chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2009, the patient was inoculated with ZOSTAVAX by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. The patient was treated by a healthcare provider for shingles in 2012. The lawyer reported that as a direct and proximate result of the ZOSTAVAX vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death - aggravation of preexisting conditions and activation - of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
The patient experienced swelling and redness around the injection site. The affected area was 4"x6".
Patient received expired Moderna Covid-19 vaccine(0.25 mL); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine(0.25 mL)) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     It was unknown regarding allergies (medications, food, and other products). Reported unknown if patient ever had COVID positive test or diagnosis and stated unknown history related to mentioned adverse event and both acute and chronic illnesses at the time of vaccination. Unknown if patient received other vaccines given within 1 month prior to Moderna COVID-19.  .     On 29-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine(0.25 mL)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine(0.25 mL)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  The vial was initially stored in the refrigerator on 30Mar2022. Patient received 2nd booster dose on 29Apr2022.  It was reported unknown that the adverse event cause patient to seek medical care (office visit, Urgent care, ER, hospitalized): Unknown the patient has experienced a similar event in the past.  The vial did not undergo any temperature excursion.   No treatment medications was provided by the reporter.   This case was linked to MOD-2022-555070 (Patient Link).
About ten hours after the vaccine I started feeling like head-achy - pretty painful, couldn't sleep. Full body aches. All of my face got puffy and sinuses got swelled and headache and mild fever. This was the first vaccine. Body aches dissipated within about 3 days. The pain from the nerve pain continued throughout my right arm - remedial nerve pain - for about an entire week. The second vaccine (02/21/21 030M20A) as well as the booster (date unknown) I had the same issues with exception of the nerve pain. I did not see a healthcare provider. My mother is a retired nurse and she supported me.
COVID 19 Treatment; COVID 19 Treatment; Dose #3: Johnson and Johnson / Dose #2: Pfizer / Dose #1: Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Dec2020 as dose 1, single (Batch/Lot number: unknown) and on 01Jul2021 as dose 2, single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 01May2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01May2022, outcome "unknown", described as "Dose #3: Johnson and Johnson / Dose #2: Pfizer / Dose #1: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (03Feb2022) Positive, notes: positive 02Dec2022 - 12Dec2022; (01Dec2022) Negative, notes: Tested negative after exposure through 01Dec2022; (02Dec2022) Positive, notes: positive 02Dec2022 - 12Dec2022; (04Dec2022) Positive, notes: positive 02Dec2022 - 12Dec2022; (05Dec2022) Positive, notes: positive 02Dec2022 - 12Dec2022; (06Dec2022) Positive, notes: positive 02Dec2022 - 12Dec2022; (07Dec2022) Positive, notes: positive 02Dec2022 - 12Dec2022; (08Dec2022) Positive, notes: positive 02Dec2022 - 12Dec2022; (09Dec2022) Positive, notes: positive 02Dec2022 - 12Dec2022; (10Dec2022) Positive, notes: positive 02Dec2022 - 12Dec2022; (11Dec2022) Positive, notes: positive 02Dec2022 - 12Dec2022; (12Dec2022) Positive; (14Dec2022) Negative, notes: Tested negative on 14Dec2022; (16Dec2022) Positive, notes: Tested positive again on 16Dec2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 05Dec2022 to 09Dec2022 for the treatment of COVID-19. Infection started 02Dec2022. Tested negative after exposure through 01Dec2022 positive 02Dec2022 positive 02Dec2022 - 12Dec2022. Symptoms resolved after initial infection on 10Dec2022. Cough and congestion came back on 14Dec2022. Tested negative on 14Dec2022 and then tested positive again on 16Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
patient presented to emergency department 6/12/2021 after testing positive 6/7/2021 (approximately 6 months after completing Pfizer mRNA vaccine series). He describes feeling generally unwell, difficulty sleeping and difficulty moving left upper extremity. Neurology and infectious disease consulted; ruled out stroke/TIA and treated with dexamethasone even though not requiring supplemental oxygen.
On an unspecified date, the pt received her 1st dose of Engerix-B without adverse event. On 7/13/01, at 08:00, the pt received her 2nd right deltoid dose of Engerix-B. Two hours later, the pt reported severe dizziness, injection site pain, nausea and chills. She was brought to the clinic where her blood sugar was found to be 55mg/dl at 08:00 and 51mg/dl at 10:00. She was treated with Benadryl and 5% dextrose and 1/2 normal saline. The pt did eat prior to receiving her 2nd dose of Engerix-B. The pt was now sleeping. As of 7/13/01, the adverse events were resolving.
pt recv vax 28DEC95 & 30DEC95 pt exp exquisite tenderness over the lt medial elbow & a small, palpable nodule in the same location;pt exp tenderness under the arm w/lymph node enlargement;29JAN96 pt tenderness under arm persisted;
Information has been received from a health professional concerning a 72 year old female with no drug allergies who on 10/15/2002 was vaccinated with hepatitis A virus vaccine inactivated.  It was reported that the vaccine had expired on 05/27/2002.  The patient did seek medical attention.  It was also reported that a 75 year old male was vaccinated with hepatitis A virus vaccine inactivated that had expired (WAES# 0301USA01140).  Additional information has been requested.
Patient had an eye infection first and then he developed pityriasis rosacea (diagnosed by the child's pediatrician) rash was treated with a topical cream (containing nystatin and a corticosteroid). Rash has not yet resolved.
Information has been received from a physician concerning a female patient who in approximately September 2002, was vaccinated with a dose of pneumococcal vaccine 23 polyvalent.  In approximately September 2002, the patient developed cellulitis at the injection site.  The patient was treated with antibiotics.  It was also reported that one male patient developed cellulitis at the injection site (WAES # 0212USA00380), one female patient developed cellulitis at the injection site in the left arm for two days (WAES # 0302USA00556), and one female patient developed cellulitis at the injection site (WAES # 0211USA02439).  The symptoms of two of the patients cleared up without event.  Two patients were seen over the weekend within "a day or two of injection" and at the time of this report follow up had not occurred.  Additional information has been requested.
She states she had the Pfizer COVID-19 Vaccines and COVID-19 Vaccine booster/ tested positive with COVID; She states she had the Pfizer COVID-19 Vaccines and COVID-19 Vaccine booster/ tested positive with COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EW6202/EN6202), on 31Mar2021 as dose 2, single (Lot number: EP6955) and on 26Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 71 years, in arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: METAMUCIL [PLANTAGO OVATA]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jun2022, outcome "not recovered" and all described as "She states she had the Pfizer COVID-19 Vaccines and COVID-19 Vaccine booster/ tested positive with COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: all tests were negative; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Caller was calling in regards to Paxlovid. She came down with COVID and tested positive Saturday and started Saturday night on Paxlovid.  She did not take last night's dose. She was not at high risk for hospitalization and was told her lungs and blood pressure was good and had no fever. She would like to discontinue the Paxlovid and wants to know the risks of stopping Paxlovid.  She states she had the Pfizer COVID-19 Vaccines and COVID-19 Vaccine booster and had no problems. She took the Advil but took none on Saturday and did not start the Advil before the Paxlovid. Caller confirms she was taking no medications while taking Paxlovid and was taking no medications in the 2 weeks prior to starting the Paxlovid. Caller states no medical conditions or test results but had a viral infection several weeks ago and was tested for COVID, Strep, and the Flu but all tests were negative. She states her daughter caught COVID and she was staying with her daughter right now.  AE(s) did not require a visit to emergency room visit or physician office. She went to the minute clinic to get Paxlovid. Prior Vaccinations (within 4 weeks) there was no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). AE(s) following prior vaccinations was none. She didn't get sick with the COVID-19 Vaccines.
Nausea, Vomiting, body aches which started in the evening after vaccination. Then later in the evening she developed numbness and tingling in the toes. Patient had previously dealt with several months of numbness, tingling, and neuropathic pain in her left leg and left arm which eventually improved after a course of steroids and had been resolved for several months prior to vaccine administration
Approximately 5-10 mins after vaccines given, pt began to experience an acute allergic & anaphylactic reaction. Wheezing with increased work of breathing. He became unresponsive & required Epi-Pen Jr (0.15 mg) admin, O2 & albuterol before transfer to ER by 911. In ER received steroids, BENADRYL, ZANTAC.
Information has been received from  a health professional concerning a female e who in 1998 was vaccinated with a dose of varicella virus vaccine live. Subsequently a titer did not show evidence  of seroconversion. Unspecified medical attention was sought. There was no product quality control complaint. Follow up infomation indicated that the vaccine was not given at this office and they do not have any additonal information. No additonal information is expected.
Severe pain in shoulder at upper arm, radiating to neck and head. Began 2-3 hours following injection,  lasted three days before easing up. Rapid pulse first two days. Nausea and stomach discomfort, loss of appetite.   Tiredness and lack of strength in limbs. Considered ER visit but decided to wait it out. These are listed as normal reactions but I felt they were way too severe and disrupted my ability to do anything for three days. Today is day five and arm/shoulder pain is gone, pulse ok now, but still have fatigue, headache, low fever and hot flashes. I am reporting the incident to my healthcare provider and the pharmacy itself.
C/o pain, ache in upper arm began 10/11/16 feeling uncomfortable to move arm. Pain in the location of admin. of flu vaccine 13 day's prior. No issues at time of vaccine. MD states tx like tendonitis with gentle ROM, ice/heat. Increase ADVIL to 800mg q 6 hours.
Reports developing a sore throat last night. Noticed pus pockets this morning; reports gargling with peroxide. Redness and pain around area of flu shot injection on LUE and edema and white patches on his uvula yesterday; localized redness noted to (L) bicep, no redness, swelling, nor white patches noted in throat/uvula. Diphenhydramine 25 mg once.
A 91-year-old gentleman with significant known history for coronary artery disease/CVA/history of B-cell lymphoma/hypertension and significant other medical history, presented to hospital due to shortness of breath; it is noted the patient was saturating at 76% on non-rebreather. The patient was desatting despite being on non-rebreather and therefore it was requested that the patient be transported to the ER. He was evaluated , was on AVAP 80%, alert, however, unable to fully follow any commands. He was placed on AVAP and his oxygenation/pulse ox increased to 90%.  Lab workup showed hypernatremia/acute renal failure/lactic acidosis with a D-dimer of more than 10,000. Transitioned to hospice care.
Fever 102.2 3.5 hours after 15 mo vaccines, would not walk for 1.5 days, vomited x 1 4 hours after vaccines, loose green smelly stool x 1, fussiness x 3 days. Treatment Acetaminophen and Ibuprofen. Fever on and off x 3 days.
My white blood count went down when I got my Covid shot; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration, on 11Jun2019 (as reported), at the age of 66 year old, as unknown dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included palbociclib (IBRANCE). It was reported that the patient's white blood count went down when she got her COVID shot. The outcome of the event was unknown.   Information about batch/ lot number has been requested.
Patient with 3 COVID vaccinations who admitted to hospital with COVID detected test.  Provider d/c note:  ""68 YO male history of hypertension, diabetes presented after being called back by the ER due to positive blood cultures from prior ER visit.  He reported fatigue, sore throat, cough that prompted his ER visit.  He was found to be COVID-19 positive and admitted for further evaluation of positive blood culture.   During his stay, blood culture revealed Kocuria Kristinae, likely skin contaminant.  Patient received 3 days of IV vancomycin while awaiting identification of bacteria.  Discuss case with Infectious Disease team who agrees that this is likely contamination.  Patient was nonseptic appearing and has been afebrile.  He has chronic left heel wound that was treated by wound care.  Patient discharged home with close follow-up with PCP"
(06/17/2021) In the morning I had Dizziness , Nausea, Tunnel vision, Details on memory foggy/lost. Only lasted a few hours. Discovered thru Echo's that she had arrhythmia. To be scheduled for further testing w/cardiologist.
Patient's right upper arm became infected shortly after I gave ADACEL shot on 11/27/11. She came to pharmacy to show me on 11/30/11. I thought it was adverse reaction, but she went to the hospital & was diagnosed with bad infection.
A dose was withdrawn and given to patient from the vial which was out for more than > 12 hrs; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose was withdrawn and given to patient from the vial which was out for more than > 12 hrs) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose was withdrawn and given to patient from the vial which was out for more than > 12 hrs). On 07-May-2021, EXPIRED PRODUCT ADMINISTERED (A dose was withdrawn and given to patient from the vial which was out for more than > 12 hrs) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   No treatment information was provided.
Beginning the evening after the injection (2/12/21), she experienced soreness in the left arm (site of injection) as well as warmth and swelling in her left hand.  She tried acetaminophen for pain and ice.  She called the pharmacy and spoke with me on 2/15/21.  At that time, her arm was not sore but her hand was still sore and swollen.  I notified her doctor who also recommended she use ice and heat and notify the clinic if not improved in the next several days.
Pt recvd 1st dose of Engerix-B 19JUN91 & the same day 19JUN91 pt exp h/a of short duration & was flushed; 19JUL91 pt recvd 2nd dose of Engerix-B & 1/2 hr p/exp h/a, stiff neck & was flushed;
Vaginal bleeding/spotting/menstruation: on hormonal IUD and don't normally have any sort of period, but started spotting ~24 hours after 2nd dose of COVID vaccine. Associated with headache and cramping
LICHEN PLANUS (NOW STARTING TO SCAR FROM THE RASH); This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced lichen planus (now starting to scar from the rash). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lichen planus (now starting to scar from the rash). This report was non-serious.
The second night after my 2nd Pfizer vaccine, my left upper arm hurts, but then there was radiating numbness to my forearm and all the way to the left hand ring finger. I was scared because all of a sudden I didn't have strength, and it hurts to put my hand in a fist and I couldn't squeeze dishwasher soap. It went on the second day, and my right arm felt numbing too. Occasionally, now it's once in awhile with weakness.
Hives on arm, leg and abdomen. Dizziness and weakness. Rapid heartbeat
Patient did not have any adverse events. These vaccines were given 3 weeks after the previous set of vaccines, which has caused them to be invalid.
Patient reported slight tongue swelling and "tingly and numb" lips after 1st dose of Pfizer. Patient transported clinic, patient was given water to swallow, lips continued to be "tingly", 25mg of Benadryl was given by mouth by ENT. At 2pm patient stated lips were no longer tingling and was ready to go.   BP 127/76, HR 108, O2 95%, Temp 97.9 F. Patient was picked up by Friend.
Information has been received from a health professional concerning a 22 year old female with amoxicillin allergy and no medical history who on 12-JUL-2007 was vaccinated IM with a first 0.5 ml dose of Gardasil (lot# 657736/0389U).  Concomitant therapy included TRINESSA.  On 14-JUL-2007, the patient experienced prolonged soreness in her arm.  It was noted that the patient did not have a lump at the injection site just soreness and pain and it was not constant.  It pained her when she moved her hand up and down.  The patient began to take DIFLUCAN for a yeast infection (onset date unknown).  At the time of this report, the patient had not recovered from soreness and pain in her arm and the outcome of yeast infection was unknown.  No product quality complaint was involved.  Additional information has been requested.
21 month old twin girls received pneumococcal vaccine; Literature report:   This literature marketed report has been received from authors of the literature article entitled as stated above.   This report referred to a 21 months old female patient born at 35 weeks with 22q11.21 microduplication syndrome. The patient had aryngomalacia and congenital heart disease including patent ductus arteriosus (PDA) and pulmonary artery sling s/p repair at 3 months of age which was well tolerated. On an unknown date, the patient was vaccinated with diphtheria vaccine, hib vaccine and tetanus vaccine. The patient had slight speech delays. The patient was healthy without history of recurrent infections and was up to date on vaccines including live virals. No other physical abnormalities such as cleft lip or palate or known electrolyte abnormalities.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, strength, route, lot# and expiration date were unknown) for prophylaxis (product administered to patient of inappropriate age.).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports obtained from the same literature (2203USA000036).; Sender's Comments:  US-009507513-2203USA000036:
Unbearable arm pain. Patient was injected into the same arm that was recently fractured. Pt went to the hospital due to the pain.