported as not recovered.  Information on the lot/batch number has been requested.
This spontaneous report as received from a pharmacist refers to a 31 years old female patient with Temporomandibular joint syndrome (TMJ), depression and Gastrooesophageal reflux disease (GERD). His medical history included migraines, interstitial cystitis and exercise induced asthma. The patient had delivered a baby recently. The patient developed nausea and itching (date unspecified) after taking tramadol hydrochloride. On 30-JAN-2014 the patient was vaccinated with a 0.5ml dose of PNEUMOVAX23 (lot# J013345, expiry date: 11-JAN-2015) intramuscular, location unspecified. Concomitant therapies included with Tdap (manufacturer unspecified as reported) and RHOPHYLAC. On 31-JAN-2014 the patient developed "shooting arm pain", could not grip things with her left hand, had a fever of 103.1 F and she also developed injection site redness and swelling 14 hours after receiving PNEUMOVAX23. The patient received the PNEUMOVAX23 shortly after delivered a baby. This reaction occurred while she was already in the hospital because she delivered a baby recently. The pharmacist reported as of 02-FEB-2014 the fever was gone and as of 05-FEB-2014 the patient's pain was almost gone but the pharmacist did not know the status of the patient currently. No product quality complaints (PQC). Pharmacist requested a lot check for this PNEUMOVAX23. Hydrocodone with acetaminophen (manufacturer unknown) and ibuprofen 800mg were given as the treatment. The patient's temperature was taken for measure. The events were considered as disability (temporarily) by reporter. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was administered 0.3mL instead of 0.5mL.                                                                                                  Flu vaccine was given correctly.
Immediately following injection a large raised, red, hot to the touch, rash developed and spread over arm and down thorax to midline and bottom of rib cage.
Hives appeared on day 12 post vaccination. Hives are on right arm and right shoulder blade and chest
Tenderness at injection site; swollen lymph nodes on affected injection site; swollen lymph nodes on affected injection site; fever; joint pain; migraine; This is a spontaneous report from a contactable nurse. A 40-year-old female non-pregnant patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EJ1686) intramuscularly in left arm on an unspecified date as a single dose for covid-19 immunization. The patient did not receive vaccine in four weeks. The patient's medical history included migraines, constipation, celiac disease, chronic pain r/t injury. The patient's concomitant medication included topamax, adderall, tramadol, maxalt, carprofen, oral birth control, linzess. The patient was not diagnosed with COVID prior vaccination. The patient was not diagnosed with COVID prior vaccination. Previously, the patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection), via unknown route of administration on an unknown date as a single dose for covid-19 immunization. On 25Jan2021 at 20:00, the patient experienced tenderness at injection site, swollen lymph nodes on affected injection site, fever, joint pain, migraine. The patient did not receive any treatment for the events. The patient tested to COVID-19 swab test on 28Jan2021 and showed negative. The outcome of the events was recovering.  Follow-up attempts are completed. No further information was expected.
cold tingling sensation in right hand; sore right arm; This is a spontaneous report from a contactable consumer. A 56-years-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK5730), via an unspecified route of administration on 18Dec2020 at a SINGLE DOSE (injection to right arm one time) for COVID-19 immunization. Medical history included Pencillin allergy, diagnosed with a sulfur allergy in her 20s and developed a rash (ongoing). There were no concomitant medications. The patient experienced cold tingling sensation in right hand in hand in same that had the injection, and sore right arm, few minutes after the injection on 18Dec2020. Treatment for sore right arm included, 24 hours after took ALEVE and did gentle stretching exercises. Event outcome was recovered completely on 18Dec2020. Event outcome was recovered on 18Dec2020.
patient received bivalent booster 09/22, then received another bivalent booster 12/22.
2/6/21 Sent to ER for evaluation of agitation and returned a few hours later on 2/7/21 with no acute findings. 2/7/21 continued with agitation and restlessness and had psychoactive medication changes 2/8/21 Had head CT with no acute findings 2/11/21 MRI of lumbar spine with compression fx T10 2/17/21 UA and KUB done with no acute findings Multiple falls within this time frame with escalating agitation, restlessness, and insomnia.  Dx psychosis and started on Seroquel 2/25/21 3/2/21 Patient died
Patient expired. 63 year old male with history of Ulcerative colitis (on Xeljanz and Sulfasalazine) with prior history of DVT (on Eliquis) with recent admission 1/20-2/4 due to UC flare complicated by colonic perforation who underwent total abdominal colectomy with end-ileostomy 1/28. He was discharged home but was re-admitted 2/7 due small bowel obstruction. He was also found to have portal vein thrombosis and was incidentally found to be COVID 19 positive. He was treated non-operatively with NGT and foley catheter placed in stoma. He was treated with Unasyn for possible aspiration given bibasilar infiltrates noted on CT. For COVID 19, he was started on Decadron course. Given persistent ileus/SBO, the patient was started on TPN 2/13 after RIJ CVC was placed. On 2/14 AM, the patient developed severe abdominal pain associated with decreased ostomy output, hypotension and tachycardia. He was brought to CT and was found to have increased intra-abdominal free air and increased small bowel wall thickening. On arrival to ICU he only required low dose vasopressors but quickly decompensated and was taken to OR which noted possible perforation located at the GE junction, feculent peritonitis. He returned to the ICU requiring high dose quad pressor support. Family updated and transitioned patient to comfort care. He was pronounced dead at 2050.    Medical Examiner Case Assessment Select Applicable Patient Criteria: Does not meet any of the listed criteria
Excruciating pain in testicles and surrounding area; Excruciating pain in testicles and surrounding area; Hydrocele; Headache; Nausea; Dizziness; Motion sickness; Severe Migraines; Cannot see straight or properly during migraines; This is a spontaneous report received from a contactable consumer (patient's mother) via Pfizer sponsored program. A 21-year-old male patient (son) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was Unknown and Expiration date was not provided), dose 2 via an unspecified route of administration on 28May2021 (at the age of 21-year-old) as dose 2, single for COVID-19 immunization. Medical history included Seasonal Allergies from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received first dose of BNT162B2 (Solution for injection, Lot Number / Expiry Date: Unknown) on an unspecified date in 2021 for COVID-19 Immunization. Facility where the vaccination was administered at pharmacy. Vaccine was not administered at Military Facility. Patient did not receive any additional vaccines administered on same date of the Pfizer suspect. Patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Prior vaccinations patient did not have adverse events. Reporter stated that her son got the second dose of the Pfizer Covid Vaccine on 28May2021 and experienced headaches, motion sickness, nausea, dizziness (2021) and excruciating pain in his testicles (28May2021), the same day. The reporter was asked if these were side effects associated with the vaccine. The patient stated that right after the second shot on 28May2021 he felt like something cinched up or stabbed him in the taint area, or the area around his testicles. Stated it was severe pain. He later found out he had a hydrocele (28May2021). The patient stated that he had been having severe migraines, headaches; motion sickness, nausea, and dizziness since about 2 weeks ago (2021). Stated that the symptoms keep fluctuating. It was really painful and bad then ease off. Stated the migraines become so painful he cannot see straight or properly (2021). The patient did not have his vaccine card available. He did not have any information on the date of his first dose of the Pfizer Covid Vaccine or on the Lot numbers of his vaccines. The patient's mother asked if her Lot Number would be the same since they got their vaccines at the same place and then call handler informed her that they could be different. Denied any medications, labs, or treatments relevant to report. Stated he went to the emergency room and they did an ultrasound and they saw fluid; that is when he learned he had a hydrocele. Time the vaccination was given, and anatomical location of Pfizer vaccine was not provided. Patient visited emergency room and physician office for excruciating pain in testicles and surrounding area. There was investigation assessment. The events were assessed as non-serious. The outcome of events was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
My sense of taste and smell has become distorted. I never tested positive for COVID-19 or had any symptoms of the virus at all, which is what makes this change in taste and smell so weird. I did not lose my sense of taste or smell, but there are many foods and smells that now either smell sickly sweet or too earthy. I hoped that this issue would resolve after getting the second dose of the vaccine, but two weeks after my second dose, I am still dealing with this side effect. It has been several weeks now and my sense of taste and smell are sometimes so distorted that it is nauseating.
MD checked pt; viral rash post MMR was dx; mom stated pt had a t101 on 8SEP92 & broke out w/red rash over entire body; rash was itchy;
Bronchospasm, dizziness, flushing (required 2 albuterol and oral steroids). Placed on 5 days oral steroids afterwards.
Night injection administered (approx 9-10 hrs after) pt began fevering temp >99.7, arm became stiff no swelling, pt reported a decrease in ability to move limb, chills, fever.
On approximately 12/18/1999, the pt received his first dose of Lymerix. 3-4 hours post vax he developed shaking chills (so much so that his teeth chattered), the pt also experienced myalgia, and arthralgia. He took ibuprofen and within one hour felt somewhat better, but not well. He then took a narcotic (probably codeine) and went to sleep. When he woke up, he felt fine and has been fine since. The most recent information reports the condition of the pt as resolved.
Crying alot, not eating well, and per mom limping alot, fever off and on up to 101 per mom a small bump noted currently no bump, no swelling but lips at times per mom. Current s/s noted by RN.
received undiluted doses of the Pfizer Biontech COVID 19 pediatric formulation; received undiluted doses of the Pfizer Biontech COVID 19 pediatric formulation; muscle pain; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 11 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Jan2022 13:09 (Lot number: FL0007, Expiration Date: 28Feb2022) at the age of 11 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 04Jan2022 13:09, outcome "unknown" and all described as "received undiluted doses of the Pfizer Biontech COVID 19 pediatric formulation"; MYALGIA (non-serious) with onset 2022, outcome "unknown", described as "muscle pain".   Additional information: The pharmacist reported the Pediatric Pfizer Covid 19 Vaccine was administered that was not mixed. He called to inquire of possible side effects after administering the Pfizer Biontech COVID 19 vaccine pediatric formulation undiluted. The NDC number of Pfizer Covid 19 Vaccine was 59267-1055-04. There were no Additional Vaccines Administered on Same Date of the Pfizer Suspect. There were no Prior Vaccinations (within 4 weeks). There were no AE(s) following prior vaccinations. The vaccination facility type was reported as Pharmacy or drug store. Prior vaccinations were none. Family medical history was none. Relevant test and specific relevant test was none. Customer received undiluted dose of Pfizer Biotech Covid-19 pediatric formulation. Preparation and administration. This following case (illegible) factors: Switching from one immunizing pharmacist to another. Miscommunication, intruption, dosing multiple task at the same time, very busy and competing demands of that day. After the error was discovered the patient was observed for over an hour and these was no adverse event(s). On 05Jan2022, the reporter called to check on the patient and his mother said these was no adverse event and the child is doing well. Spoke to the child mother again on 10Jan2022 and mother said the child has not have any adverse and doing well. "The only clinical consequence known to me is muscle pain reported to me by Pfizer/Biotech".  Follow-up (31Jan2022): This is a follow-up spontaneous report from a contactable Pharmacist. This Pharmacist reported in response to HCP letter sent that included:  Updated information: Product concentration EUA tris and product indication was updated, New event 'muscle pain' added. Time of vaccination updated. Route of administration added. Additional information updated.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200009903 same reporter/drug/AE, different patients.
Narrative:  82yo male patient died on 01/10/22 from distal esophageal adenocarcinoma (cancer). Pt had received covid vaccines on 1/22/21, 2/24/21, & 9/7/21. This death is not related to the covid vaccines.
1st dose early 2020, has not received dose 2; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in early 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 27-JUNE-2022 The reporter stated that patient had not received dose two. The reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. This was one of 4 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020193859:Same reporter US-GLAXOSMITHKLINE-US2020193848:Same reporter US-GLAXOSMITHKLINE-US2019058222:Same reporter
Initial information received on 18-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA264048 (same reporter). This case involves a 09 years old female patient who received 0.5 mL dose of vaccine FLUBLOK QIV, lot QFAA1805, expiry date- 02-06-2019 via unknown route in the right deltoid (Frequency-once) on 18 Sep 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient had no Concomitant medications. It was an actual medication error due to Inappropriate age at vaccine administration. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
pt recv vax 16OCT96 & pt exp red, swollen, tender area @ inj site which was the size of a fifty cent piece;
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 06-SEP-2012, the patient was inoculated with ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) at a clinic, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated (by unspecified healthcare professional) at the clinic, for a persistent vesicular rash, which was diagnosed as chronic herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
LOSS OF TASTE; LOSS OF SMELL; COLD SYMPTOMS; FLU-LIKE EFFECTS; HAVING DIFFICULTY TAKING FULL BREATHS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included exposure to covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced loss of taste. On MAR-2021, the subject experienced loss of smell. On MAR-2021, the subject experienced cold symptoms. On MAR-2021, the subject experienced flu-like effects. On MAR-2021, the subject experienced having difficulty taking full breaths. Laboratory data included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like effects, had not recovered from loss of taste, and loss of smell, and the outcome of cold symptoms and having difficulty taking full breaths was not reported. This report was non-serious. This case, from the same reporter is linked to 20210345873.
Pt reported a sore shoulder a few hours after administration. Today reports a "sore shoulder and that's it" on 9/28/21
vitals were 155/104, HR 59 and SP02 94% at 11:37. Patient was getting ready to leave after waiting 15 minutes. patient walked to bathroom and started with chest tightness and SOB. Chest discomfort is rate 1/10, no HTN hx. Patient has hx of panic attacks. 1141 patient states the SOB of breath is better than it was when he was walking to the bathroom. Vitals were repulled at 157/98, HR 91. at 11:47 patient denies chest pain and SOB at time. patient having full sentence conversations and laughing. kept for 15 minutes and repeated BP last time: 1208 PB at 139/95, HR 88.
As expected, my left arm was very sore the day following the vaccination. However, since then, my arm has gotten very painful, especially from the shoulder to the elbow. I cannot raise the arm,have limited range of motion, sometimes tingling, needles and pins. For about 10 days, the underarm, the armpit, turned red, black and blue and bruised looking. This has begun  to subside. But the pain continues to increase.  I have seen my personal physician twice and have had a shoulder X-ray,a neurological exam of the arm, also a vascular ultrasound.  I am still waiting for an appointment with an orthopedic specialist.
Headache, Myalgia, Arthralgia & ErythemaMultiform Narrative: